Occupational Exposure to Beryllium and Beryllium Compounds, 47565-47828 [2015-17596]
Download as PDF
<![CDATA[
Vol. 80
Friday,
No. 152
August 7, 2015
Part II
Department of Labor
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Occupational Safety and Health Administration
29 CFR Part 1910
Occupational Exposure to Beryllium and Beryllium Compounds; Proposed
Rule
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
PO 00000
Frm 00001
Fmt 4717
Sfmt 4717
E:\FR\FM\07AUP2.SGM
07AUP2
47566
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
DEPARTMENT OF LABOR
Occupational Safety and Health
Administration
29 CFR Part 1910
[Docket No. OSHA–H005C–2006–0870]
RIN 1218–AB76
Occupational Exposure to Beryllium
and Beryllium Compounds
Occupational Safety and Health
Administration (OSHA), Department of
Labor.
ACTION: Proposed rule; request for
comments.
AGENCY:
The Occupational Safety and
Health Administration (OSHA) proposes
to amend its existing exposure limits for
occupational exposure in general
industry to beryllium and beryllium
compounds and promulgate a
substance-specific standard for general
industry regulating occupational
exposure to beryllium and beryllium
compounds. This document proposes a
new permissible exposure limit (PEL),
as well as ancillary provisions for
employee protection such as methods
for controlling exposure, respiratory
protection, medical surveillance, hazard
communication, and recordkeeping. In
addition, OSHA seeks comment on a
number of alternatives, including a
lower PEL, that could affect
construction and maritime, as well as
general industry.
DATES: Written comments. Written
comments, including comments on the
information collection determination
described in Section IX of the preamble
(OMB Review under the Paperwork
Reduction Act of 1995), must be
submitted (postmarked, sent, or
received) by November 5, 2015.
Informal public hearings. The Agency
will schedule an informal public
hearing on the proposed rule if
requested during the comment period.
The location and date of the hearing,
procedures for interested parties to
notify the Agency of their intention to
participate, and procedures for
participants to submit their testimony
and documentary evidence will be
announced in the Federal Register if a
hearing is requested.
ADDRESSES: Written comments. You may
submit comments, identified by Docket
No. OSHA–H005C–2006–0870, by any
of the following methods:
Electronically: You may submit
comments and attachments
electronically at https://
www.regulations.gov, which is the
Federal e-Rulemaking Portal. Follow the
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
SUMMARY:
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
instructions on-line for making
electronic submissions. When
uploading multiple attachments into
Regulations.gov, please number all of
your attachments because
www.Regulations.gov will not
automatically number the attachments.
This will be very useful in identifying
all attachments in the beryllium rule.
For example, Attachment 1—title of
your document, Attachment 2—title of
your document, Attachment 3—title of
your document, etc. Specific
instructions on uploading all documents
are found in the Facts, Answer,
Questions portion and the commenter
check list on Regulations.gov Web page.
Fax: If your submissions, including
attachments, are not longer than 10
pages, you may fax them to the OSHA
Docket Office at (202) 693–1648.
Mail, hand delivery, express mail,
messenger, or courier service: You may
submit your comments to the OSHA
Docket Office, Docket No. OSHA–
H005C–2006–0870, U.S. Department of
Labor, Room N–2625, 200 Constitution
Avenue NW., Washington, DC 20210,
telephone (202) 693–2350 (OSHA’s TTY
number is (877) 889–5627). Deliveries
(hand, express mail, messenger, or
courier service) are accepted during the
Docket Office’s normal business hours,
8:15 a.m.–4:45 p.m., E.S.T.
Instructions: All submissions must
include the Agency name and the
docket number for this rulemaking
(Docket No. OSHA–H005C–2006–0870).
All comments, including any personal
information you provide, are placed in
the public docket without change and
may be made available online at https://
www.regulations.gov. Therefore, OSHA
cautions you about submitting personal
information such as Social Security
numbers and birthdates.
If you submit scientific or technical
studies or other results of scientific
research, OSHA requests (but is not
requiring) that you also provide the
following information where it is
available: (1) Identification of the
funding source(s) and sponsoring
organization(s) of the research; (2) the
extent to which the research findings
were reviewed by a potentially affected
party prior to publication or submission
to the docket, and identification of any
such parties; and (3) the nature of any
financial relationships (e.g., consulting
agreements, expert witness support, or
research funding) between investigators
who conducted the research and any
organization(s) or entities having an
interest in the rulemaking. If you are
submitting comments or testimony on
the Agency’s scientific or technical
analyses, OSHA requests that you
disclose: (1) The nature of any financial
PO 00000
Frm 00002
Fmt 4701
Sfmt 4702
relationships you may have with any
organization(s) or entities having an
interest in the rulemaking; and (2) the
extent to which your comments or
testimony were reviewed by an
interested party before you submitted
them. Disclosure of such information is
intended to promote transparency and
scientific integrity of data and technical
information submitted to the record.
This request is consistent with
Executive Order 13563, issued on
January 18, 2011, which instructs
agencies to ensure the objectivity of any
scientific and technological information
used to support their regulatory actions.
OSHA emphasizes that all material
submitted to the rulemaking record will
be considered by the Agency to develop
the final rule and supporting analyses.
Docket: To read or download
comments and materials submitted in
response to this Federal Register notice,
go to Docket No. OSHA–H005C–2006–
0870 at https://www.regulations.gov, or
to the OSHA Docket Office at the
address above. All comments and
submissions are listed in the https://
www.regulations.gov index; however,
some information (e.g., copyrighted
material) is not publicly available to
read or download through that Web site.
All comments and submissions are
available for inspection at the OSHA
Docket Office.
Electronic copies of this Federal
Register document are available at
https://www.regulations.gov. Copies also
are available from the OSHA Office of
Publications, Room N–3101, U.S.
Department of Labor, 200 Constitution
Avenue NW., Washington, DC 20210;
telephone (202) 693–1888. This
document, as well as news releases and
other relevant information, is also
available at OSHA’s Web site at https://
www.osha.gov.
OSHA has not provided the document
ID numbers for all submissions in the
record for this beryllium proposal. The
proposal only contains a reference list
for all submissions relied upon. The
public can find all document ID
numbers in an Excel spreadsheet that is
posted on OSHA’s rulemaking Web page
(see www.osha.gov/
berylliumrulemaking). The public will
be able to locate submissions in the
record in the public docked Web page:
https://www.regulations.gov. To locate a
particular submission contained in
https://www.regulations.gov, the public
should enter the full document ID
number in the search bar.
FOR FURTHER INFORMATION CONTACT: For
general information and press inquiries,
contact Frank Meilinger, Director, Office
of Communications, Room N–3647,
E:\FR\FM\07AUP2.SGM
07AUP2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
OSHA, U.S. Department of Labor,
200 Constitution Avenue NW.,
Washington, DC 20210; telephone: (202)
693–1999; email: meilinger.francis2@
dol.gov . For technical inquiries,
contact: William Perry or Maureen
Ruskin, Directorate of Standards and
Guidance, Room N–3718, OSHA, U.S.
Department of Labor, 200 Constitution
Avenue NW., Washington, DC 20210;
telephone (202) 693–1955 or fax (202)
693–1678; email: perry.bill@dol.gov.
SUPPLEMENTARY INFORMATION:
The preamble to the proposed
standard on occupational exposure to
beryllium and beryllium compounds
follows this outline:
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Executive Summary
I. Issues and Alternatives
II. Pertinent Legal Authority
III. Events Leading to the Proposed Standards
IV. Chemical Properties and Industrial Uses
V. Health Effects
VI. Preliminary Risk Assessment
VII. Response to Peer Review
VIII. Significance of Risk
IX. Summary of the Preliminary Economic
Analysis and Initial Regulatory
Flexibility Analysis
X. OMB Review under the Paperwork
Reduction Act of 1995
XI. Federalism
XII. State-Plan States
XIII. Unfunded Mandates Reform Act
XIV. Protecting Children from Environmental
Health and Safety Risks
XV. Environmental Impacts
XVI. Consultation and Coordination with
Indian Tribal Governments
XVII. Public Participation
XVIII. Summary and Explanation of the
Proposed Standard
(a) Scope and Application
(b) Definitions
(c) Permissible Exposure Limits (PELs)
(d) Exposure Assessment
(e) Beryllium Work Areas and Regulated
Areas
(f) Methods of Compliance
(g) Respiratory Protection
(h) Personal Protective Clothing and
Equipment
(i) Hygiene Areas and Practices
(j) Housekeeping
(k) Medical Surveillance
(l) Medical Removal
(m) Communication of Hazards to
Employees
(n) Recordkeeping
(o) Dates
XIX. References
Executive Summary
OSHA currently enforces permissible
exposure limits (PELs) for beryllium in
general industry, construction, and
shipyards. These PELs were adopted in
1971, shortly after the Agency was
created, and have not been updated
since then. The time-weighted average
(TWA) PEL for beryllium is 2
micrograms per cubic meter of air (mg/
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
m3) as an 8-hour time-weighted average.
OSHA is proposing a new TWA PEL of
0.2 mg/m3 in general industry. OSHA is
also proposing other elements of a
comprehensive health standard,
including requirements for exposure
assessment, preferred methods for
controlling exposure, respiratory
protection, personal protective clothing
and equipment (PPE), medical
surveillance, medical removal, hazard
communication, and recordkeeping.
OSHA’s proposal is based on the
requirements of the Occupational Safety
and Health Act (OSH Act) and court
interpretations of the Act. For health
standards issued under section 6(b)(5) of
the OSH Act, OSHA is required to
promulgate a standard that reduces
significant risk to the extent that it is
technologically and economically
feasible to do so. See Section II of this
preamble, Pertinent Legal Authority, for
a full discussion of OSHA legal
requirements.
OSHA has conducted an extensive
review of the literature on adverse
health effects associated with exposure
to beryllium. The Agency has also
assessed the risk of beryllium-related
diseases at the current TWA PEL, the
proposed TWA PEL and the alternative
TWA PELs. These analyses are
presented in this preamble at Section V,
Health Effects, Section VI, Preliminary
Risk Assessment, and Section VIII,
Significance of Risk. As discussed in
Section VIII of this preamble,
Significance of Risk, the available
evidence indicates that worker exposure
to beryllium at the current PEL poses a
significant risk of chronic beryllium
disease (CBD) and lung cancer, and that
the proposed standard will substantially
reduce this risk.
Section 6(b) of the OSH Act requires
OSHA to determine that its standards
are technologically and economically
feasible. OSHA’s examination of the
technological and economic feasibility
of the proposed rule is presented in the
Preliminary Economic Analysis and
Initial Regulatory Flexibility Analysis
(PEA) (OSHA, 2014), and is summarized
in Section IX of this preamble,
Summary of the Preliminary Economic
Analysis and Initial Regulatory
Flexibility Analysis. OSHA has
preliminarily concluded that the
proposed PEL of 0.2 mg/m3 is
technologically feasible for all affected
industries and application groups. Thus,
OSHA preliminarily concludes that
engineering and work practices will be
sufficient to reduce and maintain
beryllium exposures to the proposed
PEL of 0.2 mg/m3 or below in most
operations most of the time in the
affected industries. For those few
PO 00000
Frm 00003
Fmt 4701
Sfmt 4702
47567
operations within an industry or
application group where compliance
with the proposed PEL cannot be
achieved even when employers
implement all feasible engineering and
work practice controls, the proposed
standard would require employers to
supplement controls with respirators.
OSHA developed quantitative
estimates of the compliance costs of the
proposed rule for each of the affected
industry sectors. The estimated
compliance costs were compared with
industry revenues and profits to provide
a screening analysis of the economic
feasibility of complying with the revised
standard and an evaluation of the
potential economic impacts. Industries
with unusually high costs as a
percentage of revenues or profits were
further analyzed for possible economic
feasibility issues. After performing these
analyses, OSHA has preliminarily
concluded that compliance with the
requirements of the proposed rule
would be economically feasible in every
affected industry sector.
The Regulatory Flexibility Act, as
amended by the Small Business
Regulatory Enforcement Fairness Act
(SBREFA), requires that OSHA either
certify that a rule would not have a
significant economic impact on a
substantial number of small entities or
prepare a regulatory flexibility analysis
and hold a Small Business Advocacy
Review (SBAR) Panel prior to proposing
the rule. OSHA has determined that a
regulatory flexibility analysis is needed
and has provided this analysis in
Chapter IX of the PEA (OSHA, 2014). A
summary is provided in Section IX of
this preamble, Summary of the
Preliminary Economic Analysis and
Initial Regulatory Flexibility Analysis.
OSHA also previously held a SBAR
Panel for this rule. The
recommendations of the Panel and
OSHA’s response to them are
summarized in Section IX of this
preamble.
Executive Orders 13563 and 12866
direct agencies to assess all costs and
benefits of available regulatory
alternatives. Executive Order 13563
emphasizes the importance of
quantifying both costs and benefits, of
reducing costs, of harmonizing rules,
and of promoting flexibility. This rule
has been designated an economically
significant regulatory action under
section 3(f)(1) of Executive Order 12866.
Accordingly, this proposed rule has
been reviewed by the Office of
Management and Budget. The
remainder of this section summarizes
the key findings of the analysis with
respect to costs and benefits of the
proposed standard, presents alternatives
E:\FR\FM\07AUP2.SGM
07AUP2
47568
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
to the proposed standard, and requests
comments on a number of issues.
Table I–1, which is derived from
material presented in the PEA, provides
a summary of OSHA’s best estimate of
the costs and benefits of this proposed
rule. As shown, this proposed rule is
estimated to prevent 96 fatalities and 50
non-fatal beryllium-related illnesses
annually once it is fully effective, and
the monetized annualized benefits of
the proposed rule are estimated to be
$576 million using a 3-percent discount
rate and $255 million using a 7-percent
discount rate. Also as shown in Table
I–1, the estimated annualized cost of the
rule is $37.6 million using a
3-percent discount rate and $39.1
million using a 7-percent discount rate.
This proposed rule is estimated to
generate net benefits of $538 million
annually using a 3-percent discount rate
and $216 million annually using a 7percent discount rate. These estimates
are for informational purposes only and
have not been used by OSHA as the
basis for its decision concerning the
choice of a PEL or of other ancillary
requirements for this proposed
beryllium rule. The courts have ruled
that OSHA may not use benefit-cost
analysis or a criterion of maximizing net
benefits as a basis for setting OSHA
health standards.1
TABLE I–1—ANNUALIZED COSTS, BENEFITS AND NET BENEFITS OF OSHA’S PROPOSED BERYLLIUM STANDARD OF 0.2 μG/
M3
Discount rate
3%
Annualized Costs
Engineering Controls ................................................................................
Respirators ...............................................................................................
Exposure Assessment ..............................................................................
Regulated Areas and Beryllium Work Areas ...........................................
Medical Surveillance .................................................................................
Medical Removal ......................................................................................
Exposure Control Plan .............................................................................
Protective Clothing and Equipment ..........................................................
Hygiene Areas and Practices ...................................................................
Housekeeping ...........................................................................................
Training .....................................................................................................
Total Annualized Costs (Point Estimate) .........................................................
Annual Benefits: Number of Cases Prevented
Fatal Lung Cancer ....................................................................................
CBD-Related Mortality ..............................................................................
Total Beryllium Related Mortality .............................................................
Morbidity ..........................................................................................................
Monetized Annual Benefits (midpoint estimate) ..............................................
Net Benefits .......................................................................................
7%
$9,540,189
249,684
2,208,950
629,031
2,882,076
148,826
1,769,506
1,407,365
389,241
12,574,921
5,797,535
37,597,325
572,981,864
2,844,770
575,826,633
538,229,308
4.0
92.0
96.0
49.5
$10,334,036
252,281
2,411,851
652,823
2,959,448
166,054
1,828,766
1,407,365
389,891
12,917,944
5,826,975
39,147,434
253,743,368
1,590,927
255,334,295
216,186,861
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Source: OSHA, Directorate of Standards and Guidance, Office of Regulatory Analysis.
Both the costs and benefits of Table I–
1 reflect the incremental costs and
benefits associated with achieving full
compliance with the proposed standard.
They do not include costs and benefits
associated with employers’ current
exposure control measures or other
aspects of the proposed standard they
have already implemented. For
example, for employers whose
exposures are already below the
proposed PEL, OSHA’s estimated costs
and benefits for the proposed standard
do not include the costs of their
exposure control measures or the
benefits of these employers’ compliance
with the proposed PEL. The costs and
benefits of Table I–1 also do not include
costs and benefits associated with
achieving compliance with existing
requirements, to the extent that some
employers may currently not be fully
complying with applicable regulatory
requirements.
1 Am. Textile Mfrs. Inst., Inc. v. Nat’l Cotton
Council of Am., 452 U.S. 490, 513 (1981); Pub.
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
I. Issues and Alternatives
Regulatory Alternatives
In addition to the proposed standard
itself, this preamble discusses more than
two dozen regulatory alternatives,
including various sub-alternatives, to
the proposed standard and requests
comments and information on a variety
of topics pertinent to the proposed
standard. The regulatory alternatives
OSHA is considering include
alternatives to the proposed scope of the
standard, regulatory alternatives to the
proposed TWA PEL of 0.2 mg/m3 and
proposed STEL of 2 mg/m3, a regulatory
alternative that would modify the
proposed methods of compliance, and
regulatory alternatives that affect
proposed ancillary provisions. The
Agency solicits comment on the
proposed phase-in schedule for the
various provisions of the standard.
Additional requests for comments and
information follow the summaries of
regulatory alternatives, under the
‘‘Issues’’ heading.
OSHA believes that inclusion of
regulatory alternatives serves two
important functions. The first is to
explore the possibility of less costly
ways (than the proposed standard) to
provide an adequate level of worker
protection from exposure to beryllium.
The second is tied to the Agency’s
statutory requirement, which underlies
the proposed standard, to reduce
significant risk to the extent feasible.
Each regulatory alternative presented
here is described and analyzed more
fully elsewhere in this preamble or in
the PEA. Where appropriate, the
alternative is included in this preamble
at the end of the relevant section of
Section XVIII, Summary and
Explanation of the Proposed Standard,
to facilitate comparison of the
alternative to the proposed standard.
For example, alternative PELs under
consideration by the Agency are
presented in the discussion of paragraph
(c) in Section XVIII. In addition, all
Citizen Health Research Group v. U.S. Dep’t of
Labor, 557 F.3d 165, 177 (3d Cir. 2009).
PO 00000
Frm 00004
Fmt 4701
Sfmt 4702
E:\FR\FM\07AUP2.SGM
07AUP2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
alternatives are discussed in the PEA,
Chapter VIII: Regulatory Alternatives
(OSHA, 2014). The costs and benefits of
each regulatory alternative are presented
both in Section IX of this preamble and
in Chapter VIII of the PEA.
The more than two dozen regulatory
alternatives, including various subalternatives regulatory alternatives
under consideration are summarized
below, and are organized into the
following categories: alternatives to the
proposed scope of the standard;
alternatives to the proposed PELs;
alternatives to the proposed methods of
compliance; alternatives to the proposed
ancillary provisions; and the timing of
the standard.
Scope
OSHA has examined three
alternatives that would alter the groups
of employers and employees covered by
this rulemaking. Regulatory Alternative
#1a would expand the scope of the
proposed standard to include all
operations in general industry where
beryllium exists only as a trace
contaminant; that is, where the
materials used contain no more than
0.1% beryllium by weight. Regulatory
Alternative #1b is similar to Regulatory
Alternative #1a, but exempts operations
where the employer can show that
employees’ exposures will not meet or
exceed the action level or exceed the
STEL. Where the employer has objective
data demonstrating that a material
containing beryllium or a specific
process, operation, or activity involving
beryllium cannot release beryllium in
concentrations at or above the proposed
action level or above the proposed STEL
under any expected conditions of use,
that employer would be exempt from
the proposed standard except for
recordkeeping requirements pertaining
to the objective data. Alternative #1a
and Alternative #1b, like the proposed
rule, would not cover employers or
employees in construction or shipyards.
Regulatory Alternative #2a would
expand the scope of the proposed
standard to also include employers in
construction and maritime. For
example, this alternative would cover
abrasive blasters, pot tenders, and
cleanup staff working in construction
and shipyards who have the potential
for airborne beryllium exposure during
blasting operations and during cleanup
of spent media. Regulatory Alternative
#2b would update §§ 1910.1000 Tables
Z–1 and Z–2, 1915.1000 Table Z, and
1926.55 Appendix A so that the
proposed TWA PEL and STEL would
apply to all employers and employees in
general industry, shipyards, and
construction, including occupations
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
where beryllium exists only as a trace
contaminant. However, all other
provisions of the standard would be in
effect only for employers and employees
that fall within the scope of the
proposed rule. More detailed discussion
of Regulatory Alternatives #1a, #1b, #2a,
and #2b appears in Section IX of this
preamble and in Chapter VIII of the PEA
(OSHA, 2014). In addition, Section
XVIII of this preamble, Summary and
Explanation, includes a discussion of
paragraph (a) that describes the scope of
the proposed rule, issues with the
proposed scope, and Regulatory
Alternatives #1a, #1b, #2a, and #2b.
Another regulatory alternative that
would impact the scope of affected
industries, extending eligibility for
medical surveillance to employees in
shipyards, construction, and parts of
general industry excluded from the
scope of the proposed standard, is
discussed along with other medical
surveillance alternatives later in this
section (Regulatory Alternative #21) and
in the discussion of paragraph (k) in this
preamble at Section XVIII, Summary
and Explanation of the Proposed
Standard.
Permissible Exposure Limits
OSHA has examined several
regulatory alternatives that would
modify the TWA PEL or STEL for the
proposed rule. Under Regulatory
Alternative #3, OSHA would adopt a
STEL of 5 times the proposed PEL.
Thus, this alternative STEL would be
1.0 mg/m3 if OSHA adopts a PEL of 0.2
mg/m3; it would be 0.5 mg/m3 if OSHA
adopts a PEL of 0.1 mg/m3; and it would
be 2.5 mg/m3 if OSHA adopts a PEL of
0.5 mg/m3 (see Regulatory Alternatives
#4 and #5). Under Regulatory
Alternative #4, the proposed PEL would
be lowered from 0.2 mg/m3 to 0.1 mg/m3.
Under Regulatory Alternative #5, the
proposed PEL would be raised from 0.2
mg/m3 to 0.5 mg/m3. In addition, for
informational purposes, OSHA
examined a regulatory alternative that
would maintain the TWA PEL at 2.0 mg/
m3, but all of the other proposed
provisions would be required with their
triggers remaining the same as in the
proposed rule. This alternative is not
one OSHA could legally adopt because
the absence of a more protective
requirement for engineering controls
would not be consistent with section
6(b)(5) of the OSH Act. More detailed
discussion of these alternatives to the
proposed PEL appears in Section IX of
this preamble and in Chapter VIII of the
PEA (OSHA, 2014). In addition, in
Section XVIII of this preamble,
Summary and Explanation of the
Proposed Standard, the discussion of
PO 00000
Frm 00005
Fmt 4701
Sfmt 4702
47569
proposed paragraph (c) describes the
proposed TWA PEL and STEL, issues
with the proposed exposure limits, and
Regulatory Alternatives #3, #4, and #5.
Methods of Compliance
The proposed standard would require
employers to implement engineering
and work practice controls to reduce
employees’ exposures to or below the
TWA PEL and STEL. Where engineering
and work practice controls are
insufficient to reduce exposures to or
below the TWA PEL and STEL,
employers would still be required to
implement them to reduce exposure as
much as possible, and to supplement
them with a respiratory protection
program. In addition, for each operation
where there is airborne beryllium
exposure, the employer must ensure
that one or more of the engineering and
work practice controls listed in
paragraph (f)(2) are in place, unless all
of the listed controls are infeasible, or
the employer can demonstrate that
exposures are below the action level
based on two samples taken seven days
apart. Regulatory Alternative #6 would
eliminate the engineering and work
practice controls provision currently
specified in paragraph (f)(2). This
regulatory alternative does not eliminate
the need for engineering controls to
lower exposure levels to or below the
TWA PEL and STEL; rather, it dispenses
with the mandatory use of certain
engineering controls that must be
installed above the action level but at or
below the TWA PEL.
More detailed discussion of
Regulatory Alternative #6 appears in
Section IX of this preamble and in
Chapter VIII of the PEA (OSHA, 2014).
In addition, the discussion of paragraph
(f) in Section XVIII of this preamble,
Summary and Explanation, provides a
more detailed explanation of the
proposed methods of compliance, issues
with the proposed methods of
compliance, and Regulatory Alternative
#6.
Ancillary Provisions
The proposed rule contains several
ancillary provisions, including
requirements for exposure assessment,
personal protective clothing and
equipment (PPE), medical surveillance,
medical removal, training, and regulated
areas or access control. OSHA has
examined a variety of regulatory
alternatives involving changes to one or
more of these ancillary provisions.
OSHA has preliminarily determined
that several of these ancillary provisions
will increase the benefits of the
proposed rule, for example, by helping
to ensure the TWA PEL is not exceeded
E:\FR\FM\07AUP2.SGM
07AUP2
47570
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
or by lowering the risks to workers
given the significant risk remaining at
the proposed TWA PEL. However,
except for Regulatory Alternative #7
(involving the elimination of all
ancillary provisions), OSHA did not
estimate changes in monetized benefits
for the regulatory alternatives that affect
ancillary provisions. Two regulatory
alternatives that involve all ancillary
provisions are presented below (#7 and
#8), followed by regulatory alternatives
for exposure monitoring (#9, #10, and
#11), for regulated areas (#12), for
personal protective clothing and
equipment (#13), for medical
surveillance (#14 through #21), and for
medical removal (#22).
All Ancillary Provisions
During the Small Business Regulatory
Fairness Act (SBREFA) process
conducted in 2007, the SBAR Panel
recommended that OSHA analyze a
PEL-only standard as a regulatory
alternative. The Panel also
recommended that OSHA consider
applying ancillary provisions of the
standard so as to minimize costs for
small businesses where exposure levels
are low (OSHA, 2008b). In response to
these recommendations, OSHA
analyzed Regulatory Alternative #7, a
PEL-only standard, and Regulatory
Alternative #8, which would only apply
ancillary provisions of the beryllium
standard at exposures above the
proposed PEL of 0.2 mg/m3 or the
proposed STEL of 2 mg/m3. Regulatory
Alternative #7 would update the Z
tables for § 1910.1000, so that the
proposed TWA PEL and STEL would
apply to all workers in general industry.
All other provisions of the proposed
standard would be dropped.
As indicated previously, OSHA has
preliminarily determined that there is
significant risk remaining at the
proposed PEL of 0.2 mg/m3. However,
the available evidence on feasibility
suggests that 0.2 mg/m3 may be the
lowest feasible PEL (see Chapter IV of
the PEA, OSHA 2014). Therefore, the
Agency believes that it is necessary to
include ancillary provisions in the
proposed rule to further reduce the
remaining risk. In addition, the
recommended standard provided to
OSHA by representatives of the primary
beryllium manufacturing industry and
the Steelworkers Union further supports
the importance of ancillary provisions
in protecting workers from the harmful
effects of beryllium exposure (Materion
and USW, 2012).
Under Regulatory Alternative #8,
several ancillary provisions that the
current proposal would require under a
variety of exposure conditions (e.g.,
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
dermal contact; any airborne exposure;
exposure at or above the action level)
would instead only apply where
exposure levels exceed the TWA PEL or
STEL. Regulatory Alternative #8 affects
the following provisions of the proposed
standard:
—Exposure monitoring. Whereas the
proposed standard requires annual
monitoring where exposure levels are
at or above the action level and at or
below the TWA PEL, Alternative #8
would require annual exposure
monitoring only where exposure
levels exceed the TWA PEL or STEL;
— Written exposure control plan.
Whereas the proposed standard
requires written exposure control
plans to be maintained in any facility
covered by the standard, Alternative
#8 would require only facilities with
exposures above the TWA PEL or
STEL to maintain a plan;
—PPE. Whereas the proposed standard
requires PPE for employees under a
variety of conditions, such as
exposure to soluble beryllium or
visible contamination with beryllium,
Alternative #8 would require PPE
only for employees exposed above the
TWA PEL or STEL;
—Housekeeping. Whereas the proposed
standard’s housekeeping requirements
apply across a wide variety of
beryllium exposure conditions,
Alternative #8 would limit
housekeeping requirements to areas
with exposures above the TWA PEL
or STEL.
—Medical Surveillance. Whereas the
proposed standard’s medical
surveillance provisions require
employers to offer medical
surveillance to employees with signs
or symptoms of beryllium-related
health effects regardless of their
exposure level, Alternative #8 would
make surveillance available to such
employees only if they were exposed
above the TWA PEL or STEL.
More detailed discussions of Regulatory
Alternatives #7 and #8, including a
description of the considerations
pertinent to these alternatives, appear in
Section IX of this preamble and in
Chapter VIII of the PEA (OSHA, 2014).
Exposure Monitoring
OSHA has examined three regulatory
alternatives that would modify the
proposed standard’s provisions on
exposure monitoring, which require
periodic monitoring annually where
exposures are at or above the action
level and at or below the TWA PEL.
Under Regulatory Alternative #9,
employers would be required to perform
periodic exposure monitoring every 180
PO 00000
Frm 00006
Fmt 4701
Sfmt 4702
days where exposures are at or above
the action level or above the STEL, and
at or below the TWA PEL. Under
Regulatory Alternative #10, employers
would be required to perform periodic
exposure monitoring every 180 days
where exposures are at or above the
action level or above the STEL,
including where exposures exceed the
TWA PEL. Under Regulatory Alternative
#11, employers would be required to
perform periodic exposure monitoring
every 180 days where exposures are at
or above the action level or above the
STEL, and every 90 days where
exposures exceed the TWA PEL. More
detailed discussions of Regulatory
Alternatives #9, #10, and #11 appear in
Section IX of this preamble and in
Chapter VIII of the PEA (OSHA, 2014).
In addition, the discussion of proposed
paragraph (d) in Section XVIII of this
preamble, Summary and Explanation of
the Proposed Standard, provides a more
detailed explanation of the proposed
requirements for exposure monitoring,
issues with exposure monitoring, and
the considerations pertinent to
Regulatory Alternatives #9, #10, and
#11.
Regulated Areas
The proposed standard would require
employers to establish and maintain two
types of areas: beryllium work areas,
wherever employees are, or can
reasonably be expected to be, exposed to
any level of airborne beryllium; and
regulated areas, wherever employees
are, or can reasonably be expected to be,
exposed to airborne beryllium at levels
above the TWA PEL or STEL. Employers
are required to demarcate beryllium
work areas, but are not required to
restrict access to beryllium work areas
or provide respiratory protection or
other forms of PPE within work areas
that are not also regulated areas.
Employers must demarcate regulated
areas, restrict access to them, post
warning signs and provide respiratory
protection and other PPE within
regulated areas, as well as medical
surveillance for employees who work in
regulated areas for more than 30 days in
a 12-month period. During the SBREFA
process conducted in 2007, the SBAR
Panel recommended that OSHA
consider dropping or limiting the
provision for regulated areas (OSHA,
2008b). In response to this
recommendation, OSHA analyzed
Regulatory Alternative #12, which
would not require employers to
establish regulated areas. More detailed
discussion of Regulatory Alternative #12
appears in Section IX of this preamble
and in Chapter VIII of the PEA (OSHA,
2014). In addition, the discussion of
E:\FR\FM\07AUP2.SGM
07AUP2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
paragraph (e) in Section XVIII of this
preamble, Summary and Explanation,
provides a more detailed explanation of
the proposed requirements for regulated
areas, issues with regulated areas, and
considerations pertinent to Regulatory
Alternative #12.
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Personal Protective Clothing and
Equipment (PPE)
Regulatory Alternative #13 would
modify the proposed requirements for
PPE, which require PPE where exposure
exceeds the TWA PEL or STEL; where
employees’ clothing or skin may become
visibly contaminated with beryllium;
and where employees may have skin
contact with soluble beryllium
compounds. The requirement to use
PPE where work clothing or skin may
become ‘‘visibly contaminated’’ with
beryllium differs from prior standards
that do not require contamination to be
visible in order for PPE to be required.
In the case of beryllium, which OSHA
has preliminarily concluded can
sensitize through dermal exposure, the
exposure levels capable of causing
adverse health effects and the PELs in
effect are so low that beryllium surface
contamination is unlikely to be visible
(see this preamble at section V, Health
Effects). OSHA is therefore considering
Regulatory Alternative #13, which
would require appropriate PPE
wherever there is potential for skin
contact with beryllium or berylliumcontaminated surfaces. More detailed
discussion of Regulatory Alternative #13
is provided in Section IX of this
preamble and in Chapter VIII of the PEA
(OSHA, 2014). In addition, the
discussion of paragraph (h) in Section
XVIII of this preamble, Summary and
Explanation, provides a more detailed
explanation of the proposed
requirements for PPE, issues with PPE,
and the considerations pertinent to
Regulatory Alternative #13.
Medical Surveillance
The proposed requirements for
medical surveillance include: (1)
Medical examinations, including a test
for beryllium sensitization, for
employees who are exposed to
beryllium above the proposed PEL for
30 days or more per year, who are
exposed to beryllium in an emergency,
or who show signs or symptoms of CBD;
and (2) low-dose helical tomography
(low-dose computed tomography,
hereafter referred to as ‘‘CT scans’’), for
employees who were exposed above the
proposed PEL for more than 30 days in
a 12-month period for 5 years or more.
This type of CT scan is a method of
detecting tumors, and is commonly used
to diagnose lung cancer. The proposed
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
standard would require periodic
medical exams to be provided for
employees in the medical surveillance
program annually, while tests for
beryllium sensitization and CT scans
would be provided to eligible
employees biennially.
OSHA has examined eight regulatory
alternatives (#14 through #21) that
would modify the proposed rule’s
requirements for employee eligibility,
the types of exam that must be offered,
and the frequency of periodic exams.
Medical surveillance was a subject of
special concern to SERs during the
SBREFA process, and the SBREFA
Panel offered many comments and
recommendations related to medical
surveillance for OSHA’s consideration.
Some of the Panel’s concerns have been
addressed in this proposal, which was
modified since the SBREFA Panel was
convened (see this preamble at Section
XVIII, Summary and Explanation of the
Proposed Standard, for more detailed
discussion). Several of the alternatives
presented here (#16, #18, and #20) also
respond to recommendations by the
SBREFA Panel to reduce burdens on
small businesses by dropping or
reducing the frequency of medical
surveillance requirements. OSHA also
seeks to ensure that the requirements of
the final standard offer workers
adequate medical surveillance while
limiting the costs to employers. Thus,
OSHA requests feedback on several
additional alternatives and on a variety
of issues raised later in this section of
the preamble.
Regulatory Alternatives #14, #15, and
#21 would expand eligibility for
medical surveillance to a broader group
of employees than would be eligible in
the proposed standard. Under
Regulatory Alternative #14, medical
surveillance would be available to
employees who are exposed to
beryllium above the proposed PEL,
including employees exposed for fewer
than 30 days per year. Regulatory
Alternative #15 would expand
eligibility for medical surveillance to
employees who are exposed to
beryllium above the proposed action
level, including employees exposed for
fewer than 30 days per year. Regulatory
Alternative #21 would extend eligibility
for medical surveillance as set forth in
proposed paragraph (k) to all employees
in shipyards, construction, and general
industry who meet the criteria of
proposed paragraph (k)(1) (or any of the
alternative criteria under consideration).
However, all other provisions of the
standard would be in effect only for
employers and employees that fall
within the scope of the proposed rule.
PO 00000
Frm 00007
Fmt 4701
Sfmt 4702
47571
Regulatory Alternatives #16 and #17
would modify the proposed standard’s
requirements to offer beryllium
sensitization testing to eligible
employees. Under Regulatory
Alternative #16, employers would not
be required to offer employees testing
for beryllium sensitization. Regulatory
Alternative #17 would increase the
frequency of periodic sensitization
testing, from the proposed standard’s
biennial requirement to annual testing.
Regulatory Alternatives #18 and #19
would similarly modify the proposed
standard’s requirements to offer CT
scans to eligible employees. Regulatory
Alternative #18 would drop the CT scan
requirement from the proposed rule,
whereas Regulatory Alternative #19
would increase the frequency of
periodic CT scans from biennial to
annual scans. Finally, under Regulatory
Alternative #20, all periodic
components of the medical surveillance
exams would be available biennially to
eligible employees. Instead of requiring
employers to offer eligible employees a
medical examination every year,
employers would be required to offer
eligible employees a medical
examination every other year. The
frequency of testing for beryllium
sensitization and CT scans would also
be biennial for eligible employees, as in
the proposed standard.
More detailed discussions of
Regulatory Alternatives #14, #15, #16,
#17, #18, #19, #20, and #21 appear in
Section IX of this preamble and in
Chapter VIII of the PEA (OSHA, 2014).
In addition, Section XVIII of this
preamble, Summary and Explanation,
paragraph (k) provides a more detailed
explanation of the proposed
requirements for medical surveillance,
issues with medical surveillance, and
the considerations pertinent to
Regulatory Alternatives #14 through
#21.
Medical Removal Protection (MRP)
The proposed requirements for
medical removal protection provide an
option for medical removal to an
employee who is working in a job with
exposure at or above the action level
and is diagnosed with CBD or confirmed
positive for beryllium sensitization. If
the employee chooses removal, the
employer must either remove the
employee to comparable work in a work
environment where exposure is below
the action level, or if comparable work
is not available, must place the
employee on paid leave for 6 months or
until such time as comparable work
becomes available. In either case, the
employer must maintain for 6 months
the employee’s base earnings, seniority,
E:\FR\FM\07AUP2.SGM
07AUP2
47572
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
and other rights and benefits that
existed at the time of removal. During
the SBREFA process, the Panel
recommended that OSHA give careful
consideration to the impacts that an
MRP requirement could have on small
businesses (OSHA, 2008b). In response
to this recommendation, OSHA
analyzed Regulatory Alternative #22,
which would not require employers to
offer MRP. More detailed discussion of
Regulatory Alternative #22 appears in
Section IX of this preamble and in
Chapter VIII of the PEA (OSHA, 2014).
In addition, the discussion of paragraph
(l) in section XVIII of this preamble,
Summary and Explanation, provides a
more detailed explanation of the
proposed requirements for MRP, issues
with MRP, and considerations pertinent
to Regulatory Alternative #22.
Timing of the Standard
The proposed standard would become
effective 60 days following publication
of the final standard in the Federal
Register. The effective date is the date
on which the standard imposes
compliance obligations on employers.
However, the standard would not
become enforceable by OSHA until 90
days following the effective date for
exposure monitoring, work areas and
regulated areas, written exposure
control plan, respiratory protection,
other personal protective clothing and
equipment, hygiene areas and practices
(except change rooms), housekeeping,
medical surveillance, and medical
removal. The proposed requirement for
change rooms would not be enforceable
until one year after the effective date,
and the requirements for engineering
controls would not be enforceable until
two years after the effective date. In
summary, employers will have some
period of time after the standard
becomes effective to come into
compliance before OSHA will begin
enforcing it: 90 days for most
provisions, one year for change rooms,
and two years for engineering controls.
Beginning 90 days following the
effective date, during periods necessary
to install or implement feasible
engineering controls where exposure
exceed the TWA PEL or STEL,
employers must provide employees
with respiratory protection as described
in the proposed standard under section
(g), Respiratory Protection.
OSHA invites comment and
suggestions for phasing in requirements
for engineering controls, medical
surveillance, and other provisions of the
standard. A longer phase-in time would
have several advantages, such as
reducing initial costs of the standard or
allowing employers to coordinate their
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
environmental and occupational safety
and health control strategies to
minimize potential costs. However, a
longer phase-in would also postpone
and reduce the benefits of the standard.
Suggestions for alternatives may apply
to specific industries (e.g., industries
where first-year or annualized cost
impacts are highest), specific sizeclasses of employers (e.g., employers
with fewer than 20 employees),
combinations of these factors, or all
firms covered by the rule.
OSHA requests comments on these
regulatory alternatives, including the
Agency’s choice of regulatory
alternatives (and whether there are other
regulatory alternatives the Agency
should consider) and the Agency’s
analysis of them. In addition, OSHA
requests comments and information on
a number of specific topics and issues
pertinent to the proposed standard.
These are summarized below.
provisions should contain a heading
setting forth the section and the
paragraph in the proposed standard that
the comment addresses. Comments
addressing more than one section or
paragraph will have correspondingly
more headings.
Submitting comments in an organized
manner and with clear reference to the
issue raised will enable all participants
to easily see what issues the commenter
addressed and how they were
addressed. Many commenters,
especially small businesses, are likely to
confine their comments to the issues
that affect them, and they will benefit
from being able to quickly identify
comments on these issues in others’
submissions. The Agency welcomes
comments concerning all aspects of this
proposal. However, OSHA is especially
interested in responses, supported by
evidence and reasons, to the following
questions:
Regulatory Issues
In this section, we solicit public
feedback on issues associated with the
proposed standard and request
information that would help the Agency
craft the final standard. In addition to
the issues specified here, OSHA also
raises issues for comment on technical
questions and discussions of economic
issues in the PEA (OSHA, 2014). OSHA
requests comment on all relevant issues,
including health effects, risk
assessment, significance of risk,
technological and economic feasibility,
and the provisions of the proposed
regulatory text. In addition, OSHA
requests comments on all of the issues
raised by the Small Business Advocacy
Review (SBAR) Panel, as summarized in
the SBAR report (OSHA, 2008b)
We present these issues and requests
for information in the first chapter of the
preamble to assist readers as they
review the preamble and consider any
comments they may want to submit.
The issues are presented here in
summary form. However, to fully
understand the questions in this section
and provide substantive input in
response to them, the sections of the
preamble relevant to these issues should
be reviewed. These include: Section V,
Health Effects; Section VI, the
Preliminary Risk Assessment; Section
VIII, Significance of Risk; Section IX,
Summary of the Preliminary Economic
Analysis and Initial Regulatory
Flexibility Analysis; and Section XVIII,
Summary and Explanation of the
Proposed Standard.
OSHA requests that comments be
organized, to the extent possible, around
the following issues and numbered
questions. Comment on particular
Health Effects
1. OSHA has described a variety of
studies addressing the major adverse
health effects that have been associated
with exposure to beryllium. Using
currently available epidemiologic and
experimental studies, OSHA has made a
preliminary determination that
beryllium presents risks of lung cancer;
sensitization; CBD at 0.1 mg/m3; and at
higher exposures acute beryllium
disease, and hepatic, renal,
cardiovascular and ocular diseases. Is
this determination correct? Are there
additional studies or other data OSHA
should consider in evaluating any of
these health outcomes?
2. Has OSHA adequately identified
and documented all critical health
impairments associated with
occupational exposure to beryllium? If
not, what other adverse health effects
should be added? Are there additional
studies or other data OSHA should
consider in evaluating any of these
health outcomes?
3. Are there any additional studies,
other data, or information that would
affect the information discussed or
significantly change the determination
of material health impairment?
Please submit any relevant
information, data, or additional studies
(or citations to studies), and explain
your reasons for recommending any
studies you suggest.
PO 00000
Frm 00008
Fmt 4701
Sfmt 4702
Risk Assessment and Significance of
Risk
4. OSHA has developed an analysis of
health risks associated with
occupational beryllium exposure,
including an analysis of sensitization
and CBD based on a selection of recent
E:\FR\FM\07AUP2.SGM
07AUP2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
studies in the epidemiological literature,
a data set on a population of beryllium
machinists provided by the National
Jewish Medical Research Center
(NJMRC), and an assessment of lung
cancer risk using an analysis provided
by NIOSH. Did OSHA rely on the best
available evidence in its risk
assessment? Are there additional studies
or other data OSHA should consider in
evaluating risk for these health
outcomes? Please provide the studies,
citations to studies, or data you suggest.
5. OSHA preliminarily concluded that
there is significant risk of material
health impairment (lung cancer or CBD)
from a working lifetime of occupational
exposure to beryllium at the current
TWA PEL of 2 mg/m3, which would be
substantially reduced by the proposed
TWA PEL of 0.2 mg/m3 and the
alternative TWA PEL of 0.1 mg/m3.
OSHA’s preliminary risk assessment
also concludes that there is still
significant risk of CBD and lung cancer
at the proposed PEL and the alternative
PELs, although substantially less than at
the current PEL. Are these preliminary
conclusions reasonable, based on the
best available evidence? If not, please
provide a detailed explanation of your
position, including data to support your
position and a detailed analysis of
OSHA’s risk assessment if appropriate.
6. Please provide comment on
OSHA’s analysis of risk for beryllium
sensitization, CBD and lung cancer. Are
there important gaps or uncertainties in
the analysis, such that the Agency’s
preliminary conclusions regarding
significance of risk at the current,
proposed, and alternative PELs may be
in error? If so, please provide a detailed
explanation and suggestions for how
OSHA’s analysis should be corrected or
improved.
7. OSHA has made a preliminary
determination that the available data are
not sufficient or suitable for risk
analysis of effects other than beryllium
sensitization, CBD and lung cancer. Do
you have, or are you aware of, studies
or data that would be suitable for a risk
assessment for these adverse health
effects? Please provide the studies,
citations to studies, or data you suggest.
(a) Scope
8. Has OSHA defined the scope of the
proposed standard appropriately? Does
it currently include employers who
should not be covered, or exclude
employers who should be covered by a
comprehensive beryllium standard? Are
you aware of employees in construction
or maritime, or in general industry who
deal with beryllium only as a trace
contaminant, who may be at significant
risk from occupational beryllium
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
exposure? Please provide the basis for
your response and any applicable
supporting information.
(b) Definitions
9. Has OSHA defined the Beryllium
lymphocyte proliferation test
appropriately? If not, please provide the
definition that you believe is
appropriate. Please provide rationale
and citations supporting your
comments.
10. Has OSHA defined CBD
Diagnostic Center appropriately? In
particular, should a CBD diagnostic
center be required to analyze biological
samples on-site, or should diagnostic
centers be allowed to send samples offsite for analysis? Is the list of tests and
procedures a CBD Diagnostic Center is
required to be able to perform
appropriate? Should any of the tests or
procedures be removed from the
definition? Should other tests or
procedures be added to the definition?
Please provide rationale and
information supporting your comments.
(d) Exposure Monitoring
11. Do you currently monitor for
beryllium exposures in your workplace?
If so, how often? Please provide the
reasoning for the frequency of your
monitoring. If periodic monitoring is
performed at your workplace for
exposures other than beryllium, with
what frequency is it repeated?
12. Is it reasonable to allow
discontinuation of monitoring based on
one sample below the action level?
Should more than one result below the
action level be required to discontinue
monitoring?
(e) Work Areas and Regulated Areas
The proposed standard would require
employers to establish and maintain two
types of areas: beryllium work areas,
wherever employees are, or can
reasonably be expected to be, exposed to
any level of airborne beryllium; and
regulated areas, wherever employees
are, or can reasonably be expected to be,
exposed to airborne beryllium at levels
above the TWA PEL or STEL. Employers
are required to demarcate beryllium
work areas, but are not required to
restrict access to beryllium work areas
or provide respiratory protection or
other forms of PPE within work areas
with exposures at or below the TWA
PEL or STEL. Employers must also
demarcate regulated areas, including
posting warning signs; restrict access to
regulated areas; and provide respiratory
protection and other PPE within
regulated areas.
PO 00000
Frm 00009
Fmt 4701
Sfmt 4702
47573
13. Does your workplace currently
have regulated areas? If so, how are
regulated areas demarcated?
14. Please describe work settings
where establishing regulated areas could
be problematic or infeasible. If
establishing regulated areas is
problematic, what approaches might be
used to warn employees in such work
settings of high risk areas?
(f) Methods of Compliance
Paragraph (f)(2) of the proposed
standard would require employers to
implement engineering and work
practice controls to reduce employees’
exposures to or below the TWA PEL and
STEL. Where engineering and work
practice controls are insufficient to
reduce exposures to or below the TWA
PEL and STEL, employers would still be
required to implement them to reduce
exposure as much as possible, and to
supplement them with a respiratory
protection program. In addition, for
each operation where there is airborne
beryllium exposure, the employer must
ensure that at least one of the
engineering and work practice controls
listed in paragraph (f)(2) is in place,
unless all of the listed controls are
infeasible, or the employer can
demonstrate that exposures are below
the action level based on no fewer than
two samples taken seven days apart.
15. Do you usually use engineering or
work practices controls (local exhaust
ventilation, isolation, substitution) to
reduce beryllium exposures? If so,
which controls do you use?
16. Are the controls and processes
listed in paragraph (f)(2)(i)(A)
appropriate for controlling beryllium
exposures? Are there additional controls
or processes that should be added to
paragraph (f)(2)(i)(A)?
(g) Respiratory Protection
17. OSHA’s asbestos standard (CFR
1910.1001) requires employers to
provide each employee with a tightfitting, powered air-purifying respirator
(PAPR) instead of a negative pressure
respirator when the employee chooses
to use a PAPR and it provides adequate
protection to the employee. Should the
beryllium standard similarly require
employers to provide PAPRs (instead of
allowing a negative pressure respirator)
when requested by the employee? Are
there other circumstances where a PAPR
should be specified as the appropriate
respiratory protection? Please provide
the basis for your response and any
applicable supporting information.
E:\FR\FM\07AUP2.SGM
07AUP2
47574
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
(h) Personal Protective Clothing and
Equipment
18. Do you currently require specific
PPE or respirators when employees are
working with beryllium? If so, what
type?
19. The proposal requires PPE
wherever work clothing or skin may
become visibly contaminated with
beryllium; where employees’ skin can
reasonably be expected to be exposed to
soluble beryllium compounds; or where
employee exposure exceeds or can
reasonably be expected to exceed the
TWA PEL or STEL. The requirement to
use PPE where work clothing or skin
may become ‘‘visibly contaminated’’
with beryllium differs from prior
standards which do not require
contamination to be visible in order for
PPE to be required. Is ‘‘visibly
contaminated’’ an appropriate trigger for
PPE? Is there reason to require PPE
where employees’ skin can be exposed
to insoluble beryllium compounds?
Please provide the basis for your
response and any applicable supporting
information.
(i) Hygiene Areas and Practices
20. The proposal requires employers
to provide showers in their facilities if
(A) Exposure exceeds or can reasonably
be expected to exceed the TWA PEL or
STEL; and (B) Beryllium can reasonably
be expected to contaminate employees’
hair or body parts other than hands,
face, and neck. Is this requirement
reasonable and adequately protective of
beryllium-exposed workers? Should
OSHA amend the provision to require
showers in facilities where exposures
exceed the PEL or STEL, without regard
to areas of bodily contamination?
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
(j) Housekeeping
21. The proposed rule prohibits dry
sweeping or brushing for cleaning
surfaces in beryllium work areas unless
HEPA-filtered vacuuming or other
methods that minimize the likelihood
and level of exposure have been tried
and were not effective. Please comment
on this provision. What methods do you
use to clean work surfaces at your
facility? Are HEPA-filtered vacuuming
or other methods to minimize beryllium
exposure used to clean surfaces at your
facility? Have they been effective? Are
there any circumstances under which
dry sweeping or brushing are necessary?
Please explain your response.
22. The proposed rule requires that
materials designated for recycling that
are visibly contaminated with beryllium
particulate shall be cleaned to remove
visible particulate, or placed in sealed,
impermeable enclosures. However,
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
small particles (<10 mg) may not be
visible to the naked eye, and there are
studies suggesting that small particles
may penetrate the skin, beyond which
beryllium sensitization can occur
(Tinkle et al., 2003). OSHA requests
feedback on this provision. Should
OSHA require that all material to be
recycled be decontaminated regardless
of perceived surface cleanliness? Should
OSHA require that all material disposed
or discarded be in enclosures regardless
of perceived surface cleanliness? Please
provide explanation or data to support
your comments.
(k) Medical Surveillance
The proposed requirements for
medical surveillance include: (1)
Medical examinations, including a test
for beryllium sensitization, for
employees who are exposed to
beryllium above the proposed PEL for
30 days or more per year, who are
exposed to beryllium in an emergency,
or who show signs or symptoms of CBD;
and (2) CT scans for employees who
were exposed above the proposed PEL
for more than 30 days in a 12-month
period for 5 years or more. The
proposed standard would require
periodic medical exams to be provided
for employees in the medical
surveillance program annually, while
tests for beryllium sensitization and CT
scans would be provided to eligible
employees biennially.
23. Is medical surveillance being
provided for beryllium-exposed
employees at your worksite? If so:
a. Do you provide medical
surveillance to employees under
another OSHA standard or as a matter
of company policy? What OSHA
standard(s) does the program address?
b. How many employees are included,
and how do you determine which
employees receive medical surveillance
(e.g., by exposure level, other factors)?
c. Who administers and implements
the medical surveillance (e.g., company
doctor, nurse practitioner, physician
assistant, or nurse; or outside doctor,
nurse practitioner, physician assistant,
or nurse)?
d. What examinations, tests, or
evaluations are included in the medical
surveillance program, and with what
frequency are they administered? Does
your program include a surveillance
program specifically for berylliumrelated health effects (e.g., the BeLPT or
other tests for beryllium sensitization)?
e. If your facility offers the BeLPT,
please provide feedback and data on
your experience with the BeLPT,
including the analytical or interpretive
procedure you use and its role in your
facility’s exposure control program. Has
PO 00000
Frm 00010
Fmt 4701
Sfmt 4702
identification of sensitized workers led
to interventions to reduce exposures to
sensitized individuals, or in the facility
generally? If a worker is found to be
sensitized, do you track worker health
and possible progression of disease
beyond sensitization? If so, how is this
done?
f. What difficulties and benefits (e.g.,
health, reduction in absenteeism, or
financial) have you experienced with
your medical surveillance program? If
applicable, please discuss benefits and
difficulties you have experienced with
the use of the BeLPT, providing detailed
information or examples if possible.
g. What are the costs of your medical
surveillance program? How do your
costs compare with OSHA’s estimated
unit costs for the physical examination
and employee time involved in the
medical surveillance program? Are
OSHA’s baseline assumptions and cost
estimates for medical surveillance
consistent with your experiences
providing medical surveillance to your
employees?
24. Please review paragraph (k) of the
proposed rule, Medical Surveillance,
and comment on the frequency and
contents of medical surveillance in the
proposed rule. Is 30 days from initial
assignment a reasonable time at which
to provide a medical exam? Should
there be a requirement for beryllium
sensitization testing at time of
employment? Should there be a
requirement for beryllium sensitization
testing at an employee’s exit exam,
regardless of when the employee’s most
recent sensitization test was
administered? Are the tests required and
the testing frequencies specified
appropriate? Should sensitized
employees have the opportunity to be
examined at a CBD Diagnostic Center
more than once following a confirmed
positive BeLPT? Are there additional
tests or alternate testing schedules you
would suggest? Should the skin be
examined for signs and symptoms of
beryllium exposure or other medical
issues, as well as for breaks and
wounds? Please explain the basis for
your position and provide data or
studies if applicable.
25. Please provide comments on the
proposed requirements regarding
referral of a sensitized employee to a
CBD diagnostic center, which specify
referral to a diagnostic center ‘‘mutually
agreed upon’’ by the employer and
employee. Is this requirement for
mutual agreement necessary and
appropriate? How should a diagnostic
center be chosen if the employee and
employer cannot come to agreement?
Should OSHA consider alternate
language, such as referral for CBD
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
evaluation at a diagnostic center in a
reasonable location?
26. In the proposed rule, OSHA
specifies that all medical examinations
and procedures required by the standard
must be performed by or under the
direction of a licensed physician. Are
physicians available in your geographic
area to provide medical surveillance to
workers who are covered by the
proposed rule? Are other licensed
health care professionals available to
provide medical surveillance? Do you
have access to other qualified personnel
such as qualified X-ray technicians, and
pulmonary specialists? Should the
proposal be amended to allow
examination by, or under the direction
of, a physician or other licensed health
care professional (PLHCP)? Please
explain your position. Please note what
you consider your geographic area in
responding to this question.
27. The proposed standard requires
the employer to obtain the Licensed
Physician’s Written Medical Opinion
from the PLHCP within 30 days of the
examination. Should OSHA revise the
medical surveillance provisions of the
proposed standard to allow employees
to choose what, if any, medical
information goes to the employer from
the PLHCP? For example, the employer
could instead be required to obtain a
certification from the PLCHP within 30
days of the examination stating (1) when
the examination took place, (2) that the
examination complied with the
standard, and (3) that the PLHCP
provided the employee a copy of the
Licensed Physician’s Written Medical
Opinion required by the standard. The
PLHCP would need the employee’s
written consent to send the employer
the Licensed Physician’s Written
Medical Opinion or any other medical
information about the employee. This
approach might lead to corresponding
changes in proposed paragraphs (f)(1)
(written exposure control program), (l)
(medical removal) and (n)
(recordkeeping) to reflect that employers
will not automatically be receiving any
medical information about employees as
a result of the medical surveillance
required by the proposed standard, but
would instead only receive medical
information the employee chooses to
share with the employer. Please
comment on the relative merits of the
proposed standard’s requirement that
employers obtain the PLHCP’s written
opinion or an alternative that would
provide employees with greater
discretion over the information that goes
to employers, and explain the basis for
your position and the potential impact
on the benefits of medical surveillance.
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
28. Appendix A to the proposed
standard reviews procedures for
conducting and interpreting the results
of BeLPT testing for beryllium
sensitization. Is there now, or should
there be, a standard method for BeLPT
laboratory procedure? If yes, please
describe the existing or proposed
method. Is there now, or should there
be, a standard algorithm for interpreting
BeLPT results to determine
sensitization? Please describe the
existing or proposed laboratory method
or interpretation algorithm. Should
OSHA require that BeLPTs performed to
comply with the medical surveillance
provisions of this rule adhere to the
Department of Energy (DOE) analytical
and interpretive specifications issued in
2001? Should interpretation of
laboratory results be delegated to the
employee’s occupational physician or
PLHCP?
29. Should OSHA require the clinical
laboratories performing the BeLPT to be
accredited by the College of American
Pathologists or another accreditation
organization approved under the
Clinical Laboratory Improvement
Amendments (CLIA)? What other
standards, if any, should be required for
clinical laboratories providing the
BeLPT?
30. Are there now, or are there being
developed, alternative tests to the
BeLPT you would suggest? Please
explain the reasons for your suggestion.
How should alternative tests for
beryllium sensitization be evaluated and
validated? How should OSHA
determine whether a test for beryllium
sensitization is more reliable and
accurate than the BeLPT? Please see
Appendix A to the proposed standard
for a discussion of the accuracy of the
BeLPT.
31. The proposed rule requires
employers to provide OSHA with the
results of BeLPTs performed to comply
with the medical surveillance
provisions upon request, provided that
the employer obtains a release from the
tested employee. Will this requirement
be unduly burdensome for employers?
Are there alternative organizations that
would be appropriate to send test
results to?
(l) Medical Removal Protection
The proposed requirements for
medical removal protection provide an
option for medical removal to an
employee who is working in a job with
exposure at or above the action level
and is diagnosed with CBD or confirmed
positive for beryllium sensitization. If
the employee chooses removal, the
employer must remove the employee to
comparable work in a work
PO 00000
Frm 00011
Fmt 4701
Sfmt 4702
47575
environment where exposure is below
the action level, or if comparable work
is not available, must place the
employee on paid leave for 6 months or
until such time as comparable work
becomes available. In either case, the
employer must maintain for 6 months
the employee’s base earnings, seniority,
and other rights and benefits that
existed at the time of removal.
32. Do you provide MRP at your
facility? If so, please comment on the
program’s benefits, difficulties, and
costs, and the extent to which eligible
employees make use of MRP.
33. OSHA has included requirements
for medical removal protection (MRP) in
the proposed rule, which includes
provisions for medical removal for
employees with beryllium sensitization
or CBD, and an extension of removed
employees’ rights and benefits for six
months. Are beryllium sensitization and
CBD appropriate triggers for medical
removal? Are there other medical
conditions or findings that should
trigger medical removal? For what
amount of time should a removed
employee’s benefits be extended?
(p) Appendices
34. Some OSHA health standards
include appendices that address topics
such as the hazards associated with the
regulated substance, health screening
considerations, occupational disease
questionnaires, and PLHCP obligations.
In this proposed rule, OSHA has
included a non-mandatory appendix to
describe and discuss the BeLPT
(Appendix A), and a non-mandatory
appendix presenting a non-exhaustive
list of engineering controls employers
may use to comply with paragraph (f)
(Appendix B). What would be the
advantages and disadvantages of
including each appendix in the final
rule? What would be the advantages and
disadvantages of providing this
information in guidance materials?
35. What additional information, if
any, should be included in the
appendices? What additional
information, if any, should be provided
in guidance materials?
General
36. The current beryllium proposal
includes triggers that require employers
to initiate certain provisions, programs,
and activities to protect workers from
beryllium exposure. All employers
covered under an OSHA health standard
are required to initiate certain activities
such as initial monitoring to evaluate
the potential hazard to employees.
OSHA health standards typically
include ancillary provisions with
various triggers indicating when an
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47576
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
employer covered under the standard
would need to comply with a provision.
The most common triggers are ones
based an exposure level such as the PEL
or action level. These exposure level
triggers are sometimes combined with a
minimum duration of exposure (e.g., ≥
30 days per year). Other triggers may
include reasonably anticipated
exposure, medical surveillance findings,
certain work activities, or simply the
presence of the regulated substance in
the workplace.
For the current Proposal, exposures to
beryllium above the TWA PEL or STEL
trigger the provisions for regulated
areas, additional or enhanced
engineering or work practice controls to
reduce airborne exposures to or below
the TWA PEL and STEL, personal
protective clothing and equipment,
medical surveillance, showers, and
respiratory protection if feasible
engineering and work practice controls
cannot reduce airborne exposures to or
below the TWA PEL and STEL.
Exposures at or above the action level in
turn trigger the provisions for periodic
exposure monitoring, and medical
removal eligibility (along with a
diagnosis of CBD or confirmed positive
for beryllium sensitization). Finally, an
employer covered under the scope of
the proposed standard must establish a
beryllium work area where employees
are, or can reasonably be expected to be,
exposed to airborne beryllium
regardless of the level of exposure. In
beryllium work areas, employers must
implement a written exposure control
plan, provide washing facilities and
change rooms (change rooms are only
necessary if employees are required to
remove their personal clothing), and
follow housekeeping provisions. The
employers must also implement at least
one of the engineering and work
practice controls listed in paragraph
(f)(2) of the proposed standard. An
employer is exempt from this
requirement if he or she can
demonstrate that such controls are not
feasible or that exposures are below the
action level.
Certain provisions are triggered by
one condition and other provisions are
triggered only if multiple conditions are
present. For example, medical removal
is only triggered if an employee has CBD
or is confirmed positive AND the
employee is exposed at or above the
action level.
OSHA is requesting comment on the
triggers in the proposed beryllium
standard. Are the triggers OSHA has
proposed appropriate? OSHA is also
requesting comment on these triggers
relative to the regulatory alternatives
affecting the scope and PELs as
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
described in this preamble in section I,
Issues and Alternatives. For example,
are the triggers in the proposed standard
appropriate for Alternative #1a, which
would expand the scope of the proposed
standard to include all operations in
general industry where beryllium exists
only as a trace contaminant (less than
0.1% beryllium by weight)? Are the
triggers appropriate for the alternatives
that change the TWA PEL, STEL, and
action level? Please specify the trigger
and the alternative, if applicable, and
why you agree or disagree with the
trigger.
Relevant Federal Rules Which May
Duplicate, Overlap, or Conflict With the
Proposed Rule
37. In Section IX—Preliminary
Economic Analysis under the Initial
Regulatory Flexibility Analysis, OSHA
identifies, to the extent practicable, all
relevant Federal rules which may
duplicate, overlap, or conflict with the
proposed rule. One potential area of
overlap is with the U.S. Department of
Energy (DOE) beryllium program. In
1999, DOE established a chronic
beryllium disease prevention program
(CBDPP) to reduce the number of
workers (DOE employees and DOE
contractors) exposed to beryllium at
DOE facilities (10 CFR part 850,
published at 64 FR 68854–68914 (Dec.
8, 1999)). In establishing this program,
DOE has exercised its statutory
authority to prescribe and enforce
occupational safety and health
standards. Therefore pursuant to section
4(b)(1) of the OSH Act, 29 U.S.C.
653(b)(1), the DOE facilities are exempt
from OSHA jurisdiction.
Nevertheless, under 10 CFR 850.22,
DOE has included in its CBDPP
regulation a requirement for compliance
with the current OSHA permissible
exposure limit (PEL), and any lower PEL
that OSHA establishes in the future.
Thus, although DOE has preempted
OSHA’s standard from applying at DOE
facilities and OSHA cannot exercise any
authority at those facilities, DOE relies
on OSHA’s PEL in implementing its
own program. However, DOE’s decision
to tie its own standard to OSHA’s PEL
has little consequence to this
rulemaking because the requirements in
DOE’s beryllium program (controls,
medical surveillance, etc.) are triggered
by DOE’s action level of 0.2 mg/m3,
which is much lower than DOE’s
existing PEL and the same as OSHA’s
proposed PEL. DOE’s action level is not
tied to OSHA’s standard, so 10 CFR
850.22 would not require the CBDPP’s
action level or any non-PEL
requirements to be automatically
adjusted as a result of OSHA’s
PO 00000
Frm 00012
Fmt 4701
Sfmt 4702
rulemaking. For this reason, DOE has
indicated to OSHA that OSHA’s
proposed rule would not have any
impact on DOE’s CBDPP, particularly
since 10 CFR 850.25(b), Exposure
reduction and minimization, requires
DOE contractors to reduce exposures to
below the DOE’s action level of 0.2 mg/
m3, if practicable.
DOE has expressed to OSHA that DOE
facilities are already in compliance with
10 CFR 850 and its action level of 0.2
mg/m3,2 so the only potential impact on
DOE’s CBDPP that could flow from
OSHA’s rulemaking would be if OSHA
ultimately adopted a PEL of 0.1 mg/m3,
as discussed in alternative #4, instead of
the proposed PEL of 0.2 mg/m3, and DOE
did not make any additional
adjustments to its standards. Even in
that hypothetical scenario, the impact
would still be limited because of the
odd result that DOE’s PEL would drop
below its own action level, while the
action level would continue to serve as
the trigger for most of DOE’s program
requirements.
DOE also has noted some potential
overlap with a separate DOE provision
in 10 CFR part 851, which requires its
contractors to comply with DOE’s
CBDPP (10 CFR 851.23(a)(1)) and also
with all OSHA standards under 29 CFR
part 1910 except ‘‘Ionizing Radiation’’
(§ 1910.1096) (10 CFR 851.23(a)(3)).
These requirements, which DOE
established in 2006 (71 FR 6858
(February 9, 2006)), make sense in light
of OSHA’s current regulation because
OSHA’s only beryllium protection is a
PEL, so compliance with 10 CFR
851.23(a)(1) and (3) merely make
OSHA’s current PEL the relevant level
for purposes of the CBDPP. However, its
function would be less clear if OSHA
adopts a beryllium standard as
proposed. OSHA’s proposed beryllium
standard would establish additional
substantive protections beyond the PEL.
Consequently, notwithstanding the
CBDPP’s preemptive effect on the OSHA
beryllium standard as a result of 29
U.S.C. 653(b)(1), 10 CFR 851.23(a)(3)
could be read to require DOE
contractors to comply with all
provisions in OSHA’s proposal (if
finalized), including the ancillary
provisions, creating a dual regulatory
scheme for beryllium protection at DOE
facilities.
DOE officials have indicated that this
is not their intent. Instead, their intent
is that DOE contractors comply solely
with the CBDPP provisions in 10 CFR
part 850 for protection from beryllium.
2 This would mean the prevailing beryllium
exposures at DOE facilities are at or below 0.2 mg/
m3.
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
Based on its discussions with DOE
officials, OSHA anticipates that DOE
will clarify that its contractors do not
need to comply with any ancillary
provisions in a beryllium standard that
OSHA may promulgate.
OSHA can envision several potential
scenarios developing from its
rulemaking, ranging from OSHA
retaining the proposed PEL of 0.2 mg/m3
and action level of 0.1 mg/m3 in the final
rule to adopting the PEL of 0.1 mg/m3,
as discussed in alternative #4. Because
OSHA’s beryllium standard does not
apply directly to DOE facilities, and the
only impact of its rules on those
facilities is the result of DOE’s
regulatory choices, there is also a range
of actions that DOE could take to
minimize any potential impact of any
change to OSHA’s rules, including (1)
taking no action at all, (2) simply
clarifying the CBDPP, as described
above, to mean that OSHA’s beryllium
standard (other than its PEL) does not
apply to contractors, or (3) revising both
parts 850 and 851 to completely
disassociate DOE’s regulation of
beryllium at DOE facilities from OSHA’s
regulation of beryllium.
OSHA is aware that, in the preamble
to its 1999 CBDPP rule, DOE analyzed
the costs for implementing the CBDPP
for action levels of 0.1 mg/m3, 0.2 mg/m3,
and 0.5 mg/m3 (64 FR 68875, December
8, 1999). DOE estimated costs for
periodic exposure monitoring, notifying
workers of the results of such
monitoring, exposure reduction and
minimization, regulated areas, change
rooms and showers, respiratory
protection, protective clothing, and
disposal of protective clothing. All of
these provisions are triggered by DOE’s
action level (64 FR 68874, December 8,
1999). Although DOE’s rule is not
identical to OSHA’s proposed standard,
OSHA believes that DOE’s costs are
sufficiently representative to form the
basis of a preliminary estimate of the
costs that could flow from OSHA’s
standard, if finalized.
Based on the range of potential
scenarios and the prior DOE cost
estimates, OSHA estimates that the
annual cost impact on DOE facilities
could range from $0 to $4,065,768 (2010
dollars). The upper end of the cost range
would reflect the unlikely scenario in
which OSHA promulgates a final PEL of
0.1 mg/m3, 10 CFR 851.23(a)(3) is found
to compel DOE contractors to comply
with OSHA’s comprehensive beryllium
standard in addition to DOE’s CBDPP,
and DOE takes no action to clarify that
OSHA’s beryllium standard does not
apply to DOE contractors. The lower
end of the cost range assumes OSHA
promulgates its rule as proposed with a
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
PEL of 0.2 mg/m3 and action level of 0.1
mg/m3, and DOE clarifies that it intends
its contractors to follow DOE’s CBDPP
and not OSHA’s beryllium standard, so
that the ancillary provisions of OSHA’s
beryllium standard do not apply to DOE
facilities. Additionally, OSHA assumes
that DOE contractors are in compliance
with DOE’s current rule and therefore
took the difference in cost between
implementation of an action level of 0.2
mg/m3 and an action level of 0.1 mg/m3
for the above estimates. Finally, OSHA
used the GDP price deflator to present
the cost estimate in 2010 dollars.
OSHA requests comment on the
potential overlap of DOE’s rule with
OSHA’s proposed rule.
II. Pertinent Legal Authority
The purpose of the Occupational
Safety and Health Act, 29 U.S.C. 651 et
seq. (‘‘the Act’’), is to ‘‘. . . assure so far
as possible every working man and
woman in the nation safe and healthful
working conditions and to preserve our
human resources.’’ 29 U.S.C. 651(b).
To achieve this goal Congress
authorized the Secretary of Labor (the
Secretary) to promulgate and enforce
occupational safety and health
standards. 29 U.S.C. 654(b) (requiring
employers to comply with OSHA
standards), 655(a) (authorizing summary
adoption of existing consensus and
federal standards within two years of
the Act’s enactment), and 655(b)
(authorizing promulgation, modification
or revocation of standards pursuant to
notice and comment).
The Act provides that in promulgating
health standards dealing with toxic
materials or harmful physical agents,
such as this proposed standard
regulating occupational exposure to
beryllium, the Secretary, shall set the
standard which most adequately
assures, to the extent feasible, on the
basis of the best available evidence that
no employee will suffer material
impairment of health or functional
capacity even if such employee has
regular exposure to the hazard dealt
with by such standard for the period of
his working life. See 29 U.S.C. 655(b)(5).
The Supreme Court has held that
before the Secretary can promulgate any
permanent health or safety standard, he
must make a threshold finding that
significant risk is present and that such
risk can be eliminated or lessened by a
change in practices. Industrial Union
Dept., AFL–CIO v. American Petroleum
Institute, 448 U.S. 607, 641–42 (1980)
(plurality opinion) (‘‘The Benzene
case’’). Thus, section 6(b)(5) of the Act
requires health standards to reduce
significant risk to the extent feasible. Id.
PO 00000
Frm 00013
Fmt 4701
Sfmt 4702
47577
The Court further observed that what
constitutes ‘‘significant risk’’ is ‘‘not a
mathematical straitjacket’’ and must be
‘‘based largely on policy
considerations.’’ The Benzene case, 448
U.S. at 655. The Court gave the example
that if,
. . . the odds are one in a billion that a
person will die from cancer . . . the risk
clearly could not be considered significant.
On the other hand, if the odds are one in one
thousand that regular inhalation of gasoline
vapors that are 2% benzene will be fatal, a
reasonable person might well consider the
risk significant. [Id.]
OSHA standards must be both
technologically and economically
feasible. United Steelworkers v.
Marshall, 647 F.2d 1189, 1264 (D.C. Cir.
1980) (‘‘The Lead I case’’). The Supreme
Court has defined feasibility as ‘‘capable
of being done.’’ Am. Textile Mfrs. Inst.
v. Donovan, 452 U.S. 490, 509–510
(1981) (‘‘The Cotton Dust case’’). The
courts have further clarified that a
standard is technologically feasible if
OSHA proves a reasonable possibility,
. . . within the limits of the best available
evidence . . . that the typical firm will be able
to develop and install engineering and work
practice controls that can meet the PEL in
most of its operations. [See The Lead I case,
647 F.2d at 1272]
With respect to economic feasibility,
the courts have held that a standard is
feasible if it does not threaten massive
dislocation to or imperil the existence of
the industry. Id. at 1265. A court must
examine the cost of compliance with an
OSHA standard,
. . . in relation to the financial health and
profitability of the industry and the likely
effect of such costs on unit consumer prices
. . . [T]he practical question is whether the
standard threatens the competitive stability
of an industry, . . . or whether any intraindustry or inter-industry discrimination in
the standard might wreck such stability or
lead to undue concentration. [Id. (citing
Indus. Union Dep’t, AFL–CIO v. Hodgson,
499 F.2d 467 (D.C. Cir. 1974))]
The courts have further observed that
granting companies reasonable time to
comply with new PELs may enhance
economic feasibility. The Lead I case at
1265. While a standard must be
economically feasible, the Supreme
Court has held that a cost-benefit
analysis of health standards is not
required by the Act because a feasibility
analysis is required. The Cotton Dust
case, 453 U.S. at 509.
Finally, sections 6(b)(7) and 8(c) of
the Act authorize OSHA to include
among a standard’s requirements
labeling, monitoring, medical testing,
and other information-gathering and
-transmittal provisions. 29 U.S.C.
655(b)(7), 657(c).
E:\FR\FM\07AUP2.SGM
07AUP2
47578
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
III. Events Leading to the Proposed
Standards
The first occupational exposure limit
for beryllium was set in 1949 by the
Atomic Energy Commission (AEC),
which required that beryllium exposure
in the workplaces under its jurisdiction
be limited to 2 mg/m3 as an 8-hour timeweighted average (TWA), and 25 mg/m3
as a peak exposure never to be exceeded
(Department of Energy, 1999). These
exposure limits were adopted by all
AEC installations handling beryllium,
and were binding on all AEC contractors
involved in the handling of beryllium.
In 1956, the American Industrial
Hygiene Association (AIHA) published
a Hygienic Guide which supported the
AEC exposure limits. In 1959, the
American Conference of Governmental
Industrial Hygienists (ACGIH®) also
adopted a Threshold Limit Value
(TLV®) of 2 mg/m3 as an 8-hour TWA
(Borak, 2006).
In 1971, OSHA adopted, under
Section 6(a) of the Occupational Safety
and Health Act of 1970, and made
applicable to general industry, a
national consensus standard (ANSI
Z37.29–1970) for beryllium and
beryllium compounds. The standard set
a permissible exposure limit (PEL) for
beryllium and beryllium compounds at
2 mg/m3 as an 8-hour TWA; 5 mg/m3 as
an acceptable ceiling concentration; and
25 mg/m3 as an acceptable maximum
peak above the acceptable ceiling
concentration for a maximum duration
of 30 minutes in an 8-hour shift (OSHA,
1971).
Section 6(a) stipulated that in the first
two years after the effective date of the
Act, OSHA was to promulgate ‘‘startup’’ standards, on an expedited basis
and without public hearing or comment,
based on national consensus or
established Federal standards that
improved employee safety or health.
Pursuant to that authority, in 1971,
OSHA promulgated approximately 425
PELs for air contaminants, including
beryllium, derived principally from
Federal standards applicable to
government contractors under the
Walsh-Healey Public Contracts Act, 41
U.S.C. 35, and the Contract Work Hours
and Safety Standards Act (commonly
known as the Construction Safety Act),
40 U.S.C. 333. The Walsh-Healey Act
and Construction Safety Act standards,
in turn, had been adopted primarily
from ACGIH®’s TLV®s.
The National Institute for
Occupational Safety and Health
(NIOSH) issued a document entitled
Criteria for a Recommended Standard:
Occupational Exposure to Beryllium
(Criteria Document) in June 1972. OSHA
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
reviewed the findings and
recommendations contained in the
Criteria Document along with the AEC
control requirements for beryllium
exposure. OSHA also considered
existing data from animal and
epidemiological studies, and studies of
industrial processes of beryllium
extraction, refinement, fabrication, and
machining. In 1975, OSHA asked
NIOSH to update the evaluation of the
existing data pertaining to the
carcinogenic potential of beryllium. In
response to OSHA’s request, the
Director of NIOSH stated that, based on
animal data and through all possible
routes of exposure including inhalation,
‘‘beryllium in all likelihood represents a
carcinogenic risk to man.’’
In October 1975, OSHA proposed a
new beryllium standard for all
industries based on information that
beryllium caused cancer in animal
experiments (40 FR 48814 (October 17,
1975)). Adoption of this proposal would
have lowered the 8-hour TWA exposure
limit from 2 mg/m3 to 1 mg/m3. In
addition, the proposal included
ancillary provisions for such topics as
exposure monitoring, hygiene facilities,
medical surveillance, and training
related to the health hazards from
beryllium exposure. The rulemaking
was never completed.
In 1977, NIOSH recommended an
exposure limit of 0.5 mg/m3 and
identified beryllium as a potential
occupational carcinogen. In December
1998, ACGIH published a Notice of
Intended Change for its beryllium
exposure limit. The notice proposed a
lower TLV of 0.2 mg/m3 over an 8-hour
TWA based on evidence of CBD and
sensitization in exposed workers.
In 1999, the Department of Energy
(DOE) issued a Chronic Beryllium
Disease Prevention Program (CBDPP)
Final Rule for employees exposed to
beryllium in its facilities (DOE, 1999).
The DOE rule set an action level of 0.2
mg/m3, and adopted OSHA’s PEL of 2
mg/m3 or any more stringent PEL OSHA
might adopt in the future. The DOE
action level triggers workplace
precautions and control measures such
as periodic monitoring, exposure
reduction or minimization, regulated
areas, hygiene facilities and practices,
respiratory protection, protective
clothing and equipment, and warning
signs (DOE, 1999).
Also in 1999, OSHA was petitioned
by the Paper, Allied-Industrial,
Chemical and Energy Workers
International Union (PACE) (OSHA,
2002) and by Dr. Lee Newman and Ms.
Margaret Mroz, from the National
Jewish Medical Research Center
(NJMRC) (OSHA, 2002), to promulgate
PO 00000
Frm 00014
Fmt 4701
Sfmt 4702
an Emergency Temporary Standard
(ETS) for beryllium in the workplace. In
2001, OSHA was petitioned for an ETS
by Public Citizen Health Research
Group and again by PACE (OSHA,
2002). In order to promulgate an ETS,
the Secretary of Labor must prove (1)
that employees are exposed to grave
danger from exposure to a hazard, and
(2) that such an emergency standard is
necessary to protect employees from
such danger (29 U.S.C. 655(c)). The
burden of proof is on the Department
and because of the difficulty of meeting
this burden, the Department usually
proceeds when appropriate with 6(b)
rulemaking rather than a 6(c) ETS. Thus,
instead of granting the ETS requests,
OSHA instructed staff to further collect
and analyze research regarding the
harmful effects of beryllium.
On November 26, 2002, OSHA
published a Request for Information
(RFI) for ‘‘Occupational Exposure to
Beryllium’’ (OSHA, 2002). The RFI
contained questions on employee
exposure, health effects, risk
assessment, exposure assessment and
monitoring methods, control measures
and technological feasibility, training,
medical surveillance, and impact on
small business entities. In the RFI,
OSHA expressed concerns about health
effects such as CBD, lung cancer, and
beryllium sensitization. OSHA pointed
to studies indicating that even shortterm exposures below OSHA’s PEL of 2
mg/m3 could lead to CBD. The RFI also
cited studies describing the relationship
between beryllium sensitization and
CBD (67 FR at 70708). In addition,
OSHA stated that beryllium had been
identified as a carcinogen by
organizations such as NIOSH, the
International Agency for Research on
Cancer (IARC), and the Environmental
Protection Agency (EPA); and cancer
had been evidenced in animal studies
(67 FR at 70709).
On November 15, 2007, OSHA
convened a Small Business Advocacy
Review Panel for a draft proposed
standard for occupational exposure to
beryllium. OSHA convened this panel
under Section 609(b) of the Regulatory
Flexibility Act (RFA), as amended by
the Small Business Regulatory
Enforcement Fairness Act of 1996
(SBREFA) (5 U.S.C. 601 et seq.).
The Panel included representatives
from OSHA, the Solicitor’s Office of the
Department of Labor, the Office of
Advocacy within the Small Business
Administration, and the Office of
Information and Regulatory Affairs of
the Office of Management and Budget.
Small Entity Representatives (SERs)
made oral and written comments on the
E:\FR\FM\07AUP2.SGM
07AUP2
47579
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
draft rule and submitted them to the
panel.
The SBREFA Panel issued a report
which included the SERs’ comments on
January 15, 2008. SERs expressed
concerns about the impact of the
ancillary requirements such as exposure
monitoring and medical surveillance.
Their comments addressed potential
costs associated with compliance with
the draft standard, and possible impacts
of the standard on market conditions,
among other issues. In addition, many
SERs sought clarification of some of the
ancillary requirements such as the
meaning of ‘‘routine’’ contact or
‘‘contaminated surfaces.’’
The SBREFA Panel issued a number
of recommendations, which OSHA
carefully considered. In section XVIII of
this preamble, Summary and
Explanation, OSHA has responded to
the Panel’s recommendations and
clarified the requirements about which
SERs expressed confusion. OSHA also
examined the regulatory alternatives
recommended by the SBREFA Panel.
The regulatory alternatives examined by
OSHA are listed in section I of this
preamble, Issues and Alternatives. The
alternatives are discussed in greater
detail in section XVIII of this preamble,
Summary and Explanation, and in the
PEA (OSHA, 2014). In addition, the
Agency intends to develop interpretive
guidance documents following the
publication of a final rule.
In 2010, OSHA hired a contractor to
oversee an independent scientific peer
review of a draft preliminary beryllium
health effects evaluation (OSHA, 2010a)
and a draft preliminary beryllium risk
assessment (OSHA, 2010b). The
contractor identified experts familiar
with beryllium health effects research
and ensured that these experts had no
conflict of interest or apparent bias in
performing the review. The contractor
selected five experts with expertise in
such areas as pulmonary and
occupational medicine, CBD, beryllium
sensitization, the BeLPT, beryllium
toxicity and carcinogenicity, and
medical surveillance. Other areas of
expertise included animal modeling,
occupational epidemiology,
biostatistics, risk and exposure
assessment, exposure-response
modeling, beryllium exposure
assessment, industrial hygiene, and
occupational/environmental health
engineering.
Regarding the health effects
evaluation, the peer reviewers
concluded that the health effect studies
were described accurately and in
sufficient detail, and OSHA’s
conclusions based on the studies were
reasonable. The reviewers agreed that
the OSHA document covered the
significant health endpoints related to
occupational beryllium exposure. Peer
reviewers considered the preliminary
conclusions regarding beryllium
sensitization and CBD to be reasonable
and well presented in the draft health
evaluation section. All reviewers agreed
that the scientific evidence supports
sensitization as a necessary condition in
the development of CBD. In response to
reviewers’ comments, OSHA made
revisions to more clearly describe
certain sections of the health effects
evaluation. In addition, OSHA
expanded its discussion regarding the
BeLPT.
Regarding the preliminary risk
assessment, the peer reviewers were
highly supportive of the Agency’s
approach and major conclusions. The
peer reviewers stated that the key
studies were appropriate and their
selection clearly explained in the
document. They regarded the
preliminary analysis of these studies to
be reasonable and scientifically sound.
The reviewers supported OSHA’s
conclusion that substantial risk of
sensitization and CBD were observed in
facilities where the highest exposure
generating processes had median fullshift exposures around 0.2 mg/m3 or
higher, and that the greatest reduction
in risk was achieved when exposures for
all processes were lowered to 0.1 mg/m3
or below.
In February 2012 the Agency received
for consideration a draft recommended
standard for beryllium (Materion and
USW, 2012). This draft proposal was the
product of a joint effort between two
stakeholders: Materion Corporation, a
leading producer of beryllium and
beryllium products in the United States,
and the United Steelworkers, an
international labor union representing
workers who manufacture beryllium
alloys and beryllium-containing
products in a number of industries. The
United Steelworkers and Materion
sought to craft an OSHA-like model
beryllium standard that would have
support from both labor and industry.
OSHA has considered this proposal
along with other information submitted
during the development of the Notice of
Proposed Rulemaking for beryllium.
IV. Chemical Properties and Industrial
Uses
Chemical and Physical Properties
Beryllium (Be; CAS Number 7440–
41–7) is a silver-grey to greyish-white,
strong, lightweight, and brittle metal. It
is a Group IIA element with an atomic
weight of 9.01, atomic number of 4,
melting point of 1,287 °C, boiling point
of 2,970°C, and a density of 1.85 at 20
°C (NTP 2014). It occurs naturally in
rocks, soil, coal, and volcanic dust
(ATSDR, 2002). Beryllium is insoluble
in water and soluble in acids and
alkalis. It has two common oxidation
states, Be(0) and Be(+2). There are
several beryllium compounds with
unique CAS numbers and chemical and
physical properties. Table IV–1
describes the most common beryllium
compounds.
TABLE IV—1, PROPERTIES OF BERYLLIUM AND BERYLLIUM COMPOUNDS
CAS No.
Beryllium metal
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Chemical name
7440–41–7
Beryllium chloride.
7787–47–5
VerDate Sep<11>2014
19:20 Aug 06, 2015
Synonyms
and trade
names
Molecular
weight
Beryllium; beryllium-9,
beryllium
element;
beryllium
metallic.
Beryllium dichloride.
Jkt 235001
PO 00000
9.0122
79.92
Frm 00015
Melting point
(°C)
Density
(g/cm3)
Description
Solubility
1287 ..............
Grey, closepacked, hexagonal, brittle
metal.
1.85 (20
°C).
Soluble in most dilute acids
and alkali; decomposes in
hot water; insoluble in
mercury and cold water.
399.2 .............
Colorless to
slightly yellow;
orthorhombic,
deliquescent
crystal.
1.899 (25
°C).
Soluble in water, ethanol,
diethyl ether and pyridine;
slightly soluble in benzene, carbon disulfide and
chloroform; insoluble in
acetone, ammonia, and
toluene.
Fmt 4701
Sfmt 4702
E:\FR\FM\07AUP2.SGM
07AUP2
47580
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
TABLE IV—1, PROPERTIES OF BERYLLIUM AND BERYLLIUM COMPOUNDS—Continued
Chemical name
CAS No.
Synonyms
and trade
names
Molecular
weight
Melting point
(°C)
Description
Density
(g/cm3)
Solubility
Soluble in water, sulfuric
acid, mixture of ethanol
and diethyl ether; slightly
soluble in ethanol; insoluble in hydrofluoric acid.
Soluble in hot concentrated
acids and alkali; slightly
soluble in dilute alkali; insoluble in water.
Forms soluble tetrahydrate
in hot water; insoluble in
cold water.
Beryllium fluoride.
7787–49–7
(12323–05–
6)
Beryllium
difluoride.
47.01
555 ................
Colorless or
white, amorphous, hygroscopic solid.
1.986 ........
Beryllium hydroxide.
13327–32–7
(1304–49–
0)
Beryllium
dihydroxide.
43.3
White, amorphous, amphoteric powder.
1.92 ..........
Beryllium sulfate
13510–49–1
Sulfuric acid,
beryllium
salt (1:1).
105.07
Colorless crystal
2.443 ........
Beryllium sulfate
tetrhydrate.
7787–56–6
177.14
Colorless, tetragonal crystal.
1.713 ........
Beryllium Oxide
1304–56–9
Sulfuric acid;
beryllium
salt (1:1),
tetrahydrate.
Beryllia; beryllium monoxide
thermalox
TM.
138 (decomposes to
beryllium
oxide).
550–600 °C
(decomposes to
beryllium
oxide).
100 °C ...........
25.01
2508–2547 °C
3.01 (20
°C).
Beryllium carbonate.
1319–43–3
112.05
No data .........
No data ....
Soluble in acids and alkali;
insoluble in cold water; decomposes in hot water.
Beryllium nitrate
trihydrate.
7787–55–5
Carbonic acid,
beryllium
salt, mixture
with beryllium hydroxide.
Nitric acid, beryllium salt,
trihydrate.
Colorless to
white, hexagonal crystal
or amorphous,
amphoteric
powder.
White powder ....
187.97
60 ..................
1.56 ..........
Very soluble in water and
ethanol.
Beryllium phosphate.
13598–15–7
Phosphoric
acid, beryllium salt
(1:1).
104.99
No data .........
White to faintly
yellowish,
deliquescent
mass.
Not reported ......
Not reported.
Slightly soluble in water.
Soluble in water; slightly
soluble in concentrated
sulfuric acid; insoluble in
ethanol.
Soluble in concentrated
acids and alkali; insoluble
in water.
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
ATSDR, 2002.
The physical and chemical properties
of beryllium were realized early in the
20th century, and it has since gained
commercial importance in a wide range
of industries. Beryllium is lightweight,
hard, spark resistant, non-magnetic, and
has a high melting point. It lends
strength, electrical and thermal
conductivity, and fatigue resistance to
alloys (NTP, 2014). Beryllium also has
a high affinity for oxygen in air and
water, which can cause a thin surface
film of beryllium oxide to form on the
bare metal, making it extremely resistant
to corrosion. These properties make
beryllium alloys highly suitable for
defense, nuclear, and aerospace
applications (IARC, 1993).
There are approximately 45
mineralized forms of beryllium. In the
United States, the predominant mineral
form mined commercially and refined
into pure beryllium and beryllium
alloys is bertrandite. Bertrandite, while
containing less than 1% beryllium
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
compared to 4% in beryl, is easily and
efficiently processed into beryllium
hydroxide (IARC, 1993). Imported beryl
is also converted into beryllium
hydroxide as the United States has very
little beryl that can be economically
mined (USGS, 2013a).
Industrial Uses
Materion Corporation, formerly called
Brush Wellman, is the only producer of
primary beryllium in the United States.
Beryllium is used in a variety of
industries, including aerospace,
defense, telecommunications,
automotive, electronic, and medical
specialty industries. Pure beryllium
metal is used in a range of products
such as X-ray transmission windows,
nuclear reactor neutron reflectors,
nuclear weapons, precision instruments,
rocket propellants, mirrors, and
computers (NTP, 2014). Beryllium oxide
is used in components such as ceramics,
electrical insulators, microwave oven
PO 00000
Frm 00016
Fmt 4701
Sfmt 4702
components, military vehicle armor,
laser structural components, and
automotive ignition systems (ATSDR,
2002). Beryllium oxide ceramics are
used to produce sensitive electronic
items such as lasers and satellite heat
sinks.
Beryllium alloys, typically beryllium/
copper or beryllium/aluminum, are
manufactured as high beryllium content
or low beryllium content alloys. High
content alloys contain greater than 30%
beryllium. Low content alloys are
typically less than 3% beryllium.
Beryllium alloys are used in automotive
electronics (e.g., electrical connectors
and relays and audio components),
computer components, home appliance
parts, dental appliances (e.g., crowns),
bicycle frames, golf clubs, and other
articles (NTP, 2014; Ballance et al.,
1978; Cunningham et al., 1998; Mroz, et
al., 2001). Electrical components and
conductors are stamped and formed
from beryllium alloys. Beryllium-copper
E:\FR\FM\07AUP2.SGM
07AUP2
47581
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
alloys are used to make switches in
automobiles (Ballance et al., 1978, 2002;
Cunningham et al., 1998) and
connectors, relays, and switches in
computers, radar, satellite, and
telecommunications equipment (Mroz et
al., 2001). Beryllium-aluminum alloys
are used in the construction of aircraft,
high resolution medical and industrial
X-ray equipment, and mirrors to
measure weather patterns (Mroz et al.,
2001). High content and low content
beryllium alloys are precision machined
for military and aerospace applications.
Some welding consumables are also
manufactured using beryllium.
Beryllium is also found as a trace
metal in materials such as aluminum
ore, abrasive blasting grit, and coal fly
ash. Abrasive blasting grits such as coal
slag and copper slag contain varying
concentrations of beryllium, usually less
than 0.1% by weight. The burning of
bituminous and sub-bituminous coal for
power generation causes the naturally
occurring beryllium in coal to
accumulate in the coal fly ash
byproduct. Scrap and waste metal for
smelting and refining may also contain
beryllium. A detailed discussion of the
industries and job tasks using beryllium
is included in the Preliminary Economic
Analysis (OSHA, 2014).
Occupational exposure to beryllium
can occur from inhalation of dusts,
fume, and mist. Beryllium dusts are
created during operations where
beryllium is cut, machined, crushed,
ground, or otherwise mechanically
sheared. Mists can also form during
operations that use machining fluids.
Beryllium fume can form while welding
with or on beryllium components, and
from hot processes such as those found
in metal foundries.
Occupational exposure to beryllium
can also occur from skin, eye, and
mucous membrane contact with
beryllium particulate or solutions.
V. Health Effects
Beryllium-associated health effects,
including acute beryllium disease
(ABD), beryllium sensitization (also
referred to in this preamble as
‘‘sensitization’’), chronic beryllium
disease (CBD), and lung cancer, can lead
to a number of highly debilitating and
life-altering conditions including
pneumonitis, loss of lung capacity
(reduction in pulmonary function
leading to pulmonary dysfunction), loss
of physical capacity associated with
reduced lung capacity, systemic effects
related to pulmonary dysfunction, and
decreased life expectancy (NIOSH,
1972).
This Health Effects section presents
information on beryllium and its
compounds, the fate of beryllium in the
body, research that relates to its toxic
mechanisms of action, and the scientific
literature on the adverse health effects
associated with beryllium exposure,
including ABD, sensitization, CBD, and
lung cancer. OSHA considers CBD to be
a progressive illness with a continuous
spectrum of symptoms ranging from no
symptomatology at its earliest stage
following sensitization to mild
symptoms such as a slight almost
imperceptible shortness of breath, to
loss of pulmonary function, debilitating
lung disease, and, in many cases, death.
This section also discusses the nature of
these illnesses, the scientific evidence
that they are causally associated with
occupational exposure to beryllium, and
the probable mechanisms of action with
a more thorough review of the
supporting studies.
A. Beryllium and Beryllium Compounds
1. Particle Physical/Chemical Properties
Beryllium (Be; CAS No. 7440–41–7) is
a steel-grey, brittle metal with an atomic
number of 4 and an atomic weight of
9.01 (Group IIA of the periodic table).
Because of its high reactivity, beryllium
is not found as a free metal in nature;
however, there are approximately 45
mineralized forms of beryllium.
Beryllium compounds and alloys
include commercially valuable metals
and gemstones.
Beryllium has two oxidative states:
Be(0) and Be(2+) Agency for Toxic
Substance and Disease Registry
(ATSDR) 2002). It is likely that the
Be(2+) state is the most biologically
reactive and able to form a bond with
peptides leading to it becoming
antigenic (Snyder et al., 2003). This will
be discussed in more detail in the
Beryllium Sensitization section below.
Beryllium has a high charge-to-radius
ratio and in addition to forming various
types of ionic bonds, beryllium has a
strong tendency for covalent bond
formation (e.g., it can form
organometallic compounds such as
Be(CH3)2 and many other complexes)
(ATSDR, 2002; Greene et al., 1998).
However, it appears that few, if any,
toxicity studies exist for the
organometallic compounds. Additional
physical/chemical properties for
beryllium compounds that may be
important in their biological response
are summarized in Table 1 below. This
information was obtained from their
International Chemical Safety Cards
(ICSC) (beryllium metal (ICSC 0226),
beryllium oxide (ICSC 1325), beryllium
sulfate (ICSC 1351), beryllium nitrate
(ICSC 1352), beryllium carbonate (ICSC
1353), beryllium chloride (ICSC 1354),
beryllium fluoride (ICSC 1355)) and
from the hazardous substance data bank
(HSDB) for beryllium hydroxide
(CASRN: 13327–32–7), and beryllium
phosphate (CASRN: 13598–15–7).
Additional information on chemical and
physical properties as well as industrial
uses for beryllium can be found in this
preamble at Section IV, Chemical
Properties and Industrial Uses.
TABLE 1—PHYSICAL/CHEMICAL PROPERTIES OF BERYLLIUM AND COMPOUNDS
Compound name
Physical
appearance
Chemical formula
Beryllium Metal .......
Grey to White
Powder.
White Crystals or
Powder.
White Powder .......
Be ..........................
9.0
BeO .......................
25.0
Combustible; Finely dispersed particles—Explosive.
Not combustible or explosive ...............
Be2CO3(OH)/
Be2CO5H2.
BeSO4 ...................
BeN2O6/Be(NO3)2
181.07
Not combustible or explosive ...............
105.1
133.0
Be(OH)2 ................
43.0
Not combustible or explosive ...............
Enhances combustion of other substances.
Not reported .........................................
BeCl2 .....................
79.9
Not combustible or explosive ...............
Slightly soluble.
Very soluble (1.66
× 106 mg/L).
Slightly soluble 0.8
× 10¥4 mol/L
(3.44 mg/L).
Soluble.
BeF2 ......................
47.0
Not combustible or explosive ...............
Very soluble.
Beryllium Oxide ......
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Beryllium Carbonate
Beryllium Sulfate .....
Beryllium Nitrate .....
Beryllium Hydroxide
Beryllium Chloride ..
Beryllium Fluoride ...
VerDate Sep<11>2014
Colorless Crystals
White to Yellow
Solid.
White amorphous
powder or crystalline solid.
Colorless to Yellow
Crystals.
Colorless Lumps ...
19:20 Aug 06, 2015
Jkt 235001
PO 00000
Frm 00017
Molecular
mass
Fmt 4701
Sfmt 4702
Acute physical hazards
E:\FR\FM\07AUP2.SGM
07AUP2
Solubility in water
at 20 °C
None.
Very sparingly
soluble.
None.
47582
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
TABLE 1—PHYSICAL/CHEMICAL PROPERTIES OF BERYLLIUM AND COMPOUNDS—Continued
Compound name
Physical
appearance
Chemical formula
Beryllium Phosphate
White solid ............
Molecular
mass
Be3(PO4)2 ..............
271.0
Acute physical hazards
Not reported .........................................
Solubility in water
at 20 °C
Soluble.
Source: International Chemical Safety Cards (except beryllium phosphate and hydroxide—HSDB).
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Beryllium shows a high affinity for
oxygen in air and water, resulting in a
thin surface film of beryllium oxide on
the bare metal. If the surface film is
disturbed, it may become airborne or
dermal exposure may occur. The
solubility, particle surface area, and
particle size of some beryllium
compounds are examined in more detail
below. These properties have been
evaluated in many toxicological studies.
In particular, the properties related to
the calcination (firing temperatures) and
differences in crystal size and solubility
are important aspects in their
toxicological profile.
2. Factors Affecting Potency and Effect
of Beryllium Exposure
The effect and potency of beryllium
and its compounds, as for any toxicant,
immunogen, or immunotoxicant, may
be dependent upon the physical state in
which they are presented to a host. For
occupational airborne materials and
surface contaminants, it is especially
critical to understand those physical
parameters in order to determine the
extent of exposure to the respiratory
tract and skin since these are generally
the initial target organs for either route
of exposure.
For example, large particles may have
less of an effect in the lung than smaller
particles due to reduced potential to
stay airborne to be inhaled or be
deposited along the respiratory tract. In
addition, once inhalation occurs particle
size is critical in determining where the
particle will deposit along the
respiratory tract. Solubility also has an
important part in determining the
toxicity and bioavailability of airborne
materials as well. Respiratory tract
retention and skin penetration are
directly influenced by the solubility and
reactivity of airborne material.
These factors may be responsible, at
least in part, for the process by which
beryllium sensitization progresses to
CBD in exposed workers. Other factors
influencing beryllium-induced toxicity
include the surface area of beryllium
particles and their persistence in the
lung. With respect to dermal exposure,
the physical characteristics of the
particle are important as well since they
can influence skin absorption and
bioavailability. This section addresses
certain physical characteristics (i.e.,
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
solubility, particle size, particle surface
area) that are important in influencing
the toxicity of beryllium materials in
occupational settings.
a. Solubility
Solubility may be an important
determinant of the toxicity of airborne
materials, influencing the deposition
and persistence of inhaled particles in
the respiratory tract, their
bioavailability, and the likelihood of
presentation to the immune system. A
number of chemical agents, including
metals that contact and penetrate the
skin, are able to induce an immune
response, such as sensitization
(Boeniger, 2003; Mandervelt et al.,
1997). Similar to inhaled agents, the
ability of materials to penetrate the skin
is also influenced by solubility since
dermal absorption may occur at a
greater rate for soluble materials than
insoluble materials (Kimber et al.,
2011).
This section reviews the relevant
information regarding solubility, its
importance in a biological matrix and its
relevance to sensitization and beryllium
lung disease. The weight of evidence
presented below suggests that both
soluble and non-soluble forms of
beryllium can induce a sensitization
response and result in progression of
lung disease.
Beryllium salts, including the
chloride (BeCl2), fluoride (BeF2), nitrate
(Be(NO3)2), phosphate (Be3(PO4)2), and
sulfate (tetrahydrate) (BeSO4 · 4H2O)
salts, are all water soluble. However,
soluble beryllium salts can be converted
to less soluble forms in the lung (Reeves
and Vorwald, 1967). Aqueous solutions
of the soluble beryllium salts are acidic
as a result of the formation of Be(OH2)4
2+, the tetrahydrate, which will react to
form insoluble hydroxides or hydrated
complexes within the general
physiological range of pH values
(between 5 and 8) (EPA, 1998). This
may be an important factor in the
development of CBD since lowersolubility forms of beryllium have been
shown to persist in the lung for longer
periods of time and persistence in the
lung may be needed in order for this
disease to occur (NAS, 2008).
Beryllium oxide (BeO), hydroxide
(Be(OH)2), carbonate (Be2CO3(OH)2), and
sulfate (anhydrous) (BeSO4) are either
PO 00000
Frm 00018
Fmt 4701
Sfmt 4702
insoluble, slightly soluble, or
considered to be sparingly soluble
(almost insoluble or having an
extremely slow rate of dissolution). The
solubility of beryllium oxide, which is
prepared from beryllium hydroxide by
calcining (heating to a high temperature
without fusing in order to drive off
volatile chemicals) at temperatures
between 500 and 1,750 °C, has an
inverse relationship with calcination
temperature. Although the solubility of
the low-fired crystals can be as much as
10 times that of the high-fired crystals,
low-fired beryllium oxide is still only
sparingly soluble (Delic, 1992). In a
study that measured the dissolution
kinetics (rate to dissolve) of beryllium
compounds calcined at different
temperatures, Hoover et al., compared
beryllium metal to beryllium oxide
particles and found them to have similar
solubilities. This was attributed to a fine
layer of beryllium oxide that coats the
metal particles (Hoover et al., 1989). A
study conducted by Deubner et al.,
(2011) determined ore materials to be
more soluble than beryllium oxide at pH
7.2 but similar in solubility at pH 4.5.
Beryllium hydroxide was more soluble
than beryllium oxide at both pHs
(Deubner et al., 2011).
Investigators have also attempted to
determine how biological fluids can
dissolve beryllium materials. In two
studies, insoluble beryllium, taken up
by activated phagocytes, was shown to
be ionized by myeloperoxidases
(Leonard and Lauwerys, 1987;
Lansdown, 1995). The positive charge
resulting from ionization enabled the
beryllium to bind to receptors on the
surface of cells such as lymphocytes or
antigen-presenting cells which could
make it more biologically active (NAS,
2008). In a study utilizing
phagolysosomal-simulating fluid (PSF)
with a pH of 4.5, both beryllium metal
and beryllium oxide dissolved at a
greater rate than that previously
reported in water or SUF (simulant
fluid) (Stefaniak et al., 2006), and the
rate of dissolution of the multiconstituent (mixed) particles was greater
than that of the single-constituent
beryllium oxide powder. The authors
speculated that copper in the particles
rapidly dissolves, exposing the small
inclusions of beryllium oxide, which
have higher specific surface areas (SSA)
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
and therefore dissolve at a higher rate.
A follow-up study by the same
investigational team (Duling et al., 2012)
confirmed dissolution of beryllium
oxide by PSF and determined the
release rate was biphasic (initial rapid
diffusion followed by a latter slower
surface reaction-driven release). During
the latter phase, dissolution half-times
were 1,400 to 2,000 days. The authors
speculated this indicated bertrandite
was persistent in the lung (Duling et al.,
2012).
In a recent study investigating the
dissolution and release of beryllium
ions for 17 beryllium-containing
materials (ore, hydroxide, metal, oxide,
alloys, and processing intermediates)
using artificial human airway epithelial
lining fluid, Stefaniak et al., (2011)
found release of beryllium ions within
7 days (beryl ore melter dust). The
authors calculated dissolution halftimes ranging from 30 days (reduction
furnace material) to 74,000 days
(hydroxide). Stefaniak et al., (2011)
speculated that despite the rapid
mechanical clearance, billions of
beryllium ions could be released in the
respiratory tract via dissolution in
airway lining fluid (ALF). Under this
scenario beryllium-containing particles
depositing in the respiratory tract
dissolving in ALF could provide
beryllium ions for absorption in the
lung and interact with immune cells in
the respiratory tract (Stefaniak et al.,
2011).
Huang et al., (2011) investigated the
effect of simulated lung fluid (SLF) on
dissolution and nanoparticle generation
and beryllium-containing materials.
Bertrandite-containing ore, berylcontaining ore, frit (a processing
intermediate), beryllium hydroxide (a
processing intermediate) and silica
(used as a control), were equilibrated in
SLF at two pH values (4.5 and 7.2) to
reflect inter- and intra-cellular
environments in the lung tissue.
Concentrations of beryllium, aluminum,
and silica ions increased linearly during
the first 20 days in SLF, rose slowly
thereafter, reaching equilibrium over
time. The study also found nanoparticle
formation (in the size range of 10–100
nm) for all materials (Huang et al.,
2011).
In an in vitro skin model, Sutton et
al., (2003) demonstrated the dissolution
of beryllium compounds (insoluble
beryllium hydroxide, soluble beryllium
phosphate) in a simulated sweat fluid.
This model showed beryllium can be
dissolved in biological fluids and be
available for cellular uptake in the skin.
Duling et al., (2012) confirmed
dissolution and release of ions from
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
bertrandite ore in an artificial sweat
model (pH 5.3 and pH 6.5).
b. Particle Size
The toxicity of beryllium as
exemplified by beryllium oxide also is
dependent, in part, on the particle size,
with smaller particles (<10 mm) able to
penetrate beyond the larynx (Stefaniak
et al., 2008). Most inhalation studies
and occupational exposures involve
quite small (<1–2 mm) beryllium oxide
particles that can penetrate to the
pulmonary regions of the lung
(Stefaniak et al., 2008). In inhalation
studies with beryllium ores, particle
sizes are generally much larger, with
deposition occurring in several areas
throughout the respiratory tract for
particles <10 mm.
The temperature at which beryllium
oxide is calcined influences its particle
size, surface area, solubility, and
ultimately its toxicity (Delic, 1992).
Low-fired (500 °C) beryllium oxide is
predominantly made up of poorly
crystallized small particles, while
higher firing temperatures (1000—1750
°C) result in larger particle sizes (Delic,
1992).
In order to determine the extent to
which particle size plays a role in the
toxicity of beryllium in occupational
settings, several key studies are
reviewed and detailed below. The
findings on particle size have been
related, where possible, to work process
and biologically relevant toxicity
endpoints of either sensitization or CBD.
Numerous studies have been
conducted evaluating the particle size
generated during basic industrial and
machining operations. In a study by
Cohen et al., (1983), a multi-cyclone
sampler was utilized to measure the size
mass distribution of the beryllium
aerosol at a beryllium-copper alloy
casting operation. Briefly, Cohen et al.,
(1983) found variable particle size
generation based on the operations
being sampled with particle size ranging
from 3 to 16 mm. Hoover et al., (1990)
also found variable particle sizes being
generated based on operations. In
general, Hoover et al., (1990) found that
milling operations generated smaller
particle sizes than sawing operations.
Hoover et al., (1990) also found that
beryllium metal generated higher
concentrations than metal alloys.
Martyny et al., (2000) characterized
generation of particle size during
precision beryllium machining
processes. The study found that more
than 50 percent of the beryllium
machining particles collected in the
breathing zone of machinists were less
than 10 mm in aerodynamic diameter
with 30 percent of that fraction being
PO 00000
Frm 00019
Fmt 4701
Sfmt 4702
47583
particles of less than 0.6 mm. A study by
Thorat et al., (2003) found similar
results with ore mixing, crushing,
powder production and machining
ranging from 5.0 to 9.5 mm. Kent et al.,
(2001) measured airborne beryllium
using size-selective samplers in five
furnace areas at a beryllium processing
facility. A statistically significant linear
trend was reported between the above
alveolar-deposited particle mass
concentration and prevalence of CBD
and sensitization in the furnace
production areas. The study authors
suggested that the concentration of
alveolar-deposited particles (e.g., <3.5
mm) may be a better predictor of
sensitization and CBD than the total
mass concentration of airborne
beryllium.
A recent study by Virji et al. (2011)
evaluated particle size distribution,
chemistry and solubility in areas with
historically elevated risk of sensitization
and CBD at a beryllium metal powder,
beryllium oxide, and alloy production
facility. The investigators observed that
historically, exposure-response
relationships have been inconsistent
when using mass concentration to
identify process-related risk, possibly
due to incomplete particle
characterization. Two separate exposure
surveys were conducted in March 1999
and June–August 1999 using multi-stage
personal impactor samplers (to
determine particle size distribution) and
personal 37 mm closed face cassette
(CFC) samplers, both located in workers’
breathing zones. One hundred and
ninety eight time-weighted-average
(TWA) personal impactor samples were
analyzed for representative jobs and
processes. A total of 4,026 CFC samples
were collected over the 5-month
collection period and analyzed for mass
concentration, particle size, chemical
content and solubility and compared to
process areas with high risk of
sensitization and CBD. The investigators
found that total beryllium concentration
varied greatly between workers and
among process areas. Analysis of
chemical form and solubility also
revealed wide variability among process
areas, but high risk process areas had
exposures to both soluble and insoluble
forms of beryllium. Analysis of particle
size revealed most process areas had
particles ranging from 5–14 mm mass
median aerodynamic diameter (MMAD).
Rank order correlating jobs to particle
size showed high overall consistency
(Spearman r=0.84) but moderate
correlation (Pearson r=0.43). The
investigators concluded that
consideration of relevant aspects of
exposure such as particle size
E:\FR\FM\07AUP2.SGM
07AUP2
47584
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
distribution, chemical form, and
solubility will likely improve exposure
assessments (Virji et al., 2011)
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
c. Particle Surface Area.
Particle surface area has been
postulated as an important metric for
beryllium exposure. Several studies
have demonstrated a relationship
between the inflammatory and
tumorigenic potential of ultrafine
particles and their increased surface
area (Driscoll, 1996; Miller, 1995;
Oberdorster et al., 1996). While the
exact mechanism explaining how
particle surface area influences its
biological activity is not known, a
greater particle surface area has been
shown to increase inflammation,
cytokine production, anti-oxidant
defenses and apoptosis (Elder et al.,
2005; Carter et al., 2006; Refsne et al.,
2006).
Finch et al., (1988) found that
beryllium oxide calcined at 500 °C had
3.3 times greater specific surface area
(SSA) than beryllium oxide calcined at
1000 °C, although there was no
difference in size or structure of the
particles as a function of calcining
temperature. The beryllium-metal
aerosol (airborne beryllium particles),
although similar to the beryllium oxide
aerosols in aerodynamic size, had an
SSA about 30 percent that of the
beryllium oxide calcined at 1000 °C. As
discussed above, a later study by Delic
(1992) found calcining temperatures had
an effect on SSA as well as particle size.
Several studies have investigated the
lung toxicity of beryllium oxide
calcined at different temperatures and
generally had found that those calcined
at lower temperatures have greater
toxicity and effect than materials
calcined at higher temperatures. This
may be because beryllium oxide fired at
the lower temperature has a loosely
formed crystalline structure with greater
specific surface area than the fused
crystal structure of beryllium oxide fired
at the higher temperature. For example,
beryllium oxide calcined at 500 °C has
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
been found to have stronger pathogenic
effects than material calcined at 1,000
°C, as shown in several of the beagle
dog, rat, mouse and guinea pig studies
discussed in the section on CBD
pathogenesis that follows (Finch et al.,
1988; Polak et al., 1968; Haley et al.,
1989; Haley et al., 1992; Hall et al.,
1950). Finch et al. have also observed
higher toxicity of beryllium oxide
calcined at 500 °C, an observation they
attribute to the greater surface area of
beryllium particles calcined at the lower
temperature (Finch et al., 1988). These
authors found that the in vitro
cytotoxicity to Chinese hamster ovary
(CHO) cells and cultured lung epithelial
cells of 500 °C beryllium oxide was
greater than that of 1,000 °C beryllium
oxide, which in turn was greater than
that of beryllium metal. However, when
toxicity was expressed in terms of
particle surface area, the cytotoxicity of
all three forms was similar. Similar
results were observed in a study
comparing the cytotoxicity of beryllium
metal particles of various sizes to
cultured rat alveolar macrophages,
although specific surface area did not
entirely predict cytotoxicity (Finch et
al., 1991).
Stefaniak et al., (2003b) investigated
the particle structure and surface area of
particles (powder and process-sampled)
of beryllium metal, beryllium oxide, and
copper-beryllium alloy. Each of these
samples was separated by aerodynamic
size, and their chemical compositions
and structures were determined with xray diffraction and transmission
electron microscopy, respectively. In
summary, beryllium-metal powder
varied remarkably from beryllium oxide
powder and alloy particles. The metal
powder consisted of compact particles,
in which SSA decreases with increasing
surface diameter. In contrast, the alloys
and oxides consisted of small primary
particles in clusters, in which the SSA
remains fairly constant with particle
size. SSA for the metal powders varied
based on production and manufacturing
process with variations among samples
PO 00000
Frm 00020
Fmt 4701
Sfmt 4702
as high as a factor of 37. Stefaniak et al.
(2003b) found lesser variation in SSA
for the alloys or oxides. This is
consistent with data from other studies
summarized above showing that process
may affect particle size and surface area.
Particle size and/or surface area may
explain differences in the rate of BeS
and CBD observed in some
epidemiological studies. However, these
properties have not been consistently
characterized in most studies.
B. Kinetics and Metabolism of Beryllium
Beryllium enters the body by
inhalation, ingestion, or absorption
through the skin. For occupational
exposure, the airways and the skin are
the primary routes of uptake.
1. Exposure via the Respiratory System
The respiratory tract, especially the
lung, is the primary target of inhalation
exposure in workers. Inhaled beryllium
particles are deposited along the
respiratory tract in a size dependent
manner. In general, particles larger than
10 mm tend to deposit in the upper
respiratory tract or nasal region and do
not appreciably penetrate lower in the
tracheobronchial or pulmonary regions
(Figure 1). Particles less than 10 mm
increasingly penetrate and deposit in
the tracheobronchial and pulmonary
regions with peak deposition in the
pulmonary region occurring below 5 mm
in particle diameter. The CBD pathology
of concern is found in the pulmonary
region. For particles below 1 mm,
regional deposition changes
dramatically. Ultrafine particles
(generally considered to be 100 nm or
lower) have a higher rate of deposition
along the entire respiratory system
(ICRP model, 1994). Those particles
depositing in the lung and along the
entire respiratory tract may encounter
immunologic cells or may move into the
vascular system where they are free to
leave the lung and can contribute to
systemic beryllium concentrations.
BILLING CODE 4510–26–C
E:\FR\FM\07AUP2.SGM
07AUP2
Beryllium is removed from the
respiratory tract by various clearance
mechanisms. Soluble beryllium is
removed from the respiratory tract via
absorption. Sparingly soluble or
insoluble beryllium may remain in the
lungs for many years after exposure, as
has been observed in workers (Schepers,
1962). Clearance mechanisms for
sparingly soluble or insoluble beryllium
particles include: In the nasal passage,
sneezing, mucociliary transport to the
throat, or dissolution; in the
tracheobronchial region, mucociliary
transport, coughing, phagocytosis, or
dissolution; in the pulmonary or
alveolar region, phagocytosis,
movement through the interstitium
(translocation), or dissolution
(Schlesinger, 1997).
Clearance mechanisms may occur
slowly in humans, which is consistent
with some animal studies. For example,
subjects in the Beryllium Case Registry
(BCR), which identifies and tracks cases
of acute and chronic beryllium diseases,
had elevated concentrations of
beryllium in lung tissue (e.g., 3.1 mg/g of
dried lung tissue and 8.5 mg/g in a
mediastinal node) more than 20 years
after termination of short-term
(generally between 2 and 5 years)
occupational exposure to beryllium
(Sprince et al., 1976).
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
Clearance rates may depend on the
solubility, dose, and size of the
beryllium particles inhaled as well as
the sex and species of the animal tested.
As reviewed in a WHO Report (2001),
more soluble beryllium compounds
generally tend to be cleared from the
respiratory system and absorbed into the
bloodstream more rapidly than less
soluble compounds (Van Cleave and
Kaylor, 1955; Hart et al., 1980; Finch et
al., 1990). Animal inhalation or
intratracheal instillation studies
administering soluble beryllium salts
demonstrated significant absorption of
approximately 20 percent of the initial
lung burden, while sparingly soluble
compounds such as beryllium oxide
demonstrated that absorption was
slower and less significant (Delic, 1992).
Additional animal studies have
demonstrated that clearance of soluble
and sparingly soluble beryllium
compounds was biphasic: A more rapid
initial mucociliary transport phase of
particles from the tracheobronchial tree
to the gastrointestinal tract, followed by
a slower phase via translocation to
tracheobronchial lymph nodes, alveolar
macrophages uptake, and beryllium
particles dissolution (Camner et al.,
1977; Sanders et al., 1978; Delic, 1992;
WHO, 2001). Confirmatory studies in
rats have shown the half-time for the
rapid phase between 1–60 days, while
PO 00000
Frm 00021
Fmt 4701
Sfmt 4702
47585
the slow phase ranged from 0.6–2.3
years. It was also shown that this
process was influenced by the solubility
of the beryllium compounds: Weeks/
months for soluble compounds, months/
years for sparingly soluble compounds
(Reeves and Vorwald, 1967; Reeves et
al., 1967; Zorn et al., 1977; Rhoads and
Sanders, 1985). Studies in guinea-pigs
and rats indicate that 40–50 percent of
the inhaled soluble beryllium salts are
retained in the respiratory tract. Similar
data could not be found for the
sparingly or less soluble beryllium
compounds or metal administered by
this exposure route. (WHO, 2001;
ATSDR, 2002).
Evidence from animal studies
suggests that greater amounts of
beryllium deposited in the lung may
result in slower clearance times. A
comparative study of rats and mice
using a single dose of inhaled
aerosolized beryllium metal
demonstrated that an acute inhalation
exposure to beryllium metal can slow
particle clearance and induce lung
damage in rats (Haley et al., 1990) and
mice (Finch et al., 1998a). In another
study Finch et al. (1994) exposed male
F344/N rats to beryllium metal at
concentrations resulting in beryllium
lung burdens of 1.8, 10, and 100 mg.
These exposure levels resulted in an
estimated clearance half-life ranging
E:\FR\FM\07AUP2.SGM
07AUP2
EP07AU15.000</GPH>
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
47586
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
from 250–380 days for the three
concentrations. For mice (Finch et al.,
1998a), lung clearance half-lives were
91–150 days (for 1.7- and 2.6-mg lung
burden groups) or 360–400 days (for 12and 34-mg lung burden groups). While
the lower exposure groups were quite
different for rats and mice, the highest
groups were similar in clearance halflives for both species.
Beryllium absorbed from the
respiratory system is mainly distributed
to the tracheobronchial lymph nodes via
the lymph system, bloodstream, and
skeleton, which is the ultimate site of
beryllium storage (Stokinger et al., 1953;
Clary et al., 1975; Sanders et al., 1975;
Finch et al., 1990). Trace amounts are
distributed throughout the body (Zorn et
al., 1977; WHO, 2001). Studies in rats
have demonstrated accumulation of
beryllium chloride in the skeletal
system following intraperitoneal
injection (Crowley et al., 1949; Scott et
al., 1950) and accumulation of
beryllium phosphate and beryllium
sulfate in both nonparenchymal and
parenchymal cells of the liver after
intravenous administration in rats
(Skilleter and Price, 1978). Studies have
also demonstrated intracellular
accumulation of beryllium oxide in
bone marrow throughout the skeletal
system after intravenous administration
to rabbits (Fodor, 1977; WHO, 2001).
Systemic distribution of the more
soluble compounds appears to be
greater than that of the insoluble
compounds (Stokinger et al., 1953).
Distribution has also been shown to be
dose dependent in research using
intravenous administration of beryllium
in rats; small doses were preferentially
taken up in the skeleton, while higher
doses were initially distributed
preferentially to the liver. Beryllium
was later mobilized from the liver and
transferred to the skeleton (IARC, 1993).
A half-life of 450 days has been
estimated for beryllium in the human
skeleton (ICRP, 1960). This indicates the
skeleton may serve as a repository for
beryllium that may later be reabsorbed
by the circulatory system, making
beryllium available to the
immunological system.
2. Dermal Exposure
Beryllium compounds have been
shown to cause skin irritation and
sensitization in humans and certain
animal models (Van Orstrand et al.,
1945; de Nardi et al., 1953; Nishimura
1966; Epstein 1990; Belman, 1969;
Tinkle et al., 2003; Delic, 1992). The
Agency for Toxic Substances and
Disease Registry (ATSDR) estimated that
less than 0.1 percent of beryllium
compounds are absorbed through the
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
skin (ATSDR, 2002). However, even
minute contact and absorption across
the skin may directly elicit an
immunological sensitization response
(Deubner et al., 2001; Toledo et al.,
2011). Recent studies by Tinkle et al.
(2003) showed that penetration of
beryllium oxide particles was possible
ex vivo for human intact skin at particle
sizes of ≤ 1mm, as confirmed by
scanning electron microscopy. Using
confocal microscopy, Tinkle et al.
demonstrated that surrogate fluorescent
particles up to 1 mm in size could
penetrate the mouse epidermis and
dermis layers in a model designed to
mimic the flexing and stretching of
human skin in motion. Other poorly
soluble particles, such as titanium
dioxide, have been shown to penetrate
normal human skin (Tan et al., 1996)
suggesting the flexing and stretching
motion as a plausible mechanism for
dermal penetration of beryllium as well.
As earlier summarized, insoluble forms
of beryllium can be solubilized in
biological fluids (e.g., sweat) making
them available for absorption through
intact skin (Sutton et al., 2003; Stefaniak
et al., 2011; Duling et al., 2012).
Although its precise role remains to
be elucidated, there is evidence to
indicate that dermal exposure can
contribute to beryllium sensitization. As
early as the 1940s it was recognized that
dermatitis experienced by workers in
primary beryllium production facilities
was linked to exposures to the soluble
beryllium salts. Except in cases of
wound contamination, dermatitis was
rare in workers whose exposures were
restricted to exposure to poorly soluble
beryllium-containing particles (Van
Ordstrand et al., 1945). Further
investigation by McCord in 1951
indicated that direct skin contact with
soluble beryllium compounds, but not
beryllium hydroxide or beryllium metal,
caused dermal lesions (reddened,
elevated, or fluid-filled lesions on
exposed body surfaces) in susceptible
persons. Curtis, in 1951, demonstrated
skin sensitization to beryllium with
patch testing using soluble and
insoluble forms of beryllium in
¨
beryllium-naıve subjects. These subjects
later developed granulomatous skin
lesions with the classical delayed-type
contact dermatitis following repeat
challenge (Curtis, 1951). These lesions
appeared after a latent period of 1–2
weeks, suggesting a delayed allergic
reaction. The dermal reaction occurred
more rapidly and in response to smaller
amounts of beryllium in those
individuals previously sensitized (Van
Ordstrand et al., 1945). Contamination
of cuts and scrapes with beryllium can
PO 00000
Frm 00022
Fmt 4701
Sfmt 4702
result in the beryllium becoming
embedded within the skin causing a
granuloma to develop in the skin
(Epstein, 1991). Introduction of soluble
or insoluble beryllium compounds into
or under the skin as a result of abrasions
or cuts at work has been shown to result
in chronic ulcerations with granuloma
formation (Van Orstrand et al., 1945;
Lederer and Savage, 1954). Beryllium
absorption through bruises and cuts has
been demonstrated as well (Rossman et
al., 1991). In a study by Invannikov et
al., (1982), beryllium chloride was
applied directly to the skin of live
animals with three types of wounds:
abrasions (superficial skin trauma), cuts
(skin and superficial muscle trauma),
and penetration wounds (deep muscle
trauma). The percentage of the applied
dose absorbed into the systemic
circulation during a 24-hour exposure
was significant, ranging from 7.8
percent to 11.4 percent for abrasions,
from 18.3 percent to 22.9 percent for
cuts, and from 34 percent to 38.8
percent for penetration wounds (WHO,
2001).
A study by Deubner et al., (2001)
concluded that exposure across
damaged skin can contribute as much
systemic loading of beryllium as
inhalation (Deubner et al., 2001).
Deubner et al., (2001) estimated dermal
loading (amount of particles penetrating
into the skin) in workers as compared to
inhalation exposure. Deubner’s
calculations assumed a dermal loading
rate for beryllium on skin of 0.43 mg/
cm2, based on the studies of loading on
skin after workers cleaned up
(Sanderson et al., 1999), multiplied by
a factor of 10 to approximate the
workplace concentrations and the very
low absorption rate of 0.001 percent
(taken from EPA estimates). It should be
noted that these calculations did not
take into account absorption of soluble
beryllium salts that might occur across
nasal mucus membranes, which may
result from contact between
contaminated skin and the nose (EPA,
1998).
A study conducted by Day et al.
(2007) evaluated the effectiveness of a
dermal protection program
implemented in a beryllium alloy
facility in 2002. The investigators
evaluated levels of beryllium in air, on
workplace surfaces, on cotton gloves
worn over nitrile gloves, and on the
necks and faces of workers over a six
day period. The investigators found a
good correlation between air samples
and work surface contamination at this
facility. The investigators also found
measurable levels of beryllium on the
skin of workers as a result of work
processes even from workplace areas
E:\FR\FM\07AUP2.SGM
07AUP2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
promoted as ‘‘visually clean’’ by the
company housekeeping policy.
Importantly, the investigators found that
the beryllium contamination could be
transferred from body region to body
region (e.g., hand to face, neck to face).
The investigators demonstrated multiple
pathways of exposure which could lead
to sensitization, increasing risk for
developing CBD (Day, et al., 2007).
The same group of investigators
(Armstrong et al., 2014) extended their
work on investigating multiple exposure
pathways contributing to sensitization
and CBD. The investigators evaluated
four different beryllium manufacturing
and processing facilities to assess the
contribution of various exposure
pathways on worker exposure.
Airborne, work surface and cotton glove
beryllium concentrations were
evaluated. The investigators found
strong correlations between air-surface
concentrations, glove-surface
concentrations, and air-glove
concentrations at this facility. This work
confirms findings from Day et al. (2007)
demonstrating the importance of
airborne beryllium concentrations to
surface contamination and dermal
exposure even at exposures below the
current OSHA PEL (Armstrong et al.,
2014).
3. Oral and Gastrointestinal Exposure
According to the WHO Report (2001),
gastrointestinal absorption of beryllium
can occur by both the inhalation and
oral routes of exposure. Through
inhalation exposure, a fraction of the
inhaled material is transported to the
gastrointestinal tract by the mucociliary
escalator or by the swallowing of the
insoluble material deposited in the
upper respiratory tract (WHO, 2001).
Gastrointestinal absorption of beryllium
can occur by both the inhalation and
oral routes of exposure. In the case of
inhalation, a portion of the inhaled
material is transported to the
gastrointestinal tract by the mucociliary
escalator or by the swallowing of the
insoluble material deposited in the
upper respiratory tract (Schlesinger,
1997). Animal studies have shown oral
administration of beryllium compounds
to result in very limited absorption and
storage (as reviewed by U.S. EPA, 1998).
In animal ingestion studies using radiolabeled beryllium chloride in rats, mice,
dogs, and monkeys, the vast majority of
the ingested dose passed through the
gastrointestinal tract unabsorbed and
was excreted in the feces. In most
studies, <1 percent of the administered
radioactivity was absorbed into the
bloodstream and subsequently excreted
in the urine (Crowley et al., 1949;
Furchner et al., 1973; LeFevre and Joel,
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
1986). Research using soluble beryllium
sulfate has shown that as the compound
passes into the intestine, which has a
higher pH than the stomach
(approximate pH of 6 to 8 for the
intestine, pH of 1 or 2 for the stomach),
the beryllium is precipitated as the
insoluble phosphate and thus is no
longer available for absorption (Reeves,
1965; WHO, 2001).
Urinary excretion of beryllium has
been shown to correlate with the
amount of occupational exposure
(Klemperer et al., 1951). Beryllium that
is absorbed into the bloodstream is
excreted primarily in the urine (Crowley
et al., 1949; Scott et al., 1950; Furchner
et al., 1973; Stiefel et al., 1980), whereas
excretion of unabsorbed beryllium is
primarily via the fecal route (Hart et al.,
1980; Finch et al., 1990). A far higher
percentage of the beryllium
administered parenterally in various
animal species was eliminated in the
urine than in the feces (Crowley et al.,
1949; Scott et al., 1950; Furchner et al.,
1973), confirming that beryllium found
in the feces following oral exposure is
primarily unabsorbed material. A study
using percutaneous incorporation of
soluble beryllium nitrate in rats
similarly demonstrated that more than
90 percent of the beryllium in the
bloodstream was eliminated via urine
(Zorn et al., 1977; WHO, 2001). More
than 99 percent of ingested beryllium
chloride was excreted in the feces
(Mullen et al., 1972). Elimination halftimes of 890–1,770 days (2.4–4.8 years)
were calculated for mice, rats, monkeys,
and dogs injected intravenously with
beryllium chloride (Furchner et al.,
1973). Mean daily excretion of
beryllium metal was 4.6 × 10¥5 percent
of the dose administered by
intratracheal instillation in baboons and
3.1 × 10¥5 percent in rats (Andre et al.,
1987).
4. Metabolism
Beryllium and its compounds are not
metabolized or biotransformed, but
soluble beryllium salts may be
converted to less soluble forms in the
lung (Reeves and Vorwald, 1967). As
stated earlier, solubility is an important
factor for persistence of beryllium in the
lung. Insoluble beryllium, engulfed by
activated phagocytes, can be ionized by
an acidic environment and by
myeloperoxidases (Leonard and
Lauwerys, 1987; Lansdown, 1995;
WHO, 2001), and this positive charge
could potentially make it more
biologically reactive because it may
allow the beryllium to bind to a peptide
or protein and be presented to the T cell
receptor or antigen-presenting cell
(Fontenot, 2000).
PO 00000
Frm 00023
Fmt 4701
Sfmt 4702
47587
5. Preliminary Conclusion for Particle
Characterization and Kinetics of
Beryllium
The forms and concentrations of
beryllium across the workplace vary
substantially based upon location,
process, production and work task.
Many factors influence the potency of
beryllium including concentration,
composition, structure, size and surface
area of the particle.
Studies have demonstrated that
beryllium sensitization can occur via
the skin or inhalation from soluble or
poorly soluble beryllium particles.
Beryllium must be presented to a cell in
a soluble form for activation of the
immune system (NAS, 2008), and this
will be discussed in more detail in the
section to follow. Poorly soluble
beryllium can be solubilized via
intracellular fluid, lung fluid and sweat
(Sutton et al., 2003; Stefaniak et al.,
2011). For beryllium to persist in the
lung it needs to be insoluble. However,
soluble beryllium has been shown to
precipitate in the lung to form insoluble
beryllium (Reeves and Vorwald, 1967).
Some animal and epidemiological
studies suggest that the form of
beryllium may affect the rate of
development of BeS and CBD.
Beryllium in an inhalable form (either
as soluble or insoluble particles or mist)
can deposit in the respiratory tract and
interact with immune cells located
along the entire respiratory tract
(Scheslinger, 1997). However, more
study is needed to precisely determine
the physiochemical characteristics of
beryllium that influence toxicity and
immunogenicity.
C. Acute Beryllium Diseases
Acute beryllium disease (ABD) is a
relatively rapid onset inflammatory
reaction resulting from breathing high
airborne concentrations of beryllium. It
was first reported in workers extracting
beryllium oxide (Van Ordstrand et al.,
1943). Since the Atomic Energy
Commission’s adoption of occupational
exposure limits for beryllium beginning
in 1949, cases of ABD have been rare.
According to the World Health
Organization (2001), ABD is generally
associated with exposure to beryllium
levels at or above 100 mg/m3 and may
be fatal in 10 percent of cases. However,
cases have been reported with beryllium
exposures below 100 mg/m3 (Cummings
et al., 2009). The disease involves an
inflammatory reaction that may include
the entire respiratory tract, involving the
nasal passages, pharynx, bronchial
airways and alveoli. Other tissues
including skin and conjunctivae may be
affected as well. The clinical features of
E:\FR\FM\07AUP2.SGM
07AUP2
47588
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
ABD include a nonproductive cough,
chest pain, cyanosis, shortness of
breath, low-grade fever and a sharp drop
in functional parameters of the lungs.
Pathological features of ABD include
edematous distension, round cell
infiltration of the septa, proteinaceous
materials, and desquamated alveolar
cells in the lung. Monocytes,
lymphocytes and plasma cells within
the alveoli are also characteristic of the
acute disease process (Freiman and
Hardy, 1970).
Two types of acute beryllium disease
have been characterized in the
literature: a rapid and severe course of
acute fulminating pneumonitis
generally developing within 48 to 72
hours of a massive exposure, and a
second form that takes several days to
develop from exposure to lower
concentrations of beryllium (still above
the levels set by regulatory and
guidance agencies) (Hall, 1950; DeNardi
et al., 1953; Newman and Kreiss, 1992).
Evidence of a dose-response
relationship to the concentration of
beryllium is limited (Eisenbud et al.,
1948; Stokinger, 1950; Sterner and
Eisenbud, 1951). Recovery from either
type of ABD is generally complete after
a period of several weeks or months
(DeNardi et al., 1953). However, deaths
have been reported in more severe cases
(Freiman and Hardy, 1970). There have
been documented cases of progression
to CBD (ACCP, 1965; Hall, 1950)
suggesting the possibility of an immune
component to this disease (Cummings et
al., 2009) as well. According to the BCR,
in the United States, approximately 17
percent of ABD patients developed CBD
(BCR, 2010). The majority of ABD cases
occurred between 1932 and 1970
(Eisenbud, 1983; Middleton, 1998). ABD
is extremely rare in the workplace today
due to more stringent exposure controls
implemented following occupational
and environmental standards set in
1970–1972 (OSHA, 1971; ACGIH, 1971;
ANSI, 1970) and 1974 (EPA, 1974).
D. Chronic Beryllium Disease
This section provides an overview of
the immunology and pathogenesis of
BeS and CBD, with particular attention
to the role of skin sensitization, particle
size, beryllium compound solubility,
and genetic variability in individuals’
susceptibility to beryllium sensitization
and CBD.
Chronic beryllium disease (CBD),
formerly known as ‘‘berylliosis’’ or
‘‘chronic berylliosis,’’ is a
granulomatous disorder primarily
affecting the lungs. CBD was first
described in the literature by Hardy and
Tabershaw (1946) as a chronic
granulomatous pneumonitis. It was
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
proposed as early as 1951 that CBD
could be a chronic disease resulting
from an immune sensitization to
beryllium (Sterner and Eisenbud, 1951;
Curtis, 1959; Nishimura, 1966).
However, for a time, there remained
some controversy as to whether CBD
was a delayed-onset hypersensitivity
disease or a toxicant-induced disease
(NAS, 2008). Wide acceptance of CBD as
a hypersensitivity lung disease did not
occur until bronchoscopy studies and
bronchoalveolar lavage (BAL) studies
were performed demonstrating that BAL
cells from CBD patients responded to
beryllium challenge (Epstein et al.,
1982; Rossman et al., 1988; Saltini et al.,
1989).
CBD shares many clinical and
histopathological features with
pulmonary sarcoidosis, a granulomatous
lung disease of unknown etiology. This
includes such debilitating effects as
airway obstruction, diminishment of
physical capacity associated with
reduced lung function, possible
depression associated with decreased
physical capacity, and decreased life
expectancy. Without appropriate
information, CBD may be difficult to
distinguish from sarcoidosis. It is
estimated that up to 6 percent of all
patients diagnosed with sarcoidosis may
actually have CBD (Fireman et al., 2003;
Rossman and Kreiber, 2003). Among
patients diagnosed with sarcoidosis in
which beryllium exposure can be
confirmed, as many as 40 percent may
actually have CBD (Muller-Quernheim
et al., 2006; Cherry et al., 2015).
Clinical signs and symptoms of CBD
may include, but are not limited to, a
simple cough, shortness of breath or
dypsnea, fever, weight loss or anorexia,
skin lesions, clubbing of fingers,
cyanosis, night sweats, cor pulmonale,
tachycardia, edema, chest pain and
arthralgia. Changes or loss of pulmonary
function also occur with CBD such as
decrease in vital capacity, reduced
diffusing capacity, and restrictive
breathing patterns. The signs and
symptoms of CBD constitute a
continuum of symptoms that are
progressive in nature with no clear
demarcation between any stages in the
disease (Rossman, 1996; NAS, 2008).
Besides these listed symptoms from
CBD patients, there have been reported
cases of CBD that remained
asymptomatic (Muller-Querheim, 2005;
NAS, 2008).
Unlike ABD, CBD can result from
inhalation exposure to beryllium at
levels below the current OSHA PEL, can
take months to years after initial
beryllium exposure before signs and
symptoms of CBD occur (Newman 1996,
2005 and 2007; Henneberger, 2001;
PO 00000
Frm 00024
Fmt 4701
Sfmt 4702
Seidler et al., 2012; Schuler et al., 2012),
and may continue to progress following
removal from beryllium exposure
(Newman, 2005; Sawyer et al., 2005;
Seidler et al., 2012). Patients with CBD
can progress to a chronic obstructive
lung disorder resulting in loss of quality
of life and the potential for decreased
life expectancy (Rossman, et al., 1996;
Newman et al., 2005). The NAS report
(2008) noted the general lack of
published studies on progression of
CBD from an early asymptomatic stage
to functionally significant lung disease
(NAS, 2008). The report emphasized
that risk factors and time course for
clinical disease have not been fully
delineated. However, for people now
under surveillance, clinical progression
from immunological sensitization and
early pathological lesions (i.e.,
granulomatous inflammation) prior to
onset of symptoms to symptomatic
disease appears to be slow, although
more follow-up is needed (NAS, 2008).
A study by Newman (1996) emphasized
the need for prospective studies to
determine the natural history and time
course from BeS and asymptomatic CBD
to full-blown disease (Newman, 1996).
Drawing from his own clinical
experience, Newman was able to
identify the sequence of events for those
with symptomatic disease as follows:
Initial determination of beryllium
sensitization; gradual emergence of
chronic inflammation of the lung;
pathologic alterations with measurable
physiologic changes (e.g., pulmonary
function and gas exchange); progression
to a more severe lung disease (with
extrapulmonary effects such as clubbing
and cor pulmonale in some cases); and
finally death in some cases (reported
between 5.8 to 38 percent) (NAS, 2008;
Newman, 1996).
In contrast to some occupationally
related lung diseases, the early detection
of chronic beryllium disease may be
useful since treatment of this condition
can lead not only to regression of the
signs and symptoms, but also may
prevent further progression of the
disease in certain individuals
(Marchand-Adam, 2008; NAS, 2008).
The management of CBD is based on the
hypothesis that suppression of the
hypersensitivity reaction (i.e.,
granulomatous process) will prevent the
development of fibrosis. However, once
fibrosis has developed, therapy cannot
reverse the damage.
To date, there have been no controlled
studies to determine the optimal
treatment for CBD (Rossman, 1996; NAS
2008; Sood, 2009). Management of CBD
is generally modeled after sarcoidosis
treatment. Oral corticosteroid treatment
can be initiated in patients with
E:\FR\FM\07AUP2.SGM
07AUP2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
evidence of disease (either by
bronchoscopy or other diagnostic
measures before progression of disease
or after clinical signs of pulmonary
deterioration occur). This includes
treatment with other anti-inflammatory
agents (NAS, 2008; Maier et al., 2012;
Salvator et al., 2013) as well. It should
be noted, however, that treatment with
corticosteroids has side-effects of their
own that need to be measured against
the possibility of progression of disease
(Gibson et al., 1996; Zaki et al., 1987).
Alternative treatments such as
azathiopurine and infliximab, while
successful at treating symptoms of CBD,
have been demonstrated to have sideeffects as well (Pallavicino et al., 2013;
Freeman, 2012).
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
1. Development of Beryllium
Sensitization
Sensitization to beryllium is an
essential step for worker development of
CBD. Sensitization to beryllium can
result from inhalation exposure to
beryllium (Newman et al., 2005; NAS,
2008), as well as from skin exposure to
beryllium (Curtis, 1951; Newman et al.,
1996; Tinkle et al., 2003). Sensitization
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
is currently detected using a laboratory
blood test described in Appendix A.
Although there may be no clinical
symptoms associated with BeS, a
sensitized worker’s immune system has
been activated to react to beryllium
exposures such that subsequent
exposure to beryllium can progress to
serious lung disease (Kreiss et al., 1996;
Kreiss et al., 1997; Kelleher et al., 2001;
and Rossman, 2001). Since the
pathogenesis of CBD involves a
beryllium-specific, cell-mediated
immune response, CBD cannot occur in
the absence of sensitization (NAS,
2008). Various factors, including genetic
susceptibility, have been shown to
influence risk of developing
sensitization and CBD (NAS 2008) and
will be discussed later in this section.
While various mechanisms or
pathways may exist for beryllium
sensitization, the most plausible
mechanisms supported by the best
available and most current science are
discussed below. Sensitization occurs
via the formation of a beryllium-protein
complex (an antigen) that causes an
immunological response. In some
instances, onset of sensitization has
PO 00000
Frm 00025
Fmt 4701
Sfmt 4702
47589
been observed in individuals exposed to
beryllium for only a few months
(Kelleher et al., 2001; Henneberger et
al., 2001). This suggests the possibility
that relatively brief, short-term
beryllium exposures may be sufficient
to trigger the immune hypersensitivity
reaction. Several studies (Newman et
al., 2001; Henneberger et al., 2001;
Rossman, 2001; Schuler et al., 2005;
Donovan et al., 2007, Schuler et al.,
2012) have detected a higher prevalence
of sensitization among workers with less
than one year of employment compared
to some cross-sectional studies which,
due to lack of information regarding
initial exposure, cannot determine time
of sensitization (Kreiss et al., 1996;
Kreiss et al., 1997). While only very
limited evidence has described humoral
changes in certain patients with CBD
(Cianciara et al., 1980), clear evidence
exists for an immune cell-mediated
response, specifically the T-cell (NAS,
2008). Figure 2 delineates the major
steps required for progression from
beryllium contact to sensitization to
CBD.
BILLING CODE 4510–26–P
E:\FR\FM\07AUP2.SGM
07AUP2
47590
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
BILLING CODE 4510–26–C
Beryllium presentation to the immune
system is believed to occur either by
direct presentation or by antigen
processing. It has been postulated that
beryllium must be presented to the
immune system in an ionic form for
cell-mediated immune activation to
occur (Kreiss et al., 2007). Some soluble
forms of beryllium are readily
presented, since the soluble beryllium
form disassociates into its ionic
components. However, for insoluble
forms, dissolution may need to occur. A
study by Harmsen et al. (1986)
suggested that a sufficient rate of
dissolution of small amounts of poorly
soluble beryllium compounds might
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
occur in the lungs to allow persistent
low-level beryllium presentation to the
immune system. Stefaniak et al. (2005
and 2012) reported that insoluble
beryllium particles phagocytized by
macrophages were dissolved in
phagolysomal fluid (Stefaniak et al.,
2005; Stefaniak et al., 2012) and that the
dissolution rate stimulated by
phagolysomal fluid was different for
various forms of beryllium (Stefaniak et
al., 2006; Duling et al., 2012). Several
studies have demonstrated that
macrophage uptake of beryllium can
induce aberrant apoptotic processes
leading to the continued release of
beryllium ions which will continually
stimulate T-cell activation (Sawyer et
PO 00000
Frm 00026
Fmt 4701
Sfmt 4702
al., 2000; Sawyer et al., 2004; Kittle et
al., 2002). Antigen processing can be
mediated by antigen-presenting cells
(APC). These may include macrophages,
dendritic cells, or other antigenpresenting cells, although this has not
been well defined in most studies (NAS,
2008).
Because of their strong positive
charge, beryllium ions have the ability
to haptenate and alter the structure of
peptides occupying the antigen-binding
cleft of major histocompatibility
complex (MHC) class II on antigenpresenting cells (APC). The MHC class
II antigen-binding molecule for
beryllium is the human leukocyte
antigen (HLA) with specific alleles (e.g.,
E:\FR\FM\07AUP2.SGM
07AUP2
EP07AU15.001</GPH>
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
47591
bond with the Be-O-Be molecule when
the pH of the substrate is neutral (Keizer
et al., 2005). The direct binding of BeO
may eliminate the biological
requirement for antigen processing or
dissolution of beryllium oxide to
activate an immune response.
Next in sequence is the berylliumMHC–APC complex binding to a T-cell
¨
receptor (TCR) on a naıve T-cell which
stimulates the proliferation and
accumulation of beryllium-specific
CD4+ (cluster of differentiation 4+) Tcells (Saltini et al., 1989 and 1990;
Martin et al., 2011) as depicted in Figure
3. Fontenot et al. (1999) demonstrated
that diversely different variants of TCR
were expressed by CD4+ T-cells in
peripheral blood cells of CBD patients.
However, the CD4+ T-cells from the lung
were more homologous in expression of
TCR variants in CBD patients,
suggesting clonal expansion of a subset
of T-cells in the lung (Fontenot et al.,
1999). This may also indicate a
pathogenic potential for subsets of Tcell clones expressing this homologous
TCR (NAS, 2008). Fontenot et al. (2006)
reported beryllium self-presentation by
HLA–DP expressing BAL CD4+ T-cells.
Self-presentation by BAL T-cells in the
lung granuloma may result in
activation-induced cell death, which
may then lead to oligoclonality of the Tcell population characteristic of CBD
(NAS, 2008).
As CD4+ T-cells proliferate, clonal
expansion of various subsets of the
CD4+ beryllium specific T-cells occurs
(Figure 3). In the peripheral blood, the
beryllium-specific CD4+ T cells require
co-stimulation with a co-stimulant CD28
(cluster of differentiation 28). During the
proliferation and differentiation process
CD4+ T-cells secrete pro-inflammatory
cytokines that may influence this
process (Sawyer et al., 2004; Kimber et
al., 2011).
cytokines necessary for additional
recruitment of inflammatory and
immunological cells; however, they
were less proliferative and less
susceptible to cell death compared to
the CD28 dependent cells (Fontenot et
al., 2005; Mack et al., 2008). These
beryllium-specific CD4+ independent
cells are considered to be mature
memory effector cells (Ndejembi et al.,
2006; Bian et al., 2005). Repeat exposure
to beryllium in the lung resulting in a
mature population of T cell
development independent of costimulation by CD28 and development
of a population of T effector memory
cells (Tem cells) may be one of the
mechanisms that lead to the more severe
reactions observed specifically in the
lung (Fontenot et al., 2005).
CD4+ T cells created in the
sensitization process recognize the
beryllium antigen, and respond by
proliferating and secreting cytokines
and inflammatory mediators, including
IL–2, IFN-g, and TNF-a (Tinkle et al.,
1997a and b; Fontenot et al., 2002) and
MIP–1a and GRO–1 (Hong-Geller,
2006). This also results in the
accumulation of various types of
inflammatory cells including
mononuclear cells (mostly CD4+ T cells)
in the bronchoalveolar lavage fluid
(BAL fluid) (Saltini et al., 1989, 1990).
The development of granulomatous
inflammation in the lung of CBD
patients has been associated with the
accumulation of beryllium responsive
CD4+ Tem cells in BAL fluid (NAS,
2008). The subsequent release of proinflammatory cytokines, chemokines
and reactive oxygen species by these
cells may lead to migration of additional
inflammatory/immune cells and the
development of a microenvironment
that contributes to the development of
CBD (Sawyer et al., 2005; Tinkle et al.,
1996; Hong-Geller et al., 2006; NAS,
2008).
The cascade of events described above
results in the formation of a
noncaseating granulomatous lesion.
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
2. Development of CBD
The continued persistence of residual
beryllium in the lung leads to a T-cell
maturation process. A large portion of
beryllium-specific CD4+ T cells were
shown to cease expression of CD28
mRNA and protein, indicating these
cells no longer required co-stimulation
with the CD28 ligand (Fontenot et al.,
2003). This change in phenotype
correlated with lung inflammation
(Fontenot et al., 2003). The CD4+
independent cells continued to secrete
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
PO 00000
Frm 00027
Fmt 4701
Sfmt 4702
E:\FR\FM\07AUP2.SGM
07AUP2
EP07AU15.002</GPH>
HLA–DP, HLA–DR, HLA–DQ)
associated with the progression to CBD
(NAS, 2008; Yucesoy and Johnson,
2011). Several studies have also
demonstrated that the electrostatic
charge of HLA may be a factor in
binding beryllium (Snyder et al., 2003;
Bill et al., 2005; Dai et al., 2010). The
strong positive ionic charge of the
beryllium ion would have a strong
attraction for the negatively charged
patches of certain HLA alleles (Snyder
et al., 2008; Dai et al., 2010).
Alternatively, beryllium oxide has been
demonstrated to bind to the MHC class
II receptor in a neutral pH. The six
carboxylates in the amino acid sequence
of the binding pocket provide a stable
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47592
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
Release of cytokines by the
accumulating T cells leads to the
formation of granulomatous lesions that
are characterized by an outer ring of
histiocytes surrounding non-necrotic
tissue with embedded multi-nucleated
giant cells (Saltini et al., 1989, 1990).
Over time, the granulomas spread and
can lead to lung fibrosis and abnormal
pulmonary function, with symptoms
including a persistent dry cough and
shortness of breath (Saber and Dweik,
2000). Fatigue, night sweats, chest and
joint pain, clubbing of fingers (due to
impaired oxygen exchange), loss of
appetite or unexplained weight loss,
and cor pulmonale have been
experienced in certain patients as the
disease progresses (Conradi et al., 1971;
ACCP, 1965; Kriebel et al., 1988a and b).
While CBD primarily affects the lungs,
it can also involve other organs such as
the liver, skin, spleen, and kidneys
(ATSDR, 2002).
As previously mentioned, the uptake
of beryllium may lead to an aberrant
apoptotic process with rerelease of
beryllium ions and continual
stimulation of beryllium-responsive
CD4∂ cells in the lung (Sawyer et al.,
2000; Kittle et al., 2002; Sawyer et al.,
2004). Several research studies suggest
apoptosis may be one mechanism that
enhances inflammatory cell recruitment,
cytokine production and inflammation,
thus creating a scenario for progressive
granulomatous inflammation (Palmer et
al., 2008; Rana, 2008). Macrophages and
neutrophils can phagocytize beryllium
particles in an attempt to remove the
beryllium from the lung (Ding, et al.,
2009). Multiple studies (Sawyer et al.,
2004; Kittle et al., 2002) using BAL cells
(mostly macrophages and neutrophils)
from patients with CBD found that in
vitro stimulation with beryllium sulfate
induced the production of TNF-a (one
of many cytokines produced in response
to beryllium), and that production of
TNF-a might induce apoptosis in CBD
and sarcoidosis patients (Bost et al.,
1994; Dai et al., 1999). The stimulation
of CBD-derived macrophages by
beryllium sulphate resulted in cells
becoming apoptotic, as measured by
propidium iodide. These results were
confirmed in a mouse macrophage cellline (p388D1) (Sawyer et al., 2000).
However, other factors may influence
the development of CBD and are
outlined in the following section.
3. Genetic and Other Susceptibility
Factors
Evidence from a variety of sources
indicates genetic susceptibility may
play an important role in the
development of CBD in certain
individuals, especially at levels low
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
enough not to invoke a response in
other individuals. Early occupational
studies proposed that CBD was an
immune reaction based on the high
susceptibility of some individuals to
become sensitized and progress to CBD
and the lack of CBD in others who were
exposed to levels several orders of
magnitude higher (Sterner and
Eisenbud, 1951). Additional in vitro
human research has identified genes
coding for specific protein molecules on
the surface of their immune cells that
place carriers at greater risk of becoming
sensitized to beryllium and developing
CBD (McCanlies et al., 2004). Recent
studies have confirmed genetic
susceptibility to CBD involves either
HLA variants, T-cell receptor clonality,
tumor necrosis factor (TNF-a)
polymorphisms and/or transforming
growth factor-beta (TGF-b)
polymorphisms (Fontenot et al., 2000;
Amicosante et al., 2005; Tinkle et al.,
1996; Gaede et al., 2005; Van Dyke et
al., 2011; Silveira et al., 2012).
Single Nucleotide Polymorphisms
(SNPs) have been studied with regard to
genetic variations associated with
increased risk of developing CBD. SNPs
are the most abundant type of human
genetic variation. Polymorphisms in
MHC class II and pro-inflammatory
genes have been shown to contribute to
variations in immune responses
contributing to the susceptibility and
resistance in many diseases including
auto-immunity, and beryllium
sensitization and CBD (McClesky et al.,
2009). Specific SNPs have been
evaluated as a factor in Glu69 variant
from the HLA–DPB1 locus (Richeldi et
al., 1993; Cai et al., 2000; Saltini et al.,
2001; Silviera et al., 2012; Dai et al.,
2013), HLA–DRPheb47 (Amicosante et
al., 2005).
HLA–DPB1 with a glutamic acid at
amino position 69 (Glu 69) has been
shown to confer increased risk of
beryllium sensitization and CBD
(Richeldi et al., 1993; Saltini et al.,
2001; Amicosante et al., 2005; Van Dyke
et al., 2011; Silveira et al., 2012).
Fontenot et al. (2000) demonstrated that
beryllium presentation by certain alleles
of the class II human leukocyte antigenDP (HLA–DP) to CD4+ T cells is the
mechanism underlying the development
of CBD. Richeldi et al. (1993) reported
a strong association between the MHC
class II allele HLA–DP 1 and the
development of CBD in berylliumexposed workers from a Tucson, AZ
facility. This marker was found in 32 of
the 33 workers who developed CBD, but
in only 14 of 44 similarly exposed
workers without CBD. The more
common allele of the HLA–DP 1 variant
is negatively charged at this site and
PO 00000
Frm 00028
Fmt 4701
Sfmt 4702
could directly interact with the
positively charged beryllium ion. The
high percentage (∼30 percent) of
beryllium-exposed workers without
CBD who had this allele indicates that
other factors also contribute to the
development of CBD (EPA, 1998).
Additional studies by Amicosante et al.
(2005) using blood lymphocytes derived
from beryllium-exposed workers found
a high frequency of this gene in those
sensitized to beryllium. In a study of 82
CBD patients (beryllium-exposed
workers), Stubbs et al. (1996) also found
a relationship between the HLA–DP 1
allele and BeS. The glutamate-69 allele
was present in 86 percent of sensitized
subjects, but in only 48 percent of
beryllium-exposed, non-sensitized
subjects. Some variants of the HLA–
DPB1 allele convey higher risk of BeS
and CBD than others. For example,
HLA–DPB1*0201 yielded an
approximately 3-fold increase in disease
outcome relative to controls; HLA–
DPB1*1901 yielded an approximately 5fold increase, and HLA–DPB1*1701 an
approximately 10-fold increase (Weston
et al., 2005; Snyder et al., 2008). By
assigning odds ratios for specific alleles
on the basis of previous studies
discussed above, the researchers found
a strong correlation (88 percent)
between the reported risk of CBD and
the predicted surface electrostatic
potential and charge of the isotypes of
the genes. They were able to conclude
that the alleles associated with the most
negatively charged proteins carry the
greatest risk of developing beryllium
sensitization and CBD. This confirms
the importance of beryllium charge as a
key factor in haptogenic potential.
In contrast, the HLA–DRB1 allele,
which lacks Glu 69, has also been
shown to increase the risk of developing
sensitization and CBD (Amicosante et
al., 2005; Maier et al., 2003). Bill et al.
(2005) found that HLA–DR has a
glutamic acid at position 71 of the b
chain, functionally equivalent to the Glu
69 of HLA–DP (Bill et al., 2005).
Associations with BeS and CBD have
also been reported with the HLA–DQ
markers (Amicosante et al., 2005; Maier
et al., 2003). Stubbs et al. also found a
biased distribution of the MHC class II
HLA–DR gene between sensitized and
non-sensitized subjects. Neither of these
markers was completely specific for
CBD, as each study found beryllium
sensitization or CBD among individuals
without the genetic risk factor. While
there remains uncertainty as to which of
the MHC class II genes interact directly
with the beryllium ion, antibody
inhibition data suggest that the HLA–DR
gene product may be involved in the
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
presentation of beryllium to T
lymphocytes (Amicosante et al., 2002).
In addition, antibody blocking
experiments revealed that anti-HLA–DP
strongly reduced proliferation responses
and cytokine secretion by BAL CD4 T
cells (Chou et al., 2005). In the study by
Chou (2005), anti-HLA–DR ligand
antibodies mainly affected berylliuminduced proliferation responses with
little impact on cytokines other than IL–
2, thus implying that nonproliferating
BAL CD4 T cells may still contribute to
inflammation leading to the progression
of CBD (Chou et al., 2005).
TNF alpha (TNF-a) polymorphisms
and TGF beta (TGF-b) polymorphisms
have also been shown to confer a
genetic susceptibility for developing
CBD in certain individuals. TNF-a is a
pro-inflammatory cytokine associated
with a more severe pulmonary disease
in CBD (NAS, 2008). Beryllium
exposure has been shown to upregulate
transcription factors AP–1 and NF-kB
(Sawyer et al., 2007) inducing an
inflammatory response by stimulating
production of pro-inflammatory
cytokines such as TNF-a by
inflammatory cells. Polymorphisms in
the 308 position of the TNF-a gene have
been demonstrated to increase
production of the cytokine and increase
severity of disease (Maier et al., 2001;
Saltini et al., 2001; Dotti et al., 2004).
While a study by McCanlies et al. (2007)
found no relationship between TNF-a
polymorphism and BeS or CBD, the
inconsistency may be due to
misclassification, exposure differences
or statistical power (NAS, 2008).
Other genetic variations have been
shown to be associated with increased
risk of beryllium sensitization and CBD
(NAS, 2008). These include TGF-b
(Gaede et al., 2005), angiotensin-1
converting enzyme (ACE) (Newman et
al., 1992; Maier et al., 1999) and an
enzyme involved in glutathione
synthesis (glutamate cysteine ligase)
(Bekris et al., 2006). McCanlies et al.
(2010) evaluated the association
between polymorphisms in a select
group of interleukin genes (IL–1A; IL–
1B, IL–1RN, IL–2, IL–9, IL–9R) due to
their role in immune and inflammatory
processes. The study evaluated SNPs in
three groups of workers from large
beryllium manufacturing facilities in
OH and AZ. The investigators found a
significant association between variants
IL–1A–1142, IL–1A–3769 and IL–1A–
4697 and CBD but not with beryllium
sensitization. However, these still
require confirmation in larger studies
(NAS, 2008).
In addition to the genetic factors
which may contribute to the
susceptibility and severity of disease,
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
other factors such as smoking and
gender may play a role in the
development of CBD (NAS, 2008). A
recent longitudinal cohort study by
Mroz et al. (2009) of 229 individuals
identified with beryllium sensitization
or CBD through workplace medical
surveillance found that the prevalence
of CBD among ever smokers was
significantly lower than among never
smokers (38.1 percent versus 49.4
percent, p=0.025). BeS subjects that
never smoked were found to be more
likely to develop CBD over the course of
the study compared to current smokers
(12.6 percent versus 6.4 percent,
p=0.10). The authors suggested smoking
may confer a protective effect against
development of lung granulomas as has
been demonstrated with
hypersensitivity pneumonitis (Mroz et
al., 2009).
4. Beryllium Sensitization and CBD in
the Workforce
Sensitization to beryllium is currently
detected in the workforce with the
beryllium lymphocyte proliferation test
(BeLPT), a laboratory blood test
developed in the 1980s, also referred to
as the LTT (Lymphocyte Transformation
Test) or BeLT (Beryllium Lymphocyte
Transformation Test). In this test,
lymphocytes obtained from either
bronchoalveolar lavage fluid (the BAL
BeLPT) or from peripheral blood (the
blood BeLPT) are cultured in vitro and
exposed to beryllium sulfate to
stimulate lymphocyte proliferation. The
observation of beryllium-specific
proliferation indicates beryllium
sensitization. Hereafter, ‘‘BeLPT’’
generally refers to the blood BeLPT,
which is typically used in screening for
beryllium sensitization. This test is
described in more detail in subsection
D.5.b.
CBD can be detected at an
asymptomatic stage by a number of
techniques including bronchoalveolar
lavage and biopsy (Cordeiro et al., 2007;
Maier, 2001). Bronchoalveolar lavage is
a method of ‘‘washing’’ the lungs with
fluid inserted via a flexible fiberoptic
instrument known as a bronchoscope,
removing the fluid and analyzing the
content for the inclusion of immune
cells reactive to beryllium exposure, as
described earlier in this section.
Fiberoptic bronchoscopy can be used to
detect granulomatous lung
inflammation prior to the onset of CBD
symptoms as well, and has been used in
combination with the BeLPT to
diagnose pre-symptomatic CBD in a
number of recent screening studies of
beryllium-exposed workers, which are
discussed in the following section
detailing diagnostic procedures. Of
PO 00000
Frm 00029
Fmt 4701
Sfmt 4702
47593
workers who were found to be
sensitized and underwent clinical
evaluation, 31–49 percent of them were
diagnosed with CBD (Kreiss et al., 1993;
Newman et al., 1996, 2005, 2007; Mroz,
2009), however some estimate that with
increased surveillance the percent could
be much higher (Newman, 2005; Mroz,
2009). It has been estimated from
ongoing surveillance studies of
sensitized individuals with an average
follow-up time of 4.5 years that 31
percent of beryllium-sensitized
employees were estimated to progress to
CBD (Newman et al., 2005). A study of
nuclear weapons facility employees
enrolled in an ongoing medical
surveillance program found that only 20
percent of sensitized workers employed
less than 5 years eventually were
diagnosed with CBD, while 40 percent
of sensitized workers employed 10 years
or more developed CBD (Stange et al.,
2001). One limitation for all these
studies is lack of long-term follow-up. It
may be necessary to continue to monitor
these workers in order to determine
whether all BeS workers will develop
CBD (Newman et al., 2005).
CBD has a clinical spectrum ranging
from evidence of beryllium sensitization
and granulomas in the lung with little
symptomatology to loss of lung function
and end stage disease which may result
in the need for lung transplantation and
decreased life expectancy.
Unfortunately, there are very few
published clinical studies describing the
full range and progression of CBD from
the beginning to the end stages and very
few of the risk factors for progression of
disease have been delineated (NAS,
2008). Clinical management of CBD is
modeled after sarcoidosis where oral
corticosteroid treatment is initiated in
patients who have evidence of
progressive lung disease, although
progressive lung disease has not been
well defined (NAS, 2008). In advanced
cases of CBD, corticosteroids are the
standard treatment (NAS, 2008). No
comprehensive studies have been
published measuring the overall effect
of removal of workers from beryllium
exposure on sensitization and CBD
(NAS, 2008) although this has been
suggested as part of an overall treatment
regime for CBD (Mapel et al., 2002; Sood
et al., 2004; Maier et al., 2006; Sood,
2009; Maier et al., 2012). Sood et al.
reported that cessation of exposure can
sometimes have beneficial effects on
lung function (Sood et al., 2004).
However, this was based on anecdotal
evidence from six patients with CBD, so
more research is needed to better
determine the relationship between
E:\FR\FM\07AUP2.SGM
07AUP2
47594
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
exposure duration and disease
progression
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
5. Human Epidemiological Studies
This section describes the human
epidemiological data supporting the
mechanistic overview of berylliuminduced disease in workers. It has been
divided into reviews of epidemiological
studies performed prior to development
and implementation of the BeLPT in the
late 1980s and after wide use of the
BeLPT for screening purposes. Use of
the BeLPT has allowed investigators to
screen for beryllium sensitization and
CBD prior to the onset of clinical
symptoms, providing a more sensitive
and thorough analysis of the worker
population. The discussion of the
studies has been further divided by
manufacturing processes that may have
similar exposure profiles. Table A.1 in
the Appendix summarizes the
prevalence of beryllium sensitization
and CBD, range of exposure
measurements, and other salient
information from the key
epidemiological studies.
It has been well-established that
beryllium exposure, either via
inhalation or skin, may lead to
beryllium sensitization, or, with
inhalation exposure, may lead to the
onset and progression of CBD. The
available published epidemiological
literature discussed below provides
strong evidence of beryllium
sensitization and CBD in workers
exposed to airborne beryllium well
below the current OSHA PEL of 2 mg/
m3. Several studies demonstrate the
prevalence of sensitization and CBD is
related to the level of airborne exposure,
including a cross-sectional survey of
employees at a beryllium ceramics plant
in Tucson, AZ (Henneberger et al.,
2001), case-control studies of workers at
the Rocky Flats nuclear weapons facility
(Viet et al., 2000), and workers from a
beryllium machining plant in Cullman,
AL (Kelleher et al., 2001). The
prevalence of beryllium sensitization
also may be related to dermal exposure.
An increased risk of CBD has been
reported in workers with skin lesions,
potentially increasing the uptake of
beryllium (Curtis, 1951; Johnson et al.,
2001; Schuler et al., 2005). Three
studies describe comprehensive
preventive programs, which included
expanded respiratory protection, dermal
protection, and improved control of
beryllium dust migration, that
substantially reduced the rate of
beryllium sensitization among new
hires (Cummings et al., 2007; Thomas et
al., 2009; Bailey et al., 2010; Schuler et
al., 2012).
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
Some of the epidemiological studies
presented in this review suffer from
challenges common to many published
epidemiological studies: Limitations in
study design (particularly crosssectional); small sample size; lack of
personal and/or short-term exposure
data, particularly those published before
the late 1990s; and incomplete
information regarding specific chemical
form and/or particle characterization.
Challenges that are specific to beryllium
epidemiological studies include:
uncertainty regarding the contribution
of dermal exposure; use of various
BeLPT protocols; a variety of case
definitions for determining CBD; and
use of various exposure sampling/
assessment methods (e.g., daily
weighted average (DWA), lapel
sampling). Even with these limitations,
the epidemiological evidence presented
in this section clearly demonstrates that
beryllium sensitization and CBD are
continuing to occur from present-day
exposures below OSHA’s PEL. The
available literature also indicates that
the rate of BeS can be substantially
lowered by reducing inhalation
exposure and minimizing dermal
contact.
a. Studies Conducted Prior to the BeLPT
First reports of CBD came from
studies performed by Hardy and
Tabershaw (1946). Cases were observed
in industrial plants that were refining
and manufacturing beryllium metal and
beryllium alloys and in plants
manufacturing fluorescent light bulbs
(NAS, 2008). From the late 1940s
through the 1960s, clusters of nonoccupational CBD cases were identified
around beryllium refineries in Ohio and
Pennsylvania, and outbreaks in family
members of beryllium factory workers
were assumed to be from exposure to
contaminated clothes (Hardy, 1980). It
had been established that the risk of
disease among beryllium workers was
variable and generally rose with the
levels of airborne concentrations
(Machle et al., 1948). And while there
was a relationship between air
concentrations of beryllium and risk of
developing disease both in and
surrounding these plants, the disease
rates outside the plants were higher
than expected and not very different
from the rate of CBD within the plants
(Eisenbud et al., 1949; Lieben and
Metzner, 1959). There remained
considerable uncertainty regarding
diagnosis due to lack of well-defined
cohorts, modern diagnostic methods, or
inadequate follow-up. In fact, many
patients with CBD may have been
misdiagnosed with sarcoidosis (NAS,
2008).
PO 00000
Frm 00030
Fmt 4701
Sfmt 4702
The difficulties in distinguishing lung
disease caused by beryllium from other
lung diseases led to the establishment of
the BCR in 1952 to identify and track
cases of ABD and CBD. A uniform
diagnostic criterion was introduced in
1959 as a way to delineate CBD from
sarcoidosis. Patient entry into the BCR
required either: documented past
exposure to beryllium or the presence of
beryllium in lung tissue as well as
clinical evidence of beryllium disease
(Hardy et al., 1967); or any three of the
six criteria listed below (Hasan and
Kazemi, 1974). Patients identified using
the above criteria were registered and
added to the BCR from 1952 through
1983 (Eisenbud and Lisson, 1983).
The BCR listed the following criteria
for diagnosing CBD (Eisenbud and
Lisson, 1983):
(1) Establishment of significant
beryllium exposure based on sound
epidemiologic history;
(2) Objective evidence of lower
respiratory tract disease and clinical
course consistent with beryllium
disease;
(3) Chest X-ray films with radiologic
evidence of interstitial fibronodular
disease;
(4) Evidence of restrictive or
obstructive defect with diminished
carbon monoxide diffusing capacity
(DLCO) by physiologic studies of lung
function;
(5) Pathologic changes consistent with
beryllium disease on examination of
lung tissue; and
(6) Presence of beryllium in lung
tissue or thoracic lymph nodes.
Prevalence of CBD in workers during
the time period between the 1940s and
1950s was estimated to be between 1–
10% (Eisenbud and Lisson, 1983). In a
1969 study, Stoeckle et al. presented 60
case histories with a selective literature
review utilizing the above criteria
except that urinary beryllium was
substituted for lung beryllium to
demonstrate beryllium exposure.
Stoeckle et al. (1969) were able to
demonstrate corticosteroids as a
successful treatment option in one case
of confirmed CBD. This study also
presented a 28 percent mortality rate
from complications of CBD at the time
of publication. However, even with the
improved methodology for determining
CBD based on the BCR criteria, these
studies suffered from lack of welldefined cohorts, modern diagnostic
techniques or adequate follow-up.
b. Criteria for Beryllium Sensitization
and CBD Case Definition Following the
Development of the BeLPT
The criteria for diagnosis of CBD have
evolved over time as more advanced
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
diagnostic technology, such as the
(blood) BeLPT and BAL BeLPT, has
become available. More recent
diagnostic criteria have both higher
specificity than earlier methods and
higher sensitivity, identifying
subclinical effects. Recent studies
typically use the following criteria
(Newman et al., 1989; Pappas and
Newman, 1993; Maier et al., 1999):
(1) History of beryllium exposure;
(2) Histopathological evidence of
noncaseating granulomas or
mononuclear cell infiltrates in the
absence of infection; and
(3) Positive blood or BAL BeLPT
(Newman et al., 1989).
The availability of transbronchial lung
biopsy facilitates the evaluation of the
second criterion, by making
histopathological confirmation possible
in almost all cases.
A significant component for the
identification of CBD is the
demonstration of a confirmed abnormal
BeLPT result in a blood or BAL sample
(Newman, 1996). Since the development
of the BeLPT in the 1980s, it has been
used to screen beryllium-exposed
workers for sensitization in a number of
studies to be discussed below. The
BeLPT is a non-invasive in vitro blood
test which measures the beryllium
antigen-specific T-cell mediated
immune response and is the most
commonly available diagnostic tool for
identifying beryllium sensitization. The
BeLPT measures the degree to which
beryllium stimulates lymphocyte
proliferation under a specific set of
conditions, and is interpreted based
upon the number of stimulation indices
that exceed the normal value. The ‘cutoff’ is based on the mean value of the
peak stimulation index among controls
plus 2 or 3 standard deviations. This
methodology was modeled into a
statistical method known as the ‘‘least
absolute values’’ or ‘‘statisticalbiological positive’’ method and relies
on natural log modeling of the median
stimulation index values (DOE, 2001;
Frome, 2003). In most applications, two
or more stimulation indices that exceed
the cut-off constitute an abnormal test.
Early versions of the BeLPT test had
high variability, but the use of tritiated
thymidine to identify proliferating cells
has led to a more reliable test (Mroz et
al., 1991; Rossman et al., 2001). In
recent years, the peripheral blood test
has been found to be as sensitive as the
BAL assay, although larger abnormal
responses have been observed with the
BAL assay (Kreiss et al., 1993; Pappas
and Newman, 1993). False negative
results have also been observed with the
BAL BeLPT in cigarette smokers who
have marked excess of alveolar
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
macrophages in lavage fluid (Kreiss et
al., 1993). The BeLPT has also been a
useful tool in animal studies to identify
those species with a beryllium-specific
immune response (Haley et al., 1994).
Screenings for beryllium sensitization
have been conducted using the BeLPT
in several occupational surveys and
surveillance programs, including
nuclear weapons facilities operated by
the Department of Energy (Viet et al.,
2000; Strange et al., 2001; DOE/HSS
Report, 2006), a beryllium ceramics
plant in Arizona (Kreiss et al., 1996;
Henneberger et al., 2001; Cummings et
al., 2007), a beryllium production plant
in Ohio (Kreiss et al., 1997; Kent et al.,
2001), a beryllium machining facility in
Alabama (Kelleher et al., 2001; Madl et
al., 2007), a beryllium alloy plant
(Schuler et al., 2005, Thomas et al.,
2009), and another beryllium processing
plant (Rosenman et al., 2005) in
Pennsylvania. In most of these studies,
individuals with an abnormal BeLPT
result were retested and were identified
as sensitized (i.e., confirmed positive) if
the abnormal result was repeated.
There has been criticism regarding the
reliability and specificity of the BeLPT
as a screening tool (Borak et al., 2006).
Stange et al. (2004) studied the
reliability and laboratory variability of
the BeLPT by splitting blood samples
and sending samples to two laboratories
simultaneously for BeLPT analysis.
Stange et al. found the range of
agreement on abnormal (positive
BeLPT) results was 26.2—61.8 percent
depending upon the labs tested (Stange
et al., 2004). Borak et al. (2006)
contended that the positive predictive
value (PPV) (PPV is the portion of
patients with positive test result
correctly diagnosed) is not high enough
to meet the criteria of a good screening
tool. Middleton et al. (2008) used the
data from the Stange et al. (2004) study
to estimate the PPV and determined that
the PPV of the BeLPT could be
improved from 0.383 to 0.968 when an
abnormal BeLPT result is confirmed
with a second abnormal result
(Middleton et al., 2008). However, an
apparent false positive can occur in
people not occupationally exposed to
beryllium (NAS, 2008). An analysis of
survey data from the general workforce
and new employees at a beryllium
manufacturer was performed to assess
the reliability of the BeLPT (Donovan et
al. 2007). Donovan et al. analyzed more
than 10,000 test results from nearly
2400 participants over a 12-year period.
Donovan et al. found that approximately
2 percent of new employees had at least
one positive BeLPT at the time of hire
and 1 percent of new hires with no
known occupational exposure were
PO 00000
Frm 00031
Fmt 4701
Sfmt 4702
47595
confirmed positive at the time of hire
with two BeLPTs. Since there are
currently no alternatives to the BeLPT
in a screening program many programs
rely on a second test to confirm a
positive result (NAS, 2008).
The epidemiological studies
presented in this section utilized the
BeLPT as either a surveillance tool or a
screening tool for determining
sensitization status and/or sensitization/
CBD prevalence in workers for inclusion
in the published studies. Most
epidemiological studies have reported
rates of sensitization and disease based
on a single screening of a working
population (‘cross-sectional’ or
’population prevalence’ rates). Studies
of workers in a beryllium machining
plant and a nuclear weapons facility
have included follow-up of the
population originally screened,
resulting in the detection of additional
cases of sensitization over several years
(Newman et al., 2001, Stange et al.,
2001). OSHA regards the BeLPT as a
reliable medical surveillance tool. The
BeLPT is discussed in more detail in
Non-Mandatory Appendix A to the
proposed standard, Immunological
Testing for the Determination of
Beryllium Sensitization.
c. Beryllium Mining and Extraction
Mining and extraction of beryllium
usually involves the two major
beryllium minerals, beryl (an
aluminosilicate containing up to 4
percent beryllium) and bertrandite (a
beryllium silicate hydrate containing
generally less than 1 percent beryllium)
(WHO, 2001). The United States is the
world leader in beryllium extraction
and also leads the world in production
and use of beryllium and its alloys
(WHO, 2001). Most exposures from
mining and extraction come in the form
of beryllium ore, beryllium salts,
beryllium hydroxide (NAS 2008) or
beryllium oxide (Stefaniak et al., 2008).
Deubner et al. published a study of 75
workers employed at a beryllium
mining and extraction facility in Delta,
UT (Deubner et al., 2001b). Of the 75
workers surveyed for sensitization with
the BeLPT, three were identified as
sensitized by an abnormal BeLPT result.
One of those found to be sensitized was
diagnosed with CBD. Exposures at the
facility included primarily beryllium
ore and salts. General area (GA),
breathing zone (BZ), and personal lapel
(LP) exposure samples were collected
from 1970 to 1999. Jobs involving
beryllium hydrolysis and wet-grinding
activities had the highest air
concentrations, with an annual median
GA concentration ranging from 0.1 to
0.4 mg/m3. Median BZ concentrations
E:\FR\FM\07AUP2.SGM
07AUP2
47596
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
were higher than either LP or GA. The
average duration of exposure for
beryllium sensitized workers was 21.3
years (27.7 years for the worker with
CBD), compared to an average duration
for all workers of 14.9 years. However,
these exposures were less than either
the Elmore, OH, or Tucson, AZ,
facilities described below, which also
had higher reported rates of BeS and
CBD. A study by Stefaniak et al. (2008)
demonstrated that beryllium was
present at the mill in three forms:
mineral, poorly crystalline oxide, and
hydroxide.
There was no sensitization or CBD
among those who worked only at the
mine where exposure to beryllium
resulted solely from working with
bertrandite ore. The authors concluded
that the results of this study indicated
that beryllium ore and salts may pose
less of a hazard than beryllium metal
and beryllium hydroxide. These results
are consistent with the previously
discussed animal studies examining
solubility and particle size.
d. Beryllium Metal Processing and Alloy
Production
Kreiss et al. (1997) conducted a study
of workers at a beryllium production
facility in Elmore, OH. The plant, which
opened in 1953 and initially specialized
in production of beryllium-copper alloy,
later expanded its operations to include
beryllium metal, beryllium oxide, and
beryllium-aluminum alloy production;
beryllium and beryllium alloy
machining; and beryllium ceramics
production, which was moved to a
different factory in the early 1980s.
Production operations included a wide
variety of jobs and processes, such as
work in arc furnaces and furnace
rebuilding, alloy melting and casting,
beryllium powder processing, and work
in the pebble plant. Non-production
work included jobs in the analytical
laboratory, engineering research and
development, maintenance, laundry,
production-area management, and
office-area administration. While the
publication refers to the use of
respiratory protection in some areas,
such as the pebble plant, the extent of
its use across all jobs or time periods
was not reported. Use of dermal PPE
was not reported.
The authors characterized exposures
at the plant using industrial hygiene
(IH) samples collected between 1980
and 1993. The exposure samples and
the plant’s formulas for estimating
workers’ DWA exposures were used,
together with study participants’ work
histories, to estimate their cumulative
and average beryllium exposure levels.
Exposure concentrations reflected the
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
high exposures found historically in
beryllium production and processing.
Short-term BZ measurements had a
median of 1.4, with 18.5 percent of
samples exceeding OSHA’s STEL of 5.0
mg/m3. Particularly high beryllium
concentrations were reported in the
areas of beryllium powder production,
laundry, alloy arc furnace
(approximately 40 percent of DWA
estimates over 2.0 mg/m3) and furnace
rebuild (28.6 percent of short-term BZ
samples over the OSHA STEL of 5 mg/
m3). LP samples (n = 179), which were
available from 1990 to 1992, had a
median value of 1 mg/m3.
Of 655 workers employed at the time
of the study, 627 underwent BeLPT
screening. Blood samples were divided
and split between two labs for analysis,
with repeat testing for results that were
abnormal or indeterminate. Thirty-one
workers had an abnormal blood test
upon initial testing and at least one of
two subsequent tests was classified as
sensitized. These workers, together with
19 workers who had an initial abnormal
result and one subsequent
indeterminate result, were offered
clinical evaluation for CBD including
the BAL-BeLPT and transbronchial lung
biopsy. Nine with an initial abnormal
test followed by two subsequent normal
tests were not clinically evaluated,
although four were found to be
sensitized upon retesting in 1995. Of 47
workers who proceeded with evaluation
for CBD (3 of the 50 initial workers with
abnormal results declined to
participate), 24 workers were diagnosed
with CBD based on evidence of
granulomas on lung biopsy (20 workers)
or on other findings consistent with
CBD (4 workers) (Kreiss et al., 1997).
After including five workers who had
been diagnosed prior to the study, a
total of 29 (4.6 percent) current workers
were found to have CBD. In addition,
the plant medical department identified
24 former workers diagnosed with CBD
before the study.
Kreiss et al. reported that the highest
prevalence of sensitization and CBD
occurred among workers employed in
beryllium metal production, even
though the highest airborne total mass
concentrations of beryllium were
generally among employees operating
the beryllium alloy furnaces in a
different area of the plant (Kreiss et al.,
1997). Preliminary follow-up
investigations of particle size-specific
sampling at five furnace sites within the
plant determined that the highest
respirable (e.g., particles <10 mm in
diameter as defined by the authors) and
alveolar-deposited (e.g., particles <1 mm
in diameter as defined by the authors)
beryllium mass and particle number
PO 00000
Frm 00032
Fmt 4701
Sfmt 4702
concentrations, as collected by a general
area impactor device, were measured at
the beryllium metal production furnaces
rather than the beryllium alloy furnaces
(Kent et al., 2001; McCawley et al.,
2001). A statistically significant linear
trend was reported between the above
alveolar-deposited particle mass
concentration and prevalence of CBD
and sensitization in the furnace
production areas. The authors
concluded that alveolar-deposited
particles may be a more relevant
exposure metric for predicting the
incidence of CBD or sensitization than
the total mass concentration of airborne
beryllium.
Bailey et al. (2010) evaluated the
effectiveness of a workplace preventive
program in lowering BeS at the
beryllium metal, oxide, and alloy
production plant studied by Kreiss et al.
(1997). The preventive program
included use of administrative and PPE
controls (e.g., improved training, skin
protection and other PPE, half-mask or
air-purified respirators, medical
surveillance, improved housekeeping
standards, clean uniforms) as well as
engineering controls (e.g., migration
controls, physical separation of
administrative offices from production
facilities) implemented over the course
of five years.
In a cross-sectional/longitudinal
hybrid study, Bailey et al. compared
rates of sensitization in pre-program
workers to those hired after the
preventive program began. Pre-program
workers were surveyed cross-sectionally
in 1993–1994, and again in 1999 using
the BeLPT to determine sensitization
and CBD prevalence rates. The 1999
cross-sectional survey was conducted to
determine if improvements in
engineering and administrative controls
were successful, however, results
indicated no improvement in reducing
rates of sensitization or CBD.
An enhanced preventive program
including particle migration control,
respiratory and dermal protection, and
process enclosure was implemented in
2000, with continuing improvements
made to the program in 2001, 2002–
2004, and 2005. Workers hired during
this period were longitudinally
surveyed for sensitization using the
BeLPT. Both the pre-program and
program survey of worker sensitization
status utilized split-sample testing to
verify positive test results using the
BeLPT. Of the total 660 workers
employed at the production plant, 258
workers participated from the preprogram group while 290 participated
from the program group (206 partial
program, 84 full program). Prevalence
comparisons of the pre-program and
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
program groups (partial and full) were
performed by calculating prevalence
ratios. A 95 percent confidence interval
(95 percent CI) was derived using a
cohort study method that accounted for
the variance in survey techniques
(cross-sectional versus longitudinal)
(Bailey et al., 2010). The sensitization
prevalence of the pre-program group
was 3.8 times higher (95 percent CI, 1.5–
9.3) than the program group, 4.0 times
higher (95 percent CI, 1.4–11.6) than the
partial program subgroup, and 3.3 times
higher (95 percent CI, 0.8–13.7) than the
full program subgroup indicating that a
comprehensive preventive program can
reduce, but not eliminate, occurrence of
sensitization among non-sensitized
workers (Bailey et al., 2010).
Rosenman et al. (2005) studied a
group of several hundred workers who
had been employed at a beryllium
production and processing facility that
operated in eastern Pennsylvania
between 1957 and 1978. Of 715 former
workers located, 577 were screened for
BeS with the BLPT and 544 underwent
chest radiography to identify cases of
BeS and CBD. Workers were reported to
have exposure to beryllium dust and
fume in a variety of chemical forms
including beryl ore, beryllium metal,
beryllium fluoride, beryllium
hydroxide, and beryllium oxide.
Rosenman et al. used the plant’s DWA
formulas to assess workers’ full-shift
exposure levels, based on IH data
collected between 1957–1962 and 1971–
1976, to calculate exposure metrics
including cumulative, average, and peak
for each worker in the study. The DWA
was calculated based on air monitoring
that consisted of GA and short-term
task-based BZ samples. Workers’
exposures to specific chemical and
physical forms of beryllium were
assessed, including insoluble beryllium
(metal and oxide), soluble beryllium
(fluoride and hydroxide), mixed soluble
and insoluble beryllium, beryllium dust
(metal, hydroxide, or oxide), fume
(fluoride), and mixed dust and fume.
Use of respiratory or dermal protection
by workers was not reported. Exposures
in the plant were high overall.
Representative task-based IH samples
ranged from 0.9 m g/m3 to 84 m g/m3 in
the 1960s, falling to a range of 0.5–16.7
m g/m3 in the 1970s. A large number of
workers’ mean DWA estimates (25
percent) were above the OSHA PEL of
2.0 m g/m3, while most workers had
mean DWA exposures between 0.2 and
2.0 m g/m3 (74 percent) or below 0.02
m g/m3 (1 percent) (Rosenman et al.,
Table 11; revised erratum April, 2006).
Blood samples for the BeLPT were
collected from the former workers
between 1996 and 2001 and were
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
evaluated at a single laboratory.
Individuals with an abnormal test result
were offered repeat testing, and were
classified as sensitized if the second test
was also abnormal. Sixty workers with
two positive BeLPTs and 50 additional
workers with chest radiography
suggestive of disease were offered
clinical evaluation, including
bronchoscopy with bronchial biopsy
and BAL-BeLPT. Seven workers met
both criteria. Only 56 (51 percent) of
these workers proceeded with clinical
evaluation, including 57 percent of
those referred on the basis of confirmed
abnormal BeLPT and 47 percent of those
with abnormal radiographs.
Of those workers who underwent
bronchoscopy, 32 (5.5 percent) with
evidence of granulomas were classified
as ‘‘definite’’ CBD cases. Twelve (2.1
percent) additional workers with
positive BAL-BeLPT or confirmed
positive BeLPT and radiographic
evidence of upper lobe fibrosis were
classified as ‘‘probable’’ CBD cases.
Forty workers (6.9 percent) without
upper lobe fibrosis who had confirmed
abnormal BeLPT, but who were not
biopsied or who underwent biopsy with
no evidence of granuloma, were
classified as sensitized without disease.
It is not clear how many of the 40
workers underwent biopsy. Another 12
(2.1 percent) workers with upper lobe
fibrosis and negative or unconfirmed
positive BeLPT were classified as
‘‘possible’’ CBD cases. Nine additional
workers who were diagnosed with CBD
before the screening were included in
some parts of the authors’ analysis.
The authors reported a total
prevalence of 14.5 percent for CBD
(definite and probable) and
sensitization. This rate, considerably
higher than the overall prevalence of
sensitization and disease in several
other worker cohorts as described
earlier in this section, reflects in part the
very high exposures experienced by
many workers during the plant’s
operation in the 1950s, 1960s and
1970s. A total of 115 workers had mean
DWAs above the OSHA PEL of 2 m g/m3.
Of those, 7 (6.0 percent) had definite or
probable CBD and another 13 (11
percent) were classified as sensitized
without disease. The true prevalence of
CBD in the group may be higher than
reported, due to the low rate of clinical
evaluation among sensitized workers.
Although most of the workers in this
study had high exposures, sensitization
and CBD also were observed within the
small subgroup of participants believed
to have relatively low beryllium
exposures. Thirty-three cases of CBD
and 24 additional cases of sensitization
occurred among 339 workers with mean
PO 00000
Frm 00033
Fmt 4701
Sfmt 4702
47597
DWA exposures below OSHA’s PEL of
2.0 m g/m3 (Rosenman et al., Table 11,
erratum 2006). Ten cases of
sensitization and five cases of CBD were
found among office and clerical
workers, who were believed to have low
exposures (levels not reported).
Follow-up time for sensitization
screening of workers in this study who
became sensitized during their
employment had a minimum of 20 years
to develop CBD prior to screening. In
this sense the cohort is especially well
suited to compare the exposure patterns
of workers with CBD and those
sensitized without disease, in contrast
to several other studies of workers with
only recent beryllium exposures.
Rosenman et al. characterized and
compared the exposures of workers with
definite and probable CBD, sensitization
only, and no disease or sensitization
using chi-squared tests for discrete
outcomes and analysis of variance
(ANOVA) for continuous variables
(cumulative, mean, and peak exposure
levels). Exposure-response relationships
were further examined with logistic
regression analysis, adjusting for
potential confounders including
smoking, age, and beryllium exposure
from outside of the plant. The authors
found that cumulative, peak, and
duration of exposure were significantly
higher for workers with CBD than for
sensitized workers without disease (p
<0.05), suggesting that the risk of
progressing from sensitization to CBD is
related to the level or extent of exposure
a worker experiences. The risk of
developing CBD following sensitization
appeared strongly related to exposure to
insoluble forms of beryllium, which are
cleared slowly from the lung and
increase beryllium lung burden more
rapidly than quickly mobilized soluble
forms. Individuals with CBD had higher
exposures to insoluble beryllium than
those classified as sensitized without
disease, while exposure to soluble
beryllium was higher among sensitized
individuals than those with CBD.
Cumulative, mean, peak, and duration
of exposure were found to be
comparable for workers with CBD and
workers without sensitization or CBD
(‘‘normal’’ workers). Cumulative, peak,
and duration of exposure were
significantly lower for sensitized
workers without disease than for normal
workers. Rosenman et al. suggested that
genetic predisposition to sensitization
and CBD may have obscured an
exposure-response relationship in this
study, and plan to control for genetic
risk factors in future studies. Exposure
misclassification from the 1950s and
1960s may have been another limitation
in this study, introducing bias that
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47598
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
could have influenced the lack of
exposure response. It is also unknown if
the 25 percent who died from CBDrelated conditions may have had higher
exposures.
A follow-up was conducted of the
cross-sectional study of a population of
workers first evaluated by Kreiss et al.
(1997) and Rosenman et al. (2005) at a
beryllium production and processing
facility in eastern Pennsylvania by
Schuler et al. (2012), and in a
companion study by Virji et al. (2012).
Schuler et al. evaluated the worker
population employed in 1999 with six
years or less work tenure in a crosssectional study. The investigators
evaluated the worker population by
administering a work history
questionnaire with a follow-up
examination for sensitization and CBD.
A job-exposure matrix (JEM) was
combined with work histories to create
individual estimates of average,
cumulative, and highest-job-related
exposure for total, respirable, and submicron beryllium mass concentration.
Of the 291 eligible workers, 90.7 percent
(264) participated in the study.
Sensitization prevalence was 9.8
percent (26/264) with CBD prevalence
of 2.3 percent (6/264). The investigators
found a general pattern of increasing
sensitization prevalence as the exposure
quartile increased indicating an
exposure-response relationship. The
investigators found positive associations
with both total and respirable mass
concentration with sensitization
(average and highest job) and CBD
(cumulative). Increased sensitization
prevalence was observed with metal
oxide production alloy melting and
casting, and maintenance. CBD was
associated with melting and casting.
The investigators summarized that both
total and respirable mass concentration
were relevant predictors of risk (Schuler
et al., 2012).
In the companion study by Virji et al.
(2012), the investigators reconstructed
historical exposure from 1994 to 1999
utilizing the personal sampling data
collected in 1999 as baseline exposure
estimates (BEE). The study evaluated
techniques for reconstructing historical
data to evaluate exposure-response
relationships for epidemiological
studies. The investigators constructed
JEMs using the BEE and estimates of
annual changes in exposure for 25
different process areas. The
investigators concluded these
reconstructed JEMs could be used to
evaluate a range of exposure parameters
from total, respirable and submicron
mass concentration including
cumulative, average, and highest
exposure. These two studies
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
demonstrate that high-quality exposure
estimates can be developed both for
total mass and respirable mass
concentrations.
e. Beryllium Machining Operations
Newman et al. (2001) and Kelleher et
al. (2001) studied a group of 235
workers at a beryllium metal machining
plant. Since the plant opened in 1969,
its primary operations have been
machining and polishing beryllium
metal and high-beryllium content
composite materials, with occasional
machining of beryllium oxide/metal
matrix (‘E-metal’), and beryllium alloys.
Other functions include machining of
metals other than beryllium; receipt and
inspection of materials; acid etching;
final inspection, quality control, and
shipping of finished materials; tool
making; and engineering, maintenance,
administrative and supervisory
functions (Newman et al., 2001; Madl et
al., 2007). Machining operations,
including milling, grinding, lapping,
deburring, lathing, and electrical
discharge machining (EDM), were
performed in an open-floor plan
production area. Most non-machining
jobs were located in a separate, adjacent
area; however, non-production
employees had access to the machining
area.
Engineering and administrative
measures, rather than PPE, were
primarily used to control beryllium
exposures at the plant (Madl et al.,
2007). Based on interviews with longstanding employees of the plant,
Kelleher et al. reported that work
practices were relatively stable until
1994, when a worker was diagnosed
with CBD and a new exposure control
program was initiated. Between 1995
and 1999 new engineering and work
practice controls were implemented,
including removal of pressurized air
hoses and discouragement of dry
sweeping (1995), enclosure of deburring
processes (1996), mandatory uniforms
(1997), and installation or updating of
local exhaust ventilation (LEV) in EDM,
lapping, deburring, and grinding
processes (1998) (Madl et al., 2007).
Throughout the plant’s history,
respiratory protection was used mainly
for ‘‘unusually large, anticipated
exposures’’ to beryllium (Kelleher et al.,
2001), and was not routinely used
otherwise (Newman et al., 2001).
All workers at the plant participated
in a beryllium disease surveillance
program initiated in 1994, and were
screened for beryllium sensitization
with the BeLPT beginning in 1995. A
BeLPT result was considered abnormal
if two or more of six stimulation indices
exceeded the normal range (see section
PO 00000
Frm 00034
Fmt 4701
Sfmt 4702
on BeLPT testing above), and was
considered borderline if one of the
indices exceeded the normal range. A
repeat BeLPT was conducted for
workers with abnormal or borderline
initial results. Workers were identified
as beryllium sensitized and referred for
a clinical evaluation, including
bronchoalveolar lavage (BAL) and
transbronchial lung biopsy, if the repeat
test was abnormal. CBD was diagnosed
upon evidence of sensititization with
granulomas or mononuclear cell
infiltrates in the lung tissue (Newman et
al., 2001). Following the initial plantwide screening, plant employees were
offered BeLPT testing at two-year
intervals. Workers hired after the initial
screening were offered a BeLPT within
3 months of their hire date, and at 2year intervals thereafter (Madl et al.,
2007).
Kelleher et al. performed a nested
case-control study of the 235 workers
evaluated in Newman et al. (2001) to
evaluate the relationship between
beryllium exposure levels and risk of
sensitization and CBD (Kelleher et al.,
2001). The authors evaluated exposures
at the plant using IH samples they had
collected between 1996 and 1999, using
personal cascade impactors designed to
measure the mass of beryllium particles
less than 6 m m, particles less than 1 mm
in diameter, and total mass. The great
majority of workers’ exposures were
below the OSHA PEL of 2 m g/m3.
However, a few higher levels were
observed in machining jobs including
deburring, lathing, lapping, and
grinding. Based on a statistical
comparison between their samples and
historical data provided by the plant,
the authors concluded that worker
beryllium exposures across all time
periods could be approximated using
the 1996–1999 data. They estimated
workers’ cumulative and ‘lifetime
weighted’ (LTW) beryllium exposure
based on the exposure samples they
collected for each job in 1996–1999 and
company records of each worker’s job
history.
Twenty workers with beryllium
sensitization or CBD (cases) were
compared to 206 workers (controls) for
the case-control analysis from the study
evaluating workers originally conducted
by Newman et al. Thirteen workers
were diagnosed with CBD based on lung
biopsy evidence of granulomas and/or
mononuclear cell infiltrates (11) or
positive BAL results with evidence of
lymphocytosis (2). Seven were
evaluated for CBD and found to be
sensitized only, thus twenty composing
the case group. Nine of the remaining
215 workers first identified in original
study (Newman et al., 2001) were
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
excluded due to incomplete job history
information, leaving 206 workers in the
control group.
Kelleher et al.’s analysis included
comparisons of the case and control
groups’ median exposure levels;
calculation of odds ratios for workers in
high, medium, and low exposure
groups; and logistic regression testing of
the association of sensitization or CBD
with exposure level and other variables.
Median cumulative exposures for total
mass, particles <6 m m, and particles <1
mm were approximately three times
higher among the cases than controls,
although the relationships observed
were not statistically significant (p
values ∼ 0.2). No clear difference
between cases and controls was
observed for the median LTW
exposures. Odds ratios with
sensitization and CBD as outcomes were
elevated in high (upper third) and
intermediate exposure groups relative to
low (lowest third) exposure groups for
both cumulative and LTW exposure,
though the results were not statistically
significant (p > 0.1). In the logistic
regression analysis, only machinist
work history was a significant predictor
of case status in the final model.
Quantitative exposure measures were
not significant predictors of
sensitization or disease risk.
Citing an 11.5 percent prevalence of
beryllium sensitization or CBD among
machinists as compared with 2.9
percent prevalence among workers with
no machinist work history, the authors
concluded that the risk of sensitization
and CBD is increased among workers
who machine beryllium. Although
differences between cases and controls
in median cumulative exposure did not
achieve conventional thresholds for
statistical significance, the authors
noted that cumulative exposures were
consistently higher among cases than
controls for all categories of exposure
estimates and for all particle sizes,
suggesting an effect of cumulative
exposure on risk. The levels at which
workers developed CBD and
sensitization were predominantly below
OSHA’s current PEL of 2 m g/m3, and no
cases of sensitization or CBD were
observed among workers with LTW
exposure <0.02 mg/m3. Twelve (60
percent) of the 20 sensitized workers
had LTW exposures > 0.20 m g/m3.
In 2007, Madl et al. published an
additional study of 27 workers at the
machining plant who were found to be
sensitized or diagnosed with CBD
between the start of medical
surveillance in 1995 and 2005. As
previously described, workers were
offered a BeLPT in the initial 1995
screening (or within 3 months of their
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
hire date if hired after 1995) and at 2year intervals after their first screening.
Workers with two positive BeLPTs were
identified as sensitized and offered
clinical evaluation for CBD, including
bronchoscopy with BAL and
transbronchial lung biopsy. The criteria
for CBD in this study were somewhat
stricter than those used in the Newman
et al. study, requiring evidence of
granulomas on lung biopsy or detection
of X-ray or pulmonary function changes
associated with CBD, in combination
with two positive BeLPTs or one
positive BAL-BeLPT.
Based on the history of the plant’s
control efforts and their analysis of
historical IH data, Madl et al. identified
three ‘‘exposure control eras’’: A
relatively uncontrolled period from
1980–1995; a transitional period from
1996 to 1999; and a relatively wellcontrolled ‘‘modern’’ period from 2000–
2005. They found that the engineering
and work practice controls instituted in
the mid-1990s reduced workers’
exposures substantially, with nearly a
15-fold difference in reported exposure
levels between the pre-control and the
modern period (Madl et al., 2007). Madl
et al. estimated workers’ exposures
using LP samples collected between
1980 and 2005, including those
collected by Kelleher et al., and work
histories provided by the plant. As
described more fully in the study, they
used a variety of approaches to describe
individual workers’ exposures,
including approaches designed to
characterize the highest exposures
workers were likely to have
experienced. Their exposure-response
analysis was based primarily on an
exposure metric they derived by
identifying the year and job of each
worker’s pre-diagnosis work history
with the highest reported exposures.
They used the upper 95th percentile of
the LP samples collected in that job and
year (in some cases supplemented with
data from other years) to characterize
the worker’s upper-level exposures.
Based on their estimates of workers’
upper level exposures, Madl et al.
concluded that workers with
sensitization or CBD were likely to have
been exposed to airborne beryllium
levels greater than 0.2 mg/m3 as an 8hour TWA at some point in their history
of employment in the plant. They also
concluded that most sensitization and
CBD cases were likely to have been
exposed to levels greater than 0.4 mg/m3
at some point in their work at the plant.
Madl et al. did not reconstruct
exposures for workers at the plant who
did not have sensitization or CBD and
therefore could not determine whether
non-cases had upper-bound exposures
PO 00000
Frm 00035
Fmt 4701
Sfmt 4702
47599
lower than these levels. They found that
upper-bound exposure estimates were
generally higher for workers with CBD
than for those who were sensitized but
not diagnosed with CBD at the
conclusion of the study (Madl et al.,
2007). Because CBD is an
immunological disease and beryllium
sensitization has been shown to occur
within a year of exposure for some
workers, Madl et al. argued that their
estimates of workers’ short-term upperbound exposures may better capture the
exposure levels that led to sensitization
and disease than estimates of long-term
cumulative or average exposures such as
the LTW exposure measure constructed
by Kelleher et al. (Madl et al., 2007).
f. Beryllium Oxide Ceramics
Kreiss et al. (1993) conducted a
screening of current and former workers
at a plant that manufactured beryllium
ceramics from beryllium oxide between
1958 and 1975, and then transitioned to
metalizing circuitry onto beryllium
ceramics produced elsewhere. Of the
plant’s 1,316 current and 350 retired
workers, 505 participated who had not
previously been diagnosed with CBD or
sarcoidosis, including 377 current and
128 former workers. Although beryllium
exposure was not estimated
quantitatively in this survey, the authors
conducted a questionnaire to assess
study participants’ exposures
qualitatively. Results showed that 55
percent of participants reported working
in jobs with exposure to beryllium dust.
Close to 25 percent of participants did
not know if they had exposure to
beryllium, and just over 20 percent
believed they had not been exposed.
BeLPT tests were administered to all
505 participants in the 1989–1990
screening period and evaluated at a
single lab. Seven workers had confirmed
abnormal BeLPT results and were
identified as sensitized; these workers
were also diagnosed with CBD based on
findings of granulomas upon clinical
evaluation. Radiograph screening led to
clinical evaluation and diagnosis of two
additional CBD cases, who were among
three participants with initially
abnormal BeLPT results that could not
be confirmed on repeat testing. In
addition, nine workers had been
previously diagnosed with CBD, and
another five were diagnosed shortly
after the screening period, in 1991–
1992.
Eight (3.7 percent of the screening
population) of the nine CBD cases
identified in the screening population
were hired before the plant stopped
producing beryllium ceramics in 1975,
and were among the 216 participants
who had reported having been near or
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47600
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
exposed to beryllium dust. Particularly
high CBD rates of 11.1–15.8 percent
were found among screening
participants who had worked in process
development/engineering, dry pressing,
and ventilation maintenance jobs
believed to have high or uncontrolled
dust exposure. One case (0.6 percent) of
CBD was diagnosed among the 171
study participants who had been hired
after the plant stopped producing
beryllium ceramics. Although this
worker was hired eight years after the
end of ceramics production, he had
worked in an area later found to be
contaminated with beryllium dust. The
authors concluded that the study results
suggested an exposure-response
relationship between beryllium
exposure and CBD, and recommended
beryllium exposure control to reduce
workers’ risk of CBD.
Kreiss et al. later published a study of
workers at a second ceramics plant
located in Tucson, AZ (Kreiss et al.,
1996), which since 1980 had produced
beryllium ceramics from beryllium
oxide powder manufactured elsewhere.
IH measurements collected between
1981 and 1992, primarily GA or shortterm BZ samples and a few (<100) LP
samples, were available from the plant.
Airborne beryllium exposures were
generally low. The majority of area
samples were below the analytical
detection limit of 0.1 mg/m3, while LP
and short-term BZ samples had medians
of 0.3 mg/m3. However, 3.6 percent of
short-term BZ samples and 0.7 percent
of GA samples exceeded 5.0 mg/mg3,
while LP samples ranged from 0.1 to 1.8
mg/m3. Machining jobs had the highest
beryllium exposure levels among job
tasks, with short-term BZ samples
significantly higher for machining jobs
than for non-machining jobs (median
0.6 mg/m3 vs. 0.3 mg/mg3, p = 0.0001).
The authors used DWA formulas
provided by the plant to estimate
workers’ full-shift exposure levels, and
to calculate cumulative and average
beryllium exposures for each worker in
the study. The median cumulative
exposure was 591.7 mg-days/m3 and the
median average exposure was 0.35 mg/
m3.
One hundred thirty-six of the 139
workers employed at the plant at the
time of the Kreiss et al. (1996) study
underwent BeLPT screening and chest
radiographs in 1992. Blood samples
were split between two laboratories. If
one or both test results were abnormal,
an additional sample was collected and
split between the labs. Seven workers
with an abnormal result on two draws
were initially identified as sensitized.
Those with confirmed abnormal BeLPTs
or abnormal chest X-rays were offered
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
clinical evaluation for CBD, including
transbronchial lung biopsy and BAL
BeLPT. CBD was diagnosed based on
observation of granulomas on lung
biopsy, in five of the six sensitized
workers who accepted evaluation. An
eighth case of sensitization and sixth
case of CBD were diagnosed in one
worker hired in October 1991 whose
initial BeLPT was normal, but who was
confirmed as sensitized and found to
have lung granulomas less than two
years later, after sustaining a berylliumcontaminated skin wound. The plant
medical department reported 11
additional cases of CBD among former
workers (Kreiss et al., 1996). The overall
prevalence of sensitization in the plant
was 5.9 percent, with a 4.4 percent
prevalence of CBD.
Kreiss et al. reported that six (75
percent) of the eight sensitized workers
were exposed as machinists during or
before the period October 1985–March
1988, when measurements were first
available for machining jobs. The
authors reported that 14.3 percent of
machinists were sensitized, compared to
1.2 percent of workers who had never
been machinists (p <0.01). Workers’
estimated cumulative and average
beryllium exposures did not differ
significantly for machinists and nonmachinists, or for cases and non-cases.
As in the previous study of the same
ceramics plant published by Kreiss et al.
in 1993, one case of CBD was diagnosed
in a worker who had never been
employed in a production job. This
worker was employed in administration,
a job with a median DWA of 0.1 mg/m3
(range 0.1–0.3).
In 1998, Henneberger et al. conducted
a follow-up cross-sectional survey of
151 employees employed at the
beryllium ceramics plant studied by
Kreiss et al. (1996) (Henneberger et al.,
2001). Employees were eligible who
either had not participated in the Kreiss
et al. survey (‘‘short-term workers’’—74
of those studied by Henneberger et al.),
or who had participated and were not
found to have sensitization or disease
(‘‘long-term workers’’—77 of those
studied by Henneberger et al.).
The authors estimated workers’
cumulative, average, and peak beryllium
exposures based on the plant’s formulas
for estimating job-specific DWA
exposures, participants’ work histories,
and area and short-term task-specific BZ
samples collected from the start of full
production at the plant in 1981 to 1998.
The long-term workers, who were hired
before the 1992 study was conducted,
had generally higher estimated
exposures (median of average
exposures—0.39 mg/m3; mean—14.9 mg/
m3) than the short-term workers, who
PO 00000
Frm 00036
Fmt 4701
Sfmt 4702
were hired after 1992 (median 0.28 mg/
m3, mean 6.1 mg/m3).
Fifteen cases of sensitization were
found, including eight among short-term
and seven among long-term workers.
Eight of the 15 workers were found to
have CBD. Of the workers diagnosed
with CBD, seven (88 percent) were longterm workers. One non-sensitized longterm worker and one sensitized longterm worker declined clinical
examination.
Henneberger et al. reported a higher
prevalence of sensitization among longterm workers with ‘‘high’’ (greater than
median) peak exposures compared to
long-term workers with ‘‘low’’
exposures; however, this relationship
was not statistically significant. No
association was observed for average or
cumulative exposures. The authors
reported higher prevalence of
sensitization (but not statistically
significant) among short-term workers
with ‘‘high’’ (greater than median)
average, cumulative, and peak
exposures compared to short-term
workers with ‘‘low’’ exposures of each
type.
The cumulative incidence of
sensitization and CBD was investigated
in a cohort of 136 workers at the
beryllium ceramics plant previously
studied by the Kreiss and Henneberger
groups (Schuler et al., 2008). The study
cohort consisted of those who
participated in the plant-wide BeLPT
screening in 1992. Both current and
former workers from this group were
invited to participate in follow-up
BeLPT screenings in 1998, 2000, and
2002–03. A total of 106 of the 128 nonsensitized individuals in 1992
participated in the 11-year follow-up.
Sensitization was defined as a
confirmed abnormal BeLPT based on
the split blood sample-dual laboratory
protocol described earlier. CBD was
diagnosed in sensitized individuals
based on pathological findings from
transbronchial biopsy and BAL fluid
analysis. The 11-year crude cumulative
incidence of sensitization and CBD was
13 percent (14 of 106) and 8 percent (9
of 106) respectively. The cumulative
prevalence was about triple the point
prevalences determined in the initial
1992 cross-sectional survey. The
corrected cumulative prevalences for
those that ever worked in machining
were nearly twice that for nonmachinists. The data illustrate the value
of longitudinal medical screening over
time to obtain a more accurate estimate
of the occurrence of sensitization and
CBD among an exposed working
population.
Following the 1998 survey, the
company continued efforts to reduce
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
exposures and risk of sensitization and
CBD by implementing additional
engineering, administrative, and PPE
measures (Cummings et al., 2007).
Respirator use was required in
production areas beginning in 1999, and
latex gloves were required beginning in
2000. The lapping area was enclosed in
2000, and enclosures were installed for
all mechanical presses in 2001. Between
2000 and 2003, water-resistant or waterproof garments, shoe covers, and taped
gloves were incorporated to keep
beryllium-containing fluids from wet
machining processes off the skin. The
new engineering measures did not
appear to substantially reduce airborne
beryllium levels in the plant. LP
samples collected between 2000 and
2003 had a median of 0.18 mg/m3,
similar to the 1994–1999 samples.
However, respiratory protection
requirements to control workers’
airborne beryllium exposures were
instituted prior to the 2000 sample
collections.
To test the efficacy of the new
measures instituted after 1998, in
January 2000 the company began
screening new workers for sensitization
at the time of hire and at 3, 6, 12, 24,
and 48 months of employment. These
more stringent measures appear to have
substantially reduced the risk of
sensitization among new employees. Of
126 workers hired between 2000 and
2004, 93 completed BeLPT testing at
hire and at least one additional test at
3 months of employment. One case of
sensitization was identified at 24
months of employment (1 percent). This
worker had experienced a rash after an
incident of dermal exposure to lapping
fluid through a gap between his glove
and uniform sleeve, indicating that he
may have become sensitized via the
skin. He was tested again at 48 months
of employment, with an abnormal
result.
A second worker in the 2000–2004
group had two abnormal BeLPT tests at
the time of hire, and a third had one
abnormal test at hire and a second
abnormal test at 3 months. Both had
normal BeLPTs at 6 months, and were
not tested thereafter. A fourth worker
had one abnormal BeLPT result at the
time of hire, a normal result at 3
months, an abnormal result at 6 months,
and a normal result at 12 months. Four
additional workers had one abnormal
result during surveillance, which could
not be confirmed upon repeat testing.
Cummings et al. calculated two
sensitization rates based on these
screening results: (1) a rate using only
the sensitized worker identified at 24
months, and (2) a rate including all four
workers who had repeated abnormal
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
results. They reported a sensitization
incidence rate (IR) of 0.7 per 1,000
person-months to 2.7 per 1,000 personmonths for the workers hired between
2000 and 2004, using the sum of
sensitization-free months of
employment among all 93 workers as
the denominator.
The authors also estimated an
incidence rate (IR) of 5.6 per 1,000
person-months for workers hired
between 1993 and the 1998 survey. This
estimated IR was based on one BeLPT
screening, rather than BeLPTs
conducted throughout the workers’
employment. The denominator in this
case was the total months of
employment until the 1998 screening.
Because sensitized workers may have
been sensitized prior to the screening,
the denominator may overestimate
sensitization-free time in the legacy
group, and the actual sensitization IR for
legacy workers may be somewhat higher
than 5.6 per 1,000 person-months.
Based on comparison of the IRs, the
authors concluded that the addition of
respirator use, dermal protection, and
housekeeping improvements appeared
to have reduced the risk of sensitization
among workers at the plant, even
though airborne beryllium levels in
some areas of the plant had not changed
significantly since the 1998 survey.
g. Copper-Beryllium Alloy Processing
and Distribution
Schuler et al. (2005) studied a group
of 152 workers at a facility processing
copper-beryllium alloys and small
quantities of nickel-beryllium alloys,
and converting semi-finished alloy strip
and wire into finished strip, wire and
rod. Production activities included
annealing, drawing, straightening, point
and chamfer, rod and wire packing, die
grinding, pickling, slitting, and
degreasing. Periodically in the plant’s
history, they also did salt baths,
cadmium plating, welding and
deburring. Since the late 1980s, rod and
wire production processes were
physically segregated from strip metal
production. Production support jobs
included mechanical maintenance,
quality assurance, shipping and
receiving, inspection, and wastewater
treatment. Administration was divided
into staff primarily working within the
plant and personnel who mostly worked
in office areas (Schuler, et al., 2005).
Workers’ respirator use was limited,
mostly to occasional tasks where high
exposures were anticipated.
Following the 1999 diagnosis of a
worker with CBD, the company
surveyed the workforce, offering all
current employees BeLPT testing in
2000 and offering sensitized workers
PO 00000
Frm 00037
Fmt 4701
Sfmt 4702
47601
clinical evaluation for CBD, including
BAL and transbronchial biopsy. Of the
facility’s 185 employees, 152
participated in the BeLPT screening.
Samples were split between two
laboratories, with additional draws and
testing for confirmation if conflicting
tests resulted in the initial draw. Ten
participants (7 percent) had at least two
abnormal BeLPT results. The results of
nine workers who had abnormal BeLPT
results from only one laboratory were
not included because the authors
believed it was experiencing technical
problems with the test (Schuler et al.,
2005). CBD was diagnosed in six
workers (4 percent) on evidence of
pathogenic abnormalities (e.g.,
granulomas) or evidence of clinical
abnormalities consistent with CBD
based on pulmonary function testing,
pulmonary exercise testing, and/or chest
radiography. One worker diagnosed
with CBD had been exposed to
beryllium during previous work at
another copper-beryllium processing
facility.
Schuler et al. evaluated airborne
beryllium levels at the plant using IH
samples collected between 1969 and
2000, including 4,524 GA samples, 650
LP samples and 815 short-duration (3–
5 min) high volume (SD–HV) BZ taskspecific samples. Occupational
exposures to airborne beryllium were
generally low. Ninety-nine percent of all
LP measurements were below the
current OSHA PEL of 2.0 mg/m3 (8-hr
TWA); 93 percent were below the DOE
action level of 0.2 mg/m3; and the
median value was 0.02 mg/m3. The SD–
HV BZ samples had a median value of
0.44 mg/m3, with 90 percent below the
OSHA Short-Term Exposure Limit
(STEL) of 5.0 mg/m3. The highest levels
of beryllium were found in rod and wire
production, particularly in wire
annealing and pickling, the only
production job with a median personal
sample measurement greater than 0.1
mg/m3 (median 0.12 mg/m3; range 0.01–
7.8 mg/m3) (Schuler et al., Table 4).
These concentrations were significantly
higher than the exposure levels in the
strip metal area (median 0.02, range
0.01–0.72 mg/m3), in production support
jobs (median 0.02, range <0.01–0.33 mg/
m3), plant administration (median 0.02,
range <0.01–0.11 mg/m3), and office
administration jobs (median 0.01, range
<0.01–0.06 mg/m3).
The authors reported that eight of the
ten sensitized employees, including all
six CBD cases, had worked in both
major production areas during their
tenure with the plant. The 7 percent
prevalence (6 of 81 workers) of CBD
among employees who had ever worked
in rod and wire was statistically
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47602
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
significantly elevated compared with
employees who had never worked in
rod and wire (p <0.05), while the 6
percent prevalence (6 of 94 workers)
among those who had worked in strip
metal was not significantly elevated
compared to non-strip metal workers (p
> 0.1). Based on these results, together
with the higher exposure levels reported
for the rod and wire production area,
Schuler et al. concluded that work in
rod and wire was a key risk factor for
CBD in this population. Schuler et al.
also found a high prevalence (13
percent) of sensitization among workers
who had been exposed to beryllium for
less than a year at the time of the
screening, a rate similar to that found by
Henneberger et al. among beryllium
ceramics workers exposed for one year
or less (16 percent, Henneberger et al.,
2001). All four workers who were
sensitized without disease had been
exposed 5 years or less; conversely, all
six of the workers with CBD had first
been exposed to beryllium at least five
years prior to the screening (Schuler et
al., Table 2).
As has been seen in other studies,
beryllium sensitization and CBD were
found among workers who were
typically exposed to low time-weighted
average airborne concentrations of
beryllium. While jobs in the rod and
wire area had the highest exposure
levels in the plant, the median personal
sample value was only 0.12 mg/m3.
However, workers may have
occasionally been exposed to higher
beryllium levels for short periods during
specific tasks. A small fraction of
personal samples recorded in rod and
wire were above the OSHA PEL of 2.0
mg/m3, and half of workers with
sensitization or CBD reported that they
had experienced a ‘‘high-exposure
incident’’ at some point in their work
history (Schuler et al., 2005). The only
group of workers with no cases of
sensitization or CBD, a group of 26
office administration workers, was the
group with the lowest recorded
exposures (median personal sample 0.01
mg/m3, range <0.01–0.06 mg/m3).
After the BeLPT screening was
conducted in 2000, the company began
implementing new measures to further
reduce workers’ exposure to beryllium
(Thomas et al., 2009). Requirements
designed to minimize dermal contact
with beryllium, including long-sleeve
facility uniforms and polymer gloves,
were instituted in production areas in
2000. In 2001 the company installed
LEV in die grinding and polishing. LP
samples collected between June 2000
and December 2001 show reduced
exposures plant-wide. Of 2,211
exposure samples collected, 98 percent
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
were below 0.2 mg/m3, and 59 percent
below the limit of detection (LOD),
which was either 0.02 mg/m3 or 0.2 mg/
m3 depending on the method of sample
analysis (Thomas et al., 2009). Median
values below 0.03 mg/m3 were reported
for all processes except the wire
annealing and pickling process.
Samples for this process remained
somewhat elevated, with a median of
0.1 mg/m3. In January 2002, the plant
enclosed the wire annealing and
pickling process in a restricted access
zone (RAZ), requiring respiratory PPE in
the RAZ and implementing stringent
measures to minimize the potential for
skin contact and beryllium transfer out
of the zone. While exposure samples
collected by the facility were sparse
following the enclosure, they suggest
exposure levels comparable to the 2000–
01 samples in areas other than the RAZ.
Within the RAZ, required use of
powered air-purifying respirators
indicates that respiratory exposure was
negligible.
To test the efficacy of the new
measures in preventing sensitization
and CBD, in June 2000 the facility began
an intensive BeLPT screening program
for all new workers. The company
screened workers at the time of hire; at
intervals of 3, 6, 12, 24, and 48 months;
and at 3-year intervals thereafter.
Among 82 workers hired after 1999,
three (3.7 percent) cases of sensitization
were found. Two (5.4 percent) of 37
workers hired prior to enclosure of the
wire annealing and pickling process
were found to be sensitized within 3
and 6 months of beginning work at the
plant. One (2.2 percent) of 45 workers
hired after the enclosure was confirmed
as sensitized.
Thomas et al. calculated a
sensitization IR of 1.9 per 1,000 personmonths for the workers hired after the
exposure control program was initiated
in 2000 (‘‘program workers’’), using the
sum of sensitization-free months of
employment among all 82 workers as
the denominator (Thomas et al., 2009).
They calculated an estimated IR of 3.8
per 1,000 person-months for 43 workers
hired between 1993 and 2000 who had
participated in the 2000 BeLPT
screening (‘‘legacy workers’’). This
estimated IR was based on one BeLPT
screening, rather than BeLPTs
conducted throughout the legacy
workers’ employment. The denominator
in this case is the total months of
employment until the 2000 screening.
Because sensitized workers may have
been sensitized prior to the screening,
the denominator may overestimate
sensitization-free time in the legacy
group, and the actual sensitization IR for
legacy workers may be somewhat higher
PO 00000
Frm 00038
Fmt 4701
Sfmt 4702
than 3.8 per 1,000 person-months.
Based on comparison of the IRs and the
prevalence rates discussed previously,
the authors concluded that the
combination of dermal protection,
respiratory protection, housekeeping
improvements and engineering controls
implemented beginning in 2000
appeared to have reduced the risk of
sensitization among workers at the
plant. However, they noted that the
small size of the study population and
the short follow-up time for the program
workers suggested that further research
is needed to confirm the program’s
efficacy (Thomas et al., 2009).
Stanton et al. (2006) conducted a
study of workers in three different
copper-beryllium alloy distribution
centers in the United States. The
distribution centers, including one bulk
products center established in 1963 and
strip metal centers established in 1968
and 1972, sell products received from
beryllium production and finishing
facilities and small quantities of copperberyllium, aluminum-beryllium, and
nickel-beryllium alloy materials. Work
at distribution centers does not require
large-scale heat treatment or
manipulation of material typical of
beryllium processing and machining
plants, but involves final processing
steps that can generate airborne
beryllium. Slitting, the main production
activity at the two strip product
distribution centers, generates low
levels of airborne beryllium particles,
while operations such as tensioning and
welding used more frequently at the
bulk products center can generate
somewhat higher levels. Nonproduction jobs at all three centers
included shipping and receiving,
palletizing and wrapping, productionarea administrative work, and officearea administrative work.
The authors estimated workers’
beryllium exposures using IH data from
company records and job history
information collected through
interviews conducted by a company
occupational health nurse. Stanton et al.
evaluated airborne beryllium levels in
various jobs based on 393 full-shift LP
samples collected from 1996 to 2004.
Airborne beryllium levels at the plant
were generally very low, with 54
percent of all samples at or below the
LOD, which ranged from 0.02 to 0.1 mg/
m3. The authors reported a median of
0.03 mg/m3 and an arithmetic mean of
0.05 mg/m3 for the 393 full-shift LP
samples, where samples below the LOD
were assigned a value of half the
applicable LOD. Median and geometric
mean values for specific jobs ranged
from 0.01–0.07 and 0.02–0.07 mg/m3,
respectively. All measurements were
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
below the OSHA PEL of 2.0 mg/m3 and
97 percent were below the DOE action
level of 0.2 mg/m3. The paper does not
report use of respiratory or skin
protection. Exposure conditions may
have changed somewhat over the
history of the plant due to changes in
exposure control measures, including
improvements to product and container
cleaning practices instituted during the
1990s.
Eighty-eight of the 100 workers (88
percent) employed at the three centers
at the time of the study participated in
screening for beryllium sensitization.
Blood samples were collected between
November 2000 and March 2001 by the
company’s medical staff. Samples
collected from employees of the strip
metal centers were split and evaluated
at two laboratories, while samples from
the bulk product center workers were
evaluated at a single laboratory.
Participants were considered to be
‘‘sensitized’’ to beryllium if two or more
BeLPT results, from two laboratories or
from repeat testing at the same
laboratory, were found to be abnormal.
One individual was found to be
sensitized and was offered clinical
evaluation, including BAL and
fiberoptic bronchoscopy. He was found
to have lung granulomas and was
diagnosed with CBD.
The worker diagnosed with CBD had
been employed at a strip metal
distribution center from 1978 to 2000 as
a shipper and receiver, loading and
unloading trucks delivering materials
from a beryllium production facility and
to the distribution center’s customers.
Although the LP samples collected for
his job between 1996 and 2000 were
generally low (n = 35, median 0.01,
range < 0.02–0.13 mg/m3), it is not clear
whether these samples adequately
characterize his exposure conditions
over the course of his work history. He
reported that early in his work history,
containers of beryllium oxide powder
were transported on the trucks he
entered. While he did not recall seeing
any breaks or leaks in the beryllium
oxide containers, some containers were
known to have been punctured by
forklifts on trailers used by the company
during the period of his employment,
and could have contaminated trucks he
entered. With 22 years of employment at
the facility, this worker had begun
beryllium-related work earlier and
performed it longer than about 90
percent of the study population (Stanton
et al., 2006).
h. Nuclear Weapons Production
Facilities & Cleanup of Former Facilities
Primary exposure from nuclear
weapons production facilities comes
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
from beryllium metal and beryllium
alloys. A study conducted by Kreiss et
al. (1989) documented sensitization and
CBD among beryllium-exposed workers
in the nuclear industry. A company
medical department identified 58
workers with beryllium exposure among
a work force of 500, of whom 51 (88
percent) participated in the study.
Twenty-four workers were involved in
research and development (R&D), while
the remaining 27 were production
workers. The R&D workers had a longer
tenure with a mean time from first
exposure of 21.2 years, compared to a
mean time since first exposure of 5
years among the production workers.
The number of workers with abnormal
BeLPT readings was 6, with 4 being
diagnosed with CBD. This resulted in an
estimated 11.8 percent prevalence of
sensitization.
Kreiss et al. (1993) expanded the work
of Kreiss et al. (1989) by performing a
cross-sectional study of 895 (current and
former) beryllium workers in the same
nuclear weapons plant. Participants
were placed in qualitative exposure
groups (‘‘no exposure,’’ ‘‘minimal
exposure,’’ ‘‘intermittent exposure,’’ and
‘‘consistent exposure’’) based on
questionnaire responses. The number of
workers with abnormal BeLPT totaled
18 with 12 being diagnosed with CBD.
Three additional workers with
sensitization developed CBD over the
next 2 years. Sensitization occurred in
all of the qualitatively defined exposure
groups. Individuals who had worked as
machinists were statistically
overrepresented among berylliumsensitized cases, compared with noncases. Cases were more likely than noncases to report having had a measured
overexposure to beryllium (p = 0.009),
a factor which proved to be a significant
predictor of sensitization in logistic
regression analyses, as was exposure to
beryllium prior to 1970. Beryllium
sensitized cases were also significantly
more likely to report having had cuts
that were delayed in healing (p = 0.02).
The authors concluded that individual
variability and susceptibility along with
exposure circumstances are important
factors in developing beryllium
sensitization and CBD.
In 1991, the Beryllium Health
Surveillance Program (BHSP) was
established at the Rocky Flats Nuclear
Weapons Facility to offer BLPT
screening to current and former
employees who may have been exposed
to beryllium (Stange et al., 1996).
Participants received an initial BeLPT
and follow-ups at one and three years.
Based on histologic evidence of
pulmonary granulomas and a positive
BAL-BeLPT, Stange et al. published a
PO 00000
Frm 00039
Fmt 4701
Sfmt 4702
47603
study of 4,397 BHSP participants tested
from June 1991 to March 1995,
including current employees (42.8
percent) and former employees (57.2
percent). Twenty-nine cases of CBD and
76 cases of sensitization were identified.
The sensitization rate for the population
was 2.43 percent. Available exposure
data included fixed airhead (FAH)
exposure samples collected between
1970 and 1988 (mean concentration
0.016 mg/m3) and personal samples
collected between 1984 and 1987 (mean
concentration 1.04 mg/m3). Cases of CBD
and sensitization were noted in
individuals in all jobs classifications,
including those believed to involve
minimal exposure to beryllium. The
authors recommended ongoing
surveillance for workers in all jobs with
potential for beryllium exposure.
Stange et al. (2001) extended the
previous study, evaluating 5,173
participants in the Rocky Flats BHSP
who were tested between June 1991 and
December 1997. Three-year serial testing
was offered to employees who had not
been tested for three years or more and
did not show beryllium sensitization
during the previous study. This resulted
in 2,891 employees being tested. Of the
5,173 workers participating in the study,
172 were found to have abnormal
BeLPT. Ninety-eight (3.33 percent) of
the workers were found to be sensitized
(confirmed abnormal BeLPT results) in
the initial screening, conducted in 1991.
Of these workers 74 were diagnosed
with CBD (history of beryllium
exposure, evidence of non-caseating
granulomas or mononuclear cell
infiltrates on lung biopsy, and a positive
BeLPT or BAL-BeLPT). A follow-up
survey of 2,891 workers three years later
identified an additional 56 sensitized
workers and an additional seven cases
of CBD. Sensitization and CBD rates
were analyzed with respect to gender,
building work locations, and length of
employment. Historical employee data
included hire date, termination date,
leave of absences, and job title changes.
Exposure to beryllium was determined
by job categories and building or work
area codes. Personal beryllium air
monitoring results were used, when
available, from employees with the
same job title or similar job. However,
no quantitative information was
presented in the study. The authors
conclude that for some individuals,
exposure to beryllium at levels less that
the OSHA PEL could cause sensitization
and CBD.
Viet et al. (2001) conducted a casecontrol study of the Rocky Flats worker
population studied by Stange et al.
(1996 and 2001) to examine the
relationship between estimated
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47604
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
beryllium exposure level and risk of
sensitization or CBD. The worker
population included 74 berylliumsensitized workers and 50 workers
diagnosed with CBD. Beryllium
exposure levels were estimated based on
FAH airhead samples from one
building, the beryllium machine shop.
These were collected away from the BZ
of the machine operator and likely
underestimated exposure. To estimate
levels in other locations, these air
sample concentrations were used to
construct a job exposure matrix that
included the determination of the
Building 444 exposure estimates for a
30-year period; each subject’s work
history by job location, task, and time
period; and assignment of exposure
estimates to each combination of job
location, task, and time period as
compared to Building 444 machinists.
The authors adjusted the levels
observed in the machine shop by factors
based on interviews with former
workers. Workers’ estimated mean
exposure concentrations ranged from
0.083 mg/m3 to 0.622 mg/m3. Estimated
maximum air concentrations ranged
from 0.54 mg/m3 to 36.8 mg/m3. Cases
were matched to controls of the same
age, race, gender, and smoking status
(Viet et al., 2001).
Estimated mean and cumulative
exposure levels and duration of
employment were found to be
significantly higher for CBD cases than
for controls. Estimated mean exposure
levels were significantly higher for
sensitization cases than for controls. No
significant difference was observed for
estimated cumulative exposure or
duration of exposure. Similar results
were found using logistic regression
analysis, which identified statistically
significant relationships between CBD
and both cumulative and mean
estimated exposure, but did not find
significant relationships between
estimated exposure levels and
sensitization without CBD. Comparing
CBD with sensitization cases, Viet et al.
found that workers with CBD had
significantly higher estimated
cumulative and mean beryllium
exposure levels than workers who were
sensitized, but did not have CBD.
Johnson et al. (2001) conducted a
review of personal sampling records and
medical surveillance reports at an
atomic weapons establishment in
Cardiff, United Kingdom. The study
evaluated airborne samples collected
over the 36-year period of operation for
the plant. Data included 367,757 area
samples and 217,681 personal lapel
samples from 194 workers over the time
period from 1981–1997. Data was
available prior to this time period but
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
was not analyzed since this data was not
available electronically. The authors
estimated that over the 17 years of
measurement data analyzed, airborne
beryllium concentrations did exceed 2.0
mg/m3, however, due to the limitations
with regard to collection times it is
difficult to assess the full reliability of
this estimate. The authors noted that in
the entire plant’s history, only one case
of CBD had been diagnosed. It was also
noted that BeLPT has not been routinely
conducted among any of the workers at
this facility.
Armojandi et al. (2010) conducted a
cross-sectional study of workers at a
nuclear weapons research and
development (R&D) facility to determine
the risk of developing CBD in sensitized
workers at facilities with exposures
much lower than production plants. Of
the 1875 current or former workers at
the R&D facility, 59 were determined to
be sensitized based on at least two
positive BeLPTs (i.e., samples drawn on
two separate occasions or on split
samples tested in two separate DOEapproved laboratories) for a
sensitization rate of 3.1 percent.
Workers found to have positive BeLPTs
were further evaluated in an
Occupational Medicine Clinic between
1999 through 2005. Armojandi et al.
(2010) evaluated 50 of the sensitized
workers who also had medical and
occupational histories, physical
examination, chest imaging with highresolution computed tomography
(HRCT) (N = 49), and pulmonary
function testing (nine of the 59 workers
refused physical examinations so were
not included in this study). Forty of the
50 workers chosen for this study
underwent bronchoscopy for
bronchoalveolar lavage and
transbronchial biopsies in additional to
the other testing. Five of the 49 workers
had CBD at the time of evaluation
(based on histology or high-resolution
computed tomography); three others
had evidence of probable CBD; however,
none of these cases were classified as
severe at the time of evaluation. The rate
of CBD at the time of study among
sensitized individuals was 12.5 percent
(5/40) for those using pathologic review
of lung tissue, and 10.2 percent (5/49)
for those using HRCT as a criteria for
diagnosis. The rate of CBD among the
entire population (5/1875) was 0.3
percent.
The mean duration of employment at
the facility was 18 years, and the mean
latency period (from first possible
exposure) to time of evaluation and
diagnosis was 32 years. There was no
available exposure monitoring in the
breathing zone of workers at the facility
but the beryllium levels were believed
PO 00000
Frm 00040
Fmt 4701
Sfmt 4702
to be relatively low (possibly less than
0.1 mg/m3 for most jobs). There was not
an apparent exposure-response
relationship for sensitization or CBD.
The sensitization prevalence was
similar and the CBD prevalence higher
among workers with the lower-exposure
jobs. The authors concluded that these
sensitized workers, who were subjected
to an extended duration of low potential
beryllium exposures over a long latency
period, had a low prevalence of CBD
(Armojandi et al., 2010).
i. Aluminum Smelting
Bauxite ore, the primary source of
aluminum, contains naturally occurring
beryllium. Worker exposure to
beryllium can occur at aluminum
smelting facilities where aluminum
extraction occurs via electrolytic
reduction of aluminum oxide into
aluminum metal. Characterization of
beryllium exposures and sensitization
prevalence rates were examined by
Taiwo et al. (2010) in a study of nine
aluminum smelting facilities from four
different companies in the U.S., Canada,
Italy and Norway.
Of the 3,185 workers determined to be
potentially exposed to beryllium, 1,932
agreed to participate in a medical
surveillance program between 2000 and
2006 (60 percent participation rate). The
medical surveillance program included
serum BeLPT analysis, confirmation of
an abnormal BeLPT with a second
BeLPT, and follow-up of all confirmed
positive responses by a pulmonary
physician to evaluate for progression to
CBD.
Eight-hour TWAs were assessed
utilizing 1,345 personal samples
collected from the 9 smelters. The
personal beryllium samples obtained
showed a range of 0.01–13.00 mg/m3
time-weighted average with an
arithmetic mean of 0.25 mg/m3 and
geometric mean of 0.06 mg/m3. Exposure
levels to beryllium observed in
aluminum smelters are similar to those
seen in other industries that utilize
beryllium. Of the 1,932 workers
surveyed by BeLPT, nine workers were
diagnosed with sensitization
(prevalence rate of 0.47 percent, 95%
confidence interval = 0.21–0.88 percent)
with 2 of these workers diagnosed with
probable CBD after additional medical
evaluations.
The authors concluded that compared
with beryllium-exposed workers in
other industries, the rate of sensitization
among aluminum smelter workers
appears lower. The authors speculated
that this lower observed rate could be
related to a more soluble form of
beryllium found in the aluminum
smelting work environment as well as
E:\FR\FM\07AUP2.SGM
07AUP2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
the consistent use of respiratory
protection. However, the authors also
speculated that the 60 percent
participation rate may have
underestimated the sensitization rate in
this worker population.
A study by Nilsen et al. (2010) also
found a low rate of sensitization among
aluminum workers in Norway. Threehundred sixty-two workers and thirtyone control individuals were tested for
beryllium sensitization based on the
BeLPT. The results found that one
(0.28%) of the smelter workers had been
sensitized. No borderline results were
reported. The exposure estimated in this
plant was 0.1 mg/m3 to 0.31 mg/m3
(Nilsen et al., 2010).
6. Animal Models of CBD
This section reviews the relevant
animal studies supporting the
mechanisms outlined above.
Researchers have attempted to identify
animal models with which to further
investigate the mechanisms underlying
the development of CBD. A suitable
animal model should exhibit major
characteristics of CBD, including the
demonstration of a beryllium-specific
immune response, the formation of
immune granulomas following
inhalation exposure to beryllium, and
mimicking the progressive nature of the
human disease. While exposure to
beryllium has been shown to cause
chronic granulomatous inflammation of
the lung in animal studies using a
variety of species, most of the
granulomatous lesions were formed by
foreign-body reactions, which result
from persistent irritation and consist
predominantly of macrophages and
monocytes, and small numbers of
lymphocytes. Foreign-body granulomas
are distinct from the immune
granulomas of CBD, which are caused
by antigenic stimulation of the immune
system and contain large numbers of
lymphocytes. Animal studies have been
useful in providing biological
plausibility for the role of
immunological alterations and lung
inflammation and in clarifying certain
specific mechanistic aspects of
beryllium disease. However, the lack of
a dependable animal model that mimics
all facets of the human response
combined with study limitations in
terms of single dose experiments, few
animals, or abbreviated observation
periods have limited the utility of the
data. Currently, no single model has
completely mimicked the disease
process as it progresses in humans. The
following is a discussion of the most
relevant animal studies regarding the
mechanisms of sensitization and CBD
development in humans. Table A.2 in
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
the Appendix summarizes species,
route, chemical form of beryllium, dose
levels, and pathological findings of the
key studies.
Harmsen et al. performed a study to
assess whether the beagle dog could
provide an adequate model for the study
of beryllium-induced lung diseases
(Harmsen et al., 1986). One group of
dogs served as a control group (air
inhalation only) and four other groups
received high (approximately 50 mg/kg)
and low (approximately 20 mg/kg) doses
of beryllium oxide calcined at 500 °C or
1,000° C, administered as aerosols in a
single exposure. As discussed above,
calcining temperature controls the
solubility and SSA of beryllium
particles. Those particles calcined at
higher temperatures (e.g., 1,000° C) are
less soluble and have lower SSA than
particles calcined at lower temperatures
(e.g., 500 °C). Solubility and SSA are
factors in determining the toxic
potential of beryllium compounds or
materials.
Cells were collected from the dogs by
BAL at 30, 60, 90, 180, and 210 days
after exposure, and the percentages of
neutrophils and lymphocytes were
determined. In addition, the mitogenic
responses of blood lymphocytes and
lavage cells collected at 210 days were
determined with either
phytohemagglutinin or beryllium sulfate
as mitogen. The percentage of
neutrophils in the lavage fluid was
significantly elevated only at 30 days
with exposure to either dose of 500 °C
beryllium oxide. The percentage of
lymphocytes in the fluid was
significantly elevated in samples across
all times with exposure to the high dose
of this beryllium oxide form. Beryllium
oxide calcined at 1,000° C elevated
lavage lymphocytes only in high dose at
30 days. No significant effect of 1,000°
C beryllium oxide exposure on
mitogenic response of any lymphocytes
was seen. In contrast, peripheral blood
lymphocytes from the 500 °C beryllium
oxide exposed groups were significantly
stimulated by beryllium sulfate
compared with the phytohemagglutinin
exposed cells. The investigators in this
study were able to replicate some of the
same findings as those observed in
human studies—specifically, that
beryllium in soluble and insoluble
forms can be mitogenic to immune cells,
an important finding for progression of
sensitization and proliferation of
immune cells to developing full-blown
CBD.
In another beagle study Haley et al.
also found that the beagle dog appears
to model some aspects of human CBD
(Haley et al., 1989). The authors
monitored lung pathologic effects,
PO 00000
Frm 00041
Fmt 4701
Sfmt 4702
47605
particle clearance, and immune
sensitization of peripheral blood
leukocytes following a single exposure
to beryllium oxide aerosol generated
from beryllium oxide calcined at 500 °C
or 1,000° C. The aerosol was
administered to the dogs perinasally to
attain initial lung burdens of 6 or 18 mg
beryllium/kg body weight.
Granulomatous lesions and lung
lymphocyte responses consistent with
those observed in humans with CBD
were observed, including perivascular
and peribronchiolar infiltrates of
lymphocytes and macrophages,
progressing to microgranulomas with
areas of granulomatous pneumonia and
interstitial fibrosis. Beryllium specificity
of the immune response was
demonstrated by positive results in the
BeLPT, although there was considerable
inter-animal variation. The lesions
declined in severity after 64 days postexposure. Thus, while this model was
able to mimic the formation of Bespecific immune granulomas, it was not
able to mimic the progressive nature of
disease.
This study also provided an
opportunity to compare the effects of
beryllium oxide calcination temperature
on granulomatous disease in the beagle
respiratory system. Haley et al. found an
increase in the percentage and numbers
of lymphocytes in BAL fluid at 3
months post-exposure in dogs exposed
to either dose of beryllium oxide
calcined at 500 °C, but not in dogs
exposed to the material calcined at the
higher temperature. Although there was
considerable inter-animal variation,
lesions were generally more severe in
the dogs exposed to material calcined at
500 °C. Positive BeLPT results were
observed with BAL lymphocytes only in
the group with a high initial lung
burden of the material calcined at 500
°C, but positive results with peripheral
blood lymphocytes were observed at
both doses with material calcined at
both temperatures.
The histologic and immunologic
responses of canine lungs to aerosolized
beryllium oxide were investigated in
another Haley et al. (1989) study.
Beagle-dogs were exposed in a single
exposure to high dose (50 mg/kg of body
weight) or low dose (l7 mg/kg) levels of
beryllium oxide calcined at either 500°
or 1000° C. One group of dogs was
examined up to 365 days after exposure
for lung histology and biochemical
assay to determine the fate of inhaled
beryllium oxide. A second group
underwent BAL for lung lymphocyte
analysis for up to 22 months after
exposure. Histopathologic examination
revealed peribronchiolar and
perivascular lymphocytic histiocytic
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47606
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
inflammation, peaking at 64 days after
beryllium oxide exposure. Lymphocytes
were initially well differentiated, but
progressed to lymphoblastic cells and
aggregated in lymphofollicular nodules
or microgranulomas over time. Alveolar
macrophages were large, and filled with
intracytoplasmic material. Cortical and
paracortical lymphoid hyperplasia of
the tracheobronchial nodes was found.
Lung lymphocyte concentrations were
increased at 3 months and returned to
normal in both dose groups given 500 °C
treated beryllium chloride. No
significant elevations in lymphocyte
concentrations were found in dogs given
1,000° C treated beryllium oxide. Lung
retention was higher in the 500 °C
treated beryllium oxide group. The
lesions found in dog lungs closely
resembled those found in humans with
CBD: severe granulomas, lymphoblast
transformation, increased pulmonary
lymphocyte concentrations and
variation in beryllium sensitivity. It was
concluded that the canine model for
berylliosis may provide insight into this
disease.
In a follow-up experiment, control
dogs and those exposed to beryllium
oxide calcined at 500 °C were allowed
to rest for 2.5 years, and then re-exposed
to filtered air (controls) or beryllium
oxide calcined at 500 °C for an initial
lung burden (ILB) target of 50 mg
beryllium oxide/kg body weight (Haley
et al., 1992). Immune responses of blood
and BAL lymphocytes, and lung lesions
in dogs sacrificed 210 days postexposure, were compared with results
following the initial exposure. The
severity of lung lesions was comparable
under both conditions, suggesting that a
2.5-year interval was sufficient to
prevent cumulative pathologic effects.
Conradi et al. (1971) found no exposurerelated histological alterations in the
lungs of six beagle dogs exposed to a
range of 3,300–4,380 mg Be/m3 as
beryllium oxide calcined at 1,400° C for
30 min, once per month for 3 months.
Because the dogs were sacrificed 2 years
post-exposure, the long time period
between exposure and response may
have allowed for the reversal of any
beryllium-induced changes (EPA, 1998).
A 1994 study by Haley et al. showed
that intra-bronchiolar instillation of
beryllium induced immune granulomas
and sensitization in monkeys. Haley et
al. (1994) exposed male cynomolgus
monkeys to either beryllium metal or
beryllium oxide calcined at 500 °C by
intrabronchiolar instillation as a saline
suspension. Lymphocyte counts in BAL
fluid were observed, and were found to
be significantly increased in monkeys
exposed to beryllium metal on postexposure days 14 to 90, and on post-
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
exposure day 60 in monkeys exposed to
beryllium oxide. The lungs of monkeys
exposed to beryllium metal had lesions
characterized by interstitial fibrosis,
Type II cell hyperplasia, and
lymphocyte infiltration. Some monkeys
also exhibited immune granulomas.
Similar lesions were observed in
monkeys exposed to beryllium oxide,
but the incidence and severity were
much less. BAL lymphocytes from
monkeys exposed to beryllium metal,
but not from monkeys exposed to
beryllium oxide, proliferated in
response to beryllium sulfate in the
BeLPT (EPA, 1998).
In an experiment similar to the one
conducted with dogs, Conradi et al.
(1971) found no effect in monkeys
(Macaca irus) exposed via whole-body
inhalation for three 30-minute monthly
exposures to a range of 3,300–4,380 mg
Be/m3 as beryllium oxide calcined at
1,400° C. The lack of effect may have
been related to the long period (2 years)
between exposure and sacrifice, or to
low toxicity of beryllium oxide calcined
at such a high temperature.
As discussed earlier in this Health
Effects section, at the cellular level,
beryllium dissolution must occur for
either a dendritic cell or a macrophage
to present beryllium as an antigen to
induce the cell-mediated CBD immune
reactions (Stefaniak et al., 2006). Several
studies have shown that low-fired
beryllium oxide, which is
predominantly made up of poorly
crystallized small particles, is more
immunologically reactive than
beryllium oxide calcined at higher firing
temperatures that result in less
reactivity due to increasing crystal size.
As discussed previously, Haley et al.
(1989a) found more severe lung lesions
and a stronger immune response in
beagle dogs receiving a single inhalation
exposure to beryllium oxide calcined at
500 °C than in dogs receiving an
equivalent initial lung burden of
beryllium oxide calcined at 1,000° C.
Haley et al. found that beryllium oxide
calcined at 1,000° C elicited little local
pulmonary immune response, whereas
the much more soluble beryllium oxide
calcined at 500 °C produced a
beryllium-specific, cell-mediated
immune response in dogs (Haley et al.,
1991).
In a later study, beryllium metal
appeared to induce a greater toxic
response than beryllium oxide following
intrabronchiolar instillation in
cynomolgus monkeys, as evidenced by
more severe lung lesions, a larger effect
on BAL lymphocyte counts, and a
positive response in the BeLPT with
BAL lymphocytes only after exposure to
beryllium metal (Haley et al., 1994).
PO 00000
Frm 00042
Fmt 4701
Sfmt 4702
Because an oxide layer may form on
beryllium-metal surfaces after exposure
to air (Mueller and Adolphson, 1979;
Harmsen et al., 1986) dissolution of
small amounts of poorly soluble
beryllium compounds in the lungs
might be sufficient to allow persistent
low-level beryllium presentation to the
immune system (NAS, 2008).
Genetic studies in humans led to the
creation of an animal model containing
different human HLA–DP alleles
inserted into FVB/N mice for
mechanistic studies of CBD. Three
strains of genetically engineered mice
(transgenic mice) were created that
conferred different risks for developing
CBD based on human studies (Weston et
al., 2005; Snyder et al., 2008): (1) the
HLDPB1*401 transgenic strain, where
the transgene codes for lysine residue at
the 69th position of the B-chain
conferred low risk of CBD; (2) the HLA–
DPB1*201 mice, where the transgene
codes for glutamic acid residue at the
69th position of the B-chain and glycine
residues at positions 84 and 85
conferred medium risk of CBD; and (3)
the HLA–DPB1*1701 mice, where the
transgene codes for glutamic acid at the
69th position of the B-chain and
aspartic acid and glutamic acid residues
at positions 84 and 85, respectively,
conferred high risk of CBD (TarantinoHutchinson et al., 2009).
In order to validate the transgenic
model, Tarantino-Hutchison et al.
challenged the transgenic mice along
with seven different inbred mouse
strains to determine the susceptibility
and sensitivity to beryllium exposure.
Mice were dermally exposed with either
saline or beryllium, then challenged
with either saline or beryllium (as
beryllium sulfate) using the MEST
protocol (mouse ear-swelling test). The
authors determined that the high risk
HLA–DPB1*1701 transgenic strain
responded 4 times greater (as measured
via ear swelling) than control mice and
at least 2 times greater than other strains
of mice. The findings correspond to
epidemiological study results reporting
an enhanced CBD odds ratio for the
HLA–DPB1*1701 in humans (Weston et
al., 2005; Snyder et al., 2008).
Transgenic mice with the genes
corresponding to the low and medium
odds ratio study did not respond
significantly over the control group. The
authors concluded that while HLA–
DPB1*1701 is important to beryllium
sensitization and progression to CBD,
other genetic and environmental factors
contribute to the disease process as
well.
E:\FR\FM\07AUP2.SGM
07AUP2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
7. Preliminary Beryllium Sensitization
and CBD Conclusions
It is well-established that skin and
inhalation exposure to beryllium may
lead to sensitization and that inhalation
exposure, or skin exposure coupled
with inhalation exposure, may lead to
the onset and progression of CBD. This
is supported by extensive human
studies. While all facets of the biological
mechanism for this complex disease
have yet to be fully elucidated, many of
the key events in the disease sequence
have been identified and described in
the previous sections. Sensitization is a
necessary first step to the onset of CBD
(NAS, 2008). Sensitization is the process
by which the immune system recognizes
beryllium as a foreign substance and
responds in a manner that may lead to
development of CBD. It has been
documented that a substantial
proportion of sensitized workers
exposed to airborne beryllium progress
to CBD (Rosenman et al., 2005; NAS,
2008; Mroz et al., 2009). Animal studies,
particularly in dogs and monkeys, have
provided supporting evidence for T-cell
lymphocyte proliferation in the
development of granulomatous lung
lesions after exposure to beryllium
(Harmsen et al., 1986; Haley et al., 1989,
1992, 1994). The animal studies have
also provided important insights into
the roles of chemical form, genetic
susceptibility, and residual lung burden
in the development of beryllium lung
disease (Harmsen et al., 1986; Haley et
al., 1992; Tarantino-Hutchison et al.,
2009). OSHA has made a preliminary
determination to consider sensitization
and CBD to be adverse events along the
pathological continuum in the disease
process, with sensitization being the
necessary first step in the progression to
CBD.
The epidemiological evidence
presented in this section demonstrates
that sensitization and CBD are
continuing to occur from present-day
exposures below OSHA’s PEL
(Rosenman, 2005 with erratum
published 2006). The available literature
discussed above shows that disease
prevalence can be reduced by reducing
inhalation exposure (Thomas et al.,
2009). However, the available
epidemiological studies also indicate
that it may be necessary to minimize
skin exposure to further reduce the
incidence of sensitization (Bailey et al.,
2010). The preliminary risk assessment
further discusses the effectiveness of
interventions to reduce beryllium
exposures and the risk of sensitization
and CBD (see section VI, Preliminary
Risk Assessment).
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
Studies have demonstrated there
remains a prevalence of sensitization
and CBD in facilities with exposure
levels below the current OSHA PEL
(Rosenman et al., 2005; Thomas et al.,
2009), that risk of sensitization and CBD
appears to vary across industries and
processes (Deubner et al., 2001; Kreiss et
al., 1997; Newman et al., 2001;
Henneberger et al., 2001; Schuler et al.,
2005; Stange et al., 2001; Taiwo et al.,
2010), and that efforts to reduce
exposure have succeeded in reducing
the frequency of beryllium sensitization
and CBD (Bailey et al., 2010) (See Table
A–1 in the Appendix).
Of workers who were found to be
sensitized and underwent clinical
evaluation, 20–49 percent were
diagnosed with CBD (Kreiss et al., 1993;
Newman, 1996, 2005 and 2007; Stange
et al., 2001). Overall prevalence of CBD
in cross-sectional screenings ranges
from 0.6 to 8 percent (Kreiss et al.,
2007). A study by Newman (2005)
estimated from ongoing surveillance of
sensitized individuals, with an average
follow-up time of 6 years, that 31
percent of beryllium-exposed employees
progressed to CBD (Newman, 2005).
However, Newman (2005) went on to
suggest that if follow-up times were
increased the rate of progression from
sensitization to CBD could be much
higher. A study of nuclear weapons
facility employees enrolled in an
ongoing medical surveillance program
found that only about 20 percent of
sensitized individuals employed less
than five years eventually were
diagnosed with CBD, while 40 percent
of sensitized employees employed ten
years or more developed CBD (Stange et
al., 2001) indicating length of exposure
may play a role in further development
of the disease. In addition, Mroz et al.
(2009) conducted a longitudinal study
of individuals clinically evaluated at
National Jewish Health (between 1982
and 2002) who were identified as
having sensitization and CBD through
workforce medical surveillance. The
authors identified 171 cases of CBD and
229 cases of sensitization; all
individuals were identified through
workplace screening using the BeLPT
(Mroz et al., 2009). Over the 20-year
study period, 8.8 percent (i.e., 22 cases
out 251 sensitized) of individuals with
sensitization went on to develop CBD.
The findings from this study indicated
that on the average span of time from
initial beryllium exposure to CBD
diagnosis was 24 years (Mroz et al.,
2009).
E. Beryllium Lung Cancer Section
Beryllium exposure has been
associated with a variety of adverse
PO 00000
Frm 00043
Fmt 4701
Sfmt 4702
47607
health effects including lung cancer.
The potential for beryllium and its
compounds to cause cancer has been
previously assessed by various other
agencies (EPA, ATSDR, NAS, NIEHS,
and NIOSH) with each agency
identifying beryllium as a potential
carcinogen. In addition, the
International Agency for Research on
Cancer (IARC) did an extensive
evaluation in 1993 and reevaluation in
April 2009 (IARC, 2012). In brief, IARC
determined beryllium and its
compounds to be carcinogenic to
humans (Group 1 category), while EPA
considers beryllium to be a probable
human carcinogen (EPA, 1998), and the
National Toxicology Program (NTP) has
determined beryllium and its
compounds to be known carcinogens
(NTP, 2014). OSHA has conducted an
independent evaluation of the
carcinogenic potential of beryllium and
these compounds as well. The following
is a summary of the studies used to
support the Agency findings that
beryllium and its compounds are
human carcinogens.
1. Genotoxicity Studies
Genotoxicity can be an important
indicator for screening the potential of
a material to induce cancer and an
important mechanism leading to tumor
formation and carcinogenesis. In a
review conducted by the National
Academy of Science, beryllium and its
compounds have tested positively in
nearly 50 percent of the genotoxicity
studies conducted without exogenous
metabolic activity. However, they were
found to be non-genotoxic in most
bacterial assays (NAS, 2008).
Gene mutations have been observed
in mammalian cells cultured with
beryllium chloride in a limited number
of studies (EPA, 1998; ATSDR, 2002;
Gordon and Bowser, 2003). Culturing
mammalian cells with beryllium
chloride, beryllium sulfate, or beryllium
nitrate has resulted in clastogenic
alterations. However, most studies have
found that beryllium chloride,
beryllium nitrate, beryllium sulfate, and
beryllium oxide did not induce gene
mutations in bacterial assays with or
without metabolic activation. In the case
of beryllium sulfate, all mutagenicity
studies (Ames (Simmon, 1979; Dunkel
et al., 1984; Arlauskas et al., 1985;
Ashby et al., 1990); E. coli pol A
(Rosenkranz and Poirer, 1979); E. coli
WP2 uvr A (Dunkel et al., 1984) and
Saccharomyces cerevisiae (Simmon,
1979)) were negative with the exception
of results reported for Bacillus subtilis
rec assay (Kada et al., 1980; Kanematsu
et al., 1980; EPA, 1998). Beryllium
sulfate did not induce unscheduled
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47608
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
DNA synthesis in primary rat
hepatocytes and was not mutagenic
when injected intraperitoneally in adult
mice in a host-mediated assay using
Salmonella typhimurium (Williams et
al., 1982).
Beryllium nitrate was negative in the
Ames assay (Tso and Fung, 1981;
Kuroda et al., 1991) but positive in a
Bacillus subtilis rec assay (Kuroda et al.,
1991). Beryllium chloride was negative
in a variety of studies (Ames (Ogawa et
al., 1987; Kuroda et al., 1991); E. coli
WP2 uvr A (Rossman and Molina,
1984); and Bacillus subtilis rec assay
(Nishioka, 1975)). In addition, beryllium
chloride failed to induce SOS DNA
repair in E. coli (Rossman et al., 1984).
However, positive results were reported
for Bacillus subtilis rec assay using
spores (Kuroda et al., 1991), E. coli
KMBL 3835; lacI gene (Zakour and
Glickman, 1984), and hprt locus in
Chinese hamster lung V79 cells (Miyaki
et al., 1979). Beryllium oxide was
negative in the Ames assay and Bacillus
subtilis rec assays (Kuroda et al., 1991;
EPA, 1998).
Gene mutations have been observed
in mammalian cells (V79 and CHO)
cultured with beryllium chloride
(Miyaki et al., 1979; Hsie et al., 1979a,
b), and culturing of mammalian cells
with beryllium chloride (Vegni-Talluri
and Guiggiani, 1967), and beryllium
sulfate (Brooks et al., 1989; Larramendy
et al., 1981) has resulted in clastogenic
alterations—producing breakage or
disrupting chromosomes (EPA, 1998).
Beryllium chloride evaluated in a
mouse model indicated increased DNA
strand breaks and the formation of
micronuclei in bone marrow (Attia et
al., 2013).
Data on the in vivo genotoxicity of
beryllium are limited to a single study
that found beryllium sulfate (1.4 and 2.3
g/kg, 50 percent and 80 percent of
median lethal dose) administered by
gavage did not induce micronuclei in
the bone marrow of CBA mice.
However, a marked depression of
erythropoiesis (red blood cell
production) was suggestive of bone
marrow toxicity which was evident 24
hours after dosing. No mutations were
seen in p53 or c-raf-1 and only weak
mutations were detected in K-ras in
lung carcinomas from F344/N rats given
a single nose-only exposure to beryllium
metal (Nickell-Brady et al., 1994). The
authors concluded that the mechanisms
for the development of lung carcinomas
from inhaled beryllium in the rat do not
involve gene dysfunctions commonly
associated with human non-small-cell
lung cancer (EPA, 1998).
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
2. Human Epidemiological Studies
This section reviews in greater detail
the studies used to support the
mechanistic findings for berylliuminduced cancer. Table A.3 in the
Appendix summarizes the important
features and characteristics of each
study.
a. Beryllium Case Registry (BCR).
Two studies evaluated participants in
the BCR (Infante et al., 1980; Steenland
and Ward, 1991). Infante et al. (1980)
evaluated the mortality patterns of
white male participants in the BCR
diagnosed with non-neoplastic
respiratory symptoms of beryllium
disease. Of the 421 cases evaluated, 7 of
the participants had died of lung cancer.
Six of the deaths occurred more than 15
years after initial beryllium exposure.
The duration of exposure for 5 of the 7
participants with lung cancer was less
than 1 year, with the time since initial
exposure ranging from 12 to 29 years.
One of the participants was exposed for
4 years with a 26-year interval since the
initial exposure. Exposure duration for
one participant diagnosed with
pulmonary fibrosis could not be
determined; however, it had been 32
years since the initial exposure. Based
on BCR records, the participants were
classified as being in the acute
respiratory group (i.e., those diagnosed
with acute respiratory illness at the time
of entry in the registry) or the chronic
respiratory group (i.e., those diagnosed
with pulmonary fibrosis or some other
chronic lung condition at the time of
entry into the BCR). The 7 participants
with lung cancer were in the BCR
because of diagnoses of acute
respiratory illness. For only one of those
individuals was initial beryllium
exposure less than 15 years prior. Only
1 of the 6 (with greater than 15 years
since initial exposure to beryllium) had
been diagnosed with chronic respiratory
disease. The study did not report
exposure concentrations or smoking
habits. The authors concluded that the
results of this cohort agreed with
previous animal studies and with
epidemiological studies demonstrating
an increased risk of lung cancer in
workers exposed to beryllium.
Steenland and Ward (1991) extended
the work of Infante et al. (1980) to
include females and to include 13
additional years of follow-up. At the
time of entry in the BCR, 93 percent of
the women in the study, but only 50
percent of the men, had been diagnosed
with CBD. In addition, 61 percent of the
women had worked in the fluorescent
tube industry and 50 percent of the men
had worked in the basic manufacturing
industry. A total of 22 males and 6
PO 00000
Frm 00044
Fmt 4701
Sfmt 4702
females died of lung cancer. Of the 28
total deaths from lung cancer, 17 had
been exposed to beryllium for less than
4 years and 11 had been exposed for
greater than 4 years. The study did not
report exposure concentrations. Survey
data collected in 1965 provided
information on smoking habits for 223
cohort members (32 percent), on the
basis of which the authors suggested
that the rate of smoking among workers
in the cohort may have been lower than
U.S. rates. The authors concluded that
there was evidence of increased risk of
lung cancer in workers exposed to
beryllium and diagnosed with beryllium
disease.
b. Beryllium Manufacturing and/or
Processing Plants (Extraction,
Fabrication, and Processing)
Several epidemiological cohort
studies have reported excess lung
cancer mortality among workers
employed in U.S. beryllium production
and processing plants during the 1930s
to 1960s. The largest and most
comprehensive study investigated the
mortality experience of 9,225 workers
employed in seven different beryllium
processing plants over a 30-year period
(Ward et al., 1992). The workers at the
two oldest facilities (i.e., Lorain, OH,
and Reading, PA) were found to have
significant excess lung cancer mortality
relative to the U.S. population. Of the
seven plants in the study, these two
plants were believed to have the highest
exposure levels to beryllium. A different
analysis of the lung cancer mortality in
this cohort using various local reference
populations and alternate adjustments
for smoking generally found smaller,
non-significant rates of excess mortality
among the beryllium employees (Levy et
al., 2002). Both cohort studies are
limited by a lack of job history and air
monitoring data that would allow
investigation of mortality trends with
beryllium exposure. The majority of
employees at the Lorain, OH, and
Reading, PA, facilities were employed
for a relatively short period of less than
one year.
Bayliss et al. (1971) performed a
nested cohort study of more than 7,000
former workers from the beryllium
processing industry employed from
1942–1967. Information for the workers
was collected from the personnel files of
participating companies. Of the more
than 7,000 employees, a cause of death
was known for 753 male workers. The
number of observed lung cancer deaths
was 36 compared to 34.06 expected for
a standardized mortality ratio (SMR) of
1.06. When evaluated by the number of
years of employment, 24 of the 36 men
were employed for less than 1 year in
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
the industry (SMR = 1.24), 8 were
employed for 1 to 5 years (SMR 1.40),
and 4 were employed for more than 5
years (SMR = 0.54). Half of the workers
who died from lung cancer began
employment in the beryllium
production industry prior to 1947.
When grouped by job classification,
over two thirds of the workers with lung
cancer were in production-related jobs
while the rest were classified as office
workers. The authors concluded that
while the lung cancer mortality rates
were the highest of all other mortality
rates, the SMR for lung cancer was still
within range of the expected based on
death rates in the United States. The
limitations of this study included the
lack of information regarding exposure
concentrations, smoking habits, and the
age and race of the participants.
Mancuso (1970, 1979, 1980) and
Mancuso and El-Attar (1969) performed
a series of occupational cohort studies
on a group of over 3,685 workers
(primarily white males) employed in the
beryllium manufacturing industry
during 1937–1948.3 The beryllium
production facilities were located in
Ohio and Pennsylvania and the records
for the employees, including periods of
employment, were obtained from the
Social Security Administration. These
studies did not include analyses of
mortality by job title or exposure
category. In addition, there were no
exposure concentrations estimated or
adjustments for smoking. The estimated
duration of employment ranged from
less than 1 year to greater than 5 years.
In the most recent study (Mancuso,
1980), employees from the viscose rayon
industry served as a comparison
population. There was a significant
excess of lung cancer deaths based on
the total number of 80 observed lung
cancer mortalities at the end of 1976
compared to an expected number of
57.06 based on the comparison
population resulting in an SMR of 1.40
(p < 0.01) (Mancuso, 1980). There was
a statistically significant excess in lung
cancer deaths for the shortest duration
of employment (< 12 months, p < 0.05)
and the longest duration of employment
(≤ 49 months, p < 0.01). Based on the
results of this study, the author
concluded that the ability of beryllium
to induce cancer in workers does not
require continuous exposure and that it
is reasonable to assume that the amount
of exposure required to produce lung
cancer can occur within a few months
3 The third study (Mancuso et al., 1979) restricted
the cohort to workers employed between 1942 and
1948.
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
of exposure regardless of the length of
employment.
Wagoner et al. (1980) expanded the
work of Mancuso (1970; 1979; 1980)
using a cohort of 3,055 white males
from the beryllium extraction,
processing, and fabrication facility
located in Reading, Pennsylvania. The
men included in the study worked at
the facility sometime between 1942 and
1968, and were followed through 1976.
The study accounted for length of
employment. Other factors accounted
for included age, smoking history, and
regional lung cancer mortality. Fortyseven members of the cohort died of
lung cancer compared to an expected
34.29 based on U.S. white male lung
cancer mortality rates (p < .05). The
results of this cohort showed an excess
risk of lung cancer in beryllium-exposed
workers at each duration of employment
(< 5 years and ≥ 5 years), with a
statistically significant excess noted at <
5 years durations of employment and a
≥ 25-year interval since the beginning of
employment (p < 0.05). The study was
criticized by several epidemiologists
(MacMahon, 1978, 1979; Roth, 1983), by
a CDC Review Committee appointed to
evaluate the study, and by one of the
study’s coauthors (Bayliss, 1980) for
inadequate discussion of possible
alternative explanations of excess lung
cancer in the cohort. The specific issues
identified include the use of 1965–1967
U.S. white male lung cancer mortality
rates to generate expected numbers of
lung cancers in the period 1968–1975
and inadequate adjustment for smoking.
Ward et al. (1992) performed a
retrospective mortality cohort study of
9,225 male workers employed at seven
beryllium processing facilities,
including the Ohio and Pennsylvania
facilities studied by Mancuso and ElAttar (1969), Mancuso (1970; 1979;
1980), and Wagoner et al. (1980). The
men were employed for no less than 2
days between January 1940 and
December 1988. At the end of the study
61.1 percent of the cohort was known to
be living and 35.1 percent was known
to be deceased. The duration of
employment ranged from 1 year or less
to greater than 10 years with the largest
percentage of the cohort (49.7 percent)
employed for less than one year,
followed by 1 to 5 years of employment
(23.4 percent), greater than 10 years
(19.1 percent), and 5 to 10 years (7.9
percent). Of the 3,240 deaths, 280
observed deaths were caused by lung
cancer compared to 221.5 expected
deaths, yielding a statistically
significant SMR of 1.26 (p < 0.01).
Information on the smoking habits of
15.9 percent of the cohort members,
obtained from a 1968 Public Health
PO 00000
Frm 00045
Fmt 4701
Sfmt 4702
47609
Service survey conducted at four of the
plants, was used to calculate a smokingadjusted SMR of 1.12, which was not
statistically significant. The number of
deaths from lung cancer was also
examined by decade of hire. The
authors reported a relationship between
earlier decades of hire and increased
lung cancer risk.
The EPA Integrated Risk Information
System (IRIS), IARC, and California EPA
Office of Environmental Health Hazard
Assessment (OEHHA) have all based
their cancer assessment on the Ward et
al. 1992 study, with supporting data
concerning exposure concentrations
from Eisenbud and Lisson (1983) and
NIOSH (1972), who estimated that the
lower-bound estimate of the median
exposure concentration exceeded 100
mg/m3 and found that concentrations in
excess of 1,000 mg/m3 were common.
The IRIS cancer risk assessment
recalculated expected lung cancers
based on U.S. white male lung cancer
rates (including the period 1968–1975)
and used an alternative adjustment for
smoking. In addition, one individual
with lung cancer, who had not worked
at the plant, was removed from the
cohort. After these adjustments were
made, an elevated rate of lung cancer
was still observed in the overall cohort
(46 cases vs. 41.9 expected cases).
However, based on duration of
employment or interval since beginning
of employment, neither the total cohort
nor any of the subgroups had a
statistically significant excess in lung
cancer (EPA, 1987). Based on their
evaluation of this and other
epidemiological studies, the EPA
characterized the human
carcinogenicity data then available as
‘‘limited’’ but ‘‘suggestive of a causal
relationship between beryllium
exposure and an increased risk of lung
cancer’’ (IRIS database). This report
includes quantitative estimates of risk
that were derived using the information
presented in Wagoner et al. (1980), the
expected lung cancers recalculated by
the EPA, and bounds on presumed
exposure levels.
Levy et al. (2002) questioned the
results of Ward et al. (1992) and
performed a reanalysis of the Ward et al.
data. The Levy et al. reanalysis differed
from the Ward et al. analysis in the
following significant ways. First, Levy et
al. (2002) examined two alternative
adjustments for smoking, which were
based on (1) a different analysis of the
American Cancer Society (ACS) data
used by Ward et al. (1992) for their
smoking adjustment, or (2) results from
a smoking/lung cancer study of veterans
(Levy and Marimont, 1998). Second,
Levy et al. (2002) also examined the
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47610
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
impact of computing different reference
rates derived from information about the
lung cancer rates in the cities in which
most of the workers at two of the plants
lived. Finally, Levy et al. (2002)
considered a meta-analytical approach
to combining the results across
beryllium facilities. For all of the
alternatives Levy et al. (2002)
considered, except the meta-analysis,
the facility-specific and combined SMRs
derived were lower than those reported
by Ward et al. (1992). Only the SMR for
the Lorain, OH, facility remained
statistically significantly elevated in
some reanalyses. The SMR obtained
when combining over the plants was not
statistically significant in eight of the
nine approaches they examined, leading
Levy et al. (2002) to conclude that there
was little evidence of statistically
significant elevated SMRs in those
plants.
One occupational nested case-control
study evaluated lung cancer mortality in
a cohort of 3,569 male workers
employed at a beryllium alloy
production plant in Reading, PA, from
1940 to 1969 and followed through 1992
(Sanderson et al., 2001). There were a
total of 142 known lung cancer cases
and 710 controls. For each lung cancer
death, 5 age- and race-matched controls
were selected by incidence density
sampling. Confounding effects of
smoking were evaluated. Job history and
historical air measurements at the plant
were used to estimate job-specific
beryllium exposures from the 1930s to
1990s. Calendar-time-specific beryllium
exposure estimates were made for every
job and used to estimate workers’
cumulative, average, and maximum
exposure. Because of the long period of
time required for the onset of lung
cancer, an ‘‘exposure lag’’ was
employed to discount recent exposures
less likely to contribute to the disease.
The cumulative, average, and
maximum beryllium exposure
concentration estimates for the 142
known lung cancer cases were 46.06 ±
9.3mg/m3-days, 22.8 ± 3.4 mg/m3, and
32.4 ± 13.8 mg/m3, respectively. The
lung cancer mortality rate was 1.22 (95
percent CI = 1.03 ¥ 1.43). Exposure
estimates were lagged by 10 and 20
years in order to account for exposures
that did not contribute to lung cancer
because they occurred after the
induction of cancer. In the 10- and 20year lagged exposures the geometric
mean tenures and cumulative exposures
of the lung cancer mortality cases were
higher than the controls. In addition, the
geometric mean and maximum
exposures of the workers were
significantly higher than controls when
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
the exposure estimates were lagged 10
and 20 years (p < 0.01).
Results of a conditional logistic
regression analysis indicated that there
was an increased risk of lung cancer in
workers with higher exposures when
dose estimates were lagged by 10 and 20
years. There was also a lack of evidence
that confounding factors such as
smoking affected the results of the
regression analysis. The authors noted
that there was considerable uncertainty
in the estimation of exposure in the
1940’s and 1950’s and the shape of the
dose-response curve for lung cancer.
Another analysis of the study data using
a different statistical method did not
find a significantly greater relative risk
of lung cancer with increasing beryllium
exposures (Levy et al., 2007). The
average beryllium air levels for the lung
cancer cases were estimated to be an
order of magnitude above the current 8hour OSHA TWA PEL (2 mg/m3) and
roughly two orders of magnitude higher
than the typical air levels in workplaces
where beryllium sensitization and
pathological evidence of CBD have been
observed. IARC evaluated this
reanalysis in 2012 and found the study
introduced a downward bias into risk
estimates (IARC, 2012).
Schubauer-Berigan et al. reanalyzed
data from the nested case-control study
of 142 lung cancer cases in the Reading,
PA, beryllium processing plant
(Schubauer-Berigan et al., 2008). This
dataset was reanalyzed using
conditional (stratified by case age)
logistic regression. Independent
adjustments were made for potential
confounders of birth year and hire age.
Average and cumulative exposures were
analyzed using the values reported in
the original study. The objective of the
reanalysis was to correct for the known
differences in smoking rates by birth
year. In addition, the authors evaluated
the effects of age at hire to determine
differences observed by Sanderson et al.
in 2001. The effect of birth cohort
adjustment on lung cancer rates in
beryllium-exposed workers was
evaluated by adjusting in a
multivariable model for indicator
variables for the birth cohort quartiles.
Unadjusted analyses showed little
evidence of lung cancer risk associated
with beryllium occupational exposure
using cumulative exposure until a 20year lag was used. Adjusting for either
birth cohort or hire age attenuated the
risk for lung cancer associated with
cumulative exposure. Using a 10- or 20year lag in workers born after 1900 also
showed little evidence of lung cancer
risk, while those born prior to 1900 did
show a slight elevation in risk. Unlagged
and lagged analysis for average exposure
PO 00000
Frm 00046
Fmt 4701
Sfmt 4702
showed an increase in lung cancer risk
associated with occupational exposure
to beryllium. The finding was consistent
for either workers adjusted or
unadjusted for birth cohort or hire age.
Using a 10-year lag for average exposure
showed a significant effect by birth
cohort.
The authors stated that the reanalysis
indicated that differences in the hire
ages among cases and controls, first
noted by Deubner et al. (2001) and Levy
et al. (2007), were primarily due to the
fact that birth years were earlier among
controls than among cases, resulting
from much lower baseline risk of lung
cancer for men born prior to 1900
(Schubauer-Berigan et al., 2008). The
authors went on to state that the
reanalysis of the previous NIOSH casecontrol study suggested the relationship
observed previously between
cumulative beryllium exposure and
lung cancer was greatly attenuated by
birth cohort adjustment.
Hollins et al. (2009) re-examined the
weight of evidence of beryllium as a
lung carcinogen in a recent publication
(Hollins et al., 2009). Citing more than
50 relevant papers, the authors noted
the methodological shortcomings
examined above, including lack of wellcharacterized historical occupational
exposures and inadequacy of the
availability of smoking history for
workers. They concluded that the
increase in potential risk of lung cancer
was observed among those exposed to
very high levels of beryllium and that
beryllium’s carcinogenic potential in
humans at these very high exposure
levels were not relevant to today’s
industrial settings. IARC performed a
similar re-evaluation in 2009 (IARC,
2012) and found that the weight of
evidence for beryllium lung
carcinogenicity, including the animal
studies described below, still warranted
a Group I classification, and that
beryllium should be considered
carcinogenic to humans.
Schubauer-Berigan et al. (2010)
extended their analysis from a previous
study estimating associations between
mortality risk and beryllium exposure to
include workers at 7 beryllium
processing plants. The study
(Schubauer-Berigan et al., 2010)
followed the mortality incidences of
9,199 workers from 1940 through 2005
at the 7 beryllium plants. JEMs were
developed for three plants in the cohort:
The Reading plant, the Hazleton plant,
and the Elmore plant. The last is
described in Couch et al. 2010.
Including these JEMs substantially
improved the evidence base for
evaluating the carcinogenicity of
beryllium and, and this change
E:\FR\FM\07AUP2.SGM
07AUP2
47611
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
represents more than an update of the
beryllium cohort. Standardized
mortality ratios (SMRs) were estimated
based on US population comparisons
for lung, nervous system and urinary
tract cancers, chronic obstructive
pulmonary disease (COPD), chronic
kidney disease, and categories
containing chronic beryllium disease
(CBD) and cor pulmonale. Associations
with maximum and cumulative
exposure were calculated for a subset of
the workers.
Overall mortality in the cohort
compared with the US population was
elevated for lung cancer (SMR 1.17;
95% CI 1.08 to 1.28), COPD (SMR 1.23;
95% CI 1.13 to 1.32), and the categories
containing CBD (SMR 7.80; 95% CI 6.26
to 9.60) and cor pulmonale (SMR 1.17;
95% CI 1.08 to 1.26). Mortality rates for
most diseases of interest increased with
time-since-hire. For the category
including CBD, rates were substantially
elevated compared to the US population
across all exposure groups. Workers
whose maximum beryllium exposure
was ≥ 10 mg/m3 had higher rates of lung
cancer, urinary tract cancer, COPD and
the category containing cor pulmonale
than workers with lower exposure.
These studies showed strong
associations for cumulative exposure
(when short-term workers were
excluded), maximum exposure or both.
Significant positive trends with
cumulative exposure were observed for
nervous system cancers (p = 0.0006)
and, when short-term workers were
excluded, lung cancer (p = 0.01),
urinary tract cancer (p = 0.003) and
COPD (p < 0.0001).
The authors concluded the findings
from this reanalysis reaffirmed that lung
cancer and CBD are related to beryllium
exposure. The authors went on to
suggest that beryllium exposures may be
associated with nervous system and
urinary tract cancers and that cigarette
smoking and other lung carcinogens
were unlikely to explain the increased
incidences in these cancers. The study
corrected an error that was discovered
in the indirect smoking adjustment
initially conducted by Ward et al.,
concluding that cigarette smoking rates
did not differ between the cohort and
the general U.S. population. No
association was found between cigarette
smoking and either cumulative or
maximum beryllium exposure, making
it very unlikely that smoking was a
substantial confounder in this study
(Schubauer-Berigan et al., 2010).
3. Animal Cancer Studies
This section reviews the animal
literature used to support the findings
for beryllium-induced lung cancer. Lung
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
tumors have been induced via
inhalation and intratracheal
administration of beryllium to rats and
monkeys, and osteosarcomas have been
induced via intravenous and
intramedullary (inside the bone)
injection of beryllium in rabbits and
possibly in mice. The chronic oral
studies did not report increased
incidences of tumors in rodents, but
these were conducted at doses below
the maximum tolerated dose (MTD)
(EPA, 1998).
Early animal studies revealed that
some beryllium compounds are
carcinogenic when inhaled (ATSDR,
2002). Animal experiments have shown
consistent increases in lung cancers in
rats, mice and rabbits chronically
exposed to beryllium and beryllium
compounds by inhalation or
intratracheal instillation. In addition to
lung cancer, osteosarcomas have been
produced in mice and rabbits exposed
to various beryllium salts by
intravenous injection or implantation
into the bone (NTP, 1999).
In an inhalation study assessing the
potential tumorigenicity of beryllium,
Schepers et al. (1957) exposed 115
albino Sherman and Wistar rats (male
and female) via inhalation to 0.0357 mg
beryllium/m3 (1 g beryllium/ft3) 4 as an
aqueous aerosol of beryllium sulfate for
44 hours/week for 6 months, and
observed the rats for 18 months after
exposure. Three to four control rats
were killed every two months for
comparison purposes. Seventy-six lung
neoplasms, 5 including adenomas,
squamous-cell carcinomas, acinous
adenocarcinomas, papillary
adenocarcinomas, and alveolar-cell
adenocarcinomas, were observed in 52
rats exposed to beryllium sulfate
aerosol. Adenocarcinomata were the
most numerous. Pulmonary metastases
tended to localize in areas with foam
cell clustering and granulomatosis. No
neoplasia was observed in any of the
control rats. The incidence of lung
tumors in exposed rats is presented in
the following Table 2:
TABLE 2—NEOPLASM ANALYSIS
Neoplasm
Number
Adenoma ................
Metastases
18
4 Schepers et al. (1957) reported concentrations in
g Be/ft3; however, g/ft3 is no longer a common unit.
Therefore, the concentration was converted to mg/
m3.
5 While a total of 89 tumors were observed or
palpated at the time of autopsy in the BeSO4exposed animals, only 76 tumors are listed as
histologically neoplastic. Only the new growths
identified in single midcoronal sections of both
lungs were recorded.
PO 00000
Frm 00047
Fmt 4701
Sfmt 4702
TABLE 2—NEOPLASM ANALYSIS—
Continued
Neoplasm
Squamous carcinoma .................
Acinous adenocarcinoma .................
Papillary adenocarcinoma .................
Alveolar-cell adenocarcinoma ............
Mucigenous tumor ..
Endothelioma ..........
Retesarcoma ..........
Total ....................
Number
Metastases
5
1
24
2
11
1
7
7
1
3
1
3
76
8
Schepers (1962) reviewed 38 existing
beryllium studies that evaluated seven
beryllium compounds and seven
mammalian species. Beryllium sulfate,
beryllium fluoride, beryllium
phosphate, beryllium alloy
(BeZnMnSiO4), and beryllium oxide
were proven to be carcinogenic and
have remarkable pleomorphic
neoplasiogenic proclivities. Ten
varieties of tumors were observed, with
adenocarcinoma being the most
common variety.
In another study, Vorwald and Reeves
(1959) exposed Sherman albino rats via
the inhalation route to aerosols of 0.006
mg beryllium/m3 as beryllium oxide
and 0.0547 mg beryllium/m3 as
beryllium sulfate for 6 hours/day, 5
days/week for an unspecified duration.
Lung tumors (single or multifocal) were
observed in the animals sacrificed
following 9 months of daily inhalation
exposure. The histologic pattern of the
cancer was primarily adenomatous;
however, epidermoid and squamous cell
cancers were also observed. Infiltrative,
vascular, and lymphogenous extensions
often developed with secondary
metastatic growth in the
tracheobronchial lymph nodes, the
mediastinal connective tissue, the
parietal pleura, and the diaphragm.
In the first of two articles, Reeves et
al. (1967a) investigated the carcinogenic
process in lungs resulting from chronic
(up to 72 weeks) beryllium sulfate
inhalation. One hundred fifty male and
female Sprague Dawley C.D. strain rats
were exposed to beryllium sulfate
aerosol at a mean atmospheric
concentration of 34.25 mg beryllium/m3
(with an average particle diameter of
0.12 mm). Prior to initial exposure and
again during the 67–68 and 75–76
weeks of life, the animals received
prophylactic treatments of tetracyclineHCl to combat recurrent pulmonary
infections.
The animals entered the exposure
chamber at 6 weeks of age and were
E:\FR\FM\07AUP2.SGM
07AUP2
47612
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
exposed 7 hours per day/5 days per
week for up to 2,400 hours of total
exposure time. An equal number of
unexposed controls were held in a
separate chamber. Three male and three
female rats were sacrificed monthly
during the 72-week exposure period.
Mortality due to respiratory or other
infections did not appear until 55 weeks
of age, and 87 percent of all animals
survived until their scheduled
sacrifices.
Average lung weight towards the end
of exposure was 4.25 times normal with
progressively increasing differences
between control and exposed animals.
The increase in lung weight was
accompanied by notable changes in
tissue texture with two distinct
pathological processes—inflammatory
and proliferative. The inflammatory
response was characterized by marked
accumulation of histiocytic elements
forming clusters of macrophages in the
alveolar spaces. The proliferative
response progressed from early
epithelial hyperplasia of the alveolar
surfaces, through metaplasia (after 20–
22 weeks of exposure), anaplasia
(cellular dedifferentiation) (after 32–40
weeks of exposure), and finally to lung
tumors.
Although the initial proliferative
response occurred early in the exposure
period, tumor development required
considerable time. Tumors were first
identified after nine months of
beryllium sulfate exposure, with rapidly
increasing rates of incidence until
tumors were observed in 100 percent of
exposed animals by 13 months. The 9to-13-month interval is consistent with
earlier studies. The tumors showed a
high degree of local invasiveness. No
tumors were observed in control rats.
All 56 tumors studied appeared to be
alveolar adenocarcinomas and 3 ‘‘fast-
growing’’ tumors that reached a very
large size comparatively early. About
one-third of the tumors showed small
foci where the histologic pattern
differed. Most of the early tumor foci
appeared to be alveolar rather than
bronchiolar, which is consistent with
the expected pathogenesis, since
permanent deposition of beryllium was
more likely on the alveolar epithelium
rather than on the bronchiolar
epithelium. Female rats appeared to
have an increased susceptibility to
beryllium exposure. Not only did they
have a higher mortality (control males
[n = 8], exposed males [n = 9] versus
control females [n = 4], exposed females
[n = 17]) and body weight loss than male
rats, but the three ‘‘fast-growing’’ tumors
only occurred in females.
In the second article, Reeves et al.
(1967b) described the rate of
accumulation and clearance of
beryllium sulfate aerosol from the same
experiment (Reeves et al., 1967a). At the
time of the monthly sacrifice, beryllium
assays were performed on the lungs,
tracheobronchial lymph nodes, and
blood of the exposed rats. The
pulmonary beryllium levels of rats
showed a rate of accumulation which
decreased during continuing exposure
and reached a plateau (defined as
equilibrium between deposition and
clearance) of about 13.5 mg beryllium for
males and 9 mg beryllium for females in
whole lungs after approximately 36
weeks. Females were notably less
efficient than males in utilizing the
lymphatic route as a method of
clearance, resulting in slower removal of
pulmonary beryllium deposits, lower
accumulation of the inhaled material in
the tracheobronchial lymph nodes, and
higher morbidity and mortality.
There was no apparent correlation
between the extent and severity of
pulmonary pathology and total lung
load. However, when the beryllium
content of the excised tumors was
compared with that of surrounding
nonmalignant pulmonary tissues, the
former showed a notable decrease (0.50
± 0.35 mg beryllium/gram versus 1.50 ±
0.55 mg beryllium/gram). This was
believed to be largely a result of the
dilution factor operating in the rapidly
growing tumor tissue. However, other
factors, such as lack of continued local
deposition due to impaired respiratory
function and enhanced clearance due to
high vascularity of the tumor, may also
have played a role. The portion of
inhaled beryllium retained in the lungs
for a longer duration, which is in the
range of one-half of the original
pulmonary load, may have significance
for pulmonary carcinogenesis. This
pulmonary beryllium burden becomes
localized in the cell nuclei and may be
an important factor in eliciting the
carcinogenic response associated with
beryllium inhalation.
Groth et al. (1980) conducted a series
of experiments to assess the
carcinogenic effects of beryllium,
beryllium hydroxide, and various
beryllium alloys. For the beryllium
metal/alloys experiment, 12 groups of 3month-old female Wistar rats (35 rats/
group) were used. All rats in each group
received a single intratracheal injection
of either 2.5 or 0.5 mg of one of the
beryllium metals or beryllium alloys as
described in Table 3 below. These
materials were suspended in 0.4 cc of
isotonic saline followed by 0.2 cc of
saline. Forty control rats were injected
with 0.6 cc of saline. The geometric
mean particle sizes varied from 1 to 2
mm. Rats were sacrificed and autopsied
at various intervals ranging from 1 to 18
months post-injection.
TABLE 3—SUMMARY OF BERYLLIUM DOSE FROM GROTH ET AL. (1980)
Percent Be
Percent other compounds
Be metal ..........................................
100 .....................
99 .......................
0.26% Chromium ...........................
BeAl alloy ........................................
62 .......................
38% Aluminum ...............................
BeCu alloy .......................................
4 .........................
96% Copper ...................................
BeCuCo alloy ..................................
2.4 ......................
BeNi alloy ........................................
2.2 ......................
Total No. rats
autopsied
None ...............................................
Passivated Be metal .......................
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Form of Be
0.4% Cobalt ...................................
96% Copper ...................................
97.8% Nickel ..................................
Lung tumors were observed only in
rats exposed to beryllium metal,
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
passivated beryllium metal, and
beryllium-aluminum alloy. Passivation
PO 00000
Frm 00048
Fmt 4701
Sfmt 4702
16
21
26
20
24
21
28
24
33
30
28
27
Compound
dose
(mg)
2.5
0.5
2.5
0.5
2.5
0.5
2.5
0.5
2.5
0.5
2.5
0.5
Be dose
(mg)
2.5
0.5
2.5
0.5
1.55
0.3
0.1
0.02
0.06
0.012
0.056
0.011
refers to the process of removing iron
contamination from the surface of
E:\FR\FM\07AUP2.SGM
07AUP2
47613
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
beryllium metal. As discussed, metal
alloys may have a different toxicity than
beryllium alone. Rats exposed to 100
percent beryllium exhibited relatively
high mortality rates, especially in the
groups where lung tumors were
observed. Nodules varying from 1 to 10
mm in diameter were also observed in
the lungs of rats exposed to beryllium
metal, passivated beryllium metal, and
beryllium-aluminum alloy. These
nodules were suspected of being
malignant.
To test this hypothesis,
transplantation experiments involving
the suspicious nodules were conducted
in nine rats. Seven of the nine suspected
tumors grew upon transplantation. All
transplanted tumor types metastasized
to the lungs of their hosts. Lung tumors
were observed in rats injected with both
the high and low doses of beryllium
metal, passivated beryllium metal, and
beryllium-aluminum alloy. No lung
tumors were observed in rats injected
with the other compounds. From a total
of 32 lung tumors detected, most were
adenocarcinomas and adenomas;
however, two epidermoid carcinomas
and at least one poorly differentiated
carcinoma were observed. Bronchiolar
alveolar cell tumors were frequently
observed in rats injected with beryllium
metal, passivated beryllium metal, and
beryllium-aluminum alloy. All stages of
cuboidal, columnar, and squamous cell
metaplasia were observed on the
alveolar walls in the lungs of rats
injected with beryllium metal,
passivated beryllium metal, and
beryllium-aluminum alloy. These
lesions were generally reduced in size
and number or absent from the lungs of
animals injected with the other alloys
(BeCu, BeCuCo, BeNi).
The extent of alveolar metaplasia
could be correlated with the incidence
of lung cancer. The incidences of lung
tumors in the rats that received 2.5 mg
of beryllium metal, and 2.5 and 0.5 mg
of passivated beryllium metal, were
significantly different (p ≤ 0.008) from
controls. When autopsies were
performed at the 16-to-19-month
interval, the incidence (2/6) of lung
tumors in rats exposed to 2.5 mg of
beryllium-aluminum alloy was
statistically significant (p = 0.004) when
compared to the lung tumor incidence
(0/84) in rats exposed to BeCu, BeNi,
and BeCuCo alloys, which contained
much lower concentrations of Be (Groth
et al., 1980).
Finch et al. (1998b) investigated the
carcinogenic effects of inhaled
beryllium on heterozygous TSG-p53
knockout mice (p53∂/¥) and wild-type
(p53+/+) mice. Knockout mice can be
valuable tools in determining the role of
specific genes on the toxicity of a
material of interest, in this case,
beryllium. Equal numbers of
approximately 10-week-old male and
female mice were used for this study.
Two exposure groups were used to
provide dose-response information on
lung carcinogenicity. The maximum
initial lung burden (ILB) target of 60 mg
beryllium was based on previous acute
inhalation exposure studies in mice.
The lower exposure target level of 15 mg
was selected to provide a lung burden
significantly less than the high-level
group, but high enough to yield
carcinogenic responses. Mice were
exposed in groups to beryllium metal or
to filtered air (controls) via nose-only
inhalation. The specific exposure
parameters are presented in Table 4
below. Mice were sacrificed 7 days post
exposure for ILB analysis, and either at
6 months post exposure (n = 4–5 mice
per group per gender) or when 10
percent or less of the original
population remained (19 months post
exposure for p53∂/¥ knockout and 22.5
months post exposure for p53+/+ wildtype mice). The sacrifice time was
extended in the study because a
significant number of lung tumors were
not observed at 6 months post exposure.
TABLE 4—SUMMARY OF ANIMAL DATA FROM FINCH ET AL., 1998 b
Mouse strain
Knockout (p53∂/¥)
Wild-type (p53 ⁄ )
++
Knockout (p53∂/¥)
Mean
exposure concentration
(μg Be/L)
34
36
34
36
NA (air)
Target be lung
burden
(μg)
15
60
15
60
Control
Number of mice
30
30
6*
36†
30
Mean daily
exposure duration
(minutes)
112 (single)
139‡
112 (single)
139‡
60–180 (single)
Mean ILB
(μg)
NA
NA
12 ± 4
54 ± 6
NA
Number of mice
with 1 or more
lung tumors/total
number
examined
0/29
4/28
NA
0/28
0/30
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
ILB = initial lung burden; NA = not applicable
Median aerodynamic diameter of Be aerosol = 1.4 μm (sg = 1.8)
* Wild-type mice in the low exposure group were not evaluated for carcinogenic effects; however ILB was analyzed in six wild-type mice.
† Thirty wild-type mice were analyzed for carcinogenic effects; six wild-type mice were analyzed for ILB.
‡ Mice were exposed for 2.3 hours/day for three consecutive days.
Lung burdens of beryllium measured
in wild-type mice at 7 days post
exposure were approximately 70–90
percent of target levels. No exposurerelated effects on body weight were
observed in mice; however, lung
weights and lung-to-body-weight ratios
were somewhat elevated in 60 mg target
ILB p53∂/¥ knockout mice compared to
controls (0.05 < p < 0.10). In general,
p53+/+ wild-type mice survived longer
than p53∂/¥ knockout mice and
beryllium exposure tended to decrease
survival time in both groups. The
incidence of beryllium-induced lung
tumors was marginally higher in the 60
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
mg target ILB p53∂/¥ knockout mice
compared to 60 mg target ILB p53+/+
wild-type mice (p = 0.056). The
incidence of lung tumors in the 60 mg
target ILB p53∂/¥ knockout mice was
also significantly higher than controls (p
= 0.048). No tumors developed in the
control mice, 15 mg target ILB p53∂/¥
knockout mice, or 60 mg target ILB
p53+/+ wild-type mice throughout the
length of the study. Most lung tumors in
beryllium-exposed mice were squamous
cell carcinomas, three of four of which
were poorly circumscribed and all were
associated with at least some degree of
granulomatous pneumonia. The study
PO 00000
Frm 00049
Fmt 4701
Sfmt 4702
results suggest that having an
inactivated p53 allele is associated with
lung tumor progression in p53∂/¥
knockout mice. This is based on the
significant difference seen in the
incidence of beryllium-induced lung
neoplasms for the p53∂/¥knockout
mice compared with the p53+⁄+ wildtype mice. The authors conclude that
since there was a relatively late onset of
tumors in the beryllium-exposed
p53∂/¥ knockout mice, a 6-month
bioassay in this mouse strain might not
be an appropriate model for lung
carcinogenesis (Finch et al., 1998b).
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47614
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
Nickell-Brady et al. (1994)
investigated the development of lung
tumors in 12-week-old F344/N rats after
a single nose-only inhalation exposure
to beryllium aerosol, and evaluated
whether beryllium lung tumor
induction involves alterations in the Kras, p53, and c-raf¥1 genes. Four
groups of rats (30 males and 30 females
per group) were exposed to different
mass concentrations of beryllium
(Group 1: 500 mg/m3 for 8 min; Group
2: 410 mg/m3 for 30 min; Group 3: 830
mg/m3 for 48 min; Group 4: 980 mg/m3
for 39 min). The beryllium mass median
aerodynamic diameter was 1.4 mm (sg =
1.9). The mean beryllium lung burdens
for each exposure group were 40, 110,
360, and 430 mg, respectively.
To examine genetic alterations, DNA
isolation and sequencing techniques
(PCR amplification and direct DNA
sequence analysis) were performed on
wild-type rat lung tissue (i.e., control
samples) along with two mouse lung
tumor cell lines containing known K-ras
mutations, 12 carcinomas induced by
beryllium (i.e., experimental samples),
and 12 other formalin-fixed specimens.
Tumors appeared in beryllium-exposed
rats by 14 months, and 64 percent of
exposed rats developed lung tumors
during their lifetime. Lungs frequently
contained multiple tumor sites, with
some of the tumors greater than 1 cm.
A total of 24 tumors were observed.
Most of the tumors (n = 22) were
adenocarcinomas exhibiting a papillary
pattern characterized by cuboidal or
columnar cells, although a few had a
tubular or solid pattern. Fewer than 10
percent of the tumors were
adenosquamous (n = 1) or squamous
cell (n = 1) carcinomas.
No transforming mutations of the Kras gene (codons 12, 13, or 61) were
detected by direct sequence analysis in
any of the lung tumors induced by
beryllium. However, using a more
sensitive sequencing technique (PCR
enrichment restriction fragment length
polymorphism (RFLP) analysis) resulted
in the detection of K-ras codon 12 GGT
to GTT transversions in 2 of 12
beryllium-induced adenocarcinomas.
No p53 and c-raf-1 alterations were
observed in any of the tumors induced
by beryllium exposure (i.e., no
differences observed between berylliumexposed and control rat tissues). The
authors note that the results suggest that
activation of the K-ras proto-oncogene is
both a rare and late event, possibly
caused by genomic instability during
the progression of beryllium-induced rat
pulmonary adenocarcinomas. It is
unlikely that the K-ras gene plays a role
in the carcinogenicity of beryllium. The
results also indicate that p53 mutation
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
is unlikely to play a role in tumor
development in rats exposed to
beryllium.
Belinsky et al. (1997) reviewed the
findings by Nickell-Brady et al. (1994)
to further examine the role of the K-ras
and p53 genes in lung tumors induced
in the F344 rat by non-mutagenic (nongenotoxic) exposures to beryllium. Their
findings are discussed along with the
results of other genomic studies that
look at carcinogenic agents that are
either similarly non-mutagenic or, in
other cases, mutagenic. The authors
conclude that the identification of nonras transforming genes in rat lung
tumors induced by non-mutagenic
exposures, such as beryllium, as well as
mutagenic exposures will help define
some of the mechanisms underlying
cancer induction by different types of
DNA damage.
The inactivation of the p16INK4a (p16)
gene is a contributing factor in
disrupting control of the normal cell
cycle and may be an important
mechanism of action in berylliuminduced lung tumors. Swafford et al.
(1997) investigated the aberrant
methylation and subsequent
inactivation of the p16 gene in primary
lung tumors induced in F344/N rats
exposed to known carcinogens via
inhalation. The research involved a total
of 18 primary lung tumors that
developed after exposing rats to five
agents, one of which was beryllium. In
this study, only one of the 18 lung
tumors was induced by beryllium
exposure; the majority of the other
tumors were induced by radiation (xrays or plutonium-239 oxide). The
authors hypothesized that if p16
inactivation plays a central role in
development of non-small-cell lung
cancer, then the frequency of gene
inactivation in primary tumors should
parallel that observed in the
corresponding cell lines. To test the
hypothesis, a rat model for lung cancer
was used to determine the frequency
and mechanism for inactivation of p16
in matched primary lung tumors and
derived cell lines. The methylationspecific PCR (MSP) method was used to
detect methylation of p16 alleles. The
results showed that the presence of
aberrant p16 methylation in cell lines
was strongly correlated with absent or
low expression of the gene. The findings
also demonstrated that aberrant p16
CpG island methylation, an important
mechanism in gene silencing leading to
the loss of p16 expression, originates in
primary tumors.
Building on the rat model for lung
cancer and associated findings from
Swafford et al. (1997), Belinsky et al.
(2002) conducted experiments in 12-
PO 00000
Frm 00050
Fmt 4701
Sfmt 4702
week-old F344/N rats (male and female)
to determine whether berylliuminduced lung tumors involve
inactivation of the p16 gene and
estrogen receptor a (ER) gene. Rats
received a single nose-only inhalation
exposure to beryllium aerosol at four
different exposure levels. The mean
lung burdens measured in each
exposure group were 40, 110, 360, and
430 mg. The methylation status of the
p16 and ER genes was determined by
MSP. A total of 20 tumors detected in
beryllium-exposed rats were available
for analysis of gene-specific promoter
methylation. Three tumors were
classified as squamous cell carcinomas
and the others were determined to be
adenocarcinomas. Methylated p16 was
present in 80 percent (16/20), and
methylated ER was present in one-half
(10/20), of the lung tumors induced by
exposure to beryllium. Additionally,
both genes were methylated in 40
percent of the tumors. The authors
noted that four tumors from berylliumexposed rats appeared to be partially
methylated at the p16 locus. Bisulfite
sequencing of exon 1 of the ER gene was
conducted on normal lung DNA and
DNA from three methylated, berylliuminduced tumors to determine the
density of methylation within amplified
regions of exon 1 (referred to as CpG
sites). Two of the three methylated,
beryllium-induced lung tumors showed
extensive methylation, with more than
80 percent of all CpG sites methylated.
The overall findings of this study
suggest that inactivation of the p16 and
ER genes by promoter hypermethylation
are likely to contribute to the
development of lung tumors in
beryllium-exposed rats. The results
showed a correlation between changes
in p16 methylation and loss of gene
transcription. The authors hypothesize
that the mechanism of action for
beryllium-induced p16 gene
inactivation in lung tumors may be
inflammatory mediators that result in
oxidative stress. The oxidative stress
damages DNA directly through free
radicals or indirectly through the
formation of 8-hydroxyguanosine DNA
adducts, resulting primarily in a singlestrand DNA break.
Wagner et al. (1969) studied the
development of pulmonary tumors after
intermittent daily chronic inhalation
exposure to beryllium ores in three
groups of male squirrel monkeys. One
group was exposed to bertrandite ore, a
second to beryl ore, and the third served
as unexposed controls. Each of these
three exposure groups contained 12
monkeys. Monkeys from each group
were sacrificed after 6, 12, or 23 months
of exposure. The 12-month sacrificed
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
monkeys (n = 4 for bertrandite and
control groups; n = 2 for beryl group)
were replaced by a separate replacement
group to maintain a total animal
population approximating the original
numbers and to provide a source of
confirming data for biologic responses
that might arise following the ore
exposures. Animals were exposed to
bertrandite and beryl ore concentrations
of 15 mg/m3, corresponding to 210 mg
beryllium/m3 and 620 mg beryllium/m3
in each exposure chamber, respectively.
The parent ores were reduced to
particles with geometric mean diameters
of 0.27 mm (± 2.4) for bertrandite and
0.64 mm (± 2.5) for beryl. Animals were
exposed for approximately 6 hours/day,
5 days/week. The histological changes
in the lungs of monkeys exposed to
bertrandite and beryl ore exhibited a
similar pattern. The changes generally
consisted of aggregates of dust-laden
macrophages, lymphocytes, and plasma
cells near respiratory bronchioles and
small blood vessels. There were,
however, no consistent or significant
pulmonary lesions or tumors observed
in monkeys exposed to either of the
beryllium ores. This is in contrast to the
findings in rats exposed to beryl ore and
to a lesser extent bertrandite, where
atypical cell proliferation and tumors
were frequently observed in the lungs.
The authors hypothesized that the rats’
greater susceptibility may be attributed
to the spontaneous lung disease
characteristic of rats, which might have
interfered with lung clearance.
As previously described, Conradi et
al. (1971) investigated changes in the
lungs of monkeys and dogs two years
after intermittent inhalation exposure to
beryllium oxide calcined at 1,400 °C.
Five adult male and female monkeys
(Macaca irus) weighing between 3 and
5.75 kg were used in the study. The
study included two control monkeys.
Beryllium concentrations in the
atmosphere of whole-body exposed
monkeys varied between 3.30 and 4.38
mg/m3. Thirty-minute exposures
occurred once a month for three
months, with beryllium oxide
concentrations increasing at each
exposure interval. Lung tissue was
investigated using electron microscopy
and morphometric methods. Beryllium
content in portions of the lungs of five
monkeys was measured two years
following exposure by emission
spectrography. The reported
concentrations in monkeys (82.5, 143.0,
and 112.7 mg beryllium per 100 gm of
wet tissue in the upper lobe, lower lobe,
and combined lobes, respectively) were
higher than those in dogs. No neoplastic
or granulomatous lesions were observed
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
in the lungs of any exposed animals and
there was no evidence of chronic
proliferative lung changes after two
years.
4. In vitro Studies
The exact mechanism by which
beryllium induces pulmonary
neoplasms in animals remains unknown
(NAS 2008). Keshava et al. (2001)
performed studies to determine the
carcinogenic potential of beryllium
sulfate in cultured mammalian cells.
Joseph et al. (2001) investigated
differential gene expression to
understand the possible mechanisms of
beryllium-induced cell transformation
and tumorigenesis. Both investigations
used cell transformation assays to study
the cellular/molecular mechanisms of
beryllium carcinogenesis and assess
carcinogenicity. Cell lines were derived
from tumors developed in nude mice
injected subcutaneously with nontransformed BALB/c-3T3 cells that were
morphologically transformed in vitro
with 50–200 mg beryllium sulfate/ml for
72 hours. The non-transformed cells
were used as controls.
Keshava et al. (2001) found that
beryllium sulfate is capable of inducing
morphological cell transformation in
mammalian cells and that transformed
cells are potentially tumorigenic. A
dose-dependent increase (9–41 fold) in
transformation frequency was noted.
Using differential polymerase chain
reaction (PCR), gene amplification was
investigated in six proto-oncogenes (Kras, c-myc, c-fos, c-jun, c-sis, erb-B2)
and one tumor suppressor gene (p53).
Gene amplification was found in c-jun
and K-ras. None of the other genes
tested showed amplification.
Additionally, Western blot analysis
showed no change in gene expression or
protein level in any of the genes
examined. Genomic instability in both
the non-transformed and transformed
cell lines was evaluated using random
amplified polymorphic DNA
fingerprinting (RAPD analysis). Using
different primers, 5 of the 10
transformed cell lines showed genomic
instability when compared to the nontransformed BALB/c-3T3 cells. The
results indicate that beryllium sulfateinduced cell transformation might, in
part, involve gene amplification of K-ras
and c-jun and that some transformed
cells possess neoplastic potential
resulting from genomic instability.
Using the Atlas mouse 1.2 cDNA
expression microarrays, Joseph et al.
(2001) studied the expression profiles of
1,176 genes belonging to several
different functional categories.
Compared to the control cells,
expression of 18 genes belonging to two
PO 00000
Frm 00051
Fmt 4701
Sfmt 4702
47615
functional groups (nine cancer-related
genes and nine DNA synthesis, repair,
and recombination genes) was found to
be consistently and reproducibly
different (at least 2-fold) in the tumor
cells. Differential gene expression
profile was confirmed using reverse
transcription-PCR with primers specific
to the differentially expressed genes.
Two of the differentially expressed
genes (c-fos and c-jun) were used as
model genes to demonstrate that the
beryllium-induced transcriptional
activation of these genes was dependent
on pathways of protein kinase C and
mitogen-activated protein kinase and
independent of reactive oxygen species
in the control cells. These results
indicate that beryllium-induced cell
transformation and tumorigenesis are
associated with up-regulated expression
of the cancer-related genes (such as cfos, c-jun, c-myc, and R-ras) and downregulated expression of genes involved
in DNA synthesis, repair, and
recombination (such as MCM4, MCM5,
PMS2, Rad23, and DNA ligase I).
5. Preliminary Lung Cancer Conclusions
OSHA has preliminarily determined
that the weight of evidence indicates
that beryllium compounds should be
regarded as potential occupational lung
carcinogens. Other scientific
organizations, including the
International Agency for Research on
Cancer (IARC), the National Toxicology
Program (NTP), the U.S. Environmental
Protection Agency (EPA), the National
Institute for Occupational Safety and
Health (NIOSH), and the American
Conference of Governmental Industrial
Hygienists (ACGIH) have reached
similar conclusions with respect to the
carcinogenicity of beryllium.
While some evidence exists for directacting genotoxicity as a possible
mechanism for beryllium
carcinogenesis, the weight of evidence
suggests a possible indirect mechanism
may be responsible for most
tumorigenic activity of beryllium in
animal models and possibly humans
(EPA, 1998). Inflammation has been
postulated to be a key contributor to
many different forms of cancer (Jackson
et al., 2006; Pikarsky et al., 2004; Greten
et al., 2004; Leek, 2002). In fact, chronic
inflammation may be a primary factor in
the development of up to one-third of
all cancers (Ames et al., 1990; NCI,
2010).
In addition to a T-cell mediated
response beryllium has been
demonstrated to produce an
inflammatory response in animal
models similar to other particles (Reeves
et al., 1967; Swafford et al., 1997;
Wagner et al., 1969) possibly
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47616
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
contributing to its carcinogenic
potential. Animal studies, as
summarized above, have demonstrated a
consistent scenario of beryllium
exposure resulting in chronic
pulmonary inflammation. Studies
conducted in rats have demonstrated
that chronic inhalation of materials
similar in solubility to beryllium result
in increased pulmonary inflammation,
fibrosis, epithelial hyperplasia, and, in
some cases, pulmonary adenomas and
carcinomas (Heinrich et al., 1995;
Nikula et al., 1995; NTP, 1993; Lee et
al., 1985; Warheit et al., 1996). This
response is generally referred to as an
‘‘overload’’ response or threshold effect.
Substantial data indicate that tumor
formation in the rat after exposure to
some sparingly soluble particles at
doses causing marked, chronic
inflammation is due to a secondary
mechanism unrelated to the
genotoxicity (or lack thereof) of the
particle itself.
It has been hypothesized that the
recruitment of neutrophils during the
inflammatory response and subsequent
release of oxidants from these cells have
been demonstrated to play an important
role in the pathogenesis of rat lung
tumors (Borm et al., 2004; Carter and
Driscoll, 2001; Carter et al., 2006;
Johnston et al., 2000; Knaapen et al.,
2004; Mossman, 2000). Inflammatory
mediators, as characterized in many of
the studies summarized above, have
been shown to play a significant role in
the recruitment of cells responsible for
the release of reactive oxygen and
hydrogen species. These species have
been determined to be highly mutagenic
themselves as well as mitogenic,
inducing a proliferative response
(Feriola and Nettesheim, 1994; Jetten et
al., 1990; Moss et al., 1994; Coussens
and Werb, 2002). The resultant effect is
an environment rich for neoplastic
transformations and the progression of
fibrosis and tumor formation. This
finding does not imply no risk at levels
below an inflammatory response; rather,
the overall weight of evidence is
suggestive of a mechanism of an indirect
carcinogen at levels where inflammation
is seen. While tumorigenesis secondary
to inflammation is one reasonable mode
of action, other plausible modes of
action independent of inflammation
(e.g., epigenetic, mitogenic, reactive
oxygen mediated, indirect genotoxicity,
etc.) may also contribute to the lung
cancer associated with beryllium
exposure.
Epidemiological studies indicate
excess risk of lung cancer mortality from
occupational beryllium exposure levels
at or below the current OSHA PEL
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
(Schubauer-Berigan et al., 2010; Table
4).
F. Other Health Effects
Past studies on other health effects
have been thoroughly reviewed by
several scientific organizations (NTP,
1999; EPA, 1998; ATSDR, 2002; WHO,
2001; HSDB, 2010). These studies
include summaries of animal studies, in
vitro studies, and human
epidemiological studies associated with
cardiovascular, hematological, hepatic,
renal, endocrine, reproductive, ocular
and mucosal, and developmental
effects. High-dose exposures to
beryllium have been shown to have an
adverse effect upon a variety of organs
and tissues in the body, particularly the
liver. The adverse systemic effects from
human exposures mostly occurred prior
to the introduction of occupational and
environmental standards set in 1970–
1972 (OSHA, 1971; ACGIH, 1971; ANSI,
1970) and 1974 (EPA, 1974) and
therefore are less relevant today than in
the past. The available data is fairly
limited. The hepatic, cardiovascular,
renal, and ocular and mucosal effects
are briefly summarized below. Health
effects in other organ systems listed
above were only observed in animal
studies at very high exposure levels and
are, therefore, not discussed here.
1. Hepatic Effects
Beryllium has been shown to
accumulate in the liver and a correlation
has been demonstrated between
beryllium content and hepatic damage.
Different compounds have been shown
to distribute differently within the
hepatic tissues. For example, beryllium
phosphate had accumulated almost
exclusively within sinusoidal (Kupffer)
cells of the liver, while the beryllium
derived from beryllium sulfate was
found mainly in parenchymal cells.
Conversely, beryllium sulphosalicylic
acid complexes were rapidly excreted
(Skillteter and Paine, 1979).
According to a few autopsies,
beryllium-laden liver had central
necrosis, mild focal necrosis as well as
congestion, and occasionally beryllium
granuloma.
Residents near a beryllium plant may
have been exposed by inhaling trace
amounts of beryllium powder, and
different beryllium compounds may
have induced different toxicant
reactions (Yian and Yin, 1982).
2. Cardiovascular Effects
There is very limited evidence of
cardiovascular effects of beryllium and
its compounds in humans. Severe cases
of chronic beryllium disease can result
in cor pulmonale, which is hypertrophy
PO 00000
Frm 00052
Fmt 4701
Sfmt 4702
of the right heart ventricle. In a case
history study of 17 individuals exposed
to beryllium in a plant that
manufactured fluorescent lamps,
autopsies revealed right atrial and
ventricular hypertrophy (Hardy and
Tabershaw, 1946). It is not likely that
these cardiac effects were due to direct
toxicity to the heart, but rather were a
response to impaired lung function.
However, an increase in deaths due to
heart disease or ischemic heart disease
was found in workers at a beryllium
manufacturing facility (Ward et al.,
1992).
Animal studies performed in monkeys
indicate heart enlargement after acute
inhalation exposure to 13 mg beryllium/
m3 as beryllium hydrogen phosphate,
0.184 mg beryllium/m3 as beryllium
fluoride, or 0.198 mg beryllium/m3 as
beryllium sulfate (Schepers 1964).
Decreased arterial oxygen tension was
observed in dogs exposed to 30 mg
beryllium/m3 as beryllium oxide for 15
days (HSDB, 2010), 3.6 mg beryllium/
m3 as beryllium oxide for 40 days (Hall
et al., 1950), or 0.04 mg beryllium/m3 as
beryllium sulfate for 100 days
(Stokinger et al., 1950). These are
expected to be indirect effects on the
heart due to pulmonary fibrosis and
toxicity which can increase arterial
pressure and restrict blood flow.
3. Renal Effects
Renal calculi (stones) were unusually
prevalent in severe cases that resulted
from high levels of beryllium exposure.
Renal stones containing beryllium
occurred in about 10 percent of patients
affected by high exposures (Barnett, et
al., 1961). Kidney stones were observed
in 10 percent of the CBD cases collected
by the BCR up to 1959 (Hall et al.,
1959). In addition, an excess of calcium
in the blood and urine has been seen
frequently in patients with chronic
beryllium disease (ATSDR, 2002).
4. Ocular and Mucosal Effects
Both the soluble, sparingly soluble,
and insoluble beryllium compounds
have been shown to cause ocular
irritation in humans (Van Orstrand et
al., 1945; De Nardi et al., 1953;
Nishimura, 1966; Epstein, 1990; NIOSH,
1994). In addition, beryllium
compounds (soluble, sparingly soluble,
or insoluble) have been demonstrated to
induce acute conjunctivitis with corneal
maculae and diffuse erythema (HSDB,
2010).
The mucosa (mucosal membrane) is
the moist lining of certain tissues/organs
including the eyes, nose, mouth, lungs,
and the urinary and digestive tracts.
Soluble beryllium salts have been
E:\FR\FM\07AUP2.SGM
07AUP2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
shown to be directly irritating to
mucous membranes (HSDB, 2010).
G. Summary of Preliminary Conclusions
Regarding Health Effects
Through careful analysis of the
current best available scientific
information outlined in this Health
Effects Section V, OSHA has
preliminarily determined that beryllium
and beryllium-containing compounds
are able to cause sensitization, chronic
beryllium disease (CBD) and lung
cancer below the current OSHA PEL of
2 mg/m3. The Agency has preliminarily
determined through the studies outlined
in section V.A.2 of this health effects
section that skin and inhalation
exposure to beryllium can lead to
sensitization; and inhalation exposure,
or skin exposure coupled with
inhalation, can cause onset and
progression of CBD. In addition, the
Agency has preliminarily determined
through studies outlined in section V.E.
of this health effects section that
inhalation exposure to beryllium and
beryllium containing materials causes
lung cancer.
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
1. Beryllium Causes Sensitization Below
the Current PEL and Sensitization is a
Precursor to CBD
Through the biological and
immunological processes outlined in
section V.B. of the Health Effects, the
Agency believes that the scientific
evidence supports the following
mechanism for the development of
sensitization and CBD.
• Inhaled beryllium and berylliumcontaining materials able to be retained
and solubilized in the lungs initiate
sensitization and facilitate CBD
development (Section V.B.5).
• Beryllium compounds that dissolve
in biological fluids, such as sweat, can
penetrate intact skin and initiate
sensitization (section V.A.2; V.B).
Phagosomal fluid and lung fluid have
been demonstrated to dissolve
beryllium compounds in the lung
(section V.A.2a).
• Sensitization occurs through a
CD4+ T-cell mediated process with both
soluble and insoluble beryllium and
beryllium-containing compounds
through direct antigen presentation or
through further antigen processing
(section V.D.1) in the skin or lung. Tcell mediated responses, such as
sensitization, are generally regarded as
long-lasting (e.g., not transient or readily
reversible) immune conditions.
• Beryllium sensitization and CBD
are adverse events along a pathological
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
continuum in the disease process with
sensitization being the necessary first
step in the progression to CBD (section
V.D).
Æ Animal studies have provided
supporting evidence for T-cell
proliferation in the development of
granulomatous lung lesions after
beryllium exposure (section V.D.2;
V.D.6).
Æ Since the pathogenesis of CBD
involves a beryllium-specific, cellmediated immune response, CBD
cannot occur in the absence of
beryllium sensitization (V.D.1). While
no clinical symptoms are associated
with sensitization, a sensitized worker
is at risk of developing CBD upon
subsequent inhalation exposure to
beryllium.
Æ Epidemiological evidence that
covers a wide variety of different
beryllium compounds and industrial
processes demonstrates that
sensitization and CBD are continuing to
occur at present-day exposures below
OSHA’s PEL (section V.D.4; V.D.5).
• OSHA considers CBD to be a
progressive illness with a continuous
spectrum of symptoms ranging from its
earliest asymptomatic stage following
sensitization through to full-blown CBD
and death (section V.D.7).
• Genetic variabilities may enhance
risk for developing sensitization and
CBD in some groups (section V.D.3).
In addition, epidemiological studies
outlined in section V.D.5 have
demonstrated that efforts to reduce
exposures have succeeded in reducing
the frequency of sensitization and CBD.
2. Evidence Indicates Beryllium is a
Human Carcinogen
OSHA has conducted an evaluation of
the current available scientific
information of the carcinogenic
potential of beryllium and berylliumcontaining compounds (section V.E).
Based on weight of evidence and
plausible mechanistic information
obtained from in vitro and in vivo
animal studies as well as clinical and
epidemiological investigations, the
Agency has preliminarily determined
that beryllium and beryllium-containing
materials should be regarded as human
carcinogens. This information is in
accordance with findings from IARC,
NTP, EPA, NIOSH, and ACGIH (section
V.E).
• Lung cancer is an irreversible and
frequently fatal disease with an
extremely poor 5-year survival rate
(NCI, 2009).
• Epidemiological cohort studies
have reported statistically significant
PO 00000
Frm 00053
Fmt 4701
Sfmt 4702
47617
excess lung cancer mortality among
workers employed in U.S. beryllium
production and processing plants
during the 1930s to 1970s (Section
V.E.2).
• Significant positive associations
were found between lung cancer
mortality and both average and
cumulative beryllium exposures when
appropriately adjusted for birth cohort
and short-term work status (Section
V.E.2).
• Studies in which large amounts of
different beryllium compounds were
inhaled or instilled in the respiratory
tracts of experimental animals resulted
in an increased incidence of lung
tumors (Section V.E.3).
• Authoritative scientific
organizations, such as the IARC, NTP,
and EPA, have classified beryllium as a
known or probable human carcinogen.
While OSHA has preliminarily
determined there is sufficient evidence
of beryllium carcinogenicity, the exact
tumorigenic mechanism for beryllium is
unclear and a number of mechanisms
are plausibly involved, including
chronic inflammation, genotoxicity,
mitogenicity oxidative stress, and
epigenetic changes (section V.E.3).
• Studies of beryllium exposed
animals have consistently demonstrated
chronic pulmonary inflammation after
exposure (section V.E.3).
Æ Substantial data indicate that tumor
formation in certain animal models after
inhalation exposure to sparingly soluble
particles at doses causing marked,
chronic inflammation is due to a
secondary mechanism unrelated to the
genotoxicty of the particle (section
V.E.5).
• A review conducted by the NAS
(2008) found that beryllium and
beryllium-containing compounds tested
positive for genotoxicity in nearly 50
percent of studies without exogenous
metabolic activity, suggesting a possible
direct-acting mechanism may exist
(section V.E.1) as well as the potential
for epigenetic changes (section V.E.4).
Other health effects have been
summarized in sections F of the Health
Effects Section and include hepatic,
cardiovascular, renal, ocular, and
mucosal effects. The adverse systemic
effects from human exposures mostly
occurred prior to the introduction of
occupational and environmental
standards set in 1970–1972 (OSHA,
1971; ACGIH, 1971; ANSI, 1970) and
1974 (EPA, 1974) and therefore are less
relevant today than in the past.
E:\FR\FM\07AUP2.SGM
07AUP2
47618
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
APPENDIX
TABLE A.1—SUMMARY OF BERYLLIUM SENSITIZATION AND CHRONIC BERYLLIUM DISEASE EPIDEMIOLOGICAL STUDIES
(%) Prevalence
Reference
Study type
Sensitization
Range of exposure
measurements
CBD
Exposure-response
relationship
Study limitations
Additional
comments
Studies Conducted Prior to BeLPT
Hardy and
Tabershaw, 1946.
Hardy, 1980 ............
Machle et al., 1948
Case-series ...........
N/A ........
N/A ........
N/A ........................
N/A .........
Selection bias .......
Small sample size.
Case-series ...........
Case-series ...........
N/A ........
N/A ........
N/A ........
N/A ........
N/A ........................
Semi-quantitative ..
N/A .........
Yes ........
Selection bias .......
Selection bias .......
Eisenbud et al.,
1949.
Case-series ...........
N/A ........
N/A ........
...............................
Lieben and Metzner,
1959.
...............................
N/A ........
...............
Average concentra- ................
tion: 350–750 ft
from plant—
0.05–0.15 μg/m3;.
<350 ft from
plant—2.1 μg/m3.
N/A ........................ ................
Small sample size.
Small sample size;
unreliable exposure data.
Non-occupational;
ambient air sampling.
Hardy et al., 1967 ...
Case Registry Review.
N/A ........
N/A ........
N/A ........................
N/A .........
Hasan and Kazemi,
1974.
Eisenbud and
Lisson, 1983.
Stoeckle et al., 1969
...............................
N/A ........
...............
...............................
................
Incomplete exposure concentration data.
...............................
...............................
N/A ........
1–10 ......
...............................
................
...............................
Case-series (60
cases).
N/A ........
...............
...............................
No ..........
Selection bias .......
No quantitative exposure data.
Family member
contact with contaminated
clothes.
Provided information regarding
progression and
identifying sarcoidosis from
CBD.
Studies Conducted Following the Development of the BeLPT
Beryllium Mining and Extraction
Deubner et al.,
2001b.
Cross-sectional (75
workers).
4.0 (3
cases).
1.3 (1
case).
Mining, milling—
range 0.05–0.8
μg/m3;
Annual maximum
0.04–165.7 μg/
m 3.
No ..........
Small sample size
Personal sampling.
Short-term Breathing Zone sampling.
Daily weighted average:
High exposures
compared to
other studies.
Engineering and
administrative
controls primarily
used to control
exposures.
Beryllium Metal Processing and Alloy Production
Kreiss et al., 1997 ..
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Rosenman et al.,
2005.
Cross-sectional
study of 627
workers.
Cross-sectional
study of 577
workers.
6.9 (43
cases).
4.6 (29
cases).
Median—1.4 μg/m3
No ..........
14.5 (83
cases).
5.5 (32
cases).
Mean average
range—7.1–8.7
μg/m3;.
Mean peak
range—53–87
μg/m3;
Mean cumulative
range—100–209
μg/m3.
No ..........
Inconsistent BeLPT
results between
labs.
...............................
No ..........
...............................
Beryllium Machining Operations
Newman et al.,
2001.
VerDate Sep<11>2014
Longitudinal study
of 235 workers.
19:20 Aug 06, 2015
Jkt 235001
9.4 (22
cases).
PO 00000
8.5 (20
cases).
Frm 00054
...............................
Fmt 4701
Sfmt 4702
E:\FR\FM\07AUP2.SGM
07AUP2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
47619
TABLE A.1—SUMMARY OF BERYLLIUM SENSITIZATION AND CHRONIC BERYLLIUM DISEASE EPIDEMIOLOGICAL STUDIES—
Continued
(%) Prevalence
Reference
Study type
Kelleher et al., 2001
Case-control study
of 20 cases and
206 controls.
Madl et al., 2007 .....
Longitudinal study
of 27 cases.
Exposure-response
relationship
Study limitations
Additional
comments
0.08–0.6 μg/m3—
lifetime weighted
exposures.
Yes ........
...............................
Identified 20 workers with Sensitization or
CBD.
Machining ..............
1980–1995 median
¥0.33 μg/m3;
1996–1999 median—0.16 μg/
m3; 2000–2005
median—0.09
μg/m3;.
Non-machining
1980–1995 median—0.12 μg/
m3; 1996–1999
median—0.08
μg/m3; 2000–
2005 median—
0.06 μg/m3.
Yes ........
...............................
Personal sampling:
Required evidence
of granulomas
for CBD diagnosis.
Range of exposure
measurements
Sensitization
CBD
11.5 (machinists).
2.9 (nonmachinists).
...............
11.5 (machinists).
2.9 (nonmachinists).
...............
Beryllium Oxide Ceramics
Kreiss et al., 1993b
3.6 (18
cases).
1.8 (9
cases).
...............................
No
Kreiss et al., 1996 ..
Cross-sectional
survey of 505
workers.
Cross-sectional
survey of 136
workers.
5.9 (8
cases).
4.4 (6
cases).
No ..........
Small study population.
Breathing Zone
Sampling.
Henneberger et al.,
2001.
Cross-sectional
survey of 151
workers.
9.9 (15
cases).
5.3 (8
cases).
Yes ........
Small study population.
Breathing zone
sampling.
Cummings et al.,
2007.
Longitudinal study
of 93 workers.
0.7–5.6
(4
cases).
0.1—7.9
(3
cases).
Machining median—0.6 μg/m3;.
Other Areas median—<0.3 μg/
m 3;
6.4% samples >2
μg/m3; 2.4%
samples >5 μg/
m3;.
0.3% samples >25
μg/m3.
Production .............
1994–1999 median—0.1μg/m3;
2000–2003 median—0.04μg/m3;
Administrative
1994–1999 median <0.2 μg/m3;
2000–2003 median—0.02 μg/
m3
Yes ........
Small sample size
Personal sampling
was effective in
reducing rates of
new cases of
sensitization.
Small study population.
Personal sampling.
Copper-Beryllium Alloy Processing and Distribution
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Schuler et al., 2005
VerDate Sep<11>2014
Cross-sectional
survey of 153
workers.
19:20 Aug 06, 2015
Jkt 235001
7.0 (10
cases).
PO 00000
4.0 (6
cases).
Frm 00055
Rod and Wire Production median—0.12 μg/
m3;
Strip Metal Production median—
0.02 μg/m3;
Production Support
median—0.02
μg/m3;
Administration median—0.02 μg/
m 3.
Fmt 4701
Sfmt 4702
................
E:\FR\FM\07AUP2.SGM
07AUP2
47620
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
TABLE A.1—SUMMARY OF BERYLLIUM SENSITIZATION AND CHRONIC BERYLLIUM DISEASE EPIDEMIOLOGICAL STUDIES—
Continued
(%) Prevalence
Reference
Study type
Sensitization
Range of exposure
measurements
CBD
Exposure-response
relationship
Thomas et al., 2009
Cross-sectional
study of 82 workers.
3.8 (3
cases).
1.9 (1
case).
Used exposure
profile from
Schuler study.
................
Stanton et al., 2006
Cross-sectional
study of 88 workers.
1.1 (1
case).
1.1 (1
case).
................
Bailey et al., 2010 ...
Cross-sectional
11.0 .......
study of 660 total
workers (258
partial program,
290 full program).
Bulk Products Production median
0.04 μg/m3; Strip
Metal Production
median—0.03
μg/m3; Production support.
median—0.01 μg/
m3; Administration median 0.01
μg/m3.
...............................
14.5 total
................
Study limitations
Authors noted
workers may
have been sensitized prior to
available screening, underestimating sensitization rate in
legacy workers.
Study did not report use of PPE
or respirators.
Additional
comments
Instituted PPE to
reduce dermal
exposures.
Personal sampling.
Study reported
prevalence rates
for pre enhanced
control-program,
partial enhanced
control program,
and full enhanced control
program.
Nuclear Weapons Production Facilities and Cleanup of Former Facilities
Kreiss et al., 1989 ..
Cross-sectional
survey of 51
workers.
Cross-sectional
survey of 895
workers.
11.8 (6
cases).
7.8 (4
cases).
...............................
No ..........
Small study population
1.9 (18
cases).
1.7 (15
cases).
...............................
No ..........
Stange et al., 1996
Longitudinal Study
of 4,397 BHSP
participants.
2.4 (76
cases).
0.7 (29
cases).
No ..........
Personal sampling.
Stange et al., 2001
Longitudinal study
of 5,173 workers.
4.5 (154
cases).
1.6 (81
cases).
No ..........
...............................
Personal sampling.
Viet et al., 2000 ......
Case-control ..........
74 workers
sensitized.
50 workers
CBD.
Annual mean concentration.
1970–1988 0.016
μg/m3; 1984–
1987 1.04 μg/m3.
No quantitative information presented in study.
Mean exposure
range: 0.083–
0.622 μg/m3.
Maximum exposures: 0.54–36.8
μg/m.3
Study population
includes some
workers with no
reported Be exposure.
...............................
Yes ........
Likely underestiFixed airhead sammated exposures.
pling away from
breathing zone:
Matched controls
for age, sex,
smoking.
Kreiss et al., 1993a
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
N/A = Information not available from study reports.
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
PO 00000
Frm 00056
Fmt 4701
Sfmt 4702
E:\FR\FM\07AUP2.SGM
07AUP2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
47621
TABLE A.2—SUMMARY OF MECHANISTIC ANIMAL STUDIES FOR SENSITIZATION AND CBD
Reference
Species
Dose or
exposure
concentration
Study length
Type of beryllium
Study results
Other information
Intratracheal (intrabroncheal) or Nasal Instillation
Barna et al., 1981 ..
Guinea
pig.
3 month
10 mg5μm
particle
size.
beryllium oxide ......
Barna et al., 1984 ..
Guinea
pig.
3 month
5 mg ......
beryllium oxide ......
Benson et al., 2000
Mouse ....
..................................................
0, 12.5,
25,
100μg;
0, 2, 8
μg.
beryllium copper
alloy; beryllium
metal.
Haley et al., 1994 ...
Cynomolgus
monkey.
14, 60, 90 days
Huang et al., 1992
Mouse ....
..................................................
Votto et al., 1987 ....
Rat .........
3 month
0, 1, 50,
Beryllium metal,
150 μg.
beryllium oxide.
0, 2.5,
12.5,
37.5 μg.
5 μg ....... Beryllium sulfate
1–5 μg ...
immunization;
beryllium metal
challenge.
2.4 mg ...
8 mg/ml
Beryllium sulfate
immunization;
beryllium sulfate
challenge.
Granulomas, interstitial infiltrate
with fibrosis with
thickening of alveolar septae.
Granulomatous lesions in strain 2
but not strain 13
indicating a genetic component.
Acute pulmonary
toxicity associated with beryllium/copper alloy
but not beryllium
metal.
Beryllium oxide
particles were
less toxic than
the beryllium
metal.
Granulomas produced in A/J
strain but not
BALB/c or
C57BL/6.
Granulomas, however, no correlation between Tcell subsets in
lung and BAL
fluid.
Inhalation—Single Exposure
Haley et al., 1989a
Beagle
dog.
Chronic—one dose
0, 6 μg/
kg, 18
μg/kg.
500 °C; 1000 °C
beryllium oxide.
Haley et al., 1989b
Beagle
dog.
Chronic—one dose/2 year
recovery
0, 17 μg/
kg, 50
μg/kg.
500 °C; 1000 °C
beryllium oxide.
Robinson et al.,
1968.
Dog ........
Chronic
0. 115mg/
m3.
Sendelbach et al.,
1989.
Sendelbach and
Witschi, 1987.
Rat .........
2 week
Rat .........
2 week
0, 4.05
μg/L.
0, 3.3, 7
μg/L.
Beryllium oxide, beryllium fluoride,
beryllium chloride.
Beryllium as berylInterstial pneumolium sulfate.
nitis.
Beryllium as berylEnzyme changes in
lium sulfate.
BAL fluid.
Positive BeLPT results—developed
granulomas; lowcalcined beryllium oxide more
toxic than highcalcined.
Granulomas, sensitization, lowfired more toxic
than high fired.
Foreign body reaction in lung.
Granulomas resolved with time,
no full-blown
CBD.
Granulomas resolved over time.
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Inhalation—Repeat Exposure
Conradi et al., 1971
VerDate Sep<11>2014
Beagle
dog.
19:20 Aug 06, 2015
Chronic—2 year
Jkt 235001
PO 00000
Frm 00057
0. 3300
1400 °C beryllium
μg/m3,
oxide.
4380
μg/m3
once/
month
for 3
months.
Fmt 4701
Sfmt 4702
No changes detected.
E:\FR\FM\07AUP2.SGM
07AUP2
May have been
due to short exposure time followed by long recovery.
47622
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
TABLE A.2—SUMMARY OF MECHANISTIC ANIMAL STUDIES FOR SENSITIZATION AND CBD—Continued
Reference
Species
Macaca
irus
Monkey.
Haley et al., 1992 ...
Harmsen et al.,
1985.
Dose or
exposure
concentration
Study length
Chronic—2 year
Beagle
dog.
Beagle
dog.
5 dogs
per
group.
Chronic—repeat dose (2.5
year intervals)
Chronic
Type of beryllium
0. 3300
1400 °C beryllium
μg/m3,
oxide.
4380
μg/m3
once/
month
for 3
months.
17, 50
500 °C; 1000 °C
μg/kg.
beryllium oxide.
0, 20 μg/
500°C; 1000 °C bekg, 50
ryllium oxide.
μg/kg.
Study results
No changes detected.
Other information
May have been
due to short exposure time followed by long recovery.
Granulomatous
pneumonitis.
Dermal or Intradermal
Kang et al., 1977 ....
Rabbit ....
..................................................
10mg .....
Beryllium sulfate ....
Tinkle et al., 2003 ..
Mouse ....
3 month
25 μL .....
70 μg .....
Beryllium sulfate ....
Beryllium oxide ......
Skin sensitization
and skin
granulomas.
Microgranulomas
with some resolution over time
of study.
Beryllium sulfate ....
Sensitization, evidence of CBD.
Intramuscular
Eskenasy, 1979 ......
Rabbit ....
35 days (injections at 7 day
intervals)
10mg.ml
Intraperitoneal Injection
Marx and Burrell,
1973.
Guinea
pig.
24 weeks (biweekly injections)
2.6 mg +
10 μg
dermal
injections.
Beryllium sulfate ....
Sensitization.
TABLE A–3—SUMMARY OF BERYLLIUM LUNG CANCER EPIDEMIOLOGICAL STUDIES
Reference
Study type
Exposure range
Study number
Mortality ratio
Confounding factors
Study limitations
Exposure concentration data
or smoking habits not reported.
..............................
Additional comments
Beryllium Case Registry
Cohort ..................
N/D ......................
421 cases from
the BCR.
SMR 2.12 ............
7 lung cancer
deaths.
Not reported ........
Steenland and
Ward, 1991.
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Infante et al., 1980
Cohort ..................
N/D ......................
689 cases from
the BCR.
SMR 2.00 (95%
CI 1.33–2.89).
28 lung cancer
deaths.
..............................
Included women:
93% women diagnosed with
CBD; 50% men
diagnosed with
CBD;
SMR 157 for
those with CBD
and SMR 232
for those with
ABD.
Beryllium Manufacturing and/or Processing Plants (Extraction, Fabrication, and Processing)
Ward et al., 1992 ..
VerDate Sep<11>2014
Retrospective
Mortality Cohort.
19:20 Aug 06, 2015
N/D ......................
Jkt 235001
PO 00000
9,225 males .........
Frm 00058
Fmt 4701
SMR 1.26 ............
(95% CI 1.12–
1.42).
280 lung cancer
deaths.
Sfmt 4702
..............................
E:\FR\FM\07AUP2.SGM
Lack of job history
and air monitoring data.
07AUP2
Employment period 1940–1969.
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
47623
TABLE A–3—SUMMARY OF BERYLLIUM LUNG CANCER EPIDEMIOLOGICAL STUDIES—Continued
Study limitations
Additional comments
Adjusted for
smoking.
Lack of job history
and air monitoring data.
..............................
..............................
SMR 1.42 ............
(95% CI 1.1–1.8)
80 lung cancer
deaths.
Only partial smoking history.
Same OH and PA
plant analysis.
SMR 1.40 ............
No smoking adjustment.
Partial smoking
history; No job
analysis by title
or exposure category.
No adjustment by
job title or exposure.
Majority of workers studied employed for less
than one year
Employed prior to
1947 for almost
half lung cancer
deaths.
Employment period from 1937–
1948.
N/D ......................
3,685 white males
SMR 1.49 ............
Adjusted for age
and local.
Cohort ..................
N/D ......................
3,055 white males
PA plant.
SMR 1.25 ............
(95% CI 0.9–1.7)
47 lung cancer
deaths.
..............................
Sanderson et al.,
2001.
Nested case-control.
3,569 males PA
plant.
May not have adjusted properly
for birth-year or
age at hire.
Nested case-control.
SMR 1.22 ............
(95% CI 1.03–
1.43).
142 lung cancer
deaths.
SMR 1.04 ............
(95% CI 0.92–
1.17).
Smoking was
found not to be
a confounding
factor.
Levy et al., 2007 ...
— Average exposure 22.8μg/m3.
— Maximum exposure 32.4μg/
m 3.
Used log transformed exposure data.
Different methodology for smoking adjustment.
..............................
Schubauer-Berigan
et al., 2008.
Nested case-control.
Used exposure
data from
Sanderson et
al., 2001, Chen
2001, and
Couch et al.,
2010.
Reanalysis of
Sanderson et
al., 2001.
Used Odds ratio:
1.91 (95% CI
1.06–3.44)
unadjusted;.
1.29 (95% CI
0.61–2.71)
birth-year adjusted;.
1.24 (95% CI
0.58–2.65) agehire adjusted.
Adjusted for
smoking, birth
cohort, age.
..............................
Schubauer-Berigan
et al., 2010a.
Cohort ..................
N/D ......................
9199 workers
from 7 processing plants.
SMR 1.17 (95%CI
1.08–1.28).
545 deaths ..........
Adjusted for
smoking.
..............................
Schubauer-Berigan
et al., 2010b.
Cohort ..................
Used exposure
data from
Sanderson et
al., 2001.
5436 workers OH
and PA plants.
Evaluated using
hazard ratios
and excess absolute risk.
293 deaths ..........
Adjusted for age,
birth cohort, asbestos exposure, short-term
work status.
..............................
Study type
Exposure range
Study number
Mortality ratio
Levy et al., 2002 ...
Cohort ..................
N/D ......................
9225 males ..........
Bayliss et al., 1971
Nested cohort ......
..............................
8,000 workers ......
Statistically nonsignificant elevation in lung
cancer deaths.
SMR 1.06 ............
36 lung cancer
deaths.
Mancuso, 1970 .....
Cohort ..................
Cohort ..................
411–43,300 μg/m3
annual exposure (reported
from Zielinsky,
1961).
N/D ......................
1,222 workers at
OH plant; 2,044
workers at PA
plant.
Mancuso, 1980 .....
Mancuso and El
Attar, 1969.
Cohort ..................
Wagner et al.,
1980.
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Reference
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
PO 00000
Reanalysis of
Sanderson et
al., 2001.
Frm 00059
Fmt 4701
Sfmt 4702
Confounding factors
E:\FR\FM\07AUP2.SGM
No job exposure
data or smoking
adjustment.
Inadequately adjusted for smoking; Used national lung-cancer risk for cancer not PA.
07AUP2
Employment period from 1942–
1948; Used
workers at
rayon plant for
comparison.
Employment history from 1937–
1944.
Reanalysis using
PA lung-cancer
rate revealed
19% underestimation of beryllium lung cancer deaths.
Found association
with 20 year latency.
Found no association between
beryllium exposure and increased risk of
lung cancer.
— Controlled for
birth-year and
age at hire;
— Found similar
results to
Sanderson et
al., 2001;
— Found association with 10
year latency
— ‘‘0’’ = used
minuscule value
at start to eliminate the use of
0 in a logarithmic analysis
Male workers employed at least
2 days between
1940 and 1970.
— Exposure response was
found between
0–10μg/m3
mean DWA;
— Increased with
statistical significance at 4μg/
m3;
— 1 in 1000 risk
at 0.033μg/m3
mean DWA.
47624
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
TABLE A–3—SUMMARY OF BERYLLIUM LUNG CANCER EPIDEMIOLOGICAL STUDIES—Continued
Reference
Study type
Exposure range
Study number
Mortality ratio
Confounding factors
Study limitations
Additional comments
Found lung cancer excess risk
was associated
with higher levels of exposure
not relevant in
today’s industrial settings.
— Greater lung
cancer risk in
the BCR cohort
— Correlation between highest
lung cancer
rates and highest amounts of
ABD or other
non-malignant
lung diseases
— Increased risk
with longer latency
— Greater excess
lung cancers
among those
hired prior to
1950.
Re-evaluation of Published Studies
Hollins et al., 2009
Review .................
Re-examination of
weight-of-evidence from
more than 50
publications.
..............................
..............................
..............................
..............................
IARC, 2012 ...........
Multiple ................
Insufficient exposure concentration.
Data .....................
..............................
Sufficient evidence for carcinogenicity of
beryllium.
IARC concluded
beryllium lung
cancer risk was
not associated
with smoking.
..............................
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
N/D = information not determined for most studies
DWA—daily weighted average
VI. Preliminary Beryllium Risk
Assessment
The Occupational Safety and Health
(OSH) Act and court cases arising under
it have led OSHA to rely on risk
assessment to support the risk
determinations required to set a
permissible exposure limit (PEL) for a
toxic substance in standards under the
OSH Act. Section 6(b)(5) of the OSH Act
states that ‘‘The Secretary [of Labor], in
promulgating standards dealing with
toxic materials or harmful physical
agents under this subsection, shall set
the standard which most adequately
assures, to the extent feasible, on the
basis of the best available evidence, that
no employee will suffer material
impairment of health or functional
capacity even if such employee has
regular exposure to the hazard dealt
with by such standard for the period of
his working life’’ (29 U.S.C. 655(b)(5)).
In Industrial Union Department, AFL–
CIO v. American Petroleum Institute,
448 U.S. 607 (1980) (Benzene), the
United States Supreme Court ruled that
the OSH Act requires that, prior to the
issuance of a new standard, a
determination must be made that there
is a significant risk of material
impairment of health at the existing PEL
and that issuance of a new standard will
significantly reduce or eliminate that
risk. The Court stated that ‘‘before [the
Secretary] can promulgate any
permanent health or safety standard, the
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
Secretary is required to make a
threshold finding that a place of
employment is unsafe—in the sense that
significant risks are present and can be
eliminated or lessened by a change in
practices’’ (Id. at 642). The Court also
stated ‘‘that the Act does limit the
Secretary’s power to requiring the
elimination of significant risks’’ (488
U.S. at 644 n.49), and that ‘‘OSHA is not
required to support its finding that a
significant risk exists with anything
approaching scientific certainty’’ (Id. at
656).
OSHA’s approach for the risk
assessment incorporates both a review
of the recent literature on populations of
workers exposed to beryllium below the
current Permissible Exposure Limit
(PEL) of 2 mg/m3 and a statistical
exposure-response analysis. OSHA
evaluated risk at several alternate PELs
under consideration by the Agency: 2
mg/m3, 1 mg/m3, 0.5 mg/m3, 0.2 mg/m3,
and 0.1 mg/m3. A number of recently
published epidemiological studies
evaluate the risk of sensitization and
CBD for workers exposed at and below
the current PEL and the effectiveness of
exposure control programs in reducing
risk. OSHA also conducted a statistical
analysis of the exposure-response
relationship for sensitization and CBD at
the current PEL and alternate PELs the
Agency is considering. For this analysis,
OSHA used data provided by National
Jewish Medical and Research Center
PO 00000
Frm 00060
Fmt 4701
Sfmt 4702
(NJMRC) on a population of workers
employed at a beryllium machining
plant in Cullman, AL. The review of the
epidemiological studies and OSHA’s
own analysis show substantial risk of
sensitization and CBD among workers
exposed at and below the current PEL
of 2 mg/m3. They also show substantial
reduction in risk where employers have
implemented a combination of controls,
including stringent control of airborne
beryllium levels and additional
measures such as respirators, dermal
personal protective equipment (PPE),
and strict housekeeping to protect
workers against dermal and respiratory
beryllium exposure. To evaluate lung
cancer risk, OSHA relied primarily on a
quantitative risk assessment published
in 2011 by NIOSH. This risk assessment
was based on an update of the Reading
cohort analyzed by Sanderson et al., as
well as workers from two smaller plants
(Schubauer-Berigan et al., 2011) where
workers were exposed to lower levels of
beryllium and worked for longer periods
than at the Reading plant. The authors
found that lung cancer risk was strongly
and significantly related to mean,
cumulative, and maximum measures of
workers’ exposure; they predicted
substantial risk of lung cancer at the
current PEL, and substantial reductions
in risk at the alternate PELs OSHA
considered for the proposed rule
(Schubauer-Berigan et al., 2011).
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
A. Review of Epidemiological Literature
on Sensitization and Chronic Beryllium
Disease From Occupational Exposure
As discussed in the Health Effects
section, studies of beryllium-exposed
workers conducted using the beryllium
lymphocyte proliferation test (BeLPT)
have found high rates of beryllium
sensitization and CBD among workers in
many industries, including at some
facilities where exposures were
primarily below OSHA’s PEL of 2 mg/m3
(Kreiss et al., 1993; Henneberger et al.,
2001; Schuler et al., 2005; Schuler et al.,
2012). In the mid-1990s, some facilities
using beryllium began to aggressively
monitor and reduce workplace
exposures. Four plants where several
rounds of BeLPT screening were
conducted before and after
implementation of new exposure
control methods provide the best
currently available evidence on the
effectiveness of various exposure
control measures in reducing the risk of
sensitization and CBD. The experiences
of these plants—a copper-beryllium
processing facility in Reading, PA, a
beryllia ceramics facility in Tucson, AZ;
a beryllium processing facility in
Elmore, OH; and a machining facility in
Cullman, AL—show that efforts to
prevent sensitization and CBD by using
engineering controls to reduce workers’
beryllium exposures to median levels at
or around 0.2 mg/m3 and did not
emphasize PPE and stringent
housekeeping methods, had only
limited impact on risk. However,
exposure control programs implemented
more recently, which drastically
reduced respiratory exposure to
beryllium via a combination of
engineering controls and respiratory
protection, controlled dermal contact
with beryllium using PPE, and
employed stringent housekeeping
methods to keep work areas clean and
prevent transfer of beryllium between
work areas, sharply curtailed new cases
of sensitization among newly-hired
workers. There is additional, but more
limited, information available on the
occurrence of sensitization and CBD
among aluminum smelter workers with
low-level beryllium exposures (Taiwo et
al., 2008; Taiwo et al., 2010; Nilsen et
al., 2010). A discussion of the
experiences at these plants follows.
The Health Effects section also
discussed the role of particle
characteristics and beryllium compound
solubility in the development of
sensitization and CBD among berylliumexposed workers. Respirable particles
small enough to reach the deep lung are
responsible for CBD. However, larger
inhalable particles that deposit in the
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
upper respiratory tract may lead to
sensitization. The weight of evidence
indicates that both soluble and
insoluble forms of beryllium are able to
induce sensitization and CBD. Insoluble
forms of beryllium that persist in the
lung for longer periods may pose greater
risk of CBD while soluble forms may
more easily trigger immune
sensitization. Although these factors
potentially influence the toxicity of
beryllium, the available data are too
limited to reliably account for solubility
and particle size in the Agency
estimates of risk. The qualitative impact
on conclusions and uncertainties with
regard to risk are discussed in a later
section.
1. Reading, PA, Plant
Schuler et al. conducted a study of
workers at a copper-beryllium
processing facility in Reading, PA,
screening 152 workers with the BeLPT
(Schuler et al., 2005). Exposures at this
plant were believed to be low
throughout its history due to the low
percentage of beryllium in the metal
alloys used, and the relatively low
exposures found in general area samples
collected starting in 1969 (sample
median ≤ 0.1 mg/m3, 97% < 0.5 mg/m3).
The reported prevalences of
sensitization (6.5 percent) and CBD (3.9
percent) showed substantial risk at this
facility, even though airborne exposures
were primarily below OSHA’s current
PEL of 2 mg/m3.
Personal lapel samples were collected
in production and production support
jobs between 1995 and May 2000. These
samples showed primarily very low
airborne beryllium levels, with a
median of 0.073 mg/m3.6 The wire
annealing and pickling process had the
highest personal lapel sample values,
with a median of 0.149 mg/m3. Despite
these low exposure levels, cases of
sensitization continued to occur among
workers whose first exposures to
beryllium occurred in the 1990s. Five
(11.5 percent) workers of 43 hired after
1992 who had no prior beryllium
exposure became sensitized, including
four in production work and one in
production support (Thomas et al.,
2009; evaluation for CBD not reported).
Two (13 percent) of these sensitized
workers were among 15 workers in this
group who had been hired less than a
year before the screening.
After the BeLPT screening was
conducted in 2000, the company began
implementing new measures to further
6 In their publication, Schuler et al. presented
median values for plant-wide and work-categoryspecific exposure levels; they did not present
arithmetic or geometric mean values for personal
samples.
PO 00000
Frm 00061
Fmt 4701
Sfmt 4702
47625
reduce workers’ exposure to beryllium.
Requirements designed to minimize
dermal contact with beryllium,
including long-sleeve facility uniforms
and polymer gloves, were instituted in
production areas in 2000. In 2001 the
company installed local exhaust
ventilation (LEV) in die grinding and
polishing. Personal lapel samples
collected between June 2000 and
December 2001 show reduced exposures
plant-wide. Of 2,211 exposure samples
collected during this ‘‘pre-enclosure
program’’ period, 98 percent were below
0.2 mg/m3 (Thomas et al., 2009, p. 124).
Median, arithmetic mean, and geometric
mean values ≤ 0.03 mg/m3 were reported
in this period for all processes except
the wire annealing and pickling process.
Samples for this process remained
elevated, with a median of 0.1 mg/m3
(arithmetic mean of 0.127 mg/m3,
geometric mean of 0.083 mg/m3). In
January 2002, the plant enclosed the
wire annealing and pickling process in
a restricted access zone (RAZ), required
respiratory PPE in the RAZ, and
implemented stringent measures to
minimize the potential for skin contact
and beryllium transfer out of the zone.
While exposure samples collected by
the facility were sparse following the
enclosure, they suggest exposure levels
comparable to the 2000–01 samples in
areas other than the RAZ. Within the
RAZ, required use of powered airpurifying respirators (PAPRs) indicates
that respiratory exposure was negligible.
A 2009 publication on the facility
reported that outside the RAZ, ‘‘the vast
majority of employees do not wear any
form of respiratory protection due to
very low airborne beryllium
concentrations’’ (Thomas et al., 2009, p.
122).
To test the efficacy of the new
measures in preventing sensitization
and CBD, in June 2000 the facility began
an intensive BeLPT screening program
for all new workers. The company
screened workers at the time of hire; at
intervals of 3, 6, 12, 24, and 48 months;
and at 3-year intervals thereafter.
Among 82 workers hired after 1999,
three cases of sensitization were found
(3.7 percent). Two (5.4 percent) of 37
workers hired prior to enclosure of the
wire annealing and pickling process
were found to be sensitized within 3
and 6 months of beginning work at the
plant. One (2.2 percent) of 45 workers
hired after the enclosure was confirmed
as sensitized. Among these early results,
it appears that the greatest reduction in
sensitization risk was achieved after
median exposures in all areas of the
plant were reduced to below 0.1 mg/m3
E:\FR\FM\07AUP2.SGM
07AUP2
47626
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
and PPE to prevent dermal contact was
instituted.
2. Tucson, AZ, Plant
Kreiss et al. conducted a study of
workers at a beryllia ceramics plant,
screening 136 workers with the BeLPT
in 1992 (Kreiss et al., 1996). Full-shift
area samples collected between 1983
and 1992 showed primarily low
airborne beryllium levels at this facility.
Of 774 area samples, 76 percent were at
or below 0.1 mg/m3 and less than 1
percent exceeded 2 mg/m3. A small set
(75) of personal lapel samples collected
at the plant beginning in 1991 had a
median of 0.2 mg/m3 and ranged from
0.1 to 1.8 mg/m3 (arithmetic and
geometric mean values not reported)
(Kreiss et al., 1996, p. 19). However,
area samples and short-term breathing
zone samples also showed occasional
instances of very high beryllium
exposure levels, with extreme values of
several hundred mg/m3 and 3.6 percent
of short-term breathing zone samples in
excess of 5 mg/m3.
Kreiss et al. reported that eight (5.9
percent) of 136 workers tested were
sensitized, six (4.4 percent) of whom
were diagnosed with CBD. Seven of the
eight sensitized employees had worked
in machining, where general area
samples collected between October 1985
and March 1988 had a median of 0.3 mg/
m3, in contrast to a median value of less
than 0.1 mg/m3 in other areas of the
plant (Kreiss et al., 1996, p. 20; mean
values not reported). Short-term
breathing zone measurements associated
with machining had a median of 0.6 mg/
m3, double the median of 0.3 mg/m3 for
breathing zone measurements associated
with other processes (id., p. 20; mean
values not reported). One sensitized
worker was one of 13 administrative
workers screened, and was among those
diagnosed with CBD. Exposures of
administrative workers were not wellcharacterized, but were believed to be
among the lowest in the plant. Of three
personal lapel samples reported for
administrative staff during the 1990s, all
were below the then detection limit of
0.2 mg/m3 (Cummings et al., 2007,
p.138).
Following the 1992 screening, the
facility reduced exposures in machining
areas by enclosing machines and
installing HEPA filter exhaust systems.
Personal samples collected between
1994 and 1999 had a median of 0.2 mg/
m3 in production jobs and 0.1 mg/m3 in
production support (geometric means
0.21 mg/m3 and 0.11 mg/m3, respectively;
arithmetic means not reported.
Cummings et al., 2007, p. 138). In 1998,
a second screening found that 9 percent
of tested workers hired after the 1992
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
screening were sensitized, of whom one
was diagnosed with CBD. All of the
sensitized workers had been employed
at the plant for less than two years
(Henneberger et al., 2001).
Following the 1998 screening, the
company continued efforts to reduce
exposures and risk of sensitization and
CBD by implementing additional
engineering and administrative controls
and PPE. Respirator use was required in
production areas beginning in 1999, and
latex gloves were required beginning in
2000. The lapping area was enclosed in
2000, and enclosures were installed for
all mechanical presses in 2001. Between
2000 and 2003, water-resistant or waterproof garments, shoe covers, and taped
gloves were incorporated to keep
beryllium-containing fluids from wet
machining processes off the skin. The
new engineering measures did not
appear to substantially reduce airborne
beryllium levels in the plant. Personal
lapel samples collected in production
processes between 2000 and 2003 had a
median and geometric mean of 0.18 mg/
m3, similar to the 1994–1999 samples
(Cummings et al., 2007, p. 138).
However, respiratory protection
requirements were instituted in 2000 to
control workers’ airborne beryllium
exposures.
To test the efficacy of the new
measures instituted after 1998, in
January 2000 the company began
screening new workers for sensitization
at the time of hire and at 3, 6, 12, 24,
and 48 months of employment
(Cummings et al., 2007). These more
stringent measures appear to have
substantially reduced the risk of
sensitization among new employees. Of
97 workers hired between 2000 and
2004, one case of sensitization was
identified (1 percent). This worker had
experienced a rash after an incident of
dermal exposure to lapping fluid
through a gap between the glove and
uniform sleeve, indicating that
sensitization may have occurred via
skin exposure.
3. Elmore, OH, Plant
Kreiss et al., Schuler et al., and Bailey
et al. conducted studies of workers at a
beryllium metal, alloy, and oxide
production plant. Workers participated
in BeLPT surveys in 1992 (Kreiss et al.,
1997) and in 1997 and 1999 (Schuler et
al., 2012). Exposure levels at the plant
between 1984 and 1993 were
characterized by a mixture of general
area, short-term breathing zone, and
personal lapel samples. Kreiss et al.
reported that the median area samples
for various work areas ranged from 0.1
to 0.7 mg/m3, with the highest values in
the alloy arc furnace and alloy melting-
PO 00000
Frm 00062
Fmt 4701
Sfmt 4702
casting areas (other measures of central
tendency not reported). Personal lapel
samples were available from 1990–1992,
and showed high exposures overall
(median value of 1.0 mg/m3) with very
high exposures for some processes. The
authors reported median sample values
of 3.8 mg/m3 for beryllium oxide
production, 1.75 mg/m3 for alloy melting
and casting, and 1.75 mg/m3 for the arc
furnace.
Kreiss et al. reported that 43 (6.9
percent) of 627 workers tested in 1992
were sensitized, six of whom were
diagnosed with CBD (4.4 percent).
Workers with less than one year tenure
at the plant were not tested in this
survey (Bailey et al., 2010, p. 511). The
work processes that appeared to carry
the highest risk for sensitization and
CBD (e.g., ceramics) were not those with
the highest reported exposure levels
(e.g., arc furnace and melting-casting).
The authors noted several possible
reasons for this, including factors such
as solubility, particle size/number, and
particle surface area that could not be
accounted for in their analysis (Kreiss et
al., 1997).
In 1996–1999, the company took steps
to reduce workers’ beryllium exposures:
some high-exposure processes were
enclosed, special restricted-access zones
were set up, HEPA filters were installed
in air handlers, and some ventilation
systems were updated. In 1997 workers
in the pebble plant restricted access
zone were required to wear half-face airpurifying respirators, and beginning in
1999 all new employees were required
to wear loose-fitting powered airpurifying respirators (PAPR) in
manufacturing buildings (Bailey et al.,
2010, p. 506). Skin protection became
part of the protection program for new
employees in 2000, and glove use was
required in production areas and for
handling work boots beginning in 2001.
Also beginning in 2001, either half-mask
respirators or PAPRs were required in
the production facility (type determined
by airborne beryllium levels), and
respiratory protection was required for
roof work and during removal of work
boots (Bailey et al., 2010, p. 506).
Respirator use was reported to be used
on about half or less of industrial
hygiene sample records for most
processes in 1990–1992 (Kreiss et al.,
1996).
Beginning in 2000, workers were
offered periodic BeLPT testing to
evaluate the effectiveness of a new
exposure control program implemented
by the company. Bailey et al. (2010)
reported on the results of this
surveillance for 290 workers hired
between February 21, 2000 and
December 18, 2006. They compared the
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
occurrence of beryllium sensitization
and disease among 258 employees who
began work at the Elmore plant between
January 15, 1993 and August 9, 1999
(the ‘pre-program group’) and among
290 employees who were hired between
February 21, 2000 and December 18,
2006 and were tested at least once after
hire (the ‘program group’). They found
that, as of 1999, 23 (8.9 percent) of the
pre-program group were sensitized to
beryllium. Six (2.1 percent) of the
program group had confirmed abnormal
results on their final round of BeLPTs,
which occurred in different years for
different employees. In addition,
another five employees had confirmed
abnormal BeLPT results at some point
during the testing period, followed by at
least one instance of a normal test
result. One of these employees had a
confirmed abnormal baseline BeLPT at
hire, and had two subsequent normal
BeLPT results at 6 and 12 months after
hire. Four others had confirmed
abnormal BeLPT results at 3 or 6
months after hire, later followed by a
normal test. Including these four in the
count of sensitized workers, there were
a total of ten (3.5 percent) workers
sensitized after hire in the program
group. It is not clear whether the
occurrence of a normal result following
an abnormal result reflects an error in
one of the test results, a change in the
presence or level of memory T-cells
circulating in the worker’s blood, or
other possibilities. Because most of the
workers in the study had been
employed at the facility for less than
two years, Bailey et al. did not report
the incidence of CBD among the
sensitized workers (Bailey et al., 2010,
p. 511).
In addition, Bailey et al. divided the
program group into the ‘partial program
subgroup’ (206 employees hired
between February 21, 2000 and
December 31, 2003) and the ‘full
program subgroup’ (84 employees hired
between January 1, 2004 and December
18, 2006) to account for the greater
effectiveness of the exposure control
program after the first three years of
implementation (Bailey et al., pp 506–
507). Four (1.9 percent) of the partial
program group were found to be
sensitized on their final BeLPT
(excluding one with a confirmed
abnormal BeLPT from their baseline test
at hire). Two (2.4 percent) of the full
program group were found to be
sensitized on their final BeLPT (Bailey
et al., 2010, p. 509). An additional three
employees in the partial program group
and one in the full program group were
confirmed sensitized at 3 or 6 months
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
after hire, then later had a single normal
BeLPT (Bailey et al., 2010, p. 509).
Schuler et al. (2012) published a
study examining beryllium sensitization
and CBD among short-term workers at
the Elmore, OH plant, using exposure
estimates created by Virji et al. (2012).
The study population included 264
workers employed in 1999 with up to
six years tenure at the plant (91 percent
of the 291 eligible workers). By
including only short-term workers, Virji
et al. were able to construct
participants’ exposures with more
precision than was possible in studies
involving workers exposed for longer
durations and in time periods with less
exposure sampling. Each participant
completed a work history questionnaire
and was tested for beryllium
sensitization. The overall prevalence of
sensitization was 9.8 percent (26/264).
Sensitized workers were offered further
evaluation for CBD. Twenty-two
sensitized workers consented to clinical
testing for CBD via transbronchial
biopsy. Six of those sensitized were
diagnosed with CBD (2.3 percent, 6/
264).
Exposure estimates were constructed
using two exposure surveys conducted
in 1999: a survey of total mass
exposures (4022 full-shift personal
samples) and a survey of size-separated
impactor samples (198 samples). The
1999 exposure surveys and work
histories were used to estimate longterm lifetime weighted (LTW) average,
cumulative, and highest-job-worked
exposure for total, respirable, and
submicron beryllium mass
concentrations. Schuler et al. (2012)
found no cases of sensitization among
workers with total mass LTW average
exposures below 0.09 mg/m3, among
workers with total mass cumulative
exposures below 0.08 mg/m3-yr, or
among workers with total mass highest
job worked exposures below 0.12 mg/m3.
Twenty-four percent, 16 percent, and 25
percent of the study population were
exposed below those levels,
respectively. Both total and respirable
beryllium mass concentration estimates
were positively associated with
sensitization (average and highest job),
and CBD (cumulative) in logistic
regression models.
4. Cullman, AL, Plant
Newman et al. conducted a series of
BeLPT screenings of workers at a
precision machining facility between
1995 and 1999 (Newman et al., 2001). A
small set of personal lapel samples
collected in the early 1980s and in 1995
suggests that exposures in the plant
varied widely during this time period.
In some processes, such as engineering,
PO 00000
Frm 00063
Fmt 4701
Sfmt 4702
47627
lapping, and electrical discharge
machining (EDM), exposures were
apparently low (≤ 0.1 mg/m3). Madl et al.
reported that personal lapel samples
from all machining processes combined
had a median of 0.33 mg/m3, with a
much higher arithmetic mean of 1.63
mg/m3 (Madl et al., 2007, Table IV, p.
457). The majority of these samples
were collected in the high-exposure
processes of grinding (median of 1.05
mg/m3, mean of 8.48 mg/m3), milling
(median of 0.3 mg/m3, mean of 0.82 mg/
m3), and lathing (median of 0.35 mg/m3,
mean of 0.88 mg/m3) (Madl et al., 2007,
Table IV, p. 457). As discussed in
greater detail in the background
document,7 the data set of machining
exposure measurements included a few
extremely high values (41–73 mg/m3)
that a NIOSH researcher identified as
probable errors, and that appear to be
included in Madl et al.’s arithmetic
mean calculations. Because high singledata point exposure errors influence the
arithmetic mean far more than the
median value of a data range, OSHA
believes the median values reported by
Madl et al. are more reliable than the
arithmetic means they reported.
After a sentinel case of CBD was
diagnosed at the plant in 1995, the
company began BeLPT screenings to
identify workers at increased risk of
CBD and implemented engineering and
administrative controls and PPE
designed to reduce workers’ beryllium
exposures in machining operations.
Newman et al. reported 22 (9.4 percent)
sensitized workers among 235 tested, 13
of whom were diagnosed with CBD
within the study period. Between 1995
and 1997, the company built enclosures
and installed or updated local exhaust
ventilation (LEV) for several machining
departments, removed pressurized air
hoses, and required the use of company
uniforms. Madl et al. reported that
historically, engineering and work
process controls, rather than personal
protective equipment, were used to
limit workers’ exposure to beryllium;
respirators were used only in cases of
high exposure, such as during
sandblasting (Madl et al., 2007, p. 450).
In contrast to the Reading and Tucson
plants, gloves were not required at this
plant.
Personal lapel samples collected
extensively between 1996 and 1999 in
machining jobs have an overall median
of 0.16 mg/m3, showing that the new
controls achieved a marked reduction in
machinists’ exposures during this
7 When used throughout this section,
‘‘background document’’ refers to a more
comprehensive, companion risk-assessment
document that can be found at www.regulations.gov
in OSHA Docket No. ___.
E:\FR\FM\07AUP2.SGM
07AUP2
47628
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
period. Nearly half of the samples were
collected in milling (median = 0.18 mg/
m3). Exposures in other machining
processes were also reduced, including
grinding (median of 0.18 mg/m3) and
lathing (median of 0.13 mg/m3).
However, cases of sensitization and CBD
continued to occur.
At the time that Newman et al.
reviewed the results of BeLPT
screenings conducted in 1995–1999, a
subset of 60 workers had been employed
at the plant for less than a year. Four
(6.7 percent) of these workers were
found to be sensitized, of whom two
were diagnosed with CBD and one with
probable CBD (Newman et al., 2001).
All four had been hired in 1996. Two
(one CBD case, one sensitized only) had
worked only in milling, and had worked
for approximately 3–4 months (0.3–0.4
yrs) at the time of diagnosis. One of
those diagnosed with CBD worked only
in EDM, where lapel samples collected
between 1996 and 1999 had a median of
0.03 mg/m3. This worker was diagnosed
with CBD in the same year that he began
work at the plant. The last CBD case
worked as a shipper, where exposures
in 1996–1999 were similarly low, with
a median of 0.09 mg/m3.
Beginning in 2000, exposures in all
jobs at the machining facility were
reduced to extremely low levels.
Personal lapel samples collected in
machining processes between 2000 and
2005 had a median of 0.09 mg/m3, where
more than a third of samples came from
the milling process (n = 765, median of
0.09 mg/m3). A later publication on this
plant by Madl et al. reported that only
one worker hired after 1999 became
sensitized. This worker had been
employed for 2.7 years in chemical
finishing, where exposures were
roughly similar to other machining
processes (n = 153, median of 0.12 mg/
m3). Madl et al. did not report whether
this worker was evaluated for CBD.
5. Aluminum Smelting Plants
Taiwo et al. (2008) studied a
population of 734 employees at four
aluminum smelters located in Canada
(2), Italy (1), and the United States (1).
In 2000, a beryllium exposure limit of
0.2 mg/m3 8-hour TWA (action level 0.1
mg/m3) and a short-term exposure limit
(STEL) of 1.0 mg/m3 (15-minute sample)
were instituted at these plants.
Sampling to determine compliance with
the exposure limit began at all smelters
in 2000. Table VI–1 below, adapted
from Taiwo et al. (2008), shows
summary information on samples
collected from the start of sampling
through 2005.
TABLE VI–1—EXPOSURE SAMPLING DATA BY PLANT—2000–2005
Number of
samples
Smelter
Canadian smelter 1 .........................................................................................
Canadian smelter 2 .........................................................................................
Italian smelter ..................................................................................................
U.S. smelter .....................................................................................................
Arithmetic
mean
(μg/m3)
Median
(μg/m3)
246
329
44
346
0.03
0.11
0.12
0.03
Geometric
mean
(μg/m3)
0.09
0.29
0.14
0.26
0.03
0.08
0.10
0.04
Adapted from Taiwo et al., 2008, Table 1.
All employees potentially exposed to
beryllium levels at or above the action
level for at least 12 days per year, or
exposed at or above the STEL 12 or
more times per year, were offered
medical surveillance including the
BeLPT (Taiwo et al., 2008, p. 158).
Table VI–2 below, adapted from Taiwo
et al. (2008), shows test results for each
facility between 2001 and 2005.
TABLE VI–2—BeLPT RESULTS BY PLANT—2001–2005
Employees
tested
Smelter
Canadian smelter 1 .........................................................................................
Canadian smelter 2 .........................................................................................
Italian smelter ..................................................................................................
U.S. smelter .....................................................................................................
Abnormal
BeLPT
(unconfirmed)
Normal
109
291
64
270
107
290
63
268
1
1
0
2
Confirmed
Sensitized
1
0
1
0
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Adapted from Taiwo et al., 2008, Table 2.
The two workers with confirmed
beryllium sensitization were offered
further evaluation for CBD. Both were
diagnosed with CBD, based on bronchoalveolar lavage (BAL) results in one case
and pulmony function tests, respiratory
symptoms, and radiographic evidence
in the other.
In 2010, Taiwo et al. published a
study of beryllium-exposed workers
from smelters at four companies,
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
including some of the workers from the
2008 publication. 3,185 workers were
determined to be ‘‘significantly
exposed’’ to beryllium and invited to
participate in BeLPT screening. Each
company used different criteria to
determine ‘‘significant’’ exposure,
which appeared to vary considerably (p.
570). About 60 percent of invited
workers participated in the program
PO 00000
Frm 00064
Fmt 4701
Sfmt 4702
between 2000 and 2006, of whom nine
were determined to be sensitized (see
Table VI–3 below). The authors state
that all nine workers were referred to a
respiratory physician for further
evaluation for CBD. Two were
diagnosed with CBD, as described above
(Taiwo et al., 2008). The authors do not
report the details of other sensitized
workers’ evaluation for CBD.
E:\FR\FM\07AUP2.SGM
07AUP2
47629
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
TABLE VI–3—MEDICAL SURVEILLANCE FOR BeS IN ALUMINUM SMELTERS
Number of
smelters
Company
A
B
C
D
At-risk
employees
Employees
tested
BeS
.......................................................................................................................
.......................................................................................................................
......................................................................................................................
......................................................................................................................
4
3
1
1
1278
423
1100
384
734
328
508
362
4
0
4
1
Total ..........................................................................................................
9
3185
1932
9
Adapted from Taiwo et al., 2011, Table 1.
In general, there appeared to be a low
level of sensitization and CBD among
employees at the aluminum smelters
studied by Taiwo et al. This is striking
in light of the fact that many of the
employees tested had worked at the
smelters long before the institution of
exposure limits for beryllium at some
smelters in 2000. However, the authors
note that respiratory protection had long
been used at these plants to protect
workers from other hazards. The results
are roughly consistent with the observed
prevalence of sensitization following the
institution of respiratory protection at
the Tucson beryllium ceramics plant
discussed previously. A study by Nilsen
et al. (2010) also found a low rate of
sensitization among aluminum workers
in Norway. Three-hundred sixty-two
workers and thirty-one control
individuals received BeLPT testing for
beryllium sensitization. The authors
found one sensitized worker (0.28
percent). No borderline results were
reported. The authors reported that
current exposures in this plant ranged
from 0.1 mg/m3 to 0.31 mg/m3 (Nilsen et
al., 2010) and that respiratory protection
was in use, as is the case in the smelters
studied by Taiwo et al. (2008, 2010).
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
B. Preliminary Conclusions
The published literature on beryllium
sensitization and CBD shows that risk of
both can be substantial in workplaces in
compliance with OSHA’s current PEL
(Kreiss et al., 1993; Schuler et al., 2005).
The experiences of several facilities in
developing effective industrial hygiene
programs have shown that minimizing
both airborne and dermal exposure,
using a combination of engineering and
administrative controls, respiratory
protection, and dermal PPE, has
substantially lowered workers’ risk of
beryllium sensitization. In contrast, riskreduction programs that relied primarily
on engineering controls to reduce
workers’ exposures to median levels in
the range of 0.1–0.2 mg/m3, such as
those implemented in Tucson following
the 1992 survey and in Cullman during
1996–1999, had only limited impact on
reducing workers’ risk of sensitization.
VerDate Sep<11>2014
20:43 Aug 06, 2015
Jkt 235001
The prevalence of sensitization among
workers hired after such controls were
installed at the Cullman plant remained
high (Newman et al. (6.7 percent) and
Henneberger et al. (9 percent)). A
similar prevalence of sensitization was
found in the screening conducted in
2000 at the Reading plant, where the
available sampling data show median
exposure levels of less than 0.2 mg/m3
(6.5 percent). The risk of sensitization
was found to be particularly high among
newly-hired workers (≤1 year of
beryllium exposure) in the Reading
2000 screening (13 percent) and the
Tucson 1998 screening (16 percent).
Cases of CBD have also continued to
develop among workers in facilities and
jobs where exposures were below 0.2
mg/m3. One case of CBD was found in
the Tucson 1998 screening among nine
sensitized workers hired less than two
years previously (Henneberger et al.,
2001). At the Cullman plant, at least two
cases of CBD were found among four
sensitized workers screened in 1995–
1999 and hired less than a year
previously (Newman et al., 2001). These
results suggest a substantial risk of
progression from sensitization to CBD
among workers exposed at levels well
below the current PEL, especially
considering the extremely short time of
exposure and follow-up for these
workers. Six of 10 sensitized workers
identified at Reading in the 2000
screening were diagnosed with CBD.
The four sensitized workers who did not
have CBD at their last clinical
evaluation had been hired between one
and five years previously; therefore, the
time may have been too short for CBD
to develop.
In contrast, more recent exposure
control programs that have used a
combination of engineering controls,
PPE, and stringent housekeeping
measures to reduce workers’ airborne
and dermal exposures have
substantially lowered risk of
sensitization among newly-hired
workers. Of 97 workers hired between
2000 and 2004 in Tucson, where
respiratory and skin protection was
instituted for all workers in production
PO 00000
Frm 00065
Fmt 4701
Sfmt 4702
areas, only one (1 percent) worker
became sensitized, and in that case the
worker’s dermal protection had failed
during wet-machining work (Thomas et
al., 2009). In the aluminum smelters
discussed by Taiwo et al., where
available exposure samples indicated
median beryllium levels of about 0.1 mg/
m3 or below (measured as an 8-hour
TWA) and workers used respiratory and
dermal protection, confirmed cases of
sensitization were rare (zero or one case
per location). Sensitization was also rare
among workers at a Norwegian
aluminum smelter (Nilsen et al., 2010),
where estimated exposures in the plant
ranged from 0.1 mg/m3 to 0.3 mg/m3 and
respiratory protection was regularly
used. In Reading, where in 2000–2001
airborne exposures in all jobs were
reduced to a median of 0.1 mg/m3 or
below (measured as an 8-hour TWA)
and dermal protection was required for
production-area workers, two (5.4
percent) of 37 newly hired workers
became sensitized (Thomas et al., 2009).
After the process with the highest
exposures (median of 0.1 mg/m3) was
enclosed in 2002 and workers in that
process were required to use respiratory
protection, the remaining jobs had very
low exposures (medians ∼ 0.03 mg/m3).
Among 45 workers hired after the
enclosure, one was found to be
sensitized (2.2 percent). In Elmore,
where all workers were required to wear
respirators and skin PPE in production
areas beginning in 2000–2001, the
estimated prevalence of sensitization
among workers hired after these
measures were put in place was around
2–3 percent (Bailey et al., 2010). In
addition, Schuler et al. (2012) found no
cases of sensitization among short-term
Elmore workers employed in 1999 who
had total mass LTW average exposures
below 0.09 mg/m3, among workers with
total mass cumulative exposures below
0.08 mg/m3-yr, or among workers with
total mass highest job worked exposures
below 0.12 mg/m3.
Madl et al. reported one case of
sensitization among workers at the
Cullman plant hired after 2000. The
median personal exposures were about
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47630
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
0.1 mg/m3 or below for all jobs during
this period. Several changes in the
facility’s exposure control methods were
instituted in the late 1990s that were
likely to have reduced dermal as well as
respiratory exposure to beryllium. For
example, the plant installed change/
locker rooms for workers entering the
production facility, instituted
requirements for work uniforms and
dedicated work shoes for production
workers, implemented annual beryllium
hazard awareness training that
encouraged glove use, and purchased
high efficiency particulate air (HEPA)
filter vacuum cleaners for workplace
cleanup and decontamination.
The results of the Reading, Tucson,
and Elmore studies show that reducing
airborne exposures to below 0.1 mg/m3
and protecting workers from dermal
exposure, in combination, have
achieved a substantial reduction in
sensitization risk among newly-hired
workers. Because respirator use, dermal
protection, and engineering changes
were often implemented concurrently at
these plants, it is difficult to attribute
the reduced risk to any single control
measure. The reduction is particularly
evident when comparing newly-hired
workers in the most recent Reading
screenings (2.2–5.4 percent), and the
rate of sensitization found among
workers hired within the year before the
2000 screening (13 percent). There is a
similarly striking difference between the
rate of prevalence found among newlyhired workers in the most recent Tucson
study (1 percent) and the rate found
among workers hired within the year
before the 1998 screening at that plant
(16 percent). These results are echoed in
the Cullman facility, which combined
engineering controls to reduce airborne
exposures to below 0.1 mg/m3 with
measures such as housekeeping
improvements and worker training to
reduce dermal exposure.
The studies on recent programs to
reduce workers’ risk of sensitization and
CBD were conducted on populations
with very short exposure and follow-up
time. Therefore, they could not address
the question of how frequently workers
who become sensitized in environments
with extremely low airborne exposures
(median <0.1 mg/m3) develop CBD.
Clinical evaluation for CBD was not
reported for sensitized workers
identified in the most recent Tucson,
Reading, and Elmore studies. In
Cullman, however, two of the workers
with CBD had been employed for less
than a year and worked in jobs with
very low exposures (median 8-hour
personal sample values of 0.03–0.09 mg/
m3). The body of scientific literature on
occupational beryllium disease also
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
includes case reports of workers with
CBD who are known or believed to have
experienced minimal beryllium
exposure, such as a worker employed
only in shipping at a copper-beryllium
distribution center (Stanton et al., 2006),
and workers employed only in
administration at a beryllium ceramics
facility (Kreiss et al., 1996).
Arjomandi et al. published a study of
50 sensitized workers from a nuclear
weapons research and development
facility (Arjomandi et al., 2010).
Occupational and medical histories
including physical examination and
chest imaging were available for the
great majority (49) of these individuals.
Forty underwent testing for CBD via
bronchoscopy and transbronchial
biopsies. In contrast to the studies of
low-exposure populations discussed
previously, this group had much longer
follow-up time (mean time since first
exposure = 32 years) and length of
employment at the facility (mean of 18
years). Quantitative exposure estimates
for the workers were not presented;
however, the authors characterized their
probable exposures as ‘‘low’’ (13
workers), ‘‘moderate’’ (28 workers), or
‘‘high’’ (nine workers) based on the jobs
they performed at the facility.
Five of the 50 sensitized workers (10
percent) were diagnosed with CBD
based on histology or high-resolution
computed tomography. An additional
three (who had not undergone full
clinical evaluation for CBD) were
identified as probable CBD cases,
bringing the total prevalence of CBD and
probable CBD in this group to 16
percent. As discussed in the
epidemiology section of the Health
Effects chapter, the prevalence of CBD
among worker populations regularly
exposed at higher levels (e.g., median >
0.1 mg/m3) is typically much greater,
approaching 80–100% in several
studies. The lower prevalence of CBD in
this group of sensitized workers, who
were believed to have primarily low
exposure levels, suggests that
controlling respiratory exposure to
beryllium may reduce risk of CBD
among sensitized workers as well as
reducing risk of CBD via prevention of
sensitization. However, it also
demonstrates that some workers in lowexposure environments can become
sensitized and go on to develop CBD.
The next section discusses an additional
source of information on low-level
beryllium exposure and CBD: studies of
community-acquired CBD in residential
areas surrounding beryllium production
facilities.
PO 00000
Frm 00066
Fmt 4701
Sfmt 4702
C. Review of Community-Acquired CBD
Literature
The literature on community-acquired
chronic beryllium disease (CA–CBD)
documents cases of CBD among
individuals exposed to airborne
beryllium at concentrations below the
proposed PEL. OSHA notes that these
case studies do not provide information
on how frequently individuals exposed
to very low airborne levels develop CBD
and that reconstructed exposure
estimates for CA–CBD cases are less
reliable than exposure estimates for
working populations reviewed in the
previous sections. In addition, the
cumulative exposure that an
occupationally exposed person would
accrue at any given exposure
concentration is far less than would
typically accrue from long-term
environmental exposure. The literature
on CA–CBD thus has important
limitations and is not used as a basis for
quantitative risk assessment for CBD
from low-level beryllium exposure.
Nevertheless, these case reports and the
broader CA–CBD literature indicate that
individuals exposed to airborne
beryllium below the proposed PEL can
develop CBD.
Cases of CA–CBD were first reported
among residents of Lorain, OH, and
Reading, PA, who lived in the vicinity
of beryllium plants. More recently,
BeLPT screening has been used to
identify additional cases of CA–CBD in
Reading.
1. Lorain, OH
In 1948, the State of Ohio Department
of Public Health conducted an X-ray
program surveying more than 6,000
people who lived within 1.5 miles of a
Lorain beryllium plant (Eisenbud, 1949;
Eisenbud, 1982; Eisenbud, 1998). This
survey, together with a later review of
all reported cases of CBD in the area,
found 13 cases of CBD. All of the
residents who developed CBD lived
within 0.75 miles of the plant, and none
had occupational exposure or lived with
beryllium-exposed workers. Among the
population of 500 people living within
0.25 miles of the plant, seven residents
(1.4 percent) were diagnosed with CBD.
Five cases were diagnosed among
residents living between 0.25 and 0.5
miles from the plant, one case was
diagnosed among residents living
between 0.5 and 0.75 miles from the
plant, and no cases were found among
those living farther than 0.75 miles from
the plant (total populations not
reported) (Eisenbud, 1998).
Beginning in January 1948, air
sampling was conducted using a mobile
sampling station to measure
E:\FR\FM\07AUP2.SGM
07AUP2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
atmospheric beryllium downwind from
the plant. An approximate
concentration of 0.2 mg/m3 was
measured at 0.25 miles from the plant’s
exhaust stack, and concentrations
decreased with greater distance from the
plant, to 0.003 mg/m3 at a distance of 5
miles (Eisenbud, 1982). A 10-week
sampling program was conducted using
three fixed monitoring stations within
700 feet of the plant and one station
7,000 feet from the plant. Interpolating
the measurements collected at these
locations, Eisenbud and colleagues
estimated an average airborne beryllium
concentration of between 0.004 and 0.02
mg/m3 at a distance of 0.75 miles from
the plant. Accounting for the possibility
that previous exposures may have been
higher due to production level
fluctuations and greater use of rooftop
emissions, they concluded that the
lowest airborne beryllium level
associated with CA–CBD in this
community was somewhere between
0.01 mg/m3 and 0.1 mg/m3 (Eisenbud,
1982).
2. Reading, PA
Thirty-two cases of CA–CBD were
reported in a series of papers published
in 1959–1969 concerning a beryllium
refinery in Reading (Lieben and
Metzner, 1959; Metzner and Lieben,
1961; Dattoli et al., 1964; Lieben and
Williams, 1969). The plant, which
opened in 1935, manufactured
beryllium oxide, alloys and metal, and
beryllium tools and metal products
(Maier et al., 2008; Sanderson et al.,
2001b). In a follow-up study, Maier et
al. presented eight additional cases of
CA–CBD who had lived within 1.5
miles of the plant (Maier et al., 2008).
Individuals with a history of
occupational beryllium exposure and
those who had resided with
occupationally exposed workers were
not classified as having CA–CBD.
The Pennsylvania Department of
Health conducted extensive
environmental sampling in the area of
the plant beginning in 1958. Based on
samples collected in 1958, Maier et al.
stated that most cases identified in their
study would typically have been
exposed to airborne beryllium at levels
between 0.0155 and 0.028 mg/m3 on
average, with the potential for some
excursions over 0.35 mg/m3 (Maier et al
2008, p. 1015). To characterize
exposures to cases identified in the
earlier publications, Lieben and
Williams cited a sampling program
conducted by the Department of Health
between January and July 1962, using
nine sampling stations located between
0.2 and 4.8 miles from the plant. They
reported that 72 percent of 24-hour
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
samples collected were below 0.01 mg/
m3. Of samples that exceeded 0.01 mg/
m3, most were collected at close
proximity to the plant (e.g., 0.2 miles
from the plant).
In the early series of publications,
cases of CA–CBD were reported among
people living both close to the plant
(Maier et al., 2008; Dutra, 1948) and up
to several miles away. Of new cases
identified in the 1968 update, all lived
between 3 and 7.5 miles from the plant.
Lieben and Williams suggested that
some cases of CA–CBD found among
more distant residents might have
resulted from working or visiting a
graveyard closer to the plant (Lieben
and Williams, 1969). For example, a
milkman who developed CA–CBD had a
route in the neighborhood of the plant.
Another resident with CA–CBD had
worked as a cleaning woman in the area
of the plant, and a third worked within
a half-mile of the plant.
At the time of the final follow-up
study (1968), 11 residents diagnosed
with CA–CBD were alive and 21 were
deceased. Among those who had died,
berylliosis was listed as the cause of
death for three, including a 10-year-old
girl and two women in their sixties.
Fibrosis, granuloma or granulomatosis,
and chronic or fibrous pneumonitis
were listed as the cause of death for
eight more of those deceased. Histologic
evidence of CBD was reported for nine
of 12 deceased individuals who had
been evaluated for it. In addition to
showing radiologic abnormalities
associated with CBD, all living cases
were dyspneic.
Following the 1969 publication by
Liebman and Williams, no additional
CA–CBD cases were reported in the
Reading area until 1999, when a new
case was diagnosed. The individual was
a 72-year-old woman who had had
abnormal chest x-rays for the previous
six years (Maier et al., 2008). After the
diagnosis of this case, Maier et al.
reviewed medical records and/or
performed medical evaluations,
including BeLPT results for 16
community residents who were referred
by family members or an attorney.
Among those referred, eight cases of
definite or probable CBD were identified
between 1999 and 2002. All eight were
women who lived between 0.1 and 1.05
miles from the plant, beginning between
1943–1953 and ending between 1956–
2001. Five of the women were
considered definite cases of CA–CBD,
based on an abnormal blood or lavage
cell BeLPT and granulomatous
inflammation on lung biopsy. Three
probable cases of CA–CBD were
identified. One had an abnormal BeLPT
and radiography consistent with CBD,
PO 00000
Frm 00067
Fmt 4701
Sfmt 4702
47631
but granulomatous disease was not
pathologically proven. Two met
Beryllium Case Registry epidemiologic
criteria for CBD based on radiography,
pathology and a clinical course
consistent with CBD, but both died
before they could be tested for beryllium
sensitization. One of the probable cases,
who could not be definitively diagnosed
with CBD because she died before she
could be tested, was the mother of both
a definite case and the probable case
who had an abnormal BeLPT but did
not show granulomatous disease.
The individuals with CA–CBD
identified in this study suffered
significant health impacts from the
disease, including obstructive,
restrictive, and gas exchange pulmonary
defects in the majority of cases. All but
two had abnormal pulmonary
physiology. Those two were evaluated
at early stages of disease following their
mother’s diagnosis. Six of the eight
women required treatment with
prednisone, a step typically reserved for
severe cases due to the adverse side
effects of steroid treatment. Despite
treatment, three had died of respiratory
impairment from CBD as of 2002 (Maier
et al., 2008). The authors concluded that
‘‘low levels of exposures with
significant disease latency can result in
significant morbidity and mortality’’
(id., p. 1017).
OSHA notes that compared with the
occupational studies discussed in the
previous section, there is comparatively
sparse information on exposure levels of
Lorain and Reading residents. There
remains the possibility that some
individuals with CA–CBD may have had
higher exposures than were known and
reported in these studies, or have had
unreported exposure to beryllium dust
via contact with beryllium-exposed
workers. Nevertheless, the studies
conducted in Lorain and Reading
demonstrate that long-term exposure to
the apparent low levels of airborne
beryllium, with sufficient disease
latency, can lead to serious or fatal CBD.
Genetic susceptibility may play a role in
cases of CBD among individuals with
very low or infrequent exposures to
beryllium. The role of genetic
susceptibility in the CBD disease
process is discussed in detail in section
V.D.3.
D. Exposure-Response Literature on
Beryllium Sensitization and CBD
To further examine the relationship
between exposure level and risk of both
sensitization and disease, we next
review exposure-response studies in the
CBD literature. Many publications have
reported that exposure levels correlate
with risk, including a small number of
E:\FR\FM\07AUP2.SGM
07AUP2
47632
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
exposure-response analyses. Most of
these studies examined the association
between job-specific beryllium air
measurements and prevalence of
sensitization and CBD. This section
focuses on studies at three facilities that
included a more rigorous historical
reconstruction of individual worker
exposures in their exposure-response
analyses.
1. Rocky Flats, CO, Facility
In 2000, Viet et al. published a casecontrol study of participants in the
Rocky Flats Beryllium Health
Surveillance Program (BHSP), which
was established in 1991 to screen
workers at the Department of Energy’s
Rocky Flats, CO, nuclear weapons
facility for beryllium sensitization and
evaluate sensitized workers for CBD
(Viet et al., 2000). The program, which
at the time of publication had tested
over 5,000 current and former Rocky
Flats employees, had identified a total
of 127 sensitized individuals as of 1994
when Viet et al. initiated their study.
Workers were considered sensitized if
two BeLPT results were positive, either
from two blood draws or from a single
blood draw analyzed by two different
laboratories. All sensitized individuals
were offered clinical evaluation, and 51
were diagnosed with CBD based on
positive lung LPT and evidence of
noncaseating granulomas upon lung
biopsy. The number of sensitized
individuals who declined clinical
evaluation was not reported. Two cases,
one with CBD and one who was
sensitized but not diagnosed with CBD,
were excluded from the case-control
analysis due to reported or potential
prior beryllium exposure at a ceramics
plant. Another sensitized individual
who had not been diagnosed with CBD
was excluded because she could not be
matched by the study’s criteria to a nonsensitized control within the BHSP
database. Viet et al. matched a total of
50 CBD cases to 50 controls who were
negative on the BeLPT and had the same
age (± 3 years), gender, race and
smoking status, and were otherwise
randomly selected from the database.
Using the same matching criteria, 74
sensitized workers who were not
diagnosed with CBD were age-, gender, race-, and smoking status-matched to
74 control individuals who tested
negative by the BeLPT from the BHSP
database.
Viet et al. developed exposure
estimates for the cases and controls
based on daily beryllium air samples
collected in one of 36 buildings where
beryllium was used at Rocky Flats, the
Building 444 Beryllium Machine Shop.
Over half of the approximately 500,000
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
industrial hygiene samples collected at
Rocky Flats were taken from this
building. Air monitoring in other
buildings was reported to be limited and
inconsistent and, thus, not utilized in
the exposure assessment. The sampling
data used to develop worker exposure
estimates were exclusively Building 444
fixed airhead (FAH) area samples
collected at permanent fixtures placed
around beryllium work areas and
machinery.
Exposure estimates for jobs in
Building 444 were constructed for the
years 1960–1988 from this database.
Viet et al. worked with Rocky Flats
industrial hygienists and staff to assign
a ‘‘building area factor’’ (BAF) to each
of the other buildings, indicating the
likely level of exposure in a building
relative to exposures in Building 444.
Industrial hygienists and staff similarly
assigned a job factor (JF) to all jobs,
representing the likely level of
beryllium exposure relative to the levels
experienced by beryllium machinists. A
JF of 1 indicated the lowest exposures,
and a JF of 10 indicated the highest
exposures. For example, administrative
work and vehicle operation were
assigned a JF of 1, while machining,
mill operation, and metallurgical
operation were each assigned a JF of 10.
Estimated FAH values for each
combination of job, building and year in
the study subjects’ work histories were
generated by multiplying together the
job and building factors and the mean
annual FAH exposure level. Using data
collected by questionnaire from each
BHSP participant, Viet et al.
reconstructed work histories for each
case and control, including job title and
building location in each year of their
employment at Rocky Flats. These work
histories and the estimated FAH values
were used to generate a cumulative
exposure estimate (CEE) for each case
and control in the study. A long-term
mean exposure estimate (MEE) was
generated by dividing each CEE by the
individual’s number of years employed
at Rocky Flats.
Viet et al.’s statistical analysis of the
resulting data set included conditional
logistic regression analysis, modeling
the relationship between risk of each
health outcome and log-transformed
CEE and MEE. They found highly
statistically significant relationships
between log-CEE and risk of CBD (coef
= 0.837, p = 0.0006) and between logMEE (coef = 0.855, p = 0.0012) and risk
of CBD, indicating that risk of CBD
increases with exposure level. These
coefficients correspond to odds ratios of
6.9 and 7.2 per 10-fold increase in
exposure, respectively. Risk of
sensitization without CBD did not show
PO 00000
Frm 00068
Fmt 4701
Sfmt 4702
a statistically significant relationship
with log-CEE (coef = 0.111, p = 0.32),
but showed a nearly-significant
relationship with log-MEE (coef = 0.230,
p = 0.097).
2. Cullman, AL, Facility
The Cullman, AL, precision
machining facility discussed previously
was the subject of a case-control study
published by Kelleher et al. in 2001.
After the diagnosis of an index case of
CBD at the plant in 1995, NJMRC
researchers worked with the plant to
conduct a medical surveillance program
using the BeLPT to screen workers
biennially for beryllium sensitization
and CBD. Of 235 employees screened
between 1995 and 1999, 22 (9.4 percent)
were found to be sensitized, including
13 diagnosed with CBD (Newman et al.,
2001). Concurrently, research was
underway by Martyny et al. to
characterize the particle size
distribution of beryllium exposures
generated by processes at this plant
(Martyny et al., 2000). The exposure
research showed that the machining
operations during this time period
generated respirable particles (10 mm or
less) at the worker breathing zone that
made up greater than 50 percent of the
beryllium mass. Kelleher et al. used the
dataset of 100 personal lapel samples
collected by Martyny et al. and other
NJMRC researchers in 1996, 1997, and
1999 to characterize exposures for each
job in the plant. Following a statistical
analysis comparing the samples
collected by NJMRC with earlier
samples collected at the plant, Kelleher
et al. concluded that the 1996–1999 data
could be used to represent job-specific
exposures from earlier periods.
Detailed work history information
gathered from plant data and worker
interviews was used in combination
with job exposure estimates to
characterize cumulative and LTW
average beryllium exposures for workers
in the surveillance program. In addition
to cumulative and LTW exposure
estimates based the total mass of
beryllium reported in their exposure
samples, Kelleher et al. calculated
cumulative and LTW estimates based
specifically on exposure to particles < 6
mm and particles < 1 mm in diameter.
To analyze the relationship between
exposure level and risk of sensitization
and CBD, Kelleher et al. performed a
case-control analysis using measures of
both total beryllium exposure and
particle size-fractionated exposure. The
analysis included sensitization cases
identified in the 1995–1999 surveillance
and 206 controls from the group of 215
non-sensitized workers. For nine
workers, the researchers could not
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
reconstruct complete job histories.
Logistic regression models using
categorical exposure variables showed
positive associations between risk of
sensitization and the six exposure
measures tested: Total CEE, total MEE,
and variations of CEE and MEE
constructed based on particles < 6 mm
and < 1 mm in diameter. None of the
associations were statistically
significant (p < 0.05); however, the
authors noted that the dataset was
relatively small, with limited power to
detect a statistically significant
exposure-response relationship.
Although the Viet et al. and Kelleher
et al. exposure-response analyses
provide valuable insight into exposureresponse for beryllium sensitization and
CBD, both studies have limitations that
affect their suitability as a basis for
quantitative risk assessment. Their
limitations primarily involve the
exposure data used to estimate workers’
exposures. Viet et al.’s exposure
reconstruction was based on area
samples from a single building within a
large, multi-building facility. Where
possible, OSHA prefers to base risk
estimates on exposure data collected in
the breathing zone of workers rather
than area samples, because data
collected in the breathing zone more
accurately represent workers’ exposures.
Kelleher’s analysis, on the other hand,
was based on personal lapel samples.
However, the samples Kelleher et al.
used were collected between 1996 and
1999, after the facility had initiated new
exposure control measures in response
to the diagnosis of a case of CBD in
1995. OSHA believes that industrial
hygiene samples collected at the
Cullman plant prior to 1996 better
characterize exposures prior to the new
exposure controls. In addition, since the
publication of the Kelleher study, the
population has continued to be screened
for sensitization and CBD. Data
collected on workers hired in 2000 and
later, after most exposure controls had
been completed, can be used to
characterize risk at lower levels of
exposure than have been examined in
many previous studies.
To better characterize the relationship
between exposure level and risk of
sensitization and CBD, OSHA
developed an independent exposureresponse analysis based on a dataset
maintained by NJMRC on workers at the
Cullman, AL, machining plant. The
dataset includes exposure samples
collected between 1980 and 2005, and
has updated work history and screening
information for several hundred workers
through 2003. OSHA’s analysis of the
NJMRC data set is presented in the next
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
47633
elevated for average (OR 1.37) and
highest job (OR 1.32). Among the
submicron exposure estimates, only
3. Elmore, OH, Facility
highest job (OR 1.24) had a 95 percent
After OSHA completed its analysis of CI that just included unity for
the NJMRC data set, Schuler et al. (2012) sensitization. For CBD, elevated odds
published a study examining beryllium
ratios were observed only for the
sensitization and CBD among 264 short- cumulative exposure estimates and were
term workers employed at the
similar for total mass and respirable
previously described Elmore, OH plant
exposure (total mass OR 1.66, respirable
in 1999. The analysis used a high(OR 1.68). Cumulative submicron
quality exposure reconstruction by Virji exposure showed an elevated,
et al. (2012) and presented a regression
borderline significant odds ratio (OR
analysis of the relationship between
1.58). The odds ratios for average
beryllium exposure levels and beryllium exposure and highest-exposed job were
sensitization and CBD in the short-term
not statistically significantly elevated.
worker population. By including only
Schuler et al. concluded that both total
short-term workers, Virji et al. were able and respirable mass concentrations of
to construct participants’ exposures
beryllium exposure were relevant
with more precision than was possible
predictors of risk for beryllium
in studies involving workers exposed
sensitization and CBD.
for longer durations and in time periods
E. OSHA’s Exposure-Response Analysis
with less exposure sampling. In
OSHA evaluated exposure and health
addition, the focus on short-term
outcome data on a population of
workers allowed more precise
workers employed at the Cullman
knowledge of when sensitization and
CBD occurred than had been the case for machining facility. NJMRC researchers,
with consent and information provided
previously published cross-sectional
by the facility, compiled a dataset
studies of long-term workers. Each
containing employee work histories,
participant completed a work history
medical diagnoses, and air sampling
questionnaire and was tested for
results and provided it to OSHA for
beryllium sensitization, and sensitized
workers were offered further evaluation analysis. OSHA’s contractors from
Eastern Research Group (ERG) gathered
for CBD. The overall prevalence of
additional information from (1) two
sensitization was 9.8 percent (26/264).
surveys of the Cullman plant conducted
Twenty-two sensitized workers
consented to clinical testing for CBD via by OSHA’s contractor (ERG, 2003 and
ERG, 2004a), (2) published articles of
transbronchial biopsy. Six of those
investigations conducted at the plant by
sensitized were diagnosed with CBD
researchers from NJMRC (Kelleher et al.,
(2.3 percent, 6/264).
Schuler et al. (2012) used logistic
2001; Madl et al., 2007; Martyny et al.,
regression to explore the relationship
2000; and Newman et al., 2001), (3) a
between estimated beryllium exposure
case file from a 1980 OSHA complaint
and sensitization and CBD, using
inspection at the plant, (4) comments
estimates of total, respirable, and
submitted to the OSHA docket office in
submicron mass concentrations.
1976 and 1977 by representatives of the
Exposure estimates were constructed
metal machining plant regarding their
using two exposure surveys conducted
beryllium control program, and (5)
in 1999: a survey of total mass
personal communications with the
exposures (4,022 full-shift personal
plant’s current industrial hygienist
samples) and a survey of size-separated
(ERG, 2009b) and an industrial hygiene
impactor samples (198 samples). The
researcher at NJMRC (ERG, 2009a).
1999 exposure surveys and work
1. Plant Operations
histories were used to estimate longThe Cullman plant is a leading
term lifetime weighted (LTW) average,
fabricator of precision-machined and
cumulative, and highest-job-worked
processed materials including beryllium
exposure for total, respirable, and
and its alloys, titanium, aluminum,
submicron beryllium mass
quartz, and glass (ERG, 2009b). The
concentrations.
plant has approximately 210 machines,
For beryllium sensitization, logistic
primarily mills and lathes, and
models showed elevated odds ratios for
processes large quantities of beryllium
average (OR 1.48) and highest job (OR
on an annual basis. The plant provides
1.37) exposure for total mass exposure;
complete fabrication services including
the OR for cumulative exposure was
ultra-precision machining; ancillary
smaller (OR 1.23) and borderline
processing (brazing, ion milling, photo
statistically significant (95 percent CI
etching, precision cleaning, heat
barely included unity). Relationships
treating, stress relief, thermal cycling,
between sensitization and respirable
mechanical assembly, and chemical
exposure estimates were similarly
section, E. OSHA’s Exposure-Response
Analysis.
PO 00000
Frm 00069
Fmt 4701
Sfmt 4702
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47634
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
milling/etching); and coatings (plasma
spray, anodizing, chromate conversion
coating, nickel sulfamate plate, nickel
plate, gold plate, black nickel plate,
copper plate/strike, passivation, and
painting). Most of the plant’s beryllium
operations involve machining beryllium
metal and high beryllium content
composite materials (beryllium metal/
beryllium oxide metal composites called
E-Metal or E-Material), with occasional
machining of beryllium oxide/metal
matrix (such as AlBeMet, aluminum
beryllium matrix) and berylliumcontaining alloys. E-Materials such as
E–20 and E–60 are currently processed
in the E-Cell department.
The 120,000 square-foot plant has two
main work areas: a front office area and
a large, open production shop.
Operations in the production shop
include inspection of materials,
machining, polishing, and quality
assurance. The front office is physically
separated from the production shop.
Office workers enter through the front of
the facility and have access to the
production shop through a change room
where they must don laboratory coats
and shoe covers to enter the production
area. Production workers enter the shop
area at the rear of the facility where a
change/locker room is available to
change into company uniforms and
work shoes. Support operations are
located in separate areas adjacent to the
production shop and include
management and administration, sales,
engineering, shipping and receiving,
and maintenance. Management and
administrative personnel include two
groups: those primarily working in the
front offices (front office management)
and those primarily working on the
shop floor (shop management).
In 1974, the company moved its
precision machining operations to the
plant’s current location in Cullman.
Workplace exposure controls reportedly
did not change much until the diagnosis
of an index case of CBD in 1995. Prior
to 1995, exposure controls for
machining operations primarily
included a low volume/high velocity
(LVHV) central exhaust system with
operator-adjusted exhaust pickups and
wet machining methods. Protective
clothing, gloves, and respiratory
protection were not required. After the
diagnosis, the facility established an inhouse target exposure level of 0.2 mg/m3,
installed change/locker rooms for
workers entering the production facility,
eliminated pressurized air hoses,
discouraged the use of dry sweeping,
initiated biennial medical surveillance
using the BeLPT, and implemented
annual beryllium hazard awareness
training.
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
In 1996, the company instituted
requirements for work uniforms and
dedicated work shoes for production
workers, eliminated dry sweeping in all
departments, and purchased highefficiency particulate air (HEPA) filter
vacuum cleaners for workplace cleanup
and decontamination. Major engineering
changes were also initiated in 1996,
including the purchase of a new local
exhaust ventilation (LEV) system to
exhaust machining operations
producing finer aerosols (e.g., dust and
fume versus metal chips). The facility
also began installing mist eliminators
for each machine. Departments affected
by these changes included cutter grind
(tool and die), E-cell, electrical
discharge machining (EDM), flow lines,
grind, lapping, and optics. Dry
machining operations producing chips
were exhausted using the existing LVHV
exhaust system (ERG, 2004a). In the
course of making the ventilation system
changes, old ductwork and baghouses
were dismantled and new ductwork and
air cleaning devices were installed. The
company also installed Plexiglas
enclosures on machining operations in
1996–1997, including the lapping,
deburring, grinding, EDM, and tool and
die operations. In 1998, LEV was
installed in EDM and modified in the
lap, deburr, and grind departments.
Most exposure controls were
reportedly in place by 2000 (ERG,
2009a). In 2004, the plant industrial
hygienist reported that all machines had
LEV and about 65 percent were also
enclosed with either partial or full
enclosures to control the escape of
machining coolant (ERG, 2004b). Over
time, the facility has built enclosures for
operations that consistently produce
exposures greater than 0.2 mg/m3. The
company has never required workers to
use gloves or other PPE.
2. Air Sampling Database and Job
Exposure Matrix (JEM)
The NJMRC dataset includes
industrial hygiene sampling results
collected by the plant (1980–1984 and
1995–2005) and NJMRC researchers
(June 1996 to February 1997 and
September 1999), including 4,370
breathing zone (personal lapel) samples
and 712 area samples (ERG, 2004b).
Limited air sampling data is available
before 1980 and no exposure data
appears to be available for the 10-year
time period 1985 through 1994. A
review of the NJMRC air sampling
database from 1995 through 2005 shows
a significant increase in the number of
air samples collected beginning in 2000,
which the plant industrial hygienist
attributes to an increase in the number
of air sampling pumps (from 5 to 23)
PO 00000
Frm 00070
Fmt 4701
Sfmt 4702
and the purchase of an automated
atomic absorption spectrophotometer.
ERG used the personal breathing zone
sampling results contained in the
sample database to quantify exposure
levels for each year and for several-year
periods. Separate exposure statistics
were calculated for each job included in
the job history database. For each job
included in the job history database,
ERG estimated the arithmetic mean,
geometric mean, median, minimum,
maximum, and 95th percentile value for
the available exposure samples. Prior to
generating these statistics ERG made
several adjustments. After consultation
with researchers at NJMRC, four
particularly high exposures were
identified as probably erroneous and
excluded from calculations. In addition,
a 1996 sample for the HS (Health and
Safety) process was removed from the
sample calculations after ERG
determined it was for a non-employee
researcher visiting the facility.
Most samples in the sample database
for which sampling times were recorded
were long-term samples: 2,503 of the
2,557 (97.9 percent) breathing zone
samples with sampling time recorded
had times greater than or equal to 400
minutes. No adjustments were made for
sampling time, except in the case of four
samples for the ‘‘maintenance’’ process
for 1995. These results show relatively
high values and exceptionally short
sampling times consistent with the
nature of much maintenance work,
marked by short-term exposures and
periods of no exposure. The four 1995
maintenance samples were adjusted for
an eight-hour sampling time assuming
that the maintenance workers received
no further beryllium exposure over the
rest of their work shift.
OSHA examined the database for
trends in exposure by reviewing sample
statistics for individual years and
grouping years into four time periods
that correspond to stages in the plant’s
approach to beryllium exposure control.
These were: 1980–1995, a period of
relatively minimal control prior to the
1995 discovery of a case of CBD among
the plant’s workers; 1996–1997, a period
during which some major engineering
controls were in the process of being
installed on machining equipment;
1998–1999, a period during which most
engineering controls on the machining
equipment had been installed; and
2000–2003, a period when installation
of all exposure controls on machining
equipment was complete and exposures
very low throughout the plant. Table
VI–4 below summarized the available
data for each time period. As the four
probable sampling errors identified in
E:\FR\FM\07AUP2.SGM
07AUP2
47635
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
the original data set are excluded here,
arithmetic mean values are presented.
TABLE VI–4—EXPOSURE VALUES FOR MACHINING JOB TITLES, EXCLUDING PROBABLE SAMPLING ERRORS (μg/m3) IN
NJMRC DATA SET
1980–1995
1996–1997
1998–1999
2000–2003
Job title
Samples
Deburring .........................................................
Electrical Discharge Machining ........................
Grinding ............................................................
Lapping ............................................................
Lathe ................................................................
Milling ...............................................................
Reviewing the revised statistics for
individual years for different groupings,
OSHA noted that exposures in the
1996–1997 period were for some
machining jobs equivalent to, or even
higher than, exposure levels recording
during the 1980–1995 period. During
Mean
27
2
12
9
18
43
Samples
1.17
0.06
3.07
0.15
0.88
0.64
Mean
19
2
6
16
8
15
Samples
1.29
1.32
0.49
0.24
1.13
0.23
Mean
0
16
15
42
40
95
NA
0.08
0.24
0.21
0.17
0.17
Samples
Mean
67
63
68
103
200
434
0.1
0.1
0.1
0.1
0.1
0.1
These include jobs such as
administrative work, health and safety,
inspection, toolmaking (‘Tool’ and
‘Cgrind’), and others. A description of
jobs by title is available in the risk
assessment background document.
1996–1997, major engineering controls
were being installed, but exposure
levels were not yet consistently
reduced.
Table VI–5 below summarizes
exposures for the four time periods in
jobs other than beryllium machining.
TABLE VI–5—EXPOSURE VALUES FOR NON-MACHINING JOB TITLES (μg/m3) IN NJMRC DATA SET
1980–1995
1996–1997
1998–1999
2000–2003
Job title
Samples
mean
Samples
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
0
0
0
1
0
0
1
0
0
0
0
0
4
0
0
1
1
0
3
0
FromTable VI–5, it is evident that
exposure samples are not available for
many non-machining jobs prior to 2000.
Where samples are available before
2000, sample numbers are small,
particularly prior to 1998. In jobs for
which exposure values are available in
1998–1999 and 2000–2003, exposures
appear either to decline from 1998–1999
to 2000–2003 (Assembly, Chem,
Inspection, Maintenance) or to be
roughly equivalent (Administration,
Cgrind, Engineering, Msupp, PCIC, and
Spec). Among the jobs with exposure
samples prior to 1998, most had very
few (1–5) samples, with the exception of
Ecell (13 samples in 1996–1997). Based
on this limited information, it appears
that exposures declined from the period
before the first dentification of a CBD
case to the period in which exposure
controls were introduced.
Because exposure results from 1996–
1997 were not found to be consistently
reduced in comparison to the 1985–
1995 period in primary machining jobs,
these two periods were grouped together
in the JEM. Exposure monitoring for
jobs other than the primary machining
operations were represented by a single
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
PO 00000
Frm 00071
0
0
0
0
1
13
0
0
0
0
0
0
1
0
0
0
0
0
0
0
Samples
Administration ..................................
Assembly .........................................
Cathode ...........................................
Cgrind ..............................................
Chem ...............................................
Ecell .................................................
Engineering ......................................
Flow Lines .......................................
Gas ..................................................
Glass ................................................
Health and Safety 8 ..........................
Inspection ........................................
Maintenance ....................................
Msupp ..............................................
Optics ...............................................
PCIC ................................................
Qroom ..............................................
Shop ................................................
Spec .................................................
Tool ..................................................
8 An exceptionally high result (0.845 mg/m3, not
shown in Table 5) for a 1996 sample for the HS
(Health and Safety) process was removed from the
sample calculations. OSHA’s contractor determined
this sample to be associated with a non-employee
researcher visiting the facility.
NA ..........
NA ..........
NA ..........
0.120 ......
NA ..........
NA ..........
0.065 ......
NA ..........
NA ..........
NA ..........
NA ..........
NA ..........
1.257 ......
NA ..........
NA ..........
0.040 ......
0.280 ......
NA ..........
0.247 ......
NA ..........
mean
Fmt 4701
NA ..........
NA ..........
NA ..........
NA ..........
0.529 ......
1.873 ......
NA ..........
NA ..........
NA ..........
NA ..........
NA ..........
NA ..........
0.160 ......
NA ..........
NA ..........
NA ..........
NA ..........
NA ..........
NA ..........
NA ..........
Sfmt 4702
39
8
0
14
21
0
49
0
0
0
0
32
16
47
0
13
0
4
24
0
mean
0.052 ......
0.136 ......
NA ..........
0.105 ......
0.277 ......
NA ..........
0.069 ......
NA ..........
NA ..........
NA ..........
NA ..........
0.101 ......
0.200 ......
0.094 ......
NA ..........
0.071 ......
NA ..........
0.060 ......
0.083 ......
NA ..........
Samples
74
2
9
76
91
26
125
113
121
38
5
150
70
68
41
42
2
0
19
1
mean
0.061
0.051
0.156
0.112
0.152
0.239
0.062
0.083
0.058
0.068
0.076
0.066
0.126
0.081
0.090
0.083
0.130
NA
0.087
0.070
mean exposure value for 1980–2003. As
respiratory protection was not routinely
used at the plant, there was no
adjustment for respiratory protection in
workers’ exposure estimates. The job
exposure matrix is presented in full in
the background document for the
quantitative risk assessment.
3. Worker Exposure Reconstruction
The work history database contains
job history records for 348 workers,
including start years, duration of
employment, and percentage of
worktime spent in each job. One
hundred ninety-eight of the workers had
been employed at some point in primary
machining jobs, including deburring,
E:\FR\FM\07AUP2.SGM
07AUP2
47636
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
EDM, grinding, lapping, lathing, and
milling. The remainder worked only in
non-primary machining jobs, such as
administration, engineering, quality
control, and shop management. The
total number of years worked at each job
are presented as integers, leaving some
uncertainty regarding the worker’s exact
start and end date at the job.
Based on these records and the JEM
described previously, ERG calculated
cumulative and average exposure
estimates for each worker in the
database. Cumulative exposure was
calculated as, Si ei t i, where e(i) is the
exposure level for job (i), and t(i) is the
time spent in job (i). Cumulative
exposure was divided by total exposure
time to estimate each worker’s long-term
average exposure. These exposures were
computed in a time-dependent manner
for the statistical modeling. For workers
with beryllium sensitization or CBD,
exposure estimates excluded exposures
following diagnosis.
Workers who were employed for long
time periods in jobs with low-level
exposures tend to have low average and
cumulative exposures due to the way
these measures are constructed,
incorporating the worker’s entire work
history. As discussed in the Health
Effects chapter, higher-level exposures
or short-term peak exposures such as
those encountered in machining jobs
may be highly relevant to risk of
sensitization. Unfortunately, because it
is not possible to continuously monitor
individuals’ beryllium exposure levels
and sensitization status, it is not known
exactly when workers became sensitized
or what their ‘‘true’’ peak exposures
leading up to sensitization were. Only a
rough approximation of the upper levels
of exposure a worker experienced is
possible. ERG constructed a third type
of exposure estimate reflecting the
exposure level associated with the
highest-exposure job (HEJ) and time
period experienced by each worker.
This exposure estimate (HEJ), the
cumulative exposure estimate, and the
average exposure were used in the
quartile analysis and statistical analyses.
4. Prevalence of Sensitization and CBD
In the database provided to OSHA,
seven workers were reported as
sensitized only. Sixteen workers were
listed as sensitized and diagnosed with
CBD upon initial clinical evaluation.
Three workers, first shown to be
sensitized only, were later diagnosed
with CBD. Tables VI–6, VI–7, and VI–8
below present the prevalence of
sensitization and CBD cases across
several categories of lifetime-weighted
(LTW) average, cumulative, and highestexposed job (HEJ) exposure. Exposure
values were grouped by quartile. Note
that all workers with CBD are also
sensitized. Thus, the columns ‘‘Total
Sensitized’’ and ‘‘Total %’’ refer to all
sensitized workers in the dataset,
including workers with and without a
diagnosis of CBD.
TABLE VI–6—PREVALENCE OF SENSITIZATION AND CBD BY LTW AVERAGE EXPOSURE QUARTILE IN NJMRC DATA SET
Average exposure (μg/m3)
Group size
Sensitized
only
Total
sensitized
CBD
Total %
CBD %
0.0–0.080 .................................................
0.081–0.18 ...............................................
0.19–0.51 .................................................
0.51–2.15 .................................................
91
73
77
78
1
2
0
4
1
4
6
8
2
6
6
12
2.2
8.2
7.8
15.4
1.0
5.5
7.8
10.3
Total ..................................................
319
7
19
26
8.2
6.0
TABLE VI–7—PREVALENCE OF SENSITIZATION AND CBD BY CUMULATIVE EXPOSURE QUARTILE IN NJMRC DATA SET
Cumulative exposure (μg/m3-yrs)
Group size
Sensitized
only
Total
sensitized
CBD
Total %
CBD %
0.0–0.147 .................................................
0.148–1.467 .............................................
1.468–7.008 .............................................
7.009–61.86 .............................................
81
79
79
80
2
0
3
2
2
2
8
7
4
2
11
9
4.9
2.5
13.9
11.3
2.5
2.5
8.0
8.8
Total ..................................................
319
7
19
26
8.2
6.0
TABLE VI–8—PREVALENCE OF SENSITIZATION AND CBD BY HIGHEST-EXPOSED JOB EXPOSURE QUARTILE IN NJMRC
DATA SET
HEJ exposure (μg/m3)
Group size
Sensitized
only
Total
sensitized
CBD
Total %
CBD %
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
0.0–0.086 .................................................
0.091–0.214 .............................................
0.387–0.691 .............................................
0.954–2.213 .............................................
86
81
76
76
1
1
2
3
0
6
9
4
1
7
11
7
1.2
8.6
14.5
9.2
0.0
7.4
11.8
5.3
Total ..................................................
319
7
19
26
8.2
6.0
Table VI–6 shows increasing
prevalence of total sensitization and
CBD with increasing LTW average
exposure, measured both as average and
cumulative exposure. The lowest
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
prevalence of sensitization and CBD was
observed among workers with average
exposure levels less than or equal to
0.08 mg/m3, where two sensitized
workers (2.2 percent) including one case
PO 00000
Frm 00072
Fmt 4701
Sfmt 4702
of CBD (1.0 percent) were found. The
sensitized worker in this category
without CBD had worked at the facility
as an inspector since 1972, one of the
lowest-exposed jobs at the plant.
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
Because the job was believed to have
very low exposures, it was not sampled
prior to 1998. Thus, estimates of
exposures in this job are based on data
from 1998–2003 only. It is possible that
exposures earlier in this worker’s
employment history were somewhat
higher than reflected in his estimated
average exposure. The worker diagnosed
with CBD in this group had been hired
in 1996 in production control, and had
an estimated average exposure of 0.08
mg/m3. He was diagnosed with CBD in
1997.
The second quartile of LTW average
exposure (0.081—0.18 mg/m3) shows a
marked rise in overall prevalence of
beryllium-related health effects, with six
workers sensitized (8.2 percent), of
whom four (5.5 percent) were diagnosed
with CBD. Among six sensitized
workers in the third quartile (0.19—0.50
mg/m3), all were diagnosed with CBD
(7.8 percent). Another increase in
prevalence is seen from the third to the
fourth quartile, with 12 cases of
sensitization (15.4 percent), including
eight (10.3 percent) diagnosed with
CBD.
The quartile analysis of cumulative
exposure also shows generally
increasing prevalence of sensitization
and CBD with increasing exposure. As
shown in Table VI–7, the lowest
prevalences of CBD and sensitization
are in the first two quartiles of
cumulative exposure (0.0–0.147 mg/m3yrs, 0.148–1.467 mg/m3-yrs). The upper
bound on this cumulative exposure
range, 1.467 mg/m3-yrs, is the
cumulative exposure that a worker
would have if exposed to beryllium at
a level of 0.03 mg/m3 for a working
lifetime of 45 years; 0.15 mg/m3 for ten
years; or 0.3 mg/m3 for five years.
A sharp increase in prevalence of
sensitization and CBD and total
sensitization occurs in the third quartile
(1.468–7.008 mg/m3-yrs), with roughly
similar levels of both in the highest
group (7.009–61.86 mg/m3-yrs).
Cumulative exposures in the third
quartile would be experienced by a
worker exposed for 45 years to levels
between 0.03 and 0.16 mg/m3, for 10
years to levels between 0.15 and 0.7 mg/
m3, or for five years to levels between
0.3 and 1.4 mg/m3.
When workers’ exposures from their
highest-exposed job are considered, the
exposure-response pattern is similar to
that for LTW average exposure in the
lower quartiles (Table VI–8). The lowest
prevalence is observed in the first
quartile (0.0–0.86 mg/m3), with sharply
rising prevalence from first to second
and second to third exposure quartiles.
The prevalence of sensitization and CBD
in the top quartile (0.954–2.213 mg/m3)
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
decreases relative to the third, with
levels similar to the overall prevalence
in the dataset. Many workers in the
highest exposure quartiles are long-time
employees, who were hired during the
early years of the shop when exposures
were highest. One possible explanation
for the drop in prevalence in the highest
exposure quartiles is that highlyexposed workers from early periods may
have developed CBD and left the plant
before sensitization testing began in
1995.
It is of some value to compare the
prevalence analysis of the Cullman
(NJMRC) data set with the results of the
Reading and Tucson studies discussed
previously. An exact comparison is not
possible, in part because the Reading
and Tucson exposure values are
associated with jobs and the NJMRC
values are estimates of lifetime weighted
average, cumulative, and highestexposed job (HEJ) exposures for
individuals in the data set.
Nevertheless, OSHA believes it is
possible to very roughly compare the
results of the Reading and Tucson
studies and the results of the NJMRC
prevalence analysis presented above. As
discussed in detail below, OSHA found
a general consistency between the
prevalence of sensitization and CBD in
the quartiles of average exposure in the
NJMRC data set and the prevalence of
sensitization and CBD at the Reading
and Tucson plants for similar exposure
values.
Personal lapel samples collected at
the Reading plant between 1995 and
2000 were relatively low overall
(median of 0.073 mg/m3), with higher
exposures (median of 0.149 mg/m3)
concentrated in the wire annealing and
pickling process (Schuler et al., 2005).
Exposures in the Reading plant in this
time period were similar to the secondquartile average (Table VI–6–0.081–0.18
mg/m3). The prevalence of sensitization
observed in the NJMRC second quartile
was 8.2 percent and appears roughly
consistent with the prevalence of
sensitization among Reading workers in
the mid-1990s (11.5 percent). The
reported prevalence of CBD (3.9
percent) among the Reading workforce
was also consistent with that observed
in the second NJMRC quartile (5.5
percent), After 2000, exposure controls
reduced exposures in most Reading jobs
to median levels below 0.03 mg/m3, with
a median value of 0.1 mg/m3 for the wire
annealing and pickling process. The
wire annealing and pickling process was
enclosed and stringent respirator and
skin protection requirements were
applied for workers in that area after
2002, essentially eliminating airborne
and dermal exposures for those workers.
PO 00000
Frm 00073
Fmt 4701
Sfmt 4702
47637
Thomas et al. (2009) reported that one
of 45 workers (2.2 percent) hired after
the enclosure in 2002 was confirmed as
sensitized, a value in line with the
sensitization prevalence observed in the
lowest quartiles of average exposure (2.2
percent, 0.0–0.08 mg/m3).
As with Reading, the prevalence of
sensitization observed at Tucson and in
the NJMRC data set are not exactly
comparable due to the different natures
of the exposure estimates. Nevertheless,
in a rough sense the results of the
Tucson study and the NJMRC
prevalence analysis appear similar. In
Tucson, a 1998 BeLPT screening
showed that 9.5 percent of workers
hired after 1992 were sensitized
(Henneberger et al., 2001). Personal fullshift exposure samples collected in
production jobs between 1994 and 1999
had a median of 0.2 mg/m3 (0.1 mg/m3
for non-production jobs). In the NJMRC
data set, a sensitization prevalence of
8.2 percent was seen among workers
with average exposures between 0.081
and 0.18 mg/m3. At the time of the 1998
screening, workers hired after 1992 had
a median one year since first beryllium
exposure and, therefore, CBD
prevalence was only 1.4 percent. This
prevalence is likely an underestimate
since CBD often requires more than a
year to develop. Longer-term workers at
the Tucson plant with a median 14
years since first beryllium exposure had
a 9.1 percent prevalence of CBD. There
was a 5.5 percent prevalence of CBD
among the entire workforce
(Henneberger et al., 2001). As with the
Reading plant employees, this reported
prevalence is reasonably consistent with
the 5.5 percent CBD prevalence
observed in the second NJMRC quartile.
Beginning in 1999, the Tucson facility
instituted strict requirements for
respiratory protection and other PPE,
essentially eliminating airborne and
dermal exposure for most workers. After
these requirements were put in place,
Cummings et al. (2007) reported only
one case of sensitization (1 percent;
associated with a PPE failure) among 97
workers hired between 2000 and 2004.
This appears roughly in line with the
sensitization prevalence of 2.2 percent
observed in the lowest quartiles of
average exposure (0.0–0.08 mg/m3) in
the NJMRC data set.
While the literature analysis
presented here shows a clear reduction
in risk with well-controlled airborne
exposures (≤ 0.1 mg/m3 on average) and
protection from dermal exposure, the
level of detail presented in the
published studies limits the Agency’s
ability to characterize risk at all the
alternate PELs OSHA is considering. To
better understand these risks, OSHA
E:\FR\FM\07AUP2.SGM
07AUP2
47638
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
used the NJMRC dataset to characterize
risk of sensitization and CBD among
workers exposed to each of the alternate
PELs under consideration in the
proposed beryllium rule.
F. OSHA’s Statistical Modeling
OSHA’s contractor performed a
complementary log-log proportional
hazards model using the NJMRC data
set. The proportional hazards model is
a generalization of logistic regression
that allows for time-dependent
exposures and differential time at risk.
The proportional hazards model
accounts for the fact that individuals in
the dataset are followed for different
amounts of time, and that their
exposures change over time. The
proportional hazards model provides
hazards ratios, which estimate the
relative risk of disease at a specified
time for someone with exposure level 1
compared to exposure level 2. To
perform this analysis, OSHA’s
contractor constructed exposure files
with time-dependent cumulative and
average exposures for each worker in
the data set in each year that a case of
sensitization or CBD was identified.
Workers were included in only those
years after they started working at the
plant and continued to be followed.
Sensitized cases were not included in
analysis of sensitization after the year in
which they were identified as being
sensitized, and CBD cases were not
included in analyses of CBD after the
year in which they were diagnosed with
CBD. Follow-up is censored after 2002
because work histories were deemed to
be less reliable after that date.
The results of the discrete
proportional hazards analyses are
summarized in Tables VI–9–12 below.
All coefficients used in the models are
displayed, including the exposure
coefficient, the model constant for
diagnosis in 1995, and additional
exposure-independent coefficients for
each succeeding year (1996–1999 for
sensitization and 1996–2002 for CBD) of
diagnosis that are fit in the discrete time
proportional hazards modeling
procedure. Model equations and
variables are explained more fully in the
companion risk assessment background
document.
Relative risk of sensitization increased
with cumulative exposure (p = 0.05). A
positive, but not statistically significant,
association was observed with LTW
average exposure (p = 0.09). The
association was much weaker for
exposure duration (p = 0.31), consistent
with the expected biological action of an
immune hypersensitivity response
where onset is believed to be more
dependent on the concentration of the
sensitizing agent at the target site rather
than the number of years of
occupational exposure. The association
was also much weaker for highestexposed job (HEJ) exposure (p = 0.3).
TABLE VI–9—PROPORTIONAL HAZARDS MODEL—CUMULATIVE EXPOSURE AND SENSITIZATION
Variable
Coefficient
Cumulative Exposure (μg/m3–yrs) ...............................
constant ........................................................................
1996 ..............................................................................
1997 ..............................................................................
1998 ..............................................................................
1999 ..............................................................................
0.031
¥3.48
¥1.49
¥0.29
¥1.56
¥1.57
95% Confidence interval
0.00 to 0.063 ................................................................
¥4.27 to ¥2.69 ...........................................................
¥3.04 to 0.06 ...............................................................
¥1.31 to 0.72 ...............................................................
¥3.11 to ¥0.01 ...........................................................
¥3.12 to ¥0.02 ...........................................................
P-value
0.05
<0.001
0.06
0.57
0.05
0.05
TABLE VI–10—PROPORTIONAL HAZARDS MODEL—LTW AVERAGE EXPOSURE AND SENSITIZATION
Variable
Coefficient
Average Exposure (μg/m3) ...........................................
constant ........................................................................
1996 ..............................................................................
1997 ..............................................................................
1998 ..............................................................................
1999 ..............................................................................
0.54
¥3.55
¥1.48
¥0.29
¥1.54
¥1.53
95% Confidence interval
¥0.09
¥4.42
¥3.03
¥1.31
¥3.09
¥3.08
to
to
to
to
to
to
1.17 ...............................................................
¥2.69 ...........................................................
0.07 ...............................................................
0.72 ...............................................................
0.01 ...............................................................
0.03 ...............................................................
P-value
0.09
<0.001
0.06
0.57
0.05
0.05
TABLE VI–11—PROPORTIONAL HAZARDS MODEL—EXPOSURE DURATION AND SENSITIZATION
Variable
Coefficient
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Exposure Duration (years) ...........................................
constant ........................................................................
1996 ..............................................................................
1997 ..............................................................................
1998 ..............................................................................
1999 ..............................................................................
0.03
¥3.55
¥1.48
¥0.30
¥1.59
¥1.62
95% Confidence interval
¥0.03
¥4.57
¥3.03
¥1.31
¥3.14
¥3.17
to
to
to
to
to
to
0.08 ...............................................................
¥2.53 ...........................................................
0.70 ...............................................................
0.72 ...............................................................
¥0.04 ...........................................................
¥0.72 ...........................................................
P-value
0.31
<0.001
0.06
0.57
0.05
0.04
TABLE VI–12—PROPORTIONAL HAZARDS MODEL—HEJ EXPOSURE AND SENSITIZATION
Variable
Coefficient
(μg/m3)
HEJ Exposure
.................................................
constant ........................................................................
1996 ..............................................................................
1997 ..............................................................................
1998 ..............................................................................
1999 ..............................................................................
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
PO 00000
Frm 00074
95% Confidence interval
0.31
¥3.42
¥1.49
¥0.31
¥1.59
¥1.60
¥0.27
¥4.27
¥3.04
¥1.33
¥3.14
¥3.15
Fmt 4701
Sfmt 4702
to
to
to
to
to
to
0.88 ...............................................................
¥2.56 ...........................................................
0.06 ...............................................................
0.70 ...............................................................
¥0.04 ...........................................................
¥0.05 ...........................................................
E:\FR\FM\07AUP2.SGM
07AUP2
P-value
0.30
<0.001
0.06
0.55
0.05
0.04
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
The proportional hazards models for
the CBD endpoint (Tables VI–13
through 16 below) showed positive
relationships with cumulative exposure
(p = 0.09) and duration of exposure (p
= 0.10). However, the association with
the cumulative exposure metric was not
as strong as that for sensitization,
47639
probably due to the smaller number of
CBD cases. LTW average exposure and
HEJ exposure were not closely related to
relative risk of CBD (p-values > 0.5).
TABLE VI–13—PROPORTIONAL HAZARDS MODEL—CUMULATIVE EXPOSURE AND CBD
Variable
Coefficient
Cumulative Exposure (μg/m3–yrs) ...............................
constant ........................................................................
1997 ..............................................................................
1998 ..............................................................................
1999 ..............................................................................
2002 ..............................................................................
0.03
¥3.77
¥0.59
¥2.01
¥0.63
¥2.13
95% Confidence interval
.00 to 0.07 ....................................................................
¥4.67 to ¥2.86 ...........................................................
¥1.86 to 0.68 ...............................................................
¥4.13 to 0.11 ...............................................................
¥1.90 to 0.64 ...............................................................
¥4.25 to ¥0.01 ...........................................................
P-value
0.09
<0.001
0.36
0.06
0.33
0.05
TABLE VI–14—PROPORTIONAL HAZARDS MODEL—LTW AVERAGE EXPOSURE AND CBD
Variable
Coefficient
(μg/m3)
Average Exposure
...........................................
constant ........................................................................
1997 ..............................................................................
1998 ..............................................................................
1999 ..............................................................................
2002 ..............................................................................
0.24
¥3.62
¥0.61
¥2.02
¥0.64
¥2.15
95% Confidence interval
¥0.59
¥4.60
¥1.87
¥4.14
¥1.92
¥4.28
to
to
to
to
to
to
1.06 ...............................................................
¥2.64 ...........................................................
0.66 ...............................................................
0.10 ...............................................................
0.63 ...............................................................
¥0.02 ...........................................................
P-value
0.58
<0.001
0.35
0.06
0.32
0.05
TABLE VI–15—PROPORTIONAL HAZARDS MODEL—EXPOSURE DURATION AND CBD
Variable
Coefficient
Exposure Duration (yrs) ...............................................
constant ........................................................................
1997 ..............................................................................
1998 ..............................................................................
1999 ..............................................................................
2002 ..............................................................................
0.05
¥4.18
¥0.53
¥2.01
¥0.67
¥2.22
95% Confidence interval
¥0.01 to 0.11 ...............................................................
¥5.40 to ¥2.96 ...........................................................
1.84 to 0.69 ..................................................................
¥4.13 to 0.11 ...............................................................
¥1.94 to 0.60 ...............................................................
¥4.34 to ¥0.10 ...........................................................
P-value
0.10
<0.001
0.38
0.06
0.30
0.04
TABLE VI–16—PROPORTIONAL HAZARDS MODEL—HEJ EXPOSURE AND CBD
Variable
Coefficient
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
HEJ Exposure (μg/m3) .................................................
constant ........................................................................
1997 ..............................................................................
1998 ..............................................................................
1999 ..............................................................................
2002 ..............................................................................
In addition to the models reported
above, comparable models were fit to
the upper 95 percent confidence
interval of the HEJ exposure; logtransformed cumulative exposure; logtransformed LTW average exposure; and
log-transformed HEJ exposure. Each of
these measures was positively but not
significantly associated with
sensitization.
OSHA used the proportional hazards
models based on cumulative exposure,
shown in Tables VI–9 and VI–13, to
derive quantitative risk estimates. Of the
metrics related to exposure level, the
cumulative exposure metric showed the
most consistent association with
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
0.03
¥3.49
¥0.62
¥2.05
¥0.68
¥2.21
95% Confidence interval
¥0.70
¥4.45
¥1.88
¥4.16
¥1.94
¥4.33
to
to
to
to
to
to
0.77 ...............................................................
¥2.53 ...........................................................
0.65 ...............................................................
0.07 ...............................................................
0.59 ...............................................................
¥0.09 ...........................................................
sensitization and CBD in these models.
Table VI–17 summarizes these risk
estimates for sensitization and the
corresponding 95 percent confidence
intervals separately for 1995 and 1999,
the years with the highest and lowest
baseline rates, respectively. The
estimated risks for CBD are presented in
VI–18. The expected number of cases is
based on the estimated conditional
probability of being a case in the given
year. The models provide time-specific
point estimates of risk for a worker with
any given exposure level, and the
corresponding interval is based on the
uncertainty in the exposure coefficient
PO 00000
Frm 00075
Fmt 4701
Sfmt 4702
P-value
0.93
<0.001
0.34
0.06
0.30
0.04
(i.e., the predicted values based on the
95 percent confidence limits for the
exposure coefficient).
Each estimate represents the number
of sensitized workers the model predicts
in a group of 1000 workers at risk
during the given year with an exposure
history at the specified level and
duration. For example, in the exposure
scenario where 1000 workers are
occupationally exposed to 2 mg/m3 for
10 years in 1995, the model predicts
that about 56 (55.7) workers would be
sensitized that year. The model for CBD
predicts that about 42 (41.9) workers
would be diagnosed with CBD that year.
E:\FR\FM\07AUP2.SGM
07AUP2
47640
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
TABLE VI–17a—PREDICTED CASES OF SENSITIZATION PER 1000 WORKERS EXPOSED AT CURRENT AND ALTERNATE
PELS BASED ON PROPORTIONAL HAZARDS MODEL, CUMULATIVE EXPOSURE METRIC, WITH CORRESPONDING INTERVAL BASED ON THE UNCERTAINTY IN THE EXPOSURE COEFFICIENT
[1995 Baseline]
Exposure duration
5 years
1995 Exposure level
(μg/m3)
Cumulative
(μg/m3-yrs)
2.0 ....................................
5.0
0.5 ....................................
2.5
0.2 ....................................
1.0
0.1 ....................................
cases/
1000
10.0
1.0 ....................................
10 years
0.5
μg/m3-yrs
41.1
30.3–56.2
35.3
30.3–41.3
32.7
30.3–35.4
31.3
30.3–32.3
30.8
30.3–31.3
20.0
10.0
5.0
2.0
1.0
20 years
cases/
1000
cases/
1000
μg/m3-yrs
55.7
30.3–102.9
41.1
30.3–56.2
35.3
30.3–41.3
32.2
30.3–34.3
31.3
30.3–32.3
45 years
40.0
101.0
30.3–318.1
55.7
30.3–102.9
41.1
30.3–56.2
34.3
30.3–38.9
32.2
30.3–34.3
20.0
10.0
4.0
2.0
cases/
1000
μg/m3-yrs
90.0
45.0
22.5
9.0
4.5
394.4
30.3–999.9
116.9
30.3–408.2
60.0
30.3–119.4
39.9
30.3–52.9
34.8
30.3–40.1
TABLE VI–17b—PREDICTED CASES OF SENSITIZATION PER 1000 WORKERS EXPOSED AT CURRENT AND ALTERNATE
PELS BASED ON PROPORTIONAL HAZARDS MODEL, CUMULATIVE EXPOSURE METRIC, WITH CORRESPONDING INTERVAL BASED ON THE UNCERTAINTY IN THE EXPOSURE COEFFICIENT
[1999 Baseline]
Exposure duration
1999 Exposure level
(μg/m3)
5 years
Cumulative
(μg/m3-yrs)
2.0 ....................................
5.0
0.5 ....................................
2.5
0.2 ....................................
1.0
0.1 ....................................
cases/
1000
10.0
1.0 ....................................
10 years
0.5
μg/m3-yrs
8.4
6.2–11.6
7.2
6.2–8.5
6.7
6.2–7.3
6.4
6.2–6.6
6.3
6.2–6.4
20 years
cases/
1000
20.0
10.0
5.0
2.0
1.0
cases/
1000
μg/m3-yrs
11.5
6.2–21.7
8.4
6.2–11.6
7.2
6.2–8.5
6.6
6.2–7.0
6.4
6.2–6.6
45 years
40.0
21.3
6.2–74.4
11.5
6.2–21.7
8.4
6.2–11.6
7.0
6.2–8.0
6.6
6.2–7.0
20.0
10.0
4.0
2.0
cases/
1000
μg/m3-yrs
90.0
45.0
22.5
9.0
4.5
96.3
6.2–835.4
24.8
6.2–100.5
12.4
6.2–25.3
8.2
6.2–10.9
7.1
6.2–8.2
TABLE VI–18a—PREDICTED NUMBER OF CASES OF CBD PER 1000 WORKERS EXPOSED AT CURRENT AND ALTERNATIVE
PELS BASED ON PROPORTIONAL HAZARDS MODEL, CUMULATIVE EXPOSURE METRIC, WITH CORRESPONDING INTERVAL BASED ON THE UNCERTAINTY IN THE EXPOSURE COEFFICIENT
[1995 baseline]
Exposure duration
5 years
1995 Exposure level
(μg/m3)
Cumulative
(μg/m3-yrs)
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
2.0 ....................................
10.0
1.0 ....................................
5.0
0.5 ....................................
2.5
0.2 ....................................
1.0
0.1 ....................................
0.5
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
10 years
Estimated
cases/1000
95% c.i.
μg/m3-yrs
30.9
22.8–44.0
26.6
22.8–31.7
24.6
22.8–26.9
23.5
22.8–24.3
23.1
22.8–23.6
PO 00000
Frm 00076
20.0
10.0
5.0
2.0
1.0
Fmt 4701
20 years
Estimated
cases/1000
95% c.i.
41.9
22.8–84.3
30.9
22.8–44.0
26.6
22.8–31.7
24.2
22.8–26.0
23.5
22.8–24.3
Sfmt 4702
μg/m3-yrs
Estimated
cases/1000
95% c.i.
40.0
20.0
10.0
4.0
2.0
E:\FR\FM\07AUP2.SGM
76.6
22.8–285.5
41.9
22.8–84.3
30.9
22.8–44.0
25.8
22.8–29.7
24.2
22.8–26.0
07AUP2
45 years
μg/m3-yrs
90.0
45.0
22.5
9.0
4.5
Estimated
cases/1000
95% c.i.
312.9
22.8–999.9
88.8
22.8–375.0
45.2
22.8–98.9
30.0
22.8–41.3
26.2
22.8–30.7
47641
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
TABLE VI–18b—PREDICTED NUMBER OF CASES OF CBD PER 1000 WORKERS EXPOSED AT CURRENT AND ALTERNATIVE
PELS BASED ON PROPORTIONAL HAZARDS MODEL, CUMULATIVE EXPOSURE METRIC, WITH CORRESPONDING INTERVAL BASED ON THE UNCERTAINTY IN THE EXPOSURE COEFFICIENT
[2002 baseline]
Exposure duration
5 years
2002 Exposure level
(μg/m3)
Cumulative
(μg/m3-yrs)
2.5
0.2 ....................................
1.0
0.1 ....................................
0.5
The statistical modeling analysis
predicts high risk of both sensitization
(96–394 cases per 1000, or 9.6–39.4
percent) and CBD (44–313 cases per
1000, or 4.4–31.3 percent) at the current
PEL of 2 mg/m3 for an exposure duration
of 45 years (90 mg/m3-yr). The predicted
risks of < 8.2–39.9 per 1000 (0.8–3.9
percent) cases of sensitization or 3.6 to
30.0 per 1000 (0.4–3 percent) cases of
CBD are substantially less for a 45-year
exposure at the proposed PEL, 0.2 mg/m3
(9 mg/m3-yr).
The model estimates are not directly
comparable to prevalence values
discussed in previous sections. They
assume a group without turnover and
are based on a comparison of unexposed
and hypothetically exposed workers at
specific points in time, whereas the
prevalence analysis simply reports the
percentage of workers at the Cullman
plant with sensitization or CBD in each
exposure category. Despite the difficulty
of direct comparison, the level of risk
seen in the prevalence analysis and
predicted in the modeling analysis
appear roughly similar at low
exposures. In the second quartile of
cumulative exposure (0.148–1.467 mg/
m3-yr), prevalence of sensitization and
CBD was 2.5 percent. This is roughly
congruent with the model predictions
for workers with cumulative exposures
between 0.5 and 1 mg/m3-yr: 6.3–31.3
cases of sensitization per 1000 workers
(0.6–3.1 percent) and 2.8 to 23.5 cases
of CBD per 1000 workers (0.28–2.4
percent). As discussed in the
background document for this analysis,
most workers in the data set had low
cumulative exposures (roughly half
below 1.5 mg/m3-years). It is difficult to
make any statement about the results at
higher levels, because there were few
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
μg/m3-yrs
3.7
2.7–5.3
3.2
2.7–3.8
3.0
2.7–3.2
2.8
2.7–2.9
2.8
2.7–2.8
5.0
0.5 ....................................
Estimated
cases/1000
95% c.i.
10.0
1.0 ....................................
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
2.0 ....................................
10 years
20.0
10.0
5.0
2.0
1.0
20 years
Estimated
cases/1000
95% c.i.
μg/m3-yrs
5.1
2.7–10.4
3.7
2.7–5.3
3.2
2.7–3.8
2.9
2.7–3.1
2.8
2.7–2.9
workers with high exposure levels and
the higher quartiles of cumulative
exposure include an extremely wide
range of exposures. For example, the
highest quartile of cumulative exposure
was 7.009–61.86 mg/m3-yr. This quartile,
which showed an 11.3 percent
prevalence of sensitization and 8.8
percent prevalence of CBD, includes the
cumulative exposure that a worker
exposed for 45 years at the proposed
PEL would experience (9 mg/m3-yr) near
its lower bound. Its upper bound
approaches the cumulative exposure
that a worker exposed for 45 years at the
current PEL would experience (90 mg/
m3-yr).
Due to limitations including the size
of the dataset, relatively limited
exposure data from the plant’s early
years, study size-related constraints on
the statistical analysis of the dataset,
and limited follow-up time on many
workers, OSHA must interpret the
model-based risk estimates presented in
Tables VI–17 and VI–18 with caution.
The Cullman study population is a
relatively small group and can support
only limited statistical analysis. For
example, its size precludes inclusion of
multiple covariates in the exposureresponse models or a two-stage
exposure-response analysis to model
both sensitization and the subsequent
development of CBD within the
subpopulation of sensitized workers.
The limited size of the Cullman dataset
is characteristic of studies on berylliumexposed workers in modern, lowexposure environments, which are
typically small-scale processing plants
(up to several hundred workers, up to
20–30 cases). However, these recent
studies also have important strengths:
They include workers hired after the
PO 00000
Frm 00077
Fmt 4701
Sfmt 4702
45 years
Estimated
cases/1000
95% c.i.
40.0
20.0
10.0
4.0
2.0
9.4
2.7–39.2
5.1
2.7–10.4
3.7
2.7–5.3
3.1
2.7–3.6
2.9
2.7–3.1
μg/m3-yrs
90.0
45.0
22.5
9.0
4.5
Estimated
cases/1000
95% c.i.
43.6
2.7–679.8
11.0
2.7–54.3
5.5
2.7–12.3
3.6
2.7–5.0
3.1
2.7–3.7
institution of stringent exposure
controls, and have extensive exposure
sampling using full-shift personal lapel
samples. In contrast, older studies of
larger populations tend to have higher
exposures, less exposure data, and
exposure data collected in short-term
samples or outside of workers’ breathing
zones.
Another limitation of the Cullman
dataset, which is common to recent lowexposure studies, is the short follow-up
time available for many of the workers.
While in some cases CBD has been
known to develop in short periods (< 2
years), it more typically develops over a
longer time period. Sensitization occurs
in a typically shorter time frame, but
new cases of sensitization have been
observed in workers exposed to
beryllium for many years. Because the
data set is limited to individuals then
working at the plant, the Cullman data
set cannot capture CBD occurring
among workers who retire or leave the
plant. OSHA expects that the dataset
does not fully represent the risk of
sensitization, and is likely to
particularly under-represent CBD among
workers exposed to beryllium at this
facility. The Agency believes the short
follow-up time to be a significant source
of uncertainty in the statistical analysis,
a factor likely to lead to underestimation
of risk in this population.
A common source of uncertainty in
quantitative risk assessment is the series
of choices made in the course of
statistical analysis, such as model type,
inclusion or exclusion of additional
explanatory variables, and the
assumption of linearity in exposureresponse. Sensitivity analyses and
statistical checks were conducted to test
the validity of the choices and
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47642
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
assumptions in the exposure-response
analysis and the impact of alternative
choices on the end results. These
analyses did not yield substantially
different results, adding to OSHA’s
confidence in the conclusions of its
preliminary risk assessment.
OSHA’s contractor examined whether
smoking and age were confounders in
the exposure-response analysis by
adding them as variables in the discrete
proportional hazards model. Neither
smoking status nor age was a
statistically significant predictor of
sensitization or CBD. The model
coefficients, 95 percent confidence
intervals, and p values can be found in
the background document. A sensitivity
analysis was done using the standard
Cox model that treats survival time as
continuous rather than discrete. The
model coefficients with the standard
Cox using cumulative exposure were
0.025 and very similar to the 0.03
reported in Tables VI–9 and VI–13
above. The interaction between
exposure and follow-up time was not
significant in these models, suggesting
that the proportional hazard assumption
should not be rejected. The proportional
hazards model assumes a linear
relationship between exposure level and
relative risk. The linearity assumption
was assessed using a fractional
polynomial approach. For both
sensitization and CBD, the best-fitting
fractional polynomial model did not fit
significantly better than the linear
model. This result supports OSHA’s use
of the linear model to estimate risk. The
details of these statistical analyses can
be found in the background document.
The possibility that the number of
times a worker has been tested for
sensitization might influence the
probability of a positive test was
examined (surveillance bias).
Surveillance bias could occur if workers
were tested because they showed some
sign of disease, and not tested
otherwise. It is also possible that the
original analysis included erroneous
assumptions about the dates of testing
for sensitization and CBD. OSHA’s
contractor performed a sensitivity
analysis, modifying the original analysis
to gauge the effect of different
assumptions about testing dates. In the
sensitivity analysis, the exposure
coefficients increased for all four
indices of exposure when the
sensitization analysis was restricted to
times when cohort members were
assumed to be tested. The exposure
coefficient was statistically significant
for duration of exposure but not for
cumulative, LTW average, or HEJ
exposure. The increase in exposure
coefficients suggests that the original
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
models may have underestimated the
exposure-response relationship for
sensitization and CBD.
Errors in exposure measurement are a
common source of uncertainty in
quantitative risk assessments. Because
errors in high exposures can heavily
influence modeling results, OSHA’s
contractor performed sensitivity
analyses excluding the highest 5 percent
of cumulative exposures (those above
25.265 mg/m3-yrs) and the highest 10
percent of cumulative exposures (those
above 18.723 mg/m3-yrs). As discussed
in more detail in the background
document, exposure coefficients were
not statistically significant when these
exposures were dropped. This is not
surprising, given that the exclusion of
high exposure values reduced the size of
the data set. Prior to excluding high
exposure values, the data set was
already relatively small and many of the
exposure coefficients were nonsignificant or weakly significant in the
original analyses. As a result, the
sensitivity analyses did not provide
much information about uncertainty
due to exposure measurement error and
its effects on the modeling analysis.
Particle size, particle surface area, and
beryllium compound solubility are
believed to be important factors
influencing the risk of sensitization and
CBD among beryllium-exposed workers.
The workers at the Cullman machining
plant were primarily handling insoluble
beryllium compounds, such as
beryllium metal and beryllium metal/
beryllium oxide composites. Particle
size distributions from a limited number
of airborne beryllium samples collected
just after the 1996 installation of
engineering controls indicate worker
exposure to a substantial proportion of
respirable particulates. There was no
available particle size data for the 1980
to 1995 period prior to installation of
engineering controls when total
beryllium mass exposure levels were
greatest. Particle size data was also
lacking from 1998 to 2003 when
additional control measures were in
place and total beryllium mass
exposures were lowest. For these
reasons, OSHA was not able to
quantitatively account for the influence
of particle size and solubility in
developing the risk estimates based on
the Cullman data set. However, it is not
unreasonable to expect the CBD
experienced by this cohort to generally
reflect the risk from exposure to
beryllium that is relatively insoluble
and enriched with respirable particles.
As explained previously, the role of
particle size and surface area on risk of
sensitization is more difficult to predict.
PO 00000
Frm 00078
Fmt 4701
Sfmt 4702
Additional uncertainty is introduced
when extrapolating the quantitative
estimates presented above to operations
that process beryllium compounds that
have different solubility and particle
characteristics than those encountered
at the Cullman machining plant. OSHA
does not have sufficient information to
quantitatively assess the degree to
which risks of beryllium sensitization
and CBD based on the NJMRC data may
be impacted in workplaces where such
beryllium forms and processes are used.
However, OSHA does not expect this
uncertainty to alter its qualitative
conclusions with regard to the risk at
the current PEL and at alternate PELs as
low as 0.1 mg/m3. The existing studies
provide clear evidence of sensitization
and CBD risk among workers exposed to
a number of beryllium forms as a result
of different processes such as beryllium
machining, beryllium-copper alloy
production, and beryllium ceramics
production. The Agency believes all of
these forms of beryllium exposure
contribute to the overall risk of
sensitization and CBD among berylliumexposed workers.
G. Lung Cancer
OSHA considers lung cancer to be an
important health endpoint for
beryllium-exposed workers. The
International Agency for Research on
Cancer (IARC), National Toxicology
Program (NTP), and American
Conference of Governmental Industrial
Hygienists (ACGIH) have all classified
beryllium as a known human
carcinogen. The National Academy of
Sciences (NAS), Environmental
Protection Agency, the Agency for Toxic
Substances and Disease Registry
(ATSDR), the National Institute of
Occupational Safety and Health
(NIOSH), and other reputable scientific
organizations have reviewed the
scientific evidence demonstrating that
beryllium is associated with an
increased incidence of cancer. OSHA
also has performed an extensive review
of the scientific literature regarding
beryllium and cancer. This includes an
evaluation of human epidemiological,
animal cancer, and mechanistic studies
described in the Health Effects section
of this preamble. Based on the weight of
evidence, the Agency has preliminarily
determined beryllium to be an
occupational carcinogen.
Although epidemiological and animal
evidence supports a conclusion of
beryllium carcinogenicity, there is
considerable uncertainty surrounding
the mechanism of carcinogenesis for
beryllium. The evidence for direct
genotoxicity of beryllium and its
compounds has been limited and
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
inconsistent (NAS, 2008; IARC, 1993;
EPA, 1998; NTP, 2002; ATSDR, 2002).
One plausible pathway for beryllium
carcinogenicity described in the Health
Effects section of this preamble includes
a chronic, sustained neutrophilic
inflammatory response that induces
epigenetic alterations leading to the
neoplastic changes necessary for
carcinogenesis. The National Cancer
Institute estimates that nearly one-third
of all cancers are caused by chronic
inflammation (NCI, 2009). This
mechanism of action has also been
hypothesized for crystalline silica and
other agents that are known to be
human carcinogens but have limited
evidence of genotoxicity.
OSHA’s review of epidemiological
studies of lung cancer mortality among
beryllium workers found that most did
not characterize exposure levels
sufficiently for exposure-response
analysis. However, one NIOSH study
evaluated the association between
beryllium exposure and lung cancer
mortality based on data from a
beryllium processing plant in Reading,
PA (Sanderson et al., 2001a). As
discussed in the Health Effects section
of this preamble, this case-control study
evaluated lung cancer incidence in a
cohort of workers employed at the plant
from 1940 to 1969 and followed through
1992. For each lung cancer victim, 5
age- and race-matched controls were
selected by incidence density sampling,
for a total of 142 lung cancer cases and
710 controls.
Between 1971 and 1992, the plant
collected close to 7,000 high volume
filter samples consisting of both general
area and short-term, task-based
breathing zone measurements for
production jobs and exclusively area
measurements for office, lunch, and
laboratory areas (Sanderson et al.,
2001b). In addition, a few (< 200)
impinger and high-volume filter
samples were collected by other
organizations between 1947 and 1961,
and about 200 6-to-8-hour personal
samples were collected in 1972 and
1975. Daily-weighted-average (DWA)
exposure calculations based on the
impinger and high-volume samples
collected prior to the 1960s showed that
exposures in this period were extremely
high. For example, about half of
production jobs had estimated DWAs
ranging between 49 and 131 mg/m3 in
the period 1935–1960, and many of the
‘‘lower-exposed’’ jobs had DWAs of
approximately 20–30 mg/m3 (Table II,
Sanderson et al., 2001b). Exposures
were reported to have decreased
between 1959 and 1962 with the
installation of ventilation controls and
improved housekeeping and following
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
the passage of the OSH Act in 1970.
While no exposure measurements were
available from the period 1961–1970,
measurements from the period 1971–
1980 showed a dramatic reduction in
exposures plant-wide. Estimated DWAs
for all jobs in this period ranged from
0.1 mg/m3 to 1.9 mg/m3. Calendar-timespecific beryllium exposure estimates
were made for every job based on the
DWA calculations and were used to
estimate workers’ cumulative, average,
and maximum exposures. Exposure
estimates were lagged by 10 and 20
years in order to account for exposures
that did not contribute to lung cancer
because they occurred after the
induction of cancer.
Results of a conditional logistic
regression analysis showed an increased
risk of lung cancer in workers with
higher exposures when dose estimates
were lagged by 10 and 20 years
(Sanderson et al., 2001a). The authors
noted that there was considerable
uncertainty in the estimation of
exposure in the 1940s and 1950s and
the shape of the dose-response curve for
lung cancer. NIOSH later reanalyzed the
data, adjusting for potential confounders
of hire age and birth year (SchubauerBerigan et al., 2008). The study reported
a significant increasing trend (p<0.05) in
the odds ratio when increasing quartiles
of average (log transformed) exposure
were lagged by 10 years. However, it did
not find a significant trend when
quartiles of cumulative (log
transformed) exposure were lagged by 0,
10, or 20 years.
OSHA is interested in lung cancer risk
estimates from a 45-year (i.e., working
lifetime) exposure to beryllium levels
between 0.1 mg/m3 and 2 mg/m3. The
majority of case and control workers in
the Sanderson et al. case-control
analysis were first hired during the
1940s when exposures were extremely
high (estimated DWAs > 20 mg/m3 for
most jobs). The cumulative, average,
and maximum beryllium exposure
concentration estimates for the 142
known lung cancer cases were: 46.06 ±
9.3mg/m3-days, 22.8 ± 3.4 mg/m3, and
32.4 ± 13.8 mg/m3, respectively. About
two-thirds of cases and half of controls
worked at the plant for less than a year.
Thus, a risk assessment based on this
exposure-response analysis would need
to extrapolate from very high to very
low exposures, based on a working
population with extremely short tenure.
While OSHA risk assessments must
often make extrapolations to estimate
risk within the range of exposures of
interest, the Agency acknowledges that
these issues of short tenure and
extremely high exposures would create
substantial uncertainty in a risk
PO 00000
Frm 00079
Fmt 4701
Sfmt 4702
47643
assessment based on this study
population.
In addition, the relatively high
exposures of even the least-exposed
workers in the NIOSH study may create
methodological issues for the lung
cancer case-control study design.
Mortality risk is expressed as an odds
ratio that compares higher exposure
quartiles to the lowest quartile. It is
preferable that excess risks attributable
to occupational beryllium be
determined relative to an unexposed or
minimally exposed reference
population. However, in the NIOSH
study workers in the lowest quartile
were exposed well above the OSHA PEL
(average exposure <11.2 mg/m3) and may
have had a significant lung cancer risk.
This issue would introduce further
uncertainty in lung cancer risks
estimated from this epidemiological
study.
In 2010, researchers at NIOSH
published a quantitative risk assessment
based on an update of the Reading
cohort analyzed by Sanderson et al., as
well as workers from two smaller plants
(Schubauer-Berigan et al., 2010b). This
new risk assessment addresses several
of OSHA’s concerns regarding the
Sanderson et al. analysis. The new
cohort was exposed, on average, to
lower levels of beryllium and had fewer
short-term workers. Finally, the updated
cohorts followed the populations
through 2005, increasing the length of
follow-up time overall by an additional
17 years of observation. For these
reasons, OSHA considers the
Schubauer-Berigan risk analysis more
appropriate than the Sanderson et al.
analysis for its preliminary risk
assessment.
The cohort studied by SchubauerBerigan et al. included 5,436 male
workers who had worked for at least
two days at the Reading facility and
beryllium processing plants at Hazleton
PA and Elmore OH prior to 1970. The
authors developed job-exposure
matrices (JEMs) for the three plants
based on extensive historical exposure
data, primarily short-term general area
and personal breathing zone samples,
collected on a quarterly basis from a
wide variety of operations. These
samples were used to create daily
weighted average (DWA) estimates of
workers’ full-shift exposures, using
records of the nature and duration of
tasks performed by workers during a
shift. Details on the JEM and DWA
construction can be found in Sanderson
et al. (2001a), Chen et al. (2001), and
Couch et al. (2010).
Workers’ cumulative exposures (mg/
m3-days) were estimated by summing
daily average exposures (assuming five
E:\FR\FM\07AUP2.SGM
07AUP2
47644
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
workdays per week). To estimate mean
exposure (mg/m3), cumulative exposure
was divided by exposure time (in days).
Maximum exposure (mg/m3) was
estimated as the highest annual DWA on
record for a worker prior to the study
cutoff date of December 31, 2005 and
accounting where appropriate for lag
time. Exposure estimates were lagged by
5, 10, 15, and 20 years in order to
account for exposures that may not have
contributed to lung cancer because of
the long latency required for
manifestation of the disease. The
authors also fit models with no lag time.
As shown in Table VI–19 below,
estimated exposure levels for workers
from the Hazleton and Elmore plants
were on average far lower than those for
workers from the Reading plant. The
median worker from Hazleton had a
mean exposure across his tenure of less
than 2 mg/m3, while the median worker
from Elmore had a mean exposure of
less than 1 mg/m3. The Elmore and
Hazleton worker populations also had
fewer short-term workers than the
Reading population. This was
particularly evident at Hazleton where
the median value for cumulative
exposure among cases was higher than
at Reading despite the much lower
mean and maximum exposure levels.
TABLE VI–19—COHORT DESCRIPTION AND DISTRIBUTION OF CASES BY EXPOSURE LEVEL
All plants
Number of cases ...............................
Number of non-cases .......................
Median value for mean exposure .....
(μg/m3) among cases .......................
Median value for cumulative exposure.
(μg/m3-days) among cases ...............
Median value for maximum exposure
(μg/m3) among cases .......................
Number of cases with potential asbestos exposure.
Number of cases who were professional workers.
Reading plant
Hazleton plant
Elmore plant
...........................................................
...........................................................
No lag ...............................................
10-year lag .......................................
No lag ...............................................
293
5143
15.42
15.15
2843
218
3337
25
25
2895
30
583
1.443
1.443
3968
45
1223
0.885
0.972
1654
10-year lag .......................................
No lag ...............................................
10-year lag .......................................
...........................................................
2583
25
25
100 (34%)
2832
25.1
25
68 (31%)
3648
3.15
3.15
16 (53%)
1449
2.17
2.17
16 (36%)
...........................................................
26 (9%)
21 (10%)
3 (10%)
2 (4%)
Table adapted from Schubauer-Berigan et al. 2011, Table 1.
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Schubauer-Berigan et al. analyzed the
data set using a variety of exposureresponse modeling approaches,
including categorical analyses and
continuous-variable piecewise log-linear
and power models, described in
Schubauer-Berigan et al. (2011). All
models adjusted for birth cohort and
plant. As exposure values were logtransformed for the power model
analyses, the authors added small
values to exposures of 0 in lagged
analyses (0.05 mg/m3 for mean and
maximum exposure, 0.05 mg/m3-days for
cumulative exposure). The authors used
restricted cubic spline models to assess
the shape of the exposure-response
curve and suggest appropriate
parametric model forms. The Akaike
Information Criterion (AIC) value was
used to evaluate the fit of different
model forms and lag times.
Because smoking information was
available for only about 25 percent of
the cohort, smoking could not be
controlled for directly in the models.
The authors reported that within the
subset with smoking information, there
was little difference in smoking by
cumulative or maximum exposure
category (p. 6), suggesting that smoking
was unlikely to act as a confounder in
the cohort. In addition to models based
on the full cohort, Schubauer-Berigan et
al. also prepared risk estimates based on
models excluding professional workers
and workers believed to have asbestos
exposure. These models were intended
to mitigate the potential impact of
smoking and asbestos as confounders. If
professional workers had both lower
beryllium exposures and lower smoking
rates than production workers, smoking
could be a confounder in the cohort
comprising both production and
professional workers. However, the
authors reasoned that smoking was
unlikely to be correlated with beryllium
exposure among production workers,
and would therefore probably not act as
a confounder in a cohort excluding
professional workers.
The authors found that lung cancer
risk was strongly and significantly
related to mean, cumulative, and
maximum measures of workers’
exposure (all models reported in
Schubauer-Berigan et al., 2011). They
selected the best-fitting categorical,
power, and monotonic piecewise loglinear (PWL) models with a 10-year lag
to generate hazard ratios for male
workers with a mean exposure of 0.5 mg/
m3 (the current NIOSH Recommended
Exposure Limit for beryllium).9 To
estimate excess lifetime risk of cancer,
they multiplied this hazard ratio by the
2004–2006 background lifetime lung
cancer rate among U.S. males who had
survived, cancer-free, to age 30. In
addition, they estimated the mean
exposure that would be associated with
an excess lifetime risk of one in 1000,
a value often used as a benchmark for
significant risk in OSHA regulations. At
OSHA’s request, they also estimated
excess lifetime risks for workers with
mean exposures at the current PEL of 2
mg/m3 each of the other alternate PELs
under consideration: 1 mg/m3, 0.2 mg/
m3, and 0.1 mg/m3 (Schubauer-Berigan,
4/22/11). The resulting risk estimates
are presented in Table VI–20 below.
9 Here, ‘‘monotonic PWL model’’ means a model
producing a monotonic exposure-response curve in
the 0–2 ug/m3 region.
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
PO 00000
Frm 00080
Fmt 4701
Sfmt 4702
E:\FR\FM\07AUP2.SGM
07AUP2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
47645
TABLE VI–20—EXCESS LIFETIME RISK PER 1000 [95% CONFIDENCE INTERVAL] FOR MALE WORKERS AT ALTERNATE
PELS
[NIOSH models]
Mean exposure
Exposure-response model
0.1
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Best monotonic PWL—all workers ........
Best monotonic PWL—excluding professional and asbestos workers .........
Best categorical—all workers ................
Best categorical—excluding professional and asbestos workers ..............
Power model—all workers .....................
Power model—excluding professional
and asbestos workers ........................
19:20 Aug 06, 2015
Jkt 235001
0.2
μg/m3
0.5 μg/m3
1 μg/m3
2 μg/m3
7.3[2.0–13]
15[3.3–29]
45[9–98]
120[20–340]
200[29–370]
3.1[<0–11]
4.4[1.3–8]
6.4[<0–23]
9[2.7–17]
17[<0–74]
25[6–48]
39[39–230]
59[13–130]
61[<0–280]
170[29–530]
1.4[<0–6.0]
12[6–19]
2.7[<0–12]
19[9.3–29]
7.1[<0–35]
30[15–48]
15[<0–87]
40[19–66]
33[<0–290]
52[23–88]
19[8.6–31]
Schubauer-Berigan et al. discuss
several strengths, weaknesses, and
uncertainties of their analysis. Strengths
include long (> 30 years) follow-up time
for members of the cohort and the
extensive exposure and work history
data available for the development of
exposure estimates for workers in the
cohort. Among the weaknesses and
uncertainties of the study are the
limited information available on
workers’ smoking habits: smoking
information was available only for
workers employed in 1968, about 25
percent of the cohort. In addition, the
JEMs used did not account for possible
respirator use among workers in the
cohort. The authors note that workers’
exposures may therefore have been
overestimated, and that overestimation
may have been especially severe for
workers with high estimated exposures.
They suggest that overestimation of
exposures for workers in highly exposed
positions may have caused attenuation
of the exposure-response curve in some
models at higher exposures.
The NIOSH publication did not
discuss the reasons for basing risk
estimates on mean exposure rather than
cumulative exposure that is more
commonly used for lung cancer risk
analysis. OSHA believes the decision
may involve the nonmonotonic
relationship NIOSH observed between
cancer risk and cumulative exposure
level. As discussed previously, workers
from the Reading plant frequently had
very short tenures and high exposures
yielding lower cumulative exposures
compared to cohort workers from other
plants with longer employment. Despite
the low estimated cumulative exposures
among the short-term Reading workers,
they may be at high risk of lung cancer
due to the tendency of beryllium to
persist in the lung for long periods. This
exposure misclassification could lead to
the appearance of a nonmonotonic
relationship between cumulative
VerDate Sep<11>2014
μg/m3
30[13–50]
49[21–87]
68[27–130]
90[34–180]
exposure and lung cancer risk. It is
possible that a dose-rate effect may exist
for beryllium, such that the risk from a
cumulative exposure gained by longterm, low-level exposure is not
equivalent to the risk from a cumulative
exposure gained by very short-term,
high-level exposure. In this case, mean
exposure level may better correlate with
the risk of lung cancer than cumulative
exposure level. For these reasons OSHA
considers the NIOSH choice of mean
exposure metric to be appropriate and
scientifically defensible for this
particular dataset.
H. Preliminary Conclusions
As described above, OSHA’s risk
assessment for beryllium sensitization
and CBD relied on two approaches: (1)
review of the literature and (2) analysis
of a dataset provided by NJRMC. First,
the Agency reviewed the scientific
literature to ascertain whether there is
substantial risk to workers exposed at
and below the current PEL and to
characterize the expected impact of
more stringent controls on workers’ risk
of sensitization and CBD. This review
focused on facilities where exposures
were primarily below the current PEL,
and where several rounds of BeLPT and
CBD screening had been conducted to
evaluate the effectiveness of various
exposure control measures. Second,
OSHA investigated the exposureresponse relationship for beryllium
sensitization and CBD by analyzing a
dataset that NJMRC provided on
workers at a prominent, longestablished beryllium machining
facility. Although exposure-response
studies have been published on
sensitization and CBD, OSHA believes
the nature and quality of their exposure
data significantly limits their value for
the Agency’s risk assessment. Therefore,
OSHA developed an independent
exposure-response analysis using the
NJMRC dataset, which was recently
PO 00000
Frm 00081
Fmt 4701
Sfmt 4702
updated, includes workers exposed at
low levels, and includes extensive
exposure data collected in workers’
breathing zones, as is preferred by
OSHA.
OSHA’s review of the scientific
literature found substantial risk of both
sensitization and CBD in workplaces in
compliance with OSHA’s current PEL
(e.g., Kreiss et al., 1992; Schuler et al.,
2000; Madl et al., 2007). At these plants,
including a copper-beryllium processing
facility, a beryllia ceramics facility, and
a beryllium machining facility, exposure
reduction programs that primarily used
engineering controls to reduce airborne
exposures to median levels at or around
0.2 mg/m3 had only limited impact on
workers’ risk. Cases of sensitization
continued to occur frequently among
newly hired workers, and some of these
workers developed CBD within the
short follow-up time.
In contrast, industrial hygiene
programs that minimized both airborne
and dermal exposure substantially
lowered workers’ risk of sensitization in
the first years of employment. Programs
that drastically reduced respiratory
exposure via a combination of
engineering controls and respiratory
protection, minimized the potential for
skin exposure via dermal PPE, and
employed stringent housekeeping
methods to keep work areas clean and
prevent transfer of beryllium between
areas sharply curtailed new cases of
sensitization among newly-hired
workers. For example, studies
conducted at copper-beryllium
processing, beryllium production, and
beryllia ceramics facilities show that
reduction of exposures to below 0.1 mg/
m3 and protection from dermal
exposure, in combination, achieved a
substantial reduction in sensitization
risk among newly-hired workers.
However, even these stringent measures
did not protect all workers from
sensitization.
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47646
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
The most recent epidemiological
literature on programs that have been
successful in reducing workers’ risk of
sensitization have had very short
follow-up time; therefore, they cannot
address the question of how frequently
workers sensitized in very low-exposure
environments develop CBD. Clinical
evaluation for CBD was not reported for
workers at the copper-beryllium
processing, beryllium production, and
ceramics facilities. However, cases of
CBD among workers exposed at low
levels at a machining plant and cases of
CA–CBD demonstrate that individuals
exposed to low levels of airborne
beryllium can develop CBD, and over
time, can progress to severe disease.
This conclusion is also supported by
case reports within the literature of
workers with CBD who may have been
minimally exposed to beryllium, such
as a worker employed only in
administration at a beryllium ceramics
facility (Kreiss et al., 1996).
The Agency’s analysis of the Cullman
dataset provided by NJMRC showed
strong exposure-response trends using
multiple analytical approaches,
including examination of sensitization
and disease prevalence by exposure
categories and a proportional hazards
modeling approach. In the prevalence
analysis, cases of sensitization and
disease were evident at all levels of
exposure. The lowest prevalence of
sensitization (2.0 percent) and CBD (1.0
percent) was observed among workers
with LTW average exposure levels
below 0.1 mg/m3, while those with LTW
average exposure between 0.1–0.2 mg/m3
showed a marked increase in overall
prevalence of sensitization (9.8 percent)
and CBD (7.3 percent). Prevalence of
sensitization and CBD also increased
with cumulative exposure.
OSHA’s proportional hazards analysis
of the Cullman dataset found increasing
risk of sensitization with both
cumulative exposure and average
exposure. OSHA also found a positive
relationship between risk of CBD and
cumulative exposure, but not between
CBD and average exposure. The Agency
used the cumulative exposure model
results to estimate hazards ratios and
risk of sensitization and CBD at the
current PEL of 2 mg/m3 and each of the
alternate PELs under consideration: 1
mg/m3, 0.5 mg/m3, 0.2 mg/m3, and 0.1 mg/
m3. To estimate risk of CBD from a
working lifetime of exposure, the
Agency calculated the cumulative
exposure associated with 45 years of
exposure at each level, for total
cumulative exposures of 90, 45, 22.5, 9,
and 4.5 mg/m3-years. The risk estimates
for sensitization and CBD ranged from
100–403 and 40–290 cases, respectively,
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
per 1000 workers exposed at the current
PEL of 2 mg/m3. The risks are projected
to be substantially lower for both
sensitization and CBD at 0.1 mg/m3 and
range from 7.2–35 cases per 1000 and
3.1–26 cases per 1000, respectively. In
these ways, the modeling results are
similar to results observed from
published studies of the Reading,
Tucson, and Cullman plants and the
OSHA analysis of sensitization and CBD
prevalence within the Cullman plant.
OSHA has a high level of confidence
in the finding of substantial risk of
sensitization and CBD at the current
PEL, and the Agency believes that a
standard requiring a combination of
more stringent controls on beryllium
exposure will reduce workers’ risk of
both sensitization and CBD. Programs
that have reduced median levels to
below 0.1 mg/m3, tightly controlled both
respiratory and dermal exposure, and
incorporated stringent housekeeping
measures have substantially reduced
risk of sensitization within the first
years of exposure. These conclusions
are supported by the results of several
studies conducted in state-of-the-art
facilities dealing with a variety of
production activities and physical forms
of beryllium. In addition, these
conclusions are supported by OSHA’s
statistical analysis of a dataset with
highly detailed exposure and work
history information on several hundred
beryllium workers. While there is
uncertainty regarding the precision of
model-derived risk estimates, they
provide further evidence that there is
substantial risk of sensitization and CBD
associated with exposure at the current
PEL, and that this risk can be
substantially lessened by stringent
measures to reduce workers’ beryllium
exposure levels.
Furthermore, OSHA believes that
beryllium-exposed workers’ risk of lung
cancer will be reduced by more
stringent control of airborne beryllium
exposures. The risk estimates from
NIOSH’s recent lung cancer study,
described above, range from 33 to 140
excess lung cancers per 1000 workers
exposed at the current PEL of 2 mg/m3.
The NIOSH risk assessment’s six bestfitting models each predict substantial
reductions in risk with reduced
exposure, ranging from 3 to 19 excess
lung cancers per 1000 workers exposed
at the proposed PEL of 0.1 mg/m3. The
evidence of lung cancer risk from
NIOSH’s risk assessment provides
additional support for OSHA’s
preliminary conclusions regarding the
significance of risk to workers exposed
to beryllium levels at and below the
current PEL. However, the lung cancer
risks require a sizable low dose
PO 00000
Frm 00082
Fmt 4701
Sfmt 4702
extrapolation below beryllium exposure
levels experienced by workers in the
NIOSH study. As a result, there is a
greater uncertainty in the lung cancer
risk estimates and lesser confidence in
their significance of risk below the
current PEL than with beryllium
sensitization and CBD. The preliminary
conclusions with regard to significance
of risk are presented and further
discussed in section VIII of the
preamble.
VII. Expert Peer Review of Health
Effects and Preliminary Risk
Assessment
In 2010, Eastern Research Group, Inc.
(ERG), under contract to the
Occupational Safety and Health
Administration (OSHA) ,10 conducted
an independent, scientific peer review
of (1) a draft Preliminary Beryllium
Health Effects Evaluation (OSHA,
2010a), (2) a draft Preliminary Beryllium
Risk Assessment (OSHA, 2010b), and (3)
two NIOSH study manuscripts
(Schubauer-Berigan et al., 2011 and
2011a). This section of the preamble
describes the review process and
summarizes peer reviewers’ comments
and OSHA’s responses.
ERG conducted a search for nationally
recognized experts in the areas of
occupational epidemiology,
occupational medicine, toxicology,
immunology, industrial hygiene/
exposure assessment, and risk
assessment/biostatistics as requested by
OSHA. ERG sought experts familiar
with beryllium health effects research
and who had no conflict of interest
(COI) or apparent bias in performing the
review. Interested candidates submitted
evidence of their qualifications and
responded to detailed COI questions.
ERG also searched the Internet to
determine whether qualified candidates
had made public statements or declared
a particular bias regarding beryllium
regulation.
From the pool of qualified candidates,
ERG selected five experts to conduct the
review, based on:
Æ Their qualifications, including their
degrees, years of relevant experience,
number of related peer-reviewed
publications, experience serving as a
peer reviewer for OSHA or other
government organizations, and
committee and association memberships
related to the review topic;
Æ Lack of any actual, potential, or
perceived conflict of interest; and
Æ The need to ensure that the panel
collectively was sufficiently broad and
10 Task Order No. DOLQ59622303, Contract No.
GS10F0125P, with a period of performance from
May, 2010 through December, 2010.
E:\FR\FM\07AUP2.SGM
07AUP2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
diverse to fairly represent the relevant
scientific and technical perspectives
and fields of knowledge appropriate to
the review.
OSHA reviewed the qualifications of
the candidates proposed by ERG to
verify that they collectively represented
the technical areas of interest. ERG then
contracted the following experts to
perform the review.
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
(1) John Balmes, MD, Professor of
Medicine, University of California-San
Francisco
Expertise: pulmonary and occupational
medicine, CBD, occupational lung disease,
epidemiology, occupational exposures,
medical surveillance.
(2) Patrick Breysse, Ph.D., Professor, Johns
Hopkins University Bloomberg School of
Public Health
Expertise: industrial hygiene,
occupational/environmental health
engineering, exposure monitoring/analysis,
biomarkers, beryllium exposure assessment
(3) Terry Gordon, Ph.D., Professor, New
York University School of Medicine.
Expertise: inhalation toxicology,
pulmonary disease, beryllium toxicity and
carcinogenicity, CBD genetic susceptibility,
mode of action, animal models.
(4) Milton Rossman, MD, Professor of
Medicine, Hospital of the University of
Pennsylvania School of Medicine.
Expertise: pulmonary and clinical
medicine, immunology, beryllium
sensitization, BeLPT, clinical diagnosis for
CBD.
(5) Kyle Steenland, Ph.D., Professor, Emory
University, Rollins School of Public Health.
Expertise: occupational epidemiology,
biostatistics, risk and exposure assessment,
lung cancer, CBD, exposure-response models.
Reviewers were provided with the
Technical Charge and Instructions (see
ERG, 2010), a Request for Peer Review
of NIOSH Manuscripts (see ERG, 2010),
the draft Preliminary OSHA Health
Effects Evaluation (OSHA, 2010a), the
draft Preliminary Beryllium Risk
Assessment (OSHA, 2010b), and access
to relevant references. Each reviewer
independently provided comments on
the Health Effects, Risk Assessment, and
NIOSH documents. A briefing call was
held early in the review to ensure that
reviewers understood the peer review
process. ERG organized the call and
OSHA representatives were available to
respond to technical questions of
clarification. Reviewers were invited to
submit any subsequent questions of
clarification.
The written comments from each
reviewer were received and organized
by ERG by charge questions. The
unedited individual and reorganized
comments were submitted to OSHA and
the reviewers in preparation for a
follow-up conference call. The
conference call, organized and
facilitated by ERG, provided an
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
opportunity for OSHA to clarify
individual reviewer’s comments. After
the call, reviewers were given the
opportunity to revise their written
comments to include the clarifications
or additional information provided on
the call. ERG submitted the revised
comments to OSHA organized by both
individual reviewer and by charge
question. A final peer review report is
available in the docket (ERG, 2010).
Section VII.A of this preamble
summarizes the comments received on
the draft health effects document and
OSHA’s responses to those comments.
Section VII.B summarizes comments
received on the draft Preliminary Risk
Assessment and the OSHA response.
A. Peer Review of Draft Health Effects
Evaluation
The Technical Charge to peer
reviewers posed general questions on
the draft health effects document as well
as specific questions pertaining to
particle/chemical properties, kinetics
and metabolism, acute beryllium
disease, development of beryllium
sensitization and CBD, genetic
susceptibility, epidemiological studies
of sensitization and CBD, animal models
of chronic beryllium disease,
genotoxicity, lung cancer
epidemiological studies, animal cancer
studies, other health effects, and
preliminary conclusions drawn by
OSHA.
OSHA asked the peer reviewers to
generally comment on whether the draft
health effects evaluation included the
important studies, appropriately
addressed their strengths and
limitations, accurately described the
results, and drew scientifically sound
conclusions. Overall, the reviewers felt
that the studies were described in
sufficient detail, the interpretations
accurate, and the conclusions
reasonable. They agreed that the OSHA
document covered the significant health
endpoints related to occupational
beryllium exposure. However, several
reviewers requested that additional
studies and other specific information
be included in various sections of the
document and these are discussed
further below.
The reviewers had similar suggestions
to improve the section V.A of this
preamble on physical/chemical
properties and section V.B on kinetics/
metabolism. Dr. Balmes requested that
physical and chemical characteristics of
beryllium more clearly relate to
development of sensitization and
progression to CBD. Dr. Gordon
requested greater consistency in the
terminology used to describe particle
characteristics, sampling methodologies,
PO 00000
Frm 00083
Fmt 4701
Sfmt 4702
47647
and the particle deposition in the
respiratory tract. Dr. Breysse agreed and
requested that the respiratory deposition
discussion be better related to the onset
of sensitization and CBD. Dr. Rossman
suggested that the discussion of
particle/chemical characteristics might
be better placed after section V.D on the
immunobiology of sensitization and
CBD.
OSHA made a number of revisions to
sections V.A and V.B to address the peer
review comments above. Terminology
used to describe particle characteristics
in various studies was modified to be
more consistent and better reflect the
authors’ intent in the published research
articles. Section V.B.1 on respiratory
kinetics of inhaled beryllium was
modified to more clearly describe
particle deposition in the different
regions of the respiratory tract and their
influence on CBD. At the
recommendation of Dr. Gordon, a
confusing figure was removed since it
did not portray particle deposition in a
clear manner. Rather than relocate the
entire discussion of particle/chemical
characteristics, a new section V.B.5 was
added to specifically address the
influence of beryllium particle
characteristics and chemical form on the
development of sensitization and CBD.
Other section areas were shortened to
remove information that was not
necessarily relevant to the overall
disease process. Statements were added
on the effect of pre-existing diseases and
smoking on beryllium clearance from
the lung. It was made clear that the
precise role of dermal exposure in
beryllium sensitization is not
completely understood. These smaller
changes were made at the request of
individual reviewers.
There were a couple of comments
from reviewers pertaining to acute
beryllium disease (ABD). Dr. Rossman
commented that ABD did not make the
development of CBD more likely. He
requested that the document include a
reference to the Van Ordstrand et al.
(1943) article that first reported ABD in
the U.S. Dr. Balmes pointed out that
pathologists, rather than clinicians,
interpret ABD pathology from lung
tissue biopsy. Dr. Gordon commented
that ABD is of lesser importance than
CBD to the risk assessment and
suggested that discussion of ABD be
moved later in the document.
The Van Ordstrand reference was
included in section V.C on acute
beryllium diseases and statements were
modified to address the peer review
comments above. While OSHA agrees
that ABD does not have a great impact
on the Agency risk findings, the Agency
believes the current organization does
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47648
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
not create confusion on this point and
decided not to move the ABD section
later in the document. A statement that
ABD is only relevant at exposures
higher than the current PEL has been
added to section V.C. Other reviewers
did not feel the ABD discussion needed
to be moved to a later section.
Most reviewers found the description
of the development and pathogenesis of
CBD in section V.D to be accurate and
understandable. Dr. Breysse felt the
section could better delineate the steps
in disease development (e.g.,
development of beryllium sensitization,
CBD progression) and recommended the
2008 National Academy of Sciences
report as a model. He and Dr. Gordon
felt the section overemphasized the role
of apoptosis in CBD development. Dr.
Breysse and Dr. Balmes recommended
avoiding the phrase ‘subclinical’ to
describe sensitization and asymptomatic
CBD, preferring the term ‘early stage’ as
a more appropriate description. Dr.
Balmes requested clarification regarding
accumulation of inflammatory cells in
the bronchoalveolar lavage (BAL) fluid
during CBD development. Dr. Rossman
suggested some additional description
of beryllium binding with the HLA-class
II receptor and subsequent interaction
¨
with the naıve CD4+ T cells in the
development of sensitization.
OSHA extensively reorganized section
V.D to clearly delineate the disease
process in a more linear fashion starting
with the formation of beryllium antigen
¨
complex, its interaction with naıve Tcells to trigger CD4+ T-cell proliferation,
and development of beryllium
sensitization. This is presented in
section V.D.1. A figure has been added
that schematically presents this process
in its entirety and the steps at which
dermal exposure and genetic factors are
believed to influence disease
development (Figure 2 in section V.D).
Section V.D.2 describes how subsequent
inhalation and the persistent residual
presence of beryllium in the lung leads
to CD4+ T cell differentiation, cytokine
production, accumulation of
inflammatory cells in the alveolar
region, granuloma formation, and
progression of CBD. The section was
modified to present apoptosis as only
one of the plausible mechanisms for
development/progression of CBD. The
‘early stage’ terminology was adopted
and the role of inflammatory cells in
BAL was clarified.
While peer reviewers felt genetic
susceptibility was adequately
characterized, Dr. Rossman, Dr. Gordon,
and Dr. Breysse suggested that
additional study data be discussed to
provide more depth on the subject,
particularly the role genetic
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
polymorphisms in providing a
negatively charged HLA protein binding
site for the positively charged beryllium
ion. Section V.D.3 on genetic
susceptibility now includes more
information on the importance of geneenvironment interaction in the
development of CBD in low-exposed
workers. The section expands on HLA–
DPB1 alleles that influence berylliumhapten binding and its impact on CBD
risk.
All reviewers found the definition of
CBD to be clear and understandable.
However, several reviewers commented
on the document discussion of the
BeLPT which operationally defines
beryllium sensitization. Drs. Balmes and
Rossman requested a more clear
statement that two abnormal blood
BeLPT results were generally necessary
to confirm sensitization. Dr. Balmes and
Dr. Breysse requested more discussion
of historical changes in the BeLPT
method that have led to improvement in
test performance and reductions in
interlaboratory variability. These
comments were addressed in an
expanded document section V.D.5.b on
criteria for sensitization and CBD case
definition following development of the
BeLPT.
Reviewers made suggestions to
improve presentation of the many
epidemiological studies of sensitization
and CBD in the draft health effects
document. Dr. Breysse and Dr. Gordon
recommended that common weaknesses
that apply to multiple studies be more
rigorously discussed. Dr. Gordon
requested that the discussion of the
Beryllium Case Registry be modified to
clarify the case inclusion criteria. Most
reviewers called for the addition of
tables to assist in summarizing the
epidemiological study information.
A paragraph has been added near the
beginning of section V.D.5 that
identifies the common challenges to
interpreting the epidemiological
evidence that supports the occurrence of
sensitization and CBD at occupational
beryllium exposures below the current
PEL. These include studies with small
numbers of subjects and CBD cases,
potential exposure misclassification
resulting from lack of personal and
short-term exposure data prior to the
late 1990s, and uncertain dermal
contribution among other issues. Table
A.1 summarizing the key sensitization
and CBD epidemiological studies was
added to this preamble in appendix A
of section V. Subsection V.D.5.a on
studies conducted prior to the BeLPT
has been reorganized to more clearly
present the need for the Registry prior
to listing the inclusion criteria.
PO 00000
Frm 00084
Fmt 4701
Sfmt 4702
Several reviewers requested that the
draft health effects document discuss
additional occupational studies on
sensitization and CBD. Dr. Balmes
suggested including Bailey et al. (2010)
on reduction in sensitization at a
beryllium production plant and
Arjomandi et al. (2010) on CBD among
workers in a nuclear weapons facility.
Dr. Breysse recommended adding a brief
discussion of Taiwo et al. (2008) on
sensitization in aluminum smelter
workers. Dr. Gordon and Dr. Rossman
suggested mention of Curtis, (1951) on
cutaneous hypersensitivity to beryllium
as important for the role of dermal
exposure. Dr. Rossman also provided a
reference to a number of other
sensitization and CBD articles of
historical significance.
The above studies have been
incorporated in several subsections of
V.D.5 on human epidemiological
evidence. The 1951 Curtis study is
mentioned in the introduction to section
V.D.5 as evidence of sensitization from
dermal exposure. The Bailey et al.
(2010) study is discussed in subsection
V.D.5.d on beryllium metal processing
and alloy production. The Arjomandi et
al. (2010) study is discussed subsection
V.D.5.h on nuclear weapons facilities
and cleanup of former facilities. The
Taiwo et al. (2008) study is discussed in
subsection V.D.5.i on aluminum
smelting. The other historical studies of
historical significance are referenced in
subsection V.D.5.a on studies conducted
prior to the BeLPT.
Dr. Gordon suggested that the draft
health effects document make clear that
limitations in study design and lack of
an appropriate model limited
extrapolation of animal findings to the
human immune-based respiratory
disease. Dr. Rossman also remarked on
the lack of a good animal model that
consistently demonstrates a specific
cell-mediated immune response to
beryllium. Section V.D.6 was modified
to include a statement that lack of a
dependable animal model combined
with studies that used single doses, few
animals or abbreviated observation
periods have limited the utility of the
data. Table A.2 was added that
summarizes important information on
key animal studies of beryllium-induced
immune response and lung
inflammation.
In general, peer reviewers considered
the preliminary conclusions with regard
to sensitization and CBD to be
reasonable and well presented in the
draft health effects evaluation. All
reviewers agreed that the scientific
evidence supports sensitization as a
necessary condition and an early
endpoint in the development of CBD.
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
The peer reviewers did not consider the
presented evidence to convincingly
show lung burden to be an important
dose metric. Dr. Gordon explained that
some animal studies in dogs have
indicated that lung dose does influence
granuloma formation but the importance
of dose relative to genetic susceptibility,
and physical/chemical form is unclear.
He suggested the document indicate that
many factors, including lung burden,
affect the pulmonary tissue response to
beryllium particles in the workplace.
There were other suggested
improvements to the preliminary
conclusion section of the draft
document. Dr. Breysse felt that
presenting the range of observed
prevalence from occupational studies
would help support the Agency
findings. He also recommended that the
preliminary conclusions make clear that
CBD is a very complex disease and
certain steps involved in the onset and
progression are not yet clearly
understood. Dr. Rossman pointed out
that a report from Mroz et al. (2009)
updated information on the rate at
which beryllium sensitized individuals
progress to CBD.
A statement has been added to section
V.D.7 on the preliminary sensitization
and CBD conclusions to indicate that all
facets of development and progression
of sensitization and CBD are not fully
understood. Study references and
prevalence ranges were provided to
support the conclusion that
epidemiological evidence demonstrates
that sensitization and CBD occur from
present-day exposures below OSHA’s
PEL. Statements were modified to
indicate animal studies provide
important insights into the roles of
chemical form, genetic susceptibility,
and residual lung burden in the
development of beryllium lung disease.
Updated information on rate of
progression from sensitization to CBD
was also included.
Reviewers made suggestions to
improve presentation of the
epidemiological studies of lung cancer
that were similar to their comments on
the CBD studies. Dr. Steenland
requested that a table summarizing the
lung cancer studies be added. He also
recommended that more emphasis be
placed on the SMR results from the
Ward et al. (1992) study. Dr. Balmes felt
that more detail was presented on the
animal cancer studies than necessary to
convey the relevant message. All
reviewers thought that the SchubauerBerigan et al. (2010) cohort mortality
study that addressed some of the
shortcomings of earlier lung cancer
mortality studies should be discussed in
the health effects document.
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
The recent Schubauer-Berigan et al.
(2010) study conducted by the NIOSH
Division of Surveillance, Hazard
Evaluations, and Field Studies is now
described and discussed in section
V.E.2 on human epidemiology studies.
Table A.3 summarizing the range of
exposure measurements, study strengths
and limitations, and other key lung
cancer epidemiological study
information was added to the health
effects preamble. Section V.E.3 on the
animal cancer studies already contained
several tables that present study data so
OSHA decided a summary table was not
needed in this section.
Reviewers were asked two questions
regarding the OSHA preliminary
conclusions on beryllium-induced lung
cancer: was the inflammation
mechanism presented in the lung cancer
section reasonable; and were there other
mechanisms or modes of action to be
considered? All reviewers agreed that
inflammation was a reasonable
mechanistic presentation as outlined in
the document. Dr. Gordon requested
OSHA clarify that inflammation may
not be the sole mechanism for
carcinogenicity. OSHA inserted
statements in section V.E.5 on the
preliminary lung cancer conclusions
clarifying that tumorigenesis secondary
to inflammation is a reasonable
mechanism of action but other plausible
mechanisms independent of
inflammation may also contribute to the
lung cancer associated with beryllium
exposure.
There were a few comments from
reviewers on health effects other than
sensitization/CBD and lung cancer in
the draft document. Dr. Balmes
requested that the term ‘‘beryllium
poisoning’’ not be used when referring
to the hepatic effects of beryllium. He
also offered language to clarify that the
cardiovascular mortality among
beryllium production workers in the
Ward study cohort was probably due to
ischemic heart disease and not the
result of impaired lung function. Dr.
Gordon requested removal of references
to hepatic studies from in vitro and
intravenous administration done at very
high dose levels of little relevance to the
occupational exposures of interest to
OSHA. These changes were made to
section V.F on other health effects.
B. Peer Review of the Draft Preliminary
Risk Assessment
The Technical Charge to peer
reviewers for review of the draft
preliminary risk assessment was to
ensure OSHA selected appropriate
study data, assessed the data in a
scientifically credible manner, and
clearly explained its analysis. Specific
PO 00000
Frm 00085
Fmt 4701
Sfmt 4702
47649
charge questions were posed regarding
choice of data sets, risk models, and
exposure metrics; the role of dermal
exposure and dermal protection;
construction of the job exposure matrix;
characterization of the risk estimates
and their uncertainties; and whether a
quantitative assessment of lung cancer
risk, in addition to sensitization and
CBD, was warranted.
Overall, the peer reviewers were
highly supportive of the Agency’s
approach and major conclusions. They
offered valuable suggestions for
revisions and additional analysis to
improve the clarity and certain
technical aspects of the risk assessment.
These suggestions and the steps taken
by OSHA to address them are
summarized here. A final peer review
report (ERG, 2010c) and a risk
assessment background document
(OSHA, 2014a) are available in the
docket.
OSHA asked peer reviewers a series of
questions regarding its selection of
surveys from a beryllium ceramics
facility, a beryllium machining facility,
and a beryllium alloy processing facility
as the critical studies that form the basis
of the preliminary risk assessment.
Research showed that these workplaces
had well characterized and relatively
low beryllium exposures and underwent
plant-wide screenings for sensitization
and CBD before and after
implementation of exposure controls.
The reviewers were requested to
comment on whether the study
discussions were clearly presented,
whether the role of dermal exposure and
dermal protection were adequately
addressed, and whether the preliminary
conclusions regarding the observed
exposure-related prevalence and
reduction in risk were reasonable and
scientifically credible. They were also
asked to identify other studies that
should be reviewed as part of the
sensitization/CBD risk assessment.
Every peer reviewer felt the key
studies were appropriate and their
selection clearly explained in the
document. Every peer reviewer regarded
the preliminary conclusions from the
OSHA review of these studies to be
reasonable and scientifically sound.
This conclusion stated that substantial
risk of sensitization and CBD were
observed in facilities where the highest
exposed processes had median full-shift
beryllium exposures around 0.2 mg/m3
or higher and that the greatest reduction
in risk was achieved when exposures for
all processes were lowered to 0.1 mg/m3
or below.
The reviewers suggested that three
additional studies be added to the risk
assessment review of the
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47650
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
epidemiological literature. Dr. Balmes
felt the document would be
strengthened by including the Bailey et
al. (2010) investigation of sensitization
in a population of workers at the
beryllium metal, alloy, and oxide
production plant in Elmore, OH and the
Arjomandi et al. (2010) publication on
a group of 50 sensitized workers from a
nuclear plant. Dr. Breysse suggested the
study by Taiwo et al. (2008) on
sensitization among workers in four
aluminum smelters be considered.
A new subsection VI.A.3 was added
to the preliminary risk assessment that
describes the changes in beryllium
exposure measurements, prevalence of
sensitization and CBD, and
implementation of exposure controls
between 1992 and 2006 at the Elmore
plant. This subsection includes a
discussion of the Bailey et al. study. A
summary of the Taiwo et al. (2008)
study was added as subsection VI.A.5.
A discussion of the Arjomandi et al.
(2010) study was added in subsection
VI.B as evidence that sensitized workers
with primarily low beryllium exposure
go on to develop CBD. However, the low
rates of CBD among this group of
sensitized workers also suggest that low
beryllium exposure may reduce CBD
risk when compared to worker
populations with higher exposure
levels.
While the majority of reviewers stated
that OSHA adequately addressed the
role of dermal exposure in sensitization
and the importance of dermal protection
for workers, a few had additional
suggestions for OSHA’s discussion. Dr.
Breysse and Dr. Gordon pointed out that
because the beryllium exposure control
programs featured steps to reduce both
skin contact and inhalation, it was
difficult to distinguish between the
effects of reducing airborne and dermal
exposure. A statement was added to
subsection VI.B that concurrent
implementation of respirator use,
dermal protection and engineering
changes made it difficult to attribute
reduced risk to any single control
measure. Since the Cullman plant did
not require glove use, OSHA believes it
to be the best data set available for
evaluating the effects of airborne
exposure control on risk of
sensitization.
Dr. Breysse requested additional
discussion of the role of respiratory
protection in achieving reduction in
risk. Dr. Gordon suggested some
additional clarification regarding mean
and median exposure measures.
Additional information on respiratory
programs and exposure measures (e.g.,
median, arithmetic and geometric
means), where available, were presented
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
for each of the studies discussed in
subsection VI.A.
The peer reviewers generally agreed
that it was reasonable to conclude that
community-acquired CBD (CA–CBD)
resulted from low beryllium exposures.
Drs. Breysse, Balmes and others noted
that higher short-term excursions could
not be ruled out. Dr. Gordon suggested
that genetic susceptibility may have a
role in cases of CA–CBD. Dr. Rossman
raised the possibility that some CA–CBD
cases could occur from contact with
beryllium workers. All these points
were added to subsection VI.C.
OSHA asked the peer reviewers to
evaluate the choice of the National
Jewish Medical and Research Center
(NJMRC) data set on the Cullman, AL
machinist population as a basis for
exposure-response analysis and the
reliance on cumulative exposure as the
basis for the exposure-response analysis
of sensitization and CBD. All peer
reviewers indicated that the choice of
the NJMRC data set for exposureresponse analysis was clearly explained
and reasonable and that they knew of no
better data set for the analysis. Dr.
Rossman commented that the NJMRC
data set was an excellent source of
exposures to different levels of
beryllium and testing and evaluation of
the workers. Dr. Steenland and Dr.
Gordon suggested that the results from
the OSHA analysis of the NJMRC data
be compared with the available data
from the studies of other beryllium
facilities discussed in the
epidemiological literature analysis.
While a rigorous quantitative
comparison (e.g., meta analysis) is
difficult due to differences in the study
designs and data types available for
each study, subsection VI.E.4 compares
the results of OSHA’s prevalence
analysis from the Cullman data with
results from studies of the Tucson and
Reading facilities.
OSHA asked the peer reviewers to
evaluate methods used to construct the
job exposure matrix (JEM) and to
estimate beryllium exposure for each
worker in the NJMRC data set. The JEM
procedure was briefly summarized in
the review document and described in
detail as part of a risk assessment
technical background document made
available to the reviewers (OSHA,
2014a). Dr. Balmes felt that a more
thorough discussion of the JEM would
strengthen the preamble document. Dr.
Gordon requested information about
values assigned exposures below the
limit of detection. Dr. Steenland
requested that both the preamble and
technical background document contain
additional information on aspects of the
JEM construction such as the job
PO 00000
Frm 00086
Fmt 4701
Sfmt 4702
categories, job-specific exposure values,
how jobs were grouped, and how nonmachining jobs were handled in the
JEM. He suggested the entire JEM be
included in the technical background
document. OSHA greatly expanded
subsection VI.E.2 on air sampling and
JEM to include more detailed discussion
of the JEM construction. Exposure
values for machining and nonmachining job titles were provided in
Tables VI–4 and VI–5. The procedures
and rationale for grouping job-specific
measurements into four time periods
was explained. Jobs were not grouped in
the JEM; rather, individual exposure
estimates were created for each job in
the work history data set. The technical
background document further clarifies
the JEM construction and the full JEM
is included as an appendix to the
revised background document (OSHA,
2014a). Subsection VI.E.3 on worker
exposure reconstruction contains
further detail about the work histories.
Peer reviewers fully supported
OSHA’s choice of the cumulative
exposure metric to estimate risk of CBD
from the NJMRC data set. As explained
by Dr. Steenland, ‘‘cumulative exposure
is often the choice for many chronic
diseases as opposed to average or
highest exposure.’’ He pointed out that
the cumulative exposure metric also fit
the CBD data better than other metrics.
The reviewers generally felt that shortterm peak exposure was probably the
measure of airborne exposure most
relevant to risk of beryllium
sensitization. However, peer reviewers
agreed that data required to capture
workers’ short-term peak exposures and
to relate the peak exposure levels to
sensitization were not available. Dr.
Breysse explained that ‘‘short-term (hrs
to minutes) peak exposures may be
important to sensitization risk, while
long term averages are more important
for CBD risk. Unfortunately data for
short-term peak exposures may not
exist.’’ Dr. Steenland explained that of
the available metrics ‘‘cumulative
exposure fits the sensitization data
better than the two alternatives, and
hence is the best metric.’’ Statements
were added to subsection VI.E.3 to
indicate that while short-term exposures
may be highly relevant to risk of
sensitization, the individual peak
exposures leading up to onset of
sensitization was not able to be
determined in the NJRMC Cullman
study.
Peer reviewers found the methods
used in the statistical exposure-response
analysis to be clearly described. With
the exception of Dr. Steenland,
reviewers believed that a detailed
critique of the statistical approach was
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
beyond their level of expertise. Dr.
Steenland supported OSHA’s overall
approach to the risk modeling and
recommended additional analyses to
explore the sensitivity of OSHA’s results
to alternate choices and to test the
validity of aspects of the analysis. Dr.
Steenland recommended that the
logistic regression used by OSHA as a
preliminary first analysis be dropped as
an inappropriate model for a situation
where it is important to account for
changing exposures and case onset over
time. Instead, he suggested a sensitivity
analysis in which exposure-response
coefficients generated using a traditional
Cox proportionate hazards model be
compared to the discrete time Cox
model analog (i.e., complementary loglog Cox model) used by OSHA. The
sensitivity analysis would facilitate
examination of the proportional hazard
assumption implied by the use of these
models. Dr. Steenland advocated that
OSHA include a table that displayed the
mean number of BeLPT tests for the
study population in order to address
whether the number of sensitization
tests introduced a potential bias. He
inquired about the possibility of
determining a sensitization incidence
rate using cumulative or average
exposure. Dr. Steenland suggested that
the model control for additional
potential confounders, such as age,
smoking status, race and gender. He
wanted a more complete explanation of
the model constant for the year of
diagnosis in Tables VI–9 through VI–12
to be included in the preamble as it was
in the technical background document.
Dr. Steenland recommended a
sensitivity analysis that excludes the
highest 5 to 10 percent of cumulative
exposures which might address
potential model uncertainty at the high
end exposures. He requested that the
results of statistical tests for nonlinearity be included and confidence
intervals for the risk estimates in Tables
VI–17 and VI–18 be determined.
Many of Dr. Steenland’s comments
were addressed in subsection VI.F on
the statistical modeling. The logistic
regression analysis was removed from
the section. A sensitivity analysis using
the standard Cox model that treats
survival time as continuous rather than
discrete was added to the risk
assessment background document and
results were described in subsection
VI.F. The interaction between exposure
and follow-up time was not significant
in the models suggesting that the
proportional hazard assumption should
not be rejected. The model coefficients
using the standard Cox model were
similar to model coefficients for the
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
discrete model. Given this, OSHA did
not feel it necessary to further estimate
risks using the continuous Cox model at
specific exposure levels.
A table of the mean number of BeLPT
tests across the study population was
added to the risk assessment
background document. Subsection VI.F
describes the table results and its impact
on the statistical modeling. Smoking
status and age were included in the
discrete Cox proportional hazards
model and not found to be significant
predictors of beryllium sensitization.
However, the available study population
composition did not allow a confounder
analysis of race and gender. OSHA
chose not to include a detailed
explanation of the model constant for
the year of diagnosis in the preamble
section. OSHA agrees with Dr.
Steenland that the risk assessment
background document adequately
describes the model terms. For that
reason, OSHA prefers that the risk
assessment preamble focus on the
results and major points of the analysis
and refer the reader to the more
technical background document for an
explanation of model parameters. The
linearity assumption was assessed using
a fractional polynomial approach. The
best fitting polynomials did not fit
significantly better than the linear
model. The details of the analysis were
included in the risk assessment
background document. Tables VI–17
and VI–18 now include the upper 95
percent confidence limits on the modelpredicted cases of sensitization and CBD
for the current and alternative PELs.
Most peer reviewers felt the major
uncertainties of the risk assessment
were clearly and adequately discussed
in the documents they reviewed. Dr.
Breysse requested that the risk
assessment cover potential
underestimation of risk from exposure
misclassification bias. He requested
further discussion of the degree to
which the risk estimates from the
Cullman machining plant could be
extrapolated to workplaces that use
other physical (e.g., particle size) and
chemical forms of beryllium. He went
on to question the strength of evidence
that insoluble forms of beryllium cause
CBD. Dr. Breysse also suggested that the
assumptions used in the risk modeling
be consolidated and more clearly
presented. Dr. Steenland felt that there
was potential underestimation of CBD
risk resulting from exclusion of former
workers and case status of current
workers after employment.
Discussion of these uncertainties was
added in the final paragraphs of section
VI.F. The section was modified to more
clearly identify assumptions with regard
PO 00000
Frm 00087
Fmt 4701
Sfmt 4702
47651
to the risk modeling such as an assumed
linearity in exposure-response and
cumulative dose equivalency when
extrapolating risks over a 45-year
working lifetime. Section VI.F
recognizes the uncertainties in risk that
can result from reconstructing
individual exposures with very limited
sampling data prior to 1994. The
potential exposure misclassification can
limit the strength of exposure-response
relationships and result in the
underestimation of risk. A more
technical discussion of modeling
assumptions and exposure measurement
error are provided in the risk assessment
background document. Section VI.F
points out that the NJMRC data set does
not capture CBD that occurred among
workers who retired or left the Cullman
plant. This and the short follow-up time
is a source of uncertainty that likely
leads to underestimation of risk. The
section indicates that it is not
unreasonable to expect the risk
estimates to generally reflect onset of
sensitization and CBD from exposure to
beryllium forms that are relatively
insoluble and enriched with respirable
particles as encountered at the Cullman
machining plant. Additional uncertainty
is introduced when extrapolating the
risk estimates to beryllium compounds
of vastly different solubility and particle
characteristics. OSHA does not agree
with the comment suggesting that the
association between CBD and insoluble
forms of beryllium is weak. The
principle sources of beryllium
encountered at the Cullman machining
plant, the Reading copper beryllium
processing plant and the Tucson
ceramics plant where excessive CBD
was observed are insoluble forms of
beryllium, such as beryllium metal,
beryllium alloy, and beryllium oxide.
Finally, OSHA asked the peer
reviewers to evaluate its treatment of
lung cancer in the earlier draft
preliminary risk assessment (OSHA,
2010b). When that document was
prepared, OSHA had elected not to
conduct a lung cancer risk assessment.
The Agency believed that the exposureresponse data available to conduct a
lung cancer risk assessment from a
Sanderson et al. study of a Reading, PA
beryllium plant by was highly
problematic. The Sanderson study
primarily involved workers with
extremely high and short-term
exposures above airborne exposure
levels of interest to OSHA (2 mg/m3 and
below).
Just prior to arranging the peer
review, a NIOSH study was published
by Schubauer-Berigan et al. updating
the Reading, PA cohort studied by
Sanderson et al. and adding cohorts
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47652
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
from two additional plants in Elmore,
OH and Hazleton, PA (SchubauerBerigan, 2011). At OSHA’s request, the
peer reviewers reviewed this study to
determine whether it could provide a
better basis for lung cancer risk analysis
than the Sanderson et al. study. The
reviewers found that the NIOSH update
addressed the major concerns OSHA
had expressed about the Sanderson
study. In particular, they pointed out
that workers in the Elmore and Hazleton
cohorts had longer tenure at the plants
and experienced lower exposures than
those at the Reading, PA plant. Dr.
Steenland recommended that ‘‘OSHA
consider the new NIOSH data and
develop risk estimates for lung cancer as
well as sensitization and CBD.’’ Dr.
Breysse believed that the NIOSH data
‘‘suggest that a risk assessment for lung
cancer should be conducted by OSHA
and the results be compared to the CBD/
sensitization risk assessment before
recommending an appropriate exposure
concentration.’’ While acknowledging
the improvements in the quality of the
data, other reviewers were more
restrained in their support for
quantitative estimates of lung cancer
risk. Dr. Gordon stated that despite
improvements, there was ‘‘still
uncertainty associated with the paucity
of data below the current PEL of 2 mg/
m3.’’ Dr. Rossman noted that the NIOSH
study ‘‘did not address the problem of
the uncertainty of the mechanism of
beryllium carcinogenicity.’’ He felt that
the updated NIOSH lung cancer
mortality data ‘‘should not change the
Agency’s rationale for choosing to
establish its risk findings for the
proposed rule on its analysis for
beryllium sensitization and CBD.’’ Dr.
Balmes agreed that ‘‘the agency will be
on firmer ground by focusing on
sensitization and CBD.’’
The preliminary risk assessment
preamble subsection VI.G on lung
cancer includes a discussion of the
quantitative lung cancer risk assessment
published by NIOSH researchers in
2010 (Schubauer-Berigan, 2011). The
discussion describes the lower exposure
levels, longer tenure, fewer short-term
workers and additional years of
observation that make the data more
suitable for risk assessment. NIOSH
relied on several modeling approaches
to show that lung cancer risk was
significantly related to both mean and
cumulative beryllium exposure.
Subsection VI.G provides the excess
lifetime lung cancer risks predicted
from several best-fitting NIOSH models
at beryllium exposures of interest to
OSHA (Table VI–20). Using the
piecewise log-linear proportional
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
hazards model favored by NIOSH, there
is a projected drop in excess lifetime
lung cancer risks from approximately 61
cases per 1000 exposed workers at the
current PEL of 2.0 mg/m3 to
approximately 6 cases per 1000 at the
proposed PEL of 0.2 mg/m3. Subsection
VI.H on preliminary conclusions
indicates that these projections support
a reduced risk of lung cancer from more
stringent control of beryllium exposures
but that the lung cancer risk estimates
are more uncertain than those for
sensitization and CBD.
VIII. Significance of Risk
To promulgate a standard that
regulates workplace exposure to toxic
materials or harmful physical agents,
OSHA must first determine that the
standard reduces a ‘‘significant risk’’ of
‘‘material impairment.’’ The first part of
this requirement, ‘‘significant risk,’’
refers to the likelihood of harm, whereas
the second part, ‘‘material impairment,’’
refers to the severity of the
consequences of exposure.
The Agency’s burden to establish
significant risk is based on the
requirements of the OSH Act (29 U.S.C.
651 et seq). Section 3(8) of the Act
requires that workplace safety and
health standards be ‘‘reasonably
necessary or appropriate to provide safe
or healthful employment’’ (29 U.S.C.
652(8)). The Supreme Court, in the
Benzene decision, interpreted section
3(8) to mean that ‘‘before promulgating
any standard, the Secretary must make
a finding that the workplaces in
question are not safe’’ (Industrial Union
Department, AFL–CIO v. American
Petroleum Institute, 448 U.S. 607, 642
(1980) (plurality opinion)). Examining
section 3(8) more closely, the Court
described OSHA’s obligation to
demonstrate significant risk:
‘‘[S]afe’’ is not the equivalent of ‘‘risk-free.’’
A workplace can hardly be considered
‘‘unsafe’’ unless it threatens the workers with
a significant risk of harm. Therefore, before
the Secretary can promulgate any permanent
health or safety standard, he must make a
threshold finding that the place of
employment is unsafe in the sense that
significant risks are present and can be
eliminated or lessened by a change in
practices (Id).
As the Court made clear, the Agency
has considerable latitude in defining
significant risk and in determining the
significance of any particular risk. The
Court did not specify a means to
distinguish significant from
insignificant risks, but rather instructed
OSHA to develop a reasonable approach
to making a significant risk
determination. The Court stated that ‘‘it
is the Agency’s responsibility to
PO 00000
Frm 00088
Fmt 4701
Sfmt 4702
determine in the first instance what it
considers to be a ’significant’ risk,’’ (448
U.S. at 655) and it did not express ‘‘any
opinion on the . . . difficult question of
what factual determinations would
warrant a conclusion that significant
risks are present which make
promulgation of a new standard
reasonably necessary or appropriate’’
(448 U.S. at 659). The Court also stated
that, while OSHA’s significant risk
determination must be supported by
substantial evidence, the Agency ‘‘is not
required to support the finding that a
significant risk exists with anything
approaching scientific certainty’’ (448
U.S. at 656). Furthermore:
A reviewing court [is] to give OSHA some
leeway where its findings must be made on
the frontiers of scientific knowledge . . . .
[T]he Agency is free to use conservative
assumptions in interpreting the data with
respect to carcinogens, risking error on the
side of overprotection rather than
underprotection [so long as such
assumptions are based on] a body of
reputable scientific thought (448 U.S. at 656).
Thus, to make the significance of risk
determination for a new or proposed
standard, OSHA uses the best available
scientific evidence to identify material
health impairments associated with
potentially hazardous occupational
exposures and to evaluate exposed
workers’ risk of these impairments.
The OSH Act also requires that the
Agency make a finding that the toxic
material or harmful physical agent at
issue causes material impairment to
worker health. In that regard, the Act
directs the Secretary of Labor to set
standards based on the available
evidence where no employee, over his/
her working life time, will suffer from
material impairment of health or
functional capacity, even if such
employee has regular exposure to the
hazard, to the exent feasible (29 U.S.C.
655(b)(5)).
As with significant risk, what
constitutes material impairment in any
given case is a policy determination for
which OSHA is given substantial
leeway. ‘‘OSHA is not required to state
with scientific certainty or precision the
exact point at which each type of [harm]
becomes a material impairment’’ (AFL–
CIO v. OSHA, 965 F.2d 962, 975 (11th
Cir. 1992)). Courts have also noted that
OSHA should consider all forms and
degrees of material impairment—not
just death or serious physical harm—
and that OSHA may act with a
‘‘pronounced bias towards worker
safety’’ (Id; Bldg & Constr. Trades Dep’t
v. Brock, 838 F.2d 1258, 1266 (D.C. Cir.
1988)). OSHA’s long-standing policy is
to consider 45 years as a ‘‘working life,’’
E:\FR\FM\07AUP2.SGM
07AUP2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
over which it must evaluate material
impairment and risk.
In formulating this proposed
beryllium standard, OSHA has reviewed
the best available evidence pertaining to
the adverse health effects of
occupational beryllium exposure,
including lung cancer and chronic
beryllium disease (CBD), and has
evaluated the risk of these effects from
exposures allowed under the current
standard as well as the expected impact
of the proposed standard on risk. Based
on its review of extensive
epidemiological and experimental
research, OSHA has preliminarily
determined that long-term exposure at
the current Permissible Exposure Limit
(PEL) would pose a significant risk of
material impairment to workers’ health,
and that adoption of the new PEL and
other provisions of the proposed rule
will substantially reduce this risk.
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
A. Material Impairment of Health
In this preamble at section V, Health
Effects, OSHA reviewed the scientific
evidence linking occupational beryllium
exposure to a variety of adverse health
effects, including CBD and lung cancer.
Based on this review, OSHA
preliminarily concludes that beryllium
exposure causes these effects. The
Agency’s preliminary conclusion was
strongly supported by a panel of
independent peer reviewers, as
discussed in section VII.
Here, OSHA discusses its preliminary
conclusion that CBD and lung cancer
constitute material impairments of
health, and briefly reviews other
adverse health effects that can result
from beryllium exposure. Based on this
preliminary conclusion and on the
scientific evidence linking beryllium
exposure to both CBD and lung cancer,
OSHA concludes that occupational
exposure to beryllium causes ‘‘material
impairment of health or functional
capacity’’ within the meaning of the
OSH Act.
1. Chronic Beryllium Disease
CBD is a respiratory disease in which
the body’s immune system reacts to the
presence of beryllium in the lung,
causing a progression of pathological
changes including chronic inflammation
and tissue scarring. CBD can also impair
other organs such as the liver, skin,
spleen, and kidneys and cause adverse
health effects such as granulomas of the
skin and lymph nodes and cor
pulmonale (i.e., enlargement of the
heart) (Conradi et al., 1971; ACCP, 1965;
Kriebel et al., 1988a and b). In early,
asymptomatic stages of CBD, small
granulomatous lesions and mild
inflammation occur in the lungs. Early
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
stage CBD among some workers has
been observed to progress to more
serious disease even after the worker is
removed from exposure (Mroz, 2009),
probably because common forms of
beryllium have slow clearance rates and
can remain in the lung for years after
exposure. Sood et al. has reported that
cessation of exposure can sometimes
have beneficial effects on lung function
(Sood et al., 2004). However, this was
based on a small study of six patients
with CBD, and more research is needed
to better determine the relationship
between exposure duration and disease
progression. In general, progression of
CBD from early to late stages is
understood to vary widely, responding
differently to exposure cessation and
treatment for different individuals
(Sood, 2009; Mroz, 2009).
Over time, the granulomas can spread
and lead to lung fibrosis (scarring) and
moderate to severe loss of pulmonary
function, with symptoms including a
persistent dry cough and shortness of
breath (Saber and Dweik, 2000). Fatigue,
night sweats, chest and joint pain,
clubbing of fingers (due to impaired
oxygen exchange), loss of appetite, and
unexplained weight loss may occur as
the disease progresses. Corticosteroid
therapy, in workers whose beryllium
exposure has ceased, has been shown to
control inflammation, ease symptoms
(e.g., difficulty breathing, fever, cough,
and weight loss) and in some cases
prevent the development of fibrosis
(Marchand-Adam et al., 2008). Thus
early treatment can lead to CBD
regression in some patients, although
there is no cure (Sood, 2004). Other
patients have shown short-term
improvements from corticosteroid
treatment, but then developed serious
fibrotic lesions (Marchand-Adam et al.,
2008). Once fibrosis has developed in
the lungs, corticosteroid treatment
cannot reverse the damage (Sood, 2009).
Persons with late-stage CBD experience
severe respiratory insufficiency and may
require supplemental oxygen (Rossman,
1991). Historically, late-stage CBD often
ended in death (NAS, 2008).
While the use of steroid therapy has
mitigated CBD mortality, treatment with
corticosteroids has side effects that need
to be measured against the possibility of
progression of disease (Trikudanathan
and McMahon, 2008; Lipworth, 1999;
Gibson et al., 1996; Zaki et al., 1987).
Adverse effects associated with longterm corticosteroid use include, but are
not limited to, increased risk of
opportunistic infections (Lionakis and
Kontoyiannis, 2003; Trikudanathan and
McMahon, 2008); accelerated bone loss
or osteoporosis leading to increased risk
of fractures or breaks (Hamida et al.,
PO 00000
Frm 00089
Fmt 4701
Sfmt 4702
47653
2011; Lehouck et al., 2011; Silva et al.,
2011; Sweiss et al., 2011; Langhammer
et al., 2009); psychiatric effects
including depression, sleep
disturbances, and psychosis
(Warrington and Bostwick, 2006;
Brown, 2009); adrenal suppression
(Lipworth, 1999; Frauman, 1996); ocular
effects including cataracts, ocular
hypertension, and glaucoma (Ballonzolli
and Bourchier, 2010; Trikudanathan
and McMahon, 2008; Lipworth, 1999);
an increase in glucose intolerance
(Trikudanathan and McMahon, 2008);
excessive weight gain (McDonough et
al., 2008; Torres and Nowson, 2007;
Dallman et al., 2007; Wolf, 2002;
Cheskin et al., 1999); increased risk of
atherosclerosis and other cardiovascular
syndromes (Franchimont et al., 2002);
skin fragility (Lipworth, 1999); and poor
wound healing (de Silva and Fellows,
2010). Studies relating the long-term
effect of corticosteroid use for the
treatment of CBD need to be undertaken
to evaluate the treatment’s overall
effectiveness against the risk of adverse
side effects from continued usage.
OSHA considers late-stage CBD to be
a material impairment of health, as it
involves permanent damage to the
pulmonary system, causes additional
serious adverse health effects, can have
adverse occupational and social
consequences, requires treatment
associated with severe and lasting side
effects, and may in some cases be lifethreatening. Furthermore, OSHA
believes that material impairment
begins prior to the development of
symptoms of the disease.
Although there are no symptoms
associated with early-stage CBD, during
which small lesions and inflammation
appear in the lungs, the Agency has
preliminarily concluded that the earliest
stage of CBD is material impairment of
health. OSHA bases this conclusion on
evidence showing that early-stage CBD
is a measurable change in the state of
health which, with and sometimes
without continued exposure, can
progress to symptomatic disease. Thus,
prevention of the earliest stages of CBD
will prevent development of more
serious disease. The OSHA Lead
Standard established the Agency’s
position that a ‘subclinical’ health effect
may be regarded as a material
impairment of health. In the preamble to
that standard, the Agency said:
OSHA believes that while incapacitating
illness and death represent one extreme of a
spectrum of responses, other biological
effects such as metabolic or physiological
changes are precursors or sentinels of disease
which should be prevented . . . Rather than
revealing beginnings of illness the standard
must be selected to prevent an earlier point
E:\FR\FM\07AUP2.SGM
07AUP2
47654
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
of measurable change in the state of health
which is the first significant indicator of
possibly more severe ill health in the future.
The basis for this decision is twofold—first,
pathophysiologic changes are early stages in
the disease process which would grow worse
with continued exposure and which may
include early effects which even at early
stages are irreversible, and therefore
represent material impairment themselves.
Secondly, prevention of pathophysiologic
changes will prevent the onset of the more
serious, irreversible and debilitating
manifestations of disease.11 (43 FR 52952,
52954, November 14, 1978)
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Since the Lead rulemaking, OSHA has
also found other non-symptomatic
health conditions to be material
impairments of health. In the
Bloodborne Pathogens (BP) rulemaking,
OSHA maintained that material
impairment includes not only workers
with clinically ‘‘active’’ hepatitis from
the hepatitis B virus (HBV) but also
includes asymptomatic HBV ‘‘carriers’’
who remain infectious and are able to
put others at risk of serious disease
through contact with body fluids (e.g.,
blood, sexual contact) (56 FR 64004,
December 6, 1991). OSHA stated:
‘‘Becoming a carrier [of Hepatitis B] is
a material impairment of health even
though the carrier may have no
symptoms. This is because the carrier
will remain infectious, probably for the
rest of his or her life, and any person
who is not immune to HBV who comes
in contact with the carrier’s blood or
certain other body fluids will be at risk
of becoming infected’’ (56 FR 64004,
64036).
OSHA preliminarily finds that earlystage CBD is the type of asymptomatic
health effect the Agency determined to
be a material impairment of health in
the lead standard. Early stage CBD
involves lung tissue inflammation
without symptomatology that can
worsen with—or without—continued
exposure. The lung pathology
progresses over time from a chronic
inflammatory response to tissue scarring
and fibrosis accompanied by moderate
to severe loss in pulmonary function.
Early stage CBD is clearly a precursor of
advanced clinical disease, prevention of
which will prevent symptomatic
11 Even if asymptomatic CBD were not itself a
material impairment of health, the D.C. Circuit
upheld OSHA’s authority to regulate to prevent
subclinical health effects as precursors to disease in
United Steelworkers of America, AFL–CIO v.
Marshall, 647 F.2d 1189, 1252 (D.C. Cir. 1980),
which reviewed the Lead standard. Without
deciding whether the early symptoms of disease
were themselves a material impairment, the court
concluded that OSHA may regulate subclinical
effects if it can demonstrate on the basis of
substantial evidence that preventing subclinical
effects would help prevent the clinical phase of
disease (Id.).
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
disease. OSHA argued in the Lead
standard that such precursor effects
should be considered material health
impairments in their own right, and that
the Agency should act to prevent them
when it is feasible to do so. Therefore,
OSHA preliminarily finds all stages of
CBD to be material impairments of
health.
2. Lung Cancer
OSHA considers lung cancer, a
frequently fatal disease, to be a material
impairment of health. OSHA’s finding
that inhaled beryllium causes lung
cancer is based on the best available
epidemiological data, reflects evidence
from animal and mechanistic research,
and is consistent with the conclusions
of other government and public health
organizations (see this preamble at
section V, Health Effects). For example,
the International Agency for Research
on Cancer (IARC), National Toxicology
Program (NTP), and American
Conference of Governmental Industrial
Hygienists (ACGIH) have all classified
beryllium as a known human
carcinogen (IARC, 2009).
The Agency’s epidemiological
evidence comes from multiple studies of
U.S. beryllium workers (Sanderson et
al., 2001a; Ward et al., 1992; Wagoner
et al., 1980; Mancuso et al., 1979). Most
recently, a NIOSH cohort study found
significantly increased lung cancer
mortality among workers at seven
beryllium processing facilities
(Schubauer-Berigan et al., 2011). The
cohort was exposed, on average, to
lower levels of beryllium than those in
most previous studies, had fewer shortterm workers, and had sufficient followup time to observe lung cancer in the
population. OSHA considers the
Schubauer-Berigan study to be the best
available epidemiological evidence
regarding the risk of lung cancer from
beryllium at exposure levels near the
PEL.12
Supporting evidence of beryllium
carcinogenicity comes from various
animal studies as well as in vitro
genotoxicity and other studies (EPA,
1998; ATSDR, 2002; Gordon and
Bowser, 2003; NAS, 2008; Nickell-Brady
et al., 1994; NTP, 1999 and 2005; IARC,
1993 and 2009). Multiple mechanisms
may be involved in the carcinogenicity
of beryllium, and factors such as
epigenetics, mitogenicity, reactive
oxygen-mediated indirect genotoxicity,
and chronic inflammation may
contribute to the lung cancer associated
12 The scientific peer review panel for OSHA’s
Preliminary Risk Assessment agreed with the
Agency that the Schubauer-Berigan analysis
improves upon the previously available data for
lung cancer risk assessment.
PO 00000
Frm 00090
Fmt 4701
Sfmt 4702
with beryllium exposure, although the
results of studies testing the direct
genotoxicity of beryllium are mixed
(EPA summary, 1998). While there is
uncertainty regarding the exact
mechanism of carcinogenesis for
beryllium, the overall weight of
evidence for the carcinogenicity of
beryllium is strong. Therefore, the
Agency has preliminarily determined
beryllium to be an occupational
carcinogen.
3. Other Impairments
While OSHA has relied primarily on
the relationship between occupational
beryllium exposure and CBD and lung
cancer to demonstrate the necessity of
the standard, the Agency has also
determined that several other adverse
health effects can result from exposure
to beryllium. Inhalation of high airborne
concentrations of beryllium (well above
the 2 mg/m3 OSHA PEL) can cause acute
beryllium disease, a severe (sometimes
fatal), rapid-onset inflammation of the
lungs. Hepatic necrosis, damage to the
heart and circulatory system, chronic
renal disease, mucosal irritation and
ulceration, and urinary tract cancer have
also reportedly been associated with
occupational exposures well above the
current PEL (see this preamble at
section V, Health Effects, subsection E,
Epidemiological Studies, and subsection
F, Other Health Effects). These adverse
systemic effects and acute beryllium
disease mostly occurred prior to the
introduction of occupational and
environmental standards set in 1970–
1972 (OSHA, 1971; ACGIH, 1971; ANSI,
1970) and 1974 (EPA, 1974) and
therefore are less relevant today than in
the past. Because they occur only rarely
in current-day occupational
environments, they are not addressed in
OSHA’s risk analysis or significance of
risk determination.
The Agency has also determined that
beryllium sensitization, a precursor
which occurs before early stage CBD
and is an essential step for worker
development of the disease, can result
from exposure to beryllium. The Agency
takes no position at this time on
whether sensitization constitutes a
material impairment of health, because
it was unnecessary to do so as part of
this rulemaking. As discussed in
Section V, Health Effects, only
sensitized individuals can develop CBD
(NAS, 2008). OSHA’s risk assessment
for sensitization informs the Agency’s
understanding of what exposure control
measures have been successful in
preventing sensitization, which in turn
prevents development of CBD.
Therefore sensitization is considered in
the next section on significance of risk.
E:\FR\FM\07AUP2.SGM
07AUP2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
In AFL–CIO v. Marshall, 617 F.2d 636,
654 n.83 (D.C. Cir. 1979) (Cotton Dust),
the D.C. Circuit upheld OSHA’s
authority to regulate to prevent
precursors to a material impairment of
health without deciding whether the
precursors themselves constituted
material impairment of health.
B. Significance of Risk and Risk
Reduction
To evaluate the significance of the
health risks that result from exposure to
hazardous chemical agents, OSHA relies
on the best available epidemiological,
toxicological, and experimental
evidence. The Agency uses both
qualitative and quantitative methods to
characterize the risk of disease resulting
from workers’ exposure to a given
hazard over a working lifetime at levels
of exposure reflecting compliance with
current standards and compliance with
the new standards being proposed.
As discussed above, the Agency’s
characterization of risk is guided in part
by the Benzene decision. In Benzene,
the Court broadly describes the range of
risks OSHA might determine to be
significant:
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
It is the Agency’s responsibility to
determine in the first instance what it
considers to be a ‘‘significant’’ risk. Some
risks are plainly acceptable and others are
plainly unacceptable. If, for example, the
odds are one in a billion that a person will
die from cancer by taking a drink of
chlorinated water, the risk clearly could not
be considered significant. On the other hand,
if the odds are one in a thousand that regular
inhalation of gasoline vapors that are 2
percent benzene will be fatal, a reasonable
person might well consider the risk
significant and take the appropriate steps to
decrease or eliminate it (Benzene, 448 U.S. at
655).
The Court further stated, ‘‘The
requirement that a ’significant’ risk be
identified is not a mathematical
straitjacket. . . . Although the Agency
has no duty to calculate the exact
probability of harm, it does have an
obligation to find that a significant risk
is present before it can characterize a
place of employment as ’unsafe’, ‘‘and
proceed to promulgate a regulation (Id.).
In this preamble at section VI,
Preliminary Risk Assessment, OSHA
finds that the available epidemiological
data are sufficient to evaluate risk for
beryllium sensitization, CBD, and lung
cancer among beryllium-exposed
workers. The preliminary findings from
this assessment are summarized below.
1. Risk of Beryllium Sensitization and
CBD
OSHA’s preliminary risk assessment
for CBD and beryllium sensitization
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
relies on studies conducted at a Tucson,
AZ beryllium ceramics plant (Kreiss et
al., 1996; Henneberger et al., 2001;
Cummings et al., 2006); a Reading, PA
alloy processing plant (Schuler et al.,
2005; Thomas et al., 2009); a Cullman,
AL beryllium machining plant (Kelleher
et al., 2001; Madl et al., 2007); and an
Elmore, OH metal, alloy, and oxide
production plant (Kreiss et al., 1997;
Bailey et al., 2010; Schuler et al., 2012).
The Agency uses these studies to
demonstrate the significance of risk at
the current PEL and the significant
reduction in risk expected with
reduction of the PEL. In addition to the
effects OSHA anticipates from reduction
of airborne beryllium exposure, the
Agency expects that dermal protection
provisions in the proposed rule will
further reduce risk. Studies conducted
in the 1950s by Curtis et al. showed that
soluble beryllium particles could
penetrate the skin and cause beryllium
sensitization (Curtis 1951, NAS 2008).
Tinkle et al. established that 0.5- and
1.0-mm particles can penetrate intact
human skin surface and reach the
epidermis, where beryllium particles
would encounter antigen-presenting
cells and initiate sensitization (Tinkle et
al., 2003). Tinkle et al. further
demonstrated that beryllium oxide and
beryllium sulfate, applied to the skin of
mice, generate a beryllium-specific, cellmediated immune response similar to
human beryllium sensitization (Tinkle
et al., 2003). In the epidemiological
studies discussed below, the exposure
control programs that most effectively
reduced the risk of beryllium
sensitization and CBD incorporated both
respiratory and dermal protection.
OSHA has preliminarily determined
that an effective exposure control
program should incorporate both
airborne exposure reduction and dermal
protection provisions.
In the Tucson ceramics plant, 4,133
short-term breathing zone
measurements collected between 1981
and 1992 had a median of 0.3 mg/m3.
Kreiss et al. reported that eight (5.9
percent) of 136 workers tested for
beryllium sensitization in 1992 were
sensitized, six (4.4 percent) of whom
were diagnosed with CBD. Exposure
control programs were initiated in 1992
to reduce workers’ airborne beryllium
exposure, but the programs did not
address dermal exposure. Full-shift
personal samples collected between
1994 and 1999 showed a median
beryllium exposure of 0.2 mg/m3 in
production jobs and 0.1 mg/m3 in
production support (Cummings et al.,
2007). In 1998, a second screening
found that 6, (9 percent) of 69 tested
PO 00000
Frm 00091
Fmt 4701
Sfmt 4702
47655
workers hired after the 1992 screening,
were sensitized, of whom 1 was
diagnosed with CBD. All of the
sensitized workers had been employed
at the plant for less than 2 years
(Henneberger et al., 2001), too short a
time period for most people to develop
CBD following sensitization. Of the 77
Tucson workers hired prior to 1992 who
were tested in 1998, 8 (10.4 percent)
were sensitized and all but 1 of these
(9.7 percent) were diagnosed with CBD
(Henneberger et al., 2001).
Kreiss et al., studied workers at a
beryllium metal, alloy, and oxide
production plant in Elmore, OH.
Workers participated in a BeLPT survey
in 1992 (Kreiss et al., 1997). Personal
lapel samples collected during 1990–
1992 had a median value of 1.0 mg/m3.
Kreiss et al. reported that 43 (6.9
percent) of 627 workers tested in 1992
were sensitized, 6 of whom were
diagnosed with CBD (4.4 percent).
Newman et al. conducted a series of
BeLPT screenings of workers at a
Cullman, AL precision machining
facility between 1995 and 1999
(Newman et al., 2001). Personal lapel
samples collected at this plant in the
early 1980s and in 1995 from all
machining processes combined had a
median of 0.33 mg/m3 (Madl et al.,
2007). After a sentinel case of CBD was
diagnosed at the plant in 1995, the
company implemented engineering and
administrative controls and PPE
designed to reduce workers’ beryllium
exposures in machining operations.
Personal lapel samples collected
extensively between 1996 and 1999 in
machining jobs have an overall median
of 0.16 mg/m3, showing that the new
controls reduced machinists’ exposures
during this period. However, the results
of BeLPT screenings conducted in
1995–1999 showed that the exposure
control program initiated in 1995 did
not sufficiently protect workers from
beryllium sensitization and CBD. In a
group of 60 workers who had been
employed at the plant for less than a
year, and thus would not have been
working there prior to 1995, 4 (6.7
percent) were found to be sensitized.
Two of these workers (3.35 percent)
were diagnosed with CBD. (Newman et
al., 2001).
Sensitization and CBD were studied
in a population of workers at a Reading,
PA copper beryllium plant, where alloys
containing a low level of beryllium were
processed (Schuler et al., 2005).
Personal lapel samples were collected in
production and production support jobs
between 1995 and May 2000. These
samples showed primarily very low
airborne beryllium levels, with a
median of 0.073 mg/m3. The wire
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47656
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
annealing and pickling process had the
highest personal lapel sample values,
with a median of 0.149 mg/m3. Despite
these low exposure levels, a BeLPT
screening conducted in 2000 showed
that 5, (11.5 percent) workers of 43
hired after 1992 were sensitized
(evaluation for CBD not reported). Two
of the sensitized workers had been hired
less than a year before the screening
(Thomas et al., 2009).
In summary, the epidemiological
literature on beryllium sensitization and
CBD that OSHA’s risk assessment relied
on show sensitization prevalences
ranging from 6.5 percent to 11.5 percent
and CBD prevalences ranging from 1.3
percent to 9.7 percent among workers
who had full-shift exposures well below
the current PEL and median full-shift
exposures at or below the proposed PEL,
and whose follow-up time was less than
45 years. As referenced earlier, OSHA is
interested in the risk associated with a
45-year (i.e., working lifetime) exposure.
Because CBD often develops over the
course of years following sensitization,
the risk of CBD that would result from
45 years’ occupational exposure to
airborne beryllium is likely to be higher
than the prevalence of CBD observed
among these workers.13 In either case,
based on these studies, the risks to
workers appear to be significant.
The available epidemiological
evidence shows that reducing workers’
levels of airborne beryllium exposure
can substantially reduce risk of
beryllium sensitization and CBD. The
best available evidence on effective
exposure control programs comes partly
from studies of programs introduced
around 2000 at Reading, Tucson, and
Elmore that used a combination of
engineering controls, dermal and
respiratory PPE, and stringent
housekeeping measures to reduce
workers’ dermal exposures and airborne
exposures to levels well below the
proposed PEL of 0.2 mg/m3. These
programs have substantially lowered the
risk of sensitization among new
workers. As discussed earlier,
prevention of beryllium sensitization
prevents subsequent development of
CBD.
In the Reading, PA copper beryllium
plant, full-shift airborne exposures in all
jobs were reduced to a median of 0.1 mg/
m3 or below and dermal protection was
required for production-area workers
beginning in 2000–2001 (Thomas et al.,
2009). After these adjustments were
made, 2 (5.4 percent) of 37 newly hired
workers became sensitized. Thereafter,
13 This point was emphasized by members of the
scientific peer review panel for OSHA’s Preliminary
Risk Assessment (see this preamble at section VII).
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
in 2002, the process with the highest
exposures (median 0.1 mg/m3) was
enclosed and workers involved in that
process were required to use respiratory
protection. As a result, the remaining
jobs had very low exposures (medians ∼
0.03 mg/m3). Among 45 workers hired
after the enclosure was built and
respiratory protection instituted, 1 was
found to be sensitized (2.2 percent).
This is a sharp reduction in
sensitization from the 11.5 percent of 43
workers, discussed above, who were
hired after 1992 and had been sensitized
by the time of testing in 2000.
In the Tucson beryllium ceramics
plant, respiratory and skin protection
was instituted for all workers in
production areas in 2000. BeLPT testing
done in 2000–2004 showed that only 1
(1 percent) worker had been sensitized
out of 97 workers hired during that time
period (Cummings et al., 2007; testing
for CBD not reported). This contrasts
with the prevalence of sensitization in
the 1998 Tucson BeLPT screening,
which found that 6 (9 percent) of 69
workers hired after 1992 were sensitized
(Cummings et al., 2007).
The modern Elmore facility provides
further evidence that combined
reductions in respiratory exposure (via
respirator use) and dermal exposure are
effective in reducing risk of beryllium
sensitization. In Elmore, historical
beryllium exposures were higher than in
Tucson, Reading, and Cullman. Personal
lapel samples collected at Elmore in
1990–1992 had a median of 1.0 mg/m3.
In 1996–1999, the company took steps
to reduce workers’ beryllium exposures,
including engineering and process
controls (Bailey et al., 2010; exposure
levels not reported). Skin protection was
not included in the program until after
1999. Beginning in 1999 all new
employees were required to wear loosefitting powered air-purifying respirators
(PAPR) in manufacturing buildings
(Bailey et al., 2010). Skin protection
became part of the protection program
for new employees in 2000, and glove
use was required in production areas
and for handling work boots beginning
in 2001. Bailey et al., (2010) compared
the occurrence of beryllium
sensitization and CBD in 2 groups of
workers: 1) 258 employees who began
work at the Elmore plant between
January 15, 1993 and August 9, 1999
(the ‘‘pre-program group’’) and were
tested in 1997 and 1999, and 2) 290
employees who were hired between
February 21, 2000 and December 18,
2006 and underwent BeLPT testing in at
least one of frequent rounds of testing
conducted after 2000 (the ‘‘program
group’’). They found that, as of 1999, 23
(8.9 percent) of the pre-program group
PO 00000
Frm 00092
Fmt 4701
Sfmt 4702
were sensitized to beryllium. The
prevalence of sensitization among the
‘‘program group’’ workers, who were
hired after the respiratory protection
and PPE measures were put in place,
was around 2–3 percent. Respiratory
protection and skin protection
substantially reduced, but did not
eliminate, risk of sensitization.
Evaluation of sensitized workers for
CBD was not reported.
OSHA’s preliminary risk assessment
also includes analysis of a data set
provided to OSHA by the National
Jewish Research and Medical Center
(NJMRC). The data set describes a
population of 319 beryllium-exposed
workers at a Cullman, AL machining
facility. It includes exposure samples
collected between 1980 and 2005, and
has updated work history and screening
information for over three hundred
workers through 2003. Seven (2.2
percent) workers in the data set were
reported as sensitized only. Sixteen (5.0
percent) workers were listed as
sensitized and diagnosed with CBD
upon initial clinical evaluation. Three
(1.0 percent) workers, first shown to be
sensitized only, were later diagnosed
with CBD. The data set includes
workers exposed at airborne beryllium
levels near the proposed PEL, and
extensive exposure data collected in
workers’ breathing zones, as is preferred
by OSHA. Unlike the Tucson, Reading,
and Elmore facilities, respirator use was
not generally required for workers at the
Cullman facility. Thus, analysis of this
data set shows the risk associated with
varying levels of airborne exposure,
rather than the virtual elimination of
airborne exposure via respiratory PPE.
Also unlike the Tucson, Elmore, and
Reading facilities, glove use was not
reported to be mandatory in the
Cullman facility. Thus, OSHA believes
reductions in risk at the Cullman facility
to be the result of airborne exposure
control, rather than the combination of
airborne and dermal exposure controls
at the Tucson, Elmore, and Reading
facilities.
OSHA analyzed the prevalence of
beryllium sensitization and CBD among
workers at the Cullman facility who
were exposed to airborne beryllium
levels at and below the current PEL of
2 mg/m3. In addition, a statistical
modeling analysis of the NJMRC
Cullman data set was conducted under
contract with Dr. Roslyn Stone of the
University of Pittsburgh Graduate
School of Public Heath, Department of
Biostatistics. OSHA summarizes these
analyses briefly below, and in more
detail in this preamble at section VI,
Preliminary Risk Assessment.
E:\FR\FM\07AUP2.SGM
07AUP2
47657
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
Tables 1 and 2 below present the
prevalence of sensitization and CBD
cases across several categories of
lifetime-weighted (LTW) average and
highest-exposed job (HEJ) exposure at
the Cullman facility. The HEJ exposure
is the exposure level associated with the
highest-exposure job and time period
experienced by each worker. The
columns ‘‘Total’’ and ‘‘Total percent’’
refer to all sensitized workers in the
dataset, including workers with and
without a diagnosis of CBD.
TABLE 1—PREVALENCE OF SENSITIZATION AND CBD BY LIFETIME WEIGHTED AVERAGE EXPOSURE QUARTILE, CULLMAN,
AL MACHINING FACILITY
LTW Average exposure (μg/m3)
Group size
Sensitized
only
CBD
Total
Total %
CBD %
0.0–0.080 .................................................
0.081–0.18 ...............................................
0.19–0.51 .................................................
0.51–2.15 .................................................
91
73
77
78
1
2
0
4
1
4
6
8
2
6
6
12
2.2
8.2
7.8
15.4
1.0
5.5
7.8
10.3
Total ..................................................
319
7
19
26
8.2
6.0
Source: Section VI, Preliminary Risk Assessment.
TABLE 2—PREVALENCE OF SENSITIZATION AND CBD BY HIGHEST-EXPOSED JOB EXPOSURE QUARTILE, CULLMAN, AL
MACHINING FACILITY
HEJ Exposure (μg/m3)
Group size
Sensitized
only
CBD
Total
Total %
CBD %
0.0–0.086 .................................................
0.091–0.214 .............................................
0.387–0.691 .............................................
0.954–2.213 .............................................
86
81
76
76
1
1
2
3
0
6
9
4
1
7
11
7
1.2
8.6
14.5
9.2
0.0
7.4
11.8
5.3
Total ..................................................
319
7
19
26
8.2
6.0
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Source: Section VI, Preliminary Risk Assessment.
The current PEL of 2 mg/m3 is close
to the upper bound of the highest
quartile of LTW average (0.51–2.15 mg/
m3) and HEJ (0.954–2.213) exposure
levels. In the highest quartile of LTW
average exposure, there were 12 cases of
sensitization (15.4 percent), including 8
(10.3 percent) diagnosed with CBD.
Notably, the Cullman workers had been
exposed to beryllium dust for
considerably less than 45 years at the
time of testing. A high prevalence of
sensitization (9.2 percent) and CBD (5.3
percent) is seen in the top quartile of
HEJ exposure as well, with even higher
prevalences in the third quartile (0.387–
0.691 mg/m3).14
The proposed PEL of 0.2 mg/m3 is
close to the upper bound of the second
quartile of LTW average (0.81–0.18 mg/
m3) and HEJ (0.091–0.214 mg/m3)
exposure levels and to the lower bound
of the third quartile of LTW average
(0.19–0.50 mg/m3) exposures. The
second quartile of LTW average
exposure shows a high prevalence of
beryllium-related health effects, with six
workers sensitized (8.2 percent), of
whom four (5.5 percent) were diagnosed
with CBD. The second quartile of HEJ
exposure also shows a high prevalence
of beryllium-related health effects, with
seven workers sensitized (8.6 percent),
of whom 6 (7.4 percent) were diagnosed
with CBD. Among six sensitized
workers in the third quartile of LTW
average exposures, all were diagnosed
with CBD (7.8 percent). The prevalence
of CBD among workers in these quartiles
was approximately 5–8 percent, and
overall sensitization (including workers
with and without CBD) was about 8
percent. OSHA considers these rates as
evidence that the risk of developing
CBD is significant among workers
exposed at and below the current PEL,
even down to the proposed PEL. Much
lower prevalences of sensitization and
CBD were found among workers with
exposure levels less than or equal to
about 0.08 mg/m3. Two sensitized
workers (2.2 percent), including 1 case
of CBD (1.0 percent), were found among
workers with LTW average exposure
levels and HEJ exposure levels less than
or equal to 0.08 mg/m3 and 0.086 mg/m3,
respectively. Strict control of airborne
exposure to levels below 0.1 mg/m3 can,
therefore, significantly reduce risk of
sensitization and CBD. Although OSHA
recognizes that maintaining exposure
levels below 0.1 mg/m3 may not be
feasible in some operations (see this
preamble at section IX, Summary of the
Preliminary Economic Analysis and
Initial Regulatory Flexibility Analysis),
the Agency believes that workers in
facilities that meet the proposed action
level of 0.1 mg/m3 will be at less risk of
sensitization and CBD than workers in
facilities that cannot meet the action
level.
Table 3 below presents the prevalence
of sensitization and CBD cases across
cumulative exposure quartiles, based on
the same Cullman data used to derive
Tables 1 and 2. Cumulative exposure is
the sum of a worker’s exposure across
the duration of his employment.
14 This exposure-response pattern is sometimes
attributed to a ‘‘healthy worker effect’’ or to
exposure misclassification, as discussed in this
preamble at section VI, Preliminary Risk
Assessment.
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
PO 00000
Frm 00093
Fmt 4701
Sfmt 4702
E:\FR\FM\07AUP2.SGM
07AUP2
47658
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
TABLE 3—PREVALENCE OF SENSITIZATION AND CBD BY CUMULATIVE EXPOSURE QUARTILE CULLMAN, AL MACHINING
FACILITY
Cumulative exposure (μg/m3 yrs)
Group size
Sensitized
only
CBD
Total
Total %
CBD %
0.0–0.147 .................................................
0.148–1.467 .............................................
1.468–7.008 .............................................
7.009–61.86 .............................................
81
79
79
80
2
0
3
2
2
2
8
7
4
2
11
9
4.9
2.5
13.9
11.3
2.5
2.5
8.0
8.8
Total ..................................................
319
7
19
26
8.2
6.0
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Source: Section VI, Preliminary Risk Assessment.
A 45-year working lifetime of
occupational exposure at the current
PEL would result in 90 mg/m 3-years, a
value far higher than the cumulative
exposures of workers in this data set,
who worked for periods of time less
than 45 years and whose exposure
levels were mostly well below the PEL.
Workers with 45 years of exposure to
the proposed PEL would have a
cumulative exposure (9 mg/m 3-years) in
the highest quartile for this worker
population. As with the average and HEJ
exposures, the greatest risk of
sensitization and CBD appears at high
exposure levels (≤ 1.468 mg/m 3-years).
The third cumulative quartile, at which
a sharp increase in sensitization and
CBD appears, is bounded by 1.468 and
7.008 mg/m 3-years. This is equivalent to
0.73–3.50 years of exposure at the
current PEL of 2 mg/m 3, or 7.34–35.04
years of exposure at the proposed PEL
of 0.2 mg/m 3. Prevalence of both
sensitization and CBD is substantially
lower in the second cumulative quartile
(0.148–1.467 mg/m 3-years). This is
equivalent to approximately 0.7 to 7
years at the proposed PEL of 0.2 mg/m 3,
or 1.5 to 15 years at the proposed action
level of 0.1 mg/m 3. This supports that
maintaining exposure levels below the
proposed PEL, where feasible, will help
to protect long-term workers against risk
of beryllium sensitization and early
stage CBD.
As discussed in the Health Effects
section (V.D), CBD often worsens with
increased time and level of exposure. In
a longitudinal study, workers initially
identified as beryllium sensitized
through workplace surveillance
developed early stage CBD defined by
granulomatous inflammation but no
apparent physiological abnormalities
(Newman et al., 2005). A study of
workers with this early stage CBD
showed significant declines in breathing
capacity and gas exchange over the 30
years from first exposure (Mroz et al.,
2009). Many of the workers went on to
develop more severe disease that
required immunosuppressive therapy
despite being removed from exposure.
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
While precise beryllium exposure levels
were not available on the individuals in
these studies, most started work in the
1980s and 1990s and were likely
exposed to average levels below the
current 2 mg/m 3 PEL. The evidence for
time-dependent disease progression
indicates that the CBD risk estimates for
a 45-year lifetime exposure at the
current PEL will include a higher
proportion of individuals with
advanced clinical CBD than found
among the workers in the NJMRC data
set.
Studies of community-acquired (CA)
CBD support the occurrence of
advanced clinical CBD from long-term
exposure to airborne beryllium
(Eisenbud, 1998; Maier et al., 2008). A
discussion of the study findings can be
found in this preamble at section VI.C,
Preliminary Risk Assessment. For
example, one study evaluated 16
potential cases of CA–CBD in
individuals that resided near a
beryllium production facility in the
years between 1943 and 2001 (Maier et
al., 2008). Five cases of definite CBD
and three cases of probable CBD were
found. Two of the subjects with
probable cases died before they could be
confirmed with the BeLPT; the third
had an abnormal BeLPT and
radiography consistent with CBD, but
granulomatous disease was not
pathologically proven. The individuals
with CA–CBD identified in this study
suffered significant health impacts from
the disease, including obstructive,
restrictive, and gas exchange pulmonary
defects. Six of the eight cases required
treatment with prednisone, a step
typically reserved for severe cases due
to the adverse side effects of steroid
treatment. Despite treatment, three had
died of respiratory impairment as of
2002. There was insufficient
information to estimate exposure to the
individuals, but the limited amount of
ambient air sampling in the 1950s
suggested that average beryllium levels
in the area where the cases resided were
below 2 mg/m 3. The authors concluded
that ‘‘low levels of exposures with
PO 00000
Frm 00094
Fmt 4701
Sfmt 4702
significant disease latency can result in
significant morbidity and mortality’’
(Maier et al., 2008, p. 1017).
OSHA believes that the literature
review, prevalence analysis, and the
evidence for time-dependent
progression of CBD described above
provide sufficient information to draw
preliminary conclusions about
significance of risk, and that further
quantitative analysis of the NJMRC data
set is not necessary to support the
proposed rule. The studies OSHA used
to support its preliminary conclusions
regarding risk of beryllium sensitization
and CBD were conducted at modern
industrial facilities with exposure levels
in the range of interest for this
rulemaking, so a model is not needed to
extrapolate risk estimates from high to
low exposures, as has often been the
case in previous rules. Nevertheless, the
Agency felt further quantitative analysis
might provide additional insight into
the exposure-response relationship for
sensitization and CBD.
Using the NJMRC data set, Dr. Stone
ran a complementary log-log
proportional hazards model, an
extension of logistic regression that
allows for time-dependent exposures
and differential time at risk. Relative
risk of sensitization increased with
cumulative exposure (p = 0.05). A
positive, but not statistically significant
association was observed with LTW
average exposure (p = 0.09). There was
little association with highest-exposed
job (HEJ) exposure (p = 0.3). Similarly,
the proportional hazards models for the
CBD endpoint showed positive
relationships with cumulative exposure
(p = 0.09), but LTW average exposure
and HEJ exposure were not closely
related to relative risk of CBD (p-values
> 0.5). Dr. Stone used the cumulative
exposure models to generate risk
estimates for sensitization and CBD.
Tables 4 and 5 below present risk
estimates from these models, assuming
5, 10, 20, and 45 years of beryllium
exposure. The tables present
sensitization and CBD risk estimates
based on year-specific intercepts, as
E:\FR\FM\07AUP2.SGM
07AUP2
47659
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
explained in the section on Risk
Assessment and the accompanying
background document. Each estimate
represents the number of sensitized
workers the model predicts in a group
of 1000 workers at risk during the given
year with an exposure history at the
specified level and duration. For
example, in the exposure scenario for
1995, if 1000 workers were
occupationally exposed to 2 mg/m 3 for
10 years, the model predicts that about
56 (55.7) workers would be identified as
sensitized. The model for CBD predicts
that about 42 (41.9) workers would be
diagnosed with CBD that year. The year
1995 shows the highest risk estimates
generated by the model for both
sensitization and CBD, while 1999 and
2002 show the lowest risk estimates
generated by the model for sensitization
and CBD, respectively. The
corresponding 95 percent confidence
intervals are based on the uncertainty in
the exposure coefficient.
TABLE 4a—PREDICTED CASES OF SENSITIZATION PER 1000 WORKERS EXPOSED AT CURRENT AND ALTERNATE PELS
BASED ON PROPORTIONAL HAZARDS MODEL, CUMULATIVE EXPOSURE METRIC, WITH CORRESPONDING INTERVAL
BASED ON THE UNCERTAINTY IN THE EXPOSURE COEFFICIENT. 1995 BASELINE.
1995
Exposure duration
5 years
Exposure level
(μg/m3)
10 years
Cumulative
(μg/m3-yrs)
cases/1000
2.0 ....................................
10.0
1.0 ....................................
5.0
0.5 ....................................
2.5
0.2 ....................................
1.0
0.1 ....................................
0.5
41.1
30.3–56.2
35.3
30.3–41.3
32.7
30.3–35.4
31.3
30.3–32.3
30.8
30.3–31.3
μg/m3-yrs
20.0
10.0
5.0
2.0
1.0
20 years
cases/1000
μg/m3-yrs
55.7
30.3–102.9
41.1
30.3–56.2
35.3
30.3–41.3
32.2
30.3–34.3
31.3
30.3–32.3
45 years
cases/1000
40.0
101.0
30.3–318.1
55.7
30.3–102.9
41.1
30.3–56.2
34.3
30.3–38.9
32.2
30.3–34.3
20.0
10.0
4.0
2.0
μg/m3-yrs
90.0
45.0
22.5
9.0
4.5
cases/1000
394.4
30.3–999.9
116.9
30.3–408.2
60.0
30.3–119.4
39.9
30.3–52.9
34.8
30.3–40.1
Source: Section VI, Preliminary Risk Assessment.
TABLE 4b—PREDICTED CASES OF SENSITIZATION PER 1000 WORKERS EXPOSED AT CURRENT AND ALTERNATE PELS
BASED ON PROPORTIONAL HAZARDS MODEL, CUMULATIVE EXPOSURE METRIC, WITH CORRESPONDING INTERVAL
BASED ON THE UNCERTAINTY IN THE EXPOSURE COEFFICIENT. 1999 BASELINE.
1999
Exposure duration
5 years
Exposure level (μg/m3)
10 years
Cumulative
(μg/m3-yrs)
cases/1000
2.0 ....................................
10.0
1.0 ....................................
5.0
0.5 ....................................
2.5
0.2 ....................................
1.0
0.1 ....................................
0.5
8.4
6.2–11.6
7.2
6.2–8.5
6.7
6.2–7.3
6.4
6.2–6.6
6.3
6.2–6.4
μg/m3-yrs
20 years
cases/1000
20.0
μg/m3-yrs
11.5
6.2–21.7
8.4
6.2–11.6
7.2
6.2–8.5
6.6
6.2–7.0
6.4
6.2–6.6
10.0
5.0
2.0
1.0
45 years
cases/1000
40.0
21.3
6.2–74.4
11.5
6.2–21.7
8.4
6.2–11.6
7.0
6.2–8.0
6.6
6.2–7.0
20.0
10.0
4.0
2.0
μg/m3-yrs
90.0
45.0
22.5
9.0
4.5
cases/1000
96.3
6.2–835.4
24.8
6.2–100.5
12.4
6.2–25.3
8.2
6.2–10.9
7.1
6.2–8.2
Source: Section VI, Preliminary Risk Assessment.
TABLE 5a—PREDICTED NUMBER OF CASES OF CBD PER 1000 WORKERS EXPOSED AT CURRENT AND ALTERNATIVE
PELS BASED ON PROPORTIONAL HAZARDS MODEL, CUMULATIVE EXPOSURE METRIC, WITH CORRESPONDING INTERVAL BASED ON THE UNCERTAINTY IN THE EXPOSURE COEFFICIENT. 1995 BASELINE.
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
1995
Exposure duration
5 years
Exposure level
(μg/m3)
10 years
Cumulative
(μg/m3-yrs)
Estimated
cases/1000
(95% c.i.)
2.0 ....................................
10.0
1.0 ....................................
5.0
30.9
22.8–44.0
26.6
22.8–31.7
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
PO 00000
μg/m3-yrs
Frm 00095
20.0
10.0
Fmt 4701
20 years
Estimated
cases/1000
(95% c.i.)
41.9
22.8–84.3
30.9
22.8–44.0
Sfmt 4702
μg/m3-yrs
Estimated
cases/1000
(95% c.i.)
40.0
20.0
E:\FR\FM\07AUP2.SGM
76.6
22.8–285.5
41.9
22.8–84.3
07AUP2
45 years
μg/m3-yrs
90.0
45.0
Estimated
cases/1000
(95% c.i.)
312.9
22.8–999.9
88.8
22.8–375.0
47660
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
TABLE 5a—PREDICTED NUMBER OF CASES OF CBD PER 1000 WORKERS EXPOSED AT CURRENT AND ALTERNATIVE
PELS BASED ON PROPORTIONAL HAZARDS MODEL, CUMULATIVE EXPOSURE METRIC, WITH CORRESPONDING INTERVAL BASED ON THE UNCERTAINTY IN THE EXPOSURE COEFFICIENT. 1995 BASELINE.—Continued
1995
Exposure duration
5 years
Exposure level
(μg/m3)
10 years
Cumulative
(μg/m3-yrs)
Estimated
cases/1000
(95% c.i.)
0.5 ....................................
2.5
0.2 ....................................
1.0
0.1 ....................................
0.5
24.6
22.8–26.9
23.5
22.8–24.3
23.1
22.8–23.6
μg/m3-yrs
5.0
2.0
1.0
20 years
Estimated
cases/1000
(95% c.i.)
μg/m3-yrs
26.6
22.8–31.7
24.2
22.8–26.0
23.5
22.8–24.3
45 years
Estimated
cases/1000
(95% c.i.)
10.0
30.9
22.8–44.0
25.8
22.8–29.7
24.2
22.8–26.0
4.0
2.0
μg/m3-yrs
22.5
9.0
4.5
Estimated
cases/1000
(95% c.i.)
45.2
22.8–98.9
30.0
22.8–41.3
26.2
22.8–30.7
Source: Section VI, Preliminary Risk Assessment.
TABLE 5b—PREDICTED NUMBER OF CASES OF CBD PER 1000 WORKERS EXPOSED AT CURRENT AND ALTERNATIVE
PELS BASED ON PROPORTIONAL HAZARDS MODEL, CUMULATIVE EXPOSURE METRIC, WITH CORRESPONDING INTERVAL BASED ON THE UNCERTAINTY IN THE EXPOSURE COEFFICIENT. 2002 BASELINE.
2002
Exposure duration
5 years
Exposure level (μg/m3)
10 years
Cumulative
(μg/m3-yrs)
Estimated
cases/1000
(95% c.i.)
2.0 ....................................
10.0
1.0 ....................................
5.0
0.5 ....................................
2.5
0.2 ....................................
1.0
0.1 ....................................
0.5
3.7
2.7–5.3
3.2
2.7–3.8
3.0
2.7–3.2
2.8
2.7–2.9
2.8
2.7–2.8
μg/m3-yrs
20.0
10.0
5.0
2.0
1.0
20 years
Estimated
cases/1000
(95% c.i.)
μg/m3-yrs
5.1
2.7–10.4
3.7
2.7–5.3
3.2
2.7–3.8
2.9
2.7–3.1
2.8
2.7–2.9
45 years
Estimated
cases/1000
(95% c.i.)
40.0
20.0
10.0
4.0
2.0
9.4
2.7–39.2
5.1
2.7–10.4
3.7
2.7–5.3
3.1
2.7–3.6
2.9
2.7–3.1
μg/m3-yrs
90.0
45.0
22.5
9.0
4.5
Estimated
cases/1000
(95% c.i.)
43.6
2.7–679.8
11.0
2.7–54.3
5.5
2.7–12.3
3.6
2.7–5.0
3.1
2.7–3.7
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Source: Section VI, Preliminary Risk Assessment.
As shown in Tables 4 and 5, the
exposure-response models Dr. Stone
developed based on the Cullman data
set predict a high risk of both
sensitization (about 96–394 cases per
1000 exposed workers) and CBD (about
44–313 cases per 1000) at the current
PEL of 2 mg/m3 for an exposure duration
of 45 years (90 mg/m3-yr). For a 45-year
exposure at the proposed PEL of 0.2 mg/
m3, risk estimates for sensitization
(about 8–40 cases per 1000 exposed
workers) and CBD (about 4–30 per 1000
exposed workers) are substantially
reduced. Thus, the model predicts that
the risk of sensitization and CBD at a
PEL of 0.2 mg/m3 will be about 10
percent of the risk at the current PEL of
2 mg/m3.
OSHA does not believe the risk
estimates generated by these exposureresponse models to be highly accurate.
Limitations of the analysis include the
size of the dataset, relatively sparse
exposure data from the plant’s early
years, study size-related constraints on
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
the statistical analysis of the dataset,
and limited follow-up time on many
workers. The Cullman study population
is a relatively small group and can
support only limited statistical analysis.
For example, its size precludes
inclusion of multiple covariates in the
exposure-response models or a twostage exposure-response analysis to
model both sensitization and the
subsequent development of CBD within
the subpopulation of sensitized workers.
The limited size of the Cullman dataset
is characteristic of studies on berylliumexposed workers in modern, lowexposure environments, which are
typically small-scale processing plants
(up to several hundred workers, up to
20–30 cases).
Despite these issues with the
statistical analysis, OSHA believes its
main policy determinations are well
supported by the best available
evidence, including the literature
review and careful examination of the
prevalence of sensitization and CBD
PO 00000
Frm 00096
Fmt 4701
Sfmt 4702
among workers with exposure levels
comparable to the current and proposed
PELs in the NJMRC data set. The
previously described literature analysis
and prevalence analysis demonstrate
that workers with occupational
exposure to airborne beryllium at the
current PEL face a risk of becoming
sensitized to beryllium and progressing
to both early and advanced stages of
CBD that far exceeds the value of 1 in
1000 used by OSHA as a benchmark of
clearly significant risk. Furthermore,
OSHA’s preliminary risk assessment
indicates that risk of beryllium
sensitization and CBD can be
significantly reduced by reduction of
airborne exposure levels, along with
respiratory and dermal protection
measures, as demonstrated in facilities
such as the Tucson ceramics plant, the
Elmore beryllium production facility,
and the Reading copper beryllium
facility described in the literature
review.
E:\FR\FM\07AUP2.SGM
07AUP2
47661
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
OSHA’s preliminary risk assessment
also indicates that despite the reduction
in risk expected with the proposed PEL,
the risk to workers with average
exposure levels of 0.2 mg/m3 is still
clearly significant (see this preamble at
section VI). In the prevalence analysis,
workers with LTW average or HEJ
exposures close to 0.2 mg/m3
experienced high levels of sensitization
and CBD. This finding is corroborated
by the literature analysis, which showed
that workers exposed to mean plantwide airborne exposures between 0.1
and 0.5 mg/m3 had a similarly high
prevalence of sensitization and CBD.
Given the significant risk at these levels
of exposure, the Agency believes that
the proposed action level of 0.1 mg/m3,
dermal protection requirements, and
other ancillary provisions of the
proposed rule are key to reducing the
risk of beryllium sensitization and CBD
among exposed workers. OSHA
preliminarily concludes that the
proposed standard, including the PEL of
0.2 mg/m3, the action level of 0.1 mg/m3,
and provisions to limit dermal exposure
to beryllium, together will significantly
reduce workers’ risk of beryllium
sensitization and CBD from
occupational beryllium exposure.
2. Risk of Lung Cancer
OSHA’s review of epidemiological
studies of lung cancer mortality among
beryllium workers found that most did
not characterize exposure levels
sufficiently to characterize risk of lung
cancer at the current and proposed
PELs. However, as discussed in this
preamble at section V, Health Effects
and section VI, Preliminary Risk
Assessment, NIOSH recently published
a quantitative risk assessment based on
beryllium exposure and lung cancer
mortality among 5436 male workers
employed at beryllium processing
plants in Reading, PA; Elmore, OH; and
Hazleton, PA, prior to 1970 (SchubauerBerigan et al., 2010b). This new risk
assessment addresses important sources
of uncertainty for previous lung cancer
analyses, including the sole prior
exposure-response analysis for
beryllium and lung cancer, conducted
by Sanderson et al. (2001) on workers
from the Reading plant alone. Workers
from the Elmore and Hazleton plants
who were added to the analysis by
Schubauer-Berigan et al. were, in
general, exposed to lower levels of
beryllium than those at the Reading
plant. The median worker from
Hazleton had a mean exposure across
his tenure of less than 2 mg/m3, while
the median worker from Elmore had a
mean exposure of less than 1 mg/m3. The
Elmore and Hazleton worker
populations also had fewer short-term
workers than the Reading population.
Finally, the updated cohorts followed
the worker populations through 2005,
increasing the length of follow-up time
compared to the previous exposureresponse analysis. For these reasons,
OSHA based its preliminary risk
assessment for lung cancer on the
Schubauer-Berigan risk analysis.
Schubauer-Berigan et al. (2011)
analyzed the data set using a variety of
exposure-response modeling
approaches, described in this preamble
at section VI, Preliminary Risk
Assessment. The authors found that
lung cancer mortality risk was strongly
and significantly related to mean,
cumulative, and maximum measures of
workers’ exposure to beryllium (all
models reported in Schubauer-Berigan
et al., 2011). They selected the bestfitting models to generate risk estimates
for male workers with a mean exposure
of 0.5 mg/m3 (the current NIOSH
Recommended Exposure Limit for
beryllium). In addition, they estimated
the mean exposure that would be
associated with an excess lung cancer
mortality risk of one in one thousand.
At OSHA’s request, the authors also
estimated excess risks for workers with
mean exposures at each of the other
alternate PELs under consideration: 1
mg/m3, 0.2 mg/m3, and 0.1 mg/m3. Table
6 presents the estimated excess risk of
lung cancer mortality associated with
various levels of beryllium exposure
allowed under the current rule, based
on the final models presented in
Schubauer-Berigan et al’s risk
assessment.
TABLE 6—EXCESS RISK OF LUNG CANCER MORTALITY PER 1000 MALE WORKERS AT ALTERNATE PELS (NIOSH
MODELS)
Mean exposure
Exposure-response model
0.1 μg/m3
Best monotonic PWL—all workers ......................................
Best monotonic PWL—excluding professional and asbestos workers .......................................................................
Best categorical—all workers ..............................................
Best categorical—excluding professional and asbestos
workers .............................................................................
Power model—all workers ...................................................
Power model—excluding professional and asbestos workers .....................................................................................
0.2 μg/m3
0.5 μg/m3
1 μg/m3
2 μg/m3
7.3
15
45
120
200
3.1
4.4
6.4
9
17
25
39
59
61
170
1.4
12
2.7
19
7.1
30
15
40
33
52
19
30
49
68
90
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Source: Section VI, Preliminary Risk Assessment.
The lowest estimate of excess lung
cancer deaths from the six final models
presented by Schubauer-Berigan et al. is
33 per 1000 workers exposed at a mean
level of 2 mg/m3, the current PEL. Risk
estimates as high as 200 lung cancer
deaths per 1000 result from the other
five models presented. Regardless of the
model chosen, the excess risk of about
33 to 200 per 1000 workers is clearly
significant, falling well above the level
of risk the Supreme Court indicated a
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
reasonable person might consider
acceptable (See Benzene, 448 U.S. at
655). The proposed PEL of 0.2 mg/m3 is
expected to reduce these risks
significantly, to somewhere between
2.7–30 excess lung cancer deaths per
1000 workers. These risk estimates still
fall above the threshold of 1 in 1000 that
OSHA considers clearly significant.
However, the Agency believes the lung
cancer risks should be regarded with a
greater degree of uncertainty than the
PO 00000
Frm 00097
Fmt 4701
Sfmt 4702
risk estimates for CBD discussed
previously. While the risk estimates for
CBD at the proposed PEL were
determined from exposure levels
observed in occupational studies, the
lung cancer risks are extrapolated from
much higher exposure levels.
C. Conclusions
As discussed above, OSHA used the
best available scientific evidence to
identify adverse health effects of
E:\FR\FM\07AUP2.SGM
07AUP2
47662
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
occupational beryllium exposure, and to
evaluate exposed workers’ risk of these
impairments. The Agency reviewed
extensive epidemiological and
experimental research pertaining to
adverse health effects of occupational
beryllium exposure, including lung
cancer, immunological sensitization to
beryllium, and CBD, and has evaluated
the risk of these effects from exposures
allowed under the current and proposed
standards. The Agency has,
additionally, reviewed previous policy
determinations and case law regarding
material impairment of health, and has
preliminarily determined that CBD, in
all stages, and lung cancer constitute
material health impairments.
Furthermore, OSHA has preliminarily
determined that long-term exposure to
beryllium at the current PEL would pose
a risk of CBD and lung cancer greater
than the risk of 1 per 1000 exposed
workers the Agency considers clearly
significant. OSHA’s risk assessment for
beryllium indicates that adoption of the
new PEL, action level, and dermal
protection provisions of the proposed
rule will significantly reduce this risk.
OSHA therefore believes it has met the
statutory requirements pertaining to
significance of risk, consistent with the
OSH Act, Supreme Court precedent, and
the Agency’s previous policy decisions.
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
IX. Summary of the Preliminary
Economic Analysis and Initial
Regulatory Flexibility Analysis
A. Introduction and Summary
OSHA’s Preliminary Economic
Analysis and Initial Regulatory
Flexibility Analysis (PEA) addresses
issues related to the costs, benefits,
technological and economic feasibility,
and the economic impacts (including
impacts on small entities) of this
proposed respirable beryllium rule and
evaluates regulatory alternatives to the
proposed rule. Executive Orders 13563
and 12866 direct agencies to assess all
costs and benefits of available regulatory
alternatives and, if regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, and public health and
safety effects; distributive impacts; and
equity), unless a statute requires another
regulatory approach. Executive Order
13563 emphasized the importance of
quantifying both costs and benefits, of
reducing costs, of harmonizing rules,
and of promoting flexibility. The full
PEA has been placed in OSHA
rulemaking docket OSHA–H005C–
2006–0870. This rule is an economically
significant regulatory action under Sec.
3(f)(1) of Executive Order 12866 and has
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
been reviewed by the Office of
Information and Regulatory Affairs in
the Office of Management and Budget,
as required by executive order.
The purpose of the PEA is to:
• Identify the establishments and
industries potentially affected by the
proposed rule;
• Estimate current exposures and the
technologically feasible methods of
controlling these exposures;
• Estimate the benefits resulting from
employers coming into compliance with
the proposed rule in terms of reductions
in cases of lung cancer and chronic
beryllium disease;
• Evaluate the costs and economic
impacts that establishments in the
regulated community will incur to
achieve compliance with the proposed
rule;
• Assess the economic feasibility of
the proposed rule for affected
industries; and
• Assess the impact of the proposed
rule on small entities through an Initial
Regulatory Flexibility Analysis (IRFA),
to include an evaluation of significant
regulatory alternatives to the proposed
rule that OSHA has considered.
The PEA contains the following
chapters:
Chapter I. Introduction
Chapter II. Assessing the Need for Regulation
Chapter III. Profile of Affected Industries
Chapter IV. Technological Feasibility
Chapter V. Costs of Compliance
Chapter VI. Economic Feasibility Analysis
and Regulatory Flexibility Determination
Chapter VII. Benefits and Net Benefits
Chapter VIII. Regulatory Alternatives
Chapter IX. Initial Regulatory Flexibility
Analysis
The PEA includes all of the economic
analyses OSHA is required to perform,
including the findings of technological
and economic feasibility and their
supporting materials required by the
OSH Act as interpreted by the courts (in
Chapters III, IV, V, and VI); those
required by EO 12866 and EO 13563
(primarily in Chapters III, V, and VII,
though these depend on material in
other chapters); and those required by
the Regulatory Flexibility Act (in
Chapters VI, VIII, and IX, though these
depend, in part, on materials presented
in other chapters).
Key findings of these chapters are
summarized below and in sections IX.B
through IX.I of this PEA summary.
Profile of Affected Industries
This proposed rule would affect
employers and employees in many
different industries across the economy.
As described in Section IX.C and
reported in Table IX–2 of this preamble,
OSHA estimates that a total of 35,051
PO 00000
Frm 00098
Fmt 4701
Sfmt 4702
employees in 4,088 establishments are
potentially at risk from exposure to
beryllium.
Technological Feasibility
As described in more detail in Section
IX.D of this preamble and in Chapter IV
of the PEA, OSHA assessed, for all
affected sectors, the current exposures
and the technological feasibility of the
proposed PEL of 0.2 mg/m3.
Tables IX–5 in section IX.D of this
preamble summarizes all nine
application groups (industry sectors and
production processes) studied in the
technological feasibility analysis. The
technological feasibility analysis
includes information on current
exposures, descriptions of engineering
controls and other measures to reduce
exposures, and a preliminary
assessment of the technological
feasibility of compliance with the
proposed PELs.
The preliminary technological
feasibility analysis shows that for the
majority of the job groups evaluated,
exposures are either already at or below
the proposed PEL, or can be adequately
controlled with additional engineering
and work practice controls. Therefore,
OSHA preliminarily concludes that the
proposed PEL of 0.2 mg/m3 is
technologically feasible for most
operations most of the time.
Based on the currently available
evidence, it is more difficult to
determine whether an alternative PEL of
0.1 mg/m3 would also be feasible in most
operations. For some application
groups, a PEL of 0.1 mg/m3 would
almost certainly be feasible. In other
application groups, a PEL of 0.1 mg/m3
appears feasible, except for
establishments working with high
beryllium content alloys. For
application groups with the highest
exposure, the exposure monitoring data
necessary to more fully evaluate the
effectiveness of exposure controls
adopted after 2000 are not currently
available to OSHA, which makes it
difficult to determine the feasibility of
achieving exposure levels at or below
0.1 mg/m3.
OSHA also evaluated the feasibility of
a STEL of 2.0 mg/m3. The majority of the
available short-term measurements are
below 2.0 mg/m3; therefore OSHA
preliminarily concludes that the
proposed STEL of 2.0 mg/m3 can be
achieved for most operations most of the
time. OSHA recognizes that for a small
number of tasks, short-term exposures
may exceed the proposed STEL, even
after feasible control measures to reduce
TWA exposure to below the proposed
PEL have been implemented, and
therefore assumes that the use of
E:\FR\FM\07AUP2.SGM
07AUP2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
respiratory protection will continue to
be required for some short-term tasks. It
is more difficult based on the currently
available evidence to determine whether
the alternative STEL of 1.0 mg/m3 would
also be feasible in most operations based
on lack of detail in the activities of the
workers presented in the data. OSHA
expects additional use of respiratory
protection would be required for tasks
in which peak exposures can be reduced
to less than 2.0 mg/m3 but not less than
1.0 mg/m3. Due to limitations in the
available sampling data and the higher
detection limits for short term
measurements, OSHA could not
determine the percentage of the STEL
measurements that are less than or equal
to 0.5 mg/m3.
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Costs of Compliance
As described in more detail in Section
IX.E and reported, by application group
and NAICS code, in Table IX–7 of this
preamble, the total annualized cost of
compliance with the proposed standard
is estimated to be about $37.6 million.
The major cost elements associated with
the revisions to the standard are
housekeeping ($12.6 million),
engineering controls ($9.5 million),
training ($5.8 million), and medical
surveillance ($2.9 million).
The compliance costs are expressed as
annualized costs in order to evaluate
economic impacts against annual
revenue and annual profits, to be able to
compare the economic impact of the
rulemaking with other OSHA regulatory
actions, and to be able to add and track
Federal regulatory compliance costs and
economic impacts in a consistent
manner. Annualized costs also represent
a better measure for assessing the
longer-term potential impacts of the
rulemaking. The annualized costs were
calculated by annualizing the one-time
costs over a period of 10 years and
applying a discount rate of 3 percent
(and an alternative discount rate of 7
percent).
The estimated costs for the proposed
beryllium standard represent the
additional costs necessary for employers
to achieve full compliance. They do not
include costs associated with current
compliance that has already been
achieved with regard to the new
requirements or costs necessary to
achieve compliance with existing
beryllium requirements, to the extent
that some employers may currently not
be fully complying with applicable
regulatory requirements.
Economic Impacts
To assess the nature and magnitude of
the economic impacts associated with
compliance with the proposed rule,
OSHA developed quantitative estimates
of the potential economic impact of the
new requirements on entities in each of
the affected industry sectors. The
estimated compliance costs were
compared with industry revenues and
profits to provide an assessment of the
economic feasibility of complying with
the revised standard and an evaluation
of the potential economic impacts.
As described in greater detail in
Section IX.F of this preamble and in
Chapter VI of the PEA, the costs of
compliance with the proposed
rulemaking are not large in relation to
the corresponding annual financial
flows associated with each of the
affected industry sectors. The estimated
annualized costs of compliance
represent about 0.11 percent of annual
revenues and about 1.52 percent of
annual profits, on average, across all
affected firms. Compliance costs do not
represent more than 1 percent of
revenues or more than 16.25 percent of
profits in any affected industry.
Based on its analysis of the relative
inelasticity of demand for berylliumcontaining inputs and products and of
possible international trade effects,
OSHA concluded that most or all costs
arising from this proposed beryllium
rule would be passed on in higher
prices rather than absorbed in lost
profits and that any price increases
would result in minimal loss of business
to foreign competition.
Given the minimal potential impact
on prices or profits in the affected
industries, OSHA has preliminarily
concluded that compliance with the
requirements of the proposed
rulemaking would be economically
feasible in every affected industry
sector.
Benefits, Net Benefits, and CostEffectiveness
As described in more detail in Section
VIII.G of this preamble, OSHA estimated
the benefits, net benefits, and
incremental benefits of the proposed
beryllium rule. That section also
contains a sensitivity analysis to show
how robust the estimates of net benefits
are to changes in various cost and
47663
benefit parameters. A full explanation of
the derivation of the estimates presented
there is provided in Chapter VII of the
PEA for the proposed rule.
OSHA estimated the benefits
associated with the proposed beryllium
PEL of 0.2 mg/m3 and, for analytical
purposes to comply with OMB Circular
A–4, with alternative beryllium PELs of
.1 mg/m3 and .5 mg/m3 by applying the
dose-response relationship developed in
the Agency’s preliminary risk
assessment—summarized in Section VI
of this preamble—to current exposure
levels. OSHA determined current
exposure levels by first developing an
exposure profile for industries with
workers exposed to beryllium, using
OSHA inspection and site-visit data,
and then applying this exposure profile
to the total current worker population.
The industry-by-industry exposure
profile is summarized in Table IX–3 in
Section IX.C of this preamble.
By applying the dose-response
relationship to estimates of current
exposure levels across industries, it is
possible to project the number of cases
of the following diseases expected to
occur in the worker population given
current exposure levels (the ‘‘baseline’’):
• fatal cases of lung cancer,
• fatal cases of chronic beryllium
disease (CBD), and
• morbidity related to chronic
beryllium disease.
Table IX–1 provides a summary of
OSHA’s best estimate of the costs and
benefits of the proposed rule. As shown,
the proposed rule, once it is fully
effective, is estimated to prevent 96
fatalities and 50 non-fatal berylliumrelated illnesses annually, and the
monetized annualized benefits of the
proposed rule are estimated to be $575.8
million using a 3-percent discount rate
and $255.3 million using a 7-percent
discount rate. Also as shown in Table
IX–1, the estimated annualized cost of
the rule is $37.6 million using a 3percent discount rate and $39.1 million
using a 7-percent discount rate. The
proposed rule is estimated to generate
net benefits of $538.2 million annually
using a 3-percent discount rate and
$216.2 million annually using a 7percent discount rate. The estimated
costs and benefits of the proposed rule,
disaggregated by industry sector, were
previously presented in Table I–1 in this
preamble.
TABLE IX–1—ANNUALIZED COSTS, BENEFITS AND NET BENEFITS OF OSHA’S PROPOSED BERYLLIUM STANDARD OF 0.2
μg/m3
Discount Rate ......................................................................................................................
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
PO 00000
Frm 00099
Fmt 4701
Sfmt 4702
E:\FR\FM\07AUP2.SGM
3%
07AUP2
7%
47664
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
TABLE IX–1—ANNUALIZED COSTS, BENEFITS AND NET BENEFITS OF OSHA’S PROPOSED BERYLLIUM STANDARD OF 0.2
μg/m3—Continued
Annualized Costs
Engineering Controls ....................................................................................................
Respirators ...................................................................................................................
Exposure Assessment ..................................................................................................
Regulated Areas and Beryllium Work Areas ...............................................................
Medical Surveillance .....................................................................................................
Medical Removal ..........................................................................................................
Exposure Control Plan .................................................................................................
Protective Clothing and Equipment ..............................................................................
Hygiene Areas and Practices .......................................................................................
Housekeeping ...............................................................................................................
Training .........................................................................................................................
Total Annualized Costs (Point Estimate) .............................................................................
Annual Benefits: Number of Cases Prevented
Fatal Lung Cancer ........................................................................................................
CBD-Related Mortality ..................................................................................................
Total Beryllium Related Mortality .................................................................................
Morbidity .......................................................................................................................
Monetized Annual Benefits (midpoint estimate) ..................................................................
Net Benefits .........................................................................................................................
$9,540,189
249,684
2,208,950
629,031
2,882,076
148,826
1,769,506
1,407,365
389,241
12,574,921
5,797,535
37,597,325
4.0
92.0
96.0
49.5
$10,334,036
252,281
2,411,851
652,823
2,959,448
166,054
1,828,766
1,407,365
389,891
12,917,944
5,826,975
39,147,434
$572,981,864
2,844,770
575,826,633
538,229,308
$253,743,368
1,590,927
255,334,295
216,186,861
Source: OSHA, Directorate of Standards and Guidance, Office of Regulatory Analysis.
Initial Regulatory Flexibility Analysis
OSHA has prepared an Initial
Regulatory Flexibility Analysis (IRFA)
in accordance with the requirements of
the Regulatory Flexibility Act, as
amended in 1996. Among the contents
of the IRFA are an analysis of the
potential impact of the proposed rule on
small entities and a description and
discussion of significant alternatives to
the proposed rule that OSHA has
considered. The IRFA is presented in its
entirety both in Chapter IX of the PEA
and in Section IX.I of this preamble.
The remainder of this section (Section
IX) of the preamble is organized as
follows:
B. The Need for Regulation
C. Profile of Affected Industry
D. Technological Feasibility Analysis
E. Costs of Compliance
F. Economic Feasibility Analysis and
Regulatory Flexibility Determination
G. Benefits and Net Benefits
H. Regulatory Alternatives
I. Initial Regulatory Flexibility Analysis.
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
B. Need for Regulation
Employees in work environments
addressed by the proposed beryllium
rule are exposed to a variety of
significant hazards that can and do
cause serious injury and death. As
described in Chapter II of the PEA in
support of the proposed rule, the risks
to employees are excessively large due
to the existence of various types of
market failure, and existing and
alternative methods of overcoming these
negative consequences—such as
workers’ compensation systems, tort
liability options, and information
dissemination programs—have been
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
shown to provide insufficient worker
protection.
After carefully weighing the various
potential advantages and disadvantages
of using a regulatory approach to
improve upon the current situation,
OSHA preliminarily concludes that, in
the case of beryllium exposure, the
proposed mandatory standards
represent the best choice for reducing
the risks to employees. In addition,
rulemaking is necessary in this case in
order to replace older existing standards
with updated, clear, and consistent
health standards.
C. Profile of Affected Industries
1. Introduction
Chapter III of the PEA presents a
profile of industries that use beryllium,
beryllium oxide, and/or beryllium
alloys. The discussion below
summarizes the findings in that chapter.
For each industry sector identified, the
Agency describes the uses of beryllium
and estimates the number of
establishments and employees that may
be affected by this proposed rulemaking.
Employee exposure to beryllium can
also occur as a result of certain
processes such as welding that are
found in many industries. OSHA uses
the umbrella term ‘‘application group’’
to refer either to an industrial sector or
a cross-industry group with a common
process. These groups are all mutually
exclusive and are analyzed in separate
sections in Chapter III of the PEA. These
sections briefly describe each
application group and then explain how
OSHA estimated the number of
establishments working with beryllium
and the number of employees exposed
PO 00000
Frm 00100
Fmt 4701
Sfmt 4702
to beryllium. Beryllium is rarely used by
all establishments in any particular
application group because its unique
properties and relatively high cost
typically result in only very specific and
limited usage within a portion of a
group.
The information in Chapter III of the
PEA is based on reports prepared under
task order by Eastern Research Group
(ERG), an OSHA contractor; information
collected during OSHA’s Small
Business Advocacy Review Panel
(OSHA 2008b); and Agency research
and analysis. Technological feasibility
reports (summarized in Chapter IV of
the PEA) for each beryllium-using
application group provide a detailed
presentation of processes and
occupations with beryllium exposure,
including available sampling exposure
measurements and estimates of how
many employees are affected in each
specific occupation.
OSHA has identified nine application
groups that would be potentially
affected by the proposed beryllium
standard:
1. Beryllium Production
2. Beryllium Oxide Ceramics and
Composites
3. Nonferrous Foundries
4. Secondary Smelting, Refining, and
Alloying
5. Precision Turned Products
6. Copper Rolling, Drawing, and
Extruding
7. Fabrication of Beryllium Alloy
Products
8. Welding
9. Dental Laboratories
These application groups are broadly
defined, and some include
establishments in several North
E:\FR\FM\07AUP2.SGM
07AUP2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
American Industrial Classification
System (NAICS) codes. For example, the
Copper Rolling and Drawing, and
Extruding application group is made up
both of NAICS 331421 Copper Rolling,
Drawing, and Extruding and NAICS
331422 Copper Wire Drawing. While an
application group may contain
numerous NAICS six-digit industry
codes, in most cases only a fraction of
the establishments in any individual
six-digit NAICS industry use beryllium
and would be affected by the proposed
rule. For example, not all companies in
the above application group work with
copper that contains beryllium.
One application group, welding,
reflects industrial activities or processes
that take place in various industry
sectors. All of the industries in which a
given activity or process may result in
worker exposure to beryllium are
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
identified in the sections on the
application group. The section on each
application group describes the
production processes where
occupational contact with beryllium can
occur and contains estimates of the total
number of firms, employees, affected
establishments, and affected employees.
Chapter III of the PEA presents
formulas in the text, usually in
parentheses, to help explain the
derivation of estimates. Because the
values used in the formulas shown in
the text are sometimes rounded, while
the actual spreadsheet formulas used to
create final costs are not, the calculation
using the presented formula will
sometimes differ slightly from the total
presented in the text—which is the
actual total as shown in the tables.
At the end of Chapter III in the PEA,
OSHA discusses other industry sectors
PO 00000
Frm 00101
Fmt 4701
Sfmt 4702
47665
that have reportedly used beryllium in
the past or for which there are anecdotal
or informal reports of beryllium use.
The Agency was unable to verify
beryllium use in these sectors that
would be affected by the proposed
standard, and seeks further information
in this rulemaking on these or other
industries where there may be
significant beryllium use and employee
exposure.
2. Summary of Affected Establishments
and Employers
As shown in Table IX–2, OSHA
estimates that a total of 35,051 workers
in 4,088 establishments will be affected
by the proposed beryllium standard.
Also shown are the estimated annual
revenues for these entities.
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47666
VerDate Sep<11>2014
Jkt 235001
PO 00000
NAICS
Industry
Beryllium Production
331419 Primary Smelting and
Fmt 4701
Sfmt 4725
Nonferrous Foundnes
331521 Alum1num die-casting
331522 Nonferrous (except
331524 Alum1num foundries
Frm 00102
Beryllium Oxide Ceramics and Composites
327113a Porcelain electrical supply
327113b Porcelain electrical supply
334220 Cellular telephones
334310 Compact disc players
334411 Electron Tube
334415 Electronic resistor
334419 Other electronic
334510 Electromedical equipment
336322b Other motor vehicle
E:\FR\FM\07AUP2.SGM
07AUP2
EP07AU15.003</GPH>
331 ~??~. Copp~~ .f?undn~~ .(~~cept
331525b Copperfoundnes (except
Secondary Smelt1ng, Refming, and Alloying
331314 Secondary smelt1ng &
331421b Copper rolling, dravvmg,
331423 Secondary smelting,
331492 Secondary Smelting,
Precision Machining
332721a Precision turned product
332721 b Precision turned product
Total Entitles [a]
Total Establishments [a]
Total Employees [a]
Affected Entitles [b]
Affected Establishments
Affected Employees
Total Revenues
Revenues/Entlt
Revenues/Establishment {$1,000)
140
161
8,943
1
1
616
58,524,863
$60,892
$52,949
94
94
4,310
4,310
79,732
2
12
9
5
16
10
8
8
9
2
14
10
5
21
12
9
9
10
83
168
120
60
252
144
108
108
120
789,731
789,731
$8,401
$8,401
$7,450
$7,450
3S,~75,3~3
$~8,999
$~3,797
460
62
50
1,058
555
585
106
106
810
464
79
61
1,133
629
636
3,975,351
$8,642
$19,685
$11,219
228
137
365
201
201
254
140
394
208
208
18,017
6
6,362
15,178
S,123
37
7
19
24
7
38
7
20
25
98
534
98
281
1,510,799
2,518,097
1,205,574
393
1,205,574
98
70
23
217
122
4,846
1
1
3
30
9
9
27
270
$49,358
$39,649
9,849
789
1
1
3
26
4,837,129
96
12,513,425
723,759
$178,763
$130,348
$31,468
$37,769
$30,157
$33,048
18
288
18
294
222
3,542
$4,338
$4,338
$4,245
$4,245
72~
24
248
8,858
4,884
3,722
,16,836
66,107
38,475
5,123
9,696
3,057
3,124
78,749
3,057
3,124
78,749
1,220,476
560,967
10,013,730
17,480,966
12,152,053
4,310,021
8,195,807
13,262,706
13,262,706
$8,568
$49,515
$20,773
$15,449
$9,195
$8,838
$43,690
$19,107
$18,904
$11,028
$5,880
$S,998
$5,998
$10,791
$6,391
$5,796
$5,796
$9,~65
$16,969
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
19:20 Aug 06, 2015
Table IX-2
CHARACTERISTICS OF INDUSTRIES AFFECTED BY OSHA'S PROPOSED STANDARD FOR BERYLLIUM-ALL ENTITIES
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
VerDate Sep<11>2014
Jkt 235001
NAICS
Industry
Copper Rollmg, Drawng and Extrudmg
331422 Copper Wre (except
331421 a .Copper roll1ng, draWng,
PO 00000
Frm 00103
Stamping, Spring, and Connector Manufacturing
332612 ·Light gauge spring
332116 Metal stamping
334417. Electronic connector
336322a Other motor vehicle
Dental Laboratones
339116 ·Dental laboratories
62121 0 Offices of dent1sts
Fmt 4701
Sfmt 4725
E:\FR\FM\07AUP2.SGM
07AUP2
Arc and Gas Welding
331111 Iron and Steel Mills
331221 Rolled Steel Shape
331513 Steel Foundries (except
332117: POVI.der Metallurgy Part
332212 Hand and Edge Tool
332312 ·Fabricated Structural
332313 Plate Work Manufactunng
332322. Sheet Metal Work
332323 ·Ornamental and
332439 Other Metal Container
33291 9 ·Other Metal Valve and
332999 All Other Miscellaneous
333111 . Farm Machinery and
333414a Heating Equipment
333911 :Pump and Pumpmg
333922 Conveyor and Conveying
333924 ·Industrial Truck, Tractor,
333999 All Other Miscellaneous
336211 . Motor Vehicle Body
336214 ·Travel Trailer and Camper
336399a All Other Motor Vehicle
336510 ·Railroad Rolling Stock
336999 All Other Transportation
337215. ShoV\Case, Partition,
811310 Commercial and lndustnal
Total Entitles [a]
Total Establishments [a]
Total Employees [a]
Affected Establishments
Affected Employees
84
70
114
96
9,847
9,849
43
11
59
15
5,096
1,539
6,471,491
12,513,425
269
1,413
323
2,167,977
9,749,800
5,029,508
38,475
70
40
146
323
74
46
159
2,071
231
636
10,329
48,855
19,538
269
1,484
198
585
6,718
123,322
6,995
129,830
461
134
203
121
999
587
161
220
133
3,081
1,066
3,407
44,030
1,680
1,749
846,092
226
238
94,089
5
1
1
1
3
51
21
64
38
6
2
33
19
6
5
9
4
17
13
12
6
2
4
3
132
7
1
1
1
3
56
21
69
39
7
3
33
20
9,971
13,874
6,707
25,098
89,728
1,252
1,288
28,400
3,907
2,314
'1,173
2,354
321
240
3,195
975
433
445
737
347
370
265
3,262
91,3611
30,029
12,553
1,463
1,524
651
602
742
683
11156
1,350
157
366
226
374
95,1126
24,491
10,846
1,144
1,194
33,195
20,299
21,960
181,220
1,041
460
571
776
374
Affected Entitles [b]
14,688
65,821
53,133
16,768
31,272
26,970
19,974
43,401
38,587
30,803
6
7
9
4
18
15
14
7
3
4
3
143
Total Revenues
Revenues/Entlt
Revenues/Establishment l$1,000]
$77,042
$56,767
$178,763
$130,348
$6,712
$6,570
$21,773
$19,107
496
310
1,066
12,152,053
$8,059
$6,900
$15,402
$10,773
8,148
1,107
4,100,626
100,431,324
$610
$814
$586
$774
27
$92,726,004
$201,141
$157,966
6
5
4
12
224
85
270
155
8,376,271
$62,509
$10,945
$52,027
$19,327
$11,687
$10,632
$5,083
$8,478
$4,811
$4,604
$2,467
$19,100
$4,370
$24,684
$11,043
$27,855
$8,913
$4,763
$7,666
$4,677
$4,311
$2,425
$9,638
$17,198
$4,281
$23,119
$10,395
$21,708
$8,465
$21,454
$19,905
$7,500
$15,150
$12,400
$7,200
$13,312
$10,930
27
11
134
80
24
27
36
17
71
60
55
30
11
14
13
571
4,251,852
1,414,108
5,077,868
26,119,614
6,023,356
17,988,908
5,708,707
3,565,875
4,584,082
13,963,184
$24,067,145
4,781,561
12,395,387
6,569,120
7,444,451
10,972,258
$9,877,558
7,465,024
32,279,766
$11,927,191
5,250,368
5,815,404
31,650,469
$11,109
$27,92'1
$231911
$75,969
$52,775
$14,345
$14,038
$5,083
$1,559
$4,871
$1,441
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
19:20 Aug 06, 2015
Table IX-2 1 continued
CHARACTERISTICS OF INDUSTRIES AFFECTED BY OSHA'S PROPOSED STANDARD FOR BERYLLIUM-ALL ENTITIES
47667
EP07AU15.004</GPH>
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47668
VerDate Sep<11>2014
Jkt 235001
PO 00000
Frm 00104
Fmt 4701
Sfmt 4725
E:\FR\FM\07AUP2.SGM
NAICS
Industry
·Resistance Welding
333411
333412
333414b
333415
335211
335212
335221
335222
335224
335228
336311
336312
336321
336322c
336330
336340
336350
336360
336370
336391
336399b
Total
Air Purification Equipment
Industrial and Commercial
Heating Equipment
Air-Conditioning Warm
Electnc Housev,.ares and
Household Vacuum
Household Cook mg
Household Refrigerator
Household Laundry
Other MaJor Household
Carburetor, Piston, Piston
Gasol1ne Engine and
Vehicular Lighting
Other Motor Vehicle
Motor Vehicle Steer1ng
Motor Vehicle Brake
Motor Vehicle
Motor Vehicle Seatmg and
Motor Vehicle Metal
Motor Vehicle A1rAll Other Motor Vehicle
All Affected Industries
Total Entities [a]
Total Establishments [a]
Total Employees [a]
303
135
433
695
101
29
91
16
9
34
97
697
86
585
209
159
397
305
599
358
151
460
843
106
96
22
11
38
109
742
93
636
246
199
476
403
736
11,521
6,908
16,768
79,651
5,980
2,577
9,730
9,731
8,051
9,023
7,370
36,896
9,218
38,475
26,118
20,245
51,171
39,805
66,985
72
1,156
80
1,350
11,207
95,426
"
Affected Entities [b]
Affected Establishments
21
g
30
49
5
1
5
1
1
2
5
35
4
29
10
8
20
15
30
4
58
3,795
Affected Employees
Total Revenues
Revenues/Entit
Revenues/Establishment l$1,000]
10
24
20
37
379
160
487
893
80
26
73
17
8
29
82
561
70
481
186
150
360
305
557
3,060,71]1]
1,681,585
4,781,561
25,454,383
2,209,657
891,600
3,757,849
4,489,845
3,720,514
3,499,273
1,715,1]29
20,000,705
2,322,610
12,152,053
8,856,584
8,147,826
21,862,014
15,168,862
19,809,238
$10,101
$12,456
$11,043
$36,625
$21,878
$30,,5
$41,295
$280,615
$413,390
$102,920
$17,685
$28,695
$27,007
$20,773
$42,376
$51,244
$55,068
$49,734
$33,071
$8,550
$11,136
$10,395
$30,195
$20,846
$26,22,
$39,144
$204,084
$338,229
$92,086
$15,738
$26,955
$24,974
$19,107
$36,002
$40,944
$45,929
$37,640
$26,915
4
68
4,088
61
1,021
35,051
3,798,464
32,279,766
$52,756
$27,924
$47,481
$23,911
25
11
32
59
5
2
5
1
1
2
5
37
5
32
12
[a] US Census Bureau, Statistics of US Busmesses, 2010
[b] OSHA estimates of employees potentially exposed to beryllium and associated ent1t1es and establishments Affected ent1t1es and establishments constrained to be less than or equal to the number of affected employees.
·[c] Estimates based on 2007 receipts and payroll data from US Census Bureau, Statistics of US Businesses 2007, and payroll data from the US Census Bureau, Statistics of US Bus messes, 2010. Rece1pts are not reported for 2010
but V\ere estimated assum1ng the rat1o of rece1pts to payroll rema1ned unchanged from 2007 to 2010.
·Source: US Dept. of Labor, OSHA, Directorate of Evaluation and Analysis, Office of Regulatory Analysis, based on ERG, 2012
07AUP2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
19:20 Aug 06, 2015
EP07AU15.005</GPH>
Table IX-2! continued
CHARACTERISTICS OF INDUSTRIES AFFECTED BY OSHA'S PROPOSED STANDARD FOR BERYLLIUM-ALL ENTITIES
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
3. Beryllium Exposure Profile of At-Risk
Workers
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
The technological feasibility analyses
presented in Chapter IV of the PEA
contain data and discussion of worker
exposures to beryllium throughout
industry. Exposure profiles, by job
category, were developed from
individual exposure measurements that
were judged to be substantive and to
contain sufficient accompanying
description to allow interpretation of
the circumstance of each measurement.
The resulting exposure profiles show
the job categories with current
overexposures to beryllium and, thus,
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
the workers for whom beryllium
controls would be implemented under
the proposed rule.
Table IX–3 summarizes, from the
exposure profiles, the number of
workers at risk from beryllium exposure
and the distribution of 8-hour TWA
respirable beryllium exposures by
affected job category and sector.
Exposures are grouped into the
following ranges: Less than 0.1 mg/m3;
≥ 0.1 mg/m3 and ≤ 0.2 mg/m3; > 0.2 mg/
m3 and ≤ 0.5 mg/m3; > 0.5 mg/m3 and ≤
1.0 mg/m3; > 1.0 mg/m3 and ≤ 2.0 mg/m3;
and greater than 2.0 mg/m3. These
frequencies represent the percentages of
production employees in each job
PO 00000
Frm 00105
Fmt 4701
Sfmt 4702
47669
category and sector currently exposed at
levels within the indicated range.
Table IX–4 presents data by NAICS
code on the estimated number of
workers currently at risk from beryllium
exposure, as well as the estimated
number of workers at risk of beryllium
exposure above 0 mg/m3, at or above 0.1
mg/m3, at or above 0.2 mg/m3, at or above
0.5 mg/m3, at or above 1.0 mg/m3, and at
or above 2.0 mg/m3. As shown, an
estimated 12,101 workers currently have
beryllium exposures at or above the
proposed action level of 0.1 mg/m3; and
an estimated 8,091 workers currently
have beryllium exposures above the
proposed PEL of 0.2 mg/m3.
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Sector
Beryllium Production
IX~3
Beryllium Exposure Range
Job Category/Activity
Administrative
Maintenance/Furnace& Tools
Other Production Support
Machining
Other Cold Work
Welding
PO 00000
Frm 00106
Jkt 235001
Alloy Arc Furnace
Alloy Induction Furnace
Vacuum Cast
Atomization
Beryllium Oxide Furnace
Material prepara_tions operators
_Formi,ng op_erators p_ress i ng
Forming operators -extruding
Kiln operators
Mac hi ning operators
Compact loadin&"/Sintering
NNS Operator
~hemical Oper~tipns
Be Oxide- Primary
Be Oxide- Secondary
Fmt 4701
Sfmt 4725
Sand foundries
Metallization Workers
Production support
Non Sand foundries
Administrative
Molder
Material Handler
Furnace operator
Pouri r!g operator.
Shakeout operator
Abrasive blaster
Grinding/finishing operator
E:\FR\FM\07AUP2.SGM
Maintenance
Molder
Material Handler
<0.1 U2/m 3
0.1-0.2 ue/m 1
0.2-0.5 ue/m 1
84.91%
58.70%
27.78%
35.42%
86.31%
27.45%
12.61%
10.34%
70.20%
55.48%
27.78%
25.00%
9.78%
1
17.65%
23.42%
8.62%
13.88%
21.23%
72.70%
19.23%
15.79%
0.00%
5.00%
0.00%
5.15%
0.00%
0.00%
31.58%:
22,22%;
10.00%
1
2.63%
13.40%
33.33%
0.00%.
18.44%
3.85%
20.00%
15.58%
0.00%
40.00%
55.56%
74.79%
93.51%
0.00%
0.00%
0.00%
0.00%
20.51%
0.00%
0.00%
1
0.00%
22.56%
13.89%
13.45%
4.32% 1
40.00%
0.00%
0.00%
0.00%
18~18%:
. Smelting- Be Alloys
Abrasive blaster
Grinding/finishing operator
. Smelti~g- ~recipu~ !!let, Mechanical p~~cess.i ng ~per~t~r
Furnace operator
Mechanical processing operator
Machining (high)
Machining (low}
Furnace operator
Machinist (high)
Ro_lling
07AUP2
:Drawing
Springs
:Stamping
Dental tabs
·we!ding_G!
. Resistance Welding
Machinist(low)
Administrative
Other Production support
Wastewater treatment operator
Production
Administrative
Other Production support
Wastewater treatment operator
Production
Assembly operator
Deburri ng Operator
Chemical process operator
Assembly opera to~
Deburri ng Operator
Chemic?! proc~ss operator
Mechanical processing operator
Dental technicians
Welder
Welder
Source: OSHA Office of Regulatory Analysis-Health
0.00%
6.25%
25.00%
0.00%
25.00%
50.00%
13.56%
73.75%
98.53%
97.96%
33.33%
92.81%
98.53%
97.96%
33.33%
85.71%
88.37%
92.86%
85.71%
88.37%
25.00%
30.43%
56.76%
100.00%
40.00%;
100.00%
31.25%,
75.00%,
0.00%
75.00%
0.00%
11.86%
11.25%
1.47%.
2.04%.
33.33%'
2.04%
33.33%
13.33%
7.14%
0.00%
6.98%
7.14%
75.00%
21.74%:
13.51%
0.00%
0.5 -1.0 U2/m 3
3.98%
19.57%
44.44%
14.58%
2.74%
33.33%
27.03%
27.59%
6.55%
15.53%
5.13%
40.00%
8.16%
23.08%
26.32%,
40.74%
50.00%
15.79%
31.96%
22.22%
0.00%
20.00%
31.17%
1.02%
4.35%
0.00%
14.58%
0.78%·
9.80%
3.59%
2.51%
0.71%
23.08%
0.00%
29.63%
20.00%
36.84%
26.80%
11.11%
30.77%
6.67%
19.48%
10.57%
10.57%
0.00%
10.26%
2.78%
2.52%
0.54%
25.00%
100.00%
18.18%
0.00%
100.00%
22.31%
1.08%
62.50%
0.00%
9.09%
0.00%
,0.00%
0.00%
31.25%
23.08%
62.503{,
14.10%
25.00%
100.00%
18.18%
0.00%
0.00%
6.25%
0.00%
0.00%
0.00%
0.00%
15.25%
2.50%
0.00%
0.00%
0.00%
0.00%
9.09%
0.00%
0.00%
31.25%
0.00%
0.00%
0.00%
50.00%
44.07%
7.50%
0.00%
0.00%
33.33%
1.88%
0.00%
0.00%
33.33%
0.00%
0.00%
14.29%
4.65%
0.00%
14.29%
4.65%
0.0~%
13.04%
16.22%
0.00%
c
0.00%
0.00%
0.0_0%.
0.00%
0.00%
0.00%
17.39%
10.81%
0.00%
1.0-2.0 Ui!/m 3
0.61%
0.00%
0.00%
9.80%
9.91%
8.62%
3.43%
3.20%
0.00%
26.92%
15.79%
3.70%
10-DO%
18.42%
13.40%
22.22%
0.00%
20.00%
10.39%;
0.00%
2.82%
0.00%
0.84%
0.54%
0.00%
0.00%
18.18%
20.00%
100.00%
0.00%
>2.0 Ui!/m 1
0.31%
0.00%
0.00%
4.17%
0.00%
1.96%
14.41%
24.14%
2.34%
2.05%
0.00%
3.85%
10.53%
3.70%
5.00%
26.32%
9.28%
11.11%
69.23%
13.33%
10.39%
1.47%
1.47%
0.00%
2.05%
0.00%
12.50%
0.00%
36.36%
40.00%,
0.00%
0.00%
0.00%
12.50%
0.00%
0.00%
6.25%'
0.00%
18.75%
ODD%
0.00%
6.78%
1.25%
0.00%
0.00%
0.00%
0.00%
8.47%
3.75%
0.00%
0.00%
0.00%
0.00%
0.00%
0.00%
0.00%
o.oo%:
0.00%
0.00%
0.00%
0.00%
0.00%
0.00%
0.00%
0.00%
0.00%
0.00%,
0.00%
0.00%
0.00%
O.DOo/o
4.35%
0.00%
0.00%
2.70%
0.00%
Total
100.00%
100.00%
100.00%
100.00%
100.00%
100.00%
100.00%
100.00%
100.00%
100.00%
100.00%
100.00%
100.00%
100.00%
100.00%
100.00%
100.00%
100.00%
100.00%
100.00%
100.00%
100.00%
100.00%
100.00%
100.00%
100.00%
100.00%
100.00%
100.00%
100.00%
100.00%
100.00%
100.00%
100.00%
100.00%
100.00%
100.00%
100.00%
100.00%
100.00%
100.00%
100.00%
100.00%,
100.00%
100.00%
100.00%
100.00%
100.00%
100.00%
100.00%
100.00%
100.00%
100.00%
100.00%
100.00%
100.00%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
19:20 Aug 06, 2015
Wastewater Treatment
Boiler Operators
Decontamination
Other Site Support
Mix/Makeup
Scrap R~ycling
Other Hot Work
Impact Grinding
EP07AU15.006</GPH>
47670
VerDate Sep<11>2014
Table
Distribution of Beryllium Exposures by Sector and Job Category or Activity
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
VerDate Sep<11>2014
Numbers Exposed to Beryllium
NAICs
Jkt 235001
PO 00000
Frm 00107
Fmt 4701
Sfmt 4725
E:\FR\FM\07AUP2.SGM
07AUP2
327113
331111
331221
331314
331419
331421
331422
331423
331492
331513
331521
331522
331524
331525
332116
332117
332212
332312
332313
332322
332323
332439
332612
332721
332919
332999
333111
333411
333412
333414
333415
333911
333922
333924
333999
334220
334310
334411
334415
334417
334419
334510
335211
335212
335221
Industry
Porcelain Electrical Supply
Iron and Steel Mills
Rolled Steel Shape Manufacturing
Secondary Smelting and Alloying of
Primary Smelting and Refining of
Copper Rolling, Drawing, and Extruding
Copper Wire (except Mechanical)
Secondary Smelting, Refining, and
Secondary Smelting, Refining, and
Steel Foundries (except Investment)
Aluminum Die-Casting Foundries
Nonferrous (exceptAiuminum) DieAluminum Foundries (except DieCopper Foundries (except Die-Casting)
Metal Stamping
Powder Metallurgy Part Manufacturing
Hand and Edge Tool Manufacturing
Fabricated Structural Metal
Plate Work Manufacturing
Sheet Metal Work Manufacturing
Ornamental and Architectural Metal
Other Metal Container Manufacturing
Spring (Light Gauge) Manufacturing
Precision Turned Product Manufacturing
Other Metal Valve and Pipe Fitting
All Other Miscellaneous Fabricated
Farm Machinery and Equipment
Air Purification Equipment
Industrial and Commercial Fan and
Heating Equipment (except Warm Air
Air-Conditioning, Warm Air Heating, and
Pump and Pumping Equipment
Conveyor and Conveying Equipment
Industrial Truck, Tractor, Trailer, and
All Other Miscellaneous General
Radio and Television Broadcasting and
Audio and Video Equipment
Electron Tube Manufacturing
Electronic Resistor Manufacturing
Electronic Connector Manufacturing
Other Electronic Component
Electromedical and Electrotherapeutic
Electric Housewares and Household Fan
Household Vacuum Cleaner
Household Cooking Applia nee
No. of Establishments
106
587
161
122
161
96
114
24
248
220
254
140
394
208
1,484
133
1,066
3,407
1,288
4,173
2,354
370
323
3,124
265
3,262
1,041
358
151
460
843
571
776
374
1,524
810
464
79
61
231
1,133
629
106
34
96
No. of Employees
4,310
94,089
9,971
4,846
8,943
9,849
9,847
789
9,696
13,874
18,017
6,362
15,178
5,123
48,855
6,707
25,098
89,728
28,400
91,364
30,029
12,553
10,329
78,749
14,688
65,821
53,133
14,521
6,908
16,768
79,651
31,272
26,970
19,974
43,401
79,732
8,858
4,884
3,722
19,538
46,836
66,107
5,980
2,577
9,730
>0
>=0.1 J.Jg/m
3
>=0.2 J.lg/m
3
>=0.5 J.Jg/m
3
>=1.0 J.Jg/m
3
>=2.0 J.lg/m
3
251
27
117
11
80
23
616
1,548
5,096
27
270
250
97
995
25
158
166
35
531
18
90
91
12
190
18
53
28
132
18
73
14
98
534
98
674
496
94
512
94
647
58
72
393
72
507
45
40
219
40
300
21
115
21
177
15
83
15
99
97
37
119
67
12
185
1,122
67
25
81
46
30
11
37
21
74
697
333
211
152
58
34
40
24
18
11
12
224
85
274
155
27
2,071
3,764
11
134
80
379
160
511
893
27
36
17
71
120
60
252
144
310
108
108
80
26
73
10
11
16
11
31
37
19
79
45
36
34
34
21
22
11
46
26
28
20
20
10
18
10
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
19:20 Aug 06, 2015
Table IX-4
3
Numbers of Workers Exposed to Bervllium (by Affected Industry and Exposure level (1JQ/m )
47671
EP07AU15.007</GPH>
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
D. Technological Feasibility Analysis of
the Proposed Permissible Exposure
Limit to Beryllium Exposures
This section summarizes the
technological feasibility analysis
presented in Chapter IV of the PEA
(OSHA, 2014). The technological
feasibility analysis includes information
on current exposures, descriptions of
engineering controls and other measures
to reduce exposures, and a preliminary
assessment of the technological
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
feasibility of compliance with the
proposed standard, including a
reduction in OSHA’s permissible
exposure limits (PELs) in nine affected
application groups. The current PELs for
beryllium are 2.0 mg/m3 as an 8-hour
time weighted average (TWA), and 5.0
mg/m3 as an acceptable ceiling
concentration. OSHA is proposing a PEL
of 0.2 mg/m3 as an 8-hour TWA and is
additionally considering alternative
TWA PELs of 0.1 and 0.5 mg/m3. OSHA
PO 00000
Frm 00108
Fmt 4701
Sfmt 4702
is also proposing a 15-minute short-term
exposure limit (STEL) of 2.0 mg/m3, and
is considering alternative STELs of 0.5,
1.0 and 2.5 mg/m3.
The technological feasibility analysis
includes nine application groups that
correspond to specific industries or
production processes that OSHA has
preliminarily determined fall within the
scope of the proposed standard. Within
each of these application groups,
exposure profiles have been developed
E:\FR\FM\07AUP2.SGM
07AUP2
EP07AU15.008</GPH>
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47672
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
that characterize the distribution of the
available exposure measurements by job
title or group of jobs. Descriptions of
existing engineering controls for
operations that create sources of
beryllium exposure, and of additional
engineering and work practice controls
that can be used to reduce exposure are
also provided. For each application
group, a preliminary determination is
made regarding the feasibility of
achieving the proposed permissible
exposure limits. For application groups
in which the median exposures for some
jobs exceed the proposed TWA PEL, a
more detailed analysis is presented by
job or group of jobs within the
application group. The analysis is based
on the best information currently
available to the Agency, including a
comprehensive review of the industrial
hygiene literature, National Institute for
Occupational Safety and Health
(NIOSH) Health Hazard Evaluations and
case studies of beryllium exposure, site
visits conducted by an OSHA contractor
(Eastern Research Group (ERG)),
submissions to OSHA’s rulemaking
docket, and inspection data from
OSHA’s Integrated Management
Information System (IMIS). OSHA also
obtained information on production
processes, worker exposures, and the
effectiveness of existing control
measures from the primary beryllium
producer in the United States, Materion
Corporation, and from interviews with
industry experts.
The nine application groups included
in this analysis were identified based on
information obtained during
preliminary rulemaking activities that
included a SBRFA panel, a
comprehensive review of the published
literature, stakeholder input, and an
analysis of IMIS data collected during
OSHA workplace inspections where
detectable airborne beryllium was
found. The nine application groups and
their corresponding section numbers in
Chapter IV of the PEA are:
• Section 3—Beryllium Production,
• Section 4—Beryllium Oxide
Ceramics and Composites,
• Section 5—Nonferrous Foundries,
• Section 6—Secondary Smelting,
Refining, and Alloying,
• Section 7—Precision Turned
Products,
• Section 8—Copper Rolling,
Drawing, and Extruding,
• Section 9—Fabrication of Beryllium
Alloy Products,
• Section 10—Welding, and
• Section 11—Dental Laboratories.
OSHA developed exposure profiles by
job or group of jobs using exposure data
at the application, operation or task
level to the extent that such data were
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
available. In those instances where there
were insufficient exposure data to create
a profile, OSHA used analogous
operations to characterize the
operations. The exposure profiles
represent baseline conditions with
existing controls for each operation with
potential exposure. For job groups
where exposures were above the
proposed TWA PEL of 0.2 mg/m3, OSHA
identified additional controls that could
be implemented to reduce employee
exposures to beryllium. These included
engineering controls, such as process
containment, local exhaust ventilation
and wet methods for dust suppression,
and work practices, such as improved
housekeeping and the prohibition of
compressed air for cleaning berylliumcontaminated surfaces.
For the purposes of this technological
feasibility assessment, these nine
application groups can be divided into
three general categories based on
current exposure levels:
(1) application groups in which
current exposures for most jobs are
already below the proposed PEL of 0.2
mg/m3;
(2) application groups in which
exposures for most jobs are below the
current PEL, but exceed the proposed
PEL of 0.2 mg/m3, and therefore
additional controls would be required;
and
(3) application groups in which
exposures in one or more jobs routinely
exceed the current PEL, and therefore
substantial reductions in exposure
would be required to achieve the
proposed PEL.
The majority of exposure
measurements taken in the application
groups in the first category are already
at or below the proposed PEL of 0.2 mg/
m3, and most of the jobs with exposure
to beryllium in these four application
groups have median exposures below
the alternative PEL of 0.1 mg/m3 (See
Table IX–5). These four application
groups include rolling, drawing, and
extruding; fabrication of beryllium alloy
products; welding; and dental
laboratories.
The two application groups in the
second category include: precision
turned products and secondary
smelting. For these two groups, the
median exposures in most jobs are
below the current PEL, but the median
exposure levels for some job groups
currently exceed the proposed PEL.
Additional exposure controls and work
practices could be implemented that the
Agency has preliminarily concluded
would reduce exposures to or below the
proposed PEL for most jobs most of the
time. One exception is furnace
operations in secondary smelting, in
PO 00000
Frm 00109
Fmt 4701
Sfmt 4702
47673
which the median exposure exceeds the
current PEL. Furnace operations involve
high temperatures that produce
significant amounts of fumes and
particulate that can be difficult to
contain. Therefore, the proposed PEL
may not be feasible for most furnace
operations involved with secondary
smelting, and in some cases, respiratory
protection would be required to
adequately protect furnace workers
when exposures exceed 0.2 mg/m3
despite the implementation of all
feasible controls.
Exposures in the third category of
application groups routinely exceed the
current PEL for several jobs. The three
application groups in this category
include: Beryllium production,
beryllium oxide ceramics production,
and nonferrous foundries. The
individual job groups for which
exposures exceed the current PEL are
discussed in the application group
specific sections later in this summary,
and described in greater detail in the
PEA. For the jobs that routinely exceed
the current PEL, OSHA identified
additional exposure controls and work
practices that the Agency preliminarily
concludes would reduce exposures to or
below the proposed PEL most of the
time, with three exceptions: Furnace
operations in primary beryllium
production and nonferrous foundries,
and shakeout operations at nonferrous
foundries. For these jobs, OSHA
recognizes that even after installation of
feasible controls, respiratory protection
may be needed to adequately protect
workers.
In conclusion, the preliminary
technological feasibility analysis shows
that for the majority of the job groups
evaluated, exposures are either already
at or below the proposed PEL, or can be
adequately controlled with additional
engineering and work practice controls.
Therefore, OSHA preliminarily
concludes that the proposed PEL of 0.2
mg/m3 is feasible for most operations
most of the time. The preliminary
feasibility determination for the
proposed PEL is also supported by
Materion Corporation, the sole primary
beryllium production company in the
U.S., and by the United Steelworkers,
who jointly submitted a draft proposed
standard that specified an exposure
limit of 0.2 mg/m3 to OSHA (Materion
and USW, 2012). The technological
feasibility analysis conducted for each
application group is briefly summarized
below, and a more detailed discussion
is presented in Sections 3 through 11 of
Chapter IV of the PEA (OSHA, 2014).
Based on the currently available
evidence, it is more difficult to
determine whether an alternative PEL of
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47674
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
0.1 mg/m3 would also be feasible in most
operations. For some application
groups, such as fabrication of beryllium
alloy products, a PEL of 0.1 mg/m3
would almost certainly be feasible. In
other application groups, such as
precision turned products, a PEL of 0.1
mg/m3 appears feasible, except for
establishments working with high
beryllium content alloys. For
application groups with the highest
exposure, the exposure monitoring data
necessary to more fully evaluate the
effectiveness of exposure controls
adopted after 2000 are not currently
available to OSHA, which makes it
difficult to determine the feasibility of
achieving exposure levels at or below
0.1 mg/m3.
OSHA also evaluated the feasibility of
a STEL of 2.0 mg/m3, and alternative
STELs of 0.5 and 1.0 mg/m3. An analysis
of the available short-term exposure
measurements indicates that elevated
exposures can occur during short-term
tasks such as those associated with the
operation and maintenance of furnaces
at primary beryllium production
facilities, at nonferrous foundries, and at
secondary smelting operations. Peak
exposure can also occur during the
transfer and handling of beryllium oxide
powders. OSHA believes that in many
cases, reducing short-term exposures
will be necessary to reduce workers’
TWA exposures to or below the
proposed PEL. The majority of the
available short-term measurements are
below 2.0 mg/m3, therefore OSHA
preliminarily concludes that the
proposed STEL of 2.0 mg/m3 can be
achieved for most operations most of the
time. OSHA recognizes that for a small
number of tasks, short-term exposures
may exceed the proposed STEL, even
after feasible control measures to reduce
TWA exposure to below the proposed
PEL have been implemented, and
therefore assumes that the use of
respiratory protection will continue to
be required for some short-term tasks. It
is more difficult based on the currently
available evidence to determine whether
the alternative STEL of 1.0 mg/m3 would
also be feasible in most operations based
on lack of detail in the activities of the
workers presented in the data. OSHA
expects additional use of respiratory
protection would be required for tasks
in which peak exposures can be reduced
to less than 2.0 mg/m3 but not less than
1.0 mg/m3. Due to limitations in the
available sampling data and the higher
detection limits for short term
measurements, OSHA could not
determine the percentage of the STEL
measurements that are less than or equal
to 0.5 mg/m3. A detailed discussion of
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
the STELs being considered by OSHA is
presented in Section 12 of Chapter IV of
the PEA (OSHA, 2014).
OSHA requests available exposure
monitoring data and comments
regarding the effectiveness of currently
implemented control measures and the
feasibility of the PELs under
consideration, particularly the proposed
TWA PEL of 0.2 mg/m3, the alternative
TWA PEL of 0.1 mg/m3, the proposed
STEL of 2.0 mg/m3, and the alternative
STEL of 1.0 mg/m3 to inform the
Agency’s final feasibility
determinations.
Application Group Summaries
This section summarizes the
technological feasibility analysis for
each of the nine application groups
affected by the proposed standard.
Chapter IV of the PEA, Technological
Feasibility Analysis, identifies specific
jobs or job groups with potential
exposure to beryllium, and presents
exposure profiles for each of these job
groups (OSHA, 2014). Control measures
and work practices that OSHA believes
can reduce exposures are described
along with preliminary conclusions
regarding the feasibility of the proposed
PEL. Table IX–5, located at the end of
this summary, presents summary
statistics for the personal breathing zone
samples taken to measure full-shift
exposures to beryllium in each
application group. For the five
application groups in which the median
exposure level for at least one job group
exceeds the proposed PEL, the sampling
results are presented by job group. Table
IX–5 displays the number of
measurements; the range, the mean and
the median of the measurement results;
and the percentage of measurements
less than 0.1 mg/m3, less than or equal
to the proposed PEL of 0.2 mg/m3, and
less than or equal to the current PEL of
2.0 mg/m3. A more detailed discussion
of exposure levels by job or job group
for each application group is provided
in Chapter IV of the PEA, sections 3
through 11, along with a description of
the available exposure measurement
data, existing controls, and additional
controls that would be required to
achieve the proposed PEL.
Beryllium Production
Only one primary beryllium
production facility is currently in
operation in the United States, a plant
owned and operated by Materion
Corporation,15 located in Elmore, Ohio.
15 Materion Corporation was previously named
Brush Wellman. In 2011, subsequent to the
collection of the information presented in this
chapter, the name changed. ‘‘Brush Wellman’’ is
PO 00000
Frm 00110
Fmt 4701
Sfmt 4702
OSHA identified eight job groups at this
facility in which workers are exposed to
beryllium. These include: Chemical
operations, powdering operations,
production support, cold work, hot
work, site support, furnace operations,
and administrative work.
The Agency developed an exposure
profile for each of these eight job groups
to analyze the distribution of exposure
levels associated with primary
beryllium production. The job exposure
profiles are based primarily on full-shift
personal breathing zone (PBZ) (lapeltype) sample results from air monitoring
conducted by Brush Wellman’s primary
production facility in 1999 (Brush
Wellman, 2004). Starting in 2000, the
company developed the Materion
Worker Protection Program (MWPP), a
multi-faceted beryllium exposure
control program designed to reduce
airborne exposures for the vast majority
of workers to less than an internally
established exposure limit of 0.2 mg/m3.
According to information provided by
Materion, a combination of engineering
controls, work practices, and
housekeeping were used together to
reduce average exposure levels to below
0.2 mg/m3 for the majority of workers
(Materion Information Meeting, 2012).
Also, two operations with historically
high exposures, the wet plant and
pebble plants, were decommissioned in
2000, thereby reducing average
exposure levels. Therefore, the samples
taken prior to 2000 may overestimate
current exposures.
Additional exposure samples were
taken by NIOSH at the Elmore facility
from 2007 through 2008 (NIOSH, 2011).
This dataset, which was made available
to OSHA by Materion, contains fewer
samples than the 1999 survey. OSHA
did not incorporate these samples into
the exposure profile due to the limited
documentation associated with the
sampling data. The lack of detailed
information for individual samples has
made it difficult for OSHA to correlate
job classifications and identify the
working conditions associated with the
samples. Sampling data provided by
Materion for 2007 and 2008 were not
incorporated into the exposure profiles
because the data lacked specific
information on jobs and workplace
conditions. In a meeting in May 2012
held between OSHA and Materion
Corporation at the Elmore facility, the
Agency was able to obtain some general
information on the exposure control
modifications that Materion Corporation
made between 1999 and 2007, but has
been unable to determine what specific
used whenever the data being discussed pre-dated
the name change.
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
controls were in place at the time
NIOSH conducted sampling (Materion
Information Meeting, 2012).
In five of the primary production job
groups (i.e., hot work, cold work,
production support, site support, and
administrative work), the baseline
exposure profile indicates that
exposures are already lower than the
proposed PEL of 0.2 mg/m3. Median
exposure values for these job groups
range from nondetectable to 0.08 mg/m3.
For three of the job groups involved
with primary beryllium production,
(i.e., chemical operations, powdering,
and furnace operations), the median
exposure level exceeds the proposed
PEL of 0.2 mg/m3. Median exposure
values for these job groups are 0.47,
0.37, and 0.68 mg/m3 respectively, and
only 17 percent to 29 percent of the
available measurements are less than or
equal to 0.2 mg/m3. Therefore, additional
control measures for these job groups
would be required to achieve
compliance with the proposed PEL.
OSHA has identified several
engineering controls that the Agency
preliminarily concludes can reduce
exposures in chemical processes and
powdering operations to less than or
equal to 0.2 mg/m3. In chemical
processes, these include fail-safe drumhandling systems, full enclosure of
drum-handling systems, ventilated
enclosures around existing drum
positions, automated systems to prevent
drum overflow, and automated systems
for container cleaning and disposal such
as those designed for hazardous
powders in the pharmaceutical
industry. Similar engineering controls
would reduce exposures in powdering
operations. In addition, installing
remote viewing equipment (or other
equally effective engineering controls)
to eliminate the need for workers to
enter the die-loading hood during die
filling will reduce exposures associated
with this powdering task and reduce
powder spills. Based on the availability
of control methods to reduce exposures
for each of the major sources of
exposure in chemical operations, OSHA
preliminarily concludes that exposures
at or below the proposed 0.2 mg/m3 PEL
can be achieved in most chemical and
powdering operations most of the time.
OSHA believes furnace operators’
exposures can be reduced using
appropriate ventilation, including fume
capture hoods, and other controls to
reduce overall beryllium levels in
foundries, but is not certain whether the
exposures of furnace operators can be
reduced to the proposed PEL with
currently available technology. OSHA
requests additional information on
current exposure levels and the
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
effectiveness of potential control
measures for primary beryllium
production operations to further refine
this analysis.
Beryllium Oxide Ceramics Production
OSHA identified seven job groups
involved with beryllium oxide ceramics
production. These include: Material
preparation operator, forming operator,
machining operator, kiln operator,
production support, metallization, and
administrative work. Four of these jobs
(material preparation, forming operator,
machining operator and kiln operator)
work directly with beryllium oxides,
and therefore these jobs have a high
potential for exposure. The other three
job groups (production support work,
metallization, and administrative work)
have primarily indirect exposure that
occurs only when workers in these jobs
groups enter production areas and are
exposed to the same sources to which
the material preparation, forming,
machining and kiln operators are
directly exposed. However, some
production support and metallization
activities do require workers to handle
beryllium directly, and workers
performing these tasks may at times be
directly exposed to beryllium.
The Agency developed exposure
profiles for these jobs based on air
sampling data from four sources: (1)
Samples taken between 1994 and 2003
at a large beryllium oxide ceramics
facility, (2) air sampling data obtained
during a site visit to a primary beryllium
oxide ceramics producer, (3) a
published report that provides
information on beryllium oxide
ceramics product manufacturing for a
slightly earlier time period, and (4)
exposure data from OSHA’s Integrated
Management Information System
(OSHA, 2009). The exposure profile
indicates that the three job groups with
mostly indirect exposure (production
support work, metallization, and
administrative work) already achieve
the proposed PEL of 0.2 mg/m3. Median
exposure sample values for these job
groups did not exceed 0.06 mg/m3.
The four job groups with direct
exposure had higher exposures. In
forming operations and machining
operations, the median exposure levels
of 0.18 and 0.15 ug/m3, respectively, are
below the proposed PEL, while the
median exposure levels for material
preparation and kiln operations of 0.41
mg/m3 and 0.25 mg/m3, respectively,
exceed the proposed PEL.
The profile for the directly exposed
jobs may overestimate exposures due to
the preponderance of data from the mid1990s, a time period prior to the
implementation of a variety of exposure
PO 00000
Frm 00111
Fmt 4701
Sfmt 4702
47675
control measures introduced after 2000.
In forming operations, 44 percent of
sample values in the exposure profile
exceeded 0.2 ug/m3. However, the
median exposure levels for some tasks,
such as small-press and large-press
operation, based on sampling conducted
in 2003 were below 0.1 mg/m3. The
exposure profile for kiln operation was
based on three samples taken from a
single facility in 1995, and are all above
0.2 ug/m3. Since then, exposures at the
facility have declined due to changes in
operations that reduced the amount of
time kiln operators spend in the
immediate vicinity of the kilns, as well
as the discontinuation of a nearby highexposure process. More recent
information communicated to OSHA
suggests that current exposures for kiln
operators at the facility are currently
below 0.1 ug/m3. Exposures in
machining operations, most of which
were already below 0.2 ug/m3 during
the 1990s, may have been further
reduced since then through improved
work practices and exposure controls
(PEA Chapter IV, Section 7). For
forming, kiln, and machining
operations, OSHA preliminarily
concludes that the installation of
additional controls such as machine
interlocks (for forming) and improved
enclosures and ventilation will reduce
exposures to or below the proposed PEL
most of the time. OSHA requests
information on recent exposure levels
and controls in beryllium oxide forming
and kiln operations to help the Agency
evaluate the effectiveness of available
exposure controls for this application
group.
In the exposure profile for material
preparation, 73 percent of sample values
exceeded 0.2 ug/m3. As with other parts
of the exposure profile, exposure values
from the mid-1990s may overestimate
airborne beryllium levels for current
operations. During most material
preparation tasks, such as material
loading, transfer, and spray drying,
OSHA preliminarily concludes that
exposures can be reduced to or below
0.2 mg/m3 with process enclosures,
ventilation hoods, and improved
housekeeping procedures. However,
OSHA acknowledges that peak
exposures from some short-term tasks
such as servicing of the spray chamber
might continue to drive the TWA
exposures above 0.2 mg/m3 on days
when these material preparation tasks
are performed. Respirators may be
needed to protect workers from
exposures above the proposed TWA PEL
E:\FR\FM\07AUP2.SGM
07AUP2
47676
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
during these tasks.16 OSHA notes that
material preparation for production of
beryllium oxide ceramics currently
takes place at only two facilities in the
United States.
Nonferrous Foundries
OSHA identified eight job groups in
aluminum and copper foundries with
beryllium exposure: Molding, material
handling, furnace operation, pouring,
shakeout operation, abrasive blasting,
grinding/finishing, and maintenance.
The Agency developed exposure
profiles based on an air monitoring
survey conducted by NIOSH in 2007, a
Health Hazard Evaluation (HHE)
conducted by NIOSH in 1975, a site
visit by ERG in 2003, a site visit report
from 1999 by the California Cast Metals
Association (CCMA); and two sets of
data from air monitoring surveys
obtained from Materion in 2004 and
2010.
The exposure profile indicates that in
foundries processing beryllium alloys,
six of the eight job groups have median
exposures that exceed the proposed PEL
of 0.2 mg/m3 with baseline working
conditions. One exception is grinding/
finishing operations, where the median
value is 0.12 mg/m3 and 73 percent of
exposure samples are below 0.2 mg/m3.
The other exception is abrasive blasting.
The samples for abrasive blasting used
in the exposure profile were obtained
during blasting operations using
enclosed cabinets, and all 5 samples
were below 0.2 mg/m3. Exposures for
other job groups ranged from just below
to well above the proposed PEL,
including molder (all samples above 0.2
mg/m3), material handler (1 sample total,
above 0.2 mg/m3), furnace operator (81.8
percent of samples above 0.2 mg/m3),
pouring operator (60 percent of samples
above 0.2 mg/m3), shakeout operator (1
sample total, above 0.2 mg/m3), and
maintenance worker (50 percent of
samples above 0.2 mg/m3).
In some of the foundries at which the
air samples included in the exposure
profile were collected, there are
indications that the ventilation systems
were not properly used or maintained,
and dry sweeping or brushing and the
use of compressed air systems for
cleaning may have contributed to high
dust levels. OSHA believes that
exposures in foundries can be
substantially reduced by improving and
properly using and maintaining the
ventilation systems; switching from dry
brushing, sweeping and compressed air
to wet methods and use of HEPA16 One facility visited by ERG has reportedly
modified this process to reduce worker exposures,
but OSHA has no data to quantify the reduction.
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
filtered vacuums for cleaning molds and
work areas; enclosing processes;
automation of high-exposure tasks; and
modification of processes (e.g.,
switching from sand-based to alternative
casting methods). OSHA preliminarily
concludes that these additional
engineering controls and modified work
practices can be implemented to achieve
the proposed PEL most of the time for
molding, material handling,
maintenance, abrasive blasting,
grinding/finishing, and pouring
operations at foundries that produce
aluminum and copper beryllium alloys.
The Agency is less confident that
exposure can be reliably reduced to the
proposed PEL for furnace and shakeout
operators. Beryllium concentrations in
the proximity of the furnaces are
typically higher than in other areas due
to the fumes generated and the difficulty
of controlling emissions during furnace
operations. The exposure profile for
furnace operations shows a median
beryllium exposure level of 1.14 mg/m3.
OSHA believes that furnace operators’
exposures can be reduced using local
exhaust ventilation and other controls to
reduce overall beryllium levels in
foundries, but it is not clear that they
can be reduced to the proposed PEL
with currently available technology. In
foundries that use sand molds, the
shakeout operation typically involves
removing the freshly cast parts from the
sand mold using a vibrating grate that
shakes the sand from castings. The
shakeout equipment generates
substantial amounts of airborne dust
that can be difficult to contain, and
therefore shakeout operators are
typically exposed to high dust levels.
During casting of beryllium alloys, the
dust may contain beryllium and
beryllium oxide residues dislodged from
the casting during the shakeout process.
The exposure profile for the shakeout
operations contains only one result of
1.3 mg/m3. This suggests that a
substantial reduction would be
necessary to achieve compliance with a
proposed PEL of 0.2 mg/m3. OSHA
requests additional information on
recent employee exposure levels and the
effectiveness of dust controls for
shakeout operations for copper and
aluminum alloy foundries.
Secondary Smelting, Refining, and
Alloying
OSHA identified two job groups in
this application group with exposure to
beryllium: Mechanical process operators
and furnace operations workers.
Mechanical operators handle and treat
source material, and furnace operators
run heating processes for refining,
melting, and casting metal alloy. OSHA
PO 00000
Frm 00112
Fmt 4701
Sfmt 4702
developed exposure profiles for these
jobs based on exposure data from ERG
site visits to a precious/base metals
recovery facility and a facility that melts
and casts beryllium-containing alloys,
both conducted in 2003. The available
exposure data for this application group
are limited, and therefore, the exposure
profile is supplemented in part by
summary data presented in secondary
sources of information on beryllium
exposures in this application group.
The exposure profile for mechanical
processing operators indicates low
exposures (3 samples less than 0.2 mg/
m3), even though these samples were
collected at a facility where the
ventilation system was allowing visible
emissions to escape exhaust hoods.
Summary data from studies and reports
published in 2005–2009 showed that
mechanical processing operator
exposures averaged between 0.01 and
0.04 mg/m3 at facilities where mixed or
electronic waste including beryllium
alloy parts were refined. Based on these
results, OSHA preliminarily concludes
that the proposed PEL is already
achieved for most mechanical
processing operations most of the time,
and exposures could be further reduced
through improved ventilation system
design and other measures, such as
process enclosures.
As with furnace operations examined
in other application groups, the
exposure profile indicates higher worker
exposures for furnace operators in the
secondary smelting, refining, and
alloying application group (six samples
with a median of 2.15 mg/m3, and 83.3
percent above 0.2 mg/m3). The two
lowest samples in this job’s exposure
profile (0.03 and 0.5 mg/m3) were
collected at a facility engaged in
recycling and recovery of precious
metals where work with berylliumcontaining material is incidental. At this
facility, the furnace is enclosed and
fumes are ducted into a filtration
system. The four higher samples,
ranging from 1.92 to 14.08 mg/m3, were
collected at a facility engaged primarily
in beryllium alloying operations, where
beryllium content is significantly higher
than in recycling and precious metal
recovery activities, the furnace is not
enclosed, and workers are positioned
directly in the path of the exhaust
ventilation over the furnace. OSHA
believes these exposures could be
reduced by enclosing the furnace and
repositioning the worker, but is not
certain whether the reduction achieved
would be enough to bring exposures
down to the proposed PEL. Based on the
limited number of samples in the
exposure profile and surrogate data from
furnace operations, the proposed PEL
E:\FR\FM\07AUP2.SGM
07AUP2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
may not be feasible for furnace work in
beryllium recovery and alloying, and
respirators may be necessary to protect
employees performing these tasks.
Precision Turned Products
OSHA’s preliminary feasibility
analysis for precision turned products
focuses on machinists who work with
beryllium-containing alloys. The
Agency also examined the available
exposure data for non-machinists and
has preliminarily concluded that, in
most cases, controlling the sources of
exposures for machinists will also
reduce exposures for other job groups
with indirect exposure when working in
the vicinity of machining operations.
OSHA developed exposure profiles
based on exposure data from four
NIOSH surveys conducted between
1976 and 2008; ERG site visits to
precision machining facilities in 2002,
2003, and 2004; case study reports from
six facilities machining copperberyllium alloys; and exposure data
collected between 1987 and 2001 by the
U.S. Navy Environmental Health Center
(NEHC). Analysis of the exposure data
showed a substantial difference between
the median exposure level for workers
machining pure beryllium and/or highberyllium alloys compared to workers
machining low-beryllium alloys. Most
establishments in the precision turned
products application group work only
with low-beryllium alloys, such as
copper-beryllium. A relatively small
number of establishments (estimated at
15) specialize in precision machining of
pure beryllium and/or high-beryllium
alloys.
The exposure profile indicates that
machinists working with low-beryllium
alloys have mostly low exposure to
airborne beryllium. Approximately 85
percent of the 80 exposure results are
less than or equal to 0.2 mg/m3, and 74
percent are less than or equal to 0.1 mg/
m3. Some of the results below 0.1 mg/m3
were collected at a facility where
machining operations were enclosed,
and metal cutting fluids were used to
control the release of airborne
contaminants. Higher results (0.1 mg/
m3–1.07 mg/m3) were found at a facility
where cutting and grinding operations
were conducted in partially enclosed
booths equipped with LEV, but some
LEV was not functioning properly. A
few very high results (0.77 mg/m3–24 mg/
m3) were collected at a facility where
exposure controls were reportedly
inadequate and poor work practices
were observed (e.g., improper use of
downdraft tables, use of compressed air
for cleaning). Based on these results,
OSHA preliminarily concludes that
exposures below 0.2 mg/m3 can be
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
achieved most of the time for most
machinists at facilities dealing primarily
with low-beryllium alloys. OSHA
recognizes that higher exposures may
sometimes occur during some tasks
where exposures are difficult to control
with engineering methods, such as
cleaning, and that respiratory protection
may be needed at these times.
Machinists working with highberyllium alloys have higher exposure
than those working with low-beryllium
alloys. This difference is reflected in the
exposure profile for this job, where the
median of exposure is 0.31 mg/m3 and
75 percent of samples exceed the
proposed PEL of 0.2 mg/m3. The
exposure profile was based on two
machining facilities at which LEV was
used and machining operations were
performed under a liquid coolant flood.
Like most facilities where pure
beryllium and high-beryllium alloys are
machined, these facilities also used
some combination of full or partial
enclosures, as well as work practices to
minimize exposure such as prohibiting
the use of compressed air and dry
sweeping and implementing dust
migration control practices to prevent
the spread of beryllium contamination
outside production areas. At one facility
machining high-beryllium alloys, where
all machining operations were fully
enclosed and ventilated, exposures were
mostly below 0.1 mg/m3 (median 0.035
mg/m3, range 0.02–0.11 mg/m3).
Exposures were initially higher at the
second facility, where some machining
operations were not enclosed, existing
LEV system were in need of upgrades,
and some exhaust systems were
improperly positioned. Samples
collected there in 2003 and 2004 were
mostly below the proposed PEL in 2003
(median 0.1 mg/m3) but higher in 2004
(median 0.25 mg/m3), and high exposure
means in both years (1.65 and 0.68 mg/
m3 respectively) show the presence of
high exposure spikes in the facility.
However, the facility reported that
measures to reduce exposure brought
almost all machining exposures below
0.2 mg/m3 in 2006. With the use of fully
enclosed machines and LEV and work
practices that minimize worker
exposures, OSHA preliminarily
concludes that the proposed PEL is
feasible for the vast majority of
machinists working with pure beryllium
and high-beryllium alloys. OSHA
recognizes that higher exposures may
sometimes occur during some tasks
where exposures are difficult to control
with engineering methods, such as
machine cleaning and maintenance, and
that respiratory protection may be
needed at these times.
PO 00000
Frm 00113
Fmt 4701
Sfmt 4702
47677
Copper Rolling, Drawing, and Extruding
OSHA’s exposure profile for copper
rolling, drawing, and extruding includes
four job groups with beryllium
exposure: strip metal production, rod
and wire production, production
support, and administrative work.
Exposure profiles for these jobs are
based on personal breathing zone lapel
sampling conducted at the Brush
Wellman Reading, Pennsylvania, rolling
and drawing facility from 1977 to 2000.
Prior to 2000, the Reading facility had
limited engineering controls in place.
Equipment in use included LEV in some
operations, HEPA vacuums for general
housekeeping, and wet methods to
control loose dust in some rod and wire
production operations. The exposure
profile shows very low exposures for all
four job groups. All had median
exposure values below 0.1 mg/m3, and in
strip metal production, production
support, and administrative work, over
90 percent of samples were below 0.1
mg/m3. In rod and wire production, 70
percent of samples were below 0.1 mg/
m3.
To characterize exposures in
extrusion, OSHA examined the results
of an industrial hygiene survey of a
copper-beryllium extruding process
conducted in 2000 at another facility.
The survey reported eight PBZ samples,
which were not included in the
exposure profile because of their short
duration (2 hours). Samples for three of
the four jobs involved with the
extrusion process (press operator,
material handler, and billet assembler)
were below the limit of detection (LOD)
(level not reported). The two samples
for the press operator assistant, taken
when the assistant was buffing, sanding,
and cleaning extrusion tools, were very
high (1.6 and 1.9 mg/m3). Investigators
recommended a ventilated workstation
to reduce exposure during these
activities.
In summary, exposures at or below
0.2 mg/m3 have already been achieved
for most jobs in rolling, drawing, and
extruding operations, and OSHA
preliminarily concludes that the
proposed PEL of 0.2 mg/m3 is feasible for
this application group. For jobs or tasks
with higher exposures, such as tool
refinishing, use of exposure controls
such as local exhaust ventilation can
help reduce workers’ exposures. The
Agency recognizes the limitations of the
available data, which were drawn from
two facilities and did not include fullshift PBZ samples for extrusion. OSHA
requests additional exposure data from
other facilities in this application group,
especially data from facilities where
extrusion is performed.
E:\FR\FM\07AUP2.SGM
07AUP2
47678
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
Fabrication of Beryllium Alloy Products
This application group includes the
fabrication of beryllium alloy springs,
stampings, and connectors for use in
electronics. The exposure profile is
based on a study conducted at four
precision stamping companies; a NIOSH
report on a spring and stamping
company; an ERG site visit to a
precision stamping, forming, and
plating establishment; and exposure
monitoring results from a stamping
facility presented at the American
Industrial Hygiene Conference and
Exposition in 2007. The exposure
profiles for this application group
include three jobs: chemical processing
operators, deburring operators, and
assembly operators. Other jobs for
which all samples results were below
0.1 mg/m3 are not shown in the profile.
For the three jobs in the profile, the
majority of exposure samples were
below 0.1 mg/m3 (deburring operators,
79 percent; chemical processing
operators, 81 percent; assembly
operators, 93 percent). Based on these
results, OSHA preliminarily concludes
that the proposed PEL is feasible for this
application group. The Agency notes
that a few exposures above the proposed
PEL were recorded for the chemical
processing operator (in plating and
bright cleaning) and for deburring
(during corn cob deburring in an open
tumbling mill). OSHA believes the use
of LEV, improved housekeeping, and
work practice modifications would
reduce the frequency of excursions
above the proposed PEL.
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Welding
Most of the samples in OSHA’s
exposure profile for welders in general
industry were collected between 1994
and 2001 at two of Brush Wellman’s
alloy strip distribution centers, and in
1999 at Brush Wellman’s Elmore
facility. At these facilities, tungsten
inert gas (TIG) welding was conducted
on beryllium alloy strip. Seven samples
in the exposure profile came from a case
study conducted at a precision stamping
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
facility, where airborne beryllium levels
were very low (see previous summary,
Fabrication of Beryllium Alloy
Products). At this facility, resistance
welding was performed on copperberyllium parts, and welding processes
were automated and enclosed.
Most of the sample results in the
welding exposure profile were below
0.2 mg/m3. Of the 44 welding samples in
the profile, 75 percent were below 0.2
mg/m3 and 64 percent were below 0.1
mg/m3, with most values between 0.01
and 0.05 mg/m3. All but one of the 16
exposure samples above 0.1 mg/m3 were
collected in Brush Wellman’s Elmore
facility in 1999. According to company
representatives, these higher exposure
levels may have been due to beryllium
oxide that can form on the surface of the
material as a result of hot rolling. All
seven samples from the precision
stamping facility were below the limit of
detection. Based on these results, OSHA
preliminarily concludes that the
proposed PEL of 0.2 mg/m3 is feasible for
most welding operations in general
industry.
Dental Laboratories
OSHA’s exposure profile for dental
technicians includes sampling results
from a site visit conducted by ERG in
2003; a study of six dental laboratories
published by Rom et al. in 1984; a data
set of exposure samples collected
between 1987 and 2001, on dental
technicians working for the U.S. Navy;
and a docket submission from CMP
Industries including two samples from a
large commercial dental laboratory
using nickel-beryllium alloy.
Information on exposure controls in
these facilities suggests that controls in
some cases may have been absent or
improperly used.
The exposure profile indicates that 52
percent of samples are less than or equal
to 0.2 mg/m3. However, the treatment of
nondetectable samples in the feasibility
analysis may overestimate many of the
sample values in the exposure profile.
Twelve of the samples in the profile are
PO 00000
Frm 00114
Fmt 4701
Sfmt 4702
nondetectable for beryllium. In the
exposure profile, these were assigned
the highest possible value, the limit of
detection (LOD). For eight of the
nondetectable samples, the LOD was
reported as 0.2 mg/m3. For the other four
nondetectable samples, the LOD was
between 0.23 and 0.71 mg/m3. If the true
values for these four nondetectable
samples are actually less than or equal
to the assigned value of 0.2 mg/m3, then
the true percentage of profile sample
values less than or equal to 0.2 mg/m3
is between 52 and 70 percent. Of the
sample results with detectable
beryllium above 0.2 mg/m3, some were
collected in 1984 at facilities studied by
Rom et al., who reported that they
occurred during grinding with LEV that
was improperly used or, in one case, not
used at all. Others were collected at
facilities where little contextual
information was available to determine
what control equipment or work
practices might have reduced exposures.
Based on this information, OSHA
preliminarily concludes that beryllium
exposures for most dental technicians
are already below 0.2 mg/m3 most of the
time. OSHA furthermore believes that
exposure levels can be reduced to or
below 0.1 mg/m3 most of the time via
material substitution, engineering
controls, and work practices. Berylliumfree alternatives for casting dental
appliances are readily available from
commercial sources, and some alloy
suppliers have stopped carrying alloys
that contain beryllium. For those dental
laboratories that continue to use
beryllium alloys, exposure control
options include properly designed,
installed, and maintained LEV systems
(equipped with HEPA filters) and
enclosures; work practices that optimize
LEV system effectiveness; and
housekeeping methods that minimize
beryllium contamination in the
workplace. In summary, OSHA
preliminarily concludes that the
proposed PEL is feasible for dental
laboratories.
E:\FR\FM\07AUP2.SGM
07AUP2
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
PO 00000
Frm 00115
Fmt 4701
Sfmt 4702
E:\FR\FM\07AUP2.SGM
0.2 to 19.76
0.2 to 2.2
1.3
0.93
0.24 to 2.29
0.05 to 22.71
0.05 to 0.15
0.01 to 4.79
0.03 to 14.1
0.03 to 0.2
0.02 to 7.2
0.005 to 24
0.006 to 7.8
0.004 to 0.42
0.005 to 2.21
0.02 to 4.4
6
3
10.6
53.2
5.0
0.36
7.7
0.62
1.2
11
5
1
1
8
78
5
56
to
to
to
to
to
to
to
0.02
0.02
0.01
0.22
0.02
0.02
0.02
254
9.6
11.5
22.7
24.9
2.21
4.22
4.54
77
408
355
3
119
36
185
to
to
to
to
to
to
to
to
0.05
0.05
0.06
0.02
0.04
0.01
0.05
0.05
Range
172
20
72
861
555
297
879
981
80
59
650
71
44
23
Source: OSHA, Directorate of Standards and Guidance, Office of Regulatory Analysis.
Be Production Operations (Section 3)
Furnace Operations ........................................................................
Chemical Operations ......................................................................
Powdering Operations ....................................................................
Production Support .........................................................................
Cold Work .......................................................................................
Hot Work .........................................................................................
Site Support ....................................................................................
Administrative .................................................................................
Be Oxide Ceramics (Section 4)
Material Preparation Operator ........................................................
Forming Operator ...........................................................................
Machining Operator ........................................................................
Kiln Operator ...................................................................................
Production Support Worker ............................................................
Metallization Worker .......................................................................
Administrative .................................................................................
Aluminum and Copper Foundries (Section 5)
Furnace Operator ...........................................................................
Pouring Operator ............................................................................
Shakeout Operator .........................................................................
Material Handler .............................................................................
Molder .............................................................................................
Maintenance ...................................................................................
Abrasive Blasting Operator .............................................................
Grinding/finishing Operator .............................................................
Secondary Smelting (Section 6)
Furnace operations worker .............................................................
Mechanical processing operator .....................................................
Precision Turned Products (Section 7)
High Be Content Alloys ..................................................................
Low Be Content Alloys ...................................................................
Rolling, Drawing, and Extruding (Section 8)
Alloy Fabrication (Section 9)
Welding: Beryllium Alloy (Section 10)
Dental Laboratories (Section 11)
N
3.85
0.14
4.41
1.21
1.30
0.93
0.67
0.87
0.11
0.31
1.01
0.48
0.32
0.28
0.21
0.15
0.06
3.80
1.02
0.82
0.51
0.31
0.12
0.11
0.10
0.72
0.45
0.11
0.056
0.19
0.74
Mean
0.31
0.01
0.024
0.025
0.02
0.2
2.15
0.20
1.14
1.40
1.30
0.93
0.45
0.21
0.12
0.05
0.41
0.18
0.15
0.25
0.05
0.06
0.05
0.68
0.47
0.37
0.08
0.08
0.06
0.05
0.05
Median
%<0.1
TABLE IX–5—BERYLLIUM FULL-SHIFT PBZ SAMPLES BY APPLICATION/JOB GROUP (μg/m3)
Application/Job group
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
14
74
86
83
64
13
17
33
0
0
0
0
0
15
40
59
13
27
37
0
68
55
93
5
5
11
56
61
69
81
85
%≤0.2
25
85
93
94
75
52
17
100
18
40
0
0
0
50
100
73
27
56
63
0
88
69
98
17
15
29
71
80
88
92
94
%≤2.0
92
96
99
100
98
87
50
100
64
60
100
100
88
96
100
95
90
99
98
100
98
100
100
82
95
94
94
98
99
99
99
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
07AUP2
47679
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47680
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
E. Costs of Compliance
Chapter V of the PEA in support of
the proposed beryllium rule provides a
detailed assessment of the costs to
establishments in all affected
application groups of reducing worker
exposures to beryllium to an eight-hour
time-weighted average (TWA)
permissible exposure limit (PEL) of 0.2
mg/m3 and to the proposed short-term
exposure limit (STEL) of 2.0 mg/m3, as
well as of complying with the proposed
standard’s ancillary provisions. OSHA
describes its methodology and sources
in more detail in Chapter V. OSHA’s
preliminary cost assessment is based on
the Agency’s technological feasibility
analysis presented in Chapter IV of the
PEA; analyses of the costs of the
proposed standard conducted by
OSHA’s contractor, Eastern Research
Group (ERG); and the comments
submitted to the docket in response to
the request for information (RFI) and as
part of the SBREFA process.
As shown in Table IX–7 at the end of
this section, OSHA estimates that the
proposed standard would have an
annualized cost of $37.6 million. All
cost estimates are expressed in 2010
dollars and were annualized using a
discount rate of 3 percent, which—along
with 7 percent—is one of the discount
rates recommended by OMB.17
Annualization periods for expenditures
on equipment are based on equipment
life, and one-time costs are annualized
over a 10-year period.
The estimated costs for the proposed
beryllium rule represent the additional
costs necessary for employers to achieve
full compliance. They do not include
costs associated with current
compliance that may already have been
achieved with regard to existing
beryllium requirements or costs
necessary to achieve compliance with
existing beryllium requirements, to the
extent that some employers may
currently not be fully complying with
applicable regulatory requirements.
Throughout this section and in the
PEA, OSHA presents cost formulas in
the text, usually in parentheses, to help
explain the derivation of cost estimates
for individual provisions. Because the
values used in the formulas shown in
the text are shown only to the second
decimal place, while the actual
spreadsheet formulas used to create
final costs are not limited to two
decimal places, the calculation using
the presented formula will sometimes
17 Appendix V–A of the PEA presents costs by
NAICS industry and establishment size categories
using, as alternatives, a 7 percent discount rate—
shown in Table V–A–1—and a 0 percent discount
rate—shown in Table V–A–2.
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
differ slightly from the presented total
in the text, which is the actual and
mathematically correct total as shown in
the tables.
1. Compliance With the Proposed PEL/
STEL
OSHA’s estimate of the costs for
affected employers to comply with the
proposed PEL of 0.2 mg/m3 and the
proposed STEL of 2.0 mg/m3 consists of
two parts. First, costs are estimated for
the engineering controls, additional
studies and custom design requirements
to implement those controls, work
practices, and specific training required
for those work practices (as opposed to
general training in compliance with the
rule) needed for affected employers to
meet the proposed PEL and STEL, as
well as opportunity costs (lost
productivity) that may result from
working with some of the new controls.
In most cases, the PEA breaks out these
costs, but in other instances some or all
of the costs are shortened simply to
‘‘engineering controls’’ in the text, for
convenience. Second, for employers
unable to meet the proposed PEL and
STEL using engineering controls and
work practices alone, costs are
estimated for respiratory protection
sufficient to reduce worker exposure to
the proposed PEL and STEL or below.
In the technological feasibility
analysis presented in Chapter IV of the
PEA, OSHA concluded that
implementing all engineering controls
and work practices necessary to reach
the proposed PEL will, except for a
small residual group (accounting for
about 6 percent of all exposures above
the STEL), also reduce exposures below
the STEL. However, based on the nature
of the processes this residual group is
likely to be engaged in, the Agency
expects that employees would already
be using respirators to comply with the
PEL under the proposed standard.
Therefore, with the proposed STEL set
at ten times the proposed PEL, the
Agency has preliminarily determined
that engineering controls, work
practices, and (when needed)
respiratory protection sufficient to meet
the proposed PEL are also sufficient to
meet the proposed STEL. For that
reason, OSHA has taken no additional
costs for affected employers to meet the
proposed STEL. The Agency invites
comment and requests that the public
provide data on this issue.
a. Engineering Controls
For this preliminary cost analysis,
OSHA estimated the necessary
engineering controls and work practices
for each affected application group
according to the exposure profile of
PO 00000
Frm 00116
Fmt 4701
Sfmt 4702
current exposures by occupation
presented in Chapter III of the PEA.
Under the requirements of the proposed
standard, employers would be required
to implement engineering or work
practice controls whenever beryllium
exposures exceed the proposed PEL of
0.2 mg/m3 or the proposed STEL of 2.0
mg/m3.
In addition, even if employers are not
exposed above the proposed PEL or
proposed STEL, paragraph (f)(2) of the
proposed standard would require
employers at or above the action level
to use at least one engineering or work
practice control to minimize worker
exposure. Based on the technological
feasibility analysis presented in Chapter
IV of the PEA, OSHA has determined
that, for only two job categories in two
application groups—chemical process
operators in the Stamping, Spring and
Connection Manufacture application
group and machinists in the Machining
application group—do the majority of
facilities at or above the proposed action
level, but below the proposed PEL, lack
the baseline engineering or work
controls required by paragraph (f)(2).
Therefore, OSHA has estimated costs,
where appropriate, for employers in
these two application groups to comply
with paragraph (f)(2).
By assigning controls based on
application group, the Agency is best
able to identify those workers with
exposures above the proposed PEL and
to design a control strategy for, and
attribute costs specifically to, these
groups of workers. By using this
approach, controls are targeting those
specific processes, emission points, or
procedures that create beryllium
exposures. Moreover, this approach
allows OSHA to assign costs for
technologies that are demonstrated to be
the most effective in reducing exposures
resulting from a particular process.
In developing cost estimates, OSHA
took into account the wide variation in
the size or scope of the engineering or
work practice changes necessary to
minimize beryllium exposures based on
technical literature, judgments of
knowledgeable consultants, industry
observers, and other sources. The
resulting cost estimates reflect the
representative conditions for the
affected workers in each application
group and across all work settings. In all
but a handful of cases (with the
exceptions noted in the PEA), all wage
costs come from the 2010 Occupational
Employment Statistics (OES) of the
Bureau of Labor Statistics (BLS, 2010a)
and utilize the median wage for the
appropriate occupation. The wages used
include a 30.35 percent markup for
fringe benefits as a percentage of total
E:\FR\FM\07AUP2.SGM
07AUP2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
compensation, which is the average
percentage markup for fringe benefits
for all civilian workers from the 2010
Employer Costs for Employee
Compensation of the BLS (BLS, 2010b).
All descriptions of production processes
are drawn from the relevant sections of
Chapter IV of the PEA.
The specific engineering costs for
each of the applications groups, and the
NAICS industries that contain those
application groups, are discussed in
Chapter V of the PEA. Like the industry
profile and technological feasibility
analysis presented in other PEA
chapters, Chapter V of the PEA presents
engineering control costs for the
following application groups:
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Beryllium Production
Beryllium Oxide, Ceramics & Composites
Production
Nonferrous Foundries
Stamping, Spring and Connection
Manufacture
Secondary Smelting, Refining, and Alloying
Copper Rolling, Drawing, and Extruding
Secondary Smelting, Refining, and Alloying
Precision Machining
Welding
Dental Laboratories
The costs within these application
groups are estimated by occupation and/
or operation. One application group
could have multiple occupations,
operations, or activities where workers
are exposed to levels of beryllium above
the proposed PEL, and each will need
its own set of controls. The major types
of engineering controls needed to
achieve compliance with the proposed
PEL include ventilation equipment,
pharmaceutical-quality highcontainment isolators, decontainment
chambers, equipment with controlled
water sprays, closed-circuit remote
televisions, enclosed cabs, conveyor
enclosures, exhaust hoods, and portable
local-exhaust-ventilation (LEV) systems.
Capital costs and annual operation and
maintenance (O&M) costs, as well as
any other annual costs, are estimated for
the set of engineering controls estimated
to be necessary for limiting beryllium
exposures for each occupation or
operation within each application
group.
Tables V–2 through V–10 in Chapter
V of the PEA summarize capital,
maintenance, and operating costs for
each application group disaggregated by
NAICS code. Table IX–7 at the end of
this section breaks out the costs of
engineering controls/work practices by
application group and NAICS code.
Some engineering control costs are
estimated on a per-worker basis and
then multiplied by the estimated
number of affected workers—as
identified in Chapter III: Profile of
VerDate Sep<11>2014
20:43 Aug 06, 2015
Jkt 235001
Affected Industries in the PEA—to
arrive at a total cost for a particular
control within a particular application
group. This worker-based method is
necessary because—even though OSHA
has data on the number of firms in each
affected industry, the occupations and
industrial activities that result in worker
exposure to beryllium, and the exposure
profile of at-risk occupations—the
Agency does not have a way to match
up these data at the firm level. Nor does
the Agency have establishment-specific
data on worker exposure to beryllium
for all establishments, or even
establishment-specific data on the level
of activity involving worker exposure to
beryllium. Thus, OSHA could not
always directly estimate per-affectedestablishment costs, but instead first
had to estimate aggregate compliance
costs (using an estimated per-worker
cost multiplied by the number of
affected workers) and then calculate the
average per-affected-establishment costs
by dividing those aggregate costs by the
number of affected establishments. This
method, while correct on average, may
under- or over-state costs for certain
firms. For other controls that are
implemented on a fixed-cost basis per
establishment (e.g., creating a training
program, writing a control program), the
costs are estimated on an establishment
basis, and these costs were multiplied
by the number of affected
establishments in the given application
group to obtain total control costs.
In developing cost estimates, the
Agency sometimes had to make casespecific judgments about the number of
workers affected by each engineering
control. Because work environments
vary within occupations and across
establishments, there are no definitive
data on how many workers are likely to
have their exposures reduced by a given
set of controls. In the smallest
establishments, especially those that
might operate only one shift per day,
some controls would limit exposures for
only a single worker in one specific
affected occupation. More commonly,
however, several workers are likely to
benefit from each enhanced engineering
control. Many controls were judged to
reduce exposure for employees in multishift work or where workstations are
used by more than one worker per shift.
In general, improving work practices
involves operator training, actual work
practice modifications, and better
enforcement or supervision to minimize
potential exposures. The costs of these
process improvements consist of the
supervisor and worker time involved
and would include the time spent by
supervisors to develop a training
program.
PO 00000
Frm 00117
Fmt 4701
Sfmt 4702
47681
Unless otherwise specified, OSHA
viewed the extent to which exposure
controls are already in place to be
reflected in the distribution of
exposures at levels above the proposed
PEL among affected workers. Thus, for
example, if 50 percent of workers in a
given occupation are found to be
exposed to beryllium at levels above the
proposed PEL, OSHA judged this
equivalent to 50 percent of facilities
lacking adequate exposure controls. The
facilities may have, for example, the
correct equipment installed but without
adequate ventilation to provide
protection to workers exposed to
beryllium. In this example, the Agency
would expect that the remaining 50
percent of facilities to either have
installed the relevant controls to reduce
beryllium exposures below the PEL or
that they engage in activities that do not
require that the exposure controls be in
place (for example, they do not perform
any work with beryllium-containing
materials). To estimate the need for
incremental controls on a per-worker
basis, OSHA used the exposure profile
information as the best available data.
OSHA recognizes that a very small
percentage of facilities might have all
the relevant controls in place but are
still unable, for whatever reason, to
achieve the proposed PEL through
controls alone. ERG’s review of the
industrial hygiene literature and other
source materials (ERG, 2007b), however,
suggest that the large majority of
workplaces where workers are exposed
to high levels of beryllium lack at least
some of the relevant controls. Thus, in
estimating the costs associated with the
proposed standard, OSHA has generally
assumed that high levels of exposure to
beryllium occur due to the absence of
suitable controls. This assumption
likely results in an overestimate of costs
since, in some cases, employers may not
need to install and maintain new
controls in order to meet the proposed
PEL but merely need to upgrade or
better maintain existing controls, or to
improve work practices.
b. Respiratory Protection Costs
Based on the findings of the
technological feasibility analysis, a
small subset of employees working with
a few processes in a handful of
application groups will need to use
respirators, in addition to required
engineering controls and improved
work practices, to reduce employee
exposures to meet the proposed PEL.
Specifically, furnace operators—both in
non-ferrous foundries (both sand and
non-sand) and in secondary smelting,
refining, and alloying—as well as
welders in a few other processes, will
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47682
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
need to wear half-mask respirators. In
beryllium production, workers who
rebuild or otherwise maintain furnaces
and furnace tools will need to wear fullface powered air-purifying respirators.
Finally, the Agency recognizes the
possibility that, after all feasible
engineering and other controls are in
place, there may still be a residual group
with potential exposure above the
proposed PEL and/or STEL. To account
for these residual cases, OSHA estimates
that 10 percent of the workers, across all
application groups and job categories,
who are above the proposed PEL before
the beryllium proposed standard is in
place (according to the baseline
exposure profile presented in Chapter III
of the PEA), would still be above the
PEL after all feasible controls are
implemented and, hence, would need to
use half-mask respirators to achieve
compliance with the proposed PEL.
There are five primary costs for
respiratory protection. First, there is a
cost per establishment to set up a
written respirator program in
accordance with the respiratory
protection standard (29 CFR 1910.134).
The respiratory protection standard
requires written procedures for the
proper selection, use, cleaning, storage,
and maintenance of respirators. As
derived in the PEA, OSHA estimates
that, when annualized over 10 years, the
annualized per-establishment cost for a
written respirator program is $207.
For reasons unrelated to the proposed
standard, certain establishments will
already have a respirator program in
place. Table V–11 in Chapter V of the
PEA presents OSHA’s estimates, by
application group, of current levels of
compliance with the respirator program
provision of the proposed rule.
The four other major costs of
respiratory protection are the peremployee costs for all aspects of
respirator use: equipment, training, fittesting, and cleaning. Table V–12 of
Chapter V in the PEA breaks out
OSHA’s estimate of the unit costs for the
two types of respirators needed: A halfmask respirator and a full-face powered
air-purifying respirator. As derived in
the PEA, the annualized per-employee
cost for a half-mask respirator would be
$524 and the annualized per-employee
cost for a full-face powered air-purifying
respirator would be $1,017.
Table V–13 in Chapter V of the PEA
presents the number of additional
employees, by application group and
NAICS code, that would need to wear
respirators to comply with the proposed
standard and the cost to industry to
comply with the respirator protection
provisions in the proposed rule. OSHA
judges that only workers in Beryllium
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
Production work with processes that
would require a full-face respirator and
estimates that there are 23 of those
workers. Three hundred and eighteen
workers in other assorted application
groups are estimated to need half-mask
respirators. A total of 341 employees
would need to wear some type of
respirator, resulting in a total
annualized cost of $249,684 for affected
industries to comply with the
respiratory protection requirements of
the proposed standard. Table IX–7 at the
end of this section breaks out the costs
of respiratory protection by application
group and NAICS code.
2. Ancillary Provisions
This section presents OSHA’s
estimated costs for ancillary beryllium
control programs required under the
proposed rule. Based on the program
requirements contained in the proposed
standard, OSHA considered the
following cost elements in the following
employer duties: (a) Assess employees’
exposure to airborne beryllium, (b)
establish regulated areas, (c) develop a
written exposure control plan, (d)
provide protective work clothing, (e)
establish hygiene areas and practices, (f)
implement housekeeping measures, (g)
provide medical surveillance, (h)
provide medical removal for employees
who have developed CBD or been
confirmed positive for beryllium
sensitization, and (i) provide
appropriate training.
The worker population affected by
each program element varies by several
criteria discussed in detail in each
subsection below. In general, some
elements would apply to all workers
exposed to beryllium at or above the
action level. Other elements would
apply to a smaller set of workers who
are exposed above the PEL. The training
requirements would apply to all
employees who work in a beryllium
work area (e.g., an area with any level
of exposure to airborne beryllium). The
regulated area program elements
triggered by exposures exceeding the
proposed PEL of 0.2 mg/m3 would apply
to those workers for whom feasible
controls are not adequate. In the earlier
discussion of respiratory protection,
OSHA estimated that 10 percent of all
affected workers with current exposures
above the proposed PEL would fall in
this category.
Costs for each program requirement
are aggregated by employment and by
industry. For the most part, unit costs
do not vary by industry, and any
variations are specifically noted. The
estimated compliance rate for each
provision of the proposed standard by
PO 00000
Frm 00118
Fmt 4701
Sfmt 4702
application group is presented in Table
V–15 of the PEA.
a. Exposure Assessment
Most establishments wishing to
perform exposure monitoring would
require the assistance of an outside
consulting industrial hygienist (IH) to
obtain accurate results. While some
firms might already employ or train
qualified staff, OSHA judged that the
testing protocols are fairly challenging
and that few firms have sufficiently
skilled staff to eliminate the need for
outside consultants.
The proposed standard requires that,
after receiving the results of any
exposure monitoring where exposures
exceed the TWA PEL or STEL, the
employer notify each such affected
employee in writing of suspected or
known sources of exposure, and the
corrective action(s) being taken to
reduce exposure to or below the PEL.
Those workers exposed at or above the
action level and at or below the PEL
must have their exposure levels
monitored annually.
For costing purposes, OSHA estimates
that, on average, there are four workers
per work area. OSHA interpreted the
initial exposure assessment as requiring
first-year testing of at least one worker
in each distinct job classification and
work area who is, or may reasonably be
expected to be, exposed to airborne
concentrations of beryllium at or above
the action level.
The proposed standard requires that
whenever there is a change in the
production, process, control equipment,
personnel, or work practices that may
result in new or additional exposures, or
when the employer has any reason to
suspect that a change may result in new
or additional exposures, the employer
must conduct additional monitoring.
The Agency has estimated that this
provision would require an annual
sampling of 10 percent of the affected
workers.
OSHA estimates that an industrial
hygienist (IH) would spend 1 day each
year to sample 2 workers, for a per
worker IH fee of $257. This exposure
monitoring requires that three samples
be taken per worker: One TWA and two
STEL for an annual IH fee per sample
of $86. Based on the 2000 EMSL
Laboratory Testing Catalog (ERG,
2007b), OSHA estimated that analysis of
each sample would cost $137 in lab
fees. When combined with the IH fee,
OSHA estimated the annual cost to
obtain a TWA sample to be $223 per
sampled worker and the annual cost to
obtain the two STEL samples to be $445
per sampled worker. The direct
exposure monitoring unit costs are
E:\FR\FM\07AUP2.SGM
07AUP2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
summarized in Table V–16 in Chapter V
of the PEA.
The cost of the sample also
incorporates a productivity loss due to
the additional time for the worker to
participate in the sampling (30 minutes
per worker sampled) as well as for the
associated recordkeeping time incurred
by a manager (15 minutes per worker
sampled). The STEL samples are
assumed to be taken along with the
TWA sample and, thus, labor costs were
not added to both unit costs. Including
the costs related to lost productivity,
OSHA estimates the total annual cost of
a TWA sample to be $251, and 2 STEL
samples, $445. The total annual cost per
worker for all sampling taken is then
$696. OSHA estimates the total
annualized cost of this provision to be
$2,208,950 for all affected industries.
The annualized cost of this provision for
each affected NAICS industry is shown
in Table IX–6.
b. Beryllium Work Areas and Regulated
Areas
The proposed beryllium standard
requires the employer to establish and
maintain a regulated area wherever
employees are, or can reasonably
expected to be, exposed to airborne
beryllium at levels above the TWA PEL
or STEL. Regulated areas require
specific provisions that both limit
employee exposure within its
boundaries and curb the migration of
beryllium outside the area. The Agency
judged, based on the preliminary
findings of the technological feasibility
analysis, that companies can reduce
establishment-wide exposure by
ensuring that only authorized
employees wearing proper protective
equipment have access to areas of the
establishment where such higher
concentrations of beryllium exist, or can
be reasonably expected to exist. Workers
in other parts of the establishment are
also likely to see a reduction in
beryllium exposures due to these
measures since fewer employees would
be traveling through regulated areas and
subsequently carrying beryllium residue
to other work areas on their clothes and
shoes.
Requirements in the proposed rule for
a regulated area include: Demarcating
the boundaries of the regulated area as
separate from the rest of the workplace,
limiting access to the regulated area,
providing an appropriate respirator to
each person entering the regulated area
and other protective clothing and
equipment as required by paragraph (g)
and paragraph (h), respectively.
OSHA estimated that the total
annualized cost per regulated area,
including set-up costs ($76), respirators
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
($1,768) and protective clothing
($4,500), is $6,344.
When establishments are in full
compliance with the standard, regulated
areas would be required only for those
workers for whom controls could not
feasibly reduce their exposures to or
below the 0.2 mg/m3 TWA PEL and the
2 mg/m3 STEL. Based on the findings of
the technological feasibility analysis,
OSHA estimated that 10 percent of the
affected workers would be exposed
above the TWA PEL or STEL after
implementation of engineering controls
and thus would require regulated areas
(with one regulated area, on average, for
every four workers exposed above the
proposed TWA PEL or STEL).
The proposed standard requires that
all beryllium work areas are adequately
established and demarcated. ERG
estimated that one work area would
need to be established for every 12 atrisk workers. OSHA estimates that the
annualized cost would be $33 per work
area.
OSHA estimates the total annualized
cost of the regulated areas and work
areas is $629,031 for all affected
industries. The cost for each affected
application group and NAICS code is
shown in Table IX–6.
c. Written Exposure Control Plan
The proposed standard requires that
employers must establish and maintain
a written exposure control plan for
beryllium work areas. The written
program must contain:
1. An inventory of operations and job
titles reasonably expected to have
exposure.
2. An inventory of operations and job
titles reasonably expected to have
exposure at or above the action level.
3. An inventory of operations and job
titles reasonably expected to have
exposure above the TWA PEL or STEL.
4. Procedures for minimizing crosscontamination, including but not
limited to preventing the transfer of
beryllium between surfaces, equipment,
clothing, materials and articles within
beryllium work areas.
5. Procedures for keeping surfaces in
the beryllium work area free as
practicable of beryllium.
6. Procedures for minimizing the
migration of beryllium from beryllium
work areas to other locations within or
outside the workplace.
7. An inventory of engineering and
work practice controls required by
paragraph (f)(2) of this standard.
8. Procedures for removal, laundering,
storage, cleaning, repairing, and
disposal of beryllium-contaminated
personal protective clothing and
equipment, including respirators.
PO 00000
Frm 00119
Fmt 4701
Sfmt 4702
47683
The unit cost estimates take into
account the judgment that (1) most
establishments have an awareness of
beryllium risks and, thus, should be
able to develop or modify existing
safeguards in an expeditious fashion,
and (2) many operations have limited
beryllium activities and these
establishments need to make only
modest changes in procedures to create
the necessary exposure control plan.
ERG’s experts estimated that managers
would spend eight hours per
establishment to develop and
implement such a written exposure
control plan, yielding a total cost per
establishment to develop and
implement the written control plan of
$563.53 and an annualized cost of $66.
In addition, because larger firms with
more affected workers will need to
develop more complicated written
control plans, the development of a plan
would require an extra thirty minutes of
a manager’s time per affected employee,
for a cost of $35 per affected employee
and an annualized cost of $4 per
employee. Managers would also need 12
minutes (0.2 hours) per affected
employee per quarter, or 48 minutes per
affected employee per year to review
and update the plan, for a recurring cost
of $56 per affected employee per year to
maintain and update the plan. Five
minutes of clerical time would also be
needed per employee for providing each
employee with a copy of the written
exposure control plan—yielding an
annualized cost of $2 per employee. The
total annual per-employee cost for
development, implementation, review,
and update of a written exposure
control plan is then $62. The Agency
estimates the total annualized cost of
this provision to be $1,769,506 for all
affected establishments. The breakdown
of these costs by application group and
NAICS code is presented in Table
IX–6.
d. Personal Protective Clothing and
Equipment
The proposed standard requires
personal protective clothing and
equipment for workers:
1. Whose exposure can reasonably be
expected to exceed the TWA PEL or
STEL.
2. When work clothing or skin may
become visibly contaminated with
beryllium, including during
maintenance and repair activities or
during non-routine tasks.
3. Where employees’ skin can
reasonably be expected to be exposed to
soluble beryllium compounds.
OSHA has determined that it would
be necessary for employers to provide
reusable overalls and/or lab coats at a
E:\FR\FM\07AUP2.SGM
07AUP2
47684
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
cost of $284 and $86, respectively, for
operations in the following application
groups:
Beryllium Production
Beryllium Oxide, Ceramics & Composites
Nonferrous Foundries
Fabrication of Beryllium Alloy Products
Copper Rolling, Drawing & Extruding
Secondary Smelting, Refining and Alloying
Precision Turned Products
Dental Laboratories
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Chemical process operators in the
spring and stamping application group
would require chemical resistant
protective clothing at an annual cost of
$849. Gloves and/or shoe covers would
be required when performing operations
in several different application groups,
depending on the process being
performed, at an annual cost of $50 and
$78, respectively.
The proposed standard requires that
all reusable protective clothing and
equipment be cleaned, laundered,
repaired, and replaced as needed to
maintain their effectiveness. This
includes such safeguards as transporting
contaminated clothing in sealed and
labeled impermeable bags and
informing any third party businesses
coming in contact with such materials
of the risks associated with beryllium
exposure. OSHA estimates that the
lowest cost alternative to satisfy this
provision is for an employer to rent and
launder reusable protective clothing—at
an estimated annual cost per employee
of $49. Ten minutes of clerical time
would also be needed per establishment
with laundry needs to notify the
cleaners in writing of the potentially
harmful effects of beryllium exposure
and how the protective clothing and
equipment must be handled in
accordance with this standard—at a per
establishment cost of $3.
The Agency estimates the total
annualized cost of this provision to be
$1,407,365 for all affected
establishments. The breakdown of these
costs by application group and NAICS
code is shown in Table IX–6.
e. Hygiene Areas and Practices
The proposed standard requires
employers to provide readily accessible
washing facilities to remove beryllium
from the hands, face, and neck of each
employee working in a beryllium work
area and also to provide a designated
change room in workplaces where
employees would have to remove their
personal clothing and don the
employer-provided protective clothing.
The proposed standard also requires
that employees shower at the end of the
work shift or work activity if the
employee reasonably could have been
exposed to beryllium at levels above the
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
PEL or STEL, and if those exposures
could reasonably be expected to have
caused contamination of the employee’s
hair or body parts other than hands,
face, and neck.
In addition to other forms of PPE
costed previously, for processes where
hair may become contaminated, head
coverings can be purchased at an annual
cost of $28 per employee. This could
satisfy the requirement to avoid
contaminated hair. If workers are
covered by protective clothing such that
no body parts (including their hair
where necessary, but not including their
hands, face, and neck) could reasonably
be expected to have been contaminated
by beryllium, and they could not
reasonably be expected to be exposed to
beryllium while removing their
protective clothing, they would not
need to shower at the end of a work
shift or work activity. OSHA notes that
some facilities already have showers,
and the Agency judges that all
employers either already have showers
where needed or will have sufficient
measures in place to ensure that
employees could not reasonably be
expected to be exposed to beryllium
while removing protective clothing.
Therefore, OSHA has preliminarily
determined that employers will not
need to provide any new shower
facilities to comply with the standard.
The Agency estimated the costs for
the addition of a change room and
segregated lockers based on the costs for
acquisition of portable structures. The
change room is presumed to be used in
providing a transition zone from general
working areas into beryllium-using
regulated areas. OSHA estimated that
portable building, adequate for 10
workers per establishment can be rented
annually for $3,251, and that lockers
could be procured for a capital cost of
$407—or $48 annualized—per
establishment. This results in an
annualized cost of $3,299 per facility to
rent a portable change room with
lockers. OSHA estimates that the 10
percent of affected establishments
unable to meet the proposed TWA PEL
would require change rooms. The
Agency estimated that a worker using a
change room would need 2 minutes per
day to change clothes. Assuming 250
days per year, this annual time cost for
changing clothes is $185 per employee.
The Agency estimates the total
annualized cost of the provision on
hygiene areas and practices to be
$389,241 for all affected establishments.
The breakdown of these costs by
application group and NAICS code can
be seen in Table IX–6.
PO 00000
Frm 00120
Fmt 4701
Sfmt 4702
f. Housekeeping
The proposed rule specifies
requirements for cleaning and disposing
of beryllium-contaminated wastes. The
employer shall maintain all surfaces in
beryllium work areas as free as
practicable of accumulations of
beryllium and shall ensure that all spills
and emergency releases of beryllium are
cleaned up promptly, in accordance
with the employer’s written exposure
control plan and using a HEPA-filtered
vacuum or other methods that minimize
the likelihood and level of exposure.
The employer shall not allow dry
sweeping or brushing for cleaning
surfaces in beryllium work areas unless
HEPA-filtered vacuuming or other
methods that minimize the likelihood
and level of exposure have been tried
and were not effective.
ERG’s experts estimated that each
facility would need to purchase a single
vacuum at a cost of $2,900 for every five
affected employees in order to
successfully integrate housekeeping into
their daily routine. The per-employee
cost would be $580, resulting in an
annualized cost of $68 per worker.
ERG’s experts also estimated that all
affected workers would require an
additional five minutes per work day
(.083 hours) to complete vacuuming
tasks and to label and dispose of
beryllium-contaminated waste. While
this allotment is modest, OSHA judged
that the steady application of this
incremental additional cleaning, when
combined with currently conducted
cleaning, would be sufficient in average
establishments to address dust or
surface contamination hazards.
Assuming that these affected workers
would be working 250 days per year,
OSHA estimates that the annual labor
cost per employee for additional time
spent cleaning in order to comply with
this provision is $462.
The proposed standard requires each
disposal bag with contaminated
materials to be properly labeled. ERG
estimated a cost of 10 cents per label
with one label needed per day for every
five workers. With the disposal of one
labeled bag each day and 250 working
days, the per-employee annual cost
would be $5. The annualized cost of a
HEPA-filtered vacuum, combined with
the additional time needed to perform
housekeeping and the labeling of
disposal bags, results in a total
annualized cost of $535 per employee.
The Agency estimates the total
annualized cost of this provision to be
$12,574,921 for all affected
establishments. The breakdown of these
costs by application group and NAICS
code is shown in Table IX–6.
E:\FR\FM\07AUP2.SGM
07AUP2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
g. Medical Surveillance
The proposed standard requires the
employer to make medical surveillance
available at no cost to the employee, and
at a reasonable time and place, for the
following employees:
1. Employees who have worked in a
regulated area for more than 30 days in
the last 12 months
2. Employees showing signs or
symptoms of chronic beryllium disease
(CBD)
3. Employees exposed to beryllium
during an emergency; and
4. Employees exposed to airborne
beryllium above 0.2 mg/m3 for more than
30 days in a 12-month period for 5 years
or more.
As discussed in the regulated areas
section of this analysis of program costs,
the Agency estimates that
approximately 10 percent of affected
employees would have exposure in
excess of the PEL after the standard goes
into effect and would therefore be
placed in regulated areas. The Agency
further estimates that a very small
number of employees will be affected by
emergencies in a given year, likely less
than 0.1 percent of the affected
population, representing a small
additional cost. The number of workers
who would suffer signs and symptoms
of CBD after the rule takes effect is
difficult to estimate, but would likely
substantially exceed those with actual
cases of CBD.
While the symptoms of CBD vary
greatly, the first to appear are usually
chronic dry cough (generally defined as
a nonproductive cough, without phlegm
or sputum, lasting two months or more)
and shortness of breath during exertion.
Ideally, in developing these costs
estimates, OSHA would first estimate
the percent of affected workers who
might be presenting with a chronic
cough and/or experiencing shortness of
breath.
Studies have found the prevalence of
a chronic cough ranging from 10 to 38
percent across various community
populations, with smoking accounting
for up to 18 percent of cough prevalence
(Irwin, 1990; Barbee, 1991). However,
these studies are over 20 years old, and
the number of smokers has decreased
substantially since then. It’s also not
clear whether the various segments of
the U.S. population studied are similar
enough to the population of workers
exposed to beryllium such that results
of these studies could be generalized to
the affected worker population.
A more recent study from a plant in
Cullman, Alabama that works with
beryllium alloy found that about five
percent of employees said they were
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
current smokers, with roughly 52
percent saying they were previous
smokers and approximately 43 percent
stating they had never smoked
(Newman et al., 2001). This study does
not, however, report on the prevalence
of chronic cough in this workplace.
OSHA was unable to identify any
studies on the general prevalence of the
other common early symptom of CBD,
shortness of breath. Lacking any better
data to base an estimate on, the Agency
used the studies cited above (Irwin,
1990; Barbee, 1991) showing the
prevalence of chronic cough in the
general population, adjusted to account
for the long term decrease in smoking
prevalence (and hence, the amount of
overall cases of chronic cough), and
estimated that 15 percent of the worker
population with beryllium exposure
would exhibit a chronic cough or other
sign or symptom of CBD that would
trigger medical surveillance. The
Agency welcomes comment and further
data on this question.
According to the proposed rule, the
initial (baseline) medical examination
would consist of the following:
1. A medical and work history, with
emphasis on past and present exposure,
smoking history and any history of
respiratory system dysfunction;
2. A physical examination with
emphasis on the respiratory tract;
3. A physical examination for skin
breaks and wounds;
4. A pulmonary function test;
5. A standardized beryllium
lymphocyte proliferation test (BeLPT)
upon the first examination and within
every two years from the date of the first
examination until the employee is
confirmed positive for beryllium
sensitization;
6. A CT scan, offered every two years
for the duration of the employee’s
employment, if the employee was
exposed to airborne beryllium at levels
above 0.2 mg/m3 for more than 30 days
in a 12-month period for at least 5 years.
This obligation begins on the start-up
date of this standard, or on the 15th year
after the employee’s first exposure
above for more than 30 days in a 12month period, whichever is later; and
7. Any other test deemed appropriate
by the Physician or other Licensed
Health Care Professional (PLHCP).
Table V–17 in Chapter V of the PEA
lists the direct unit costs for initial
medical surveillance activities
including: Work and medical history,
physical examination, pulmonary
function test, BeLPT, CT scan, and costs
of additional tests. In OSHA’s cost
model, all of the activities will take
place during an employee’s initial visit
and on an annual basis thereafter and
PO 00000
Frm 00121
Fmt 4701
Sfmt 4702
47685
involve a single set of travel costs,
except that: (1) The BeLPT tests will
only be performed at two-year intervals
after the initial test, but will be
conducted in conjunction with the
annual general examination (no
additional travel costs); and (2) the CT
scans will typically involve different
specialists and are therefore treated as
separate visits not encompassed by the
general exams (therefore requiring
separate travel costs). Not all employees
would require CT scans, and employers
would only be required to offer them
every other year.
In addition to the fees for the annual
medical exam, employers may also
incur costs for lost work time when
their employees are unavailable to
perform their jobs. This includes time
for traveling, a health history review,
the physical exam, and the pulmonary
function test. Each examination would
require 15 minutes (or 0.25 hours) of a
human resource manager’s time for
recording the results of the exam and
tests and the PLHCP’s written opinion
for each employee and any necessary
post-exam consultation with the
employee. There is also a cost of 15
minutes of supervisor time to provide
information to the physician, five
minutes of supervisor time to process a
licensed physician’s written medical
opinion, and five minutes for an
employee to receive a licensed
physician’s written medical opinion.
The total unit annual cost for the
medical examinations and tests,
excluding the BeLPT test, and the time
required for both the employee and the
supervisor is $297.
The estimated fee for the BeLPT is
$259. With the addition of the time
incurred by the worker to undergo the
test, the total cost for a BeLPT is $261.
The standard requires a biennial BeLPT
for each employee covered by the
medical surveillance provision, so most
workers would receive between two and
five BeLPT tests over a ten year period
(including the BeLPT performed during
the initial examination), depending on
whether the results of these tests were
positive. OSHA therefore estimates a net
present value (NPV) of $1,417 for all
five tests. This NPV annualized over a
ten year period is $166.
Together, the annualized net present
value of the BeLPT and the annualized
cost of the remaining medical
surveillance produce an annual cost of
$436 per employee.
The proposed standard requires that a
helical tomography (CT scan) be offered
to employees exposed to airborne
beryllium above 0.2 mg/m3 for more than
30 days in a 12-month period, for a
period of 5 years or more. The five years
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47686
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
do not need to be consecutive, and the
exposure does not need to occur after
the effective date of the standard. The
CT scan shall be offered every 2 years
starting on the 15th year after the first
year the employee was exposed above
0.2 mg/m3 for more than 30 days in a 12month period, for the duration of their
employment. The total yearly cost for
biennial CT scans consists of medical
costs totaling $1,020, comprised of a
$770 fee for the scan and the cost of a
specialist to review the results, which
OSHA estimates would cost $250. The
Agency estimates an additional cost of
$110 for lost work time, for a total of
$1,131. The annualized yearly cost for
biennial CT scans is $574.
Based on OSHA’s estimates explained
earlier in this section, all workers in
regulated areas, workers exposed in
emergencies, and an estimated 15
percent of workers not in regulated
areas who exhibit signs and symptoms
of CBD will be eligible for medical
surveillance other than CT scans. The
estimate for the number of workers
eligible to receive CT scans is 25 percent
of workers who are exposed above 0.2
in the exposure profile. The estimate of
25 percent is based on the facts that
roughly this percentage of workers have
15-plus years of job tenure in the
durable manufacturing sector and the
estimate that all those with 15-plus
years of job tenure and current exposure
over 0.2 would have had at least 5 years
of such exposure in the past.
The costs estimated for this provision
are likely to be significantly
overestimated, since not all affected
employees offered medical surveillance
would necessarily accept the offer. At
Department of Energy facilities, only
about 50 percent of eligible employees
participate in the voluntary medical
surveillance tests, and a report on an
initial medical surveillance program at
four aluminum manufacture facilities
found participation rates to be around
57 percent (Taiwo et al., 2008). Where
employers already offer equivalent
health surveillance screening, no new
costs are attributable to the proposed
standard.
Within 30 days after an employer
learns that an employee has been
confirmed positive for beryllium
sensitization, the employer’s designated
licensed physician shall consult with
the employee to discuss referral to a
CBD diagnostic center that is mutually
agreed upon by the employer and the
employee. If, after this consultation, the
employee wishes to obtain a clinical
evaluation at a CBD diagnostic center,
the employer must provide the
evaluation at no cost to the employee.
OSHA estimates this consultation will
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
take 15 minutes, with an estimated total
cost of $33.
Table V–18 in Chapter V of the PEA
lists the direct unit costs for a clinical
evaluation with a specialist at a CBD
diagnostic center. To estimate these
costs, ERG contacted a healthcare
provider who commonly treats patients
with beryllium-related disease, and
asked them to provide both the typical
tests given and associated costs of an
initial examination for a patient with a
positive BeLPT test, presented in Table
V–18 in Chapter V of the PEA. Their
typical evaluation includes
bronchoscopy with lung biopsy, a
pulmonary stress test, and a chest CAT
scan. The total cost for the entire suite
of tests is $6,305.
In addition, there are costs for lost
productivity and travel. The Agency has
estimated the clinical evaluation would
take three days of paid time for the
worker to travel to and from one of two
locations: Penn Lung Center at the
Cleveland Clinic Foundation in
Cleveland, Ohio or National Jewish
Medical Center in Denver, Colorado.
OSHA estimates lost work time is 24
hours, yielding total cost for the 3 days
of $532.
OSHA estimates that roundtrip airfare would be available for most
facilities at $400, and the cost of a hotel
room would be approximately $100 per
night, for a total cost of $200 for the
hotel room. OSHA estimates a per diem
cost of $50 for three days, for a total of
$150. The total cost per trip for traveling
expenses is therefore $750.
The total cost of a clinical evaluation
with a specialist at a CBD diagnostic
center is equal to the cost of the
examination plus the cost of lost worktime and the cost for the employee to
travel to the CBD diagnostic center, or
$7,620.
Based on the data from the exposure
profile and the prevalence of beryllium
sensitization observed at various levels
of cumulative exposure,18 OSHA
estimated the number of workers
eligible for BeLPT testing (4,181) and
the percentage of workers who will be
confirmed positive for sensitization (two
positive BeLPT tests, as specified in the
proposed standard) and referred to a
CBD diagnostic center. During the first
year that the medical surveillance
provisions are in effect, OSHA estimates
that 9.4 percent of the workers who are
tested for beryllium sensitization will be
identified as sensitized. This percentage
is an average based on: (1) The number
of employees in the baseline exposure
profile that are in a given cumulative
18 See Table VI–6 in Section VI of the preamble,
Preliminary Risk Assessment.
PO 00000
Frm 00122
Fmt 4701
Sfmt 4702
exposure range; (2) the expected
prevalence for a given cumulative
exposure range (from Table VI–6 in
Section VI of the preamble); and (3) an
assumed even distribution of employees
by cumulative years of exposure at a
given level—20 percent having
exposures at a given level for 5 years, 20
percent for 15 years, 20 percent for 25
years, 20 percent for 30 years, and 20
percent for 40 years.
OSHA did not assume that all workers
with confirmed sensitization would
choose to undergo evaluation at a CBD
diagnostic center, which may involve
invasive procedures and/or travel. For
purposes of this cost analysis, OSHA
estimates that approximately two-thirds
of workers who are confirmed positive
for beryllium sensitization will choose
to undergo evaluation for CBD. OSHA
requests comment on the CBD
evaluation participation rate. OSHA
estimates that about 264 of all nondental lab workers will go to a
diagnostic center for CBD evaluation in
the first year.
The calculation method described
above applies to all workers except
dental technicians, who were analyzed
with one modification. The rates for
dental technicians are calculated
differently due to the estimated 75
percent beryllium-substitution rate at
dental labs, where the 75 percent of labs
that eliminate all beryllium use are
those at higher exposure levels. None of
the remaining labs affected by this
standard had exposures above 0.1 mg/
m3. For the dental labs, the same
calculation was done as presented in the
previous paragraph, but only the
remaining 25 percent of employees
(2,314) who would still face beryllium
exposures were included in the baseline
cumulative exposure profile. With that
one change, and all other elements of
the calculation the same, OSHA
estimates that 9 percent of dental lab
workers tested for beryllium
sensitization will be identified as
sensitized. The predicted prevalence of
sensitization among those dental lab
workers tested in the first year after the
standard takes effect is slightly lower
than the predicted prevalence among all
other tested workers combined. This
slightly lower rate is not surprising
because only dental lab workers with
exposures below 0.1 mg/m3 are included
(after adjusting for substitution), and
OSHA’s exposure profile indicates that
the vast majority of non-dental workers
exposed to beryllium are also exposed at
0.1 mg/m3 or lower. OSHA estimates that
20 dental lab workers (out of 347 tested
for sensitization) would go to a
diagnostic center for CBD evaluation in
the first year.
E:\FR\FM\07AUP2.SGM
07AUP2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
In each year after the first year, OSHA
relied on a 10 percent worker turnover
rate in a steady state (as discussed in
Chapter VII of the PEA) to estimate that
the annual sensitization incidence rate
is 10 percent of the first year’s incidence
rate. Based on that rate and the number
of workers in the medical surveillance
program, the CBD evaluation rate for
workers other than those in dental labs
would drop to 0.63 percent (.063 × .10).
The evaluation rate for dental labs
technicians is similarly estimated to
drop to 0.58 percent (.058 × .10).
Based on these unit costs and the
number of employees requiring medical
surveillance estimated above, OSHA
estimates that the medical surveillance
and referral provisions would result in
an annualized total cost of $2,882,706.
These costs are presented by application
group and NAICS code in Table IX–7.
h. Medical Removal Provision
Once a licensed physician diagnoses
an employee with CBD or the employee
is confirmed positive for sensitization to
beryllium, that employee is eligible for
medical removal and has two choices:
(a) Removal from current job, or
(b) Remain in a job with exposure
above the action level while wearing a
respirator pursuant to 29 CFR 1910.134.
To be eligible for removal, the
employee must accept comparable work
if such is available, but if not available
the employer would be required to place
the employee on paid leave for six
months or until such time as
comparable work becomes available,
whichever comes first. During that sixmonth period, whether the employee is
re-assigned or placed on paid leave, the
employer must continue to maintain the
employee’s base earnings, seniority and
other rights, and benefits that existed at
the time of the first test.
For purposes of this analysis, OSHA
has conservatively estimated the costs
as if all employees will choose removal,
rather than remaining in the current job
while wearing a respirator. In practice,
many workers may prefer to continue
working at their current job while
wearing a respirator, and the employer
would only incur the respirator costs
identified earlier in this chapter. The
removal costs are significantly higher
over the same six-month period, so this
analysis likely overestimates the total
costs for this provision.
OSHA estimated that the majority of
firms would be able to reassign the
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
worker to a job at least at the clerical
level. The employer will often incur a
cost for re-assigning the worker because
this provision requires that, regardless
of the comparable work the medically
removed worker is performing, the
employee must be paid the full base
earnings for the previous position for six
months. The cost per hour of
reassigning a worker to a clerical job is
based on the wage difference of a
production worker of $22.16 and a
clerical worker of $19.97, for a
difference of $2.19. Over the six-month
period, the incremental cost of
reassigning a worker to a clerical
position would be $2,190 per employee.
This estimate is based on the employee
remaining in a clerical position for the
entire 6-month period, but the actual
cost would be lower if there is turnover
or if the employee is placed in any
alternative position (for any part of the
six-month period) that is compensated
at a wage closer to the employee’s
previous wage.
Some firms may not have the ability
to place the worker in an alternate job.
If the employee chooses not to remain
in the current position, the additional
cost to the employer would be at most
the cost of equipping that employee
with a respirator, which would be
required if the employee would
continue to face exposures at or above
the action level. Based on the earlier
discussion of respirator costs, that
option would be significantly cheaper
than the alternative of providing the
employee with six months of paid leave.
Therefore, in order to estimate the
maximum potential economic cost of
the remaining alternatives, the Agency
has conservatively estimated the cost
per worker based on the cost of 6
months paid leave.
Using the wage rate of a production
worker of $22.16 for 6 months (or 8
hours a day for 125 days), the total perworker cost for this provision when a
firm cannot place a worker in an
alternate job is $22,161.
OSHA has estimated an average
medical removal cost per worker
assuming 75 percent of firms are able to
find the employee an alternate job, and
the remaining 25 percent of firms would
not. The weighted average of these costs
is $7,183. Based on these unit costs,
OSHA estimates that the medical
removal provision would result in an
annualized total cost of $148,826. The
PO 00000
Frm 00123
Fmt 4701
Sfmt 4702
47687
breakdown of these costs by application
group and NAICS code is shown in
Table IX–6.
i. Training
As specified in the proposed standard
and existing OSHA standard 29 CFR
1910.1200 on hazard communication,
training is required for all employees
where there is potential exposure to
beryllium. In addition, newly hired
employees would require training before
starting work.
OSHA anticipates that training in
accordance with the requirements of the
proposed rule, which includes hazard
communication training, would be
conducted by in-house safety or
supervisory staff with the use of training
modules or videos. ERG estimated that
this training would last, on average,
eight hours. (Note that this estimate
does not include the time taken for
hazard communication training that is
already required by 29 CFR 1910.1200.)
The Agency judged that establishments
could purchase sufficient training
materials at an average cost of $2 per
worker, encompassing the cost of
handouts, video presentations, and
training manuals and exercises. For
initial and periodic training, ERG
estimated an average class size of five
workers with one instructor over an
eight hour period. The per-worker cost
of initial training totals to $239.
Annual retraining of workers is also
required by the standard. OSHA
estimates the same unit costs as for
initial training, so retraining would
require the same per-worker cost of
$239.
Finally, to calculate training costs, the
Agency needs the turnover rate of
affected workers to know how many
workers are receiving initial training
versus retraining. Based on a 26.3
percent new hire rate in manufacturing,
OSHA calculated a total net present
value (NPV) of ten years of initial and
annual retraining of $2,101 per
employee. Annualizing this NPV gives a
total annual cost for training of $246.
Based on these unit costs, OSHA
estimates that the training requirements
in the standard would result in an
annualized total cost of $5,797,535. The
breakdown of these costs by application
group and NAICS code is presented in
Table IX–6.
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47688
VerDate Sep<11>2014
Jkt 235001
PO 00000
Frm 00124
Fmt 4701
NAICS
Code
lndustr
Be1ylliumPmcluction
331419 Pnmmy smeltmg and refinmg ofnonterrous metals
Beryllium Ohlde Ceranncs and Composites
327113a Porcelain electncal supply manufacturin,Q (prirrruy)
327113b Pmcelain electncal sup ply manu factming ( o;;econcl my)
334:220 Cellular telephones rnanutactunng
334310 Compact disc players manufacturing
334411
Electron tube manufacturing
334415 Electronic 1es1stmmanufuctming
334419 Other electromc component manu±actunng
334510 Electromedical equipment manufacturing
336322b Othermotorvelucle electncal and electromc eqmpment
manufacturing
Regulated Areas
and Beryllium
WorkAn•as
Exposure
Assessment
Pro~sed
Derl:!lium Standard !?l:· A~lication Groul! and Six-Digit NAICS lndustri ~in 2010 dollars2
1\Jedical
Surveillance
:Medical Remov.tl Written Exposure
Protective Work
Hygiene Areas
Control Plan
Clothing & Equipment and Practices
Pro"'sion
House-keeping
Total Program
Costs
Training
Sfmt 4725
E:\FR\FM\07AUP2.SGM
$0
$1,683
$11,121
$6,359
$0
$17,801
$8,112
$0
$0
$45,075
$6,959
$17,311
$12,365
$6,183
$25,967
$14,838
$11,129
$1U29
$12,365
$4,162
$5,303
$3,788
$1,894
$7,955
$4,545
$3,409
$3,409
$3,788
$9,205
$2C,,307
$14,505
$7252
$30,460
$17,406
$13,054
$13,054
$H,505
$1,912
$1,276
$911
$456
$1,914
$1,094
$820
$820
$911
$2,645
$11,365
$8,118
$4,059
$17,048
$9,742
$7,306
$7,306
$8,118
$2,761
$4,938
$8,526
$11,252
$6,346
$3,227
$8,193
$5,2!J3
$2,432
$1,959
$1,399
$864
$2,938
$1,679
$1,292
$1,292
$1,399
$22,189
$67,370
$48,122
$24,061
$101,055
$57,746
$43,309
$43,309
$!J8,122
$10,230
$3LOW
$22,186
$1LU93
$46590
$26,623
$19,967
$19.967
$22,186
$62,495
$160,889
$119,920
$56,692
$245,179
$140,019
$103,514
$108,480
$116,637
$18,965
$102,953
$18,965
$54,186
$11,764
$63,860
$11,764
$33,610
$22,386
$121,522
$22,386
$63,959
$2,948
$16,003
$2,948
$8,423
$6,580
$35,718
$6,580
$18,799
$14,421
$50,165
$7,835
$14,318
$3,882
$20,536
$3,882
$10,808
$39,473
$21,1,281
$39,473
$112,780
$18.199
$98,792
$18199
$51,996
$138,616
$723,831
$132,030
$368,879
$7),7(16
$4R,627
$91,1'0
$11,940
$26,047
$31,197
$1"',"'20
$1'57,416
$72,'57)
$'30,377
$1,687
$1,6R7
$1,926
$1,926
$5,779
$251
$2)1
$752
$625
$02)
$Ul76
$284
$733
$706
$294
$294
$3,609
$3,609
:R\~2
$10,~27
$L664
$1,664
$4,992
$11,325
$11,774
$5,tl62
$984
$984
$2,953
$38,355
$15,256
$40,496
$4,129
$18,761
$9,889
$4,411
$108,274
$49.918
$289,489
$830
A lumnnm cmd C'..0pper Founclries
331521
331522
331524
331525
Aluminum die-casting foundries
Nonferrous (except aluminum) die-casting foundries
Aluminumfoundnes (excepl die-cas ling)
a Copperfonndries (except dw-casting) (non-sand casting foundries)
11112
"'h Coppcrfonndncs (except dlC-castmg) (sand castmg foundncs)
Secondary Smelting, Refining, and Alloying
331314 Secondary smelting & alloying of aluminum
111421b l;opperrolling, drawmg, nnrl e-xtmrling
331423
331492
Secondary smeltmg, retinmg, & alloymg of copper
Secondary smelting, refinmg, & alloying of nonferrous metal (except
coppe1 & ahunimun)
Prcctston Turned Products
332721
a Precision turned product manufacturing (high beryllium content)
07AUP2
332721
b Precision turned product manufacturing (lowbe:rylltumcontent)
Copper Rolling, Drawing aml Exlrud:ing
331422 Copper wrre (except mechantcal) drawmg
331421a Copperrolling, dmwmg, illld extruding
$33,~29
$19,773
$20,306
$39,419
$6,022
$11,265
$22,809
$8,725
$59,373
$27.373
$215,066
$339,855
$93,938
$406,491
$22,244
$:239,550
$363,790
$35,735
$1,420,434
$654,876
$3,576,912
$330,266
$77,074
$77,096
$7,662
$426,151
$109,469
$23,234
$L983
$:240,458
$72,471
$349,147
$105,427
$27,975
$1,919
$2,043,664
$617,121
$942,210
$284.517
$4,460,202
$1,277,644
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
19:20 Aug 06, 2015
EP07AU15.009</GPH>
Table IX-6
Annualized Cost of Program Reguirements for Industries Affected !?l: the
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
VerDate Sep<11>2014
Jkt 235001
Exposure
Assessment
NAICS
Code
PO 00000
Industry
Fabncat10n ofBerylliumAlloy Products
332612 Light gauge sp1ing IIIdltufacLUiing
112110 Metill stilmping
Frm 00125
334417 l::lcctromc conncctormanutactUilllg
336322a Other motor vehicle electrical & electronic equipment
A1c and Gas Welding
111111
Tmn <~nd steel mills
Fmt 4701
Sfmt 4725
E:\FR\FM\07AUP2.SGM
331221
331513
332117
112212
Kolicd steel shape manutacturmg
Steel form dries (except investment)
Powdei metallu1gy pml manufactuiing
Hnnrl cmrl edge tonl milnnfCJ.cturing
332312
332313
332322
112321
Fabncatcd structural metal manutacturmg
Plate v,-orkmanufacturing
33243SJ
332919
332999
other metal contamcr manutacturmg
Other metal valve and pipe fitting manufacturmg
333111
Farm machinery and equipment manufacturing
Regulated Areas
and Beryllium
\Vork Areas
Medical
Surwillance
Medical Remo,al
Pro,ision
Written Exposure
Contml Plan
$22,281
$9,640
$192,128
$51,182
$4,170
$1)))
$150,032
$:1),720
$80.612
$11,240
~46
$6,01~
$20,712
$32,079
$110,102
$2,911
$22,31)4
$76,762
$18014
$11,357
$1,107
$1,407
$1,792
$29)
$2,0R"'
$0
$1,0R"'
$14,171
$6,)1:1
$1"',19)
$65~
$305
$300
$201
$78~
$0
$0
$0
$0
$2,493
$9112
$3,053
$1,722
$3.379
$3,378
$3,352
$1,469
$21,713
S2,945
S2,897
S1,946
S0,2?i9
:1)119,636
$,15,228
:1)9,926
$32,010
$12,101
$39,207
$22,117
$433
$1126
$286
$918
$17,61)1
$1,35~
$775
$521
$1,6l'i9
$61
$60
$41
$BO
$617
$435
$1,194
$646
H681
$15,168
$R,'5'50
$3,206
$1,300
$16,000
$1,4~5
$3,83~
$602
$7,410
$1,556
$19,155
$299
$121
$1,492
333414a Heating equipment (except Wllim ai.r furnaces) manufactming
$9,531
$2,858
$4,414
$1,324
$11,411
$3,421
333911
333922
333921
$3,174
$4,314
$2,079
$1,470
$1,998
$963
$8,472
$7,157
333999
Pump and pumpmg eqmpment manu±ilcturmg
Conveyor 8lld conveying equipment manufacturmg
Industrial truck tmctm. tmile1-. and stacker machinety manufachuing
All othernnscellaneous general purpose machinery manufacturmg
07AUP2
336211
336214
336399a
3365W
Motorveh1de body manufacturmg
Travel trailer and campermanufacturmg
All other motorveh1ele parts rrn.nufacturing
Raihoad wiling stock
336999
337215
All other transportation eqmpment manu±ilcturmg
Showcase, part1tion, shelvmg, and lockermanufacturmg
811310
Corrrrncrc1al and mdustnal rnachmcty and cqmpmcnt rcparr
Tolal Program
Cost<o:
~23,146
$12,3~3
All othermscellnneous fCJ.bncilted met<Jl product m<~nnt"<lctnring
Training
$79,660
~26,737
Sheet metal wUikmanufacluring
CJ.nrl ilrchitechtml met<~ I workm<~nnfnctunng
House-keeping
$3,613
$2,229
$1,392
$;1,789
$147,766
$:17,074
$10,108
$32,749
$18,474
Om<Jment<~l
Prolecliw Work
Hygiene Areas
Clothing & F.quipment and Practices
$6,588
$3,531
$1,293
$1,712
$1,562
$68,217
$6,65~
$21,558
$12,161
$2,ll1
$0
$0
$0
$0
$8,208
$26,594
$1),01)2
$3,690
$1,107,234
$26),110
:1)165,639
S510,479
S122,11R
$2,218,314
$'510,2RO
$570,058
$76,366
S262,819
$U72,171
$1,336
$897
$2,R70
:1)55,157
$345,~05
$9,819
$7,679
$17)41
$2~,731)
$108,775
$146,534
$R2,000
$20,852
$67,558
$?iR,llO
$14,346
S5,816
$71,590
$6,614
$2,681
$33,0()5
$16,389
$172,178
$352,421
$198,802
$35,5~9
$856
$10,532
$0
$0
$0
$889
$266
$6,274
$1,881
$0
$0
$7,740
$3,647
$42,647
$12,788
$19,662
$5,896
$102,568
$32,081
$3,800
$5,164
$2,189
$296
$402
$191
$2.089
$2,840
$1,369
$0
$0
$0
$3.686
$3,825
$3,552
$14,202
$19,301
S9,303
$6,548
$8,899
H289
$35,266
$46,743
$21,237
$3,924
$10,142
$790
$5,577
$0
$6,880
$37,906
$17,476
$91,167
$3,315
$3,051
$1,636
$599
$793
$8,569
$7,888
$4,228
$1,548
$667
$614
$329
$121
$4,712
$4,337
$2,325
$851
$0
$0
$0
$C•
$5.812
$5,350
$3,729
$3.456
$32,026
$29,480
$15,802
S5,787
$14,765
$13,591
$7,285
$2,668
$77,024
$70,900
$38,865
$16,323
$2,050
$1,870
$81,669
$160
$146
$6,360
$Ll27
$1,028
$44,9Cti
$0
$0
$0
$3.508
$3,489
$55,397
S7,661
S6,988
$305,236
$3,532
$3,22:2
S140,726
$20,542
$19,027
$734,105
$723
$31,594
$3,;157
$12,993
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
19:20 Aug 06, 2015
Table IX-6, continued
1\.nnualizedCostofP•·ogram Requirement<o: for Tndustdes Affected by the Proposed Re•·yllium Standard by Application Group and Six-OigitNATCS Tndustry (in 2010 dollars)
47689
EP07AU15.010</GPH>
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47690
VerDate Sep<11>2014
Jkt 235001
NAICS
Code
fu.lJOSure
Assessment
PO 00000
Jndustrv
Resistance Welding
333411 All pUiificalmn equipmenl HlllitufaclUiing
113412 TndustriCJ.l cmd wnnnerciCJl f<ln CJnd hlrnivermCJnufCJchtring
Regulated Areas
and Beryllium
Work Areas
Pro~sed
Ber;rllium Standard !?;r
:vledical
Surveillance
:Medical Remov.tl
Provision
A~lication
Groul! and Six-Digit NA.ICS btdustrl:· ~in 2010 dollars)
Written Exposure
Protective Work
Hygiene Areas
Control Plan
Clothing & Equipment and Practices
House-keeping
Training
Total Program
Costs
Frm 00126
Fmt 4701
Sfmt 4725
E:\FR\FM\07AUP2.SGM
07AUP2
$1,036
$437
$1,331
$32,575
$1?.,740
3334140 Heating equipment (except wannarr fumaces)manufactunng
822,068
$9,?iOR
S2K356
33341)
S'51,96)
$2,419
$4,667
$1,497
:84,227
$969
$484
$1,671
$219
$70
$23
$79
$715
$2,470
$4,799
S32,671
$4,095
S28,004
$225
$1,533
$192
$1,314
$7,084
$18,225
$6,044
$41,336
S10,832
$508
$15,988
$0
$12,374
$0
$0
$99,474
$45,862
$185,039
$8,762
S20,959
lY111
$984
$12,93,1
$30,937
$0
$0
$10,010
$23,944
$0
$0
$0
$0
$80,;169
$192,479
$37,099
$88,740
$119,686
$358,042
S17,7,11
S32,407
$3,5:22
859,441
$833
$1,521
$165
$2,789
$26,192
$47,835
$5,199
$87,741
$0
$0
$0
$0
$20,272
$37,1)23
$4,1)24
$67,S~J9
$0
$0
$0
$0
$0
$0
$0
$0
$162,960
$297,614
$32,349
$545,896
$75,131
$137,212
$14,914
$251,680
$303,132
$553,612
S60,175
$1,015,456
$118,601
S16,107
$14,334
$1,947
$172,420
$23,417
$0
$0
$155,480
$21,116
$187,007
$26,293
$0
$0
$816,900
$110,944
$376,623
$51,150
$1,841,363
$250,973
S2,208,950
$629,031
$2,882,076
$148,826
$1,769,506
$1,407,365
$389,241
$12,574,921
$5,797,535
$27,807,451
1\ir-conrlihoning, W<lnn mrhenting, CJnrl indnstriCJl refngerntion
cqmpmcnt manufactunng
335211 Eleclric housewaies aitd household fdlt Hlllitufaclur:ing
33)212 Househ0ld vncunm cleCJnermCJnut"clctnring
335221 Household cooking appltanec manufactunng
335222 Household refrigerator and home freezermanufaetunng
335224 Household laundry equipmenl rmnufacluring
11'522R OthermCJ.jl'rhonsehnld ClppliCJ.nce mmnfCJctnring
336311 Carburetor, piston, piston ring, and vllive manufactunng
336312 Gasoline engme and engine parts manufacturing
336321 Vehicular lighling equipment mmufaduring
336322c Other motorveh1cle electncal and electromc eqmpment
manufacturing
336330 :\1olm vehicle steering 01ml su-;pension cumpunenls (except spring)
manufactunng
3363,10 :\1otorvehicle brake system manufacturing
336350
:\1otorvehlcle transnnsston and power tram parts rrn.nutactunng
:\1otor vehicle seatmg and interior trim manufacturing
:\1otm vehicle metal stampmg
:\1otor veh1cle arr-cond1ttonmg rnanutactunng
336399b All other motor vehicle pmts llllilufacturing
Dental Laboratories
339116 Dentallabomtmies
621210 O±liees of dentists
336360
336370
336391
Total
Source: OSHA, lJrrcctoratc of standards and Gmdancc, Office of Regulatory Analys1s.
$198
$,15
$25,212
$10,6:14
$32,395
$0
$0
$0
$0
$0
$0
$202,669
$R\483
$26l!Al3
$93,438
$39,411
:!)120,061
$376,997
$1'59,011
$41,~56
$0
$0
$0
$76,70)
$0
$'59,167
$0
$0
$477,21)
$220,024
$RR7,714
$6,889
$2,210
:!)6,239
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$5,332
$1,710
$4,K29
$1,107
$553
$1,912
$5,483
$37,325
$4,678
$31,993
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$42,863
$1?.,74R
$19,762
$6,339
$17))97
$'1,101
$2,051
$7,0R4
$20,321
$138,331
$17,338
$118,569
S79,732
S2"',"'74
S72,211J
S16,5 118
$8,274
$1,~30
$3~,~19
$8,896
$4,448
$1"',:166
$44,(176
$31Xi,0111
$37,606
$:257,178
$4~AW
S2R,"'R1
881,989
$558,125
S69,954
$478,393
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
19:20 Aug 06, 2015
EP07AU15.011</GPH>
Table IX-6, continued
Annualized Cost of Pro~ram Requirements for btdustries Affected !!l· the
47691
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
Total Annualized Cost
As shown in Table IX–7, the total
annualized cost of the proposed rule is
estimated to be about $37.6 million. As
shown, at $27.8 million, the program
costs represent about 74 percent of the
total annualized costs of the proposed
rule. The annualized cost of complying
with the PEL accounts for the remaining
26 percent, almost all of which is for
engineering controls and work practices.
Respiratory protection, at about
$237,600, represents only 3 percent of
the annualized cost of complying with
the PEL and less than 1 percent of the
annualized cost of the proposed rule.
Table IX-7
Annualized Costs to Industries Affected by tbe Proposed Beryllium Standard, by Application Group and Six-DigitNAICS
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Jkt 235001
PO 00000
Total Costs
Frm 00127
Fmt 4701
Sfmt 4725
$1,188,758
$23,381
$45,075
$1,257,214
$175,546
$72,102
$51,502
$25,751
$108,154
$61,802
$46,352
$46,352
$2,702
$1,744
$1,246
$675
$2,617
$1,495
$1,132
$1,132
$62,495
$160,889
$119,920
$56,692
$245,179
$140,019
$103,514
$108,480
$240,744
$234,736
$172,668
$83,118
$355,950
$203,316
$150,998
$155,964
$51,502
$1,246
$116,637
$169,385
$182,887
$992,813
$182,887
$522,533
$682,229
$3,899
$20,999
$3,899
$11,052
$15,962
$138,616
$723,831
$132,030
$368,879
$530,377
$325,402
$1,737,643
$318,816
$902,464
$1,228,568
$19,186
$19,186
$57,558
$3,246
$3,246
$9,820
$11,325
$11,775
$33,831
$33,757
$34,207
$101,209
$287,789
$5,024
$289,489
$582,301
$162,739
$888,502
$8,864
$30,866
$215,066
$3,576,912
$386,669
$4,496,280
$23,656
$96,231
$1,677
$28,425
$1,277,644
$4,460,202
$1,302,977
$4,584,858
$588,200
$134,748
$84,126
$289,526
$8,874
$3,531
$2,204
$7,586
$2,218,314
$536,280
$345,805
$1,172,471
$2,815,387
$674,558
$432,136
$1,469,583
$18,123
$3,766
$679
$679
$35,195
$9,926
$53,997
$14,371
$679
$9,819
$14,203
$2,489
$7,979
$153,001
$57,841
$187,400
$105,713
$18,347
$7,438
$91,556
$54,540
Steel foundries (except investment)
Powder metallurgy part manufacturing
Hand and edge tool manufacturing
Fabricated structural metal manufacturing
Plate work manufacturing
Sheet metal work manufacturing
Ornamental and architectural metal work manufacturing
Other metal container manufacturing
Other metal valve and pipe fitting manufacturing
All other miscellaneous fabricated metal product manufacturing
Farm machinery and equipment manufacturing
19:20 Aug 06, 2015
Program Costs
$3,705
331513
332117
332212
332312
332313
332322
332323
332439
332919
332999
333111
VerDate Sep<11>2014
Fngineering Controls Respirator
and Work Practices
Costs
$679
$679
$4,352
$1,645
$5,330
$3,007
$679
$679
$2,604
$1,551
$7,679
$17,341
$287,730
$108,775
$352,421
$198,802
$35,589
$16,389
$172,178
$102,568
$10,846
$25,998
$445,083
$168,261
$545,151
$307,521
$54,614
$24,506
$266,338
$158,660
E:\FR\FM\07AUP2.SGM
07AUP2
EP07AU15.012</GPH>
NAICS
code
Industr
Eery ilium Production
331419 Primary smelting and refming of nonferrous metals
Eery ilium Oxide Ceramics and Composites
327113a Porcelain electrical supply manufacturing (primary)
327113b Porcelain electrical supply manufacturing (secondary)
334220
Cellular telephones manufacturing
334310
Compact disc players manufacturing
Electron tube manufacturing
334411
334415
Electronic res is tor manufacturing
Other electronic component manufacturing
334419
334510 Electro medical equipment manufacturing
336322b Other motor vehicle electrical and electronic equipment
manufacturing
Nonferrous Foundries
331521
Alurnill.umdie-casting foundries
331522 Nonferrous (except aluminum) die-casting foundries
331524 Aluminum foundries (except die-casting)
331525a Copper foundries (except die-casting) (non-sand casting foundries)
331525b Copper foundries (except die-casting) (sand casting foundries)
Secondary Smelting, Refming, and Alloying
331314 Secondary smelting & alloying of aluminum
33142lb Copper rolling, drawing, and extruding
331423
Secondary smelting, refming, & alloying of copper
Secondary smelting, refming, & alloying of nonferrous metal
331492
(except copper & aluminum)
Precision Turned Products
33272la Precision turned product manufacturing (high beryllium content)
33272lb Precision turned product manufacturing (low bery ilium content)
Copper Rolling, Drawing and Extruding
33142la Copper rolling, drawing, and extruding
331422
Copper wire (except mechanical) drawing
Fabrication ofEerylliumAlloy Products
332612 Light gauge spring manufacturing
332116 Metal stamping
334417 Electronic connector manufacturing
336322a Other motor vehicle electrical & electronic equipment
Arc and Gas Welding
33llll
Iron and steel mills
331221
Rolled steel shape manufacturing
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
F. Economic Feasibility Analysis and
Regulatory Flexibility Determination
Chapter VI of the PEA, summarized
here, investigates the economic impacts
of the proposed beryllium rule on
affected employers. This impact
investigation has two overriding
objectives: (1) To establish whether the
proposed rule is economically feasible
for all affected application groups/
industries, and (2) to determine if the
Agency can certify that the proposed
rule will not have a significant
economic impact on a substantial
number of small entities.
In the discussion below, OSHA first
presents its approach for achieving
these objectives and next applies this
approach to industries with affected
employers. The Agency invites
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
comment on any aspect of the methods,
data, or preliminary findings presented
here or in Chapter VI of the PEA.
1. Analytic Approach
a. Economic Feasibility
Section 6(b)(5) of the OSH Act directs
the Secretary of Labor to set standards
based on the available evidence where
no employee, over his/her working life
time, will suffer from material
impairment of health or functional
capacity, even if such employee has
regular exposure to the hazard, ‘‘to the
exent feasible’’ (29 U.S.C. 655(b)(5)).
OSHA interpreted the phrase ‘‘to the
extent feasible’’ to encompass economic
feasibility and was supported in this
view by the U.S. Court of Appeals for
the D.C. Circuit, which has long held
PO 00000
Frm 00128
Fmt 4701
Sfmt 4702
that OSHA standards would satisfy the
economic feasibility criterion even if
they imposed significant costs on
regulated industries and forced some
marginal firms out of business, so long
as they did not cause massive economic
dislocations within a particular industry
or imperil the existence of that industry.
Am. Iron and Steel Inst. v. OSHA, 939
F.2d 975, 980 (D.C. Cir. 1991); United
Steelworkers of Am., AFL–CIO–CLC v.
Marshall, 647 F.2d 1189, 1265 (D.C. Cir.
1980); Indus. Union Dep’t v. Hodgson,
499 F.2d 467 (D.C. Cir. 1974).
b. The Price Elasticity of Demand and
Its Relationship to Economic Feasibility
In practice, the economic burden of
an OSHA standard on an industry—and
whether the standard is economically
feasible for that industry—depends on
E:\FR\FM\07AUP2.SGM
07AUP2
EP07AU15.013</GPH>
47692
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
the magnitude of compliance costs
incurred by establishments in that
industry and the extent to which they
are able to pass those costs on to their
customers. That, in turn, depends, to a
significant degree, on the price elasticity
of demand for the products sold by
establishments in that industry.
The price elasticity of demand refers
to the relationship between the price
charged for a product and the demand
for that product: The more elastic the
relationship, the less an establishment’s
compliance costs can be passed through
to customers in the form of a price
increase and the more the establishment
has to absorb compliance costs in the
form of reduced profits. When demand
is inelastic, establishments can recover
most of the costs of compliance by
raising the prices they charge; under
this scenario, profit rates are largely
unchanged and the industry remains
largely unaffected. Any impacts are
primarily on those customers using the
relevant product. On the other hand,
when demand is elastic, establishments
cannot recover all compliance costs
simply by passing the cost increase
through in the form of a price increase;
instead, they must absorb some of the
increase from their profits. Commonly,
this will mean reductions both in the
quantity of goods and services produced
and in total profits, though the profit
rate may remain unchanged. In general,
‘‘[w]hen an industry is subjected to a
higher cost, it does not simply swallow
it; it raises its price and reduces its
output, and in this way shifts a part of
the cost to its consumers and a part to
its suppliers,’’ in the words of the court
in Am. Dental Ass’n v. Sec’y of Labor
(984 F.2d 823, 829 (7th Cir. 1993)).
The court’s summary is in accord
with microeconomic theory. In the long
run, firms can remain in business only
if their profits are adequate to provide
a return on investment that ensures that
investment in the industry will
continue. Over time, because of rising
real incomes and productivity increases,
firms in most industries are able to
ensure an adequate profit. As
technology and costs change, however,
the long-run demand for some products
naturally increases and the long-run
demand for other products naturally
decreases. In the face of additional
compliance costs (or other external
costs), firms that otherwise have a
profitable line of business may have to
increase prices to stay viable. Increases
in prices typically result in reduced
quantity demanded, but rarely eliminate
all demand for the product. Whether
this decrease in the total production of
goods and services results in smaller
output for each establishment within
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
the industry or the closure of some
plants within the industry, or a
combination of the two, is dependent on
the cost and profit structure of
individual firms within the industry.
If demand is perfectly inelastic (i.e.,
the price elasticity of demand is zero),
then the impact of compliance costs that
are one percent of revenues for each
firm in the industry would be a one
percent increase in the price of the
product, with no decline in quantity
demanded. Such a situation represents
an extreme case, but might be observed
in situations in which there were few,
if any, substitutes for the product in
question, or if the products of the
affected sector account for only a very
small portion of the revenue or income
of its customers.
If the demand is perfectly elastic (i.e.,
the price elasticity of demand is
infinitely large), then no increase in
price is possible and before-tax profits
would be reduced by an amount equal
to the costs of compliance (net of any
cost savings—such as reduced workers’
compensation insurance premiums—
resulting from the proposed standard) if
the industry attempted to maintain
production at the same level as
previously. Under this scenario, if the
costs of compliance are such a large
percentage of profits that some or all
plants in the industry could no longer
operate in the industry with hope of an
adequate return on investment, then
some or all of the firms in the industry
would close. This scenario is highly
unlikely to occur, however, because it
can only arise when there are other
products—unaffected by the proposed
rule—that are, in the eyes of their
customers, perfect substitutes for the
products the affected establishments
make.
A commonly-discussed intermediate
case would be a price elasticity of
demand of one (in absolute terms). In
this situation, if the costs of compliance
amount to one percent of revenues, then
production would decline by one
percent and prices would rise by one
percent. As a result, industry revenues
would remain the same, with somewhat
lower production, but with similar
profit rates per unit of output (in most
situations where the marginal costs of
production net of regulatory costs
would fall as well). Customers would,
however, receive less of the product for
their (same) expenditures, and firms
would have lower total profits; this, as
the court described in Am. Dental Ass’n
v. Sec’y of Labor, is the more typical
case.
PO 00000
Frm 00129
Fmt 4701
Sfmt 4702
47693
c. Variable Costs Versus Fixed Costs
A decline in output as a result of an
increase in price may occur in a variety
of ways: individual establishments
could each reduce their levels of
production; some marginal plants could
close; or, in the case of an expanding
industry, new entry may be delayed
until demand equals supply. In some
situations, there could be a combination
of these three effects. Which possibility
is most likely depends on the form that
the costs of the regulation take. If the
costs are variable costs (i.e., costs that
vary with the level of production at a
facility), then economic theory suggests
that any reductions in overall output
will be the result of reductions in output
at each affected facility, with few, if any,
plant closures. If, on the other hand, the
costs of a regulation primarily take the
form of fixed costs (i.e., costs that do not
vary with the level of production at a
facility), then reductions in overall
output are more likely to take the form
of plant closures or delays in new entry.
Most of the costs of this regulation, as
estimated in Chapter V of the PEA, are
variable costs in the sense that they will
tend to vary by production levels and/
or employment levels. Almost all of the
major costs of program elements, such
as medical surveillance and training,
will vary in proportion to the number of
employees (which is a rough proxy for
the amount of production). Exposure
monitoring costs will vary with the
number of employees, but do have some
economies of scale to the extent that a
larger firm need only conduct
representative sampling rather than
sample every employee. Finally, the
costs of operating and maintaining
engineering controls tend to vary by
usage—which typically closely tracks
the level of production and are not fixed
costs in the strictest sense.
This leaves two kinds of costs that
are, in some sense, fixed costs—capital
costs of engineering controls and certain
initial costs. The capital costs of
engineering controls due to the
standard—many of which are scaled to
production and/or employment levels—
constitute a relatively small share of the
total costs, representing 10 percent of
total annualized costs (or approximately
$870 per year per affected
establishment).
Some ancillary provisions require
initial costs that are fixed in the sense
that they do not vary by production
activity or the number of employees.
Some examples are the costs to develop
a training plan for general training not
currently required and to develop a
written exposure control plan.
E:\FR\FM\07AUP2.SGM
07AUP2
47694
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
As a result of these considerations,
OSHA expects it to be quite likely that
any reductions in total industry output
would be due to reductions in output at
each affected facility rather than as a
result of plant closures. However,
closures of some marginal plants or
poorly performing facilities are always
possible.
d. Economic Feasibility Screening
Analysis
To determine whether a rule is
economically feasible, OSHA begins
with two screening tests to consider
minimum threshold effects of the rule
under two extreme cases: (1) All costs
are passed through to customers in the
form of higher prices (consistent with a
price elasticity of demand of zero), and
(2) all costs are absorbed by the firm in
the form of reduced profits (consistent
with an infinite price elasticity of
demand).
In the former case, the immediate
impact of the rule would be observed in
increased industry revenues. While
there is no hard and fast rule, in the
absence of evidence to the contrary,
OSHA generally considers a standard to
be economically feasible for an industry
when the annualized costs of
compliance are less than a threshold
level of one percent of annual revenues.
Retrospective studies of previous OSHA
regulations have shown that potential
impacts of such a small magnitude are
unlikely to eliminate an industry or
significantly alter its competitive
structure,19 particularly since most
industries have at least some ability to
raise prices to reflect increased costs,
and normal price variations for products
typically exceed three percent a year.
In the latter case, the immediate
impact of the rule would be observed in
reduced industry profits. OSHA uses the
ratio of annualized costs to annual
profits as a second check on economic
feasibility. Again, while there is no hard
and fast rule, in the absence of evidence
to the contrary, OSHA generally
considers a standard to be economically
feasible for an industry when the
annualized costs of compliance are less
than a threshold level of ten percent of
annual profits. In the context of
economic feasibility, the Agency
believes this threshold level to be fairly
modest, given that normal year-to-year
variations in profit rates in an industry
can exceed 40 percent or more. OSHA
also considered whether this threshold
would be adequate to assure that
upfront costs would not create major
19 See OSHA’s Web page, https://www.osha.gov/
dea/lookback.html#Completed, for a link to all
completed OSHA lookback reviews.
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
credit problems for affected employers.
To do this, OSHA examined a worst
case scenario in which annualized costs
were ten percent of profits and all of the
annualized costs were the result of
upfront costs. In this scenario, assuming
a three percent discount rate and a ten
year life of equipment, total costs would
be 85 percent of profits 20 in the year in
which these upfront costs were
incurred. Because upfront costs would
be less than one year’s profits in the
year they were incurred, this means that
an employer could pay for all of these
costs from that year’s profits and would
not necessarily have to incur any new
borrowing. As a result, it is unlikely that
these costs would create a credit crunch
or other major credit problems. It would
be true, however, that paying regulatory
costs from profits might reduce
investment from profits in that year.
OSHA’s choice of a threshold level of
ten percent of annual profits is low
enough that even if, in a hypothetical
worst case, all compliance costs were
upfront costs, then upfront costs—
assuming a three percent discount rate
and a ten-year time period—would be
no more than 85 percent of first-year
profits and thus would be affordable
from profits without resort to credit
markets. If the threshold level were firstyear costs of ten percent of annual
profits, firms could even more easily
expect to cover first-year costs at the
threshold level out of current profits
without having to access capital markets
and otherwise being threatened with
short-term insolvency.
In general, because it is usually the
case that firms would be able to pass on
to their customers some or all of the
costs of the proposed rule in the form
of higher prices, OSHA will tend to give
much more weight to the ratio of
industry costs to industry revenues than
to the ratio of industry costs to industry
profits. However, if costs exceed either
the threshold percentage of revenue or
the threshold percentage of profits for
an industry, or if there is other evidence
of a threat to the viability of an industry
because of the proposed standard,
OSHA will examine the effect of the
rule on that industry more closely. Such
an examination would include market
factors specific to the industry, such as
20 At a discount rate of 3 percent over a life of
investment of 10 years, the present value of that
stream of annualized costs would be 8.53 times a
single year’s annualized costs. Hence, if yearly
annualized costs are 10 percent of profits, upfront
costs would be 85 percent of the profits in that first
year. As a simple example, assume annualized costs
are $1 for each of the 10 years. If annualized costs
are 10 percent of profits, this translates to a yearly
profit of $10. The present value of that stream of
$1 for each year is $8.53. (The formula for this
calculation is ($1*(1.03∧10)¥1)/((.03)×(1.03)∧10).
PO 00000
Frm 00130
Fmt 4701
Sfmt 4702
normal variations in prices and profits,
and any special circumstances, such as
close domestic substitutes of equal cost,
which might make the industry
particularly vulnerable to a regulatory
cost increase.
The preceding discussion focused on
the economic viability of the affected
industries in their entirety. However,
even if OSHA found that a proposed
standard did not threaten the survival of
affected industries, there is still the
question of whether the industries’
competitive structure would be
significantly altered. For example, if the
annualized costs of an OSHA standard
were equal to 10 percent of an
industry’s annual profits, and the price
elasticity of demand for the products in
that industry were equal to one, then
OSHA would not expect the industry to
go out of business. However, if the
increase in costs were such that most or
all small firms in that industry would
have to close, it might reasonably be
concluded that the competitive
structure of the industry had been
altered. For this reason, OSHA also
calculates compliance costs by size of
firm and conducts its economic
feasibility screening analysis for small
and very small entities.
e. Regulatory Flexibility Screening
Analysis
The Regulatory Flexibility Act (RFA),
Public Law 96–354, 94 Stat. 1164
(codified at 5 U.S.C. 601), requires
Federal agencies to consider the
economic impact that a proposed
rulemaking will have on small entities.
The RFA states that whenever a Federal
agency is required to publish general
notice of proposed rulemaking for any
proposed rule, the agency must prepare
and make available for public comment
an initial regulatory flexibility analysis
(IRFA). 5 U.S.C. 603(a). Pursuant to
section 605(b), in lieu of an IRFA, the
head of an agency may certify that the
proposed rule will not have a significant
economic impact on a substantial
number of small entities. A certification
must be supported by a factual basis. If
the head of an agency makes a
certification, the agency shall publish
such certification in the Federal
Register at the time of publication of
general notice of proposed rulemaking
or at the time of publication of the final
rule. 5 U.S.C. 605(b).
To determine if the Assistant
Secretary of Labor for OSHA can certify
that the proposed beryllium rule will
not have a significant economic impact
on a substantial number of small
entities, the Agency has developed
screening tests to consider minimum
threshold effects of the proposed rule on
E:\FR\FM\07AUP2.SGM
07AUP2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
small entities. These screening tests do
not constitute hard and fast rules and
are similar in concept to those OSHA
developed above to identify minimum
threshold effects for purposes of
demonstrating economic feasibility.
There are, however, two differences.
First, for each affected industry, the
screening tests are applied, not to all
establishments, but to small entities
(defined as ‘‘small business concerns’’
by SBA) and also to very small entities
(as defined by OSHA as businesses with
fewer than 20 employees). Second,
although OSHA’s regulatory flexibility
screening test for revenues also uses a
minimum threshold level of annualized
costs equal to one percent of annual
revenues, OSHA has established a
minimum threshold level of annualized
costs equal to five percent of annual
profits for the average small entity or
very small entity. The Agency has
chosen a lower minimum threshold
level for the profitability screening
analysis and has applied its screening
tests to both small entities and very
small entities in order to ensure that
certification will be made, and an IRFA
will not be prepared, only if OSHA can
be highly confident that a proposed rule
will not have a significant economic
impact on a substantial number of small
entities or very small entities in any
affected industry.
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
Furthermore, certification will not be
made, and an IRFA will be prepared, if
OSHA believes the proposed rule might
otherwise have a significant economic
impact on a substantial number of small
entities, even if the minimum threshold
levels are not exceeded for revenues or
profitability for small entities or very
small entities in all affected industries.
2. Impacts on Affected Industries
In this section, OSHA applies its
screening criteria and other analytic
methods, as needed, to determine (1)
whether the proposed rule is
economically feasible for all affected
industries within the scope of this
proposed rule, and (2) whether the
Agency can certify that the proposed
rule will not have a significant
economic impact on a substantial
number of small entities.
a. Economic Feasibility Screening
Analysis: All Establishments
To determine whether the proposed
rule’s projected costs of compliance
would threaten the economic viability
of affected industries, OSHA first
compared, for each affected industry,
annualized compliance costs to annual
revenues and profits per (average)
affected establishment. The results for
all affected establishments in all
affected industries are presented in
PO 00000
Frm 00131
Fmt 4701
Sfmt 4702
47695
Table IX–8. Shown in the table for each
affected industry are the total number of
establishments, the total number of
affected establishments, annualized
costs per affected establishment, annual
revenues per establishment, the profit
rate, annual profits per establishment,
annualized compliance costs as a
percentage of annual revenues, and
annualized compliance costs as a
percentage of annual profits.
The annualized costs per affected
establishment for each affected industry
were calculated by distributing the
industry-level (incremental) annualized
compliance costs among all affected
establishments in the industry, where
annualized compliance costs reflect a 3
percent discount rate. The annualized
cost of the proposed rule for the average
affected establishment is estimated at
$9,197 in 2010 dollars. It is clear from
Table IX–8 that the estimates of the
annualized costs per affected
establishment vary widely from
industry to industry. These estimates
range from $1,257,214 for NAICS
331419 (Beryllium Production) and
$120,372 for NAICS 327113a (Porcelain
Electrical Supply Manufacturing
(primary)) to $1,636 for NAICS 621210
(Offices of Dentists) and $1,632 for
NAICS 339116 (Dental Laboratories).
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47696
VerDate Sep<11>2014
Table IX-8
Screening Analysis tOr Establislunents Atlected by the Proposed Beryllium Standard
With Costs Calculated Usi~a Three Percent Discount Rate
_l_
Revenues
_l
Profit
Per
Indusll]'_
Betyllium Productlon
331419
Primmy smelting and refining of nonferrous metals
Betyllium Ozjde Ceramics and Composites
Jkt 235001
327113a
Porcelain electrical supply mmufacturing (prirna:Iy)
327113b
Porcelain electrical supply mmufacturing (secondrny)
334220
Cellular telephones manufacturing
334310
Compact d1scplayers manufactunng
334411
Electron tube mmufacturing
334415
Electromc resistor manufacturing
PO 00000
334419
Other electronic component manufacturing
334510
Electrornedical equipment manufacturing
336322b
Other motor vehicle electncal and electronic eqmpment mmufacturing
Total
Establishments
Total Affected
Establishments
161
Establis lunent
To1al ($1,000)
($)
Rate
Frm 00132
2
$789,731
$35,475,343
5
79
61
1,133
629
21
12
9
9
$3,975,351
$1,220,476
636
10
254
140
7
38
$L257,214
$789,731
14
10
$560,967
$10,013,730
$27,480,966
$12,152,053
Costs
Per
Per
As a
As a
Establishment Establishment Percent of Percent of
($)
($)
Revenues
Profits
$8,524,863
106
106
810
464
Co~ance
$120,372
Fmt 4701
Sfmt 4725
7,450,295
43,796,720
8,567,567
5.01%
6.08%
4.39%
373,542
2,663,922
376,456
15,449,068
9,196,181
8,838,244
43,689,930
7.85%
7.85<}0
7.85%
6.75%
1,212,421
721,703
693,613
2,947,904
19,107,002
1.83%
348,832
16,968,585
10,791,418
5.22%
5.22%
885,603
563,212
6,391,108
5,796,031
5.22%
5.22%
333,557
302,499
5,796,031
5.22%
302,499
39,648,599
130,348,178
4.54%
4.79%
1,802,008
6,248,900
30,156,619
33,047,610
4.79%
4.79%
1,445,710
1,584,305
0.23~0
$16,767
$17,267
0.04%
$16,624
$16,950
0.11%
0.19~0
4.49%
0.65%
4.42o/o
$16,943
$16,778
0.19%
$17,329
$16,939
0.04~0
1.40%
2.35%
2.42%
0.59%
0.09%
4.86%
$46,486
0.27%
$45,727
$45,545
$45,123
$49,143
0.42~0
5.25%
8.12o/o
13.65%
14.92%
16.25%
0.18~0
Nonferrous Foundries
331521
Aluminum die-casting foundries
331522
Nonferrous (except aluminum) die-casting foundries
331524
331525a
Aluminumfmmdries (except die-casting)
Copper foundries (except die-casting) (non-sand castmg foundries)
394
208
7
20
331525b
Copper foundries (except die-casting) (sand casting foundries)
208
25
$4,310,021
$1,510,799
$2,518,097
$1,205,574
$1,205,574
0.71%
0.78~0
0.85%
Secondary Smelting, Refining, and Alloying
331314
Secondrny slll31ting & alloying of aluminum
331421b
Copper rolling, drawing, and extruding
331423
Secondrny slll31ting, refining, & alloying of copper
331492
Secondrny slll31ting, refining, & alloying ofnonfenuus Ill3tal (except copper & aluminum)
Precision Turned Products
$4,837,129
$12,513,425
$723,759
122
96
24
248
30
$8,195,807
E:\FR\FM\07AUP2.SGM
$33,757
$34,206
$33,639
0.09%
$19,410
0.06~0
0.49~0
8.49%
0.36%
6.19%
0.07%
0.14~0
1.39%
2.86%
0.13~0
2.31%
0.14%
0.04~0
2.71%
0.55%
0.05%
2.65%
0.10%
0.37%
0.03~0
0.11%
1.87%
0.55%
2.33%
1.23%
332721a
Precision turned product manufacturing (high berylliumcontent)
3,124
18
5.82%
247,032
Precision turned product manufacturing Gowbetylliumcontent)
3,124
294
$13,262,706
$13,262,706
4,245,425
332721b
4,245,425
5.82%
247,032
$20,979
$15,295
96
114
15
59
$12,513,425
$6,471,491
130,348,178
56,767,462
4.79%
4.79%
6,248,900
2,721,436
$86,865
$77,709
$2,167,977
$9,749,800
$5,029,508
$12,152,053
6,712,003
5.61%
376,763
6,569,946
21,772,761
5.12%
7.85%
336,300
1,708,696
19,107,002
1.83%
348,832
$8,716
$9,116
$9,354
$9,243
$92,726,004
$8,376,271
157,965,934
52,026,531
5.41%
5.41%
8,542,604
2,813,531
$8,149
$10,438
0.01%
0.02%
$4,251,852
$1,414,108
19,326,599
10,632,394
5.22%
1,008,670
544,246
$10,486
$11,921
0.05%
1.04%
0.11~&
2.19~0
Copper Rolling, Drmv:ing and Extruding
331421a
Copper rolling, drawing, and extruding
331422
Coppenvire (except mechanical) drawing
Fabrication ofBetyllmmAlloy Products
74
46
336322a
Other motor vehicle electncal & electronic equipment
Arc and Gas Welding
636
159
331111
331221
Iron and s tee! rrills
Rolled steel shape manufacturing
587
161
7
Steel foundries (except mvestlll3nt)
332117
Powder metallmgy pmt manufacturing
220
133
332212
Hand and edge tool manufacturing
1,066
3
$5,077,868
4,763,479
5.61%
267,387
$8,913
0.19%
3.33q'O
332312
Fabricated structural metal manufacturing
332313
Plate work manufacturing
3,407
1,288
56
21
$26,119,614
$6,023,356
7,666,455
4,676,519
4.74%
4.74%
363,273
221,596
$7,957
$7,957
0.10%
0.17%
2.19%
3.59q'O
332322
Sheet metal work manufacturing
4,173
332323
Ornamental and arch1tcctural tnJtal work manufacturing
2,354
69
39
$17,988,908
$5,708,707
4,310,786
2,425,109
4.74%
4.74%
204,266
114,913
$7,957
$7,957
0.18%
0.33%
3.90%
6.92q'O
332439
Other metal container manufactunng
332919
Other metal valve and pipe fitting manufacturing
9,637,500
17,298,424
4.30%
7.00%
414,839
1,211,086
$8,142
$9,012
0.08%
0.05%
1.96%
0.74q'O
332999
All other miscellaneous fabricated metal product manufacturing
Fannmachmcry and equipment mmufacturing
7
3
33
20
$3,565,875
$4,584,082
333111
07AUP2
323
331513
EP07AU15.014</GPH>
323
1,484
231
$13,963,184
$24,067,145
4,280,559
23,119,255
7.00%
6.36%
299,688
1,471,196
$7,957
$7,957
0.19%
0.03%
2.66%
0.54q'O
332612
light gauge spnng manufactunng
332116
Metal stamping
334417
Electromc connector manufacturing
370
265
3,262
1,041
5.12~iJ
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
19:20 Aug 06, 2015
NAICS
Code
_l
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
I
NAICS
Code
Industry
Total
Establishments
Total Affected
Establislnnents
Jkt 235001
Frm 00133
Fmt 4701
Sfmt 4702
07AUP2
8,549,565
11,136,327
10,394,697
30,194,998
20,845,825
26,223,543
39,144,257
204,083,854
338,228,505
92,086,126
15,737,881
26,955,128
4.68%
4.68%
4.68%
4.68%
4.03%
4.03%
4.03%
4.03%
4.03%
4.03%
1.83%
1.83%
400,062
521,106
486,402
1,412,924
840,119
1,056,849
1,577,573
8,224,892
13,631,126
3,711,212
287,323
492,114
$2,322,610
$12,152,053
24,974,299
19,107,002
1.~%
32
$g,g56,5g4
EP07AU15.015</GPH>
1350
7
All other transportation equipment manufacturing
226
374
Ll94
21.960
3
4
3
143
358
151
460
843
106
34
96
22
11
38
109
742
25
11
32
59
Conveyor and conveying equipment manufacturing
333924
Industrial truck, tractor, trailer, and stacker machinery manufacturing
333999
All other miscellaneous general purpose machinery manufacturing
336211
Motor vehicle body manufacturmg
336214
337215
Showcase, partition, shelving, and locker manufacturing
811310
Commercial and mdustnalmachmery and eqmpment reparr
6
7
9
4
18
15
14
0.08%
0.04%
0.09%
0.04%
0.11%
0.06%
0.07%
O.O:l%
1.69%
0.70%
1.76%
0.79%
2.06%
3.27%
3.99%
l.S5%
0.31%
0.94%
0.02%
0.06%
0.18%
0.55%
10.19%
$15,044
$15,044
$15,044
$15,044
$15,044
$15,044
$15,044
$15,044
$15,044
$15,044
$15,044
$15,044
0.18%
0.14%
0.14%
0.05%
0.07%
0.06%
0.04%
0.01%
0.00%
0.02%
0.10%
0.06%
3.76%
2.89%
3.09%
1.06%
1.79%
1.42%
0.95%
0.18%
0.11%
0.41%
5.24%
3.06%
455,950
348,832
$15,044
$15,044
0.06%
0.08%
3.30%
4.31%
657,2g7
747,503
838,508
687,183
491,376
866,847
436,537
$15,044
$15,044
$15,044
$15,044
$15,044
$15,044
$15,044
0.04%
0.04%
0.03%
0.04%
006%
0.03%
0.06%
2.29%
2.01%
1.79%
2.19%
306%
1.74%
3.45%
4.23~'0
Resistance Welding
333411
Air purification equipment manufacturing
333412
Industrial and commercial fan and blower manufacturing
333414b
Heating eqmpment (except warm air furnaces) manufacturmg
333415
Air-conditioning, warm air heating, and industrial refrigeration equipment manufacturing
33<211
Electric housewares and household fan manufacturing
335212
Household vacuum cleaner manufacturing
335221
Household cooking appliance manufacturing
335222
Household refngerator and home freezer manufacturng
335224
Household laundry equipmentmanufacturmg
335228
336311
Other major household appliance manufacturmg
Carburetor, piston, piston ring, and valve manufacturing
336312
Gasoline engme and engine parts manufacturing
33G321
Vehicular lighting equipment manufactuting
336322c
Other motor vehicle electrical and electronic equipment manufacturing
336330
Motor vehicle steering and suspension components (except spring) manufacturmg
336340
Motor vehicle brake system manufacturing
336350
Motor vehicle transmission and power train parts manufacturir_g
336360
Motor vehicle seatmg and interior trim manufacturing
336370
Motor vehicle metal o;t3mping
336391
Motor vehicle air-conditioning manufacturing
336399b
All other motor vehicle parts manufacturing
93
636
2
2
1.~%
$8,147,826
$21,862,014
$15,168,862
$19,809,238
$3,798,464
$32,279,766
36,002,374
40,943,850
45,928,600
37,639,856
26,914,725
47,480,804
23,910,938
1.~%
1350
12
10
24
20
37
4
68
246
199
476
403
736
80
1.~%
1.~%
1.~%
1~%
1.~%
1.~%
Dental Laboratones
339116
Dental laboratories
Otlices of dentiSts
6,995
129,830
1,749
238
$4,100,626
$100,431,324
586,222
773,560
10. 55%
621210
8.47%
61,873
65,557
$1,632
$1,636
0.28%
0.21%
2.64%
2.50%
Totals I Averages
207.586
4,088
$877,101,106
8,145,219
7.42%
604,340
$9,197
0.11%
1.52%
11
--
11
indicates areas where data are not avmlah le (\\.-'hile the average revenues and implied profits for the Beryllium Production (T\AT\::S :l1141 9) and Beryllium Oxide (NA TC-::S 1271 Ba) industries can he
calculated, they would in no way reflect the actual revenues and profits of the affected facilities
Source: OSHA, Drcctoratc of Standards and Guidance, Office ofRcgulatory Analysis.
47697
annualized costs equal to 10 percent of
annual profits—below which the
E:\FR\FM\07AUP2.SGM
37
$3,060,744
$1,681,585
$4,781,561
$25,454,383
$2,209,657
$891,600
$3,757,849
$4,489,845
$3,720,514
$3,499,273
$1,715,429
$20,000,705
A II other motor vehicle p8rts manufrrctming
336999
of annualized costs equal to one percent
of annual revenues—and, secondarily,
PO 00000
$8,214
$8,148
$7,994
$8,464
$7,957
$7,957
$7,957
$8,0S7
$9,019
$8,660
$8,766
$7,957
Railroad rolling stock
333922
Compliance Costs
As a
As a
Eda~ishrnent Perct'nt of Pernnt of
($)
Rewnues
Profits
Per
486,402
1,163,538
453,735
1,066,885
385,894
243,036
199,542
436,5:17
2,887,552
921,324
207,405
78,080
336510
Pump and pumping equipment manufactunng
Rate
Per
Establishment
($)
4.68%
5.36%
5.36%
5.36%
5.36%
1.83%
1.83%
l.Kl%
5.47%
6.56%
4.26%
5.42%
Travel trailer and camper manufacturing
333911
Total ($1,000)
I
Profit
10,394,697
21,708,209
8,465,361
19,904,948
7,199,644
13,312,072
10,929,757
2:l,910,9.lS
52,775,180
14,038,417
4,870,523
1,441,278
336399a
Heating eqmpment (except warm air furnaces) manufacturmg
Per
E'!>tablishment
($)
$4,781,561
$12,395,387
$6,569,120
$7,444,451
$10,972,258
$9,877,558
$7,465,024
$:12,279,766
$11,927,191
$5,250,368
$5,815,404
$31,650,469
460
571
776
374
L524
742
683
333414a
I
Revenues
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
19:20 Aug 06, 2015
As previously discussed, OSHA has
established a minimum threshold level
VerDate Sep<11>2014
Table TX-R, continued
Screening Analysis for Establishments Affected by the Proposed Beryllium Standard
With Costs C:alculatedUdng a Three Percent Discount Rate
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47698
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
Agency has concluded that costs are
unlikely to threaten the economic
viability of an affected industry. The
results of OSHA’s threshold tests for all
affected establishments are displayed in
Table IX–8. For all affected
establishments, the estimated
annualized cost of the proposed rule is,
on average, equal to 0.11 percent of
annual revenue and 1.52 percent of
annual profit.
As Table IX–8 shows, there are no
industries in which the annualized costs
of the proposed rule exceed one percent
of annual revenues. However there are
three six-digit NAICS industries where
annualized costs exceed ten percent of
annual profits.
NAICS 331525 (Copper foundries
except die-casting) has the highest cost
impact as a percentage of profits. NAICS
331525 is made up of two types of
copper foundries: sand casting
foundries and non-sand casting
foundries, incurring an annualized cost
as a percent of profit of 16.25 percent
and 14.92 percent, respectively. The
other two six-digit NAICS industries
where annualized costs exceed ten
percent of annual profits are NAICS
331534: Aluminum foundries (except
die-casting), 13.65 percent; and NAICS
811310: Commercial and industrial
machinery and equipment repair, 10.19
percent.
OSHA believes that the berylliumcontaining inputs used by these
industries have a relatively inelastic
demand for three reasons. First,
beryllium has rare and unique
characteristics, including low mass,
high melting temperature, dimensional
stability over a wide temperature range,
strength, stiffness, light weight, and
high elasticity (‘‘springiness’’) that can
significantly improve the performance
of various alloys. These characteristics
cannot easily be replicated by other
materials. In economic terms, this
means that the elasticity of substitution
between beryllium and non-beryllium
inputs will be low. Second, products
which contain beryllium or berylliumalloy components typically have highperformance applications (whose
performance depends on the use of
higher-cost beryllium). The lack of
available competing products with these
performance characteristics suggests
that the price elasticity of demand for
products containing beryllium or
beryllium-alloy components will be
low. Third, components made of
beryllium or beryllium-containing
alloys typically account for only a small
portion of the overall cost of the
finished goods that these parts are used
to make. For example, the cost of brakes
made of a beryllium-alloy used in the
VerDate Sep<11>2014
20:43 Aug 06, 2015
Jkt 235001
production of a jet airplane represents a
trivial percentage of the overall cost to
produce that airplane. As economic
theory indicates, the elasticity of
derived demand for a factor of
production (such as beryllium) varies
directly with the elasticity of
substitution between the input in
question and other inputs; the price
elasticity of demand for the final
product that the input is used to
produce; and, in general, the share of
the cost of the final product that the
input accounts for. Applying these three
conditions to beryllium points to the
relative inelastic derived demand for
this factor of production and the
likelihood that cost increases resulting
from the proposed rule would be passed
on to the consumer in the form of higher
prices.
A secondary point is that the
establishments in an industry that use
beryllium may be more profitable than
those that don’t. This follows from the
prior arguments about beryllium’s rare
and desirable characteristics and its
valuable applications. For example, of
the 208 establishments that make up
NAICS 331525, OSHA estimated that 45
establishments (or 21 percent) work
with beryllium. Of the 394
establishments that make up NAICS
331524, OSHA estimated that only 7
establishments (less than 2 percent)
work with beryllium. Of the 21,960
establishments that make up NAICS
811310, OSHA estimated that 143 (0.7
percent) work with beryllium. However,
when OSHA calculated the cost-toprofit ratio, it used the average profit per
firm for the entire NAICs industry, not
the average profit per firm for firms
working with beryllium.
(1) Normal Year-to-Year Variations in
Prices and Profit Rates
The United States has a dynamic and
constantly changing economy in which
an annual percentage increase in
industry revenues or prices of one
percent or more are common. Examples
of year-to-year changes in an industry
that could cause such an increase in
revenues or prices include increases in
fuel, material, real estate, or other costs;
tax increases; and shifts in demand.
To demonstrate the normal year-toyear variation in prices for all the
manufacturers in general industry
affected by the proposed rule, OSHA
developed in the PEA year-to-year
producer price indices and year-to-year
percentage changes in producer prices,
by industry, for the years 1999–2010.
For all of the industries estimated to be
affected by this proposed standard over
the 12-year period, the average change
in producer prices was 4.4 percent a
PO 00000
Frm 00134
Fmt 4701
Sfmt 4702
year—which is over 4 times as high as
OSHA’s 1 percent cost-to-revenue
threshold. For the industries found to
have the largest estimated potential
annual cost impact as a percentage of
revenue shown in Chapter VI of the PEA
are—NAICS 331524: Aluminum
Foundries (except Die-Casting), (0.71
percent); NAICS 331525(a and b):
Copper Foundries (except Die-Casting)
(average of 0.81 percent); NAICS
332721a: Precision Turned Product
Manufacturing of high content
beryllium (0.49 percent); 21 and NAICS
811310: Commercial and Industrial
Machinery and Equipment (Except
Automotive and Electronic) Repair and
Maintenance (0.55 percent)—the
average annual changes in producer
prices in these industries over the 12year period analyzed were 3.1 percent,
8.2 percent, 3.6 percent and 2.3 percent,
respectively.
Based on these data, it is clear that the
potential price impacts of the proposed
rule in affected industries are all well
within normal year-to-year variations in
prices in those industries. The
maximum cost impact of the proposed
rule as a percentage of revenue in any
affected industry is 0.84 percent, while,
as just noted, the average annual change
in producer prices for affected
industries was 4.4 percent for the period
1999–2010. In fact, Chapter VI of the
PEA shows two of the industries within
the secondary smelting, refining, and
alloying group, for example, the prices
rose over 60 percent in one year without
imperiling the existence of those
industries. Thus, OSHA preliminarily
concludes that the potential price
impacts of the proposal would not
threaten the economic viability of any
industries affected by this proposed
standard.
Profit rates are also subject to the
dynamics of the U.S. economy. A
recession, a downturn in a particular
industry, foreign competition, or the
increased competitiveness of producers
of close domestic substitutes are all
easily capable of causing a decline in
profit rates in an industry of well in
excess of ten percent in one year or for
several years in succession.
To demonstrate the normal year-toyear variation in profit rates for all the
manufacturers affected by the proposed
rule, OSHA presented data in the PEA
on year-to-year profit rates and year-toyear percentage changes in profit rates,
by industry, for the years 2002–2009.
For the industries that OSHA has
estimated will be affected by this
21 By contrast, NAICS 332721b: Precision Turned
Product Manufacturing of low content beryllium
alloys has a cost to revenue ratio below 0.4 percent.
E:\FR\FM\07AUP2.SGM
07AUP2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
proposed standard over the 8-year
period, the average change in profit
rates is calculated to be 39 percent per
year. For the industries with the largest
estimated potential annual cost impacts
as a percentage of profit—NAICS
331524: Aluminum foundries (except
die-casting), (14 percent); NAICS
331525(a and b): Copper foundries
(except die-casting) (16 percent); NAICS
332721a: Precision Turned Product
Manufacturing of high content
beryllium (8 percent); 22 and NAICS
811310 Commercial and Industrial
Machinery and Equipment (Except
Automotive and Electronic) Repair and
Maintenance (10 percent)—the average
annual changes in profit rates in these
industries over the eight-year period
were 35 percent, 35 percent, 11 percent,
and 5 percent, respectively.
A longer-term loss of profits in excess
of 10 percent a year could be more
problematic for some affected industries
and might conceivably, under
sufficiently adverse circumstances,
threaten an industry’s economic
viability. However, as previously
discussed, OSHA’s analysis indicates
that affected industries would generally
not absorb the costs of the proposed rule
in reduced profits but, instead, would
be able to pass on most or all of those
costs in the form of higher prices (due
to the relative price inelasticity of
demand for beryllium and berylliumcontaining inputs). It is possible that
such price increases will result in some
reduction in output, and the reduction
in output might be met through the
closure of a small percentage of the
plants in the industry. The only realistic
circumstance where an entire industry
would be significantly affected by small
potential price increases would be
where there is a very close or perfect
substitute product available not subject
to OSHA regulation. In most cases
where beryllium is used, there is no
substitute product that could be used in
place of beryllium and achieve the same
level of performance. The main
potential concern would be substitution
by foreign competition, but the
following discussion reveals why such
competition is not likely.
(2) International Trade Effects
World production of beryllium is a
thin market, with only a handful of
countries known to process beryllium
ores and concentrates into beryllium
products, and characterized by a high
degree of variation and uncertainty. The
United States accounts for
22 By contrast, NAICS 332721b: Precision Turned
Product Manufacturing of low content beryllium
alloys has a cost to profit ratio of 6 percent.
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
approximately 65 percent of world
beryllium deposits and 90 percent of
world production, but there is also a
significant stockpiling of beryllium
materials in Kazakhstan, Russia, China,
and possibly other countries (USGS,
2013a). For the individual years 2008–
2012, the United States’ net import
reliance as a percentage of apparent
consumption (that is, imports minus
exports net of industry and government
stock adjustments) ranged from 10
percent to 61 percent (USGS, 2013b). To
assure an adequate stockpile of
beryllium materials to support national
defense interests, the U.S. Department
of Defense, in 2005, under the Defense
Production Act, Title III, invested in a
public-private partnership with the
leading U.S. beryllium producer to
build a new $90.4 million primary
beryllium facility in Elmore, Ohio.
Construction of that facility was
completed in 2011 (USGS, 2013b).
One factor of importance to firms
working with beryllium and beryllium
alloys is to have a reliable supply of
beryllium materials. U.S. manufacturers
can have a relatively high confidence in
the availability of beryllium materials
relative to manufacturers in many
foreign countries, particularly those that
do not have economic or national
security partnerships with the United
States.
Firms using beryllium in production
must consider not just the cost of the
chemical itself but also the various
regulatory costs associated with the use,
transport, and disposal of the material.
For example, for marine transport,
metallic beryllium powder and
beryllium compounds are classified by
the International Maritime Organization
(IMO) as poisonous substances,
presenting medical danger. Beryllium is
also classified as flammable. The United
Nations classification of beryllium and
beryllium compounds for the transport
of dangerous goods is ‘‘poisonous
substance’’ and, for packing, a
‘‘substance presenting medium danger’’
(WHO, 1990). Because of beryllium’s
toxicity, the material is subject to
various workplace restrictions as well as
international, national, and State
requirements and guidelines regarding
beryllium content in environmental
media (USGS, 2013a).
As the previous discussion indicates,
the production and use of beryllium and
beryllium alloys in the United States
and foreign markets appears to depend
on the availability of production
facilities; beryllium stockpiles; national
defense and political considerations;
regulations limiting the shipping of
beryllium and beryllium products;
international, national, and State
PO 00000
Frm 00135
Fmt 4701
Sfmt 4702
47699
regulations and guidelines regarding
beryllium content in environmental
media; and, of course, the special
performance properties of beryllium and
beryllium alloys in various applications.
Relatively small changes in the price of
beryllium would seem to have a minor
effect on the location of beryllium
production and use. In particular, as a
result of this proposed rule, OSHA
would expect that, if all compliance
costs were passed through in the form
of higher prices, a price increase of 0.11
percent, on average, for firms
manufacturing or using beryllium in the
United States—and not exceeding 1
percent in any affected industry—would
have a negligible effect on foreign
competition and would therefore not
threaten the economic viability of any
affected domestic industries.
(b) Economic Feasibility Screening
Analysis: Small and Very Small
Businesses
The preceding discussion focused on
the economic viability of the affected
industries in their entirety. Even though
OSHA found that the proposed standard
did not threaten the survival of these
industries, there is still the possibility
that the competitive structure of these
industries could be significantly altered
such as by small entities exiting from
the industry as a result of the proposed
standard.
To address this possibility, OSHA
examined the annualized costs of the
proposed standard per affected small
entity, and per affected very small
entity, for each affected industry. Again,
OSHA used a minimum threshold level
of annualized compliance costs equal to
one percent of annual revenues—and,
secondarily, annualized compliance
costs equal to ten percent of annual
profits—below which the Agency has
concluded that the costs are unlikely to
threaten the survival of small entities or
very small entities or, consequently, to
alter the competitive structure of the
affected industries.
Based on the results presented in
Table IX–9, the annualized cost of
compliance with the proposed rule for
the average affected small entity is
estimated to be $8,108 in 2010 dollars.
Based on the results presented in Table
IX–10, the annualized cost of
compliance with the proposed rule for
the average affected very small entity is
estimated to be $1,955 in 2010 dollars.
These tables also show that there are no
industries in which the annualized costs
of the proposed rule for small entities or
very small entities exceed one percent
of annual revenues. NAICS 331525b:
Sand Copper Foundries (except diecasting) has the highest estimated cost
E:\FR\FM\07AUP2.SGM
07AUP2
47700
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
impact as a percentage of revenues for
small entities, 0.95 percent, and NAICS
336322b: Other motor vehicle electrical
and electronic equipment has the
highest estimated cost impact as a
percentage of revenues for very small
entities, 0.70 percent.
Small entities in four industries—
NAICS 331525: Sand and non-sand
foundries (except die-casting); NAICS
331524(a and b): Aluminum foundries
(except die-casting); NAICS 811310:
Commercial and Industrial Machinery
and Equipment; and NAICS 331522:
Nonferrous (except aluminum) diecasting foundries—have annualized
costs in excess of 10 percent of annual
profits (17.45 percent, 16.12 percent,
11.68 percent, and 10.64 percent,
respectively). Very small entities in 7
industries are estimated to have
annualized costs in excess of 10 percent
of annual profit; NAICS 336322b: Other
motor vehicle electrical and electronic
equipment (38.49 percent); 23 NAICS
336322a: Other motor vehicle electrical
and electronic equipment, (18.18
percent); NAICS 327113: Porcelain
electrical Supply Manufacturing (13.82
percent); NAICS 811310: Commercial
and Industrial Machinery and
Equipment (Except Automotive and
Electronic) Repair and Maintenance
(12.76 percent); NAICS 332721a:
Precision turned product manufacturing
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
23 NAICS 336322 contains entities that fall into
three separate application groups. NAICS 336322b
is in the Beryllium Oxide Ceramics and Composites
application group. NAICS 336322a (which follows
in the text) is in the Fabrication of Beryllium Alloy
Products application group.
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
(10.50 percent); NAICS 336214: Travel
trailer and camper manufacturing (10.75
percent); and NAICS 336399: All other
motor vehicle parts manufacturing
(10.38 percent).
In general, cost impacts for affected
small entities or very small entities will
tend to be somewhat higher, on average,
than the cost impacts for the average
business in those affected industries.
That is to be expected. After all, smaller
businesses typically suffer from
diseconomies of scale in many aspects
of their business, leading to less revenue
per dollar of cost and higher unit costs.
Small businesses are able to overcome
these obstacles by providing specialized
products and services, offering local
service and better service, or otherwise
creating a market niche for themselves.
The higher cost impacts for smaller
businesses estimated for this rule—other
than very small entities in NAICS
336322b: Other motor vehicle electrical
and electronic equipment—generally
fall within the range observed in other
OSHA regulations and, as verified by
OSHA’s lookback reviews, have not
been of such a magnitude to lead to the
economic failure of regulated small
businesses.
The ratio of annualized costs to
annual profit is a sizable 38.49 percent
in NAICS 336322b: Other motor vehicle
electrical and electronic equipment.
However, OSHA believes that the actual
ratio is significantly lower. There are
386 very small entities in NAICS
336322, of which only 6, or 1.5 percent,
are affected entities using beryllium.
When OSHA calculated the cost-to-
PO 00000
Frm 00136
Fmt 4701
Sfmt 4702
profit ratio, it used the average profit per
firm for the entire NAICs industry, not
the average profit rate for firms working
with beryllium. The profit rate for all
establishments in NAICS 336322b was
estimated at 1.83 percent. If, for
example, the average profit rate for a
very small entity in NAICS 336322b
were equal to 5.95 percent, the average
profit rate for its application group,
Beryllium Oxide Ceramics and
Composites, then the ratio of the very
small entity’s annualized cost of the
proposed rule to its annual profit would
actually be 11.77 percent. OSHA
tentatively concludes the 6
establishments in the NAICS
specializing in beryllium production
will have a higher than average profit
rate and will be able to pass much of the
cost onto the consumer for three main
reasons: (1) The absence of substitutes
containing the rare performance
characteristics of beryllium; (2) the
relative price insensitivity of (other)
motor vehicles containing the special
performance characteristics of beryllium
and beryllium alloys; and (3) the fact
that electrical and electronic
components made of beryllium or
beryllium-containing alloys typically
account for only a small portion of the
overall cost of the finished (other) motor
vehicles. The annualized compliance
cost to annual revenue ratio for NAICS
336332b is 0.70 percent, 0.30 percent
below the 1 percent threshold. Based on
OSHA’s experience, price increases of
this magnitude have not historically
been associated with the economic
failure of small businesses.
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
VerDate Sep<11>2014
TableiX-9
Jkt 235001
PO 00000
Cellular telephones rmmcuacumrq•
334411
Electron rube manutBcturb..Q
disc
460
62
$326.127
9
5
6. 75~/0
0.65°o
4.420.)
14JJD/(.
2.29qt,
5.01%
$35.475,343
$48.999,093
6.08~0
4.39g0
$2,980,355
$379,730
$19318
7.85%
7.85%
33cl415
0.27~(,
3.41~(,
0.12q-o
L72'}o
4.86°&
Sfmt 4725
0.56%
0.84°/o
l0.64q.•i}
E:\FR\FM\07AUP2.SGM
Frm 00137
334220
1
11
0.95%
7.85~-Q
8
7
9
33cl419
Fmt 4701
$18.415
6
o.07ofi
0.02<:·n
16.12°•o
16.6"1°(,
18.22%
I. 50°6
0.40%;
2.33q··O
07AUP2
331-!22
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
19:20 Aug 06, 2015
85
85
327113h
332612
176
585
.336312a
EP07AU15.016</GPH>
o.o?~o
2.91%
0.83%..
0.05%
2.65~l:.
136"'
33cl4!7
Othermoior vehicle electrical & electronic equ'
l-f6
20.772 7 -lO
1.83q··b
379.243
$10,048
47701
332116
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47702
VerDate Sep<11>2014
Table IX -9. continued
PO 00000
Fabricated
3323.13
Plate workmanufaduring
33232:..:
Sheet metal \;;to1X nm1u:tScturing
33:3.23
Omamcnlal and architec:uml metal worl: manu!
331-.09
Other metal
332919
Other metal valw and pipe fithng
207
-
333111
Fanntmchll:tely
941
18
353414<1
Heating equiptn::nt (except wannair furnaces)
707
5
8
4
Frm 00138
Jkt 235001
332312
332117
Hand and edge tool rnanufacturing
975
3,001
L220
~287
5,622,904
9.799,278
5
nnnufa cturi:ng
~
4 30'1o
Fmt 4701
.B391l
rn'l!Himcturing
Sfmt 4725
33392~
<;
and
333922
Industrial
E:\FR\FM\07AUP2.SGM
333999
}.1otor ,·ehide body mmufacturing
3.\6214
652
585
336399a
336510
Railroad
336999
All other transportation equipment tmnufactut
337215
Sho'\\rase.
157
349
5.454.538
6.30Ll51
$3.348.262
$7,444,451
All other miscellaneous general purpose rnachi
336211
$5.132720
4.68%
5.36%
6,744,933
21.453. 748
4,04-l-,530
15.149.628
12
6
1
24L034
7.00%
33.:999
07AUP2
33341411
333415
283
118
410
33521.2
Household ·vacuutn cleaner 11Bnuf3.ctu.t1ng
335.221
Household cooL-ing appliance !m::tufactming
335211
5.369&
5.36%
L839o
33522S
036~-ll
0.10%
2.42~o
o.o6~o
229,602
347.100
294.852
449,783
$5,769
$4.457
0.05~A)
0.100\J
1.88%,
1.149$99
$9J22
o.o4~o
$5~282
0.13'}•{,
2:76.583
$9.055
0.06~il
0.21%
0.10°o
0.03%
o.02"·"
0.16%
5.47~6
2,698.100
8A90,124
8
29
6.56%1
4,156,603
177.073
140,227
$12,983
$4.339
$6,966
$
4.68~\J
219,418
397.281
$8,363
$11,780
o.:mo.
0.18%
3.Sl~o
2.97~··0
3.45~·o
21,877,797
29
91
5
$89L600
$3,757,849
9
24
l
1
1
$185~373,
Household Iefrigemtorand honr fi·eeZCTlnanu.
35522-t
O.l8°o
0.2]<;;,
1.83%
$941,637
1
$7379
$7,010
$6.548
$5,858
$6.301
3.980,&
2.50"&
3.88%
4.50°o
7.670•(;
1
5
335211
2.04~&
0.22~·b
5.36~h
s he!vin~. and lo~ker n1<1ni
Industrial and COl1llll::1'Cia1 t[m and blower 1rnnr
0.10%1
o.92'lo
2.95°&
U2"o
l. 96°'o
0.99'%
19,857
333412
EP07AU15.017</GPH>
$8,278
$7m'
Po\vden:netallurgy pru1 tYhmufacturin.g
33.2212
4 03~o
4.03%>
4.03%
o.o5q·o
0.07%
1.06q&
881,709
L239JJ64
1.664,253
$15,789
$15,870
0.04Qil
o.Ol?o
0.95qo
15Qi<)
0.050,'0
31L284
$1,7-ID
o.02"·o
0.56~&
L42~&
4.03%
4.03~.;)
1. 79"&
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
19:20 Aug 06, 2015
0.37%
1.14%
!34
331221
331513
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
VerDate Sep<11>2014
Jkt 235001
PO 00000
Frm 00139
Fmt 4701
Sfmt 4725
E:\FR\FM\07AUP2.SGM
697
75
336321
336322c
4
209'
159
397
29
10
8
20
273
14
..,..,
l~
-·4
1.156
58
6.703
336312
1,676
Other motor ,-ehicle electrical and electronic eq
336330
l\·Iotor vehicle brake
336350
~lot or vehide
33636()
Motor vehicle
336370
iV!oto;· vehicle m::tal stamping
336391
!vlotor \-·ehide air...c-onditioning nnnufacturing
336399b
A 11 oth eT nDt or vehide oarts
339116
Dental laboratories
transmission and
and
pov;,~er
train
interiort.rllnn1a.nufa~
lll.::.'lllllfac ttuin.£
193,274
3,741
07AUP2
are not
calculated, thev would in no way ret1ec: the actual revenues and pror!ts ofthe affected fucilities
Sour~c:
OSHI\. Directorate ofStmHlards and Guidance. otlice
1. 83°1J
L83Q0
1.83%
1.83%
1.83%
1.83%
13,448,854
523.886
163,568
379.243
935,554
1.005.365
2:_<2.903
$16.015
3.06%
3.71q,,(i
$16.355'
$17.
$18,828
0.08"-o
$3.156.130
$687,134,666
470.853
764,
4.31%
1.29~~o
2.0l~o
0.03%
0.05%
i.
1.83~0
$16.715
225
Totai/Awrage
28,695.417
umo
")"'7
Offices of de:ntis ts
areas \Vhere
$20.000.705
10.55~0
49.696
0.03"-<>
0.06°/o
SL394
0.30":"
0.21"-o
SL630
7.55°/o
550,848
2.81%t
2.51%
1.47%
32"1
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
19:20 Aug 06, 2015
Table IX-9, continued
47703
EP07AU15.018</GPH>
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47704
VerDate Sep<11>2014
Jkt 235001
PO 00000
334310
Frm 00140
334411
$192368
Porcelain electlical
rmnufucruring \seconda!J'L
CeUuiar telephon;;s nRnnfucturi:ng
445
4
Con~ act
373
4
.38
jl)
discplaversn11nufucturitcg
!111.nufactu.r:ing
Bectro:n
57{\956
$L296530
$3.025,51)3
6.08?\)
4.39%'
$379,730
$1,196,149
7.85%
Fmt 4701
Sfmt 4725
0.5~%
$6,8~8
OA5°•o
6.
$5125()3
$6,962
$6,171
1.83~hL
$379243
$6,368
$247,7~0
7.85~<1}
$1,297,053
624
334510
3363~::b
Electro:n:edicai eq_uiprn:nt rrnnufucturing
O:hernDtorvehi:1e electrical and elechD!lic eq-c,ip:rent manu fa
386
331521
6.31%>
$6.430
$L024999
Od1er electron:¥: compo:nent Gm.mra.ctunng"
7.95Q,,(t
$8,383
$658J64
$L5081l6l
334419
0.69"1>
5.229'b,
45.454
17
334U5
$6,346
$2.980,355
6.85%,
5.78~:¢
8.65%}
Alunlinum di~-ca3ting foundrhs
3315:24
3315.25a
Ahtrnlnum foundries (except die--::asting)
Copperfm:.ndde-s
casting. found
6
349,811
217
alurninun:l) di2-cas tm~g foundrie-s
33152.2
3
0
0
E:\FR\FM\07AUP2.SGM
Secundmy suElting & a1loying ofaiunfu1J!E
38,.:19~(;
84
0
331314
0.48%>
.20-U97
131
$906246
45
139.372
0
306,390
-154%
$12.t3,316
0
33142111
5.80%
07AUP2
3J~721b
1,970
1
35;
18
2.2og_,9
332612
li~ht,gau~e sp~g. n:anufu.cturin,g
164
164
332116
:Metal
807
40
5~LB··&
$288,086
$3.5-B
334417
Electro:nk conne-ctor nanu.fuct-uring
Othertmtorvehicle el~trical & electrm1k' equipn1ent
106
ll
7 .85~'0
$694211
386
60
1.83%
$379,.H3
33632::a
EP07AU15.019</GPH>
6,18%
3-19,811
$906,::-16
SAO%,
$3.Ql4:
0.28%
0.25('./Q
$3,007
0.33%
HUS%
3.1:5~/Q
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
19:20 Aug 06, 2015
53
3C!7113h
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
VerDate Sep<11>2014
Table lX-Hl. COIItin!led
Jkt 235001
PO 00000
0
0
$100,643
$68!375
332~12
~51
~
332312
.1,1 '9
35
845
14
2~778
5.12q-s·
406J6l
176,.878
$3.171
0.35~%J
243.251
$2.299
0.16%
3.29~<c{,
190330
$2.891
0.24%
5.129/{t
46
Frm 00141
332313
Plate
332322
Sllc>elmo!alworlcmamd3clurillg
Oman::en!aland archliecrr:ral n::etal worlcrr,ru::ufactming.
332323
nunufacturing
907290
L~/4,043
$1.00~.308
1.192.1}80
5.61%
7..f'!/('h
.+. 74q,·s
$2,620
Fmt 4701
O:her:m::-tal ccntainer1mnnfaeturinF£
203
33;919
331.99'9
Othern::etalval\·e and pipe fitting manufacturing
ns:
333111
Fann nncllh:e:Ty at:d equ_ipilll"11t manufacturing
othernUscella.ne-ous
""
924.1 ~4
242~03-4
S2.'17!
0.27~~
7.00%
686,061
$4.302
0.27%>
6.21%
3.90(YO
899,831
24
.uo%'
1575,580
$187,.607
l
7.00%
0.28~'&
4.06%.
$2,299
0.20%
3.100,0
Sfmt 4725
$785,-160
$365551
1,167,103
$.t97
!,981,660
5.369'fL
$541.532
1.33054"7
5.36%1
$213,335
1,G9·1,026
673
~
283
2
.251
$Ll5U52
Ll80.669
E:\FR\FM\07AUP2.SGM
333924
mdusttial tmek, !1nc:or. !railer, and s!ackerulll.cl:ine1y manufac1
195
l
4
l
333999
All other miscellaneous
975
10
336211
:V1otorvehicle body :rnu1u:fi1c0_~ring
Tm~:el
5
294$52
0.10~,c{l
4.2oo,;,
H9,783
0.12%
l.33{h)
4
336214
333911
333912
fu~
and purrping -equipme!:t rnanufucturing
conveyiEg equipr:.1e11t
-107
trail2-r and canpernnnufa.:nuatg
653
307
07AUP2
Airpud:fication e-~uip:rrentnnnufactur:ing
Indu.~trialand conn1E1"Cia1 fan and b1ov.,ertmnufucnn1ng
333414b
Heating
l
$189,164.
i..
189
13
60
r:e,xrept sarmairfu1naces! manufuctu1~E
283
wannairheati11g,aud indumia!refrigemtbn'
395
1
0 ..25%
0.19%
1.83%
1.839-'0
5A7;;Ya'
78..t.l5
$2.300
509.796
$2,424
0.19%
lO.JS%
46.622
$3,949
0.69%
12.76%
219.+18
~2506
$253,916
4
20
28
~quipment
333415
$.2.761
$2.298
5.-t2~~o
333411
$2.335
Ul9,899
0.17%
1.171958
0
336510
333412
5.84%1
9.70~/o
32
332439
623~-·~
10
Household vactnlmcleantt· manufacturing
18
House]:old cooking appliance rnauufacturing
:)i'
2
335:222
Housel:: old
6
335224
Household hnndry
Othenmiorhm;sehold aoolianre mmufacrurina
!5
0
~.68'~{,
357ft/()
3.91~,6
3.84%,
294.852
0.05~/{}
0
335228
1.291.699
$806,99-1
0
335:211
$365.551
L500,678
O.J7%,
0.18%
$.2S3.62R
4
335.:!12
.:1.156.603.
335211
ru:d household fan n1anufacturing
hon:e
equ.iprr:et~t
1T1[tllt:fachuing-
0
$1.151
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
19:20 Aug 06, 2015
331513
332117
!.417.419
0.08°"0
!,239,064
$66.863
$1.831
1.66-1253
1,1 i3.037
-L03~}"[,
$1.056
2.23%;
16.660266
4.03%>
47705
EP07AU15.020</GPH>
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47706
VerDate Sep<11>2014
Jkt 235001
PO 00000
Frm 00142
~.49%
Fmt 4701
-1.5
2
4.3513·tr
Ot.h ernvtorq~!Jicle electlicai and elec:romc equipm=nt ummfu
386
19
8.78~l>
Niotorvehick stecfu1g :a.nd suspension conJ)onents (except
116
5
0.67°~
336321
33S3.22t:
'336330
3.363--10
:..,-1otor,~ehic Ie brake
sv·otem ~1Jal1U:tacnnulQ
82
Sfmt 4725
336350
:ivlotorvehicle transmission. and po,Yer train parts manufacrnrin.
2-1.0
3
9
336360
:V::Iotorve!:icle sea1ing and
!67
7
3JG370
NiotorYehk1e metal s':'EtmpU:~g
225
336391
E:\FR\FM\07AUP2.SGM
-1,.55%·
3.mo
0.21%
1.52%·
0.291?,·0
3..18%
$1.329
34
339116
Dental labcm:ories
6:.::1:::10
$283.285
128.3-17.342
TOO!J/Average
$6i9.421
10.55%)
$-19,696
$922
8A79,Q
1.807,075
Offices ofdt:11tists
$64,809
$1A6-l
8.27~·'0
$56,189
07AUP2
Beryl!iumProd·Gction (NAICS 331419) a"d Beavlli:umO;tide(NAICS 317113a)bduslries can
'.;:-ayrefle-ct
Source: OSHA. Directorate ofStandardsru:d 0Jidance. OfficeofRegulato:y Anatysi>.
EP07AU15.021</GPH>
0.08?·0
0.06%
$1.056
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
19:20 Aug 06, 2015
Table IX-10, continued
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
(c) Regulatory Flexibility Screening
Analysis
To determine if the Assistant
Secretary of Labor for OSHA can certify
that the proposed beryllium standard
will not have a significant economic
impact on a substantial number of small
entities, the Agency has developed
screening tests to consider minimum
threshold effects of the proposed
standard on small entities. The
minimum threshold effects for this
purpose are annualized costs equal to
one percent of annual revenues, and
annualized costs equal to five percent of
annual profits, applied to each affected
industry. OSHA has applied these
screening tests both to small entities and
to very small entities. For purposes of
certification, the threshold level cannot
be exceeded for affected small entities
or very small entities in any affected
industry.
Tables IX–9 and Table IX–10,
presented above, show that the
annualized costs of the proposed
standard do not exceed one percent of
annual revenues for affected small
entities or affected very small entities in
any affected industry. These tables also
show that the annualized costs of the
proposed standard exceed five percent
of annual profits for affected small
entities in 12 industries and for affected
very small entities in 30 industries.
OSHA is therefore unable to certify that
the proposed standard will not have a
significant economic impact on a
substantial number of small entities and
must prepare an Initial Regulatory
Flexibility Analysis (IRFA). The IRFA is
presented in Chapter IX of the PEA and
is reproduced in Section IX.I of this
preamble.
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
G. Benefits and Net Benefits
In this section, OSHA presents a
summary of the estimated benefits and
net benefits of the proposed beryllium
rule. This section proceeds in five steps.
The first step estimates the numbers of
diseases and deaths prevented by
comparing the current (baseline)
situation to a world in which the
proposed PEL is adopted in a final
standard to a world in which employees
are exposed at the level of the proposed
PEL throughout their working lives. The
second step also assumes that the
proposed PEL is adopted, but uses the
results from the first step to estimate
what would happen under a more
realistic scenario in which employees
have been exposed for varying periods
of time to the baseline situation and will
thereafter be exposed to the new PEL.
The third step covers the
monetization of benefits. Then, in the
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
fourth step, OSHA estimates the net
benefits and incremental benefits of the
proposed rule by comparing the
monetized benefits to the costs
presented in Chapter V of the PEA. The
models underlying each step inevitably
need to make a variety of assumptions
based on limited data. In the fifth step,
OSHA provides a sensitivity analysis to
explore the robustness of the estimates
of net benefits with respect to many of
the assumptions made in developing
and applying the underlying models. A
full explanation of the derivation of the
estimates presented here is provided in
Chapter VII of the PEA for the proposed
rule. OSHA invites comments on any
aspect of the data and methods used to
estimate the benefits and net benefits of
this proposed rule. Because dental labs
constitute a significant source of both
costs and benefits to the rule (over 40
percent), OSHA is particularly
interested in comments regarding the
appropriateness of the model,
assumptions, and data to estimating the
benefits to workers in that industry.
OSHA has added to the docket the
spreadsheets used to calculate the
estimates of benefits outlined below
(OSHA, 2015a). Those interested in
exploring the details and methodology
of OSHA’s benefits analysis, such as
how the life table referred to below was
developed and applied, should consult
those spreadsheets.
Step 1—Estimation of the Steady-State
Number of Beryllium-Related Diseases
Avoided
Methods of Estimation
The first step in OSHA’s development
of the benefits analysis compares the
situation in which employees continue
to be at baseline exposure levels for
their entire working lives to the
situation in which all employees have
been exposed at a given PEL for their
entire working lives. This is a
comparison of two steady-state
situations. To do this, OSHA must
estimate both the risk associated with
the baseline exposure levels and the risk
following the promulgation of a new
beryllium standard. OSHA’s approach
assumes for inputs such as the turnover
rate and the exposure response function
that they are similar across all workers
exposed to beryllium, regardless of
industry.
An exposure-response model,
discussed below, is used to estimate a
worker’s risk of beryllium-related
disease based on the worker’s
cumulative beryllium exposure. The
Agency used a lifetime risk model to
estimate the baseline risk and the
associated number of cases for the
PO 00000
Frm 00143
Fmt 4701
Sfmt 4702
47707
various disease endpoints. A lifetime
risk model explicitly follows a worker
each year, from work commencement
onwards, accumulating the worker’s
beryllium exposure in the workplace
and estimating outcomes each year for
the competing risks that can occur. To
go from exposure to number of cases,
the Agency needs to estimate an
exposure-response relationship, and this
is discussed below. The possible
outcomes are no change, or the various
health endpoints OSHA has considered
(beryllium sensitization, CBD, lung
cancer, and the mortality associated
with these endpoints). As part of the
estimation discussion, OSHA will
mention specific parameters used in
some of the estimation methods, but
will further discuss how these
parameters were derived later in this
section.
The baseline lifetime risk model is the
most complicated part of the analysis.
The Agency only needs to make
relatively simple adjustments to this
model to reflect changes in activities
and conditions due to the standard,
which, working through the model, then
lead to changes in relevant health
outcomes. There are three channels by
which the standard generates benefits.
First are estimated benefits due to the
lowering of the PEL. Second are
estimated benefits with further exposure
reductions from the substitution of nonberyllium for beryllium-containing
materials, ending workers’ beryllium
exposures entirely. This potential
source of benefits is particularly
significant with respect to OSHA’s
assumptions for how dental labs are
likely to reduce exposures (see below).
Finally, the model estimates benefits
due to the ancillary programs that are
required by the proposed standard. The
last channel affects CBD and
sensitization, endpoints which may be
mitigated or prevented with the help of
ancillary provisions such as dermal
protection and medical surveillance for
early detection, and for which the
Agency has some information on the
effects on risk of ancillary provisions.
The benefits of ancillary provisions are
not estimated for lung cancer because
the benefits from reducing lung cancer
are considered to be the result of
reducing airborne exposure only and
thus the ancillary provisions will have
no separable effect on airborne
exposures. The discussion here will
concentrate on CBD as being the most
important and complex endpoint, and
most illustrative of other endpoints: The
structure for other endpoints is the
same; only the exposure response
functions are different. Here OSHA will
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47708
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
discuss first the exposure-response
model, then the structure of the year-toyear changes for a worker, then the
estimated exposure distribution in the
affected population and the risk model
with the lowering of the PEL, and, last,
the other adjustments for the ancillary
benefits and the substitution benefits.
The exposure response model is
designed to translate beryllium
exposure to risk of adverse health
endpoints. In the case of beryllium
sensitization and CBD, the Agency uses
the cumulative exposure data from a
beryllium manufacturing facility.
Specifically, OSHA uses the quartile
data from the Cullman plant that is
presented in Table VI–7 of the
Preliminary Risk Assessment in the
preamble. The raw data from this study
show cases of CBD with cumulative
exposures that would represent an
average exposure level of less than 0.1
mg/m3 if exposed for 10 years; show
cases of CBD with exposures lasting less
than one year; and show cases of CBD
with actual average exposure of less
than 0.1 mg/m3.
Prevalence is defined as the
percentage of persons with a condition
in a population at a given point in time.
The quartile data in Table VI–7 of the
Preliminary Risk Assessment are
prevalence percentages (the number of
cases of illness documented over several
years in the 319 person cohort from the
Cullman plant) at different cumulative
exposure levels. The Cullman data do
not cover persons who left the work
force or what happened to persons who
remained in the workforce after the
study was completed. For the lifetime
risk model, the prevalence percentages
will be translated into incidence
percentages—the estimated number of
new cases predicted to occur each year.
For this purpose OSHA assumed that
the incidence for any given cumulative
exposure level is constant from year to
year and continues after exposure
ceases.
To calculate incidence from
prevalence, OSHA assumed a steady
state in which both the size of the
beryllium-exposed affected population,
exposure concentrations during
employment and prevalence are
constant over time. If these conditions
are met, and turnover among workers
with a condition is equal to turnover for
workers without a condition, then the
incidence rate will be equal to the
turnover rate multiplied by the
prevalence rate. If the turnover rate
among persons with a condition is
higher than the turnover rate for
workers without the condition, then this
assumption will underestimate
incidence. This might happen if, in
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
addition to other reasons for leaving
work, persons with a condition leave a
place of employment more frequently
because their disabilities cause them to
have difficulty continuing to do the
work. If the turnover rate among persons
with a condition is lower than the
turnover rate for workers without the
condition, then this assumption will
overestimate incidence. This could
happen if an employer provides special
benefits to workers with the condition,
and the employer would cease to
provide these benefits if the employee
left work.
To illustrate, if 10 percent of the work
force (including 10 percent of those
with the condition) leave each year and
if the overall prevalence is at 20 percent,
then a 2 percent (10 percent times 20
percent) incidence rate will be needed
in order to keep a steady 20 percent
group prevalence rate each year.
OSHA’s model assumes a constant 10
percent turnover rate (see later in this
section for the rationale for this
particular turnover rate). While turnover
rates are not available for the specific set
of employees in question, for
manufacturing as a whole, the turnover
rates are greater than 20 percent, and
greater than 30 percent for the economy
as a whole (BLS, 2013). For this
analysis, OSHA assumed an effective
turnover rate of 10 percent. Different
turnover rates will result in different
incidence rates. The lower the turnover
rate the lower the estimated incidence
rate. This is a conservative assumption
for the industries where turnover rates
may be higher. However, some
occupations/industries, such as dental
lab technicians, may have lower
turnover rates than manufacturing
workers. Additionally, the typical
dental technician even if leaving one
workplace, has significant likelihood of
continuing to work as a dental
technician and going to another
workplace that uses beryllium. OSHA
welcomes comments on its turnover
estimates and on sectors, such as dental
laboratories, where turnover may be
lower than ten percent.
Using Table VI–7 of the Preliminary
Risk Assessment, when a worker’s
cumulative exposure is below 0.147 (mg/
m3-years), the prevalence of CBD is 2.5
percent and so the derived annual risk
would be 0.25 percent (0.10 × 2.5
percent). It will stay at this level until
the worker has reached a cumulative
exposure of 1.468, where it will rise to
0.80 percent.
The model assumes a maximum 45year (250 days per year) working life
(ages 20 through 65 or age of death or
onset of CBD, whichever is earlier) and
follows workers after retirement through
PO 00000
Frm 00144
Fmt 4701
Sfmt 4702
age 80. The 45-year working life is based
on OSHA’s legal requirements and is
longer than the working lives of most
exposed workers. A shorter working life
will be examined later in this section.
While employed, the worker
accumulates beryllium exposure at a
rate depending on where the worker is
in the empirical exposure profile
presented in Chapter IV of the PEA (i.e.,
OSHA calculates a general risk model
which depends on the exposure level
and then plug in our empirical exposure
distribution to estimate the final number
of cases of various health outcomes).
Following a worker’s retirement, there is
no increased exposure, just a constant
annual risk resulting from the worker’s
final cumulative exposure.
OSHA’s model follows the population
of workers each year, keeping track of
cumulative exposure and various health
outcomes. Explicitly, each year the
model calculates: The increased
cumulative exposure level for each
worker versus last year, the incidence at
the new exposure level, the survival rate
for this age bracket, and the percentage
of workers who have not previously
developed CBD in earlier years.
For any individual year, the equation
for predicting new cases of CBD for
workers at age t is:
New CBD cases rate(t) = modeled
incidence rate(t) * survival rate(t) * (1currently have CBD rate(t)), where the
variables used are:
New CBD cases rate(t) is the output
variable to be calculated;
cumulative exposure(t) = cumulative
exposure(t-1) + current exposure;
modeled incidence rate(t) is a function of
cumulative exposure; and
survival rate(t) is the background survival
rate from mortality due to other causes in the
national population.
Then for the next year the model
updates the survival rate (due to an
increase in the worker’s age), incidence
rate (due to any increased cumulative
exposure), and the rate of those
currently having CBD, which increases
due to the new CBD case rate of the year
before. This process then repeats for all
60 years.
It is important to note that this model
is based on the assumption that
prevalence is explained by an
underlying constant incidence, and as a
result, prevalence will be different
depending on the average number of
years of exposure in the population
examined and (though a sensitivity
analysis is provided later) on the
assumption of a maximum of 45 years
of exposure. OSHA also examined
(OSHA 2015c) a model in which
prevalence is constant at the levels
shown in Table VI–7 of the preliminary
E:\FR\FM\07AUP2.SGM
07AUP2
47709
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
risk assessment, with a population age
(and thus exposure) distribution
estimated based on an assumed constant
turnover rate. OSHA solicits comment
on this and other alternative approaches
to using the available prevalence data to
develop an exposure-response function
for this benefits analysis.
In the next step, OSHA uses its model
to take into account the adoption of the
lower proposed PEL. OSHA uses the
exposure profile for workers as
estimated in Chapter IV of the PEA for
each of the various application groups.
These exposure profiles estimate the
number of workers at various exposure
levels, specifically the ranges less than
0.1 mg/m3, 0.1 to 0.2, 0.2 to 0.5, 0.5 to
1.0, 1.0 to 2.0, and greater than 2.0 mg/
m3. Translating these ranges into
exposure levels for the risk model, the
model assumes an average exposure
equal to the midpoint of the range,
except for the lower end, where it was
assumed to be equal to 0.1 mg/m3, and
the upper end, where it was assumed to
be equal to 2.0 mg/m3.
The model increases the workers’
cumulative exposure each year by these
midpoints and then plugs these new
values into the new case equation. This
alters the incidence rate as cumulative
exposure crosses a threshold of the
quartile data. So then using the
exposure profiles by application group
from Chapter IV of the PEA, the baseline
exposure flows through the life time risk
model to give us a baseline number of
cases. Next OSHA calculated the
number of cases estimated to occur after
the implementation of the proposed PEL
of 0.2 mg/m3. Here OSHA simply takes
the number of workers with current
average exposure above 0.2 mg/m3 and
set their exposure level at 0.2 mg/m3; all
exposures for workers exposed below
0.2 mg/m3 stay the same. After adjusting
the worker exposure profile in this way,
OSHA goes through all the same
calculations and obtains a post-standard
number of CBD cases. Subtracting
estimated post-standard CBD cases from
estimated pre-standard CBD cases gives
us the number of CBD cases that would
be averted due to the proposed change
in the PEL.
Based on these methods, OSHA’s
estimate of benefits associated with the
proposed rule does not include benefits
associated with current compliance that
have already been achieved with regard
to the new requirements, or benefits
obtained from future compliance with
existing beryllium requirements.
However, available exposure data
indicate that few employees are
currently exposed above the existing
standard’s PEL of 2.0 mg/m3. To achieve
consistency with the cost estimation
method in chapter V, all employees in
the exposure profile that are above 2.0
mg/m3 are assumed to be at the 2.0 mg/
m3 level.
There is also a component that
applies only to dental labs. OSHA has
preliminarily assumed, based on the
estimates of higher costs for engineering
controls than using substitutes
presented in the cost chapter, that rather
than incur the costs of compliance with
the proposed standard, many dental labs
are likely to stop using berylliumcontaining materials after the
promulgation of the proposed
standard.24 OSHA estimated earlier in
this PEA that, for the baseline, only 25
percent of dental lab workers still work
with beryllium. OSHA estimates that, if
OSHA adopts the proposed rule, 75
percent of the 25 percent still using
beryllium will stop working with
beryllium; their beryllium exposure
level will therefore drop to zero. OSHA
estimates that the 75 percent of workers
will not be a random sample of the
dental lab exposure profile but instead
will concentrate among workers who are
currently at the highest exposure levels
because it would cost more to reduce
those higher exposures into compliance
with the proposed PEL. Under this
judgment OSHA is estimating that the
rule would eliminate all cases of CBD in
the 75 percent of dental lab workers
with the highest exposure levels. As
discussed in the sensitivity analysis
below, dental labs constitute a
significant source of both costs and
benefits to the rule (over 40 percent),
and the extent to which dental
laboratories substitute other materials
for beryllium has significant effects on
the benefits and costs of the rule. To
derive its baseline estimate of cases of
CBD in dental laboratories, OSHA (1)
estimated baseline cases of CBD using
the existing rate of beryllium use in
dental labs without a projection of
further substitution; (2) estimated cases
of CBD with the proposed regulation
using an estimate that 75 percent of the
dental labs with higher exposure would
switch to other materials and thus
eliminate exposure to beryllium; and (3)
estimated that the turnover rate in the
industry is 10 percent. OSHA welcomes
comments on all aspects of the analysis
of substitution away from beryllium in
the dental laboratories sector.
Estimation results for both dental labs
and non-dental workplaces appear in
the table below.
CBD CASE ESTIMATES, 45-YEAR TOTALS, BASELINE AND WITH PEL OF 0.2 μg/m3
Current beryllium exposure
(μg/m3)
< 0.1
0.1–0.2
0.2–0.5
0.5–1.0
Total
1.0–2.0
> 2.0
Dental labs ...................
Non-dental ...................
827
5,912
636
631
432
738
608
287
155
112
466
214
3,124
7,893
PEL = 0.2 μg/m3 ..........
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Baseline .......................
Total ......................
Dental labs ...................
Non-dental ...................
6,739
679
5,912
1,267
0
631
1,171
0
693
895
0
255
267
0
98
679
0
186
11,017
679
7,774
Total ......................
Dental labs ...................
6,591
148
631
636
693
432
255
608
98
155
186
466
8,454
2,444
Non-dental ...................
0
0
45
32
14
27
119
Total ......................
148
636
478
640
169
493
2,563
Prevented by PEL reduction.
24 In Chapter V (Costs) of the PEA, OSHA
explored the cost of putting in LEV instead of
substitution. The Agency costed an enclosure for 2
technicians: The Powder Safe Type A Enclosure, 32
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
inch wide with HEPA filter, AirClean Systems
(2011), which including operating and
maintenance, was annualized at $411 per worker.
This is significantly higher than the annual cost for
PO 00000
Frm 00145
Fmt 4701
Sfmt 4702
substitution of $166 per worker, shown later in this
section.
E:\FR\FM\07AUP2.SGM
07AUP2
47710
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
In contrast to this PEL component of
the benefits, both the ancillary program
benefits calculation and the substitution
benefits calculation are relatively
simple. Both are percentages of the
lifetime-risk-model CBD cases that still
occur in the post-standard world. OSHA
notes that in the context of existing CBD
prevention programs, some ancillaryprovision programs similar to those
included in OSHA’s proposal have
eliminated a significant percentage of
the remaining CBD cases (discussed
later in this chapter). If the ancillary
provisions reduce remaining CBD cases
by 90 percent for example, and if the
estimated baseline contains 120 cases of
CBD, and post-standard compliance
with a lower PEL reduces the total to
100 cases of CBD, then 90 of those
remaining 100 cases of CBD would be
averted due to the ancillary programs.
OSHA assumed, based on the clinical
experience discussed further below, that
approximately 65 percent of CBD cases
ultimately result in death. Later in this
chapter, OSHA provides a sensitivity
analysis of the effects of different values
for assuming this percentage at 50
percent and 80 percent on the number
of CBD deaths prevented. OSHA
welcomes comment on this assumption.
OSHA’s exposure-response model for
lung cancer is based on lung cancer
mortality data. Thus, all of the estimated
cases of lung cancer in the benefits
analysis are cases of premature death
from beryllium-related lung cancer.
Finally, in recognition of the
uncertainty in this aspect of these
models, OSHA presents a ‘‘high’’
estimate, a ‘‘low’’ estimate, and uses the
midpoint of these two as our ‘‘primary’’
estimate. The low estimate is simply
those CBD fatalities prevented due to
everything except the ancillary
provisions, i.e., both the reduction in
the PEL and the substitution by dental
labs. The high estimate includes both of
these factors plus all the ancillary
benefits calculated at an effectiveness
rate of 90 percent in preventing cases of
CBD not averted by the reduction of the
PEL. The midpoint is the combination
of reductions attributed to adopting the
proposed PEL, substitution by dental
labs, and the ancillary provisions
calculated at an effectiveness rate of
only 45 percent.
a. Chronic Beryllium Disease
CBD is a respiratory disease in which
the body’s immune system reacts to the
presence of beryllium in the lung,
causing a progression of pathological
changes including chronic inflammation
and tissue scarring. Immunological
sensitization to beryllium (BeS) is a
precursor that occurs before early-stage
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
CBD. Only sensitized individuals can go
on to develop CBD. In early,
asymptomatic stages of CBD, small
granulomatous lesions and mild
inflammation occur in the lungs. As
CBD progresses, the capacity and
function of the lungs decrease, which
eventually affects other organs and
bodily functions as well. Over time the
spread of lung fibrosis (scarring) and
loss of pulmonary function cause
symptoms such as: A persistent dry
cough, shortness of breath, fatigue, night
sweats, chest and join pain, clubbing of
fingers due to impaired oxygen
exchange, and loss of appetite. In these
later stages CBD can also impair the
liver, spleen, and kidneys, and cause
health effects such as granulomas of the
skin and lymph nodes, and cor
pulmonale (enlargement of the heart).
The speed and extent of disease
progression may be influenced by the
level and duration of exposure,
treatment with corticosteroids, and
genetics, but these effects are not fully
understood.
Corticosteroid therapy, in workers
whose beryllium exposure has ceased,
has been shown to control
inflammation, ease symptoms, and in
some cases prevent the development of
fibrosis. However, corticosteroid use can
have adverse effects, including
increased risk of infections; accelerated
bone loss or osteoporosis; psychiatric
effects such as depression, sleep
disturbances, and psychosis; adrenal
suppression; ocular effects; glucose
intolerance; excessive weight gain;
increased risk of cardiovascular disease;
and poor wound healing. The effects of
CBD, and of common treatments for
CBD, are discussed in detail in this
preamble at Section V, Health Effects,
and Section VIII, Significance of Risk.
OSHA’s review of the literature on
CBD suggests three broad types of CBD
progression (see this preamble at
Section V, Health Effects). In the first,
individuals progress relatively directly
toward death related to CBD. They
suffer rapidly advancing disability and
their death is significantly premature.
Medical intervention is not applied, or
if it is, does little to slow the
progression of disease. In the second
type, individuals live with CBD for an
extended period of time. The
progression of CBD in these individuals
is naturally slow, or may be medically
stabilized. They may suffer significant
disability, in terms of loss of lung
function—and quality of life—and
require medical oversight their
remaining years. They would be
expected to lose some years of normal
lifespan. As discussed previously,
advanced CBD can involve organs and
PO 00000
Frm 00146
Fmt 4701
Sfmt 4702
systems beyond the respiratory system;
thus, CBD can contribute to premature
death from other causes. Finally,
individuals with the third type of CBD
progression do not die prematurely from
causes related to CBD. The disease is
stabilized and may never progress to a
debilitating state. These individuals
nevertheless may experience some
disability or loss of lung function, as
well as side effects from medical
treatment, and may be affected by the
disease in many areas of their lives:
Work, recreation, family, etc.25
In the analysis that follows, OSHA
assumes, based on the clinical
experience discussed below, that 35
percent of workers who develop CBD
experience the third type of progression
and do not die prematurely from CBD.
The remaining 65 percent were
estimated to die prematurely, whether
from rapid disease progression (type 1)
or slow (type 2). Although the
proportion of CBD patients who die
prematurely as a result of the disease is
not well understood or documented at
this time, OSHA believes this
assumption is consistent with the
information submitted in response to
the RFI. Newman et al. (2003) presented
a scenario for what they considered to
be the ‘‘typical’’ CBD patient:
We have included an example of a life care
plan for a typical clinical case of CBD. In this
example, the hypothetical case is diagnosed
at age 40 and assumed to live an additional
33.7 years (approximately 5% reduced life
expectancy in this model). In this
hypothetical example, this individual would
be considered to have moderate severity of
chronic beryllium disease at the time of
initial diagnosis. They require treatment with
prednisone and treatment for early cor
pulmonale secondary to CBD. They have
experienced some, but not all, of the side
effects of treatment and only the most
common CBD-related health effects.
In short, most workers diagnosed with
CBD are expected to have shortened life
expectancy, even if they do not progress
rapidly and directly to death. It should
be emphasized that this represents the
Agency’s best estimate of the mortality
related to CBD based upon the current
available evidence. As described in
Section V, Health Effects, there is a
substantial degree of uncertainty as to
the prognosis for those contracting CBD,
particularly as the relatively less severe
25 As indicated in the Health Effects section of
this preamble: ‘‘It should be noted, however, that
treatment with corticosteroids has side-effects of
their own that need to be measured against the
possibility of progression of disease (Gibson et al.,
1996; Zaki et al., 1987). Alternative treatments such
as azathiopurine and infliximab, while successful at
treating symptoms of CBD, have been demonstrated
to have side-effects as well (Pallavicino et al., 2013;
Freeman, 2012)’’.
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
cases are likely not to be studied closely
for the remainder of their lives.
As mentioned previously, OSHA used
the Cullman data set for empirical
estimates of beryllium sensitization and
CBD prevalence in its exposure
response model, which translates
beryllium exposure to risk of adverse
health endpoints for the purpose of
determining the benefits that could be
achieved by preventing those adverse
health endpoints.
OSHA chose the cumulative exposure
quartile data as the basis for this
benefits analysis. The choice of
cumulative quartiles was based in part
on the need to use the cumulative
exposure forecast developed in the
model, and in part on the fact that in
statistically fitted models for CBD, the
cumulative exposure tended to fit the
CBD data better than other exposure
variables. OSHA also chose the quartile
model because the outside expert who
examined the logistic and proportional
hazards models believed statistical
modeling of the data set to be unreliable
due to its small size. In addition, the
proportional hazards model with its
dummy variables by year of detection is
difficult to interpret for purposes of this
section. Of course regression analyses
are often useful in empirical analysis.
They can be a useful compact
representation of a set of data, allow
investigations of various variable
interactions and possible causal
relationships, have added flexibility due
to covariate transformations, and under
certain conditions can be shown to be
statistically ‘‘optimal.’’ However, they
are only useful when used in the proper
setting. The possibility of
misspecification of functional form,
endogeneity, or incorrect distributional
assumptions are just three reasons to be
cautious about using regression
analyses.
On the other hand, the use of results
produced by a quartile analysis as
inputs in a benefits assessment implies
that the analytic results are being
interpreted as evidence of an exposureresponse causal relationship. Regression
analysis is a more sophisticated
approach to estimating causal
relationships (or even correlations) than
quartile or other quantile analysis, and
any data limitations that may apply to
a particular regression-based exposureresponse estimation also apply to
exposure-response estimation
conducted with a quartile analysis using
the same data set. In this case, OSHA
adopted the quartile analysis because
the logistic regression analysis yielded
extremely high prevalence rates for
higher level of exposure over long time
periods that some might not find
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
credible. Use of the quartile analysis
serves to show that there are significant
benefits even without using an
extremely high estimate of prevalence
for long periods of exposure at high
levels. As a check on the quartile model,
the Agency performed the same benefits
calculation using the logit model
estimated by the Agency’s outside
expert, and these benefit results are
presented in a separate OSHA
background document (OSHA, 2015b).
The difference in benefits between the
two models is slight, and there is no
qualitative change in final outcomes.
The Agency solicits comment on these
issues.
(1) Number of CBD Cases Prevented by
the Proposed PEL
To examine the effect of simply
changing the PEL, including the effect of
the standard on some dental labs to
discontinue their use of beryllium,
OSHA compared the number of CBDrelated deaths (mortality) and cases of
non-fatal CBD (morbidity) that would
occur if workers were exposed for a 45year working life to PELs of 0.1, 0.2, or
0.5 mg/m3 to the number of cases that
would occur at levels of exposure at or
below the current PEL. The number of
avoided cases over a hypothetical
working life of exposure for the current
population at a lower PEL is then equal
to the difference between the number of
cases at levels of exposure at or below
the current PEL for that population
minus the number of cases at the lower
PEL. This approach represents a steadystate comparison based on what would
hypothetically happen to workers who
received a specific average level of
occupational exposure to beryllium
during an entire working life. (Chapter
VII in the PEA modifies this approach
by introducing a model that takes into
account the timing of benefits before
steady state is reached.)
As indicated in Table IX–11, the
Agency estimates that there would be
16,240 cases of beryllium sensitization,
from which there would be 11,017, or
about 70 percent, progressing to CBD.
The Agency arrived at these estimates
by using the CBD and BeS prevalence
values from the Agency’s preliminary
risk analysis, the exposure profile at
current exposure levels (under an
assumption of full, or fixed, compliance
with the existing beryllium PEL), and
the model outlined in the previous
methods of estimation section after a
working lifetime of exposure. Applying
the prior midpoint estimate, as
explained above, that 65 percent of CBD
cases cause or contribute to premature
death, the Agency predicts a total of
7,161 cases of mortality and 3,856 cases
PO 00000
Frm 00147
Fmt 4701
Sfmt 4702
47711
of morbidity from exposure at current
levels; this translates, annually, to 165
cases of mortality and 86 cases of
morbidity. At the proposed PEL,
OSHA’s base model estimates that, due
to the airborne factor only, a total of
2,563 CBD cases would be avoided from
exposure at current levels, including
1,666 cases of mortality and 897 cases
of morbidity—or an average of 37 cases
of mortality and 20 cases of morbidity
annually. OSHA has not estimated the
quantitative benefits of sensitization
cases avoided.
OSHA requests comment on this
analysis, including feedback on the data
relied on and the approach and
assumptions used. As discussed earlier,
based on information submitted in
response to the RFI, the Agency
estimates that most of the workers with
CBD will progress to an early death,
even if it comes after retirement, and
has quantified those cases prevented.
However, given the evolving nature of
science and medicine, the Agency
invites public comment on the current
state of CBD-related mortality.
The proposed standard also includes
provisions for medical surveillance and
removal. The Agency believes that to
the extent the proposal provides
medical surveillance sooner and to more
workers than would have been the case
in the absence of the proposed standard,
workers will be more likely to receive
appropriate treatment and, where
necessary, removal from beryllium
exposure. These interventions may
lessen the severity of beryllium-related
illnesses, and possibly prevent
premature death. The Agency requests
public comment on this issue.
(2) CBD Cases Prevented by the
Ancillary Provisions of the Proposed
Standard
The nature of the chronic beryllium
disease process should be emphasized.
As discussed in this preamble at Section
V, Heath Effects, the chronic beryllium
disease process involves two steps.
First, workers become sensitized to
beryllium. In most epidemiological
studies of CBD conducted to date, a
large percentage of sensitized workers
have progressed to CBD. A certain
percentage of the population has an
elevated risk of this occurring, even at
very low exposure levels, and
sensitization can occur from dermal as
well as inhalation exposure to
beryllium. For this reason, the threat of
beryllium sensitization and CBD persist
to a substantial degree, even at very low
levels of airborne beryllium exposure. It
is therefore desirable not only to
significantly reduce airborne beryllium
exposure, but to avoid nearly any source
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47712
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
of beryllium exposure, so as to prevent
beryllium sensitization.
The analysis presented above
accounted only for CBD-prevention
benefits associated with the proposed
reduction of the PEL, from 2 ug/m3 to
0.2 ug/m3. However, the proposed
standard also includes a variety of
ancillary provisions—including
requirements for respiratory protection,
personal protective equipment (PPE),
housekeeping procedures, hygiene
areas, medical surveillance, medical
removal, and training—that the Agency
believes would further reduce workers’
risk of disease from beryllium exposure.
These provisions were described in
Chapter I of the PEA and discussed
extensively in Section XVIII of this
preamble, Summary and Explanation of
the Proposed Standard.
The leading manufacturer of
beryllium in the U.S., Materion
Corporation (Materion), has
implemented programs including these
types of provisions in several of its
plants and has worked with NIOSH to
publish peer-reviewed studies of their
effectiveness in reducing workers’ risk
of sensitization and CBD. The Agency
used the results of these studies to
estimate the health benefits associated
with a comprehensive standard for
beryllium.
The best available evidence on
comprehensive beryllium programs
comes from studies of programs
introduced at Materion plants in
Reading, PA; Tucson, AZ; and Elmore,
OH. These studies are discussed in
detail in this preamble at Section VI,
Preliminary Risk Assessment, and
Section VIII, Significance of Risk. All
three facilities were in compliance with
the current PEL prior to instituting
comprehensive programs, and had taken
steps to reduce airborne levels of
beryllium below the PEL, but their
medical surveillance programs
continued to identify cases of
sensitization and CBD among their
workers. Beginning around 2000, these
facilities introduced comprehensive
beryllium programs that used a
combination of engineering controls,
dermal and respiratory PPE, and
stringent housekeeping measures to
reduce workers’ dermal exposures and
airborne exposures. These
comprehensive beryllium programs
have substantially lowered the risk of
sensitization among workers. At the
times that studies of the programs were
published, insufficient follow-up time
had elapsed to report directly on the
results for CBD. However, since only
sensitized workers can develop CBD,
reduction of sensitization risk
necessarily reduces CBD risk as well.
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
In the Reading, PA copper beryllium
plant, full-shift airborne exposures in all
jobs were reduced to a median of 0.1 ug/
m3 or below, and dermal protection was
required for production-area workers,
beginning in 2000–2001 (Thomas et al.,
2009). In 2002, the process with the
highest exposures (with a median of 0.1
ug/m3) was enclosed, and workers
involved in that process were required
to use respiratory protection. Among 45
workers hired after the enclosure was
built and respiratory protection
instituted, one was found to be
sensitized (2.2 percent). This is more
than an 80 percent reduction in
sensitization from a previous group of
43 workers hired after 1992, 11.5
percent of whom had been sensitized by
the time of testing in 2000.
In the Tucson beryllium ceramics
plant, respiratory and skin protection
was instituted for all workers in
production areas in 2000 (Cummings et
al., 2007). BeLPT testing in 2000–2004
showed that only 1 (1 percent) of 97
workers hired during that time period
was sensitized to beryllium. This is a 90
percent reduction from the prevalence
of sensitization in a 1998 BeLPT
screening, which found that 6
(9 percent) of 69 workers hired after
1992 were sensitized.
In the Elmore, OH beryllium
production and processing facility, all
new workers were required to wear
loose-fitting powered air-purifying
respirators (PAPRs) in manufacturing
buildings, beginning in 1999 (Bailey et
al., 2010). Skin protection became part
of the protection program for new
workers in 2000, and glove use was
required in production areas and for
handling work boots, beginning in 2001.
Bailey et al. (2010) found that 23 (8.9
percent) of 258 workers hired between
1993 and 1999, before institution of
respiratory and dermal protection, were
sensitized to beryllium. The prevalence
of sensitization among the 290 workers
who were hired after the respiratory
protection and PPE measures were put
in place was about 2 percent, close to an
80 percent reduction in beryllium
sensitization.
In a response to OSHA’s 2002 Request
for Information (RFI), Lee Newman et al.
from National Jewish Medical and
Research Center (NJMRC) summarized
results of beryllium program
effectiveness from several sources. Said
Dr. Newman (in response to Question
#33):
Q. 33. What are the potential impacts of
reducing occupational exposures to
beryllium in terms of costs of controls, costs
for training, benefits from reduction in the
number or severity of illnesses, effects on
revenue and profit, changes in worker
PO 00000
Frm 00148
Fmt 4701
Sfmt 4702
productivity, or any other impact measures
than you can identify?
A: From experience in [the Tucson, AZ
facility discussed above], one can infer that
approximately 90 percent of beryllium
sensitization can be eliminated. Furthermore,
the preliminary data would suggest that
potentially 100 percent of CBD can be
eliminated with appropriate workplace
control measures.
In a study by Kelleher 2001, Martyny 2000,
Newman, JOEM 2001) in a plant that
previously had rates of sensitization as high
as 9.7 percent, the data suggests that when
lifetime weighted average exposures were
below 0.02 mg per cu meter that the rate of
sensitization fell to zero and the rate of CBD
fell to zero as well.
In an unpublished study, we have been
conducting serial surveillance including
testing new hires in a precision machining
shop that handles beryllium and beryllium
alloys in the Southeast United States. At the
time of the first screening with the blood
BeLPT of people tested within the first year
of hire, we had a rate of 6.7 percent (4/60)
sensitization and with 50 percent of these
individuals showing CBD at the time of
initial clinical evaluation. At that time, the
median exposures in the machining areas of
the plant was 0.47 mg per cu meter.
Subsequently, efforts were made to reduce
exposures, further educate the workforce,
and increase monitoring of exposure in the
plant. Ongoing testing of newly hired
workers within the first year of hire
demonstrated an incremental decline in the
rate of sensitization and in the rate of CBD.
For example, at the time of most recent
testing when the median airborne exposures
in the machining shop were 0.13 mg per cu
meter, the percentage of newly hired workers
found to have beryllium sensitization or CBD
was now 0 percent (0/55). Notably, we also
saw an incremental decline in the percentage
of longer term workers being detected with
sensitization and disease across this time
period of exposure reduction and improved
hygiene practices.
Thus, in calculating the potential economic
benefit, it’s reasonable to work with the
assumption that with appropriate efforts to
control exposures in the work place, rates of
sensitization can be reduced by over 90
percent. (NJMRC, RFI Ex. 6–20)
OSHA has reviewed these papers and
is in agreement with Dr. Newman’s
testimony. OSHA judges Dr. Newman’s
estimate to be an upper bound of the
effectiveness of ancillary programs and
examined the results of using Dr.
Newman’s estimate that beryllium
ancillary programs can reduce BeS by
90 percent, and potentially eliminate
CBD where sensitization is reduced,
because CBD can only occur where
there is sensitization. OSHA applied
this 90 percent reduction factor to all
cases of CBD remaining after application
of the reductions due to lowering the
PEL alone. OSHA applied this reduction
broadly because the proposed standard
would require housekeeping and PPE
related to skin exposure (18,000 of
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
28,000 employees will need PPE
because of possible skin exposure) to
apply to all or most employees likely to
come in contact with beryllium and not
just those with exposure above the
action level. Table IX–11 shows that
there are 11,017 baseline cases of CBD
and that the proposed PEL of 0.2 mg/m3
would prevent 2,563 cases through
airborne prevention alone. The
remaining number of cases of CBD is
then 8,454 (11,017 minus 2,563). If
OSHA applies the full ninety percent
reduction factor to account for
prevention of skin exposure (‘‘nonairborne’’ protections), then 7,609 (90
percent of 8,454 cases) additional cases
of CBD would be prevented.
The Agency recognizes that there are
significant differences between the
comprehensive programs discussed
above and the proposed standard. While
the proposed standard includes many of
the same elements, it is generally less
stringent. For example, the proposed
standard’s requirements for respiratory
protection and PPE are narrower, and
many provisions of the standard apply
only to workers exposed above the
proposed TWA PEL or STEL. However,
many provisions, such as housekeeping
and beryllium work areas, apply to all
employers covered by the proposed
standard. To account for these
differences, OSHA has provided a range
of benefits estimates (shown in Table
IX–11), first, assuming that there are no
ancillary provisions to the standard,
and, second, assuming that the
comprehensive standard achieves the
full 90-percent reduction in risk
documented in existing programs. The
Agency is taking the midpoint of these
two numbers as its main estimate of the
benefits of avoided CBD due to the
ancillary provisions of the proposed
standard. The results in Table IX–11
suggest that approximately 60 percent of
the beryllium sensitization cases and
the CBD cases avoided would be
attributable to the ancillary provisions
of the standard. OSHA solicits comment
on all aspects of this approach to
analyzing ancillary provisions and
solicits additional data that might serve
to make more accurate estimates of the
effects of ancillary provisions. OSHA is
interested in the extent of the effects of
ancillary provisions and whether these
apply to all exposed employees or only
those exposed above or below a given
exposure level.
(3) Morbidity Only Cases
As previously indicated, the Agency
does not believe that all CBD cases will
ultimately result in premature death.
While currently strong empirical data
on this are lacking, the Agency
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
estimates that approximately 35 percent
of cases would not ultimately be fatal,
but would result in some pain and
suffering related to having CBD, and
possible side effects from steroid
treatment, as well as the dread of not
knowing whether the disease will
ultimately lead to premature death.
These would be described as ‘‘mild’’
cases of CBD relative to the others.
These are the residual cases of CBD after
cases with premature mortality have
been counted. As indicated in Table IX–
11, the Agency estimates the standard
will prevent 2,228 such cases
(midpoint) over 45 years, or an
estimated 50 cases annually.
b. Lung Cancer
In addition to the Agency’s
determinations with respect to the risk
of chronic beryllium disease, the
Agency has preliminarily determined
that chronic beryllium exposure at the
current PEL can lead to a significantly
elevated risk of (fatal) lung cancer.
OSHA used the estimation methodology
outlined at the beginning of this section.
However, unlike with chronic beryllium
disease, the underlying data were based
on incidence of lung cancer and thus
there was no need to address the
possible limitations of prevalence data.
The Agency also used lifetime excess
risk estimates of lung cancer mortality,
presented in Table VI–20 in Section VI
of this preamble, Preliminary Risk
Assessment, to estimate the benefits of
avoided lung cancer mortality. The lung
cancer risk estimates are derived from
one of the best-fitting models in a
recent, high-quality NIOSH lung cancer
study, and are based on average
exposure levels. The estimates of excess
lifetime risk of lung cancer were taken
from the line in Table VI–20 in the risk
assessment labeled PWL (piecewise loglinear) not including professional and
asbestos workers. This model avoids
possible confounding from asbestos
exposure and reduces the potential for
confounding due to smoking, as
smoking rates and beryllium exposures
can be correlated via professional
worker status. Of the three estimates in
the NIOSH study that excluded
professional workers and those with
asbestos exposure, this model was
chosen because it was at the midpoint
of risk results.
Table IX–11 shows the number of
avoided fatal lung cancers for PELs of
0.2 mg/m3, 0.1 mg/m3, and 0.5 mg/m3. At
the proposed PEL of 0.2 mg/m3, an
estimated 180 lung cancers would be
prevented over the lifetime of the
current worker population. This is the
equivalent of 4.0 cases avoided
PO 00000
Frm 00149
Fmt 4701
Sfmt 4702
47713
annually, given a 45-year working life of
exposure.
Combining the two major fatal health
endpoints—for lung cancer and CBDrelated mortality—OSHA estimates that
the proposed PEL would prevent
between 1,846 and 6,791 premature
fatalities over the lifetime of the current
worker population, with a midpoint
estimate of 4,318 fatalities prevented.
This is the equivalent of between 41 and
151 premature fatalities avoided
annually, with a midpoint estimate of
96 premature fatalities avoided
annually, given a 45-year working life of
exposure.
Note that the Agency based its
estimates of reductions in the number of
beryllium-related diseases over a
working life of constant exposure for
workers who are employed in a
beryllium-exposed occupation for their
entire working lives, from ages 20 to 65.
In other words, workers are assumed not
to enter or exit jobs with beryllium
exposure mid-career or to switch to
other exposure groups during their
working lives. While the Agency is
legally obligated to examine the effect of
exposures from a working lifetime of
exposure and set its standard
accordingly,26 in an alternative analysis
purely for informational purposes, using
the same underlying risk model for
CBD, the Agency examined, in Chapter
VII of the PEA, the effect of assuming
that workers are exposed for a
maximum of only 25 working years, as
opposed to the 45 years assumed in the
main analysis. While all workers are
assumed to have less cumulative
exposure under the 25-years-ofexposure assumption, the effective
exposed population over time is
proportionately increased.
A comparison of exposures over a
maximum of 25 working years versus
over a potentially 45-year working life
shows variations in the number of
estimated prevented cases by health
outcome. For chronic beryllium disease,
there is a substantial increase in the
number of estimated baseline and
prevented cases if one assumes that the
typical maximum exposure period is 25
years, as opposed to 45. This reflects the
26 Section (6)(b)(5) of the OSH Act states: ‘‘The
Secretary, in promulgating standards dealing with
toxic materials or harmful physical agents under
this subsection, shall set the standard which most
adequately assures, to the extent feasible, on the
basis of the best available evidence, that no
employee will suffer material impairment of health
or functional capacity even if such employee has
regular exposure to the hazard dealt with by such
standard for the period of his working life.’’ Given
that it is necessary for OSHA to reach a
determination of significant risk over a working life,
it is a logical extension to estimate what this
translates into in terms of estimated benefits for the
affected population over the same period.
E:\FR\FM\07AUP2.SGM
07AUP2
47714
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
relatively flat CBD risk function within
the relevant exposure range, given
varying levels of airborne beryllium
exposure—shortening the average
tenure and increasing the exposed
population over time translates into
larger total numbers of people sensitized
to beryllium. This, in turn, results in
larger populations of individuals
contracting CBD. Since the lung cancer
model itself is based on average, as
opposed to cumulative, exposure, it is
not adaptable to estimate exposures over
a shorter period of time. As a practical
matter, however, over 90 percent of
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
illness and mortality attributable to
beryllium exposure in this analysis
comes from CBD.
Overall, the 45-year-maximumworking-life assumption yields smaller
estimates of the number of cases of
avoided fatalities and illnesses than
does the maximum-25-years-of-exposure
assumption. For example, the midpoint
estimates of the number of avoided
fatalities and illnesses related to CBD
under the proposed PEL of 0.2 mg/m3
increases from 92 and 50, respectively,
under the maximum-45-year-workinglife assumption to 145 and 78,
PO 00000
Frm 00150
Fmt 4701
Sfmt 4702
respectively, under the maximum-25year-working-life assumption—or
approximately a 57 to 58 percent
increase.27
27 Technically, this analysis assumes that workers
receive 25 years’ worth of beryllium exposure, but
that they receive it over 45 working years, as is
assumed by the risk models in the risk assessment.
It also accounts for the turnover implied by 25, as
opposed to 45, years of work. However, it is
possible that an alternate analysis, which accounts
for the larger number of post-exposure worker-years
implied by workers departing their jobs before the
end of their working lifetime, might find even larger
health effects for workers receiving 25 years’ worth
of beryllium exposure.
E:\FR\FM\07AUP2.SGM
07AUP2
47715
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
Table IX-11
Prevented Mortality and Morbidity by PEL Option (45-Year Working Life Case)
(Quartile Model)
Airborne Factor Only
Baseline
PEL Option (1Jg/m 3 )
Total Cases Total Number of Avoided Cases
0.1
0.2
0.5
PEL Option (1Jg/m3 )
Baseline
Annual Cases Annual Number of Avoided Cases
0.1
0.2
0.5
361
245
85.0
61.4
79.9
56.9
77.9
54.7
163
6.2
4.3
4.0
3.6
1,666
1,601
159
39.9
37.0
35.6
1,988
1,846
1,764
165
44.2
41.0
39.2
967
897
862
86
21.5
19.9
19.2
Total Cases
Be S
CBD
16,240
11,017
3,826
2,763
3,594
2,563
3,503
2,463
Mortality
Lung Cancer
279
192
180
CBD-Related
7,161
1,796
Total Mortality
7,440
Morbidity
3,856
Non-Airborne Factor Included
3
Baseline
PEL Option (1Jg/m )
Total Cases Total Number of Avoided Cases
0.1
0.2
0.5
3
Baseline
PEL Option (1Jg/m )
Annual Cases Annual Number of Avoided Cases
0.1
0.2
0.5
361
245
333.3
226.5
332.8
226.0
205.2
140.3
163
6
4.3
4.0
3.6
6,611
4,103
159
147.2
146.9
91.2
6,816
6,791
4,266
165
151.5
150.9
94.8
3,567
3,560
2,209
86
79.3
79.1
49.1
Total Cases
Be S
CBD
16,240
11,017
14,998
10,191
14,975
10,171
9,235
6,312
Mortality
Lung Cancer
279
192
180
CBD-Related
7,161
6,624
Total Mortality
7,440
Morbidity
3,856
Midpoint Estimates
3
3
Baseline
PEL Option (1Jg/m )
Baseline
PEL Option (1Jg/m )
Total Cases Total Number of Avoided Cases
Annual Cases Annual Number of Avoided Cases
0.1
0.2
0.5
0.1
0.2
0.5
Total Cases
Be S- Total
16,240
11,017
9,412
6,477
9,284
6,367
6,369
4,387
361
245
209.2
143.9
206.3
141.5
141.5
97.5
Mortality
Lung Cancer
279
192
180
163
6
4.3
4.0
3.6
CBD-Related
7,161
4,210
4,139
2,852
159
93.6
92.0
63.4
Total Mortality
7,440
4,402
4,318
3,015
165
97.8
96.0
67.0
Morbidity
3,856
2,267
2,228
1,536
86
50.4
49.5
34.1
Source: Office of Regulatory Analysis, Directorate of Standards and Guidance
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
PO 00000
Frm 00151
Fmt 4701
Sfmt 4725
E:\FR\FM\07AUP2.SGM
07AUP2
EP07AU15.022</GPH>
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
CBD
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47716
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
Step 2—Estimating the Stream of
Benefits Over Time
Risk assessments in the occupational
environment are generally designed to
estimate the risk of an occupationally
related illness over the course of an
individual worker’s lifetime. As
demonstrated previously in this section,
the current occupational exposure
profile for a particular substance for the
current cohort of workers can be
matched up against the expected profile
after the proposed standard takes effect,
creating a ‘‘steady state’’ estimate of
benefits. However, in order to annualize
the benefits for the period of time after
the beryllium rule takes effect, it is
necessary to create a timeline of benefits
for an entire active workforce over that
period.
While there are various approaches
that could be taken for modeling the
workforce, there seem to be two polar
extremes. At one extreme, one could
assume that none of the benefits occur
until after the worker retires, or at least
45 years in the future. In the case of lung
cancer, that period would effectively be
at least 55 years, since the 45 years of
exposure must be added to a 10-year
latency period during which it is
assumed that lung cancer does not
develop.28 At the other extreme, one
could assume that the benefits occur
immediately, or at least immediately
after a designated lag. However, based
on the various risk models discussed in
this preamble at Section VI, Risk
Assessment, which reflect real-world
experience with development of disease
over an extended period of time, it
appears that the actual pattern occurs at
some point between these two extremes.
At first glance, the simplest
intermediate approach would be to
follow the pattern of the risk
assessments, which are based in part on
life tables, and observe that typically the
risk of the illness grows gradually over
the course of a working life and into
retirement. Thus, the older the person
exposed to beryllium, the higher the
odds that that person will have
developed the disease.
However, while this is a good working
model for an individual exposed over a
working life, it is not very descriptive of
the effect of lowering exposures for an
entire working population. In the latter
case, in order to estimate the benefits of
the standard over time, one has to
consider that workers currently being
exposed to beryllium are going to vary
considerably in age. Since the
calculated health risks from beryllium
28 This
assumption is consistent with the 10-year
lag incorporated in the lung cancer risk models
used in OSHA’s preliminary risk assessment.
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
exposure depend on a worker’s
cumulative exposure over a working
lifetime, the overall benefits of the
proposed standard will phase in over
several decades, as the cumulative
exposure gradually falls for all age
groups, until those now entering the
workforce reach retirement and the
annual stream of beryllium-related
illnesses reaches a new, significantly
lowered ‘‘steady state.’’ 29 That said, the
near-term impact of the proposed rule
estimated for those workers with similar
current levels of cumulative exposure
will be greater for workers who are now
middle-aged or older. This conclusion
follows in part from the structure of the
relative risk model used for lung cancer
in this analysis and the fact that the
background mortality rates for lung
cancer increase with age.
In order to characterize the magnitude
of benefits before the steady state is
reached, OSHA created a linear phasein model to reflect the potential timing
of benefits. Specifically, OSHA
estimated that, for all non-cancer cases,
while the number of cases of berylliumrelated disease would gradually decline
as a result of the proposed rule, they
would not reach the steady-state level
until 45 years had passed. The
reduction in cases estimated to occur in
any given year in the future was
estimated to be equal to the steady-state
reduction (the number of cases in the
baseline minus the number of cases in
the new steady state) times the ratio of
the number of years since the standard
was implemented and a working life of
45 years. Expressed mathematically:
Nt = (C¥S) × (t/45),
Where 10 ≤ t ≤ 55 and Lt is the number of
lung cancer cases avoided in year t as a
result of the proposed rule; Cm is the
current annual number of berylliumrelated lung cancers; and Sm is the
steady-state annual number of berylliumrelated lung cancers.
Where Nt is the number of non-malignant
beryllium-related diseases avoided in
year t; C is the current annual number of
non-malignant beryllium-related
diseases; S is the steady-state annual
number of non-malignant berylliumrelated diseases; and t represents the
number of years after the proposed
standard takes effect, with t ≤ 45.
Separating the Timing of Mortality
In previous sections, OSHA modeled
the timing and incidence of morbidity.
OSHA’s benefit estimates are based on
an underlying CBD-related mortality
rate of 65 percent. However, this
mortality is not simultaneous with the
onset of morbidity. Although mortality
from CBD has not been well studied,
OSHA believes, based on discussions
with experienced clinicians, that the
average lag for a larger population has
a range of 10 to 30 years between
morbidity and mortality. The Agency’s
review of Workers Compensation data
related to beryllium exposure from the
Office of Worker Compensation
Programs (OWCP) Division of Energy
Employees Occupational Illness
Compensation is consistent with this
range. Hence, for the purposes of this
In the case of lung cancer, the
function representing the decline in the
number of beryllium-related cases as a
result of the proposed rule is similar,
but there would be a 10-year lag before
any reduction in cancer cases would be
achieved. Expressed mathematically, for
lung cancer:
Lt = (Cm¥Sm) × ((t¥10)/45)),
29 Technically, the RA lung cancer model is based
on average exposure, Nonetheless, as noted in the
RA, the underlying studies found lung cancer to be
significantly related to cumulative exposure.
Particularly since the large majority of the benefits
are related to CBD, the Agency considers this fairly
descriptive of the overall phase-in of benefits from
the standard.
PO 00000
Frm 00152
Fmt 4701
Sfmt 4702
This model was extended to 60 years
for all the health effects previously
discussed in order to incorporate the 10year lag, in the case of lung cancer, and
a maximum-45-year working life, as
well as to capture some occupationallyrelated disease that manifests itself after
retirement.30 As a practical matter,
however, there is no overriding reason
for stopping the benefits analysis at 60
years. An internal analysis by OSHA
indicated that, both in terms of cases
prevented, and even with regard to
monetized benefits, particularly when
lower discount rates are used, the
estimated benefits of the standard are
larger on an annualized basis if the
analysis extends further into the future.
The Agency welcomes comment on the
merit of extending the benefits analysis
beyond the 60-years analyzed in the
PEA.
In order to compare costs to benefits,
OSHA assumes that economic
conditions remain constant and that
annualized costs—and the underlying
costs—will repeat for the entire 60-year
time horizon used for the benefits
analysis (as discussed in Chapter V of
the PEA). OSHA welcomes comments
on the assumption for both the benefit
and cost analysis that economic
conditions remain constant for sixty
years. OSHA is particularly interested in
what assumptions and time horizon
should be used instead and why.
30 The left-hand columns in the tables in
Appendix VII–A of the PEA provide estimates using
this model of the stream of prevented fatalities and
illnesses due to the proposed beryllium rule.
E:\FR\FM\07AUP2.SGM
07AUP2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
proposal, OSHA estimates that mortality
occurs on average 20 years after the
onset of CBD morbidity. Thus, for
example, the prevented deaths that
would have occurred in year 21 after the
promulgation of the rule are associated
with the CBD morbidity cases prevented
in year one. OSHA requests comment on
this estimate and range.
The Agency invites comment on each
of these elements of the analysis,
particularly on the estimates of the
expected life expectancy of a patient
with CBD.
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Step 3—Monetizing the Benefits of the
Proposed Rule
To estimate the monetary value of the
reductions in the number of berylliumrelated fatalities, OSHA relied, as OMB
recommends, on estimates developed
from the willingness of affected
individuals to pay to avoid a marginal
increase in the risk of fatality. While a
willingness-to-pay (WTP) approach
clearly has theoretical merit, it should
be noted that an individual’s
willingness to pay to reduce the risk of
fatality would tend to underestimate the
total willingness to pay, which would
include the willingness of others—
particularly the immediate family—to
pay to reduce that individual’s risk of
fatality.
For estimates using the willingnessto-pay concept, OSHA relied on existing
studies of the imputed value of fatalities
avoided based on the theory of
compensating wage differentials in the
labor market. These studies rely on
certain critical assumptions for their
accuracy, particularly that workers
understand the risks to which they are
exposed and that workers have
legitimate choices between high- and
low-risk jobs. These assumptions are far
from obviously met in actual labor
markets.31 A number of academic
studies, as summarized in Viscusi &
Aldy (2003), have shown a correlation
between higher job risk and higher
wages, suggesting that employees
demand monetary compensation in
return for a greater risk of injury or
fatality. The estimated trade-off between
lower wages and marginal reductions in
fatal occupational risk—that is, workers’
willingness to pay for marginal
reductions in such risk—yields an
imputed value of an avoided fatality:
The willingness-to-pay amount for a
31 On the former assumption, see the discussion
in Chapter II of the PEA on imperfect information.
On the latter, see, for example, the discussion of
wage compensation for risk for union versus
nonunion workers in Dorman and Hagstrom (1998).
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
reduction in risk divided by the
reduction in risk.32
OSHA has used this approach in
many recent proposed and final rules.
Although this approach has been
criticized for yielding results that are
less than statistically robust (see, for
example, Hintermann, Alberini and
Markandya, 2010), a more recent WTP
analysis, by Kniesner et al. (2012), of the
trade-off between fatal job risks and
wages, using panel data, seems to
address many of the earlier econometric
criticisms by controlling for
measurement error, endogeneity, and
heterogeneity. In conclusion, the
Agency views the WTP approach as the
best available and will rely on it to
monetize benefits.33 OSHA welcomes
comments on the use of willingness-topay measures and estimates based on
compensating wage differentials.
Viscusi & Aldy (2003) conducted a
meta-analysis of studies in the
economics literature that use a
willingness-to-pay methodology to
estimate the imputed value of lifesaving programs and found that each
fatality avoided was valued at
approximately $7 million in 2000
dollars. Using the GDP Deflator (U.S.
BEA, 2010), this $7 million base number
in 2000 dollars yields an estimate of
$8.7 million in 2010 dollars for each
fatality avoided.34
In addition to the benefits that are
based on the implicit value of fatalities
avoided, workers also place an implicit
value on occupational injuries or
illnesses avoided, which reflect their
willingness to pay to avoid monetary
costs (for medical expenses and lost
wages) and quality-of-life losses as a
result of occupational illness. Chronic
beryllium disease and lung cancer can
adversely affect individuals for years, or
even decades, in non-fatal cases, or
before ultimately proving fatal. Because
measures of the benefits of avoiding
32 For example, if workers are willing to pay $90
each for a 1/100,000 reduction in the probability of
dying on the job, then the imputed value of an
avoided fatality would be $90 divided by 1/100,000,
or $9,000,000. Another way to consider this result
would be to assume that 100,000 workers made this
trade-off. On average, one life would be saved at a
cost of $9,000,000.
33 Note that, consistent with the economics
literature, these estimates would be for reducing the
risk of an acute (immediate) fatality. They do not
include an individual’s willingness to pay to avoid
a higher risk of illness prior to fatality, which is
separately estimated in the following section.
34 An alternative approach to valuing an avoided
fatality is to monetize, for each year that a life is
extended, an estimate from the economics literature
of the value of that statistical life-year (VSLY). See,
for instance, Aldy and Viscusi (2007) for discussion
of VSLY theory and FDA (2003), pp. 41488–9, for
an application of VSLY in rulemaking. OSHA has
not investigated this approach, but welcomes
comment on the issue.
PO 00000
Frm 00153
Fmt 4701
Sfmt 4702
47717
these illnesses are rare and difficult to
find, OSHA has included a range based
on a variety of estimation methods.
For both CBD and lung cancer, there
is typically some permanent loss of lung
function and disability, on-going
medical treatments, side effects of
medicines, and major impacts on one’s
ability to work, marry, enjoy family life,
and quality of life.
While diagnosis with CBD is evidence
of material impairment of health,
placing a precise monetary value on this
condition is difficult, in part because
the severity of symptoms may vary
significantly among individuals. For
that reason, for this preliminary
analysis, the Agency employed a broad
range of valuation, which should
encompass the range of severity these
individuals may encounter.
Using the willingness-to-pay
approach, discussed in the context of
the imputed value of fatalities avoided,
OSHA has estimated a range in
valuations (updated and reported in
2010 dollars) that runs from
approximately $62,000 per case—which
reflects estimates developed by Viscusi
and Aldy (2003), based on a series of
studies primarily describing simple
accidents—to upwards of $5 million per
case—which reflects work developed by
Magat, Viscusi, and Huber (1996) for
non-fatal cancer. The latter number is
based on an approach that places a
willingness-to-pay value to avoid
serious illness that is calibrated relative
to the value of an avoided fatality.
OSHA previously used this approach in
the Preliminary Economic Analysis
(PEA) supporting its respirable
crystalline silica proposal (2013) and in
the Final Economic Analysis (FEA)
supporting its hexavalent chromium
final rule (2006), and EPA (2003) used
this approach in its Stage 2 Disinfection
and Disinfection Byproducts Rule
concerning regulation of primary
drinking water. Based on Magat,
Viscusi, and Huber (1996), EPA used
studies on the willingness to pay to
avoid nonfatal lymphoma and chronic
bronchitis as a basis for valuing a case
of nonfatal cancer at 58.3 percent of the
value of a fatal cancer. OSHA’s estimate
of $5 million for an avoided case of nonfatal cancer is based on this 58.3 percent
figure.
The Agency believes this range of
estimates, between $62,000 and $5
million, is descriptive of the value of
preventing morbidity associated with
moderate to severe CBD that ultimately
results in premature death. 35
35 There are several benchmarks for valuation of
health impairment due to beryllium exposure, using
E:\FR\FM\07AUP2.SGM
Continued
07AUP2
47718
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
While the Agency has estimated that
65 percent of CBD cases will result in
premature mortality, the Agency has
also estimated that approximately 35
percent of CBD cases will not result in
premature mortality. However, the
Agency acknowledges that it is possible
there have been new developments in
medicine and industrial hygiene related
to the benefits of early detection,
medical intervention, and greater
control of exposure achieved within the
past decade. For that reason, as
elsewhere, the Agency requests
comment on these issues.
Also not clear are the negative effects
of the illness in terms of lost
productivity, medical costs, and
potential side-effects of a lifetime of
immunosuppressive medication.
Nonetheless, the Agency is assigning a
valuation of $62,000 per case, to reflect
the WTP value of a prevented injury not
estimated to precede premature
mortality. The Agency believes this is
conservative, in part because, with any
given case of CBD, the outcome is not
known in advance, certainly not at the
point of discovery; indeed much of the
psychic value of preventing the cases
may come from removing the threat of
premature mortality. In addition, as
previously noted, some of these cases
could involve relatively severe forms of
CBD where the worker died of other
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
a variety of techniques, which provide a number of
mid-range estimates between OSHA’s high and low
estimates. For a fuller discussion of these
benchmarks, see Chapter VII of the PEA.
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
causes; however, in those cases, the
duration of the disease would be
shortened. While beryllium
sensitization is a critical precursor of
CBD, this preliminary analysis does not
attempt to assign a separate value to
sensitization itself.
Particularly given the uncertainties in
valuation on these questions, the
Agency is interested in public input on
the issue of valuing the cost to society
of morbidity associated with CBD, both
in cases preceding mortality, and those
that may not result in premature
mortality. The Agency is also interested
in comments on whether it is
appropriate to assign a separate
valuation to prevented sensitization
cases in their own right, and if so, how
such cases should be valued.
a. Summary of Monetized Benefits
Table IX–12 presents the estimated
annualized (over 60 years, using a 0
percent discount rate) benefits from
each of these components of the
valuation, and the range of estimates,
based on uncertainty of the prevention
factor (i.e., the estimated range of
prevented cases, depending on how
large an impact the rule has on cases
beyond an airborne-only effect), and the
range of uncertainty regarding valuation
of morbidity. (Mid-point estimates of
the undiscounted benefits for each of
the first 60 years are provided in the
middle columns of Table VII–A–1 in
Appendix VII–A at the end of Chapter
VII in the PEA. The estimates by year
PO 00000
Frm 00154
Fmt 4701
Sfmt 4702
reach a peak of $3.5 billion in the 60th
year. Note that, by using a 60-year timeperiod, OSHA is not including any
monetized fatality benefits associated
with reduced worker CBD cases
originating after year 40 because the 20year lag takes these CBD fatalities
beyond the 60-year time horizon. To
this extent, OSHA will have
underestimated benefits.)
As shown in Table IX–12, the full
range of monetized benefits,
undiscounted, for the proposed PEL of
0.2 mg/m3 runs from $291 million
annually, in the case of the lowest
estimate of prevented cases of CBD, and
the lowest valuation for morbidity, up to
$2.1 billion annually, for the highest of
both. Note that the value of total
benefits is more sensitive to the
prevention factor used (ranging from
$430 million to $1.6 billion, given
estimates at the midpoint of the
morbidity valuation) than to the
valuation of morbidity (ranging from
$666 million to $1.3 billion, given
estimates at the midpoint of prevention
factor).
Also, the analysis illustrates that most
of the morbidity benefits are related to
CBD and lung cancer cases that are
ultimately fatal. At the valuation and
case frequency midpoint, $663 million
in benefits are related to mortality, $226
million are related to morbidity
preceding mortality, and $4.3 million
are related to morbidity not preceding
mortality.
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Estimated Annualized Undiscounted Monetized Benefits of the Beryllium Proposal for Morbidity and Mortality
PEL
Low
I
0.1 ~g/m 3
Valuation
Midpoint
I
High
Low
I
0.2 ~g/m 3
Valuation
Midpoint
I
High
Low
I
0.5 ~g/m 3
Valuation
Midpoint
I
High
Frm 00155
Fmt 4701
Sfmt 4702
07AUP2
Fatalities- Total
Low
Midpoint
High
$308,027,593
$666,610,424
$1,025,193,255
$308,027,593
$666,610,424
$1,025,193,255
$308,027,593
$666,610,424
$1,025,193,255
$285,909,109
$653,373,439
$1,020,660,530
$285,909,109
$653,373,439
$1,020,660,530
$285,909,109
$653,373,439
$1,020,660,530
$272,760,749
$458,581,095
$644,401,440
$272,760,749
$458,581,095
$644,401,440
$272,760,749
$458,581,095
$644,401,440
Morbidity Preceding Mortality- CBD and lung cancer deaths
Low
Midpoint
High
$3,765,360
$8,431,448
$13,097,537
$153,711,707
$344,193,474
$534,675,242
$303,658,053
$679,955,500
$1,056,252,947
$3,495,142
$8,274,496
$13,053,849
$142,680,735
$337,786,267
$532,891,800
$281,866,327
$667,298,039
$1,052,729,751
$3,343,232
$5,761,234
$8,179,237
$136,479,355
$235, 188,453
$333,897, 551
$269,615,478
$464,615,672
$659,615,865
Morbidity Not Preceding Mortality
Low
Midpoint
High
$1,869,166
$4,381,675
$7,320,735
$1,869,166
$4,381,675
$7,320,735
$1,869,166
$4,381,675
$7,320,735
$1,733,636
$4,307,133
$7,306,343
$1,733,636
$4,307,133
$7,306,343
$1,733,636
$4,307,133
$7,306,343
$1,665,847
$2,967,849
$4,321,800
$1,665,847
$2,967,849
$4,321,800
$1,665,847
$2,967,849
$4,321,800
TOTAL
Low
Midpoint
High
$313,662,119
$679,423,547
$1,045,611,526
$463,608,465
$1,015,185,573
$1,567,189,232
$613,554,812
$1,350,947,599
$2,088,766,937
$291, 137,887
$665,955,068
$1,041,020,722
$430,323,479
$995,466,840
$1,560,858,673
$569,509,072
$1,324,978,612
$2,080,696,625
$277,769,829
$467,310,178
$656,902,477
$410,905,952
$696,737,396
$982,620,791
$544,042,075
$926, 164,615
$1,308,339,106
Source: Office of Regulatory Analysis, Directorate of Standards & Guidance
47719
avoid a fatality (with an imputed value
per fatality avoided of $8.7 million in
2010 dollars) and to avoid a berylliumrelated disease (with an imputed value
per disease avoided of between $62,000
E:\FR\FM\07AUP2.SGM
on the imputed value of each avoided
fatality and each avoided berylliumrelated disease. As previously
discussed, these, in turn, are derived
from a worker’s willingness to pay to
PO 00000
Cases
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
Jkt 235001
b. Adjustment of WTP Estimates to
Reflect Rising Real Income Over Time
19:20 Aug 06, 2015
OSHA’s estimates of the monetized
benefits of the proposed rule are based
VerDate Sep<11>2014
EP07AU15.023</GPH>
TABLE IX-12
47720
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
and $5 million in 2010 dollars). To this
point, these imputed values have been
assumed to remain constant over time.
However, two related factors suggest
that these values will tend to increase
over time.
First, economic theory indicates that
the value of reducing life-threatening
and health-threatening risks—and
correspondingly the willingness of
individuals to pay to reduce these
risks—will increase as real per capita
income increases. With increased
income, an individual’s health and life
becomes more valuable relative to other
goods because, unlike other goods, they
are without close substitutes and in
relatively fixed or limited supply.
Expressed differently, as income
increases, consumption will increase
but the marginal utility of consumption
will decrease. In contrast, added years
of life (in good health) is not subject to
the same type of diminishing returns—
implying that an effective way to
increase lifetime utility is by extending
one’s life and maintaining one’s good
health (Hall and Jones, 2007).
Second, real per capita income has
broadly been increasing throughout U.S.
history, including recent periods. For
example, for the period 1950 through
2000, real per capita income grew at an
average rate of 2.31 percent a year (Hall
and Jones, 2007),36 although real per
capita income for the recent 25-year
period 1983 through 2008 grew at an
average rate of only 1.3 percent a year
(U.S. Census Bureau, 2010). More
important is the fact that real U.S. per
capita income is projected to grow
significantly in future years. For
example, the Annual Energy Outlook
(AEO) projections, prepared by the
Energy Information Administration
(EIA) in the Department of Energy
(DOE), show an average annual growth
rate of per capita income in the United
States of 2.7 percent for the period
2011–2035.37 The U.S. Environmental
Protection Agency prepared its
economic analysis of the Clean Air Act
using the AEO projections. OSHA
believes that it is reasonable to use the
same AEO projections employed by
DOE and EPA, and correspondingly
projects that per capita income in the
36 The results are similar if the historical period
includes a major economic downturn (such as the
United States has recently experienced). From 1929
through 2003, a period in U.S. history that includes
the Great Depression, real per capita income still
grew at an average rate of 2.22 percent a year
(Gomme and Rupert, 2004).
37 The EIA used DOE’s National Energy Modeling
System (NEMS) to produce the Annual Energy
Outlook (AEO) projections (EIA, 2011). Future per
capita GDP was calculated by dividing the projected
real gross domestic product each year by the
projected U.S. population for that year.
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
United States will increase by 2.7
percent a year.
On the basis of the predicted increase
in real per capita income in the United
States over time and the expected
resulting increase in the value of
avoided fatalities and diseases, OSHA
has adjusted its estimates of the benefits
of the proposed rule to reflect the
anticipated increase in their value over
time. This type of adjustment has been
recognized by OMB (2003), supported
by EPA’s Science Advisory Board (EPA,
2000), and applied by EPA 38. OSHA
proposes to accomplish this adjustment
by modifying benefits in year i from [Bi]
to [Bi * (1 + k)i], where ‘‘k’’ is the
estimated annual increase in the
magnitude of the benefits of the
proposed rule.
What remains is to estimate a value
for ‘‘k’’ with which to increase benefits
annually in response to annual
increases in real per capita income,
where ‘‘k’’ is equal to ‘‘(1+g) * (h)’’, ‘‘g’’
is the expected annual percentage
increase in real per capita income, and
‘‘h’’ is the income elasticity of the value
of a statistical life. Probably the most
direct evidence of the value of ‘‘k’’
comes from the work of Costa and Kahn
(2003, 2004). They estimate repeated
labor market compensating wage
differentials from cross-sectional
hedonic regressions using census and
fatality data from the Bureau of Labor
Statistics for 1940, 1950, 1960, 1970,
and 1980. In addition, with the imputed
income elasticity of the value of life on
per capita GNP of 1.7 derived from the
1940–1980 data, they then predict the
value of an avoided fatality in 1900,
1920, and 2000. Given the change in the
value of an avoided fatality over time,
it is possible to estimate a value of ‘‘k’’
of 3.4 percent a year from 1900–2000; of
4.3 percent a year from 1940–1980; and
of 2.5 percent a year from 1980–2000.
Other, more indirect evidence comes
from estimates in the economics
literature of ‘‘h’’, the income elasticity of
the value of a statistical life. Viscusi and
Aldy (2003) performed a meta-analysis
on 0.2 wage-risk studies and concluded
that the confidence interval upper
bound on the income elasticity did not
exceed 1.0 and that the point estimates
across a variety of model specifications
ranged between 0.5 and 0.6. Applied to
a long-term increase in per capita
income of about 2.7 percent a year, this
would suggest a value of ‘‘k’’ of about
1.5 percent a year.
More recently, Kniesner, Viscusi, and
Ziliak (2010), using panel data quintile
regressions, developed an estimate of
the overall income elasticity of the value
38 See,
PO 00000
for example, EPA (2003, 2008).
Frm 00156
Fmt 4701
Sfmt 4702
of a statistical life of 1.44. Applied to a
long-term increase in per capita income
of about 2.7 percent a year, this would
suggest a value of ‘‘k’’ of about 3.9
percent a year.
Based on the preceding discussion of
these three approaches for estimating
the annual increase in the value of the
benefits of the proposed rule and the
fact that the projected increase in real
per capita income in the United States
has flattened in recent years and could
flatten in the long run, OSHA suggests
a conservative value for ‘‘k’’ of
approximately two percent a year. The
Agency invites comment on this
estimate and on estimates of the income
elasticity of the value of a statistical life.
The Agency believes that the rising
value, over time, of health benefits is a
real phenomenon that should be taken
into account in estimating the
annualized benefits of the proposed
rule. Table IX–13, in the following
section on discounting benefits, shows
estimates of the monetized benefits of
the proposed rule (under alternative
discount rates) with this estimated
increase in monetized benefits over
time. The Agency invites comment on
this adjustment to monetized benefits.
c. The Discounting of Monetized
Benefits
As previously noted, the estimated
stream of benefits arising from the
proposed beryllium rule is not constant
from year to year, both because of the
45-year delay after the rule takes effect
until all active workers obtain reduced
beryllium exposure over their entire
working lives and because of, in the
case of lung cancer, a 10-year latency
period between reduced exposure and a
reduction in the probability of disease.
An appropriate discount rate 39 is
needed to reflect the timing of benefits
over the 60-year period after the rule
takes effect and to allow conversion to
an equivalent steady stream of
annualized benefits.
1. Alternative Discount Rates for
Annualizing Benefits
Following OMB (2003) guidelines,
OSHA has estimated the annualized
benefits of the proposed rule using
separate discount rates of 3 percent and
7 percent. Consistent with the Agency’s
own practices in recent rulemakings,
OSHA has also estimated, for
benchmarking purposes, undiscounted
benefits—that is, benefits using a zero
percent discount rate.
39 Here and elsewhere throughout this section,
unless otherwise noted, the term ‘‘discount rate’’
always refers to the real discount rate—that is, the
discount rate net of any inflationary effects.
E:\FR\FM\07AUP2.SGM
07AUP2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
The question remains, what is the
‘‘appropriate’’ or ‘‘preferred’’ discount
rate to use to monetize health benefits?
The choice of discount rate is a
controversial topic, one that has been
the source of scholarly economic debate
for several decades. However, in
simplest terms, the basic choices
involve a social opportunity cost of
capital approach or social rate of time
preference approach.
The social opportunity cost of capital
approach reflects the fact that private
funds spent to comply with government
regulations have an opportunity cost in
terms of foregone private investments
that could otherwise have been made.
The relevant discount rate in this case
is the pre-tax rate of return on the
foregone investments (Lind, 1982, pp.
24–32).
The rate of time preference approach
is intended to measure the tradeoff
between current consumption and
future consumption, or in the context of
the proposed rule, between current
benefits and future benefits. The
individual rate of time preference is
influenced by uncertainty about the
availability of the benefits at a future
date and whether the individual will be
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
alive to enjoy the delayed benefits. By
comparison, the social rate of time
preference takes a broader view over a
longer time horizon—ignoring
individual mortality and the riskiness of
individual investments (which can be
accounted for separately).
The usual method for estimating the
social rate of time preference is to
calculate the post-tax real rate of return
on long-term, risk-free assets, such as
U.S. Treasury securities (OMB, 2003, p.
33). A variety of studies have estimated
these rates of return over time and
reported them to be in the range of
approximately 1–4 percent.
In accordance with OMB Circular A–
4 (2003), OSHA presents benefits and
net benefits estimates using discount
rates of 3 percent (representing the
social rate of time preference) and 7
percent (a rate estimated using the
social cost of capital approach). The
Agency is interested in any evidence,
theoretical or applied, that would
inform the application of discount rates
to the costs and benefits of a regulation.
2. Summary of Annualized Benefits
under Alternative Discount Rates
Table IX–13 presents OSHA’s
estimates of the sum of the annualized
PO 00000
Frm 00157
Fmt 4701
Sfmt 4702
47721
benefits of the proposed rule, using
alternative discount rates of 0, 3, and 7
percent, with the suggested adjustment
for increasing monetized benefits in
response to annual increases in per
capita income over time.
Given that the stream of benefits
extends out 60 years, the value of future
benefits is sensitive to the choice of
discount rate. The undiscounted
benefits in Table IX–13 range from $291
million to $2.1 billion annually. Using
a 7 percent discount rate, the
annualized benefits range from $60
million to $591 million. As can be seen,
going from undiscounted benefits to a 7
percent discount rate has the effect of
cutting the annualized benefits of the
proposed rule by about 74 percent.
Taken as a whole, the Agency’s best
preliminary estimate of the total
annualized benefits of the proposed
rule—using a 3 percent discount rate
with an adjustment for the increasing
value of health benefits over time—is
between $158 million and $1.2 billion,
with a mid-point value of $576 million.
E:\FR\FM\07AUP2.SGM
07AUP2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Step 4: Net Benefits of the Proposed
Rule
OSHA has estimated, in Table IX–14,
the monetized and annualized net
benefits of the proposed rule (with a
PEL of 0.2 mg/m3), based on the benefits
and costs previously presented. Table
IX–14 also provides estimates of
annualized net benefits for alternative
PELs of 0.1 and 0.5 mg/m3. Both the
proposed rule and the alternatives PEL
options have the same ancillary
provisions and an action level equal to
half of the PEL in both cases.
Table IX–14 is being provided for
informational purposes only. As
previously noted, the OSH Act requires
the Agency to set standards based on
eliminating significant risk to the extent
feasible. An alternative criterion of
maximizing net (monetized) benefits
may result in very different regulatory
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
outcomes. Thus, this analysis of net
benefits has not been used by OSHA as
the basis for its decision concerning the
choice of a PEL or of other ancillary
requirements for the proposed beryllium
rule.
Table IX–14 shows net benefits using
alternative discount rates of 0, 3, and 7
percent for benefits and costs, having
previously included an adjustment to
monetized benefits to reflect increases
in real per capita income over time.
OSHA has relied on a uniform discount
rate applied to both costs and benefits.
The Agency is interested in any
evidence, theoretical or applied, that
would support or refute the application
of differential discount rates to the costs
and benefits of a regulation.
As previously noted in this section,
the choice of discount rate for
annualizing benefits has a significant
PO 00000
Frm 00158
Fmt 4701
Sfmt 4702
effect on annualized benefits. The same
is true for net benefits. For example, the
net benefits using a 7 percent discount
rate for benefits are considerably smaller
than the net benefits using a 3 percent
discount rate, declining by over half
under all scenarios. (Conversely, as
noted in Chapter V of the PEA, the
choice of discount rate for annualizing
costs has a relatively minor effect on
annualized costs.)
Based on the results presented in
Table IX–14, OSHA finds:
• While the net benefits of the
proposed rule vary considerably—
depending on the choice of discount
rate used to annualize benefits and on
whether the benefits being used are in
the high, midpoint, or low range—
benefits exceed costs for the proposed
0.2 mg/m3 PEL in all cases that OSHA
considered.
E:\FR\FM\07AUP2.SGM
07AUP2
EP07AU15.024</GPH>
47722
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
47723
between $120 million and $1.2 billion,
with a midpoint value of $538 million.
• The alternative of a 0.5 mg/m3 PEL
has lower net benefits under all
assumptions, whereas the effect on net
benefits of the 0.1 mg/m3 PEL is mixed,
relative to the proposed 0.2 mg/m3 PEL.
However, for these alternative PELs,
benefits were also found to exceed costs
in all cases that OSHA considered.
Incremental Benefits of the Proposed
Rule
Incremental costs and benefits are
those that are associated with increasing
the stringency of the standard. A
comparison of incremental benefits and
costs provides an indication of the
relative efficiency of the proposed PEL
and the alternative PELs. Again, OSHA
has conducted these calculations for
informational purposes only and has not
used these results as the basis for
selecting the PEL for the proposed rule.
OSHA provides, in Table IX–15,
estimates of the net benefits of the
alternative 0.1 and 0.5 mg/m3 PELs. The
incremental costs, benefits, and net
benefits of meeting a 0.5mg/m3 PEL and
then going to a 0.2 mg/m3 PEL (as well
as meeting a 0.2 mg/m3 PEL and then
going to a 0.1 mg/m3 PEL—which the
Agency has not yet determined is
feasible), for alternative discount rates
of 3 and 7 percent, are presented in
Table IX–15. Table IX–15 breaks out
costs by provision and benefits by type
of disease and by morbidity/mortality.
As Table IX–15 shows, at a discount rate
of 3 percent, a PEL of 0.2 mg/m3, relative
to a PEL of 0.5 mg/m3, imposes
additional costs of $4.4 million per year;
additional benefits of $172.7 million per
year; and additional net benefits of
$168.2 million per year. The proposed
PEL of 0.2 mg/m3 also has higher net
benefits, relative to a PEL of 0.5 mg/m3,
using a 7 percent discount rate.
Table IX–15 demonstrates that,
regardless of discount rate, there are net
benefits to be achieved by lowering
exposures from the current PEL of 2.0
mg/m3 to 0.5 mg/m3 and then, in turn,
lowering them further to 0.2 mg/m3.
However, the majority of the benefits
and costs attributable to the proposed
rule are from the initial effort to lower
exposures to 0.5 mg/m3. Consistent with
the previous analysis, net benefits
decline across all increments as the
discount rate for annualizing benefits
increases. As also shown in Table IX–
15, there is a slight positive net
incremental benefit from going from a
PEL of 0.2 mg/m3 to 0.1 mg/m3 for a
discount rate of 3 percent, and a slight
negative net increment for a discount
rate of 7 percent. (Note that these results
are for OSHA’s midpoint estimate of
benefits, although as indicated in Table
IX–14, this is not universal across all
estimation parameters.)
In addition to examining alternative
PELs, OSHA also examined alternatives
to other provisions of the standard.
These regulatory alternatives are
discussed Section IX.H of this preamble.
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
PO 00000
Frm 00159
Fmt 4701
Sfmt 4702
E:\FR\FM\07AUP2.SGM
07AUP2
EP07AU15.025</GPH>
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
• The Agency’s best estimate of the
net annualized benefits of the proposed
rule—using a uniform discount rate for
both benefits and costs of 3 percent—is
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47724
Jkt 235001
Millions ($2010)
Alternative 4
Alternative 5
Incremental Costs/Benefits
Frm 00160
Fmt 4701
Sfmt 4702
Alternative 5
(PEL= 0.5 ~g/m 3 , AL = 0.25 ~g/m 3 )
Incremental Costs/Benefits
3%
7%
------
3%
7%
$9.5
$0.2
$2.2
$0.6
$2.9
$0.1
$1.8
$1.4
$0.4
$12.6
3%
$10.3
$0.3
$2.4
$0.7
$3.0
$0.2
$1.8
$1.4
$0.4
$12.9
7%
3%
7%
Annualized Costs
$12.9
$0.7
$3.8
$0.9
$3.0
$0.4
$1.8
$1.4
$0.6
$12.6
Contrd Costs
Respiratcrs
Exposure Assessment
Regulated Areas
Medical Surveillance
Medical Removal
Exposure Contrd Plan
Prdective Cldhing and Equipment
Hygiene Areas and Practices
Housekeeping
$13.9
$0.7
$3.9
$0.9
$3.1
$0.5
$1.8
$1.4
$0.6
$12.9
$3.3
$0.4
$1.6
$0.3
$0.1
$0.3
$0.0
$0.0
$0.2
$0.0
~~
Training
$43.7
Total Annualized Costs (point estimate)
07AUP2
EP07AU15.026</GPH>
Annual Benefits: Number of Cases Prevented
$3.5
$0.5
$1.5
$0.3
$0.1
$0.3
$0.0
$0.0
$0.2
$0.0
~~
$45.5
$6.1
~
$6.3
$37.6
$3.6
$0.1
$0.3
$0.3
$0.1
$0.1
$0.0
$0.0
$0.0
$0.0
~
$39.1
~
$4.8
$33.2
$34.4
Cases
Fatal Chronic Beryllium Disease
4
94
0
2
98
$584.4
$258.8
2
$11.1
$4.9
96
$573.0
$253.7
29
$171.8
$76.1
67
$401.2
$177.7
Beryllium rvbrbidity
50
$2.9
$1.6
1
$0.0
$0.0
50
$2.8
$1.6
15
$0.9
$0.5
34
$2.0
$1.1
Monetized Annual Benefits (midpoint estimate)
$587.3
$260.4
$11.2
$5.1
$575.8
$255.3
$172.7
$76.6
$403.1
$178.8
I
$543.5
$214.9
$5.3
-$1.3
$538.2
$216.2
$168.2
$71.8
$370.0
$144.4
Net Benefits
Soorce: OSHA, Directorate of Standards and Guidance, Office of Regulatcry Analysis
Cases
$6.0
$0.1
$1.9
$0.3
$2.8
$0.1
$1.8
$1.4
$0.4
$12.6
Cases
Fatal Lung Cancers (midpoint estimate)
Cases
~
$6.5
$0.1
$2.1
$0.4
$2.9
$0.1
$1.8
$1.4
$0.4
$12.9
$5.8
$4.4
~
$3.9
$0.1
$0.3
$0.3
$0.1
$0.1
$0.0
$0.0
$0.0
$0.0
Beryllium-Related Matality
cost and benefit input parameters in
order to determine their effects on the
Agency’s estimates of annualized costs,
annualized benefits, and annualized net
benefits. In the second type of
E:\FR\FM\07AUP2.SGM
robust the estimates of net benefits are
to changes in various cost and benefit
parameters. In the first type of
sensitivity analysis, OSHA made a
series of isolated changes to individual
PO 00000
3%
7%
------
Discount Rate
Proposed PEL
Alternative 4
(PEL= 0.1 ~g/m 3 , AL = 0.05 ~g/m 3 )
4
92
Cases
0
29
4
63
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
Step 5: Sensitivity Analysis
19:20 Aug 06, 2015
In this section, OSHA presents the
results of two different types of
sensitivity analysis to demonstrate how
VerDate Sep<11>2014
Table IX-15: Annualized Costs, Benefits and Incremental Benefits of OSHA's Proposed Beryllium Standard of of 0.1 1Jg/m3 and 0.51Jg/m3 PEL Alternative
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
sensitivity analysis—a so-called ‘‘breakeven’’ analysis—OSHA also investigated
isolated changes to individual cost and
benefit input parameters, but with the
objective of determining how much they
would have to change for annualized
costs to equal annualized benefits. For
both types of sensitivity analyses, OSHA
used the annualized costs and benefits
obtained from a three-percent discount
rate as the reference point.
Again, the Agency has conducted
these calculations for informational
purposes only and has not used these
results as the basis for selecting the PEL
for the proposed rule.
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
a. Analysis of Isolated Changes to Inputs
The methodology and calculations
underlying the estimation of the costs
and benefits associated with this
rulemaking are generally linear and
additive in nature. Thus, the sensitivity
of the results and conclusions of the
analysis will generally be proportional
to isolated variations in a particular
input parameter. For example, if the
estimated time that employees need to
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
travel to (and from) medical screenings
were doubled, the corresponding labor
costs would double as well.
OSHA evaluated a series of such
changes in input parameters to test
whether and to what extent the general
conclusions of the economic analysis
held up. OSHA first considered changes
to input parameters that affected only
costs and then changes to input
parameters that affected only benefits.
Each of the sensitivity tests on cost
parameters had only a very minor effect
on total costs or net costs. Much larger
effects were observed when the benefits
parameters were modified; however, in
all cases, net benefits remained
significantly positive. On the whole,
OSHA found that the conclusions of the
analysis are reasonably robust, as
changes in any of the cost or benefit
input parameters still show significant
net benefits for the proposed rule. The
results of the individual sensitivity tests
are summarized in Table IX–16 and are
described in more detail below.
In the first of these sensitivity tests,
where OSHA doubled the estimated
PO 00000
Frm 00161
Fmt 4701
Sfmt 4702
47725
portion of employees in need of
protective clothing and equipment
(PPE), essentially doubling the
estimated baseline non-compliance rate
(e.g., from 10 to 20 percent), and
estimates of other input parameters
remained unchanged, Table IX–16
shows that the estimated total costs of
compliance would increase by $1.4
million annually, or by about 3.7
percent, while net benefits would also
decline by $1.4 million annually, from
$538.2 million to $536.8 million
annually.
In a second sensitivity test, OSHA
increased the estimated unit cost of
ventilation from $13.18 per cfm for most
sectors to $25 per cfm for most sectors.
As shown in Table IX–16, if OSHA’s
estimates of other input parameters
remained unchanged, the total
estimated costs of compliance would
increase by $2.0 million annually, or by
about 5.3 percent, while net benefits
would also decline by $2.0 million
annually, from $538.2 million to $536.2
million annually.
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47726
Uncertainty Scenarios
Percentage Impact
Jkt 235001
Frm 00162
Fmt 4701
Sfmt 4702
07AUP2
annually, or by about 4.1 percent, while
net benefits would also decline by $1.5
million annually, from $538.2 million to
$536.7 million annually.
In a fourth sensitivity test, OSHA
increased its estimated incremental time
per workers for housekeeping by 50
E:\FR\FM\07AUP2.SGM
Difference From
Estimate
Primary Estimate
NA
$0
0.0%
$37,597,325
$538,229, 309
$1,385,575
3.7%
$38,982,900
$536,843,733
$1,993,863
5.3%
$39, 591, 188
$536,235,445
$1,545,310
4.1%
$39,142,635
$536,683,999
$5,429,113
14.4%
$43,026,437
$532,800,196
$4,483,148
11.9%
$42,080,472
$533,7 46, 161
$0
0.0%
$575,826,633
$538,229, 309
-$216,839,627
-37.7%
$358,987,006
$321,389,682
$443,411,757
77.0%
$1,019,238,390
$981,641,066
-$314,319,477
-54.6%
$261,507,156
$223,909,831
on Costs or
Benefits
Total Annualized
Cost or Benefit
Net Benefit
Cost Scenarios
Proposed Rule- OSHA's best estimate
Reduced PPE Compliance Rates
Double PPE non-compliance
rates
Increased CFM Unit Cost
Increase CFM Unit Cost to $25
for most sectors
another reason (working in a regulated
area, exposed during an emergency,
etc.). As shown in Table IX–16, if
OSHA’s estimates of other input
parameters remained unchanged, the
total estimated costs of compliance
would increase by $1.5 million
PO 00000
Change from OSHA's Primary
EP07AU15.027</GPH>
Increased share of workers showing signs and symptoms
Increase share of workers
showing signs and symtoms to
25%
Increased housekeeping
Increase the estimated
incremental time per worker
for housekeeping by 50"/o
Increased establishment-based costs
For establishment-based costs,
increased the number of
affected establishments by up
to 100"/o
Benefit Secnarios
Proposed Rule- OSHA's best estimate
Low morbidity valuation
NA
Benefits estimated using low
morbidity value
High morbidity valuation
Benefits estimated using high
morbidity value
Remove adjustment for future valuation of benefits (due to
Set the growth in future
positive income elasticity of health benefits
benefits to 0.0"/o
Source: OSHA, Directorate of Standards and Guidance, Office of Regulatory Analysis
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
19:20 Aug 06, 2015
In a third sensitivity test, OSHA
increased the estimated share of workers
showing signs and symptoms of CBD
from 15 to 25 percent, thereby adding
these workers to the group eligible for
medical surveillance and assuming that
they would not be otherwise eligible for
VerDate Sep<11>2014
Table IX-16 Sensitivity Tests
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
percent. As shown in Table IX–16, if
OSHA’s estimates of other input
parameters remained unchanged, the
total estimated costs of compliance
would increase by $5.4 million
annually, or by about 14.4 percent,
while net benefits would also decline by
$5.4 million annually, from $538.2
million to $532.8 million annually.
In a fifth sensitivity test, OSHA
increased the estimated number of
establishments needing engineering
controls. For this sensitivity test, if less
than 50 percent of the establishments in
an industry needed engineering
controls, OSHA doubled the percentage
of establishments needing engineering
controls. If more than 50 percent of
establishments in an industry needed
engineering controls, then OSHA
increased the percentage of
establishment needing engineering
control to 100 percent. The purpose of
this sensitivity analysis was to check the
importance of using a methodology that
treated 50 percent of workers in a given
occupation exposed above the PEL as
equivalent to 50 percent of facilities
lacking adequate exposure controls. As
shown in Table IX–16, if OSHA’s
estimates of other input parameters
remained unchanged, the total
estimated costs of compliance would
increase by $4.5 million, or by about
11.9 percent, while net benefits would
also decline by $4.5 million, from
$538.2 million to $533.7 million
annually.
The Agency also performed
sensitivity tests on several input
parameters used to estimate the benefits
of the proposed rule. In the first two
tests, in an extension of results
previously presented in Table IX–12,
the Agency examined the effect on
annualized net benefits of employing
the high-end estimate of the benefits, as
well as the low-end estimate,
specifically examining the effect on
undiscounted benefits of varying the
valuation of individual morbidity cases.
Table IX–16 presents the effect on
annualized net benefits of using the
extreme values of these ranges: the high
morbidity valuation case and the low
morbidity valuation case. For the low
estimate of valuation, the benefits
decline by 37.7 percent, to $359 million
annually, yielding net benefits of $321
million annually. As shown, using the
high estimate of morbidity valuation,
the benefits rise by 77.0 percent to $1.0
billion annually, yielding net benefits of
$982 million annually.
In a third sensitivity test of benefits,
the Agency examined the effect of
removing the component for the
estimated rising value of health and
safety over time. This would reduce the
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
benefits by 54.6 percent, or $314 million
annually, lowering the net benefits to
$224 million annually.
In Chapter VII of the PEA the Agency
examined the effect of raising the
discount rate for costs and benefits to 7
percent. Raising the discount rate to 7
percent would increase costs by $1.5
million annually and lower benefits by
$320.5 million annually, yielding
annualized net benefits of $216.2
million.
Also in Chapter VII of the PEA the
Agency performed a sensitivity analysis
of dental lab substitution. In the PEA,
OSHA estimates that 75 percent of the
dental laboratory industry will react to
a new standard on beryllium by
substituting away from using beryllium
to the use of other materials.
Substitution is not costless, and Chapter
V of the PEA estimates the increased
cost due to the higher costs of using
non-beryllium alloys. These costs are
smaller than the avoided costs of the
ancillary provisions and engineering
controls. Thus, as indicated in Table
VII–8 of the PEA, the benefits of the
proposal would be lower and the costs
higher if there were less substitution out
of beryllium in dental labs. The lowest
net benefits would occur if labs were
unable to substitute out berylliumcontaining materials at all, and had to
use ventilation to control exposures. In
this case, the proposal would yield only
$420 million in net benefits. The highest
net benefits, larger than assumed for
OSHA’s primary estimate, would be if
all dental labs substituted out of
beryllium-containing materials as a
result of the proposal; as a result, the
proposal would yield $573 million in
net benefits. Another possibility is a
scenario is which technology and the
market move along rapidly away from
using beryllium-containing materials,
independently of an OSHA rule, and the
proposal itself would therefore produce
neither costs nor benefits in this sector.
If dental labs are removed from the PEA,
the net benefits for the proposal—for the
remaining industry sectors—decline to
$284 million. This analysis
demonstrates, however, that regardless
of any assumption regarding
substitution in dental labs, the proposal
would generate substantially more
monetized benefits than costs.
Finally, the Agency examined in
Chapter VII of the PEA the effects of
changes in two important inputs to the
benefits analysis: the factor that
transforms CBD prevalence rates into
incidence rates, needed for the
equilibrium lifetime risk model, and the
percentage of CBD cases that eventually
lead to a fatality.
PO 00000
Frm 00163
Fmt 4701
Sfmt 4702
47727
From the Cullman dataset, the Agency
has estimated the prevalence of CBD
cases at any point in time as a function
of cumulative beryllium exposure. In
order to utilize the lifetime risk model,
which tracks workers over their working
life in a job, OSHA has turned these
prevalence rates into an incidence rate,
which is the rate of contracting CBD at
a point in time. OSHA’s baseline
estimate of the turnover rate in the
model is 10 percent. In Table VII–10 in
the PEA, OSHA also presented
alternative turnover rates of 5 percent
and 20 percent. A higher turnover rate
translates into a higher incidence rate,
and the table shows that, from a
baseline midpoint estimate with 10
percent turnover the number of CBD
cases prevented is 6,367, while raising
the turnover rate to 20 percent causes
this midpoint estimate to rise to 11,751.
Conversely, a rate of 5 percent lowers
the number of CBD cases prevented to
3,321. Translated into monetary
benefits, the table shows that the
baseline midpoint estimate of $575.8
million now ranges from $314.4 million
to $1,038 million.
Also in TableVII–10 of the PEA, the
Agency looked at the effects of varying
the percentage of CBD cases that
eventuate in fatality. The Agency’s
baseline estimate of this outcome is 65
percent, with half of this occurring
relatively soon, and the other half after
an extended debilitating condition. The
Agency judged that a reasonable range
to investigate was a low of 50 percent
and a high of 80 percent, while
maintaining the shares of short-term and
long-term endpoint fatality. At a
baseline of 65 percent, the midpoint
estimate of total CBD cases prevented is
4,139. At the low end of 50 percent
mortality this estimate lowers to 3,183
while at the high end of 80 percent
mortality this estimate rises to 5,094.
Translated into monetary benefits, the
table shows that the baseline midpoint
estimate of $575.8 million now ranges
from $500.1 million to $651.5 million.
b. ‘‘Break-Even’’ Analysis
OSHA also performed sensitivity tests
on several other parameters used to
estimate the net costs and benefits of the
proposed rule. However, for these, the
Agency performed a ‘‘break-even’’
analysis, asking how much the various
cost and benefits inputs would have to
vary in order for the costs to equal, or
break even with, the benefits. The
results are shown in Table IX–17.
In one break-even test on cost
estimates, OSHA examined how much
total costs would have to increase in
order for costs to equal benefits. As
shown in Table IX–17, this point would
E:\FR\FM\07AUP2.SGM
07AUP2
47728
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
be reached if costs increased by $538.2
million, or by 1,431 percent.
In a second test, looking specifically
at the estimated engineering control
costs, the Agency found that these costs
would need to increase by $566.7
million, or 6,240 percent, for costs to
equal benefits.
In a third sensitivity test, on benefits,
OSHA examined how much its
estimated monetary valuation of an
avoided illness or an avoided fatality
would need to be reduced in order for
the costs to equal the benefits. Since the
total valuation of prevented mortality
and morbidity are each estimated to
exceed the estimated costs of $38
million, an independent break-even
point for each is impossible. In other
words, for example, if no value is
attached to an avoided illness associated
with the rule, but the estimated value of
an avoided fatality is held constant, the
rule still has substantial net benefits.
Only through a reduction in the
estimated net value of both components
is a break-even point possible.
The Agency, therefore, examined how
large an across-the-board reduction in
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
the monetized value of all avoided
illnesses and fatalities would be
necessary for the benefits to equal the
costs. As shown in Table IX–17, a 94
percent reduction in the monetized
value of all avoided illnesses and
fatalities would be necessary for costs to
equal benefits, reducing the estimated
value to $733,303 per fatality prevented,
and an equivalent percentage reduction
to about $4,048 per illness prevented.
In a fourth break-even sensitivity test,
OSHA estimated how many fewer
beryllium-related fatalities and illnesses
would be required for benefits to equal
costs. Paralleling the previous
discussion, eliminating either the
prevented mortality or morbidity cases
alone would be insufficient to lower
benefits to the break-even point. The
Agency therefore examined them as a
group. As shown in Table IX–17, a
reduction of 96 percent, for both
simultaneously, is required to reach the
break-even point—90 fewer fatalities
prevented annually, and 46 fewer
beryllium-related illnesses-only cases
prevented annually.
PO 00000
Frm 00164
Fmt 4701
Sfmt 4702
Taking into account both types of
sensitivity analysis the Agency
performed on its point estimates of the
annualized costs and annualized
benefits of the proposed rule, the results
demonstrate that net benefits would be
positive in all plausible cases tested. In
particular, this finding would hold even
with relatively large variations in
individual input parameters.
Alternately, one would have to imagine
extremely large changes in costs or
benefits for the rule to fail to produce
net benefits. OSHA concludes that its
finding of significant net benefits
resulting from the proposed rule is a
robust one.
OSHA welcomes input from the
public regarding all aspects of this
sensitivity analysis, including any data
or information regarding the accuracy of
the preliminary estimates of compliance
costs and benefits and how the
estimates of costs and benefits may be
affected by varying assumptions and
methodological approaches. OSHA also
invites comment on the risk analysis
and risk estimates from which the
benefits estimates were derived.
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Jkt 235001
Break-Even Sensitivity Analysis
Frm 00165
Fmt 4701
Sfmt 4702
07AUP2
Factor
Factor Value at Which
Benefits Equal Costs
Required Factor
Dollar/Number
Change
Percentage
Factor Change
Total Costs
$37,597,325
$575,826,633
$538,229,309
1431.6%
Engineering Control Costs
$9,082,884
$575,826,633
$566,743,749
6239.7%
$11,231,000
$62,000
$733,303
$4,048
-$10,497,697
-$57,952
-93.5%
-93.5%
96
50
6
3
-90
-46
-93.5%
-93.5%
Benefits Valuation per Case Avoided
Monetized Benefit per Fatality Avoided
Monetized Benefit per Illness Avoided
Cases Avoided
Deaths Avoided
Illnesses Avoided
Source: OSHA, Directorate of Standards and Guidance, Office of Regulatory Analysis
47729
distributive impacts; and equity), unless
a statute requires another regulatory
approach.’’ The OSH Act, as interpreted
by the courts, requires health
regulations to reduce significant risk to
E:\FR\FM\07AUP2.SGM
Order 12866 instructs agencies to
‘‘select those approaches that maximize
net benefits (including potential
economic, environmental, public health
and safety, and other advantages;
PO 00000
OSHA's Best Estimate of
Annualized Cost or Benefit
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
H. Regulatory Alternatives
19:20 Aug 06, 2015
This section discusses various
regulatory alternatives to the proposed
OSHA beryllium standard. Executive
VerDate Sep<11>2014
EP07AU15.028</GPH>
Table IX-17
47730
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
the extent feasible. Nevertheless OSHA
has examined possible regulatory
alternatives that may not meet its
statutory requirements.
Each regulatory alternative presented
here is described and analyzed relative
to the proposed rule. Where
appropriate, the Agency notes whether
the regulatory alternative, to be a
legitimate candidate for OSHA
consideration, requires evidence
contrary to the Agency’s preliminary
findings of significant risk and
feasibility. To facilitate comment, OSHA
has organized some two dozen specific
regulatory alternatives into five
categories: (1) Scope; (2) exposure
limits; (3) methods of compliance; (4)
ancillary provisions; and (5) timing.
1. Scope Alternatives
The first set of regulatory alternatives
would alter scope of the proposed
standard—that is, the groups of
employees and employers covered by
the proposed standard. The scope of the
current beryllium proposal applies only
to general industry work, and does not
apply to employers when engaged in
construction or maritime activities. In
addition, the proposed rule provides an
exemption for those working with
materials that contain beryllium only as
a trace contaminant (less than
0.1percent composition by weight).40
As discussed in the explanation of
paragraph (a) in Section XVIII of this
preamble, Summary and Explanation of
the Proposed Standard, OSHA is
considering alternatives to the proposed
scope that would increase the range of
employers and employees covered by
the standard. OSHA’s review of several
industries indicates that employees in
some construction and maritime
industries, as well as some employees
who deal with materials containing less
than 0.1 percent beryllium, may be at
significant risk of CBD and lung cancer
as a result of their occupational
exposures. Regulatory Alternatives #1a,
#1b, #2a, and #2b would increase the
scope of the proposed standard to
provide additional protection to these
workers.
Regulatory Alternative #1a would
expand the scope of the proposed
standard to also include all operations
in general industry where beryllium
exists only as a trace contaminant; that
is, where the materials used contain less
than 0.1 percent beryllium by weight.
Regulatory Alternative #1b is similar to
Regulatory Alternative #1a, but exempts
40 Employers engaged in general industry
activities exempted from the proposed rule must
still ensure that their employees are protected from
beryllium exposure above the current PEL, as listed
in 29 CFR 1910.1000 Table Z–2.
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
operations where beryllium exists only
as a trace contaminant and the employer
can show that employees’ exposures
will not meet or exceed the action level
or exceed the STEL. Where the
employer has objective data
demonstrating that a material containing
beryllium or a specific process,
operation, or activity involving
beryllium cannot release beryllium in
concentrations at or above the proposed
action level or above the proposed STEL
under any expected conditions of use,
that employer would be exempt from
the proposed standard except for
recordkeeping requirements pertaining
to the objective data. Alternative #1a
and Alternative #1b, like the proposed
rule, would not cover employers or
employees in construction or shipyards.
OSHA has identified two industries
with workers engaged in general
industry work that would be excluded
under the proposed rule but would fall
within the scope of the standard under
Regulatory Alternatives #1a and #1b:
Primary aluminum production and coalfired power generation. Beryllium exists
as a trace contaminant in aluminum ore
and may result in exposures above the
proposed permissible exposure limits
(PELs) during aluminum refining and
production. Coal fly ash in coalpowered power plants is also known to
contain trace amounts of beryllium,
which may become airborne during
furnace and baghouse operations and
might also result in worker exposures.
See Appendices VIII–A and VIII–B at
the end of Chapter VIII in the PEA for
a discussion of beryllium exposures and
available controls in these two
industries.
As discussed in Appendix IV–B of the
PEA, beryllium exposures from fly ash
high enough to exceed the proposed
PEL would usually be coupled with
arsenic exposures exceeding the arsenic
PEL. Employers would in that case be
required to implement all feasible
engineering controls, work practices,
and necessary PPE (including
respirators) to comply with the OSHA
Inorganic Arsenic standard (29 CFR
1910.1018)—which would be sufficient
to comply with those aspects of the
proposed beryllium standard as well.
The degree of overlap between the
applicability of the two standards and,
hence, the increment of costs
attributable to this alternative are
difficult to gauge. To account for this
uncertainty, the Agency at this time is
presenting a range of costs for
Regulatory Alternative #1a: From no
costs being taken for ancillary
provisions under Regulatory Alternative
#1a to all such costs being included. At
the low end, the only additional costs
PO 00000
Frm 00166
Fmt 4701
Sfmt 4702
under Regulatory Alternative #1a are
due to the engineering control costs
incurred by the aluminum smelters (see
Appendix VIII–A).
Similarly, the proposed beryllium
standard would not result in additional
benefits from a reduction in the
beryllium PEL or from ancillary
provisions similar to those already in
place for the arsenic standard, but
OSHA does anticipate some benefits
will flow from ancillary provisions
unique to the proposed beryllium
standard. To account for significant
uncertainty in the benefits that would
result from the proposed beryllium
standard for workers in primary
aluminum production and coal-fired
power generation, OSHA estimated a
range of benefits for Regulatory
Alternative #1a. The Agency estimated
that the proposed ancillary provisions
would avert between 0 and 45 percent 41
of those baseline CBD cases not averted
by the proposed PEL. Though the
Agency is presenting a range for both
costs and benefits for this alternative,
the Agency judges the degree of overlap
with the arsenic standard is likely to be
substantial, so that the actual costs and
benefits are more likely to be found at
the low end of this range. The Agency
invites comment on all these issues.
Table IX–18 presents, for
informational purposes, the estimated
costs, benefits, and net benefits of
Regulatory Alternative #1a using
alternative discount rates of 3 percent
and 7 percent. In addition, this table
presents the incremental costs,
incremental benefits, and incremental
net benefits of this alternative relative to
the proposed rule. Table IX–18 also
breaks out costs by provision, and
benefits by type of disease and by
morbidity/mortality.
As shown in Table IX–18, Regulatory
Alternative #1a would increase the
annualized cost of the rule from $37.6
million to between $39.6 and $56.0
million using a 3 percent discount rate
and from $39.1 million to between $41.3
and $58.1 million using a 7 percent
discount rate. OSHA estimates that
regulatory Alternative #1a would
prevent as few as an additional 0.3 (i.e.,
almost one fatality every 3 years) or as
many as an additional 31.8 berylliumrelated fatalities annually, relative to the
proposed rule. OSHA also estimates that
Regulatory Alternative #1a would
prevent as few as an additional 0.002 or
as many as an additional 9 berylliumrelated non-fatal illnesses annually,
relative to the proposed rule. As a
result, annualized benefits in monetized
41 As discussed in Chapter VII of the PEA, OSHA
used 45 percent to develop its best estimate.
E:\FR\FM\07AUP2.SGM
07AUP2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
terms would increase from $575.8
million to between $578.0 and $765.2
million, using a 3 percent discount rate,
and from $255.3 million to between
$256.3 and $339.3 million using a 7
percent discount rate. Net benefits
would increase from $538.2 million to
between $538.4 and $709.2 million
using a 3 percent discount rate and from
$216.2 million to somewhere between
$215.1 to $281.2 million using a 7
percent discount rate. As noted in
Appendix VIII–B of Chapter VIII in the
PEA, the Agency emphasizes that these
estimates of benefits are subject to a
significant degree of uncertainty, and
the benefits associated with Regulatory
Alternative #1a arguably could be a
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
small fraction of OSHA’s best estimate
presented here.
OSHA estimates that the costs and the
benefits of Regulatory Alternative #1b
will be somewhat lower than the costs
of Regulatory Alternative #1a, because
most—but not all—of the provisions of
the proposed standard are triggered by
exposures at the action level, 8-hour
time-weighted average (TWA) PEL, or
STEL. For example, where exposures
exist but are below the action level and
at or below the STEL, Alternative #1a
would require employers to establish
work areas; develop, maintain, and
implement a written exposure control
plan; provide medical surveillance to
employees who show signs or
PO 00000
Frm 00167
Fmt 4701
Sfmt 4702
47731
symptoms of CBD; and provide PPE in
some instances. Regulatory Alternative
#1b would not require employers to take
these measures in operations where they
can produce objective data
demonstrating that exposures are below
the action level and at or below the
STEL. OSHA only analyzed costs, not
benefits, for this alternative, consistent
with the Agency’s treatment of
Regulatory Alternatives in the past.
Total costs for Regulatory Alternative
#1b versus #1a, assuming full ancillary
costs, drop from to $56.0 million to
$49.9 million using a 3 percent discount
rate, and from $58.1 million to $51.8
million using a 7 percent discount rate.
BILLING CODE 4510–26–P
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47732
Jkt 235001
Millions ($2010)
Alternative 1a
(Include trace contaminants)
Frm 00168
Fmt 4701
Sfmt 4702
(PEL= 0.2 ~9Im 3 , AL = 0.10 ~9Im 3 )
3%
$11.7-$11.7
$0.3- $0.3
$2.5- $4.1
$0.7- $0.7
$3.1- $4.5
$0.2- $0.3
$1.8- $2.8
$0.0- $0.0
$0.4- $0.4
$13.3- $22.0
$6.0- $9.9
$1.3-$1.3
$0.0- $0.0
$0.1-$1.5
$0.0- $0.1
$0.1-$1.5
$0.0- $0.1
$0.0- $1.0
$0.0- $0.0
$0.0- $0.0
$0.4- $8.8
$0.2- $4.1
$20-$184
$01-$179
Cases
$10.3
$0.3
$2.4
$0.7
$3.0
$0.2
$1.8
$1.4
$0.4
$12.9
__
$5.8
~
$37.6
$39.1
Cases
Cases
4.1-41
92.1- 123.7
______lli.
$9.5
$0.2
$2.2
$0.6
$2.9
$0.1
$1.8
$1.4
$0.4
$12.6
$1.3-$1.3
$0.0- $0.0
$0.1-$2.1
$0.0- $0.1
$0.7-$2.7
$0.0- $0.1
$0.0-$1.3
$0.2- $0.2
$0.0- $0.0
$0.4-$10.9
$0.2- $4.9
$413-$581
~
7%
$396-$560
Total Annualized Costs(point estimate)
Annual Benefits: Number of Cases Prevented
Fatal Lung Cancers (midpoint estimate)
Fatal Chronic Beryllium Disease
3%
$10.8-$10.8
$0.3-$0.3
$2.3-$3.8
$0.7-$0.7
$3.0-$4.3
$0.2-$0.3
$1.8-$2.8
$1.4-$1.4
$0.4- $0.4
$12.9-$21.4
$6.0-$9.9
Annualized Costs
Control Costs
Respi raters
Exposure Assessment
Regulated Areas and Beryllium Work Areas
Medical Surveillance
Medical Removal
Exposure Control Plan
Protective Clothing and Equipment
Hygiene Areas and Practices
Housekeeping
Training
7%
0.1-0.1
0.2-31.7
4
~
Beryllium-Related Mortality
96.3- 127.8
$575.0- $761.4
$254.6- $337.2
0.3-31.8
$2 0-$188.4
$0.9- $83.4
96
$573.0
$253.7
Bery11ium Morbidity
49.5- 58.5
$3.0-$3.8
$1.7- $2.1
0.0- 9.0
$0.2- $1.0
$0.1 - $0.5
50
$2.8
$1.6
Monetized Annual Benefits (midpoint estimate)
07AUP2
example, this alternative would cover
abrasive blasters, pot tenders, and
E:\FR\FM\07AUP2.SGM
standard to include employers in
construction and maritime. For
PO 00000
Discount Rate
Proposed PEL
Alternative 1a
Incremental Costs/Benefits
EP07AU15.029</GPH>
I
$578.0-$765.2
$256.3 - $339.3
$2.2-$189.4
$1.0-$84.0
$575.8
$255.3
Net Benefits
I
$538.4-$709.2
$215.1-$281.2
$0.2-$171.0
$-1.1-$65.0
$538.2
$216.2
Source: OSHA, Directorate of Standards and Guidance, Office of Regulatory Analysis
*Benefits are assessed over a 60-year time horizon, during VV'hich it is assumed that economic conditions remain constant. Costs are annualized over ten years, vvith the exception of
equipment expenditures, VV'hich are annualized over the life of the equipment. Annualized costs are assumed to continue at the same level for sixty years, VV'hich is consistent vvith
assuming that economic conditions remain constant for the sixty year time horizon.
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
19:20 Aug 06, 2015
Regulatory Alternative #2a would
expand the scope of the proposed
VerDate Sep<11>2014
Table IX-18: Annualized Costs, Benefits and Incremental Benefits of OSHA's Proposed Beryllium Standard of Alternative Scope
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
cleanup staff working in construction
and shipyards who have the potential
for airborne beryllium exposure during
blasting operations and during cleanup
of spent media. Regulatory Alternative
#2b would update 29 CFR 1910.1000
Tables Z–1 and Z–2, 1915.1000 Table Z,
and 1926.55 Appendix A so that the
proposed TWA PEL and STEL would
apply to all employers and employees in
general industry, shipyards, and
construction, including occupations
where beryllium exists only as a trace
contaminant. For example, this
alternative would cover abrasive
blasters, pot tenders, and cleanup staff
working in construction and shipyards
who have the potential for significant
airborne exposure during blasting
operations and during cleanup of spent
media. The changes to the Z tables
would also apply to workers exposed to
beryllium during aluminum refining
and production, and workers engaged in
maintenance operations at coal-powered
utility facilities. All provisions of the
standard other than the PELs, such as
exposure monitoring, medical removal,
and PPE, would be in effect only for
employers and employees that fall
within the scope of the proposed rule.42
Alternative #2b would not be as
protective as Alternative #1a or
Alternative #1b for employees in
aluminum refining and production or
coal-powered utility facilities because
the other provisions of the proposed
standard would not apply.
As discussed in the explanation of
proposed paragraph (a) in this preamble
at Section XVIII, Summary and
Explanation of the Proposed Standard,
abrasive blasting is the primary
application group in construction and
maritime industries where workers may
be exposed to beryllium. OSHA has
judged that abrasive blasters and their
helpers in construction and maritime
industries have the potential for
significant airborne exposure during
blasting operations and during cleanup
of spent media. Airborne concentrations
of beryllium have been measured above
the current TWA PEL of 2 mg/m3 when
blast media containing beryllium are
used as intended (see Appendix IV–C in
the PEA for details).
To address high concentrations of
various hazardous chemicals in abrasive
blasting material, employers must
42 However, many of the occupations excluded
from the scope of the proposed beryllium standard
receive some ancillary provision protections from
other rules, such as Personal Protective Equipment
(29 CFR 1910 subpart I, 1915 subpart I, 1926.28,
also 1926 subpart E), Ventilation (including
abrasive blasting) (§§ 1926.57 and 1915.34), Hazard
Communication (§ 1910.1200), and specific
provisions for welding (parts 1910 subpart Q, 1915
subpart D, and 1926 subpart J).
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
already be using engineering and work
practice controls to limit workers’
exposures and must be supplementing
these controls with respiratory
protection when necessary. For
example, abrasive blasters in the
construction industry fall under the
protection of the Ventilation standard
(29 CFR 1926.57). The Ventilation
standard includes an abrasive blasting
subsection (29 CFR 1926.57(f)), which
requires that abrasive blasting
respirators be worn by all abrasive
blasting operators when working inside
blast-cleaning rooms (29 CFR
1926.57(f)(5)(ii)(A)), or when using
silica sand in manual blasting
operations where the nozzle and blast
are not physically separated from the
operator in an exhaust-ventilated
enclosure (29 CFR 1926.57(f)(5)(ii)(B)),
or when needed to protect workers from
exposures to hazardous substances in
excess of the limits set in § 1926.55 (29
CFR 1926.57(f)(5)(ii)(C); ACGIH, 1971).
For maritime, standard 29 CFR
1915.34(c) covers similar requirements
for respiratory protection needed in
blasting operations. Due to these
requirements, OSHA believes that
abrasive blasters already have controls
in place and wear respiratory protection
during blasting operations. Thus, in
estimating costs for Regulatory
Alternatives #2a and #2b, OSHA judged
that the reduction of the TWA PEL
would not impose costs for additional
engineering controls or respiratory
protection in abrasive blasting (see
Appendix VIII–C of Chapter VIII in the
PEA for details). OSHA requests
comment on this issue—in particular,
whether abrasive blasters using blast
material that may contain beryllium as
a trace contaminant are already using all
feasible engineering and work practice
controls, respiratory protection, and PPE
that would be required by Regulatory
Alternatives #2a and #2b.
In the estimation of benefits for
Regulatory Alternative #2a, OSHA has
estimated a range to account for
significant uncertainty in the benefits to
this population from some of the
ancillary provisions of the proposed
beryllium standard. It is unclear how
many of the workers associated with
abrasive blasting work would benefit
from dermal protection, as
comprehensive dermal protection may
already be used by most blasting
operators. It is also unclear whether the
housekeeping requirements of the
proposed standard would be feasible to
implement in the context of abrasive
blasting work, and to what extent they
would benefit blasting helpers, who are
themselves exposed while performing
PO 00000
Frm 00169
Fmt 4701
Sfmt 4702
47733
cleanup activities. OSHA estimated that
the proposed ancillary provisions would
avert between 0 and 45 percent of those
baseline CBD cases not averted by the
proposed PEL.
These considerations also lead the
Agency to present a range for the costs
of this alternative: From no costs being
estimated for ancillary provisions under
Regulatory Alternative #2a to including
all such costs. Based on the
considerations discussed above, the
Agency judges that costs and benefits at
the low end of this range are more likely
to be correct. The Agency invites
comment on these issues.
In addition, OSHA believes that a
small number of welders in the
maritime industry may be exposed to
beryllium via arc and gas welding (and
none through resistance welding). The
number of maritime welders was
estimated using the same methodology
as was used to estimate the number of
general industry welders. Brush
Wellman’s customer survey estimated
2,000 total welders on berylliumcontaining products (Kolanz, 2001).
Based on ERG’s assumption of 4 welders
per establishment, ERG estimated that a
total of 500 establishments would be
affected. These affected establishments
were then distributed among the 26
NAICS industries with the highest
number of IMIS samples for welders
that were positive for beryllium. To do
this, ERG first consulted the BLS OES
survey to determine what share of
establishments in each of the 26 NAICS
employed welders and estimated the
total number of establishments that
perform welding regardless of beryllium
exposure (BLS, 2010a). Then ERG
distributed the 500 affected beryllium
welding facilities among the 26 NAICS
based on the relative share of the total
number of establishments performing
welding. Finally, to estimate the number
of welders, ERG used the assumption of
four welders per establishment. Based
on the information from ERG, OSHA
estimated that 30 welders would be
covered in the maritime industry under
this regulatory alternative. For these
welders, OSHA used the same controls
and exposure profile that were used to
estimate costs for arc and gas welders in
Chapter V of the PEA. ERG judged there
to be no construction welders exposed
to beryllium due to a lack of any
evidence that the construction sector
uses beryllium-containing products or
electrodes in resistance welding. OSHA
solicits comment and any relevant data
on beryllium exposures for welders in
construction and maritime employment.
Estimated costs and benefits for
Regulatory Alternative #2a are shown in
Table IX–18a. Regulatory Alternative
E:\FR\FM\07AUP2.SGM
07AUP2
47734
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
#2a would increase costs from $37.6
million to between $37.7 and $55.3
million, using a 3 percent discount rate,
and from $39.1 million to between $39.2
and $57.3 million using a 7 percent
discount rate. Annualized benefits
would increase from $575.8 million to
between $575.9 and $675.3 million
using a 3 percent discount rate, and
from $255.3 million to between $255.4
and $299.4 million using a 7 percent
discount rate. Net benefits would
change from $538.2 million to between
$538.2 and $620.0 million using a 3
percent discount rate, and from $216.2
million to between $216.1 and $242.1
million using a 7 percent discount rate.
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
Table IX–18b presents, for
informational purposes, the estimated
costs, benefits, and net benefits, of
Regulatory Alternative #2b using
alternative discount rates of 3 percent
and 7 percent. In addition, this table
presents the incremental costs,
incremental benefits, and incremental
net benefits of this alternative relative to
the proposed rule. Table IX–18b also
breaks out costs by provision and
benefits by type of disease and by
morbidity/mortality.
As shown in Table IX–18b, this
regulatory alternative would increase
the annualized cost of the rule from
$37.6 million to $39.6 million, using a
3 percent discount rate, and from $39.1
PO 00000
Frm 00170
Fmt 4701
Sfmt 4702
million to $41.1 million using a 7
percent discount rate. Regulatory
Alternative #2b would prevent less than
one additional beryllium-related
fatalities and less than one berylliumrelated illness annually relative to the
proposed rule. As a result, annualized
benefits would increase from $575.8
million to $578.1 million, using a 3
percent discount rate, and from $255.3
million to $256.3 million using a 7
percent discount rate. Net benefits
would increase from $538.2 million to
$538.5 million using a 3 percent
discount rate and slightly decrease from
$216.2 million to $215.2 million using
a 7 percent discount rate.
BILLING CODE 4510–26–P
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
VerDate Sep<11>2014
Millions($2010)
Jkt 235001
Alternative 2a
Alternative 2a
Include Maritime and Construction Sectors
Include Maritime and Construction Sectors
(incremental costs and benefits]
Proposed PEL
[PEL= 0.2 ~gtm', AL = 0.10 ~gtm')
Frm 00171
7%
3%
7%
Control Costs
$9.6-$96
$10.4-$10.4
$0.0-$00
$0.0- 50.0
$9.5
Respirators
PO 00000
3%
$0.3-$0 3
$2.4-$4 0
$0.7-$1 4
$0.0-$00
$0.0-$15
$0.0-$07
$0.0- 50.0
$0.0- 51.6
$0.0- 50.7
$0.2
$0.3
Regulated areas and Beryllium Work Areas
$0.3-$03
$2.2-$38
$0.6-$14
Medical Surveillance
$29-$62
$3 0- $6 4
$00-$33
$00-533
$2.2
$0.6
$2 9
$2.4
$0.7
$3 0
Medical Removal
$0.1-$05
$1.8-$27
$0.2-$0 6
$1.8-$2 8
$0.0-$04
$0.0-$10
$0.0- 50.4
$0.0- 51.0
$0.1
$1.8
$0.2
$1.8
$1.4-$1 4
$0.4-$16
$1.4-$1 4
$0.4-$1 6
$0.0-$00
$0.0-$12
$0.0- 50.0
$0.0- 51.1
$1.4
$1.4
$126-$191
$58-$88
$129-$196
$58- $8 9
$00-$66
$00-$30
$00-567
$00-530
$0.4
$12 6
$58
$0.4
$12 9
$58
$37 7- $55.3
$39.2- $57.3
50.1-$17.7
$0 1 - $17.9
Discount Rate
3%
7%
Annualized Costs
Exposure Assessment
Exposure Control Plan
Fmt 4701
Protective Clothing and Equipment
Hyg1ene Areas and Practices
Housekeeping
Training
Sfmt 4725
----
$37.6
Total Annualized Costs (point estimate)
E:\FR\FM\07AUP2.SGM
Annual Benefits: Number of Cases Prevented
$10.3
Cases
$39.1
Cases
Cases
07AUP2
Fatal Chronic Beryllium Disease
4.0-4 0
92.0-108 7
Beryllium-Related Mortality
96.0-1127
$573.0-$6719
$253.8 - $297 6
0.0 -16.7
50.0- $00.0
$0 0- $43.8
96
$573.0
$253.7
Beryllium Morbid1ty
495-585
$28-$34
$1 6-$1 9
00-90
$00-$05
$00-503
50
$2 8
$1 6
Monetized Annual Benefits(midpoint estimate)
$575.9- $675.3
$255.4 - $299.4
$0.0-$99.0
$0.0-$44.1
$575.8
$255.3
Net Benefits
$538.2- $620.0
$216.1 - $242.1
$0.0-$81.8
$0.0-$25.9
$538.2
$216.2
Fatal Lung Cancers (midpoint est1mate)
0.0-0.0
0.0-16.7
4
92
Source OSHA, Directorate of Standards and Guidance, Off1ce of Regulatory Analysis
*Benefits are assessed over a 60-year time horizon during v1.hich it is assumed that economic conditions remain constant. Costs are annualized over ten years, wth the exception of
equipment expenditures, Wlich are annualized over the life of the equipment. Annualized costs are assumed to cont1nue at the same level for sixty years, Wlich is consistent Wth
assuming that economic conditions remain constant for the sixty year time horizon.
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
19:20 Aug 06, 2015
Table IX-18a: Annualized Costs, Benefits and Incremental Benefits of OSHA's Proposed Beryllium Standard of Alternative Scope Including Maritime and Construction
47735
EP07AU15.030</GPH>
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47736
Millions ($2010)
Jkt 235001
Alternative 2b
Alternative 2b
Proposed PEL
Update Z Tables 1910.1000, 1915.1000, and 1926.55 and
Update Z Tables 1910.1000, 1915.1000, and 1926.55 and
Require Control Costs for Industries with Trace
Contaminants
Require Control Costs for Industries with Trace
Contaminants (incremental costs and benefits)
Fmt 4701
Sfmt 4702
3%
7%
$11.5
$0.2
$2.2
$0.6
$2.9
$0.1
$1.8
$1.4
$0.4
$12.6
3%
$12.3
$0.3
$2.4
$0.7
$3.0
$0.2
$1.8
$1.4
$0.4
$12.9
7%
3%
7%
Annualized Costs
Control Costs
Respiratcrs
Exposure Assessment
Regulated areas and Beryllium Work Areas
Medical Surveillance
Medical Removal
Exposure Contrd Plan
Prdective Cldhing and Equipment
Hygiene Areas and Practices
Housekeeping
~
Training
$39.6
Total Annualized Costs (point estimate)
Annual Benefits: Number of Cases Prevented
Fatal Lung Cancers (midpoint estimate)
Fatal Chrooic Beryllium Disease
$2.0
$0.0
$0.0
$0.0
$0.0
$0.0
$0.0
$0.0
$0.0
$0.0
~
$9.5
$0.2
$2.2
$0.6
$2.9
$0.1
$1.8
$1.4
$0.4
$12.6
$10.3
$0.3
$2.4
$0.7
$3.0
$0.2
$1.8
$1.4
$0.4
$12.9
______!2:2...
______!2:2...
~
$2.0
$41.1
Cases
4.1
92.1
$2.0
$0.0
$0.0
$0.0
$0.0
$0.0
$0.0
$0.0
$0.0
$0.0
$2.0
$37.6
$39.1
Cases
Cases
0.1
0.2
~
4.0
92.0
07AUP2
EP07AU15.031</GPH>
Beryllium-Related Matality
96.3
$575.0
$254.6
0.3
$2.02
$0.90
96.0
$573.0
$253.7
Beryllium rvbrbidity
of 2.0 mg/m3 for all application groups
covered by the rule. OSHA’s proposal is
based on the requirements of the
Occupational Safety and Health Act
(OSH Act) and court interpretations of
E:\FR\FM\07AUP2.SGM
2. Exposure Limit (TWA PEL, STEL, and
ACTION LEVEL) Alternatives
Frm 00172
OSHA is proposing a new TWA PEL
for beryllium of 0.2 mg/m3 and a STEL
PO 00000
Discount Rate
(PEL = 0.2 ~g/m 3 , AL = 0.10 ~g/m 3 )
49.6
$3.0
$1.7
0.1
$0.20
$0.11
49.5
$2.8
$1.6
Monetized Annual Benefits (midpoint estimate)
$578.1
$256.3
$2.2
$1.0
$575.8
$255.3
Net Benefits
$538.5
$215.2
$0.3
-$1.0
$538.2
$216.2
Soorce: OSHA, Directorate of Standards and Guidance, Office of Regulatory Analysis
*Benefits are assessed over a 60-year time horizon, during VV'hich it is assumed that economic conditions remain coostant. Costs are annualized over ten years, vvith the exception of
equipment expenditures, vvhich are annualized 0\lerthe life of the equipment. Annualized costs are assumed to continue at the same level fcr sixty years, vvhich is consistent vvith
assuming that ecooanic conditioos remain constant fcr the sixty year time hcrizoo.
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
19:20 Aug 06, 2015
BILLING CODE 4510–26–P
VerDate Sep<11>2014
Table IX-18b: Annualized Costs, Benefits and Incremental Benefits of OSHA's Proposed Beryllium Standard of Updating Z Tables 1910.1000, 1915.1000, and 1926.55 and Requiring Control Costs for Industries with Trace Contaminants
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
47737
practical effect because a STEL ten
times the TWA PEL will rarely be
exceeded without also driving
exposures above the TWA PEL. For
example, assuming a background
exposure level of 0.1 mg/m3, a STEL ten
times the TWA PEL could only be
exceeded once in a work shift for 15
minutes without driving exposures
above the TWA PEL, whereas a STEL
five times the TWA PEL could be
exceeded three times before driving
exposures above the TWA PEL. OSHA’s
standards for methylene chloride (29
CFR 1910.1052), acrylonitrile (29 CFR
1910.1045), benzene (29 CFR
1910.1028), ethylene oxide (29 CFR
1910.1047), and 1,3-Butadiene (29 CFR
1910.1051) all set STELs at five times
the TWA PEL. Thus, if OSHA
promulgates the proposed TWA PEL of
0.2 mg/m3, the accompanying STEL
under this regulatory alternative would
be set at 1 mg/m3.
As discussed in this preamble at
Section V, Health Effects,
immunological sensitization can be
triggered by short-term exposures.
OSHA believes a STEL for beryllium
will help reduce the risk of sensitization
and CBD in beryllium-exposed
employees. For instance, without a
STEL, workers’ exposures could be as
high as 6.4 mg/m3 (32 × 0.2 mg/m3) for
15 minutes under the proposed TWA
PEL, if exposures during the remainder
of the 8-hour work shift are nondetectable. A STEL serves to minimize
high task-based exposures by requiring
feasible controls in these situations, and
has the added effect of further reducing
the TWA exposure.
OSHA requests comment on the range
of short-term exposures in covered
industries, the types of operations
where these are occurring, and on the
proposed and alternative STELs,
including any data or information that
may help OSHA choose between them.
OSHA identified two job categories
where workers would be expected to
have short-term exposures in the range
between the proposed STEL and the
STEL under Regulatory Alternative #3
(that is, between 2.0 and 1.0 mg/m3):
Furnace operators in nonferrous
foundries and material preparation
operators in the beryllium oxide
ceramics application group. To estimate
the costs for this alternative, OSHA
judged, conservatively, that all workers
in these job categories would need to
wear respirators to meet a STEL of 1.0.
OSHA also estimated costs for
additional regulated areas and medical
surveillance for workers in these two job
categories. The costs for this alternative
are presented in Table IX–19. Total
costs rise from $37.6 million to $37.7
million using a 3 percent discount rate
and from $39.1 million to $39.3 million
using a 7 percent discount rate.
Under Regulatory Alternative #4, the
TWA PEL would be 0.1 mg/m3 with an
action level of 0.05 mg/m3. The Agency’s
preliminary risk assessment indicates
that the risks remaining at the proposed
TWA PEL of 0.2 mg/m3—while lower
than risks at the current TWA PEL—are
still significant (see this preamble at
Section VIII, Significance of Risk). A
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
PO 00000
Frm 00173
Fmt 4701
Sfmt 4702
E:\FR\FM\07AUP2.SGM
07AUP2
EP07AU15.032</GPH>
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
the Act. For health standards issued
under section 6(b)(5) of the OSH Act,
OSHA is required to promulgate a
standard that reduces significant risk to
the extent that it is technologically and
economically feasible to do so. See
Section II of this preamble, Pertinent
Legal Authority, for a full discussion of
OSHA legal requirements.
Paragraph (c) of the proposed
standard establishes two PELs for
beryllium in all forms, compounds, and
mixtures: An 8-hour TWA PEL of 0.2
mg/m3 (proposed paragraph (c)(1)), and
a 15-minute short-term exposure limit
(STEL) of 2.0 mg/m3 (proposed
paragraph (c)(2)). OSHA has defined the
action level for the proposed standard as
an airborne concentration of beryllium
of 0.1 mg/m3 calculated as an eight-hour
TWA (proposed paragraph (b)). In this
proposal, as in other standards, the
action level has been set at one-half of
the TWA PEL.
As discussed in this preamble
explanation of paragraph (c) in Section
XVIII, Summary and Explanation of the
Proposed Standard, OSHA is
considering three regulatory alternatives
that would modify the PELs for the
proposed standard.
Regulatory Alternative #3 would
modify the proposed STEL to be five
times the TWA PEL, as is typical for
OSHA standards that have STELs. A
STEL five times the TWA PEL has more
47738
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
TWA PEL of 0.1 mg/m3 would reduce
some of the remaining risks to workers
at the proposed PEL. The OSH Act
requires the Agency to set its standards
to address significant risks of harm to
the extent economically and
technologically feasible, so OSHA
would have very limited flexibility to
adopt a higher PEL if a lower PEL is
technologically and economically
feasible.
While OSHA’s preliminary analysis
indicates that the proposed TWA PEL of
0.2 mg/m3 is economically and
technologically feasible, OSHA has less
confidence in the feasibility of a TWA
PEL of 0.1 mg/m3. In some industry
sectors it is difficult to determine
whether a TWA PEL of 0.1 mg/m3 could
be achieved in most operations most of
the time (see Section IX.D of this
preamble, Technological Feasibility).
OSHA believes that one way this
uncertainty could be resolved would be
with additional information on
exposure control technologies and the
exposure levels that are currently being
achieved in these industry sectors.
OSHA requests additional data and
information to inform its final
determinations on feasibility (see
Section IX.D of this preamble,
Technological Feasibility) and the
alternative PELs under consideration.
Regulatory Alternative #5, which
would set a TWA PEL at 0.5 mg/m3 and
an action level at 0.25 mg/m3, both
higher than in the proposal, responds to
an issue raised during the Small
Business Advocacy Review (SBAR)
process conducted in 2007 to consider
a draft OSHA beryllium proposed rule
that culminated in an SBAR Panel
report (SBAR, 2008). That report
included a recommendation that OSHA
consider both the economic impact of a
low TWA PEL and regulatory
alternatives that would ease cost burden
for small entities. OSHA has provided a
full analysis of the economic impact of
its proposed PELs (see Chapter VI of the
PEA), and Regulatory Alternative #5
addresses the second half of that
recommendation. However, the higher
0.5 mg/m3 TWA PEL does not appear to
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
be consistent with the Agency’s
mandate under the OSH Act to
promulgate a lower PEL if it is feasible
and could prevent additional fatalities
and non-fatal illnesses. The data
presented in Table IX–20 below indicate
that the lower TWA PEL would prevent
additional fatalities and non-fatal
illnesses, but nevertheless the Agency
solicits comments on this alternative
and OSHA’s analysis of the costs and
benefits associated with it.
Table IX–20 below presents, for
informational purposes, the estimated
costs, benefits, and net benefits of the
proposed rule under the proposed TWA
PEL of 0.2 mg/m3 and for the regulatory
alternatives of a TWA PEL of 0.1 mg/m3
and a TWA PEL of 0.5 mg/m3
(Regulatory Alternatives #4 and #5,
respectively), using alternative discount
rates of 3 percent and 7 percent. In
addition, the table presents the
incremental costs, the incremental
benefits, and the incremental net
benefits, of going from a TWA PEL of
0.5 mg/m3 to the proposed TWA PEL of
0.2 mg/m3 and then of going from the
proposed TWA PEL of 0.2 mg/m3 to a
TWA PEL of 0.1 mg/m3. Table IX–20 also
breaks out costs by provision and
benefits by type of disease and by
morbidity/mortality.
OSHA has not made a determination
that a TWA PEL of 0.1 mg/m3 would be
feasible for all application groups (that
is, engineering and work practices
would be sufficient to reduce and
maintain beryllium exposures to a TWA
PEL of 0.1 mg/m3 or below in most
operations most of the time in the
affected industries). For Regulatory
Alternative #4, the Agency attempted to
identify engineering controls and their
costs for those affected application
groups where the technology feasibility
analysis in Chapter IV of the PEA
indicated that a TWA PEL of 0.1 mg/m3
could be achieved. For those application
groups, OSHA costed out the set of
feasible controls necessary to meet this
alternative PEL. For the rest of the
affected application groups, OSHA
assumed that all workers exposed
between 0.2 mg/m3 and 0.1 mg/m3 would
PO 00000
Frm 00174
Fmt 4701
Sfmt 4702
have to wear respirators to achieve
compliance with the 0.1 mg/m3 TWA
PEL and estimated the associated
additional costs for respiratory
protection. For all affected industries,
OSHA also estimated the costs to satisfy
the ancillary requirements specified in
the proposed rule for all affected
workers under the alternative TWA PEL
of 0.1 mg/m3. For both controls and
respirators, the unit costs were the same
as presented in Chapter V of the PEA.
The estimated benefits for Regulatory
Alternative #4 were calculated based on
the number of workers identified with
exposures between 0.1 and 0.2 mg/m3,
using the methods and unit benefit
values developed in Chapter VII of the
PEA.
As Table IX–20 shows, going from a
TWA PEL of 0.5 mg/m3 to a TWA PEL
of 0.2 mg/m3 would prevent, annually,
an additional 29 beryllium-related
fatalities and an additional 15 non-fatal
illnesses. This is consistent with
OSHA’s preliminary risk assessment,
which indicates significant risk to
workers exposed at a TWA PEL of 0.5
mg/m3; furthermore, OSHA’s
preliminary feasibility analysis
indicates that a lower TWA PEL than
0.5 mg/m3 is feasible. Net benefits of this
regulatory alternative versus the
proposed TWA PEL of 0.2 mg/m3 would
decrease from $538.2 million to $370.0
million using a 3 percent discount rate
and from $216.2 million to $144.4
million using 7 percent discount rate.
Table IX–20 also shows the costs and
benefits of going from the proposed
TWA PEL of 0.2 mg/m3 to a TWA PEL
of 0.1 mg/m3. As shown there, going
from a TWA PEL of 0.2 mg/m3 to a TWA
PEL of 0.1 mg/m3 would prevent an
additional 2 beryllium-related fatalities
and 1 additional non-fatal illness. Net
benefits of this regulatory alternative
versus the proposed TWA PEL of 0.2 mg/
m3 would increase from $538.2 million
to $543.5 million using a 3 percent
discount rate and decrease from $216.2
million to $214.9 million using a 7
percent discount rate.
BILLING CODE 4510–26–P
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
VerDate Sep<11>2014
Jkt 235001
PO 00000
Alternative 4
(PEL= 0.1 ~g/m 3 , AL = 0.05 ~g/m 3 )
Discount Rate
_ _3_%_._
Frm 00175
Fmt 4701
Annualized Costs
Contrd Costs
Respirators
Exposure Assessment
Regulated areas and Beryllium Work Areas
Medical Surveillance
Medical Removal
Exposure Control Plan
Protect1ve Clothing and Equipment
Hygiene Areas and Practices
Housekeeping
Training
$12 9
$0.7
$3.8
$0.9
$3.0
$0.4
$1 8
$1.4
$0.6
$12.6
~
Sfmt 4725
E:\FR\FM\07AUP2.SGM
Beryllium Morbidity
50
$258.8
SO.O
$9
$0
$2
$0
$2
$0
$1
$1
$0
$12
SO.O
50.2
SO.O
~
$6.1
2
_____1li._
S3 5
50.5
51.5
50.3
50.1
S0.3
so 0
SO.O
5
2
2
6
9
1
8
4
4
6
~
~
$6.3
$37.6
$11.4
55.0
96
50
Alternative 5
Incremental Costs/Benefits
~
7%
$10 3
$0.3
$2.4
$0.7
$3.0
$0.2
$1 8
$1.4
$0.4
$12.9
$5.8
$3 6
$0.1
$0.3
$0.3
$0.1
$0.1
$0 0
$0.0
$0.0
$0.0
_____1li._
_____TIL_
$3 9
$0.1
$0.3
$0.3
$0.1
$0.1
$0 0
$0.0
$0.0
$0.0
56 0
50.1
51.9
50.3
52.8
S0.1
51 8
51.4
50.4
$12.6
~
$6
$0
$2
$0
$2
$0
$1
$1
$0
$12
5
1
1
4
9
1
8
4
4
9
~
~
~
$4.4
$4.8
$33.2
$34.4
$401.2
$177 7
Cases
0
_2_9_
$573 0
Alternative 5
(PEL= 0.5 ~g/m 3 , AL = 0.25 ~g/m 3 )
~
$39.1
~
4
_ _9_2_ _
Cases
0
2
$584.4
Proposed PEL
(PEL= 0.2 ~glm 3 , AL = 0.10 ~g/m 3 }
~
50.2
$45.5
~
4
_ __ _
94
98
53 3
50.4
51.6
50.3
50.1
S0.3
so 0
~
$43.7
Beryllium-Related Mortality
~
$13 9
$0.7
$3.9
$0.9
$3.1
$0.5
$1 8
$1.4
$0.6
$12.9
~
Total Annualized Costs (point estimate)
Annual Benefits: Number of Cases Prevented
Fatal Lung Cancers (mldpomt estimate)
Fatal Chronic Beryllium Disease
Alternative 4
Incremental Cost9'Benefits
5253.7
29
15
Cases
4
63
$171.8
$76.1
67
34
$2.9
$1.6
SO.O
SO.O
$2 8
$1.6
$0.9
$0.5
52.0
$1 1
Monetized Annual Benefits (midpoint estimate)
$587.3
$260.4
$11.4
$5.1
$575.8
$255.3
$172.7
$76.6
$403.1
$178.8
Net Benefits
$543.5
$214.9
$5.3
-$1.3
$538.2
$216.2
$168.2
$71.9
$370.0
$144.4
Source OSHA, Directorate of Standards and Guidance, Office of Regulatory Analysis
07AUP2
"Benefits are assessed over a 60-yeart1me honzon, dunng Vvt11ch 1t 1s assumed that economic cond1t1ons rema1n constant. Costs are annualized over ten years, v11th the exception of
equipment expenditures, which are annualized over the life of the equipment. Annualized costs are assumed to continue at the same level for sixty years which IS consistent v•
.,th
assuming that economic conditions remain constant for the sixty year time horizon
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
19:20 Aug 06, 2015
Table IX-20: Annualized Costs, Benefits and Incremental Benefits of OSHA's Proposed Beryllium Standard of 0.1 1Jglm3 and 0.5 1Jglm3 PEL Alternative
Millions ($2010)
47739
EP07AU15.033</GPH>
47740
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Informational Alternative Featuring
Unchanged PEL but Full Ancillary
Provisions
An Informational Analysis: This
proposed regulation has the somewhat
unusual feature for an OSHA substancespecific health standard that most of the
quantified benefits would come from
the ancillary provisions rather than from
meeting the PEL with engineering
controls. OSHA decided to analyze for
informational purposes the effect of
retaining the existing PEL but applying
all of the ancillary provisions, including
respiratory protection. Under this
approach, the TWA PEL would remain
at 2.0 micrograms per cubic meter, but
all of the other proposed provisions
(including respiratory protection, which
OSHA does not consider an ancillary
provision) would be required with their
triggers remaining the same as in the
proposed rule—either the presence of
airborne beryllium at any level (e.g.,
initial monitoring, written exposure
control plan), at certain kinds of dermal
exposure (PPE), at the action level of 0.1
mg/m3 (e.g., periodic monitoring,
medical removal), or at 0.2 mg/m3 (e.g.,
regulated areas, respiratory protection,
medical surveillance).
Given the record regarding beryllium
exposures, this approach is not one
OSHA could legally adopt because the
absence of a more protective
requirement for engineering controls
would not be consistent with section
6(b)(5) of the OSH Act, which requires
OSHA to ‘‘set the standard which most
adequately assures, to the extent
feasible, on the basis of the best
available evidence, that no employee
will suffer material impairment of
health or functional capacity even if
such employee has regular exposure to
the hazard dealt with by such standard
for the period of his working life.’’ For
that reason, this additional analysis is
provided strictly for informational
purposes. E.O. 12866 and E.O. 13563
direct agencies to identify approaches
that maximize net benefits, and this
analysis is purely for the purpose of
exploring whether this approach would
hold any real promise to maximize net
benefits if it was permissible under the
OSH Act. It does not appear to hold
such promise because an ancillaryprovisions-only approach would not be
as protective and thus offers fewer
benefits than one that includes a lower
PEL and engineering controls, and
OSHA estimates the costs would be
about the same (or slightly lower,
depending on certain assumptions)
under that approach as under the
traditional proposed approach.
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
On an industry by industry basis,
OSHA found that some industries
would have lower costs if they could
adopt the ancillary-provisions-only
approach. Some employers would use
engineering controls where they are
cheaper, even if they are not mandatory.
OSHA does not have sufficient
information to do an analysis of the
employer-by-employer situations in
which there exist some employers for
whom the ancillary-provisions-only
approach might be cheaper. In the
majority of affected industries, the
Agency estimates there are no costs
saving to the ancillary-provisions-only
approach. However, OSHA estimates a
total of $2,675,828 per year in costs
saving for entire industries where the
ancillary-provisions-only approach
would be less expensive.
The above discussion does not
account for the possibility that the lack
of engineering controls would result in
higher beryllium exposures for workers
in adjacent (non-production) work areas
due to the increased level of beryllium
in the air. Because of a lack of data, and
because the issue did not arise in the
other regulatory alternatives OSHA
considered (all of which have a PEL of
less than 2.0 mg/m3), OSHA did not
carefully examine exposure levels in
non-production areas for either cost or
benefit purposes. To the extent such
exposure levels would be above the
action level, there would be additional
costs for respiratory protection.
The ancillary-provisions-only
approach adds uncertainty to the
benefits analysis such that the benefits
of the rule as proposed may exceed, and
perhaps greatly exceed, the benefits of
this ancillary-provisions-only approach:
(1) Most exposed individuals would
be in respirators, which OSHA
considers less effective than engineering
controls in preventing employee
exposure to beryllium. OSHA last did
an extensive review of the evidence on
effectiveness of respirators for its APFs
rulemaking in 2006 (71 FR 50128–45,
August 24, 2006). OSHA has not in the
past tried to quantify the size of this
effect, but it could partially negate the
estimated benefits of 92 CBD deaths
prevented per year and 4 lung cancer
cases prevented per year by the
proposed standard.
(2) As noted above, in the proposal
OSHA did not consider benefits caused
by reductions in exposure in nonproduction areas. Unless employers act
to reduce exposures in the production
areas, the absence of a requirement for
such controls would largely negate such
benefits from reductions in exposure in
the non-productions areas.
PO 00000
Frm 00176
Fmt 4701
Sfmt 4702
(3) OSHA believes that there is a
strong possibility that the benefits of the
ancillary provisions (a midpoint
estimate of eliminating 45 percent of all
remaining cases of CBD) would be
partially or wholly negated in the
absence of engineering controls that
would reduce both airborne and surface
dust levels. The measured reduction in
benefits from ancillary provision was in
a facility with average exposure levels of
less than 0.2 mg/m3.
Based on these considerations, OSHA
believes that the ancillary-provisionsonly approach is not one that is likely
to maximize net benefits. The costs
saving, if any, are estimated to be small,
and the difficult-to-measure declines in
benefits could be substantial.
3. A Method-of-Compliance Alternative
Paragraph (f)(2) of the proposed rule
contains requirements for the
implementation of engineering and
work practice controls to minimize
beryllium exposures in beryllium work
areas. For each operation in a beryllium
work area, employers must ensure that
at least one of the following engineering
and work practice controls is in place to
minimize employee exposure: Material
and/or process substitution; ventilated
enclosures; local exhaust ventilation; or
process controls, such as wet methods
and automation. Employers are exempt
from using engineering and work
practice controls only when they can
show that such controls are not feasible
or where exposures are below the action
level based on two exposure samples
taken seven days apart.
These requirements, which are based
on the stakeholders’ recommended
beryllium standard that beryllium
industry and union stakeholders
submitted to OSHA in 2012 (Materion
and United Steelworkers, 2012), address
a concern associated with the proposed
TWA PEL. OSHA expects that day-today changes in workplace conditions,
such as workers’ positioning or patterns
of airflow, may cause frequent
exposures above the TWA PEL in
workplaces where periodic sampling
indicates exposures are between the
action level and the TWA PEL. As a
result, the default under the standard is
that the controls are required until the
employer can demonstrate that
exposures have not exceeded the action
level from at least two separate
measurements taken seven days apart.
OSHA believes that substitution or
engineering controls such as those
outlined in paragraph (f)(2)(i) provide
the most reliable means to control
variability in exposure levels. However,
OSHA also recognizes that the
requirements of paragraph (f)(2)(i) are
E:\FR\FM\07AUP2.SGM
07AUP2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
47741
decrease the annualized cost of the
proposed rule by about $457,000 using
a discount rate of 3 percent and by
about $480,000 using a discount rate of
7 percent. OSHA has not been able to
estimate the change in benefits resulting
from Regulatory Alternative #6 at this
time and invites public comment on this
issue.
In particular, OSHA is proposing the
requirements for exposure assessment to
provide a basis for ensuring that
appropriate measures are in place to
limit worker exposures. Medical
surveillance is especially important
because workers exposed above the
proposed TWA PEL, as well as many
workers exposed below the proposed
TWA PEL, are at significant risk of
death and illness. Medical surveillance
would allow for identification of
beryllium-related adverse health effects
at an early stage so that appropriate
intervention measures can be taken.
OSHA is proposing regulated areas and
access control because they serve to
limit exposure to beryllium to as few
employees as possible. OSHA is
proposing worker training to ensure that
employers inform employees of the
hazards to which they are exposed,
along with associated protective
measures, so that employees understand
how they can minimize their exposure
to beryllium. Worker training on
beryllium-related work practices is
particularly important in controlling
beryllium exposures because
engineering controls frequently require
action on the part of workers to function
effectively.
OSHA has examined a variety of
regulatory alternatives involving
changes to one or more of the proposed
ancillary provisions. The incremental
cost of each of these regulatory
alternatives and its impact on the total
costs of the proposed rule is
summarized in Table IX–22 at the end
of this section. OSHA has preliminarily
determined that several of these
ancillary provisions will increase the
benefits of the proposed rule, for
example, by helping to ensure the TWA
PEL is not exceeded or by lowering the
risks to workers given the significant
risk remaining at the proposed TWA
PEL. However, except for Regulatory
Alternative #7 (involving the
elimination of all ancillary provisions),
OSHA did not estimate changes in
monetized benefits for the regulatory
alternatives that affect ancillary
provisions. Two regulatory alternatives
that involve all ancillary provisions are
presented below (#7 and #8), followed
by regulatory alternatives for exposure
monitoring (#9, #10, and #11), for
regulated areas (#12), for personal
The proposed standard contains
several ancillary provisions (provisions
other than the exposure limits),
including requirements for exposure
assessment, medical surveillance,
medical removal, training, and regulated
areas or access control. As reported in
Chapter V of the PEA, these ancillary
provisions account for $27.8 million
(about 72 percent) of the total
annualized costs of the rule ($37.6
million) using a 3 percent discount rate,
or $28.6 million (about 73 percent) of
the total annualized costs of the rule
($39.1 million) using a 7 percent
discount rate. The most expensive of the
ancillary provisions are the
requirements for housekeeping and
training, with annualized costs of $12.6
million and $5.8 million, respectively,
at a 3 percent discount rate ($12.9
million and $5.8 million, respectively,
at a 7 percent discount rate).
OSHA’s reasons for including each of
the proposed ancillary provisions are
explained in Section XVIII of this
preamble, Summary and Explanation of
the Standards.
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
PO 00000
Frm 00177
Fmt 4701
Sfmt 4702
E:\FR\FM\07AUP2.SGM
07AUP2
EP07AU15.034</GPH>
alternative does not eliminate the need
for engineering controls to comply with
the proposed TWA PEL and STEL, but
does eliminate the requirement to use
one or more of the specified engineering
or work practice controls where
exposures equal or exceed the action
level. As shown in Table IX–21,
Regulatory Alternative #6 would
4. Regulatory Alternatives That Affect
Ancillary Provisions
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
not typical of OSHA standards, which
usually require engineering controls
only where exposures exceed the TWA
PEL or STEL. The Agency is therefore
considering Regulatory Alternative #6,
which would drop the provisions of
(f)(2)(i) from the proposed standard and
make conforming edits to paragraphs
(f)(2)(ii) and (iii). This regulatory
47742
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
protective clothing and equipment
(#13), for medical surveillance (#14
through #21), and for medical removal
(#22).
a. All Ancillary Provisions
The SBAR Panel recommended that
OSHA analyze a PEL-only standard as a
regulatory alternative. The Panel also
recommended that OSHA consider not
applying ancillary provisions of the
standard where exposure levels are low
so as to minimize costs for small
businesses (SBAR, 2008). In response to
these recommendations, OSHA
analyzed Regulatory Alternative #7, a
PEL-only standard, and Regulatory
Alternative #8, which would apply
ancillary provisions of the beryllium
standard only where exposures exceed
the proposed TWA PEL of 0.2 mg/m3 or
the proposed STEL of 2 mg/m3.
Regulatory Alternative #7 would
solely update 1910.1000 Tables Z–1 and
Z–2, so that the proposed TWA PEL and
STEL would apply to all workers in
general industry. This alternative would
eliminate all of the ancillary provisions
of the proposed rule, including
exposure assessment, medical
surveillance, medical removal, PPE,
housekeeping, training, and regulated
areas or access control. Under this
regulatory alternative, OSHA estimates
that the costs for the proposed ancillary
provisions of the rule (estimated at
$27.8 million annually at a 3 percent
discount rate) would be eliminated. In
order to meet the PELs, employers
would still commonly need to do
monitoring, train workers on the use of
controls, and set up some kind of
regulated areas to indicate where
respirator use would be required. It is
also likely that, under this alternative,
many employers would follow the
recommendations of Materion and the
United Steelworkers to provide medical
surveillance, PPE, and other protective
measures for their workers (Materion
and USW, 2012). OSHA has not
attempted to estimate the extent to
which these ancillary-provision costs
would be incurred if they were not
formally required or whether any of
these costs under Regulatory Alternative
#7 would reasonably be attributable to
the proposed rule. OSHA welcomes
comment on the issue.
OSHA has also estimated the effect of
this regulatory alternative on the
benefits of the rule. As a result of
eliminating all of the ancillary
provisions, annualized benefits are
estimated to decrease 57 percent,
relative to the proposed rule, from
$575.8 million to $249.1 million, using
a 3 percent discount rate, and from
$255.3 million to $110.4 million using
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
a 7 percent discount rate. This estimate
follows from OSHA’s analysis of
benefits in Chapter VII of the PEA,
which found that about 57 percent of
the benefits of the proposed rule,
evaluated at their mid-point value, were
attributable to the combination of the
ancillary provisions. As these estimates
show, OSHA expects that the benefits
estimated under the proposed rule will
not be fully achieved if employers do
not implement the ancillary provisions
of the proposed rule.
Both industry and worker groups have
recognized that a comprehensive
standard is needed to protect workers
exposed to beryllium. The stakeholders’
recommended standard that
representatives of the primary beryllium
manufacturing industry and the United
Steelworkers union provided to OSHA
confirms the importance of ancillary
provisions in protecting workers from
the harmful effects of beryllium
exposure (Materion and USW, 2012).
Ancillary provisions such as personal
protective clothing and equipment,
regulated areas, medical surveillance,
hygiene areas, housekeeping
requirements, and hazard
communication all serve to reduce the
risks to beryllium-exposed workers
beyond that which the proposed TWA
PEL alone could achieve.
Moreover, where there is continuing
significant risk at the TWA PEL, the
decision in the Asbestos case (Bldg. and
Constr. Trades Dep’t, AFL–CIO v. Brock,
838 F.2d 1258, 1274 (D.C. Cir. 1988))
indicated that OSHA should use its
legal authority to impose additional
requirements on employers to further
reduce risk when those requirements
will result in a greater than de minimis
incremental benefit to workers’ health.
Nevertheless, OSHA requests comment
on this alternative.
Under Regulatory Alternative #8,
several ancillary provisions that the
current proposal would require under a
variety of exposure conditions (e.g.,
dermal contact, any airborne exposure,
exposure at or above the action level)
would instead only apply where
exposure levels exceed the TWA PEL or
STEL. Regulatory Alternative #8 affects
the following provisions of the proposed
standard:
—Exposure monitoring: Whereas the
proposed standard requires annual
monitoring when exposure levels are
at or above the action level and at or
below the TWA PEL, Regulatory
Alternative #8 would require annual
exposure monitoring only where
exposure levels exceed the TWA PEL
or STEL;
—Written exposure control plan:
Whereas the proposed standard
PO 00000
Frm 00178
Fmt 4701
Sfmt 4702
requires written exposure control
plans to be maintained in any facility
covered by the standard, Regulatory
Alternative #8 would require only
facilities with exposures above the
TWA PEL or STEL to maintain a plan;
—Housekeeping: Whereas the proposed
standard’s housekeeping requirements
apply across a wide variety of
beryllium exposure conditions,
Alternative #8 would limit
housekeeping requirements to areas
and employees with exposures above
the TWA PEL or STEL;
—PPE: Whereas the proposed standard
requires PPE for employees under a
variety of conditions, such as
exposure to soluble beryllium or
visible contamination with beryllium,
Alternative #8 would require PPE
only for employees exposed above the
TWA PEL or STEL;
—Medical Surveillance: Whereas the
proposed standard’s medical
surveillance provisions require
employers to offer medical
surveillance to employees with signs
or symptoms of beryllium-related
health effects regardless of their
exposure level, Alternative #8 would
require surveillance only for those
employees exposed above the TWA
PEL or STEL.
To estimate the cost savings for this
alternative, OSHA re-estimated the
group of workers that would fall under
the above provisions and the changes to
their scope. Combining these various
adjustments along with associated unit
costs, OSHA estimates that, under this
regulatory alternative, the costs for the
proposed rule would decline from $37.6
million to $18.9 million using a 3
percent discount rate and from $39.1
million to $20.0 million using a 7
percent discount rate.
The Agency has not quantified the
impact of this alternative on the benefits
of the rule. However, ancillary
provisions that offer protective
measures to workers exposed below the
proposed TWA PEL, such as personal
protective clothing and equipment,
beryllium work areas, hygiene areas,
housekeeping requirements, and hazard
communication, all serve to reduce the
risks to beryllium-exposed workers
beyond that which the proposed TWA
PEL and STEL could achieve. OSHA’s
preliminary conclusion is that the
requirements triggered by the action
level and other exposures below the
proposed PELs will result in very real
and necessary, but difficult to quantify,
further reduction in risk beyond that
provided by the PELs alone.
The remainder of this section
discusses additional regulatory
alternatives that apply to individual
E:\FR\FM\07AUP2.SGM
07AUP2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
ancillary provisions. At this time, OSHA
is not able to quantify the effects of
these regulatory alternatives on benefits.
The Agency solicits comment on the
effects of these regulatory alternatives
on the benefits of the proposed rule.
b. Exposure Monitoring
Paragraph (d) of the proposed
standard, Exposure Monitoring, requires
annual monitoring where exposures are
at or above the action level and at or
below the TWA PEL. It does not require
periodic monitoring where exposure
levels have been determined to be below
the action level, or above the TWA PEL.
The rationale for this provision is
provided in this preamble discussion of
paragraph (a) in Section XVIII,
Summary and Explanation of the
Proposed Standard. Below is a brief
summary, followed by a discussion of
three alternatives.
Because of the variable nature of
employee exposures to airborne
concentrations of beryllium,
maintaining exposures below the action
level provides reasonable assurance that
employees will not be exposed to
beryllium at levels above the TWA PEL
on days when no exposure
measurements are made. Even when all
measurements on a given day fall at or
below the TWA PEL, if those
measurements are still at or above the
action level, there is a smaller safety
margin and a greater chance that on
another day, when exposures are not
measured, the employee’s exposure may
exceed the TWA PEL. When exposure
measurements are at or above the action
level, the employer cannot be
reasonably confident that employees
have not been exposed to beryllium
concentrations in excess of the TWA
PEL during at least some part of the
work week. Therefore, requiring
periodic exposure measurements when
the action level is met or exceeded
provides the employer with a reasonable
degree of confidence in the results of the
exposure monitoring. The proposed
action level that would trigger the
exposure monitoring is one-half of the
TWA PEL, which reflects the Agency’s
typical approach to setting action levels
(see, e.g., Inorganic arsenic (29 CFR
1910.1018), Ethylene oxide (29 CFR
1910.1047), Benzene (29 CFR
1910.1028), and Methylene Chloride (29
CFR 1910.1052)).
Certain other aspects of the proposed
periodic monitoring requirements,
which the Agency based on the
stakeholders’ recommended standard
submitted by Materion and the United
Steelworkers (Materion and USW,
2012), depart significantly from OSHA’s
usual exposure monitoring
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
requirements. The proposed standard
only requires annual monitoring, and
does not require periodic monitoring
when exposures are recorded above the
TWA PEL, whereas most OSHA
standards require monitoring at least
every 6 months when exposure levels
exceed the action level, and every 3
months when exposures are above the
TWA PEL. For example, the standards
for vinyl chloride (29 CFR 1910.1017),
inorganic arsenic (29 CFR 1910.1018),
lead (29 CFR 1910.1025), cadmium (29
CFR 1910.1027), methylene chloride (29
CFR 1910.1052), acrylonitrile (29 CFR
1910.1045), ethylene oxide (29 CFR
1910.1047), and formaldehyde (29 CFR
1910.1048), all specify periodic
monitoring at least every six months
when exposures are at, or above, the
action level. Monitoring is required
every three months when exposures
exceed the TWA PEL in the standards
for methylene chloride, ethylene oxide,
acrylonitrile, inorganic arsenic, lead,
and vinyl chloride. In the standards for
cadmium, 1,3-Butadiene, formaldehyde,
benzene and asbestos (29 CFR
1910.1001), monitoring is required
every six months when exposures
exceed the TWA PEL. In these
standards, monitoring workers exposed
above the TWA PEL ensures that
employers know workers’ exposure
levels in order to select appropriate
respirators and other PPE, and that
records of their exposures are available
if needed for medical, legal, or
epidemiological purposes.
OSHA has examined three regulatory
alternatives that would modify the
requirements of paragraph (d) to be
more similar to OSHA’s typical periodic
monitoring requirements. Under
Regulatory Alternative #9, employers
would be required to perform periodic
exposure monitoring every 180 days
when exposures are at or above the
action level or above the STEL, but at
or below the TWA PEL. As shown in
Table IX–22, Regulatory Alternative #9
would increase the annualized cost of
the proposed rule by about $773,000
using either a 3 percent or 7 percent
discount rate.
Under Regulatory Alternative #10,
employers would be required to perform
periodic exposure monitoring every 180
days when exposures are at or above the
action level or above the STEL,
including where exposures exceed the
TWA PEL. As shown in Table IX–22,
Regulatory Alternative #10 would
increase the annualized cost of the
proposed rule by about $929,000 using
either a 3 percent or 7 percent discount
rate.
Under Regulatory Alternative #11,
employers would be required to perform
PO 00000
Frm 00179
Fmt 4701
Sfmt 4702
47743
periodic exposure monitoring every 180
days when exposures are at or above the
action level, and every 90 days where
exposures exceed the TWA PEL or
STEL. This alternative is similar to the
periodic monitoring requirements in the
draft proposed rule presented to the
SERs during the 2007 OSHA beryllium
SBAR Panel process. Of the exposure
monitoring alternatives, it is also the
most similar to the exposure monitoring
provisions of most other 6(b)(5)
standards. As shown in Table IX–22,
Regulatory Alternative #11 would
increase the annualized cost of the
proposed rule by about $1.07 million
using either a 3 percent or 7 percent
discount rate.
c. Regulated Areas
Proposed paragraph (e) requires
employers to establish and maintain
beryllium work areas wherever
employees are exposed to airborne
beryllium, regardless of the level of
exposure, and regulated areas wherever
airborne concentrations of beryllium
exceed the TWA PEL or STEL.
Employers are required to demarcate
beryllium work areas and regulated
areas and limit access to regulated areas
to authorized persons.
The SBAR Panel report recommended
that OSHA consider dropping or
limiting the provision for regulated
areas (SBAR, 2008). In response to this
recommendation, OSHA examined
Regulatory Alternative #12, which
would eliminate the requirement that
employers establish regulated areas.
This alternative is meant only to
eliminate the requirement to set up and
demarcate specific physical areas: All
ancillary provisions would be triggered
by the same conditions as under the
standard’s definition of a ‘‘regulated
area.’’ For example, under the current
proposal, employees who work in
regulated areas for at least 30 days
annually are eligible for medical
surveillance. If OSHA were to remove
the requirement to establish regulated
areas, the medical surveillance
provisions would be altered so that
employees who work more than 30 days
annually in jobs or areas with exposures
that exceed the TWA PEL or STEL are
eligible for medical surveillance. This
alternative would not eliminate the
proposed requirement to establish
beryllium work areas. As shown in
Table IX–22, Regulatory Alternative #12
would decrease the annualized cost of
the proposed rule by about $522,000
using a 3 percent discount rate, and by
about $523,000 using a 7 percent
discount rate.
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47744
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
d. Personal Protective Clothing and
Equipment
Regulatory Alternative #13 would
modify the requirements for personal
protective equipment (PPE) by requiring
appropriate PPE whenever there is
potential for skin contact with beryllium
or beryllium-contaminated surfaces.
This alternative would be broader, and
thus more protective, than the PPE
requirement in the proposed standard,
which requires PPE to be used in three
circumstances: (1) Where exposure
exceeds the TWA PEL or STEL; (2)
where employees’ clothing or skin may
become visibly contaminated with
beryllium; and (3) where employees
may have skin contact with soluble
beryllium compounds. These PPE
requirements were based on the
stakeholders’ recommended standard
that Materion and the United
Steelworkers submitted to the Agency
(Materion and USW, 2012).
The proposed rule’s requirement to
use PPE where work clothing or skin
may become ‘‘visibly contaminated’’
with beryllium differs from prior
standards, which do not require
contamination to be visible in order for
PPE to be required. While OSHA’s
language regarding PPE requirements
varies somewhat from standard to
standard, previous standards tend to
emphasize potential for contact with a
substance that can trigger health effects
via dermal exposure, rather than
‘‘visible contamination’’ with the
substance. For example, the standard for
chromium (VI) requires the employer to
provide appropriate PPE where a hazard
is present or is likely to be present from
skin or eye contact with chromium (VI)
(29 CFR 1910.1026). The lead and
cadmium standards require PPE where
employees are exposed above the PEL or
where there is potential for skin or eye
irritation, regardless of airborne
exposure level. Under the
Methylenedianiline (MDA) standard (29
CFR 1910.1050), PPE must be provided
where employees are subject to dermal
exposure to MDA, where liquids
containing MDA can be splashed into
the eyes, or where airborne
concentrations of MDA are in excess of
the PEL.
OSHA requests comment on the
proposed PPE requirements in
Regulatory Alternative #13, which
would modify the proposed PPE
requirements to be similar to the
chromium (VI), lead, cadmium, and
MDA standards. Because small
beryllium particles can pass through
intact or broken skin and cause
sensitization, limiting the requirements
for PPE based on surfaces that are
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
‘‘visibly contaminated’’ may not
adequately protect workers from
beryllium exposure. Submicron
particles (less than 1 mg in diameter) are
not visible to the naked eye and yet may
pass through the skin and cause
beryllium sensitization. Although
solubility may play a role in the level
of sensitization risk, the available
evidence suggests that contact with
insoluble, as well as soluble, beryllium
can cause sensitization via dermal
contact (see this preamble at Section V,
Health Effects). Sensitized workers are
at significant risk of developing CBD
(see this preamble at Section V, Health
Effects, and Section VIII, Significance of
Risk).
To estimate the cost of Regulatory
Alternative #13, OSHA assumed that all
at-risk workers, except administrative
occupations, would require protective
clothing and a pair of work gloves that
would need to be replaced annually.
The economic analysis of the proposed
standard already contained costs for
protective clothing for all employees
whose clothing might be contaminated
by beryllium (the analysis assumed that
all clothing contamination would be
visible, or the clothing is already
provided even if not required by this
standard) and gloves for many jobs
where workers were expected to be
exposed to visible contamination or
soluble beryllium; thus OSHA estimated
the cost of this alternative as the cost of
providing gloves for the remainder of
the jobs where workers have potential
for skin exposure even in the absence of
visible contamination. As shown in
Table IX–22, Regulatory Alternative #13
would increase the annualized cost of
the proposed rule by about $138,000
using either a 3 percent or 7 percent
discount rate.
e. Medical Surveillance
The proposed requirements for
medical surveillance include: (1)
Medical examinations, including a test
for beryllium sensitization, for
employees who are exposed to
beryllium in a regulated area (i.e., above
the proposed TWA PEL or STEL) for 30
days or more per year, who are exposed
to beryllium in an emergency, or who
show signs or symptoms of CBD; and (2)
CT scans for employees who were
exposed above the proposed TWA PEL
or STEL for more than 30 days in a 12month period for 5 years or more. The
proposed standard would require
annual medical exams to be provided
for employees exposed in a regulated
area for 30 days or more per year and
for employees showing signs or
symptoms of CBD, while tests for
beryllium sensitization and CT scans
PO 00000
Frm 00180
Fmt 4701
Sfmt 4702
would be provided to eligible
employees biennially.
OSHA estimated in Chapter V of the
PEA that the medical surveillance
requirements would apply to 4,528
workers in general industry, of whom
387 already receive that surveillance.43
In Chapter V, OSHA estimated the costs
of medical surveillance for the
remaining 4,141 workers who would
now have such protection due to the
proposed standard. The Agency’s
preliminary analysis indicates that 4
workers with beryllium sensitization
and 6 workers with CBD will be referred
to pulmonary specialists annually as a
result of this medical surveillance.
Medical surveillance is particularly
important for this rule because
beryllium-exposed workers, including
many workers exposed below the
proposed PELs, are at significant risk of
illness. OSHA did not estimate, and the
benefits analysis does not include,
monetized benefits resulting from early
discovery of illness.
OSHA has examined eight regulatory
alternatives (#14 through #21) that
would modify the proposed rule’s
requirements for employee eligibility,
the tests that must be offered, and the
frequency of periodic exams. Medical
surveillance was a subject of special
concern to SERs during the SBAR Panel
process, and the SBAR Panel offered
many comments and recommendations
related to medical surveillance for
OSHA’s consideration. Some of the
Panel’s concerns have been partially
addressed in this proposal, which was
modified since the SBAR Panel was
convened (see this preamble at Section
XVIII, Summary and Explanation of the
Proposed Standard, for more detailed
discussion). Several of the regulatory
alternatives presented here (#16, #18,
and #20) also respond to
recommendations by the SBAR Panel to
reduce burdens on small businesses by
dropping or reducing the frequency of
medical surveillance requirements.
OSHA is also considering several
additional regulatory alternatives that
would increase the frequency of
surveillance or the range of employees
covered by medical surveillance (#14,
#15, #17, #19, and #21).
OSHA has preliminarily determined
that a significant risk of beryllium
sensitization, CBD, and lung cancer
exists at exposure levels below the
proposed TWA PEL and that there is
evidence that beryllium sensitization
can occur even from short-term
exposures (see this preamble at Section
V, Health Effects, and Section VIII,
43 See current compliance rates for medical
surveillance in Chapter V of the PEA, Table V–15.
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
Significance of Risk). The Agency
therefore anticipates that more
employees would develop adverse
health effects without receiving the
benefits of early intervention in the
disease process because they are not
eligible for medical surveillance (see
this preamble at Section V, Health
Effects).
OSHA is considering three regulatory
alternatives that would expand
eligibility for medical surveillance to a
broader group of employees than those
eligible under the proposed standard.
Under Regulatory Alternative #14,
medical surveillance would be available
to employees who are exposed to
beryllium above the proposed TWA PEL
or STEL, including employees exposed
for fewer than 30 days per year.
Regulatory Alternative #15 would
expand eligibility for medical
surveillance to employees who are
exposed to beryllium above the
proposed action level, including
employees exposed for fewer than 30
days per year. Regulatory Alternative
#21 would extend eligibility for medical
surveillance as set forth in proposed
paragraph (k) to all employees in
shipyards, construction, and general
industry who meet the criteria of
proposed paragraph (k)(1). However, all
other provisions of the standard would
be in effect only for employers and
employees that fall within the scope of
the proposed rule. Each of these
alternatives would provide surveillance
to fewer workers (and cost less to
employers) than the draft proposed rule
presented to SERs during the SBAR
Panel process, which included skin
contact as a trigger and would therefore
cover most beryllium-exposed workers
in general industry, construction, and
maritime. These alternatives would
provide more surveillance (and cost
more to employers) than the medical
surveillance requirements in the current
proposal.
To estimate the cost of Regulatory
Alternative #14, OSHA assumed that 1
person would enter regulated areas for
less than 30 days a year for every 4
people working in regulated areas on a
regular basis. Thus, this alternative
includes costs for an incremental
number of annual medical exams equal
to 25 percent of the number of workers
estimated to be working in regulated
areas after the standard is promulgated.
As shown in Table IX–22, Regulatory
Alternative #14 would increase the
annualized cost of the proposed rule by
about $38,000 using either a 3 percent
or 7 percent discount rate.
To estimate the cost of Regulatory
Alternative #15, OSHA assumed that all
workers exposed above the action level
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
before the standard would continue to
be exposed after the standard is
promulgated. OSHA also assumed that 1
person would enter areas exceeding the
action level for fewer than 30 days a
year for every 4 people working in an
area exceeding the action level on a
regular basis. Thus, this alternative
includes costs for medical exams for the
number of workers exposed between the
action level and the TWA PEL as well
as an incremental 25 percent of all
workers exposed above the action level.
As shown in Table IX–22, Regulatory
Alternative #15 would increase the
annualized cost of the proposed rule by
about $3.9 million using a discount rate
of 3 percent, and by about $4.0 million
using a discount rate of 7 percent.
For Alternative #21, OSHA is
considering two different scenarios to
estimate costs: One where the TWA PEL
for the groups outside the scope of the
proposed standard changes from 2 mg/
m3 to 0.2 mg/m3, as in Regulatory
Alternative #2; and one where the TWA
PEL remains at the current level of 2.0
mg/m3. For costing purposes, these have
been designated as Regulatory
Alternative #21a and Regulatory
Alternative #21b, respectively.
For Regulatory Alternative #21a,
medical surveillance above the
proposed TWA PEL of 0.2, OSHA
estimated the cost of extending medical
surveillance to workers in aluminum
production, abrasive blasting in
construction, maritime abrasive
blasting, maritime welding, and coal
fired power plants, assuming that all
feasible controls are in place to reduce
exposures to the proposed TWA PEL of
0.2 mg/m3 or lower. OSHA did not
include control costs to achieve
compliance with a TWA PEL of 0.2 mg/
m3, as these costs were addressed in
Regulatory Alternative #2. (For a
summary of the estimates of affected
workers and the exposure profile, see
the discussion accompanying
Regulatory Alternative # 2.) As shown
in Table IX–22, Regulatory Alternative
#21a would increase the annualized cost
of the proposed rule by about $4.4
million using a 3-percent discount rate
and $4.5 million using a 7-percent
discount rate.
For Alternative #21b, medical
surveillance above the current TWA
PEL of 2.0 mg/m3, OSHA estimated that
all abrasive blasters in construction and
shipyards who are currently above the
current TWA PEL of 2.0 mg/m3would be
eligible for medical surveillance. As
discussed under alternative #2, outside
of abrasive blasting, OSHA has
identified a small group of maritime
welders who may be exposed to
beryllium above the current TWA PEL
PO 00000
Frm 00181
Fmt 4701
Sfmt 4702
47745
in their work. Of these workers, 90
percent would be below the current
TWA PEL if their employers instituted
all feasible engineering and work
practice controls to meet the existing
standard. If they came into compliance
with the current PELs, they would not
be required to offer employees medical
surveillance under Alternative #21b.
OSHA estimated that the other 10
percent of these maritime welders, and
10 percent of workers in primary
aluminum production and coal-fired
power generation, with all feasible
engineering controls and work practices
in place, would still be exposed above
the current TWA PEL and would be
eligible for medical surveillance under
Alternative #21b. OSHA’s customary
method in preparing an economic
analysis of a new standard is to cost out
the incremental cost of the new
standard assuming full compliance with
existing standards. Finally, OSHA
estimated that 15 percent of the workers
excluded from the scope of the
proposed standard absent the alternative
would show signs and symptoms of
CBD or be exposed in emergencies, and
so would be eligible for medical
surveillance. As shown in Table IX–22,
under these assumptions Regulatory
Alternative #21b would increase the
annualized cost of the proposed rule by
about $3.0 million using a 3-percent
discount rate and $3.1 million using a
7-percent discount rate. The Agency
notes that, as abrasive blasters are the
primary application group with
beryllium exposure in construction and
shipyards, it is unlikely that as many as
15 percent of other workers would show
signs and symptoms of beryllium
exposure or be exposed to beryllium in
an emergency. Thus, OSHA believes the
stated cost of about $3.0 million may
overestimate the true costs for this
alternative and invites comment on this
issue.
In response to concerns raised during
the SBAR Panel process about testing
requirements, OSHA is considering two
regulatory alternatives that would
provide greater flexibility in the
program of tests provided as part of an
employer’s medical surveillance
program. Under Regulatory Alternative
#16, employers would not be required to
offer employees testing for beryllium
sensitization. As shown in Table IX–22,
this alternative would decrease the
annualized cost of the proposed rule by
about $710,000 using a discount rate of
3 percent, and by about $724,000 using
a discount rate of 7 percent.
Regulatory Alternative #18 would
eliminate the CT scan requirement from
the proposed rule. This alternative
would decrease the annualized cost of
E:\FR\FM\07AUP2.SGM
07AUP2
47746
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
the proposed rule by about $472,000
using a discount rate of 3 percent, and
by about $481,000 using a discount rate
of 7 percent.
OSHA is considering several
alternatives to the proposed frequency
of sensitization testing, CT scans, and
general medical examinations. The
frequency of periodic medical
surveillance is an important factor in
the efficacy of the surveillance in
protecting worker health. Regular,
appropriately frequent medical
surveillance promotes awareness of
beryllium-related health effects and
early intervention in disease processes
among workers. In addition, the longer
the time interval between when a
worker becomes sensitized and when
the worker’s case is identified in the
surveillance program, the more difficult
it will be to identify and address the
exposure conditions that led to
sensitization. Therefore, reducing the
frequency of sensitization testing would
reduce the usefulness of the
surveillance information in identifying
problem areas and reducing risks to
other workers. These concerns must be
weighed against the costs and other
burdens of surveillance.
Regulatory alternative #17 would
require employers to offer annual testing
for beryllium sensitization to eligible
employees, as in the draft proposal
presented to the SBAR Panel. As shown
in Table IX–22, this alternative would
increase the annualized cost of the
proposed rule by about $392,000 using
a discount rate of 3 percent, and by
about $381,000 using a discount rate of
7 percent.
Regulatory Alternative #19 would
similarly increase the frequency of
periodic CT scans from biennial to
annual scans, increasing the annualized
cost of the proposed rule by about
$459,000 using a discount rate of 3
percent, and by about $450,000 using a
discount rate of 7 percent.
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
Finally, under Regulatory Alternative
#20, employers would only have to
provide all periodic components of the
medical surveillance exams biennially
to eligible employees. This alternative
would decrease the annualized cost of
the proposed rule by about $446,000
using a discount rate of 3 percent and
by about $433,000 using a discount rate
of 7 percent.
f. Medical Removal
Under paragraph (l) of the proposed
standard, Medical Removal, employees
in jobs with exposure at or above the
action level become eligible for medical
removal when they are diagnosed with
CBD or confirmed positive for beryllium
sensitization. When an employee
chooses removal, the employer is
required to remove the employee to
comparable work in an environment
where beryllium exposure is below the
action level if such work is available
and the employee is either already
qualified or can be trained within one
month. If comparable work is not
available, paragraph (l) would require
the employer to place the employee on
paid leave for six months or until
comparable work becomes available
(whichever comes first). Or, rather than
choosing removal, an eligible employee
could choose to remain in a job with
exposure at or above the action level
and wear a respirator. The proposed
medical removal protection (MRP)
requirements are based on the
stakeholders’ recommended beryllium
standard that representatives of the
beryllium production industry and the
United Steelworkers union submitted to
OSHA in 2012 (Materion and USW,
2012).
The scientific information on effects
of exposure cessation is limited at this
time, but the available evidence suggests
that removal from exposure can be
beneficial for individuals who are
sensitized or have early-stage CBD (see
PO 00000
Frm 00182
Fmt 4701
Sfmt 4702
this preamble at Section VIII,
Significance of Risk). As CBD
progresses, symptoms become serious
and debilitating. Steroid treatment is
less effective at later stages, once
fibrosis has developed (see this
preamble at Section VIII, Significance of
Risk). Given the progressive nature of
the disease, OSHA believes it is
reasonable to conclude that removal
from exposure to beryllium will benefit
sensitized employees and those with
CBD. Physicians at National Jewish
Health, one of the main CBD research
and treatment sites in the US, ‘‘consider
it important and prudent for individuals
with beryllium sensitization and CBD to
minimize their exposure to airborne
beryllium,’’ and ‘‘recommend
individuals diagnosed with beryllium
sensitization and CBD who continue to
work in a beryllium industry to have
exposure of no more than 0.01
micrograms per cubic meter of
beryllium as an 8-hour time-weighted
average’’ (NJMRC, 2013). However,
OSHA is aware that MRP may prove
costly and burdensome for some
employers and that the scientific
literature on the effects of exposure
cessation on the development of CBD
among sensitized individuals and the
progression from early-stage to late-stage
CBD is limited.
The SBAR Panel report included a
recommendation that OSHA give careful
consideration to the impacts that an
MRP requirement could have on small
businesses (SBAR, 2008). In response to
this recommendation, OSHA analyzed
Regulatory Alternative #22, which
would remove the proposed
requirement that employers offer MRP.
As shown in Table IX–22, this
alternative would decrease the
annualized cost of the proposed rule by
about $149,000 using a discount rate of
3 percent, and by about $166,000 using
a discount rate of 7 percent.
E:\FR\FM\07AUP2.SGM
07AUP2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
47747
Table IX-22: Cost of Regulatory Alternatives Affecting Ancillary Provisions
(Proposed PEL=0.2, STEL=2.0, AL=0.1)
Incremental Cost
!3% Discount Ratel
Total Cost
Relative to Proposal
Proposed Rule
$37,597,325
Alternative 1b: Include Trace Contaminants; Offer Opt Out
for Trace Contaminant Industries with Objective Data
$49,863,812
-$27,807,451
Alternative 8: Ancillary provisions apply only when
exposure above PELISTEL
$18,917,028
-$18,680,297
Alternative 9: semiannual monitoring
when exposure between ALISTEL and PEL
$38,370,615
$773,291
Alternative 10: semiannual monitoring
when exposure above ALISTEL
$38,526,658
$929,333
Alternative 11: semiannual monitoring
when exposure above ALISTE,
quarterly monitoring when exposure above PEL
$38,670,043
$1,072,719
Alternative 12: No regulated areas,
ancillary provisions triggered by PEL or STEL
$37,075,072
-$522,252
Alternative 13: PPE wherever there is contact with
beryllium or beryllium contaminated surfaces
$37,735,352
$138,027
Alternative 14: No 30 day minimum for medical
surveillance in regulated areas
$37,635,572
$38,248
Alternative 15: No 30 day minimum for medical
surveillance and triggered by AL
$41,466,339
$3,869,014
Alternative 16: No BeLPTs in medical
surveillance
$36,887,307
-$710,018
Alternative 17: BeLPTs part of annual exam,
rather than biannually.
$37,989,639
$392,314
Alternative 18: No CT Scans
$37,124,958
-$472,367
Alternative 19: Annual CT scans rather than
biannual
$38,056,056
$458,732
Alternative 20: All periodic components of medical
surveillance are biannual
$37,150,975
-$446,349
Alternative 21a: Medical Surveillance (PEL 0.2)
$42,042,633
$4,445,308
Alternative 21b: Medical Surveillance (PEL 2.0)
$40,573,150
$2,975,826
Alternative 22: No medical removal protection
$37,448,499
Relative to the Prorx>sal
$12,266,488
$9,789,873
Incremental Benefits
Benefits
-$148,826
Alternative 7: Update Z table 1910.1000 only,
$575,826,633
$249,099,326
-$326, 727' 308
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
PO 00000
Frm 00183
Fmt 4701
Sfmt 4725
E:\FR\FM\07AUP2.SGM
07AUP2
EP07AU15.035</GPH>
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
(No ancillary provisions)
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
5. Timing
As proposed, the new standard would
become effective 60 days following
publication in the Federal Register. The
majority of employer duties in the
standard would become enforceable 90
days following the effective date.
Change rooms, however, would not be
required until one year after the
effective date, and the deadline for
engineering controls would be no later
than two years after the effective date.
OSHA invites suggestions for
alternative phase-in schedules for
engineering controls, medical
surveillance, and other provisions of the
standard. Although OSHA did not
explicitly develop or quantitatively
analyze any other regulatory alternatives
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
involving longer-term or more complex
phase-ins of the standard (possibly
involving more delayed implementation
dates for small businesses), some
general outcomes are likely. For
example, a longer phase-in time would
have several advantages, such as
reducing initial costs of the standard or
allowing employers to coordinate their
environmental and occupational safety
and health control strategies to
minimize potential costs. However, a
longer phase-in would also postpone
and reduce the benefits of the standard.
Suggestions for alternatives may apply
to specific industries (e.g., industries
where first-year or annualized cost
impacts are highest), specific sizeclasses of employers (e.g., employers
with fewer than 20 employees),
PO 00000
Frm 00184
Fmt 4701
Sfmt 4702
combinations of these factors, or all
firms covered by the rule.
OSHA requests comments on all these
regulatory alternatives, including the
Agency’s regulatory alternatives
presented above, the Agency’s analysis
of these alternatives, and whether there
are other regulatory alternatives the
Agency should consider.
I. Initial Regulatory Flexibility Analysis
The Regulatory Flexibility Act, as
amended in 1996, requires the
preparation of an Initial Regulatory
Flexibility Analysis (IRFA) for proposed
rules where there would be a significant
economic impact on a substantial
number of small entities. (5 U.S.C. 601–
612). Under the provisions of the law,
each such analysis shall contain:
E:\FR\FM\07AUP2.SGM
07AUP2
EP07AU15.036</GPH>
47748
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
1. A description of the impact of the
proposed rule on small entities;
2. A description of the reasons why
action by the agency is being
considered;
3. A succinct statement of the
objectives of, and legal basis for, the
proposed rule;
4. A description of and, where
feasible, an estimate of the number of
small entities to which the proposed
rule will apply;
5. A description of the projected
reporting, recordkeeping, and other
compliance requirements of the
proposed rule, including an estimate of
the classes of small entities which will
be subject to the requirements and the
type of professional skills necessary for
preparation of the report or record;
6. An identification, to the extent
practicable, of all relevant Federal rules
which may duplicate, overlap, or
conflict with the proposed rule;
7. A description and discussion of any
significant alternatives to the proposed
rule which accomplish the stated
objectives of applicable statutes and
which minimize any significant
economic impact of the proposed rule
on small entities, such as:
(a) The establishment of differing
compliance or reporting requirements or
timetables that take into account the
resources available to small entities;
(b) The clarification, consolidation, or
simplification of compliance and
reporting requirements under the rule
for such small entities;
(c) The use of performance rather than
design standards; and
(d) An exemption from coverage of
the rule, or any part thereof, for such
small entities.
5 U.S.C. 603, 607. The Regulatory
Flexibility Act further states that the
required elements of the IRFA may be
performed in conjunction with, or as
part of, any other agenda or analysis
required by any other law if such other
analysis satisfies the provisions of the
IRFA. 5 U.S.C. 605.
While a full understanding of OSHA’s
analysis and conclusions with respect to
costs and economic impacts on small
entities requires a reading of the
complete PEA and its supporting
materials, the IRFA summarizes the key
aspects of OSHA’s analysis as they
affect small entities.
1. A Description of the Impact of the
Proposed Rule on Small Entities
Section IX.F of this preamble
summarized the impacts of the
proposed rule on small entities. Table
IX–9 showed costs as a percentage of
profits and revenues for small entities,
classified as small by the Small
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
Business Administration, and Tables
IX–10 showed costs as a percentage of
revenues and profits for business
entities with fewer than 20 employees.
(The costs in these tables were
annualized using a discount rate of 3
percent.)
2. A Description of the Reasons Why
Action by the Agency Is Being
Considered
Chronic beryllium disease (CBD) is a
hypersensitivity, or allergic reaction, to
beryllium that leads to a chronic
inflammatory disease of the lungs. It
takes months to years after initial
beryllium exposure before signs and
symptoms of CBD occur. Removing an
employee with CBD from the beryllium
source does not always lead to recovery.
In some cases CBD continues to progress
following removal from beryllium
exposure. CBD is not a chemical
pneumonitis but an immune-mediated
granulomatous lung disease. OSHA’s
preliminary risk assessment, presented
in Section VI of this preamble, indicates
that there is significant risk of beryllium
sensitization and chronic beryllium
disease from a 45-year (working life)
exposure to beryllium at the current
TWA PEL of 2 mg/m3. The risk
assessment further indicates that there
is significant risk of lung cancer to
workers exposed to beryllium at the
current TWA PEL of 2 mg/m3. The
proposed standard, with a lower PEL of
.2 mg/m3, will help to address these
health concerns.
For CBD to occur, an employee must
first become sensitized (i.e., allergic) to
beryllium. Once an employee is
sensitized, inhaled beryllium that
deposits and persists in the lung may
trigger a cell-mediated immune
response (i.e., hypersensitivity reaction)
that results in the formation of a type of
lung scarring known as a granuloma.
The granuloma consists of a localized
mass of immune and inflammatory cells
that have formed around a beryllium
particle lodged in the interstitium,
which is tissue between the air sacs that
can be affected by fibrosis or scarring.
With time, the granulomas spread and
can lead to chronic cough, shortness of
breath (especially upon exertion),
fatigue, abnormal pulmonary function,
and lung fibrosis.
While CBD primarily affects the
lungs, it can also involve other organs
such as the liver, skin, spleen, and
kidneys. As discussed in more detail in
this preamble, some studies
demonstrate that sensitization and CBD
cases have occurred in workplaces that
use a wide range of beryllium
compounds, including several beryllium
salts, refined beryllium metal, beryllium
PO 00000
Frm 00185
Fmt 4701
Sfmt 4702
47749
oxide, and the beryllium alloys. While
water-soluble and insoluble beryllium
compounds have the potential to cause
sensitization, it has been suggested that
CBD is the result of occupational
exposure to beryllium oxide and other
water-insoluble berylliums rather than
exposure to water-soluble beryllium or
beryllium ores. However, there are
inadequate data, at this time, on
employees selectively exposed to
specific beryllium compounds to
eliminate a potential CBD concern for
any particular form of this metal.
Regardless of the type of beryllium
compound, in order to cause respiratory
disease the inhaled beryllium must
contain particulates that are small
enough to reach the bronchoalveolar
region of the lung where the disease
takes place (OSHA, 2007).
Some research suggests that skin
exposure to small beryllium particles or
beryllium-containing solutions may also
lead to sensitization (Tinkle et al.,
2003). These additional risk factors may
explain why some individuals with
seemingly brief, low level exposure to
airborne beryllium become sensitized
while others with long-term high
exposures do not. Other studies indicate
that even though employees sensitized
to beryllium do not exhibit clinical
symptoms, their immune function is
altered such that inhalation to
previously safe levels of beryllium can
now trigger serious lung disease (Kreiss
et al., 1996; Kreiss et al., 1997; Kelleher
et al., 2001 and Rossman, 2001).
In the 1980s, the laboratory blood test
known as the BeLPT was developed.
The test substantially improved
identification of beryllium-sensitized
individuals and provides an
opportunity to diagnose CBD at an early
stage. The BeLPT measures the ability of
immune cells (i.e., peripheral blood
lymphocytes) to react with beryllium. It
has been reported that the BeLPT can
identify 70 to 90 percent of those
sensitized with a high specificity
(approximately 1 to 3 percent false
positives) (Newman et al., 2001; Stange
et al., 2004).
An employee with an abnormal
BeLPT (i.e., the individual is sensitized)
can undergo fiber-optic bronchoscopy to
obtain a lung biopsy sample from which
granulomatous lung inflammation can
be pathologically observed prior to the
onset of symptoms. The combination of
a confirmed abnormal BeLPT (that is, a
second abnormal result from the BeLPT)
and microscopic evidence of granuloma
formation is considered diagnostic for
CBD. The BeLPT assists in
differentiating CBD from other
granulomatous lung diseases (e.g.,
sarcoidosis) with similar lung
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47750
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
pathology. This pre-clinical diagnostic
tool provides opportunities for early
intervention that did not exist when
diagnosis relied on clinical symptoms,
chest x-rays, and abnormal pulmonary
function (OSHA, 2007).
The BeLPT/lung biopsy diagnostic
approach has been utilized in several
occupational surveys and surveillance
programs over the last fifteen years. The
findings have expanded scientific
awareness of sensitization and CBD
prevalence among beryllium employees
and provided a better understanding of
its work-related risk factors. Some of the
more informative studies come from
nuclear weapons facilities operated by
the Department of Energy (Viet et al.,
2000; Stange et al., 2001; DOE/HSS
Report, 2006), a beryllium ceramics
plant in Arizona (Kreiss et al., 1996;
Henneberger et al., 2001; Cummings et
al., 2007), a beryllium production plant
in Ohio (Kreiss et al., 1997; Kent et al.,
2001), a beryllium machining facility in
Alabama (Kelleher et al., 2001; Madl et
al., 2007), and a beryllium alloy plant
(Shuler et al., 2005) and another
beryllium processing plant (Rosenman
et al., 2005), both in Pennsylvania. The
prevalence of beryllium sensitization
from these surveyed workforces
generally ranged from 1 to 10 percent
with a prevalence of CBD from 0.6 to 8
percent.
In most of the surveys discussed
above, 36–100 percent of those workers
who initially tested positive with the
BeLPT were diagnosed with CBD upon
pathological evaluation. Most of these
workers diagnosed with CBD had
worked four to10 years on the job,
although some were diagnosed within
several months of employment. Surveys
that found a high proportion (e.g., larger
than 50 percent) of CBD among the
sensitized employees were from
facilities with a large number of
employees who had been exposed to
respirable beryllium for many years. It
has been estimated from ongoing
surveillance of sensitized individuals,
with an average follow-up time of 4.5
years, that 37 percent of berylliumexposed employees were estimated to
progress to CBD (Newman et al, 2005).
Another study of nuclear weapons
facility employees enrolled in an
ongoing medical surveillance program
found that only about 20 percent of
sensitized individuals employed less
than five years eventually were
diagnosed with CBD while 40 percent of
sensitized employees employed ten
years or more developed CBD (Stange et
al., 2001). This observation, along with
the study findings that CBD prevalence
increases with cumulative exposure
(described below), suggests that
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
sensitized employees who acquire a
higher lung burden of beryllium may be
at greater risk of developing CBD than
sensitized employees who have lesser
amounts of beryllium in their lungs.
The greatest prevalence of
sensitization and CBD were reported for
production processes that involve
heating beryllium metal (e.g., furnace
operations, hot wire pickling, and
annealing) or generating and handling
beryllium powder (e.g., machining,
forming, firing). For example, nearly 15
percent of machinists at the Arizona
beryllium ceramics plant were
sensitized, compared to just 1 percent of
workers who never worked in
machining (Kreiss et al., 1996). A low
prevalence of sensitization and CBD was
reported among current employees at
the Department of Energy (DOE) cleanup sites where beryllium was once used
in the production of nuclear weapons
(DOE/OSS, 2006). These sites have been
subject to the DOE CBD-prevention
programs since 1999. While the
prevalence of sensitization and CBD in
non-production jobs was less, cases of
CBD were found among secretaries,
office employees, and security guards.
CBD cases have also been reported in
downstream uses of beryllium such as
dental laboratories and metal recycling
(OSHA, 2007).
The potential importance of respirable
and ultrafine beryllium particulates in
the onset of CBD is illustrated in studies
of employees at a large beryllium metal,
alloy, and oxide production plant in
Ohio. An initial cross-sectional survey
reported that the highest prevalence of
sensitization and CBD occurred among
workers employed in beryllium metal
production, even though the highest
airborne total mass concentrations of
beryllium were generally among
employees operating the beryllium alloy
furnaces in a different area of the plant
(Kreiss et al., 1997). Preliminary followup investigations of particle sizespecific sampling at five furnace sites
within the plant determined that the
highest respirable (e.g., particles less
than10 mm in diameter) and alveolardeposited (e.g., particles less than1 mm
in diameter) beryllium mass and
particle number concentrations, as
collected by a general area impactor
device, were measured at the beryllium
metal production furnaces rather than
the beryllium alloy furnaces (Kent et al.,
2001; McCawley et al., 2001). A
statistically significant linear trend was
reported between the above alveolardeposited particle mass concentration
and prevalence of CBD and sensitization
in the furnace production areas. On the
other hand, a linear trend was not found
for CBD and sensitization prevalence
PO 00000
Frm 00186
Fmt 4701
Sfmt 4702
and total beryllium mass concentration.
The authors concluded that these
findings suggest that alveolar-deposited
particles may be a more relevant
exposure metric for predicting the
incidence of CBD or sensitization than
the total mass concentration of airborne
beryllium (OSHA, 2007).
Several epidemiological cohort
studies have reported excess lung
cancer mortality among workers
employed in U.S. beryllium production
and processing plants during the 1930s
to 1960s. The largest and most
comprehensive study investigated the
mortality experience of over 9,000
workers employed in seven different
beryllium processing plants over a 30
year period (Ward et. al., 1992). The
employees at the two oldest facilities
(i.e., Lorain, OH and Reading, PA) were
found to have significant excess lung
cancer mortality relative to the U.S.
population. These two plants were
believed to have the highest exposure
levels to beryllium. A different analysis
of the lung cancer mortality in this
cohort using various local reference
populations and alternate adjustments
for smoking generally found smaller,
non-significant, excess mortality among
the beryllium employees (Levy et al.,
2002). All the cohort studies are limited
by a lack of job history and air
monitoring data that would allow
investigation of mortality trends with
beryllium exposure.
The weight of evidence indicates that
beryllium compounds should be
regarded as potential occupational lung
carcinogens, and OSHA has regulated it
since 1974. Other organizations, such as
the International Agency for Research
on Cancer (IARC), the National
Toxicology Program (NTP), the U.S.
Environmental Protection Agency
(EPA), the National Institute for
Occupational Safety and Health
(NIOSH), and the American Conference
of Governmental Industrial Hygienists
(ACGIH) have reached similar
conclusions with respect to the
carcinogenicity of beryllium.
3. A Statement of the Objectives of, and
Legal Basis for, the Proposed Rule
The objective of the proposed
beryllium standard is to reduce the
number of fatalities and illnesses
occurring among employees exposed to
beryllium. This objective will be
achieved by requiring employers to
install engineering controls where
appropriate and to provide employees
with the equipment, respirators,
training, medical surveillance, and other
protective measures to perform their
jobs safely. The legal basis for the rule
is the responsibility given the U.S.
E:\FR\FM\07AUP2.SGM
07AUP2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
Department of Labor through the
Occupational Safety and Health Act of
1970 (OSH Act). The OSH Act provides
that, in promulgating health standards
dealing with toxic materials or harmful
physical agents, the Secretary ‘‘shall set
the standard which most adequately
assures, to the extent feasible, on the
basis of the best available evidence that
no employee will suffer material
impairment of health or functional
capacity even if such employee has
regular exposure to the hazard dealt
with by such standard for the period of
his working life.’’ 29 U.S.C. 655(b)(5).
See Section II of this preamble for a
more detailed discussion.
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
4. A Description of, and an Estimate of,
the Number of Small Entities to Which
the Proposed Rule Will Apply
OSHA has completed a preliminary
analysis of the impacts associated with
this proposed rule, including an
analysis of the type and number of small
entities to which the proposed rule
would apply. In order to determine the
number of small entities potentially
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
affected by this rulemaking, OSHA used
the definitions of small entities
developed by the Small Business
Administration (SBA) for each industry.
The proposed standard would impact
occupational exposures to beryllium in
all forms, compounds, and mixtures in
general industry. Based on the
definitions of small entities developed
by SBA for each industry, the proposal
is estimated to potentially affect a total
of 3,741 small entities as shown in
Table IX–1 in Chapter IX of the PEA.
The Agency also estimated costs and
conducted a screening analysis for very
small employers (those with fewer than
20 employees). OSHA estimates that
approximately 2,875 very small entities
would be affected by the proposed
standard, as shown in Table III–13 in
Chapter III of the PEA.
5. A Description of the Projected
Reporting, Recordkeeping, and Other
Compliance Requirements of the
Proposed Rule
Tables IX–23 and IX–24 show the
average costs of the proposed standard
PO 00000
Frm 00187
Fmt 4701
Sfmt 4702
47751
by NAICS code and by compliance
requirement (PEL/STEL or ancillary
provisions) for, respectively, small
entities (classified as small by SBA) and
very small entities (those with fewer
than 20 employees). Total costs are
reported as N/A for NAICS codes with
no affected entities in the relevant size
classification. The weighted average
cost per small entity for the proposed
rule would be about $8,638 annually,
with PEL/STEL compliance accounting
for about 23 percent of the costs and
ancillary provisions accounting for
about 77 percent of the costs.
The weighted average cost per very
small entity for the proposed rule would
be about $2,212 annually, with PEL/
STEL compliance accounting for about
39 percent of the costs and ancillary
provisions accounting for about 61
percent of the costs.
E:\FR\FM\07AUP2.SGM
07AUP2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
Table IX-23
Average Costs for Small Entities Affected by the ProJllsed Beryllium Standard (20 10 dollars)
PEL
Compliance
Ancillary
(lncludes
lndustr
Provisons
Application
Grou
NAICS
Beryllium Production
331419 Primary Smelting and Refining ofNonferrous Metals
Beryllium Oxide Ceramics and Composites
327113a Porcelain electrical supply manufacturing (primary)
327113b Porcelain electrical supply manufacturing (secondary)
334220 Cellular telephones manufacturing
334310 Compact disc players manufacturing
334411 Electron Tube Manufacturing BeO traveling wave tubes
334415 Electronic res is tor manufacturing
334419 Other electronic component manufacturing
334510 Electromedical equipment manufacturing
336322b Other motor vehicle electrical & electronic equipment
Nonferrous Foundries
331521 Aluminum die-casting foundries
331522 Nonferrous (except aluminum) die-casting foundries
331524 Aluminumfoundries (except die-casting)
331525a Copper foundries (except die-casting) (non-sand casting foundries)
331525b Copper foundries (except die-casting) (sand casting foundries)
Secondary Smelting, Refining, and Alloying
331314 Secondary smelting & alloying of aluminum
331421b Copper rolling, drawing, and extruding
331423 Secondary smelting, refining, & alloying of copper
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Secondary Smelting, Refining, and Alloying ofNonferrous Metal
331492 (Except Copper and Aluminum)
Precision Machining
332721a Precision turned product manufacturing (high beryllium content)
332721b Precision turned product manufacturing (low beryllium content)
Copper Rolling, Drawing and Extruding
331421a Copper rolling, drawing, and extruding
331422 Copper wire (except mechanical) drawing
Stamping, Spring, and Connector Manufacturing
332612 light gauge spring manufacturing
332116 Metals tamping
334417 Electronic connector manufacturing
336322a Other motor vehicle electrical & electronic equipment
Arc and Gas Welding
331111 Iron and Steel Mills
331221 Rolled Steel Shape Manufacturing
331513 Steel Foundries (except Investment)
332117 Powder Metallurgy Part Manufacturing
332212 Hand and Edge Tool Manufacturing
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
PO 00000
Frm 00188
Fmt 4701
Sfmt 4725
Total
N/A
N/A
N/A
$85,376
$5,478
$5,901
$5,331
$6,721
$5,812
$5,357
$5,268
$5,735
$10,438
$7,502
$13,417
$11,438
$14,878
$9,241
$7,625
$3,545
$12,681
$95,814
$12,979
$19,319
$16,769
$21,599
$15,052
$12,982
$8,812
$18,416
$24,256
$23,001
$25,338
$25,540
$27,012
$14,141
$12,013
$15,180
$15,755
$18,120
$38,397
$35,015
$40,518
$41,295
$45,132
$22,432
$22,432
$23,335
$11,325
$11,775
$11,767
$33,757
$34,206
$35,102
$11,155
$11,029
$22,183
$8,643
$2,904
$10,839
$11,304
$19,482
$14,208
$2,316
$2,867
$116,815
$102,598
$119,132
$105,465
$2,035
$1,935
$1,905
$2,032
$5,242
$6,460
$3,860
$8,017
$7,277
$8,395
$5,765
$10,049
$3,613
$3,879
$2,472
$2,113
$2,234
$6,764
$8,663
$6,185
$6,166
$4,803
$10,377
$12,541
$8,657
$8,278
$7,037
E:\FR\FM\07AUP2.SGM
07AUP2
EP07AU15.037</GPH>
47752
47753
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
Application
Grou
NAICS
332312
332313
332322
332323
332439
332919
332999
333111
333414a
333911
333922
333924
333999
336211
336214
336399a
336510
336999
337215
811310
Resistance Welding
333411
333412
333414b
Table IX-23, continued
Average Costs for Small Entities Affected by the ProJllsed Beryllium Standard (20 10 dollars)
PEL
Compliance
(lncludes
Ancillary
lndustr
Provisons
Fabricated Structural Metal Manufacturing
$2,111
$3,%4
Plate Work Manufacturing
$2,597
$4,783
Sheet Metal Work Manufacturing
$2,459
$4,552
Ornamental and Architectural Metal Work Manufacturing
$2,289
$4,258
Other Metal Container Manufacturing
$1,975
$3,883
Other Metal Valve and Pipe Fitting Manufacturing
$1,927
$4,374
All Other Miscellaneous Fabricated Metal Product Manufacturing
$2,376
$4,407
Farm Machinery and Equipment Manufacturing
$1,304
$2,594
$1,933
$3,836
Heating Equipment (except Warm Air Furnaces) Manufacturing
Pump and Pumping Equipment Manufacturing
$1,455
$3,002
Conveyor and Conveying Equipment Manufacturing
$2,370
$4,439
$3,116
$6,006
Industrial Truck, Tractor, Trailer, and Stacker Machinery Manufacturing
All Other Miscellaneous General Purpose Machinery Manufacturing
$1,820
$3,463
Motor Vehicle Body Manufacturing
$3,201
$5,854
$2,914
Travel Trailer and Camper Manufacturing
$1,490
All Other Motor Vehicle Parts Manufacturing
$3,302
$6,143
Railroad Rolling Stock
$4,298
$8,685
All Other Transportation Equipment Manufacturing
$1,291
$3,048
$2,253
$4,713
Showcase, Partition, Shelving, and Locker Manufacturing
$3,565
Commercial and Indus trial Machinery and Equipment Repair
$1,880
Total
$6,076
$7,379
$7,010
$6,548
$5,858
$6,301
$6,782
$3,899
$5,769
$4,457
$6,809
$9,122
$5,282
$9,055
$4,404
$9,445
$12,983
$4,339
$6,966
$5,445
Air Purification Equipment Manufacturing
Indus trial and Commercial Fan and Blower Manufacturing
Heating Equipment (except Warm Air Furnaces) Manufacturing
$0
$0
$0
$8,363
$11,780
$10,186
$8,363
$11,780
$10,186
333415
335211
335212
335221
335222
335224
335228
336311
336312
336321
336322c
Air-Conditioning, Warm Air Heating, and Indus trial Refrigeration
Equipment Manufacturing
Electric Housewares and Household Fan Manufacturing
Household Vacuum Cleaner Manufacturing
Household Cooking Appliance Manufacturing
Household Refrigerator and Home Freezer Manufacturing
Household Laundry Equipment Manufacturing
Other Major Household Appliance Manufacturing
Carburetor, Piston, Piston Ring, and Valve Manufacturing
Gasoline Engine and Engine Parts Manufacturing
Vehicular lighting Equipment Manufacturing
Other Motor Vehicle Electrical and Electronic Equipment Manufacturing
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$0
$18,247
$15,789
$17,638
$15,870
$16,548
$8,274
$1,740
$5,227
$16,015
$6,084
$16,355
$18,247
$15,789
$17,638
$15,870
$16,548
$8,274
$1,740
$5,227
$16,015
$6,084
$16,355
336330
336340
336350
336360
Motor Vehicle Steering and Suspension Components (except Spring)
Manufacturing
Motor Vehicle Brake System Manufacturing
Motor Vehicle Transmission and Power Train Parts Manufacturing
Motor Vehicle Seatin and Interior Trim Manufacturin
$0
$0
$0
$0
$17,707
$18,828
$18,037
$6,586
$17,707
$18,828
$18,037
$6,586
Table IX-23, continued
Dental laboratories
Offices of dentists
$494
$577
$900
$1,053
$1,394
$1,630
$1,969
$6,669
$8,638
Source: OSHA, Directorate of Standards and Guidance, Office ofRegulatory Analysis.
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
PO 00000
Frm 00189
Fmt 4701
Sfmt 4725
E:\FR\FM\07AUP2.SGM
07AUP2
EP07AU15.038</GPH>
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
NAICS
336370
336391
336399b
Dental Laboratories
339116
621210
Total
$8,894
$16,715
$17,568
Weighted Average
Application
Grou
Average Costs for Small Entities Affected by the ProJllsed Beryllium Standard (20 10 dollars)
PEL
Compliance
(lncludes
Ancillary
lndustr
Res
Provisions
Motor Vehicle Metal Stamping
$8,894
Motor Vehicle Air-Conditioning Manufacturing
$0
$16,715
All Other Motor Vehicle Parts Manufacturing
$0
$17,568
47754
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
TaHe IX-24
Average Costs for Very Small Entities (<20 em!ioyees) Affected by the Proposed Beryllium Staodard (20 10 dollars)
Ap!iication
Grou
NAICS
lndustr
Beryllium Production
331419 Primary Smelting and Refining ofNonferrous Metals (Brush Wellman)
Beryllium Oxide Ceramics and Composites
327113a Porcelain electrical supply manufacturing (primary)
327113b Porcelain electrical supply manufacturing (secondary)
334220 Cellular telephones manufacturing
334310 Compact disc players manufacturing
334411 Electron Tube Manufacturing BeO traveling wave tubes
334415 Electronic resistor manufacturing
334419 Other electronic component manufacturing
334510 Electromedical equipment manufacturing
336322b Other motor vehicle electrical & electronic equipment
Nonferrous Foundries
331521 Aluminum die-casting foundries
331522 Nonferrous (except aluminum) die-casting foundries
331524 Aluminum foundries (except die-casting)
331525a Copper foundries (except die-casting) (non-sand casting foundries)
331525b Copper foundries (except die-casting) (sand casting foundries)
Secondary Smelting, Refining, and Alloying
331314 Secondary smelting & alloying of aluminum
331421b Copper rolling, drawing, and extruding
331423 Secondary smelting, refining, & alloying of copper
Secondary Smelting, Refining, and Alloying ofNonferrous Metal
331492 (Except Copper and Aluminum)
Precision Machining
332721a Precision turned product manufacturing (high beryllium content)
332721b Precision turned product manufacturing (low beryllium content)
Copper Rolling, Drawing and Extruding
331421a Copper rolling, drawing, and extruding
331422 Copper wire (except mechanical) drawing
Stamping, Spring, and Connector Manufacturing
332612 light gauge spring manufacturing
332116 Metals tamping
334417 Electronic connector manufacturing
336322a Other motor vehicle electrical & electronic equipment
Arc and Gas Welding
PEL
Com!iiance
(lncludes
Ancillary
Provisions
Total
N/A
N/A
N/A
N/A
$5,176
$5,182
$5,202
$5,172
$5,176
$5,179
$5,171
$5,198
N/A
$1,670
$1,091
$3,181
$1,258
$1,673
$1,783
$1,099
$1,170
N/A
$6,846
$6,273
$8,383
$6,430
$6,849
$6,%2
$6,271
$6,368
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
$19,724
N/A
N/A
$1,864
N/A
N/A
$21,589
$9,626
$1,430
$11,055
$3,033
$1,023
$3,849
$4,022
$6,882
$5,046
$1,133
$1,304
$4,550
$6,379
$5,684
$7,682
$1,839
$1,846
$1,841
$1,851
$1,471
$1,697
$1,173
$1,157
$3,310
$3,543
$3,014
$3,007
N/A
N/A
N/A
N/A
N/A
N/A
Powder Metallurgy Part Manufacturing
N/A
N/A
N/A
Hand and Edge Tool Manufacturing
$782
$2,389
$3,171
19:20 Aug 06, 2015
Jkt 235001
PO 00000
Frm 00190
Fmt 4701
Sfmt 4725
E:\FR\FM\07AUP2.SGM
07AUP2
EP07AU15.039</GPH>
N/A
N/A
N/A
332212
VerDate Sep<11>2014
Iron and Steel Mills
Rolled Steel Shape Manufacturing
Steel Foundries (except Investment)
332117
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
331111
331221
331513
47755
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
TaHe IX-24, continued
Average Costs for Very Small Entities (<20 em!ioyees) Affected~ the Proposed Beryllium Standard (2010 dollars)
PEL
Com!iiance
(lncludes
Ancillary
Ap!iication
Grou
NAICS
lndustr
Provisions
332312 Fabricated Structural Metal Manufacturing
$1,584
332313 Plate Work Manufacturing
$935
$1,956
332322 Sheet Metal Work Manufacturing
$834
$1,786
$2,121
332323 Ornamental and Architectural Metal Work Manufacturing
$1,032
332439 Other Metal Container Manufacturing
$726
$1,745
332919 Other Metal Valve and Pipe Fitting Manufacturing
$834
$3,469
$1,748
332999 All Other Miscellaneous Fabricated Metal Product Manufacturing
$812
333111 Farm Machinery and Equipment Manufacturing
$715
$1,584
333414a Heating Equipment (except Warm Air Furnaces) Manufacturing
$732
$1,805
$727
$1,750
333911 Pump and Pumping Equipment Manufacturing
$717
$1,619
333922 Conveyor and Conveying Equipment Manufacturing
333924 Industrial Truck, Tractor, Trailer, and Stacker Machinery Manufacturing
$750
$2,011
333999 All Other Miscellaneous General Purpose Machinery Manufacturing
$715
$1,583
336211 Motor Vehicle Body Manufacturing
$715
$1,583
336214 Travel Trailer and Camper Manufacturing
$715
$1,585
336399a All Other Motor Vehicle Parts Manufacturing
$723
$1,702
336510 Railroad Rolling Stock
N/A
N/A
336999 All Other Transportation Equipment Manufacturing
$764
$2,174
337215 Showcase, Partition, Shelving, and Locker Manufacturing
$771
$2,264
811310 Commercial and Industrial Machinery and Equipment Repair
$1,327
$2,623
Res is lance Welding
$0
$0
333411 Air Purification Equipment Manufacturing
$0
$2,506
333412 Indus trial and Commercial Fan and Blower Manufacturing
$0
$2,401
333414b Heating Equipment (except Warm Air Furnaces) Manufacturing
$0
$2,321
333415
335211
335212
335221
335222
335224
335228
336311
336312
336321
336322c
336330
336340
336350
336360
Air-Conditioning, Warm Air Heating, and Indus trial Refrigeration
Equipment Manufacturing
Electric Housewares and Household Fan Manufacturing
Household Vacuum Cleaner Manufacturing
Household Cooking Appliance Manufacturing
Household Refrigerator and Home Freezer Manufacturing
Household Laundry Equipment Manufacturing
Other Major Household Appliance Manufacturing
Carburetor, Pis ton, Pis ton Ring, and Valve Manufacturing
Gasoline Engine and Engine Parts Manufacturing
Vehicular Lighting Equipment Manufacturing
Other Motor Vehicle Electrical and Electronic Equipment Manufacturing
Motor Vehicle Steering and Suspension Components (except Spring)
Manufacturing
Motor Vehicle Brake System Manufacturing
Motor Vehicle Transmission and Power Train Parts Manufacturing
Motor Vehicle Seatin and Interior TrimManufacturin
Total
$2,299
$2,891
$2,620
$3,153
$2,471
$4,302
$2,560
$2,299
$2,536
$2,477
$2,335
$2,761
$2,298
$2,298
$2,300
$2,424
N/A
$2,938
$3,035
$3,949
$0
$2,506
$2,401
$2,321
$0
$0
N/A
$0
N/A
N/A
N/A
$0
$0
$0
$0
$1,094
$1,151
N/A
$1,056
N/A
N/A
N/A
$1,395
$1,331
$1,056
$1,452
$1,094
$1,151
N/A
$1,056
N/A
N/A
N/A
$1,395
$1,331
$1,056
$1,452
$0
$0
$0
$0
$1,056
$1,056
$1,056
$1,056
$1,056
$1,056
$1,056
$1,056
TaHe IX-24, continued
Ap!iication
Group
Average Costs for Very Small Entities (<20 em!ioyees) Affected o/ the Proposed Beryllium Standard(2010 dollars)
PEL
Com!iiance
(lncludes
Ancillary
NAICS
Industry
Respirators)
Provisions
336370 Motor Vehicle Metal Stamping
$0
$1,329
Motor Vehicle Air-Conditioning Manufacturing
All Other Motor Vehicle Parts Manufacturing
Total
$1,329
$862
$1,350
$2,212
$0
$923
$1,465
Source: OSHA, Directorate of Standards and Guidance, Office of Regulatory Analysis.
6. Federal Rules Which May Duplicate,
Overlap or Conflict With the Proposed
Rule
Section 4(b)(1) of the OSH Act
exempts the working conditions for
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
certain Federal and non-Federal
employees from the provisions of the
OSH Act to the extent that other Federal
agencies exercise statutory authority to
prescribe and enforce occupational
safety and health standards. The
PO 00000
Frm 00191
Fmt 4701
Sfmt 4702
Department of Energy (DOE) issued a
regulation in 1999 entitled Chronic
Beryllium Disease Prevention Program
(CBDPP) (10 CFR part 850, 64 FR
68854–68914, December 8, 1999).
Additionally, DOE issued 10 CFR part
E:\FR\FM\07AUP2.SGM
07AUP2
EP07AU15.040</GPH>
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
$1,056
$1,267
$0
$598
$947
$1,056
$1,267
Dental laboratories
Offices of dentists
$0
$0
$0
$325
$518
Weighted Average
336391
336399b
Dental Laboratories
339116
621210
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47756
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
851, Worker Safety and Health Program
(71 FR 6931–6948, February 9, 2006),
which establishes requirements for
worker safety and health for DOE
contractors at DOE sites. The CBDPP
establishes a beryllium program for DOE
employees and DOE contractor
employees. Therefore, under Section
4(b)(1) of the OSH Act, OSHA’s
beryllium standard would not apply to
work subject to the CBDPP. DOE has
included in its regulations a
requirement for compliance with any
more stringent PEL established by
OSHA in rulemaking (10 CFR 850.22).
OSHA requests comment on the
potential overlap of DOE’s rule with
OSHA’s proposed rule. (See I. Issues
and Alternatives in this preamble).
There is also a Federal statute
addressing the compensation of some
employees with beryllium related
illnesses—The Energy Employees
Occupational Illness Compensation
Program Act (EEOICPA) of 2000 and its
subsequent amendments. The EEOICPA
creates a Federal employees’
compensation program that covers
beryllium-related health effects for DOE
employees and its contractor employees,
including many private companies that
work away from DOE sites. Several of
the private companies whose employees
are covered by the OSH Act, either
directly in amendments to the OSH Act
or identified in subsequent Department
of Labor regulations on that Act, would
be covered by an OSHA occupational
health standard for beryllium and
EEOICPA.
There would be no conflict or
duplication, however, between an
OSHA standard and the EEOICPA. In
general, the OSHA standard would have
requirements to protect employee health
in the future, and the EEOICPA provides
compensation for employees who have
developed beryllium-related illness.
There is some overlap between the two
in that they may both require similar
medical examinations, or require
employers to provide some
compensation to employees, but the
proposed OSHA standard specifically
contemplates and addresses that overlap
to avoid conflict and duplication. The
explanation for proposed paragraph (k)
in Section XVIII of this preamble,
Summary and Explanation, notes that
employers may satisfy the both
examination requirements with a single
examination, and the proposed standard
specifies that the amount of an
employer’s financial obligations will be
reduced by the amount of EEOICPA
payments received by that employee
(see proposed paragraph (l)(4)).
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
7. Alternatives to the Proposed Rule
Which Accomplish the Stated
Objectives of Applicable Statutes and
Which Minimize Any Significant
Economic Impact of the Proposed Rule
on Small Entities
This section first discusses several
provisions in the proposed standard that
OSHA has adopted or modified based
on comments from small entity
representatives (SERs) during the
SBREFA process or on
recommendations made by the SBAR
Panel as potentially alleviating impacts
on small entities. Then, the Agency
presents various regulatory alternatives
to the proposed OSHA beryllium
standard.
a. Elements of the Proposed Rule To
Reduce Impacts on Small Entities
During the SBAR Panel, SERs
requested a clearer definition of the
triggers for medical surveillance. This
concern was rooted in the cost of
BeLPTs and the trigger of potential skin
contact. For the proposed rule, the
Agency has removed skin contact as a
trigger for medical surveillance along
with providing four clearly defined
trigger mechanisms. The newly defined
medical surveillance provision reduces
the number of employees requiring a
BeLPT, particularly for small businesses
with low exposures.
Some of the SERs in low-exposure
industries wanted to be ‘‘shielded’’ from
‘‘expensive’’ compliance with a
standard they perceive to be
unnecessary and suggested a PEL-only
standard that triggered provisions on the
PEL. The alternative of a PEL-only
standard and ancillary provisions
triggered only by the PEL are discussed
in Chapter 8 of the PEA (and is repeated
in the following section).
Some SERs were already applying
many of the protective controls and
practices that would be required by the
ancillary provisions of the standard.
However, many SERs objected to the
requirements regarding hygiene
facilities. For this proposed rule, OSHA
has preliminarily concluded that all
affected employers currently have hand
washing facilities. OSHA has also
preliminarily concluded that no affected
employers will be required to install
showers. The Agency has determined
that the long-term rental of modular
units was representative of costs for a
range of reasonable approaches to
comply with the change room part of
the provision. Alternatively, employers
could renovate and rearrange their work
areas in order to meet the requirements
of this provision.
PO 00000
Frm 00192
Fmt 4701
Sfmt 4702
b. Regulatory Alternatives
For the convenience of those persons
interested only in OSHA’s regulatory
flexibility analysis, this section repeats
the discussion of the various regulatory
alternatives to the proposed OSHA
beryllium standard presented in Chapter
VIII of the PEA, but only for the
regulatory alternatives to the proposed
OSHA beryllium standard that lower
costs. OSHA believes that this
presentation of specific regulatory
alternatives explores the possibility of
less costly ways (than the proposed
rule) to provide an adequate level of
worker protection from exposure to
beryllium.
Each regulatory alternative presented
here is described and analyzed relative
to the proposed rule. Where
appropriate, the Agency notes whether
the regulatory alternative, to be a
legitimate candidate for OSHA
consideration, requires evidence
contrary to the Agency’s preliminary
findings of significant risk and
feasibility. As noted above, for this
chapter on the Initial Regulatory
Flexibility Analysis, the Agency is only
presenting regulatory alternatives that
reduce costs for small entities. (See
Chapter VIII for the full list of all
alternatives analysed.) There are eight
regulatory alternatives and an
informational alternative that reduce
costs for small entities (and for all
businesses in total). Using the
numbering scheme from Chapter VIII,
these are Regulatory Alternatives #5, #6,
#7, #8. #12, #16, #18, and #22. To
facilitate comment, OSHA has organized
these potentially less costly regulatory
alternatives (and a general discussion of
possible phase-ins of the rule) into four
categories: (1) Exposure limits; (2)
methods of compliance; (3) ancillary
provisions; and (4) timing.
(1) Exposure limit (TWA PEL, STEL,
and ACTION LEVEL) alternatives
Regulatory Alternative #5, which
would set a TWA PEL at 0.5 mg/m3 and
an action level at 0.25 mg/m3, both
higher than in the proposal, responds to
an issue raised during the Small
Business Advocacy Review (SBAR)
process conducted in 2007 to consider
a draft OSHA beryllium proposed rule
that culminated in an SBAR Panel
report (SBAR, 2008). That report
included a recommendation that OSHA
consider both the economic impact of a
low TWA PEL and regulatory
alternatives that would ease cost burden
for small entities. OSHA has provided a
full analysis of the economic impact of
its proposed PELs (see Chapter VI of the
PEA), and Regulatory Alternative #5
E:\FR\FM\07AUP2.SGM
07AUP2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
addresses the second half of that
recommendation. However, the higher
0.5 mg/m3 TWA PEL does not appear to
be consistent with the Agency’s
mandate under the OSH Act to
promulgate a lower PEL if it is feasible
and could prevent additional fatalities
and non-fatal illnesses. The data
presented in Table IX–25 below indicate
that the lower TWA PEL would prevent
additional fatalities and non-fatal
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
illnesses, but nevertheless the Agency
solicits comments on this alternative
and OSHA’s analysis of the costs and
benefits associated with it.
Table IX–25 below presents, for
informational purposes, the estimated
costs, benefits, and net benefits of the
proposed rule under the proposed TWA
PEL of 0.2 mg/m3 and for the regulatory
alternative of a TWA PEL of 0.5 mg/m3
(Regulatory Alternative #5), using
PO 00000
Frm 00193
Fmt 4701
Sfmt 4702
47757
alternative discount rates of 3 percent
and 7 percent. Table IX–25 also breaks
out costs by provision and benefits by
type of disease and by morbidity/
mortality. As Table IX–25 shows, going
from a TWA PEL of 0.5 mg/m3 to a TWA
PEL of 0.2 mg/m3 would prevent,
annually, an additional 29 berylliumrelated fatalities and an additional 15
non-fatal illnesses.
BILLING CODE 4510–26–P
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47758
VerDate Sep<11>2014
Jkt 235001
Proposed PEL
(PEL= 0.2 j!gim 3 , AL = 0.10 j!gim 3)
PO 00000
Frm 00194
Fmt 4701
Sfmt 4702
Discount Rate
3%
Annualized Costs
Control Costs
Respirators
Exposure Assessment
Regulated areas and Beryllium Work Areas
Medical Surveillance
Medical Removal
Exposure Control Plan
Protective Clothing and Equipment
Hygiene Areas and Practices
Housekeeping
Training
$9.5
$0.2
$2.2
$0.6
$2.9
$0.1
$1.8
$1.4
$0.4
$12.6
$5.8
Total Annualized Costs (point estimate)
$37.6
E:\FR\FM\07AUP2.SGM
Annual Benefits: Number of Cases Prevented
Fatal Lung Cancers (midpoint estimate)
Fatal Chronic Beryllium Disease
Alternative 5
Incremental Costs/Benefits
7%
3%
Alternative 5
(PEL = 0.5 j!gim 3 , AL = 0.25 j!gim 3 )
7%
$10.3
$0.3
$2.4
$0.7
$3.0
$0.2
$1.8
$1.4
$0.4
$12.9
-$3.6
-$0.1
-$0.3
-$0.3
-$0.1
-$0.1
$0.0
$0.0
$0.0
$0.0
~
~
7%
$6.0
$0.1
$1.9
$0.3
$2.8
$0.1
$1.8
$1.4
$0.4
$12.6
_!58
$6.5
$0.1
$2.1
$0.4
$2.9
$0.1
$1.8
$1.4
$0.4
$12.9
$5.8
$33.2
$34.4
67
$401.2
$177.7
34
$2.0
$1.1
-$3.9
-$0.1
-$0.3
-$0.3
-$0.1
-$0.1
$0.0
$0.0
$0.0
$0.0
$0.0
-$4.4
3%
-$4.8
$39.1
Cases
0
-29
Cases
4
92
1
eases
4
~
07AUP2
Beryllium-Related Mortality
96
$573.0
$253.7
-28
-$171.8
-$76.1
Beryllium Morbidity
50
$2.8
$1.6
-15
-$0.9
-$0.5
Monetized Annual Benefits (midpoint estimate)
$575.8
$255.3
-$172.7
-$76.6
$403.1
$178.8
Net Benefits
$538.2
$216.2
-$168.2
-$71.9
$370.0
$144.4
Source: OSHA, Directorate of Standards and Guidance, Office of Regulatory Analysis
* Benefits are assessed over a 60-year time horizon, during which it is assumed that economic conditions remain constant. Costs are annualized over ten years, \/lith the exception of
equipment expenditures, which are annualized over the life of the equipment. Annualized costs are assumed to continue at the same level for sixty years, which is consistent \'lith
assuming that economic conditions remain constant for the sixty year time horizon.
EP07AU15.041</GPH>
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
19:20 Aug 06, 2015
Table IX-25: Annualized Costs, Benefits and Incremental Benefits of OSHA's Proposed Beryllium Standard of 0.51Jg/m3 PEL Alternative
Millions ($2010)
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
BILLING CODE 4510–26–P
Informational Alternative Featuring
Unchanged PEL but Full Ancillary
Provisions
An Informational Analysis: This
proposed regulation has the somewhat
unusual feature for an OSHA substancespecific health standard that most of the
quantified benefits would come from
the ancillary provisions rather than from
meeting the PEL with engineering
controls. OSHA decided to analyze for
informational purposes the effect of
retaining the existing PEL but applying
all of the ancillary provisions, including
respiratory protection. Under this
approach, the TWA PEL would remain
at 2.0 micrograms per cubic meter, but
all of the other proposed provisions
(including respiratory protection, which
OSHA does not consider an ancillary
provision) would be required with their
triggers remaining the same as in the
proposed rule—either the presence of
airborne beryllium at any level (e.g.,
initial monitoring, written exposure
control plan), at certain kinds of dermal
exposure (PPE), at the action level of 0.1
mg/m3 (e.g., periodic monitoring,
medical removal), or at 0.2 mg/m3 (e.g.,
regulated areas, respiratory protection,
medical surveillance).
Given the record regarding beryllium
exposures, this approach is not one
OSHA could legally adopt because the
absence of a more protective
requirement for engineering controls
would not be consistent with section
6(b)(5) of the OSH Act, which requires
OSHA to ‘‘set the standard which most
adequately assures, to the extent
feasible, on the basis of the best
available evidence, that no employee
will suffer material impairment of
health or functional capacity even if
such employee has regular exposure to
the hazard dealt with by such standard
for the period of his working life.’’ For
that reason, this additional analysis is
provided strictly for informational
purposes. EO 12866 and EO 13563
direct agencies to identify approaches
that maximize net benefits, and this
analysis is purely for the purpose of
exploring whether this approach would
hold any real promise to maximize net
benefits if it was permissible under the
OSH Act. It does not appear to hold
such promise because an ancillaryprovisions-only approach would not be
as protective and thus offers fewer
benefits than one that includes a lower
PEL and engineering controls, and
OSHA estimates the costs would be
about the same (or slightly lower,
depending on certain assumptions)
under that approach as under the
traditional proposed approach.
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
On an industry by industry basis,
OSHA found that some industries
would have lower costs if they could
adopt the ancillary-provisions-only
approach. Some employers would use
engineering controls where they are
cheaper, even if they are not mandatory.
OSHA does not have sufficient
information to do an analysis of the
employer-by-employer situations in
which there exist some employers for
whom the ancillary-provisions-only
approach might be cheaper. In the
majority of affected industries, the
Agency estimates there are no costs
saving to the ancillary-provisions-only
approach. However, OSHA estimates a
total of $2,675,828 per year in costs
saving for entire industries where the
ancillary-provisions-only approach
would be less expensive.
The above discussion does not
account for the possibility that the lack
of engineering controls would result in
higher beryllium exposures for workers
in adjacent (non-production) work areas
due to the increased level of beryllium
in the air. Because of a lack of data, and
because the issue did not arise in the
other regulatory alternatives OSHA
considered (all of which have a PEL of
less than 2.0 mg/m3), OSHA did not
carefully examine exposure levels in
non-production areas for either cost or
benefit purposes. To the extent such
exposure levels would be above the
action level, there would be additional
costs for respiratory protection.
The ancillary-provisions-only
approach adds uncertainty to the
benefits analysis such that the benefits
of the rule as proposed may exceed, and
perhaps greatly exceed, the benefits of
this ancillary-provisions-only approach:
(1) Most exposed individuals would
be in respirators, which OSHA
considers less effective than engineering
controls in preventing employee
exposure to beryllium. OSHA last did
an extensive review of the evidence on
effectiveness of respirators for its APFs
rulemaking in 2006 (71 FR 50128–45
Aug 24, 2006). OSHA has not in the past
tried to quantify the size of this effect,
but it could partially negate the
estimated benefits of 92 CBD deaths
prevented per year and 4 lung cancer
cases prevented per year by the
proposed standard.
(2) As noted above, in the proposal
OSHA did not consider benefits caused
by reductions in exposure in nonproduction areas. Unless employers act
to reduce exposures in the production
areas, the absence of a requirement for
such controls would largely negate such
benefits from reductions in exposure in
the non-productions areas.
PO 00000
Frm 00195
Fmt 4701
Sfmt 4702
47759
(3) OSHA believes that there is a
strong possibility that the benefits of the
ancillary provisions (a midpoint
estimate of eliminating 45 percent of all
remaining cases of CBD) would be
partially or wholly negated in the
absence of engineering controls that
would reduce both airborne and surface
dust levels. The measured reduction in
benefits from ancillary provision was in
a facility with average exposure levels of
less than 0.2 mg/m 3.
Based on these considerations, OSHA
believes that the ancillary-provisionsonly approach is not one that is likely
to maximize net benefits. The costs
saving, if any, are estimated to be small,
and the difficult-to-measure declines in
benefits could be substantial.
(2) A Method-of-compliance Alternative
Paragraph (f)(2) of the proposed rule
contains requirements for the
implementation of engineering and
work practice controls to minimize
beryllium exposures in beryllium work
areas. For each operation in a beryllium
work area, employers must ensure that
at least one of the following engineering
and work practice controls is in place to
minimize employee exposure: Material
and/or process substitution; ventilated
enclosures; local exhaust ventilation; or
process controls, such as wet methods
and automation. Employers are exempt
from using engineering and work
practice controls only when they can
show that such controls are not feasible
or where exposures are below the action
level based on two exposure samples
taken seven days apart.
These requirements, which are based
on the stakeholders’ recommended
beryllium standard that beryllium
industry and union stakeholders
submitted to OSHA in 2012 (Materion
and USW, 2012), address a concern
associated with the proposed TWA PEL.
OSHA expects that day-to-day changes
in workplace conditions, such as
workers’ positioning or patterns of
airflow, may cause frequent exposures
above the TWA PEL in workplaces
where periodic sampling indicates
exposures are between the action level
and the TWA PEL. As a result, the
default under the standard is that the
controls are required until the employer
can demonstrate that exposures have
not exceeded the action level from at
least two separate measurements taken
seven days apart.
OSHA believes that substitution or
engineering controls such as those
outlined in paragraph (f)(2)(i) provide
the most reliable means to control
variability in exposure levels. However,
OSHA also recognizes that the
requirements of paragraph (f)(2)(i) are
E:\FR\FM\07AUP2.SGM
07AUP2
47760
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
decrease the annualized cost of the
proposed rule by about $457,000 using
a discount rate of 3 percent and by
about $480,000 using a discount rate of
7 percent. OSHA has not been able to
estimate the change in benefits resulting
from Regulatory Alternative #6 at this
time and invites public comment on this
issue.
the Standards. In particular, OSHA is
proposing the requirements for exposure
assessment to provide a basis for
ensuring that appropriate measures are
in place to limit worker exposures.
Medical surveillance is especially
important because workers exposed
above the proposed TWA PEL, as well
as many workers exposed below the
proposed TWA PEL, are at significant
risk of death and illness. Medical
surveillance would allow for
identification of beryllium-related
adverse health effects at an early stage
so that appropriate intervention
measures can be taken. OSHA is
proposing regulated areas and access
control because they serve to limit
exposure to beryllium to as few
employees as possible. OSHA is
proposing worker training to ensure that
employers inform employees of the
hazards to which they are exposed,
along with associated protective
measures, so that employees understand
how they can minimize their exposure
to beryllium. Worker training on
beryllium-related work practices is
particularly important in controlling
beryllium exposures because
engineering controls frequently require
action on the part of workers to function
effectively.
OSHA has examined a variety of
regulatory alternatives involving
changes to one or more of the proposed
ancillary provisions. The incremental
cost of each of these regulatory
alternatives and its impact on the total
costs of the proposed rule is
summarized in Table IX–27 at the end
of this section. OSHA has preliminarily
determined that several of these
ancillary provisions will increase the
benefits of the proposed rule, for
example, by helping to ensure the TWA
PEL is not exceeded or by lowering the
risks to workers given the significant
risk remaining at the proposed TWA
PEL. However, except for Regulatory
Alternative #7 (involving the
elimination of all ancillary provisions),
OSHA did not estimate changes in
monetized benefits for the regulatory
alternatives that affect ancillary
provisions. Two regulatory alternatives
that involve all ancillary provisions are
presented below (#7 and #8), followed
The proposed standard contains
several ancillary provisions (provisions
other than the exposure limits),
including requirements for exposure
assessment, medical surveillance,
medical removal, training, and regulated
areas or access control. As reported in
Chapter V of the PEA, these ancillary
provisions account for $27.8 million
(about 72 percent) of the total
annualized costs of the rule ($37.6
million) using a 3 percent discount rate,
or $28.6 million (about 73 percent) of
the total annualized costs of the rule
($39.1 million) using a 7 percent
discount rate. The most expensive of the
ancillary provisions are the
requirements for housekeeping and
training, with annualized costs of $12.6
million and $5.8 million, respectively,
at a 3 percent discount rate ($12.9
million and $5.8 million, respectively,
at a 7 percent discount rate).
OSHA’s reasons for including each of
the proposed ancillary provisions are
explained in Section XVIII of this
preamble, Summary and Explanation of
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
PO 00000
Frm 00196
Fmt 4701
Sfmt 4702
E:\FR\FM\07AUP2.SGM
07AUP2
EP07AU15.042</GPH>
alternative does not eliminate the need
for engineering controls to comply with
the proposed TWA PEL and STEL, but
does eliminate the requirement to use
one or more of the specified engineering
or work practice controls where
exposures equal or exceed the action
level. As shown in Table IX–26,
Regulatory Alternative #6 would
(3) Regulatory Alternatives That Affect
Ancillary Provisions
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
not typical of OSHA standards, which
usually require engineering controls
only where exposures exceed the TWA
PEL or STEL. The Agency is therefore
considering Regulatory Alternative #6,
which would drop the provisions of
(f)(2)(i) from the proposed standard and
make conforming edits to paragraphs
(f)(2)(ii) and (iii). This regulatory
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
by regulatory alternatives for regulated
areas (#12), for medical surveillance
(#16 and #18), and for medical removal
(#22).
(a) All Ancillary Provisions
The SBAR Panel recommended that
OSHA analyze a PEL-only standard as a
regulatory alternative. The Panel also
recommended that OSHA consider not
applying ancillary provisions of the
standard where exposure levels are low
so as to minimize costs for small
businesses (SBAR, 2008). In response to
these recommendations, OSHA
analyzed Regulatory Alternative #7, a
PEL-only standard, and Regulatory
Alternative #8, which would apply
ancillary provisions of the beryllium
standard only where exposures exceed
the proposed TWA PEL of 0.2 mg/m3 or
the proposed STEL of 2 mg/m3.
Regulatory Alternative #7 would
solely update 1910.1000 Tables Z–1 and
Z–2, so that the proposed TWA PEL and
STEL would apply to all workers in
general industry. This alternative would
eliminate all of the ancillary provisions
of the proposed rule, including
exposure assessment, medical
surveillance, medical removal, PPE,
housekeeping, training, and regulated
areas or access control. Under this
regulatory alternative, OSHA estimates
that the costs for the proposed ancillary
provisions of the rule (estimated at
$27.8 million annually at a 3 percent
discount rate) would be eliminated. In
order to meet the PELs, employers
would still commonly need to do
monitoring, train workers on the use of
controls, and set up some kind of
regulated areas to indicate where
respirator use would be required. It is
also likely that, under this alternative,
many employers would follow the
recommendations of Materion and the
United Steelworkers to provide medical
surveillance, PPE, and other protective
measures for their workers (Materion
and USW, 2012). OSHA has not
attempted to estimate the extent to
which these ancillary-provision costs
would be incurred if they were not
formally required or whether any of
these costs under Regulatory Alternative
#7 would reasonably be attributable to
the proposed rule. OSHA welcomes
comment on the issue.
OSHA has also estimated the effect of
this regulatory alternative on the
benefits of the rule. As a result of
eliminating all of the ancillary
provisions, annualized benefits are
estimated to decrease 57 percent,
relative to the proposed rule, from
$575.8 million to $249.1 million, using
a 3 percent discount rate, and from
$255.3 million to $110.4 million using
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
a 7 percent discount rate. This estimate
follows from OSHA’s analysis of
benefits in Chapter VII of the PEA,
which found that about 57 percent of
the benefits of the proposed rule,
evaluated at their mid-point value, were
attributable to the combination of the
ancillary provisions. As these estimates
show, OSHA expects that the benefits
estimated under the proposed rule will
not be fully achieved if employers do
not implement the ancillary provisions
of the proposed rule.
Both industry and worker groups have
recognized that a comprehensive
standard is needed to protect workers
exposed to beryllium. The stakeholders’
recommended standard that
representatives of the primary beryllium
manufacturing industry and the United
Steelworkers union provided to OSHA
confirms the importance of ancillary
provisions in protecting workers from
the harmful effects of beryllium
exposure (Materion and USW, 2012).
Ancillary provisions such as personal
protective clothing and equipment,
regulated areas, medical surveillance,
hygiene areas, housekeeping
requirements, and hazard
communication all serve to reduce the
risks to beryllium-exposed workers
beyond that which the proposed TWA
PEL alone could achieve.
Moreover, where there is continuing
significant risk at the TWA PEL, the
decision in the Asbestos case (Bldg. and
Constr. Trades Dep’t, AFL–CIO v. Brock,
838 F.2d 1258, 1274 (D.C. Cir. 1988))
indicated that OSHA should use its
legal authority to impose additional
requirements on employers to further
reduce risk when those requirements
will result in a greater than de minimis
incremental benefit to workers’ health.
Nevertheless, OSHA requests comment
on this alternative.
Under Regulatory Alternative #8,
several ancillary provisions that the
current proposal would require under a
variety of exposure conditions (e.g.,
dermal contact, any airborne exposure,
exposure at or above the action level)
would instead only apply where
exposure levels exceed the TWA PEL or
STEL. Regulatory Alternative #8 affects
the following provisions of the proposed
standard:
— Exposure monitoring: Whereas the
proposed standard requires annual
monitoring when exposure levels are
at or above the action level and at or
below the TWA PEL, Regulatory
Alternative #8 would require annual
exposure monitoring only where
exposure levels exceed the TWA PEL
or STEL;
—Written exposure control plan:
Whereas the proposed standard
PO 00000
Frm 00197
Fmt 4701
Sfmt 4702
47761
requires written exposure control
plans to be maintained in any facility
covered by the standard, Regulatory
Alternative #8 would require only
facilities with exposures above the
TWA PEL or STEL to maintain a plan;
— Housekeeping: Whereas the
proposed standard’s housekeeping
requirements apply across a wide
variety of beryllium exposure
conditions, Alternative #8 would
limit housekeeping requirements to
areas and employees with exposures
above the TWA PEL or STEL;
— PPE: Whereas the proposed standard
requires PPE for employees under a
variety of conditions, such as
exposure to soluble beryllium or
visible contamination with beryllium,
Alternative #8 would require PPE
only for employees exposed above the
TWA PEL or STEL;
— Medical Surveillance: Whereas the
proposed standard’s medical
surveillance provisions require
employers to offer medical
surveillance to employees with signs
or symptoms of beryllium-related
health effects regardless of their
exposure level, Alternative #8 would
require surveillance only for those
employees exposed above the TWA
PEL or STEL.
To estimate the cost savings for this
alternative, OSHA re-estimated the
group of workers that would fall under
the above provisions and the changes to
their scope. Combining these various
adjustments along with associated unit
costs, OSHA estimates that, under this
regulatory alternative, the costs for the
proposed rule would decline from $37.6
million to $18.9 million using a 3
percent discount rate and from $39.1
million to $20.0 million using a 7
percent discount rate.
The Agency has not quantified the
impact of this alternative on the benefits
of the rule. However, ancillary
provisions that offer protective
measures to workers exposed below the
proposed TWA PEL, such as personal
protective clothing and equipment,
beryllium work areas, hygiene areas,
housekeeping requirements, and hazard
communication, all serve to reduce the
risks to beryllium-exposed workers
beyond that which the proposed TWA
PEL and STEL could achieve. OSHA’s
preliminary conclusion is that the
requirements triggered by the action
level and other exposures below the
proposed PELs will result in very real
and necessary, but difficult to quantify,
further reduction in risk beyond that
provided by the PELs alone.
The remainder of this section
discusses additional regulatory
alternatives that apply to individual
E:\FR\FM\07AUP2.SGM
07AUP2
47762
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
ancillary provisions. At this time, OSHA
is not able to quantify the effects of
these regulatory alternatives on benefits.
The Agency solicits comment on the
effects of these regulatory alternatives
on the benefits of the proposed rule.
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
(b) Regulated Areas
Proposed paragraph (e) requires
employers to establish and maintain
beryllium work areas wherever
employees are exposed to airborne
beryllium, regardless of the level of
exposure, and regulated areas wherever
airborne concentrations of beryllium
exceed the TWA PEL or STEL.
Employers are required to demarcate
beryllium work areas and regulated
areas and limit access to regulated areas
to authorized persons.
The SBAR Panel report recommended
that OSHA consider dropping or
limiting the provision for regulated
areas (SBAR, 2008). In response to this
recommendation, OSHA examined
Regulatory Alternative #12, which
would eliminate the requirement that
employers establish regulated areas.
This alternative is meant only to
eliminate the requirement to set up and
demarcate specific physical areas: All
ancillary provisions would be triggered
by the same conditions as under the
standard’s definition of a ‘‘regulated
area.’’ For example, under the current
proposal, employees who work in
regulated areas for at least 30 days
annually are eligible for medical
surveillance. If OSHA were to remove
the requirement to establish regulated
areas, the medical surveillance
provisions would be altered so that
employees who work more than 30 days
annually in jobs or areas with exposures
that exceed the TWA PEL or STEL are
eligible for medical surveillance. This
alternative would not eliminate the
proposed requirement to establish
beryllium work areas. As shown in
Table IX–27, Regulatory Alternative #12
would decrease the annualized cost of
the proposed rule by about $522,000
using a 3 percent discount rate, and by
about $523,000 using a 7 percent
discount rate.
(e) Medical Surveillance
The proposed requirements for
medical surveillance include: (1)
Medical examinations, including a test
for beryllium sensitization, for
employees who are exposed to
beryllium in a regulated area (i.e., above
the proposed TWA PEL or STEL) for 30
days or more per year, who are exposed
to beryllium in an emergency, or who
show signs or symptoms of CBD; and (2)
CT scans for employees who were
exposed above the proposed TWA PEL
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
or STEL for more than 30 days in a 12month period for 5 years or more. The
proposed standard would require
annual medical exams to be provided
for employees exposed in a regulated
area for 30 days or more per year and
for employees showing signs or
symptoms of CBD, while tests for
beryllium sensitization and CT scans
would be provided to eligible
employees biennially.
OSHA estimated in Chapter V of the
PEA that the medical surveillance
requirements would apply to 4,528
workers in general industry, of whom
387 already receive that surveillance.44
In Chapter V, OSHA estimated the costs
of medical surveillance for the
remaining 4,141 workers who would
now have such protection due to the
proposed standard. The Agency’s
preliminary analysis indicates that four
workers with beryllium sensitization
and six workers with CBD will be
referred to pulmonary specialists
annually as a result of this medical
surveillance. Medical surveillance is
particularly important for this rule
because beryllium-exposed workers,
including many workers exposed below
the proposed PELs, are at significant
risk of illness. OSHA did not estimate,
and the benefits analysis does not
include, monetized benefits resulting
from early discovery of illness.
Medical surveillance was a subject of
special concern to SERs during the
SBAR Panel process, and the SBAR
Panel offered many comments and
recommendations related to medical
surveillance for OSHA’s consideration.
Some of the Panel’s concerns have been
partially addressed in this proposal,
which was modified since the SBAR
Panel was convened (see this preamble
at Section XVIII, Summary and
Explanation of the Proposed Standard,
for more detailed discussion). The
regulatory alternatives presented in this
sub-section (#16, #18, and #20) also
respond to recommendations by the
SBAR Panel to reduce burdens on small
businesses by dropping or reducing the
frequency of medical surveillance
requirements. OSHA has preliminarily
determined that a significant risk of
beryllium sensitization, CBD, and lung
cancer exists at exposure levels below
the proposed TWA PEL and that there
is evidence that beryllium sensitization
can occur even from short-term
exposures (see this preamble at Section
V, Health Effects, and Section VIII,
Significance of Risk). The Agency
therefore anticipates that more
employees would develop adverse
44 See current compliance rates for medical
surveillance in Chapter V of the PEA, Table V–15.
PO 00000
Frm 00198
Fmt 4701
Sfmt 4702
health effects without receiving the
benefits of early intervention in the
disease process because they are not
eligible for medical surveillance (see
this preamble at Section V, Health
Effects).
In response to concerns raised during
the SBAR Panel process about testing
requirements, OSHA is considering two
regulatory alternatives that would
provide greater flexibility in the
program of tests provided as part of an
employer’s medical surveillance
program. Under Regulatory Alternative
#16, employers would not be required to
offer employees testing for beryllium
sensitization. As shown in Table IX–27,
this alternative would decrease the
annualized cost of the proposed rule by
about $710,000 using a discount rate of
3 percent, and by about $724,000 using
a discount rate of 7 percent.
Regulatory Alternative #18 would
eliminate the CT scan requirement from
the proposed rule. This alternative
would decrease the annualized cost of
the proposed rule by about $472,000
using a discount rate of 3 percent, and
by about $481,000 using a discount rate
of 7 percent.
OSHA is considering several
alternatives to the proposed frequency
of sensitization testing, CT scans, and
general medical examinations. The
frequency of periodic medical
surveillance is an important factor in
the efficacy of the surveillance in
protecting worker health. Regular,
appropriately frequent medical
surveillance promotes awareness of
beryllium-related health effects and
early intervention in disease processes
among workers. In addition, the longer
the time interval between when a
worker becomes sensitized and when
the worker’s case is identified in the
surveillance program, the more difficult
it will be to identify and address the
exposure conditions that led to
sensitization. Therefore, reducing the
frequency of sensitization testing would
reduce the usefulness of the
surveillance information in identifying
problem areas and reducing risks to
other workers. These concerns must be
weighed against the costs and other
burdens of surveillance.
Finally, under Regulatory Alternative
#20, employers would only have to
provide all periodic components of the
medical surveillance exams biennially
to eligible employees. This alternative
would decrease the annualized cost of
the proposed rule by about $446,000
using a discount rate of 3 percent and
by about $433,000 using a discount rate
of 7 percent.
E:\FR\FM\07AUP2.SGM
07AUP2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
(d) Medical Removal
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Under paragraph (l) of the proposed
standard, Medical Removal, employees
in jobs with exposure at or above the
action level become eligible for medical
removal when they are diagnosed with
CBD or confirmed positive for beryllium
sensitization. When an employee
chooses removal, the employer is
required to remove the employee to
comparable work in an environment
where beryllium exposure is below the
action level if such work is available
and the employee is either already
qualified or can be trained within one
month. If comparable work is not
available, paragraph (l) would require
the employer to place the employee on
paid leave for six months or until
comparable work becomes available
(whichever comes first). Or, rather than
choosing removal, an eligible employee
could choose to remain in a job with
exposure at or above the action level
and wear a respirator. The proposed
medical removal protection (MRP)
requirements are based on the
stakeholders’ recommended beryllium
standard that representatives of the
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
beryllium production industry and the
United Steelworkers union submitted to
OSHA in 2012 (Materion and USW,
2012).
The scientific information on effects
of exposure cessation is limited at this
time, but the available evidence suggests
that removal from exposure can be
beneficial for individuals who are
sensitized or have early-stage CBD (see
this preamble at Section VIII,
Significance of Risk). As CBD
progresses, symptoms become serious
and debilitating. Steroid treatment is
less effective at later stages, once
fibrosis has developed (see this
preamble at Section VIII, Significance of
Risk). Given the progressive nature of
the disease, OSHA believes it is
reasonable to conclude that removal
from exposure to beryllium will benefit
sensitized employees and those with
CBD. Physicians at National Jewish
Health, one of the main CBD research
and treatment sites in the US, ‘‘consider
it important and prudent for individuals
with beryllium sensitization and CBD to
minimize their exposure to airborne
beryllium,’’ and ‘‘recommend
individuals diagnosed with beryllium
PO 00000
Frm 00199
Fmt 4701
Sfmt 4702
47763
sensitization and CBD who continue to
work in a beryllium industry to have
exposure of no more than 0.01
micrograms per cubic meter of
beryllium as an 8-hour time-weighted
average’’ (NJMRC, 2013). However,
OSHA is aware that MRP may prove
costly and burdensome for some
employers and that the scientific
literature on the effects of exposure
cessation on the development of CBD
among sensitized individuals and the
progression from early-stage to late-stage
CBD is limited.
The SBAR Panel report included a
recommendation that OSHA give careful
consideration to the impacts that an
MRP requirement could have on small
businesses (SBAR, 2008). In response to
this recommendation, OSHA analyzed
Regulatory Alternative #22, which
would remove the proposed
requirement that employers offer MRP.
As shown in Table IX–27, this
alternative would decrease the
annualized cost of the proposed rule by
about $149,000 using a discount rate of
3 percent, and by about $166,000 using
a discount rate of 7 percent.
E:\FR\FM\07AUP2.SGM
07AUP2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
(5) Timing
As proposed, the new standard would
become effective 60 days following
publication in the Federal Register. The
majority of employer duties in the
standard would become enforceable 90
days following the effective date.
Change rooms, however, would not be
required until one year after the
effective date, and the deadline for
engineering controls would be no later
than two years after the effective date.
OSHA invites suggestions for
alternative phase-in schedules for
engineering controls, medical
surveillance, and other provisions of the
standard. Although OSHA did not
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
explicitly develop or quantitatively
analyze any other regulatory alternatives
involving longer-term or more complex
phase-ins of the standard (possibly
involving more delayed implementation
dates for small businesses), some
general outcomes are likely. For
example, a longer phase-in time would
have several advantages, such as
reducing initial costs of the standard or
allowing employers to coordinate their
environmental and occupational safety
and health control strategies to
minimize potential costs. However, a
longer phase-in would also postpone
and reduce the benefits of the standard.
Suggestions for alternatives may apply
to specific industries (e.g., industries
PO 00000
Frm 00200
Fmt 4701
Sfmt 4702
where first-year or annualized cost
impacts are highest), specific sizeclasses of employers (e.g., employers
with fewer than 20 employees),
combinations of these factors, or all
firms covered by the rule.
OSHA requests comments on all these
regulatory alternatives, including the
Agency’s regulatory alternatives
presented above, the Agency’s analysis
of these alternatives, and whether there
are other regulatory alternatives the
Agency should consider.
SBAR Panel
Table IX–28 lists all of the SBAR
Panel recommendations and OSHA’s
response to those recommendations.
E:\FR\FM\07AUP2.SGM
07AUP2
EP07AU15.043</GPH>
47764
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
47765
TABLE IX–28—SBAR PANEL RECOMMENDATIONS AND OSHA RESPONSES
Panel recommendation
OSHA response
The Panel recommends that OSHA evaluate carefully the costs and
technological feasibility of engineering controls at all PEL options, especially those at the lowest levels.
The Panel recommends that OSHA consider alternatives that would alleviate the need for monitoring in operations with exposures far
below the PEL. The Panel also recommends that OSHA consider explaining more clearly how employers may use ‘‘objective data’’ to estimate exposures. Although the draft proposal contains a provision
allowing employers to initially estimate exposures using ‘‘objective
data’’ (e.g., data showing that the action level is unlikely to be exceeded for the kinds of process or operations an employer has), the
SERs did not appear to have fully understood how this alternative
may be used.
OSHA has reviewed its cost estimates and the technological feasibility
of engineering controls at various PEL levels. These issues are discussed in the Regulatory Alternatives Chapter of the PEA.
OSHA has removed the initial exposure monitoring requirement for
workers likely to be exposed to beryllium by skin or eye contact
through routine handling of beryllium powders or dusts or contact
with contaminated surfaces.
The periodic monitoring requirement presented in the SBAR Panel report required monitoring every 6 months for airborne levels at or
above the action level but below the PEL, and every 3 months for
exposures at or above the PEL. The proposed standard requires annual exposure monitoring for levels at or above the action level and
at or below the PEL.
By reducing the frequency of periodic monitoring from every 6 months
(version submitted to the SBAR panel) to annually where exposure
levels are at or below the PEL (the proposed standard), the Agency
has lessened the need for monitoring in small business operations
with exposures at or below the PEL.
In this preamble, OSHA has clarified the circumstances under which an
employer may use historical and objective data in lieu of initial monitoring.
OSHA is also considering whether to create a guidance product on the
use of objective data. These issues are discussed in this preamble
at Section XVIII, Summary and Explanation of the Proposed Standard, (d): Exposure Monitoring.
In this preamble, OSHA has clarified the circumstances under which an
employer may use historical and objective data in lieu of initial monitoring. OSHA is also considering whether to create a guidance product on the use of objective data to satisfy the requirements of the
proposed rule.
These issues are discussed in this preamble at Section XVIII, Summary and Explanation of the Proposed Standard, (d): Exposure Monitoring.
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
The Panel recommends that OSHA consider providing some type of
guidance to describe how to use objective data to estimate exposures in lieu of conducting personal sampling.
Using objective data could provide significant regulatory relief to several industries where airborne exposures are currently reported by
SERs to be well below even the lowest PEL option. In particular,
since several ancillary provisions, which may have significant costs
for small entities may be triggered by the PEL or an action level,
OSHA should consider encouraging and simplifying the development
of objective data from a variety of sources.
The Panel recommends that OSHA revisit its analysis of the costs of
regulated areas if a very low PEL is proposed. Drop or limit the provision for regulated areas: SERs with very low exposure levels or
only occasional work with beryllium questioned the need for separating areas of work by exposure level. Segregating machines or operations, SERs said, would affect productivity and flexibility. Until the
health risks of beryllium are known in their industries, SERs challenged the need for regulated areas.
The Panel recommends that OSHA revisit its cost model for hygiene
areas to reflect SERs’ comments that estimated costs are too low
and more carefully consider the opportunity costs of using space for
hygiene areas where SERs report they have no unused space in
their physical plant for them. The Panel also recommends that OSHA
consider more clearly defining the triggers (skin exposure and contaminated surfaces) for the hygiene areas provisions. In addition, the
Panel recommends that OSHA consider alternative requirements for
hygiene areas dependent on airborne exposure levels or types of
processes. Such alternatives might include, for example, hand washing facilities in lieu of showers in particular cases or different hygiene
area triggers where exposure levels are very low.
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
PO 00000
Frm 00201
Fmt 4701
SERs with very low exposure levels or only occasional work with beryllium will not be required to have regulated areas unless exposures
are above the proposed PEL of 0.2 μg/m3.
The proposed standard requires the employer to establish and maintain a regulated area wherever employees are, or can be expected
to be exposed to airborne beryllium at levels above a PEL of 0.2 μg/
m 3.
The Agency has removed skin exposure as a trigger for the hygiene
provision. The requirement for washing facilities applies to each employee working in a beryllium work area. A beryllium work area
means any work area where employees are, or can reasonably be
expected to be, exposed to airborne beryllium. OSHA has preliminarily concluded that all affected employers currently have handwashing facilities.
OSHA has also preliminarily concluded that no affected employers will
be required to install showers.
Change rooms have only been costed for regulated areas or where
employees are, or can reasonably be expected to be, exposed to airborne beryllium at levels above the PEL. The Agency has determined that the long-term rental of modular units was representative
of costs for a range of reasonable approaches to comply with the
change room part of the provision. Alternatively, employers could
renovate and rearrange their work areas in order to meet the requirements of this provision.
Sfmt 4702
E:\FR\FM\07AUP2.SGM
07AUP2
47766
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
TABLE IX–28—SBAR PANEL RECOMMENDATIONS AND OSHA RESPONSES—Continued
Panel recommendation
OSHA response
The Panel recommends that OSHA consider clearly explaining the purpose of the housekeeping provision and describing what affected
employers must do to achieve it. For example, OSHA should consider explaining more specifically what surfaces need to be cleaned
and how frequently they need to be cleaned. The Panel recommends
that the Agency consider providing guidance in some form so that
employers understand what they must do. The Panel also recommends that once the requirements are clarified that the Agency
re-analyzes its cost estimates.
The Panel also recommends that OSHA reconsider whether the risk
and cost of all parts of the medical surveillance provisions are appropriate where exposure levels are very low. In that context, the Panel
recommends that OSHA should also consider the special problems
and costs to small businesses that up until now may not have had to
provide or manage the various parts of an occupational health standard or program.
In this preamble, OSHA has clarified the purpose of the housekeeping
provision. However, due to the variety of work settings in which beryllium is used, OSHA has preliminarily concluded that a highly specific directive on what surfaces need to be cleaned, and how frequently, would not provide effective guidance to businesses. Instead,
at the suggestion of industry and union stakeholders (Materion and
USW, 2012), OSHA’s proposed standard includes a more flexible requirement for employers to develop a written exposure control plan
specific to their facilities. The written exposure control plan must include documentation of operations and jobs with beryllium exposure
and housekeeping procedures, including surface cleaning and beryllium migration control. OSHA requests suggestions for examples of
specific guidance that could be helpful to employers preparing written exposure control plans.
These issues are discussed in this preamble at Section XVIII, Summary and Explanation of the Proposed Standard, (f) Methods of
Compliance and (j) Housekeeping.
Regulatory Alternative #20 would reduce the frequency of physical examinations from annual to biennial, matching the frequency of
BeLPT testing in the proposed rule.
These alternatives for medical surveillance are discussed in the Regulatory Alternatives Chapter and in this preamble at section XVIII,
Summary and Explanation of the Proposed Standard, (k) Medical
Surveillance.
Under the proposed standard, employees are only eligible for medical
removal if they are sensitized or have been diagnosed with CBD;
skin exposure is not a trigger for medical removal (unlike the version
submitted by the SBAR Panel). After becoming eligible for medical
removal an employee may choose to remain in a job with exposure
at or above the action level, provided that the employee wears a respirator in accordance with the Respiratory Protection standard (29
CFR 1910.134). If the employee chooses removal, the employer is
only required to place the employee in comparable work with exposure below the action level if such work is available; if such work is
not available, the employer may place the employee on paid leave
for six months or until such work becomes available.
OSHA discusses the basis of the provision and requests comments on
it in this preamble at Section XVIII, Summary and Explanation of the
Proposed Standard, (l) Medical Removal Protection. OSHA provides
an analysis of costs and economic impacts of the provision in the
PEA in Chapter 5 and Chapter 6, respectively.
As stated above, the triggers for medical surveillance in the proposed
standard have changed from those presented to the SBAR Panel.
Whereas the draft standard presented at the SBAR Panel required
medical surveillance for employees with skin contact—potentially applying to employees with any level of airborne exposure—the proposed standard ties medical surveillance to exposures above the
proposed PEL of 0.2 μg/m3 (or signs or symptoms of beryllium-related health effects, or emergency exposure). Thus, small businesses with exposures below the proposed PEL would not need to
provide or manage medical surveillance for their employees unless
employees develop signs or symptoms of beryllium-related health effects or are exposed in emergencies.
These issues are discussed in this preamble at section XVIII, Summary
and Explanation of the Proposed Standard, (k) Medical Surveillance.
OSHA has reviewed the possible effects of the proposed regulation on
market demand and/or foreign production, in addition to the Agency’s
usual measures of economic impact (costs as a fraction of revenues
and profits). This discussion can be found in Chapter VI of the PEA
(entitled Economic Feasibility Analysis and Regulatory Flexibility Determination).
The Panel recommends that OSHA consider that small entities may
lack the flexibility and resources to provide alternative jobs to employees who test positive for the BeLPT, and whether MRP achieves
its intended purpose given the course of beryllium disease. The
Panel also recommends that if MRP is implemented, that its effects
on the viability of very small firms with a sensitized employee be
considered carefully.
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
The Panel recommends that OSHA consider more clearly defining the
trigger mechanisms for medical surveillance and also consider additional or alternative triggers—such as limiting the BeLPT to a narrower range of exposure scenarios and reducing the frequency of
BeLPT tests and physical exams. The Panel also recommends that
OSHA reconsider whether the risk and cost of all parts of the medical surveillance provisions are appropriate where exposure levels
are very low. In that context, the Panel recommends that OSHA
should also consider the special problems and costs to small businesses that up until now may not have had to provide or manage the
various parts of an occupational health standard or program.
The Panel recommends that the Agency, in evaluating the economic
feasibility of a potential regulation, consider not only the impacts of
estimated costs on affected establishments, but also the effects of
the possible outcomes cited by SERs: loss of market demand, the
loss of market to foreign competitors, and of U.S. production being
moved abroad by U.S. firms. The Panel also recommends that
OSHA consider the potential burdens on small businesses of dealing
with employees who have a positive test from the BeLPT. OSHA
may wish to address this issue by examining the experience of small
businesses that currently provide the BeLPT.
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
PO 00000
Frm 00202
Fmt 4701
Sfmt 4702
E:\FR\FM\07AUP2.SGM
07AUP2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
47767
TABLE IX–28—SBAR PANEL RECOMMENDATIONS AND OSHA RESPONSES—Continued
Panel recommendation
OSHA response
The Panel recommends that OSHA consider seeking ways of minimizing costs for small businesses where the exposure levels may be
very low. Clarifying the use of objective data, in particular, may allow
industries and establishments with very low exposures to reduce
their costs and involvement with many provisions of a standard. The
Panel also recommends that the Agency consider tiering the application of ancillary provisions of the standard according to exposure levels and consider a more limited or narrowed scope of industries.
The provisions in the standard presented in the SBAR panel report applied to all employees, whereas the proposed standard’s ancillary
provisions are only applied to employees in work areas who are, or
can reasonably be expected to be, exposed to airborne beryllium.
In addition, the scope of the proposed standard includes several limitations. Whereas the standard presented in the SBAR panel report
covered beryllium in all forms and compounds in general industry,
construction, and maritime, the scope of the proposed standard (1)
applies only to general industry; (2) does not apply to beryllium-containing articles that the employer does not process; and (3) does not
apply to materials that contain less than 0.1 percent beryllium by
weight.
In this preamble, OSHA has clarified the circumstances under which an
employer may use historical and objective data in lieu of initial monitoring (Section XVIII, Summary and Explanation of this Proposed
Standard, (d) Exposure Monitoring). OSHA is also considering
whether to create a guidance product on the use of objective data to
comply with the requirements of this proposed standard. OSHA is
considering two Regulatory Alternatives that would reduce the impact
of ancillary alternatives on employers, including small businesses.
Regulatory Alternative #7, a PEL-only standard, would drop all ancillary provisions from the standard. Regulatory Alternative #8 would
limit the application of several ancillary provisions, including Exposure Monitoring, the written exposure control plan section of Method
of Compliance, PPE, Housekeeping, and Medical Surveillance, to
operations or employees with exposure levels exceeding the TWA
PEL or STEL. These alternatives are discussed in the Regulatory Alternatives Chapter and in this preamble at Section I, Issues and Alternatives.
The explanation and analysis for all health outcomes (and their scientific basis) are discussed in this preamble at Section V, Health Effects, and Section VI, Preliminary Risk Assessment. They are also
reviewed in this preamble at Section VIII, Significance of Risk, and
the Benefits Chapter of the PEA. OSHA requests comment on these
health outcomes.
As discussed above, OSHA is considering Regulatory Alternatives #7
and #8, which would eliminate or reduce the impact of ancillary provisions on employers, respectively. These alternatives are discussed
in the Regulatory Alternatives Chapter of the PEA and in this preamble at Section I, Issues and Alternatives. OSHA seeks comment
on other ways to avoid costs of ancillary provisions when they are
not necessary to protect employees from exposure to beryllium.
OSHA has removed skin exposure as a trigger for several ancillary
provisions in this proposed standard, including Exposure Monitoring,
Hygiene Areas and Practices, and Medical Surveillance. In addition,
the language of this proposed standard regarding skin exposure has
changed: for some ancillary provisions, including PPE and Housekeeping, the requirements are triggered by visible contamination with
beryllium or dermal contact with soluble beryllium compounds. These
requirements are discussed in this preamble at Section XVIII, Summary and Explanation of this Proposed Standard. The Agency has
also explained the basis and need for compliance with ancillary provisions in this preamble at Section XVIII, Summary and Explanation.
In the Technological Feasibility Analysis presented in the PEA, OSHA
has described the exposure level in each industry or application
group.
In this preamble, OSHA has clarified the circumstances under which an
employer may use historical and objective data in lieu of initial monitoring (section XVIII, Summary and Explanation of this Proposed
Standard, (d) Exposure Monitoring). Industry-wide data may be used
as objective data to support an employer’s case that exposures at its
facilities are far below the PEL. OSHA is also considering whether to
create a guidance product on the use of objective data to comply
with requirements in the proposed standard.
The Panel recommends that OSHA provide an explanation and analysis for all health outcomes (and their scientific basis) upon which it
is regulating employee exposure to beryllium. The Panel also recommends that OSHA consider to what extent a very low PEL (and
lower action level) may result in increased costs of ancillary provisions to small entities (without affecting airborne employee exposures). Since in the draft proposal the PEL and action level are critical triggers, the Panel recommends that OSHA consider alternate
action levels, including an action level set at the PEL, if a very low
PEL is proposed.
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
The Panel recommends that OSHA consider more clearly and thoroughly defining the triggers for ancillary provisions, particularly the
skin exposure trigger. In addition, the Panel recommends that OSHA
clearly explain the basis and need for small entities to comply with
ancillary provisions. The Panel also recommends that OSHA consider narrowing the trigger related to skin and contamination to capture only those situations where surfaces and surface dust may contain beryllium in a concentration that is significant enough to pose
any risk—or limiting the application of the trigger for some ancillary
provisions.
Several SERs said that OSHA should first assume the burden of describing the exposure level in each industry rather than employers
doing so. Others said that the Agency should accept exposure determinations made on an industry-wide basis, especially where exposures were far below the PEL options under consideration.
As noted above, the Panel recommends that OSHA consider alternatives that would alleviate the need for monitoring in operations or
processes with exposures far below the PEL. The use of objective
data is a principal method for industries with low exposures to satisfy
compliance with a proposed standard. The Panel recommends that
OSHA consider providing some guidance to small entities in the use
of objective data.
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
PO 00000
Frm 00203
Fmt 4701
Sfmt 4702
E:\FR\FM\07AUP2.SGM
07AUP2
47768
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
TABLE IX–28—SBAR PANEL RECOMMENDATIONS AND OSHA RESPONSES—Continued
Panel recommendation
OSHA response
The Panel recommends that OSHA consider more fully evaluating
whether the BeLPT is suitable as a test for beryllium sensitization in
an OSHA standard and respond to the points raised by the SERs
about its efficacy. In addition, the Agency should consider the availability of other tests under development for detecting beryllium sensitization and not limit either employers’ choices or new science and
technology in this area. Finally, the Panel recommends that OSHA
re-consider the trigger for medical surveillance where exposures are
low and consider if there are appropriate alternatives.
OSHA has provided discussion of the BeLPT in Appendix A to the regulatory text; in this preamble at section V, Health Effects; and in this
preamble at section XVIII, Summary and Explanation, (k) Medical
Surveillance. In the regulatory text, OSHA has clarified that a test for
beryllium sensitization other than the BeLPT may be used in lieu of
the BeLPT if a more reliable and accurate diagnostic test is developed. In this preamble at Section I, Issues and Alternatives, the
Agency requests comments on the BeLPT and on the reliability and
accuracy of alternate tests.
As stated above, the triggers for medical surveillance in this proposed
standard have changed from those presented to the SBAR Panel.
Whereas the draft standard presented during the SBREFA process
required medical surveillance for employees with skin contact—potentially applying to employees with any level of airborne exposure—
this proposed standard ties medical surveillance to exposures above
the proposed PEL of 0.2 μg/m3 (or signs or symptoms of berylliumrelated health effects, or emergency exposure). The triggers for medical surveillance are discussed in this preamble at section XVIII,
Summary and Explanation, (k) Medical Surveillance.
OSHA is considering Regulatory Alternative #16, which would eliminate
BeLPT testing requirements from this proposed standard. This alternative is discussed in the Regulatory Alternatives Chapter and in in
this preamble at Section XVIII, Summary and Explanation of the Proposed Standard, (k) Medical Surveillance.
The standard presented in the SBAR panel report had skin exposure
as a trigger. The only skin exposure trigger in this proposed standard
is the requirement for PPE when employees’ skin is potentially exposed to soluble beryllium compounds. OSHA uses an exposure
profile to determine which workers will be affected by the standard.
As a result, this proposed standard establishes regulated work areas
and exposure monitoring only with respect to employees who are, or
can reasonably be expected to be, exposed to airborne beryllium.
In addition, the scope of this proposed standard includes several limitations. Whereas the standard presented in the SBAR panel report
covered beryllium in all forms and compounds in general industry,
construction, and maritime, the scope of this proposed standard (1)
applies only to general industry; (2) does not apply to beryllium-containing articles that the employer does not process; and (3) does not
apply to materials that contain less than 0.1 percent beryllium by
weight. In this preamble, OSHA has clarified the circumstances
under which an employer may use historical and objective data in
lieu of initial monitoring (Section XVIII, Summary and Explanation of
this Proposed Standard, (d) Exposure Monitoring). OSHA is also
considering whether to create a guidance product on the use of objective data.
OSHA is considering Regulatory Alternative #7, a PEL-only standard.
This alternative is discussed in the Regulatory Alternatives Chapter
of the PEA and in this preamble at Section I, Issues and Alternatives.
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Seeking ways of minimizing costs to low risk processes and operations: OSHA should consider alternatives for minimizing costs to industries, operations, or processes that have low exposures. Such alternatives may include, but not be limited to: encouraging the use of
objective data by such mechanisms as providing guidance for objective data; assuring that triggers for skin exposure and surface contamination are clear and do not pull in low risk operations; providing
guidance on least-cost ways for low risk facilities to determine what
provisions of the standard they need to comply with; and considering
ways to limit the scope of 28 the standard if it can be ascertained
that certain processes do not represent a significant risk.
PEL-only standard: One SER recommended a PEL-only standard. This
would protect employees from airborne exposure risks while relieving
the beryllium industry of the cost of the ancillary provisions. The
Panel recommends that OSHA, consistent with its statutory obligations, analyze this alternative.
Alternative triggers for ancillary provisions: The Panel recommends that
OSHA clarify and consider eliminating or narrowing the triggers for
ancillary provisions associated with skin exposure or contamination.
In addition, the Panel recommends that OSHA should consider trying
ancillary provisions dependent on exposure rather than have these
provisions all take effect with the same trigger. If OSHA does rely on
a trigger related to skin exposure, OSHA should thoroughly explain
and justify this approach based on an analysis of the scientific or research literature that shows a risk of sensitization via exposure to
skin. If OSHA adopts a relatively low PEL, OSHA should consider
the effects of alternative airborne action levels in pulling in many low
risk facilities that may be unlikely to exceed the PEL—and consider
using only the PEL as a trigger at very low levels.
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
PO 00000
Frm 00204
Fmt 4701
OSHA has removed skin exposure as a trigger for several ancillary
provisions in this proposed standard, including Exposure Monitoring,
Hygiene Areas and Practices, and Medical Surveillance. In addition,
the language of this proposed standard regarding skin exposure has
changed: for some ancillary provisions, including PPE and Housekeeping, the requirements are triggered by visible contamination with
beryllium or skin contact with soluble beryllium compounds. These
requirements are discussed in this preamble at Section XVIII, Summary and Explanation. OSHA has explained the scientific basis for
minimizing skin exposure to beryllium in this preamble at Section V,
Health Effects, and explains the basis for specific ancillary provisions
related to skin exposure in this preamble at Section XVIII, Summary
and Explanation.
Sfmt 4702
E:\FR\FM\07AUP2.SGM
07AUP2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
47769
TABLE IX–28—SBAR PANEL RECOMMENDATIONS AND OSHA RESPONSES—Continued
Panel recommendation
OSHA response
Revise the medical surveillance provisions, including eliminating the
BeLPT: The BeLPT was the most common complaint from SERs.
The Panel recommends that OSHA carefully examine the value of
the BeLPT and consider whether it should be a requirement of a
medical surveillance program. The Panel recommends that OSHA
present the scientific evidence that supports the use of the BeLPT as
several SERs were doubtful of its reliability. The Panel recommends
that OSHA also consider reducing the frequency of physicals and the
BeLPT, if these provisions are included in a proposal. The Panel recommends that OSHA also consider a performance-based medical
surveillance program, permitting employers in consultation with physicians and health experts to develop appropriate tests and their frequency.
No medical removal protection (MRP): OSHA’s draft proposed standard
did not include any provision for medical removal protection, but
OSHA did ask the SERs to comment on MRP as a possibility. Based
on the SER comments, the Panel recommends that if OSHA includes an MRP provision, the agency provide a thorough analysis of
why such a provision is needed, what it might accomplish, and what
its full costs and economic impacts on those small businesses that
need to use it might be.
X. OMB Review Under the Paperwork
Reduction Act of 1995
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
A. Overview
The proposed general industry
standard for occupational exposure to
beryllium contains collection of
information (paperwork) requirements
that are subject to review by the Office
of Management and Budget (OMB)
under the Paperwork Reduction Act of
1995 (PRA–95), 44 U.S.C. 3501 et seq.,
and OMB’s regulations at 5 CFR part
1320. PRA–95 defines ‘‘collection of
information’’ to mean, ‘‘the obtaining,
causing to be obtained, soliciting, or
requiring the disclosure to third parties
or the public, of facts or opinions by or
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
In this proposed standard, the application of ancillary provisions is dependent on exposure, and not all provisions take effect with the
same trigger. A number of requirements are triggered by exposures
(or a reasonable expectation of exposures) above the PEL or action
level (AL). As discussed above, OSHA is considering Regulatory Alternatives #7 and #8, which would eliminate or reduce the impact of
ancillary provisions on employers, respectively. These alternatives
are discussed in the Regulatory Alternatives Chapter of the PEA and
in this preamble at Section I, Issues and Alternatives.
Responding to comments from SERs, OSHA has revised the medical
surveillance provision and removed the skin exposure trigger for
medical surveillance. As a result, OSHA estimates that the number
of small-business employees requiring a BeLPT will be substantially
reduced.
OSHA has provided discussion of the BeLPT in Appendix A to the regulatory text; in this preamble at section V, Health Effects; and in this
preamble at section XVIII, Summary and Explanation, (k) Medical
Surveillance. In the regulatory text, OSHA has clarified that a test for
beryllium sensitization other than the BeLPT may be used in lieu of
the BeLPT if a more reliable and accurate diagnostic test is developed. In this preamble at Section I, Issues and Alternatives, the
Agency requests comments on the BeLPT and on the reliability and
accuracy of alternate tests.
The frequency of periodic BeLPT testing in this proposed standard is
biennial, whereas annual testing was included in the draft standard
presented to the SBAR Panel.
Regulatory Alternative #20 would reduce the frequency of physical examinations from annual to biennial, matching the frequency of
BeLPT testing in this proposed rule.
In response to the suggestion to allow performance-based medical surveillance, OSHA is considering two regulatory alternatives that would
provide greater flexibility in the program of tests provided as part of
an employer’s medical surveillance program. Regulatory Alternative
#16 would eliminate BeLPT testing requirements from this proposed
standard. Regulatory Alternative #18 would eliminate the CT scan requirement from this proposed standard. These alternatives are discussed in the Regulatory Alternatives Chapter and in this preamble
at Section XVIII, Summary and Explanation, (k) Medical Surveillance.
This proposed standard includes an MRP provision. OSHA discusses
the basis of the provision and requests comments on it in this preamble at Section XVIII, Summary and Explanation, (l) Medical Removal Protection. OSHA provides an analysis of costs and economic
impacts of the provision in the PEA in Chapter V and Chapter VI, respectively.
The Agency is considering Alternative #22, which would eliminate the
MRP requirement from the standard. This alternative is discussed in
the Regulatory Alternatives Chapter and in in this preamble at section XVIII, Summary and Explanation, (l) Medical Removal Protection.
for an agency, regardless of form or
format’’ (44 U.S.C. 3502(3)(A)).
Under PRA–95, a Federal agency
cannot conduct or sponsor a collection
of information unless OMB approves it,
and the agency displays a currently
valid OMB control number. In addition,
the public is not required to respond to
a collection of information unless the
collection of information displays a
currently valid OMB control number.
Also, notwithstanding any other
provision of law, no person shall be
subject to penalty for failing to comply
with a collection of information if the
collection of information does not
display a currently valid OMB control
number.
PO 00000
Frm 00205
Fmt 4701
Sfmt 4702
B. Solicitation of Comments
OSHA prepared and submitted an
Information Collection Request (ICR) for
the collection of information
requirements identified in this NPRM to
OMB for review in accordance with 44
U.S.C. 3507(d). The Agency solicits
comments on the proposed collection of
information requirements and the
estimated burden hours and costs
associated with these requirements,
including comments on the following
items:
• Whether the proposed collection of
information requirements are necessary
for the proper performance of the
E:\FR\FM\07AUP2.SGM
07AUP2
47770
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
Agency’s functions, including whether
the information is useful;
• The accuracy of OSHA’s estimate of
the burden (time and cost) of the
information collection requirements,
including the validity of the
methodology and assumptions used;
• The quality, utility and clarity of
the information collected; and
• Ways to minimize the compliance
burden on employers, for example, by
using automated or other technological
techniques for collecting and
transmitting information.
C. Proposed Collection of Information
Requirements
As required by 5 CFR 1320.5(a)(1)(iv)
and 1320.8(d)(1), the following
paragraphs provide information about
this ICR.
1. Title: Occupational Exposure to
Beryllium
2. Description of the ICR: The
proposed Beryllium standard contains
collection of information requirements
which are essential components of the
occupational safety and health standard
that will assist both employers and their
employees in identifying the exposures
to beryllium and beryllium compounds,
the medical effects of such exposures,
and the means to reduce the risk of
overexposures to beryllium and
beryllium compounds.
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
3. Brief Summary of the Collection of
Information Requirements
Below is a summary of the collection
of information requirements identified
in the Beryllium proposal. Specific
details contained in the following
collections of information requirements
are discussed in Section XVIII:
Summary and Explanation of the
Proposed Standard.
§ 1910.1024(d) Exposure Monitoring
Under paragraph (d)(5)(i) of the
proposed standard, within 15 working
days after receiving the results of any
exposure monitoring completed under
this standard, employers must notify
each employee whose exposure is
characterized by the monitoring in
writing. Employers must either notify
each of these employees individually in
writing, or post the exposure monitoring
results in an appropriate location
accessible to all of these employees. In
this proposed standard, the following
provisions require exposure monitoring:
§ 1910.1024(d)(1), General;
§ 1910.1024(d)(2), Initial Exposure
Monitoring; § 1910.1024(d)(3), Periodic
Exposure Monitoring; § 1910.1024(d)(4),
Additional Monitoring.
Proposed paragraph (d)(5)(ii) details
additional information an employer
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
would need to include in the written
notification in (d)(5)(i), should
beryllium exposure exceed the TWA
PEL or STEL: a description of the
suspected or known sources of
exposure, and the corrective action(s)
the employer has taken or will take to
reduce the employee’s exposure to or
below the applicable PEL.
§ 1910.1024(e)(2)(i) & (ii) Demarcation of
Beryllium Work Areas
Proposed paragraph (e)(2)(i) would
require employers to identify each
beryllium work area through signs or
any other methods that adequately
establish and inform each employee of
the boundaries of each beryllium work
area. Paragraph (e)(2)(ii) would require
employers to identify each regulated
area in accordance with paragraph
(m)(2).
§ 1910.1024(f)(1)(i), (ii), and (iii) Written
Exposure Control Plan
Proposed paragraph (f)(1)(i) would
require employers to establish,
implement, and maintain a written
exposure control plan for beryllium
work areas. The plan must contain: (A)
An inventory of operations and job titles
reasonably expected to have exposure;
(B) an inventory of operations and job
titles reasonably expected to have
exposure at or above the action level; (C)
an inventory of operations and job titles
reasonably expected to have exposure
above the TWA PEL or STEL; (D)
procedures for minimizing crosscontamination, including but not
limited to preventing the transfer of
beryllium between surfaces, equipment,
clothing, materials, and articles within
beryllium work areas; (E) procedures for
keeping surfaces in the beryllium work
area as free as practicable of beryllium;
(F) procedures for minimizing the
migration of beryllium from beryllium
work areas to other locations within or
outside the workplace; (G) an inventory
of engineering and work practice
controls; and (H) procedures for
removal, laundering, storage, cleaning,
repairing, and disposal of berylliumcontaminated personal protective
clothing and equipment, including
respirators.
Proposed paragraph (f)(1)(ii) would
require employers to update their
exposure control plans whenever any
change in production processes,
materials, equipment, personnel, work
practices, or control methods results or
can reasonably be expected to result in
new or additional exposures to
beryllium. Paragraph (f)(1)(ii) also
requires employers to update their plans
when an employee is confirmed positive
for beryllium sensitization, is diagnosed
PO 00000
Frm 00206
Fmt 4701
Sfmt 4702
with CBD, or shows other signs or
symptoms related to beryllium
exposure. In addition, this paragraph
requires employers to update their plans
if the employer has any reason to
believe that new or additional exposures
are occurring or will occur. Proposed
paragraph (f)(1)(iii) would require
employers to make a copy of the
exposure control plan accessible to each
employee who is or can reasonably be
expected to be exposed to airborne
beryllium in accordance with OSHA’s
Access to Employee Exposure and
Medical Records (Records Access)
standard (29 CFR 1910.1020(e)).
§ 1910.1024(g) Respiratory Protection
Proposed paragraph (g)(1) would
require employers to provide at no cost
and ensure that each employee uses
respiratory protection during certain
periods or operations. Where the
proposed standard requires an employee
to use respiratory protection, proposed
paragraph (g)(2) requires such use to be
in accordance with the Respiratory
Protection Standard (29 CFR 1910.134).
The Respiratory Protection Standard’s
collection of information requirements
indicate that employers must: develop a
written respirator program; obtain and
maintain employee medical evaluation
records; provide the physician or other
licensed health care professional
(PLHCP) with information about the
employee’s respirator and the
conditions under which the employee
will use the respirator; administer fit
tests for employees who will use
negative- or positive-pressure, tightfitting facepieces; and establish and
retain written information regarding
medical evaluations, fit testing, and the
respirator program.
§ 1910.1024(h) Personal Protective
Clothing and Equipment
§ 1910.1024(h)(2)(v) Removal and
Storage
Proposed paragraph (h)(2)(v) would
require employers to ensure that any
protective clothing or equipment
required by the standard which is
removed from the workplace for
laundering, cleaning, maintenance, or
disposal is labeled in accordance with
paragraph (m)(3) of the proposed
standard and the Hazard
Communication standard at 29 CFR
1910.1200.
§ 1910.1024(h)(3)(iii) Cleaning and
Replacement
Proposed paragraph (h)(3)(iii) would
require employers to inform in writing
the persons or the business entities who
launder, clean or repair the protective
clothing or equipment required by this
E:\FR\FM\07AUP2.SGM
07AUP2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
standard of the potentially harmful
effects of exposure to airborne beryllium
and contact with soluble beryllium
compounds and how the protective
clothing and equipment must be
handled in accordance with the
standard.
§ 1910.1024(j)(3) Housekeeping
Proposed paragraph (j)(3)(i) requires
waste, debris, and materials visibly
contaminated with beryllium and
consigned for disposal to be disposed of
in sealed, impermeable enclosures.
Proposed paragraph (j)(3)(ii) requires
these enclosures to be labeled in
accordance with proposed paragraph
(m)(3) of the standard.
Proposed paragraph (j)(3)(iii) requires
materials designated for recycling that
are visibly contaminated with beryllium
to be cleaned to remove the visible
particulate or placed in sealed,
impermeable enclosures that are labeled
in accordance with proposed paragraph
(m)(3) of the standard.
§ 1910.1024(k) Medical Surveillance
§ 1910.1024(k)(1), (2), and (3) Employee
Medical Surveillance
Proposed paragraph (k)(1) details
when and under what conditions an
employer must make medical
surveillance available to its employees.
Paragraph (k)(2) of the proposed
standard specifies the frequency of
medical examinations that are to be
offered to those employees covered by
the medical surveillance program, and
proposed paragraph (k)(3) details the
content of the medical examinations.
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
§ 1910.1024(k)(4) Information Provided
to the PLHCP
Proposed paragraph (k)(4) would
require employers to provide a copy of
this standard and its appendices to the
examining PLHCP. In addition, the
proposed paragraph would require
employers to provide the following
information, if known, to the PLHCP:
(A) A description of the employee’s
former and current duties that relate to
the employee’s occupational exposure;
(B) the employee’s former and current
levels of occupational exposure; (C) a
description of any protective clothing
and equipment, including respirators,
used by the employee, including when
and for how long the employee has used
that protective clothing and equipment;
and (D) information from records of
employment-related medical
examinations previously provided to the
employee, currently within the control
of the employer, after obtaining a
medical release from the employee.
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
§ 1910.1024(k)(5)(i), (ii), and (iii)
Licensed Physician’s Written Medical
Opinion
Under proposed paragraph (k)(5)(i),
the employer must obtain a written
medical opinion from the licensed
physician within 30 days of the
employee’s medical examination. The
written medical opinion must contain
the following information: (A) The
licensed physician’s opinion as to
whether the employee has any detected
medical condition that would place the
employee at increased risk of CBD from
further exposure; (B) any recommended
limitations on the employee’s exposure,
including the use and limitations of
protective clothing or equipment,
including respirators; and (C) a
statement that the PLHCP has explained
the results of the medical examination
to the employee, including any tests
conducted, any medical conditions
related to exposure that require further
evaluation or treatment, and any special
provisions for use of protective clothing
or equipment.
Proposed paragraph (k)(5)(ii) would
require the employer to ensure that
neither the licensed physician nor any
other PLHCP reveals to the employer
findings or diagnoses which are
unrelated to beryllium exposure.
Proposed paragraph (k)(5)(iii) would
require the employer to provide a copy
of the licensed physician’s written
medical opinion to the employee within
two weeks after receiving it.
47771
and ensure that each employee has
access to labels on containers and safety
data sheets for beryllium.
Proposed paragraph (m)(2)(i) would
require employers to post warning signs
at each approach to a regulated area so
that each employee is able to read and
understand the signs and take necessary
protective steps before entering the area.
Proposed paragraph (m)(2)(ii) would
require these signs to be legible and
readily visible, and contains language
that would be required to appear on
each warning sign.
Proposed paragraph (m)(3) would
require employers to label each bag and
container of clothing, equipment, and
materials visibly contaminated with
beryllium consistent with the Hazard
Communication standard at 29 CFR
1910.1200. Proposed paragraph (m)(3)
also contains language that would be
required to appear on every such label.
Proposed paragraph (m)(4)(iv) would
require employers to make copies of the
standard and its appendices readily
available at no cost to each employee
and designated employee
representative.
§ 1910.1024(m)(4)(iv) Employee
Information
Paragraph (m)(4)(iv) requires that
employers make copies of the standard
and its appendices readily available at
no cost to each employee and
designated employee representative.
§ 1910.1024(n) Recordkeeping
§ 1910.1024(k)(7) Beryllium
Sensitization Test Results Research
§ 1910.1024(n)(1)(i), (ii), and (iii)
Exposure Measurements.
Proposed paragraph (k)(7) would
require employers, upon request by
OSHA, to convey employees’ beryllium
sensitization test results to OSHA for
evaluation and analysis.
Proposed paragraph (n)(1)(i) would
require employers to keep records of all
measurements taken to monitor
employee exposure to beryllium as
required by paragraph (d) of the
standard.
Proposed paragraph (n)(1)(ii) would
require employers to include at least the
following information in the records:
(A) The date of measurement for each
sample taken; (B) the operation that is
being monitored; (C) the sampling and
analytical methods used and evidence
of their accuracy; (D) the number,
duration, and results of samples taken;
(E) the type of personal protective
clothing and equipment, including
respirators, worn by monitored
employees at the time of monitoring;
and, (F) the name, social security
number, and job classification of each
employee represented by the
monitoring, indicating which employees
were actually monitored.
Proposed paragraph (n)(1)(iii) would
require employers to maintain employee
exposure monitoring records in
§ 1910.1024(m) Communication of
Hazards
Proposed paragraph (m)(1)(i) would
require chemical manufacturers,
importers, distributors, and employers
to comply with all applicable
requirements of the Hazard
Communication Standard (HCS) for
beryllium (29 CFR 1910.1200). Proposed
paragraph (m)(1)(ii) requires that when
classifying the hazards of beryllium, the
employer must address at least the
following: cancer; lung effects (chronic
beryllium disease and acute beryllium
disease); beryllium sensitization; skin
sensitization; and skin, eye, and
respiratory tract irritation.
Proposed paragraph (m)(1)(iii) would
require employers to include beryllium
in the hazard communication program
established to comply with the HCS,
PO 00000
Frm 00207
Fmt 4701
Sfmt 4702
E:\FR\FM\07AUP2.SGM
07AUP2
47772
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
accordance with 29 CFR
1910.1020(d)(1)(ii).
§ 1910.1024(n)(2)(i), (ii), and (iii)
Historical Monitoring Data
Proposed paragraph (n)(2)(i) would
require employers to establish an
accurate record of any historical
monitoring data used to satisfy the
initial monitoring requirements in
paragraph (d)(2) of the proposed
standard. Paragraph (n)(2)(ii) would
require the employer to demonstrate
that the data comply with the
requirements of paragraph (d)(2) of the
standard. Paragraph (n)(2)(iii) would
require the employer to maintain
historical monitoring data in accordance
with 29 CFR 1910.1020.
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
§ 1910.1024(n)(3)(i), (ii), and (iii)
Objective Data
Proposed paragraph (n)(3)(i) would
require employers to establish accurate
records of any objective data relied
upon to satisfy the requirement for
initial monitoring in proposed
paragraph (d)(2). Proposed paragraph
(n)(3)(ii) would require employers to
have at least the following information
in such records: (A) The data relied
upon; (B) the beryllium-containing
material in question; (C) the source of
the objective data; (D) a description of
the operation exempted from initial
monitoring and how the data support
the exemption; and (E) other
information demonstrating that the data
meet the requirements for objective data
contained in paragraph (d)(2)(ii) of the
proposed standard. Proposed paragraph
(n)(3)(iii) would require employers to
maintain objective data records in
accordance with 29 CFR 1910.1020.
§ 1910.1024(n)(4)(i), (ii), & (iii) Medical
Surveillance
Proposed paragraph (n)(4)(i) would
require employers to establish accurate
records for each employee covered by
the medical surveillance requirements
in proposed paragraph (k). Proposed
paragraph (n)(4)(ii) would require
employers to include in employee
medical records the following
information about the employee: (A)
Name, social security number, and job
classification; (B) a copy of all licensed
physicians’ written opinions; and (C) a
copy of the information provided to the
PLHCP as required by paragraph (k)(4)
of the proposed standard. Proposed
paragraph (n)(4)(iii) would require
employers to maintain medical records
in accordance with 29 CFR 1910.1020.
§§ 1910.1024(n)(5)(i) & (ii) Training
Proposed paragraph (n)(5)(i) would
require employers to prepare an
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
employee training record at the
completion of any training required by
the proposed standard. The training
record must contain the following
information: The name, social security
number, and job classification of each
employee trained; the date the training
was completed; and the topic of the
training. Proposed paragraph (n)(5)(ii)
would require employers to maintain
employee training records for three
years after the completion of training.
This record maintenance requirement
would also apply to records of annual
retraining or additional training as
described in paragraph (m)(4) of the
proposed standard.
§ 1910.1024(n)(6) Access to Records
Under proposed paragraph (n)(6),
employers must make all records
maintained as a requirement of the
standard available for examination and
copying to the Assistant Secretary, the
Director of NIOSH, each employee, and
each employee’s designated
representative(s) in accordance with the
Access to employee exposure and
medical records standard (29 CFR
1910.1020).
§ 1910.1024(n)(7) Transfer of Records
Paragraph (n)(7) of the proposed
standard would require employers to
comply with the transfer requirements
contained in the Access to employee
exposure and medical records standard
(29 CFR 1910.1020(h)). That existing
standard requires employers either to
transfer records to successor employers
or, if there is no successor employer, to
inform employees of their access rights
at least three months before the
cessation of the employer’s business.
4. Affected Public: Business or other
for-profit. This standard applies to
employers in general industry who have
employees that may have occupational
exposures to any form of beryllium,
including compounds and mixtures,
except those articles and materials
exempted by paragraphs (a)(2) and (a)(3)
of the proposed standard. This standard
does not apply to articles, as defined in
the Hazard Communication standard
(HCS) (29 CFR 1910.1200(c)), that
contain beryllium and that the employer
does not process. Also, this standard
does not apply to materials containing
less than 0.1% beryllium by weight.
5. Number of respondents: Employers
in general industry that have employees
working in jobs affected by beryllium
exposure (4,088 employers).
6. Frequency of responses: Frequency
of response varies depending on the
specific collection of information.
7. Number of responses:155,818.
PO 00000
Frm 00208
Fmt 4701
Sfmt 4702
8. Average time per response: Varies
from 5 minutes (.08 hours) for a clerical
worker to generate and maintain an
employee medical record, to 8 hours for
a human resource manager to develop
and implement a written exposure
control plan.
9. Estimated total burden hours:
80,776.
10. Estimated cost (capital-operation
and maintenance): $10,900,579.
D. Submitting Comments
Members of the public who wish to
comment on the paperwork
requirements in this proposal must send
their written comments to the Office of
Information and Regulatory Affairs,
Attn: OMB Desk Officer for the
Department of Labor, OSHA (RIN–1218–
AB76), Office of Management and
Budget, Room 10235, Washington, DC
20503, Fax: 202–395–5806 (this is not a
toll-free numbers), email: OIRA_
submission@omb.eop.gov. The Agency
encourages commenters also to submit
their comments on these paperwork
requirements to the rulemaking docket
(Docket Number OSHA–H005C–2006–
0870), along with their comments on
other parts of the proposed rule. For
instructions on submitting these
comments to the rulemaking docket, see
the sections of this Federal Register
notice titled DATES and ADDRESSES.
E. Docket and Inquiries
To access the docket to read or
download comments and other
materials related to this paperwork
determination, including the complete
Information Collection Request (ICR)
(containing the Supporting Statement
with attachments describing the
paperwork determinations in detail) use
the procedures described under the
section of this notice titled
ADDRESSES. You also may obtain an
electronic copy of the complete ICR by
visiting the Web page at https://
www.reginfo.gov/public/do/PRAMain,
scroll under ‘‘Currently Under Review’’
to ‘‘Department of Labor (DOL)’’ to view
all of the DOL’s ICRs, including those
ICRs submitted for proposed
rulemakings. To make inquiries, or to
request other information, contact Mr.
Todd Owen, Directorate of Standards
and Guidance, OSHA, Room N–3609,
U.S. Department of Labor, 200
Constitution Avenue NW., Washington,
DC 20210; telephone (202) 693–2222.
XI. Federalism
The Agency reviewed the proposed
beryllium rule according to the
Executive Order (E.O.) on Federalism
(E.O. 13132, 64 FR 43255, Aug. 10,
1999), which requires that Federal
E:\FR\FM\07AUP2.SGM
07AUP2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
agencies, to the extent possible, refrain
from limiting State policy options,
consult with States before taking actions
that would restrict States’ policy options
and take such actions only when clear
constitutional authority exists and the
problem is of national scope. The E.O.
allows Federal agencies to preempt
State law only with the expressed
consent of Congress; in such cases,
Federal agencies must limit preemption
of State law to the extent possible.
Under Section 18 of the Occupational
Safety and Health Act (the ‘‘Act’’ or
‘‘OSH Act,’’ 29 U.S.C. 667), Congress
expressly provides that States may
adopt, with Federal approval, a plan for
the development and enforcement of
occupational safety and health
standards; States that obtain Federal
approval for such a plan are referred to
as ‘‘State-Plan States.’’ (29 U.S.C. 667).
Occupational safety and health
standards developed by State-Plan
States must be at least as effective in
providing safe and healthful
employment and places of employment
as the Federal standards.
While OSHA drafted this proposed
rule to protect employees in every State,
Section 18(c)(2) of the OSHA Act
permits State-Plan States to develop and
enforce their own standards, provided
the requirements in these standards are
at least as safe and healthful as the
requirements specified in this proposed
rule if it is promulgated.
In summary, this proposed rule
complies with E.O. 13132. In States
without OSHA-approved State plans,
Congress expressly provides for OSHA
standards to preempt State occupational
safety and health standards in areas
addressed by the Federal standards; in
these States, this rule limits State policy
options in the same manner as every
standard promulgated by the Agency. In
States with OSHA-approved State plans,
this rulemaking does not significantly
limit State policy options.
XII. State-Plan States
When Federal OSHA promulgates a
new standard or a more stringent
amendment to an existing standard, the
27 State and U.S. territories with their
own OSHA-approved occupational
safety and health plans (‘‘State-Plan
States’’) must revise their standards to
reflect the new standard or amendment.
The State standard must be at least as
effective as the Federal standard or
amendment, and must be promulgated
within six months of the publication
date of the final Federal rule. 29 CFR
1953.5(a).
The State may demonstrate that a
standard change is not necessary
because, for example, the State standard
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
is already the same as or at least as
effective as the Federal standard change.
In order to avoid delays in worker
protection, the effective date of the State
standard and any of its delayed
provisions must be the date of State
promulgation or the Federal effective
date, whichever is later. The Assistant
Secretary may permit a longer time
period if the State makes a timely
demonstration that good cause exists for
extending the time limitation. 29 CFR
1953.5(a).
Of the 27 States and territories with
OSHA-approved State plans, 22 cover
public and private-sector employees:
Alaska, Arizona, California, Hawaii,
Indiana, Iowa, Kentucky, Maryland,
Michigan, Minnesota, Nevada, New
Mexico, North Carolina, Oregon, Puerto
Rico, South Carolina, Tennessee, Utah,
Vermont, Virginia, Washington, and
Wyoming. The five states and territories
whose OSHA-approved State plans
cover only public-sector employees are:
Connecticut, Illinois, New Jersey, New
York, and the Virgin Islands.
This proposed beryllium rule applies
to general industry. If adopted as
proposed, all State Plan States would be
required to revise their general industry
standard appropriately within six
months of Federal promulgation.
XIII. Unfunded Mandates Reform Act
Under Section 202 of the Unfunded
Mandates Reform Act of 1995 (UMRA),
2 U.S.C. 1532, an agency must prepare
a written ‘‘qualitative and quantitative
assessment’’ of any regulation creating a
mandate that ‘‘may result in the
expenditure by the State, local, and
tribal governments, in the aggregate, or
by the private sector, of $100,000,000 or
more’’ in any one year before issuing a
notice of proposed rulemaking. OSHA’s
proposal does not place a mandate on
State or local governments, for purposes
of the UMRA, because OSHA cannot
enforce its regulations or standards on
State or local governments (see 29
U.S.C. 652(5)). Under voluntary
agreement with OSHA, some States
enforce compliance with their State
standards on public sector entities, and
these agreements specify that these State
standards must be equivalent to OSHA
standards. The OSH Act also does not
cover tribal governments in the
performance of traditional governmental
functions, though it does when tribal
governments engage in commercial
activity. However, the proposal would
not require tribal governments to
expend, in the aggregate, $100,000,000
or more in any one year for their
commercial activities. Thus, although
OSHA may include compliance costs for
affected governmental entities in its
PO 00000
Frm 00209
Fmt 4701
Sfmt 4702
47773
analysis of the expected impacts
associated with a proposal, the proposal
does not trigger the requirements of
UMRA based on its impact on State,
local, or tribal governments.
Based on the analysis presented in the
Preliminary Economic Analysis (see
Section IX above), OSHA concludes that
the proposal would impose a Federal
mandate on the private sector in excess
of $100 million in expenditures in any
one year. The Preliminary Economic
Analysis constitutes the written
statement containing a qualitative and
quantitative assessment of the
anticipated costs and benefits required
under Section 202(a) of the UMRA (2
U.S.C. 1532).
XIV. Protecting Children From
Environmental Health and Safety Risks
E.O.13045 (66 FR 19931 (Apr. 23,
2003)) requires that Federal agencies
submitting covered regulatory actions to
OMB’s Office of Information and
Regulatory Affairs (OIRA) for review
pursuant to E.O. 12866 (58 FR 51735
(Oct. 4, 1993)) must provide OIRA with
(1) an evaluation of the environmental
health or safety effects that the planned
regulation may have on children, and
(2) an explanation of why the planned
regulation is preferable to other
potentially effective and reasonably
feasible alternatives considered by the
agency. E.O.13045 defines ‘‘covered
regulatory actions’’ as rules that may (1)
be economically significant under E.O.
12866 (i.e., a rulemaking that has an
annual effect on the economy of $100
million or more, or would adversely
affect in a material way the economy, a
sector of the economy, productivity,
competition, jobs, the environment,
public health or safety, or State, local,
or tribal governments or communities),
and (2) concern an environmental
health risk or safety risk that an agency
has reason to believe may
disproportionately affect children. In
this context, the term ‘‘environmental
health risks and safety risks’’ means
risks to health or safety that are
attributable to products or substances
that children are likely to come in
contact with or ingest (e.g., through air,
food, water, soil, product use).
The proposed beryllium rule is
economically significant under E.O.
12866 (see Section IX of this preamble).
However, after reviewing the proposed
beryllium rule, OSHA has determined
that the rule would not impose
environmental health or safety risks to
children as set forth in E.O. 13045. The
proposed rule would require employers
to limit employee exposure to beryllium
and take other precautions to protect
employees from adverse health effects
E:\FR\FM\07AUP2.SGM
07AUP2
47774
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
associated with exposure to beryllium.
OSHA is not aware of any studies
showing that exposure to beryllium
disproportionately affects children or
that employees under 18 years of age
who may be exposed to beryllium are
disproportionately affected by such
exposure. Based on this preliminary
determination, OSHA believes that the
proposed beryllium rule does not
constitute a covered regulatory action as
defined by E.O. 13045. However, if such
conditions exist, children who are
exposed to beryllium in the workplace
would be better protected from exposure
to beryllium under the proposed rule
than they are currently.
XV. Environmental Impacts
OSHA has reviewed the beryllium
proposal according to the National
Environmental Policy Act of 1969
(NEPA) (42 U.S.C. 4321 et seq.), the
regulations of the Council on
Environmental Quality (40 CFR part
1500), and the Department of Labor’s
NEPA procedures (29 CFR part 11).
Based on that review, OSHA does not
expect that the proposed rule, in and of
itself, would create additional
environmental issues. OSHA has made
a preliminary determination that the
proposed standard will have no impact
on air, water, or soil quality; plant or
animal life; the use of land or aspects of
the external environment. Therefore,
OSHA concludes that the proposed
beryllium standard would have no
significant environmental impacts.
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
XVI. Consultation and Coordination
With Indian Tribal Governments
OSHA reviewed this proposed rule in
accordance with E.O. 13175 on
Consultation and Coordination with
Indian Tribal Governments (65 FR
67249, November 9, 2000), and
determined that it does not have ‘‘tribal
implications’’ as defined in that order.
The rule, if promulgated, would not
have substantial direct effects on one or
more Indian tribes, on the relationship
between the Federal government and
Indian tribes, or on the distribution of
power and responsibilities between the
Federal government and Indian tribes.
XVII. Public Participation
OSHA encourages members of the
public to participate in this rulemaking
by submitting comments on the
proposal.
Written Comments. OSHA invites
interested persons to submit written
data, views, and arguments concerning
this proposal. In particular, OSHA
encourages interested persons to
comment on the issues raised at the end
of each section. When submitting
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
comments, persons must follow the
procedures specified above in the
sections titled DATES and ADDRESSES.
Informal public hearings. The Agency
will schedule an informal public
hearing on the proposed rule if
requested during the comment period.
Introduction
employers with greater flexibility in
determining the most effective strategies
for controlling beryllium hazards in
their workplaces. OSHA believes this
approach allows employers to
incorporate changes and advancements
in control strategy, technology, and
industry practice, thereby reducing the
need to revise the rule when those
changes occur.
This section of the preamble explains
the requirements that OSHA proposes to
control occupational exposure to
beryllium, including the purpose of
these requirements and how they will
protect workers from hazardous
beryllium exposures.
OSHA believes, based on currently
available information, that the proposed
requirements are necessary and
appropriate to protect workers exposed
to beryllium. In developing this
proposed rule, OSHA has considered
many sources of data and information,
including responses to the Request for
Information (RFI) for ‘‘Occupational
Exposure to Beryllium’’ (OSHA, 2002);
the responses from Small Entity
Representatives (SERs) who participated
in the Small Business Regulatory
Enforcement Fairness Act of 1996
(SBREFA) (5 U.S.C. 601 et seq.) process
(OSHA, 2007a); recommendations of the
Small Business Advocacy Review
(SBAR) Panel (OSHA, 2008b); the
Department of Energy (DOE) Chronic
Beryllium Disease Prevention Program
rule (DOE, 1999); and numerous
scientific studies, professional journal
articles, and other data obtained by the
Agency.
The provisions in the proposed
standard are generally consistent with
other recent OSHA health standards,
such as chromium (VI)(29 CFR
1910.1026) and cadmium (29 CFR
1910.1027). Using a similar approach
across health standards, when possible,
makes them more understandable and
easier for employers to follow, and
helps to facilitate uniformity of
interpretation. This approach is also
consistent with section 6(b)(5) of the
OSH Act, which states that health
standards shall consider ‘‘experience
gained under this and other health and
safety laws’’ (29 U.S.C. 655(b)(5)).
However, to the extent that protecting
workers from occupational exposure to
beryllium requires different or unique
approaches, the Agency has formulated
proposed requirements to address the
specific hazards and working conditions
associated with beryllium exposure.
Also pursuant to section 6(b)(5),
OSHA has expressed the proposed
requirements in performance-based
language, where possible, to provide
(a) Scope and Application
In paragraph (a)(1), OSHA proposes to
apply this standard to occupational
exposure to beryllium in all forms,
compounds, and mixtures in general
industry.
For the purpose of the proposed rule,
OSHA is treating beryllium generally,
instead of individually addressing
specific compounds, forms, and
mixtures. Based on a review of scientific
studies, OSHA has preliminarily
determined that the toxicological effects
of beryllium exposure on the human
body are similar regardless of the form
of beryllium (see the Health Effects
section of this preamble at V.B.5; V.G).
OSHA is not aware of any information
that would lead the Agency to conclude
that exposure to different forms of
beryllium necessitates different
regulatory approaches or requirements.
OSHA has preliminarily decided to
limit the scope of the rulemaking to
general industry. This proposal is
modeled on a suggested rule that was
crafted by two major stakeholders in
general industry, Materion Brush and
the United Steelworkers Union
(Materion and USW, 2012). In the
course of developing this proposal, they
provided OSHA with data on exposure
and control measures and information
on their experiences with handling
beryllium in general industry settings.
At this time, the information available
to OSHA on beryllium exposures
outside of general industry is limited,
but suggests that most operations in
other sectors are unlikely to involve
beryllium exposure. The Agency hopes
to expedite the rulemaking process by
limiting the scope of this proposal to
general industry and relying on already
existing standards to protect workers in
those operations outside of general
industry where beryllium exposure may
exist.
The proposed rule would not apply to
marine terminals, longshoring, or
agriculture. OSHA has not found
evidence indicating that beryllium is
used or handled in these sectors in a
way that might result in beryllium
exposure. The proposed rule also
excludes the construction and shipyard
sectors. OSHA believes that
occupational exposures to beryllium in
XVIII. Summary and Explanation
PO 00000
Frm 00210
Fmt 4701
Sfmt 4702
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
the construction and shipyard sectors
occur primarily in abrasive blasting
operations.
Abrasive blasters and ancillary
abrasive blasting workers are exposed to
beryllium from coal slag and other
abrasive blast material that may contain
beryllium as a trace contaminant.
Airborne concentrations of beryllium
have been measured above the current
TWA PEL of 2 mg/m3 when blast
material containing beryllium is used as
intended (see Appendix IV–C in the
PEA, OSHA 2014). Abrasive blasters,
pot tenders, and cleanup workers have
the potential for significant airborne
exposure during blasting operations and
during cleanup of spent material that
may contain beryllium as a trace
contaminant.
To address high concentrations of
various hazardous chemicals in abrasive
blasting material, employers must
already be using engineering and work
practice controls to limit workers’
exposures and must be supplementing
these controls with respiratory
protection when necessary. For
example, abrasive blasters in the
construction industry fall under the
protection of the Ventilation standard
(29 CFR 1926.57). The Ventilation
standard includes an abrasive blasting
subsection (29 CFR 1926.57(f)), which
requires that abrasive blasting
respirators be worn by all abrasive
blasting operators when working inside
blast-cleaning rooms (29 CFR
1926.57(f)(5)(ii)(A)), or when using
silica sand in manual blasting
operations where the nozzle and blast
are not physically separated from the
operator in an exhaust-ventilated
enclosure (29 CFR 1926.57(f)(5)(ii)(B)),
or when needed to protect workers from
exposures to hazardous substances in
excess of the limits set in § 1926.55 (29
CFR 1926.57(f)(5)(ii)(C); ACGIH, 1971)).
For maritime, standard 29 CFR
1915.34(c) covers similar requirements
for respiratory protection needed in
blasting operations. Due to these
requirements, OSHA believes that
abrasive blasters already have controls
in place and wear respiratory protection
during blasting operations. Thus, in
estimating costs for Regulatory
Alternatives #2a and #2b, OSHA judged
that the reduction of the TWA PEL
would not impose costs for additional
engineering controls or respiratory
protection in abrasive blasting (see
Appendix VIII–C in this chapter for
details). OSHA requests comment on
this issue—in particular, whether
abrasive blasters using blast material
that may contain beryllium as a trace
contaminant are already using all
feasible engineering and work practice
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
controls, respiratory protection, and PPE
that would be required by Regulatory
Alternatives #2a and #2b.
OSHA requests comment on the
limitation of the scope to general
industry, as well as information on
beryllium exposures in all industry
sectors. The Agency requests
information on whether employees in
the construction, maritime, longshoring,
shipyard, and agricultural sectors are
exposed to beryllium in any form and,
if so, their levels of exposure and what
types of exposure controls are currently
in place. In particular, OSHA requests
comment on whether abrasive blasters
using blast material that may contain
beryllium as a trace contaminant are
already using all feasible engineering
and work practice controls, respiratory
protection, and PPE. OSHA also
requests comment on Regulatory
Alternatives #2a and #2b, presented at
the end of this section, that would
provide protection to workers in sectors
outside of general industry. Regulatory
Alternative #2a would expand the scope
of the proposed standard to include
employers in construction and
maritime. Regulatory #2b would change
the Z tables in 29 CFR 1910.1000 and
29 CFR 1915.1000, and Appendix A of
29 CFR 1926.55, to lower the
permissible exposure limits for
beryllium for workers in all berylliumexposed occupations. Another
regulatory alternative that would impact
the scope of affected industries,
extending eligibility for medical
surveillance to employees in shipyards,
construction, and parts of general
industry excluded from the scope of the
proposed standard, is discussed along
with other medical surveillance
alternatives (see this preamble at
Section XVIII, paragraph (k), Regulatory
Alternative #21). Depending on the
nature of the data and comments
provided, OSHA envisions possible
expansions of its regulation of beryllium
either as part of this rulemaking or at a
later time.
Paragraph (a)(2) specifies that the
proposed rule would not apply to
articles, as defined in the Hazard
Communication standard (HCS) (29 CFR
1910.1200(c)), that contain beryllium
and that the employer does not process.
The HCS defines an article as ‘‘a
manufactured item other than a fluid or
particle: (i) Which is formed to a
specific shape or design during
manufacture; (ii) which has end use
function(s) dependent in whole or in
part upon its shape or design during end
use; and (iii) which under normal
conditions of use does not release more
than very small quantities e.g., minute
or trace amounts of a hazardous
PO 00000
Frm 00211
Fmt 4701
Sfmt 4702
47775
chemical (as determined under
paragraph (d) of this section), and does
not pose a physical hazard or health risk
to employees.’’ For example, items or
parts containing beryllium that
employers assemble where the physical
integrity of the item is not compromised
are unlikely to release more than a very
small quantity of beryllium that would
not pose a physical or health hazard for
workers. These items would be
considered articles that are exempt from
the scope of the proposed standard.
Similarly, finished or processed items or
parts containing beryllium that
employers are simply packing in
containers or affixing with shipping tags
or labels are unlikely to release more
than a minute or trace amount of
beryllium. These items would also come
within the proposed exemption. By
contrast, if an employer performs
operations such as machining, grinding,
blasting, sanding, or other processes that
physically alter an item, these
operations would not fall within the
exemption in proposed paragraph (a)(2)
because they involve processing of the
item and could result in significant
exposure to beryllium-containing
material.
Paragraph (a)(3) specifies that the
proposed rule would not apply to
materials containing less than 0.1%
beryllium by weight. A similar
exemption is included in several
previously promulgated standards,
including Benzene (29 CFR 1910.1028),
Methylenedianiline (MDA) (29 CFR
1910.1050), and 1,3-Butadiene (BD) (29
CFR 1910.1051). These exemptions were
established to limit the regulatory
burden on employers who do not use
materials containing 0.1 percent or more
of the substance in question, on the
premise that workers in exempted
industries are not exposed at levels of
concern. In the preamble to the MDA
standard, OSHA states that the Agency
relied on data showing that worker
exposure to mixtures or materials of
MDA containing less than 0.1 percent
MDA did not create any hazards other
than those expected from worker
exposure beneath the action level (57 FR
35630, 35645–46, August 10, 1992). The
exemption in the BD standard does not
apply where airborne concentrations
generated by such mixtures can exceed
the action level or STEL. The exemption
in the Benzene standard was based on
indications that exposures resulting
from substances containing trace
amounts of benzene would generally be
below the exposure limit, and on
OSHA’s belief that the exemption would
encourage employers to reduce the
concentration of benzene in certain
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47776
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
substances (43 FR 27962, 27968, June
27, 1978).
OSHA is aware of two industries in
the general industry sector that would
be exempted from the proposed
standard under proposed paragraph
(a)(3): Coal-fired electric power
generation and primary aluminum
production. As discussed in the PEA,
Chapter IV, Appendices A and B, most
employees’ TWA exposures in these
industries do not exceed the proposed
action level of 0.1 mg/m3. However,
exposures above the proposed PEL of
0.2 mg/m3 have been found in some jobs
and in facilities with poor housekeeping
and work practices. In coal-fired electric
power generation, these higher
exposures are associated with
intermittent exposure to fly ash during
maintenance work in and around
baghouses and boilers. Fly ash contains
less than 0.01% beryllium; however,
exposures between 0.1 and 0.4 mg/m3
were observed among workers
maintaining boilers. Exposures for
baghouse cleaning frequently exceeded
the current PEL, reaching as high as 13
mg/m3. In aluminum production, the
bauxite ore used as a raw material
contains naturally occurring beryllium
in the part per million range (i.e.
<0.0001%); however, a study of four
smelters showed that the arithmetic
mean exposure was slightly above the
proposed PEL, and the 95th percentile
exposure (of 965 samples) was above 1
mg/m3. BeLPT testing in a group of 734
aluminum workers found two cases of
confirmed beryllium sensitization
(0.27%) and an additional few abnormal
results that could not be confirmed,
either because the worker was not
retested or the retest appeared normal
(Taiwo et al., 2008).
OSHA requests comment on the
exemption proposed for the beryllium
standard. Is it appropriate to include an
exemption for operations where
beryllium exists only as a trace
contaminant, but some workers can
nevertheless be significantly exposed?
Should the Agency consider dropping
the exemption, or constraining it to
operations where exposures are below
the proposed action level and STEL?
OSHA requests additional data
describing the levels of airborne
beryllium in workplaces that fall under
this exemption and comments on
regulatory alternatives, discussed at the
end of this section, that would eliminate
or modify the exemption.
A number of stakeholders, including
SERs who participated in the SBREFA
process, urged OSHA to exempt certain
industries or processes and activities
from the proposed standard. In support
of this request, SERs from the stamping
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
industry argued that their exposures are
low, below 0.2 mg/m3 (OSHA, 2007a). In
addition, some SERs requested
exemptions from particular
requirements. SERs from the dental
laboratory industry requested
exemptions from all requirements other
than training and the permissible
exposure limit (PEL). In support of this
request, they also argued that their
exposures are very low, around 0.02 mg/
m3 when ventilation is used. They
indicated that they already have
sufficient engineering and work practice
controls in place to keep exposures low
(OSHA, 2008b). The SBREFA Panel
recommended that OSHA consider a
more limited scope of industries
(OSHA, 2008b).
The Panel’s recommendation is
addressed in part in this proposed
standard, which has a much more
limited scope than the draft standard
reviewed by the SBREFA Panel.
Whereas the draft reviewed by the Panel
covered beryllium in all forms and
compounds in general industry,
construction, and maritime, the scope of
the current beryllium proposal includes
general industry only, and does not
apply to employers in construction and
maritime. In addition, it provides an
exemption for those working with
materials that contain beryllium only as
a trace contaminant (less than 0.1
percent composition by weight).
Although much narrower than the
scope in the SBREFA draft, the current
proposal’s scope includes industries of
concern for some SERs. OSHA’s
preliminary feasibility analysis
indicates that worker exposures in both
dental laboratories and stamping
facilities exceed or have the potential to
exceed the proposed TWA PEL where
appropriate controls are not in place
(see section IX of this preamble,
Summary of the Preliminary Economic
Analysis and Initial Regulatory
Flexibility Analysis). Accordingly,
OSHA has not exempted them from the
proposed standard. However, if
employers in these industries have
historical or objective data that meet the
requirements set forth in proposed
paragraph (d)(2) demonstrating that they
have no exposures or that exposures are
below the action level and at or below
the STEL, these employers may be able
to satisfy many of their obligations
under this proposed standard by
reference to these data.
Some stakeholders, including
employers who do stripping operations,
urged that OSHA exempt them from the
proposed rule because any beryllium
exposures generated in their facilities
were comprised of larger-sized particles,
which they contended were not as
PO 00000
Frm 00212
Fmt 4701
Sfmt 4702
harmful as smaller ones (OSHA, 2008b).
OSHA has decided not to exempt
operations based on particle size. As
discussed in this preamble at section V,
Health Effects, there is not sufficient
evidence to demonstrate that particle
size has a significant bearing on health
outcomes.
While acknowledging the concerns
raised by SERs that the scope of the
standard might be too broad, OSHA is
concerned that the scope of the current
proposal might be too narrow.
Exposures have the potential to exceed
the proposed PEL in some blasting
operations in construction and
maritime, and in some general industry
operations where beryllium exists as a
trace contaminant. Abrasive blasters and
ancillary abrasive blasting workers are
exposed to beryllium from coal slags
and other abrasive blast material, which
contain beryllium in amounts less than
0.1 percent. Airborne concentrations of
beryllium have been measured above
the current TWA PEL of 2 mg/m3 when
the blast material is used as intended.
Abrasive blasters, pot tenders, and
cleanup workers working primarily in
construction and shipyards have the
potential for significant airborne
exposure during blasting operations and
during cleanup of spent blast material.
Coal fly ash in coal powered utility
facilities is also known to contain trace
amounts of beryllium, which may
become airborne during furnace and bag
house operations and result in
exposures exceeding the current PELs.
Similarly, beryllium exists as a
contaminant in aluminum ore and may
result in exposures above the proposed
PELs during aluminum refining and
production.
OSHA invites comment on the
proposed scope of the standard and on
Regulatory Alternatives 1 and 2 below,
which would increase protection for
workers in maritime and construction
industries and in occupations dealing
with beryllium as a trace contaminant.
Regulatory Alternatives 1a and 1b
Regulatory Alternative #1a would
modify the proposed scope to eliminate
the exemption for materials containing
less than 0.1 percent beryllium by
weight. Under this alternative, the scope
of the rule would cover employers in
general industry, including industries or
occupations where beryllium exists as a
trace contaminant. Regulatory
Alternative #1a would expand the scope
of the proposed standard to include all
operations in general industry where
beryllium exists only as a trace
contaminant; that is, where the
materials used contain no more than 0.1
percent beryllium by weight. Regulatory
E:\FR\FM\07AUP2.SGM
07AUP2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Alternative #1b is similar to Regulatory
Alternative #1a, but exempts operations
where the employer can show that
employees’ exposures will not meet or
exceed the action level or exceed the
STEL. Where the employer has objective
data demonstrating that a material
containing beryllium or a specific
process, operation, or activity involving
beryllium cannot release beryllium in
concentrations at or above the proposed
action level or above the proposed STEL
under any expected conditions of use,
the specific process, operation, or
activity would be exempt from the
proposed standard except for
recordkeeping requirements pertaining
to the objective data. Alternative #1a
and Alternative #1b, like the proposed
rule, would not cover employers or
employees in construction or shipyards.
Regulatory Alternatives 2a and 2b
These two alternatives would increase
protections for workers in the
construction and maritime sectors.
Regulatory alternative #2a would
expand the scope of the proposed
standard to also include employers in
construction and maritime. For
example, this alternative would cover
abrasive blasters, pot tenders, and
cleanup staff working in construction
and shipyards who have the potential
for airborne beryllium exposure during
blasting operations and during cleanup
of spent media. Regulatory alternative
#2b would amend 29 CFR 1910.1000
Table Z–1, 29 CFR 1915.1000 Table Z,
and 29 CFR 1926.55 Appendix A to
replace the current permissible
exposure limits for beryllium and
beryllium compounds (and the
reference in 1910.1000 Table Z–1 to
Table Z–2) with the TWA PEL and STEL
adopted through this rulemaking. This
alternative would also delete the entry
for beryllium and beryllium compounds
in 29 CFR 1910.1000 Table Z–2 because
the entry would instead be listed in
Table Z–1 as described above. Note that
OSHA is proposing an 8-hour TWA PEL
of 0.2 mg/m3 and a 15-minute STEL of
2 mg/m3, and is also considering
alternative TWA PELs of 0.1 mg/m3 and
0.5 mg/m3, and alternative STELs of 0.5
mg/m3, 1 mg/m3, and 2.5 mg/m3. This
alternative would limit permissible
airborne beryllium exposures for
workers in all beryllium-exposed
occupations including construction,
maritime and other industries where
beryllium is a trace contaminant.
The Z Tables and 1926.55 Appendix
A do not incorporate ancillary
provisions such as exposure monitoring,
medical surveillance, medical removal,
and PPE. However, many of the
occupations excluded from the scope of
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
the proposed beryllium standard receive
some ancillary provision protections
from other rules, such as Personal
Protective Equipment (1910 Subpart I,
1915 Subpart I, 1926.28, also 1926
Subpart E), Ventilation (1926.57),
Hazard Communication (1910.1200),
and specific provisions for welding
(1910 Subpart Q, 1915 Subpart D, 1926
Subpart J) and abrasive blasting
(1910.109, 1926 Subpart U).
(b) Definitions
Proposed paragraph (b) includes
definitions of key terms used in the
proposed standard. To the extent
possible, OSHA uses the same terms
and definitions in the proposed
standard as the Agency has used in
other OSHA health standards. Using
similar terms across health standards,
when possible, makes them more
understandable and easier for employers
to follow. In addition, using similar
terms and definitions helps to facilitate
uniformity of interpretation.
‘‘Action level’’ means an airborne
concentration of beryllium of 0.1
micrograms per cubic meter of air (mg/
m3) calculated as an eight-hour timeweighted average (TWA). Exposures at
or above the action level but below the
TWA PEL trigger the proposed
requirements for periodic exposure
monitoring (see paragraph (d)(3)). In
addition, paragraph (f)(1)(i)(B) requires
employers to list as part of their Written
Exposure Control Plan the operations
and job titles reasonably expected to
have exposure at or above the action
level. Paragraph (f)(2)(i) requires
employers to ensure that at least one of
the controls listed in paragraph
(f)(2)(i)(A) is in place unless employers
can demonstrate for each operation or
process either that such controls are not
feasible, or that employee exposures do
not exceed the action level based on at
least two representative personal
breathing zone samples taken seven
days apart. Furthermore, whenever an
employer allows employees to consume
food or beverages in a beryllium work
area, the employer must ensure that no
employee is exposed to beryllium at or
above the action level (paragraph
(i)(4)(ii)). The action level is also
relevant to the proposed medical
removal requirements. Employees
eligible for removal can chose to remain
in environments with exposures above
the action level provided they wear
respirators (paragraph (l)(2)(ii)). These
employees may also choose to be
transferred to comparable work in
environments with exposures below the
action level (or if comparable work is
not available, they may choose to be
PO 00000
Frm 00213
Fmt 4701
Sfmt 4702
47777
placed on paid leave for a period of at
least six months (paragraph (l)(3)).
OSHA’s preliminary risk assessment
indicates that significant risk remains at
the proposed TWA PEL (see this
preamble at section VI, Significance of
Risk). When there is a continuing
exposure risk at the PEL, the courts have
ruled that OSHA has the legal authority
to impose additional requirements, such
as action levels, on employers to further
reduce risk when those requirements
will result in a greater than minimal
incremental benefit to workers’ health
(Asbestos II, 838 F.2d at 1274). OSHA’s
preliminary conclusion is that an action
level for beryllium exposure will result
in a further reduction in risk beyond
that provided by the PEL alone.
Another important reason for
proposing an action level involves the
variable nature of employee exposures
to beryllium. Because of this fact, OSHA
believes that maintaining exposures
below the action level provides
reasonable assurance that employees
will not be exposed to beryllium above
the TWA PEL on days when no
exposure measurements are made. This
consideration is discussed later in this
section of the preamble regarding
proposed paragraph (d)(3).
OSHA’s decision to propose an action
level of one-half of the TWA PEL is
consistent with previous standards,
including those for inorganic arsenic (29
CFR 1910.1018), chromium (VI) (29 CFR
1910.1026), benzene (29 CFR
1910.1028), ethylene oxide (29 CFR
1910.1047), and methylene chloride (29
CFR 1910.1052).
‘‘Assistant Secretary’’ means the
Assistant Secretary of Labor for
Occupational Safety and Health, United
States Department of Labor, or designee.
Proposed paragraph (k)(7) requires
employers to report employee BeLPT
results to OSHA for evaluation and
analysis if requested by the Assistant
Secretary. Proposed paragraph (n)(6)
requires employers to make all records
required under this section available, if
requested, to the Assistant Secretary for
examination and copying.
‘‘Beryllium lymphocyte proliferation
test (BeLPT)’’ means the measurement of
blood lymphocyte proliferation in a
laboratory test when lymphocytes are
challenged with a soluble beryllium
salt. A confirmed positive test result
indicates the person has beryllium
sensitization. For additional explanation
of the BeLPT, see the Health Effects
section of this preamble (section V), and
Appendix A of this proposed standard.
Under paragraph (f)(1)(ii)(B), employers
must update the exposure control plan
when an employee is confirmed
positive. The BeLPT could be used to
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47778
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
determine whether an employee is
confirmed positive (see definition of
confirmed positive in paragraph (b) of
this proposed standard). Paragraph
(k)(3)(ii)(E) requires the BeLPT unless a
more reliable and accurate test becomes
available (see section I of this preamble,
Issues and Alternatives, for discussion
and request for comment regarding how
OSHA should determine whether a test
is more reliable and accurate than the
BeLPT). Under paragraph (k)(7),
employers must convey the results of
medical tests such as the BeLPT to
OSHA if requested.
‘‘Beryllium work area’’ means any
work area where employees are, or can
reasonably be expected to be, exposed to
airborne beryllium, regardless of the
level of exposure. OSHA notes both a
distinction and some overlap between
the definitions of beryllium work area
and regulated area in this proposal.
Beryllium work areas are areas where
employees are or can reasonably be
expected to be exposed to airborne
beryllium at any level, whereas an area
is a regulated area only if employees are
or can reasonably be expected to be
exposed above the TWA PEL or STEL.
Therefore, while not all beryllium work
areas are regulated areas, all regulated
areas are beryllium work areas because
they are areas with exposure to
beryllium. Accordingly, all
requirements for beryllium work areas
also apply in all regulated areas, but
requirements specific to regulated areas
apply only to regulated areas and not to
beryllium work areas where exposures
do not exceed the TWA PEL or STEL.
The presence of a beryllium work area
triggers a number of the requirements in
this proposal. Under paragraphs
(d)(1)(ii) and (iii), employers must
determine exposures for each beryllium
work area. Furthermore, paragraphs
(e)(1)(i) and (e)(2)(i) require employers
to establish, maintain, identify, and
demarcate the boundaries of each
beryllium work area. Under paragraph
(f)(1)(i), employers must establish and
maintain a written exposure control
plan for beryllium work areas. And
paragraph (f)(2)(i) requires employers to
implement at least one of the controls
listed in (f)(2)(i)(A)(1) through (4) for
each operation in a beryllium work area
unless one of the exemptions in
(f)(2)(i)(B) applies. In addition,
paragraph (i)(1) requires employers to
provide readily accessible washing
facilities to employees working in a
beryllium work area, and to instruct
employees to use these facilities when
necessary. Where employees are
allowed to eat or drink in beryllium
work areas, employers must ensure that
surfaces in these areas are as free as
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
practicable of beryllium, that exposures
are below the action level, and that
these areas comply with the Sanitation
standard (29 CFR 1910.141) (paragraph
(i)(4)). Employers must maintain
surfaces in all beryllium work areas as
free as practicable of beryllium
(paragraph (j)(1)(i)). Paragraph (j)(2)
requires certain practices and prohibits
other practices for cleaning surfaces in
beryllium work areas.
‘‘CBD Diagnostic Center’’ means a
medical facility that has the capability
of performing an on-site clinical
evaluation for the presence of chronic
beryllium disease (CBD) that includes
bronchoalveolar lavage, transbronchial
biopsy and interpretation of the biopsy
pathology, and the beryllium
bronchoalveolar lavage lymphocyte
proliferation test (BeBALLPT). For
purposes of this proposal, the term
‘‘CBD Diagnostic Center’’ refers to any
medical facility that meets these criteria,
whether or not the medical facility
formally refers to itself as a CBD
diagnostic center. For example, if a
hospital has all of the capabilities
required by this proposal for CBD
diagnostic centers, the hospital would
be considered a CBD diagnostic center
for purposes of this proposal.
Proposed paragraph (k)(6) requires
employers to offer employees who have
been confirmed positive a referral to a
CBD diagnostic center for a clinical
evaluation.
‘‘Chronic beryllium disease (CBD)’’
means a chronic lung disease associated
with exposure to airborne beryllium.
The Health Effects section of this
preamble, section V, contains more
information on CBD. CBD is relevant to
several provisions of this proposal.
Paragraph (f)(1)(ii)(B) requires
employers to update the exposure
control plan whenever an employee is
diagnosed with CBD. Under paragraph
(k)(1)(i)(B), employers must make
medical surveillance available at no cost
to employees who show signs and
symptoms of CBD. Paragraph
(k)(3)(ii)(B) requires medical
examinations conducted under this
standard to emphasize screening for
respiratory conditions, which would
include CBD. Under paragraph
(k)(5)(i)(A), the licensed physician’s
opinion must advise the employee on
whether or not the employee has any
detected medical condition that would
place the employee at an increased risk
of CBD from further exposure to
beryllium. Furthermore, CBD is a
criterion for medical removal under
paragraph (l)(1). Under paragraph
(m)(1)(ii), employers must address CBD
in classifying beryllium hazards under
the HCS. Employers must also train
PO 00000
Frm 00214
Fmt 4701
Sfmt 4702
employees on the signs and symptoms
of CBD (see paragraph (m)(4)(ii)(A)).
‘‘Confirmed positive’’ means two
abnormal test results from consecutive
BeLPTs or a second abnormal BeLPT
result within a two-year period of the
first abnormal result. The definition of
confirmed positive also includes a
single result of a more reliable test
indicating that a person has been
identified as sensitized to beryllium.
OSHA recognizes that diagnostic tests
for beryllium sensitization could
eventually be developed that would not
require a second test to confirm
sensitization. OSHA requests comment
on how best to determine whether a
new method is more reliable and
accurate than the BeLPT for detecting
beryllium sensitization (see section I of
this preamble, Issues and Alternatives).
Paragraph (f)(1)(ii)(B) requires
employers to update the exposure
control plan whenever an employee is
confirmed positive or is diagnosed with
CBD. Under proposed paragraph
(k)(3)(ii)(E), employers are required to
ensure that a BeLPT is offered to each
eligible employee at the employee’s first
medical examination under this
proposed standard, and every two years
from the date of the first examination
unless the employee receives an
abnormal BeLPT result. If the
employee’s first BeLPT result is
abnormal, the employer must provide
the employee a second test within one
month of the first test. If the employee’s
second BeLPT result is also abnormal,
the employee is considered confirmed
positive for purposes of this proposed
standard. OSHA requests comment on
the methods used to determine when a
BeLPT test result is abnormal, and on
standardizing the use and interpretation
of the BeLPT (see section I of this
preamble, Issues and Alternatives).
A confirmed positive result will
indicate to the licensed physician that
the employee is sensitized to beryllium
and is at increased risk of developing
CBD (see paragraph (k)(5)(i)(A)).
Employees who are confirmed positive
are eligible for medical removal under
proposed paragraph (l)(1).
‘‘Director’’ means the Director of the
National Institute for Occupational
Safety and Health (NIOSH), U.S.
Department of Health and Human
Services, or designee. The proposed
recordkeeping requirements mandate
that, upon request, employers make all
records required by this standard
available to the Director (as well as the
Assistant Secretary) for examination and
copying (see paragraph (n)(6)).
Typically, the Assistant Secretary sends
representatives to review workplace
safety and health records. However, the
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
Director may also review these records
while conducting studies such as Health
Hazard Evaluations of workplaces, or for
other purposes.
‘‘Emergency’’ means any uncontrolled
release of airborne beryllium. An
emergency could result from equipment
failure, rupture of containers, or failure
of control equipment, among other
causes.
Emergencies trigger several
requirements of this proposed standard.
Under paragraph (g)(1)(iv), respiratory
protection is required during
emergencies to protect employees from
potential overexposures. Emergencies
also trigger clean-up requirements under
paragraph (j)(1)(ii), and medical
surveillance under paragraph
(k)(1)(i)(C). In addition, under paragraph
(m)(4)(ii)(D), employers must train
employees in applicable emergency
procedures.
‘‘Exposure’’ and ‘‘exposure to
beryllium’’ mean the exposure to
airborne beryllium that would occur if
the employee were not using a
respirator. This definition is consistent
with the term ‘‘employee exposure’’ in
other OSHA standards such as Asbestos
(29 CFR 1910.1001), Benzene (29 CFR
1910.1028), Chromium (VI) (29 CFR
1910.1026), Butadiene (29 CFR
1910.1051), and Methylene chloride (29
CFR 1910.1052). Many OSHA standards
establish action levels and permissible
exposure limits based on quantitative
airborne exposures, and many of these
standards’ requirements are tied to
exposures at or above the applicable
action level, or above the applicable
permissible exposure limit(s). This
definition is also consistent with
OSHA’s hierarchy of controls policy,
which requires employers to implement
engineering and work practices controls
to control exposure before resorting to
respiratory protection. For additional
discussion of OSHA’s hierarchy of
controls policy, see the discussion of
paragraph (f) in this section of the
preamble.
‘‘High-efficiency particulate air
(HEPA) filter’’ means a filter that is at
least 99.97 percent effective in removing
particles 0.3 micrometers in diameter
(see Department of Energy Technical
Standard DOE–STD–3020–2005). HEPA
filtration is an effective means of
removing hazardous beryllium particles
from the air. The proposed standard
requires beryllium-contaminated
surfaces to be cleaned by HEPA
vacuuming or other methods that
minimize the likelihood of exposure
(see paragraphs (j)(2)(i) and (ii)). Other
OSHA health standards also require the
use of vacuum systems equipped with
HEPA filtration (see Chromium (VI) (29
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
CFR 1910.1026) and Lead in
construction (29 CFR 1926.62)).
‘‘Physician or other licensed health
care professional (PLHCP)’’ means an
individual whose legally permitted
scope of practice, such as license,
registration, or certification, allows the
person to independently provide or be
delegated the responsibility to provide
some or all of the health care services
required in proposed paragraph (k). The
Agency recognizes that personnel
qualified to provide medical
surveillance may vary from State to
State, depending on State licensing
requirements. Whereas all licensed
physicians would meet this proposed
definition of PLHCP, not all PLHCPs
must be physicians.
Under paragraph (k)(5) of the
proposed standard, the written medical
opinion must be completed by a
licensed physician. However, other
requirements of paragraph (k) may be
performed by a PLHCP under the
supervision of a licensed physician (see
paragraphs (k)(1)(ii), (k)(3)(i),
(k)(3)(ii)(G), (k)(5)(i)(C), and (k)(5)(ii)).
The proposed standard also identifies
what information must be given to the
PLHCP providing the services listed in
this standard, and requires that
employers maintain a record of this
information (see paragraphs (k)(4) and
(n)(4)(ii)(C)).
Allowing a PLHCP to provide some of
the services required under this rule is
consistent with other recent OSHA
health standards, such as bloodborne
pathogens (29 CFR 1910.1030),
respiratory protection (29 CFR
1910.134), and methylene chloride (29
CFR 1910.1052).
‘‘Regulated area’’ means an area that
the employer must demarcate where
employee exposure to airborne
concentrations of beryllium exceeds, or
can reasonably be expected to exceed,
either the TWA PEL or STEL. These
areas include temporary work areas
where maintenance or non-routine tasks
are performed. For an explanation of the
distinction and overlap between
beryllium work areas and regulated
areas, see the explanation of beryllium
work areas earlier in this section of the
preamble. The requirements triggered by
regulated areas are discussed below.
Paragraphs (e)(1)(ii) and (e)(2)(ii)
require employers to establish and
demarcate regulated areas. Note that the
demarcation requirements for regulated
areas are more specific than those for
other beryllium work areas (see also
proposed paragraph (m)). Paragraph
(e)(3) requires employers to restrict
access to regulated areas to authorized
persons, and paragraph (e)(4) requires
employers to provide all employees in
PO 00000
Frm 00215
Fmt 4701
Sfmt 4702
47779
regulated areas appropriate respiratory
protection and personal protective
clothing and equipment, and to ensure
that these employees use the required
respiratory protection and protective
clothing and equipment. Proposed
paragraph (i)(5)(i) prohibits employers
from allowing employees to eat, drink,
smoke, chew tobacco or gum, or apply
cosmetics in regulated areas.
Under proposed paragraph
(k)(1)(i)(A), employees who have
worked in a regulated area for more than
30 days in the previous 12 months are
eligible for medical surveillance. In
addition, proposed paragraph (m)(2)
requires warning signs associated with
regulated areas to meet certain
specifications. Proposed paragraph
(m)(4) requires employers to train
employees in the written exposure
control plan required by paragraph
(f)(1), including the location of regulated
areas.
This proposed definition of regulated
areas is consistent with other substancespecific health standards, such as
Cadmium (29 CFR 1910.1027),
Butadiene (29 CFR 1910.1051), and
Methylene Chloride (29 CFR
1910.1052).
‘‘This standard’’ means this beryllium
standard, 29 CFR 1910.1024.
(c) Permissible Exposure Limits (PELs)
Paragraph (c) of the proposed
standard establishes two permissible
exposure limits (PELs) for beryllium in
all forms, compounds, and mixtures: An
8-hour time-weighted average (TWA)
PEL of 0.2 mg/m3 (proposed paragraph
(c)(1)), and a 15-minute short-term
exposure limit (STEL) of 2.0 mg/m3
(proposed paragraph (c)(2)).
The TWA PEL section of the proposed
standard requires employers to ensure
that each employee’s exposure to
beryllium, averaged over the course of
an 8-hour work shift, does not exceed
0.2 mg/m3. The STEL section of the
proposed standard requires employers
to ensure that each employee’s exposure
sampled over any 15-minute period
during the work shift does not exceed
2.0 mg/m3. The existing Air
Contaminants standard (29 CFR
1910.1000 Table Z–2) has two PELs for
‘‘beryllium and beryllium compounds’’:
(1) a 2 mg/m3 TWA PEL, and (2) a ceiling
concentration of 5 mg/m3 that employers
must ensure is not exceeded during the
8-hour work shift, except for a
maximum peak of 25 mg/m3 over a 30minute period in an 8-hour work shift.
OSHA adopted the current PELs in 1972
pursuant to section 6(a) of the OSH Act
(29 U.S.C. 655(a)). Section 6(a)
permitted OSHA, during the first two
years after the OSH Act became
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47780
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
effective, to adopt as OSHA standards
any established Federal standard or
national consensus standard. The
existing PELs were based on the
American National Standards Institute
(ANSI) Beryllium and Beryllium
Compounds standard (ANSI, 1970),
which in turn was based on a 1949 U.S.
Atomic Energy Commission adoption of
a threshold limit for beryllium of 2.0 m/
m3 and was included in the 1971
American Conference of Governmental
Industrial Hygienists Documentation of
the Threshold Limit Values for
Substances in Workroom Air (ACGIH,
1971).
TWA PEL. OSHA is proposing the
new TWA PEL because published
studies and more recent exposure data
submitted in the record from industrial
facilities involved in beryllium work
provide evidence that occupational
exposure to a variety of beryllium
compounds at levels below the current
PELs pose a significant risk to workers
(see this preamble at section VIII,
Significance of Risk). OSHA’s
preliminary risk assessment, presented
in section VI of this preamble, indicates
that there is significant risk of beryllium
sensitization 45 and CBD from a 45-year
(working life) exposure to beryllium at
the current TWA PEL of 2 mg/m3. The
risk assessment further indicates that
there is significant risk of lung cancer to
workers exposed to beryllium at the
current TWA PEL of 2 mg/m3.
OSHA believes this proposed PEL
would be feasible across all affected
industry sectors (see section IX.D of this
preamble, Technological Feasibility)
and that compliance with the proposed
PEL would substantially reduce
employees’ risks of beryllium
sensitization, CBD, and lung cancer (see
section VI of this preamble, Preliminary
Beryllium Risk Assessment). OSHA’s
confidence in the feasibility of the
proposed PEL is high, based both on the
preliminary results of the Agency’s
feasibility analysis and on the
recommendation of the proposed PEL
by Materion Corporation and the United
Steelworkers. Materion is the sole
beryllium producer in the U.S., and its
facilities include some of the processes
where OSHA expects it will be most
challenging to control beryllium
exposures. As with several other
provisions of the proposed standard,
OSHA’s proposal for the TWA PEL
follows the draft recommended standard
submitted to the Agency by Materion
and the Steelworkers Union (see this
45 As discussed in section VIII of this preamble,
Significance of Risk, beryllium sensitization is a
necessary precursor to developing CBD.
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
preamble at section III, Events Leading
to the Proposed Standard).
OSHA’s preliminary risk assessment
indicates that the risks remaining at the
proposed TWA PEL—while much lower
than risks at the current PEL—are still
significant (see this preamble at section
VIII, Significance of Risk). In addition to
the proposed PEL, the Agency is
considering an alternative PEL of 0.1 mg/
m3 that would reduce risks to workers
further than the proposed PEL would,
although significant risk remains at 0.1
mg/m3 as well (see section VIII of this
preamble, Significance of Risk, and
Regulatory Alternatives presented at the
end of this discussion). Compared with
the proposed PEL, OSHA has less
confidence in the feasibility of a PEL of
0.1 mg/m3. In some industry sectors it is
difficult to determine whether a PEL of
0.1 mg/m3 could be achieved in most
operations, most of the time. However,
OSHA believes this uncertainty could
be resolved with additional information
on current exposure levels and exposure
control technologies. OSHA requests
additional data and information to
inform its final determinations on
feasibility (see section IX.D of this
preamble, Technological Feasibility)
and the alternative PELs under
consideration.
Because significant risks of
sensitization and CBD remain at both
0.1 mg/m3 and 0.2 mg/m3, OSHA is also
proposing a variety of ancillary
provisions to help reduce risk to
workers. These ancillary provisions
include implementation of feasible
engineering controls in beryllium work
areas, respiratory protection, personal
protective clothing and equipment,
exposure monitoring, regulated areas,
medical surveillance, medical removal,
hygiene areas, housekeeping
requirements, and hazard
communication. The Agency believes
these provisions will reduce the risk
beyond that which the proposed TWA
PEL alone could achieve. These
provisions are discussed later in this
section of the preamble.
Other federal agencies and
organizations have recommended
occupational exposure limits for
beryllium. As mentioned in this
preamble at section III, Events Leading
to the Proposed Standard, in 1999 the
Department of Energy (DOE) issued its
Chronic Beryllium Disease Prevention
Program rule (10 CFR part 850). The
DOE rule established a beryllium action
level of 0.2 mg/m3. This action level
triggers many of the same requirements
found in OSHA’s proposed standard
such as regulated areas, periodic
exposure monitoring, hygiene facilities
and practices, respiratory protection,
PO 00000
Frm 00216
Fmt 4701
Sfmt 4702
and protective clothing and equipment
(10 CFR 850.23(b)). Although the DOE
rule retained OSHA’s current TWA PEL,
it also stated that employers would be
required to ensure that employees are
not exposed above any ‘‘more stringent
TWA PEL’’ that OSHA may promulgate
(10 CFR 850.22; 64 FR 68873 and 68906,
December 8, 1999).
NIOSH has published a
Recommended Exposure Limit (REL) of
0.5 mg/m3 as a Ceiling Limit and a
NIOSH Alert on preventing CBD and
beryllium sensitization (NIOSH, 1977;
NIOSH, 2011). The NIOSH Alert
provides guidance to workers and
employers on the hazards of exposure to
beryllium and ways to reduce or
minimize exposure. In 2009, ACGIH
adopted a revised Threshold Limit
Value (TLV) for beryllium that lowered
the TWA to 0.05 mg/m3 from 2 mg/m3
(ACGIH, 2009).
The SERs who participated in the
SBREFA process had few comments
about the proposed PELs (OSHA,
2008b). The major concerns about a
reduced TWA PEL were economic
impact and belief that beryllium-related
health effects did not frequently occur
in their industries (OSHA, 2008b). The
Panel recommended that OSHA
consider to what extent a very low PEL
may result in increased costs to small
entities. In section V of the Preliminary
Economic Analysis (OSHA, 2014),
OSHA considers the costs of the
proposed PEL and ancillary provisions
triggered by the PEL to all affected
entities. In addition, the Agency is
considering an alternative PEL of 0.5 mg/
m3 (see Regulatory Alternative 5 below).
The Agency seeks comment on whether
different PELs should be considered and
the justification for the PELs.
STEL. OSHA is also proposing a STEL
of 2.0 mg/m3, as determined over a
sampling period of 15 minutes. Where
a significant risk of material impairment
of health remains at the TWA PEL,
OSHA has the authority to impose a
STEL if doing so would further reduce
risk and is feasible to implement. Pub.
Citizen Health Research Grp. v. Tyson,
796 F.2d 1479, 1505 (D.C. Cir. 1986)
(Ethylene Oxide).
As discussed in section VIII of this
preamble, Significance of Risk,
significant risk of CBD remains at the
proposed TWA PEL of 0.2 mg/m3 and
the proposed alternative TWA PEL of
0.1 mg/m3. OSHA believes the proposed
STEL would further reduce this risk.
The goal of a STEL is to protect
employees from the risk of harm that
can occur as a result of brief exposures
that exceed the TWA PEL. Without a
STEL, the only protection workers
would have from high short-duration
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
exposures is that, when those exposures
are factored in, they cannot exceed the
cumulative 8-hour exposure at the
proposed 0.2 mg/m3 TWA PEL (i.e., 1.6
mg/m3). Since there are 32 15-minute
periods in an 8-hour work shift,
exposures could be as high as 6.4 mg/m3
(32 × 0.2 mg/m3) for 15 minutes under
the proposed TWA PEL without a STEL,
if exposures during the remainder of the
8-hour work shift are non-detectable. A
STEL serves to minimize high taskbased exposures by requiring feasible
controls in these situations, and has the
added effect of further reducing the
TWA exposure.
OSHA believes a STEL for beryllium
will help reduce the risk of sensitization
and CBD in beryllium-exposed
employees. As discussed in this
preamble at section V, Health Effects,
beryllium sensitization is the initial step
in the development of CBD.
Sensitization has been observed in some
workers that were only exposed to
beryllium for a few months (see section
V.D.1 of this preamble), and tends to be
more strongly associated with ‘peak’
and highest-job-worked exposure
metrics than cumulative exposure (see
section V.D.5 of this preamble). Shortterm exposures to beryllium have been
shown to contribute to the development
of lung disease in experimental animals.
Beagle dogs that were administered a
single short-term perinasal exposure to
aerosolized beryllium oxide developed a
granulomatous lung inflammation
similar to CBD, accompanied by an
abnormal BeLPT response (Haley et al.,
1989). These study findings indicate
that adverse effects to the lung may
occur from beryllium exposures of
relatively short duration. OSHA believes
that a STEL in combination with a TWA
PEL adds further protection from risk of
harm than that afforded by the proposed
0.2 mg/m3 TWA PEL alone.
STEL exposures are typically
associated with, and need to be
measured during, the highest-exposure
operations that an employee performs
(see proposed paragraph (d)(1)(iii)).
OSHA has preliminarily determined
that the proposed STEL of 2.0 mg/m3 can
be measured for this brief period of time
using OSHA’s available sampling and
analytical methodology, and feasible
means exist to maintain 15-minute
short-term exposures at or below the
proposed STEL (see section IX.D of this
preamble, Technological Feasibility).
The current entry for beryllium and
beryllium compounds (as Be) in 29 CFR
1910.1000 Table Z–1 directs the reader
to the entry for beryllium and beryllium
compounds in 29 CFR 1910.1000 Table
Z–2. Table Z–2’s entry for beryllium and
beryllium compounds includes the
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
current TWA PEL of 2 mg/m3, an
acceptable ceiling concentration of 5 mg/
m3, and an acceptable maximum peak
above the acceptable ceiling
concentration of 25 mg/m3, allowable for
30 minutes in an 8-hour shift. Table Z
in 29 CFR 1915.1000, and 29 CFR
1926.55 Appendix A each include the
current TWA PEL of 2 mg/m3 beryllium
and beryllium compounds for
construction and maritime industries,
but no ceiling or peak exposure limit.
As discussed in this Summary and
Explanation section of the preamble
regarding paragraph (a), the scope of the
proposed rule is limited to general
industry. In addition, it provides an
exemption for those working with
materials that contain beryllium only as
a trace contaminant (less than 0.1
percent composition by weight). The
proposal would amend the entry for
beryllium and beryllium compounds (as
Be) in 29 CFR 1910.1000 Table Z–1, to
add a cross reference to the new
standard for operations or sectors that
fall within the scope of the proposed
standard, and note that industries not
covered under the proposed standard
would continue to be covered by the
entry in 29 CFR 1910.1000 Table Z–2.
The TWA, ceiling, and maximum peak
exposure limits in 29 CFR 1910.1000
Table Z–2 would still apply to general
industry applications and sectors
exempted from the proposed standard.
Under the proposed standard, the
exposure limits in the current 29 CFR
1915.1000 Table Z and 29 CFR 1926.55
Appendix A would continue to apply in
construction and maritime industries.
As discussed previously in this
preamble at Section I, Issues and
Alternatives, and Section XVIII,
paragraph (a), OSHA is considering
Regulatory Alternative #2b, which
would update 29 CFR 1915.1000 Tables
Z–1 and Z–2, 29 CFR 1915.1000 Table
Z, and 29 CFR 1926.55 Appendix A to
the PEL and STEL adopted through this
rulemaking to the general industry,
construction, and maritime sectors and
applications that do not fall within the
scope of the proposed rule. Note that
OSHA is proposing a TWA PEL of 0.2
mg/m3 and a STEL of 2 mg/m3, and
OSHA is also considering alternative
TWA PELs of .1 mg/m3 and .5 mg/m3,
and alternative STELs of .5 mg/m3, 1 mg/
m3, and 2.5 mg/m3.
OSHA invites comment on the
proposed TWA PEL and STEL and on
Regulatory Alternatives 3, 4, and 5
below, which specify a lower STEL, a
lower TWA PEL, and a higher TWA PEL
than those proposed, respectively.
OSHA also requests comments and data
on the range of TWA and short-term
exposures in covered industries and the
PO 00000
Frm 00217
Fmt 4701
Sfmt 4702
47781
types of operations and engineering or
work practice controls in place where
these exposures are occurring.
Regulatory Alternative 3
This alternative would modify the
proposed STEL to be five times the
TWA PEL, rather than ten times the
TWA PEL. Thus, if OSHA promulgates
the proposed TWA PEL of 0.2 mg/m3,
the STEL would be 1 mg/m3; if OSHA
promulgates the alternative TWA PEL of
0.1 mg/m3, the STEL would be 0.5 mg/
m3; and if OSHA promulgates the
alternative TWA PEL of 0.5 mg/m3; the
STEL would be 2.5 mg/m3.
As discussed above, OSHA has
preliminarily determined that shortterm exposures to beryllium can cause
beryllium sensitization, and that
therefore a STEL in combination with a
TWA PEL adds further protection from
risk of harm than that afforded by the
proposed 0.2 mg/m3 TWA PEL alone.
When OSHA regulations in the past
have included a STEL, it is typically
five times the PEL. For example,
OSHA’s standard for methylene
chloride (29 CFR 1910.1052) specifies
an 8-hour TWA PEL of 25 ppm, and a
short-term limit of 125 ppm averaged
over 15 minutes. The standard for
acrylonitrile (29 CFR 1910.1045) sets an
8-hour TWA PEL of 2 ppm, and a shortterm limit of 10 ppm averaged over 15
minutes. The final standards for
benzene (29 CFR 1910.1028), for
ethylene oxide (29 CFR 1910.1047) and
for 1,3-Butadiene (29 CFR 1910.1051)
specify an 8-hour time-weighted average
TWA PEL of 1 ppm and short-term
limits of 5 ppm averaged over 15
minutes. OSHA has occasionally
deviated from its usual practice of
setting a STEL at five times the TWA
PEL, as in the cases of formaldehyde (29
CFR 1910.1048) (TWA PEL 0.75 ppm,
STEL 2 ppm) and methylenedianiline
(29 CFR 1910.1050) (TWA PEL 10 ppb,
STEL 100 ppb). OSHA requests
comment on whether the beryllium
standard should set a STEL at ten times
the TWA PEL, as suggested by the
Materion-USW joint proposed rule and
specified in this proposal, or should it
maintain its more usual practice of
setting a STEL at five times the PEL.
Regulatory Alternative 4
This alternative would modify the
proposed TWA PEL to be 0.1 mg/m3. As
discussed above, OSHA believes a PEL
of 0.1 mg/m3 would better protect
workers from significant risk of CBD
and lung cancer than the proposed TWA
PEL of 0.2 mg/m3. OSHA’s preliminary
risk assessment indicates that the risk of
CBD and lung cancer remaining at the
proposed TWA PEL are significant, and
E:\FR\FM\07AUP2.SGM
07AUP2
47782
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
that an alternative PEL of 0.1 mg/m3
would reduce these risks to workers
further than the proposed PEL would.
However, compared with the proposed
PEL, OSHA has less confidence in the
feasibility of a PEL of 0.1 mg/m3 (see
section IX.D of this preamble,
Technological Feasibility). This
alternative would also lower the action
level from 0.1 mg/m3 to .05 mg/m3.
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Regulatory Alternative 5
This alternative would modify the
proposed TWA PEL to be 0.5 mg/m3.
This alternative would also raise the
proposed action level to 2.5 mg/m3. As
discussed above, the SBREFA Panel
recommended that OSHA consider the
economic impact of a reduced PEL and
consider regulatory alternatives that
would ease cost burden for small
entities. The economic impact of a
reduced PEL is considered in section
VIII of the Preliminary Economic
Analysis (OSHA, 2014). However,
OSHA’s preliminary risk assessment
indicates significant risk to workers
exposed at a PEL of 0.5 mg/m3, and
OSHA’s preliminary feasibility analysis
indicates that a lower PEL is feasible.
Unless OSHA receives new evidence
showing that a PEL lower than 0.5 mg/
m3 is not feasible or not needed to
reduce significant risk, OSHA cannot
adopt this alternative PEL due to its
statutory obligation to set the PEL at the
lowest feasible level to reduce or
eliminate significant risk.
(d) Exposure Monitoring
Paragraph (d) of the proposed
standard imposes monitoring
requirements pursuant to section 6(b)(7)
of the OSH Act (29 U.S.C. 655(b)(7)),
which mandates that any standard
promulgated under section 6(b) shall,
where appropriate, ‘‘provide for
monitoring or measuring employee
exposure at such locations and
intervals, and in such manner as may be
necessary for the protection of
employees.’’
The purposes of requiring assessment
of employee exposures to beryllium
include determination of the extent and
degree of exposure at the worksite;
identification and prevention of
employee overexposure; identification
of the sources of exposure to beryllium;
collection of exposure data so that the
employer can select the proper control
methods to be used; and evaluation of
the effectiveness of those selected
methods. Exposure assessment enables
employers to meet their legal obligation
to ensure that their employees are not
exposed to beryllium in excess of the
permissible exposure limits and to
notify employees of their exposure
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
levels, including any overexposures as
required by section 8(c)(3) of the Act (29
U.S.C. 657(c)(3)). In addition, the
availability of exposure data enables
PLHCPs performing medical
examinations to be informed of the
extent of an employee’s occupational
exposures.
Paragraph (d)(1) contains proposed
general requirements for exposure
monitoring. Under paragraph (d)(1)(i),
the monitoring requirements apply
whenever there is actual exposure to
airborne beryllium at any level, or a
reasonable expectation of such
exposure. As reflected in the definition
of ‘‘exposure’’ in paragraph (b) of this
standard, exposure monitoring results
must reflect the amount of beryllium an
employee would be exposed to without
the use of a respirator.
Under paragraph (d)(1)(ii), monitoring
to determine employee time-weighted
average exposures must represent the
employee’s average exposure to airborne
beryllium over an eight-hour workday.
Under paragraph (d)(1)(iii), short term
exposures must be characterized by
sampling periods of 15 minutes for each
operation likely to produce exposures
above the STEL.46 Samples taken
pursuant to paragraphs (d)(1)(ii) and
(d)(1)(iii) must reflect the exposure of
employees on each work shift, for each
job classification, in each beryllium
work area. Samples must be taken
within an employee’s breathing zone.
Employers must accurately
characterize the exposure of each
employee. In some cases, this will entail
monitoring all exposed employees. In
other cases, monitoring of
‘‘representative’’ employees is
sufficient. Under paragraph (d)(1)(iv),
representative exposure sampling is
permitted when a number of employees
perform essentially the same job under
the same conditions. For such
situations, it may be sufficient to
monitor a fraction of these employees in
order to obtain data that are
representative of the remaining
employees. Representative personal
sampling for employees engaged in
similar work with beryllium exposure of
similar frequency and duration can be
achieved by monitoring the employee(s)
reasonably expected to have the highest
exposures. For example, this may
46 Although OSHA has used the phrase ‘‘most
likely to produce exposures’’ in other standards in
the past (e.g., Ethylene Oxide (29 CFR 1910.1047)),
OSHA’s intended meaning for previous standards
and for the proposed standard is that employers
must characterize exposures for all operations likely
to produce exposures above the STEL. Accordingly,
OSHA is using the phrase ‘‘likely to produce
exposures’’ rather than ‘‘most likely to produce
exposures’’ in this proposed standard to clarify this
longstanding intent.
PO 00000
Frm 00218
Fmt 4701
Sfmt 4702
involve monitoring the beryllium
exposure of the employee closest to an
exposure source. This exposure result
may then be attributed to the remaining
employees in the group.
Representative exposure monitoring
must at a minimum include one fullshift sample taken for each job
classification, in each beryllium work
area, for each shift. These samples must
consist of at least one sample
characteristic of the entire shift or
consecutive representative samples
taken over the length of the shift. Where
employees are not performing the same
job tasks under the same conditions,
representative sampling will not
adequately characterize actual
exposures, and employers must monitor
each employee individually.
Under paragraph (d)(1)(v), the
employer would be required to use
monitoring and analytical methods that
can measure airborne levels of
beryllium to an accuracy of plus or
minus 25 percent (+/¥25 percent and
can produce accurate measurements at a
statistical confidence level of 95 percent
for airborne concentrations at or above
the action level. OSHA believes the
following methods could meet these
criteria: NIOSH 7704 (also ASTM
D7202), ASTM D7439, OSHA 206,
OSHA 125G, and OSHA 125G using
ICP–MS. All of these methods are
available to commercial laboratories
analyzing beryllium samples. It should
be noted that most of these analytical
methods were validated using soluble
beryllium compounds and hence the
efficacy of the sample preparation
(specifically digestion of particulate
beryllium in mineral acids) step must be
verified prior to use (Stefaniak et al.,
2008). Verification can be aided, in part,
through use of an appropriate reference
material. However, not all of these
methods are appropriate for measuring
beryllium oxide, so employers must
verify that the analytical methods they
use are appropriate for measuring the
form(s) of beryllium present in the
workplace. A certified reference
material consisting of high-fired
beryllium oxide is available from the
National Institute of Standards and
Technology as Standard Reference
Material 1877: Beryllium oxide powder.
This reference material carries a
certified value for beryllium content and
was developed to meet the need to
demonstrate analytical method efficacy
for poorly soluble forms of beryllium
(Winchester et al., 2009). OSHA
requests comment on whether these
methods would satisfy the requirements
of proposed paragraph (d)(1)(v), and
whether other methods would also meet
these criteria.
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
Rather than specifying a particular
method that must be used, OSHA
proposes to take a performance-oriented
approach and instead allow the
employer to use the method of its
choosing as long as that method meets
the accuracy specifications in paragraph
(d)(1)(v), and the reported results
represent the total airborne
concentration of beryllium for the
operation and worker being
characterized. For example, a respirable
fraction sample or size selective sample
would not be directly comparable to
either PEL, and therefore would not be
considered valid.
Paragraph (d)(2) contains proposed
requirements for initial monitoring.
OSHA proposes that employers
characterize the 8-hour TWA exposure
and 15-minute short-term exposure for
each employee who is known to be
exposed to airborne beryllium at any
level or whose exposure is reasonably
expected. Further obligations under the
standard would be based on the results
of this assessment. These obligations
may include periodic monitoring,
establishment of regulated areas, and
implementation of control measures.
Initial monitoring need not be
conducted in two circumstances. First,
under paragraph (d)(2)(i), initial
monitoring is not required where the
employer has previously monitored for
beryllium exposure and the data were
obtained during work operations and
under workplace conditions closely
resembling the processes, types of
material, control methods, work
practices, and environmental conditions
used and prevailing in the employer’s
current operations. In addition, the
characteristics of the berylliumcontaining material being handled when
the employer previously monitored
must closely resemble the
characteristics of the berylliumcontaining material used in the
employer’s current operations. Such
historical monitoring must satisfy all
other requirements of this section,
including the accuracy and confidence
requirements in paragraph (d)(1)(v). If
these requirements are satisfied, the
employer may rely on such earlier
monitoring results to satisfy the initial
monitoring requirements of this section.
This provision is designed to make it
clear that OSHA does not intend to
require employers who have recently
performed appropriate employee
monitoring to conduct initial
monitoring. For historical data to satisfy
the employer’s obligation to monitor for
8-hour TWA exposures under paragraph
(d)(1)(ii), these data must characterize 8hour TWA exposures that satisfy the
requirements of paragraph (d)(2)(i). For
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
historical monitoring to satisfy an
employer’s obligation to monitor for 15minute short-term exposures under
paragraph (d)(1)(iii), these data must
reflect 15-minute short-term exposures.
OSHA anticipates that paragraph
(d)(2)(i) will reduce the compliance
burden on employers, since redundant
monitoring would not be required.
Second, under paragraph (d)(2)(ii),
where the employer has objective data
demonstrating that a particular product
or material containing beryllium or a
specific process, operation, or activity
involving beryllium cannot release dust,
fumes, or mist in concentrations at or
above the action level or STEL under
any reasonably expected conditions of
use, the employer may rely upon such
data to satisfy initial monitoring
requirements. The data must reflect
workplace conditions closely
resembling the processes, types of
material, control methods, work
practices, and environmental conditions
in the employer’s current operations.
Objective data used in place of initial
monitoring under paragraph (d)(2) must
demonstrate that the work operation or
the product cannot reasonably be
foreseen to release beryllium in airborne
concentrations at or above the action
level or above the STEL under the
expected conditions of use that will
cause the greatest possible release. The
data must demonstrate that exposures
cannot meet or exceed the action level
and that exposures cannot exceed the
STEL; if the data do not satisfy both of
these requirements, they do not meet
the criteria of paragraph (d)(2)(ii) and
would not exempt the employer from
conducting initial monitoring. When
using the term ‘‘objective data,’’ OSHA
is referring to manufacturers’ case
studies, laboratory studies, and other
research that demonstrates, usually by
means of exposure data, that exposures
above the action level or STEL cannot
occur. The objective data may include
monitoring data, or mathematical
modeling or calculations based on the
chemical and physical properties of a
material. For example, data collected by
a trade association from its members
that reflect workplace conditions closely
resembling the processes, material,
control methods, work practices, and
environmental conditions in the
employer’s current operations may be
used. OSHA has allowed employers to
use objective data in lieu of initial
monitoring in other standards, such as
those for formaldehyde (29 CFR
1910.1048) and asbestos (29 CFR
1910.1001).
Paragraph (d)(3) contains
requirements for periodic monitoring.
The requirement for this continued
PO 00000
Frm 00219
Fmt 4701
Sfmt 4702
47783
monitoring depends on the results of
initial monitoring. If the initial
monitoring indicates that employee
exposures are below the action level, no
further monitoring would be required
unless, under paragraph (d)(4), changes
in the workplace could result in new or
additional exposures. If the initial
determination reveals employee
exposures to be at or above the action
level and at or below the TWA PEL, the
employer must perform periodic
monitoring at least annually. In stating
‘‘at least annually,’’ OSHA intends that
employers must monitor at least once
during the 12-month period after initial
monitoring is performed, and then at
least once in every subsequent 12month period. Of course, the proposed
requirement for annual monitoring does
not preclude employers from
monitoring more frequently.
OSHA recognizes that exposures in
the workplace can vary from day to day,
between shifts, and even within the
same operation. Beryllium exposures for
many operations have been shown to be
highly variable, with some exposures
exceeding the current TWA PEL. When
airborne concentrations fluctuate in this
way, the probability of exceeding the
PELs increases. Periodic monitoring
provides the employer with additional
and up-to-date information to use to
make informed decisions on whether
additional control measures are
necessary.
Periodic monitoring provides the
employer with exposure information for
additional use beyond that of
determining compliance with the PELs.
Periodic monitoring will provide data to
determine whether or not engineering
controls are working properly and work
practices are effective in preventing
exposure. Selection of appropriate
respiratory protection also depends on
adequate knowledge of employee
exposures obtained through periodic
monitoring.
This proposal does not require
periodic monitoring where exposures
are above the TWA PEL, which
represents a departure from past OSHA
standards such as Chromium (29 CFR
1910.1026) and Cadmium (29 CFR
1910.1027). OSHA has eliminated the
requirement for periodic monitoring
where exposures are above the PEL in
response to a multi-stakeholder
proposal to this effect (Materion and
Steelworkers, 2012). OSHA anticipates
this could be an appropriate way to
reduce costs for employers where
exposures are above the TWA PEL after
the employer has implemented all
feasible engineering and work practice
controls. However, the employer must
continue to assess the status of available
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47784
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
feasible engineering and work practice
controls to ensure that the employer has
reduced exposures to the lowest level
feasible. And even where this standard
does not explicitly require periodic
monitoring, employers may need to
conduct periodic monitoring to ensure
that controls are working properly, and
that employees are adequately protected
and are receiving the services and
benefits to which they are entitled
under this standard such as medical
surveillance and medical removal.
OSHA requests comment on whether
the proposed annual periodic
monitoring for exposures at or above the
action level but below the TWA PEL is
sufficiently protective for employees, or
whether annual periodic monitoring
should be required when exposures
exceed the TWA PEL (see Section I of
this preamble, Issues and Alternatives).
Under paragraph (d)(4), employers are
to perform additional monitoring when
there is a change in production
processes, materials, equipment,
personnel, work practices, or control
methods, that may result in new or
additional exposures to beryllium. In
addition, there may be other situations
that can result in new or additional
exposures that are unique to an
employer’s work situation. In order to
cover those special situations, OSHA
requires the employer to perform
additional monitoring whenever the
employer has any reason to believe that
a change has occurred that may result in
new or additional exposures. For
example, an employer would be
required to perform additional
monitoring when an employee has a
confirmed positive result for beryllium
sensitization, exhibits signs or
symptoms of CBD, or is diagnosed with
CBD. These conditions necessitate
additional monitoring to ascertain if
airborne exposures contributed to the
positive results of the medical testing.
Another example of a situation
requiring additional monitoring would
be a process modification that would
increase the amount of berylliumcontaining material used thereby
possibly increasing employee exposure.
Once additional monitoring has been
performed and exposures characterized,
the employer can take appropriate
action to protect exposed employees.
Under paragraph (d)(5) employers
must notify each employee of his or her
monitoring results within 15 working
days after receiving the results.
Employees who must be notified
include both the employees whose
exposures were monitored directly and
those whose exposures are represented
by the monitoring. The employer must
either notify each employee
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
individually in writing, or post the
monitoring results in an appropriate
location accessible to all employees
required to be notified. This proposed
requirement is consistent with other
OSHA standards, such as those for
methylenedianiline (29 CFR 1910.1050),
1,3-butadiene (29 CFR 1910.1051), and
methylene chloride (29 CFR 1910.1052).
In addition, whenever the TWA PEL or
STEL has been exceeded, the written
notification required by paragraph
(d)(5)(i) must contain a description of
the suspected or known sources of
exposure as well as the corrective
action(s) being taken by the employer to
reduce the employee’s exposure to or
below the applicable PEL. This
requirement is necessary to assure
employees that the employer is making
efforts to furnish them with a safe and
healthful work environment, and is
required under section 8(c)(3) of the Act
(29 U.S.C. 657(c)(3)).
Paragraph (d)(6) requires the
employer to provide employees and
their designated representatives an
opportunity to observe any monitoring
of employee exposure to beryllium.
Employees who must be allowed to
observe monitoring include both the
employees whose exposures are being
monitored and those whose exposures
are represented by the monitoring.
When observation of monitoring
requires entry into an area where the
use of protective clothing or equipment
is required, the employer must provide
the observer with that protective
clothing or equipment, at no cost. The
employer must also assure that the
observer uses such clothing or
equipment appropriately and complies
with all other applicable safety and
health requirements and procedures.
The requirement for employers to
provide employees and their
representatives the opportunity to
observe monitoring is consistent with
the OSH Act. Section 8(c)(3) of the Act
(29 U.S.C. 657(c)(3)) mandates that
regulations requiring employers to keep
records of employee exposures to toxic
materials or harmful physical agents
provide employees or their
representatives with the opportunity to
observe monitoring or measurements.
Also, Section 6(b)(7) of the Act (29
U.S.C. 655(b)(7)) states that, where
appropriate, OSHA standards are to
prescribe suitable protective equipment
to be used in dealing with hazards. The
provision for observation of monitoring
and protection of the observers is also
consistent with OSHA’s other
substance-specific health standards,
such as those for cadmium (29 CFR
1910.1027) and methylene chloride (29
CFR 1910.1052).
PO 00000
Frm 00220
Fmt 4701
Sfmt 4702
After reviewing commenter responses
to the SBREFA inquiry and the Agency’s
RFI on beryllium, OSHA has learned
that the amount of employer effort and
diligence in assessing exposure levels is
proportional to the presumed degree of
exposure (OSHA, 2008b). Commenters
whose companies make products with
high-content beryllium are much more
likely to have incorporated considerable
sampling into their exposure assessment
protocol. (Brush Wellman, 2003,
Honeywell, 2003). In other instances,
where manufacturers use less beryllium
or low-content beryllium alloys, such as
in specialty or precision products,
sampling occurs less frequently. (OSHA,
2007a).
Representatives of various stamping
firms who are currently experiencing
low levels of exposure felt that their
industry as a whole should be exempt
from the initial exposure assessment
provision of this standard and any
additional requirements related to
exposure monitoring. (OSHA, 2007a).
However, available information
demonstrates that initial exposure
assessment needs to be applied to all
industries where beryllium is processed
or otherwise handled (see this preamble
at section V, Health Effects). For
example, OSHA’s technological
feasibility analysis for fabrication of
beryllium alloy products summarizes
exposures for workers in the stamped
and formed metal products sector (see
this preamble at Section IX.D,
Technological Feasibility). Exposure
monitoring data indicate that while for
most production tasks, the median
baseline exposure is less than the
proposed action level of 0.1 mg/m3,
some tasks have the potential to
generate exposures greater than 0.1 mg/
m3. Initial exposure monitoring will
help identify the areas and job tasks
needing additional controls, or
demonstrate that no additional controls
are needed. Initial monitoring also aids
the employer in determining whether
controls currently in use to prevent or
reduce beryllium exposure are effective.
To address many of these comments,
OSHA has established performanceoriented language for the exposure
assessment provisions of this standard,
allowing employers to choose any
method of exposure monitoring that
meets the accuracy specifications in
paragraph (d)(1)(v) of this standard, and
that measures the total airborne
concentration of beryllium for the
operation and worker exposures being
characterized. In addition, employers
may use historical or objective data in
accordance with proposed paragraph
(d)(2) of this standard to satisfy their
initial monitoring obligations. OSHA
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
believes this flexibility in the proposal
accommodates commenters’ concerns
without jeopardizing beryllium-exposed
workers’ health.
SERs also commented that exposure
monitoring is costly and that OSHA
should consider alternatives that allow
employers with very low exposures to
be exempt from monitoring. As a
possible means of alleviating costs, the
Panel recommended that OSHA
encourage the use of objective data and
explain more clearly the requirements
for its use. (OSHA, 2008b). OSHA has
clarified in this preamble the
circumstances under which an
employer may use historical and
objective data in lieu of initial
monitoring. OSHA is also considering
whether to create a guidance product on
the use of objective data. The Agency
requests comments on whether a
guidance product on the use of objective
data would be helpful to businesses
seeking to comply with the beryllium
standard, and what questions or areas of
information it should address.
In addition, OSHA has reduced to
annually the frequency of periodic
monitoring where exposures are at or
above the action level and at or below
the TWA PEL, rather than the six-month
frequency proposed during the SBREFA
process. OSHA has also removed the
requirement for periodic monitoring
every three months where exposures
exceed the PEL. The new provisions
were suggested in the Materion-USW
recommended standard submitted to
OSHA in 2012 (Materion and USW,
2012). While these changes to the
proposed standard reduce the cost
burden of exposure monitoring for
employers, they also may reduce
employees’ protection from
overexposure to beryllium.
OSHA notes that the frequency and
performance of exposure monitoring in
the draft proposal presented to the
SBREFA Panel are similar to OSHA’s
typical approach to periodic exposure
monitoring. Most OSHA standards
require monitoring at least every six
months where exposure levels meet or
exceed the action level, and every three
months where exposures are above the
TWA PEL. For example, the standards
for vinyl chloride (29 CFR 1910.1017),
inorganic arsenic (29 CFR 1910.1018),
lead (29 CFR 1910.1025), cadmium (29
CFR 1910.1027), methylene chloride (29
CFR 1910.1052), acrylonitrile (29 CFR
1910.1045), ethylene oxide (29 CFR
1910.1047), formaldehyde (29 CFR
1910.1048), all specify periodic
monitoring at least every six months
where exposures are above the action
level. Periodic exposure monitoring is
also required where exposures exceed
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
the PEL in most health standards issued
since OSHA began specifying frequency
for periodic monitoring. In many cases
monitoring is required every three
months where exposures exceed the
PEL (methylene chloride (29 CFR
1910.1052), ethylene oxide (29 CFR
1910.1047), acrylonitrile (29 CFR
1910.1045), inorganic arsenic (29 CFR
1910.1018), lead (29 CFR 1910.1025),
and vinyl chloride (29 CFR 1910.1017));
in other cases, it is required at least
every six months (cadmium (29 CFR
1910.1027), 1,3-Butadiene (29 CFR
1910.1051), formaldehyde (29 CFR
1910.1048), benzene (29 CFR 1910.1028)
and asbestos (29 CFR 1910.1001)). Thus,
the periodic monitoring requirements
outlined in this proposal and in the
Materion-USW recommended standard
depart significantly from OSHA’s usual
requirements.
OSHA requests comment on the
proposed schedule for periodic
monitoring. Are the proposed
requirements both practical for
employers and protective for
employees? OSHA also requests
comment on Regulatory Alternatives 9,
10, and 11 below, which would modify
the frequency and performance of
exposure monitoring to be more similar
to previous standards and to the draft
proposal presented to the SBREFA
Panel.
Regulatory Alternative 9
This alternative would require
employers to perform exposure
monitoring at least every 180 days
where exposures are at or above the
action level or above the STEL, and at
or below the TWA PEL. If the initial
monitoring required by paragraph (d)(2)
of this section reveals employee 8-hour
TWA exposure at or above the action
level, the employer shall repeat such
monitoring for each such employee at
least every 180 days to evaluate the
employee’s TWA exposures. If the
initial 15-minute short-term exposure
monitoring reveals employee exposure
above the STEL, the employer shall
repeat such monitoring for each such
employee at least every 180 days to
evaluate the employee’s 15-minute
short-term exposures. Where 8-hour
TWA exposures are above the TWA
PEL, no monitoring would be required.
Regulatory Alternative 10
This alternative would require
employers to perform monitoring at
least every 180 days where exposures
are at or above the action level or above
the STEL. Unlike the periodic
monitoring requirement in the current
proposal, this alternative would include
periodic monitoring where exposures
PO 00000
Frm 00221
Fmt 4701
Sfmt 4702
47785
are above the TWA PEL. If the initial 8hour TWA exposure monitoring
required by paragraph (d)(2) of this
section reveals employee exposure at or
above the action level, the employer
shall repeat such monitoring for each
such employee at least every 180 days
to evaluate the employee’s TWA
exposures. If the initial 15-minute shortterm exposure monitoring reveals
employee exposure above the STEL, the
employer shall repeat such monitoring
for each such employee at least every
180 days to evaluate the employee’s
short-term exposures.
Regulatory Alternative 11
This alternative would require
employers to perform monitoring at
least every 180 days where exposures
are at or above the action level and at
or below the TWA PEL. It would require
employers to perform monitoring at
least every 90 days where exposures are
above the TWA PEL or STEL.
If the initial 8-hour TWA exposure
monitoring required by paragraph (d)(2)
of this section reveals employee TWA
exposure at or above the action level
and at or below the TWA PEL, the
employer shall repeat such monitoring
for each such employee at least every
180 days to evaluate the employee’s
TWA exposures. If this initial
monitoring reveals employee exposure
above the TWA PEL or STEL, the
employer shall repeat such monitoring
for each such employee at least every 90
days to evaluate the employee’s 8-hour
TWA and 15-minute short-term
exposures.
(e) Beryllium Work Areas and Regulated
Areas
Proposed paragraph (e) requires
employers to establish and maintain
beryllium work areas wherever
employees are, or can reasonably be
expected to be, exposed to airborne
beryllium, regardless of the level of
exposure, and regulated areas wherever
employees are, or can reasonably be
expected to be, exposed to airborne
concentrations of beryllium in excess of
the TWA PEL or STEL. Paragraph (e)
would also require employers to
demarcate beryllium work areas and
regulated areas, and limit access to
regulated areas to authorized persons.
The proposed requirements for these
areas serve several important purposes.
First, requiring employers to establish
and demarcate beryllium work areas
and regulated areas ensures that workers
and other persons are aware of the
potential presence of airborne
beryllium. Second, the demarcation of
regulated areas must include warning
signs describing the dangers of
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47786
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
beryllium exposure in accordance with
paragraph (m) of this standard, which
ensures that persons entering regulated
areas will be aware of these dangers.
Third, limiting access to regulated areas
restricts the number of people
potentially exposed to beryllium at
levels above the TWA PEL or STEL, and
the serious health effects associated
with such exposure. Limiting access to
regulated areas has the added benefit of
reducing the employer’s obligation to
implement certain provisions of the
proposed rule triggered by employee
exposure in a regulated area.
Proposed paragraph (e)(1)(i) would
require employers to establish beryllium
work areas where employees are, or can
reasonably be expected to be, exposed to
airborne beryllium. OSHA intends this
provision to apply to all areas and
situations where employees are actually
exposed to airborne beryllium and to
areas and situations where the employer
has reason to anticipate or believe that
airborne exposures may occur. The
requirements for beryllium work areas
under proposed paragraph (e)(1)(i) are
not tied to a particular level of exposure,
but rather are triggered by the presence
of airborne beryllium at any exposure
level.
Proposed paragraph (e)(1)(ii) would
require employers to establish regulated
areas wherever employees are actually
exposed to airborne beryllium above
either the TWA PEL or STEL, and
wherever such exposure can reasonably
be expected. This requirement would
apply if any exposure monitoring or
historical or objective data indicate that
airborne exposures are in excess of
either the TWA PEL or STEL, or if the
employer has reason to anticipate or
believe that airborne exposures may be
above the TWA PEL or STEL, even if the
employer has not yet characterized or
monitored those exposures. For
example, if newly introduced processes
involving beryllium appear to be
creating dust and have not yet been
monitored, the employer should
reasonably anticipate that airborne
exposures could exceed the TWA PEL
or STEL. In this situation the employer
must designate and demarcate the area
as a regulated area to protect workers
and other persons until monitoring
results establish that exposures are at or
below the TWA PEL and STEL. The
employer may then remove the
regulated area designation.
Proposed paragraph (e)(2)(i) requires
employers to demarcate each beryllium
work area to distinguish it from the rest
of the workplace. The proposal specifies
that employers must identify beryllium
work areas ‘‘through signs or any other
methods that adequately establish and
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
inform each employee of the boundaries
of each beryllium work area.’’ This
means that the demarcation must
effectively alert workers and other
persons that airborne beryllium may be
present. Proposed paragraph (e)(2)(ii)
requires employers to identify regulated
areas and post warning signs at each
approach to the regulated area in
accordance with proposed paragraph
(m)(2) of this standard.
This proposed rule gives employers
flexibility in determining the best means
to demarcate beryllium work areas and
regulated areas (with the exception of
paragraph (m), which sets forth specific
requirements for warning signs at entry
points to regulated areas). OSHA is
aware that employers use various
methods to demarcate certain areas in
the workplace, including barricades,
textured flooring, roped-off areas, ‘‘No
entry’’/‘‘No access’’ signs, and painted
boundary lines (AIA, 2003, Honeywell,
2003, DOD, 2003). Allowing employers
to choose the methods that best
demarcate beryllium work areas and
regulated areas is consistent with
OSHA’s belief that employers are in the
best position to make such
determinations, based on the specific
conditions in their workplaces.
Whatever demarcation methods the
employer selects must be clear and
understandable enough to alert workers
to the boundaries of the beryllium work
area or regulated area. This may mean,
for example, including more than one
language on a sign, if the inclusion of a
second language would make the sign
understandable to workers with limited
English reading skills.
In determining what demarcation
might be necessary and effective,
employers should consider factors
including:
• The configuration of the beryllium
work area or regulated area;
• Whether the beryllium work area or
regulated area is permanent or
temporary;
• The airborne concentrations of
beryllium in the beryllium work area or
regulated area;
• The number of employees working
in areas adjacent to any beryllium work
area or regulated area; and
• The period of time the beryllium
work area or regulated area is expected
to have hazardous exposures.
OSHA requests comment on the
proposed requirement to demarcate
beryllium work areas and regulated
areas. OSHA also requests comment on
whether the standard should allow the
performance-based approach indicated
in the proposal or whether the rule
should specify what types of
demarcation employers must use.
PO 00000
Frm 00222
Fmt 4701
Sfmt 4702
Proposed paragraph (e)(3) requires
employers to limit access to regulated
areas. Because of the potentially serious
health effects of exposure to beryllium
and the need for persons entering the
regulated area to be properly protected,
OSHA believes that the number of
persons allowed to access regulated
areas should be limited to those
individuals listed in proposed
paragraph (e)(3). Specifically, this
provision would require employers to
limit access to regulated areas to: (i)
persons the employer authorizes or
requires to be in a regulated area to
perform work duties; (ii) persons
entering a regulated area as designated
representatives of employees for the
purposes of exercising the right to
observe exposure monitoring
procedures under paragraph (d)(6) of
this standard; and (iii) persons
authorized by law to be in a regulated
area.
The first group, persons the employer
authorizes or requires to be in a
regulated area to perform work duties,
may include workers and other persons
whose jobs involve operating
machinery, equipment, and processes
located in regulated areas; performing
maintenance and repair operations on
machinery, equipment, and processes in
those areas; conducting inspections or
quality control tasks; and supervising
those who work in regulated areas.
The second group is made up of
persons entering a regulated area as
designated representatives of employees
for the purpose of exercising the right to
observe exposure monitoring under
paragraph (d)(6). As explained in this
section of the preamble regarding
paragraph (d), providing employees and
their representatives with the
opportunity to observe monitoring is
consistent with the OSH Act and
OSHA’s other substance-specific health
standards, such as those for cadmium
(29 CFR 1910.1027) and methylene
chloride (29 CFR 1910.1052).
The third consists of persons
authorized by law to be in a regulated
area. This category includes persons
authorized to enter regulated areas by
the OSH Act, OSHA regulations, or any
other applicable law. OSHA compliance
officers would fall into this group.
Proposed paragraph (e)(4) requires
employers to provide and ensure that
each employee entering a regulated area
uses personal protective clothing and
equipment, including respirators, in
accordance with paragraphs (g) and (h)
of this standard.
In general, commenters did not
oppose the concept of regulated areas.
Stakeholders responding to the RFI
supported the need for regulated areas
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
(ASAS, 2002; AFL–CIO, 2003;
Honeywell, 2003). For example, the
Department of Defense thought the use
of regulated areas was a good way to
limit the number of workers potentially
exposed to beryllium (DOD, 2003).
Most small entity representatives
(SERs) who participated in the SBREFA
process were not concerned about the
impact of tying the regulated area
requirements to one of the PEL options
presented in the SBREFA draft proposed
standard (OSHA, 2007b). Only one of
the SERs indicated that it may have a
process where typical or average
exposures are above the lowest PEL
option of 0.1 mg/m3 (OSHA, 2007a),
which is one half the currently
proposed TWA PEL.
SERs were divided on the issue of
whether it was possible to isolate or
segregate operations to meet the
conditions of a regulated area. Most of
the SERs did not currently isolate or
segregate their beryllium processes, and
several expressed concern about the
difficulty and costs associated with
isolating or segregating their beryllium
processes (OSHA, 2008b). Some SERs
said they have large, open plant floors
making it difficult to isolated specific
beryllium operations (OSHA, 2008b).
Other SERs said the proposed
requirement for a regulated area would
be difficult and costly because they
move machinery and equipment for
production purposes. They said that
segregating or restricting processes or
machines and equipment to certain
areas would affect productivity to some
extent (OSHA, 2008b). SERs who use
beryllium-containing materials only
occasionally, frequently as part of a
larger order, said that it would be
impractical to isolate specific areas or
machines for beryllium work (OSHA,
2008b). SERs in the precision metal
products industry indicated their
beryllium operations already were well
controlled with machine enclosures
(e.g., lathes and forming machines) and
therefore would not need to segregate
these operations (OSHA, 2008b). The
Panel recommended that OSHA revisit
the cost analysis of regulated areas if the
lowest PEL option (0.1 mg/m3) is
proposed (OSHA, 2008b). The Panel
also recommended that OSHA consider
dropping or limiting the provision for
regulated areas (OSHA, 2008b). In
response to this recommendation,
OSHA analyzed Regulatory Alternative
#12, which would not require
employers to establish regulated areas.
The proposed rule presented during
the SBREFA process did not contain any
requirements for beryllium work areas.
These requirements were added by
OSHA after the SBREFA process in
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
response to a proposal OSHA received
from a stakeholder group (Materion and
USW, 2012). However, because the
proposal presented during the SBREFA
process included a range of proposed
TWA PELs down to 0.1 mg/m3, SERs had
the opportunity to comment on the
requirements for regulated areas at very
low exposure levels. OSHA believes that
SER comments about regulated areas
should reflect SER concerns about
beryllium work areas as well. OSHA has
also made the establishment and
demarcation requirements for beryllium
work areas flexible and performancebased to address SER concerns. OSHA
invites comment on the proposed
requirements for beryllium work areas
and regulated areas, and on Regulatory
Alternative 12 below. OSHA also
requests comments and information on
work settings where establishing
regulated areas could be problematic or
infeasible and what other approaches
might be used to warn employees in
such work settings of high risk areas.
Regulatory Alternative 12
This alternative would eliminate the
requirement to establish and demarcate
regulated areas within facilities where
there is beryllium exposure. It does not
eliminate the proposal’s requirement to
establish and demarcate beryllium work
areas.
OSHA is aware that eliminating the
requirement for regulated areas may
ease the costs and burdens of
compliance for some employers.
However, this potential benefit of
Alternative #12 must be considered in
light of the reasons regulated areas were
included in the proposal, and are a
feature of most OSHA health
regulations. As discussed previously,
the proposed requirements for regulated
areas serve to ensure that access to areas
where beryllium exposures exceed the
TWA PEL or STEL is restricted,
reducing the number of people exposed
to beryllium at levels that create a high
risk of adverse health effects. Second,
the requirement for warning signs
ensures that persons who enter areas
where exposures exceed the TWA PEL
or STEL will be aware of the hazards
present and take appropriate
precautions such as the proper use of
personal protective equipment.
OSHA believes the proposed
requirements for beryllium work areas
and regulated areas balance
commenters’ concerns with the need to
reduce the number of employees
exposed to beryllium and notify those
exposed of the risks involved. The
proposed standard does not require
employers to establish and demarcate
beryllium work areas or regulated areas
PO 00000
Frm 00223
Fmt 4701
Sfmt 4702
47787
by permanently segregating and
isolating processes generating airborne
beryllium. Instead, the standard allows
employers to use temporary or flexible
methods to demarcate beryllium work
areas and regulated areas.
OSHA believes that these flexible,
performance-based requirements could
accommodate open work spaces,
changeable plant layouts, and sporadic
or occasional beryllium use without
imposing undue costs or burdens. For
example, the standard does not prohibit
employers from moving machinery or
equipment for production purposes as
occurs in the beryllium-copper alloy
industry (OSHA, 2008b). Where
employers need to move machinery and
equipment, the proposed rule allows
employers to use methods such as
temporary designations and flexible
demarcations. OSHA also notes that
some employers have enclosed
machines (e.g., lathes) to prevent the
release of airborne beryllium into the
workplace, thereby potentially
eliminating the need for the machine to
be in a regulated area (OSHA, 2008b).
(f) Methods of Compliance
Paragraph (f) of the proposed rule
establishes methods for reducing
employee exposure to beryllium
through the use of a written exposure
control plan and engineering and work
practice controls.
Under proposed paragraph (f)(1)(i),
employers must establish, implement,
and maintain a written exposure control
plan for beryllium work areas. OSHA
believes that adherence to the written
exposure control plan will help reduce
skin contact with beryllium, which can
lead to beryllium sensitization, and
airborne exposure, which can lead to
beryllium sensitization, CBD, and lung
cancer. Because skin contact and
airborne exposure can occur in any
workplace within the scope of the
standard, OSHA has made the
preliminary determination to require a
written exposure control plan for all
employers within the scope of the
standard. In addition, requiring
employers to establish and maintain a
written exposure control plan is
consistent with other OSHA health
standards, including 1,3 butadiene (29
CFR 1910.1051) and bloodborne
pathogens (29 CFR 1910.1030).
OSHA’s proposal to require a written
exposure control plan is based in part
on the recommendation of two
stakeholders, Materion Corporation and
the Steelworkers Union. Materion and
the Steelworkers submitted a joint
proposal for a standard to the Agency
(Materion and Steelworkers, 2012) that
includes a requirement for a written
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47788
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
exposure control plan. In the
stakeholders’ joint proposal, the written
exposure control plan included
requiring documentation of operations
and jobs likely to have exposure to
beryllium at various levels; procedures
for minimizing the migration of
beryllium; procedures for keeping work
surfaces clean; and documentation of
engineering and work practice controls.
OSHA’s proposed requirements for
maintaining and implementing a written
exposure control plan follow the
example of the stakeholders’ proposal in
most respects.
Under proposed paragraphs
(f)(1)(i)(A), (B), and (C), the written
exposure control plan must contain
inventories of operations and job titles
reasonably expected to have any
exposure to airborne beryllium,
exposure at or above the action level,
and exposure above the TWA PEL or
STEL. And, under proposed paragraph
(f)(1)(i)(G), the plan must include an
inventory of engineering and work
practice controls required by paragraph
(f)(2) of this standard.
A record of which operations and job
titles are likely to have exposures at
certain levels and which engineering
and work practice controls the company
has selected to control exposures will
make it easier for employers to
implement monitoring, hygiene
practices, housekeeping, engineering
and work practice controls, and other
measures. These inventories will also
help to assure employees’ awareness of
the exposures associated with their jobs,
their eligibility for medical surveillance,
and the controls that should be in use
throughout the workplace. This will
enable employees to work together with
employers to ensure that the appropriate
engineering controls and work practices
are in use and functioning and that
provisions such as medical surveillance,
housekeeping, and PPE are properly
implemented. In addition, these
inventories, like all of the items
required to be included in the written
exposure control plan, will help safety
and health personnel, including OSHA
Compliance Officers, carry out their
duties. A written plan provides detailed
information to interested parties
including employees, employee
representatives, supervisors, and safety
consultants of the employer’s
determination of the jobs and operations
that may place employees at risk of
exposure and the measures the
employer has selected to control
exposure.
Under proposed paragraph (f)(1)(D)
through (F) and (H), the exposure
control plan must contain procedures
for: minimizing cross-contamination,
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
including preventing the transfer of
beryllium between surfaces, equipment,
clothing, materials, and articles within
beryllium work areas; keeping surfaces
in the beryllium work area as free as
practicable of beryllium; minimizing the
migration of beryllium from beryllium
work areas to other locations within or
outside the workplace; and removal,
laundering, storage, cleaning, repairing,
and disposal of beryllium-contaminated
personal protective clothing and
equipment, including respirators. Each
of these procedures serves to minimize
the spread of beryllium throughout and
outside the workplace. They also work
to reduce the likelihood of skin contact
and re-entrainment of beryllium
particulate into the workplace
atmosphere. Additional discussion of
some of these requirements may be
found in this section of the preamble,
Summary and Explanation, at paragraph
(h), Personal Protective Clothing and
Equipment; paragraph (i), Hygiene
Areas and Practices; and paragraph (j),
Housekeeping.
The requirement to document these
procedures in writing, as part of the
exposure control plan, will help to
ensure that employees are advised of
their responsibilities and can easily
review the procedures if they have
questions. Because employees play an
important part in exposure control
through compliance with the rules
regarding hygiene practices,
housekeeping, and other measures,
employees should have easy access to
documentation detailing the procedures
in place in their workplace. A review of
the written exposure control plan
should be part of the hazard
communication training for employees
as required by 1910.1200 and proposed
paragraph (m). Additionally, the
documentation of the procedures will
help OSHA Compliance Officers assess
employers’ procedures.
Proposed paragraph (f)(1)(ii) requires
that employers update their exposure
control plans whenever any change in
production processes, materials,
equipment, personnel, work practices,
or control methods results or can
reasonably be expected to result in new
or additional exposures to beryllium.
Paragraph (f)(1)(ii) also requires
employers to update their plans when
an employee is confirmed positive for
beryllium sensitization, is diagnosed
with CBD, or shows other signs and
symptoms related to beryllium
exposure. In addition, the paragraph
requires employers to update their plans
if the employer has any reason to
believe that new or additional exposures
are occurring or will occur.
PO 00000
Frm 00224
Fmt 4701
Sfmt 4702
The requirements to update the
exposure control plan if changes in the
workplace result in or can be expected
to result in new or additional exposures,
or where the employer has any reason
to believe that such exposures are
occurring or will occur, ensure that an
employer’s plan reflects the current
conditions in the workplace. If an
employee becomes sensitized or
develops CBD, the employer should
investigate the source(s) of exposure
responsible, and must make any
necessary changes to address the
source(s) of exposure, and update the
written exposure control plan as
necessary to reflect any new information
or corrective action resulting from the
employer’s investigation. For example,
the employer may find that
housekeeping procedures in the
employee’s area need improvement, or
that more appropriate PPE could be
used. In some cases, the employer may
find that additional engineering or work
practice controls are appropriate to the
processes in use. When the employer
discovers new sources of exposure or
makes changes in its control strategy,
the employer must update its written
exposure control plan to reflect current
conditions in the workplace. Employers
such as Materion and Axsys
Technologies, who have worked to
identify and document the exposure
sources associated with cases of
sensitization and CBD in their facilities,
have used this information to develop
and update beryllium exposure control
plans (Bailey et al., 2010; Schuler et al.,
2012; Madl et al., 2007). OSHA believes
this proposed process, whereby an
employer uses employee health
outcome data to check and improve the
effectiveness of the employer’s exposure
control plan, is consistent with other
performance-oriented aspects of this
proposed standard.
Proposed paragraph (f)(1)(iii) requires
employers to make a copy of the
exposure control plan accessible to each
employee who is or can reasonably be
expected to be exposed to airborne
beryllium in accordance with OSHA’s
Access to Employee Exposure and
Medical Records Standard (29 CFR
1910.1020). As mentioned above, access
to the exposure control plan will enable
employees to partner with their
employers in keeping the workplace
safe.
Paragraph (f)(2) of the proposed rule
contains requirements for the
implementation of engineering and
work practice controls to minimize
beryllium exposures in beryllium work
areas. The proposed rule relies on
engineering and work practice controls
as the primary means to reduce
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
exposures. Where, after the
implementation of feasible engineering
and work practice controls, exposures
exceed or can reasonably be expected to
exceed the TWA PEL or STEL,
employers are required to supplement
these controls with respiratory
protection, according to the
requirements of paragraph (g) of the
proposed rule. OSHA proposes to
require primary reliance on engineering
and work practice controls because
reliance on these methods is consistent
with good industrial hygiene practice,
with the Agency’s experience in
ensuring that workers have a healthy
workplace, and with OSHA’s traditional
adherence to a hierarchy of controls.
OSHA requires adherence to this
hierarchy of controls in a number of
standards, including the Air
Contaminants (29 CFR 1910.1000) and
Respiratory Protection (29 CFR
1910.134) standards, as well as other
substance-specific standards. The
Agency’s adherence to the hierarchy of
controls has been successfully upheld
by the courts (see AFL–CIO v. Marshall,
617 F.2d 636 (D.C. Cir. 1979) (cotton
dust standard); United Steelworkers v.
Marshall, 647 F.2d 1189 (D.C. Cir.
1980), cert. denied, 453 U.S. 913 (1981)
(lead standard); ASARCO v. OSHA, 746
F.2d 483 (9th Cir. 1984) (arsenic
standard); Am. Iron & Steel v. OSHA,
182 F.3d 1261 (11th Cir. 1999)
(respiratory protection standard); Pub.
Citizen v. U.S. Dep’t of Labor, 557 F.3d
165 (3rd Cir. 2009) (hexavalent
chromium standard)).
The Agency understands that
engineering controls are reliable,
provide consistent levels of protection
to a large number of workers, can be
monitored continually and
inexpensively, allow for predictable
performance levels, and can efficiently
remove toxic substances from the
workplace. Once removed, the toxic
substances no longer pose a threat to
employees. The effectiveness of
engineering controls does not generally
depend to any substantial degree on
human behavior, and the operation of
control equipment is not as vulnerable
to human error as is personal protective
equipment. For these reasons,
engineering controls are preferred by
OSHA and the safety and health
professional community in general.
The provisions related to engineering
and work practice controls begin in
paragraph (f)(2)(i)(A). For each
operation in a beryllium work area,
employers must ensure that at least one
of the following engineering and work
practice controls is in place to minimize
employee exposure:
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
(1) Material and/or process
substitution;
(2) Ventilated partial or full
enclosures;
(3) Local exhaust ventilation at the
points of operation, material handling,
and transfer; or
(4) Process control, such as wet
methods and automation. OSHA has
included a non-mandatory appendix
presenting a non-exhaustive list of
engineering controls employers may use
to comply with paragraph (f)(2)(i)
(Appendix B).
Proposed paragraph (f)(2)(i)(B) offers
two exemptions from the engineering
and work practice controls
requirements. First, under paragraph
(f)(2)(i)(B)(1), an employer is exempt
from using engineering and work
practice controls where the employer
can establish that the controls are not
feasible.
Second, under paragraph
(f)(2)(i)(B)(2), an employer is exempt
from using the controls where the
employer can demonstrate that
exposures are below the action level,
using no fewer than two representative
personal breathing zone samples taken 7
days apart, for each affected operation.
The engineering work practice control
requirement in paragraph (f)(2)(i)(A),
like the written exposure control plan
requirement, was proposed by the
United Steelworkers and Materion as
part of their joint submission to OSHA
(Materion and United Steelworkers,
2012). The inclusion of the engineering
work practice control provision in
paragraph (f)(2)(i)(A) addresses a
concern regarding the proposed PEL.
OSHA expects that day-to-day changes
in workplace conditions may cause
frequent excursions above the PEL in
workplaces where periodic sampling
indicates exposures are between the
action level and the PEL. Normal
variability in the workplace and work
processes, such as workers’ positioning
or patterns of airflow, can lead to
excursions above the PEL. OSHA
believes that substitution or engineering
controls such as those outlined in
paragraph (f)(2)(i)(A) provide the most
reliable means to control variability in
exposure levels. OSHA therefore
included this requirement in the
proposal. The Agency included the
exemption in paragraph (f)(2)(i)(B)(2) to
reduce the cost burden to employers
with operations where measured
exposures are below the action level,
and therefore less likely to exceed the
PEL in the course of typical exposure
fluctuations. This exemption is similar
to a provision in 1,3 Butadiene (29 CFR
1910.1051), which requires an exposure
PO 00000
Frm 00225
Fmt 4701
Sfmt 4702
47789
goal program where exposures exceed
the action level.
OSHA recognizes that the
requirements of paragraph (f)(2)(i) are
not typical of OSHA standards, which
usually require engineering controls
only where exposures exceed the
PEL(s). The Agency is therefore
considering Regulatory Alternative #6,
which would drop the provisions of
paragraph (f)(2)(i) from the proposed
standard. OSHA requests comments on
the potential benefits of including such
a provision in the beryllium standard,
the potential costs and burdens
associated with it, and whether OSHA
should include or exclude this
provision in the final standard.
Proposed paragraph (f)(2)(ii) applies
when exposures exceed the TWA PEL or
STEL after employers have
implemented the control(s) required by
paragraph (f)(2)(i). It requires employers
to implement additional or enhanced
engineering and work practice controls
to reduce exposures to or below the
PELs. For example, an enhanced
engineering control may entail a
redesigned hood on a local ventilation
system to more effectively capture
airborne beryllium at the source.
However, under proposed paragraph
(f)(2)(iii), wherever the employer
demonstrates that it is not feasible to
reduce exposures to or below the PELs
by the engineering and work practice
controls required by paragraphs (f)(2)(i)
and (f)(2)(ii), the employer shall
implement and maintain engineering
and work practice controls to reduce
exposures to the lowest levels feasible
and supplement these controls by using
respiratory protection in accordance
with paragraph (g) of this standard.
Paragraph (f)(3) of the proposed rule
would prohibit the employer from
rotating workers to different jobs to
achieve compliance with the PELs.
Worker rotation can potentially reduce
exposures to individual employees, but
increases the number of employees
exposed. Because OSHA has made a
preliminary determination that
exposure to beryllium can result in
sensitization, CBD, and cancer, the
Agency considers it inappropriate to
place more workers at risk. Since no
absolute threshold has been established
for sensitization or resulting CBD or the
carcinogenic effects of beryllium, it is
prudent to limit the number of workers
exposed at any concentration.
This provision is not a general
prohibition of worker rotation wherever
workers are exposed to beryllium. It is
only intended to restrict its use as a
compliance method for the proposed
PEL; worker rotation may be used as
deemed appropriate by the employer in
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47790
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
activities such as to provide crosstraining or to allow workers to alternate
physically demanding tasks with less
strenuous activities. This same
provision was used for the asbestos (29
CFR 1910.1001 and 29 CFR 1926.1101),
chromium (VI) (29 CFR 1910.1026), 1,3
butadiene (29 CFR 1910.1051),
methylene chloride (29 CFR 1910.1052),
cadmium (29 CFR 1910.1027 and 29
CFR 1926.1127), and
methylenedianiline (29 CFR 1926.60)
OSHA standards.
The SERs who participated in the
SBREFA process did not voice
opposition to a requirement for a
written exposure control program or
challenge the utility of a written
program in helping to control exposures
(OSHA, 2008b). Several indicated that
they already had a beryllium exposure
control program in place. Some SERs
suggested that OSHA should tie the
written exposure control program
requirement to exposures exceeding a
revised PEL (OSHA, 2008b). The SERs’
request to tie the written exposure
control program requirement to the PEL
appears to emerge from their belief that
employees exposed below the proposed
PEL are not at risk from beryllium
exposure (OSHA, 2008b).
As stated earlier, OSHA’s proposed
standard would require a written
exposure control plan for all beryllium
work areas; i.e., wherever airborne
beryllium is found in the workplace.
OSHA believes a written exposure
control plan is needed to reduce
employees’ risks in low-exposure areas,
where the proposed standard does not
require employers to install engineering
controls, as well as in high-risk areas.
The Agency’s preliminary risk
assessment shows that adverse health
effects from beryllium exposure occur at
levels below the proposed PEL, and
even below the proposed action level
(see this preamble at Section VIII,
Significance of Risk). In addition,
dermal contact with beryllium can
occur in jobs where exposures are below
the PEL or the action level. Dermal
exposure to beryllium can cause
beryllium sensitization, a necessary first
step in the development of CBD (see this
preamble at Section V, Health Effects,
and Section VIII, Significance of Risk).
However, in response to the SERs’
comments on the written exposure
control plan and other requirements that
may affect workplaces with exposure
levels below the proposed PEL, OSHA
is considering Regulatory Alternative #8
(see chapter VIII of the PEA). Where the
proposed standard requires written
exposure control plans to be maintained
in any facility covered by the standard,
Regulatory Alternative #8 would require
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
only facilities with exposures above the
TWA PEL or STEL to maintain a plan.
OSHA requests comment on the
proposed written exposure control plan
requirement and on Regulatory
Alternative #8.
Several SERs expressed doubt that
material substitution could be an
effective means of reducing beryllium
exposures in their facilities. One SER
stated that substitutes for beryllium
alloys are not presently viable for
industrial uses that require certain highperformance electrical characteristics, or
wear resistance (OSHA, 2007a). Another
SER commented that substitutes for
beryllium alloys in the dental appliance
industry have also been associated with
occupational disease (OSHA, 2007a).
OSHA recognizes that the use of
substitutes for beryllium may not be
feasible or appropriate for some
employers. The Agency’s intent is to
offer material substitution as one
possible means of compliance with the
proposed standard. Employers must
determine whether material substitution
is an effective and appropriate means of
exposure control for their facilities. In
addition, it is employers’ responsibility
to check the toxicity of any material
they may use in their facilities,
including potential substitutes for
beryllium.
OSHA anticipates that most small
businesses will be able to comply with
the proposed standard regardless of
whether they choose to substitute other
materials for beryllium in their
facilities.
(g) Respiratory Protection
Paragraph (g) of the proposed
standard lays out the situations in
which employers are required to protect
employees’ health through the use of
respiratory protection. Specifically, this
paragraph would require that employers
provide respiratory protection at no cost
and ensure that employees utilize the
protection during the situations listed in
paragraph (g)(1). As detailed in
proposed paragraph (g)(2), the required
respiratory protection must comply with
the Respiratory Protection standard (29
CFR 1910.134).
Proposed paragraph (g)(1) requires
employers to ensure that each employee
required to use a respirator does so.
Accordingly, simply providing
respirators to employees will not satisfy
an employer’s obligations under
proposed paragraph (g)(1) unless the
employer also ensures that its
employees wear the respirators when
required. Proposed paragraph (g)(1)
would also require employers to provide
required respirators at no cost to
employees. This requirement is
PO 00000
Frm 00226
Fmt 4701
Sfmt 4702
consistent with OSHA’s Respiratory
Protection standard, which also requires
employers to provide required
respiratory protection to employees at
no cost (29 CFR 1910.134(c)(4)).
Paragraph (g)(1) requires appropriate
respiratory protection during certain
enumerated situations. Proposed
paragraph (g)(1)(i) requires respiratory
protection during the installation and
implementation of engineering and/or
work practice controls where exposures
exceed or can reasonably be expected to
exceed the TWA PEL or STEL. The
Agency realizes that changing
workplace conditions may require
employers to install new engineering
controls, modify existing controls, or
make other workplace changes to reduce
employee exposure to beryllium to at or
below the TWA PEL and STEL. In these
cases, the proposed standard recognizes
that installing appropriate engineering
controls and implementing proper work
practices may take time. During this
time, employers must demonstrate that
they are making prompt, good faith
efforts to purchase and install
appropriate engineering controls and
implement effective work practices, and
to evaluate their effectiveness for
reducing exposure to beryllium to at or
below the TWA PEL and STEL.
Proposed paragraph (g)(1)(ii) requires
the provision of respiratory protection
during any operations, including
maintenance and repair operations and
other non-routine tasks, when
engineering and work practice controls
are not feasible and exposures exceed or
can reasonably be expected to exceed
the TWA PEL or STEL. OSHA included
this provision because the Agency
realizes that certain operations may take
place when engineering and work
practice controls are not operational or
capable of controlling exposures to at or
below the TWA PEL and STEL. For
example, during maintenance and repair
operations, engineering controls may
lose their full effectiveness or require
partial or total breach, bypass, or
shutdown. Under these circumstances,
if exposures exceed or can reasonably be
expected to exceed the TWA PEL or
STEL, the employer must provide and
ensure the use of respiratory protection.
Proposed paragraph (g)(1)(iii) requires
the provision of respiratory protection
where beryllium exposures exceed the
TWA PEL or STEL even after the
employer has installed and
implemented all feasible engineering
and work practice controls. OSHA
anticipates that there will be very few
situations where feasible engineering
and work practice controls are incapable
of lowering employee exposure to
beryllium to at or below the TWA PEL
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
or STEL (see this preamble at section
IX.D, Technological Feasibility). In such
cases, the proposed standard requires
that employers install and implement
all feasible engineering and work
practice controls and supplement those
controls by providing respiratory
protection (proposed paragraph
(f)(2)(iii)). OSHA reiterates that
paragraph (f)(2)(iii) would also require
employers to demonstrate that
engineering and work practice controls
are not feasible or sufficient to reduce
exposure to levels at or below the TWA
PEL and STEL. OSHA requests
comment about the proposed situations
during which employers should be
required to provide and ensure the use
of respiratory protection.
Proposed paragraph (g)(1)(iv) requires
the provision of respiratory protection
in emergencies. At such times,
engineering controls may not be
functioning fully or may be
overwhelmed or rendered inoperable.
Also, emergencies may occur in areas
where there are no engineering controls.
The proposed standard recognizes that
the provision of respiratory protection is
critical in emergencies, as beryllium
exposures may be very high and
engineering controls may not be
adequate to control an unexpected
release of beryllium.
The situations in which respiratory
protection is required are generally
consistent with the requirements in
other OSHA health standards, such as
those for chromium (VI)(29 CFR
1910.1026), butadiene (29 CFR
1910.1051), and methylene chloride (29
CFR 1910.1052). Those standards and
this proposed standard also reflect the
Agency’s traditional adherence to a
hierarchy of controls in which
engineering and work practice controls
are preferred to respiratory protection
(see the discussion of proposed
paragraph (f) earlier in this section of
the preamble).
Whenever respirators are used to
comply with the requirements of this
proposed standard, paragraph (g)(2)
requires that the employer implement a
comprehensive written respiratory
protection program in accordance with
OSHA’s Respiratory Protection standard
(29 CFR 1910.134). The Respiratory
Protection standard is designed to
ensure that employers properly select
and use respiratory protection in a
manner that effectively protects exposed
workers. Under 29 CFR 1910.134(c)(1),
the employer’s respiratory protection
program must include:
• Procedures for selecting appropriate
respirators for use in the workplace;
• Medical evaluations of employees
required to use respirators;
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
• Respirator fit testing procedures;
• Procedures for proper use of
respirators in routine and reasonably
foreseeable emergency situations;
• Procedures and schedules for
maintaining respirators;
• Procedures to ensure adequate
quality, quantity, and flow of breathing
air for atmosphere-supplying
respirators;
• Training of employees in the
respiratory hazards to which they are
potentially exposed during routine and
emergency situations, and in the proper
use of respirators; and
• Procedures for evaluating the
effectiveness of the program.
In accordance with the Agency’s
policy to avoid duplication and to
establish regulatory consistency,
proposed paragraph (g)(2) incorporates
by reference the requirements of 29 CFR
1910.134 rather than reprinting those
requirements in this proposed standard.
OSHA notes that the respirator selection
provisions in 1910.134 include
requirements for Assigned Protection
Factors (APFs) and Maximum Use
Concentrations (MUCs) that OSHA
adopted in 2006 (71 FR 50122–50192,
August 24, 2006). The APFs and MUCs
provide employers with critical
information for the selection of
respirators to protect workers from
exposure to atmospheric workplace
contaminants.
OSHA believes that the proposed
respiratory protection requirements are
feasible even for small employers.
Although none of the SERs who
participated in the SBREFA process
made specific recommendations about
respiratory protection, some said that
they currently have existing respiratory
protection programs in place as
supplemental support to engineering
and work practice controls (OSHA,
2008b).
OSHA requests comment on the
proposed requirement to establish and
maintain a respiratory protection
program that complies with 29 CFR
1910.134. OSHA would like to hear
from companies of all sizes regarding
whether they have respiratory
protection programs to protect
employees from beryllium exposures. If
so, please explain the parameters of
your program including types of
respirators used, when and where
respirators are required, program
evaluation, and annual costs.
(h) Personal Protective Clothing and
Equipment
Paragraph (h) of the proposed
standard requires employers to provide
employees with personal protective
clothing and equipment (PPE) where
PO 00000
Frm 00227
Fmt 4701
Sfmt 4702
47791
employee exposure exceeds or can
reasonably be expected to exceed the
TWA PEL or STEL; where work clothing
or skin may become visibly
contaminated with beryllium, including
during maintenance and repair activities
or during non-routine tasks; and where
employees are exposed to soluble
beryllium compounds. These PPE
requirements are intended to prevent
adverse health effects associated with
dermal exposure to beryllium, and
accumulation of beryllium on clothing,
shoes, and equipment that can result in
additional inhalation exposure. The
requirements also protect employees in
other work areas from exposures that
could occur if contaminated clothing
carried beryllium to those areas, as well
as employees and other individuals
outside the workplace. The proposed
standard requires the employer to
provide PPE at no cost to employees,
and to ensure that employees use the
provided PPE in accordance with the
written exposure control plan as
described in paragraph (f)(1) of this
proposed standard and OSHA’S
Personal Protective Equipment
standards (29 CFR part 1910 subpart I).
Proposed paragraph (h)(1)(i) requires
the provision and use of PPE for
employees exposed to airborne
beryllium in any form exceeding the
TWA PEL or STEL because such
exposure would likely result in skin
contact by means of deposits on
employees’ skin or clothes or on
surfaces touched by employees. And,
OSHA believes that regardless of the
level of exposure, the use of PPE further
reduces exposure where employees’
clothing or skin could become visibly
contaminated with beryllium (paragraph
(h)(1)(ii)).
The term ‘‘visibly contaminated with
beryllium’’ means visibly contaminated
with any material that contains
beryllium. The proposed standard does
not specify criteria for determining
whether work clothing or skin may
become visibly contaminated with
beryllium. When evaluating whether
this definition is satisfied, OSHA
expects that the employer will assess
the workplace in a manner consistent
with the Agency’s general requirements
for the use of personal protective
equipment in general industry (29 CFR
part 1910 subpart I). These standards
require the employer to assess the
workplace to determine if hazards
associated with dermal or inhalation
exposure to a substance such as
beryllium are, or are likely to be,
present.
The proposed standard also requires
the provision and use of PPE where
employees are exposed to soluble
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47792
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
beryllium compounds, regardless of the
level of airborne exposure (paragraph
(h)(1)(iii)). Solubility is a concern
because dermal absorption may occur at
a greater rate for soluble beryllium than
for insoluble beryllium. Once absorbed
through the skin, beryllium can induce
a sensitization response that is a
necessary first step toward CBD (See the
Health Effects section of this preamble,
section V.A.2). However, there is also
evidence that beryllium in other forms
can be absorbed through the skin and
cause sensitization (see this preamble at
section V.B.2, Health Effects). OSHA
requests comment on this provision,
and whether employers should also be
required to provide PPE to limit dermal
contact with insoluble forms of
beryllium as specified in Regulatory
Alternative #13 below.
Requiring PPE is consistent with
section 6(b)(7) of the OSH Act which
states that, where appropriate, standards
shall prescribe suitable protective
equipment to be used in connection
with hazards. The proposed
requirements for PPE are based upon
widely accepted principles and
conventional practices of industrial
hygiene, and in some respects are
similar to other OSHA health standards
such as those for chromium (VI) (29 CFR
1910.1026), lead (29 CFR 1910.1025),
cadmium (29 CFR 1910.1027), and
methylenedianiline (MDA; 29 CFR
1910.1050). However, the requirement
to use PPE where work clothing or skin
may become ‘‘visibly contaminated’’
with beryllium differs from prior health
standards, which do not require
contamination to be visible in order for
PPE to be required. For example, the
standard for chromium (VI) requires the
employer to provide appropriate PPE
where a hazard is present or is likely to
be present from skin or eye contact with
chromium (VI) (29 CFR 1910.1026). The
lead (29 CFR 1910.1025) and cadmium
(29 CFR 1910.127) standards require
PPE where employees are exposed
above the PEL or where there is
potential for skin or eye irritation,
regardless of airborne exposure level. In
the case of MDA, PPE must be provided
where employees are subject to dermal
exposure to MDA, where liquids
containing MDA can be splashed into
the eyes, or where airborne
concentrations of MDA are in excess of
the PEL (29 CFR 1910.1050). While
OSHA’s language regarding PPE
requirements varies somewhat from
standard to standard, previous
standards tend to emphasize potential
for contact with a substance that can
trigger health effects via dermal
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
exposure, rather than ‘‘visible
contamination’’ with the substance.
The employer must exercise
reasonable judgment in selecting
appropriate PPE. This requirement is
consistent with OSHA’s current
standards for provision of personal
protective equipment for general
industry (29 CFR part 1910 subpart I).
As described in the non-mandatory
appendix providing guidance on
conducting a hazard assessment for
OSHA general industry standards (29
CFR 1910 subpart I appendix B), the
employer should ‘‘exercise common
sense and appropriate expertise’’ in
assessing hazards. By ‘‘appropriate
expertise,’’ OSHA expects individuals
conducting hazard assessments to be
familiar the employer’s work processes,
materials, and work environment. A
thorough hazard assessment should
include a walk-through survey to
identify sources of hazards to
employees, wipe sampling to detect
beryllium contamination on surfaces,
review of injury and illness data, and
employee input on the hazards to which
they are exposed. Information obtained
in this manner provides a basis for the
identification and evaluation of
potential hazards. OSHA believes that
the implementation of a comprehensive
and thorough program to determine
areas of potential exposure, consistent
with the employer’s written exposure
control plan, is a sound safety and
health practice and a necessary element
of ensuring overall worker protection.
Based on the hazard assessment
results, the employer must determine
what PPE is necessary to protect
employees. The proposed requirement
is performance-oriented, and is
designed to allow the employer
flexibility in selecting the PPE most
suitable for each particular workplace.
The type of PPE needed will depend on
the potential for exposure, the physical
properties of the beryllium-containing
material used, and the conditions of use
in the workplace. For example, shipping
and receiving activities may necessitate
only work uniforms and gloves. In other
situations such as when a worker is
performing facility maintenance, gloves,
work uniforms, coveralls, and
respiratory protection may be
appropriate. Beryllium compounds can
exist in acidic or alkaline form, and
these characteristics may influence the
choice of PPE. Face shields may be
appropriate in situations where there is
a danger of being splashed in the face
with soluble beryllium or a liquid
containing beryllium. Coveralls with a
head covering may be appropriate when
a sudden release of airborne beryllium
could result in beryllium contamination
PO 00000
Frm 00228
Fmt 4701
Sfmt 4702
of clothing, hair, or skin. Respirators are
addressed separately in the explanation
of proposed paragraph (g) earlier in this
section of the preamble.
Note that paragraph (i)(2) of this
proposed standard requires change
rooms only where employees are
required to remove their personal
clothing. Although some personal
protective clothing may be worn over
street clothing, it is not appropriate for
workers to wear protective clothing over
street clothing if doing so could
reasonably result in contamination of
the workers’ street clothes. In situations
in which it is not appropriate for
workers to wear protective clothing over
their street clothes, the employer must
select and ensure the use of protective
clothing that is worn in lieu of (rather
than over) street clothing.
Paragraph (h)(2) contains proposed
requirements for removal and storage of
PPE. This provision is intended to
reduce beryllium contamination in the
workplace and limit beryllium exposure
outside the workplace. Wearing
contaminated clothing outside the
beryllium work area could lengthen the
duration of exposure and carry
beryllium from beryllium work areas to
other areas of the workplace. In
addition, contamination of personal
clothing could result in beryllium being
carried to employees’ cars and homes,
increasing employees’ exposure as well
as exposing others to beryllium hazards.
A National Jewish Medical and
Research Center collaborative study
with NIOSH documented inadvertent
transfer of beryllium from the workplace
to workers’ automobiles, and stressed
the need for separating clean and
contaminated (‘‘dirty’’) PPE (Sanderson,
1999). Toxic metals brought by workers
into the home via contaminated clothing
and vehicles continue to result in
exposure to children and other
household members. A recent study of
battery recycling workers found that
lead surface contamination above the
Environmental Protection Agency level
of concern (> 40 mg/ft2) was common in
the workers’ homes and vehicles
(Centers for Disease Control and
Prevention, 2012).
Under proposed paragraph
(h)(2)(i)(A), beryllium-contaminated
PPE must be removed at the end of the
work shift or at the completion of tasks
involving beryllium exposure,
whichever comes first. This language is
intended to convey that PPE
contaminated with beryllium should not
be worn when tasks involving beryllium
exposure have been completed for the
day. For example, if employees perform
work tasks involving beryllium
exposure for the first two hours of a
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
work shift, and then perform tasks that
do not involve exposure, they should
remove their PPE after the exposure
period to avoid the possibility of
increasing the duration of exposure and
contamination of the work area from
beryllium residues on the PPE (i.e., reentrainment of beryllium particulate). If,
however, employees are performing
tasks involving exposure intermittently
throughout the day, or if employees are
exposed to other contaminants where
PPE is needed, this provision is not
intended to prevent them from wearing
the PPE until the completion of their
shift, unless it has become visibly
contaminated with beryllium (paragraph
(h)(2)(i)(B)).
Paragraph (h)(2)(i)(B) would require
employers to ensure that employees
remove PPE that has become visibly
contaminated with beryllium. This
language is intended to convey that PPE
that is visibly contaminated with
beryllium should be changed at the
earliest reasonable opportunity, for
example, at the end of the task during
which it became visibly contaminated.
This language is intended to protect
employees working with beryllium and
their co-workers from exposure due to
accumulation of beryllium on PPE, and
reduces the likelihood of crosscontamination from berylliumcontaminated PPE.
Proposed paragraph (h)(2)(ii) requires
employees to remove PPE consistent
with the written exposure control plan
required by proposed paragraph (f)(1).
Paragraph (f)(1) specifies that the
employer’s written exposure control
plan must contain procedures for
minimizing cross-contamination, and
procedures for the storage of berylliumcontaminated PPE, among other
provisions (see (f)(1)(i)(D) & (H)).
Paragraph (h)(2)(iii) would require
employers to ensure that protective
clothing is stored separately from
employees’ street clothing. OSHA
believes these provisions are necessary
to prevent the spread of beryllium
throughout and outside the workplace.
To further limit exposures outside the
workplace, OSHA proposes in
paragraph (h)(2)(iv) that the employer
ensure that beryllium-contaminated PPE
is only removed by employees who are
authorized to do so for the purpose of
laundering, cleaning, maintaining, or
disposing of such PPE. These items
must be brought to an appropriate
location away from the workplace. To
be an appropriate location for purposes
of paragraph (h)(2)(iv), the facility must
be equipped to handle berylliumcontaminated items in accordance with
this proposed standard. The standard
would further require in paragraph
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
(h)(2)(v) that PPE removed from the
workplace for laundering, cleaning,
maintenance, or discarding be placed in
closed, impermeable bags or containers.
These requirements are intended to
minimize cross-contamination and
migration of beryllium, and to protect
employees or other individuals who
later handle beryllium-contaminated
items. Required warning labels would
alert those handling the contaminated
PPE of the potential hazards of exposure
to beryllium. Such labels must conform
with the HCS (29 CFR 1910.1200) and
paragraph (m)(3) of this proposed
standard. These warning requirements
are meant to reduce confusion and
ambiguity regarding critical information
communicated in the workplace by
requiring that this information be
presented in a clear and uniform
manner.
Proposed paragraph (h)(3)(i) would
require the employer to ensure that
reusable PPE is cleaned, laundered,
repaired, and replaced as needed to
maintain its effectiveness. These
requirements must be completed at a
frequency, and in a manner, necessary
to ensure that PPE continues to serve its
intended purpose of protecting workers
from beryllium exposure.
In keeping with the performanceorientation of the proposed standard,
OSHA does not specify how often PPE
should be cleaned, repaired or replaced.
The Agency believes that appropriate
time intervals may vary widely based on
the types of PPE used, the nature of the
beryllium exposures, and other
circumstances in the workplace.
However, even in the absence of a
mandated schedule, the employer is still
obligated to keep the PPE in the
condition necessary to perform its
protective function. A number of Small
Entity Representatives (SERS) from
OSHA’s SBREFA panel noted they now
use low maintenance Tyvek disposable
protective suits for some high exposure
areas to address potential contamination
situations (OSHA, 2007a).
Under paragraph (h)(3)(ii), removal of
beryllium from PPE by blowing,
shaking, or any other means which
disperses beryllium in the air would be
prohibited as this practice could result
in unnecessary exposure to airborne
beryllium.
Paragraph (h)(3)(iii) would require the
employer to inform in writing any
person or business entity who launders,
cleans, or repairs PPE required by this
standard of the potentially harmful
effects of exposure to airborne beryllium
and dermal contact with soluble
beryllium compounds, and of the need
to handle the PPE in accordance with
this standard. This provision is
PO 00000
Frm 00229
Fmt 4701
Sfmt 4702
47793
intended to limit dermal or inhalation
exposure to beryllium, and to
emphasize the need for hazard
awareness and protective measures
consistent with the proposed standard
among persons who clean, launder, or
repair beryllium-contaminated items.
Comments from SERs indicate that a
number of beryllium-related businesses
already have comprehensive protocols
in place for the use and maintenance of
PPE (OSHA, 2007a). One commenter
indicated that it has effectively reduced
sensitization and CBD through the use
of respirators, other PPE, and
engineering controls (OSHA, 2007a).
Another commenter stated that it
utilizes PPE to reduce skin exposure
(OSHA, 2007a). These existing PPE
programs achieve many of the Agency’s
goals and incorporate many of the
requirements of this proposed standard.
The primary objections from SERs
came from companies that raised
concerns regarding the ‘‘trigger’’ (e.g.,
exposure level or surface
contamination) for PPE in the draft
standard, and particularly the use of
such terms as ‘‘anticipated,’’ ‘‘routine,’’
and ‘‘contaminated surface area’’ in
connection with the requirements to
protect against dermal exposure to
beryllium (OSHA, 2007a). They also
contend that for certain processes such
as stamping, change rooms, PPE, and
other hygiene practices are not
necessary (OSHA, 2007a). Much of this
criticism was based on early preproposal drafts in circulation to the
SBREFA Panel (OSHA, 2007b). Since
that time, OSHA has endeavored to
refine the regulatory text to reflect the
concerns and comments submitted on
this topic. ‘‘Contaminated surface area’’
is no longer a trigger for PPE; however,
employers must provide PPE if a
contaminated surface presents the
potential for workers’ skin or clothing to
become visibly contaminated with
beryllium (paragraph (h)(1)(ii)). The
term ‘‘routine’’ has been removed as a
trigger, and paragraph (h)(1)(ii) makes
clear that protections are required where
skin or clothing may become visibly
contaminated whether during routine or
non-routine tasks. OSHA clarified that
dermal protections are required only
where the skin may become visibly
contaminated with beryllium. OSHA
believes that this proposed standard
addresses commenters’ objections with
textual changes and this explanation of
the text, which together provide further
guidance to those who would be
covered by the standard.
However, OSHA is concerned that the
requirement to use PPE where work
clothing or skin may become ‘‘visibly
contaminated’’ with beryllium or where
E:\FR\FM\07AUP2.SGM
07AUP2
47794
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
soluble forms of beryllium are used may
not be sufficiently protective of
beryllium-exposed workers. OSHA has
preliminarily concluded that
sensitization can occur through dermal
exposure. And although solubility may
play a role in the level of sensitization
risk, the available evidence suggests that
contact with insoluble as well as soluble
beryllium can cause sensitization via
dermal contact (see this preamble at
section V, Health Effects). Furthermore,
at exposure levels below the current or
proposed PEL, beryllium surface
contamination is unlikely to be visible
yet may still cause sensitization. The
specification of ‘‘visible contamination’’
is a departure from most OSHA
standards, which do not specify that
contamination must be visible in order
for PPE to be required. OSHA is
therefore considering Regulatory
Alternative #13, which would require
appropriate PPE wherever there is
potential for skin contact with beryllium
or beryllium-contaminated surfaces.
Please provide comments on this
alternative, including the benefits and
drawbacks of a comprehensive PPE
requirement, and any relevant data or
studies the Agency should consider.
(i) Hygiene Areas and Practices
Paragraph (i) of the proposed standard
requires that, when certain conditions
are met, employers must provide
employees with readily accessible
washing facilities, change rooms, and
showers. Proposed paragraph (i) also
requires employers to take certain steps
to minimize exposure in eating and
drinking areas, and prohibits certain
practices that may contribute to
beryllium exposure. OSHA believes that
strict compliance with these provisions
would substantially reduce employee
exposure to beryllium.
The proposed standard requires
certain hygiene facilities and procedures
in beryllium work areas, and additional
hygiene facilities and procedures when
airborne exposures exceed the TWA
PEL or STEL. OSHA believes that skin
contact with beryllium can occur even
at low airborne exposures. Skin wipe
sample analysis of dental laboratory
technicians performing grinding
operations demonstrated that beryllium
was present on the hands of workers
even when airborne exposures were
well below the PEL (ERG, 2006).
As discussed in the Health Effects
section of this preamble, section V,
respiratory tract, skin, eye, or mucosal
contact with beryllium can result in
sensitization, which is a necessary first
step toward the development of CBD.
Also, beryllium can contaminate
employees’ clothing, shoes, skin, and
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
hair, prolonging workers’ beryllium
exposure and exposing others such as
family members if proper hygiene
practices are not observed. A study by
the National Jewish Medical and
Research Center of Denver, Colorado,
measured the levels of beryllium on
workers’ skin and vehicle surfaces at a
machining plant where many workers
did not change out of their clothes and
shoes at the end of their shifts. The
study showed elevated surface levels of
beryllium were present on workers’ skin
and in their vehicles, demonstrating that
workers carried residual beryllium on
their hands and shoes when leaving
work (Sanderson et al., 1999). Paragraph
(i) of the proposed standard would
reduce employees’ skin contact with
beryllium, the possibility of accidental
ingestion and inhalation of beryllium,
and the spread of beryllium within and
outside the workplace.
Paragraph (i)(1) would require the
employer to provide readily accessible
washing facilities capable of removing
beryllium from the hands, face, and
neck, and to ensure that employees
working in beryllium work areas use
these facilities when necessary. This
requirement is performance-oriented,
and does not specify any particular
frequency. At a minimum, employees
working in a beryllium work area must
wash their hands, faces, and necks at
the end of the shift to remove any
residual beryllium. Likewise, washing
prior to eating, drinking, smoking,
chewing tobacco or gum, applying
cosmetics, or using the toilet would also
protect employees against beryllium
ingestion and inhalation.
Typically, washing facilities would
consist of one or more sinks, soap or
another cleaning agent, and a means for
employees to dry themselves after
washing. OSHA does not intend to
require the use of any particular soap or
cleaning agent. Employers can provide
whatever washing materials and
equipment they choose, as long as those
materials and equipment are effective in
removing beryllium from the skin and
do not themselves cause skin or eye
problems.
Washing reduces exposure by limiting
the period of time that beryllium is in
contact with the skin, and helps prevent
accidental ingestion. Although
engineering and work practice controls
and protective clothing and equipment
are designed to prevent hazardous skin
and eye contact, OSHA realizes that in
some circumstances exposure will
nevertheless occur. For example, an
employee who wears gloves to protect
against hand contact with beryllium
may inadvertently touch his or her face
with the contaminated glove during the
PO 00000
Frm 00230
Fmt 4701
Sfmt 4702
course of the day. The purpose of
requiring washing facilities is to
mitigate adverse health effects when
skin or eye contact with beryllium
occurs.
Under proposed paragraph (i)(2),
where employees are required to remove
their personal clothing in order to use
personal protective clothing, the
employer must provide designated
change rooms with separate storage
facilities for street and work clothing to
prevent cross contamination. Change
rooms must be in accordance with the
Sanitation standard (29 CFR 1910.141).
OSHA intends the change rooms
requirement to apply to all covered
workplaces where employees must
change their clothing (i.e., take off their
street clothes) to use protective clothing.
In situations where removal of street
clothes is not necessary (e.g., in a
workplace where only gloves are used
as protective clothing), change rooms
are not required. Note that paragraph (h)
of this proposed standard requires
employers to provide ‘‘appropriate’’
personal protective clothing. It is not
appropriate for employees to wear
protective clothing over street clothing
if doing so results in contamination of
the employee’s street clothes. In such
situations, the employer must ensure
that employees wear protective clothing
in lieu of (rather than over) street
clothing, and provide change rooms.
Change rooms must be designed in
accordance with the written exposure
control plan required by paragraph (f)(1)
of this proposed standard, and with the
Sanitation standard (29 CFR 1910.141).
These provisions require change rooms
to be equipped with storage facilities
(e.g., lockers) for protective clothing,
and separate storage facilities for street
clothes, to prevent cross-contamination.
Minimizing contamination of
employees’ personal clothes will also
reduce the likelihood that beryllium
will contaminate employees’ cars and
homes, and other areas outside the
workplace.
Because of the risk of beryllium
sensitization via the skin as described in
section V of this preamble, Health
Effects, OSHA has determined that
employers must provide showers if their
employees could reasonably be
expected to be exposed above the TWA
PEL or STEL (paragraph (i)(3)(i)(A)), and
if employees’ hair or body parts other
than hands, face, and neck could
reasonably be expected to be
contaminated with beryllium (paragraph
(i)(3)(i)(B)). Employers are only required
to provide showers if paragraphs
(i)(3)(i)(A) and (B) both apply. Other
OSHA health standards, such as the
standards for cadmium (29 CFR
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
1910.1027) and lead (29 CFR
1910.1025), also require showers when
exposures exceed the PEL. OSHA’s
standard for coke oven emissions (29
CFR 1910.1029) requires employers to
provide showers and ensure that
employees working in a regulated area
shower at the end of the work shift. The
standard for methylenedianiline (MDA)
(29 CFR 1910.1050) requires employers
to ensure that employees who may
potentially be exposed to MDA above
the action level shower at the end of the
work shift.
Paragraph (i)(3)(ii) requires employers
to ensure that employees use the
showers at the end of the work activity
or shift involving beryllium if the
employees reasonably could have been
exposed above the TWA PEL or STEL,
and if beryllium could reasonably have
contaminated the employees’ body parts
other than hands, face, and neck. This
language is intended to convey that
showers are required for employees who
satisfy both paragraphs (i)(3)(ii)(A) and
(B) when work activities involving
beryllium exposure have been
completed for the day. For example, if
employees perform work activities
involving beryllium exposure for the
first two hours of a work shift, and then
perform activities that do not involve
exposure, they should shower after the
exposure period to avoid increasing the
duration of exposure, potential of
accidental ingestion, and contamination
of the work area from beryllium residue
on their hair and body parts other than
hands, face, and neck. If, however,
employees are performing tasks
involving exposure intermittently
throughout the day, this provision is not
intended to require them to shower
before the completion of the last task
involving exposure.
To minimize the possibility of food
contamination and the likelihood of
additional exposure to beryllium
through inhalation or ingestion,
paragraph (i)(4) would require that
employers provide employees with a
place to eat and drink where beryllium
exposure is below the action level, and
where the surfaces are maintained as
free as practicable of beryllium. Eating
and drinking areas must further comply
with the Sanitation standard (29 CFR
1910.141(g)), which prohibits
consuming food or beverages in a toilet
area or in any area with exposures above
an OSHA PEL.
The requirement to maintain surfaces
as free as practicable of beryllium is
included in other OSHA health
standards such as those for lead in
general industry (29 CFR 1910.1025),
lead in construction (29 CFR 1926.62),
chromium (IV) (29 CFR 1910.1026), and
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
asbestos (29 CFR 1910.1001). As OSHA
explained in a January 13, 2003, letter
of interpretation concerning the
meaning of ‘‘as free as practicable’’ in
OSHA’s Lead in Construction standard
(29 CFR 1926.62), OSHA evaluates
whether a surface is ‘‘as free as
practicable’’ of a contaminant by the
rigor of the employer’s program to keep
surfaces clean (OSHA, 2003). A
sufficient housekeeping program may be
indicated by a routine cleaning schedule
and the use of effective cleaning
methods to minimize the possibility of
exposure from accumulation of
beryllium on surfaces. OSHA’s
compliance directive on Inspection
Procedures for Chromium (IV)
Standards provides additional detail on
how OSHA interprets ‘‘as free as
practicable’’ for enforcement purposes
(OSHA, 2008a). As explained in the
directive, if a wipe sample reveals a
toxic substance on a surface, and the
employer has not taken practicable
measures to keep the surface clean, the
employer has not kept the surface as
free as practicable of the toxic
substance.
The proposed standard does not
require the employer to provide separate
eating and drinking areas to employees
at the worksite. Employees may
consume food or beverages offsite.
However, where the employer chooses
to allow employees to consume food or
beverages at a worksite where beryllium
is present, the employer would be
required to maintain the area in
accordance with paragraph (i)(4) of this
proposed standard.
Paragraph (i)(5)(i) would prohibit
eating, drinking, smoking, chewing
tobacco or gum, or applying cosmetics
in regulated areas. Where exposures can
reasonably be expected at levels above
the proposed TWA PEL or STEL, there
is a greater risk of beryllium
contaminating the food, drink, tobacco,
gum, or cosmetics. Prohibiting these
activities would reduce the potential for
this manner of exposure.
Under paragraph (i)(5)(ii), employers
would also be required to ensure that
employees do not enter eating or
drinking areas wearing contaminated
protective clothing or equipment. This
is to further minimize the likelihood
that employees will be exposed to
beryllium in eating and drinking areas
through inhalation, dermal contact, and
ingestion.
The draft regulatory text presented
during the SBREFA process would have
required handwashing facilities and
certain other hygiene provisions when
exposures exceeded the TWA PEL, or
when there was ‘‘anticipated skin
exposure.’’ Small Entity Representatives
PO 00000
Frm 00231
Fmt 4701
Sfmt 4702
47795
(SERs) from OSHA’s SBREFA panel
expressed concern that the phrase
‘‘anticipated skin exposure’’ was vague
and lacked definition (OSHA, 2007a).
Commenters suggested that this could
require employers at workplaces with
low exposures to make significant
modifications to the workplace, such as
installing showers and change rooms.
OSHA has evaluated the hygiene
triggers and clarified that change rooms
are only required when employees must
remove their street clothes in order to
wear protective clothing. Showers are
only required when exposures exceed
the TWA PEL or STEL, and beryllium
could reasonably contaminate
employees’ hair or body parts other than
hands, face, and neck. OSHA has
removed the phrase ‘‘anticipated skin
exposure’’ from the proposed standard.
OSHA believes these changes address
the commenters’ concerns.
(j) Housekeeping
Paragraph (j) of the proposed standard
requires employers to maintain surfaces
in beryllium work areas as free as
practicable of accumulations of
beryllium; promptly clean spills and
emergency releases; use appropriate
cleaning methods; and properly dispose
of beryllium-contaminated waste,
debris, and materials. These provisions
are especially important because they
minimize additional sources of
exposure that engineering controls are
not designed to address. Good
housekeeping measures are a costeffective way to control employee
exposures by removing settled
beryllium that could otherwise become
re-entrained into the surrounding
atmosphere by physical disturbances or
air currents and could enter an
employee’s breathing zone. Contact with
contaminated surfaces may also result
in dermal exposure to beryllium. As
discussed in this preamble at section V,
Health Effects, researchers have
identified skin exposure to beryllium as
a pathway to sensitization. The
proposed provisions in this paragraph
are consistent with housekeeping
requirements in other OSHA standards
for toxic metals including cadmium (29
CFR 1910.1027), chromium (VI)(29 CFR
1910.1026), and lead (29 CFR
1910.1025).
Paragraph (j)(1) requires the employer
to ensure that all surfaces in beryllium
work areas are maintained as free as
practicable of accumulations of
beryllium, and that spills and
emergency releases are cleaned up
promptly. Employers must follow the
procedures that they have listed under
their exposure control plan required by
paragraph (f)(1) to clean beryllium-
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47796
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
contaminated surfaces, and use the
cleaning methods required by paragraph
(j)(2). Good housekeeping practices are
essential in controlling beryllium
exposure. Beryllium-containing material
deposited on ledges, equipment, floors,
and other surfaces must be promptly
removed to prevent these deposits from
becoming airborne and to minimize the
likelihood of skin contact with
beryllium.
Paragraph (j)(1) directs the employer
to maintain surfaces where beryllium
may accumulate ‘‘as free as practicable’’
of beryllium. In this context, the phrase
‘‘as free as practicable’’ sets forth the
baseline goal in the development of an
employer’s housekeeping program to
keep work areas free from surface
contamination. For a detailed
discussion of the meaning of the phrase
‘‘as free as practicable,’’ see the
discussion of proposed paragraph (i)
earlier in this section of the preamble.
Employers must regularly clean
surfaces in beryllium work areas to
minimize re-entrainment of dust into
the work environment, and to ensure
that accumulations of beryllium do not
become sources of exposure. Although
OSHA does not define ‘‘surface’’ in the
proposed standard, the term would
include surfaces workers come into
contact with such as working surfaces,
floors, and storage facilities, as well as
surfaces workers do not directly contact
such as rafters. Because all surfaces in
beryllium work areas could potentially
accumulate beryllium that workers
could later inhale, touch, or ingest, all
surfaces in beryllium works areas must
be kept as free as practicable of
beryllium.
OSHA has preliminarily decided not
to require employers to measure
beryllium contamination on surfaces,
because the Agency does not have the
necessary data to understand the
relationship between surface level of
beryllium and risk of absorption
through the skin. The use of wipe
samples, however, remains a useful
qualitative tool to detect the presence of
beryllium on surfaces.
As mentioned above, when beryllium
is released into the workplace as a result
of a spill or emergency release,
paragraph (j)(1)(ii) would require the
employer to ensure prompt and proper
cleanup in accordance with the written
exposure control plan required by
paragraph (f)(1) and to use the cleaning
methods required by paragraph (j)(2) of
this proposed standard. Spills or
emergency releases not attended to
promptly are likely to result in
additional employee exposure or skin
contact.
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
Paragraph (j)(2) provides that clean-up
procedures for beryllium-containing
material must minimize employee
exposure. OSHA recognizes that each
work environment is unique, so OSHA
has established performance-oriented
requirements for housekeeping to allow
employers to determine how best to
clean beryllium work areas while
minimizing employee exposure.
Paragraph (j)(2)(i) of the proposed
standard would require that surfaces
contaminated with beryllium be cleaned
by high efficiency particulate air filter
(HEPA) vacuuming or other methods
that minimize the likelihood of
beryllium exposure. OSHA believes
HEPA vacuuming is a highly effective
method of cleaning berylliumcontaminated surfaces. However, other
cleaning methods equally effective at
minimizing the likelihood of beryllium
exposure may be used.
Paragraph (j)(2)(ii) would permit dry
sweeping or brushing in certain cases
only. The employer must demonstrate
that it has tried cleaning with a HEPAfilter vacuum or another method that
minimizes the likelihood of exposure,
and that those methods were not
effective under the particular
circumstances found in the workplace.
OSHA has included this provision in an
attempt to provide employers flexibility
when exposure-minimizing cleaning
methods would not be effective, but
OSHA is not aware of any
circumstances in which dry sweeping or
brushing would be necessary. OSHA
requests comment on whether dry
sweeping or brushing would ever be
necessary, and if so, under what
circumstances (see section I of this
preamble, Issues and Alternatives).
Paragraph (j)(2)(iii) would prohibit the
use of compressed air in cleaning
beryllium-contaminated surfaces unless
it is used in conjunction with a
ventilation system designed to capture
any resulting airborne beryllium. This
provision is also intended to prevent the
dispersal of beryllium into the air.
Proposed paragraph (j)(2)(iv) details
further protections for those employees
who are using certain cleaning methods.
Under this provision, where employees
use dry sweeping, brushing, or
compressed air to clean berylliumcontaminated surfaces, the employer
must provide respiratory protection and
protective clothing and equipment and
ensure that each employee uses this
protection in accordance with
paragraphs (g) and (h) of this standard.
The failure to provide proper and
adequate protection to those employees
performing cleanup activities would
defeat the purpose of the housekeeping
PO 00000
Frm 00232
Fmt 4701
Sfmt 4702
practices required to control beryllium
exposure.
Paragraph (j)(2)(v) would require
employers to ensure that equipment
used to clean beryllium from surfaces is
handled in a manner that minimizes
employee exposure and the reentrainment of beryllium into the
workplace environment. For example,
cleaning and maintenance of HEPAfiltered vacuum equipment must be
done carefully to avoid exposure to
beryllium. Similarly, filter changes and
bag and waste disposal must be
performed in a manner that minimizes
the risk of employee exposure to
airborne beryllium. This provision is
consistent with the requirement in
proposed paragraph (f)(1)(i)(F) for the
written exposure control plan, under
which employers must establish and
implement procedures for minimizing
the migration of beryllium. And of
course, employees handling and
maintaining cleaning equipment must
be protected in accordance with the
other paragraphs of this proposed
standard as well, including the
requirements for respiratory protection
and PPE in paragraphs (g) and (h).
Proposed paragraph (j)(3)(i) would
require that items visibly contaminated
with beryllium and consigned for
disposal be disposed of in sealed,
impermeable bags or other closed
impermeable containers. Proposed
paragraph (j)(3)(ii) requires these
containers to be marked with warning
labels to inform individuals who handle
these items of the potential hazards
associated with beryllium exposure, and
the labels must contain specific
language in accordance with paragraph
(m)(3) of the proposed standard.
Alerting employers and employees who
are involved in disposal to the potential
hazards of beryllium exposure will
better enable them to implement
protective measures.
Proposed paragraph (j)(3)(iii) gives
employers two options for materials
designated for recycling that are visibly
contaminated with beryllium: Sealing
them in impermeable enclosures and
labeling them in accordance with
proposed paragraph (m)(3), or cleaning
them to remove visible particulate.
Proposed paragraph (j)(3)(iii) allows
employers this flexibility to facilitate
the recycling process, and ensures that
employees handling these items for
recycling purposes will not be exposed
to visible particulate if the items are not
sealed in impermeable enclosures and
labeled with warnings about the dangers
of beryllium exposure.
OSHA believes that the concept and
importance of housekeeping programs
in protecting workers from beryllium
E:\FR\FM\07AUP2.SGM
07AUP2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
exposure are generally well understood
and acknowledged by the affected
employer community. Small Entity
Representatives (SERs) on the SBREFA
Advisory Panel indicated that most of
the responding small business entities
engaged in regular and routine
housekeeping activities in areas where
beryllium-containing material has been
used or processed (OSHA, 2008b).
Housekeeping activities included wet
mopping, vacuuming, and sweeping in
and around machinery and other
surfaces. In performing these tasks,
respirator and PPE usage varied. In
some cases, employers provided the
protection, but did not require its usage.
In other instances, no protection was
available to workers performing
housekeeping duties. (OSHA, 2007a).
Those companies that did have
comprehensive housekeeping policies
provided the Agency with a number of
useful practices and examples in
response to the RFI as well as during the
SBREFA process. One company offered
its 8-step housekeeping and control
strategy into the record as a
comprehensive model (Brush Wellman,
2003). Another company presented its
facility housekeeping program
specifying a number of containment
measures such as tack mats, absorbent
carpet, and damp disposable towels to
collect any contamination from
beryllium operations. Certain practices
were expressly prohibited such as dry
sweeping, brushing, wiping, and the use
of compressed air systems to clean
machinery (Honeywell, 2003).
Researchers with the National Jewish
Hospital and Research Center found that
most of the beryllium facilities that they
visited prohibited the use of compressed
air in beryllium areas (NJMRC, 2003).
Several commenters also questioned
the vagueness of the term
‘‘contaminated surfaces’’ (OSHA,
2008b). The proposed standard no
longer uses this term. Rather, proposed
paragraph (j) would require employers
to maintain surfaces in beryllium work
areas ‘‘as free as practicable of
accumulations of beryllium,’’ which is
explained earlier in this section.
(k) Medical Surveillance
Under paragraph (k)(1) of the
proposed standard, OSHA would
require employers to make medical
surveillance available at no cost, and at
a reasonable time and place, for all
employees who have worked in a
regulated area for more than 30 days in
the past 12 months; show signs and
symptoms of CBD; are exposed to
beryllium during an emergency; or were
exposed to beryllium in concentrations
above 0.2 mg/m3 for more than 30 days
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
in a 12-month period for 5 years or
more.
Under paragraph (k)(1)(ii), the
required medical surveillance must be
performed by or under the direction of
a licensed physician. OSHA chose to
require licensed physicians, as opposed
to PLHCPs, to oversee medical
surveillance in this standard, and to
provide certain services required by this
standard (see, e.g., paragraphs (k)(1)(ii)
and (k)(5)). OSHA has in the past
allowed a PLHCP to perform all aspects
of medical surveillance, regardless of
whether the PLHCP is a licensed
physician (see OSHA’s standards
regulating chromium (VI) (29 CFR
1910.1026) and methylene chloride (29
CFR 1910.1052)). OSHA has proposed
that a licensed physician perform some
of the requirements of paragraph (k) in
response to a multi-stakeholder
coalition proposal to this effect. OSHA
believes this requirement strikes an
appropriate balance between ensuring
that a licensed physician supervises the
overall care of the employee, while
giving the employer the flexibility to
retain the services of a variety of
qualified licensed health care
professionals to perform certain other
services required by paragraph (k).
However, OSHA also believes it may be
appropriate to allow a PLHCP who is
not a licensed physician to perform all
of the services required by proposed
paragraph (k) (see also section I of this
preamble, Issues and Alternatives).
OSHA requests comment on this
proposed requirement.
The purpose of medical surveillance
for beryllium is, where reasonably
possible, to identify beryllium-related
adverse health effects so that
appropriate intervention measures can
be taken, and to determine the
employee’s fitness to use personal
protective equipment such as
respirators. The proposed standard is
consistent with Section 6(b)(7) of the
OSH Act (29 U.S.C. 655(b)(7)), which
requires that, where appropriate,
medical surveillance programs be
included in OSHA health standards to
aid in determining whether the health of
employees is adversely affected by
exposure to toxic substances. Other
OSHA health standards, such as
Chromium (VI) (29 CFR 1910.1026),
Methylene Chloride (29 CFR
1910.1052), and Cadmium (29 CFR
1910.1027), also include medical
surveillance requirements.
The proposed standard is intended to
encourage participation in medical
surveillance by requiring at paragraph
(k)(1)(i) that the employer provide
medical examinations without cost to
employees (also required by section
PO 00000
Frm 00233
Fmt 4701
Sfmt 4702
47797
6(b)(7) of the Act (29 U.S.C. 655(b)(7)),
and at a reasonable time and place. If
participation requires travel away from
the worksite, the employer would be
required to bear all travel costs.
Employees must be paid for time away
from work spent attending medical
examinations, including travel time.
Paragraph (k)(1)(i)(A) proposes to
require employers to make medical
surveillance available to all employees
who worked in a regulated area for more
than 30 days in the past 12 months. This
requirement attempts to ensure that
those employees who are at most risk
for developing beryllium-related
adverse health effects have access to
medical services so that such adverse
health effects can be detected early.
In addition, paragraph (k)(1)(i)(B)
would require that employers provide
medical surveillance to any employee
who shows signs or symptoms of CBD.
It is expected that employees
experiencing signs and symptoms of
exposure will report them to their
employers. If an employer becomes
aware that an employee shows signs and
symptoms of CBD either through
employee self-reporting or from
observation of the employee, the
employer is required to provide medical
surveillance to the employee. However,
this provision is not intended to force
employers to survey their workforce,
make diagnoses, or determine causality.
Proposed paragraph (k)(1)(i)(B)
recognizes that some employees may
exhibit signs and symptoms of the
adverse health effects associated with
beryllium exposure even when not
exposed above the TWA PEL or the
STEL for more than 30 days per year.
OSHA’s preliminary risk assessment
concludes that there is significant risk of
adverse health effects from beryllium
exposure below the proposed PEL (see
this preamble at section VI, Preliminary
Risk Assessment). In addition,
beryllium sensitization and CBD could
develop in employees who are
especially sensitive to beryllium, may
have been unknowingly exposed, or
may have been exposed to greater
amounts than the exposure assessment
suggests.
Self-reporting by employees will be
supported by the training required
under proposed paragraph (m)(4)(ii) on
the health hazards of beryllium
exposure and the signs and symptoms of
CBD, and the medical surveillance and
medical removal requirements of the
proposed standard in paragraphs (k) and
(l). Employees have a right under
section 11(c) of the OSH Act to report
suspected work-related health effects to
their employers without retaliation. Any
employer program or practice that
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47798
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
discourages employees from reporting
or penalizes workers who report workrelated health effects would violate
section 11(c). See Memorandum from
Richard E. Fairfax to Regional
Administrators (March 12, 2012),
available at https://www.osha.gov/as/
opa/whistleblowermemo.html.
As discussed in this preamble at
section V, Health Effects, CBD causes
fatigue, weakness, difficulty breathing,
and a persistent dry cough, among other
symptoms. In more advanced cases,
CBD may also result in anorexia and
weight loss, as well as right side heart
enlargement (cor pulmonale) and heart
disease. By requiring covered employers
to make a medical exam available when
an employee exhibits these types of
symptoms, the proposed standard
would protect all employees who may
have developed CBD, whether or not
these employees have been exposed to
beryllium in an emergency or for more
than 30 days in a regulated area.
Paragraph (k)(1)(i)(C) would require
that appropriate surveillance also be
made available for employees exposed
to beryllium during an emergency,
regardless of the airborne concentrations
of beryllium to which these employees
are routinely exposed in the workplace.
Emergency situations involve
uncontrolled releases of airborne
beryllium, and the significant exposures
that can occur in these situations justify
a requirement for medical surveillance.
The proposed requirement for medical
examinations after exposure in an
emergency is consistent with several
other OSHA health standards, including
the standards for chromium (VI) (29
CFR 1910.1026), methylenedianiline (29
CFR 1910.1050), butadiene (29 CFR
1910.1051), and methylene chloride (29
CFR 1910.1052).
Paragraph (k)(1)(i)(D) would require
medical surveillance to be provided to
employees who have been exposed to
beryllium above 0.2 mg/m3 for more than
30 days in a 12-month period for 5 years
or more. The five-years of exposure
would not need to be consecutive to
satisfy this provision. OSHA included
this provision to ensure that these
employees receive the low-dose helical
tomography (CT scan, low-dose
computed tomography (LDCT), or CT
screening) required by paragraph
(k)(3)(ii)(F) of the proposed standard,
even if these employees have not been
exposed above 0.2 mg/m3 in the previous
12-month period, are not exhibiting
signs and symptoms of CBD, and have
not been exposed in an emergency. The
CT scan is a method of detecting
tumors, and is commonly used to
diagnose lung cancer.
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
Paragraph (k)(2) of the proposed
standard specifies how frequently
medical examinations are to be offered
to those employees covered by the
medical surveillance program. Under
paragraph (k)(2)(i)(A), employers would
be required to provide each employee
with a medical examination within 30
days after the employee has worked in
a regulated area for more than 30 days
in the past 12 months, unless the
employee has received a medical
examination provided in accordance
with this standard within the previous
12 months. Paragraph (k)(2)(i)(B)
requires employers to provide medical
examinations to employees exposed to
beryllium during an emergency, and to
those who are showing signs or
symptoms of CBD, within 30 days of the
employer becoming aware that these
employees meet the criteria of
paragraph (k)(1)(i)(B) or (C). Paragraph
(k)(2)(i)(B) requires an examination
without regard to whether these
employees received an exam in the
previous 12 months.
Paragraph (k)(2)(ii) of the proposed
standard requires that employers
provide an examination annually (after
the first examination is made available)
to employees who continue to meet the
criteria of paragraph (k)(1)(i)(A) or (B).
This includes employees who have
worked in a regulated area for more than
30 days in the past 12 months and
employees who continue to exhibit
signs and symptoms of CBD. The
requirement for annual examinations in
paragraph (k)(2)(ii) means that an
examination must be made available at
least once every 12 months.
Employees exposed in an emergency,
who are covered by paragraph
(k)(1)(i)(C), are not included in the
annual examination requirement unless
they also meet the criteria of paragraph
(k)(1)(i)(A) or (B), because OSHA
expects that most effects of exposure
will be detected during the medical
examination provided within 30 days of
the emergency, pursuant to paragraph
(k)(2)(i)(A). An exception to this is
beryllium sensitization, which OSHA
believes may result from exposure in an
emergency, but may not be detected
within 30 days of the emergency. Thus,
proposed paragraph (k)(3)(ii)(E) requires
biennial testing for beryllium
sensitization for employees exposed in
emergencies. This paragraph is
discussed in more detail later in this
section of the preamble. Employees
covered by paragraph (k)(1)(i)(D) are
also not required to receive exams
annually unless they also meet the
criteria of paragraph (k)(1)(i)(A) or (B).
OSHA believes that the annual
provision of medical surveillance, and
PO 00000
Frm 00234
Fmt 4701
Sfmt 4702
the biennial provision of beryllium
sensitization testing and CT scans for
certain employees, are appropriate
frequencies for screening employees for
beryllium-related diseases. The main
goals of medical surveillance for
employees are to detect beryllium
sensitization before employees develop
CBD, and to detect CBD, lung cancer,
and other adverse health effects at an
early stage. The proposed requirement
for annual examinations is consistent
with other OSHA health standards,
including those for chromium (VI) (29
CFR 1910.1026) and formaldehyde (29
CFR 1910.1048). Based on the Agency’s
experience, OSHA believes that annual
surveillance and biennial tests for
beryllium sensitization and CT scans
would strike a reasonable balance
between the need to diagnose health
effects at an early stage, while being
sufficiently affordable for employers.
Finally, proposed paragraph (k)(2)(iii)
would require the employer to offer a
medical examination at the termination
of employment, if the departing
employee meets the criteria of
paragraph (k)(1)(i)(A), (B), or (C) at the
time the employee’s employment is
terminated. This would apply to
employees who worked in a regulated
area for more than 30 days during the
previous 12 months, employees
showing signs or symptoms of CBD, and
employees who were exposed to
beryllium in an emergency at any time
during their employment. This
proposed requirement is waived if the
employer provided the departing
employee with an exam during the six
months prior to the date of termination.
The provision of an exam at termination
is intended to ensure that no employee
terminates employment while carrying a
detectable, but undiagnosed, health
condition related to beryllium exposure.
Proposed paragraph (k)(3) details the
contents of the examination. Paragraph
(k)(3)(i) would require the employer to
ensure that the PLHCP advises the
employee of the risks and benefits of
participating in the medical surveillance
program and the employee’s right to opt
out of any or all parts of the medical
examination. Benefits of participating in
medical surveillance may include early
detection of adverse health effects, and
aiding intervention efforts to prevent or
treat disease. However, there may also
be risks associated with medical testing
for some conditions, which the PLHCP
should communicate to the employee.
Paragraph (k)(3)(ii) then specifies that
the medical examination must consist of
a medical and work history; a physical
examination with emphasis on the
respiratory tract, skin breaks, and
wounds; and pulmonary function tests.
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
Special emphasis is placed on the
portions of the medical and work
history focusing on beryllium exposure,
health effects associated with beryllium
exposure, and smoking.
The physical exam focuses on organs
and systems known to be susceptible to
beryllium toxicity. For example,
proposed paragraph (k)(3)(ii)(C) focuses
on the skin, and paragraph (k)(3)(ii)(D)
focuses on the lungs. The information
obtained will allow the PLHCP and
supervising physician to assess the
employee’s health status, identify
adverse health effects related to
beryllium exposure, and determine if
limitations should be placed on the
employee’s exposure to beryllium. The
proposed standard does not include a
comprehensive list of specific tests that
must be part of the medical
examination. OSHA does not believe
that any particular test—beyond those
listed in paragraph (k)(3)(ii)(D)–(F)—is
necessarily applicable to all employees
covered by the medical surveillance
requirements. The Agency proposes to
give the PLCHP the flexibility to
determine any other appropriate tests to
be selected for a given employee, as
provided in paragraph (k)(3)(ii)(G).
Under paragraph (k)(3)(ii)(E), an
employee must be offered a BeLPT (or
a more reliable and accurate test for
identifying beryllium sensitization) at
the employee’s first examination, and
then every two years after the first
examination unless the employee is
confirmed positive. The requirement to
test for beryllium sensitization applies
whether or not an employee is
otherwise entitled to a medical
examination in a given year. For
example, for an employee exposed
during an emergency who would
normally be entitled to 1 exam within
30 days of the emergency but not annual
exams thereafter, the employer must
still provide this employee with a test
for beryllium sensitization every 2
years. This biennial requirement applies
until the employee is confirmed
positive. OSHA believes that the
biennial testing required under
paragraph (k)(3)(ii)(E) is adequate to
monitor employees that have the
potential to develop sensitization while
being sufficiently affordable for
employers.
OSHA considers the BeLPT to be a
reliable medical surveillance tool for the
purposes of a medical surveillance
program. However, OSHA considers two
abnormal test results necessary to
confirm a finding of beryllium
sensitization when using the BeLPT
(‘‘confirmed positive’’). Therefore, a
BeLPT must also be offered within one
month of an employee receiving a single
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
abnormal result. However, this
requirement is waived if a more reliable
and accurate test becomes available that
could confirm beryllium sensitization
based on one test result. OSHA requests
comment on how to determine whether
a test is more reliable and accurate than
the BeLPT for identifying beryllium
sensitization. OSHA has included a
non-mandatory appendix that describes
the BeLPT, discusses several studies of
the BeLPT’s validity and reliability, and
states criteria OSHA believes are
important to judge a new test’s validity
and reliability (Appendix A).
Under paragraph (k)(3)(ii)(F), a CT
scan must be offered to employees who
have been exposed to beryllium at
concentrations above 0.2 mg/m3 for more
than 30 days in a 12-month period for
5 years or more. The five years of
exposure do not need to be consecutive.
As with the requirement for
sensitization testing explained above,
the CT scan must be offered to an
employee who meets the criteria of
paragraph (k)(1)(i)(D) without regard to
whether the employee is otherwise
required to receive a medical exam in a
given year. The CT scan must be offered
to employees who meet the criteria of
paragraph (k)(1)(i)(D) for the first time
beginning on the start-up date of this
standard, or 15 years after the
employee’s first exposure to beryllium
above 0.2 mg/m3 for more than 30 days
in a 12-month period, whichever is
later. OSHA proposed the requirement
for CT screening based in part on the
Agency’s consideration of the draft
recommended standard submitted by
industry and union stakeholders
(Materion and USW, 2012).
The CT scan requirement may be
triggered by exposures that occurred
before or after the effective date of this
standard, or a combination of exposures
before and after the effective date. This
requirement may also be triggered by
exposures that occurred when the
employee was working for a different
employer. An employer is required to
offer a CT scan to employees who meet
the criteria of paragraph (k)(1)(i)(D) if
the employer has exposure records
demonstrating that the employee meets
the criteria, regardless of whether the
exposure records were generated by the
employer or given to the employer by
the employee or a third party.
In a recent systematic review of CT
screening trials for lung cancer, Bach et
al. found a significant (20 percent)
mortality reduction in the population
studied (26,309 men and women
between ages 55 and 74, with at least 30
pack-years of smoking history) (National
Lung Screening Trial, 2011). The
benefits of screening for other
PO 00000
Frm 00235
Fmt 4701
Sfmt 4702
47799
populations are less clear at this time.
CT screening was not shown to offer
significant reduction in mortality in two
other, smaller trial populations with at
least 20 pack-years of smoking history
(DANTE, 2009; DLCST, 2012). In
addition, there is yet to be agreement on
how to properly compute and set the
radiation dose for LDCT. Clarification
on such procedural issues will help
inform analyses of LDCT-associated
radiation exposure and its risks as part
of a screening protocol for employees
exposed to occupational carcinogens
(Christensen, 2014).
OSHA seeks comment on the
proposed requirement and whether it is
likely to benefit the beryllium-exposed
employee population. As appropriate,
please submit information, studies and
data to support your comments.
OSHA notes that another form of CT
scanning, High Resolution Computed
Tomography (HRCT), is available and
may be useful in screening for CBD. In
patients with CBD, HRCT scanning of
the chest is more sensitive than plain
chest radiography in identifying
abnormalities (NAS, 2008). However,
HRCT scans showing no signs
consistent with CBD have been reported
in 25 percent of patients with biopsyproven noncaseating granulomas
(Newman et al., 1994). OSHA seeks
comment on whether HRCT should be
included in the list of diagnostic
procedures a CBD Diagnostic Center
should be able to provide (see this
Preamble at Section XVIII, paragraph
(b), Definitions).
Other types of tests and examinations
not mentioned in this standard,
including X-ray, arterial blood gas,
diffusing capacity, and oxygen
desaturation during exercise, may also
be useful in evaluating the effects of
beryllium exposure. In addition,
medical examinations that include more
invasive testing, such as bronchoscopy,
alveolar lavage, and transbronchial
biopsy, have been demonstrated to
provide additional valuable medical
information. OSHA believes that the
PLHCP is in the best position to decide
which medical tests are necessary for
each individual examined. Where
specific tests are deemed appropriate by
the PLHCP, the proposed standard, at
paragraph (k)(3)(ii)(G), would require
that they be provided.
Proposed paragraph (k)(4) details
which information must be provided to
the PHLCP. Specifically, the proposed
standard would require the employer to
ensure the examining PLHCP has a copy
of the standard and all the appendices,
and to provide to the examining PLHCP
the following information, if known or
reasonably available to the employer: a
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47800
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
description of the employee’s former
and current duties as they relate to
beryllium exposure ((k)(4)(i)); the
employee’s former and current exposure
levels ((k)(4)(ii)); a description of any
personal protective clothing and
equipment, including respirators, used
or to be used by the employee,
including when and for how long the
employee has used that clothing and
equipment ((k)(4)(iii)); and information
the employer has obtained from
previous medical examinations
provided to the employee, that is
currently within the employer’s control
((k)(4)(iv)). OSHA believes making this
information available to the PLHCP will
aid in the PLHCP’s evaluation of the
employee’s health as it relates to the
employee’s assigned duties and fitness
to use personal protective equipment,
including respirators, when necessary.
In order to protect the employee’s
privacy, employee medical information
may only be provided to the PLHCP by
the employer after the employee has
signed a medical release.
Providing the PLHCP with exposure
monitoring results, as required under
paragraph (k)(4)(ii), will assist the
physician completing the written
medical opinion in determining if an
employee is likely to be at risk of
adverse effects from beryllium exposure
at work. A well-documented exposure
history would also assist the PLCHP in
determining if a condition (e.g.,
dermatitis, decrease in diffusing
capacity, or gradual changes in arterial
blood gases) may be related to beryllium
exposure. See this preamble at section
V, Health Effects, for a more detailed
discussion of the health effects
associated with beryllium exposure.
Proposed paragraph (k)(5) would
require employers to obtain a written
medical opinion from the licensed
physician who performed or directed
the exam within 30 days of the
examination. The purpose of requiring
the physician to supply a written
opinion to the employer is to provide
the employer with a documented
medical basis for the employee’s
eligibility for medical removal, and to
assess the employee’s ability to use
protective clothing and equipment,
including respirators. In addition,
provision of the written opinion to the
employer may alert the employer to
sources of beryllium exposure or
problems with exposure controls at its
worksite. OSHA believes the 30-day
period will allow the licensed physician
sufficient time to receive and consider
the results of any tests included in the
examination, and allow the employer to
take any necessary protective measures
in a timely manner. The proposed
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
requirement that the opinion be in
written form is intended to ensure that
employers and employees have the
benefit of the same information and that
no information gets lost in oral
communications. OSHA requests
comment on the relative merits of the
proposed standard’s requirement that
employers obtain the PLHCP’s written
opinion or an alternative that would
provide employees with greater
discretion over the information that goes
to employers (see this preamble at
Section 1, Issues and Alternatives, Issue
#26).
Paragraphs (k)(5)(i)(A)–(C) of the
proposed standard specify what must be
included in the licensed physician’s
written opinion. The first item for
inclusion is the licensed physician’s
opinion as to whether the employee has
any detected medical condition that
would place the employee at increased
risk of CBD from further exposure. The
standard also proposes that the medical
opinion include any recommended
limitations on the employee’s exposure,
including recommended use of, and
limitations on the use of, personal
protective clothing or equipment such
as respirators.
The licensed physician would also
need to state in the written opinion that
the PLHCP has explained the results of
the medical examination to the
employee, including the results of any
tests conducted, any medical conditions
related to exposure that require further
evaluation or treatment, and any special
provisions for use of protective clothing
or equipment, including respirators.
Under proposed paragraph (k)(5)(i)(C),
OSHA anticipates that the employee
will be informed directly by the PLCHP
of all results of his or her medical
examination, including conditions of
non-occupational origin. Direct
consultation between the PLHCP and
employee ensures that the employee
will receive all information about the
employee’s health status, including nonoccupationally related conditions that
are not communicated to the employer.
Proposed paragraph (k)(5)(ii) would
require the employer to ensure that
neither the licensed physician nor any
other PLHCP reveals to the employer
findings or diagnoses which are
unrelated to beryllium exposure. OSHA
has proposed this provision to reassure
employees participating in medical
surveillance that they will not be
penalized or embarrassed as a result of
the employer obtaining information
about them not directly pertinent to
beryllium exposure. Paragraph (k)(5)(iii)
would also require the employer to
provide a copy of the licensed
physician’s written opinion to the
PO 00000
Frm 00236
Fmt 4701
Sfmt 4702
employee within two weeks after
receiving it to ensure that the employee
has been informed of the results of the
examination in a timely manner.
Proposed paragraph (k)(6)(i) provides
for the referral to a CBD diagnostic
center of any employee who is
confirmed positive for beryllium
sensitization. Within 30 days after the
employer learns of the confirmed
positive result, the employer must
ensure that a licensed physician
designated by the employer consults
with the employee about referral to a
CBD diagnostic center for further
testing, to determine whether a
sensitized employee has CBD. If the
employee chooses to obtain a clinical
evaluation at a CBD diagnostic center,
the diagnostic center must be agreed
upon by the employer and the
employee. The employer and employee
must make a good faith effort to agree
on a CBD diagnostic center that is
acceptable to them both. Under
paragraph (k)(6)(ii), the employer is
responsible for all costs associated with
testing performed at the center. The
term CBD diagnostic center is defined in
proposed paragraph (b), and discussed
in this section of the preamble regarding
proposed paragraph (b).
Finally, under paragraph (k)(7), the
employer would be required to convey
the results of the medical tests to OSHA
for evaluation and analysis at the
request of the Assistant Secretary. The
results of the tests may be used to
evaluate the nature, variability,
reliability, and relevance of the
beryllium sensitization test results, to
evaluate the effectiveness of the
beryllium standard in reducing
beryllium-related occupational disease,
or for other scientific purposes. Results
conveyed to OSHA must first be
stripped of employees’ names, social
security numbers, and other identifying
information.
Employees of beryllium vendors who
qualify for benefits under the Energy
Employees Occupational Illness
Compensation Program Act (EEOICPA)
(42 U.S.C. 7384–7385s–15) and its
implementing regulations (20 CFR part
30) may also qualify for medical
surveillance benefits under this
proposed standard. Covered medical
surveillance provided to eligible
persons under the EEOICPA program is
paid for by the federal government.
Employees covered by both the
EEOICPA program and this proposed
standard would not be required to
attend separate medical examinations
for the separate programs. Rather, these
dual-coverage employees could attend
consolidated medical examinations at
which they would receive the services
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
required under both programs. These
examinations would be paid for by the
federal government under the EEOICPA
program to the extent that the services
provided are covered under the
EEOICPA program. If this proposed
standard requires services that are not
covered by the EEOICPA program, the
employer would be required to pay for
these additional services.
As stated in the SBREFA Report, the
medical surveillance section ‘‘was the
most controversial part of the draft
standard for most SERs and received the
most comment’’ (OSHA, 2008b). SERs
generally were concerned about the cost
of medical surveillance, commenting
that surveillance is unnecessary for
employees with low beryllium
exposures (OSHA, 2008b). The
requirement of dermal triggers for
medical surveillance was confusing for
SERs and led to a number of comments
(OSHA, 2008b). One SER suggested that
the medical surveillance requirements
should be performance-based, which
would allow employers to determine
which tests were appropriate for their
employees (OSHA, 2008b). Use of the
BeLPT was also controversial, given
SERs’ concerns about its accuracy and
costs (OSHA, 2008b). OSHA requests
comment on the proposed requirements
for beryllium sensitization testing,
including issues raised in this preamble
at section I, Issues and Alternatives, and
on the regulatory alternatives presented
later in this section.
In response to these concerns, OSHA
notes several changes made to the
regulatory text since the SBREFA panel
was convened. In the proposed
standard, medical surveillance is
limited to those employees who have
worked in a regulated area for more than
30 days per year in the previous 12month period, employees showing signs
and symptoms of CBD, employees
exposed during emergencies, and
employees who have been exposed
above 0.2 mg/m3 for more than 30 days
in a 12-month period for five years or
more. Requiring medical surveillance
for employees with exposures in a
regulated area (i.e., with exposures
above the TWA PEL or STEL for more
than 30 days in a year) should alleviate
some SERs’ concerns that surveillance is
not necessary for employees with low
exposures. Employees with exposures at
or above the action level but below the
PEL are no longer included in medical
surveillance, unless they show signs or
symptoms of CBD or were exposed
during an emergency. Since the
SBREFA panel was held, OSHA has also
removed the requirement for medical
surveillance based only on dermal
exposure to beryllium, eliminating the
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
confusion caused by the dermal
exposure provision.
These changes will result in fewer
employees being eligible for medical
surveillance than were covered in the
draft standard presented to the SBREFA
panel. The changes will thereby reduce
costs to employers. However, OSHA has
preliminarily determined that a
significant risk of beryllium
sensitization, CBD, and lung cancer
exist at exposure levels below the
proposed PEL, and there is evidence
that beryllium sensitization can occur
from short-term exposures (see this
preamble at Section V, Health Effects,
and Section VIII, Significance of Risk).
The Agency therefore anticipates that
some employees will develop adverse
health effects and may not receive the
benefits of early intervention in the
disease process because they are not
eligible for medical surveillance (see
this preamble at Section V, Health
Effects). Thus, OSHA is considering
three regulatory alternatives that would
expand eligibility for medical
surveillance to a broader group of
employees than those eligible in the
proposed standard. Under Regulatory
Alternative #14, medical surveillance
would be available to employees who
are exposed to beryllium above the
proposed PEL, including employees
exposed for fewer than 30 days per year.
Regulatory Alternative #15 would
expand eligibility for medical
surveillance to employees who are
exposed to beryllium above the
proposed action level, including
employees exposed for fewer than 30
days per year. Regulatory Alternative
#21 would extend eligibility for medical
surveillance as set forth in proposed
paragraph (k) to all employees in
shipyards, construction, and general
industry who meet the criteria of
proposed paragraph (k)(1). However, all
other provisions of the standard would
be in effect only for employers and
employees that fall within the scope of
the proposed rule. Most of these
alternatives would provide surveillance
to fewer employees (and cost less to
employers) than the draft regulation
presented to the SBREFA Panel, but
would provide more surveillance (and
cost more to employers) than the
medical surveillance requirements in
the current proposal.
The SER who suggested allowing
performance-based surveillance stated
that this would permit employers ‘‘to
design and determine what tests were
appropriate’’ (OSHA, 2008b). OSHA is
considering two regulatory alternatives
that would provide greater flexibility in
the program of tests provided as part of
an employer’s medical surveillance
PO 00000
Frm 00237
Fmt 4701
Sfmt 4702
47801
program. Under Regulatory Alternative
#16, employers would not be required to
offer employees testing for beryllium
sensitization. Regulatory Alternative
#18 would eliminate the CT scan
requirement from the proposed rule.
OSHA is evaluating these alternatives
and has also included some
performance-based elements in its
medical surveillance requirements (e.g.,
(k)(3)(G)). However, the Agency has
preliminarily determined that the
testing required by the proposed
standard is necessary and appropriate
for the employees who must be offered
medical surveillance. OSHA believes it
is important to detect cases of
sensitization, CBD and other berylliumrelated health effects early so that
employees can quickly be removed from
exposure, be provided appropriate
protective clothing and equipment,
benefit from medical removal, and
receive treatment, as applicable. As
discussed in this preamble at section
VIII, Significance of Risk, early
intervention in the disease process may
slow or prevent progression to more
advanced disease. Further, this
surveillance is particularly necessary in
a standard such as this one, where
OSHA has preliminarily found a
significant risk of material impairment
of health at the proposed PEL. OSHA
requests comments on the proposed
requirements for sensitization testing,
CT scans, and medical examinations,
and on Regulatory Alternatives #14 and
#15 discussed above.
Finally, at least one SER commented
that providing annual BeLPTs would
result in high costs with no added
benefit to employees (OSHA, 2008b). As
discussed previously, OSHA would also
allow substitution of a more accurate
and reliable test for the BeLPT should
such a test become available. When this
occurs, employers can choose to use
whichever test is less expensive. OSHA
has also, in its proposed standard,
reduced the frequency of required
BeLPTs (or other test substituted for the
BeLPT) to every two years, with followup tests for employees who receive
abnormal test results. This change
would significantly reduce the cost of
testing, but would also delay early
detection of beryllium-related health
effects and intervention to prevent
disease progression among employees in
medical surveillance. In addition, the
longer the time interval between when
an employee becomes sensitized and
when the employee’s case is identified
in the surveillance program, the more
difficult it will be to identify and
address the exposure conditions that led
to the employee’s sensitization.
Therefore, lengthening the time between
E:\FR\FM\07AUP2.SGM
07AUP2
47802
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
sensitization tests will diminish the
usefulness of the surveillance
information in identifying and
correcting problem areas and reducing
risks to other employees.
The benefits of regular medical
surveillance for beryllium-related health
effects and the costs of surveillance to
employers are important and complex
factors in the proposed standard, and
OSHA requests feedback from the
regulated and medical communities to
help determine the most appropriate
schedule for periodic testing. In
particular, the Agency requests
comments on several alternatives to the
proposed frequency of sensitization
testing, CT scans, and general medical
examinations. Regulatory alternative
#17 would require employers to offer
annual testing for beryllium
sensitization to eligible employees, as in
the draft proposal presented to the
SBREFA panel. Regulatory Alternative
#19 would similarly increase the
frequency of periodic CT scans from
biennial to annual scans. Finally, under
Regulatory Alternative #20, all periodic
components of the medical surveillance
exams would be available biennially to
eligible employees. Instead of requiring
employers to offer eligible employees a
medical examination every year,
employers would be required to offer
eligible employees a medical
examination every other year. The
frequency of testing for beryllium
sensitization and CT scans would also
be biennial for eligible employees, as in
the proposed standard. For all
comments on the medical surveillance
provisions of the proposed standard,
please provide an explanation of your
position, and supporting data or studies
as appropriate.
(l) Medical Removal Protection
Paragraph (l) of the proposed rule
contains the provisions related to
medical removal protection (MRP).
Proposed paragraph (l)(1) explains that
employees in jobs with exposure at or
above the action level become eligible
for medical removal when they are
diagnosed with CBD or confirmed
positive for beryllium sensitization.
These medical findings may be made
pursuant to the surveillance
requirements of proposed paragraph (k).
The terms ‘‘CBD’’ and ‘‘confirmed
positive’’ are defined in proposed
paragraph (b).
Proposed paragraph (l)(1) is in
keeping with OSHA’s provisions for
MRP in past standards, where the
Agency has specified objective removal
criteria. For example, the Lead standard
(29 CFR 1910.1025) requires that an
employee be removed from exposure at
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
or above the action level when an
employee’s blood lead concentration
exceeds a certain value. Similarly, the
Cadmium standard (29 CFR 1910.1027)
includes objective biological monitoring
criteria that trigger removal.
Paragraph (l)(2) lays out the options
for employees who are eligible for MRP.
Specifically, paragraph (l)(2)(i) would
permit eligible employees to choose
removal as described under proposed
paragraph (l)(3), and proposed
paragraph (l)(2)(ii) would permit them
to remain in a job with exposure at or
above the action level and wear a
respirator in accordance with the
Respiratory Protection standard (29 CFR
1910.134). Eligible employees must
choose one of these two options. OSHA
requests comment on whether the
standard should establish a timeframe
in which eligible employees must
choose one of the options in paragraph
(l)(3) (such as within 7 days, 14 days, or
30 days), and whether the standard
should require the employee to wear a
respirator if the employee fails to choose
one of the options within the specified
timeframe.
Proposed paragraph (l)(3) describes
eligible employees’ removal options.
When an employee chooses removal,
the employer is required to remove the
employee to comparable work if such
work is available. Comparable work is a
position for which the employee is
already qualified or can be trained
within one month, in an environment
where beryllium exposure is below the
action level. Comparable work would
not require the employee to use a
respirator, although the employee may
choose to use a respirator to minimize
beryllium exposure. An employer is not
required to place an employee on paid
leave if the employee refuses
comparable work offered under
paragraph (l)(3)(i). An employee must be
transferred to comparable work, trained
for comparable work, or placed on paid
leave immediately after choosing
removal.
If comparable work is not
immediately available, paragraph
(l)(3)(ii) would require the employer to
place the employee on paid leave for six
months or until comparable work
becomes available, whichever occurs
first. If comparable work becomes
available before the end of the six
month paid leave period, the employer
is obligated to offer the open position to
the employee. Should the employee
decline, the employer has no further
obligation to continue the paid leave.
Proposed paragraph (l)(3)(iii) would
continue a removed employee’s rights
and benefits for six months, regardless
of whether the employee is removed to
PO 00000
Frm 00238
Fmt 4701
Sfmt 4702
comparable work or placed on paid
leave. The six month period would
begin when the employee is removed,
which means either the day the
employer transfers the employee to
comparable work, or the day the
employer places the employee on paid
leave. For this period, the provision
would require the employer to maintain
the employee’s base earnings, seniority,
and other rights and benefits of
employment as they existed at the time
of removal. This provision is typical of
medical removal provisions in other
OSHA standards, such as Cadmium (29
CFR 1910.1027) and Benzene (29 CFR
1910.1028).
Paragraph (l)(4) would reduce an
employer’s obligation to provide MRP
benefits to a removed employee if, and
to the extent that, the employee receives
compensation from a publicly or
employer-funded compensation
program for earnings lost during the
removal period, or receives income from
another employer made possible by
virtue of the employee’s removal.
Benefits received under the Energy
Employees Occupational Illness
Compensation Program Act (EEOICPA)
do not constitute wage replacement, and
therefore would not offset the
employee’s medical removal benefits
under this proposed standard.
By protecting an employee’s rights
and benefits during the first six months
of removal, and by reducing in certain
circumstances an employer’s obligation
to compensate employees for earnings
lost, OSHA emphasizes that MRP is not
intended to serve as a workers’
compensation system. The primary
reason MRP has been included in this
standard is to provide eligible
employees a six-month period to adjust
to the comparable work arrangement or
seek alternative employment, without
any further exposure at or above the
action level.
The prospect of a medical removal
provision concerned some SERS. Some
stated that there is no evidence that
removing sensitized employees will
change their health outcomes (OSHA
2008b). Others commented that they did
not believe medical removal was
appropriate because neither
sensitization nor CBD is reversible
(OSHA 2008b).
OSHA believes that medical removal
is an important means of protecting
employees who have become sensitized
or developed CBD, and is an appropriate
means to enable them to avoid further
exposure. The scientific information on
effects of exposure cessation is limited
at this time, but the available evidence
suggests that removal from exposure can
be beneficial for individuals who are
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
sensitized or have early-stage CBD (see
this preamble at section VIII,
Significance of Risk). As discussed in
the Health Effects section of this
preamble, section V, only those who are
sensitized can develop CBD. As CBD
progresses, symptoms become serious
and debilitating. Steroid treatment is
less effective at later stages, once
fibrosis has developed (see this
preamble at section VIII, Significance of
Risk). Given the progressive nature of
the disease, OSHA believes it is
reasonable to conclude that removal
from exposure to beryllium will benefit
sensitized employees and those with
CBD.
There is widespread support for
removal of individuals with
sensitization or CBD from further
beryllium exposure in the medical
community and among other experts in
beryllium disease prevention and
treatment. Physicians at National
Jewish, one of the main CBD research
and treatment sites in the US, ‘‘consider
it important and prudent for individuals
with beryllium sensitization and CBD to
minimize their exposure to airborne
beryllium,’’ and ‘‘recommend
individuals diagnosed with beryllium
sensitization and CBD who continue to
work in a beryllium industry to have
exposure of no more than 0.01
micrograms per cubic meter of
beryllium as an 8-hour time-weighted
average’’ (National Jewish site on
Chronic Beryllium Disease: Work
Environment Management, accessed
May 2013). The Department of Energy
included MRP in its Chronic Beryllium
Disease Prevention Program (10 CFR
part 850), stating that without MRP,
employers would be ‘‘free to maintain
high-risk workers in their current jobs,
which would not be sufficiently
protective of their health’’ (64 FR 68894,
December 8, 1999). MRP is included in
the recommended beryllium standard
that beryllium industry and union
stakeholders submitted to OSHA in
2012 (Materion and United
Steelworkers, 2012).
OSHA believes that MRP also
improves the medical surveillance
program described in proposed
paragraph (k). Paragraph (k)(1)(i)(B)
requires medical examinations for
employees showing signs or symptoms
of CBD. The success of that program
will depend in part on employees’
willingness to report their symptoms,
submit to examinations, respond to
questions, and comply with
instructions. Guaranteeing paid leave or
comparable work can help allay an
employee’s fear that a CBD diagnosis
will negatively affect earnings or career
prospects. MRP encourages employees
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
to report their symptoms and seek
treatment, as OSHA has previously
recognized when including medical
removal in regulations governing the
exposure to lead (43 FR 52973,
November 14, 1978), benzene (52 FR
34557, September 11, 1987), and
cadmium (57 FR 42367–68, September
14, 1992). This reasoning was also cited
by the Department of Energy in support
of the medical removal provisions of its
Chronic Beryllium Disease Prevention
Program, stating that the availability of
medical removal benefits encourages
worker participation and cooperation in
medical surveillance (64 FR 68893,
December 8, 1999).
MRP also provides an incentive for
employers to keep employee exposures
low. The risk of developing CBD or
beryllium sensitization decreases at
lower exposures (see this preamble at
section VI, Preliminary Risk
Assessment), meaning that employers
can improve their chances of avoiding
MRP costs by lowering employee
exposure levels. OSHA previously noted
this incentive when describing MRP
provisions in the Lead standard (43 FR
52973, November 14, 1978) and the
Cadmium standard (57 FR 42368,
September 14, 1992).
Finally, OSHA’s preliminary risk
assessment indicates that significant
risk remains at the proposed TWA PEL
(see this preamble at section VI,
Preliminary Risk Assessment). MRP
offers additional protection for
situations in which workers develop
CBD or beryllium sensitization despite
exposures at or below the PEL. As
discussed above regarding the definition
of ‘‘action level’’ in paragraph (b), if
OSHA finds a continuing exposure risk
at the PEL, it has the authority to
impose additional feasible requirements
on employers to further reduce risk
when those requirements will result in
a greater than minimal incremental
benefit to workers’ health (Asbestos II,
838 F.2d at 1274).
During the SBREFA process, SERs
commented that small entities may lack
the flexibility and resources to provide
comparable positions for MRP-eligible
employees (OSHA 2008b). The SBREFA
Panel recommended that OSHA give
careful consideration to the impacts that
an MRP requirement could have on
small businesses (OSHA, 2008b). In
response to this recommendation, the
Agency has provided flexibility in how
employers may comply with MRP
requirements. Where employers have no
comparable positions in environments
with exposures below the action level,
the proposed standard permits an
employer to place eligible employees on
paid leave for six months, or until
PO 00000
Frm 00239
Fmt 4701
Sfmt 4702
47803
comparable work becomes available.
Under proposed paragraph (l)(4), if an
employee is placed on paid leave and
receives government or employerprovided compensation, or such paid
leave allows the employee to secure
other work, the original employer’s
compensation obligations would be
offset. Also in response to the Panel’s
recommendations, OSHA analyzed
Regulatory Alternative #22, which
would eliminate the proposed
requirement to offer MRP to employees
with beryllium sensitization or CBD.
Finally, OSHA notes that there is
considerable scientific uncertainty
about the effects of exposure cessation
on the development of CBD among
sensitized individuals and the
progression from early-stage to late-stage
CBD. Members of the medical
community support removal from
beryllium exposure as a prudent step in
the management of beryllium
sensitization and disease. For example,
physicians at National Jewish Medical
Center, a leading organization in CBD
research and treatment, recommend
individuals diagnosed with beryllium
sensitization and CBD who continue to
work in a beryllium industry to have
exposure of no more than 0.01
micrograms per cubic meter of
beryllium as an 8-hour TWA (https://
www.nationaljewish.org/healthinfo/
conditions/beryllium-disease/
environment-management/). However,
the scientific literature on the effects of
exposure cessation is limited. It suggests
that removal from exposure can have
beneficial effects for some individuals,
but provides no conclusive evidence on
whether exposure cessation will prevent
CBD or CBD progression for most people
(see this preamble at Section V, Health
Effects, and Section VIII, Significance of
Risk).
OSHA proposes to include MRP in
the beryllium standard, providing
workers with sensitization or CBD the
opportunity and means to minimize
their further exposure to beryllium via
MRP in keeping with the
recommendation of beryllium
specialists in the medical community
and with the draft recommended
standard provided by union and
industry stakeholders (Materion and
Steelworkers, 2012).
OSHA solicits comments on the
health effects of MRP and the proposed
provisions for MRP. Is MRP an
appropriate means of intervention in the
disease process for workers with
beryllium sensitization or CBD? Do the
proposed MRP provisions appropriately
balance SBREFA commenters’ concerns
with the need to reduce beryllium
exposure for employees with
E:\FR\FM\07AUP2.SGM
07AUP2
47804
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
sensitization or CBD? Please comment
on whether MRP should be included in
the standard (Regulatory Alternative
#22). Please explain your positions on
these issues and provide any relevant
data or studies.
(m) Communication of Hazards to
Employees
Paragraph (m) of this proposal sets
forth the employer’s obligations to
comply with OSHA’s Hazard
Communication standard (HCS)(29 CFR
1910.1200), and to take additional steps
to warn and train employees about the
hazards of beryllium.
Paragraph (m)(1)(i) of this proposal
requires chemical manufacturers,
importers, distributors, and employers
to comply with all applicable
requirements of the HCS for beryllium.
As described in this preamble at section
V, Health Effects, and section VI,
Preliminary Beryllium Risk Assessment,
OSHA considers beryllium a hazardous
chemical.
In classifying the hazards of
beryllium, the employer must address at
least the following: Cancer; lung effects
(chronic beryllium disease and acute
beryllium disease); beryllium
sensitization; skin sensitization; and
skin, eye, and respiratory tract irritation
(paragraph (m)(1)(ii)). According to the
HCS, employers must classify hazards if
they do not rely on the classifications of
chemical manufacturers, importers, and
distributors (see 29 CFR
1910.1200(d)(1)).
Paragraph (m)(1)(iii) requires that
employers include beryllium in the
hazard communication program
established to comply with the HCS,
and ensure that each employee has
access to labels on containers and safety
data sheets for beryllium and is trained
in accordance with the HCS and
paragraph (m)(4) of this proposal.
According to paragraph (e)(1)(ii) of
this proposal, employers must establish
and maintain regulated areas wherever
employees are or can reasonably be
expected to be exposed to beryllium at
levels above the TWA PEL or STEL, and
each employee entering a regulated area
must wear a respirator and protective
clothing and equipment in accordance
with paragraphs (g) and (h) of this
standard. Under paragraph (m)(2) of this
proposal, employers must provide and
display warning signs at each approach
to a regulated area so that each
employee is able to read and understand
the signs and take necessary protective
steps before entering the area.
Employers must ensure that warning
signs required by paragraph (m)(2) are
legible and readily visible, and that they
bear the following legend:
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
Danger; Beryllium; May Cause Cancer;
Causes Damage to Lungs; Authorized
Personnel Only; Wear respiratory protection
and protective clothing and equipment in
this area.
Some SERs objected to having cancer
warnings displayed on the legends for
warning signs and labels. They
expressed the opinion that cancer
warnings would unnecessarily scare
customers and employees. Further, they
alleged evidence for beryllium causation
of cancer was not sufficient (OSHA,
2008b). OSHA disagrees with these
comments. OSHA has thoroughly
reviewed the literature for beryllium
carcinogenicity, and has preliminarily
concluded that beryllium is
carcinogenic. OSHA’s finding that
inhaled beryllium causes lung cancer is
based on the best available
epidemiological data, reflects evidence
from animal and mechanistic research,
and is consistent with the conclusions
of other government and public health
organizations (see this preamble at
section V, Health Effects). For example,
the International Agency for Research
on Cancer (IARC), National Toxicology
Program (NTP), and American
Conference of Governmental Industrial
Hygienists (ACGIH) have all classified
beryllium as a known human
carcinogen (IARC, 2009). OSHA believes
that the weight of evidence is sufficient
to support the requirement for cancer
warnings on signs and labels.
The signs required by paragraph
(m)(2) of this proposal are intended to
serve as a warning to employees and
others who may not be aware that they
are entering a regulated area, and to
remind them of the hazards of beryllium
so that they take necessary protective
steps before entering the area. These
signs are also intended to supplement
the training that employees must receive
regarding the hazards of beryllium,
since even trained employees need to be
reminded of the locations of regulated
areas and of the precautions necessary
before entering these dangerous areas
(see paragraph (m)(4) of this proposal
and 29 CFR 1910.1200(h) for training
requirements).
The use of warning signs is important
to make employees who are regularly
scheduled to work at these sites aware
of beryllium hazards, to alert employees
who have limited access to these sites
of beryllium hazards, and to warn those
who do not have access to regulated
areas to avoid the area. Access must be
limited to authorized personnel to
ensure that those entering the area are
adequately trained and equipped, and to
limit exposure to those whose presence
is absolutely necessary. By limiting
access to authorized persons, employers
PO 00000
Frm 00240
Fmt 4701
Sfmt 4702
can minimize employee exposure to
beryllium in regulated areas and thereby
minimize the number of employees that
may require medical surveillance or be
subject to the other requirements in this
proposal associated with working in a
regulated area.
Paragraph (m)(2) specifies the
wording of the warning signs for
regulated areas in order to ensure that
the proper warning is consistently given
to employees, and to notify employees
that respirators and personal protective
clothing and equipment are required in
the regulated area. OSHA believes that
the use of the word ‘‘Danger’’ is
appropriate, based on the evidence of
the toxicity of beryllium. ‘‘Danger’’ is
used to attract the attention of
employees to alert them to the fact that
they are entering an area where the
TWA PEL or STEL may be exceeded,
and to emphasize the importance of the
message that follows. The use of the
word ‘‘Danger’’ is also consistent with
other OSHA health standards dealing
with toxins such as cadmium (29 CFR
1910.1027), methylenedianiline (29 CFR
1910.1050), asbestos (29 CFR
1910.1001), and benzene (29 CFR
1910.1028). In addition, use of the word
‘‘Danger’’ for this chemical is consistent
with the Globally Harmonized System
of Classification and Labeling of
Chemical guidelines (GHS) (77 FR
17740–48, March 26, 2012). In the
Federal Register notice for the revised
HCS, which incorporates the GHS,
OSHA explains that for substancespecific standards, warning signs must
be as consistent as possible with label
information for that substance (Id.).
Paragraph (m)(3) requires that labels
be affixed to all bags and containers of
clothing, equipment, and materials
visibly contaminated with beryllium.
The term ‘‘materials’’ includes waste,
scrap, debris, and any other items
visibly contaminated with beryllium
that are consigned for disposal or
recycling (see paragraphs (h)(2)(iv) and
(v) and (j)(3)(i) through (iii)). The labels
must state:
Danger; Contains Beryllium; May Cause
Cancer; Causes Damage to Lungs; Avoid
Creating Dust; Do Not Get on Skin.
The purpose of this labeling
requirement is to ensure that all affected
employees, not only the employees of a
particular employer, are apprised of the
presence of beryllium-containing
materials and the hazardous nature of
beryllium exposure. With this
knowledge, employees can take steps to
protect themselves through proper work
practices established by their
employers. Employees are also better
able to alert their employers if they
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
believe exposures or skin contamination
can occur.
As discussed previously, these
labeling requirements are consistent
with the HCS, which requires
classification of hazardous chemicals
and labeling appropriate for the
classification (see 77 FR 17740–48,
March 26, 2012). In addition, these
requirements for labeling are consistent
with the mandate of section (6)(b)(7) of
the OSH Act, which requires that OSHA
health standards prescribe the use of
labels or other appropriate forms of
warning to apprise employees of the
hazards to which they are exposed.
Paragraph (m)(4) contains
requirements for employee information
and training, and applies to all
employees who are or can reasonably be
expected to be exposed to airborne
beryllium. Employers must ensure that
employees receive information and
training in accordance with the
requirements of the HCS (29 CFR
1910.1200(h)), including specific
information on beryllium as well as any
other hazards addressed in the
workplace hazard communication
program. Under the HCS, employers
must provide their employees with
information such as the location and
availability of the written hazard
communication program, including lists
of hazardous chemicals and safety data
sheets, and the location of operations in
their work areas where hazardous
chemicals are present. The HCS also
requires employers to train their
employees on ways to detect the
presence or release of hazardous
chemicals in the work area such as any
monitoring conducted, the physical and
health hazards of the chemicals in the
work area, measures employees can take
to protect themselves, and the details of
the employer’s hazard communication
program (29 CFR 1910.1200(h)(3)).
Under paragraph (m)(4)(i)(B), training
must be provided to each employee by
the time of initial assignment, which
means before the employee’s first day of
work in a job that could reasonably be
expected to involve exposure to
airborne beryllium. This training must
be repeated at least annually thereafter
((m)(4)(i)(C)). OSHA believes that
annual retraining is necessary due to the
hazards of beryllium exposure, and for
reinforcement of employees’ knowledge
of those hazards. The annual training
requirement is consistent with other
OSHA standards such as those for lead
(29 CFR 1910.1025), cadmium (29 CFR
1910.1027), benzene (29 CFR
1910.1028), coke oven emissions (29
CFR 1910.1029), cotton dust (29 CFR
1910.1043), and butadiene (29 CFR
1910.1051).
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
Paragraph (m)(4)(ii) requires the
employer to ensure that each employee
who is or can reasonably be expected to
be exposed to airborne beryllium can
demonstrate knowledge of nine
enumerated categories of information
(see paragraph (m)(4)(ii)(A)—(I)).
Providing information and training on
these topics is essential to informing
employees of current hazards and
explaining how to minimize potential
health hazards associated with
beryllium exposure. As part of an
overall hazard communication program,
training serves to explain and reinforce
the information presented on labels and
safety data sheets. These written forms
of communication will be most effective
when employees understand the
information presented and are aware of
how to avoid or minimize exposures,
thereby reducing the possibility of
experiencing adverse health effects.
Training should lead to better work
practices and hazard avoidance.
The training requirements in
paragraph (m)(4)(ii) are performanceoriented. This paragraph lists the topics
that training must address, but does not
prescribe specific training methods.
OSHA believes that the employer is in
the best position to determine how to
conduct training that imparts
knowledge and promotes retention.
Appropriate training may include video,
DVD or slide presentations; classroom
instruction; hands-on training; informal
discussions during safety meetings;
written materials; or a combination of
these methods. This performanceoriented approach is intended to
encourage employers to tailor training to
the needs of their workplaces, thereby
resulting in the most effective training
program in each individual workplace.
For training to be effective, the
employer must ensure that it is
provided in a manner that each
employee is able to understand. OSHA
recognizes that employees have varying
education levels, literacy levels, and
language skills, and is requiring that
they receive training in a language and
at a level of complexity that accounts for
these differences. This may require, for
example, providing materials,
instruction, or assistance in Spanish
rather than English if the employees
being trained are Spanish-speaking and
do not understand English well. The
employer would not be required to
provide training in the employee’s
preferred language if the employee
understands both languages; as long as
the employee is able to understand the
language used, the intent of the
proposed standard would be met.
To ensure that employees
comprehend the material presented
PO 00000
Frm 00241
Fmt 4701
Sfmt 4702
47805
during training, it is critical that trainees
have the opportunity to ask questions
and receive answers if they do not fully
understand the material that is
presented to them. When video
presentations or computer-based
programs are used, employers may meet
this requirement by having a qualified
trainer available to address questions
after the presentation, or providing a
telephone hotline so that trainees will
have direct access to a qualified trainer.
In addition to being performanceoriented, these training requirements are
also results-oriented. Paragraph
(m)(4)(ii) requires employers to ensure
that affected employees can demonstrate
knowledge of the nine topics
enumerated in paragraph (m)(4)(ii)(A)
through (I). Accordingly, employers
must ensure that employees participate
in and comprehend the training, and are
able to demonstrate knowledge of the
specified topics. Some examples of
methods to ensure knowledge are
discussions of the required training
subjects, written tests, or oral quizzes.
Although the standard only requires
annual retraining, employers must
ensure that employees can demonstrate
up-to-date knowledge of the listed
topics at all times.
Paragraph (m)(4)(iii) requires
employers to provide additional
training, even if a year has not passed
since the previous training, when
workplace changes (such as
modification of equipment, tasks, or
procedures) result in new or increased
employee exposure that exceeds or can
reasonably be expected to exceed either
the TWA PEL or the STEL. Some
examples of changes in work conditions
triggering the requirement for additional
training include changes in work
production operations or personnel that
affect the way employees operate
equipment. Additional training would
also be required if employers introduce
new production or personal protective
equipment where employees do not yet
know how to properly use the new
equipment. Misuse of either the new
production equipment or PPE could
result in new exposures above the TWA
PEL or STEL. As another example,
employers must provide additional
training before employees repair or
upgrade engineering controls if
exposures during these activities will
exceed or can reasonably be expected to
exceed either the TWA PEL or the STEL.
OSHA believes the additional training
requirement in this proposal is essential
because it ensures that employees are
able to actively participate in protecting
themselves under the conditions found
in the workplace, even if those
conditions change.
E:\FR\FM\07AUP2.SGM
07AUP2
47806
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Paragraph (m)(5) requires that
employers make copies of the standard
and its appendices readily available at
no cost to each employee and
designated employee representative.
This requirement ensures that
employees and their representatives
have direct access to regulations
affecting them, and knowledge of the
protective measures employers must
take on employees’ behalf.
Commenters to both the RFI and
SBREFA recognized the importance of
educating and training their employees
about the hazards of beryllium
exposure. In commenting on an earlier
OSHA draft standard for beryllium
during the SBREFA process, several
companies (e.g., Morgan Bronze
Products, Precision Stamping, and Mid
Atlantic Coatings) supported training
that was understandable to the
employee. They agreed that employees
should be able to demonstrate
knowledge of health hazards associated
with beryllium exposure, and the
medical surveillance program as
described in paragraph (k) of this
section. They also supported additional
training when exposures exceed the PEL
(OSHA 2008b). Most SERs reported
already training their employees about
beryllium risks and how employees can
protect themselves (OSHA, 2008b).
OSHA agrees with comments
supporting the necessity of training, and
in order to assist in the development of
training programs, intends to develop
outreach materials and other guidance
materials.
(n) Recordkeeping
Paragraph (n) of the proposed
standard requires employers to maintain
records of exposure measurements,
historical monitoring data, objective
data, medical surveillance, and training.
The recordkeeping requirements are
proposed in accordance with section
8(c) of the OSH Act (29 U.S.C. 657(c)),
which authorizes OSHA to require
employers to keep and make available
records as necessary or appropriate for
the enforcement of the Act or for
developing information regarding the
causes and prevention of occupational
injuries and illnesses. The proposed
recordkeeping provisions are also
consistent with OSHA’s standard
addressing access to employee exposure
and medical records (29 CFR
1910.1020).
Proposed paragraph (n)(1)(i) requires
employers to keep records of all
measurements taken to monitor
employee exposure to beryllium as
required by paragraph (d) of this
standard. Paragraph (n)(1)(ii) would
require that such records include the
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
following information: The date of
measurement for each sample taken; the
operation involving exposure to
beryllium that was monitored; the
sampling and analytical methods used
and evidence of their accuracy; the
number, duration, and results of
samples taken; the types of respiratory
protection and other personal protective
equipment used; and the name, social
security number, and job classification
of each employee represented by the
monitoring, indicating which employees
were actually monitored.
These requirements are consistent
with those found in other OSHA
standards, such as those for methylene
chloride (29 CFR 1910.1052) and
chromium (VI) (29 CFR 1910.1026).
These standards, like most of OSHA’s
substance-specific standards, require
that exposure monitoring and medical
surveillance records include the
employee’s social security number.
OSHA has included this requirement in
the past because social security numbers
are particularly useful in identifying
employees, since each number is unique
to an individual for a lifetime and does
not change when an employee changes
employers. When employees have
identical or similar names, identifying
employees solely by name makes it
difficult to determine to which
employee a particular record pertains.
However, based on privacy concerns,
OSHA examined alternatives to
requiring social security numbers for
employee identification as part of its
Standards Improvement Project-Phase II
(‘‘SIPs’’) Final Rule. The Agency
analyzed public comment on the
necessity, usefulness, and effectiveness
of social security numbers as a means of
identifying employee records. OSHA
also analyzed comments regarding
privacy concerns raised by this
requirement, as well as the availability
of other effective methods of identifying
employees for OSHA recordkeeping
purposes. Comments were divided
regarding whether social security
information should be retained for
exposure and medical records. The
Agency examined the comments and
decided not to take any action in the
SIPs final rule regarding the use of
social security numbers because the
conflicting comments all raised
significant concerns, and OSHA wished
to study the issue further. (See 70 FR
1112, 1126–27, March 7, 2005).
In this rulemaking, OSHA proposes to
continue to require the use of social
security numbers. OSHA emphatically
recommends against distributing or
posting employees’ social security
numbers with monitoring results. OSHA
welcomes comment on this issue.
PO 00000
Frm 00242
Fmt 4701
Sfmt 4702
Proposed paragraph (n)(2) addresses
historical monitoring data. Paragraph
(n)(2)(i) would require employers to
establish and maintain an accurate
record of any historical monitoring data
used to satisfy the initial monitoring
requirements in paragraph (d)(2) of this
standard. As explained earlier in this
preamble, paragraph (d)(2) permits
employers to substitute beryllium
monitoring results obtained at an earlier
time for the initial monitoring
requirements, as long as employers
abide by the criteria specified.
Paragraph (n)(2)(ii) requires the
employer to establish and maintain
records or documents showing that the
criteria discussed in paragraph (d)(2) are
met. This would mean documenting the
workplace conditions present when the
historical data were collected, for
purposes of showing that those
conditions closely resemble the
conditions present in the employer’s
current operations. Employers should
also document the dates of reliance on
the historical data as well as the dates
on which the historical data were
collected.
Proposed paragraph (n)(3) addresses
objective data. Proposed paragraph
(n)(3)(i) requires employers to establish
and maintain accurate records of the
objective data relied upon to satisfy the
requirement for initial monitoring in
proposed paragraph (d)(2). Under
proposed paragraph (n)(3)(ii), the record
must contain the following information:
The data relied upon; the berylliumcontaining material in question; the
source of the data; a description of the
operation exempted from initial
monitoring and how the data support
the exemption; and other information
demonstrating that the data meet the
requirements for objective data in
accordance with paragraph (d)(2). Such
other information may include reports
of engineering controls, work area
layout and dimensions, and natural air
movements pertaining to the data and
current conditions.
Since historical and objective data
may be used to exempt the employer
from certain types of monitoring, as
specified in paragraph (d), it is critical
that the use of these types of data be
carefully documented. Historical and
objective data are intended to provide
the same degree of assurance that
employee exposures have been correctly
characterized as would exposure
monitoring. The records must
demonstrate a reasonable basis for
conclusions drawn from the data.
Under proposed paragraph (n)(4)(i)
employers must establish and maintain
accurate medical surveillance records
for each employee covered by the
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
medical surveillance requirements of
the standard in paragraph (k). Paragraph
(n)(4)(ii) lists the categories of
information that an employer would be
required to record: the employee’s
name, social security number, and job
classification; a copy of all physicians’
written opinions; and a copy of the
information provided to the PLHCP as
required by paragraph (k)(4) of this
standard.
OSHA believes that medical records,
like exposure records, are necessary and
appropriate. Medical records document
the results of medical surveillance and
the screening of employees. Employers
can use the information contained in the
records to identify and adjust hazardous
workplace conditions and mitigate
exposures. Employees can use these
records to make informed decisions
regarding medical surveillance and
medical removal. PLHCPs would have
the records to use in any further
employee consultations or in making
recommendations at a later time. In
sum, medical records play an important
part in properly evaluating the effects of
beryllium exposure on employees’
health.
Paragraph (n)(5)(i) would require that
employers prepare and maintain records
of any training required by this
standard. At the completion of training,
the employer would be required to
prepare a record that indicates the
name, social security number, and job
classification of each employee trained;
the date the training was completed;
and the topic of the training. This record
maintenance requirement would also
apply to records of annual retraining or
additional training as described in
paragraph (m)(4).
Proposed paragraphs (n)(1) through
(4) require employers to maintain
exposure measurements, historical
monitoring data, and medical
surveillance records, respectively, in
accordance with OSHA’s Records
Access standard (29 CFR 1910.1020).
That standard, specifically 29 CFR
1910.1020(d), requires employers to
ensure the preservation and retention of
exposure and medical records. Exposure
measurements and historical monitoring
data are considered employee exposure
records that must be maintained for at
least 30 years in accordance with 29
CFR 1910.1020(d)(1)(ii). Medical
surveillance records must be maintained
for at least the duration of employment
plus 30 years in accordance with 29
CFR 1910.1020(d)(1)(i).
Proposed paragraph (n)(5)(ii) requires
employers to retain training records,
including records of annual retraining
or additional training required under
this standard, for a period of three years
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
after the completion of the training.
OSHA believes that the retention period
for training records is reasonable for
documentation purposes. The three year
period for the maintenance of training
records is consistent with the
Bloodborne Pathogens standard (29 CFR
1910.1030). Other OSHA standards
require training records to be kept for
one year beyond the last date of
employment (e.g., Asbestos (29 CFR
1910.1001), Methylenedianiline in
construction (29 CFR 1926.60), and
Asbestos in construction (29 CFR
1926.1101)).
These maintenance provisions, as
well as the access requirements
discussed below, ensure that records are
available to employees so that they may
examine the employer’s exposure
measurements, historical monitoring
data, and objective data, as well as
medical surveillance and training
records, and evaluate whether
employees are being adequately
protected. Moreover, compliance with
the requirement to maintain records of
exposure data will enable the employer
to show, at least for the duration of the
retention-of-records period, that the
requirements of this standard were
carried out appropriately. For example,
maintenance of these types of data
could protect employers from
allegations of violating paragraph (d)(2).
The lengthy record retention period is
necessitated by the long latency period
commonly associated with diseases
such as chronic beryllium disease and
cancer (see this preamble at section V,
Health Effects).
Paragraph (n)(6) requires that all
records mandated by this standard must
be made available for examination and
copying to the Assistant Secretary, the
Director of NIOSH, each employee, and
each employee’s designated
representative as stipulated by OSHA’s
Records Access standard (29 CFR
1910.1020).
Paragraph (n)(7) requires that
employers comply with the Records
Access standard regarding the transfer
of records. Specifically, the
requirements for the transfer of records
are explained in 29 CFR 1910.1020(h),
which instructs employers either to
transfer records to successor employers
or, if there is no successor employer, to
inform employees of their access rights
at least three months before the
cessation of the employer’s business.
Commenters to the RFI fully endorsed
the need for the collection and
maintenance of health-related records
dealing with beryllium exposure, as
well as those for employee hazard
training (Brush Wellman, 2003). No
comments were received in opposition
PO 00000
Frm 00243
Fmt 4701
Sfmt 4702
47807
to the need for such recordkeeping.
However, one commenter suggested that
most dental labs will not have any
incentive to comply with the
recordkeeping requirements because
they have fewer than ten employees and
therefore would not be subject to OSHA
audits of their records. The commenter
noted that OSHA will have difficulty
measuring the effectiveness of the
standard if small businesses do not keep
accurate records (OSHA, 2007a). OSHA
does not intend to exempt small
businesses from the recordkeeping
requirements in this proposal because
the Agency believes the severity of
disease resulting from beryllium
exposure is great enough to justify
requiring small businesses to maintain
employee health records in accordance
with this proposal. Also, recordkeeping
for fewer employees should be less
resource-intensive than for a larger
organization. OSHA requests comment
on the appropriateness of the proposed
recordkeeping requirements.
(o) Dates
According to paragraph (o), this
standard will become effective 60 days
after the publication of the final rule in
the Federal Register. OSHA intends for
this period to allow affected employers
the opportunity to familiarize
themselves with the standard and to
make preparations in order to be in
compliance by the start-up dates. Under
paragraph (o)(2), employer obligations
to comply with most requirements of
the final rule would begin 90 days after
the effective date (150 days after
publication of the final rule). This
additional time period is designed to
allow employers to complete initial
exposure assessments or otherwise
make exposure determinations by use of
historical or objective data, to establish
regulated areas, to obtain appropriate
work clothing and equipment, and to
comply with other provisions of the
rule.
There are two exceptions to the
normal start-up intervals—establishing
change rooms and implementing
engineering controls—that provide
additional time for employers to
comply. Change rooms are required no
later than one year after the effective
date of the standard, and engineering
controls need to be in place within two
years after the effective date. The
delayed start-up dates allow affected
employers sufficient time to design and
construct change rooms where
necessary, and to design, obtain, and
install any required control equipment.
In addition, the longer intervals for
change rooms and engineering controls
are consistent with other OSHA
E:\FR\FM\07AUP2.SGM
07AUP2
47808
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
substance-specific standards such as
those for chromium (VI) (29 CFR
1910.1026) and cadmium (29 CFR
1910.1027). OSHA solicits comment on
the appropriateness of these proposed
start-up dates.
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
XIX. References
[ACCP] American College of Chest
Physicians. (1965). Beryllium disease:
report of the section on nature and
prevalence. Dis Chest 48:550–558.
[ACGIH] American Conference of
Governmental Industrial Hygienists.
(1949).
[ACGIH] American Conference of
Governmental Industrial Hygienists.
(1971). Documentation of the Threshold
Limit Values for Substances in
Workroom Air With Supplements for
Those Substances Added or Changed in
1971. American Conference of
Governmental Industrial Hygienists,
Cincinnati, OH.
[ACGIH] American Conference of
Governmental Industrial Hygienists.
(2009). Threshold limit values for
chemical substances and physical agents
and biological exposure indices.
American Conference of Governmental
Industrial Hygienists, Cincinnati, OH.
[AFL–CIO] American Federation of Labor
and Congress of Industrial Organizations.
(2003). AFL–CIO’s response to OSHA’s
Request for Information (along with
attachments). Dated: February 24, 2003.
[AIA] Aerospace Industries Association.
(2003). Aerospace Industries
Association’s comments on OSHA’s
Request for Information. Dated: February
24, 2003.
AirClean Systems. (2011). Price Quote from
AirClean Systems for 32″ Ductless Type
A Balance Enclosure. Includes HEPA
filter. March 10.
Aldy, J.E., and W.K. Viscusi, 2007. Age
Differences in the Value of Statistical
Life, Discussion Paper RFF DP 07005,
Resources for the Future, April 2007.
Alekseeva OG. (1965) Ability of beryllium
compounds to cause allergy of the
delayed type. Fed Proc Transl Suppl.
Sep-Oct; 25(5):843–6.
[ANSI] American National Standards
Institute. (1970). Acceptable
concentrations of beryllium and
beryllium compounds. (Z37.29–1970)
New York: American National Standards
Institute.
Ames BN and Gold LS. (1990). Chemical
Carcinogenesis: Too many rodent
carcinogens. Proc Natl Acad Sci U.S.A.
Oct; 87(19):7772–6.
Amicosante M, Berretta F, Franchi A,
Rogliani P, Dotti C, Losi M, Dweik R,
Saltini C. (2002). HLA–DP-unrestricted
TNF-alpha release in berylliumstimulated peripheral blood
mononuclear cells. Eur Respir J Nov 20;
1174–1178.
Amicosante M, Berretta F, Rossman M, Butler
RH, Rogliani P, van den Berg-Loonen E,
Saltini C. (2005) Identification of HLA–
DRPheb47 as the susceptibility marker of
hypersensitivity to beryllium in
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
individuals lacking the berylliosisassociated supratypic marker HLA–
DPGlub69. Respir Res. Aug 14; 6: 94.
Amicosante M, Deubner D, Saltini C. (2005)
Role of the berylliosis-associated HLA–
DPGlu69 supratypic variant in
determining the response to beryllium in
a blood T-cells beryllium-stimulated
proliferation test. Sarcoidosis Vasc
Diffuse Lung Dis. Oct; 22(3):175–9.
Amicosante M, Fontenot AP. (2006) T cell
recognition in chronic beryllium disease.
Clin Immunol. Nov; 121(2):134–43.
Andre SM, Metivier H, Lantenois G, Boyer M,
Nolibe D, Masse R. (1987) Beryllium
metal solubility in the lung: comparison
of metal hot-pressed forms by in-vivo
and in-vitro dissolution bioassays.
Human toxicology, 6(3):233–240.
Arjomandi M, Seward J, Gotway MB,
Nishimura S, Fulton GP, Thundiyil J,
King TE Jr, Harber P, Balmes JR. (2010)
Low Prevalence of Chronic Beryllium
Disease Among Workers at a Nuclear
Weapons Research and Development
Facility. JOEM 52: 647–52.
Arlauskas A, Baker RS, Bonin AM, Tandon
RK, Crisp PT, Ellis J. (1985) Mutagenicity
of metal ions in bacteria. Environ Res. 36
(2); 379–388.
Armstrong JL, Day GA, Park JY, Stefaniak AB,
Stanton ML, Deubner DC, Kent MS,
Schuler CR, Virji MA. (2014) Migration
of beryllium via multiple exposure
pathways among work processes in four
different facilities. J Occup Environ Hyg;
11 (12): 781–792.
[ASAS] Aviation Safety Advisory Services.
(2002). ASAS’s response to OSHA’s
Request for Information (along with
attachments) Dated: December 18, 2002.
Ashby J, Ishidate M, Stoner GD, Morgan MA,
Ratpan F, Callander RD. (1990) Studies
on the genotoxicity of beryllium sulphate
in vitro and in vivo. Mutat Res. 240(3);
217–225.
[ATSDR] Agency for Toxic Substance and
Disease Registry. (1993) Toxicological
Profile of Beryllium. April, 1993.
[ATSDR] Agency for Toxic Substance and
Disease Registry. (2002) Toxicological
Profile of Beryllium. Sept, 2002.
Attia SM, Harisa GI, Hassan MH, Bakheet SA.
(2013) Beryllium chloride-induced
oxidative DNA damage and alterations I
the expression patterns of DNA repairrelated genes. Mutatgenesis. 28 (5); 555–
559.
Bailey RL, Thomas CA, Deubner DC, Kent
MS, Kreiss K, Schuler CR. (2010)
Evaluation of a preventive program to
reduce sensitization at a beryllium metal
oxide and alloy production plant. J
Occup Environ med. 52(5); 505–512.
Ballonzoli L, Bouchier T. (2010) Ocular sideeffects of steroids and other
immunosupproessive agents. Therapie;
65 (2): 115–120.
Barbee RA, Halonen M, Kaltenborn WT, and
Burrows B, 1991. ‘‘A longitudinal study
of respiratory symptoms in a community
population sample. Correlations with
smoking, allergen skin-test reactivity,
and serum IgE,’’ Chest, 1991 Jan;99(1):
20–6.
Bargon J, Kronenberger H, Bergmann L, et al.
(1986). Lymphocyte transformation test
PO 00000
Frm 00244
Fmt 4701
Sfmt 4702
in a group of foundry workers exposed
to beryllium and non-exposed controls.
Eur J Respir Dis 69:211–215.
Barna BP, Chiang T, Pillarisetti SG, et al.
(1981) Immunological studies of
experimental beryllium lung disease in
the guinea pig. Clin Immunol
Immunopathol 20:402–411.
Barna BP, Deodhar SD, Chiang T, et al.
(1984a) Experimental beryllium-induced
lung disease. I. Differences in
immunologic response to beryllium
compounds in strains 2 and 13 guinea
pigs. Int Arch Allergy Appl Immunol
73:42–48.
Barna BP, Deodhar SD, Gautam S, et al.
(1984b) Experimental beryllium-induced
lung disease. II. Analyses of bronchial
lavage cells in strains 2 and 13 guinea
pigs. Int Arch Allergy Appl Immunol
73:49–55.
Barnett RN, Brown DS, Cadora CB, Baker GP.
(1961) Beryllium disease with death
from renal failure. Conn Med. 25; 142–
147.
Bayliss DL, Lainhart WS, Crally LJ, et al.
(1971) Mortality patterns in a group of
former beryllium workers. In:
Proceedings of the American Conference
of Governmental Industrial Hygienists
33rd Annual Meeting, Toronto, Canada,
94–107.
[BEA] Bureau of Economic Analysis. 2010.
National Income and Product Accounts
Table: Table 1.1.9. Implicit Price
Deflators for Gross Domestic Product
[Index numbers, 2005=100]. Revised
May 27, 2010. https://www.bea.gov/
national/nipaweb/TableView.asp?
SelectedTable=13&Freq=Qtr&FrstYear=
2006&LastYear=2008.
Belinsky SA, Snow SS, Nikula KJ, Finch GL,
Tellez CS, and Palmisano WA. (2002)
Aberrant CpG island methylation of the
p16INK4a and estrogen receptor genes in
rat lung tumors induced by particulate
carcinogens. Carcinogenesis 23: 335–339.
Belman S. (1969) Beryllium binding in
epidermal constituents. J Occup Med,
Apr;11(4):175–83.
Benson JM, Holmes AM, Barr EB, Nikula KJ,
and March TH. (2000) Particle clearance
and histopathology in lungs of C3H/HeJ
mice administered beryllium/copper
alloy by intratracheal instillation.
Inhalation Toxicology 12: 733–749.
Bernard A, Torma-Krajewski J, Viet S. (1996)
Retrospective beryllium exposure
assessment at the Rocky Flats
Environmental Site. Am Ind Hyg Assoc
J 57:804–808.
Beryllium Industry Scientific Advisory
Committee. (1997) Is beryllium
carcinogenic in humans. J Occup
Environ Med 39:205–208.
Bian Y, Hiraoka S, Tomura M, Zhou XY,
Yashiro-Ohtani Y, Mori Y, Shimizu J,
Ono S, Dunussi-Joannopoulos K, Wolf S,
Fujiwara H. (2005). The Capacity of the
Natural Ligands for CD28 to Drive IL–4
¨
Expression in Naıve And AntigenPrimed CD4+ and CD8+ T Cells. Int
Immunol; 17(1): 73–83.
Bill JR, Mack DG, Falta MT, Maier LA,
Sullivan AK, Joslin FG, Martin AK,
Freed BM, Kotzin BL, Fontenot AP.
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
(2005) Beryllium presentation to CD4+ T
cells is dependent on a single amino acid
residue of the MHC class II beta-chain.
J Immunol; 175(10): 7029–7037.
[BLS] Bureau of Labor Statistics. (2010a).
2010 Occupational Employment
Statistics Survey, U.S. Bureau of Labor
Statistics. Available at https://
www.bls.gov/oes/.
[BLS] Bureau of Labor Statistics. (2010b).
2010 Employer Costs for Employee
Compensation, U.S. Bureau of Labor
Statistics. Available at https://
www.bls.gov/ncs/ect/.
[BLS] Bureau of Labor Statistics. (2013). BLS
Job Openings and Labor Turnover
Survey (JOLTS). Available at: https://
www.bls.gov/jlt/.
Boeniger MF. (2003). The significance of skin
exposure. Ann Occup Hyg.
Nov;47(8):591–593.
Borak J, Woolf SH, Fields CA. (2006) Use if
beryllium lymphocyte proliferation
testing for screening of asymptomatic
individuals: an evidence-based
assessment. J Occup Environ Med. 48 (9);
937–947.
Borm PJ, Schins RP, Albrecht C. (2004)
Inhaled particles and lung cancer. Part B:
Paradigms and risk assessments. Int J
Cancer. May 20;110(1):3–14.
Bost TW, Riches DWH, Schumacher B, et al.
(1994) Alveolar macrophages from
patients with beryllium disease and
sarcoidosis express increased levels of
mRNA for tumor necrosis factor-alpha
and interleukin-6 but not interleukin1beta. Am J Respir Cell Mol Biol
10(5):506–513.
Brooks AL, Griffith WC, Johnson NF, Finch
GL, Cuddihy RG. (1989) The induction of
chromosome damage in CHO cells by
beryllium and radiation given alone and
in combination. Radiat Res. 120 (3); 494–
507.
Brown ES. (2009). Effects of glucocorticoids
on mood, memory, and the
hippocampus. Treatment and preventive
therapy. Ann NY Acad Sci. Oct;1179:41–
55.
Brush Wellman (2003). Brush Wellman’s
response to OSHA’s Request for
Information.
Brush Wellman (2004). Brush Wellman’s
1999 baseline full-shift personal
breathing zone (lapel-type) exposure
results for its Elmore, Ohio, primary
beryllium production facility. Data
provided to Eastern Research Group,
Inc., Lexington, Massachusetts, on
August 23, 2004. [Unpublished].
Cai H, White S, Torney D, Deshpande A,
Wang Z, Marrone B, Nolan JP. (2000)
Flow cytometry-based minisequencing: a
new platform for high-throughput singlenucleotide polymorphism scoring.
Genomics 66: 135–143.
Camner P, Hellstrom PA, Lundborg M,
Philipson K. (1977). Lung clearance of
4mm particles coated with silver, carbon
or beryllium. Arch Environ Health,
32:58–62.
Carter JM, Corson N, Driscoll KE, Elder A,
Finkelstein JN, Harkema JR, Gelein R,
¨
Wade-Mercer P, Nguyen K, Oberdorster
G. (2006) A Comparative Dose-Related
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
Response of Several Key Pro- and Antiinflammatory Mediators in the Lungs of
Rats, Mice and Hamsters after
Subchronic Inhalation of Carbon Black. J
Occup Environ Med. Dec; 48(12): 1265–
1278.
Carter JM and Driscoll KE. (2001) The role of
inflammation, oxidative stress, and
proliferation in silica-induced disease: a
species comparison. J Environ Pathol
Toxicol Oncol. 2001;20 Suppl 1:33–43.
[CCMA] California Cast Metals Association
(2000). Ventilation Control of Airborne
Metals and Silica in Foundries. El
Dorado Hills, California. April.
[CDC] Centers for Disease Control and
Prevention. (2012). Take-Home Lead
Exposure Among Children with
Relatives Employed at a Battery
Recycling Facility—Puerto Rico, 2011,
MMWR: 2012; 61 (47): 967–970.
Chen MJ. (2001) Development of beryllium
exposure matrices for workers in a
former beryllium manufacturing plant.
[Dissertation]. University of Cincinnati,
Cincinnati, OH.
Cherry N, Beach J, Burstyn I, Parboosingh J,
Schouchen J, Senthilselvan A, Svenson
L, Tamminga J, Yiannakoulias N. (2015)
Genetic susceptibility to beryllium: a
case-referent study of men and women of
working age with sarcoisosi or oterh
chronic lung disease. Occup Envion
Med; 72: 21–27.
Cheskin LJ, Bartlett SJ, Zayas R, Twiley CH,
Allison DB, Contoreggi C. (1999).
Prescription medications: a modifiable
contributor to obesity. South Med J. 1999
Sep;92(9):898–904.
Chiappino G, Cirla A, Vigliani EC. (1969)
Delayed-type hypersensitivity reactions
to beryllium compounds. An
experimental Study. Arch Pathol
Feb;87(2):131–40.
Cholack J, Schafer L, Yeager D. (1967)
Exposures to beryllium in a beryllium
alloying plant. Am Ind Hyg Assoc J
28:399–407.
Chou YK, Edwards DM, Weinberg AD,
Vadenbark AA, Kotzin BL, Fontenot AP,
Burrows GG. (2005) Activation pathways
implicate anti-HLA–DP and anti_LFA–1
antibodies as lead candidates for
intervention in chronic berylliosis. J
Immunol 174: 4316–4324.
Christensen JD, Tong BC. (2014) Computed
Tomography Screening for Lung Cancer:
Where Are We Now? NC Med J; 74(5):
406–410.
Cianciara MJ, Volkova AP, Aizina NL,
Alekseeva OG. (1980) A study of
humoral and cellular responsiveness in a
population occupationally exposed to
beryllium. Int Arch Occup Environ
Health. 1980 Jan;45(1):87–94.
Clary JJ, Bland LS, Stokinger HE. (1975) The
effect of reproduction and lactation on
the onset of latent chronic beryllium
disease. Toxicol Appl Pharmacol
33:214–221.
Cohen BS, Harley NH, Martinelli CA, and
Lippman M. (1983) Sampling artifacts in
the breathing zone. Proceedings of the
International Symposium on Aerosols in
the Mining and Industrial Work
Environment pp 347–360. B. Y. H. Liu
PO 00000
Frm 00245
Fmt 4701
Sfmt 4702
47809
and V. A. Maples eds. Minneapolis, MN:
Ann Arbor Press.
Conradi C, Burri PH, Kapanet Y, and
Robinson FR. (1971) Lung changes after
beryllium inhalation: Ultrastructural and
morphometric study. Arch Environ
Health 23: 348–358.
Cordeiro CR, Jones JC, Alfaro T, Ferriera AJ.
(2007) Bronchoalveolar lavage in
occupational lung diseases. Semin
Respir Crit Care Med. Oct;28(5):504–13.
Costa D., and M. Kahn, 2003. ‘‘The Rising
Value of Nonmarket Goods,’’ American
Economic Review, 93:2, pp. 227–233.
Costa D., and M. Kahn, 2004. ‘‘Changes in the
Value of Life, 1940–1980,’’ Journal of
Risk and Uncertainty, 29:2, pp. 159–180.
Couch JR, Petersen M, Rice C, SchubauerBerigan MK. (2011) Development of
Retrospective Quantitative and
Qualitative Job-Exposure Matrices for
Exposures at a Beryllium Processing
Facility. Occup Environ Med. May;68(5):
361–5.
Coussens LM, Werb Z. (2002) Inflammation
and cancer. Nature. 420(6917); 860–867.
Crowley JF, Hamilton JG, Scott KG. (1949)
The metabolism of carrier-free
radioberyllium in the rat. Journal of
biological chemistry, 177:975–984.
Cummings KJ, Deubner DC, Day GA,
Henneberger PK, Kitt MM, Kent MS,
Kreiss K, Schuler CR. (2007) Enhanced
preventive programme at a beryllium
oxide ceramics facility reduces beryllium
sensitization among workers. Occup
Environ Med. Feb; 64 2):134–40.
Cummings KJ, Stefaniak AB, Virji MA, Kreiss
K. (2009) A reconsiderationof acute
beryllium disease. Environ Health
Perspect. Aug;117(8):1250–6.
Curtis GH. (1951) Cutaneous hypersensitivity
due to beryllium; A study of thirteen
cases. AMA Arch Derm Syphiol. Oct;
64(4):470–82.
Curtis GH. (1959) The diagnosis of beryllium
disease, with special reference to the
patch test. AMA Arch Ind Health 19 (2):
150–153.
DANTE (2009). The DANTE Trial. A
Randomized Study in Lung Cancer
Screening with Low-Dose Spiral
Computed Topography.
Dattoli JA, Lieben J, Bisbing J. (1964) Chronic
Beryllium Disease. A Follow-Up Study.
J Occup Med. 6:189–94.
Dai H, Guzman J, Costabel U. (1999)
Increased expression of apoptosis
signaling receptors by alveolar
macrophages in sarcoidosis. Eur Respir J;
13(6): 1451–1454.
Dai S, Crawford F, Marrack P, Kappler JW.
(2008) The structure of HLA–DR52c:
comparison to other HLA–DRB3
Isotypes. Proc Natl Acad Sci 105
(33):11893–7.
Dai S, Murphy GA, Crawford F, Mack DG,
Falta MT, Marrack P, Kappler JW,
Fontenot AP. (2010) Crystal structure of
HLA–DP2 and implications for chronic
beryllium disease. Proc Natl Acad Sci;
107(16): 7425–7430.
Dai S, Falta MT, Bowerman NA, McKee AS,
Fontenot AP. (2013). T Cell Recognition
of Beryllium. Curr Opin Immunol 25(6):
775–780.
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47810
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
Dallman MF, Akana SF, Pecoraro NC, Warne
JP, la Fleur SE., Foster MT. (2007).
Glucocorticoids, the etiology of obesity
and the metabolic syndrome. Curr
Alzheimer Res. 2007 Apr;4(2):199–204.
Day GA, Dufresne A, Stefaniak AB, Schuler
CR, Stanton ML, Miller WE, Kent MS,
Deubner DC, Kreiss K, Hoover MD.
(2007) Exposure assessment pathway at
a copper-beryllium alloy facitilty. Ann
Occup Hyg. Jan; 51(1):67–80.
Day GA, Hoover MD, Stefaniak AB,
Dickerson RM, Peterson EJ, and Esmen
NA. (2005) Bioavailability of beryllium
oxide particles: An in vitro study in the
murine J774A.1 macrophage cell line
model. Exp. Lung Res. 31(3):341–360.
Delic J (1992) Toxicity Review 27 (Part 2):
Beryllium and beryllium compounds.
London, Her Majesty’s Stationery Office
(ISBN 0 11 886343 6).
De Nardi JM, Van Ordstrand HS, Carmody
MG. (1949) Acute dermatitis and
pneumonitis in beryllium workers;
review of 406 cases in 8-year period with
follow-up on recoveries. Ohio Med. 1949
Jun; 45(6):567–75.
De Nardi JM, Van Orstrand HS, Curtis GH,
Zielinski J. (1953) Berylliosis: Summary
and survey of all clinical types observed
in a twelve-year period. American
Medical Association archives of
industrial hygiene and occupational
medicine, 8:1–24.
Deodhar SD and BP Barna. (1991) Immune
mechanisms in beryllium lung disease.
Cleve Clin J Med. Mar-Apr;58(2):157–60.
de Silva PS, Fellows IW. (2010) Failure in
wound healing following percutaneous
gastrostomy insertion in patients on
corticosteroids. J Gastrointestin Liver
Dis. Dec;19(4):463.
Deubner D, Kelsh M, Shum M, et al. (2001a)
Beryllium sensitization, chronic
beryllium disease, and exposures at a
beryllium mining and extraction facility.
Appl Occup Environ Hyg 16(5):579–592.
Deubner DC, Goodman M, Iannuzzi J. (2001b)
Variability, predictive value, and uses of
the beryllium blood lymphocyte
proliferation test (BLPT): Preliminary
analysis of the ongoing workforce
survey. Appl Occup Environ Hyg
16(5):521–526.
Deubner DC, Sabey P, Huang W, Fernandez
D, Rudd A, Johnson WP, Storrs J, Larson
R. (2011) Solubility and Chemistry of
Materials Encountered by Beryllium
Mine and Ore Extraction workers:
Relation to Risk. J Occup Environ Med
53 (10) 1187–1193.
Diaconita G and Eskenasy A. (1978)
Experimental aerogenic pulmonary
berylliosis in rabbits. Morphol. Embryol.
24:75–79.
Ding J, Lin L, Hang W, Yan X. (2009)
Beryllium uptake and related biological
effects studied in THP–1 differentiated
macrophages. Metallomics; 1(6): 471–
478.
DLCST (2012). Danish Lung Cancer
Screening Trial.
[DOD] Department of Defense. (2003). DOD’s
response to OSHA’s Request for
Information (along with attachments).
Dated: February 24, 2003.
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
[DOE] Department of Energy. (1999) 10 CFR
part 850 Chronic Beryllium Disease
Prevention Program; Final Rule.
December 8, 1999 https://
www.hss.doe.gov/HealthSafety/WSHP/
be/docs/berule.pdf.
[DOE] Department of Energy. (2001)
Beryllium Lymphocyte Proliferation
Testing. DOE SPEC 1142–2001.
[DOE] Department of Energy. (2006) 10 CFR
parts 850 and 851 Chronic Beryllium
Disease Prevention Program; Worker
Safety and Health Program; Final Rule
December 9, 2006 https://
www.hss.energy.gov/HealthSafety/wshp/
be/docs/beryllium_amendments.pdf.
DOE/HSS, 2006. ‘‘Beryllium Current Worker
Health Surveillance Through 2005,’’
Publication ORISE 05–1711, https://
www3.orau.gov/BAWR/pdf/
beregistryrpt_2–13–2007.pdf.
Donovan EP, Kolanz ME, Galbraith DA,
Chapman PS, Paustenbach DJ. (2007)
Performance of the beryllium blood
lymphocyte proliferation test based on a
long-term occupational surveillance
program. Int Arch Occup Environ
Health; 81 (2); 165–178.
Dorman, P., and P. Hagstrom, 1998. ‘‘Wage
Compensation for Dangerous Work
Revisited,’’ Industrial and Labor
Relations Review, 52:1, pp. 116–135.
Dotti C, D’Apice MR, Rogliani P, Novelli G,
Saltini C, Amicosante M. (2004) Analysis
of TNF-a promoter polymorphisms in
the susceptibility to beryllium
sensitization. Sarcoidosis Vasc Diffuse
Lung Dis. Mar; 21(1):29–34.
Driscoll KE. (1996) Role of inflammation in
the development of rat lung tumors in
response to chronic particle exposure.
Inhal Toxicol. 8 (Suppl): 139–153.
Duling MC, Stephaniak AB, Lawrence RB,
Chipera SJ, Virji AM. (2012) Release of
beryllium from mineral ores in artificial
lung and skin surface fluids. Environ
Geochem Health 34 (3) 313–322.
Dunkel VC, Pienta RJ, Sivak A, Traul KA.
(1981) Comparative Neoplastic
Transformation Response of Balb/3T3
Cells, Syrian Hamster Embryo Cells, and
Rauscher Murine Leukemia Virus_
infected Fisher 344 Rat Embryo Cells to
Chemical Carcinogens. J Nat Cancer Inst.
67(6); 1303–1315.
Dutra FR. (1948) The pneumonitis and
granulomatosis peculiar to beryllium
workers. Am J Pathol. 24(6):1137–65.
[EIA] U. S. Energy Information
Administration. (2011). Annual Energy
Outlook. Available at: https://
www.eia.gov/forecasts/archive/aeo11/.
Eidson, A.F., A. Taya, G.L. Finch, M.D.
Hoover, and C. Cook. (1991) Dosimetry
of beryllium in cultured canine
pulmonary alveolar macrophages. J.
Toxicol. Environ. Health 34(4):433–448.
Eisenbud M, Berghourt CF, Steadman LT.
(1948) Environmental studies in plants
and laboratories using beryllium; the
acute disease. J Ind Hyg Toxicol; 30 (5):
281–285.
Eisenbud M, Wanta RC, Dustan C, Steadman
LT, Harris WB, Wolf BS. (1949) Nonoccupational berylliosis. J Ind Hyg
Toxicol. 31: 281–294.
PO 00000
Frm 00246
Fmt 4701
Sfmt 4702
Eisenbud M. (1982) Origins of the standards
for control of beryllium disease (1947–
1949). Environ Res. 27(1):79–88.
Eisenbud M, Lisson J. (1983) Epidemiological
aspects of beryllium-induced nonmalignant lung disease: A 30-year
update. J Occup Med 25 (3): 196–202.
Eisenbud M. (1993) Re: Lung cancer
incidence among patients with beryllium
disease [Letter]. J Natl Cancer Inst
85:1697–1698.
Eisenbud, M. (1998) The Standard for Control
of Chronic Beryllium Disease. Appl
Occup Environ Hyg 13(1): 25–31.
Elder A, Gelein R, Finkelstein JN, Driscoll
¨
KE, Harkema J, Oberdorster G. (2005)
Effects of subchronically inhaled carbon
black in three species. I. Retention
kinetics, lung inflammation, and
histopathology. Toxicol Sci.
Dec;88(2):614–29.
[EPA] Environmental Protection Agency.
(1974) National emission standards for
hazardous air pollutants. U.S.
Environmental Protection Agency. Code
of Federal Regulations 40:61.30–61.34.
[EPA] Environmental Protection Agency.
(1987) Health Assessment Document for
Beryllium. U. S. Environmental
Protection Agency, Washington, DC.
[EPA] Environmental Protection Agency.
(1998) Toxicological review of beryllium
and compounds. (CASRN 7440–41–7). In
Support of Summary Information on the
Integrated Risk Information System
(IRIS)U.S. Environmental Protection
Agency, Washington DC EPA/635/R–98/
008 Pp. 1–93.
[EPA] Environmental Protection Agency.
(2000). ‘‘SAB Report on EPA’s White
Paper Valuing the Benefits of Fatal
Cancer Risk Reduction,’’ EPA–SAB–
EEAC–00–013. OSHA Docket OSHA–
2010–0034–0652.
[EPA] Environmental Protection Agency.
(2003). ‘‘National Primary Drinking
Water Regulations; Stage 2 Disinfectants
and Disinfection Byproducts Rule;
National Primary and Secondary
Drinking Water Regulations; Approval of
Analytical methods for Chemical
Contaminants; Proposed Rule,’’ Federal
Register, Volume 68, Number 159,
August 18.
[EPA] Environmental Protection Agency.
(2008). ‘‘Final Ozone NAAQS Regulatory
Impact Analysis,’’ Office of Air Quality
Planning and Standards, Health and
Environmental Impacts Division, Air
Benefit and Cost Group, March.
Eastern Research Group (2003). ERG
Beryllium Site 5, 2003. Site visit to a
dental laboratory, January 28–29, 2003.
Eastern Research Group, Inc., Lexington,
Massachusetts. Attachment 4.
Epstein PE, Daubner JH, Rossman MD,
Daniele RP. (1982) Bronchoalveolar
Lavage in a Patient with Chronic
Berylliosis: Evidence for
Hypersensitivity Pneumonitis. Annals
Int Med; 97 (2): 213–216.
Epstein, W. L. (1991). Cutaneous effects of
beryllium. Beryllium Biomedical and
Environmental Aspects.
[ERG] Eastern Research Group. (2003).
Survey of the Cullman machining plant
conducted by ERG.
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
[ERG] Eastern Research Group. (2004a).
Survey of the Cullman machining plant
conducted by ERG.
[ERG] Eastern Research Group. (2004b). ERG
personal communication. ‘‘In 2004, the
plant industrial hygienist reported that
all machines had LEV and about 65
percent were also enclosed with either
partial or full enclosures to control the
escape of machining coolant’’.
[ERG] Eastern Research Group. (2007b).
Rulemaking Support for Supplemental
Economic Feasibility Data for a
Preliminary Economic Impact Analysis
of a Proposed Crystalline Silica
Standard; Updated Cost and Impact
Analysis of the Draft Crystalline Silica
Standard for General Industry. Task
Report. Eastern Research Group, Inc.
Lexington, MA. Submitted to
Occupational Safety And Health
Administration, Directorate of
Evaluation and Analysis, Office of
Regulatory Analysis under Task Order
11, Contract No. DOLJ049F10022. April
20.
[ERG] Eastern Research Group. (2009a).
Personal communication with an
industrial hygiene researcher at NJMRC.
[ERG] Eastern Research Group. (2009b).
Personal communication with Cullman
machining plant’s industrial hygienist.
[ERG] Eastern Research Group. (2010).
External Peer Review of OSHA’s Draft
‘‘Preliminary Health Effects Section for
Beryllium,’’ ‘‘Preliminary Risk
Assessment for Beryllium,’’ and External
Peer Review of NIOSH Papers.
Submitted to Occupational Safety and
Health Administration, Directorate of
Standards and Guidance under Task
Order 80, Contract No. DOLQ059622303.
December 2, 2010.
Eskenasy A. (1979) Experimental pulmonary
berylliosis in rabbits sensitized to
beryllium sulfate: Contact
hypersensitivity. Morphol. Embryol.
25(3):257–262.
[FDA] Food and Drug Administration. (2003).
‘‘Food Labeling: Trans Fatty Acids in
Nutrition Labeling, Nutrient Content
Claims, and Health Claims. Final Rule,’’
Federal Register, 68 FR 41434.
Ferriola PC, Nettesheim P. (1994) Regulation
of normal and transformed
tracheobronchial epithelial cell
proliferation by autocrine growth factors.
Crit Rev oncop. 5(2–3); 107–120.
Finch GL et al; (1986) Inhalation Toxicol
Research Institute Annual Report: The
Cytotoxicity of Beryllium Compounds to
Cultured Canine Alveolar Macrophages
p.286–90.
Finch, G., J. Mewhinney, A. Eidson, M.
Hoover, and S. Rothenberg. (1988) In
Vitro Dissolution Characteristics of
Beryllium Oxide and Beryllium Metal
Aerosols. J. Aerosol Sci. 19(3):333–342.
Finch GL, Mewhinney JA, Hoover MD, et al.
(1990) Clearance, translocation, and
excretion of beryllium following acute
inhalation of beryllium oxide by beagle
dogs. Fundam Appl Toxicol 15:231–241.
Finch GL, Finch GL, Lowther WT, Hoover
MD, Brooks AL. (1991) Effects of
beryllium metal particles on the viability
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
and function of cultured rat alveolar
macrophages. J Toxicol Environ Health.
Sep; 34(1):103–14.
Finch GL, Hahn FF, Carlton WW, Rebar AH,
Hoover MD, Griffith WC, Mewhinney JA,
and Cuddihy RG. (1994) Combined
exposure of F344 rats to beryllium metal
and 239PuO2 aerosols. In Inhalation
Toxicology Research Institute Annual
Report 1993–1994 (Belinsky SA, Hoover
MD, and Bradley PL, Eds.), pp 77–80.
1TRI–144, National Technical
Information Service, Springfield, VA.
Finch G, March T, Hahn F, Barr E, Belinsky
S, Hoover M, Lechner J, Nikula K, Hobbs
C. (1998a) Carcinogenic responses of
transgenic heterozygous p53 knockout
mice to inhaled 239PuO2 or metallic
beryllium. Toxicol Pathol 26:484–491.
Finch GL, Nikula KJ, Hoover MD. (1998b)
Dose-response relationships between
inhaled beryllium metal and lung
toxicity in C3H mice. Toxicol Sci
42(1):36–48.
Finch GL, March TH, Hahn FF, Barr EB,
Belinsky SA, Hoover, MD, Lechner JF,
Nikula KJ, and Hobbs CH. (1998c)
Carcinogenic responses of transgenic
heterozygous p53 knockout mice to
inhaled 239PuO2 or metallic beryllium.
Toxicologic Pathology 26 (4): 484–491.
Fireman E, Haimsky E, Noiderfer M, Priel I,
Lerman Y. (2003) Misdiagnosis of
sarcoidosis in patients with chronic
beryllium disease. Sarcoidosis Vasc
Diffuse Lung Dis. Jun; 20(2):144–8.
Fodor I. (1977) Histogenesis of berylliuminduced bone tumours. Acta Morphol
Acad Sci Hung. 25(2–3): 99–105.
Fontenot AP, Falta MT, Freed BM, Newman
LS, Kotzin BL. (1999) Identification of
pathogenic T cells in patients with
beryllium-induced lung disease. J
Immunol; 163(2): 1019–1026.
Fontenot AP, Torres M, Marshall WH,
Newman LS, Kotzin BL. (2000)
Beryllium presentation CD4+ T cells
underlies disease-susceptibility HLA–DP
alleles in chronic beryllium Disease.
Proc Natl Acad Sci. 97 (23): 12717–
12722.
Fontenot AP, Canavera SJ, Gharavi L,
Newman LS, Kotzin BL. (2002) Target
organ localization of member CD4(+) T
cells in patients with chronic beryllium
disease. J Clin Invest. Nov 2002; 110(10):
1473–1482.
Fontenot AP, Gharavi L, Bennett SR,
Canavera SJ, Newman LS, and Kotzin
BL. (2003) CD28 co-stimulation
independence of target organ versus
circulating memory antigen-specific
CD4+ T cells. J Clin Invest. 112 (5): 776–
784.
Fontenot AP, Palmer BE, Sullivan AK, Joslin
FG, Wilson CC, Maier LA, Newman LS,
Kotzin BL. (2005) Frequency of
beryllium specific, central memory CD
4+ T cells in blood determines
proliferation response. J Clin Invest. Oct;
115(10):2886–93.
Fontenot AP, Maier LA. (2005) Genetic
susceptibility and immune-mediated
destruction in beryllium-induced
disease. Trends Immunol; 26(10): 543–
549.
PO 00000
Frm 00247
Fmt 4701
Sfmt 4702
47811
Fontenot AP, Keizer TS, McClesky M, Mack
DG, Meza-RomeroR, Huan J, Edwards
DM, Chou YK, Vandenbark AA, Scott B,
Burrow GG. (2006) Recombinant HLA–
DP2 binds beryllium and toerizes
beryllium-specific pathogenic CD4+ T
cells. J Immunol; 177;3874–3883.
Franchimont D, Kino T, Galon J, Meduri GU.
(2002). Glucocorticoids and
inflammation revisited: the state of the
art. NIH clinical staff conference.
Neuroimmunomodulation. 2002–
2003;10(5):247–60.
Franchimont D, Galon J, Vacchio MS, Fan S,
Visconti R, Frucht DM, Geenen V,
Chrousos G, Ashwell JD, O’Shea JJ.
(2002). Posititive effects of
glucocorticoids on T cell function by upregulation of IL–7 receptor alpha. J
Immunol Mar 1:168(5):2212–8.
Frauman AG. (1996). An overview of the
adverse reactions to adrenal
corticosteroids. Adverse Drug React
Toxicol Rev. Nov;15(4):203–6.
Freeman H. (2012) Colitis associated with
biological agents. World J Gastroenterol;
18 (16): 1871–1874.
Freiman DG, Hardy HL. (1970) Beryllium
disease. The relation of pulmonary
pathology to clinical course and
prognosis based on a study of 130 cases
from the U.S. beryllium case registry.
Hum Pathol. Mar;1(1):25–44.
Frome EL, Smith MH, Littlefield LG, et al.
(1996). Statistical methods for the blood
beryllium lymphocyte proliferation test.
Environ Health Perspect 104(Suppl.
5):957–968.
Frome E, Cragle D, Watkins J, Wing S, Shy
C, Tankersley W, West C. (1997) A
mortality study of employees of the
nuclear industry in Oak Ridge,
Tennessee. Radiat Res 148:64–80.
Frome EL, Newman LS, Cragle DL, Colyer SP,
Wambach PF. (2003) Identification of an
abnormal beryllium lymphocyte
proliferation test. Toxicology 183 (1–3);
39–56. Erratum in Toxicology 188 (2–3);
335–336.
Fuchs B and Protchard DJ. (2002) Etiology of
Osteosarcoma. Clin Orthop Relat Res.
2002 Apr;(397):40–52.
Furchner JE, Richmond CR, London JE.
(1973). Comparative metabolism of
radionuclides in mammals.VIII.
Retention of beryllium in the mouse, rat,
monkey and dog. Health Phys 24:293–
300.
Gaede KI, Amiconsante M, Schurmann M,
Fireman E, Saltini C, Muller-Quernheim.
(2005) Function associated transforming
growth factor-beta gene polymorphism in
chronic beryllium disease. J Mol Med
(Berl); 83(5): 397–405.
Gelman I. (1936) Poisoning by vapors of
beryllium oxyfluoride. J Ind Hyg Toxicol
18:371±379.
Gibson GJ, Prescott RJ, Muers MF, Middleton
WG, Mitchell DN, Connolly CK, Harrison
BD (1996). British Thoracic Society
Sarcoidosis Study: effects of long-term
corticosteroid treatment. Thorax. Mar;
51(3):238–47.
Gomme, P., and P. Rupert, 2004. ‘‘Per Capita
Income Growth and Disparity in the
United States, 1929–2003,’’ Federal
Reserve Bank of Cleveland, August 15.
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47812
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
Gordon T and Bowser D. (2003) Beryllium:
genotoxicity and carcinogenicity. Mutat
Res. Dec 10; 533(1–2):99–105.
Greene TM, Lanzisera DV, Andrews L,
Downs AJ (1998) Matrix-isolation and
density functional theory study of the
reactions of laser-abated beryllium,
magnesium, and calcium atoms with
methane. Journal of the American
Chemical Society, 120 (24):6097–6104.
Greten FR, Karin M. (2004) The IKK/NFkappa B activation pathway- a target for
prevention and treatment of cancer.
Cancer Lett. Apr 8;206(2):193–9.
Groth DH, Kommineni C, and Mackay GR.
(1980) Carcinogenicity of beryllium
hydroxide and alloys. Environmental
Research 21: 63–84.
Haley PJ, Finch GL, Mewhinney JA, et al.
(1989). A canine model of berylliuminduced granulomatous lung disease.
Lab Invest 61:219–227.
Haley PJ, Finch GL, Hoover, MD, et al. (1990)
The acute toxicity of inhaled beryllium
metal in rats. Fundam Appl Toxicol
15:767–778.
Haley PJ. (1991) Mechanisms of
granulomatous lung disease from inhaled
beryllium: the role of antigenicity in
granuloma formation. Toxicol Pathol,
19(4 Pt 1):514–25.
Haley PJ, Finch GL, Hoover MD, et al. (1992).
Beryllium-induced lung disease in the
dog following two exposures to BeO.
Environ Res 59:400–415.
Haley P, Pavia KF, Swafford DS, et al. (1994)
The comparative pulmonary toxicity of
beryllium metal and beryllium oxide in
cynomolgus monkeys.
Immunopharmacol Immunotoxicol
16(4):627–644.
Hall, R.E., and C.I. Jones, 2007. ‘‘The Value
of Life and the Rise in Health Spending,’’
Quarterly Journal of Economics, CXXII,
pp. 39–72.
Hall RH, Scott JK, Laskin S, Stroud CA,
Stokinger HE. (1950) Acute toxicity of
inhaled beryllium: Observations
correlating toxicity with the
physicochemical properties of beryllium
oxide dust. Arch Ind Hyg Occup Med. 2
(1): 25–48.
Hamida, KS, Fajraoui KN, Ben Ghars Amara
K, Haouachi R, Sahli H, Sellami S, Charfi
MR, Zouri B. (2011). [Effect of inhaled
corticosteroids on bone mineral density
in asthmatic adults: a 20 cases study].
Tunis Med. May;89(5):434–9.
Hanifin JM, Epstein WL and MJ Cline. (1970)
In vitro studies on granulomatous
hypersensitivity to beryllium. J Invest
Derm. Oct; 55(4):284–8.
Hardy HL, Tabershaw IR. (1946) Delayed
chemical pneumonitis occurring in
workers exposed to beryllium
compounds. J Ind Hyg Toxicol 28:197–
211.
Hardy HL, Rabe EW, Lorch S. (1967). United
States Beryllium Case Registry: (1952–
1966) Review of its methods and utility.
J Occup Med. Jun; 9(6):271–6.
Hardy HL. (1980) Beryllium disease: a
clinical perspective. Environ Res.
Feb;21(1):1–9.
Harmsen AG, Finch GL, Mewhinney JA, et al.
(1986) Lung cellular response and
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
lymphocyte blastogenesis in beagle dogs
exposed to beryllium oxide. In:
Muggenburg BA, Sun JD, eds. Annual
report of the Inhalation Toxicology
Research Institute, October 1, 1985
through September 30, 1986. Lovelace
Biomedical and Environmental Research
Institute, Albuquerque, New Mexico,
291–295.
Hart BA, Bickford PC, Whatlen MC,
Hemanway D (1980) Distribution and
retention of beryllium in guinea pigs
after administration of a beryllium
chloride aerosol. US Department of
Energy symposium series (pulmonary
toxicology of respirable particulates),
53:87–102.
Hart BA, Harmsen AG, Low RB, Emerson R.
(1984) Biochemical, cytological, and
histological alterations in rat lung
following acute beryllium aerosol
exposure. Toxicol Appl Pharmacol. Sep
30;75(3):454–65.
Hasan FM, Kazemi H. (1974) Chronic
beryllium diseae: a continued
epidemiolic hazard. Chest. 65 (3); 289–
293.
[HSDB] Hazardous Substance Database.
(2010). Beryllium and Beryllium
compounds. https://toxnet.nlm.nih.gov/.
Heinrich U, Fuhst R, Rittenhausen S,
Creutzenber O, Bellamn B, Koch W,
Levsen K. (1995) Chronic inhalation
exposure of Wistar rats and two different
strains of mice to diesel engine exhaust,
carbon black, and titanium dioxide.
Inhal Toxicol. 7: 533–556.
Henneberger PK, Cumro D, Deubner DD.
(2001) Beryllium sensitization and
disease among long-term and short-term
workers in a beryllium ceramics plant.
Int Arch Occup Health 74:167–176.
Hintermann, B., A. Alberini, and A.
Markandya, 2010. ‘‘Estimating the value
of safety with labour market data: are the
results trustworthy?’’ Applied
Economics, 42(9), pp. 1085–1100.
Hollins DM, McKinley MA, Williams C,
Wiman A, Fillos D, Chapman PS, Madl
AK. (2009) Beryllium and lung cancer: a
weight of evidence evaluation of the
toxicological and epidemiological
literature. Crit Rev Toxicol. 2009;39
Suppl 1:1–32.
Honeywell (2003). Honeywell’s comments on
OSHA’s Request for Information. Dated:
February 24, 2003. Pp. 11.
Hong-Geller. (2006) Chemokine response to
beryllium exposure in human peripheral
blood mononuclear and dendritic cells.
Toxicology. Feb 1; 218(2–3):216–28.
Hoover MD, Castorina BT, Finch GL,
Rothenberg SJ. (1989) Determination of
oxide layer thickness on beryllium metal
particles. Am Ind Hyg Assoc J. Oct;
50(10):550–3.
Hoover MD, Finch GL, Mewhinney JA,
Eidson AF. (1990) Release of aerosols
during sawing and milling of beryllium
exposure in human peripheral blood
mononuclear and dendritic cells. Appl
Occup Environ Hyg 5 (11): 787–791.
Hsie AW (1978) Quantitative mammalian cell
genetic toxicology. Environ Sci Res. 15;
291–315.
Huang H, Meyer KC, Kubai L, and Auerbach
R. (1992) An immune model of
PO 00000
Frm 00248
Fmt 4701
Sfmt 4702
beryllium-induced pulmonary
granulomata in mice: Histopathology,
immune reactivity, and flow-cytometric
analysis of bronchoalveolar lavagederived cells. Lab Invest 67:138–146.
Huang W, Fernandez D, Rudd A, Johnson
WP, Deubner D, Sabey P, Storrs J, Larsen
R. (2011) Dissolution and nanoparticle
generation behavior of Be-associated
materials in synthetic lung fluid using
inductively coupled plasma mass
spectroscopy and flow field-flow
fractionation. J Chromatogr A 1218 (27)
4149–4159.
[IARC] International Agency for Research on
Cancer. (1993). Beryllium, cadmium,
mercury and exposures in the glass
manufacturing industry. Monogr Eval
Carcinog Risk Hum 58:41–117.
[IARC] International Agency for Research on
Cancer. (2009). Special Report: Policy A
review of human carcinogens—Part C:
metals, arsenic, dusts, and fibres. The
Lancet/Oncology. Vol 10 May 2009.
[IARC] International Agency for Research on
Cancer. (2012) A review of the human
carcinogens: arsenic, metals, fibres, and
dusts.
[ICRP] International Commission on
Radiological Protection. (1960) Report of
ICRP Committee II on Permissible Dose
for Internal Radiation. Health physics,
3:154–155.
[ICRP] International Commission on
Radiological Protection. (1994). ICRP
Publication 66: Human Respiratory Tract
Model for Radiological Protection (No.
66). ICRP (Ed.). Elsevier Health Sciences.
[ICSC] International Chemical Safety Card
0226 (beryllium metal). https://
www.ilo.org/dyn/icsc/
showcard.display?p_lang=en&p_card_
id=0226.
[ICSC] International Chemical Safety Card
1325 (beryllium oxide) https://
www.inchem.org/documents/icsc/icsc/
eics1325.htm.
[ICSC] International Chemical Safety Card
1351 (beryllium sulfate) https://
www.inchem.org/documents/icsc/icsc/
eics1351.htm.
[ICSC] International Chemical Safety Card
1352 (beryllium nitrate) https://
www.inchem.org/documents/icsc/icsc/
eics1352.htm.
[ICSC] International Chemical Safety Card
1353 (beryllium carbonate) https://
www.inchem.org/documents/icsc/icsc/
eics1353.htm.
[ICSC] International Chemical Safety Card
1354 (beryllium chloride) https://
www.ilo.org/dyn/icsc/
showcard.display?p_lang=en&p_card_
id=1354.
[ICSC] International Chemical Safety Card
1355 (beryllium fluoride) https://
www.inchem.org/documents/icsc/icsc/
eics1355.htm.
Infante P, Wagoner J, Sprince N. (1980)
Mortality patterns from lung cancer and
nonneoplastic respiratory disease among
white males in the Beryllium Case
Registry. Environ Res 21:35–43.
Invanokov AT, Popov BA, Parfenova IM
(1982) Resorption of soluble beryllium
compounds through the injured skin. Gig
Tr Prof Zabol 9: 50–52.
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
Irwin, R.S., F.J. Curley, and C.L. French,
1990. ‘‘Chronic cough: the spectrum and
frequency of causes, key components of
the diagnostic evaluation, and outcome
of specific therapy,’’ Am Rev Respir Dis
1990; 141: 640–7.
Jackson L, Evers BM. (2006) Chronic
inflammation and pathogenesis of GI and
pancreatic cancers. Cancer Treat Res.
130:39–65.
Johnson JS, Foote K, McClean M, Cogbill G.
(2001) Beryllium exposure control
program at Cardiff Atomic Weapons
Establishment in the United Kingdom.
Appl Occup Environ Hyg.
May;16(5):619–30.
Johnston CJ, Driscoll KE, Finkelstein JN,
Baggs R, O’Reilly MA, Carter J, Gelein R,
¨
Oberdorster G. (2000) Pulmonary
chemokine and mutagenic responses in
rats after subchronic inhalation of
amorphous and crystalline silica.
Toxicol Sci. 2000 Aug;56(2):405–13.
Joseph, P., T. Muchnok, and T. Ong. (2001)
Gene expression profile in BALB/c-3T3
cells transformed with beryllium sulfate.
Mol. Carcinog. 32(1):28–35.
Kada T. (1980) Mutagenicity of selected
chemicals in the rec-assay in bacillus
subtilis. Cmpoarative Chemical
Mutagenesis, pp 19–22.
KanematsuN, Hara M, Kada T. (1980) Rec
assay and mutagenicity studies on metal
compounds. Mutat Res. Feb;77(2):109–
16.
Kang KY, Bice D, Hoffman E, D’Amato R,
Ziskind M, Salviggio. (1977)
Experimental studies of sensitization to
beryllium, zirconium, and aluminum
compounds in the rabbit. J. Allergy Clin
Immunol. Jun;59(6):425–36.
Keizer TS, Sauer NN, McClesky TM. (2005)
Beryllium binding at neutral pH: the
importance of the Be-O-Be motif. J Inorg
Biochem; 99(5): 1174–1181.
Kelleher PC, Martyny JW, Mroz MM, Maier
LA, Ruttenber AJ, Young DA, et al.
(2001) Beryllium particulate exposure
and disease relations in a beryllium
machining plant. J Occup Environ Med
43: 238–249.
Kent MS, Robins TG, Madl AK. (2001) Is total
mass or mass of alveolar –deposited
airborne particles of beryllium a better
predictor of the prevalence of disease? A
preliminary study of a beryllium
processing facility. Appl Occup Environ
Hyg. 16 (5): 539–558.
Keshava, N, Zhou G, Spruill M, Ensell M,
Ong TM. (2001) Carcinogenic potential
and genomic instability of beryllium
sulphate in BALB/c-3T3 cells. Mol. Cell.
Biochem. 222(1–2):69–76.
Kimber I, Basketter, DA, Gerberick GF, Ryan
CA, Dearman RJ. 2011. Chemical Allergy:
Transplating Biology into Hazard
Characterization. Toxicol. Sci. 120 (S1):
S238–S268.
Kittle LA, Sawyer RT, Fadok VA, Maier LA,
Newman LS. (2002) Beryllium induces
apoptosis in human lung macrophages.
Sarcoidsis Vasc Diffuse Lung Dis; 19(2):
101–113.
Klemperer FW, Martin AP, Van Riper J.
(1951) Beryllium excretion in humans. A
M A Arch Ind Hyg Occup Med. Sep;
4(3):251–6.
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
Knaapen AM, Borm PJ, Albrecht C, Schins
RP. (2004) Inhaled particles and cancer.
Part A: Mechanisms. Int J Cancer. May
10;109(6):799–809.
Kniesner, T.J., W.K. Viscusi, and J.P. Ziliak,
2010. ‘‘Policy relevant heterogeneity in
the value of statistical life: New evidence
from panel data quantile regression,’’
Journal of Risk and Uncertainty, 40, pp.
15–31.
Kniesner, T.J., W.K. Viscusi, C. Woock, and
J.P. Ziliak, 2012. ‘‘The Value of a
Statistical Life: Evidence from Panel
Data,’’ Review of Economics and
Statistics, 94(1), pp. 74–87.
Kolanz, M., 2001. Brush Wellman Customer
Data Summary. OSHA Presentation, July
2, 2001. Washington, DC.
Kreiss K, Newman LS, Mroz MM, Campbell
PA. (1989) Screening blood test
identifies subclinical beryllium diease. J
Occup Med. 31 (7): 603–608.
Kreiss K, Mroz MM, Zhen B, Martyny JW,
Newman LS. (1993a) Epidemiology of
beryllium sensitization and disease in
nuclear workers. Am Rev Respir Dis
148:985–991.
Kreiss K, Wasserman S, Mroz MM, Newman
LS. (1993b) Beryllium disease screening
in the ceramics industry. Blood
lymphocyte test performance and
exposure-disease relations. J Occup Med
35:267–274.
Kreiss K, Mroz MM, Newman LS, Martyny J,
Zhen B. (1996) Machining Risk of
Beryllium Disease and Sensitization
With Median Exposures Below 2
micrograms/m3. Am J Ind Med. 30(1):16–
25.
Kreiss K, Mroz MM, Zhen B, Wiedemann H,
Barna B. (1997) Risks of beryllium
disease related processes at a metal,
alloy, and oxide production plant. Occup
Environ Med. 54 (8): 605–612.
Kreiss K, Day GA, Schuler CR. (2007)
Beryllium: a modern industrial hazard.
Annu Rev Public Health. 28:259–77.
Kriebel D, Sprince N, Eisen E, Greaves I.
(1988a) Pulmonary function in beryllium
workers: assessment of exposure. Br J Ind
Med 45:83–92.
Kriebel D, Sprince NL, Eisen EA, et al.
(1988b) Beryllium exposure and
pulmonary function: A cross sectional
study of beryllium workers. Br J Ind Med
45:167–173.
Krivanek, Reeves. (1972) The effects of
chemical forms of beryllium on the
production of the immunological
response. Am Ind Hyg Assoc J. Jan;
33(1):45–52.
Kuroda K, Endo G, Okamoto A, Yoo YS,
Horiguchi S. (1991) Genotoxicity of
beryllium, gallium and antimony in
short-term assays. Mutat Res.
Dec;264(4):163–70.
Lang L. (1994) Beryllium: a chronic problem.
Environ Health Perspect 102:526–531.
Langhammer A, Forsmo S, Syversen U.
(2009). Long-term therapy in COPD: any
evidence of adverse effect on bone? Int
J Chron Obstruct Pulmon Dis. 4:365–80.
Lansdown ABG (1995) Physiological and
toxicological changes in the skin
resulting from the action and interaction
of metal ions. Critical reviews in
toxicology, 25(5):397–462.
PO 00000
Frm 00249
Fmt 4701
Sfmt 4702
47813
Larramendy ML, Popescu NC, DiPaolo JA.
(1981) Induction by inorganic metal salts
of sister chromatid exchanges and
chromosome aberrations in human and
Syrian hamster cell strains. Environ
Mutagen. 3 (6): 597–606.
Lederer H and J Savage. (1954) Beryllium
Granuloma of the Skin. Br J Ind Med.
Jan; 11(1):45–8.
Lee KP, Trochimowicz HJ, Reinhardt CF.
(1985) Pulmonary response of rats
exposed to titanium dioxide (TiO2) by
inhalation for two years. Toxicol Appl
Pharmacol. Jun 30;79(2):179–92.
Leek RD, Harris AL. (2002) Tumor-associated
macrophages in breast cancer. J
Mammary Gland Biol Neoplasia 2002,
7:177–189.
LeFevre ME, Joel DD. (1986) Distribution of
label after intragastric administration of
7Be-labeled carbon to weanling and aged
mice. Proc Soc Exp Biol Med 182:112–
119.
Lehouck A, Boonen S, Decramer M, Janssens
W. (2011). COPD, bone metabolism, and
osteoporosis. Chest. Mar;139(3):648–57.
Leonard A, Lauwerys R. (1987) Mutagenicity,
carcinogenicity and teratogenicity of
beryllium. Mutat Res 186:35–42.
Levy PS, Roth HD, Hwang PMT, Powers TE.
(2002) Beryllium and lung cancer: A
reanalysis of a NIOSH cohort mortality
study. Inhal Toxicol. 14 (10): 1003–1015.
Levy, P.S., H.D. Roth, P.M.T. Hwang, and
T.E. Powers, 2002. ‘‘Beryllium and Lung
Cancer: A Reanalysis of a NIOSH Cohort
Mortality Study,’’ Inhalation Toxicology,
14:1003–1015.
Levy PS, Roth HD, Deubner DC. (2007)
Exposure to beryllium and occurrence of
lung cancer: A reexamination of findings
from a nested case-control study. J
Occup Environ Med. 49 (1): 96–101.
Lieben J, Metzner,F. (1959) Epidemiological
findings associated with beryllium
extraction. Am IndHyg Assoc J 20(6):152.
Lieben J, Williams RR. (1969) Respiratory
Disease Associated With Beryllium
Refining And Alloy Fabrication. 1968
Follow-up. J Occup Med. 11(9):480–5.
Lind, R.C. (Ed.), 1982. Discounting for Time
and Risk in Energy Policy, Washington,
DC: Resources for the Future.
Lionakis MS and Kontoyiannis DP. (2003).
Glucocorticoids and ivasive fungal
infections. Lancet. Nov
29:362(9398):1828–38.
Lipworth BJ. (1999). Systemic adverse effects
of inhaled corticosteroid therapy: A
systematic review and meta-analysis.
Arch Intern Med. May 10: 159(9): 941–
955.
Machle W, Beyer E, Gregorious F. (1948).
Berylliosis; acute pneumonitis and
pulmonary granulomatosis of beryllium
workers. Occup Med (Chic Ill).
Jun;5(6):671–83.
Mack DG, Lanham AK, Palmer PE, Maier LA,
Watts TH, Fontenot AP. (2008) 4–4BB
enhances proliferation of berylliumspecific T cells in the lung of subjects
with chronic beryllium disease. J
Immunol. Sep 15;181(6):4381–8.
MacMahon B. (1994) The epidemiological
evidence on the carcinogenicity of
beryllium in humans. J Occup Med
36:15–24.
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47814
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
Madl AK, Unice K, Brown JL, Kolanz ME,
Kent MS. (2007) Exposure-response
analysis for beryllium sensitization and
chronic beryllium disease among
workers in a beryllium metal machining
plant. J Occup Environ Hyg.
Jun;4(6):448–66.
Magat W., W. Viscusi, and J. Huber, 1996. ‘‘A
Reference Lottery Metric for Valuing
Health,’’ Management Science, (42: 8),
pp. 1118–1130.
Maier LA. (2001) Beryllium health effects in
the era of the beryllium lymphocyte
proliferation test. Appl Occup Environ
Hyg 16(5):514–520.
Maier LA, Reynolds MV, Young DA, et al.
(1999) Angiotensin-1 converting enzyme
polymorphisms in chronic beryllium
disease. Am J Respir Crit Care Med 159(4
Pt 1):1342–1350.
Maier LA, Tinkle SS, Kittie LA, et al. (2001)
IL–4 fails to regulate in vitro berylliuminduced cytokines in berylliosis. Eur
Resp J 17:403–415.
Maier LA. (2001) Beryllium health effects in
the era of the beryllium lymphocyte
proliferation test. Appl Occup Environ
Hyg. 16 (5): 514–520.
Maier LA, McGrath DS, Sato H, Lympany P,
Welsh K, Du Bois R, Silveira L, Fontenot
AP, Sawyer RT, Wilcox E, Newman LS.
(2003) Influence of MHC class II in
susceptibility to beryllium sensitization
and chronic beryllium disease. J
Immunol 171(12): 6910–6918.
Maier LA, Martyny JW, Liang J, Rossman MD.
(2008) Recent Chronic Beryllium Disease
in Residents Surrounding a Beryllium
Facility. Am J Respir Crit Care Med.
1;177(9):1012–7.
Maier LA, Barkes BQ, Mroz M, Rossman MD,
Barnard J, Gillespie M, Martin A, Mack
DG, Silveira L, Sawyer RT, Newman LS,
Fontenot AP. (2012) Infliximab therapy
modulates an antigen-specific immune
response in chronic beryllium disease.
Respir Med; 106 (12): 1810–1813.
Mancuso TF, El-Attar AA. (1969)
Epidemiological study of the beryllium
industry. Cohort methodology and
mortality studies. J Occup Med.
Aug;11(8):422–34.
Mancuso TF. (1970) Relation of duration of
employment and prior respiratory illness
to respiratory cancer among beryllium
workers. Environ. Research 3: 251–275.
Mancuso TF. (1979) Occupational lung
cancer among beryllium workers. Dusts
and Diseases, R. Lemen and JM Dement
eds. Park Forest South, Il: Pathotox
Publishers. Pp 463–471.
Mancuso T. (1980) Mortality study of
beryllium industry workers’
occupational lung cancer. Environ Res
21:48–55.
Mandervelt C, Clottens FL, Demedts M,
Nemery B. (1997) Assessment of the
sensitization potential of five metals in
the murine local nymph node assay.
Toxicology. Jun 6;120(1):65–73.
Marchand-Adam S, El Khatib A, Guillon F,
Brauner MW, Lamberto C, Lepage V,
Naccache JM, Valeyre D. (2008) Shortand long-term response to corticosteroid
therapy in chronic beryllium disease.
Eur Respir J; 32 (3): 683–693.
VerDate Sep<11>2014
20:56 Aug 06, 2015
Jkt 235001
Martin AK, mack DG, Falta MT, Mroz MM,
Newman LS, Maier LA, Fontenot AP.
(2011) Beryllium-specific CD4+ T cells
in blood as a biomarker of disease
progression. J Allergy Clin Immunol;
128(5): 1100–1106.
Martyny J, Hoover M, Mroz M, Ellis K, Maier
L, Sheff K, Newman L. (2000) Aerosols
generated during beryllium machining. J
Occup Environ Med 42:8–18.
Marx JJ and R Burrell. (1973) Delayed
hypersensitivity to beryllium
compounds. J Immunol.l
Aug;111(2):590–8.
Materion and USW (2012). Industry and
Labor Joint Submission to OSHA of a
Recommended Standard for Beryllium.
February, 2012.
Materion Information Meeting, 2012.
Personal communication during meeting
between Materion Corporation and the
U.S. Occupational Safety and Health
Administration. Elmore, Ohio. May 8–9.
Materion (2004). [previously Brush Wellman,
2004]. Brush Wellman’s 1999 Baseline
Full-Shift Personal Breathing Zone
(Lapel-Type) Exposure Results for its
Elmore, Ohio, Primary Beryllium
Production Facility. Brush Wellman,
Inc., Cleveland, Ohio. Data provided to
Eastern Research Group, Inc. August 23.
[Unpublished].
McCanlies EC, Ensey JS, Schuler CR, Kreiss
K, Weston A. (2004) The association
between HLA–DPB1Glu69 and chronic
beryllium disease and beryllium
sensitization. Am J Ind Med. 46 (2): 95–
103.
McCanlies EC, Schuler CR, Kreiss K, Frye BL,
Ensey JS, Weston A. (2007) TNF-alpha
polymorphism in chronic beryllium
disease and beryllium sensitization. J
Occup Environ Med. 49(4): 446–452.
McCanlies EC, YUCesoy B, Mnatsakanova A,
Slaven JE, Andrew M, Frye BL, Schuler
CR, Kreiss K, Weston A. (2010)
Association between IL–1A single
nucleotide polymorphisms and chronic
beryllium disease and beryllium
sensitization. JOEM 52 (7): 680–684.
McCawley MA, Kent MS, Berakis MT. (2001)
Ultrafine beryllium number
concentration as a possible metric for
chronic beryllium disease risk. Appl
Occup Environ Hyg 16(5):631–638.
McCord DP. (1951) Beryllium as a sensitizing
agent. Ind Med Surg. Jul; 20(7):336–7.
McDonough AK, Curtis JR, Saag KG. (2008).
The epidemiology of glucocorticoidassociated adverse events. Curr Opin
Rheumatol. Mar;20(2):131–7.
Metzner FN, Lieben J. (1961) Respiratory
disease associated with beryllium
refining and alloy fabrication; a case
study. J Occup Med. Jul; 3:341–5.
Meyer KC. (1994) Beryllium and Lung
Disease. Chest 106; 942–946.
Middleton DC. (1998) Chronic beryllium
disease: Uncommon disease, less
common diagnosis. Environ Health
Perspect 106(12):765–767.
Middleton DC, Lewin MD, Kowalski PJ, Cox
SS, Kleinbaum D. (2006) The BeLPT:
algorithms and implications. Am J Ind
Med. Jan; 49(1):36–44.
Middleton DC, Fink J, Kowalski PJ, Lewin
MD, Sinks T. (2008) Optimizing BeLPT
PO 00000
Frm 00250
Fmt 4701
Sfmt 4702
criteria for beryllium sensitization. Am J
Ind Med. 49 (1); 36–44.
Middleton DC, Mayer AS, Lewin MD, Mroz
MM, Maier LA. (2011) Interpreting
borderline BeLPT results. Am J Ind Med.
Mar;54(3):205–9.
Miller FJ, Anjilvel S, Menache MG,
Asgharian B, Gerrity T. (1995)
Dosimetric issues relating to particulate
toxicity. Inhal Toxicol. 7 (5): 615–632.
Misra, U.K., G. Gawdi, and S.V. Pizzo. (2002)
Beryllium fluoride-induced cell
proliferation: A process requiring P21rasdependent activated signal
transduction and NF-kB-dependent gene
regulation. J. Leukoc. Biol. 71(3):487–
494.
Miyaki M, Akamatsu N, Ono T, Koymam H.
(1979) Mutagenicity of metal cations in
cultured cells from Chinese hamster.
Mutat Res. 68 (3); 25–263.
Mossman BT. (2000) Mechanisms of action of
poorly soluble particulates in overloadrelated lung pathology. Inhal Toxicol.
Jan–Feb;12(1–2):141–8.
Mroz MM, Kreiss K, Lezotte DC, Campbell
PA, Newman LS. (1991) Reexamination
of the blood lymphocyte transformation
test in the diagnosis of chronic beryllium
disease. J allergy Clin Immunol. 88 (1);
54–60.
Mroz MM, Maier LA, Strand M, Silviera L,
Newman LS. (2009) Beryllium
lymphocyte proliferation test
surveillance identifies clinically
significant beryllium disease. Am J Ind
Med. Oct; 52(10):762–73.
Mueller JJ, Adolphson DR. (1979) Corrosion/
Electrochemistry of Beryllium and
Beryllium. In Beryllium Science and
Technology, Vol 2, DR Floyd and JN
Lowe, eds New York: Plenum Press pp
417–433.
Mullen AL, Stanley RE, Lloyd SR, Moghissi
AA. (1972) Radioberyllium metabolism
by the dairy cow. Health physics, 22:17–
22.
Muller-Quernheim, J. (2005) Chronic
Beryllium Disease. Orphanet
encyclopedia. https://www.orpha.net/
consor/cgibin/Disease_
Search.php?lng=EN&data_
id=1061&Disease_Disease_Search_
diseaseGroup=chronic-berylliumdisease&Disease_Disease_Search_
diseaseType=Pat&Disease(s)/group of
diseases=Chronic-berylliosis—Chronicberyllium-disease-&title=Chronicberylliosis-Chronic-beryllium-disease&search=Disease_Search_Simple.
Muller-Quernheim J, Gaede KI, Fireman E,
Zissel G. (2006) Diagnoses of chronic
beryllium disease with cohorts of
sarcoidosis patients. Eur Respir J. Jun;
27(6):1190–5.
[NAS] National Academies of Science (2008)
Managing Health Effects of Beryllium
Exposure Committee on Beryllium Alloy
Exposures. National Research Council of
the National Academies; The National
Academies Press, Washington, DC.
[NCI] National Cancer Institute. Cancer
Trends Progress Report—2009/2010
Update, National Cancer Institute, NIH,
DHHS, Bethesda, MD, April 2010,
https://progressreport.cancer.gov.
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
Ndejembi MP, Teijaro JR, Patke DS,
Bingaman AW, Chandok MR, Azimadeh
A, Nadler SG, Farber DL. (2006) Control
of memory CD4 T cell recall by the
CD28/B7 costimulatory pathway. J
Immunol; 177(11): 7698–7706.
[NEHC] Navy Environmental Health Center.
(2003a). Navy Response to Occupational
Safety and Health Administration’s
Occupational Exposure to Beryllium;
Request for Information, February 2003.
Navy Environmental Health Center,
Portsmouth, VA.
[NEHC] Navy Environmental Health Center.
(2003b). Attachment (1) Navy
Occupational Exposure Database (NOED)
Query Report Personal Breathing Zone
Air Sampling Results for Beryllium.
Samples taken May 7, 1982 through June
7, 2002. Navy Environmental Health
Center, Portsmouth, VA.
Newman LS, Kreiss K, King TE, Seay S,
Campbell PA. (1989) Pathologic and
immunologic alterations in early stages
of beryllium disease. Reexamination of
disease definition and natural history.
Am Rev Respir Dis. 139 (6); 1479–1486.
Newman LS, Kreiss K. (1992) Nonoccupational beryllium disease
masquerading as sarcoidosis;
identification by blood lymphocyte
proliferation response to beryllium. Am
Rev Respir Dis. May;145(5):1212–4.
Newman et al. (1994). Beryllium disease:
assessment with CT. Radiology; 190(3):
835–840.
Newman LS. (1996) Immunology Genetics
and Epidemiology of Beryllium Disease.
Chest. 109; 40S–43S.
Newman LS, Llyody J, Daniloff E. (1996) The
natural history of beryllium sensitization
and chronic beryllium disease. Environ
Health Perspect. Oct;104 Suppl 5:937–
43.
Newman LS, Mroz MM, Maier LA, Daniloff
DA, Balkissoon. (2001) Efficacy of serial
medical surveillance from chronic
beryllium disease in a beryllium
machining plant. J Occup Environ
Health. 43(3): 231–237.
Newman, L.S., L.A. Maier, J.W. Martyny,
M.M. Mroz, and E.A. Barker, 2003.
National Jewish Medical and Research
Center public comment to ‘‘Occupational
Exposure to Beryllium: Request for
Information,’’ OSHA Docket No. OSHA–
H005C–2006–0870–0155.
Newman LS, Mroz MM, Balkissoon R, Maier
LA. (2005) Beryllium sensitization
progresses to chronic beryllium disease:
A longitudinal study of disease risk. Am
J Respir Crit Care Med. 171 (1): 54–60.
Newman LS. (2007) Immunotoxicology of
beryllium lung disease. Environ Health
Prev Med; 12 (4): 161–164.
Nicholson W. (1976) Case study 1: asbestos—
the TLV approach. Ann NY Acad Sci
271:152–169.
Nickell-Brady C, Hahn FF, Finch GL, and
Belinsky SA. (1994) Analysis of K-ras,
p53, and c-raf-1 mutations in berylliuminduced rat lung tumors. Carcinogenesis
15:257–262.
Nikula KJ, Swafford DS, Hoover MD, Tohulka
MD, and Finch GL. (1997) Chronic
granulomatous pneumonia and
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
lymphocytic responses induced by
inhaled beryllium metal in A/J and
C3HlHe J mice. Toxicologic Pathology 25
(1): 2–12.
Nilsen AM, Vik R, Behrens C, Drablos PA,
Espevik T. (2010) Beryllium sensitivity
among workers at a Norwegian
aluminum smelter. Am J Ind Med. 53 (7);
724–732.
[NIOSH] National Institute of Occupational
Safety and Health. (1972) Occupational
Exposure to Beryllium; Criteria for a
Recommended Standard. DHEW (HSM)
72–10268. US Department of Health,
Education, and Welfare, Health Services
and Mental Health Administration,
National Institute of Occupational Safety
and Health, Rockville, MD.
[NIOSH] National Institute of Occupational
Safety and Health. HHE 75–87–280.
Health Hazard Evaluation Determination
Report No. 75–87–280, Kawecki Berylco
Industries, Inc., Reading, Pennsylvania
(NTIS document number PB89–161251).
Cincinnati, Ohio. April 1976.
[NIOSH] National Institute of Occupational
Safety and Health. HHE 78–17–567.
Health Hazard Evaluation Determination
Report No. 78–17–567, Kawecki Berylco
Industries, Inc., Reading, Pennsylvania
(NTIS document number PB81–143703).
Cincinnati, Ohio. March 1979.
[NIOSH] National Institute for Occupational
Safety and Health. (1994) NIOSH Pocket
Guide to Chemical Hazards. DHHS
(NIOSH) Publication No. 94–116.
Washington, DC: U.S. Government
Printing Office, June 1994, p. 29.
[NIOSH] National Institute of Occupational
Safety and Health. (2005) NIOSH Pocket
Guide to Chemical Hazards.
[NIOSH] National Institute of Occupational
Safety and Health. NIOSH Elmore
database, 2011. Spreadsheet containing
beryllium exposure values collected by
NIOSH at the Materion Elmore facility in
2007 and 2008; provided by Materion
Corporation to OSHA–Directorate of
Standards and Guidance. Fall 2011.
Nishimura M. (1966). Clinical and
experimental studies on acute beryllium
disease. Nagoya J Med Sci. Nov;
29(1):17–44.
Nishioka H. (1975). Mutagenic activites pf
metal compounds I bacteria. Mutat Res.
31(3); 185–189.
[NJMRC] National Jewish Medical and
Research Center. (2003). NJMRC’s
response to OSHA’s Request for
Information on occupational exposure to
beryllium. Dated: February 20, 2003. Pp.
17.
[NJMRC] National Jewish Medical and
Research Center. (2013). Web page on
Chronic Beryllium Disease: Work
Environment Management, from https://
www.nationaljewish.org/healthinfo/
conditions/beryllium-disease/
environment-management/, accessed
May 2013.
[NLST] National Lung Screening Trial
(2011).—Bach PB (2011). Inconsistencies
in findings from the early lung cancer
action project studies of lung cancer
screening. J Natl Cancer Instl 103(13):
1002–1006.
PO 00000
Frm 00251
Fmt 4701
Sfmt 4702
47815
[NTP] National Toxicology Program. (1993).
Toxicology and Carcinogenesis Studies
of Talc (CAS No. 14807–96–6)(NonAsbestiform) in F344/N Rats and B6C3F1
Mice (Inhalation Studies).
[NTP] National Toxicology Program. (1999).
Final Report on Carcinogens:
Background Document for Beryllium and
Beryllium Compounds. https://
ntp.niehs.nih.gov/ntp/newhomeroc/
roc10/be_no_appendices_508.
[NTP] National Toxicology Program. (2002).
Tenth report on carcinogens. U.S.
Department of Health and Human
Services, National Toxicology Program,
Research Triangle Park, NC. https://ntpserver.niehs.nih.gov/NewHomeROC/
RAHC_list.html. July 12, 2002.
[NTP] National Toxicology Program. (2014).
Report on Carcinogens, Thirteenth
Edition. Beryllium and Beryllium
compounds. CAS No. 7440–41–7.
https://ntp.niehs.nih.gov/go/roc13.
Oberdorster G. (1996). Significance of
particle parameters in the evaluation of
exposure-dose-response relationships of
inhaled particles. Inhal Toxicol. 8
Suppl:73–89.
[OMB] U.S. Office of Management and
Budget. (2003). Circular A–4, Regulatory
Analysis, September 17, 2003. Available
at: https://www.whitehouse.gov/omb/
circulars_a004_a-4/.
[OSHA] U.S. Occupational Safety and Health
Administration. (2002). Request for
Information (RFI) for ‘‘Occupational
Exposure to Beryllium’’, 67 FR 70707,
70708, 70709, November 26, 2002.
[OSHA] U.S. Occupational Safety and Health
Administration. (2003). Letter of
Interpretation. Directorate of
Enforcement Programs. https://
www.osha.gov/pls/oshaweb/
owadisp.show_document?p_
table=INTERPRETATIONS&p_id=25617.
[OSHA] U.S. Occupational Safety and Health
Administration. (2006). Final Economic
and Regulatory Flexibility Analysis for
OSHA’s Final Standard for Occupational
Exposure to Hexavalent Chromium;
Docket H054A, Exhibit 49, pp. VI–16 to
VI–18.
[OSHA] U.S. Occupational Safety and Health
Administration. (2007). Preliminary
Initial Regulatory Flexibility Analysis of
the Preliminary Draft Standard for
Occupational Exposure to Beryllium,
September 17. OSHA Beryllium Docket
Document ID Number: OSHA–H005C–
2006–0870–0338.
[OSHA] U.S. Occupational Safety and Health
Administration. (2007a). Appendix C.
Beryllium Small Business Advocacy
Review (SBAR) Panel Report. Written
comments from Small Entity
Representatives (SERs).
[OSHA] U.S. Occupational Safety and Health
Administration. (2007b). Preliminary
Initial Considerations for a Draft
Proposed Standard for General
Industries, Construction and Maritime.
[OSHA] U.S. Occupational Safety and Health
Administration. (2008a). Compliance
Directive, CPL 02–02–074.
[OSHA] U.S. Occupational Safety and Health
Administration. (2008b). Report of the
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47816
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
Small Business Advocacy Review Panel
on the OSHA Draft Proposed Standard
for Occupational Exposure to Beryllium.
January 15, 2008.
[OSHA] U.S. Occupational Safety and Health
Administration. (2009). Integrated
Management Information System (IMIS).
Beryllium exposure data, updated April
21, 2009, covering the period 1978
through September 2008. Data provided
to Eastern Research Group, Inc. by the
U.S. Department of Labor, Occupational
Safety and Health Administration,
Washington, DC. [Unpublished,
electronic files].
[OSHA] Occupational Safety and Health
Administration. (2010a). Occupational
Exposure to Beryllium: Preliminary
OSHA Health Effects Evaluation. August
3, 2010.
[OSHA] Occupational Safety and Health
Administration. (2010b). Preliminary
Beryllium Risk Assessment. August 3,
2010.
[OSHA] U.S. Occupational Safety and Health
Administration. (2013). Occupational
Exposure to Respirable Crystalline Silica,
Proposed Rule, Federal Register, 78 FR
56273.
[OSHA] U.S. Occupational Safety and Health
Administration. (2014). Preliminary
Economic Analysis and Initial
Regulatory Flexibility Analysis in
support of the Notice of Proposed
Rulemaking for Occupational Exposure
to Beryllium.
[OSHA] Occupational Safety and Health
Administration. (2014a). Risk Analysis of
a Worker Population at a Beryllium
Machining Facility.
[OSHA] Occupational Safety and Health
Administration. (2015a). Spreadsheets in
Support of OSHA’s Preliminary
Economic Analysis for the Proposed
Beryllium Standard.
[OSHA] Occupational Safety and Health
Administration. (2015b). ‘‘Comparing
Two Models for Beryllium Benefits.’’
[OSHA] Occupational Safety and Health
Administration. (2015c). ‘‘Spreadsheet
for an Alternative Benefit Model.’’
Pallavicino F., Pellicano R., Reggiani S.,
Simondi D., Sguazzini C., Bonagura A.G.,
Cisaro F., Rizzetto M., Astegiano M.
(2013). Inflammatory Bowel Disease And
Primary Sclerosing Cholangitis: Hepatic
And Pancreatic Side Effects Due To
Azathioprine. Eur Rev Med Pharma Sci;
17: 84–87.
Palmer B.E., Mack D.G., Martin A.K.,
Gillespie M., Mroz M.M., Maier L.A.,
Fontenot A.P. (2008). Up-regulation of
programmed death-1 expression on
beryllium-specific CD4+ T cells in
chronic beryllium disease. J Immunol;
180(4): 2704–2712.
Pappas G.P., Newman L.S. (1993). Early
pulmonary physiologic abnormalities in
beryllium disease. American review of
respiratory disease, 148:661–666.
Pikarsky E., Porat R.M., Stein I., Abramovitch
R., Amit S., Kasem S., Gutkovich-Pyest
E., Urieli-Shoval S., Galun E., BenNeriah Y. (2004). NF-kappaB functions
as a tumour promoter in inflammationassociated cancer. Nature. Sep 23;
431(7007):461–6.
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
Polak L., Barnes J.M., Turk J.L. (1968). The
genetic control of contact sensitization to
inorganic metal compounds in guineapigs. Immunology. 1968 May; 14(5):707–
11.
Rana S.V. (2008). Metals and apoptosis:
Recent developments. J trace Elem Biol;
22(4):262–284.
Reeves A.L. (1965). The absorption of
beryllium from the gastrointestinal tract.
Arch Environ Health. Aug; 11(2):209–14.
Reeves A.L., Vorwald A.J. (1967). Beryllium
carcinogenesis. II. Pulmonary deposition
and clearance of inhaled beryllium
sulfate in the rat. Cancer Res 27:446–451.
Reeves A.L., Deitch D., Vorwald A.J. (1967).
Beryllium carcinogenesis. I. Inhalation
exposure of rats to beryllium sulfate
aerosol. Cancer Res 27:439–445.
Reeves A.L., Krivanek N.D., Busby E.K.,
Swanborg R.H. (1972). Immunity to
pulmonary berylliosis in guinea pigs. Int
Arch Arbeitsmed. 29(3):209–20.
Refsnes M., Hetland R.B., Ovrevik J., Sundfor
I., Schwarze P.E., Lag M. (2006).
Different particle determinants induce
apoptosis and cytokine release in
primary alveolar macrophage cultures.
Part Fibre Toxicol. Jun 14;3:10.
Rhoads K., Sanders C.L. (1985). Lung
clearance, translocation, and acute
toxicity of arsenic, beryllium, cadmium,
cobalt, lead, selenium, vanadium, and
ytterbium oxides following deposition in
rat lung.Environ Res 36:359–378.
Richeldi L., Sorrentino R., Saltini C. (1993).
HLA–DPB1 glutamate 69: A genetic
marker of beryllium disease. Science.
Oct 8;262(5131):242–4.
Ritz B., Morgenstern H., Froines J., Young B.
(1999). Effects of exposure to external
ionizing radiation on cancer mortality in
nuclear workers monitored for radiation
at Rocketdyne/Atomics International.
Am J Ind Med 35:21–31.
Robinson F.R., Schaffner F., and
Trachtenburg E. (1968). Ultrastructure of
the lungs of dogs exposed to berylliumcontaining dusts. Arch. Environ. Health
16:374–379.
Rom, W.N., J.E. Lockey, J.S. Lee, A.C.
Kimball, K.M. Bang, H. Leaman, R.E.
Johns, D. Perrota, and H.L. Gibbons.
(1984). Pneumoconiosis and Exposures
of Dental Laboratory Technicians.
American Journal of Public Health
74(11):1252–1257. November.
Rosenkranz H.S. and Poirer L.A. (1979).
Evaluation of the mutagenicity and DNAmodifying activity of carcinogens and
noncarcinogens in microbial systems. J
Natl Cancer Inst. 62(4):873–891.
Rosenman K., Hertzberg V., Rice C., Reilly
M.J., Aronchick J., Parker J.E., Regovich
J., Rossman M. (2005). Chronic beryllium
disease and sensitization at a beryllium
processing facility. Environ Health
Perspect Oct;113(10):1366–72; Erratum
(2006).
Rossman T.G., Molina M. (1984). The genetic
toxicology of metal compounds: I.
Induction of prophage in E coli WP2.
Environ Mut. 6(1); 59–69.
Rossman M.D., Kern J.A., Elias J.A., Cullen
M.R., Epstein P.E., Preuss O.P., Markham
T.N., Daniele R.P. (1988). Proliferative
PO 00000
Frm 00252
Fmt 4701
Sfmt 4702
Response of Bronchoalveolar
Lymphocytes to Beryllium: A test for
chronic beryllium disease. Annals Int
Med; 108(5):687–693.
Rossman M.D., Preuss O.P., Powers M.B.,
eds. (1991). Beryllium: Biomedical and
Environmental Aspects.
Immunopathogenesis of Chronic
Beryllium Disease. Chapter 10.
Baltimore, MD: Williams and Wilkins.
Rossman M. (1996). Chronic beryllium
disease; diagnosis and management.
Environ Health Perspect. Oct; 104 Suppl
5:945–7.
Rossman M.D. (2001). Chronic beryllium
disease: A hypersensitivity disorder.
Appl Occup Environ Hyg. May;
16(5):615–8.
Rossman M., Kreider. (2003). Is chronic
beryllium disease sarcoidosis of known
etiology? Sarcoidosis Vasc Diffuse Lung
Dis. Jun; 20(2):104–9.
Roth H.D. Memorandum to Brush Wellman
enclosing a critique of the EPA health
assessment document for beryllium.
February 22, 1985.
Saber W., Dweik R.A. (2000). A 65-year-old
factory worker with dyspnea on exertion
and a normal chest x-ray. Cleve Clin J
Med. Nov; 67(11):791–2, 794, 797–8,
800.
Saltini C., Winestock K., Kirby M., Pinkston
P., Crystal R.G. (1989). Maintenace of
alveolitis in patients with chronic
beryllium disease by beryllium-specific
helper T cells. N Engl J Med. Apr 27;
320(17):1103–9.
Saltini C., Kirby M., Trapnell B.C., Tamura
N., Crystal R.G. (1990). Biased
accumulation of T-lymphocytes with
‘‘memory’’-type CD45 leukocyte common
antigen gene expression on the epithelial
surface of human lung. J Exp Med. Apr
1; 171(4):1123–40.
Saltini C., Amicosante M. (2001). Beryllium
disease. Am J Med Sci 321(1):89–98.
Saltini C., Richeldi L., Losi M., Amicosante
M., Voorter C., van den Berg-Loonen E.,
Dweik R.A., Wiedmeann H.P., Deubner
D.C., Tinelli C. (2001). Major
Histocompatibility Locus Genetic
Markers of Beryllium Sensitization and
Disease. Eur Respir J 18(4):677–684.
Salvator H., Gille T., Herve A., Bron C.,
Lamberto C., Valeyre D. (2013). Chronic
beryllium disease: Azathioprine as a
possible alternative to corticosteroid
treatment. Eur Respir J; 41(1):234–236.
Sanders C.L., Cannon W.C., Powers G.J., et al.
(1975). Toxicology of high-fired
beryllium oxide inhaled by rodents.
Arch Environ Health 30:546–551.
Sanders, C.L., W.C. Cannon, and G.J. Powers.
(1978). Lung carcinogenesis induced by
inhaled high-fired oxides of beryllium
and plutonium. Health Phys. 35(2):193–
199.
Sanderson W.T., Henneberger P.K., Martyny
J., Ellis K., Mroz M.M., Newman L.S.
(1999). Beryllium contamination inside
vehicles of machine shop workers. Appl
Occup Environ Hyg 14(4):223–230.
Sanderson W.T., Ward E.M., Steenland K.,
Petersen M.R. (2001a). Lung Cancer Case
Control Study of Beryllium Workers. Am
J Ind Med. 39(2):133–44.
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
Sanderson W.T., Petersen M.R., Ward E.M.
(2001b). Estimating Historical Exposures
Of Workers In A Beryllium
Manufacturing Plant. Am J Ind Med.
39(2):145–57.
Saracci R. (1991) Beryllium and lung cancer:
Adding another piece to the puzzle of
epidemiologic evidence. J Natl Cancer
Inst 83:1362–1363.
Sawyer, R.T., V.A. Fadok, L.A. Kittle, L.A.
Maier, and L.S. Newman. (2000).
Beryllium-stimulated apoptosis in
macrophage cell lines. Toxicology
149(2–3):129–142.
Sawyer R.T., Parsons C.E., Fontenot A.P.,
Maier L.A., Gillespie M.M., Gottschall
E.B., Silveira L., Newman L.S. (2004).
Beryllium-induced tumor necrosis
factor-alpha production by CD4+ T cells
is mediated by HLA–DP. Am J Respir
Cell Mol Biol. Jul; 31(1):122–30.
Sawyer, R.T., D.R. Dobis, M. Goldstein, L.
Velsor, L.A. Maier, A.P. Fontenot, L.
Silveira, L.S. Newman, and B.J. Day.
(2005). Beryllium-stimulated reactive
oxygen species and macrophage
apoptosis. Free Radic. Biol. Med.
38(7):928–937.
[SBAR] Small Business Advocacy Review.
(2008). Report of the Small Business
Advocacy Review (SBAR) Panel on the
OSHA Draft Proposed Standard for
Occupational Exposure to Beryllium.
Small Business Advisory Review Panel
Report with Appendices A, B, C, and D.
Final version, January 15, 2008. OSHA
Beryllium Docket Document ID Number:
OSHA–H005C–2006–0870–0345.
Schepers GW, Durkan TM, Delahant AB,
Creedon FT. (1957) The biological action
of inhalaed beryllium sulfate; a
preliminary chronic toxicity study in
rats. AMA Arch Ind Health. 15 (1); 32–
58.
Schepers GW. (1962) The mineral content of
the lung in chronic berylliosis. Dis Chest.
Dec; 42:600–7.
Schlesinger RB, Ben-Jebria A, Dahl AR,
Snipes MB, Ultman J 1997. Chapter 12.
Disposition of inhaled toxicants. In:
Handbook of Human Toxicology
(Massaro EJ, ed). New York:CRC Press,
493–550.
Schubauer-Berigan MK, Deddens JA,
Steenland K, Sanderson WT, Petersen
MR. (2008) Adjustment for temporal
confounders in a reanalysis of a casecontrol study of beryllium and lung
cancer. Occup Environ Med. Jun;
65(6):379–83.
Schubauer-Berigan MK, Deddens JA,
Peterson MR. (2011) Risk of lung cancer
associated with quantitative beryllium
exposure metrics within an occupational
cohort. Occup Environ Med 68(5): 354–
60.
Schubauer-Berigan, 4–22–2011, NIOSH,
personal communication. (table of
lifetime risk estimates, Table VI–20 p. 64
of draft risk doc).
Schuler CR, Kent MS, Deubner DC, Berakis
MT, McCawley M, Henneberger PK,
Rossman MD, Kreiss K. (2005) ProcessRelated Risk of Beryllium Sensitization
and Disease in a Copper-Beryllium Alloy
Facility. Am J Ind Med. 47(3):195–205.
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
Schuler CR, Kitt MM, Henneberger PK,
Deubner, DC, Kreiss K. (2008)
Cumulative Sensitization and Disease in
a Beryllium Oxide Ceramics Worker
Cohort. J Occup Environ Med.
Dec;50(12):1343–1350.
Schuler CR, Virji MA, Deubner DC, Stanton
ML, Stefaniak AB, Day GA, Park JY, Kent
MS, Sparks R, Kreiss K. (2012)
Sensitization and Chronic Beryllium
Disease at a Primary Manufacturing
Facility, Part 3: Exposure-Response
Among Short-Term Workers. Scand J
Work Environ Health. May;38(3): 270–
81. Epub 2011 Aug 29.
Scott JK, Neumann WF, Allen R. (1950) The
effect of added carrier on the distribution
and excretion of soluble beryllium. J Biol
Chem, 182:291–298.
Seidler A, Euler U, Muller-Quernheim J,
Gaede KI, Latza U, Groneberg D, Letzel
S. (2012) Systematic review: progression
of beryllium sensitization to chronic
beryllium disease. Occup Med; 62 (7):
506–513.
Seiler D, Rice C, Herrick R, Hertzberg V.
(1996) A study of beryllium exposure
measurements: parts 1 and 2. Appl
Occup Environ Hyg 11:89–102.
Sendelbach LE, Witschi HP, Tryka AF. (1986)
Acute pulmonary toxicity of beryllium
sulfate inhalation in rats and mice: Cell
kinetics and histopathology. Toxicol
Appl Pharmacol 85:248–256.
Sendelbach LE, Witschi HP. (1987)
Bronchoalveolar lavage in rats and mice
following beryllium sulfate inhalation.
Toxicol Appl Pharmacol 90:322–329.
Sendelbach LE, Tryka AF, Witschi H. (1989)
Progressive lung injury over a one-year
period after a single inhalation exposure
to beryllium sulfate. Am Rev Respir Dis
139:1003–1009.
Silva DR, Coelho AC, Dumke A, Valentini JD,
de Nunes JN, Stefani CL, da Silva
Mendes LF, Knorst MM (2011)
Osteoporosis prevalence and associated
factors in patients with COPD: a crosssectional study. Respir Care. 56(7):961–
8.
Silveira LJ, McCanlies EC, Fingerlin TE, Van
Dyke MV, Mroz MM, Strand M, Fontenot
AP, Bowerman N, Dabelea DM, Schuler
CR, Weston A, Maier LA. (2012) Chronic
beryllium disease, HLA–DPB1, and the
DP peptide binding groove. J Immunol
189(8): 4014–4023.
Simmon VF. (1979) In vitro assays for
recombinogenic activity of chemical
carcinogens and realted compounds with
saccharomyces cerevisiae D3. Nat Cancer
Inst. 62 (4); 901–909.
Skilleter DN, Price RJ. (1978) The uptake and
subsequent loss of beryllium by rat liver
parenchymal and non-parenchymal cells
after the intravenous administration of
particulate and soluble forms. Chem Biol
Interact. Mar;20(3):383–96.
Skilleter DN, Paine AJ. (1979) Relative
toxicities of particulate and soluble
forms of beryllium to a rat liver
parenchymal cell line in culture and
possible mechanisms of uptake. Chem
Biol Interact. Jan; 24(1):19–33.
Skilleter DN, Price RJ. (1981) Effects of
beryllium compounds on rat liver
PO 00000
Frm 00253
Fmt 4701
Sfmt 4702
47817
Kupffer cells in culture. Toxicol Appl
Pharmacol. Jun 30;59(2):279–86.
Skilleter DN, Price RJ. (1988) Effects of
beryllium ions on tyrosine
phosphorylation. Biochem SocTrans
16:1047–1048.
Snyder, J. A., Weston, A., Tinkle, S. S., &
Demchuk, E. (2003). Electrostatic
potential on human leukocyte antigen:
implications for putative mechanism of
chronic beryllium disease.
Environmental health perspectives,
111(15), 1827.
Snyder JA, Demchuk E, McCanlies EC,
Schuler CR, Kreiss K, Andrew ME, Frye
BL, Ensey JS, Stanton ML, Weston A.
(2008) Impact of negatively charged
patches on the surface of MHC class II
antigen-presneting proteins on risk of
chronic beryllium disease. J R Soc
Interface; 5(24): 749–758.
Sood A, Beckett WS, Cullen MR. (2004)
Variable response to long-term
corticosteroid therapy in chronic
beryllium disease. Chest; 126 (6): 2000–
2007.
Sood A. (2009) Current treatment of chronic
beryllium disease. J Occup Environ Hyg;
6 (12): 762–765.
Spencer HC, Sadek SE., Jones JC, Hook RH,
Blumentshine JA, McCollister SB. (1967)
Toxicological studies on beryllium
oxides and beryllium containing exhaust
products, technical report. AMRL–TR–
67–46. Wright Patterson Air Force Base,
Aerospace Medical Research
Laboratories. May: 1–53.
Sprince NL, Kazemi H, Hardy HL. (1976)
Current (1975) problem of differentiating
between beryllium disease and
sarcoidosis. Ann N Y Acad Sci. 278:654–
64.
Sprince NL, Kazemi H. (1980) U.S. beryllium
case registry through 1977.
Environmental research, 21:44–47.
Stange AW, Hilmas DE, Furman FJ, Gatliffe
TR. (2001) Beryllium sensitization and
chronic beryllium disease at a former
nuclear weapons facility. Appl Occup
Environ Hyg. 16(3): 405–417.
Stange AW, Furman FJ, Hilmas DE. (2004)
The beryllium lymphocyte proliferation
test: Relevant issues in beryllium helath
surveillance. Am J Ind Med. 46 (5): 453–
462.
Stanton ML, Henneberger PK, Kent MS,
Deubner DC, Kreiss K, Schuler CR.
(2006) Sensitization and chronic
berullium disease among workers in
copper-beryllium distribution centers. J
Occup Environ Med. 48 (2): 204–211.
Steele VE, Wilkinson BP, Arnold JT, and
Kutzman RS. (1989) Study of beryllium
oxide genotoxicity in cultured
respiratory epithelial cells. Inhalation
Toxicology 1: 95–110.
Steenland K, Ward E. (1991) Lung cancer
incidence among patients with beryllium
disease: A cohort mortality study. J Natl
Cancer Inst 83:1380–1385.
Stefaniak AB, Weaver VM, Cadorette M,
Puckett LG, Schwartz BS, Wiggs LD,
Jankowski MD, and Breysse PN. (2003)
Summary of historical beryllium uses
and airborne concentration levels at Los
Alamos National Laboratory. Appl.
Occup. Environ. Hyg. 18(9):708–715.
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47818
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
Stefaniak AB, Hoover MD, Dickerson RM,
Peterson EJ, Day GA, Breysse PN, Kent
MS, Scripsick RC. (2003a) Surface area of
respirable beryllium metal, oxide, and
copper alloy aerosols and implications
for assessment of exposure risk of
chronic beryllium disease. Am. Ind. Hyg.
Assoc. J. 64(3):297–305.
Stefaniak AB, Guilmette RA, Day GA, Hoover
MD, Breysse PN, Scripsick RC. (2005)
Characterization of phagolysomal
simulant fluid of beryllium aerosol
particle dissolution. Toxicol In Vitro;
19(1):123–134.
Stefaniak, AB, Day GA, Hoover MD, Breysse
PN, Scripsick RC. (2006) Differences in
dissolution behavior in a
phagolysosomal stimulant fluid for
single-constituent and multi-constituent
materials associated with beryllium
sensitization and chronic beryllium
disease. Toxicol. In Vitro 20(1):82–95.
Stefaniak AB, Chipera SJ, Day GA, Sabey P,
Dickerson RM, Sbarra DC, Duling MG,
Lawrence RB, Stanton ML, Scripsick RC.
(2008) Physicochemical characteristics of
aerosol particles generated during the
milling of beryllium silicate ores:
Implications for risk assessment. J
Toxicol Environ Health A. 71(22):1468–
81.
Stefaniak AB, et al. 2008. Size-selective
poorly soluble particulate reference
materials for evaluation of quantitative
analytical methods. Anal. Bioan. Chem.
391:2071–2077.
Stefaniak, A. B., Virji, M. A., & Day, G. A.
(2011). Dissolution of beryllium in
artificial lung alveolar macrophage
phagolysosomal fluid. Chemosphere,
83(8), 1181–1187.
Stefaniak AB, Virji A, Day GA. (2012) Release
of beryllium into artificial airway
epithelial lining fluid. Arch Environ
Occup Health; 67(4):219–228.
Stiefel T, Schultze K, Zorn H, Tolg G. (1980)
Toxicokinetic and toxicodynamic studies
on beryllium. Arch Toxicol. Jul;
45(2):81–92.
Sterner JH and Eisenbud M. (1951)
Epidemiology of Beryllium
Intoxification. A M A Arch Ind Hyg
Occup Med. Aug; 4(2):123–51.
Stoeckle JD, Hardy HL, Weber AL. (1969)
Chronic beryllium disease. Long-term
follow-up of sixty cases and selective
review of the literature. Am J Med. 46
(4); 545–561.
Stokes RF, Rossman MD. (1991) Blood cell
proliferation response to beryllium:
Analysis by receiver-operating
characteristics. J Occup Med. Jan;
33(1):23–8.
Stokinger HE, Sprague GF, Hall RH, et al.
(1950) Acute inhalation toxicity of
beryllium. I. Four definitive studies of
beryllium sulfate at exposure
concentrations of 100, 50, 10 and 1 mg
per cubic meter. Arch Ind Hyg Occup
Med 1:379–397.
Stokinger HE, Altman KI, Salomon K. (1953)
The effect of various pathologicalconditions on in vivo hemoglobin
synthesis. I. Hemoglobin synthesis in
beryllium-induced anemia as studied
with alpha-14C-acetate. Biochim
Biophys Acta. Nov; 12(3):439–44.
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
Stubbs J, Argyris E, Lee CW, Monos D,
Rossman MD. (1996) Genetic markers in
beryllium hypersensitization. Chest.
Mar; 109 (3 Suppl): 45S.
Sutton M, Burastero SR. (2003) Beryllium
chemical speciation in elemental human
biological fluids. Chem Res Toxicol. Sep;
16(9):1145–54.
Swafford DS, Middleton SK, Palmisano WA,
Nikula KJ, Tesfaigzi J, Baylin SB,
Herman JG, and Belinsky SJ. (1997)
Frequent aberrant methylation of
p16INK4a in primary rat lung tumors.
Molecular and Cellular Biology 17
(3):1366–1374.
Sweiss NJ, Lower EE, Korsten P, Niewold TB,
Favus MJ, Baughman RP. (2011). Bone
health issues in sarcoidosis. Curr
Rheumatol Rep. Jun; 13(3):265–72.
Taiwo OA, Slade MD, Cantley LF, Fiellin
MG, Wesdock JC, Bayer FJ, Cullen MR.
(2008) Beryllium Sensitization in
Aluminum Smelter Workers. JOEM
50(2):157–162.
Taiwo OA, Slade MD, Cantley LF, Kirsche
SR, Wesdock JC, Cullen MR. (2010)
Prevalence of beryllium sensitization
among aluminum smelter workers.
Occup Med 60:569–571.
Tan MH, Commens CA, Burnett L, Snitch PJ.
(1996) A pilot study on the percutaneous
absorption of microfine titanium dioxide
from sunscreens. Australas J Dermatol.
Nov; 37(4):185–7.
Tarantino-Hutchison LM, Sorrentino C,
Nadas A, Zhu Y, Rubin EM, Tinkle SS,
Weston A, Gordon T (2009). Genetic
determinants of sensitivity to beryllium
in mice. J Immunotoxicol. 6 (2):130–135.
Thomas CA, Bailey RL, Kent MS, Deubner
DC, Kreiss K, Schuler CR. (2009) Efficacy
of a program to prevent beryllium
sensitization among new employees at a
copper-beryllium alloy processing
facility. Public Health Rep. Jul–Aug; 124
Suppl 1:112–24.
Thaler, R., and S. Rosen, 1976. ‘‘The Value
of Saving a Life: Evidence from the Labor
Market,’’ in Household Production and
Consumption, N E. Terleckyj (ed.), New
York: Columbia University Press, 1976,
pp. 265–298.
Thomas CA, Bailey RL, Kent MS, Deubner
DC, Kreiss K, Schuler CR. (2009) Efficacy
of a Program to Prevent Beryllium
Sensitization Among New Employees at
a Copper-Beryllium Alloy Processing
Facility. Public Health Rep.124 Suppl
1:112–24.
Thorat DD, Mahadevan TN, Ghosh DK.
(2003) Particle size distribution and
respiratory deposition estimates of
beryllium aerosols in an extraction and
processing plant. Am Ind Hyg Assoc J. 64
(4):522–527.
Tinkle SS, Newman LS. (1997) Berylliumstimulated release of tumor necrosis
factor-alpha, IL–6 and their soluble
receptors in chronic beryllium disease.
Am J Respir Crit Care Med. Dec; 156
(6):1884–91.
Tinkle SS, Kittle LA, Schumacher BA,
Newman LS. (1997) Beryllium induces
IL–2 and IFN-gamma in berylliosis. J
Immunol. Jan 1; 158(1):518–26.
Tinkle S, Kittle L, Schwitters PW, Addison
JR, Newman LS. (1996) Beryllium
PO 00000
Frm 00254
Fmt 4701
Sfmt 4702
stimulates release of T helper 1 cytokines
interleukin-2 and interferon gamma from
BAL cells in chronic beryllium disease.
Chest; 109 (Suppl 3):5S–6S.
Tinkle SS, Antonini JM, Rich BA, Roberts JR,
Salmen R, DePree K, Adkins EJ. (2003)
Skin as a route of exposure and
sensitization in chronic beryllium
disease. Environ Health Perspect. Jul;
111(9):1202–8.
Toledo, F., Silvestre, J. F., Cuesta, L., Latorre,
N., & Monteagudo, A. (2011). Contact
allergy to beryllium chloride: Report of
12 cases. Contact dermatitis, 64(2), 104–
109.
Torres, S.J., & Nowson, C.A. (2007).
Relationship between stress, eating
behavior, and obesity. Nutrition, 23,
887–94.
Trikudanathan S, McMahon GT. (2008).
Optimum management of glucocorticoidtreated patients. Nat Clin Pract
Endocrinol Metab. May; 4(5):262–71.
Tso WW, Fung WP. (1981) Mutagencity of
metallic cations. Toxicol Lett. 8 (4–5);
195–200.
Turk J.L. and Polak L. (1969) Experimental
studies on metal dermatitis in guinea
pigs. Int Arch Allergy Appl Immunol.
36(1):75–81.
U.S. Census Bureau. (2010). Income, Poverty,
and Health Insurance Coverage in the
United States: 2008, Current Population
Reports, P60–236(RV), and Historical
Tables—Table P–1, September 2009.
Internet release date: December 15, 2010.
Available at: https://www.census.gov/
hhes/www/income/data/historical/
people/.
[USGS] United States Geological Survey.
(2013a). 2011 Minerals Yearbook:
Beryllium [Advance Release]. Available
at: https://minerals.usgs.gov/minerals/
pubs/commodity/beryllium/myb1-2011beryl.pdf.
[USGS] United States Geological Survey.
(2013b). Mineral Commodity Summaries.
[Online]. Available at https://
minerals.usgs.gov/minerals/pubs/mcs/
2013/mcs2013.pdf.
Vacher J. (1972) Immunological response of
guinea pigs to beryllium salts. J Med
Microbiol. Feb; 5(1):91–108.
Van Cleave C.D., Kaylor C.T. (1955)
Distribution, retention, and elimination
of Be in the rat after intratracheal
injection. Archives of industrial health,
11:375–392.
Van Dyke M.V., Martyny J.W., Mroz M.M.,
Silveira L.J., Strand M., Fingerlin T.E.,
Sato H., Newman L.S., Maier L.A. (2011)
Risk of chronic beryllium disease by
HLA–DPB1 E69 genotype and beryllium
exposure in nuclear workers. Am J
Respir Crit Care Med 183 (12):1680–
1688.
Van Ordstrand H., Hughes R., Carmody M.G.
(1943). Chemical Pneumonia in Workers
Extracting Beryllium Oxide. Archives of
the Cleveland Clinic Quarterly. The
Cleveland Clinic Foundation. (1984)
51(2): 431–439. (originally in Cleveland
Clinic Quarterly 10:10–18, 1943).
Van Ordstrand H., Hughes R., DeNardi J.M.,
et al. (1945). Beryllium poisoning. J Am
Med Assoc129:1084–1090.
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
Vainio H., Rice J. Beryllium revisted. (1997)
J Occup Environ Med 39:203–204.
Vegni-Talluri M. and Guiggiani V. (1967)
Action of beryllium ions on primary
cultures of swine cells. Carlogia 20:355–
367.
Viet S.M., Torma-Krajewski J., Rogers J.
(2000) Chronic beryllium disease and
beryllium sensitization at Rocky Flats: A
case-control study. Am Ind Hyg Assoc J
61:244–254.
Virji M.A., Stefaniak A.B., Day G.A., Stanton
M.L., Kent M.S., Kreiss K., Schuler C.R.
(2011). Characteristics of Beryllium
Exposure to Small Particles At A
Beryllium Production Facility. Ann
Occup Hyg; 55 (1):70–85.
Virji M.A., Park J.Y., Stefaniak A.B., Stanton
M.L., Day G.A., Kent M.S., Kreiss K.,
Schuler C.R. (2012) Sensitization and
chronic beryllium disease at a primary
manufacturing facility, part 1: Historical
exposure reconstruction. Scand J Work
Environ Health; 38 (3):247–258.
Viscusi, W. and J. Aldy, 2003. ‘‘The Value of
a Statistical Life: A Critical Review of
Market Estimates Throughout the
World,’’ Journal of Risk and Uncertainty,
27, pp. 5–76.
Votto J.J., Barton R.W., Gionfriddo M.A., Cole
S.R., McCormick J.R., and Thrall R.S.
(1987) A model of pulmonary
granulomata induced by beryllium
sulfate in the rat. Sarcoidosis 4(1):71–76.
Vorwald A.J. (1968) Biologic manifestations
of toxic inhalants in monkeys. In:
Vagrborg H., ed. Use of Nonhuman
primates in drug evaluation: A
symposium. Southwest Foundation for
Research and Education. Austin, Texas:
University of Texas Press, 222–228.
Vorwald A.J., Reeves A.L. (1959) Pathologic
changes induced by beryllium
compounds. Arch Ind Health 19:190–
199.
Vourlekis J.A., R.T. Sawyer, L.S. Newman.
(2000) Sarcoidosis: Developments in
etiology, immunology, and therapeutics.
Adv Intern Med; 45:209–257.
Wagoner J., Infante P., Bayliss D. (1980)
Beryllium: An etiologic agent in the
induction of lung cancer, nonneoplastic
respiratory disease and heart disease
among industrially exposed workers.
Environ Res 21:15–34.
Wagner W.D., Groth D.H., Holtz J.L., Madden
G.E., and Stokinger H.E. (1969)
Comparative chronic inhalation toxicity
of beryllium ores, bertrandite and beryl,
with production of pulmonary tumors by
beryl. Toxicology and Applied
Pharmacology 15:10–29.
Ward E., Okun A., Ruder A., Fingerhut M.,
Steenland K. (1992) A mortality study of
workers at seven beryllium processing
plants. Am J Ind Med 22:885–904.
Warrington T.P., Bostwick J.M. (2006).
Psychiatric adverse effects of
corticosteroids. Mayo Clin Proc. Oct;
81(10):1361–7.
Warheit D.B., Yuen I.S., Kelly D.P., Snajdr S.,
Hartsky M.A. (1996) Subchronic
inhalation of high concentrations of low
toxicity, low solubility particulates
produces sustained pulmonary
inflammation and cellular proliferation.
Toxicol Lett. Nov; 88(1–3):249–53.
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
Weston A., Snyder J., McCanlies E.C.,
Schuler C.R., Andrew M.E., Kreiss K.,
Demchuk E. (2005) Immunogenetic
factors in beryllium sensitization and
chronic beryllium disease. Mutat Res 592
(1–2):68–78.
Williams W.J. and Williams W.R. (1983)
Value of beryllium lymphocyte
transformation tests in chronic beryllium
disease and in potentially exposed
workers. Thorax. Jan; 38(1):41–4.
[WHO] World Health Organization. (1990).
International Programme on Chemical
Safety (IPCS 1990). Beryllium: Health
and safety guide. No. 44. [online].
Available at: https://www.inchem.org/
documents/hsg/hsg/
hsg044.htm#SectionNumber:7.3.
[WHO] World Health Organization. (2001).
Concise International Chemical
Assessment Document (CICAD) 32
Beryllium and Beryllium compounds.
Winchester M.R., et al. (2009). Certification
of beryllium mass fraction in SRM 1877
Beryllium Oxide Powder using highperformance inductively-coupled plasma
optical emission spectrometry with exact
matching. Analytical Chemistry.
81:2208–2217.
Wolf G. (2002). Glucocorticoids in adipocytes
stimulate visceral obesity. Nutr Rev.
May; 60(5 Pt 1):148–51.
Yeh H.C., Cuddihy R.G., Phalen R.F., Chang
I.Y. (1996) Comparison of calculated
respiratory tract deposition of particles
based on the proposed NCRP model and
the new ICRP 66 model. Aerosol Sci
Techn; 25:134–140.
Yoshida T., Shima S., Nagaoka K., Taniwaki
H., Wada A., Kurita H., Morita K. (1997)
A study on the beryllium lymphocyte
transformation test and the beryllium
levels in working environment. Ind
Health 35:374–379.
Yucesoy B., Johnson V.J. (2011) Genetic
variability in susceptibility to
occupational respiratory sensitization. J
Allergy; 2011, 346719:1–7.
Zaki M.H., Lyons H.A., Leilop L., Huang C.T.
(1987) Corticosteroid therapy in
sarcoidosis. A five-year, controlled
follow-up study. NY State J Med. Sep;
87(9):496–9.
Zakour R.A., Glickman B.W. (1984) Metalinduced mutagenesis in the lacI gene of
Escherichia coli. Mutation research,
126:9–18.
Zissu D., Binet S., Cavelier C. (1996) Patch
testing with beryllium alloy samples in
guinea pigs. Contact Dermatitis. Mar;
34(3):196–200.
Zorn, H., Stiefel, T., & Diem, H. (1977). The
importance of beryllium and its
compounds for the industrial physician¨
2. communication. Zentralblatt fur
Arbeitsmedizin, Arbeitsschutz und
Prophylaxe, 27(4), 8.
List of Subjects in 29 CFR Part 1910
Cancer, Chemicals, Hazardous
substances, Health, Occupational safety
and health, Reporting and
recordkeeping requirements.
PO 00000
Frm 00255
Fmt 4701
Sfmt 4702
47819
Authority and Signature
David Michaels, Ph.D., MPH,
Assistant Secretary of Labor for
Occupational Safety and Health, U.S.
Department of Labor, 200 Constitution
Avenue NW., Washington, DC 20210,
directed the preparation of this notice.
OSHA is issuing this notice under
Sections 4, 6, and 8 of the Occupational
Safety and Health Act of 1970 (29 U.S.C.
653, 655, 657); section 41 of the
Longshore and Harbor Worker’s
Compensation Act (33 U.S.C. 941);
section 107 of the Contract Work Hours
and Safety Standards Act (Construction
Safety Act) (40 U.S.C. 3704); Secretary
of Labor’s Order 1–2012 (77 FR 3912,
January 25, 2012); and 29 CFR part
1911.
Signed at Washington, DC, on July 14,
2015.
David Michaels,
Assistant Secretary of Labor for Occupational
Safety and Health.
Proposed Standard
Chapter XVII of Title 29 of the Code
of Federal Regulations is proposed to be
amended as follows:
PART 1910—OCCUPATIONAL SAFETY
AND HEALTH STANDARDS
Subpart Z—Toxic and Hazardous
Substances
1. The authority citation for subpart Z
of part 1910 is revised to read as
follows:
■
Authority: Sections 4, 6, 8 of the
Occupational Safety and Health Act of 1970
(29 U.S.C. 653, 655, 657); Secretary of Labor’s
Order No. 8–76 (41 FR 25059), 9–83 (48 FR
35736), 1–90 (55 FR 9033), 6–96 (62 FR 111),
3–2000 (65 FR 50017), 5–2002 (67 FR 65008),
5–2007 (72 FR 31159), 4–2010 (75 FR 55355),
or 1–2012 (77 FR 3912), as applicable; and
29 CFR part 1911.
All of subpart Z issued under section 6(b)
of the Occupational Safety and Health Act of
1970, except those substances that have
exposure limits listed in Tables Z–1, Z–2,
and Z–3 of 29 CFR 1910.1000. The latter
were issued under section 6(a) (29 U.S.C.
655(a)).
Section 1910.1000, Tables Z–1, Z–2 and Z–
3 also issued under 5 U.S.C. 553, but not
under 29 CFR part 1911 except for the
arsenic (organic compounds), benzene,
cotton dust, and chromium (VI) listings.
Section 1910.1001 also issued under
section 107 of the Contract Work Hours and
Safety Standards Act (40 U.S.C. 3704) and 5
U.S.C. 553.
Section 1910.1002 also issued under 5
U.S.C. 553, but not under 29 U.S.C. 655 or
29 CFR part 1911.
Sections 1910.1018, 1910.1029, and
1910.1200 also issued under 29 U.S.C. 653.
Section 1910.1030 also issued under Pub. L.
106–430, 114 Stat. 1901.
E:\FR\FM\07AUP2.SGM
07AUP2
47820
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
§ 1910.1000
[Amended]
The revisions and additions read as
follows:
compounds (as Be)’’; and by adding
footnote ‘‘W’’; and
■ b. Table Z–2 is amended by adding
footnote ‘‘Y’’.
2. In § 1910.1000:
a. Table Z–1 is amended by revising
the entry for ‘‘Beryllium and beryllium
■
■
TABLE Z–1—LIMITS FOR AIR CONTAMINANTS
Substance
CAS No. (c)
*
*
*
Beryllium and beryllium compounds (as Be); see 1910.1024 W.
*
*
ppm (a) 1
mg/m3 (b) 1
Skin
designation
*
*
*
*
*
*
*
*
*
1 The
PELs are 8-hour TWAs unless otherwise noted; a (C) designation denotes a ceiling limit. They are to be determined from breathing-zone
air samples.
a. Parts of vapor or gas per million parts of contaminated air by volume at 25 °C and 760 torr.
b. Milligrams of substance per cubic meter of air. When entry is in this column only, the value is exact; when listed with a ppm entry, it is approximate.
c. The CAS number is for information only. Enforcement is based on the substance name. For an entry covering more than one metal compound, measured as the metal, the CAS number for the metal is given—not CAS numbers for the individual compounds.
d. The final benzene standard in § 1910.1028 applies to all occupational exposures to benzene except in some circumstances the distribution
and sale of fuels, sealed containers and pipelines, coke production, oil and gas drilling and production, natural gas processing, and the percentage exclusion for liquid mixtures; for the excepted subsegments, the benzene limits in Table Z–2 apply. See § 1910.1028 for specific circumstances.
e. This 8-hour TWA applies to respirable dust as measured by a vertical elutriator cotton dust sampler or equivalent instrument. The timeweighted average applies to the cottom waste processing operations of waste recycling (sorting, blending, cleaning and willowing) and
garnetting. See also § 1910.1043 for cotton dust limits applicable to other sectors.
f. All inert or nuisance dusts, whether mineral, inorganic, or organic, not listed specifically by substance name are covered by the Particulates
Not Otherwise Regulated (PNOR) limit which is the same as the inert or nuisance dust limit of Table Z–3.
*
*
*
*
*
*
*
W See Table Z–2 for the exposure limits for any operations or sectors for which the exposure limits in § 1910.1024 are not in effect.
TABLE Z–2
8-hour time
weighted
average
Substance
Acceptable
ceiling
concentration
Acceptable maximum peak
above the acceptable ceiling
average concentration for an
8-hr shift
Concentration
*
*
*
*
Beryllium and beryllium compounds (as Be) Y .................................................
*
Y This
*
*
5 μg/m3
*
*
25μg/m3
*
*
30 minutes
*
*
*
*
*
*
*
standard applies to any operations or sectors for which the Beryllium standard, 1910.1024, is not in effect.
3. Section 1910.1024 is added to
subpart Z to read as follows:
■
§ 1910.1024
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
*
*
2 μg/m3
Maximum
duration
Beryllium
(a) Scope and application. (1) This
section applies to occupational
exposures to beryllium in all forms,
compounds, and mixtures in general
industry, except those articles and
materials exempted by paragraphs (a)(2)
and (3) of this section.
(2) This section does not apply to
articles, as defined in the Hazard
Communication standard (HCS) (29 CFR
1910.1200(c)), that contain beryllium
and that the employer does not process.
(3) This section does not apply to
materials containing less than 0.1%
beryllium by weight.
(b) Definitions.
Action level means a concentration of
airborne beryllium of 0.1 micrograms
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
per cubic meter of air (mg/m3) calculated
as an 8-hour time-weighted average
(TWA).
Assistant Secretary means the
Assistant Secretary of Labor for
Occupational Safety and Health, United
States Department of Labor, or designee.
Beryllium lymphocyte proliferation
test (BeLPT) means the measurement of
blood lymphocyte proliferation in a
laboratory test when lymphocytes are
challenged with a soluble beryllium
salt. A confirmed positive test result
indicates the person has beryllium
sensitization.
Beryllium work area means any work
area where employees are, or can
reasonably be expected to be, exposed to
airborne beryllium, regardless of the
level of exposure.
PO 00000
Frm 00256
Fmt 4701
Sfmt 4702
CBD Diagnostic Center means a
medical diagnostic center that has onsite facilities to perform a clinical
evaluation for the presence of chronic
beryllium disease (CBD) that includes
bronchoalveolar lavage, transbronchial
biopsy and interpretation of the biopsy
pathology, and the beryllium
bronchoalveolar lavage lymphocyte
proliferation test (BeBALLPT).
Chronic beryllium disease (CBD)
means a chronic lung disease associated
with exposure to airborne beryllium.
Confirmed Positive means two
abnormal test results from either
consecutive BeLPTs or a second
abnormal BeLPT result within a 2-year
period of the first abnormal test result.
It also means the result of a more
reliable and accurate test indicating a
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
person has been identified as having
beryllium sensitization.
Director means the Director of the
National Institute for Occupational
Safety and Health (NIOSH), U.S.
Department of Health and Human
Services, or designee.
Emergency means any uncontrolled
release of airborne beryllium.
Exposure and exposure to beryllium
mean the exposure to airborne
beryllium that would occur if the
employee were not using a respirator.
High-efficiency particulate air (HEPA)
filter means a filter that is at least 99.97
percent efficient in removing particles
0.3 micrometers in diameter.
Physician or other licensed health
care professional (PLHCP) means an
individual whose legally permitted
scope of practice (i.e., license,
registration, or certification) allows the
individual to independently provide or
be delegated the responsibility to
provide some or all of the health care
services required by paragraph (k) of
this standard.
Regulated area means an area that the
employer must demarcate, including
temporary work areas where
maintenance or non-routine tasks are
performed, where an employee’s
exposure exceeds, or can reasonably be
expected to exceed, either of the
permissible exposure limits (PELs).
This standard means this beryllium
standard, 29 CFR 1910.1024.
(c) Permissible Exposure Limits
(PELs). (1) Time-weighted average
(TWA) PEL. The employer shall ensure
that each employee’s exposure does not
exceed 0.2 mg/m3 calculated as an 8hour TWA.
(2) Short-term exposure limit (STEL).
The employer shall ensure that each
employee’s exposure does not exceed
2.0 mg/m3 as determined over a
sampling period of 15 minutes.
(d) Exposure monitoring—(1) General.
(i) These exposure monitoring
requirements apply when employees
are, or may reasonably be expected to
be, exposed to airborne beryllium.
(ii) Except as provided in paragraphs
(d)(2)(i) and (ii) of this section, the
employer shall determine the 8-hour
TWA exposure for each employee based
on one or more breathing zone samples
that reflect the exposure of employees
on each work shift, for each job
classification, in each beryllium work
area.
(iii) Except as provided in paragraph
(d)(2)(i) and (ii) of this section, the
employer shall determine short-term
exposure from 15-minute breathing zone
samples measured in operations that are
likely to produce exposures above the
STEL for each work shift, for each job
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
classification, and in each beryllium
work area.
(iv) The employer may perform
representative sampling to characterize
exposure, provided that the employer:
(A) Performs representative sampling
where several employees perform the
same job tasks, in the same job
classification, on the same work shift,
and in the same work area, and have
similar duration and frequency of
exposure;
(B) Takes sufficient personal
breathing zone air samples to accurately
characterize exposure on each work
shift, for each job classification, in each
work area; and
(C) Samples those employee(s) who
are expected to have the highest
exposure.
(v) Accuracy of measurement. The
employer shall use a method of
exposure monitoring and analysis that
can measure beryllium to an accuracy of
plus or minus 25 percent within a
statistical confidence level of 95 percent
for airborne concentrations at or above
the action level.
(2) Initial exposure monitoring. The
employer shall conduct initial exposure
monitoring to determine the 8-hour
TWA exposure and 15-minute shortterm exposure for each employee. The
employer does not have to conduct
initial exposure monitoring in the
following situations:
(i) Where the employer has conducted
exposure monitoring for beryllium and
relies on these historical data, provided
that:
(A) The work operations and
workplace conditions that were in place
when the historical monitoring data
were obtained reflect workplace
conditions closely resembling the
processes, material, control methods,
work practices, and environmental
conditions used and prevailing in the
employer’s current operations;
(B) The characteristics of the
beryllium-containing material being
handled when the historical monitoring
data were obtained closely resemble the
characteristics of the berylliumcontaining material used during the job
for which initial monitoring will not be
performed; and
(C) The exposure monitoring satisfied
all other requirements of this section,
including Accuracy of Measurement in
paragraph (d)(1)(v).
(ii) Where the employer relies on
objective data to satisfy initial
monitoring requirements, provided that
such data:
(A) Demonstrate that any material
containing beryllium or any specific
process, operation, or activity involving
beryllium cannot release beryllium dust,
PO 00000
Frm 00257
Fmt 4701
Sfmt 4702
47821
fumes, or mist in concentrations at or
above the action level or above the STEL
under any expected conditions of use;
and
(B) Reflect workplace conditions
closely resembling the processes,
material, control methods, work
practices, and environmental conditions
used and prevailing in the employer’s
current operations.
(3) Periodic exposure monitoring. If
initial exposure monitoring indicates
that exposures are at or above the action
level and at or below the TWA PEL, the
employer shall conduct periodic
exposure monitoring at least annually in
accordance with paragraph (d)(1) of this
section.
(4) Additional monitoring. The
employer also shall conduct exposure
monitoring within 30 days after any of
the following situations occur:
(i) Any change in production
processes, equipment, materials,
personnel, work practices, or control
methods that can reasonably be
expected to result in new or additional
exposure; or
(ii) The employer has any other
reason to believe that new or additional
exposure is occurring.
(5) Employee notification of
monitoring results. (i) Within 15
working days after receiving the results
of any exposure monitoring completed
under this standard, the employer shall
notify each employee whose exposure is
measured or represented by the
monitoring individually in writing of
the monitoring results or shall post the
monitoring results in an appropriate
location that is accessible to each of
these employees.
(ii) Where exposures exceed the TWA
PEL or STEL, the written notification
required by paragraph (d)(5)(i) of this
section shall include suspected or
known sources of exposure and the
corrective action(s) the employer has
taken or will take to reduce exposure to
or below the PELs, where feasible
corrective action exists but had not been
implemented when the monitoring was
conducted.
(6) Observation of monitoring. (i) The
employer shall provide an opportunity
to observe any exposure monitoring
required by this standard to each
employee whose exposures are
measured or represented by the
monitoring and each employee’s
representative(s).
(ii) When observation of monitoring
requires entry into an area where the
use of protective clothing or equipment
(which may include respirators) is
required, the employer shall provide
each observer with appropriate
protective clothing and equipment at no
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47822
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
cost to the observer and shall ensure
that each observer uses such clothing
and equipment.
(iii) The employer shall ensure that
each observer complies with all
applicable OSHA requirements and the
employer’s workplace safety and health
procedures.
(e) Beryllium work areas and
regulated areas—(1) Establishment. (i)
The employer shall establish and
maintain a beryllium work area
wherever employees are, or can
reasonably be expected to be, exposed to
airborne beryllium, regardless of the
level of exposure.
(ii) The employer shall establish and
maintain a regulated area wherever
employees are, or can reasonably be
expected to be, exposed to airborne
beryllium at levels above the TWA PEL
or STEL.
(2) Demarcation. (i) The employer
shall identify each beryllium work area
through signs or any other methods that
adequately establish and inform each
employee of the boundaries of each
beryllium work area.
(ii) The employer shall identify each
regulated area in accordance with
paragraph (m)(2) of this section.
(3) Access.The employer shall limit
access to regulated areas to:
(i) Persons the employer authorizes or
requires to be in a regulated area to
perform work duties;
(ii) Persons entering a regulated area
as designated representatives of
employees for the purpose of exercising
the right to observe exposure monitoring
procedures under paragraph (d)(6) of
this section; and
(iii) Persons authorized by law to be
in a regulated area.
(4) Provision of personal protective
clothing and equipment, including
respirators. The employer shall provide
and ensure that each employee entering
a regulated area uses:
(i) Respiratory protection in
accordance with paragraph (g) of this
section; and
(ii) Personal protective clothing and
equipment in accordance with
paragraph (h) of this section.
(f) Methods of compliance—(1)
Written exposure control plan.
(i) The employer shall establish,
implement, and maintain a written
exposure control plan for beryllium
work areas, which shall contain:
(A) An inventory of operations and
job titles reasonably expected to have
exposure;
(B) An inventory of operations and job
titles reasonably expected to have
exposure at or above the action level;
(C) An inventory of operations and job
titles reasonably expected to have
exposure above the TWA PEL or STEL;
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
(D) Procedures for minimizing crosscontamination, including but not
limited to preventing the transfer of
beryllium between surfaces, equipment,
clothing, materials, and articles within
beryllium work areas;
(E) Procedures for keeping surfaces in
the beryllium work area as free as
practicable of beryllium;
(F) Procedures for minimizing the
migration of beryllium from beryllium
work areas to other locations within or
outside the workplace;
(G) An inventory of engineering and
work practice controls required by
paragraph (f)(2) of this standard; and
(H) Procedures for removal,
laundering, storage, cleaning, repairing,
and disposal of beryllium-contaminated
personal protective clothing and
equipment, including respirators.
(ii) The employer shall update the
exposure control plan when:
(A) Any change in production
processes, materials, equipment,
personnel, work practices, or control
methods results or can reasonably be
expected to result in new or additional
exposures to beryllium;
(B) An employee is confirmed
positive, is diagnosed with CBD, or
shows signs or symptoms associated
with exposure; or
(C) The employer has any reason to
believe that new or additional exposures
are occurring or will occur.
(iii) The employer shall make a copy
of the exposure control plan accessible
to each employee who is or can
reasonably be expected to be exposed to
airborne beryllium in accordance with
OSHA’s Access to Employee Exposure
and Medical Records (Records Access)
standard (29 CFR 1910.1020(e)).
(2) Engineering and work practice
controls. (i) (A) For each operation in a
beryllium work area, the employer shall
ensure that at least one of the following
engineering and work practice controls
is in place to minimize employee
exposure:
(1) Material and/or process
substitution;
(2) Ventilated partial or full
enclosures;
(3) Local exhaust ventilation at the
points of operation, material handling,
and transfer; or
(4) Process control, such as wet
methods and automation.
(B) An employer is exempt from using
the above controls to the extent that:
(1) The employer can establish that
such controls are not feasible; or
(2) The employer can demonstrate
that exposures are below the action
level, using no fewer than two
representative personal breathing zone
samples taken 7 days apart, for each
affected operation.
PO 00000
Frm 00258
Fmt 4701
Sfmt 4702
(ii) If after implementing the
control(s) required by (f)(2)(i)(A)
exposures exceed the TWA PEL or
STEL, the employer shall implement
additional or enhanced engineering and
work practice controls to reduce
exposures to or below the PELs.
(iii) Wherever the employer
demonstrates that it is not feasible to
reduce exposures to or below the PELs
by the engineering and work practice
controls required by paragraphs (f)(2)(i)
and (ii) of this section, the employer
shall implement and maintain
engineering and work practice controls
to reduce exposures to the lowest levels
feasible and supplement these controls
by using respiratory protection in
accordance with paragraph (g) of this
section.
(3) Prohibition of rotation. The
employer shall not rotate employees to
different jobs to achieve compliance
with the PELs.
(g) Respiratory protection—(1)
General. The employer shall provide at
no cost and ensure that each employee
uses respiratory protection during:
(i) Periods necessary to install or
implement feasible engineering and
work practice controls where exposures
exceed or can reasonably be expected to
exceed the TWA PEL or STEL;
(ii) Operations, including
maintenance and repair activities and
non-routine tasks, when engineering
and work practice controls are not
feasible and exposures exceed or can
reasonably be expected to exceed the
TWA PEL or STEL;
(iii) Work operations for which an
employer has implemented all feasible
engineering and work practice controls
when such controls are not sufficient to
reduce exposure to or below the TWA
PEL or STEL;
(iv) Emergencies.
(2) Respiratory protection program.
Where this standard requires an
employee to use respiratory protection,
such use shall be in accordance with the
Respiratory Protection Standard (29 CFR
1910.134).
(h) Personal protective clothing and
equipment—(1) Provision and use. The
employer shall provide at no cost and
ensure that each employee uses
appropriate personal protective clothing
and equipment in accordance with the
written exposure control plan required
under paragraph (f)(1) of this section
and OSHA’s Personal Protective
Equipment standards (29 CFR part 1910
subpart I):
(i) Where employee exposure exceeds
or can reasonably be expected to exceed
the TWA PEL or STEL;
(ii) Where employees’ clothing or skin
may become visibly contaminated with
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
beryllium including during
maintenance and repair activities or
during non-routine tasks; or
(iii) Where employees’ skin can
reasonably be expected to be exposed to
soluble beryllium compounds.
(2) Removal and storage. (i) The
employer shall ensure that each
employee removes all berylliumcontaminated protective clothing and
equipment:
(A) At the end of the work shift or at
the completion of tasks involving
beryllium, whichever comes first, or
(B) When protective clothing or
equipment becomes visibly
contaminated with beryllium.
(ii) The employer shall ensure that
each employee removes protective
clothing visibly contaminated with
beryllium as specified in the exposure
control plan required by paragraph (f)(1)
of this section.
(iii) The employer shall ensure that
each employee stores and keeps
required protective clothing separate
from street clothing.
(iv) The employer shall ensure that no
employee removes berylliumcontaminated protective clothing or
equipment from the workplace, except
for employees authorized to do so for
the purposes of laundering, cleaning,
maintaining or disposing of berylliumcontaminated protective clothing and
equipment at an appropriate location or
facility away from the workplace.
(v) When protective clothing or
equipment required by this standard is
removed from the workplace for
laundering, cleaning, maintenance or
disposal, the employer shall ensure that
protective clothing and equipment are
stored and transported in sealed bags or
other closed containers that are
impermeable and are labeled in
accordance with paragraph (m)(3) of this
section and the HCS (29 CFR
1910.1200).
(3) Cleaning and replacement. (i) The
employer shall ensure that all reusable
protective clothing and equipment
required by this standard is cleaned,
laundered, repaired, and replaced as
needed to maintain its effectiveness.
(ii) The employer shall ensure that
beryllium is not removed from
protective clothing and equipment by
blowing, shaking or any other means
that disperses beryllium into the air.
(iii) The employer shall inform in
writing the persons or the business
entities who launder, clean or repair the
protective clothing or equipment
required by this standard of the
potentially harmful effects of exposure
to airborne beryllium and contact with
soluble beryllium compounds and that
the protective clothing and equipment
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
must be handled in accordance with
this standard.
(i) Hygiene areas and practices—(1)
General. For each employee working in
a beryllium work area, the employer
shall:
(i) Provide readily accessible washing
facilities to remove beryllium from the
hands, face, and neck; and
(ii) Ensure each employee exposed to
beryllium to use these facilities when
necessary.
(2) Change rooms. In addition to the
requirements of paragraph (i)(1)(i) of
this section, the employer shall provide
affected employees with a designated
change room and washing facilities in
accordance with this standard and the
Sanitation Standard (29 CFR 1910.141)
where employees are required to remove
their personal clothing.
(3) Showers. (i) The employer shall
provide showers in accordance with the
Sanitation standard (29 CFR 1910.141)
where:
(A) Exposure exceeds or can
reasonably be expected to exceed the
TWA PEL or STEL; and
(B) Beryllium can reasonably be
expected to contaminate employees’
hair or body parts other than hands,
face, and neck.
(ii) Employers required to provide
showers under paragraph (i)(3)(i) of this
section shall ensure that each employee
showers at the end of the work shift or
work activity if:
(A) The employee reasonably could
have been exposed above the TWA PEL
or STEL; and
(B) Beryllium could reasonably have
contaminated the employee’s hair or
body parts other than hands, face, and
neck.
(4) Eating and drinking areas.
Whenever the employer allows
employees to consume food or
beverages in a beryllium work area, the
employer shall ensure that:
(i) Surfaces in eating and drinking
areas are as free as practicable of
beryllium;
(ii) No employee in eating and
drinking areas is exposed to airborne
beryllium at or above the action level;
and
(iii) Eating and drinking facilities
provided by the employer are in
accordance with the Sanitation standard
(29 CFR 1910.141).
(5) Prohibited activities. (i) The
employer shall ensure that no
employees eat, drink, smoke, chew
tobacco or gum, or apply cosmetics in
regulated areas.
(ii) The employer shall ensure that no
employees enter any eating or drinking
area with protective work clothing or
equipment unless surface beryllium has
PO 00000
Frm 00259
Fmt 4701
Sfmt 4702
47823
been removed from the clothing or
equipment by methods that do not
disperse beryllium into the air or onto
an employee’s body.
(j) Housekeeping—(1) General. (i) The
employer shall maintain all surfaces in
beryllium work areas as free as
practicable of accumulations of
beryllium and in accordance with the
exposure control plan required under
paragraph (f)(1) of this section and the
cleaning methods required under
paragraph (j)(2) of this section; and
(ii) The employer shall ensure that all
spills and emergency releases of
beryllium are cleaned up promptly and
in accordance with the exposure control
plan required under paragraph (f)(1) of
this section and the cleaning methods
required under paragraph (j)(2) of this
section.
(2) Cleaning methods. (i) The
employer shall ensure that surfaces in
beryllium work areas are cleaned by
HEPA-filter vacuuming or other
methods that minimize the likelihood
and level of exposure.
(ii) The employer shall not allow dry
sweeping or brushing for cleaning
surfaces in beryllium work areas unless
HEPA-filtered vacuuming or other
methods that minimize the likelihood
and level of exposure have been tried
and were not effective.
(iii) The employer shall not allow the
use of compressed air for cleaning
beryllium-contaminated surfaces unless
the compressed air is used in
conjunction with a ventilation system
designed to capture the particulates
made airborne by the use of compressed
air.
(iv) Where employees use dry
sweeping, brushing, or compressed air
to clean beryllium-contaminated
surfaces, the employer shall provide and
ensure that each employee uses
respiratory protection and protective
clothing and equipment in accordance
with paragraphs (g) and (h) of this
section.
(v) The employer shall ensure that
cleaning equipment is handled and
maintained in a manner that minimizes
the likelihood and level of employee
exposure and the re-entrainment of
airborne beryllium in the workplace.
(3) Disposal. The employer shall
ensure that:
(i) Waste, debris, and materials visibly
contaminated with beryllium and
consigned for disposal are disposed of
in sealed, impermeable enclosures, such
as bags or containers;
(ii) Bags or containers of waste,
debris, and materials required by (j)(3)(i)
of this section are labeled in accordance
with paragraph (m)(3) of this section;
and
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47824
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
(iii) Materials designated for recycling
that are visibly contaminated with
beryllium shall be cleaned to remove
visible particulate, or placed in sealed,
impermeable enclosures, such as bags or
containers, that are labeled in
accordance with paragraph (m)(3) of this
section.
(k) Medical surveillance—(1) General.
(i) The employer shall make medical
surveillance as required by this
paragraph available at no cost to the
employee, and at a reasonable time and
place, as follows:
(A) For each employee who has
worked in a regulated area for more than
30 days in the last 12 months;
(B) For each employee showing signs
or symptoms of CBD, such as shortness
of breath after a short walk or climbing
stairs, persistent dry cough, chest pain,
or fatigue;
(C) For each employee exposed to
beryllium during an emergency; and
(D) For each employee who was
exposed to airborne beryllium above .2
mg/m3 for more than 30 days in a 12month period for 5 years or more,
limited to the procedures described in
paragraph (k)(3)(ii)(F) of this section
unless the employee also qualifies for an
examination under paragraph
(k)(1)(i)(A), (B), or (C) of this section.
(ii) The employer shall ensure that all
medical examinations and procedures
required by this standard are performed
by or under the direction of a licensed
physician.
(2) Frequency. The employer shall
provide a medical examination:
(i) Within 30 days after determining
that:
(A) An employee meets the criteria of
paragraph (k)(1)(i)(A) of this section,
unless the employee has received a
medical examination, provided in
accordance with this standard, within
the last 12 months; or
(B) An employee meets the criteria of
paragraph (k)(1)(i)(B) or (C) of this
section.
(ii) Annually thereafter for each
employee who continues to meet the
criteria of paragraph (k)(1)(i)(A) or (B) of
this section; and
(iii) At the termination of employment
for each employee who meets the
criteria of paragraph (k)(1)(i)(A), (B), or
(C) of this section at the time the
employee’s employment is terminated,
unless an examination has been
provided in accordance with this
standard during the 6 months prior to
the date of termination.
(3) Contents of examination. (i) The
employer shall ensure that the PLHCP
advises the employee of the risks and
benefits of participating in the medical
surveillance program and the
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
employee’s right to opt out of any or all
parts of the medical examination.
(ii) The employer shall ensure that the
employee is offered a medical
examination that includes:
(A) A medical and work history, with
emphasis on past and present exposure,
smoking history, and any history of
respiratory system dysfunction;
(B) A physical examination with
emphasis on the respiratory tract;
(C) A physical examination for skin
breaks and wounds;
(D) Pulmonary function tests,
performed in accordance with the
guidelines established by the American
Thoracic Society including forced vital
capacity and forced expiratory volume
at one (1) second (FEV1);
(E) (1) A standardized BeLPT upon
the first examination and within every
2 years from the date of the first
examination until the employee is
confirmed positive. If a more reliable
and accurate diagnostic test is
developed after [EFFECTIVE DATE OF
FINAL RULE] of this standard such that
beryllium sensitization can be
confirmed after one test, a second
confirmation test need not be
performed.
(2) If an employee who has not been
confirmed positive receives an abnormal
BeLPT result, a second BeLPT is to be
performed within 1 month. This
requirement for a second test is waived
if a more reliable and accurate test for
beryllium sensitization does not need to
be repeated due to variability,
repeatability and accuracy of the test
methodology.
(F) Each employee who meets the
criteria of paragraph (k)(1)(i)(D) shall be
offered a low dose helical tomography
(CT Scan). The CT Scan shall be offered
every 2 years for the duration of the
employee’s employment. This
obligation begins on the [EFFECTIVE
DATE OF FINAL RULE], or on the 15th
year after the employee’s first exposure
above .2 mg/m3 for more than 30 days in
a 12-month period, whichever is later;
and
(G) Any other test deemed appropriate
by the PLHCP.
(4) Information provided to the
PLHCP. The employer shall ensure that
the examining PLHCP has a copy of this
standard and all appendices and shall
provide the following information, if
known:
(i) A description of the employee’s
former and current duties that relate to
the employee’s occupational exposure;
(ii) The employee’s former and
current levels of occupational exposure;
(iii) A description of any protective
clothing and equipment, including
respirators, used by the employee,
PO 00000
Frm 00260
Fmt 4701
Sfmt 4702
including when and for how long the
employee has used that protective
clothing and equipment; and
(iv) Information from records of
employment-related medical
examinations previously provided to the
employee, currently within the control
of the employer, after obtaining a
medical release from the employee.
(5) Licensed physician’s written
medical opinion. (i) The employer shall
obtain a written medical opinion from
the licensed physician within 30 days of
the examination, which contains:
(A) The licensed physician’s opinion
as to whether the employee has any
detected medical condition that would
place the employee at increased risk of
CBD from further exposure;
(B) Any recommended limitations on
the employee’s exposure, including the
use and limitations of protective
clothing or equipment, including
respirators; and
(C) A statement that the PLHCP has
explained the results of the medical
examination to the employee, including
any tests conducted, any medical
conditions related to exposure that
require further evaluation or treatment,
and any special provisions for use of
protective clothing or equipment.
(ii) The employer shall ensure that
neither the licensed physician nor any
other PLHCP reveals to the employer
specific findings or diagnoses unrelated
to exposure to airborne beryllium or
contact with soluble beryllium
compounds.
(iii) The employer shall provide a
copy of the licensed physician’s written
medical opinion to the employee within
2 weeks after receiving it.
(6) Referral to a CBD diagnostic
center. (i) Within 30 days after an
employer learns that an employee has
been confirmed positive, the employer’s
designated licensed physician shall
consult with the employee to discuss
referral to a CBD diagnostic center that
is mutually agreed upon by the
employer and the employee.
(ii) If, after this consultation, the
employee wishes to obtain a clinical
evaluation at a CBD diagnostic center,
the employer shall provide the
evaluation at no cost to the employee.
(7) Beryllium sensitization test results
research. Upon request by OSHA,
employers must convey employees’
beryllium sensitization test results to
OSHA for evaluation and analysis.
Employers must remove employees’
names, social security numbers, and
other personally identifying information
from the test results before conveying
them to OSHA.
(l) Medical removal. (1) If an
employee works in a job with exposure
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
at or above the action level and is
diagnosed with CBD or confirmed
positive, the employee is eligible for
medical removal.
(2) If an employee is eligible for
medical removal, the employee must
choose:
(i) Removal as described in paragraph
(l)(3) of this section; or
(ii) To remain in a job with exposure
at or above the action level, provided
that the employee wears a respirator in
accordance with the Respiratory
Protection standard (29 CFR 1910.134).
(3) If the employee chooses removal:
(i) The employer shall remove the
employee to comparable work for which
the employee is qualified or can be
trained within 1 month. In this
standard, comparable work must be in
a work environment where the exposure
is below the action level. The employee
must accept comparable work if such
work is available;
(ii) If comparable work is not
available, the employer shall place the
employee on paid leave for 6 months or
until such time as comparable work
becomes available, whichever comes
first; and
(iii) Whether the employee is removed
to comparable work or placed on paid
leave, the employer shall maintain for 6
months the employee’s base earnings,
seniority, and other rights and benefits
that existed at the time of removal.
(4) The employer’s obligation to
provide medical removal protection
benefits to a removed employee shall be
reduced to the extent that the employee
receives compensation for earnings lost
during the period of removal from a
publicly or employer-funded
compensation program, or receives
income from another employer made
possible by virtue of the employee’s
removal.
(m) Communication of hazards— (1)
General. (i) Chemical manufacturers,
importers, distributors, and employers
shall comply with all requirements of
the HCS (29 CFR 1910.1200) for
beryllium.
(ii) In classifying the hazards of
beryllium, the employer shall address at
least the following hazards: Cancer; lung
effects (CBD and acute beryllium
disease); beryllium sensitization; skin
sensitization; and skin, eye, and
respiratory tract irritation.
(iii) Employers shall include
beryllium in the hazard communication
program established to comply with the
HCS. Employers shall ensure that each
employee has access to labels on
containers of beryllium and to safety
data sheets, and is trained in accordance
with the requirements of the HCS (29
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
CFR 1910.1200) and paragraph (m)(4) of
this section.
(2) Warning signs—(i) Posting. The
employer shall provide and display
warning signs at each approach to a
regulated area so that each employee is
able to read and understand the signs
and take necessary protective steps
before entering the area.
(ii) Sign specification. (A) The
employer shall ensure that the warning
signs required by paragraph (m)(2)(i) of
this section are legible and readily
visible.
(B) The employer shall ensure each
warning sign required by paragraph
(m)(2)(i) of this section bears the
following legend:
DANGER
BERYLLIUM
MAY CAUSE CANCER
CAUSES DAMAGE TO LUNGS
AUTHORIZED PERSONNEL ONLY
WEAR RESPIRATORY PROTECTION AND PROTECTIVE CLOTHING AND EQUIPMENT IN THIS
AREA
(3) Warning labels. The employer
shall label each bag and container of
clothing, equipment, and materials
visibly contaminated with beryllium
consistent with the HCS (29 CFR
1910.1200), and shall, at a minimum,
include the following on the label:
DANGER
CONTAINS BERYLLIUM
MAY CAUSE CANCER
CAUSES DAMAGE TO LUNGS
AVOID CREATING DUST
DO NOT GET ON SKIN
(4) Employee information and
training. (i) For each employee who is
or can reasonably be expected to be
exposed to airborne beryllium:
(A) The employer shall provide
information and training in accordance
with the HCS (29 CFR 1910.1200(h));
(B) The employer shall provide initial
training to each employee by the time of
initial assignment; and
(C) The employer shall repeat the
training required under this section
annually for each employee.
(ii) The employer shall ensure that
each employee who is or can reasonably
be expected to be exposed to airborne
beryllium can demonstrate knowledge
of the following:
(A) The health hazards associated
with exposure to beryllium and contact
with soluble beryllium compounds,
including the signs and symptoms of
CBD;
(B) The written exposure control plan,
with emphasis on the location(s) of
beryllium work areas, including any
regulated areas, and the specific nature
of operations that could result in
PO 00000
Frm 00261
Fmt 4701
Sfmt 4702
47825
employee exposure, especially
employee exposure above the TWA PEL
or STEL;
(C) The purpose, proper selection,
fitting, proper use, and limitations of
personal protective clothing and
equipment, including respirators;
(D) Applicable emergency procedures;
(E) Measures employees can take to
protect themselves from exposure to
beryllium and contact with soluble
beryllium compounds, including
personal hygiene practices;
(F) The purpose and a description of
the medical surveillance program
required by paragraph (k) of this section
including risks and benefits of each test
to be offered;
(G) The purpose and a description of
the medical removal protection
provided under paragraph (l) of this
section;
(H) The contents of the standard; and
(I) The employee’s right of access to
records under the Records Access
standard (29 CFR 1910.1020).
(iii) When a workplace change (such
as modification of equipment, tasks, or
procedures) results in new or increased
employee exposure that exceeds, or can
reasonably be expected to exceed, either
the TWA PEL or the STEL, the employer
shall provide additional training to
those employees affected by the change
in exposure.
(iv) Employee information. The
employer shall make a copy of this
standard and its appendices readily
available at no cost to each employee
and designated employee
representative(s).
(n) Recordkeeping—(1) Exposure
measurements. (i) The employer shall
maintain a record of all measurements
taken to monitor employee exposure as
prescribed in paragraph (d) of this
section.
(ii) This record shall include at least
the following information:
(A) The date of measurement for each
sample taken;
(B) The operation that is being
monitored;
(C) The sampling and analytical
methods used and evidence of their
accuracy;
(D) The number, duration, and results
of samples taken;
(E) The type of personal protective
clothing and equipment, including
respirators, worn by monitored
employees at the time of monitoring;
and
(F) The name, social security number,
and job classification of each employee
represented by the monitoring,
indicating which employees were
actually monitored.
(iii) The employer shall maintain this
record as required by the Records
E:\FR\FM\07AUP2.SGM
07AUP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
47826
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
Access standard (29 CFR
1910.1020(d)(1)(ii)).
(2) Historical monitoring data. (i) The
employer shall establish and maintain
an accurate record of any historical data
used to satisfy the initial monitoring
requirements of paragraph (d)(2) of this
standard.
(ii) The record shall demonstrate that
the data comply with the requirements
of paragraph (d)(2) of this section.
(iii) The employer shall maintain this
record as required by the Records
Access standard (29 CFR 1910.1020).
(3) Objective data. (i) Where an
employer uses objective data to satisfy
the monitoring requirements under
paragraph (d)(2) of this section, the
employer shall establish and maintain a
record of the objective data relied upon.
(ii) This record shall include at least
the following information:
(A) The data relied upon;
(B) The beryllium-containing material
in question;
(C) The source of the objective data;
(D) A description of the operation
exempted from initial monitoring and
how the data support the exemption;
and
(E) Other information demonstrating
that the data meet the requirements for
objective data contained in paragraph
(d)(2)(ii) of this section.
(iii) The employer shall maintain this
record as required by the Records
Access standard (29 CFR 1910.1020).
(4) Medical surveillance. (i) The
employer shall establish and maintain a
record for each employee covered by
medical surveillance under paragraph
(k) of this section.
(ii) The record shall include the
following information about the
employee:
(A) Name, social security number, and
job classification;
(B) A copy of all licensed physicians’
written opinions; and
(C) A copy of the information
provided to the PLHCP as required by
paragraph (k)(4) of this section.
(iii) The employer shall ensure that
medical records are maintained in
accordance with the Records Access
standard (29 CFR 1910.1020).
(5) Training. (i) At the completion of
any training required by this standard,
the employer shall prepare a record that
indicates the name, social security
number, and job classification of each
employee trained, the date the training
was completed, and the topic of the
training.
(ii) This record shall be maintained
for 3 years after the completion of
training.
(6) Access to records. Upon request,
the employer shall make all records
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
maintained as a requirement of this
standard available for examination and
copying to the Assistant Secretary, the
Director, each employee, and each
employee’s designated representative(s)
in accordance the Records Access
standard (29 CFR 1910.1020).
(7) Transfer of records. The employer
shall comply with the requirements
involving transfer of records set forth in
the Records Access standard (29 CFR
1910.1020).
(o) Dates. (1) Effective date.This
standard shall become effective [DATE
60 DAYS AFTER PUBLICATION OF
FINAL RULE IN THE Federal Register].
(2) Start-up dates. All obligations of
this standard commence and become
enforceable [DATE 90 DAYS AFTER
EFFECTIVE DATE OF FINAL RULE]
except:
(i) Change rooms required by
paragraph (i) of this section shall be
provided no later than 1 year after
[EFFECTIVE DATE OF FINAL RULE];
and
(ii) Engineering controls required by
paragraph (f) of this standard shall be
implemented no later than 2 years after
[EFFECTIVE DATE OF FINAL RULE].
(p) Appendices. Appendices A and B
of this section are non-mandatory.
Appendix A to § 1910.1024—
Immunological Testing for the
Determination of Beryllium
Sensitization (Non-Mandatory)
I. Background
Exposure to beryllium via inhalation or
dermal contact has been determined to cause
an immunological reaction (sensitization) in
some individuals. Beryllium sensitization
can progress to chronic beryllium disease
(CBD). Identifying sensitized workers
through an immunological screening program
is an essential element in any monitoring and
surveillance program designed to reduce the
risk of developing CBD in the workplace
(Kreiss, 1993b, Newman, 2005).
Immunological testing for sensitization to
beryllium serves to identify workers at risk
for progression to CBD. The medical
surveillance and medical removal provisions
of the proposed standard provide for clinical
evaluation of sensitized workers for earlystage CBD and intervention before
progression to more debilitating health
effects occurs.
2. This appendix provides an overview of
the test currently used to detect beryllium
sensitization, the peripheral blood Beryllium
Lymphocyte Proliferation Test (BeLPT) as
well as a description of the test procedure,
the best available information on the
accuracy of the test, and several repeattesting algorithms designed to improve the
predictive value of the test. It is important
that this information be made available to
employers, employees, physicians and other
medical personnel to ensure their
understanding of the test and the meaning of
test results, and to provide a basis to compare
PO 00000
Frm 00262
Fmt 4701
Sfmt 4702
the reliability and validity (utility) of any
other sensitization tests that may be
developed with the utility of the BeLPT.
II. The Peripheral Blood Beryllium
Lymphocyte Proliferation Test (BeLPT)
1. The BeLPT is an in-vitro blood test that
measures the beryllium antigen-specific Tcell mediated immune response. Currently,
the BeLPT is the most commonly available
diagnostic tool for identifying beryllium
sensitization.
2. To perform the BeLPT, venous blood is
collected in heparinized tubes. Lymphocytes
are isolated from the blood using
centrifugation and washed in salt solution.
The lymphocytes are counted and evaluated
for cell viability. These cells are then
cultured in quadruplicate in the presence or
absence of beryllium sulfate at 1, 10, and 100
mM concentrations for 3–7 days. During the
last 4 hours of the culture, cells are pulsed
with a radiolabeled DNA precursor (tritiated
thymidine deoxyriboside), harvested onto
filters and counted in a liquid scintillation
counter. The counts per minute (cpm) from
each set of quadruplicates are averaged and
expressed as a ratio of the cpm of the
beryllium stimulated cells to the
unstimulated cells. This ratio is called the
stimulation index (SI) (Maier, 2003).
3. The BeLPT is interpreted based on the
proportion of SIs that exceeds a cut-off value,
the expected SI for non-sensitized
individuals. Each laboratory sets its own cutoff for the test (Newman 1996). Traditionally,
this cut-off value is determined by testing
cells from control/non-exposed individuals,
and must be determined with each new
serum lot that will be used for culturing the
peripheral blood lymphocytes. The cut-off is
based on the mean value of the peak
stimulation index among controls plus 2 or
3 standard deviations. This methodology was
modeled into a statistical method known as
the ‘‘least absolute values’’ (an adaptation of
the ‘‘statistical-biological positive’’ method)
and relies on natural log modeling of the
median stimulation index values (DOE 2001,
Frome 2003). This methodology is
recommended by the Department of Energy
in guidance (DOE–SPEC–1142–2001)
developed by DOE to optimize and
standardize beryllium sensitivity testing. It is
recommended, but not mandated, to be used
in all DOE contracts with laboratories for the
purchase of BeLPT services. Other labs have
used a standard ratio of 3.0 (stimulated to
unstimulated) as the cut-off for an abnormal
result (Stange 2004, Deubner 2001).
4. BeLPT results are reported as ‘‘normal,’’
‘‘abnormal,’’ or ‘‘borderline abnormal.’’
According to the DOE a BeLPT result is
considered ‘‘abnormal’’ if at least two of the
six stimulation indices are elevated (DOE
2001). If only one of the six stimulation
indices is elevated, the test is considered
‘‘borderline abnormal’’ (DOE 2001). If no
stimulation index is elevated, the test is
normal. A BeLPT may be considered
uninterpretable if there are problems with the
viability of the cells or lack of response to
mitogen, or other problems with the test
procedure. (DOE 2001).
5. Due to the nature of the test, issues with
variability and reproducibility of a test can
E:\FR\FM\07AUP2.SGM
07AUP2
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
arise between and within labs. Potential
sources of variability include: technical
problems such as bacterial contamination,
cell death, omission of tritiated thymidine
pulse, technician skill, degree of automation,
use of flat- or round-bottom culture plates,
serum concentration, use of beryllium sulfate
versus beryllium fluoride, concentration of
the culture serum, and the handling of outlier
SIs (Mroz 1991).
6. Test characteristics and testing
algorithms. The utility of any diagnostic,
screening or surveillance test relies on the
capacity of the test to predict whether or not
an individual indeed has the condition
intended to be reflected by the test. In the
discussion below, sensitivity refers to the
proportion of sensitized persons who test
positive for sensitization using the BeLPT.
Specificity refers to the proportion of nonsensitized persons who test negative. Positive
predictive value (PPV) refers to the
proportion of persons who test positive, who
are actually sensitized. The PPV is related
not only to the utility of the test, but also to
the prevalence of the condition in the tested
population. In the remainder of this
discussion, we will refer to the results of a
single BeLPT as ‘‘abnormal,’’ ‘‘normal,’’ and
‘‘borderline,’’ and will refer to the outcome
of a testing algorithm as ‘‘positive’’ for
sensitization or ‘‘negative.’’
7. Stange et al. (2004) investigated the
utility of BeLPT testing in a population of
employees of 18 United States Department of
Energy (DOE) sites. At these sites, 12,194
current and former employees were tested for
beryllium sensitization at four laboratories
with BeLPT expertise. Stange et al. reported
that 68.3 percent of beryllium-sensitized
workers tested positive based on a single
abnormal BeLPT result (sensitivity). Thus,
the rate of false negatives (undetected cases
of beryllium sensitization) based on one
normal result was 31.7 percent. Stange et al.
reported a false positive rate of 1.09 percent
for one abnormal BeLPT result and a PPV of
0.253, which they found comparable to other
widely accepted medical tests. Middleton et
al. (2006) adjusted Stange’s parameters to
consider borderline test results and estimated
that 59.7 percent of sensitized persons would
test abnormal, 27.7 percent would test
normal, and 12.6 percent would have
borderline results. They estimated that
among non-sensitized persons, 97.37 percent
would test normal, 1.09 percent would test
abnormal, and 1.58 percent would have
borderline results. Stange et al.
recommended repeat testing to confirm an
abnormal BeLPT result to assure appropriate
referral for CBD medical evaluation (Stange
et al., 2004).
8. Middleton et al. (2006) studied the
characteristics of two testing algorithms. The
more basic algorithm used a single initial test
plus subsequent split specimen confirmation
tests. In the second, enhanced algorithm, an
initial test was split and sent to different
laboratories for analysis. The sensitivity,
specificity, and PPV reported by Middleton
were 65.7 percent, 99.9 percent, and 93
47827
percent respectively for the basic algorithm,
and 86 percent, 99.8 percent, and 90 percent
respectively for the enhanced algorithm. The
authors concluded that an algorithm for
BeLPT testing and interpretation is best
selected or designed after considering the (1)
likelihood and level of exposure; (2) purpose
of testing (i.e., screening versus medical
testing of patients; (3) opportunity for onetime testing versus serial testing; (4)
importance of getting the right answer the
first time; and (5) number of persons to be
tested and the funds available.
9. In April 2006, the Agency for Toxic
Substances and Disease Registry (ATSDR)
convened an expert panel of seven
physicians and scientists to discuss the
BeLPT and to consider what algorithm
should be used to interpret BeLPT results to
establish beryllium sensitization (Middleton
et al., 2008). The three criteria proposed by
panel members were Criteria A (one
abnormal BeLPT result establishes
sensitization); Criteria B (one abnormal and
one borderline result establish sensitization);
and Criteria C (two abnormal results establish
sensitization).
10. Using the single-test outcome
probabilities developed by Stange et al., the
panel convened by ATSDR calculated and
compared the sensitivity, specificity, and
positive predictive values (PPVs) for each
algorithm. The characteristics for each
algorithm were as follows:
TABLE A.1—CHARACTERISTICS OF BeLPT ALGORITHMS
[Adapted from Middleton et al., 2008]
Criteria A
(1 abnormal)
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Sensitivity .........................................................................................................................
Specificity .........................................................................................................................
PPV at 1% prevalence ....................................................................................................
PPV at 10% prevalence ..................................................................................................
False positives per 10,000 ..............................................................................................
study further demonstrates borderline
results’ value in predicting beryllium
sensitization using the BeLPT.
11. The study demonstrated that
confirmation of BeLPT results, whether as
one abnormal and one borderline abnormal
or as two abnormals, enhances the test’s PPV
and protects the persons tested from
unnecessary and invasive medical
procedures. In populations with a high
prevalence of beryllium sensitization (i.e., 10
percent or more), however, a single test may
be adequate to predict sensitization
(Middleton et al., 2008).
12. In a later analysis, Middleton et al.
(2011) conducted an evaluation using
borderline results from BeLPT testing.
Utilizing the common clinical algorithm with
a criterion that accepted 1 abnormal and 1
borderline as establishing beryllium
sensitization resulted in a PPV of 94.4
percent. This study also found that 3
borderline results resulted in a PPV of 91
percent. Both of these PPVs were based on
a population prevalence of 2 percent. This
1. In the medical surveillance provisions of
this standard, OSHA requires the use of a
standardized BeLPT, but states that a ‘‘more
reliable and accurate diagnostic test’’ for
beryllium sensitization may be used in lieu
of the BeLPT if such a test is developed. The
Agency considers the following criteria to be
important in judging a new test’s validity and
reliability:
a. A test report prepared by an
independent 1 research laboratory stating that
the laboratory has tested the protocol and has
found it to be valid and reliable; and
b. An article that has been published in a
peer-reviewed journal describing the protocol
1 An example of an ‘‘independent’’ research
laboratory would be a laboratory with no financial
Criteria B
(1 abnormal + 1
borderline)
68.2%
98.89%
38.3%
87.2%
111
65.7%
99.92%
89.3%
98.9%
8
interest in the protocol, and no affiliation with the
manufacture or supply of beryllium.
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
III. New Beryllium-Specific Immunological
Test Protocols
PO 00000
Frm 00263
Fmt 4701
Sfmt 4702
Criteria C
(2 abnormal)
61.2%
99.98%
96.8%
99.7%
2
and explaining how test data support the
protocol’s validity and reliability.
c. Sensitivity and specificity that meet or
exceed those reported for the BeLPT in peerreviewed publications.
Appendix B to § 1910.1024: Control
Strategies To Minimize Beryllium
Exposure (Non-Mandatory)
Paragraph (f)(2)(i) of § 1910.1024 requires
employers to use one or more of the control
methods listed in paragraph (f)(2)(i)(A) of
§ 1910.1024 to minimize worker exposure in
each operation in a beryllium work area,
unless the operation is exempt under
paragraph (f)(2)(i)(B) of § 1910.1024. This
appendix sets forth a non-exhaustive list of
control options that employers could use to
comply with paragraph (f)(2)(i)(A) of
§ 1910.1024 for a number of specific
beryllium operations.
E:\FR\FM\07AUP2.SGM
07AUP2
47828
Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules
TABLE B.1—EXPOSURE CONTROL RECOMMENDATIONS
Operation
Minimal control strategy *
Application group
Beryllium Oxide Forming
(e.g., pressing, extruding).
For pressing operations: ..............................................................................................
(1) Install local exhaust ventilation (LEV) on oxide press tables, oxide feed
drum breaks, press tumblers, powder rollers, and die set disassembly stations;
(2) Enclose the oxide presses; and
(3) Install mechanical ventilation (make-up air) in processing areas.
For extruding operations: .............................................................................................
(1) Install LEV on extruder powder loading hoods, oxide supply bottles, rod
breaking operations, centerless grinders, rod laydown tables, dicing operations, surface grinders, discharge end of extrusion presses;
(2) Enclose the centerless grinders; and
(3) Install mechanical ventilation (make-up air) in processing areas.
For medium and high gassing operations ...................................................................
(1) Perform operation with a hood having a maximum of one open side; and
(2) Design process so as to minimize spills; if accidental spills occur, perform
immediate cleanup.
Primary Beryllium Production; Beryllium Oxide Ceramics and Composites.
Chemical Processing Operations (e.g., leaching,
pickling, degreasing, etching, plating).
Finishing (e.g., grinding,
sanding, polishing,
deburring).
Furnace Operations (e.g.,
Melting and Casting).
Machining .............................
Mechanical Processing (e.g.,
material handling (including scrap), sorting, crushing, screening, pulverizing,
shredding, pouring, mixing, blending).
Metal Forming (e.g., rolling,
drawing, straightening, annealing, extruding).
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Welding ................................
(1) Perform portable finishing operations in a ventilated hood. The hood should include both downdraft and backdraft ventilation, and have at least two sides and a
top.
(2) Perform stationary finishing operations using a ventilated and enclosed hood at
the point of operation. The grinding wheel of the stationary unit should be enclosed and ventilated.
(1) Use LEV on furnaces, pelletizer; arc furnace ingot machine discharge; pellet
sampling; arc furnace bins and conveyors; beryllium hydroxide drum dumper and
dryer; furnace rebuilding; furnace tool holders; arc furnace tundish and tundish
skimming, tundish preheat hood, and tundish cleaning hoods; dross handling
equipment and drums; dross recycling; and tool repair station, charge make-up
station, oxide screener, product sampling locations, drum changing stations, and
drum cleaning stations.
(2) Use mechanical ventilation (make-up air) in furnace building.
Use (1) LEV consistent with ACGIH® ventilation guidelines on deburring hoods, wet
surface grinder enclosures, belt sanding hoods, and electrical discharge machines (for operations such as polishing, lapping, and buffing);
(2) high velocity low volume hoods or ventilated enclosures on lathes, vertical mills,
CNC mills, and tool grinding operations;
(3) for beryllium oxide ceramics, LEV on lapping, dicing, and laser cutting; and
(4) wet methods (e.g., coolants).
(1) Enclose and ventilate sources of emission;
(2) Prohibit open handling of materials; and
(3) Use mechanical ventilation (make-up air) in processing areas.
(1) For rolling operations, install LEV on mill stands and reels such that a hood extends the length of the mill;
(2) For point and chamfer operations, install LEV hoods at both ends of the rod;
(3) For annealing operations, provide an inert atmosphere for annealing furnaces,
and LEV hoods at entry and exit points;
(4) For swaging operations, install LEV on the cutting head;
(5) For drawing, straightening, and extruding operations, install LEV at entry and
exit points; and
(6) For all metal forming operations, install mechanical ventilation (make-up air) for
processing areas.
For fixed welding operations:
(1) Enclose work locations around the source of fume generation and use local
exhaust ventilation; and
(2) Install close capture hood enclosure designed so as to minimize fume
emission from the enclosure welding operation.
For manual operations:
(1) Use portable local exhaust and general ventilation.
Primary Beryllium Production; Beryllium Oxide Ceramics and Composites;
Copper Rolling, Drawing
and Extruding.
Secondary Smelting; Fabrication of Beryllium Alloy
Products; Dental Labs.
Primary Beryllium Production; Beryllium Oxide Ceramics and Composites;
Nonferrous Foundries;
Secondary Smelting.
Primary Beryllium Production; Beryllium Oxide Ceramics and Composites;
Copper Rolling, Drawing,
and Extruding; Precision
Turned Products.
Primary Beryllium Production; Beryllium Oxide Ceramics and Composites;
Aluminum and Copper
Foundries; Secondary
Smelting.
Primary Beryllium Production; Copper Rolling,
Drawing, and Extruding;
Fabrication of Beryllium
Alloy Products.
Primary Beryllium Production; Fabrication of Beryllium Alloy Products;
Welding.
* All LEV specifications should be in accordance with the ACGIH® Publication No. 2094, ‘‘Industrial Ventilation—A Manual of Recommended
Practice’’ wherever applicable.
[FR Doc. 2015–17596 Filed 8–6–15; 8:45 am]
BILLING CODE 4510–26–P
VerDate Sep<11>2014
19:20 Aug 06, 2015
Jkt 235001
PO 00000
Frm 00264
Fmt 4701
Sfmt 9990
E:\FR\FM\07AUP2.SGM
07AUP2
]]>Agencies
[Federal Register Volume 80, Number 152 (Friday, August 7, 2015)]
[Proposed Rules]
[Pages 47565-47828]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-17596]
[[Page 47565]]
Vol. 80
Friday,
No. 152
August 7, 2015
Part II
Department of Labor
-----------------------------------------------------------------------
Occupational Safety and Health Administration
-----------------------------------------------------------------------
29 CFR Part 1910
Occupational Exposure to Beryllium and Beryllium Compounds; Proposed
Rule
Federal Register / Vol. 80 , No. 152 / Friday, August 7, 2015 /
Proposed Rules
[[Page 47566]]
-----------------------------------------------------------------------
DEPARTMENT OF LABOR
Occupational Safety and Health Administration
29 CFR Part 1910
[Docket No. OSHA-H005C-2006-0870]
RIN 1218-AB76
Occupational Exposure to Beryllium and Beryllium Compounds
AGENCY: Occupational Safety and Health Administration (OSHA),
Department of Labor.
ACTION: Proposed rule; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Occupational Safety and Health Administration (OSHA)
proposes to amend its existing exposure limits for occupational
exposure in general industry to beryllium and beryllium compounds and
promulgate a substance-specific standard for general industry
regulating occupational exposure to beryllium and beryllium compounds.
This document proposes a new permissible exposure limit (PEL), as well
as ancillary provisions for employee protection such as methods for
controlling exposure, respiratory protection, medical surveillance,
hazard communication, and recordkeeping. In addition, OSHA seeks
comment on a number of alternatives, including a lower PEL, that could
affect construction and maritime, as well as general industry.
DATES: Written comments. Written comments, including comments on the
information collection determination described in Section IX of the
preamble (OMB Review under the Paperwork Reduction Act of 1995), must
be submitted (postmarked, sent, or received) by November 5, 2015.
Informal public hearings. The Agency will schedule an informal
public hearing on the proposed rule if requested during the comment
period. The location and date of the hearing, procedures for interested
parties to notify the Agency of their intention to participate, and
procedures for participants to submit their testimony and documentary
evidence will be announced in the Federal Register if a hearing is
requested.
ADDRESSES: Written comments. You may submit comments, identified by
Docket No. OSHA-H005C-2006-0870, by any of the following methods:
Electronically: You may submit comments and attachments
electronically at https://www.regulations.gov, which is the Federal e-
Rulemaking Portal. Follow the instructions on-line for making
electronic submissions. When uploading multiple attachments into
Regulations.gov, please number all of your attachments because
www.Regulations.gov will not automatically number the attachments. This
will be very useful in identifying all attachments in the beryllium
rule. For example, Attachment 1_title of your document, Attachment 2_
title of your document, Attachment 3_title of your document, etc.
Specific instructions on uploading all documents are found in the
Facts, Answer, Questions portion and the commenter check list on
Regulations.gov Web page.
Fax: If your submissions, including attachments, are not longer
than 10 pages, you may fax them to the OSHA Docket Office at (202) 693-
1648.
Mail, hand delivery, express mail, messenger, or courier service:
You may submit your comments to the OSHA Docket Office, Docket No.
OSHA-H005C-2006-0870, U.S. Department of Labor, Room N-2625, 200
Constitution Avenue NW., Washington, DC 20210, telephone (202) 693-2350
(OSHA's TTY number is (877) 889-5627). Deliveries (hand, express mail,
messenger, or courier service) are accepted during the Docket Office's
normal business hours, 8:15 a.m.-4:45 p.m., E.S.T.
Instructions: All submissions must include the Agency name and the
docket number for this rulemaking (Docket No. OSHA-H005C-2006-0870).
All comments, including any personal information you provide, are
placed in the public docket without change and may be made available
online at https://www.regulations.gov. Therefore, OSHA cautions you
about submitting personal information such as Social Security numbers
and birthdates.
If you submit scientific or technical studies or other results of
scientific research, OSHA requests (but is not requiring) that you also
provide the following information where it is available: (1)
Identification of the funding source(s) and sponsoring organization(s)
of the research; (2) the extent to which the research findings were
reviewed by a potentially affected party prior to publication or
submission to the docket, and identification of any such parties; and
(3) the nature of any financial relationships (e.g., consulting
agreements, expert witness support, or research funding) between
investigators who conducted the research and any organization(s) or
entities having an interest in the rulemaking. If you are submitting
comments or testimony on the Agency's scientific or technical analyses,
OSHA requests that you disclose: (1) The nature of any financial
relationships you may have with any organization(s) or entities having
an interest in the rulemaking; and (2) the extent to which your
comments or testimony were reviewed by an interested party before you
submitted them. Disclosure of such information is intended to promote
transparency and scientific integrity of data and technical information
submitted to the record. This request is consistent with Executive
Order 13563, issued on January 18, 2011, which instructs agencies to
ensure the objectivity of any scientific and technological information
used to support their regulatory actions. OSHA emphasizes that all
material submitted to the rulemaking record will be considered by the
Agency to develop the final rule and supporting analyses.
Docket: To read or download comments and materials submitted in
response to this Federal Register notice, go to Docket No. OSHA-H005C-
2006-0870 at https://www.regulations.gov, or to the OSHA Docket Office
at the address above. All comments and submissions are listed in the
https://www.regulations.gov index; however, some information (e.g.,
copyrighted material) is not publicly available to read or download
through that Web site. All comments and submissions are available for
inspection at the OSHA Docket Office.
Electronic copies of this Federal Register document are available
at https://www.regulations.gov. Copies also are available from the OSHA
Office of Publications, Room N-3101, U.S. Department of Labor, 200
Constitution Avenue NW., Washington, DC 20210; telephone (202) 693-
1888. This document, as well as news releases and other relevant
information, is also available at OSHA's Web site at https://www.osha.gov.
OSHA has not provided the document ID numbers for all submissions
in the record for this beryllium proposal. The proposal only contains a
reference list for all submissions relied upon. The public can find all
document ID numbers in an Excel spreadsheet that is posted on OSHA's
rulemaking Web page (see www.osha.gov/berylliumrulemaking). The public
will be able to locate submissions in the record in the public docked
Web page: https://www.regulations.gov. To locate a particular submission
contained in https://www.regulations.gov, the public should enter the
full document ID number in the search bar.
FOR FURTHER INFORMATION CONTACT: For general information and press
inquiries, contact Frank Meilinger, Director, Office of Communications,
Room N-3647,
[[Page 47567]]
OSHA, U.S. Department of Labor, 200 Constitution Avenue NW.,
Washington, DC 20210; telephone: (202) 693-1999; email:
meilinger.francis2@dol.gov . For technical inquiries, contact: William
Perry or Maureen Ruskin, Directorate of Standards and Guidance, Room N-
3718, OSHA, U.S. Department of Labor, 200 Constitution Avenue NW.,
Washington, DC 20210; telephone (202) 693-1955 or fax (202) 693-1678;
email: perry.bill@dol.gov.
SUPPLEMENTARY INFORMATION:
The preamble to the proposed standard on occupational exposure to
beryllium and beryllium compounds follows this outline:
Executive Summary
I. Issues and Alternatives
II. Pertinent Legal Authority
III. Events Leading to the Proposed Standards
IV. Chemical Properties and Industrial Uses
V. Health Effects
VI. Preliminary Risk Assessment
VII. Response to Peer Review
VIII. Significance of Risk
IX. Summary of the Preliminary Economic Analysis and Initial
Regulatory Flexibility Analysis
X. OMB Review under the Paperwork Reduction Act of 1995
XI. Federalism
XII. State-Plan States
XIII. Unfunded Mandates Reform Act
XIV. Protecting Children from Environmental Health and Safety Risks
XV. Environmental Impacts
XVI. Consultation and Coordination with Indian Tribal Governments
XVII. Public Participation
XVIII. Summary and Explanation of the Proposed Standard
(a) Scope and Application
(b) Definitions
(c) Permissible Exposure Limits (PELs)
(d) Exposure Assessment
(e) Beryllium Work Areas and Regulated Areas
(f) Methods of Compliance
(g) Respiratory Protection
(h) Personal Protective Clothing and Equipment
(i) Hygiene Areas and Practices
(j) Housekeeping
(k) Medical Surveillance
(l) Medical Removal
(m) Communication of Hazards to Employees
(n) Recordkeeping
(o) Dates
XIX. References
Executive Summary
OSHA currently enforces permissible exposure limits (PELs) for
beryllium in general industry, construction, and shipyards. These PELs
were adopted in 1971, shortly after the Agency was created, and have
not been updated since then. The time-weighted average (TWA) PEL for
beryllium is 2 micrograms per cubic meter of air ([mu]g/m\3\) as an 8-
hour time-weighted average. OSHA is proposing a new TWA PEL of 0.2
[mu]g/m\3\ in general industry. OSHA is also proposing other elements
of a comprehensive health standard, including requirements for exposure
assessment, preferred methods for controlling exposure, respiratory
protection, personal protective clothing and equipment (PPE), medical
surveillance, medical removal, hazard communication, and recordkeeping.
OSHA's proposal is based on the requirements of the Occupational
Safety and Health Act (OSH Act) and court interpretations of the Act.
For health standards issued under section 6(b)(5) of the OSH Act, OSHA
is required to promulgate a standard that reduces significant risk to
the extent that it is technologically and economically feasible to do
so. See Section II of this preamble, Pertinent Legal Authority, for a
full discussion of OSHA legal requirements.
OSHA has conducted an extensive review of the literature on adverse
health effects associated with exposure to beryllium. The Agency has
also assessed the risk of beryllium-related diseases at the current TWA
PEL, the proposed TWA PEL and the alternative TWA PELs. These analyses
are presented in this preamble at Section V, Health Effects, Section
VI, Preliminary Risk Assessment, and Section VIII, Significance of
Risk. As discussed in Section VIII of this preamble, Significance of
Risk, the available evidence indicates that worker exposure to
beryllium at the current PEL poses a significant risk of chronic
beryllium disease (CBD) and lung cancer, and that the proposed standard
will substantially reduce this risk.
Section 6(b) of the OSH Act requires OSHA to determine that its
standards are technologically and economically feasible. OSHA's
examination of the technological and economic feasibility of the
proposed rule is presented in the Preliminary Economic Analysis and
Initial Regulatory Flexibility Analysis (PEA) (OSHA, 2014), and is
summarized in Section IX of this preamble, Summary of the Preliminary
Economic Analysis and Initial Regulatory Flexibility Analysis. OSHA has
preliminarily concluded that the proposed PEL of 0.2 [mu]g/m\3\ is
technologically feasible for all affected industries and application
groups. Thus, OSHA preliminarily concludes that engineering and work
practices will be sufficient to reduce and maintain beryllium exposures
to the proposed PEL of 0.2 [mu]g/m\3\ or below in most operations most
of the time in the affected industries. For those few operations within
an industry or application group where compliance with the proposed PEL
cannot be achieved even when employers implement all feasible
engineering and work practice controls, the proposed standard would
require employers to supplement controls with respirators.
OSHA developed quantitative estimates of the compliance costs of
the proposed rule for each of the affected industry sectors. The
estimated compliance costs were compared with industry revenues and
profits to provide a screening analysis of the economic feasibility of
complying with the revised standard and an evaluation of the potential
economic impacts. Industries with unusually high costs as a percentage
of revenues or profits were further analyzed for possible economic
feasibility issues. After performing these analyses, OSHA has
preliminarily concluded that compliance with the requirements of the
proposed rule would be economically feasible in every affected industry
sector.
The Regulatory Flexibility Act, as amended by the Small Business
Regulatory Enforcement Fairness Act (SBREFA), requires that OSHA either
certify that a rule would not have a significant economic impact on a
substantial number of small entities or prepare a regulatory
flexibility analysis and hold a Small Business Advocacy Review (SBAR)
Panel prior to proposing the rule. OSHA has determined that a
regulatory flexibility analysis is needed and has provided this
analysis in Chapter IX of the PEA (OSHA, 2014). A summary is provided
in Section IX of this preamble, Summary of the Preliminary Economic
Analysis and Initial Regulatory Flexibility Analysis. OSHA also
previously held a SBAR Panel for this rule. The recommendations of the
Panel and OSHA's response to them are summarized in Section IX of this
preamble.
Executive Orders 13563 and 12866 direct agencies to assess all
costs and benefits of available regulatory alternatives. Executive
Order 13563 emphasizes the importance of quantifying both costs and
benefits, of reducing costs, of harmonizing rules, and of promoting
flexibility. This rule has been designated an economically significant
regulatory action under section 3(f)(1) of Executive Order 12866.
Accordingly, this proposed rule has been reviewed by the Office of
Management and Budget. The remainder of this section summarizes the key
findings of the analysis with respect to costs and benefits of the
proposed standard, presents alternatives
[[Page 47568]]
to the proposed standard, and requests comments on a number of issues.
Table I-1, which is derived from material presented in the PEA,
provides a summary of OSHA's best estimate of the costs and benefits of
this proposed rule. As shown, this proposed rule is estimated to
prevent 96 fatalities and 50 non-fatal beryllium-related illnesses
annually once it is fully effective, and the monetized annualized
benefits of the proposed rule are estimated to be $576 million using a
3-percent discount rate and $255 million using a 7-percent discount
rate. Also as shown in Table I-1, the estimated annualized cost of the
rule is $37.6 million using a 3-percent discount rate and $39.1 million
using a 7-percent discount rate. This proposed rule is estimated to
generate net benefits of $538 million annually using a 3-percent
discount rate and $216 million annually using a 7-percent discount
rate. These estimates are for informational purposes only and have not
been used by OSHA as the basis for its decision concerning the choice
of a PEL or of other ancillary requirements for this proposed beryllium
rule. The courts have ruled that OSHA may not use benefit-cost analysis
or a criterion of maximizing net benefits as a basis for setting OSHA
health standards.\1\
---------------------------------------------------------------------------
\1\ Am. Textile Mfrs. Inst., Inc. v. Nat'l Cotton Council of
Am., 452 U.S. 490, 513 (1981); Pub. Citizen Health Research Group v.
U.S. Dep't of Labor, 557 F.3d 165, 177 (3d Cir. 2009).
Table I-1--Annualized Costs, Benefits and Net Benefits of OSHA's Proposed Beryllium Standard of 0.2 [mu]g/m\3\
----------------------------------------------------------------------------------------------------------------
Discount rate 3% 7%
----------------------------------------------------------------------------------------------------------------
Annualized Costs
Engineering Controls......................... $9,540,189 $10,334,036
Respirators.................................. 249,684 252,281
Exposure Assessment.......................... 2,208,950 2,411,851
Regulated Areas and Beryllium Work Areas..... 629,031 652,823
Medical Surveillance......................... 2,882,076 2,959,448
Medical Removal.............................. 148,826 166,054
Exposure Control Plan........................ 1,769,506 1,828,766
Protective Clothing and Equipment............ 1,407,365 1,407,365
Hygiene Areas and Practices.................. 389,241 389,891
Housekeeping................................. 12,574,921 12,917,944
Training..................................... 5,797,535 5,826,975
Total Annualized Costs (Point Estimate).......... 37,597,325 39,147,434
Annual Benefits: Number of Cases Prevented
Fatal Lung Cancer............................ 4.0
CBD-Related Mortality........................ 92.0
Total Beryllium Related Mortality............ 96.0 572,981,864 253,743,368
Morbidity........................................ 49.5 2,844,770 1,590,927
Monetized Annual Benefits (midpoint estimate).... 575,826,633 255,334,295
Net Benefits............................. 538,229,308 216,186,861
----------------------------------------------------------------------------------------------------------------
Source: OSHA, Directorate of Standards and Guidance, Office of Regulatory Analysis.
Both the costs and benefits of Table I-1 reflect the incremental
costs and benefits associated with achieving full compliance with the
proposed standard. They do not include costs and benefits associated
with employers' current exposure control measures or other aspects of
the proposed standard they have already implemented. For example, for
employers whose exposures are already below the proposed PEL, OSHA's
estimated costs and benefits for the proposed standard do not include
the costs of their exposure control measures or the benefits of these
employers' compliance with the proposed PEL. The costs and benefits of
Table I-1 also do not include costs and benefits associated with
achieving compliance with existing requirements, to the extent that
some employers may currently not be fully complying with applicable
regulatory requirements.
I. Issues and Alternatives
In addition to the proposed standard itself, this preamble
discusses more than two dozen regulatory alternatives, including
various sub-alternatives, to the proposed standard and requests
comments and information on a variety of topics pertinent to the
proposed standard. The regulatory alternatives OSHA is considering
include alternatives to the proposed scope of the standard, regulatory
alternatives to the proposed TWA PEL of 0.2 [mu]g/m\3\ and proposed
STEL of 2 [mu]g/m\3\, a regulatory alternative that would modify the
proposed methods of compliance, and regulatory alternatives that affect
proposed ancillary provisions. The Agency solicits comment on the
proposed phase-in schedule for the various provisions of the standard.
Additional requests for comments and information follow the summaries
of regulatory alternatives, under the ``Issues'' heading.
Regulatory Alternatives
OSHA believes that inclusion of regulatory alternatives serves two
important functions. The first is to explore the possibility of less
costly ways (than the proposed standard) to provide an adequate level
of worker protection from exposure to beryllium. The second is tied to
the Agency's statutory requirement, which underlies the proposed
standard, to reduce significant risk to the extent feasible. Each
regulatory alternative presented here is described and analyzed more
fully elsewhere in this preamble or in the PEA. Where appropriate, the
alternative is included in this preamble at the end of the relevant
section of Section XVIII, Summary and Explanation of the Proposed
Standard, to facilitate comparison of the alternative to the proposed
standard. For example, alternative PELs under consideration by the
Agency are presented in the discussion of paragraph (c) in Section
XVIII. In addition, all
[[Page 47569]]
alternatives are discussed in the PEA, Chapter VIII: Regulatory
Alternatives (OSHA, 2014). The costs and benefits of each regulatory
alternative are presented both in Section IX of this preamble and in
Chapter VIII of the PEA.
The more than two dozen regulatory alternatives, including various
sub-alternatives regulatory alternatives under consideration are
summarized below, and are organized into the following categories:
alternatives to the proposed scope of the standard; alternatives to the
proposed PELs; alternatives to the proposed methods of compliance;
alternatives to the proposed ancillary provisions; and the timing of
the standard.
Scope
OSHA has examined three alternatives that would alter the groups of
employers and employees covered by this rulemaking. Regulatory
Alternative #1a would expand the scope of the proposed standard to
include all operations in general industry where beryllium exists only
as a trace contaminant; that is, where the materials used contain no
more than 0.1% beryllium by weight. Regulatory Alternative #1b is
similar to Regulatory Alternative #1a, but exempts operations where the
employer can show that employees' exposures will not meet or exceed the
action level or exceed the STEL. Where the employer has objective data
demonstrating that a material containing beryllium or a specific
process, operation, or activity involving beryllium cannot release
beryllium in concentrations at or above the proposed action level or
above the proposed STEL under any expected conditions of use, that
employer would be exempt from the proposed standard except for
recordkeeping requirements pertaining to the objective data.
Alternative #1a and Alternative #1b, like the proposed rule, would not
cover employers or employees in construction or shipyards.
Regulatory Alternative #2a would expand the scope of the proposed
standard to also include employers in construction and maritime. For
example, this alternative would cover abrasive blasters, pot tenders,
and cleanup staff working in construction and shipyards who have the
potential for airborne beryllium exposure during blasting operations
and during cleanup of spent media. Regulatory Alternative #2b would
update Sec. Sec. 1910.1000 Tables Z-1 and Z-2, 1915.1000 Table Z, and
1926.55 Appendix A so that the proposed TWA PEL and STEL would apply to
all employers and employees in general industry, shipyards, and
construction, including occupations where beryllium exists only as a
trace contaminant. However, all other provisions of the standard would
be in effect only for employers and employees that fall within the
scope of the proposed rule. More detailed discussion of Regulatory
Alternatives #1a, #1b, #2a, and #2b appears in Section IX of this
preamble and in Chapter VIII of the PEA (OSHA, 2014). In addition,
Section XVIII of this preamble, Summary and Explanation, includes a
discussion of paragraph (a) that describes the scope of the proposed
rule, issues with the proposed scope, and Regulatory Alternatives #1a,
#1b, #2a, and #2b.
Another regulatory alternative that would impact the scope of
affected industries, extending eligibility for medical surveillance to
employees in shipyards, construction, and parts of general industry
excluded from the scope of the proposed standard, is discussed along
with other medical surveillance alternatives later in this section
(Regulatory Alternative #21) and in the discussion of paragraph (k) in
this preamble at Section XVIII, Summary and Explanation of the Proposed
Standard.
Permissible Exposure Limits
OSHA has examined several regulatory alternatives that would modify
the TWA PEL or STEL for the proposed rule. Under Regulatory Alternative
#3, OSHA would adopt a STEL of 5 times the proposed PEL. Thus, this
alternative STEL would be 1.0 [mu]g/m\3\ if OSHA adopts a PEL of 0.2
[mu]g/m\3\; it would be 0.5 [mu]g/m\3\ if OSHA adopts a PEL of 0.1
[mu]g/m\3\; and it would be 2.5 [micro]g/m\3\ if OSHA adopts a PEL of
0.5 [micro]g/m\3\ (see Regulatory Alternatives #4 and #5). Under
Regulatory Alternative #4, the proposed PEL would be lowered from 0.2
[mu]g/m\3\ to 0.1 [mu]g/m\3\. Under Regulatory Alternative #5, the
proposed PEL would be raised from 0.2 [mu]g/m\3\ to 0.5 [mu]g/m\3\. In
addition, for informational purposes, OSHA examined a regulatory
alternative that would maintain the TWA PEL at 2.0 [mu]g/m\3\, but all
of the other proposed provisions would be required with their triggers
remaining the same as in the proposed rule. This alternative is not one
OSHA could legally adopt because the absence of a more protective
requirement for engineering controls would not be consistent with
section 6(b)(5) of the OSH Act. More detailed discussion of these
alternatives to the proposed PEL appears in Section IX of this preamble
and in Chapter VIII of the PEA (OSHA, 2014). In addition, in Section
XVIII of this preamble, Summary and Explanation of the Proposed
Standard, the discussion of proposed paragraph (c) describes the
proposed TWA PEL and STEL, issues with the proposed exposure limits,
and Regulatory Alternatives #3, #4, and #5.
Methods of Compliance
The proposed standard would require employers to implement
engineering and work practice controls to reduce employees' exposures
to or below the TWA PEL and STEL. Where engineering and work practice
controls are insufficient to reduce exposures to or below the TWA PEL
and STEL, employers would still be required to implement them to reduce
exposure as much as possible, and to supplement them with a respiratory
protection program. In addition, for each operation where there is
airborne beryllium exposure, the employer must ensure that one or more
of the engineering and work practice controls listed in paragraph
(f)(2) are in place, unless all of the listed controls are infeasible,
or the employer can demonstrate that exposures are below the action
level based on two samples taken seven days apart. Regulatory
Alternative #6 would eliminate the engineering and work practice
controls provision currently specified in paragraph (f)(2). This
regulatory alternative does not eliminate the need for engineering
controls to lower exposure levels to or below the TWA PEL and STEL;
rather, it dispenses with the mandatory use of certain engineering
controls that must be installed above the action level but at or below
the TWA PEL.
More detailed discussion of Regulatory Alternative #6 appears in
Section IX of this preamble and in Chapter VIII of the PEA (OSHA,
2014). In addition, the discussion of paragraph (f) in Section XVIII of
this preamble, Summary and Explanation, provides a more detailed
explanation of the proposed methods of compliance, issues with the
proposed methods of com pli ance, and Regulatory Alternative #6.
Ancillary Provisions
The proposed rule contains several ancillary provisions, including
requirements for exposure assessment, personal protective clothing and
equipment (PPE), medical surveillance, medical removal, training, and
regulated areas or access control. OSHA has examined a variety of
regulatory alternatives involving changes to one or more of these
ancillary provisions. OSHA has preliminarily determined that several of
these ancillary provisions will increase the benefits of the proposed
rule, for example, by helping to ensure the TWA PEL is not exceeded
[[Page 47570]]
or by lowering the risks to workers given the significant risk
remaining at the proposed TWA PEL. However, except for Regulatory
Alternative #7 (involving the elimination of all ancillary provisions),
OSHA did not estimate changes in monetized benefits for the regulatory
alternatives that affect ancillary provisions. Two regulatory
alternatives that involve all ancillary provisions are presented below
(#7 and #8), followed by regulatory alternatives for exposure
monitoring (#9, #10, and #11), for regulated areas (#12), for personal
protective clothing and equipment (#13), for medical surveillance (#14
through #21), and for medical removal (#22).
All Ancillary Provisions
During the Small Business Regulatory Fairness Act (SBREFA) process
conducted in 2007, the SBAR Panel recommended that OSHA analyze a PEL-
only standard as a regulatory alternative. The Panel also recommended
that OSHA consider applying ancillary provisions of the standard so as
to minimize costs for small businesses where exposure levels are low
(OSHA, 2008b). In response to these recommendations, OSHA analyzed
Regulatory Alternative #7, a PEL-only standard, and Regulatory
Alternative #8, which would only apply ancillary provisions of the
beryllium standard at exposures above the proposed PEL of 0.2 [micro]g/
m\3\ or the proposed STEL of 2 [micro]g/m\3\. Regulatory Alternative #7
would update the Z tables for Sec. 1910.1000, so that the proposed TWA
PEL and STEL would apply to all workers in general industry. All other
provisions of the proposed standard would be dropped.
As indicated previously, OSHA has preliminarily determined that
there is significant risk remaining at the proposed PEL of 0.2 [mu]g/
m\3\. However, the available evidence on feasibility suggests that 0.2
[mu]g/m\3\ may be the lowest feasible PEL (see Chapter IV of the PEA,
OSHA 2014). Therefore, the Agency believes that it is necessary to
include ancillary provisions in the proposed rule to further reduce the
remaining risk. In addition, the recommended standard provided to OSHA
by representatives of the primary beryllium manufacturing industry and
the Steelworkers Union further supports the importance of ancillary
provisions in protecting workers from the harmful effects of beryllium
exposure (Materion and USW, 2012).
Under Regulatory Alternative #8, several ancillary provisions that
the current proposal would require under a variety of exposure
conditions (e.g., dermal contact; any airborne exposure; exposure at or
above the action level) would instead only apply where exposure levels
exceed the TWA PEL or STEL. Regulatory Alternative #8 affects the
following provisions of the proposed standard:
--Exposure monitoring. Whereas the proposed standard requires annual
monitoring where exposure levels are at or above the action level and
at or below the TWA PEL, Alternative #8 would require annual exposure
monitoring only where exposure levels exceed the TWA PEL or STEL;
-- Written exposure control plan. Whereas the proposed standard
requires written exposure control plans to be maintained in any
facility covered by the standard, Alternative #8 would require only
facilities with exposures above the TWA PEL or STEL to maintain a plan;
--PPE. Whereas the proposed standard requires PPE for employees under a
variety of conditions, such as exposure to soluble beryllium or visible
contamination with beryllium, Alternative #8 would require PPE only for
employees exposed above the TWA PEL or STEL;
--Housekeeping. Whereas the proposed standard's housekeeping
requirements apply across a wide variety of beryllium exposure
conditions, Alternative #8 would limit housekeeping requirements to
areas with exposures above the TWA PEL or STEL.
--Medical Surveillance. Whereas the proposed standard's medical
surveillance provisions require employers to offer medical surveillance
to employees with signs or symptoms of beryllium-related health effects
regardless of their exposure level, Alternative #8 would make
surveillance available to such employees only if they were exposed
above the TWA PEL or STEL.
More detailed discussions of Regulatory Alternatives #7 and #8,
including a description of the considerations pertinent to these
alternatives, appear in Section IX of this preamble and in Chapter VIII
of the PEA (OSHA, 2014).
Exposure Monitoring
OSHA has examined three regulatory alternatives that would modify
the proposed standard's provisions on exposure monitoring, which
require periodic monitoring annually where exposures are at or above
the action level and at or below the TWA PEL. Under Regulatory
Alternative #9, employers would be required to perform periodic
exposure monitoring every 180 days where exposures are at or above the
action level or above the STEL, and at or below the TWA PEL. Under
Regulatory Alternative #10, employers would be required to perform
periodic exposure monitoring every 180 days where exposures are at or
above the action level or above the STEL, including where exposures
exceed the TWA PEL. Under Regulatory Alternative #11, employers would
be required to perform periodic exposure monitoring every 180 days
where exposures are at or above the action level or above the STEL, and
every 90 days where exposures exceed the TWA PEL. More detailed
discussions of Regulatory Alternatives #9, #10, and #11 appear in
Section IX of this preamble and in Chapter VIII of the PEA (OSHA,
2014). In addition, the discussion of proposed paragraph (d) in Section
XVIII of this preamble, Summary and Explanation of the Proposed
Standard, provides a more detailed explanation of the proposed
requirements for exposure monitoring, issues with exposure monitoring,
and the considerations pertinent to Regulatory Alternatives #9, #10,
and #11.
Regulated Areas
The proposed standard would require employers to establish and
maintain two types of areas: beryllium work areas, wherever employees
are, or can reasonably be expected to be, exposed to any level of
airborne beryllium; and regulated areas, wherever employees are, or can
reasonably be expected to be, exposed to airborne beryllium at levels
above the TWA PEL or STEL. Employers are required to demarcate
beryllium work areas, but are not required to restrict access to
beryllium work areas or provide respiratory protection or other forms
of PPE within work areas that are not also regulated areas. Employers
must demarcate regulated areas, restrict access to them, post warning
signs and provide respiratory protection and other PPE within regulated
areas, as well as medical surveillance for employees who work in
regulated areas for more than 30 days in a 12-month period. During the
SBREFA process conducted in 2007, the SBAR Panel recommended that OSHA
consider dropping or limiting the provision for regulated areas (OSHA,
2008b). In response to this recommendation, OSHA analyzed Regulatory
Alternative #12, which would not require employers to establish
regulated areas. More detailed discussion of Regulatory Alternative #12
appears in Section IX of this preamble and in Chapter VIII of the PEA
(OSHA, 2014). In addition, the discussion of
[[Page 47571]]
paragraph (e) in Section XVIII of this preamble, Summary and
Explanation, provides a more detailed explanation of the proposed
requirements for regulated areas, issues with regulated areas, and
considerations pertinent to Regulatory Alternative #12.
Personal Protective Clothing and Equipment (PPE)
Regulatory Alternative #13 would modify the proposed requirements
for PPE, which require PPE where exposure exceeds the TWA PEL or STEL;
where employees' clothing or skin may become visibly contaminated with
beryllium; and where employees may have skin contact with soluble
beryllium compounds. The requirement to use PPE where work clothing or
skin may become ``visibly contaminated'' with beryllium differs from
prior standards that do not require contamination to be visible in
order for PPE to be required. In the case of beryllium, which OSHA has
preliminarily concluded can sensitize through dermal exposure, the
exposure levels capable of causing adverse health effects and the PELs
in effect are so low that beryllium surface contamination is unlikely
to be visible (see this preamble at section V, Health Effects). OSHA is
therefore considering Regulatory Alternative #13, which would require
appropriate PPE wherever there is potential for skin contact with
beryllium or beryllium-contaminated surfaces. More detailed discussion
of Regulatory Alternative #13 is provided in Section IX of this
preamble and in Chapter VIII of the PEA (OSHA, 2014). In addition, the
discussion of paragraph (h) in Section XVIII of this preamble, Summary
and Explanation, provides a more detailed explanation of the proposed
requirements for PPE, issues with PPE, and the considerations pertinent
to Regulatory Alternative #13.
Medical Surveillance
The proposed requirements for medical surveillance include: (1)
Medical examinations, including a test for beryllium sensitization, for
employees who are exposed to beryllium above the proposed PEL for 30
days or more per year, who are exposed to beryllium in an emergency, or
who show signs or symptoms of CBD; and (2) low-dose helical tomography
(low-dose computed tomography, hereafter referred to as ``CT scans''),
for employees who were exposed above the proposed PEL for more than 30
days in a 12-month period for 5 years or more. This type of CT scan is
a method of detecting tumors, and is commonly used to diagnose lung
cancer. The proposed standard would require periodic medical exams to
be provided for employees in the medical surveillance program annually,
while tests for beryllium sensitization and CT scans would be provided
to eligible employees biennially.
OSHA has examined eight regulatory alternatives (#14 through #21)
that would modify the proposed rule's requirements for employee
eligibility, the types of exam that must be offered, and the frequency
of periodic exams. Medical surveillance was a subject of special
concern to SERs during the SBREFA process, and the SBREFA Panel offered
many comments and recommendations related to medical surveillance for
OSHA's consideration. Some of the Panel's concerns have been addressed
in this proposal, which was modified since the SBREFA Panel was
convened (see this preamble at Section XVIII, Summary and Explanation
of the Proposed Standard, for more detailed discussion). Several of the
alternatives presented here (#16, #18, and #20) also respond to
recommendations by the SBREFA Panel to reduce burdens on small
businesses by dropping or reducing the frequency of medical
surveillance requirements. OSHA also seeks to ensure that the
requirements of the final standard offer workers adequate medical
surveillance while limiting the costs to employers. Thus, OSHA requests
feedback on several additional alternatives and on a variety of issues
raised later in this section of the preamble.
Regulatory Alternatives #14, #15, and #21 would expand eligibility
for medical surveillance to a broader group of employees than would be
eligible in the proposed standard. Under Regulatory Alternative #14,
medical surveillance would be available to employees who are exposed to
beryllium above the proposed PEL, including employees exposed for fewer
than 30 days per year. Regulatory Alternative #15 would expand
eligibility for medical surveillance to employees who are exposed to
beryllium above the proposed action level, including employees exposed
for fewer than 30 days per year. Regulatory Alternative #21 would
extend eligibility for medical surveillance as set forth in proposed
paragraph (k) to all employees in shipyards, construction, and general
industry who meet the criteria of proposed paragraph (k)(1) (or any of
the alternative criteria under consideration). However, all other
provisions of the standard would be in effect only for employers and
employees that fall within the scope of the proposed rule.
Regulatory Alternatives #16 and #17 would modify the proposed
standard's requirements to offer beryllium sensitization testing to
eligible employees. Under Regulatory Alternative #16, employers would
not be required to offer employees testing for beryllium sensitization.
Regulatory Alternative #17 would increase the frequency of periodic
sensitization testing, from the proposed standard's biennial
requirement to annual testing. Regulatory Alternatives #18 and #19
would similarly modify the proposed standard's requirements to offer CT
scans to eligible employees. Regulatory Alternative #18 would drop the
CT scan requirement from the proposed rule, whereas Regulatory
Alternative #19 would increase the frequency of periodic CT scans from
biennial to annual scans. Finally, under Regulatory Alternative #20,
all periodic components of the medical surveillance exams would be
available biennially to eligible employees. Instead of requiring
employers to offer eligible employees a medical examination every year,
employers would be required to offer eligible employees a medical
examination every other year. The frequency of testing for beryllium
sensitization and CT scans would also be biennial for eligible
employees, as in the proposed standard.
More detailed discussions of Regulatory Alternatives #14, #15, #16,
#17, #18, #19, #20, and #21 appear in Section IX of this preamble and
in Chapter VIII of the PEA (OSHA, 2014). In addition, Section XVIII of
this preamble, Summary and Explanation, paragraph (k) provides a more
detailed explanation of the proposed requirements for medical
surveillance, issues with medical surveillance, and the considerations
pertinent to Regulatory Alternatives #14 through #21.
Medical Removal Protection (MRP)
The proposed requirements for medical removal protection provide an
option for medical removal to an employee who is working in a job with
exposure at or above the action level and is diagnosed with CBD or
confirmed positive for beryllium sensitization. If the employee chooses
removal, the employer must either remove the employee to comparable
work in a work environment where exposure is below the action level, or
if comparable work is not available, must place the employee on paid
leave for 6 months or until such time as comparable work becomes
available. In either case, the employer must maintain for 6 months the
employee's base earnings, seniority,
[[Page 47572]]
and other rights and benefits that existed at the time of removal.
During the SBREFA process, the Panel recommended that OSHA give careful
consideration to the impacts that an MRP requirement could have on
small businesses (OSHA, 2008b). In response to this recommendation,
OSHA analyzed Regulatory Alternative #22, which would not require
employers to offer MRP. More detailed discussion of Regulatory
Alternative #22 appears in Section IX of this preamble and in Chapter
VIII of the PEA (OSHA, 2014). In addition, the discussion of paragraph
(l) in section XVIII of this preamble, Summary and Explanation,
provides a more detailed explanation of the proposed requirements for
MRP, issues with MRP, and considerations pertinent to Regulatory
Alternative #22.
Timing of the Standard
The proposed standard would become effective 60 days following
publication of the final standard in the Federal Register. The
effective date is the date on which the standard imposes compliance
obligations on employers. However, the standard would not become
enforceable by OSHA until 90 days following the effective date for
exposure monitoring, work areas and regulated areas, written exposure
control plan, respiratory protection, other personal protective
clothing and equipment, hygiene areas and practices (except change
rooms), housekeeping, medical surveillance, and medical removal. The
proposed requirement for change rooms would not be enforceable until
one year after the effective date, and the requirements for engineering
controls would not be enforceable until two years after the effective
date. In summary, employers will have some period of time after the
standard becomes effective to come into compliance before OSHA will
begin enforcing it: 90 days for most provisions, one year for change
rooms, and two years for engineering controls. Beginning 90 days
following the effective date, during periods necessary to install or
implement feasible engineering controls where exposure exceed the TWA
PEL or STEL, employers must provide employees with respiratory
protection as described in the proposed standard under section (g),
Respiratory Protection.
OSHA invites comment and suggestions for phasing in requirements
for engineering controls, medical surveillance, and other provisions of
the standard. A longer phase-in time would have several advantages,
such as reducing initial costs of the standard or allowing employers to
coordinate their environmental and occupational safety and health
control strategies to minimize potential costs. However, a longer
phase-in would also postpone and reduce the benefits of the standard.
Suggestions for alternatives may apply to specific industries (e.g.,
industries where first-year or annualized cost impacts are highest),
specific size-classes of employers (e.g., employers with fewer than 20
employees), combinations of these factors, or all firms covered by the
rule.
OSHA requests comments on these regulatory alternatives, including
the Agency's choice of regulatory alternatives (and whether there are
other regulatory alternatives the Agency should consider) and the
Agency's analysis of them. In addition, OSHA requests comments and
information on a number of specific topics and issues pertinent to the
proposed standard. These are summarized below.
Regulatory Issues
In this section, we solicit public feedback on issues associated
with the proposed standard and request information that would help the
Agency craft the final standard. In addition to the issues specified
here, OSHA also raises issues for comment on technical questions and
discussions of economic issues in the PEA (OSHA, 2014). OSHA requests
comment on all relevant issues, including health effects, risk
assessment, significance of risk, technological and economic
feasibility, and the provisions of the proposed regulatory text. In
addition, OSHA requests comments on all of the issues raised by the
Small Business Advocacy Review (SBAR) Panel, as summarized in the SBAR
report (OSHA, 2008b)
We present these issues and requests for information in the first
chapter of the preamble to assist readers as they review the preamble
and consider any comments they may want to submit. The issues are
presented here in summary form. However, to fully understand the
questions in this section and provide substantive input in response to
them, the sections of the preamble relevant to these issues should be
reviewed. These include: Section V, Health Effects; Section VI, the
Preliminary Risk Assessment; Section VIII, Significance of Risk;
Section IX, Summary of the Preliminary Economic Analysis and Initial
Regulatory Flexibility Analysis; and Section XVIII, Summary and
Explanation of the Proposed Standard.
OSHA requests that comments be organized, to the extent possible,
around the following issues and numbered questions. Comment on
particular provisions should contain a heading setting forth the
section and the paragraph in the proposed standard that the comment
addresses. Comments addressing more than one section or paragraph will
have correspondingly more headings.
Submitting comments in an organized manner and with clear reference
to the issue raised will enable all participants to easily see what
issues the commenter addressed and how they were addressed. Many
commenters, especially small businesses, are likely to confine their
comments to the issues that affect them, and they will benefit from
being able to quickly identify comments on these issues in others'
submissions. The Agency welcomes comments concerning all aspects of
this proposal. However, OSHA is especially interested in responses,
supported by evidence and reasons, to the following questions:
Health Effects
1. OSHA has described a variety of studies addressing the major
adverse health effects that have been associated with exposure to
beryllium. Using currently available epidemiologic and experimental
studies, OSHA has made a preliminary determination that beryllium
presents risks of lung cancer; sensitization; CBD at 0.1 [micro]g/m\3\;
and at higher exposures acute beryllium disease, and hepatic, renal,
cardiovascular and ocular diseases. Is this determination correct? Are
there additional studies or other data OSHA should consider in
evaluating any of these health outcomes?
2. Has OSHA adequately identified and documented all critical
health impairments associated with occupational exposure to beryllium?
If not, what other adverse health effects should be added? Are there
additional studies or other data OSHA should consider in evaluating any
of these health outcomes?
3. Are there any additional studies, other data, or information
that would affect the information discussed or significantly change the
determination of material health impairment?
Please submit any relevant information, data, or additional studies
(or citations to studies), and explain your reasons for recommending
any studies you suggest.
Risk Assessment and Significance of Risk
4. OSHA has developed an analysis of health risks associated with
occupational beryllium exposure, including an analysis of sensitization
and CBD based on a selection of recent
[[Page 47573]]
studies in the epidemiological literature, a data set on a population
of beryllium machinists provided by the National Jewish Medical
Research Center (NJMRC), and an assessment of lung cancer risk using an
analysis provided by NIOSH. Did OSHA rely on the best available
evidence in its risk assessment? Are there additional studies or other
data OSHA should consider in evaluating risk for these health outcomes?
Please provide the studies, citations to studies, or data you suggest.
5. OSHA preliminarily concluded that there is significant risk of
material health impairment (lung cancer or CBD) from a working lifetime
of occupational exposure to beryllium at the current TWA PEL of 2
[micro]g/m\3\, which would be substantially reduced by the proposed TWA
PEL of 0.2 [micro]g/m\3\ and the alternative TWA PEL of 0.1 [micro]g/
m\3\. OSHA's preliminary risk assessment also concludes that there is
still significant risk of CBD and lung cancer at the proposed PEL and
the alternative PELs, although substantially less than at the current
PEL. Are these preliminary conclusions reasonable, based on the best
available evidence? If not, please provide a detailed explanation of
your position, including data to support your position and a detailed
analysis of OSHA's risk assessment if appropriate.
6. Please provide comment on OSHA's analysis of risk for beryllium
sensitization, CBD and lung cancer. Are there important gaps or
uncertainties in the analysis, such that the Agency's preliminary
conclusions regarding significance of risk at the current, proposed,
and alternative PELs may be in error? If so, please provide a detailed
explanation and suggestions for how OSHA's analysis should be corrected
or improved.
7. OSHA has made a preliminary determination that the available
data are not sufficient or suitable for risk analysis of effects other
than beryllium sensitization, CBD and lung cancer. Do you have, or are
you aware of, studies or data that would be suitable for a risk
assessment for these adverse health effects? Please provide the
studies, citations to studies, or data you suggest.
(a) Scope
8. Has OSHA defined the scope of the proposed standard
appropriately? Does it currently include employers who should not be
covered, or exclude employers who should be covered by a comprehensive
beryllium standard? Are you aware of employees in construction or
maritime, or in general industry who deal with beryllium only as a
trace contaminant, who may be at significant risk from occupational
beryllium exposure? Please provide the basis for your response and any
applicable supporting information.
(b) Definitions
9. Has OSHA defined the Beryllium lymphocyte proliferation test
appropriately? If not, please provide the definition that you believe
is appropriate. Please provide rationale and citations supporting your
comments.
10. Has OSHA defined CBD Diagnostic Center appropriately? In
particular, should a CBD diagnostic center be required to analyze
biological samples on-site, or should diagnostic centers be allowed to
send samples off-site for analysis? Is the list of tests and procedures
a CBD Diagnostic Center is required to be able to perform appropriate?
Should any of the tests or procedures be removed from the definition?
Should other tests or procedures be added to the definition? Please
provide rationale and information supporting your comments.
(d) Exposure Monitoring
11. Do you currently monitor for beryllium exposures in your
workplace? If so, how often? Please provide the reasoning for the
frequency of your monitoring. If periodic monitoring is performed at
your workplace for exposures other than beryllium, with what frequency
is it repeated?
12. Is it reasonable to allow discontinuation of monitoring based
on one sample below the action level? Should more than one result below
the action level be required to discontinue monitoring?
(e) Work Areas and Regulated Areas
The proposed standard would require employers to establish and
maintain two types of areas: beryllium work areas, wherever employees
are, or can reasonably be expected to be, exposed to any level of
airborne beryllium; and regulated areas, wherever employees are, or can
reasonably be expected to be, exposed to airborne beryllium at levels
above the TWA PEL or STEL. Employers are required to demarcate
beryllium work areas, but are not required to restrict access to
beryllium work areas or provide respiratory protection or other forms
of PPE within work areas with exposures at or below the TWA PEL or
STEL. Employers must also demarcate regulated areas, including posting
warning signs; restrict access to regulated areas; and provide
respiratory protection and other PPE within regulated areas.
13. Does your workplace currently have regulated areas? If so, how
are regulated areas demarcated?
14. Please describe work settings where establishing regulated
areas could be problematic or infeasible. If establishing regulated
areas is problematic, what approaches might be used to warn employees
in such work settings of high risk areas?
(f) Methods of Compliance
Paragraph (f)(2) of the proposed standard would require employers
to implement engineering and work practice controls to reduce
employees' exposures to or below the TWA PEL and STEL. Where
engineering and work practice controls are insufficient to reduce
exposures to or below the TWA PEL and STEL, employers would still be
required to implement them to reduce exposure as much as possible, and
to supplement them with a respiratory protection program. In addition,
for each operation where there is airborne beryllium exposure, the
employer must ensure that at least one of the engineering and work
practice controls listed in paragraph (f)(2) is in place, unless all of
the listed controls are infeasible, or the employer can demonstrate
that exposures are below the action level based on no fewer than two
samples taken seven days apart.
15. Do you usually use engineering or work practices controls
(local exhaust ventilation, isolation, substitution) to reduce
beryllium exposures? If so, which controls do you use?
16. Are the controls and processes listed in paragraph (f)(2)(i)(A)
appropriate for controlling beryllium exposures? Are there additional
controls or processes that should be added to paragraph (f)(2)(i)(A)?
(g) Respiratory Protection
17. OSHA's asbestos standard (CFR 1910.1001) requires employers to
provide each employee with a tight-fitting, powered air-purifying
respirator (PAPR) instead of a negative pressure respirator when the
employee chooses to use a PAPR and it provides adequate protection to
the employee. Should the beryllium standard similarly require employers
to provide PAPRs (instead of allowing a negative pressure respirator)
when requested by the employee? Are there other circumstances where a
PAPR should be specified as the appropriate respiratory protection?
Please provide the basis for your response and any applicable
supporting information.
[[Page 47574]]
(h) Personal Protective Clothing and Equipment
18. Do you currently require specific PPE or respirators when
employees are working with beryllium? If so, what type?
19. The proposal requires PPE wherever work clothing or skin may
become visibly contaminated with beryllium; where employees' skin can
reasonably be expected to be exposed to soluble beryllium compounds; or
where employee exposure exceeds or can reasonably be expected to exceed
the TWA PEL or STEL. The requirement to use PPE where work clothing or
skin may become ``visibly contaminated'' with beryllium differs from
prior standards which do not require contamination to be visible in
order for PPE to be required. Is ``visibly contaminated'' an
appropriate trigger for PPE? Is there reason to require PPE where
employees' skin can be exposed to insoluble beryllium compounds? Please
provide the basis for your response and any applicable supporting
information.
(i) Hygiene Areas and Practices
20. The proposal requires employers to provide showers in their
facilities if (A) Exposure exceeds or can reasonably be expected to
exceed the TWA PEL or STEL; and (B) Beryllium can reasonably be
expected to contaminate employees' hair or body parts other than hands,
face, and neck. Is this requirement reasonable and adequately
protective of beryllium-exposed workers? Should OSHA amend the
provision to require showers in facilities where exposures exceed the
PEL or STEL, without regard to areas of bodily contamination?
(j) Housekeeping
21. The proposed rule prohibits dry sweeping or brushing for
cleaning surfaces in beryllium work areas unless HEPA-filtered
vacuuming or other methods that minimize the likelihood and level of
exposure have been tried and were not effective. Please comment on this
provision. What methods do you use to clean work surfaces at your
facility? Are HEPA-filtered vacuuming or other methods to minimize
beryllium exposure used to clean surfaces at your facility? Have they
been effective? Are there any circumstances under which dry sweeping or
brushing are necessary? Please explain your response.
22. The proposed rule requires that materials designated for
recycling that are visibly contaminated with beryllium particulate
shall be cleaned to remove visible particulate, or placed in sealed,
impermeable enclosures. However, small particles (<10 [mu]g) may not be
visible to the naked eye, and there are studies suggesting that small
particles may penetrate the skin, beyond which beryllium sensitization
can occur (Tinkle et al., 2003). OSHA requests feedback on this
provision. Should OSHA require that all material to be recycled be
decontaminated regardless of perceived surface cleanliness? Should OSHA
require that all material disposed or discarded be in enclosures
regardless of perceived surface cleanliness? Please provide explanation
or data to support your comments.
(k) Medical Surveillance
The proposed requirements for medical surveillance include: (1)
Medical examinations, including a test for beryllium sensitization, for
employees who are exposed to beryllium above the proposed PEL for 30
days or more per year, who are exposed to beryllium in an emergency, or
who show signs or symptoms of CBD; and (2) CT scans for employees who
were exposed above the proposed PEL for more than 30 days in a 12-month
period for 5 years or more. The proposed standard would require
periodic medical exams to be provided for employees in the medical
surveillance program annually, while tests for beryllium sensitization
and CT scans would be provided to eligible employees biennially.
23. Is medical surveillance being provided for beryllium-exposed
employees at your worksite? If so:
a. Do you provide medical surveillance to employees under another
OSHA standard or as a matter of company policy? What OSHA standard(s)
does the program address?
b. How many employees are included, and how do you determine which
employees receive medical surveillance (e.g., by exposure level, other
factors)?
c. Who administers and implements the medical surveillance (e.g.,
company doctor, nurse practitioner, physician assistant, or nurse; or
outside doctor, nurse practitioner, physician assistant, or nurse)?
d. What examinations, tests, or evaluations are included in the
medical surveillance program, and with what frequency are they
administered? Does your program include a surveillance program
specifically for beryllium-related health effects (e.g., the BeLPT or
other tests for beryllium sensitization)?
e. If your facility offers the BeLPT, please provide feedback and
data on your experience with the BeLPT, including the analytical or
interpretive procedure you use and its role in your facility's exposure
control program. Has identification of sensitized workers led to
interventions to reduce exposures to sensitized individuals, or in the
facility generally? If a worker is found to be sensitized, do you track
worker health and possible progression of disease beyond sensitization?
If so, how is this done?
f. What difficulties and benefits (e.g., health, reduction in
absenteeism, or financial) have you experienced with your medical
surveillance program? If applicable, please discuss benefits and
difficulties you have experienced with the use of the BeLPT, providing
detailed information or examples if possible.
g. What are the costs of your medical surveillance program? How do
your costs compare with OSHA's estimated unit costs for the physical
examination and employee time involved in the medical surveillance
program? Are OSHA's baseline assumptions and cost estimates for medical
surveillance consistent with your experiences providing medical
surveillance to your employees?
24. Please review paragraph (k) of the proposed rule, Medical
Surveillance, and comment on the frequency and contents of medical
surveillance in the proposed rule. Is 30 days from initial assignment a
reasonable time at which to provide a medical exam? Should there be a
requirement for beryllium sensitization testing at time of employment?
Should there be a requirement for beryllium sensitization testing at an
employee's exit exam, regardless of when the employee's most recent
sensitization test was administered? Are the tests required and the
testing frequencies specified appropriate? Should sensitized employees
have the opportunity to be examined at a CBD Diagnostic Center more
than once following a confirmed positive BeLPT? Are there additional
tests or alternate testing schedules you would suggest? Should the skin
be examined for signs and symptoms of beryllium exposure or other
medical issues, as well as for breaks and wounds? Please explain the
basis for your position and provide data or studies if applicable.
25. Please provide comments on the proposed requirements regarding
referral of a sensitized employee to a CBD diagnostic center, which
specify referral to a diagnostic center ``mutually agreed upon'' by the
employer and employee. Is this requirement for mutual agreement
necessary and appropriate? How should a diagnostic center be chosen if
the employee and employer cannot come to agreement? Should OSHA
consider alternate language, such as referral for CBD
[[Page 47575]]
evaluation at a diagnostic center in a reasonable location?
26. In the proposed rule, OSHA specifies that all medical
examinations and procedures required by the standard must be performed
by or under the direction of a licensed physician. Are physicians
available in your geographic area to provide medical surveillance to
workers who are covered by the proposed rule? Are other licensed health
care professionals available to provide medical surveillance? Do you
have access to other qualified personnel such as qualified X-ray
technicians, and pulmonary specialists? Should the proposal be amended
to allow examination by, or under the direction of, a physician or
other licensed health care professional (PLHCP)? Please explain your
position. Please note what you consider your geographic area in
responding to this question.
27. The proposed standard requires the employer to obtain the
Licensed Physician's Written Medical Opinion from the PLHCP within 30
days of the examination. Should OSHA revise the medical surveillance
provisions of the proposed standard to allow employees to choose what,
if any, medical information goes to the employer from the PLHCP? For
example, the employer could instead be required to obtain a
certification from the PLCHP within 30 days of the examination stating
(1) when the examination took place, (2) that the examination complied
with the standard, and (3) that the PLHCP provided the employee a copy
of the Licensed Physician's Written Medical Opinion required by the
standard. The PLHCP would need the employee's written consent to send
the employer the Licensed Physician's Written Medical Opinion or any
other medical information about the employee. This approach might lead
to corresponding changes in proposed paragraphs (f)(1) (written
exposure control program), (l) (medical removal) and (n)
(recordkeeping) to reflect that employers will not automatically be
receiving any medical information about employees as a result of the
medical surveillance required by the proposed standard, but would
instead only receive medical information the employee chooses to share
with the employer. Please comment on the relative merits of the
proposed standard's requirement that employers obtain the PLHCP's
written opinion or an alternative that would provide employees with
greater discretion over the information that goes to employers, and
explain the basis for your position and the potential impact on the
benefits of medical surveillance.
28. Appendix A to the proposed standard reviews procedures for
conducting and interpreting the results of BeLPT testing for beryllium
sensitization. Is there now, or should there be, a standard method for
BeLPT laboratory procedure? If yes, please describe the existing or
proposed method. Is there now, or should there be, a standard algorithm
for interpreting BeLPT results to determine sensitization? Please
describe the existing or proposed laboratory method or interpretation
algorithm. Should OSHA require that BeLPTs performed to comply with the
medical surveillance provisions of this rule adhere to the Department
of Energy (DOE) analytical and interpretive specifications issued in
2001? Should interpretation of laboratory results be delegated to the
employee's occupational physician or PLHCP?
29. Should OSHA require the clinical laboratories performing the
BeLPT to be accredited by the College of American Pathologists or
another accreditation organization approved under the Clinical
Laboratory Improvement Amendments (CLIA)? What other standards, if any,
should be required for clinical laboratories providing the BeLPT?
30. Are there now, or are there being developed, alternative tests
to the BeLPT you would suggest? Please explain the reasons for your
suggestion. How should alternative tests for beryllium sensitization be
evaluated and validated? How should OSHA determine whether a test for
beryllium sensitization is more reliable and accurate than the BeLPT?
Please see Appendix A to the proposed standard for a discussion of the
accuracy of the BeLPT.
31. The proposed rule requires employers to provide OSHA with the
results of BeLPTs performed to comply with the medical surveillance
provisions upon request, provided that the employer obtains a release
from the tested employee. Will this requirement be unduly burdensome
for employers? Are there alternative organizations that would be
appropriate to send test results to?
(l) Medical Removal Protection
The proposed requirements for medical removal protection provide an
option for medical removal to an employee who is working in a job with
exposure at or above the action level and is diagnosed with CBD or
confirmed positive for beryllium sensitization. If the employee chooses
removal, the employer must remove the employee to comparable work in a
work environment where exposure is below the action level, or if
comparable work is not available, must place the employee on paid leave
for 6 months or until such time as comparable work becomes available.
In either case, the employer must maintain for 6 months the employee's
base earnings, seniority, and other rights and benefits that existed at
the time of removal.
32. Do you provide MRP at your facility? If so, please comment on
the program's benefits, difficulties, and costs, and the extent to
which eligible employees make use of MRP.
33. OSHA has included requirements for medical removal protection
(MRP) in the proposed rule, which includes provisions for medical
removal for employees with beryllium sensitization or CBD, and an
extension of removed employees' rights and benefits for six months. Are
beryllium sensitization and CBD appropriate triggers for medical
removal? Are there other medical conditions or findings that should
trigger medical removal? For what amount of time should a removed
employee's benefits be extended?
(p) Appendices
34. Some OSHA health standards include appendices that address
topics such as the hazards associated with the regulated substance,
health screening considerations, occupational disease questionnaires,
and PLHCP obligations. In this proposed rule, OSHA has included a non-
mandatory appendix to describe and discuss the BeLPT (Appendix A), and
a non-mandatory appendix presenting a non-exhaustive list of
engineering controls employers may use to comply with paragraph (f)
(Appendix B). What would be the advantages and disadvantages of
including each appendix in the final rule? What would be the advantages
and disadvantages of providing this information in guidance materials?
35. What additional information, if any, should be included in the
appendices? What additional information, if any, should be provided in
guidance materials?
General
36. The current beryllium proposal includes triggers that require
employers to initiate certain provisions, programs, and activities to
protect workers from beryllium exposure. All employers covered under an
OSHA health standard are required to initiate certain activities such
as initial monitoring to evaluate the potential hazard to employees.
OSHA health standards typically include ancillary provisions with
various triggers indicating when an
[[Page 47576]]
employer covered under the standard would need to comply with a
provision. The most common triggers are ones based an exposure level
such as the PEL or action level. These exposure level triggers are
sometimes combined with a minimum duration of exposure (e.g., >= 30
days per year). Other triggers may include reasonably anticipated
exposure, medical surveillance findings, certain work activities, or
simply the presence of the regulated substance in the workplace.
For the current Proposal, exposures to beryllium above the TWA PEL
or STEL trigger the provisions for regulated areas, additional or
enhanced engineering or work practice controls to reduce airborne
exposures to or below the TWA PEL and STEL, personal protective
clothing and equipment, medical surveillance, showers, and respiratory
protection if feasible engineering and work practice controls cannot
reduce airborne exposures to or below the TWA PEL and STEL. Exposures
at or above the action level in turn trigger the provisions for
periodic exposure monitoring, and medical removal eligibility (along
with a diagnosis of CBD or confirmed positive for beryllium
sensitization). Finally, an employer covered under the scope of the
proposed standard must establish a beryllium work area where employees
are, or can reasonably be expected to be, exposed to airborne beryllium
regardless of the level of exposure. In beryllium work areas, employers
must implement a written exposure control plan, provide washing
facilities and change rooms (change rooms are only necessary if
employees are required to remove their personal clothing), and follow
housekeeping provisions. The employers must also implement at least one
of the engineering and work practice controls listed in paragraph
(f)(2) of the proposed standard. An employer is exempt from this
requirement if he or she can demonstrate that such controls are not
feasible or that exposures are below the action level.
Certain provisions are triggered by one condition and other
provisions are triggered only if multiple conditions are present. For
example, medical removal is only triggered if an employee has CBD or is
confirmed positive AND the employee is exposed at or above the action
level.
OSHA is requesting comment on the triggers in the proposed
beryllium standard. Are the triggers OSHA has proposed appropriate?
OSHA is also requesting comment on these triggers relative to the
regulatory alternatives affecting the scope and PELs as described in
this preamble in section I, Issues and Alternatives. For example, are
the triggers in the proposed standard appropriate for Alternative #1a,
which would expand the scope of the proposed standard to include all
operations in general industry where beryllium exists only as a trace
contaminant (less than 0.1% beryllium by weight)? Are the triggers
appropriate for the alternatives that change the TWA PEL, STEL, and
action level? Please specify the trigger and the alternative, if
applicable, and why you agree or disagree with the trigger.
Relevant Federal Rules Which May Duplicate, Overlap, or Conflict With
the Proposed Rule
37. In Section IX--Preliminary Economic Analysis under the Initial
Regulatory Flexibility Analysis, OSHA identifies, to the extent
practicable, all relevant Federal rules which may duplicate, overlap,
or conflict with the proposed rule. One potential area of overlap is
with the U.S. Department of Energy (DOE) beryllium program. In 1999,
DOE established a chronic beryllium disease prevention program (CBDPP)
to reduce the number of workers (DOE employees and DOE contractors)
exposed to beryllium at DOE facilities (10 CFR part 850, published at
64 FR 68854-68914 (Dec. 8, 1999)). In establishing this program, DOE
has exercised its statutory authority to prescribe and enforce
occupational safety and health standards. Therefore pursuant to section
4(b)(1) of the OSH Act, 29 U.S.C. 653(b)(1), the DOE facilities are
exempt from OSHA jurisdiction.
Nevertheless, under 10 CFR 850.22, DOE has included in its CBDPP
regulation a requirement for compliance with the current OSHA
permissible exposure limit (PEL), and any lower PEL that OSHA
establishes in the future. Thus, although DOE has preempted OSHA's
standard from applying at DOE facilities and OSHA cannot exercise any
authority at those facilities, DOE relies on OSHA's PEL in implementing
its own program. However, DOE's decision to tie its own standard to
OSHA's PEL has little consequence to this rulemaking because the
requirements in DOE's beryllium program (controls, medical
surveillance, etc.) are triggered by DOE's action level of 0.2
[micro]g/m\3\, which is much lower than DOE's existing PEL and the same
as OSHA's proposed PEL. DOE's action level is not tied to OSHA's
standard, so 10 CFR 850.22 would not require the CBDPP's action level
or any non-PEL requirements to be automatically adjusted as a result of
OSHA's rulemaking. For this reason, DOE has indicated to OSHA that
OSHA's proposed rule would not have any impact on DOE's CBDPP,
particularly since 10 CFR 850.25(b), Exposure reduction and
minimization, requires DOE contractors to reduce exposures to below the
DOE's action level of 0.2 [micro]g/m\3\, if practicable.
DOE has expressed to OSHA that DOE facilities are already in
compliance with 10 CFR 850 and its action level of 0.2 [micro]g/
m\3\,\2\ so the only potential impact on DOE's CBDPP that could flow
from OSHA's rulemaking would be if OSHA ultimately adopted a PEL of 0.1
[micro]g/m\3\, as discussed in alternative #4, instead of the proposed
PEL of 0.2 [micro]g/m\3\, and DOE did not make any additional
adjustments to its standards. Even in that hypothetical scenario, the
impact would still be limited because of the odd result that DOE's PEL
would drop below its own action level, while the action level would
continue to serve as the trigger for most of DOE's program
requirements.
---------------------------------------------------------------------------
\2\ This would mean the prevailing beryllium exposures at DOE
facilities are at or below 0.2 [micro]g/m\3\.
---------------------------------------------------------------------------
DOE also has noted some potential overlap with a separate DOE
provision in 10 CFR part 851, which requires its contractors to comply
with DOE's CBDPP (10 CFR 851.23(a)(1)) and also with all OSHA standards
under 29 CFR part 1910 except ``Ionizing Radiation'' (Sec. 1910.1096)
(10 CFR 851.23(a)(3)). These requirements, which DOE established in
2006 (71 FR 6858 (February 9, 2006)), make sense in light of OSHA's
current regulation because OSHA's only beryllium protection is a PEL,
so compliance with 10 CFR 851.23(a)(1) and (3) merely make OSHA's
current PEL the relevant level for purposes of the CBDPP. However, its
function would be less clear if OSHA adopts a beryllium standard as
proposed. OSHA's proposed beryllium standard would establish additional
substantive protections beyond the PEL. Consequently, notwithstanding
the CBDPP's preemptive effect on the OSHA beryllium standard as a
result of 29 U.S.C. 653(b)(1), 10 CFR 851.23(a)(3) could be read to
require DOE contractors to comply with all provisions in OSHA's
proposal (if finalized), including the ancillary provisions, creating a
dual regulatory scheme for beryllium protection at DOE facilities.
DOE officials have indicated that this is not their intent.
Instead, their intent is that DOE contractors comply solely with the
CBDPP provisions in 10 CFR part 850 for protection from beryllium.
[[Page 47577]]
Based on its discussions with DOE officials, OSHA anticipates that DOE
will clarify that its contractors do not need to comply with any
ancillary provisions in a beryllium standard that OSHA may promulgate.
OSHA can envision several potential scenarios developing from its
rulemaking, ranging from OSHA retaining the proposed PEL of 0.2
[micro]g/m\3\ and action level of 0.1 [micro]g/m\3\ in the final rule
to adopting the PEL of 0.1 [micro]g/m\3\, as discussed in alternative
#4. Because OSHA's beryllium standard does not apply directly to DOE
facilities, and the only impact of its rules on those facilities is the
result of DOE's regulatory choices, there is also a range of actions
that DOE could take to minimize any potential impact of any change to
OSHA's rules, including (1) taking no action at all, (2) simply
clarifying the CBDPP, as described above, to mean that OSHA's beryllium
standard (other than its PEL) does not apply to contractors, or (3)
revising both parts 850 and 851 to completely disassociate DOE's
regulation of beryllium at DOE facilities from OSHA's regulation of
beryllium.
OSHA is aware that, in the preamble to its 1999 CBDPP rule, DOE
analyzed the costs for implementing the CBDPP for action levels of 0.1
[micro]g/m\3\, 0.2 [micro]g/m\3\, and 0.5 [micro]g/m\3\ (64 FR 68875,
December 8, 1999). DOE estimated costs for periodic exposure
monitoring, notifying workers of the results of such monitoring,
exposure reduction and minimization, regulated areas, change rooms and
showers, respiratory protection, protective clothing, and disposal of
protective clothing. All of these provisions are triggered by DOE's
action level (64 FR 68874, December 8, 1999). Although DOE's rule is
not identical to OSHA's proposed standard, OSHA believes that DOE's
costs are sufficiently representative to form the basis of a
preliminary estimate of the costs that could flow from OSHA's standard,
if finalized.
Based on the range of potential scenarios and the prior DOE cost
estimates, OSHA estimates that the annual cost impact on DOE facilities
could range from $0 to $4,065,768 (2010 dollars). The upper end of the
cost range would reflect the unlikely scenario in which OSHA
promulgates a final PEL of 0.1 [micro]g/m\3\, 10 CFR 851.23(a)(3) is
found to compel DOE contractors to comply with OSHA's comprehensive
beryllium standard in addition to DOE's CBDPP, and DOE takes no action
to clarify that OSHA's beryllium standard does not apply to DOE
contractors. The lower end of the cost range assumes OSHA promulgates
its rule as proposed with a PEL of 0.2 [micro]g/m\3\ and action level
of 0.1 [micro]g/m\3\, and DOE clarifies that it intends its contractors
to follow DOE's CBDPP and not OSHA's beryllium standard, so that the
ancillary provisions of OSHA's beryllium standard do not apply to DOE
facilities. Additionally, OSHA assumes that DOE contractors are in
compliance with DOE's current rule and therefore took the difference in
cost between implementation of an action level of 0.2 [micro]g/m\3\ and
an action level of 0.1 [micro]g/m\3\ for the above estimates. Finally,
OSHA used the GDP price deflator to present the cost estimate in 2010
dollars.
OSHA requests comment on the potential overlap of DOE's rule with
OSHA's proposed rule.
II. Pertinent Legal Authority
The purpose of the Occupational Safety and Health Act, 29 U.S.C.
651 et seq. (``the Act''), is to ``. . . assure so far as possible
every working man and woman in the nation safe and healthful working
conditions and to preserve our human resources.'' 29 U.S.C. 651(b).
To achieve this goal Congress authorized the Secretary of Labor
(the Secretary) to promulgate and enforce occupational safety and
health standards. 29 U.S.C. 654(b) (requiring employers to comply with
OSHA standards), 655(a) (authorizing summary adoption of existing
consensus and federal standards within two years of the Act's
enactment), and 655(b) (authorizing promulgation, modification or
revocation of standards pursuant to notice and comment).
The Act provides that in promulgating health standards dealing with
toxic materials or harmful physical agents, such as this proposed
standard regulating occupational exposure to beryllium, the Secretary,
shall set the standard which most adequately assures, to the extent
feasible, on the basis of the best available evidence that no employee
will suffer material impairment of health or functional capacity even
if such employee has regular exposure to the hazard dealt with by such
standard for the period of his working life. See 29 U.S.C. 655(b)(5).
The Supreme Court has held that before the Secretary can promulgate
any permanent health or safety standard, he must make a threshold
finding that significant risk is present and that such risk can be
eliminated or lessened by a change in practices. Industrial Union
Dept., AFL-CIO v. American Petroleum Institute, 448 U.S. 607, 641-42
(1980) (plurality opinion) (``The Benzene case''). Thus, section
6(b)(5) of the Act requires health standards to reduce significant risk
to the extent feasible. Id.
The Court further observed that what constitutes ``significant
risk'' is ``not a mathematical straitjacket'' and must be ``based
largely on policy considerations.'' The Benzene case, 448 U.S. at 655.
The Court gave the example that if,
. . . the odds are one in a billion that a person will die from
cancer . . . the risk clearly could not be considered significant.
On the other hand, if the odds are one in one thousand that regular
inhalation of gasoline vapors that are 2% benzene will be fatal, a
reasonable person might well consider the risk significant. [Id.]
OSHA standards must be both technologically and economically
feasible. United Steelworkers v. Marshall, 647 F.2d 1189, 1264 (D.C.
Cir. 1980) (``The Lead I case''). The Supreme Court has defined
feasibility as ``capable of being done.'' Am. Textile Mfrs. Inst. v.
Donovan, 452 U.S. 490, 509-510 (1981) (``The Cotton Dust case''). The
courts have further clarified that a standard is technologically
feasible if OSHA proves a reasonable possibility,
. . . within the limits of the best available evidence . . .
that the typical firm will be able to develop and install
engineering and work practice controls that can meet the PEL in most
of its operations. [See The Lead I case, 647 F.2d at 1272]
With respect to economic feasibility, the courts have held that a
standard is feasible if it does not threaten massive dislocation to or
imperil the existence of the industry. Id. at 1265. A court must
examine the cost of compliance with an OSHA standard,
. . . in relation to the financial health and profitability of
the industry and the likely effect of such costs on unit consumer
prices . . . [T]he practical question is whether the standard
threatens the competitive stability of an industry, . . . or whether
any intra-industry or inter-industry discrimination in the standard
might wreck such stability or lead to undue concentration. [Id.
(citing Indus. Union Dep't, AFL-CIO v. Hodgson, 499 F.2d 467 (D.C.
Cir. 1974))]
The courts have further observed that granting companies reasonable
time to comply with new PELs may enhance economic feasibility. The Lead
I case at 1265. While a standard must be economically feasible, the
Supreme Court has held that a cost-benefit analysis of health standards
is not required by the Act because a feasibility analysis is required.
The Cotton Dust case, 453 U.S. at 509.
Finally, sections 6(b)(7) and 8(c) of the Act authorize OSHA to
include among a standard's requirements labeling, monitoring, medical
testing, and other information-gathering and -transmittal provisions.
29 U.S.C. 655(b)(7), 657(c).
[[Page 47578]]
III. Events Leading to the Proposed Standards
The first occupational exposure limit for beryllium was set in 1949
by the Atomic Energy Commission (AEC), which required that beryllium
exposure in the workplaces under its jurisdiction be limited to 2
[micro]g/m\3\ as an 8-hour time-weighted average (TWA), and 25
[micro]g/m\3\ as a peak exposure never to be exceeded (Department of
Energy, 1999). These exposure limits were adopted by all AEC
installations handling beryllium, and were binding on all AEC
contractors involved in the handling of beryllium.
In 1956, the American Industrial Hygiene Association (AIHA)
published a Hygienic Guide which supported the AEC exposure limits. In
1959, the American Conference of Governmental Industrial Hygienists
(ACGIH[supreg]) also adopted a Threshold Limit Value (TLV[supreg]) of 2
[micro]g/m\3\ as an 8-hour TWA (Borak, 2006).
In 1971, OSHA adopted, under Section 6(a) of the Occupational
Safety and Health Act of 1970, and made applicable to general industry,
a national consensus standard (ANSI Z37.29-1970) for beryllium and
beryllium compounds. The standard set a permissible exposure limit
(PEL) for beryllium and beryllium compounds at 2 [micro]g/m\3\ as an 8-
hour TWA; 5 [micro]g/m\3\ as an acceptable ceiling concentration; and
25 [micro]g/m\3\ as an acceptable maximum peak above the acceptable
ceiling concentration for a maximum duration of 30 minutes in an 8-hour
shift (OSHA, 1971).
Section 6(a) stipulated that in the first two years after the
effective date of the Act, OSHA was to promulgate ``start-up''
standards, on an expedited basis and without public hearing or comment,
based on national consensus or established Federal standards that
improved employee safety or health. Pursuant to that authority, in
1971, OSHA promulgated approximately 425 PELs for air contaminants,
including beryllium, derived principally from Federal standards
applicable to government contractors under the Walsh-Healey Public
Contracts Act, 41 U.S.C. 35, and the Contract Work Hours and Safety
Standards Act (commonly known as the Construction Safety Act), 40
U.S.C. 333. The Walsh-Healey Act and Construction Safety Act standards,
in turn, had been adopted primarily from ACGIH[supreg]'s TLV[supreg]s.
The National Institute for Occupational Safety and Health (NIOSH)
issued a document entitled Criteria for a Recommended Standard:
Occupational Exposure to Beryllium (Criteria Document) in June 1972.
OSHA reviewed the findings and recommendations contained in the
Criteria Document along with the AEC control requirements for beryllium
exposure. OSHA also considered existing data from animal and
epidemiological studies, and studies of industrial processes of
beryllium extraction, refinement, fabrication, and machining. In 1975,
OSHA asked NIOSH to update the evaluation of the existing data
pertaining to the carcinogenic potential of beryllium. In response to
OSHA's request, the Director of NIOSH stated that, based on animal data
and through all possible routes of exposure including inhalation,
``beryllium in all likelihood represents a carcinogenic risk to man.''
In October 1975, OSHA proposed a new beryllium standard for all
industries based on information that beryllium caused cancer in animal
experiments (40 FR 48814 (October 17, 1975)). Adoption of this proposal
would have lowered the 8-hour TWA exposure limit from 2 [micro]g/m\3\
to 1 [micro]g/m\3\. In addition, the proposal included ancillary
provisions for such topics as exposure monitoring, hygiene facilities,
medical surveillance, and training related to the health hazards from
beryllium exposure. The rulemaking was never completed.
In 1977, NIOSH recommended an exposure limit of 0.5 [micro]g/m\3\
and identified beryllium as a potential occupational carcinogen. In
December 1998, ACGIH published a Notice of Intended Change for its
beryllium exposure limit. The notice proposed a lower TLV of 0.2
[micro]g/m\3\ over an 8-hour TWA based on evidence of CBD and
sensitization in exposed workers.
In 1999, the Department of Energy (DOE) issued a Chronic Beryllium
Disease Prevention Program (CBDPP) Final Rule for employees exposed to
beryllium in its facilities (DOE, 1999). The DOE rule set an action
level of 0.2 [mu]g/m\3\, and adopted OSHA's PEL of 2 [mu]g/m\3\ or any
more stringent PEL OSHA might adopt in the future. The DOE action level
triggers workplace precautions and control measures such as periodic
monitoring, exposure reduction or minimization, regulated areas,
hygiene facilities and practices, respiratory protection, protective
clothing and equipment, and warning signs (DOE, 1999).
Also in 1999, OSHA was petitioned by the Paper, Allied-Industrial,
Chemical and Energy Workers International Union (PACE) (OSHA, 2002) and
by Dr. Lee Newman and Ms. Margaret Mroz, from the National Jewish
Medical Research Center (NJMRC) (OSHA, 2002), to promulgate an
Emergency Temporary Standard (ETS) for beryllium in the workplace. In
2001, OSHA was petitioned for an ETS by Public Citizen Health Research
Group and again by PACE (OSHA, 2002). In order to promulgate an ETS,
the Secretary of Labor must prove (1) that employees are exposed to
grave danger from exposure to a hazard, and (2) that such an emergency
standard is necessary to protect employees from such danger (29 U.S.C.
655(c)). The burden of proof is on the Department and because of the
difficulty of meeting this burden, the Department usually proceeds when
appropriate with 6(b) rulemaking rather than a 6(c) ETS. Thus, instead
of granting the ETS requests, OSHA instructed staff to further collect
and analyze research regarding the harmful effects of beryllium.
On November 26, 2002, OSHA published a Request for Information
(RFI) for ``Occupational Exposure to Beryllium'' (OSHA, 2002). The RFI
contained questions on employee exposure, health effects, risk
assessment, exposure assessment and monitoring methods, control
measures and technological feasibility, training, medical surveillance,
and impact on small business entities. In the RFI, OSHA expressed
concerns about health effects such as CBD, lung cancer, and beryllium
sensitization. OSHA pointed to studies indicating that even short-term
exposures below OSHA's PEL of 2 [micro]g/m\3\ could lead to CBD. The
RFI also cited studies describing the relationship between beryllium
sensitization and CBD (67 FR at 70708). In addition, OSHA stated that
beryllium had been identified as a carcinogen by organizations such as
NIOSH, the International Agency for Research on Cancer (IARC), and the
Environmental Protection Agency (EPA); and cancer had been evidenced in
animal studies (67 FR at 70709).
On November 15, 2007, OSHA convened a Small Business Advocacy
Review Panel for a draft proposed standard for occupational exposure to
beryllium. OSHA convened this panel under Section 609(b) of the
Regulatory Flexibility Act (RFA), as amended by the Small Business
Regulatory Enforcement Fairness Act of 1996 (SBREFA) (5 U.S.C. 601 et
seq.).
The Panel included representatives from OSHA, the Solicitor's
Office of the Department of Labor, the Office of Advocacy within the
Small Business Administration, and the Office of Information and
Regulatory Affairs of the Office of Management and Budget. Small Entity
Representatives (SERs) made oral and written comments on the
[[Page 47579]]
draft rule and submitted them to the panel.
The SBREFA Panel issued a report which included the SERs' comments
on January 15, 2008. SERs expressed concerns about the impact of the
ancillary requirements such as exposure monitoring and medical
surveillance. Their comments addressed potential costs associated with
compliance with the draft standard, and possible impacts of the
standard on market conditions, among other issues. In addition, many
SERs sought clarification of some of the ancillary requirements such as
the meaning of ``routine'' contact or ``contaminated surfaces.''
The SBREFA Panel issued a number of recommendations, which OSHA
carefully considered. In section XVIII of this preamble, Summary and
Explanation, OSHA has responded to the Panel's recommendations and
clarified the requirements about which SERs expressed confusion. OSHA
also examined the regulatory alternatives recommended by the SBREFA
Panel. The regulatory alternatives examined by OSHA are listed in
section I of this preamble, Issues and Alternatives. The alternatives
are discussed in greater detail in section XVIII of this preamble,
Summary and Explanation, and in the PEA (OSHA, 2014). In addition, the
Agency intends to develop interpretive guidance documents following the
publication of a final rule.
In 2010, OSHA hired a contractor to oversee an independent
scientific peer review of a draft preliminary beryllium health effects
evaluation (OSHA, 2010a) and a draft preliminary beryllium risk
assessment (OSHA, 2010b). The contractor identified experts familiar
with beryllium health effects research and ensured that these experts
had no conflict of interest or apparent bias in performing the review.
The contractor selected five experts with expertise in such areas as
pulmonary and occupational medicine, CBD, beryllium sensitization, the
BeLPT, beryllium toxicity and carcinogenicity, and medical
surveillance. Other areas of expertise included animal modeling,
occupational epidemiology, biostatistics, risk and exposure assessment,
exposure-response modeling, beryllium exposure assessment, industrial
hygiene, and occupational/environmental health engineering.
Regarding the health effects evaluation, the peer reviewers
concluded that the health effect studies were described accurately and
in sufficient detail, and OSHA's conclusions based on the studies were
reasonable. The reviewers agreed that the OSHA document covered the
significant health endpoints related to occupational beryllium
exposure. Peer reviewers considered the preliminary conclusions
regarding beryllium sensitization and CBD to be reasonable and well
presented in the draft health evaluation section. All reviewers agreed
that the scientific evidence supports sensitization as a necessary
condition in the development of CBD. In response to reviewers'
comments, OSHA made revisions to more clearly describe certain sections
of the health effects evaluation. In addition, OSHA expanded its
discussion regarding the BeLPT.
Regarding the preliminary risk assessment, the peer reviewers were
highly supportive of the Agency's approach and major conclusions. The
peer reviewers stated that the key studies were appropriate and their
selection clearly explained in the document. They regarded the
preliminary analysis of these studies to be reasonable and
scientifically sound. The reviewers supported OSHA's conclusion that
substantial risk of sensitization and CBD were observed in facilities
where the highest exposure generating processes had median full-shift
exposures around 0.2 [micro]g/m\3\ or higher, and that the greatest
reduction in risk was achieved when exposures for all processes were
lowered to 0.1 [micro]g/m\3\ or below.
In February 2012 the Agency received for consideration a draft
recommended standard for beryllium (Materion and USW, 2012). This draft
proposal was the product of a joint effort between two stakeholders:
Materion Corporation, a leading producer of beryllium and beryllium
products in the United States, and the United Steelworkers, an
international labor union representing workers who manufacture
beryllium alloys and beryllium-containing products in a number of
industries. The United Steelworkers and Materion sought to craft an
OSHA-like model beryllium standard that would have support from both
labor and industry. OSHA has considered this proposal along with other
information submitted during the development of the Notice of Proposed
Rulemaking for beryllium.
IV. Chemical Properties and Industrial Uses
Chemical and Physical Properties
Beryllium (Be; CAS Number 7440-41-7) is a silver-grey to greyish-
white, strong, lightweight, and brittle metal. It is a Group IIA
element with an atomic weight of 9.01, atomic number of 4, melting
point of 1,287 [deg]C, boiling point of 2,970[deg]C, and a density of
1.85 at 20 [deg]C (NTP 2014). It occurs naturally in rocks, soil, coal,
and volcanic dust (ATSDR, 2002). Beryllium is insoluble in water and
soluble in acids and alkalis. It has two common oxidation states, Be(0)
and Be(+2). There are several beryllium compounds with unique CAS
numbers and chemical and physical properties. Table IV-1 describes the
most common beryllium compounds.
Table IV--1, Properties of Beryllium and Beryllium Compounds
--------------------------------------------------------------------------------------------------------------------------------------------------------
Synonyms and Molecular Melting point
Chemical name CAS No. trade names weight ([deg]C) Description Density (g/cm3) Solubility
--------------------------------------------------------------------------------------------------------------------------------------------------------
Beryllium metal............... 7440-41-7 Beryllium; 9.0122 1287............ Grey, close- 1.85 (20 [deg]C) Soluble in most
beryllium-9, packed, dilute acids and
beryllium hexagonal, alkali; decomposes
element; brittle metal. in hot water;
beryllium insoluble in mercury
metallic. and cold water.
Beryllium chloride............ 7787-47-5 Beryllium 79.92 399.2........... Colorless to 1.899 (25 Soluble in water,
dichloride. slightly [deg]C). ethanol, diethyl
yellow; ether and pyridine;
orthorhombic, slightly soluble in
deliquescent benzene, carbon
crystal. disulfide and
chloroform;
insoluble in
acetone, ammonia,
and toluene.
[[Page 47580]]
Beryllium fluoride............ 7787-49-7 Beryllium 47.01 555............. Colorless or 1.986........... Soluble in water,
(12323-05-6 difluoride. white, sulfuric acid,
) amorphous, mixture of ethanol
hygroscopic and diethyl ether;
solid. slightly soluble in
ethanol; insoluble
in hydrofluoric
acid.
Beryllium hydroxide........... 13327-32-7 Beryllium 43.3 138 (decomposes White, 1.92............ Soluble in hot
(1304-49-0) dihydroxide. to beryllium amorphous, concentrated acids
oxide). amphoteric and alkali; slightly
powder. soluble in dilute
alkali; insoluble in
water.
Beryllium sulfate............. 13510-49-1 Sulfuric acid, 105.07 550-600 [deg]C Colorless 2.443........... Forms soluble
beryllium salt (decomposes to crystal. tetrahydrate in hot
(1:1). beryllium water; insoluble in
oxide). cold water.
Beryllium sulfate tetrhydrate. 7787-56-6 Sulfuric acid; 177.14 100 [deg]C...... Colorless, 1.713........... Soluble in water;
beryllium salt tetragonal slightly soluble in
(1:1), crystal. concentrated
tetrahydrate. sulfuric acid;
insoluble in
ethanol.
Beryllium Oxide............... 1304-56-9 Beryllia; 25.01 2508-2547 [deg]C Colorless to 3.01 (20 [deg]C) Soluble in
beryllium white, concentrated acids
monoxide hexagonal and alkali;
thermalox TM. crystal or insoluble in water.
amorphous,
amphoteric
powder.
Beryllium carbonate........... 1319-43-3 Carbonic acid, 112.05 No data......... White powder.... No data......... Soluble in acids and
beryllium salt, alkali; insoluble in
mixture with cold water;
beryllium decomposes in hot
hydroxide. water.
Beryllium nitrate trihydrate.. 7787-55-5 Nitric acid, 187.97 60.............. White to faintly 1.56............ Very soluble in water
beryllium salt, yellowish, and ethanol.
trihydrate. deliquescent
mass.
Beryllium phosphate........... 13598-15-7 Phosphoric acid, 104.99 No data......... Not reported.... Not reported.... Slightly soluble in
beryllium salt water.
(1:1).
--------------------------------------------------------------------------------------------------------------------------------------------------------
ATSDR, 2002.
The physical and chemical properties of beryllium were realized
early in the 20th century, and it has since gained commercial
importance in a wide range of industries. Beryllium is lightweight,
hard, spark resistant, non-magnetic, and has a high melting point. It
lends strength, electrical and thermal conductivity, and fatigue
resistance to alloys (NTP, 2014). Beryllium also has a high affinity
for oxygen in air and water, which can cause a thin surface film of
beryllium oxide to form on the bare metal, making it extremely
resistant to corrosion. These properties make beryllium alloys highly
suitable for defense, nuclear, and aerospace applications (IARC, 1993).
There are approximately 45 mineralized forms of beryllium. In the
United States, the predominant mineral form mined commercially and
refined into pure beryllium and beryllium alloys is bertrandite.
Bertrandite, while containing less than 1% beryllium compared to 4% in
beryl, is easily and efficiently processed into beryllium hydroxide
(IARC, 1993). Imported beryl is also converted into beryllium hydroxide
as the United States has very little beryl that can be economically
mined (USGS, 2013a).
Industrial Uses
Materion Corporation, formerly called Brush Wellman, is the only
producer of primary beryllium in the United States. Beryllium is used
in a variety of industries, including aerospace, defense,
telecommunications, automotive, electronic, and medical specialty
industries. Pure beryllium metal is used in a range of products such as
X-ray transmission windows, nuclear reactor neutron reflectors, nuclear
weapons, precision instruments, rocket propellants, mirrors, and
computers (NTP, 2014). Beryllium oxide is used in components such as
ceramics, electrical insulators, microwave oven components, military
vehicle armor, laser structural components, and automotive ignition
systems (ATSDR, 2002). Beryllium oxide ceramics are used to produce
sensitive electronic items such as lasers and satellite heat sinks.
Beryllium alloys, typically beryllium/copper or beryllium/aluminum,
are manufactured as high beryllium content or low beryllium content
alloys. High content alloys contain greater than 30% beryllium. Low
content alloys are typically less than 3% beryllium. Beryllium alloys
are used in automotive electronics (e.g., electrical connectors and
relays and audio components), computer components, home appliance
parts, dental appliances (e.g., crowns), bicycle frames, golf clubs,
and other articles (NTP, 2014; Ballance et al., 1978; Cunningham et
al., 1998; Mroz, et al., 2001). Electrical components and conductors
are stamped and formed from beryllium alloys. Beryllium-copper
[[Page 47581]]
alloys are used to make switches in automobiles (Ballance et al., 1978,
2002; Cunningham et al., 1998) and connectors, relays, and switches in
computers, radar, satellite, and telecommunications equipment (Mroz et
al., 2001). Beryllium-aluminum alloys are used in the construction of
aircraft, high resolution medical and industrial X-ray equipment, and
mirrors to measure weather patterns (Mroz et al., 2001). High content
and low content beryllium alloys are precision machined for military
and aerospace applications. Some welding consumables are also
manufactured using beryllium.
Beryllium is also found as a trace metal in materials such as
aluminum ore, abrasive blasting grit, and coal fly ash. Abrasive
blasting grits such as coal slag and copper slag contain varying
concentrations of beryllium, usually less than 0.1% by weight. The
burning of bituminous and sub-bituminous coal for power generation
causes the naturally occurring beryllium in coal to accumulate in the
coal fly ash byproduct. Scrap and waste metal for smelting and refining
may also contain beryllium. A detailed discussion of the industries and
job tasks using beryllium is included in the Preliminary Economic
Analysis (OSHA, 2014).
Occupational exposure to beryllium can occur from inhalation of
dusts, fume, and mist. Beryllium dusts are created during operations
where beryllium is cut, machined, crushed, ground, or otherwise
mechanically sheared. Mists can also form during operations that use
machining fluids. Beryllium fume can form while welding with or on
beryllium components, and from hot processes such as those found in
metal foundries.
Occupational exposure to beryllium can also occur from skin, eye,
and mucous membrane contact with beryllium particulate or solutions.
V. Health Effects
Beryllium-associated health effects, including acute beryllium
disease (ABD), beryllium sensitization (also referred to in this
preamble as ``sensitization''), chronic beryllium disease (CBD), and
lung cancer, can lead to a number of highly debilitating and life-
altering conditions including pneumonitis, loss of lung capacity
(reduction in pulmonary function leading to pulmonary dysfunction),
loss of physical capacity associated with reduced lung capacity,
systemic effects related to pulmonary dysfunction, and decreased life
expectancy (NIOSH, 1972).
This Health Effects section presents information on beryllium and
its compounds, the fate of beryllium in the body, research that relates
to its toxic mechanisms of action, and the scientific literature on the
adverse health effects associated with beryllium exposure, including
ABD, sensitization, CBD, and lung cancer. OSHA considers CBD to be a
progressive illness with a continuous spectrum of symptoms ranging from
no symptomatology at its earliest stage following sensitization to mild
symptoms such as a slight almost imperceptible shortness of breath, to
loss of pulmonary function, debilitating lung disease, and, in many
cases, death. This section also discusses the nature of these
illnesses, the scientific evidence that they are causally associated
with occupational exposure to beryllium, and the probable mechanisms of
action with a more thorough review of the supporting studies.
A. Beryllium and Beryllium Compounds
1. Particle Physical/Chemical Properties
Beryllium (Be; CAS No. 7440-41-7) is a steel-grey, brittle metal
with an atomic number of 4 and an atomic weight of 9.01 (Group IIA of
the periodic table). Because of its high reactivity, beryllium is not
found as a free metal in nature; however, there are approximately 45
mineralized forms of beryllium. Beryllium compounds and alloys include
commercially valuable metals and gemstones.
Beryllium has two oxidative states: Be(0) and Be(2\+\) Agency for
Toxic Substance and Disease Registry (ATSDR) 2002). It is likely that
the Be(2\+\) state is the most biologically reactive and able to form a
bond with peptides leading to it becoming antigenic (Snyder et al.,
2003). This will be discussed in more detail in the Beryllium
Sensitization section below. Beryllium has a high charge-to-radius
ratio and in addition to forming various types of ionic bonds,
beryllium has a strong tendency for covalent bond formation (e.g., it
can form organometallic compounds such as
Be(CH3)2 and many other complexes) (ATSDR, 2002;
Greene et al., 1998). However, it appears that few, if any, toxicity
studies exist for the organometallic compounds. Additional physical/
chemical properties for beryllium compounds that may be important in
their biological response are summarized in Table 1 below. This
information was obtained from their International Chemical Safety Cards
(ICSC) (beryllium metal (ICSC 0226), beryllium oxide (ICSC 1325),
beryllium sulfate (ICSC 1351), beryllium nitrate (ICSC 1352), beryllium
carbonate (ICSC 1353), beryllium chloride (ICSC 1354), beryllium
fluoride (ICSC 1355)) and from the hazardous substance data bank (HSDB)
for beryllium hydroxide (CASRN: 13327-32-7), and beryllium phosphate
(CASRN: 13598-15-7). Additional information on chemical and physical
properties as well as industrial uses for beryllium can be found in
this preamble at Section IV, Chemical Properties and Industrial Uses.
Table 1--Physical/Chemical Properties of Beryllium and Compounds
--------------------------------------------------------------------------------------------------------------------------------------------------------
Solubility in water at
Compound name Physical appearance Chemical formula Molecular mass Acute physical hazards 20 [deg]C
--------------------------------------------------------------------------------------------------------------------------------------------------------
Beryllium Metal.................... Grey to White Powder.. Be.................... 9.0 Combustible; Finely None.
dispersed particles--
Explosive.
Beryllium Oxide.................... White Crystals or BeO................... 25.0 Not combustible or Very sparingly
Powder. explosive. soluble.
Beryllium Carbonate................ White Powder.......... Be2CO3(OH)/Be2CO5H2... 181.07 Not combustible or None.
explosive.
Beryllium Sulfate.................. Colorless Crystals.... BeSO4................. 105.1 Not combustible or Slightly soluble.
explosive.
Beryllium Nitrate.................. White to Yellow Solid. BeN2O6/Be(NO3)2....... 133.0 Enhances combustion of Very soluble (1.66 x
other substances. 10\6\ mg/L).
Beryllium Hydroxide................ White amorphous powder Be(OH)2............... 43.0 Not reported............... Slightly soluble 0.8 x
or crystalline solid. 10-4 mol/L
(3.44 mg/L).
Beryllium Chloride................. Colorless to Yellow BeCl2................. 79.9 Not combustible or Soluble.
Crystals. explosive.
Beryllium Fluoride................. Colorless Lumps....... BeF2.................. 47.0 Not combustible or Very soluble.
explosive.
[[Page 47582]]
Beryllium Phosphate................ White solid........... Be3(PO4)2............. 271.0 Not reported............... Soluble.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: International Chemical Safety Cards (except beryllium phosphate and hydroxide--HSDB).
Beryllium shows a high affinity for oxygen in air and water,
resulting in a thin surface film of beryllium oxide on the bare metal.
If the surface film is disturbed, it may become airborne or dermal
exposure may occur. The solubility, particle surface area, and particle
size of some beryllium compounds are examined in more detail below.
These properties have been evaluated in many toxicological studies. In
particular, the properties related to the calcination (firing
temperatures) and differences in crystal size and solubility are
important aspects in their toxicological profile.
2. Factors Affecting Potency and Effect of Beryllium Exposure
The effect and potency of beryllium and its compounds, as for any
toxicant, immunogen, or immunotoxicant, may be dependent upon the
physical state in which they are presented to a host. For occupational
airborne materials and surface contaminants, it is especially critical
to understand those physical parameters in order to determine the
extent of exposure to the respiratory tract and skin since these are
generally the initial target organs for either route of exposure.
For example, large particles may have less of an effect in the lung
than smaller particles due to reduced potential to stay airborne to be
inhaled or be deposited along the respiratory tract. In addition, once
inhalation occurs particle size is critical in determining where the
particle will deposit along the respiratory tract. Solubility also has
an important part in determining the toxicity and bioavailability of
airborne materials as well. Respiratory tract retention and skin
penetration are directly influenced by the solubility and reactivity of
airborne material.
These factors may be responsible, at least in part, for the process
by which beryllium sensitization progresses to CBD in exposed workers.
Other factors influencing beryllium-induced toxicity include the
surface area of beryllium particles and their persistence in the lung.
With respect to dermal exposure, the physical characteristics of the
particle are important as well since they can influence skin absorption
and bioavailability. This section addresses certain physical
characteristics (i.e., solubility, particle size, particle surface
area) that are important in influencing the toxicity of beryllium
materials in occupational settings.
a. Solubility
Solubility may be an important determinant of the toxicity of
airborne materials, influencing the deposition and persistence of
inhaled particles in the respiratory tract, their bioavailability, and
the likelihood of presentation to the immune system. A number of
chemical agents, including metals that contact and penetrate the skin,
are able to induce an immune response, such as sensitization (Boeniger,
2003; Mandervelt et al., 1997). Similar to inhaled agents, the ability
of materials to penetrate the skin is also influenced by solubility
since dermal absorption may occur at a greater rate for soluble
materials than insoluble materials (Kimber et al., 2011).
This section reviews the relevant information regarding solubility,
its importance in a biological matrix and its relevance to
sensitization and beryllium lung disease. The weight of evidence
presented below suggests that both soluble and non-soluble forms of
beryllium can induce a sensitization response and result in progression
of lung disease.
Beryllium salts, including the chloride (BeCl2),
fluoride (BeF2), nitrate (Be(NO3)2),
phosphate (Be3(PO4)2), and sulfate
(tetrahydrate) (BeSO4 [middot] 4H2O) salts, are
all water soluble. However, soluble beryllium salts can be converted to
less soluble forms in the lung (Reeves and Vorwald, 1967). Aqueous
solutions of the soluble beryllium salts are acidic as a result of the
formation of Be(OH2)4 2\+\, the tetrahydrate,
which will react to form insoluble hydroxides or hydrated complexes
within the general physiological range of pH values (between 5 and 8)
(EPA, 1998). This may be an important factor in the development of CBD
since lower-solubility forms of beryllium have been shown to persist in
the lung for longer periods of time and persistence in the lung may be
needed in order for this disease to occur (NAS, 2008).
Beryllium oxide (BeO), hydroxide (Be(OH)2), carbonate
(Be2CO3(OH)2), and sulfate (anhydrous)
(BeSO4) are either insoluble, slightly soluble, or
considered to be sparingly soluble (almost insoluble or having an
extremely slow rate of dissolution). The solubility of beryllium oxide,
which is prepared from beryllium hydroxide by calcining (heating to a
high temperature without fusing in order to drive off volatile
chemicals) at temperatures between 500 and 1,750 [deg]C, has an inverse
relationship with calcination temperature. Although the solubility of
the low-fired crystals can be as much as 10 times that of the high-
fired crystals, low-fired beryllium oxide is still only sparingly
soluble (Delic, 1992). In a study that measured the dissolution
kinetics (rate to dissolve) of beryllium compounds calcined at
different temperatures, Hoover et al., compared beryllium metal to
beryllium oxide particles and found them to have similar solubilities.
This was attributed to a fine layer of beryllium oxide that coats the
metal particles (Hoover et al., 1989). A study conducted by Deubner et
al., (2011) determined ore materials to be more soluble than beryllium
oxide at pH 7.2 but similar in solubility at pH 4.5. Beryllium
hydroxide was more soluble than beryllium oxide at both pHs (Deubner et
al., 2011).
Investigators have also attempted to determine how biological
fluids can dissolve beryllium materials. In two studies, insoluble
beryllium, taken up by activated phagocytes, was shown to be ionized by
myeloperoxidases (Leonard and Lauwerys, 1987; Lansdown, 1995). The
positive charge resulting from ionization enabled the beryllium to bind
to receptors on the surface of cells such as lymphocytes or antigen-
presenting cells which could make it more biologically active (NAS,
2008). In a study utilizing phagolysosomal-simulating fluid (PSF) with
a pH of 4.5, both beryllium metal and beryllium oxide dissolved at a
greater rate than that previously reported in water or SUF (simulant
fluid) (Stefaniak et al., 2006), and the rate of dissolution of the
multi-constituent (mixed) particles was greater than that of the
single-constituent beryllium oxide powder. The authors speculated that
copper in the particles rapidly dissolves, exposing the small
inclusions of beryllium oxide, which have higher specific surface areas
(SSA)
[[Page 47583]]
and therefore dissolve at a higher rate. A follow-up study by the same
investigational team (Duling et al., 2012) confirmed dissolution of
beryllium oxide by PSF and determined the release rate was biphasic
(initial rapid diffusion followed by a latter slower surface reaction-
driven release). During the latter phase, dissolution half-times were
1,400 to 2,000 days. The authors speculated this indicated bertrandite
was persistent in the lung (Duling et al., 2012).
In a recent study investigating the dissolution and release of
beryllium ions for 17 beryllium-containing materials (ore, hydroxide,
metal, oxide, alloys, and processing intermediates) using artificial
human airway epithelial lining fluid, Stefaniak et al., (2011) found
release of beryllium ions within 7 days (beryl ore melter dust). The
authors calculated dissolution half-times ranging from 30 days
(reduction furnace material) to 74,000 days (hydroxide). Stefaniak et
al., (2011) speculated that despite the rapid mechanical clearance,
billions of beryllium ions could be released in the respiratory tract
via dissolution in airway lining fluid (ALF). Under this scenario
beryllium-containing particles depositing in the respiratory tract
dissolving in ALF could provide beryllium ions for absorption in the
lung and interact with immune cells in the respiratory tract (Stefaniak
et al., 2011).
Huang et al., (2011) investigated the effect of simulated lung
fluid (SLF) on dissolution and nanoparticle generation and beryllium-
containing materials. Bertrandite-containing ore, beryl-containing ore,
frit (a processing intermediate), beryllium hydroxide (a processing
intermediate) and silica (used as a control), were equilibrated in SLF
at two pH values (4.5 and 7.2) to reflect inter- and intra-cellular
environments in the lung tissue. Concentrations of beryllium, aluminum,
and silica ions increased linearly during the first 20 days in SLF,
rose slowly thereafter, reaching equilibrium over time. The study also
found nanoparticle formation (in the size range of 10-100 nm) for all
materials (Huang et al., 2011).
In an in vitro skin model, Sutton et al., (2003) demonstrated the
dissolution of beryllium compounds (insoluble beryllium hydroxide,
soluble beryllium phosphate) in a simulated sweat fluid. This model
showed beryllium can be dissolved in biological fluids and be available
for cellular uptake in the skin. Duling et al., (2012) confirmed
dissolution and release of ions from bertrandite ore in an artificial
sweat model (pH 5.3 and pH 6.5).
b. Particle Size
The toxicity of beryllium as exemplified by beryllium oxide also is
dependent, in part, on the particle size, with smaller particles (<10
[mu]m) able to penetrate beyond the larynx (Stefaniak et al., 2008).
Most inhalation studies and occupational exposures involve quite small
(<1-2 [mu]m) beryllium oxide particles that can penetrate to the
pulmonary regions of the lung (Stefaniak et al., 2008). In inhalation
studies with beryllium ores, particle sizes are generally much larger,
with deposition occurring in several areas throughout the respiratory
tract for particles <10 [mu]m.
The temperature at which beryllium oxide is calcined influences its
particle size, surface area, solubility, and ultimately its toxicity
(Delic, 1992). Low-fired (500 [deg]C) beryllium oxide is predominantly
made up of poorly crystallized small particles, while higher firing
temperatures (1000--1750 [deg]C) result in larger particle sizes
(Delic, 1992).
In order to determine the extent to which particle size plays a
role in the toxicity of beryllium in occupational settings, several key
studies are reviewed and detailed below. The findings on particle size
have been related, where possible, to work process and biologically
relevant toxicity endpoints of either sensitization or CBD.
Numerous studies have been conducted evaluating the particle size
generated during basic industrial and machining operations. In a study
by Cohen et al., (1983), a multi-cyclone sampler was utilized to
measure the size mass distribution of the beryllium aerosol at a
beryllium-copper alloy casting operation. Briefly, Cohen et al., (1983)
found variable particle size generation based on the operations being
sampled with particle size ranging from 3 to 16 [mu]m. Hoover et al.,
(1990) also found variable particle sizes being generated based on
operations. In general, Hoover et al., (1990) found that milling
operations generated smaller particle sizes than sawing operations.
Hoover et al., (1990) also found that beryllium metal generated higher
concentrations than metal alloys. Martyny et al., (2000) characterized
generation of particle size during precision beryllium machining
processes. The study found that more than 50 percent of the beryllium
machining particles collected in the breathing zone of machinists were
less than 10 [mu]m in aerodynamic diameter with 30 percent of that
fraction being particles of less than 0.6 [mu]m. A study by Thorat et
al., (2003) found similar results with ore mixing, crushing, powder
production and machining ranging from 5.0 to 9.5 [mu]m. Kent et al.,
(2001) measured airborne beryllium using size-selective samplers in
five furnace areas at a beryllium processing facility. A statistically
significant linear trend was reported between the above alveolar-
deposited particle mass concentration and prevalence of CBD and
sensitization in the furnace production areas. The study authors
suggested that the concentration of alveolar-deposited particles (e.g.,
<3.5 [mu]m) may be a better predictor of sensitization and CBD than the
total mass concentration of airborne beryllium.
A recent study by Virji et al. (2011) evaluated particle size
distribution, chemistry and solubility in areas with historically
elevated risk of sensitization and CBD at a beryllium metal powder,
beryllium oxide, and alloy production facility. The investigators
observed that historically, exposure-response relationships have been
inconsistent when using mass concentration to identify process-related
risk, possibly due to incomplete particle characterization. Two
separate exposure surveys were conducted in March 1999 and June-August
1999 using multi-stage personal impactor samplers (to determine
particle size distribution) and personal 37 mm closed face cassette
(CFC) samplers, both located in workers' breathing zones. One hundred
and ninety eight time-weighted-average (TWA) personal impactor samples
were analyzed for representative jobs and processes. A total of 4,026
CFC samples were collected over the 5-month collection period and
analyzed for mass concentration, particle size, chemical content and
solubility and compared to process areas with high risk of
sensitization and CBD. The investigators found that total beryllium
concentration varied greatly between workers and among process areas.
Analysis of chemical form and solubility also revealed wide variability
among process areas, but high risk process areas had exposures to both
soluble and insoluble forms of beryllium. Analysis of particle size
revealed most process areas had particles ranging from 5-14 [micro]m
mass median aerodynamic diameter (MMAD). Rank order correlating jobs to
particle size showed high overall consistency (Spearman r=0.84) but
moderate correlation (Pearson r=0.43). The investigators concluded that
consideration of relevant aspects of exposure such as particle size
[[Page 47584]]
distribution, chemical form, and solubility will likely improve
exposure assessments (Virji et al., 2011)
c. Particle Surface Area.
Particle surface area has been postulated as an important metric
for beryllium exposure. Several studies have demonstrated a
relationship between the inflammatory and tumorigenic potential of
ultrafine particles and their increased surface area (Driscoll, 1996;
Miller, 1995; Oberdorster et al., 1996). While the exact mechanism
explaining how particle surface area influences its biological activity
is not known, a greater particle surface area has been shown to
increase inflammation, cytokine production, anti-oxidant defenses and
apoptosis (Elder et al., 2005; Carter et al., 2006; Refsne et al.,
2006).
Finch et al., (1988) found that beryllium oxide calcined at 500
[deg]C had 3.3 times greater specific surface area (SSA) than beryllium
oxide calcined at 1000 [deg]C, although there was no difference in size
or structure of the particles as a function of calcining temperature.
The beryllium-metal aerosol (airborne beryllium particles), although
similar to the beryllium oxide aerosols in aerodynamic size, had an SSA
about 30 percent that of the beryllium oxide calcined at 1000 [deg]C.
As discussed above, a later study by Delic (1992) found calcining
temperatures had an effect on SSA as well as particle size.
Several studies have investigated the lung toxicity of beryllium
oxide calcined at different temperatures and generally had found that
those calcined at lower temperatures have greater toxicity and effect
than materials calcined at higher temperatures. This may be because
beryllium oxide fired at the lower temperature has a loosely formed
crystalline structure with greater specific surface area than the fused
crystal structure of beryllium oxide fired at the higher temperature.
For example, beryllium oxide calcined at 500 [deg]C has been found to
have stronger pathogenic effects than material calcined at 1,000
[deg]C, as shown in several of the beagle dog, rat, mouse and guinea
pig studies discussed in the section on CBD pathogenesis that follows
(Finch et al., 1988; Polak et al., 1968; Haley et al., 1989; Haley et
al., 1992; Hall et al., 1950). Finch et al. have also observed higher
toxicity of beryllium oxide calcined at 500 [deg]C, an observation they
attribute to the greater surface area of beryllium particles calcined
at the lower temperature (Finch et al., 1988). These authors found that
the in vitro cytotoxicity to Chinese hamster ovary (CHO) cells and
cultured lung epithelial cells of 500 [deg]C beryllium oxide was
greater than that of 1,000 [deg]C beryllium oxide, which in turn was
greater than that of beryllium metal. However, when toxicity was
expressed in terms of particle surface area, the cytotoxicity of all
three forms was similar. Similar results were observed in a study
comparing the cytotoxicity of beryllium metal particles of various
sizes to cultured rat alveolar macrophages, although specific surface
area did not entirely predict cytotoxicity (Finch et al., 1991).
Stefaniak et al., (2003b) investigated the particle structure and
surface area of particles (powder and process-sampled) of beryllium
metal, beryllium oxide, and copper-beryllium alloy. Each of these
samples was separated by aerodynamic size, and their chemical
compositions and structures were determined with x-ray diffraction and
transmission electron microscopy, respectively. In summary, beryllium-
metal powder varied remarkably from beryllium oxide powder and alloy
particles. The metal powder consisted of compact particles, in which
SSA decreases with increasing surface diameter. In contrast, the alloys
and oxides consisted of small primary particles in clusters, in which
the SSA remains fairly constant with particle size. SSA for the metal
powders varied based on production and manufacturing process with
variations among samples as high as a factor of 37. Stefaniak et al.
(2003b) found lesser variation in SSA for the alloys or oxides. This is
consistent with data from other studies summarized above showing that
process may affect particle size and surface area. Particle size and/or
surface area may explain differences in the rate of BeS and CBD
observed in some epidemiological studies. However, these properties
have not been consistently characterized in most studies.
B. Kinetics and Metabolism of Beryllium
Beryllium enters the body by inhalation, ingestion, or absorption
through the skin. For occupational exposure, the airways and the skin
are the primary routes of uptake.
1. Exposure via the Respiratory System
The respiratory tract, especially the lung, is the primary target
of inhalation exposure in workers. Inhaled beryllium particles are
deposited along the respiratory tract in a size dependent manner. In
general, particles larger than 10 [mu]m tend to deposit in the upper
respiratory tract or nasal region and do not appreciably penetrate
lower in the tracheobronchial or pulmonary regions (Figure 1).
Particles less than 10 [mu]m increasingly penetrate and deposit in the
tracheobronchial and pulmonary regions with peak deposition in the
pulmonary region occurring below 5 [mu]m in particle diameter. The CBD
pathology of concern is found in the pulmonary region. For particles
below 1 [mu]m, regional deposition changes dramatically. Ultrafine
particles (generally considered to be 100 nm or lower) have a higher
rate of deposition along the entire respiratory system (ICRP model,
1994). Those particles depositing in the lung and along the entire
respiratory tract may encounter immunologic cells or may move into the
vascular system where they are free to leave the lung and can
contribute to systemic beryllium concentrations.
BILLING CODE 4510-26-C
[[Page 47585]]
[GRAPHIC] [TIFF OMITTED] TP07AU15.000
Beryllium is removed from the respiratory tract by various
clearance mechanisms. Soluble beryllium is removed from the respiratory
tract via absorption. Sparingly soluble or insoluble beryllium may
remain in the lungs for many years after exposure, as has been observed
in workers (Schepers, 1962). Clearance mechanisms for sparingly soluble
or insoluble beryllium particles include: In the nasal passage,
sneezing, mucociliary transport to the throat, or dissolution; in the
tracheobronchial region, mucociliary transport, coughing, phagocytosis,
or dissolution; in the pulmonary or alveolar region, phagocytosis,
movement through the interstitium (translocation), or dissolution
(Schlesinger, 1997).
Clearance mechanisms may occur slowly in humans, which is
consistent with some animal studies. For example, subjects in the
Beryllium Case Registry (BCR), which identifies and tracks cases of
acute and chronic beryllium diseases, had elevated concentrations of
beryllium in lung tissue (e.g., 3.1 [mu]g/g of dried lung tissue and
8.5 [mu]g/g in a mediastinal node) more than 20 years after termination
of short-term (generally between 2 and 5 years) occupational exposure
to beryllium (Sprince et al., 1976).
Clearance rates may depend on the solubility, dose, and size of the
beryllium particles inhaled as well as the sex and species of the
animal tested. As reviewed in a WHO Report (2001), more soluble
beryllium compounds generally tend to be cleared from the respiratory
system and absorbed into the bloodstream more rapidly than less soluble
compounds (Van Cleave and Kaylor, 1955; Hart et al., 1980; Finch et
al., 1990). Animal inhalation or intratracheal instillation studies
administering soluble beryllium salts demonstrated significant
absorption of approximately 20 percent of the initial lung burden,
while sparingly soluble compounds such as beryllium oxide demonstrated
that absorption was slower and less significant (Delic, 1992).
Additional animal studies have demonstrated that clearance of soluble
and sparingly soluble beryllium compounds was biphasic: A more rapid
initial mucociliary transport phase of particles from the
tracheobronchial tree to the gastrointestinal tract, followed by a
slower phase via translocation to tracheobronchial lymph nodes,
alveolar macrophages uptake, and beryllium particles dissolution
(Camner et al., 1977; Sanders et al., 1978; Delic, 1992; WHO, 2001).
Confirmatory studies in rats have shown the half-time for the rapid
phase between 1-60 days, while the slow phase ranged from 0.6-2.3
years. It was also shown that this process was influenced by the
solubility of the beryllium compounds: Weeks/months for soluble
compounds, months/years for sparingly soluble compounds (Reeves and
Vorwald, 1967; Reeves et al., 1967; Zorn et al., 1977; Rhoads and
Sanders, 1985). Studies in guinea-pigs and rats indicate that 40-50
percent of the inhaled soluble beryllium salts are retained in the
respiratory tract. Similar data could not be found for the sparingly or
less soluble beryllium compounds or metal administered by this exposure
route. (WHO, 2001; ATSDR, 2002).
Evidence from animal studies suggests that greater amounts of
beryllium deposited in the lung may result in slower clearance times. A
comparative study of rats and mice using a single dose of inhaled
aerosolized beryllium metal demonstrated that an acute inhalation
exposure to beryllium metal can slow particle clearance and induce lung
damage in rats (Haley et al., 1990) and mice (Finch et al., 1998a). In
another study Finch et al. (1994) exposed male F344/N rats to beryllium
metal at concentrations resulting in beryllium lung burdens of 1.8, 10,
and 100 [micro]g. These exposure levels resulted in an estimated
clearance half-life ranging
[[Page 47586]]
from 250-380 days for the three concentrations. For mice (Finch et al.,
1998a), lung clearance half-lives were 91-150 days (for 1.7- and 2.6-
[mu]g lung burden groups) or 360-400 days (for 12- and 34-[mu]g lung
burden groups). While the lower exposure groups were quite different
for rats and mice, the highest groups were similar in clearance half-
lives for both species.
Beryllium absorbed from the respiratory system is mainly
distributed to the tracheobronchial lymph nodes via the lymph system,
bloodstream, and skeleton, which is the ultimate site of beryllium
storage (Stokinger et al., 1953; Clary et al., 1975; Sanders et al.,
1975; Finch et al., 1990). Trace amounts are distributed throughout the
body (Zorn et al., 1977; WHO, 2001). Studies in rats have demonstrated
accumulation of beryllium chloride in the skeletal system following
intraperitoneal injection (Crowley et al., 1949; Scott et al., 1950)
and accumulation of beryllium phosphate and beryllium sulfate in both
nonparenchymal and parenchymal cells of the liver after intravenous
administration in rats (Skilleter and Price, 1978). Studies have also
demonstrated intracellular accumulation of beryllium oxide in bone
marrow throughout the skeletal system after intravenous administration
to rabbits (Fodor, 1977; WHO, 2001).
Systemic distribution of the more soluble compounds appears to be
greater than that of the insoluble compounds (Stokinger et al., 1953).
Distribution has also been shown to be dose dependent in research using
intravenous administration of beryllium in rats; small doses were
preferentially taken up in the skeleton, while higher doses were
initially distributed preferentially to the liver. Beryllium was later
mobilized from the liver and transferred to the skeleton (IARC, 1993).
A half-life of 450 days has been estimated for beryllium in the human
skeleton (ICRP, 1960). This indicates the skeleton may serve as a
repository for beryllium that may later be reabsorbed by the
circulatory system, making beryllium available to the immunological
system.
2. Dermal Exposure
Beryllium compounds have been shown to cause skin irritation and
sensitization in humans and certain animal models (Van Orstrand et al.,
1945; de Nardi et al., 1953; Nishimura 1966; Epstein 1990; Belman,
1969; Tinkle et al., 2003; Delic, 1992). The Agency for Toxic
Substances and Disease Registry (ATSDR) estimated that less than 0.1
percent of beryllium compounds are absorbed through the skin (ATSDR,
2002). However, even minute contact and absorption across the skin may
directly elicit an immunological sensitization response (Deubner et
al., 2001; Toledo et al., 2011). Recent studies by Tinkle et al. (2003)
showed that penetration of beryllium oxide particles was possible ex
vivo for human intact skin at particle sizes of <= 1[mu]m, as confirmed
by scanning electron microscopy. Using confocal microscopy, Tinkle et
al. demonstrated that surrogate fluorescent particles up to 1 [mu]m in
size could penetrate the mouse epidermis and dermis layers in a model
designed to mimic the flexing and stretching of human skin in motion.
Other poorly soluble particles, such as titanium dioxide, have been
shown to penetrate normal human skin (Tan et al., 1996) suggesting the
flexing and stretching motion as a plausible mechanism for dermal
penetration of beryllium as well. As earlier summarized, insoluble
forms of beryllium can be solubilized in biological fluids (e.g.,
sweat) making them available for absorption through intact skin (Sutton
et al., 2003; Stefaniak et al., 2011; Duling et al., 2012).
Although its precise role remains to be elucidated, there is
evidence to indicate that dermal exposure can contribute to beryllium
sensitization. As early as the 1940s it was recognized that dermatitis
experienced by workers in primary beryllium production facilities was
linked to exposures to the soluble beryllium salts. Except in cases of
wound contamination, dermatitis was rare in workers whose exposures
were restricted to exposure to poorly soluble beryllium-containing
particles (Van Ordstrand et al., 1945). Further investigation by McCord
in 1951 indicated that direct skin contact with soluble beryllium
compounds, but not beryllium hydroxide or beryllium metal, caused
dermal lesions (reddened, elevated, or fluid-filled lesions on exposed
body surfaces) in susceptible persons. Curtis, in 1951, demonstrated
skin sensitization to beryllium with patch testing using soluble and
insoluble forms of beryllium in beryllium-na[iuml]ve subjects. These
subjects later developed granulomatous skin lesions with the classical
delayed-type contact dermatitis following repeat challenge (Curtis,
1951). These lesions appeared after a latent period of 1-2 weeks,
suggesting a delayed allergic reaction. The dermal reaction occurred
more rapidly and in response to smaller amounts of beryllium in those
individuals previously sensitized (Van Ordstrand et al., 1945).
Contamination of cuts and scrapes with beryllium can result in the
beryllium becoming embedded within the skin causing a granuloma to
develop in the skin (Epstein, 1991). Introduction of soluble or
insoluble beryllium compounds into or under the skin as a result of
abrasions or cuts at work has been shown to result in chronic
ulcerations with granuloma formation (Van Orstrand et al., 1945;
Lederer and Savage, 1954). Beryllium absorption through bruises and
cuts has been demonstrated as well (Rossman et al., 1991). In a study
by Invannikov et al., (1982), beryllium chloride was applied directly
to the skin of live animals with three types of wounds: abrasions
(superficial skin trauma), cuts (skin and superficial muscle trauma),
and penetration wounds (deep muscle trauma). The percentage of the
applied dose absorbed into the systemic circulation during a 24-hour
exposure was significant, ranging from 7.8 percent to 11.4 percent for
abrasions, from 18.3 percent to 22.9 percent for cuts, and from 34
percent to 38.8 percent for penetration wounds (WHO, 2001).
A study by Deubner et al., (2001) concluded that exposure across
damaged skin can contribute as much systemic loading of beryllium as
inhalation (Deubner et al., 2001). Deubner et al., (2001) estimated
dermal loading (amount of particles penetrating into the skin) in
workers as compared to inhalation exposure. Deubner's calculations
assumed a dermal loading rate for beryllium on skin of 0.43 [mu]g/
cm\2\, based on the studies of loading on skin after workers cleaned up
(Sanderson et al., 1999), multiplied by a factor of 10 to approximate
the workplace concentrations and the very low absorption rate of 0.001
percent (taken from EPA estimates). It should be noted that these
calculations did not take into account absorption of soluble beryllium
salts that might occur across nasal mucus membranes, which may result
from contact between contaminated skin and the nose (EPA, 1998).
A study conducted by Day et al. (2007) evaluated the effectiveness
of a dermal protection program implemented in a beryllium alloy
facility in 2002. The investigators evaluated levels of beryllium in
air, on workplace surfaces, on cotton gloves worn over nitrile gloves,
and on the necks and faces of workers over a six day period. The
investigators found a good correlation between air samples and work
surface contamination at this facility. The investigators also found
measurable levels of beryllium on the skin of workers as a result of
work processes even from workplace areas
[[Page 47587]]
promoted as ``visually clean'' by the company housekeeping policy.
Importantly, the investigators found that the beryllium contamination
could be transferred from body region to body region (e.g., hand to
face, neck to face). The investigators demonstrated multiple pathways
of exposure which could lead to sensitization, increasing risk for
developing CBD (Day, et al., 2007).
The same group of investigators (Armstrong et al., 2014) extended
their work on investigating multiple exposure pathways contributing to
sensitization and CBD. The investigators evaluated four different
beryllium manufacturing and processing facilities to assess the
contribution of various exposure pathways on worker exposure. Airborne,
work surface and cotton glove beryllium concentrations were evaluated.
The investigators found strong correlations between air-surface
concentrations, glove-surface concentrations, and air-glove
concentrations at this facility. This work confirms findings from Day
et al. (2007) demonstrating the importance of airborne beryllium
concentrations to surface contamination and dermal exposure even at
exposures below the current OSHA PEL (Armstrong et al., 2014).
3. Oral and Gastrointestinal Exposure
According to the WHO Report (2001), gastrointestinal absorption of
beryllium can occur by both the inhalation and oral routes of exposure.
Through inhalation exposure, a fraction of the inhaled material is
transported to the gastrointestinal tract by the mucociliary escalator
or by the swallowing of the insoluble material deposited in the upper
respiratory tract (WHO, 2001). Gastrointestinal absorption of beryllium
can occur by both the inhalation and oral routes of exposure. In the
case of inhalation, a portion of the inhaled material is transported to
the gastrointestinal tract by the mucociliary escalator or by the
swallowing of the insoluble material deposited in the upper respiratory
tract (Schlesinger, 1997). Animal studies have shown oral
administration of beryllium compounds to result in very limited
absorption and storage (as reviewed by U.S. EPA, 1998). In animal
ingestion studies using radio-labeled beryllium chloride in rats, mice,
dogs, and monkeys, the vast majority of the ingested dose passed
through the gastrointestinal tract unabsorbed and was excreted in the
feces. In most studies, <1 percent of the administered radioactivity
was absorbed into the bloodstream and subsequently excreted in the
urine (Crowley et al., 1949; Furchner et al., 1973; LeFevre and Joel,
1986). Research using soluble beryllium sulfate has shown that as the
compound passes into the intestine, which has a higher pH than the
stomach (approximate pH of 6 to 8 for the intestine, pH of 1 or 2 for
the stomach), the beryllium is precipitated as the insoluble phosphate
and thus is no longer available for absorption (Reeves, 1965; WHO,
2001).
Urinary excretion of beryllium has been shown to correlate with the
amount of occupational exposure (Klemperer et al., 1951). Beryllium
that is absorbed into the bloodstream is excreted primarily in the
urine (Crowley et al., 1949; Scott et al., 1950; Furchner et al., 1973;
Stiefel et al., 1980), whereas excretion of unabsorbed beryllium is
primarily via the fecal route (Hart et al., 1980; Finch et al., 1990).
A far higher percentage of the beryllium administered parenterally in
various animal species was eliminated in the urine than in the feces
(Crowley et al., 1949; Scott et al., 1950; Furchner et al., 1973),
confirming that beryllium found in the feces following oral exposure is
primarily unabsorbed material. A study using percutaneous incorporation
of soluble beryllium nitrate in rats similarly demonstrated that more
than 90 percent of the beryllium in the bloodstream was eliminated via
urine (Zorn et al., 1977; WHO, 2001). More than 99 percent of ingested
beryllium chloride was excreted in the feces (Mullen et al., 1972).
Elimination half-times of 890-1,770 days (2.4-4.8 years) were
calculated for mice, rats, monkeys, and dogs injected intravenously
with beryllium chloride (Furchner et al., 1973). Mean daily excretion
of beryllium metal was 4.6 x 10-5 percent of the dose
administered by intratracheal instillation in baboons and 3.1 x
10-5 percent in rats (Andre et al., 1987).
4. Metabolism
Beryllium and its compounds are not metabolized or biotransformed,
but soluble beryllium salts may be converted to less soluble forms in
the lung (Reeves and Vorwald, 1967). As stated earlier, solubility is
an important factor for persistence of beryllium in the lung. Insoluble
beryllium, engulfed by activated phagocytes, can be ionized by an
acidic environment and by myeloperoxidases (Leonard and Lauwerys, 1987;
Lansdown, 1995; WHO, 2001), and this positive charge could potentially
make it more biologically reactive because it may allow the beryllium
to bind to a peptide or protein and be presented to the T cell receptor
or antigen-presenting cell (Fontenot, 2000).
5. Preliminary Conclusion for Particle Characterization and Kinetics of
Beryllium
The forms and concentrations of beryllium across the workplace vary
substantially based upon location, process, production and work task.
Many factors influence the potency of beryllium including
concentration, composition, structure, size and surface area of the
particle.
Studies have demonstrated that beryllium sensitization can occur
via the skin or inhalation from soluble or poorly soluble beryllium
particles. Beryllium must be presented to a cell in a soluble form for
activation of the immune system (NAS, 2008), and this will be discussed
in more detail in the section to follow. Poorly soluble beryllium can
be solubilized via intracellular fluid, lung fluid and sweat (Sutton et
al., 2003; Stefaniak et al., 2011). For beryllium to persist in the
lung it needs to be insoluble. However, soluble beryllium has been
shown to precipitate in the lung to form insoluble beryllium (Reeves
and Vorwald, 1967).
Some animal and epidemiological studies suggest that the form of
beryllium may affect the rate of development of BeS and CBD. Beryllium
in an inhalable form (either as soluble or insoluble particles or mist)
can deposit in the respiratory tract and interact with immune cells
located along the entire respiratory tract (Scheslinger, 1997).
However, more study is needed to precisely determine the physiochemical
characteristics of beryllium that influence toxicity and
immunogenicity.
C. Acute Beryllium Diseases
Acute beryllium disease (ABD) is a relatively rapid onset
inflammatory reaction resulting from breathing high airborne
concentrations of beryllium. It was first reported in workers
extracting beryllium oxide (Van Ordstrand et al., 1943). Since the
Atomic Energy Commission's adoption of occupational exposure limits for
beryllium beginning in 1949, cases of ABD have been rare. According to
the World Health Organization (2001), ABD is generally associated with
exposure to beryllium levels at or above 100 [mu]g/m\3\ and may be
fatal in 10 percent of cases. However, cases have been reported with
beryllium exposures below 100 [micro]g/m\3\ (Cummings et al., 2009).
The disease involves an inflammatory reaction that may include the
entire respiratory tract, involving the nasal passages, pharynx,
bronchial airways and alveoli. Other tissues including skin and
conjunctivae may be affected as well. The clinical features of
[[Page 47588]]
ABD include a nonproductive cough, chest pain, cyanosis, shortness of
breath, low-grade fever and a sharp drop in functional parameters of
the lungs. Pathological features of ABD include edematous distension,
round cell infiltration of the septa, proteinaceous materials, and
desquamated alveolar cells in the lung. Monocytes, lymphocytes and
plasma cells within the alveoli are also characteristic of the acute
disease process (Freiman and Hardy, 1970).
Two types of acute beryllium disease have been characterized in the
literature: a rapid and severe course of acute fulminating pneumonitis
generally developing within 48 to 72 hours of a massive exposure, and a
second form that takes several days to develop from exposure to lower
concentrations of beryllium (still above the levels set by regulatory
and guidance agencies) (Hall, 1950; DeNardi et al., 1953; Newman and
Kreiss, 1992). Evidence of a dose-response relationship to the
concentration of beryllium is limited (Eisenbud et al., 1948;
Stokinger, 1950; Sterner and Eisenbud, 1951). Recovery from either type
of ABD is generally complete after a period of several weeks or months
(DeNardi et al., 1953). However, deaths have been reported in more
severe cases (Freiman and Hardy, 1970). There have been documented
cases of progression to CBD (ACCP, 1965; Hall, 1950) suggesting the
possibility of an immune component to this disease (Cummings et al.,
2009) as well. According to the BCR, in the United States,
approximately 17 percent of ABD patients developed CBD (BCR, 2010). The
majority of ABD cases occurred between 1932 and 1970 (Eisenbud, 1983;
Middleton, 1998). ABD is extremely rare in the workplace today due to
more stringent exposure controls implemented following occupational and
environmental standards set in 1970-1972 (OSHA, 1971; ACGIH, 1971;
ANSI, 1970) and 1974 (EPA, 1974).
D. Chronic Beryllium Disease
This section provides an overview of the immunology and
pathogenesis of BeS and CBD, with particular attention to the role of
skin sensitization, particle size, beryllium compound solubility, and
genetic variability in individuals' susceptibility to beryllium
sensitization and CBD.
Chronic beryllium disease (CBD), formerly known as ``berylliosis''
or ``chronic berylliosis,'' is a granulomatous disorder primarily
affecting the lungs. CBD was first described in the literature by Hardy
and Tabershaw (1946) as a chronic granulomatous pneumonitis. It was
proposed as early as 1951 that CBD could be a chronic disease resulting
from an immune sensitization to beryllium (Sterner and Eisenbud, 1951;
Curtis, 1959; Nishimura, 1966). However, for a time, there remained
some controversy as to whether CBD was a delayed-onset hypersensitivity
disease or a toxicant-induced disease (NAS, 2008). Wide acceptance of
CBD as a hypersensitivity lung disease did not occur until bronchoscopy
studies and bronchoalveolar lavage (BAL) studies were performed
demonstrating that BAL cells from CBD patients responded to beryllium
challenge (Epstein et al., 1982; Rossman et al., 1988; Saltini et al.,
1989).
CBD shares many clinical and histopathological features with
pulmonary sarcoidosis, a granulomatous lung disease of unknown
etiology. This includes such debilitating effects as airway
obstruction, diminishment of physical capacity associated with reduced
lung function, possible depression associated with decreased physical
capacity, and decreased life expectancy. Without appropriate
information, CBD may be difficult to distinguish from sarcoidosis. It
is estimated that up to 6 percent of all patients diagnosed with
sarcoidosis may actually have CBD (Fireman et al., 2003; Rossman and
Kreiber, 2003). Among patients diagnosed with sarcoidosis in which
beryllium exposure can be confirmed, as many as 40 percent may actually
have CBD (Muller-Quernheim et al., 2006; Cherry et al., 2015).
Clinical signs and symptoms of CBD may include, but are not limited
to, a simple cough, shortness of breath or dypsnea, fever, weight loss
or anorexia, skin lesions, clubbing of fingers, cyanosis, night sweats,
cor pulmonale, tachycardia, edema, chest pain and arthralgia. Changes
or loss of pulmonary function also occur with CBD such as decrease in
vital capacity, reduced diffusing capacity, and restrictive breathing
patterns. The signs and symptoms of CBD constitute a continuum of
symptoms that are progressive in nature with no clear demarcation
between any stages in the disease (Rossman, 1996; NAS, 2008). Besides
these listed symptoms from CBD patients, there have been reported cases
of CBD that remained asymptomatic (Muller-Querheim, 2005; NAS, 2008).
Unlike ABD, CBD can result from inhalation exposure to beryllium at
levels below the current OSHA PEL, can take months to years after
initial beryllium exposure before signs and symptoms of CBD occur
(Newman 1996, 2005 and 2007; Henneberger, 2001; Seidler et al., 2012;
Schuler et al., 2012), and may continue to progress following removal
from beryllium exposure (Newman, 2005; Sawyer et al., 2005; Seidler et
al., 2012). Patients with CBD can progress to a chronic obstructive
lung disorder resulting in loss of quality of life and the potential
for decreased life expectancy (Rossman, et al., 1996; Newman et al.,
2005). The NAS report (2008) noted the general lack of published
studies on progression of CBD from an early asymptomatic stage to
functionally significant lung disease (NAS, 2008). The report
emphasized that risk factors and time course for clinical disease have
not been fully delineated. However, for people now under surveillance,
clinical progression from immunological sensitization and early
pathological lesions (i.e., granulomatous inflammation) prior to onset
of symptoms to symptomatic disease appears to be slow, although more
follow-up is needed (NAS, 2008). A study by Newman (1996) emphasized
the need for prospective studies to determine the natural history and
time course from BeS and asymptomatic CBD to full-blown disease
(Newman, 1996). Drawing from his own clinical experience, Newman was
able to identify the sequence of events for those with symptomatic
disease as follows: Initial determination of beryllium sensitization;
gradual emergence of chronic inflammation of the lung; pathologic
alterations with measurable physiologic changes (e.g., pulmonary
function and gas exchange); progression to a more severe lung disease
(with extrapulmonary effects such as clubbing and cor pulmonale in some
cases); and finally death in some cases (reported between 5.8 to 38
percent) (NAS, 2008; Newman, 1996).
In contrast to some occupationally related lung diseases, the early
detection of chronic beryllium disease may be useful since treatment of
this condition can lead not only to regression of the signs and
symptoms, but also may prevent further progression of the disease in
certain individuals (Marchand-Adam, 2008; NAS, 2008). The management of
CBD is based on the hypothesis that suppression of the hypersensitivity
reaction (i.e., granulomatous process) will prevent the development of
fibrosis. However, once fibrosis has developed, therapy cannot reverse
the damage.
To date, there have been no controlled studies to determine the
optimal treatment for CBD (Rossman, 1996; NAS 2008; Sood, 2009).
Management of CBD is generally modeled after sarcoidosis treatment.
Oral corticosteroid treatment can be initiated in patients with
[[Page 47589]]
evidence of disease (either by bronchoscopy or other diagnostic
measures before progression of disease or after clinical signs of
pulmonary deterioration occur). This includes treatment with other
anti-inflammatory agents (NAS, 2008; Maier et al., 2012; Salvator et
al., 2013) as well. It should be noted, however, that treatment with
corticosteroids has side-effects of their own that need to be measured
against the possibility of progression of disease (Gibson et al., 1996;
Zaki et al., 1987). Alternative treatments such as azathiopurine and
infliximab, while successful at treating symptoms of CBD, have been
demonstrated to have side-effects as well (Pallavicino et al., 2013;
Freeman, 2012).
1. Development of Beryllium Sensitization
Sensitization to beryllium is an essential step for worker
development of CBD. Sensitization to beryllium can result from
inhalation exposure to beryllium (Newman et al., 2005; NAS, 2008), as
well as from skin exposure to beryllium (Curtis, 1951; Newman et al.,
1996; Tinkle et al., 2003). Sensitization is currently detected using a
laboratory blood test described in Appendix A. Although there may be no
clinical symptoms associated with BeS, a sensitized worker's immune
system has been activated to react to beryllium exposures such that
subsequent exposure to beryllium can progress to serious lung disease
(Kreiss et al., 1996; Kreiss et al., 1997; Kelleher et al., 2001; and
Rossman, 2001). Since the pathogenesis of CBD involves a beryllium-
specific, cell-mediated immune response, CBD cannot occur in the
absence of sensitization (NAS, 2008). Various factors, including
genetic susceptibility, have been shown to influence risk of developing
sensitization and CBD (NAS 2008) and will be discussed later in this
section.
While various mechanisms or pathways may exist for beryllium
sensitization, the most plausible mechanisms supported by the best
available and most current science are discussed below. Sensitization
occurs via the formation of a beryllium-protein complex (an antigen)
that causes an immunological response. In some instances, onset of
sensitization has been observed in individuals exposed to beryllium for
only a few months (Kelleher et al., 2001; Henneberger et al., 2001).
This suggests the possibility that relatively brief, short-term
beryllium exposures may be sufficient to trigger the immune
hypersensitivity reaction. Several studies (Newman et al., 2001;
Henneberger et al., 2001; Rossman, 2001; Schuler et al., 2005; Donovan
et al., 2007, Schuler et al., 2012) have detected a higher prevalence
of sensitization among workers with less than one year of employment
compared to some cross-sectional studies which, due to lack of
information regarding initial exposure, cannot determine time of
sensitization (Kreiss et al., 1996; Kreiss et al., 1997). While only
very limited evidence has described humoral changes in certain patients
with CBD (Cianciara et al., 1980), clear evidence exists for an immune
cell-mediated response, specifically the T-cell (NAS, 2008). Figure 2
delineates the major steps required for progression from beryllium
contact to sensitization to CBD.
BILLING CODE 4510-26-P
[[Page 47590]]
[GRAPHIC] [TIFF OMITTED] TP07AU15.001
BILLING CODE 4510-26-C
Beryllium presentation to the immune system is believed to occur
either by direct presentation or by antigen processing. It has been
postulated that beryllium must be presented to the immune system in an
ionic form for cell-mediated immune activation to occur (Kreiss et al.,
2007). Some soluble forms of beryllium are readily presented, since the
soluble beryllium form disassociates into its ionic components.
However, for insoluble forms, dissolution may need to occur. A study by
Harmsen et al. (1986) suggested that a sufficient rate of dissolution
of small amounts of poorly soluble beryllium compounds might occur in
the lungs to allow persistent low-level beryllium presentation to the
immune system. Stefaniak et al. (2005 and 2012) reported that insoluble
beryllium particles phagocytized by macrophages were dissolved in
phagolysomal fluid (Stefaniak et al., 2005; Stefaniak et al., 2012) and
that the dissolution rate stimulated by phagolysomal fluid was
different for various forms of beryllium (Stefaniak et al., 2006;
Duling et al., 2012). Several studies have demonstrated that macrophage
uptake of beryllium can induce aberrant apoptotic processes leading to
the continued release of beryllium ions which will continually
stimulate T-cell activation (Sawyer et al., 2000; Sawyer et al., 2004;
Kittle et al., 2002). Antigen processing can be mediated by antigen-
presenting cells (APC). These may include macrophages, dendritic cells,
or other antigen-presenting cells, although this has not been well
defined in most studies (NAS, 2008).
Because of their strong positive charge, beryllium ions have the
ability to haptenate and alter the structure of peptides occupying the
antigen-binding cleft of major histocompatibility complex (MHC) class
II on antigen-presenting cells (APC). The MHC class II antigen-binding
molecule for beryllium is the human leukocyte antigen (HLA) with
specific alleles (e.g.,
[[Page 47591]]
HLA-DP, HLA-DR, HLA-DQ) associated with the progression to CBD (NAS,
2008; Yucesoy and Johnson, 2011). Several studies have also
demonstrated that the electrostatic charge of HLA may be a factor in
binding beryllium (Snyder et al., 2003; Bill et al., 2005; Dai et al.,
2010). The strong positive ionic charge of the beryllium ion would have
a strong attraction for the negatively charged patches of certain HLA
alleles (Snyder et al., 2008; Dai et al., 2010). Alternatively,
beryllium oxide has been demonstrated to bind to the MHC class II
receptor in a neutral pH. The six carboxylates in the amino acid
sequence of the binding pocket provide a stable bond with the Be-O-Be
molecule when the pH of the substrate is neutral (Keizer et al., 2005).
The direct binding of BeO may eliminate the biological requirement for
antigen processing or dissolution of beryllium oxide to activate an
immune response.
Next in sequence is the beryllium-MHC-APC complex binding to a T-
cell receptor (TCR) on a na[iuml]ve T-cell which stimulates the
proliferation and accumulation of beryllium-specific CD4\+\ (cluster of
differentiation 4\+\) T-cells (Saltini et al., 1989 and 1990; Martin et
al., 2011) as depicted in Figure 3. Fontenot et al. (1999) demonstrated
that diversely different variants of TCR were expressed by CD4\+\ T-
cells in peripheral blood cells of CBD patients. However, the CD4\+\ T-
cells from the lung were more homologous in expression of TCR variants
in CBD patients, suggesting clonal expansion of a subset of T-cells in
the lung (Fontenot et al., 1999). This may also indicate a pathogenic
potential for subsets of T-cell clones expressing this homologous TCR
(NAS, 2008). Fontenot et al. (2006) reported beryllium self-
presentation by HLA-DP expressing BAL CD4\+\ T-cells. Self-presentation
by BAL T-cells in the lung granuloma may result in activation-induced
cell death, which may then lead to oligoclonality of the T-cell
population characteristic of CBD (NAS, 2008).
[GRAPHIC] [TIFF OMITTED] TP07AU15.002
As CD4\+\ T-cells proliferate, clonal expansion of various subsets
of the CD4\+\ beryllium specific T-cells occurs (Figure 3). In the
peripheral blood, the beryllium-specific CD4\+\ T cells require co-
stimulation with a co-stimulant CD28 (cluster of differentiation 28).
During the proliferation and differentiation process CD4\+\ T-cells
secrete pro-inflammatory cytokines that may influence this process
(Sawyer et al., 2004; Kimber et al., 2011).
2. Development of CBD
The continued persistence of residual beryllium in the lung leads
to a T-cell maturation process. A large portion of beryllium-specific
CD4\+\ T cells were shown to cease expression of CD28 mRNA and protein,
indicating these cells no longer required co-stimulation with the CD28
ligand (Fontenot et al., 2003). This change in phenotype correlated
with lung inflammation (Fontenot et al., 2003). The CD4\+\ independent
cells continued to secrete cytokines necessary for additional
recruitment of inflammatory and immunological cells; however, they were
less proliferative and less susceptible to cell death compared to the
CD28 dependent cells (Fontenot et al., 2005; Mack et al., 2008). These
beryllium-specific CD4\+\ independent cells are considered to be mature
memory effector cells (Ndejembi et al., 2006; Bian et al., 2005).
Repeat exposure to beryllium in the lung resulting in a mature
population of T cell development independent of co-stimulation by CD28
and development of a population of T effector memory cells
(Tem cells) may be one of the mechanisms that lead to the
more severe reactions observed specifically in the lung (Fontenot et
al., 2005).
CD4\+\ T cells created in the sensitization process recognize the
beryllium antigen, and respond by proliferating and secreting cytokines
and inflammatory mediators, including IL-2, IFN-[gamma], and TNF-
[alpha] (Tinkle et al., 1997a and b; Fontenot et al., 2002) and MIP-
1[alpha] and GRO-1 (Hong-Geller, 2006). This also results in the
accumulation of various types of inflammatory cells including
mononuclear cells (mostly CD4\+\ T cells) in the bronchoalveolar lavage
fluid (BAL fluid) (Saltini et al., 1989, 1990).
The development of granulomatous inflammation in the lung of CBD
patients has been associated with the accumulation of beryllium
responsive CD4\+\ Tem cells in BAL fluid (NAS, 2008). The
subsequent release of pro-inflammatory cytokines, chemokines and
reactive oxygen species by these cells may lead to migration of
additional inflammatory/immune cells and the development of a
microenvironment that contributes to the development of CBD (Sawyer et
al., 2005; Tinkle et al., 1996; Hong-Geller et al., 2006; NAS, 2008).
The cascade of events described above results in the formation of a
noncaseating granulomatous lesion.
[[Page 47592]]
Release of cytokines by the accumulating T cells leads to the formation
of granulomatous lesions that are characterized by an outer ring of
histiocytes surrounding non-necrotic tissue with embedded multi-
nucleated giant cells (Saltini et al., 1989, 1990).
Over time, the granulomas spread and can lead to lung fibrosis and
abnormal pulmonary function, with symptoms including a persistent dry
cough and shortness of breath (Saber and Dweik, 2000). Fatigue, night
sweats, chest and joint pain, clubbing of fingers (due to impaired
oxygen exchange), loss of appetite or unexplained weight loss, and cor
pulmonale have been experienced in certain patients as the disease
progresses (Conradi et al., 1971; ACCP, 1965; Kriebel et al., 1988a and
b). While CBD primarily affects the lungs, it can also involve other
organs such as the liver, skin, spleen, and kidneys (ATSDR, 2002).
As previously mentioned, the uptake of beryllium may lead to an
aberrant apoptotic process with rerelease of beryllium ions and
continual stimulation of beryllium-responsive CD4+ cells in
the lung (Sawyer et al., 2000; Kittle et al., 2002; Sawyer et al.,
2004). Several research studies suggest apoptosis may be one mechanism
that enhances inflammatory cell recruitment, cytokine production and
inflammation, thus creating a scenario for progressive granulomatous
inflammation (Palmer et al., 2008; Rana, 2008). Macrophages and
neutrophils can phagocytize beryllium particles in an attempt to remove
the beryllium from the lung (Ding, et al., 2009). Multiple studies
(Sawyer et al., 2004; Kittle et al., 2002) using BAL cells (mostly
macrophages and neutrophils) from patients with CBD found that in vitro
stimulation with beryllium sulfate induced the production of TNF-
[alpha] (one of many cytokines produced in response to beryllium), and
that production of TNF-[alpha] might induce apoptosis in CBD and
sarcoidosis patients (Bost et al., 1994; Dai et al., 1999). The
stimulation of CBD-derived macrophages by beryllium sulphate resulted
in cells becoming apoptotic, as measured by propidium iodide. These
results were confirmed in a mouse macrophage cell-line (p388D1) (Sawyer
et al., 2000). However, other factors may influence the development of
CBD and are outlined in the following section.
3. Genetic and Other Susceptibility Factors
Evidence from a variety of sources indicates genetic susceptibility
may play an important role in the development of CBD in certain
individuals, especially at levels low enough not to invoke a response
in other individuals. Early occupational studies proposed that CBD was
an immune reaction based on the high susceptibility of some individuals
to become sensitized and progress to CBD and the lack of CBD in others
who were exposed to levels several orders of magnitude higher (Sterner
and Eisenbud, 1951). Additional in vitro human research has identified
genes coding for specific protein molecules on the surface of their
immune cells that place carriers at greater risk of becoming sensitized
to beryllium and developing CBD (McCanlies et al., 2004). Recent
studies have confirmed genetic susceptibility to CBD involves either
HLA variants, T-cell receptor clonality, tumor necrosis factor (TNF-
[alpha]) polymorphisms and/or transforming growth factor-beta (TGF-
[beta]) polymorphisms (Fontenot et al., 2000; Amicosante et al., 2005;
Tinkle et al., 1996; Gaede et al., 2005; Van Dyke et al., 2011;
Silveira et al., 2012).
Single Nucleotide Polymorphisms (SNPs) have been studied with
regard to genetic variations associated with increased risk of
developing CBD. SNPs are the most abundant type of human genetic
variation. Polymorphisms in MHC class II and pro-inflammatory genes
have been shown to contribute to variations in immune responses
contributing to the susceptibility and resistance in many diseases
including auto-immunity, and beryllium sensitization and CBD (McClesky
et al., 2009). Specific SNPs have been evaluated as a factor in Glu69
variant from the HLA-DPB1 locus (Richeldi et al., 1993; Cai et al.,
2000; Saltini et al., 2001; Silviera et al., 2012; Dai et al., 2013),
HLA-DRPhe[beta]47 (Amicosante et al., 2005).
HLA-DPB1 with a glutamic acid at amino position 69 (Glu 69) has
been shown to confer increased risk of beryllium sensitization and CBD
(Richeldi et al., 1993; Saltini et al., 2001; Amicosante et al., 2005;
Van Dyke et al., 2011; Silveira et al., 2012). Fontenot et al. (2000)
demonstrated that beryllium presentation by certain alleles of the
class II human leukocyte antigen-DP (HLA-DP) to CD4+ T cells is the
mechanism underlying the development of CBD. Richeldi et al. (1993)
reported a strong association between the MHC class II allele HLA-DP 1
and the development of CBD in beryllium-exposed workers from a Tucson,
AZ facility. This marker was found in 32 of the 33 workers who
developed CBD, but in only 14 of 44 similarly exposed workers without
CBD. The more common allele of the HLA-DP 1 variant is negatively
charged at this site and could directly interact with the positively
charged beryllium ion. The high percentage (~30 percent) of beryllium-
exposed workers without CBD who had this allele indicates that other
factors also contribute to the development of CBD (EPA, 1998).
Additional studies by Amicosante et al. (2005) using blood lymphocytes
derived from beryllium-exposed workers found a high frequency of this
gene in those sensitized to beryllium. In a study of 82 CBD patients
(beryllium-exposed workers), Stubbs et al. (1996) also found a
relationship between the HLA-DP 1 allele and BeS. The glutamate-69
allele was present in 86 percent of sensitized subjects, but in only 48
percent of beryllium-exposed, non-sensitized subjects. Some variants of
the HLA-DPB1 allele convey higher risk of BeS and CBD than others. For
example, HLA-DPB1*0201 yielded an approximately 3-fold increase in
disease outcome relative to controls; HLA-DPB1*1901 yielded an
approximately 5-fold increase, and HLA-DPB1*1701 an approximately 10-
fold increase (Weston et al., 2005; Snyder et al., 2008). By assigning
odds ratios for specific alleles on the basis of previous studies
discussed above, the researchers found a strong correlation (88
percent) between the reported risk of CBD and the predicted surface
electrostatic potential and charge of the isotypes of the genes. They
were able to conclude that the alleles associated with the most
negatively charged proteins carry the greatest risk of developing
beryllium sensitization and CBD. This confirms the importance of
beryllium charge as a key factor in haptogenic potential.
In contrast, the HLA-DRB1 allele, which lacks Glu 69, has also been
shown to increase the risk of developing sensitization and CBD
(Amicosante et al., 2005; Maier et al., 2003). Bill et al. (2005) found
that HLA-DR has a glutamic acid at position 71 of the [beta] chain,
functionally equivalent to the Glu 69 of HLA-DP (Bill et al., 2005).
Associations with BeS and CBD have also been reported with the HLA-DQ
markers (Amicosante et al., 2005; Maier et al., 2003). Stubbs et al.
also found a biased distribution of the MHC class II HLA-DR gene
between sensitized and non-sensitized subjects. Neither of these
markers was completely specific for CBD, as each study found beryllium
sensitization or CBD among individuals without the genetic risk factor.
While there remains uncertainty as to which of the MHC class II genes
interact directly with the beryllium ion, antibody inhibition data
suggest that the HLA-DR gene product may be involved in the
[[Page 47593]]
presentation of beryllium to T lymphocytes (Amicosante et al., 2002).
In addition, antibody blocking experiments revealed that anti-HLA-DP
strongly reduced proliferation responses and cytokine secretion by BAL
CD4 T cells (Chou et al., 2005). In the study by Chou (2005), anti-HLA-
DR ligand antibodies mainly affected beryllium-induced proliferation
responses with little impact on cytokines other than IL-2, thus
implying that nonproliferating BAL CD4 T cells may still contribute to
inflammation leading to the progression of CBD (Chou et al., 2005).
TNF alpha (TNF-[alpha]) polymorphisms and TGF beta (TGF-[beta])
polymorphisms have also been shown to confer a genetic susceptibility
for developing CBD in certain individuals. TNF-[alpha] is a pro-
inflammatory cytokine associated with a more severe pulmonary disease
in CBD (NAS, 2008). Beryllium exposure has been shown to upregulate
transcription factors AP-1 and NF-[kappa]B (Sawyer et al., 2007)
inducing an inflammatory response by stimulating production of pro-
inflammatory cytokines such as TNF-[alpha] by inflammatory cells.
Polymorphisms in the 308 position of the TNF-[alpha] gene have been
demonstrated to increase production of the cytokine and increase
severity of disease (Maier et al., 2001; Saltini et al., 2001; Dotti et
al., 2004). While a study by McCanlies et al. (2007) found no
relationship between TNF-[alpha] polymorphism and BeS or CBD, the
inconsistency may be due to misclassification, exposure differences or
statistical power (NAS, 2008).
Other genetic variations have been shown to be associated with
increased risk of beryllium sensitization and CBD (NAS, 2008). These
include TGF-[beta] (Gaede et al., 2005), angiotensin-1 converting
enzyme (ACE) (Newman et al., 1992; Maier et al., 1999) and an enzyme
involved in glutathione synthesis (glutamate cysteine ligase) (Bekris
et al., 2006). McCanlies et al. (2010) evaluated the association
between polymorphisms in a select group of interleukin genes (IL-1A;
IL-1B, IL-1RN, IL-2, IL-9, IL-9R) due to their role in immune and
inflammatory processes. The study evaluated SNPs in three groups of
workers from large beryllium manufacturing facilities in OH and AZ. The
investigators found a significant association between variants IL-1A-
1142, IL-1A-3769 and IL-1A-4697 and CBD but not with beryllium
sensitization. However, these still require confirmation in larger
studies (NAS, 2008).
In addition to the genetic factors which may contribute to the
susceptibility and severity of disease, other factors such as smoking
and gender may play a role in the development of CBD (NAS, 2008). A
recent longitudinal cohort study by Mroz et al. (2009) of 229
individuals identified with beryllium sensitization or CBD through
workplace medical surveillance found that the prevalence of CBD among
ever smokers was significantly lower than among never smokers (38.1
percent versus 49.4 percent, p=0.025). BeS subjects that never smoked
were found to be more likely to develop CBD over the course of the
study compared to current smokers (12.6 percent versus 6.4 percent,
p=0.10). The authors suggested smoking may confer a protective effect
against development of lung granulomas as has been demonstrated with
hypersensitivity pneumonitis (Mroz et al., 2009).
4. Beryllium Sensitization and CBD in the Workforce
Sensitization to beryllium is currently detected in the workforce
with the beryllium lymphocyte proliferation test (BeLPT), a laboratory
blood test developed in the 1980s, also referred to as the LTT
(Lymphocyte Transformation Test) or BeLT (Beryllium Lymphocyte
Transformation Test). In this test, lymphocytes obtained from either
bronchoalveolar lavage fluid (the BAL BeLPT) or from peripheral blood
(the blood BeLPT) are cultured in vitro and exposed to beryllium
sulfate to stimulate lymphocyte proliferation. The observation of
beryllium-specific proliferation indicates beryllium sensitization.
Hereafter, ``BeLPT'' generally refers to the blood BeLPT, which is
typically used in screening for beryllium sensitization. This test is
described in more detail in subsection D.5.b.
CBD can be detected at an asymptomatic stage by a number of
techniques including bronchoalveolar lavage and biopsy (Cordeiro et
al., 2007; Maier, 2001). Bronchoalveolar lavage is a method of
``washing'' the lungs with fluid inserted via a flexible fiberoptic
instrument known as a bronchoscope, removing the fluid and analyzing
the content for the inclusion of immune cells reactive to beryllium
exposure, as described earlier in this section. Fiberoptic bronchoscopy
can be used to detect granulomatous lung inflammation prior to the
onset of CBD symptoms as well, and has been used in combination with
the BeLPT to diagnose pre-symptomatic CBD in a number of recent
screening studies of beryllium-exposed workers, which are discussed in
the following section detailing diagnostic procedures. Of workers who
were found to be sensitized and underwent clinical evaluation, 31-49
percent of them were diagnosed with CBD (Kreiss et al., 1993; Newman et
al., 1996, 2005, 2007; Mroz, 2009), however some estimate that with
increased surveillance the percent could be much higher (Newman, 2005;
Mroz, 2009). It has been estimated from ongoing surveillance studies of
sensitized individuals with an average follow-up time of 4.5 years that
31 percent of beryllium-sensitized employees were estimated to progress
to CBD (Newman et al., 2005). A study of nuclear weapons facility
employees enrolled in an ongoing medical surveillance program found
that only 20 percent of sensitized workers employed less than 5 years
eventually were diagnosed with CBD, while 40 percent of sensitized
workers employed 10 years or more developed CBD (Stange et al., 2001).
One limitation for all these studies is lack of long-term follow-up. It
may be necessary to continue to monitor these workers in order to
determine whether all BeS workers will develop CBD (Newman et al.,
2005).
CBD has a clinical spectrum ranging from evidence of beryllium
sensitization and granulomas in the lung with little symptomatology to
loss of lung function and end stage disease which may result in the
need for lung transplantation and decreased life expectancy.
Unfortunately, there are very few published clinical studies describing
the full range and progression of CBD from the beginning to the end
stages and very few of the risk factors for progression of disease have
been delineated (NAS, 2008). Clinical management of CBD is modeled
after sarcoidosis where oral corticosteroid treatment is initiated in
patients who have evidence of progressive lung disease, although
progressive lung disease has not been well defined (NAS, 2008). In
advanced cases of CBD, corticosteroids are the standard treatment (NAS,
2008). No comprehensive studies have been published measuring the
overall effect of removal of workers from beryllium exposure on
sensitization and CBD (NAS, 2008) although this has been suggested as
part of an overall treatment regime for CBD (Mapel et al., 2002; Sood
et al., 2004; Maier et al., 2006; Sood, 2009; Maier et al., 2012). Sood
et al. reported that cessation of exposure can sometimes have
beneficial effects on lung function (Sood et al., 2004). However, this
was based on anecdotal evidence from six patients with CBD, so more
research is needed to better determine the relationship between
[[Page 47594]]
exposure duration and disease progression
5. Human Epidemiological Studies
This section describes the human epidemiological data supporting
the mechanistic overview of beryllium-induced disease in workers. It
has been divided into reviews of epidemiological studies performed
prior to development and implementation of the BeLPT in the late 1980s
and after wide use of the BeLPT for screening purposes. Use of the
BeLPT has allowed investigators to screen for beryllium sensitization
and CBD prior to the onset of clinical symptoms, providing a more
sensitive and thorough analysis of the worker population. The
discussion of the studies has been further divided by manufacturing
processes that may have similar exposure profiles. Table A.1 in the
Appendix summarizes the prevalence of beryllium sensitization and CBD,
range of exposure measurements, and other salient information from the
key epidemiological studies.
It has been well-established that beryllium exposure, either via
inhalation or skin, may lead to beryllium sensitization, or, with
inhalation exposure, may lead to the onset and progression of CBD. The
available published epidemiological literature discussed below provides
strong evidence of beryllium sensitization and CBD in workers exposed
to airborne beryllium well below the current OSHA PEL of 2 [mu]g/m\3\.
Several studies demonstrate the prevalence of sensitization and CBD is
related to the level of airborne exposure, including a cross-sectional
survey of employees at a beryllium ceramics plant in Tucson, AZ
(Henneberger et al., 2001), case-control studies of workers at the
Rocky Flats nuclear weapons facility (Viet et al., 2000), and workers
from a beryllium machining plant in Cullman, AL (Kelleher et al.,
2001). The prevalence of beryllium sensitization also may be related to
dermal exposure. An increased risk of CBD has been reported in workers
with skin lesions, potentially increasing the uptake of beryllium
(Curtis, 1951; Johnson et al., 2001; Schuler et al., 2005). Three
studies describe comprehensive preventive programs, which included
expanded respiratory protection, dermal protection, and improved
control of beryllium dust migration, that substantially reduced the
rate of beryllium sensitization among new hires (Cummings et al., 2007;
Thomas et al., 2009; Bailey et al., 2010; Schuler et al., 2012).
Some of the epidemiological studies presented in this review suffer
from challenges common to many published epidemiological studies:
Limitations in study design (particularly cross-sectional); small
sample size; lack of personal and/or short-term exposure data,
particularly those published before the late 1990s; and incomplete
information regarding specific chemical form and/or particle
characterization. Challenges that are specific to beryllium
epidemiological studies include: uncertainty regarding the contribution
of dermal exposure; use of various BeLPT protocols; a variety of case
definitions for determining CBD; and use of various exposure sampling/
assessment methods (e.g., daily weighted average (DWA), lapel
sampling). Even with these limitations, the epidemiological evidence
presented in this section clearly demonstrates that beryllium
sensitization and CBD are continuing to occur from present-day
exposures below OSHA's PEL. The available literature also indicates
that the rate of BeS can be substantially lowered by reducing
inhalation exposure and minimizing dermal contact.
a. Studies Conducted Prior to the BeLPT
First reports of CBD came from studies performed by Hardy and
Tabershaw (1946). Cases were observed in industrial plants that were
refining and manufacturing beryllium metal and beryllium alloys and in
plants manufacturing fluorescent light bulbs (NAS, 2008). From the late
1940s through the 1960s, clusters of non-occupational CBD cases were
identified around beryllium refineries in Ohio and Pennsylvania, and
outbreaks in family members of beryllium factory workers were assumed
to be from exposure to contaminated clothes (Hardy, 1980). It had been
established that the risk of disease among beryllium workers was
variable and generally rose with the levels of airborne concentrations
(Machle et al., 1948). And while there was a relationship between air
concentrations of beryllium and risk of developing disease both in and
surrounding these plants, the disease rates outside the plants were
higher than expected and not very different from the rate of CBD within
the plants (Eisenbud et al., 1949; Lieben and Metzner, 1959). There
remained considerable uncertainty regarding diagnosis due to lack of
well-defined cohorts, modern diagnostic methods, or inadequate follow-
up. In fact, many patients with CBD may have been misdiagnosed with
sarcoidosis (NAS, 2008).
The difficulties in distinguishing lung disease caused by beryllium
from other lung diseases led to the establishment of the BCR in 1952 to
identify and track cases of ABD and CBD. A uniform diagnostic criterion
was introduced in 1959 as a way to delineate CBD from sarcoidosis.
Patient entry into the BCR required either: documented past exposure to
beryllium or the presence of beryllium in lung tissue as well as
clinical evidence of beryllium disease (Hardy et al., 1967); or any
three of the six criteria listed below (Hasan and Kazemi, 1974).
Patients identified using the above criteria were registered and added
to the BCR from 1952 through 1983 (Eisenbud and Lisson, 1983).
The BCR listed the following criteria for diagnosing CBD (Eisenbud
and Lisson, 1983):
(1) Establishment of significant beryllium exposure based on sound
epidemiologic history;
(2) Objective evidence of lower respiratory tract disease and
clinical course consistent with beryllium disease;
(3) Chest X-ray films with radiologic evidence of interstitial
fibronodular disease;
(4) Evidence of restrictive or obstructive defect with diminished
carbon monoxide diffusing capacity (DLCO) by physiologic
studies of lung function;
(5) Pathologic changes consistent with beryllium disease on
examination of lung tissue; and
(6) Presence of beryllium in lung tissue or thoracic lymph nodes.
Prevalence of CBD in workers during the time period between the
1940s and 1950s was estimated to be between 1-10% (Eisenbud and Lisson,
1983). In a 1969 study, Stoeckle et al. presented 60 case histories
with a selective literature review utilizing the above criteria except
that urinary beryllium was substituted for lung beryllium to
demonstrate beryllium exposure. Stoeckle et al. (1969) were able to
demonstrate corticosteroids as a successful treatment option in one
case of confirmed CBD. This study also presented a 28 percent mortality
rate from complications of CBD at the time of publication. However,
even with the improved methodology for determining CBD based on the BCR
criteria, these studies suffered from lack of well-defined cohorts,
modern diagnostic techniques or adequate follow-up.
b. Criteria for Beryllium Sensitization and CBD Case Definition
Following the Development of the BeLPT
The criteria for diagnosis of CBD have evolved over time as more
advanced
[[Page 47595]]
diagnostic technology, such as the (blood) BeLPT and BAL BeLPT, has
become available. More recent diagnostic criteria have both higher
specificity than earlier methods and higher sensitivity, identifying
subclinical effects. Recent studies typically use the following
criteria (Newman et al., 1989; Pappas and Newman, 1993; Maier et al.,
1999):
(1) History of beryllium exposure;
(2) Histopathological evidence of noncaseating granulomas or
mononuclear cell infiltrates in the absence of infection; and
(3) Positive blood or BAL BeLPT (Newman et al., 1989).
The availability of transbronchial lung biopsy facilitates the
evaluation of the second criterion, by making histopathological
confirmation possible in almost all cases.
A significant component for the identification of CBD is the
demonstration of a confirmed abnormal BeLPT result in a blood or BAL
sample (Newman, 1996). Since the development of the BeLPT in the 1980s,
it has been used to screen beryllium-exposed workers for sensitization
in a number of studies to be discussed below. The BeLPT is a non-
invasive in vitro blood test which measures the beryllium antigen-
specific T-cell mediated immune response and is the most commonly
available diagnostic tool for identifying beryllium sensitization. The
BeLPT measures the degree to which beryllium stimulates lymphocyte
proliferation under a specific set of conditions, and is interpreted
based upon the number of stimulation indices that exceed the normal
value. The `cut-off' is based on the mean value of the peak stimulation
index among controls plus 2 or 3 standard deviations. This methodology
was modeled into a statistical method known as the ``least absolute
values'' or ``statistical-biological positive'' method and relies on
natural log modeling of the median stimulation index values (DOE, 2001;
Frome, 2003). In most applications, two or more stimulation indices
that exceed the cut-off constitute an abnormal test.
Early versions of the BeLPT test had high variability, but the use
of tritiated thymidine to identify proliferating cells has led to a
more reliable test (Mroz et al., 1991; Rossman et al., 2001). In recent
years, the peripheral blood test has been found to be as sensitive as
the BAL assay, although larger abnormal responses have been observed
with the BAL assay (Kreiss et al., 1993; Pappas and Newman, 1993).
False negative results have also been observed with the BAL BeLPT in
cigarette smokers who have marked excess of alveolar macrophages in
lavage fluid (Kreiss et al., 1993). The BeLPT has also been a useful
tool in animal studies to identify those species with a beryllium-
specific immune response (Haley et al., 1994).
Screenings for beryllium sensitization have been conducted using
the BeLPT in several occupational surveys and surveillance programs,
including nuclear weapons facilities operated by the Department of
Energy (Viet et al., 2000; Strange et al., 2001; DOE/HSS Report, 2006),
a beryllium ceramics plant in Arizona (Kreiss et al., 1996; Henneberger
et al., 2001; Cummings et al., 2007), a beryllium production plant in
Ohio (Kreiss et al., 1997; Kent et al., 2001), a beryllium machining
facility in Alabama (Kelleher et al., 2001; Madl et al., 2007), a
beryllium alloy plant (Schuler et al., 2005, Thomas et al., 2009), and
another beryllium processing plant (Rosenman et al., 2005) in
Pennsylvania. In most of these studies, individuals with an abnormal
BeLPT result were retested and were identified as sensitized (i.e.,
confirmed positive) if the abnormal result was repeated.
There has been criticism regarding the reliability and specificity
of the BeLPT as a screening tool (Borak et al., 2006). Stange et al.
(2004) studied the reliability and laboratory variability of the BeLPT
by splitting blood samples and sending samples to two laboratories
simultaneously for BeLPT analysis. Stange et al. found the range of
agreement on abnormal (positive BeLPT) results was 26.2--61.8 percent
depending upon the labs tested (Stange et al., 2004). Borak et al.
(2006) contended that the positive predictive value (PPV) (PPV is the
portion of patients with positive test result correctly diagnosed) is
not high enough to meet the criteria of a good screening tool.
Middleton et al. (2008) used the data from the Stange et al. (2004)
study to estimate the PPV and determined that the PPV of the BeLPT
could be improved from 0.383 to 0.968 when an abnormal BeLPT result is
confirmed with a second abnormal result (Middleton et al., 2008).
However, an apparent false positive can occur in people not
occupationally exposed to beryllium (NAS, 2008). An analysis of survey
data from the general workforce and new employees at a beryllium
manufacturer was performed to assess the reliability of the BeLPT
(Donovan et al. 2007). Donovan et al. analyzed more than 10,000 test
results from nearly 2400 participants over a 12-year period. Donovan et
al. found that approximately 2 percent of new employees had at least
one positive BeLPT at the time of hire and 1 percent of new hires with
no known occupational exposure were confirmed positive at the time of
hire with two BeLPTs. Since there are currently no alternatives to the
BeLPT in a screening program many programs rely on a second test to
confirm a positive result (NAS, 2008).
The epidemiological studies presented in this section utilized the
BeLPT as either a surveillance tool or a screening tool for determining
sensitization status and/or sensitization/CBD prevalence in workers for
inclusion in the published studies. Most epidemiological studies have
reported rates of sensitization and disease based on a single screening
of a working population (`cross-sectional' or 'population prevalence'
rates). Studies of workers in a beryllium machining plant and a nuclear
weapons facility have included follow-up of the population originally
screened, resulting in the detection of additional cases of
sensitization over several years (Newman et al., 2001, Stange et al.,
2001). OSHA regards the BeLPT as a reliable medical surveillance tool.
The BeLPT is discussed in more detail in Non-Mandatory Appendix A to
the proposed standard, Immunological Testing for the Determination of
Beryllium Sensitization.
c. Beryllium Mining and Extraction
Mining and extraction of beryllium usually involves the two major
beryllium minerals, beryl (an aluminosilicate containing up to 4
percent beryllium) and bertrandite (a beryllium silicate hydrate
containing generally less than 1 percent beryllium) (WHO, 2001). The
United States is the world leader in beryllium extraction and also
leads the world in production and use of beryllium and its alloys (WHO,
2001). Most exposures from mining and extraction come in the form of
beryllium ore, beryllium salts, beryllium hydroxide (NAS 2008) or
beryllium oxide (Stefaniak et al., 2008).
Deubner et al. published a study of 75 workers employed at a
beryllium mining and extraction facility in Delta, UT (Deubner et al.,
2001b). Of the 75 workers surveyed for sensitization with the BeLPT,
three were identified as sensitized by an abnormal BeLPT result. One of
those found to be sensitized was diagnosed with CBD. Exposures at the
facility included primarily beryllium ore and salts. General area (GA),
breathing zone (BZ), and personal lapel (LP) exposure samples were
collected from 1970 to 1999. Jobs involving beryllium hydrolysis and
wet-grinding activities had the highest air concentrations, with an
annual median GA concentration ranging from 0.1 to 0.4 [mu]g/m\3\.
Median BZ concentrations
[[Page 47596]]
were higher than either LP or GA. The average duration of exposure for
beryllium sensitized workers was 21.3 years (27.7 years for the worker
with CBD), compared to an average duration for all workers of 14.9
years. However, these exposures were less than either the Elmore, OH,
or Tucson, AZ, facilities described below, which also had higher
reported rates of BeS and CBD. A study by Stefaniak et al. (2008)
demonstrated that beryllium was present at the mill in three forms:
mineral, poorly crystalline oxide, and hydroxide.
There was no sensitization or CBD among those who worked only at
the mine where exposure to beryllium resulted solely from working with
bertrandite ore. The authors concluded that the results of this study
indicated that beryllium ore and salts may pose less of a hazard than
beryllium metal and beryllium hydroxide. These results are consistent
with the previously discussed animal studies examining solubility and
particle size.
d. Beryllium Metal Processing and Alloy Production
Kreiss et al. (1997) conducted a study of workers at a beryllium
production facility in Elmore, OH. The plant, which opened in 1953 and
initially specialized in production of beryllium-copper alloy, later
expanded its operations to include beryllium metal, beryllium oxide,
and beryllium-aluminum alloy production; beryllium and beryllium alloy
machining; and beryllium ceramics production, which was moved to a
different factory in the early 1980s. Production operations included a
wide variety of jobs and processes, such as work in arc furnaces and
furnace rebuilding, alloy melting and casting, beryllium powder
processing, and work in the pebble plant. Non-production work included
jobs in the analytical laboratory, engineering research and
development, maintenance, laundry, production-area management, and
office-area administration. While the publication refers to the use of
respiratory protection in some areas, such as the pebble plant, the
extent of its use across all jobs or time periods was not reported. Use
of dermal PPE was not reported.
The authors characterized exposures at the plant using industrial
hygiene (IH) samples collected between 1980 and 1993. The exposure
samples and the plant's formulas for estimating workers' DWA exposures
were used, together with study participants' work histories, to
estimate their cumulative and average beryllium exposure levels.
Exposure concentrations reflected the high exposures found historically
in beryllium production and processing. Short-term BZ measurements had
a median of 1.4, with 18.5 percent of samples exceeding OSHA's STEL of
5.0 [mu]g/m\3\. Particularly high beryllium concentrations were
reported in the areas of beryllium powder production, laundry, alloy
arc furnace (approximately 40 percent of DWA estimates over 2.0 [mu]g/
m\3\) and furnace rebuild (28.6 percent of short-term BZ samples over
the OSHA STEL of 5 [mu]g/m\3\). LP samples (n = 179), which were
available from 1990 to 1992, had a median value of 1 [mu]g/m\3\.
Of 655 workers employed at the time of the study, 627 underwent
BeLPT screening. Blood samples were divided and split between two labs
for analysis, with repeat testing for results that were abnormal or
indeterminate. Thirty-one workers had an abnormal blood test upon
initial testing and at least one of two subsequent tests was classified
as sensitized. These workers, together with 19 workers who had an
initial abnormal result and one subsequent indeterminate result, were
offered clinical evaluation for CBD including the BAL-BeLPT and
transbronchial lung biopsy. Nine with an initial abnormal test followed
by two subsequent normal tests were not clinically evaluated, although
four were found to be sensitized upon retesting in 1995. Of 47 workers
who proceeded with evaluation for CBD (3 of the 50 initial workers with
abnormal results declined to participate), 24 workers were diagnosed
with CBD based on evidence of granulomas on lung biopsy (20 workers) or
on other findings consistent with CBD (4 workers) (Kreiss et al.,
1997). After including five workers who had been diagnosed prior to the
study, a total of 29 (4.6 percent) current workers were found to have
CBD. In addition, the plant medical department identified 24 former
workers diagnosed with CBD before the study.
Kreiss et al. reported that the highest prevalence of sensitization
and CBD occurred among workers employed in beryllium metal production,
even though the highest airborne total mass concentrations of beryllium
were generally among employees operating the beryllium alloy furnaces
in a different area of the plant (Kreiss et al., 1997). Preliminary
follow-up investigations of particle size-specific sampling at five
furnace sites within the plant determined that the highest respirable
(e.g., particles <10 [mu]m in diameter as defined by the authors) and
alveolar-deposited (e.g., particles <1 [mu]m in diameter as defined by
the authors) beryllium mass and particle number concentrations, as
collected by a general area impactor device, were measured at the
beryllium metal production furnaces rather than the beryllium alloy
furnaces (Kent et al., 2001; McCawley et al., 2001). A statistically
significant linear trend was reported between the above alveolar-
deposited particle mass concentration and prevalence of CBD and
sensitization in the furnace production areas. The authors concluded
that alveolar-deposited particles may be a more relevant exposure
metric for predicting the incidence of CBD or sensitization than the
total mass concentration of airborne beryllium.
Bailey et al. (2010) evaluated the effectiveness of a workplace
preventive program in lowering BeS at the beryllium metal, oxide, and
alloy production plant studied by Kreiss et al. (1997). The preventive
program included use of administrative and PPE controls (e.g., improved
training, skin protection and other PPE, half-mask or air-purified
respirators, medical surveillance, improved housekeeping standards,
clean uniforms) as well as engineering controls (e.g., migration
controls, physical separation of administrative offices from production
facilities) implemented over the course of five years.
In a cross-sectional/longitudinal hybrid study, Bailey et al.
compared rates of sensitization in pre-program workers to those hired
after the preventive program began. Pre-program workers were surveyed
cross-sectionally in 1993-1994, and again in 1999 using the BeLPT to
determine sensitization and CBD prevalence rates. The 1999 cross-
sectional survey was conducted to determine if improvements in
engineering and administrative controls were successful, however,
results indicated no improvement in reducing rates of sensitization or
CBD.
An enhanced preventive program including particle migration
control, respiratory and dermal protection, and process enclosure was
implemented in 2000, with continuing improvements made to the program
in 2001, 2002-2004, and 2005. Workers hired during this period were
longitudinally surveyed for sensitization using the BeLPT. Both the
pre-program and program survey of worker sensitization status utilized
split-sample testing to verify positive test results using the BeLPT.
Of the total 660 workers employed at the production plant, 258 workers
participated from the pre-program group while 290 participated from the
program group (206 partial program, 84 full program). Prevalence
comparisons of the pre-program and
[[Page 47597]]
program groups (partial and full) were performed by calculating
prevalence ratios. A 95 percent confidence interval (95 percent CI) was
derived using a cohort study method that accounted for the variance in
survey techniques (cross-sectional versus longitudinal) (Bailey et al.,
2010). The sensitization prevalence of the pre-program group was 3.8
times higher (95 percent CI, 1.5-9.3) than the program group, 4.0 times
higher (95 percent CI, 1.4-11.6) than the partial program subgroup, and
3.3 times higher (95 percent CI, 0.8-13.7) than the full program
subgroup indicating that a comprehensive preventive program can reduce,
but not eliminate, occurrence of sensitization among non-sensitized
workers (Bailey et al., 2010).
Rosenman et al. (2005) studied a group of several hundred workers
who had been employed at a beryllium production and processing facility
that operated in eastern Pennsylvania between 1957 and 1978. Of 715
former workers located, 577 were screened for BeS with the BLPT and 544
underwent chest radiography to identify cases of BeS and CBD. Workers
were reported to have exposure to beryllium dust and fume in a variety
of chemical forms including beryl ore, beryllium metal, beryllium
fluoride, beryllium hydroxide, and beryllium oxide.
Rosenman et al. used the plant's DWA formulas to assess workers'
full-shift exposure levels, based on IH data collected between 1957-
1962 and 1971-1976, to calculate exposure metrics including cumulative,
average, and peak for each worker in the study. The DWA was calculated
based on air monitoring that consisted of GA and short-term task-based
BZ samples. Workers' exposures to specific chemical and physical forms
of beryllium were assessed, including insoluble beryllium (metal and
oxide), soluble beryllium (fluoride and hydroxide), mixed soluble and
insoluble beryllium, beryllium dust (metal, hydroxide, or oxide), fume
(fluoride), and mixed dust and fume. Use of respiratory or dermal
protection by workers was not reported. Exposures in the plant were
high overall. Representative task-based IH samples ranged from 0.9 [mu]
g/m\3\ to 84 [mu] g/m\3\ in the 1960s, falling to a range of 0.5-16.7
[mu] g/m\3\ in the 1970s. A large number of workers' mean DWA estimates
(25 percent) were above the OSHA PEL of 2.0 [mu] g/m\3\, while most
workers had mean DWA exposures between 0.2 and 2.0 [mu] g/m\3\ (74
percent) or below 0.02 [mu] g/m\3\ (1 percent) (Rosenman et al., Table
11; revised erratum April, 2006).
Blood samples for the BeLPT were collected from the former workers
between 1996 and 2001 and were evaluated at a single laboratory.
Individuals with an abnormal test result were offered repeat testing,
and were classified as sensitized if the second test was also abnormal.
Sixty workers with two positive BeLPTs and 50 additional workers with
chest radiography suggestive of disease were offered clinical
evaluation, including bronchoscopy with bronchial biopsy and BAL-BeLPT.
Seven workers met both criteria. Only 56 (51 percent) of these workers
proceeded with clinical evaluation, including 57 percent of those
referred on the basis of confirmed abnormal BeLPT and 47 percent of
those with abnormal radiographs.
Of those workers who underwent bronchoscopy, 32 (5.5 percent) with
evidence of granulomas were classified as ``definite'' CBD cases.
Twelve (2.1 percent) additional workers with positive BAL-BeLPT or
confirmed positive BeLPT and radiographic evidence of upper lobe
fibrosis were classified as ``probable'' CBD cases. Forty workers (6.9
percent) without upper lobe fibrosis who had confirmed abnormal BeLPT,
but who were not biopsied or who underwent biopsy with no evidence of
granuloma, were classified as sensitized without disease. It is not
clear how many of the 40 workers underwent biopsy. Another 12 (2.1
percent) workers with upper lobe fibrosis and negative or unconfirmed
positive BeLPT were classified as ``possible'' CBD cases. Nine
additional workers who were diagnosed with CBD before the screening
were included in some parts of the authors' analysis.
The authors reported a total prevalence of 14.5 percent for CBD
(definite and probable) and sensitization. This rate, considerably
higher than the overall prevalence of sensitization and disease in
several other worker cohorts as described earlier in this section,
reflects in part the very high exposures experienced by many workers
during the plant's operation in the 1950s, 1960s and 1970s. A total of
115 workers had mean DWAs above the OSHA PEL of 2 [mu] g/m\3\. Of
those, 7 (6.0 percent) had definite or probable CBD and another 13 (11
percent) were classified as sensitized without disease. The true
prevalence of CBD in the group may be higher than reported, due to the
low rate of clinical evaluation among sensitized workers.
Although most of the workers in this study had high exposures,
sensitization and CBD also were observed within the small subgroup of
participants believed to have relatively low beryllium exposures.
Thirty-three cases of CBD and 24 additional cases of sensitization
occurred among 339 workers with mean DWA exposures below OSHA's PEL of
2.0 [mu] g/m\3\ (Rosenman et al., Table 11, erratum 2006). Ten cases of
sensitization and five cases of CBD were found among office and
clerical workers, who were believed to have low exposures (levels not
reported).
Follow-up time for sensitization screening of workers in this study
who became sensitized during their employment had a minimum of 20 years
to develop CBD prior to screening. In this sense the cohort is
especially well suited to compare the exposure patterns of workers with
CBD and those sensitized without disease, in contrast to several other
studies of workers with only recent beryllium exposures. Rosenman et
al. characterized and compared the exposures of workers with definite
and probable CBD, sensitization only, and no disease or sensitization
using chi-squared tests for discrete outcomes and analysis of variance
(ANOVA) for continuous variables (cumulative, mean, and peak exposure
levels). Exposure-response relationships were further examined with
logistic regression analysis, adjusting for potential confounders
including smoking, age, and beryllium exposure from outside of the
plant. The authors found that cumulative, peak, and duration of
exposure were significantly higher for workers with CBD than for
sensitized workers without disease (p <0.05), suggesting that the risk
of progressing from sensitization to CBD is related to the level or
extent of exposure a worker experiences. The risk of developing CBD
following sensitization appeared strongly related to exposure to
insoluble forms of beryllium, which are cleared slowly from the lung
and increase beryllium lung burden more rapidly than quickly mobilized
soluble forms. Individuals with CBD had higher exposures to insoluble
beryllium than those classified as sensitized without disease, while
exposure to soluble beryllium was higher among sensitized individuals
than those with CBD.
Cumulative, mean, peak, and duration of exposure were found to be
comparable for workers with CBD and workers without sensitization or
CBD (``normal'' workers). Cumulative, peak, and duration of exposure
were significantly lower for sensitized workers without disease than
for normal workers. Rosenman et al. suggested that genetic
predisposition to sensitization and CBD may have obscured an exposure-
response relationship in this study, and plan to control for genetic
risk factors in future studies. Exposure misclassification from the
1950s and 1960s may have been another limitation in this study,
introducing bias that
[[Page 47598]]
could have influenced the lack of exposure response. It is also unknown
if the 25 percent who died from CBD-related conditions may have had
higher exposures.
A follow-up was conducted of the cross-sectional study of a
population of workers first evaluated by Kreiss et al. (1997) and
Rosenman et al. (2005) at a beryllium production and processing
facility in eastern Pennsylvania by Schuler et al. (2012), and in a
companion study by Virji et al. (2012). Schuler et al. evaluated the
worker population employed in 1999 with six years or less work tenure
in a cross-sectional study. The investigators evaluated the worker
population by administering a work history questionnaire with a follow-
up examination for sensitization and CBD. A job-exposure matrix (JEM)
was combined with work histories to create individual estimates of
average, cumulative, and highest-job-related exposure for total,
respirable, and sub-micron beryllium mass concentration. Of the 291
eligible workers, 90.7 percent (264) participated in the study.
Sensitization prevalence was 9.8 percent (26/264) with CBD prevalence
of 2.3 percent (6/264). The investigators found a general pattern of
increasing sensitization prevalence as the exposure quartile increased
indicating an exposure-response relationship. The investigators found
positive associations with both total and respirable mass concentration
with sensitization (average and highest job) and CBD (cumulative).
Increased sensitization prevalence was observed with metal oxide
production alloy melting and casting, and maintenance. CBD was
associated with melting and casting. The investigators summarized that
both total and respirable mass concentration were relevant predictors
of risk (Schuler et al., 2012).
In the companion study by Virji et al. (2012), the investigators
reconstructed historical exposure from 1994 to 1999 utilizing the
personal sampling data collected in 1999 as baseline exposure estimates
(BEE). The study evaluated techniques for reconstructing historical
data to evaluate exposure-response relationships for epidemiological
studies. The investigators constructed JEMs using the BEE and estimates
of annual changes in exposure for 25 different process areas. The
investigators concluded these reconstructed JEMs could be used to
evaluate a range of exposure parameters from total, respirable and
submicron mass concentration including cumulative, average, and highest
exposure. These two studies demonstrate that high-quality exposure
estimates can be developed both for total mass and respirable mass
concentrations.
e. Beryllium Machining Operations
Newman et al. (2001) and Kelleher et al. (2001) studied a group of
235 workers at a beryllium metal machining plant. Since the plant
opened in 1969, its primary operations have been machining and
polishing beryllium metal and high-beryllium content composite
materials, with occasional machining of beryllium oxide/metal matrix
(`E-metal'), and beryllium alloys. Other functions include machining of
metals other than beryllium; receipt and inspection of materials; acid
etching; final inspection, quality control, and shipping of finished
materials; tool making; and engineering, maintenance, administrative
and supervisory functions (Newman et al., 2001; Madl et al., 2007).
Machining operations, including milling, grinding, lapping, deburring,
lathing, and electrical discharge machining (EDM), were performed in an
open-floor plan production area. Most non-machining jobs were located
in a separate, adjacent area; however, non-production employees had
access to the machining area.
Engineering and administrative measures, rather than PPE, were
primarily used to control beryllium exposures at the plant (Madl et
al., 2007). Based on interviews with long-standing employees of the
plant, Kelleher et al. reported that work practices were relatively
stable until 1994, when a worker was diagnosed with CBD and a new
exposure control program was initiated. Between 1995 and 1999 new
engineering and work practice controls were implemented, including
removal of pressurized air hoses and discouragement of dry sweeping
(1995), enclosure of deburring processes (1996), mandatory uniforms
(1997), and installation or updating of local exhaust ventilation (LEV)
in EDM, lapping, deburring, and grinding processes (1998) (Madl et al.,
2007). Throughout the plant's history, respiratory protection was used
mainly for ``unusually large, anticipated exposures'' to beryllium
(Kelleher et al., 2001), and was not routinely used otherwise (Newman
et al., 2001).
All workers at the plant participated in a beryllium disease
surveillance program initiated in 1994, and were screened for beryllium
sensitization with the BeLPT beginning in 1995. A BeLPT result was
considered abnormal if two or more of six stimulation indices exceeded
the normal range (see section on BeLPT testing above), and was
considered borderline if one of the indices exceeded the normal range.
A repeat BeLPT was conducted for workers with abnormal or borderline
initial results. Workers were identified as beryllium sensitized and
referred for a clinical evaluation, including bronchoalveolar lavage
(BAL) and transbronchial lung biopsy, if the repeat test was abnormal.
CBD was diagnosed upon evidence of sensititization with granulomas or
mononuclear cell infiltrates in the lung tissue (Newman et al., 2001).
Following the initial plant-wide screening, plant employees were
offered BeLPT testing at two-year intervals. Workers hired after the
initial screening were offered a BeLPT within 3 months of their hire
date, and at 2-year intervals thereafter (Madl et al., 2007).
Kelleher et al. performed a nested case-control study of the 235
workers evaluated in Newman et al. (2001) to evaluate the relationship
between beryllium exposure levels and risk of sensitization and CBD
(Kelleher et al., 2001). The authors evaluated exposures at the plant
using IH samples they had collected between 1996 and 1999, using
personal cascade impactors designed to measure the mass of beryllium
particles less than 6 [mu] m, particles less than 1 [mu]m in diameter,
and total mass. The great majority of workers' exposures were below the
OSHA PEL of 2 [mu] g/m\3\. However, a few higher levels were observed
in machining jobs including deburring, lathing, lapping, and grinding.
Based on a statistical comparison between their samples and historical
data provided by the plant, the authors concluded that worker beryllium
exposures across all time periods could be approximated using the 1996-
1999 data. They estimated workers' cumulative and `lifetime weighted'
(LTW) beryllium exposure based on the exposure samples they collected
for each job in 1996-1999 and company records of each worker's job
history.
Twenty workers with beryllium sensitization or CBD (cases) were
compared to 206 workers (controls) for the case-control analysis from
the study evaluating workers originally conducted by Newman et al.
Thirteen workers were diagnosed with CBD based on lung biopsy evidence
of granulomas and/or mononuclear cell infiltrates (11) or positive BAL
results with evidence of lymphocytosis (2). Seven were evaluated for
CBD and found to be sensitized only, thus twenty composing the case
group. Nine of the remaining 215 workers first identified in original
study (Newman et al., 2001) were
[[Page 47599]]
excluded due to incomplete job history information, leaving 206 workers
in the control group.
Kelleher et al.'s analysis included comparisons of the case and
control groups' median exposure levels; calculation of odds ratios for
workers in high, medium, and low exposure groups; and logistic
regression testing of the association of sensitization or CBD with
exposure level and other variables. Median cumulative exposures for
total mass, particles <6 [mu] m, and particles <1 [mu]m were
approximately three times higher among the cases than controls,
although the relationships observed were not statistically significant
(p values ~ 0.2). No clear difference between cases and controls was
observed for the median LTW exposures. Odds ratios with sensitization
and CBD as outcomes were elevated in high (upper third) and
intermediate exposure groups relative to low (lowest third) exposure
groups for both cumulative and LTW exposure, though the results were
not statistically significant (p > 0.1). In the logistic regression
analysis, only machinist work history was a significant predictor of
case status in the final model. Quantitative exposure measures were not
significant predictors of sensitization or disease risk.
Citing an 11.5 percent prevalence of beryllium sensitization or CBD
among machinists as compared with 2.9 percent prevalence among workers
with no machinist work history, the authors concluded that the risk of
sensitization and CBD is increased among workers who machine beryllium.
Although differences between cases and controls in median cumulative
exposure did not achieve conventional thresholds for statistical
significance, the authors noted that cumulative exposures were
consistently higher among cases than controls for all categories of
exposure estimates and for all particle sizes, suggesting an effect of
cumulative exposure on risk. The levels at which workers developed CBD
and sensitization were predominantly below OSHA's current PEL of 2 [mu]
g/m\3\, and no cases of sensitization or CBD were observed among
workers with LTW exposure <0.02 [mu]g/m\3\. Twelve (60 percent) of the
20 sensitized workers had LTW exposures > 0.20 [mu] g/m\3\.
In 2007, Madl et al. published an additional study of 27 workers at
the machining plant who were found to be sensitized or diagnosed with
CBD between the start of medical surveillance in 1995 and 2005. As
previously described, workers were offered a BeLPT in the initial 1995
screening (or within 3 months of their hire date if hired after 1995)
and at 2-year intervals after their first screening. Workers with two
positive BeLPTs were identified as sensitized and offered clinical
evaluation for CBD, including bronchoscopy with BAL and transbronchial
lung biopsy. The criteria for CBD in this study were somewhat stricter
than those used in the Newman et al. study, requiring evidence of
granulomas on lung biopsy or detection of X-ray or pulmonary function
changes associated with CBD, in combination with two positive BeLPTs or
one positive BAL-BeLPT.
Based on the history of the plant's control efforts and their
analysis of historical IH data, Madl et al. identified three ``exposure
control eras'': A relatively uncontrolled period from 1980-1995; a
transitional period from 1996 to 1999; and a relatively well-controlled
``modern'' period from 2000-2005. They found that the engineering and
work practice controls instituted in the mid-1990s reduced workers'
exposures substantially, with nearly a 15-fold difference in reported
exposure levels between the pre-control and the modern period (Madl et
al., 2007). Madl et al. estimated workers' exposures using LP samples
collected between 1980 and 2005, including those collected by Kelleher
et al., and work histories provided by the plant. As described more
fully in the study, they used a variety of approaches to describe
individual workers' exposures, including approaches designed to
characterize the highest exposures workers were likely to have
experienced. Their exposure-response analysis was based primarily on an
exposure metric they derived by identifying the year and job of each
worker's pre-diagnosis work history with the highest reported
exposures. They used the upper 95th percentile of the LP samples
collected in that job and year (in some cases supplemented with data
from other years) to characterize the worker's upper-level exposures.
Based on their estimates of workers' upper level exposures, Madl et
al. concluded that workers with sensitization or CBD were likely to
have been exposed to airborne beryllium levels greater than 0.2 [mu]g/
m\3\ as an 8-hour TWA at some point in their history of employment in
the plant. They also concluded that most sensitization and CBD cases
were likely to have been exposed to levels greater than 0.4 [mu]g/m\3\
at some point in their work at the plant. Madl et al. did not
reconstruct exposures for workers at the plant who did not have
sensitization or CBD and therefore could not determine whether non-
cases had upper-bound exposures lower than these levels. They found
that upper-bound exposure estimates were generally higher for workers
with CBD than for those who were sensitized but not diagnosed with CBD
at the conclusion of the study (Madl et al., 2007). Because CBD is an
immunological disease and beryllium sensitization has been shown to
occur within a year of exposure for some workers, Madl et al. argued
that their estimates of workers' short-term upper-bound exposures may
better capture the exposure levels that led to sensitization and
disease than estimates of long-term cumulative or average exposures
such as the LTW exposure measure constructed by Kelleher et al. (Madl
et al., 2007).
f. Beryllium Oxide Ceramics
Kreiss et al. (1993) conducted a screening of current and former
workers at a plant that manufactured beryllium ceramics from beryllium
oxide between 1958 and 1975, and then transitioned to metalizing
circuitry onto beryllium ceramics produced elsewhere. Of the plant's
1,316 current and 350 retired workers, 505 participated who had not
previously been diagnosed with CBD or sarcoidosis, including 377
current and 128 former workers. Although beryllium exposure was not
estimated quantitatively in this survey, the authors conducted a
questionnaire to assess study participants' exposures qualitatively.
Results showed that 55 percent of participants reported working in jobs
with exposure to beryllium dust. Close to 25 percent of participants
did not know if they had exposure to beryllium, and just over 20
percent believed they had not been exposed.
BeLPT tests were administered to all 505 participants in the 1989-
1990 screening period and evaluated at a single lab. Seven workers had
confirmed abnormal BeLPT results and were identified as sensitized;
these workers were also diagnosed with CBD based on findings of
granulomas upon clinical evaluation. Radiograph screening led to
clinical evaluation and diagnosis of two additional CBD cases, who were
among three participants with initially abnormal BeLPT results that
could not be confirmed on repeat testing. In addition, nine workers had
been previously diagnosed with CBD, and another five were diagnosed
shortly after the screening period, in 1991-1992.
Eight (3.7 percent of the screening population) of the nine CBD
cases identified in the screening population were hired before the
plant stopped producing beryllium ceramics in 1975, and were among the
216 participants who had reported having been near or
[[Page 47600]]
exposed to beryllium dust. Particularly high CBD rates of 11.1-15.8
percent were found among screening participants who had worked in
process development/engineering, dry pressing, and ventilation
maintenance jobs believed to have high or uncontrolled dust exposure.
One case (0.6 percent) of CBD was diagnosed among the 171 study
participants who had been hired after the plant stopped producing
beryllium ceramics. Although this worker was hired eight years after
the end of ceramics production, he had worked in an area later found to
be contaminated with beryllium dust. The authors concluded that the
study results suggested an exposure-response relationship between
beryllium exposure and CBD, and recommended beryllium exposure control
to reduce workers' risk of CBD.
Kreiss et al. later published a study of workers at a second
ceramics plant located in Tucson, AZ (Kreiss et al., 1996), which since
1980 had produced beryllium ceramics from beryllium oxide powder
manufactured elsewhere. IH measurements collected between 1981 and
1992, primarily GA or short-term BZ samples and a few (<100) LP
samples, were available from the plant. Airborne beryllium exposures
were generally low. The majority of area samples were below the
analytical detection limit of 0.1 [mu]g/m\3\, while LP and short-term
BZ samples had medians of 0.3 [mu]g/m\3\. However, 3.6 percent of
short-term BZ samples and 0.7 percent of GA samples exceeded 5.0 [mu]g/
mg\3\, while LP samples ranged from 0.1 to 1.8 [mu]g/m\3\. Machining
jobs had the highest beryllium exposure levels among job tasks, with
short-term BZ samples significantly higher for machining jobs than for
non-machining jobs (median 0.6 [mu]g/m\3\ vs. 0.3 [mu]g/mg\3\, p =
0.0001). The authors used DWA formulas provided by the plant to
estimate workers' full-shift exposure levels, and to calculate
cumulative and average beryllium exposures for each worker in the
study. The median cumulative exposure was 591.7 mg-days/m\3\ and the
median average exposure was 0.35 [mu]g/m\3\.
One hundred thirty-six of the 139 workers employed at the plant at
the time of the Kreiss et al. (1996) study underwent BeLPT screening
and chest radiographs in 1992. Blood samples were split between two
laboratories. If one or both test results were abnormal, an additional
sample was collected and split between the labs. Seven workers with an
abnormal result on two draws were initially identified as sensitized.
Those with confirmed abnormal BeLPTs or abnormal chest X-rays were
offered clinical evaluation for CBD, including transbronchial lung
biopsy and BAL BeLPT. CBD was diagnosed based on observation of
granulomas on lung biopsy, in five of the six sensitized workers who
accepted evaluation. An eighth case of sensitization and sixth case of
CBD were diagnosed in one worker hired in October 1991 whose initial
BeLPT was normal, but who was confirmed as sensitized and found to have
lung granulomas less than two years later, after sustaining a
beryllium-contaminated skin wound. The plant medical department
reported 11 additional cases of CBD among former workers (Kreiss et
al., 1996). The overall prevalence of sensitization in the plant was
5.9 percent, with a 4.4 percent prevalence of CBD.
Kreiss et al. reported that six (75 percent) of the eight
sensitized workers were exposed as machinists during or before the
period October 1985-March 1988, when measurements were first available
for machining jobs. The authors reported that 14.3 percent of
machinists were sensitized, compared to 1.2 percent of workers who had
never been machinists (p <0.01). Workers' estimated cumulative and
average beryllium exposures did not differ significantly for machinists
and non-machinists, or for cases and non-cases. As in the previous
study of the same ceramics plant published by Kreiss et al. in 1993,
one case of CBD was diagnosed in a worker who had never been employed
in a production job. This worker was employed in administration, a job
with a median DWA of 0.1 [mu]g/m\3\ (range 0.1-0.3).
In 1998, Henneberger et al. conducted a follow-up cross-sectional
survey of 151 employees employed at the beryllium ceramics plant
studied by Kreiss et al. (1996) (Henneberger et al., 2001). Employees
were eligible who either had not participated in the Kreiss et al.
survey (``short-term workers''--74 of those studied by Henneberger et
al.), or who had participated and were not found to have sensitization
or disease (``long-term workers''--77 of those studied by Henneberger
et al.).
The authors estimated workers' cumulative, average, and peak
beryllium exposures based on the plant's formulas for estimating job-
specific DWA exposures, participants' work histories, and area and
short-term task-specific BZ samples collected from the start of full
production at the plant in 1981 to 1998. The long-term workers, who
were hired before the 1992 study was conducted, had generally higher
estimated exposures (median of average exposures--0.39 [mu]g/m\3\;
mean--14.9 [mu]g/m\3\) than the short-term workers, who were hired
after 1992 (median 0.28 [mu]g/m\3\, mean 6.1 [mu]g/m\3\).
Fifteen cases of sensitization were found, including eight among
short-term and seven among long-term workers. Eight of the 15 workers
were found to have CBD. Of the workers diagnosed with CBD, seven (88
percent) were long-term workers. One non-sensitized long-term worker
and one sensitized long-term worker declined clinical examination.
Henneberger et al. reported a higher prevalence of sensitization
among long-term workers with ``high'' (greater than median) peak
exposures compared to long-term workers with ``low'' exposures;
however, this relationship was not statistically significant. No
association was observed for average or cumulative exposures. The
authors reported higher prevalence of sensitization (but not
statistically significant) among short-term workers with ``high''
(greater than median) average, cumulative, and peak exposures compared
to short-term workers with ``low'' exposures of each type.
The cumulative incidence of sensitization and CBD was investigated
in a cohort of 136 workers at the beryllium ceramics plant previously
studied by the Kreiss and Henneberger groups (Schuler et al., 2008).
The study cohort consisted of those who participated in the plant-wide
BeLPT screening in 1992. Both current and former workers from this
group were invited to participate in follow-up BeLPT screenings in
1998, 2000, and 2002-03. A total of 106 of the 128 non-sensitized
individuals in 1992 participated in the 11-year follow-up.
Sensitization was defined as a confirmed abnormal BeLPT based on the
split blood sample-dual laboratory protocol described earlier. CBD was
diagnosed in sensitized individuals based on pathological findings from
transbronchial biopsy and BAL fluid analysis. The 11-year crude
cumulative incidence of sensitization and CBD was 13 percent (14 of
106) and 8 percent (9 of 106) respectively. The cumulative prevalence
was about triple the point prevalences determined in the initial 1992
cross-sectional survey. The corrected cumulative prevalences for those
that ever worked in machining were nearly twice that for non-
machinists. The data illustrate the value of longitudinal medical
screening over time to obtain a more accurate estimate of the
occurrence of sensitization and CBD among an exposed working
population.
Following the 1998 survey, the company continued efforts to reduce
[[Page 47601]]
exposures and risk of sensitization and CBD by implementing additional
engineering, administrative, and PPE measures (Cummings et al., 2007).
Respirator use was required in production areas beginning in 1999, and
latex gloves were required beginning in 2000. The lapping area was
enclosed in 2000, and enclosures were installed for all mechanical
presses in 2001. Between 2000 and 2003, water-resistant or water-proof
garments, shoe covers, and taped gloves were incorporated to keep
beryllium-containing fluids from wet machining processes off the skin.
The new engineering measures did not appear to substantially reduce
airborne beryllium levels in the plant. LP samples collected between
2000 and 2003 had a median of 0.18 [mu]g/m\3\, similar to the 1994-1999
samples. However, respiratory protection requirements to control
workers' airborne beryllium exposures were instituted prior to the 2000
sample collections.
To test the efficacy of the new measures instituted after 1998, in
January 2000 the company began screening new workers for sensitization
at the time of hire and at 3, 6, 12, 24, and 48 months of employment.
These more stringent measures appear to have substantially reduced the
risk of sensitization among new employees. Of 126 workers hired between
2000 and 2004, 93 completed BeLPT testing at hire and at least one
additional test at 3 months of employment. One case of sensitization
was identified at 24 months of employment (1 percent). This worker had
experienced a rash after an incident of dermal exposure to lapping
fluid through a gap between his glove and uniform sleeve, indicating
that he may have become sensitized via the skin. He was tested again at
48 months of employment, with an abnormal result.
A second worker in the 2000-2004 group had two abnormal BeLPT tests
at the time of hire, and a third had one abnormal test at hire and a
second abnormal test at 3 months. Both had normal BeLPTs at 6 months,
and were not tested thereafter. A fourth worker had one abnormal BeLPT
result at the time of hire, a normal result at 3 months, an abnormal
result at 6 months, and a normal result at 12 months. Four additional
workers had one abnormal result during surveillance, which could not be
confirmed upon repeat testing.
Cummings et al. calculated two sensitization rates based on these
screening results: (1) a rate using only the sensitized worker
identified at 24 months, and (2) a rate including all four workers who
had repeated abnormal results. They reported a sensitization incidence
rate (IR) of 0.7 per 1,000 person-months to 2.7 per 1,000 person-months
for the workers hired between 2000 and 2004, using the sum of
sensitization-free months of employment among all 93 workers as the
denominator.
The authors also estimated an incidence rate (IR) of 5.6 per 1,000
person-months for workers hired between 1993 and the 1998 survey. This
estimated IR was based on one BeLPT screening, rather than BeLPTs
conducted throughout the workers' employment. The denominator in this
case was the total months of employment until the 1998 screening.
Because sensitized workers may have been sensitized prior to the
screening, the denominator may overestimate sensitization-free time in
the legacy group, and the actual sensitization IR for legacy workers
may be somewhat higher than 5.6 per 1,000 person-months. Based on
comparison of the IRs, the authors concluded that the addition of
respirator use, dermal protection, and housekeeping improvements
appeared to have reduced the risk of sensitization among workers at the
plant, even though airborne beryllium levels in some areas of the plant
had not changed significantly since the 1998 survey.
g. Copper-Beryllium Alloy Processing and Distribution
Schuler et al. (2005) studied a group of 152 workers at a facility
processing copper-beryllium alloys and small quantities of nickel-
beryllium alloys, and converting semi-finished alloy strip and wire
into finished strip, wire and rod. Production activities included
annealing, drawing, straightening, point and chamfer, rod and wire
packing, die grinding, pickling, slitting, and degreasing. Periodically
in the plant's history, they also did salt baths, cadmium plating,
welding and deburring. Since the late 1980s, rod and wire production
processes were physically segregated from strip metal production.
Production support jobs included mechanical maintenance, quality
assurance, shipping and receiving, inspection, and wastewater
treatment. Administration was divided into staff primarily working
within the plant and personnel who mostly worked in office areas
(Schuler, et al., 2005). Workers' respirator use was limited, mostly to
occasional tasks where high exposures were anticipated.
Following the 1999 diagnosis of a worker with CBD, the company
surveyed the workforce, offering all current employees BeLPT testing in
2000 and offering sensitized workers clinical evaluation for CBD,
including BAL and transbronchial biopsy. Of the facility's 185
employees, 152 participated in the BeLPT screening. Samples were split
between two laboratories, with additional draws and testing for
confirmation if conflicting tests resulted in the initial draw. Ten
participants (7 percent) had at least two abnormal BeLPT results. The
results of nine workers who had abnormal BeLPT results from only one
laboratory were not included because the authors believed it was
experiencing technical problems with the test (Schuler et al., 2005).
CBD was diagnosed in six workers (4 percent) on evidence of pathogenic
abnormalities (e.g., granulomas) or evidence of clinical abnormalities
consistent with CBD based on pulmonary function testing, pulmonary
exercise testing, and/or chest radiography. One worker diagnosed with
CBD had been exposed to beryllium during previous work at another
copper-beryllium processing facility.
Schuler et al. evaluated airborne beryllium levels at the plant
using IH samples collected between 1969 and 2000, including 4,524 GA
samples, 650 LP samples and 815 short-duration (3-5 min) high volume
(SD-HV) BZ task-specific samples. Occupational exposures to airborne
beryllium were generally low. Ninety-nine percent of all LP
measurements were below the current OSHA PEL of 2.0 [mu]g/m\3\ (8-hr
TWA); 93 percent were below the DOE action level of 0.2 [mu]g/m\3\; and
the median value was 0.02 [mu]g/m\3\. The SD-HV BZ samples had a median
value of 0.44 [mu]g/m\3\, with 90 percent below the OSHA Short-Term
Exposure Limit (STEL) of 5.0 [mu]g/m\3\. The highest levels of
beryllium were found in rod and wire production, particularly in wire
annealing and pickling, the only production job with a median personal
sample measurement greater than 0.1 [mu]g/m\3\ (median 0.12 [mu]g/m\3\;
range 0.01-7.8 [mu]g/m\3\) (Schuler et al., Table 4). These
concentrations were significantly higher than the exposure levels in
the strip metal area (median 0.02, range 0.01-0.72 [mu]g/m\3\), in
production support jobs (median 0.02, range <0.01-0.33 [mu]g/m\3\),
plant administration (median 0.02, range <0.01-0.11 [mu]g/m\3\), and
office administration jobs (median 0.01, range <0.01-0.06 [mu]g/m\3\).
The authors reported that eight of the ten sensitized employees,
including all six CBD cases, had worked in both major production areas
during their tenure with the plant. The 7 percent prevalence (6 of 81
workers) of CBD among employees who had ever worked in rod and wire was
statistically
[[Page 47602]]
significantly elevated compared with employees who had never worked in
rod and wire (p <0.05), while the 6 percent prevalence (6 of 94
workers) among those who had worked in strip metal was not
significantly elevated compared to non-strip metal workers (p > 0.1).
Based on these results, together with the higher exposure levels
reported for the rod and wire production area, Schuler et al. concluded
that work in rod and wire was a key risk factor for CBD in this
population. Schuler et al. also found a high prevalence (13 percent) of
sensitization among workers who had been exposed to beryllium for less
than a year at the time of the screening, a rate similar to that found
by Henneberger et al. among beryllium ceramics workers exposed for one
year or less (16 percent, Henneberger et al., 2001). All four workers
who were sensitized without disease had been exposed 5 years or less;
conversely, all six of the workers with CBD had first been exposed to
beryllium at least five years prior to the screening (Schuler et al.,
Table 2).
As has been seen in other studies, beryllium sensitization and CBD
were found among workers who were typically exposed to low time-
weighted average airborne concentrations of beryllium. While jobs in
the rod and wire area had the highest exposure levels in the plant, the
median personal sample value was only 0.12 [mu]g/m\3\. However, workers
may have occasionally been exposed to higher beryllium levels for short
periods during specific tasks. A small fraction of personal samples
recorded in rod and wire were above the OSHA PEL of 2.0 [mu]g/m\3\, and
half of workers with sensitization or CBD reported that they had
experienced a ``high-exposure incident'' at some point in their work
history (Schuler et al., 2005). The only group of workers with no cases
of sensitization or CBD, a group of 26 office administration workers,
was the group with the lowest recorded exposures (median personal
sample 0.01 [mu]g/m\3\, range <0.01-0.06 [mu]g/m\3\).
After the BeLPT screening was conducted in 2000, the company began
implementing new measures to further reduce workers' exposure to
beryllium (Thomas et al., 2009). Requirements designed to minimize
dermal contact with beryllium, including long-sleeve facility uniforms
and polymer gloves, were instituted in production areas in 2000. In
2001 the company installed LEV in die grinding and polishing. LP
samples collected between June 2000 and December 2001 show reduced
exposures plant-wide. Of 2,211 exposure samples collected, 98 percent
were below 0.2 [mu]g/m\3\, and 59 percent below the limit of detection
(LOD), which was either 0.02 [micro]g/m\3\ or 0.2 [micro]g/m\3\
depending on the method of sample analysis (Thomas et al., 2009).
Median values below 0.03 [mu]g/m\3\ were reported for all processes
except the wire annealing and pickling process. Samples for this
process remained somewhat elevated, with a median of 0.1 [mu]g/m\3\. In
January 2002, the plant enclosed the wire annealing and pickling
process in a restricted access zone (RAZ), requiring respiratory PPE in
the RAZ and implementing stringent measures to minimize the potential
for skin contact and beryllium transfer out of the zone. While exposure
samples collected by the facility were sparse following the enclosure,
they suggest exposure levels comparable to the 2000-01 samples in areas
other than the RAZ. Within the RAZ, required use of powered air-
purifying respirators indicates that respiratory exposure was
negligible.
To test the efficacy of the new measures in preventing
sensitization and CBD, in June 2000 the facility began an intensive
BeLPT screening program for all new workers. The company screened
workers at the time of hire; at intervals of 3, 6, 12, 24, and 48
months; and at 3-year intervals thereafter. Among 82 workers hired
after 1999, three (3.7 percent) cases of sensitization were found. Two
(5.4 percent) of 37 workers hired prior to enclosure of the wire
annealing and pickling process were found to be sensitized within 3 and
6 months of beginning work at the plant. One (2.2 percent) of 45
workers hired after the enclosure was confirmed as sensitized.
Thomas et al. calculated a sensitization IR of 1.9 per 1,000
person-months for the workers hired after the exposure control program
was initiated in 2000 (``program workers''), using the sum of
sensitization-free months of employment among all 82 workers as the
denominator (Thomas et al., 2009). They calculated an estimated IR of
3.8 per 1,000 person-months for 43 workers hired between 1993 and 2000
who had participated in the 2000 BeLPT screening (``legacy workers'').
This estimated IR was based on one BeLPT screening, rather than BeLPTs
conducted throughout the legacy workers' employment. The denominator in
this case is the total months of employment until the 2000 screening.
Because sensitized workers may have been sensitized prior to the
screening, the denominator may overestimate sensitization-free time in
the legacy group, and the actual sensitization IR for legacy workers
may be somewhat higher than 3.8 per 1,000 person-months. Based on
comparison of the IRs and the prevalence rates discussed previously,
the authors concluded that the combination of dermal protection,
respiratory protection, housekeeping improvements and engineering
controls implemented beginning in 2000 appeared to have reduced the
risk of sensitization among workers at the plant. However, they noted
that the small size of the study population and the short follow-up
time for the program workers suggested that further research is needed
to confirm the program's efficacy (Thomas et al., 2009).
Stanton et al. (2006) conducted a study of workers in three
different copper-beryllium alloy distribution centers in the United
States. The distribution centers, including one bulk products center
established in 1963 and strip metal centers established in 1968 and
1972, sell products received from beryllium production and finishing
facilities and small quantities of copper-beryllium, aluminum-
beryllium, and nickel-beryllium alloy materials. Work at distribution
centers does not require large-scale heat treatment or manipulation of
material typical of beryllium processing and machining plants, but
involves final processing steps that can generate airborne beryllium.
Slitting, the main production activity at the two strip product
distribution centers, generates low levels of airborne beryllium
particles, while operations such as tensioning and welding used more
frequently at the bulk products center can generate somewhat higher
levels. Non-production jobs at all three centers included shipping and
receiving, palletizing and wrapping, production-area administrative
work, and office-area administrative work.
The authors estimated workers' beryllium exposures using IH data
from company records and job history information collected through
interviews conducted by a company occupational health nurse. Stanton et
al. evaluated airborne beryllium levels in various jobs based on 393
full-shift LP samples collected from 1996 to 2004. Airborne beryllium
levels at the plant were generally very low, with 54 percent of all
samples at or below the LOD, which ranged from 0.02 to 0.1 [mu]g/m\3\.
The authors reported a median of 0.03 [mu]g/m\3\ and an arithmetic mean
of 0.05 [mu]g/m\3\ for the 393 full-shift LP samples, where samples
below the LOD were assigned a value of half the applicable LOD. Median
and geometric mean values for specific jobs ranged from 0.01-0.07 and
0.02-0.07 [micro]g/m\3\, respectively. All measurements were
[[Page 47603]]
below the OSHA PEL of 2.0 [mu]g/m\3\ and 97 percent were below the DOE
action level of 0.2 [mu]g/m\3\. The paper does not report use of
respiratory or skin protection. Exposure conditions may have changed
somewhat over the history of the plant due to changes in exposure
control measures, including improvements to product and container
cleaning practices instituted during the 1990s.
Eighty-eight of the 100 workers (88 percent) employed at the three
centers at the time of the study participated in screening for
beryllium sensitization. Blood samples were collected between November
2000 and March 2001 by the company's medical staff. Samples collected
from employees of the strip metal centers were split and evaluated at
two laboratories, while samples from the bulk product center workers
were evaluated at a single laboratory. Participants were considered to
be ``sensitized'' to beryllium if two or more BeLPT results, from two
laboratories or from repeat testing at the same laboratory, were found
to be abnormal. One individual was found to be sensitized and was
offered clinical evaluation, including BAL and fiberoptic bronchoscopy.
He was found to have lung granulomas and was diagnosed with CBD.
The worker diagnosed with CBD had been employed at a strip metal
distribution center from 1978 to 2000 as a shipper and receiver,
loading and unloading trucks delivering materials from a beryllium
production facility and to the distribution center's customers.
Although the LP samples collected for his job between 1996 and 2000
were generally low (n = 35, median 0.01, range < 0.02-0.13 [micro]g/
m\3\), it is not clear whether these samples adequately characterize
his exposure conditions over the course of his work history. He
reported that early in his work history, containers of beryllium oxide
powder were transported on the trucks he entered. While he did not
recall seeing any breaks or leaks in the beryllium oxide containers,
some containers were known to have been punctured by forklifts on
trailers used by the company during the period of his employment, and
could have contaminated trucks he entered. With 22 years of employment
at the facility, this worker had begun beryllium-related work earlier
and performed it longer than about 90 percent of the study population
(Stanton et al., 2006).
h. Nuclear Weapons Production Facilities & Cleanup of Former Facilities
Primary exposure from nuclear weapons production facilities comes
from beryllium metal and beryllium alloys. A study conducted by Kreiss
et al. (1989) documented sensitization and CBD among beryllium-exposed
workers in the nuclear industry. A company medical department
identified 58 workers with beryllium exposure among a work force of
500, of whom 51 (88 percent) participated in the study. Twenty-four
workers were involved in research and development (R&D), while the
remaining 27 were production workers. The R&D workers had a longer
tenure with a mean time from first exposure of 21.2 years, compared to
a mean time since first exposure of 5 years among the production
workers. The number of workers with abnormal BeLPT readings was 6, with
4 being diagnosed with CBD. This resulted in an estimated 11.8 percent
prevalence of sensitization.
Kreiss et al. (1993) expanded the work of Kreiss et al. (1989) by
performing a cross-sectional study of 895 (current and former)
beryllium workers in the same nuclear weapons plant. Participants were
placed in qualitative exposure groups (``no exposure,'' ``minimal
exposure,'' ``intermittent exposure,'' and ``consistent exposure'')
based on questionnaire responses. The number of workers with abnormal
BeLPT totaled 18 with 12 being diagnosed with CBD. Three additional
workers with sensitization developed CBD over the next 2 years.
Sensitization occurred in all of the qualitatively defined exposure
groups. Individuals who had worked as machinists were statistically
overrepresented among beryllium-sensitized cases, compared with non-
cases. Cases were more likely than non-cases to report having had a
measured overexposure to beryllium (p = 0.009), a factor which proved
to be a significant predictor of sensitization in logistic regression
analyses, as was exposure to beryllium prior to 1970. Beryllium
sensitized cases were also significantly more likely to report having
had cuts that were delayed in healing (p = 0.02). The authors concluded
that individual variability and susceptibility along with exposure
circumstances are important factors in developing beryllium
sensitization and CBD.
In 1991, the Beryllium Health Surveillance Program (BHSP) was
established at the Rocky Flats Nuclear Weapons Facility to offer BLPT
screening to current and former employees who may have been exposed to
beryllium (Stange et al., 1996). Participants received an initial BeLPT
and follow-ups at one and three years. Based on histologic evidence of
pulmonary granulomas and a positive BAL-BeLPT, Stange et al. published
a study of 4,397 BHSP participants tested from June 1991 to March 1995,
including current employees (42.8 percent) and former employees (57.2
percent). Twenty-nine cases of CBD and 76 cases of sensitization were
identified. The sensitization rate for the population was 2.43 percent.
Available exposure data included fixed airhead (FAH) exposure samples
collected between 1970 and 1988 (mean concentration 0.016 [micro]g/
m\3\) and personal samples collected between 1984 and 1987 (mean
concentration 1.04 [micro]g/m\3\). Cases of CBD and sensitization were
noted in individuals in all jobs classifications, including those
believed to involve minimal exposure to beryllium. The authors
recommended ongoing surveillance for workers in all jobs with potential
for beryllium exposure.
Stange et al. (2001) extended the previous study, evaluating 5,173
participants in the Rocky Flats BHSP who were tested between June 1991
and December 1997. Three-year serial testing was offered to employees
who had not been tested for three years or more and did not show
beryllium sensitization during the previous study. This resulted in
2,891 employees being tested. Of the 5,173 workers participating in the
study, 172 were found to have abnormal BeLPT. Ninety-eight (3.33
percent) of the workers were found to be sensitized (confirmed abnormal
BeLPT results) in the initial screening, conducted in 1991. Of these
workers 74 were diagnosed with CBD (history of beryllium exposure,
evidence of non-caseating granulomas or mononuclear cell infiltrates on
lung biopsy, and a positive BeLPT or BAL-BeLPT). A follow-up survey of
2,891 workers three years later identified an additional 56 sensitized
workers and an additional seven cases of CBD. Sensitization and CBD
rates were analyzed with respect to gender, building work locations,
and length of employment. Historical employee data included hire date,
termination date, leave of absences, and job title changes. Exposure to
beryllium was determined by job categories and building or work area
codes. Personal beryllium air monitoring results were used, when
available, from employees with the same job title or similar job.
However, no quantitative information was presented in the study. The
authors conclude that for some individuals, exposure to beryllium at
levels less that the OSHA PEL could cause sensitization and CBD.
Viet et al. (2001) conducted a case-control study of the Rocky
Flats worker population studied by Stange et al. (1996 and 2001) to
examine the relationship between estimated
[[Page 47604]]
beryllium exposure level and risk of sensitization or CBD. The worker
population included 74 beryllium-sensitized workers and 50 workers
diagnosed with CBD. Beryllium exposure levels were estimated based on
FAH airhead samples from one building, the beryllium machine shop.
These were collected away from the BZ of the machine operator and
likely underestimated exposure. To estimate levels in other locations,
these air sample concentrations were used to construct a job exposure
matrix that included the determination of the Building 444 exposure
estimates for a 30-year period; each subject's work history by job
location, task, and time period; and assignment of exposure estimates
to each combination of job location, task, and time period as compared
to Building 444 machinists. The authors adjusted the levels observed in
the machine shop by factors based on interviews with former workers.
Workers' estimated mean exposure concentrations ranged from 0.083
[micro]g/m\3\ to 0.622 [micro]g/m\3\. Estimated maximum air
concentrations ranged from 0.54 [micro]g/m\3\ to 36.8 [micro]g/m\3\.
Cases were matched to controls of the same age, race, gender, and
smoking status (Viet et al., 2001).
Estimated mean and cumulative exposure levels and duration of
employment were found to be significantly higher for CBD cases than for
controls. Estimated mean exposure levels were significantly higher for
sensitization cases than for controls. No significant difference was
observed for estimated cumulative exposure or duration of exposure.
Similar results were found using logistic regression analysis, which
identified statistically significant relationships between CBD and both
cumulative and mean estimated exposure, but did not find significant
relationships between estimated exposure levels and sensitization
without CBD. Comparing CBD with sensitization cases, Viet et al. found
that workers with CBD had significantly higher estimated cumulative and
mean beryllium exposure levels than workers who were sensitized, but
did not have CBD.
Johnson et al. (2001) conducted a review of personal sampling
records and medical surveillance reports at an atomic weapons
establishment in Cardiff, United Kingdom. The study evaluated airborne
samples collected over the 36-year period of operation for the plant.
Data included 367,757 area samples and 217,681 personal lapel samples
from 194 workers over the time period from 1981-1997. Data was
available prior to this time period but was not analyzed since this
data was not available electronically. The authors estimated that over
the 17 years of measurement data analyzed, airborne beryllium
concentrations did exceed 2.0 [micro]g/m\3\, however, due to the
limitations with regard to collection times it is difficult to assess
the full reliability of this estimate. The authors noted that in the
entire plant's history, only one case of CBD had been diagnosed. It was
also noted that BeLPT has not been routinely conducted among any of the
workers at this facility.
Armojandi et al. (2010) conducted a cross-sectional study of
workers at a nuclear weapons research and development (R&D) facility to
determine the risk of developing CBD in sensitized workers at
facilities with exposures much lower than production plants. Of the
1875 current or former workers at the R&D facility, 59 were determined
to be sensitized based on at least two positive BeLPTs (i.e., samples
drawn on two separate occasions or on split samples tested in two
separate DOE-approved laboratories) for a sensitization rate of 3.1
percent. Workers found to have positive BeLPTs were further evaluated
in an Occupational Medicine Clinic between 1999 through 2005. Armojandi
et al. (2010) evaluated 50 of the sensitized workers who also had
medical and occupational histories, physical examination, chest imaging
with high-resolution computed tomography (HRCT) (N = 49), and pulmonary
function testing (nine of the 59 workers refused physical examinations
so were not included in this study). Forty of the 50 workers chosen for
this study underwent bronchoscopy for bronchoalveolar lavage and
transbronchial biopsies in additional to the other testing. Five of the
49 workers had CBD at the time of evaluation (based on histology or
high-resolution computed tomography); three others had evidence of
probable CBD; however, none of these cases were classified as severe at
the time of evaluation. The rate of CBD at the time of study among
sensitized individuals was 12.5 percent (5/40) for those using
pathologic review of lung tissue, and 10.2 percent (5/49) for those
using HRCT as a criteria for diagnosis. The rate of CBD among the
entire population (5/1875) was 0.3 percent.
The mean duration of employment at the facility was 18 years, and
the mean latency period (from first possible exposure) to time of
evaluation and diagnosis was 32 years. There was no available exposure
monitoring in the breathing zone of workers at the facility but the
beryllium levels were believed to be relatively low (possibly less than
0.1 [mu]g/m\3\ for most jobs). There was not an apparent exposure-
response relationship for sensitization or CBD. The sensitization
prevalence was similar and the CBD prevalence higher among workers with
the lower-exposure jobs. The authors concluded that these sensitized
workers, who were subjected to an extended duration of low potential
beryllium exposures over a long latency period, had a low prevalence of
CBD (Armojandi et al., 2010).
i. Aluminum Smelting
Bauxite ore, the primary source of aluminum, contains naturally
occurring beryllium. Worker exposure to beryllium can occur at aluminum
smelting facilities where aluminum extraction occurs via electrolytic
reduction of aluminum oxide into aluminum metal. Characterization of
beryllium exposures and sensitization prevalence rates were examined by
Taiwo et al. (2010) in a study of nine aluminum smelting facilities
from four different companies in the U.S., Canada, Italy and Norway.
Of the 3,185 workers determined to be potentially exposed to
beryllium, 1,932 agreed to participate in a medical surveillance
program between 2000 and 2006 (60 percent participation rate). The
medical surveillance program included serum BeLPT analysis,
confirmation of an abnormal BeLPT with a second BeLPT, and follow-up of
all confirmed positive responses by a pulmonary physician to evaluate
for progression to CBD.
Eight-hour TWAs were assessed utilizing 1,345 personal samples
collected from the 9 smelters. The personal beryllium samples obtained
showed a range of 0.01-13.00 [mu]g/m\3\ time-weighted average with an
arithmetic mean of 0.25 [mu]g/m\3\ and geometric mean of 0.06 [mu]g/
m\3\. Exposure levels to beryllium observed in aluminum smelters are
similar to those seen in other industries that utilize beryllium. Of
the 1,932 workers surveyed by BeLPT, nine workers were diagnosed with
sensitization (prevalence rate of 0.47 percent, 95% confidence interval
= 0.21-0.88 percent) with 2 of these workers diagnosed with probable
CBD after additional medical evaluations.
The authors concluded that compared with beryllium-exposed workers
in other industries, the rate of sensitization among aluminum smelter
workers appears lower. The authors speculated that this lower observed
rate could be related to a more soluble form of beryllium found in the
aluminum smelting work environment as well as
[[Page 47605]]
the consistent use of respiratory protection. However, the authors also
speculated that the 60 percent participation rate may have
underestimated the sensitization rate in this worker population.
A study by Nilsen et al. (2010) also found a low rate of
sensitization among aluminum workers in Norway. Three-hundred sixty-two
workers and thirty-one control individuals were tested for beryllium
sensitization based on the BeLPT. The results found that one (0.28%) of
the smelter workers had been sensitized. No borderline results were
reported. The exposure estimated in this plant was 0.1 [micro]g/m\3\ to
0.31 [micro]g/m\3\ (Nilsen et al., 2010).
6. Animal Models of CBD
This section reviews the relevant animal studies supporting the
mechanisms outlined above. Researchers have attempted to identify
animal models with which to further investigate the mechanisms
underlying the development of CBD. A suitable animal model should
exhibit major characteristics of CBD, including the demonstration of a
beryllium-specific immune response, the formation of immune granulomas
following inhalation exposure to beryllium, and mimicking the
progressive nature of the human disease. While exposure to beryllium
has been shown to cause chronic granulomatous inflammation of the lung
in animal studies using a variety of species, most of the granulomatous
lesions were formed by foreign-body reactions, which result from
persistent irritation and consist predominantly of macrophages and
monocytes, and small numbers of lymphocytes. Foreign-body granulomas
are distinct from the immune granulomas of CBD, which are caused by
antigenic stimulation of the immune system and contain large numbers of
lymphocytes. Animal studies have been useful in providing biological
plausibility for the role of immunological alterations and lung
inflammation and in clarifying certain specific mechanistic aspects of
beryllium disease. However, the lack of a dependable animal model that
mimics all facets of the human response combined with study limitations
in terms of single dose experiments, few animals, or abbreviated
observation periods have limited the utility of the data. Currently, no
single model has completely mimicked the disease process as it
progresses in humans. The following is a discussion of the most
relevant animal studies regarding the mechanisms of sensitization and
CBD development in humans. Table A.2 in the Appendix summarizes
species, route, chemical form of beryllium, dose levels, and
pathological findings of the key studies.
Harmsen et al. performed a study to assess whether the beagle dog
could provide an adequate model for the study of beryllium-induced lung
diseases (Harmsen et al., 1986). One group of dogs served as a control
group (air inhalation only) and four other groups received high
(approximately 50 [mu]g/kg) and low (approximately 20 [mu]g/kg) doses
of beryllium oxide calcined at 500 [deg]C or 1,000[deg] C, administered
as aerosols in a single exposure. As discussed above, calcining
temperature controls the solubility and SSA of beryllium particles.
Those particles calcined at higher temperatures (e.g., 1,000[deg] C)
are less soluble and have lower SSA than particles calcined at lower
temperatures (e.g., 500 [deg]C). Solubility and SSA are factors in
determining the toxic potential of beryllium compounds or materials.
Cells were collected from the dogs by BAL at 30, 60, 90, 180, and
210 days after exposure, and the percentages of neutrophils and
lymphocytes were determined. In addition, the mitogenic responses of
blood lymphocytes and lavage cells collected at 210 days were
determined with either phytohemagglutinin or beryllium sulfate as
mitogen. The percentage of neutrophils in the lavage fluid was
significantly elevated only at 30 days with exposure to either dose of
500 [deg]C beryllium oxide. The percentage of lymphocytes in the fluid
was significantly elevated in samples across all times with exposure to
the high dose of this beryllium oxide form. Beryllium oxide calcined at
1,000[deg] C elevated lavage lymphocytes only in high dose at 30 days.
No significant effect of 1,000[deg] C beryllium oxide exposure on
mitogenic response of any lymphocytes was seen. In contrast, peripheral
blood lymphocytes from the 500 [deg]C beryllium oxide exposed groups
were significantly stimulated by beryllium sulfate compared with the
phytohemagglutinin exposed cells. The investigators in this study were
able to replicate some of the same findings as those observed in human
studies--specifically, that beryllium in soluble and insoluble forms
can be mitogenic to immune cells, an important finding for progression
of sensitization and proliferation of immune cells to developing full-
blown CBD.
In another beagle study Haley et al. also found that the beagle dog
appears to model some aspects of human CBD (Haley et al., 1989). The
authors monitored lung pathologic effects, particle clearance, and
immune sensitization of peripheral blood leukocytes following a single
exposure to beryllium oxide aerosol generated from beryllium oxide
calcined at 500 [deg]C or 1,000[deg] C. The aerosol was administered to
the dogs perinasally to attain initial lung burdens of 6 or 18 [mu]g
beryllium/kg body weight. Granulomatous lesions and lung lymphocyte
responses consistent with those observed in humans with CBD were
observed, including perivascular and peribronchiolar infiltrates of
lymphocytes and macrophages, progressing to microgranulomas with areas
of granulomatous pneumonia and interstitial fibrosis. Beryllium
specificity of the immune response was demonstrated by positive results
in the BeLPT, although there was considerable inter-animal variation.
The lesions declined in severity after 64 days post-exposure. Thus,
while this model was able to mimic the formation of Be-specific immune
granulomas, it was not able to mimic the progressive nature of disease.
This study also provided an opportunity to compare the effects of
beryllium oxide calcination temperature on granulomatous disease in the
beagle respiratory system. Haley et al. found an increase in the
percentage and numbers of lymphocytes in BAL fluid at 3 months post-
exposure in dogs exposed to either dose of beryllium oxide calcined at
500 [deg]C, but not in dogs exposed to the material calcined at the
higher temperature. Although there was considerable inter-animal
variation, lesions were generally more severe in the dogs exposed to
material calcined at 500 [deg]C. Positive BeLPT results were observed
with BAL lymphocytes only in the group with a high initial lung burden
of the material calcined at 500 [deg]C, but positive results with
peripheral blood lymphocytes were observed at both doses with material
calcined at both temperatures.
The histologic and immunologic responses of canine lungs to
aerosolized beryllium oxide were investigated in another Haley et al.
(1989) study. Beagle-dogs were exposed in a single exposure to high
dose (50 [micro]g/kg of body weight) or low dose (l7 [micro]g/kg)
levels of beryllium oxide calcined at either 500[deg] or 1000[deg] C.
One group of dogs was examined up to 365 days after exposure for lung
histology and biochemical assay to determine the fate of inhaled
beryllium oxide. A second group underwent BAL for lung lymphocyte
analysis for up to 22 months after exposure. Histopathologic
examination revealed peribronchiolar and perivascular lymphocytic
histiocytic
[[Page 47606]]
inflammation, peaking at 64 days after beryllium oxide exposure.
Lymphocytes were initially well differentiated, but progressed to
lymphoblastic cells and aggregated in lymphofollicular nodules or
microgranulomas over time. Alveolar macrophages were large, and filled
with intracytoplasmic material. Cortical and paracortical lymphoid
hyperplasia of the tracheobronchial nodes was found. Lung lymphocyte
concentrations were increased at 3 months and returned to normal in
both dose groups given 500 [deg]C treated beryllium chloride. No
significant elevations in lymphocyte concentrations were found in dogs
given 1,000[deg] C treated beryllium oxide. Lung retention was higher
in the 500 [deg]C treated beryllium oxide group. The lesions found in
dog lungs closely resembled those found in humans with CBD: severe
granulomas, lymphoblast transformation, increased pulmonary lymphocyte
concentrations and variation in beryllium sensitivity. It was concluded
that the canine model for berylliosis may provide insight into this
disease.
In a follow-up experiment, control dogs and those exposed to
beryllium oxide calcined at 500 [deg]C were allowed to rest for 2.5
years, and then re-exposed to filtered air (controls) or beryllium
oxide calcined at 500 [deg]C for an initial lung burden (ILB) target of
50 [mu]g beryllium oxide/kg body weight (Haley et al., 1992). Immune
responses of blood and BAL lymphocytes, and lung lesions in dogs
sacrificed 210 days post-exposure, were compared with results following
the initial exposure. The severity of lung lesions was comparable under
both conditions, suggesting that a 2.5-year interval was sufficient to
prevent cumulative pathologic effects. Conradi et al. (1971) found no
exposure-related histological alterations in the lungs of six beagle
dogs exposed to a range of 3,300-4,380 [mu]g Be/m\3\ as beryllium oxide
calcined at 1,400[deg] C for 30 min, once per month for 3 months.
Because the dogs were sacrificed 2 years post-exposure, the long time
period between exposure and response may have allowed for the reversal
of any beryllium-induced changes (EPA, 1998).
A 1994 study by Haley et al. showed that intra-bronchiolar
instillation of beryllium induced immune granulomas and sensitization
in monkeys. Haley et al. (1994) exposed male cynomolgus monkeys to
either beryllium metal or beryllium oxide calcined at 500 [deg]C by
intrabronchiolar instillation as a saline suspension. Lymphocyte counts
in BAL fluid were observed, and were found to be significantly
increased in monkeys exposed to beryllium metal on post-exposure days
14 to 90, and on post-exposure day 60 in monkeys exposed to beryllium
oxide. The lungs of monkeys exposed to beryllium metal had lesions
characterized by interstitial fibrosis, Type II cell hyperplasia, and
lymphocyte infiltration. Some monkeys also exhibited immune granulomas.
Similar lesions were observed in monkeys exposed to beryllium oxide,
but the incidence and severity were much less. BAL lymphocytes from
monkeys exposed to beryllium metal, but not from monkeys exposed to
beryllium oxide, proliferated in response to beryllium sulfate in the
BeLPT (EPA, 1998).
In an experiment similar to the one conducted with dogs, Conradi et
al. (1971) found no effect in monkeys (Macaca irus) exposed via whole-
body inhalation for three 30-minute monthly exposures to a range of
3,300-4,380 [mu]g Be/m\3\ as beryllium oxide calcined at 1,400[deg] C.
The lack of effect may have been related to the long period (2 years)
between exposure and sacrifice, or to low toxicity of beryllium oxide
calcined at such a high temperature.
As discussed earlier in this Health Effects section, at the
cellular level, beryllium dissolution must occur for either a dendritic
cell or a macrophage to present beryllium as an antigen to induce the
cell-mediated CBD immune reactions (Stefaniak et al., 2006). Several
studies have shown that low-fired beryllium oxide, which is
predominantly made up of poorly crystallized small particles, is more
immunologically reactive than beryllium oxide calcined at higher firing
temperatures that result in less reactivity due to increasing crystal
size. As discussed previously, Haley et al. (1989a) found more severe
lung lesions and a stronger immune response in beagle dogs receiving a
single inhalation exposure to beryllium oxide calcined at 500 [deg]C
than in dogs receiving an equivalent initial lung burden of beryllium
oxide calcined at 1,000[deg] C. Haley et al. found that beryllium oxide
calcined at 1,000[deg] C elicited little local pulmonary immune
response, whereas the much more soluble beryllium oxide calcined at 500
[deg]C produced a beryllium-specific, cell-mediated immune response in
dogs (Haley et al., 1991).
In a later study, beryllium metal appeared to induce a greater
toxic response than beryllium oxide following intrabronchiolar
instillation in cynomolgus monkeys, as evidenced by more severe lung
lesions, a larger effect on BAL lymphocyte counts, and a positive
response in the BeLPT with BAL lymphocytes only after exposure to
beryllium metal (Haley et al., 1994). Because an oxide layer may form
on beryllium-metal surfaces after exposure to air (Mueller and
Adolphson, 1979; Harmsen et al., 1986) dissolution of small amounts of
poorly soluble beryllium compounds in the lungs might be sufficient to
allow persistent low-level beryllium presentation to the immune system
(NAS, 2008).
Genetic studies in humans led to the creation of an animal model
containing different human HLA-DP alleles inserted into FVB/N mice for
mechanistic studies of CBD. Three strains of genetically engineered
mice (transgenic mice) were created that conferred different risks for
developing CBD based on human studies (Weston et al., 2005; Snyder et
al., 2008): (1) the HLDPB1*401 transgenic strain, where the transgene
codes for lysine residue at the 69th position of the B-chain conferred
low risk of CBD; (2) the HLA-DPB1*201 mice, where the transgene codes
for glutamic acid residue at the 69th position of the B-chain and
glycine residues at positions 84 and 85 conferred medium risk of CBD;
and (3) the HLA-DPB1*1701 mice, where the transgene codes for glutamic
acid at the 69th position of the B-chain and aspartic acid and glutamic
acid residues at positions 84 and 85, respectively, conferred high risk
of CBD (Tarantino-Hutchinson et al., 2009).
In order to validate the transgenic model, Tarantino-Hutchison et
al. challenged the transgenic mice along with seven different inbred
mouse strains to determine the susceptibility and sensitivity to
beryllium exposure. Mice were dermally exposed with either saline or
beryllium, then challenged with either saline or beryllium (as
beryllium sulfate) using the MEST protocol (mouse ear-swelling test).
The authors determined that the high risk HLA-DPB1*1701 transgenic
strain responded 4 times greater (as measured via ear swelling) than
control mice and at least 2 times greater than other strains of mice.
The findings correspond to epidemiological study results reporting an
enhanced CBD odds ratio for the HLA-DPB1*1701 in humans (Weston et al.,
2005; Snyder et al., 2008). Transgenic mice with the genes
corresponding to the low and medium odds ratio study did not respond
significantly over the control group. The authors concluded that while
HLA-DPB1*1701 is important to beryllium sensitization and progression
to CBD, other genetic and environmental factors contribute to the
disease process as well.
[[Page 47607]]
7. Preliminary Beryllium Sensitization and CBD Conclusions
It is well-established that skin and inhalation exposure to
beryllium may lead to sensitization and that inhalation exposure, or
skin exposure coupled with inhalation exposure, may lead to the onset
and progression of CBD. This is supported by extensive human studies.
While all facets of the biological mechanism for this complex disease
have yet to be fully elucidated, many of the key events in the disease
sequence have been identified and described in the previous sections.
Sensitization is a necessary first step to the onset of CBD (NAS,
2008). Sensitization is the process by which the immune system
recognizes beryllium as a foreign substance and responds in a manner
that may lead to development of CBD. It has been documented that a
substantial proportion of sensitized workers exposed to airborne
beryllium progress to CBD (Rosenman et al., 2005; NAS, 2008; Mroz et
al., 2009). Animal studies, particularly in dogs and monkeys, have
provided supporting evidence for T-cell lymphocyte proliferation in the
development of granulomatous lung lesions after exposure to beryllium
(Harmsen et al., 1986; Haley et al., 1989, 1992, 1994). The animal
studies have also provided important insights into the roles of
chemical form, genetic susceptibility, and residual lung burden in the
development of beryllium lung disease (Harmsen et al., 1986; Haley et
al., 1992; Tarantino-Hutchison et al., 2009). OSHA has made a
preliminary determination to consider sensitization and CBD to be
adverse events along the pathological continuum in the disease process,
with sensitization being the necessary first step in the progression to
CBD.
The epidemiological evidence presented in this section demonstrates
that sensitization and CBD are continuing to occur from present-day
exposures below OSHA's PEL (Rosenman, 2005 with erratum published
2006). The available literature discussed above shows that disease
prevalence can be reduced by reducing inhalation exposure (Thomas et
al., 2009). However, the available epidemiological studies also
indicate that it may be necessary to minimize skin exposure to further
reduce the incidence of sensitization (Bailey et al., 2010). The
preliminary risk assessment further discusses the effectiveness of
interventions to reduce beryllium exposures and the risk of
sensitization and CBD (see section VI, Preliminary Risk Assessment).
Studies have demonstrated there remains a prevalence of
sensitization and CBD in facilities with exposure levels below the
current OSHA PEL (Rosenman et al., 2005; Thomas et al., 2009), that
risk of sensitization and CBD appears to vary across industries and
processes (Deubner et al., 2001; Kreiss et al., 1997; Newman et al.,
2001; Henneberger et al., 2001; Schuler et al., 2005; Stange et al.,
2001; Taiwo et al., 2010), and that efforts to reduce exposure have
succeeded in reducing the frequency of beryllium sensitization and CBD
(Bailey et al., 2010) (See Table A-1 in the Appendix).
Of workers who were found to be sensitized and underwent clinical
evaluation, 20-49 percent were diagnosed with CBD (Kreiss et al., 1993;
Newman, 1996, 2005 and 2007; Stange et al., 2001). Overall prevalence
of CBD in cross-sectional screenings ranges from 0.6 to 8 percent
(Kreiss et al., 2007). A study by Newman (2005) estimated from ongoing
surveillance of sensitized individuals, with an average follow-up time
of 6 years, that 31 percent of beryllium-exposed employees progressed
to CBD (Newman, 2005). However, Newman (2005) went on to suggest that
if follow-up times were increased the rate of progression from
sensitization to CBD could be much higher. A study of nuclear weapons
facility employees enrolled in an ongoing medical surveillance program
found that only about 20 percent of sensitized individuals employed
less than five years eventually were diagnosed with CBD, while 40
percent of sensitized employees employed ten years or more developed
CBD (Stange et al., 2001) indicating length of exposure may play a role
in further development of the disease. In addition, Mroz et al. (2009)
conducted a longitudinal study of individuals clinically evaluated at
National Jewish Health (between 1982 and 2002) who were identified as
having sensitization and CBD through workforce medical surveillance.
The authors identified 171 cases of CBD and 229 cases of sensitization;
all individuals were identified through workplace screening using the
BeLPT (Mroz et al., 2009). Over the 20-year study period, 8.8 percent
(i.e., 22 cases out 251 sensitized) of individuals with sensitization
went on to develop CBD. The findings from this study indicated that on
the average span of time from initial beryllium exposure to CBD
diagnosis was 24 years (Mroz et al., 2009).
E. Beryllium Lung Cancer Section
Beryllium exposure has been associated with a variety of adverse
health effects including lung cancer. The potential for beryllium and
its compounds to cause cancer has been previously assessed by various
other agencies (EPA, ATSDR, NAS, NIEHS, and NIOSH) with each agency
identifying beryllium as a potential carcinogen. In addition, the
International Agency for Research on Cancer (IARC) did an extensive
evaluation in 1993 and reevaluation in April 2009 (IARC, 2012). In
brief, IARC determined beryllium and its compounds to be carcinogenic
to humans (Group 1 category), while EPA considers beryllium to be a
probable human carcinogen (EPA, 1998), and the National Toxicology
Program (NTP) has determined beryllium and its compounds to be known
carcinogens (NTP, 2014). OSHA has conducted an independent evaluation
of the carcinogenic potential of beryllium and these compounds as well.
The following is a summary of the studies used to support the Agency
findings that beryllium and its compounds are human carcinogens.
1. Genotoxicity Studies
Genotoxicity can be an important indicator for screening the
potential of a material to induce cancer and an important mechanism
leading to tumor formation and carcinogenesis. In a review conducted by
the National Academy of Science, beryllium and its compounds have
tested positively in nearly 50 percent of the genotoxicity studies
conducted without exogenous metabolic activity. However, they were
found to be non-genotoxic in most bacterial assays (NAS, 2008).
Gene mutations have been observed in mammalian cells cultured with
beryllium chloride in a limited number of studies (EPA, 1998; ATSDR,
2002; Gordon and Bowser, 2003). Culturing mammalian cells with
beryllium chloride, beryllium sulfate, or beryllium nitrate has
resulted in clastogenic alterations. However, most studies have found
that beryllium chloride, beryllium nitrate, beryllium sulfate, and
beryllium oxide did not induce gene mutations in bacterial assays with
or without metabolic activation. In the case of beryllium sulfate, all
mutagenicity studies (Ames (Simmon, 1979; Dunkel et al., 1984;
Arlauskas et al., 1985; Ashby et al., 1990); E. coli pol A (Rosenkranz
and Poirer, 1979); E. coli WP2 uvr A (Dunkel et al., 1984) and
Saccharomyces cerevisiae (Simmon, 1979)) were negative with the
exception of results reported for Bacillus subtilis rec assay (Kada et
al., 1980; Kanematsu et al., 1980; EPA, 1998). Beryllium sulfate did
not induce unscheduled
[[Page 47608]]
DNA synthesis in primary rat hepatocytes and was not mutagenic when
injected intraperitoneally in adult mice in a host-mediated assay using
Salmonella typhimurium (Williams et al., 1982).
Beryllium nitrate was negative in the Ames assay (Tso and Fung,
1981; Kuroda et al., 1991) but positive in a Bacillus subtilis rec
assay (Kuroda et al., 1991). Beryllium chloride was negative in a
variety of studies (Ames (Ogawa et al., 1987; Kuroda et al., 1991); E.
coli WP2 uvr A (Rossman and Molina, 1984); and Bacillus subtilis rec
assay (Nishioka, 1975)). In addition, beryllium chloride failed to
induce SOS DNA repair in E. coli (Rossman et al., 1984). However,
positive results were reported for Bacillus subtilis rec assay using
spores (Kuroda et al., 1991), E. coli KMBL 3835; lacI gene (Zakour and
Glickman, 1984), and hprt locus in Chinese hamster lung V79 cells
(Miyaki et al., 1979). Beryllium oxide was negative in the Ames assay
and Bacillus subtilis rec assays (Kuroda et al., 1991; EPA, 1998).
Gene mutations have been observed in mammalian cells (V79 and CHO)
cultured with beryllium chloride (Miyaki et al., 1979; Hsie et al.,
1979a, b), and culturing of mammalian cells with beryllium chloride
(Vegni-Talluri and Guiggiani, 1967), and beryllium sulfate (Brooks et
al., 1989; Larramendy et al., 1981) has resulted in clastogenic
alterations--producing breakage or disrupting chromosomes (EPA, 1998).
Beryllium chloride evaluated in a mouse model indicated increased DNA
strand breaks and the formation of micronuclei in bone marrow (Attia et
al., 2013).
Data on the in vivo genotoxicity of beryllium are limited to a
single study that found beryllium sulfate (1.4 and 2.3 g/kg, 50 percent
and 80 percent of median lethal dose) administered by gavage did not
induce micronuclei in the bone marrow of CBA mice. However, a marked
depression of erythropoiesis (red blood cell production) was suggestive
of bone marrow toxicity which was evident 24 hours after dosing. No
mutations were seen in p53 or c-raf-1 and only weak mutations were
detected in K-ras in lung carcinomas from F344/N rats given a single
nose-only exposure to beryllium metal (Nickell-Brady et al., 1994). The
authors concluded that the mechanisms for the development of lung
carcinomas from inhaled beryllium in the rat do not involve gene
dysfunctions commonly associated with human non-small-cell lung cancer
(EPA, 1998).
2. Human Epidemiological Studies
This section reviews in greater detail the studies used to support
the mechanistic findings for beryllium-induced cancer. Table A.3 in the
Appendix summarizes the important features and characteristics of each
study.
a. Beryllium Case Registry (BCR).
Two studies evaluated participants in the BCR (Infante et al.,
1980; Steenland and Ward, 1991). Infante et al. (1980) evaluated the
mortality patterns of white male participants in the BCR diagnosed with
non-neoplastic respiratory symptoms of beryllium disease. Of the 421
cases evaluated, 7 of the participants had died of lung cancer. Six of
the deaths occurred more than 15 years after initial beryllium
exposure. The duration of exposure for 5 of the 7 participants with
lung cancer was less than 1 year, with the time since initial exposure
ranging from 12 to 29 years. One of the participants was exposed for 4
years with a 26-year interval since the initial exposure. Exposure
duration for one participant diagnosed with pulmonary fibrosis could
not be determined; however, it had been 32 years since the initial
exposure. Based on BCR records, the participants were classified as
being in the acute respiratory group (i.e., those diagnosed with acute
respiratory illness at the time of entry in the registry) or the
chronic respiratory group (i.e., those diagnosed with pulmonary
fibrosis or some other chronic lung condition at the time of entry into
the BCR). The 7 participants with lung cancer were in the BCR because
of diagnoses of acute respiratory illness. For only one of those
individuals was initial beryllium exposure less than 15 years prior.
Only 1 of the 6 (with greater than 15 years since initial exposure to
beryllium) had been diagnosed with chronic respiratory disease. The
study did not report exposure concentrations or smoking habits. The
authors concluded that the results of this cohort agreed with previous
animal studies and with epidemiological studies demonstrating an
increased risk of lung cancer in workers exposed to beryllium.
Steenland and Ward (1991) extended the work of Infante et al.
(1980) to include females and to include 13 additional years of follow-
up. At the time of entry in the BCR, 93 percent of the women in the
study, but only 50 percent of the men, had been diagnosed with CBD. In
addition, 61 percent of the women had worked in the fluorescent tube
industry and 50 percent of the men had worked in the basic
manufacturing industry. A total of 22 males and 6 females died of lung
cancer. Of the 28 total deaths from lung cancer, 17 had been exposed to
beryllium for less than 4 years and 11 had been exposed for greater
than 4 years. The study did not report exposure concentrations. Survey
data collected in 1965 provided information on smoking habits for 223
cohort members (32 percent), on the basis of which the authors
suggested that the rate of smoking among workers in the cohort may have
been lower than U.S. rates. The authors concluded that there was
evidence of increased risk of lung cancer in workers exposed to
beryllium and diagnosed with beryllium disease.
b. Beryllium Manufacturing and/or Processing Plants (Extraction,
Fabrication, and Processing)
Several epidemiological cohort studies have reported excess lung
cancer mortality among workers employed in U.S. beryllium production
and processing plants during the 1930s to 1960s. The largest and most
comprehensive study investigated the mortality experience of 9,225
workers employed in seven different beryllium processing plants over a
30-year period (Ward et al., 1992). The workers at the two oldest
facilities (i.e., Lorain, OH, and Reading, PA) were found to have
significant excess lung cancer mortality relative to the U.S.
population. Of the seven plants in the study, these two plants were
believed to have the highest exposure levels to beryllium. A different
analysis of the lung cancer mortality in this cohort using various
local reference populations and alternate adjustments for smoking
generally found smaller, non-significant rates of excess mortality
among the beryllium employees (Levy et al., 2002). Both cohort studies
are limited by a lack of job history and air monitoring data that would
allow investigation of mortality trends with beryllium exposure. The
majority of employees at the Lorain, OH, and Reading, PA, facilities
were employed for a relatively short period of less than one year.
Bayliss et al. (1971) performed a nested cohort study of more than
7,000 former workers from the beryllium processing industry employed
from 1942-1967. Information for the workers was collected from the
personnel files of participating companies. Of the more than 7,000
employees, a cause of death was known for 753 male workers. The number
of observed lung cancer deaths was 36 compared to 34.06 expected for a
standardized mortality ratio (SMR) of 1.06. When evaluated by the
number of years of employment, 24 of the 36 men were employed for less
than 1 year in
[[Page 47609]]
the industry (SMR = 1.24), 8 were employed for 1 to 5 years (SMR 1.40),
and 4 were employed for more than 5 years (SMR = 0.54). Half of the
workers who died from lung cancer began employment in the beryllium
production industry prior to 1947. When grouped by job classification,
over two thirds of the workers with lung cancer were in production-
related jobs while the rest were classified as office workers. The
authors concluded that while the lung cancer mortality rates were the
highest of all other mortality rates, the SMR for lung cancer was still
within range of the expected based on death rates in the United States.
The limitations of this study included the lack of information
regarding exposure concentrations, smoking habits, and the age and race
of the participants.
Mancuso (1970, 1979, 1980) and Mancuso and El-Attar (1969)
performed a series of occupational cohort studies on a group of over
3,685 workers (primarily white males) employed in the beryllium
manufacturing industry during 1937-1948.\3\ The beryllium production
facilities were located in Ohio and Pennsylvania and the records for
the employees, including periods of employment, were obtained from the
Social Security Administration. These studies did not include analyses
of mortality by job title or exposure category. In addition, there were
no exposure concentrations estimated or adjustments for smoking. The
estimated duration of employment ranged from less than 1 year to
greater than 5 years. In the most recent study (Mancuso, 1980),
employees from the viscose rayon industry served as a comparison
population. There was a significant excess of lung cancer deaths based
on the total number of 80 observed lung cancer mortalities at the end
of 1976 compared to an expected number of 57.06 based on the comparison
population resulting in an SMR of 1.40 (p < 0.01) (Mancuso, 1980).
There was a statistically significant excess in lung cancer deaths for
the shortest duration of employment (< 12 months, p < 0.05) and the
longest duration of employment (> 49 months, p < 0.01). Based on the
results of this study, the author concluded that the ability of
beryllium to induce cancer in workers does not require continuous
exposure and that it is reasonable to assume that the amount of
exposure required to produce lung cancer can occur within a few months
of exposure regardless of the length of employment.
---------------------------------------------------------------------------
\3\ The third study (Mancuso et al., 1979) restricted the cohort
to workers employed between 1942 and 1948.
---------------------------------------------------------------------------
Wagoner et al. (1980) expanded the work of Mancuso (1970; 1979;
1980) using a cohort of 3,055 white males from the beryllium
extraction, processing, and fabrication facility located in Reading,
Pennsylvania. The men included in the study worked at the facility
sometime between 1942 and 1968, and were followed through 1976. The
study accounted for length of employment. Other factors accounted for
included age, smoking history, and regional lung cancer mortality.
Forty-seven members of the cohort died of lung cancer compared to an
expected 34.29 based on U.S. white male lung cancer mortality rates (p
< .05). The results of this cohort showed an excess risk of lung cancer
in beryllium-exposed workers at each duration of employment (< 5 years
and >= 5 years), with a statistically significant excess noted at < 5
years durations of employment and a >= 25-year interval since the
beginning of employment (p < 0.05). The study was criticized by several
epidemiologists (MacMahon, 1978, 1979; Roth, 1983), by a CDC Review
Committee appointed to evaluate the study, and by one of the study's
coauthors (Bayliss, 1980) for inadequate discussion of possible
alternative explanations of excess lung cancer in the cohort. The
specific issues identified include the use of 1965-1967 U.S. white male
lung cancer mortality rates to generate expected numbers of lung
cancers in the period 1968-1975 and inadequate adjustment for smoking.
Ward et al. (1992) performed a retrospective mortality cohort study
of 9,225 male workers employed at seven beryllium processing
facilities, including the Ohio and Pennsylvania facilities studied by
Mancuso and El-Attar (1969), Mancuso (1970; 1979; 1980), and Wagoner et
al. (1980). The men were employed for no less than 2 days between
January 1940 and December 1988. At the end of the study 61.1 percent of
the cohort was known to be living and 35.1 percent was known to be
deceased. The duration of employment ranged from 1 year or less to
greater than 10 years with the largest percentage of the cohort (49.7
percent) employed for less than one year, followed by 1 to 5 years of
employment (23.4 percent), greater than 10 years (19.1 percent), and 5
to 10 years (7.9 percent). Of the 3,240 deaths, 280 observed deaths
were caused by lung cancer compared to 221.5 expected deaths, yielding
a statistically significant SMR of 1.26 (p < 0.01). Information on the
smoking habits of 15.9 percent of the cohort members, obtained from a
1968 Public Health Service survey conducted at four of the plants, was
used to calculate a smoking-adjusted SMR of 1.12, which was not
statistically significant. The number of deaths from lung cancer was
also examined by decade of hire. The authors reported a relationship
between earlier decades of hire and increased lung cancer risk.
The EPA Integrated Risk Information System (IRIS), IARC, and
California EPA Office of Environmental Health Hazard Assessment (OEHHA)
have all based their cancer assessment on the Ward et al. 1992 study,
with supporting data concerning exposure concentrations from Eisenbud
and Lisson (1983) and NIOSH (1972), who estimated that the lower-bound
estimate of the median exposure concentration exceeded 100 [micro]g/
m\3\ and found that concentrations in excess of 1,000 [micro]g/m\3\
were common. The IRIS cancer risk assessment recalculated expected lung
cancers based on U.S. white male lung cancer rates (including the
period 1968-1975) and used an alternative adjustment for smoking. In
addition, one individual with lung cancer, who had not worked at the
plant, was removed from the cohort. After these adjustments were made,
an elevated rate of lung cancer was still observed in the overall
cohort (46 cases vs. 41.9 expected cases). However, based on duration
of employment or interval since beginning of employment, neither the
total cohort nor any of the subgroups had a statistically significant
excess in lung cancer (EPA, 1987). Based on their evaluation of this
and other epidemiological studies, the EPA characterized the human
carcinogenicity data then available as ``limited'' but ``suggestive of
a causal relationship between beryllium exposure and an increased risk
of lung cancer'' (IRIS database). This report includes quantitative
estimates of risk that were derived using the information presented in
Wagoner et al. (1980), the expected lung cancers recalculated by the
EPA, and bounds on presumed exposure levels.
Levy et al. (2002) questioned the results of Ward et al. (1992) and
performed a reanalysis of the Ward et al. data. The Levy et al.
reanalysis differed from the Ward et al. analysis in the following
significant ways. First, Levy et al. (2002) examined two alternative
adjustments for smoking, which were based on (1) a different analysis
of the American Cancer Society (ACS) data used by Ward et al. (1992)
for their smoking adjustment, or (2) results from a smoking/lung cancer
study of veterans (Levy and Marimont, 1998). Second, Levy et al. (2002)
also examined the
[[Page 47610]]
impact of computing different reference rates derived from information
about the lung cancer rates in the cities in which most of the workers
at two of the plants lived. Finally, Levy et al. (2002) considered a
meta-analytical approach to combining the results across beryllium
facilities. For all of the alternatives Levy et al. (2002) considered,
except the meta-analysis, the facility-specific and combined SMRs
derived were lower than those reported by Ward et al. (1992). Only the
SMR for the Lorain, OH, facility remained statistically significantly
elevated in some reanalyses. The SMR obtained when combining over the
plants was not statistically significant in eight of the nine
approaches they examined, leading Levy et al. (2002) to conclude that
there was little evidence of statistically significant elevated SMRs in
those plants.
One occupational nested case-control study evaluated lung cancer
mortality in a cohort of 3,569 male workers employed at a beryllium
alloy production plant in Reading, PA, from 1940 to 1969 and followed
through 1992 (Sanderson et al., 2001). There were a total of 142 known
lung cancer cases and 710 controls. For each lung cancer death, 5 age-
and race-matched controls were selected by incidence density sampling.
Confounding effects of smoking were evaluated. Job history and
historical air measurements at the plant were used to estimate job-
specific beryllium exposures from the 1930s to 1990s. Calendar-time-
specific beryllium exposure estimates were made for every job and used
to estimate workers' cumulative, average, and maximum exposure. Because
of the long period of time required for the onset of lung cancer, an
``exposure lag'' was employed to discount recent exposures less likely
to contribute to the disease.
The cumulative, average, and maximum beryllium exposure
concentration estimates for the 142 known lung cancer cases were 46.06
9.3[micro]g/m\3\-days, 22.8 3.4 [micro]g/
m\3\, and 32.4 13.8 [micro]g/m\3\, respectively. The lung
cancer mortality rate was 1.22 (95 percent CI = 1.03 - 1.43). Exposure
estimates were lagged by 10 and 20 years in order to account for
exposures that did not contribute to lung cancer because they occurred
after the induction of cancer. In the 10- and 20-year lagged exposures
the geometric mean tenures and cumulative exposures of the lung cancer
mortality cases were higher than the controls. In addition, the
geometric mean and maximum exposures of the workers were significantly
higher than controls when the exposure estimates were lagged 10 and 20
years (p < 0.01).
Results of a conditional logistic regression analysis indicated
that there was an increased risk of lung cancer in workers with higher
exposures when dose estimates were lagged by 10 and 20 years. There was
also a lack of evidence that confounding factors such as smoking
affected the results of the regression analysis. The authors noted that
there was considerable uncertainty in the estimation of exposure in the
1940's and 1950's and the shape of the dose-response curve for lung
cancer. Another analysis of the study data using a different
statistical method did not find a significantly greater relative risk
of lung cancer with increasing beryllium exposures (Levy et al., 2007).
The average beryllium air levels for the lung cancer cases were
estimated to be an order of magnitude above the current 8-hour OSHA TWA
PEL (2 [mu]g/m\3\) and roughly two orders of magnitude higher than the
typical air levels in workplaces where beryllium sensitization and
pathological evidence of CBD have been observed. IARC evaluated this
reanalysis in 2012 and found the study introduced a downward bias into
risk estimates (IARC, 2012).
Schubauer-Berigan et al. reanalyzed data from the nested case-
control study of 142 lung cancer cases in the Reading, PA, beryllium
processing plant (Schubauer-Berigan et al., 2008). This dataset was
reanalyzed using conditional (stratified by case age) logistic
regression. Independent adjustments were made for potential confounders
of birth year and hire age. Average and cumulative exposures were
analyzed using the values reported in the original study. The objective
of the reanalysis was to correct for the known differences in smoking
rates by birth year. In addition, the authors evaluated the effects of
age at hire to determine differences observed by Sanderson et al. in
2001. The effect of birth cohort adjustment on lung cancer rates in
beryllium-exposed workers was evaluated by adjusting in a multivariable
model for indicator variables for the birth cohort quartiles.
Unadjusted analyses showed little evidence of lung cancer risk
associated with beryllium occupational exposure using cumulative
exposure until a 20-year lag was used. Adjusting for either birth
cohort or hire age attenuated the risk for lung cancer associated with
cumulative exposure. Using a 10- or 20-year lag in workers born after
1900 also showed little evidence of lung cancer risk, while those born
prior to 1900 did show a slight elevation in risk. Unlagged and lagged
analysis for average exposure showed an increase in lung cancer risk
associated with occupational exposure to beryllium. The finding was
consistent for either workers adjusted or unadjusted for birth cohort
or hire age. Using a 10-year lag for average exposure showed a
significant effect by birth cohort.
The authors stated that the reanalysis indicated that differences
in the hire ages among cases and controls, first noted by Deubner et
al. (2001) and Levy et al. (2007), were primarily due to the fact that
birth years were earlier among controls than among cases, resulting
from much lower baseline risk of lung cancer for men born prior to 1900
(Schubauer-Berigan et al., 2008). The authors went on to state that the
reanalysis of the previous NIOSH case-control study suggested the
relationship observed previously between cumulative beryllium exposure
and lung cancer was greatly attenuated by birth cohort adjustment.
Hollins et al. (2009) re-examined the weight of evidence of
beryllium as a lung carcinogen in a recent publication (Hollins et al.,
2009). Citing more than 50 relevant papers, the authors noted the
methodological shortcomings examined above, including lack of well-
characterized historical occupational exposures and inadequacy of the
availability of smoking history for workers. They concluded that the
increase in potential risk of lung cancer was observed among those
exposed to very high levels of beryllium and that beryllium's
carcinogenic potential in humans at these very high exposure levels
were not relevant to today's industrial settings. IARC performed a
similar re-evaluation in 2009 (IARC, 2012) and found that the weight of
evidence for beryllium lung carcinogenicity, including the animal
studies described below, still warranted a Group I classification, and
that beryllium should be considered carcinogenic to humans.
Schubauer-Berigan et al. (2010) extended their analysis from a
previous study estimating associations between mortality risk and
beryllium exposure to include workers at 7 beryllium processing plants.
The study (Schubauer-Berigan et al., 2010) followed the mortality
incidences of 9,199 workers from 1940 through 2005 at the 7 beryllium
plants. JEMs were developed for three plants in the cohort: The Reading
plant, the Hazleton plant, and the Elmore plant. The last is described
in Couch et al. 2010. Including these JEMs substantially improved the
evidence base for evaluating the carcinogenicity of beryllium and, and
this change
[[Page 47611]]
represents more than an update of the beryllium cohort. Standardized
mortality ratios (SMRs) were estimated based on US population
comparisons for lung, nervous system and urinary tract cancers, chronic
obstructive pulmonary disease (COPD), chronic kidney disease, and
categories containing chronic beryllium disease (CBD) and cor
pulmonale. Associations with maximum and cumulative exposure were
calculated for a subset of the workers.
Overall mortality in the cohort compared with the US population was
elevated for lung cancer (SMR 1.17; 95% CI 1.08 to 1.28), COPD (SMR
1.23; 95% CI 1.13 to 1.32), and the categories containing CBD (SMR
7.80; 95% CI 6.26 to 9.60) and cor pulmonale (SMR 1.17; 95% CI 1.08 to
1.26). Mortality rates for most diseases of interest increased with
time-since-hire. For the category including CBD, rates were
substantially elevated compared to the US population across all
exposure groups. Workers whose maximum beryllium exposure was >= 10
[mu]g/m\3\ had higher rates of lung cancer, urinary tract cancer, COPD
and the category containing cor pulmonale than workers with lower
exposure. These studies showed strong associations for cumulative
exposure (when short-term workers were excluded), maximum exposure or
both. Significant positive trends with cumulative exposure were
observed for nervous system cancers (p = 0.0006) and, when short-term
workers were excluded, lung cancer (p = 0.01), urinary tract cancer (p
= 0.003) and COPD (p < 0.0001).
The authors concluded the findings from this reanalysis reaffirmed
that lung cancer and CBD are related to beryllium exposure. The authors
went on to suggest that beryllium exposures may be associated with
nervous system and urinary tract cancers and that cigarette smoking and
other lung carcinogens were unlikely to explain the increased
incidences in these cancers. The study corrected an error that was
discovered in the indirect smoking adjustment initially conducted by
Ward et al., concluding that cigarette smoking rates did not differ
between the cohort and the general U.S. population. No association was
found between cigarette smoking and either cumulative or maximum
beryllium exposure, making it very unlikely that smoking was a
substantial confounder in this study (Schubauer-Berigan et al., 2010).
3. Animal Cancer Studies
This section reviews the animal literature used to support the
findings for beryllium-induced lung cancer. Lung tumors have been
induced via inhalation and intratracheal administration of beryllium to
rats and monkeys, and osteosarcomas have been induced via intravenous
and intramedullary (inside the bone) injection of beryllium in rabbits
and possibly in mice. The chronic oral studies did not report increased
incidences of tumors in rodents, but these were conducted at doses
below the maximum tolerated dose (MTD) (EPA, 1998).
Early animal studies revealed that some beryllium compounds are
carcinogenic when inhaled (ATSDR, 2002). Animal experiments have shown
consistent increases in lung cancers in rats, mice and rabbits
chronically exposed to beryllium and beryllium compounds by inhalation
or intratracheal instillation. In addition to lung cancer,
osteosarcomas have been produced in mice and rabbits exposed to various
beryllium salts by intravenous injection or implantation into the bone
(NTP, 1999).
In an inhalation study assessing the potential tumorigenicity of
beryllium, Schepers et al. (1957) exposed 115 albino Sherman and Wistar
rats (male and female) via inhalation to 0.0357 mg beryllium/m\3\ (1
[gamma] beryllium/ft\3\) \4\ as an aqueous aerosol of beryllium sulfate
for 44 hours/week for 6 months, and observed the rats for 18 months
after exposure. Three to four control rats were killed every two months
for comparison purposes. Seventy-six lung neoplasms, \5\ including
adenomas, squamous-cell carcinomas, acinous adenocarcinomas, papillary
adenocarcinomas, and alveolar-cell adenocarcinomas, were observed in 52
rats exposed to beryllium sulfate aerosol. Adenocarcinomata were the
most numerous. Pulmonary metastases tended to localize in areas with
foam cell clustering and granulomatosis. No neoplasia was observed in
any of the control rats. The incidence of lung tumors in exposed rats
is presented in the following Table 2:
---------------------------------------------------------------------------
\4\ Schepers et al. (1957) reported concentrations in [gamma]
Be/ft\3\; however, [gamma]/ft\3\ is no longer a common unit.
Therefore, the concentration was converted to mg/m\3\.
\5\ While a total of 89 tumors were observed or palpated at the
time of autopsy in the BeSO4-exposed animals, only 76
tumors are listed as histologically neoplastic. Only the new growths
identified in single midcoronal sections of both lungs were
recorded.
Table 2--Neoplasm Analysis
------------------------------------------------------------------------
Neoplasm Number Metastases
------------------------------------------------------------------------
Adenoma.......................................... 18
Squamous carcinoma............................... 5 1
Acinous adenocarcinoma........................... 24 2
Papillary adenocarcinoma......................... 11 1
Alveolar-cell adenocarcinoma..................... 7
Mucigenous tumor................................. 7 1
Endothelioma..................................... 1
Retesarcoma...................................... 3 3
----------------------
Total.......................................... 76 8
------------------------------------------------------------------------
Schepers (1962) reviewed 38 existing beryllium studies that
evaluated seven beryllium compounds and seven mammalian species.
Beryllium sulfate, beryllium fluoride, beryllium phosphate, beryllium
alloy (BeZnMnSiO4), and beryllium oxide were proven to be
carcinogenic and have remarkable pleomorphic neoplasiogenic
proclivities. Ten varieties of tumors were observed, with
adenocarcinoma being the most common variety.
In another study, Vorwald and Reeves (1959) exposed Sherman albino
rats via the inhalation route to aerosols of 0.006 mg beryllium/m\3\ as
beryllium oxide and 0.0547 mg beryllium/m\3\ as beryllium sulfate for 6
hours/day, 5 days/week for an unspecified duration. Lung tumors (single
or multifocal) were observed in the animals sacrificed following 9
months of daily inhalation exposure. The histologic pattern of the
cancer was primarily adenomatous; however, epidermoid and squamous cell
cancers were also observed. Infiltrative, vascular, and lymphogenous
extensions often developed with secondary metastatic growth in the
tracheobronchial lymph nodes, the mediastinal connective tissue, the
parietal pleura, and the diaphragm.
In the first of two articles, Reeves et al. (1967a) investigated
the carcinogenic process in lungs resulting from chronic (up to 72
weeks) beryllium sulfate inhalation. One hundred fifty male and female
Sprague Dawley C.D. strain rats were exposed to beryllium sulfate
aerosol at a mean atmospheric concentration of 34.25 [mu]g beryllium/
m\3\ (with an average particle diameter of 0.12 [micro]m). Prior to
initial exposure and again during the 67-68 and 75-76 weeks of life,
the animals received prophylactic treatments of tetracycline-HCl to
combat recurrent pulmonary infections.
The animals entered the exposure chamber at 6 weeks of age and were
[[Page 47612]]
exposed 7 hours per day/5 days per week for up to 2,400 hours of total
exposure time. An equal number of unexposed controls were held in a
separate chamber. Three male and three female rats were sacrificed
monthly during the 72-week exposure period. Mortality due to
respiratory or other infections did not appear until 55 weeks of age,
and 87 percent of all animals survived until their scheduled
sacrifices.
Average lung weight towards the end of exposure was 4.25 times
normal with progressively increasing differences between control and
exposed animals. The increase in lung weight was accompanied by notable
changes in tissue texture with two distinct pathological processes--
inflammatory and proliferative. The inflammatory response was
characterized by marked accumulation of histiocytic elements forming
clusters of macrophages in the alveolar spaces. The proliferative
response progressed from early epithelial hyperplasia of the alveolar
surfaces, through metaplasia (after 20-22 weeks of exposure), anaplasia
(cellular dedifferentiation) (after 32-40 weeks of exposure), and
finally to lung tumors.
Although the initial proliferative response occurred early in the
exposure period, tumor development required considerable time. Tumors
were first identified after nine months of beryllium sulfate exposure,
with rapidly increasing rates of incidence until tumors were observed
in 100 percent of exposed animals by 13 months. The 9-to-13-month
interval is consistent with earlier studies. The tumors showed a high
degree of local invasiveness. No tumors were observed in control rats.
All 56 tumors studied appeared to be alveolar adenocarcinomas and 3
``fast-growing'' tumors that reached a very large size comparatively
early. About one-third of the tumors showed small foci where the
histologic pattern differed. Most of the early tumor foci appeared to
be alveolar rather than bronchiolar, which is consistent with the
expected pathogenesis, since permanent deposition of beryllium was more
likely on the alveolar epithelium rather than on the bronchiolar
epithelium. Female rats appeared to have an increased susceptibility to
beryllium exposure. Not only did they have a higher mortality (control
males [n = 8], exposed males [n = 9] versus control females [n = 4],
exposed females [n = 17]) and body weight loss than male rats, but the
three ``fast-growing'' tumors only occurred in females.
In the second article, Reeves et al. (1967b) described the rate of
accumulation and clearance of beryllium sulfate aerosol from the same
experiment (Reeves et al., 1967a). At the time of the monthly
sacrifice, beryllium assays were performed on the lungs,
tracheobronchial lymph nodes, and blood of the exposed rats. The
pulmonary beryllium levels of rats showed a rate of accumulation which
decreased during continuing exposure and reached a plateau (defined as
equilibrium between deposition and clearance) of about 13.5 [mu]g
beryllium for males and 9 [mu]g beryllium for females in whole lungs
after approximately 36 weeks. Females were notably less efficient than
males in utilizing the lymphatic route as a method of clearance,
resulting in slower removal of pulmonary beryllium deposits, lower
accumulation of the inhaled material in the tracheobronchial lymph
nodes, and higher morbidity and mortality.
There was no apparent correlation between the extent and severity
of pulmonary pathology and total lung load. However, when the beryllium
content of the excised tumors was compared with that of surrounding
nonmalignant pulmonary tissues, the former showed a notable decrease
(0.50 0.35 [mu]g beryllium/gram versus 1.50
0.55 [mu]g beryllium/gram). This was believed to be largely a result of
the dilution factor operating in the rapidly growing tumor tissue.
However, other factors, such as lack of continued local deposition due
to impaired respiratory function and enhanced clearance due to high
vascularity of the tumor, may also have played a role. The portion of
inhaled beryllium retained in the lungs for a longer duration, which is
in the range of one-half of the original pulmonary load, may have
significance for pulmonary carcinogenesis. This pulmonary beryllium
burden becomes localized in the cell nuclei and may be an important
factor in eliciting the carcinogenic response associated with beryllium
inhalation.
Groth et al. (1980) conducted a series of experiments to assess the
carcinogenic effects of beryllium, beryllium hydroxide, and various
beryllium alloys. For the beryllium metal/alloys experiment, 12 groups
of 3-month-old female Wistar rats (35 rats/group) were used. All rats
in each group received a single intratracheal injection of either 2.5
or 0.5 mg of one of the beryllium metals or beryllium alloys as
described in Table 3 below. These materials were suspended in 0.4 cc of
isotonic saline followed by 0.2 cc of saline. Forty control rats were
injected with 0.6 cc of saline. The geometric mean particle sizes
varied from 1 to 2 [micro]m. Rats were sacrificed and autopsied at
various intervals ranging from 1 to 18 months post-injection.
Table 3--Summary of Beryllium Dose From Groth et al. (1980)
----------------------------------------------------------------------------------------------------------------
Percent other Total No. rats Compound dose
Form of Be Percent Be compounds autopsied (mg) Be dose (mg)
----------------------------------------------------------------------------------------------------------------
Be metal..................... 100............. None........... 16 2.5 2.5
21 0.5 0.5
Passivated Be metal.......... 99.............. 0.26% Chromium. 26 2.5 2.5
20 0.5 0.5
BeAl alloy................... 62.............. 38% Aluminum... 24 2.5 1.55
21 0.5 0.3
BeCu alloy................... 4............... 96% Copper..... 28 2.5 0.1
24 0.5 0.02
BeCuCo alloy................. 2.4............. 0.4% Cobalt.... 33 2.5 0.06
96% Copper..... 30 0.5 0.012
BeNi alloy................... 2.2............. 97.8% Nickel... 28 2.5 0.056
27 0.5 0.011
----------------------------------------------------------------------------------------------------------------
Lung tumors were observed only in rats exposed to beryllium metal,
passivated beryllium metal, and beryllium-aluminum alloy. Passivation
refers to the process of removing iron contamination from the surface
of
[[Page 47613]]
beryllium metal. As discussed, metal alloys may have a different
toxicity than beryllium alone. Rats exposed to 100 percent beryllium
exhibited relatively high mortality rates, especially in the groups
where lung tumors were observed. Nodules varying from 1 to 10 mm in
diameter were also observed in the lungs of rats exposed to beryllium
metal, passivated beryllium metal, and beryllium-aluminum alloy. These
nodules were suspected of being malignant.
To test this hypothesis, transplantation experiments involving the
suspicious nodules were conducted in nine rats. Seven of the nine
suspected tumors grew upon transplantation. All transplanted tumor
types metastasized to the lungs of their hosts. Lung tumors were
observed in rats injected with both the high and low doses of beryllium
metal, passivated beryllium metal, and beryllium-aluminum alloy. No
lung tumors were observed in rats injected with the other compounds.
From a total of 32 lung tumors detected, most were adenocarcinomas and
adenomas; however, two epidermoid carcinomas and at least one poorly
differentiated carcinoma were observed. Bronchiolar alveolar cell
tumors were frequently observed in rats injected with beryllium metal,
passivated beryllium metal, and beryllium-aluminum alloy. All stages of
cuboidal, columnar, and squamous cell metaplasia were observed on the
alveolar walls in the lungs of rats injected with beryllium metal,
passivated beryllium metal, and beryllium-aluminum alloy. These lesions
were generally reduced in size and number or absent from the lungs of
animals injected with the other alloys (BeCu, BeCuCo, BeNi).
The extent of alveolar metaplasia could be correlated with the
incidence of lung cancer. The incidences of lung tumors in the rats
that received 2.5 mg of beryllium metal, and 2.5 and 0.5 mg of
passivated beryllium metal, were significantly different (p <= 0.008)
from controls. When autopsies were performed at the 16-to-19-month
interval, the incidence (2/6) of lung tumors in rats exposed to 2.5 mg
of beryllium-aluminum alloy was statistically significant (p = 0.004)
when compared to the lung tumor incidence (0/84) in rats exposed to
BeCu, BeNi, and BeCuCo alloys, which contained much lower
concentrations of Be (Groth et al., 1980).
Finch et al. (1998b) investigated the carcinogenic effects of
inhaled beryllium on heterozygous TSG-p53 knockout mice
(p53+/-) and wild-type (p53+/+) mice. Knockout mice can be
valuable tools in determining the role of specific genes on the
toxicity of a material of interest, in this case, beryllium. Equal
numbers of approximately 10-week-old male and female mice were used for
this study. Two exposure groups were used to provide dose-response
information on lung carcinogenicity. The maximum initial lung burden
(ILB) target of 60 [mu]g beryllium was based on previous acute
inhalation exposure studies in mice. The lower exposure target level of
15 [mu]g was selected to provide a lung burden significantly less than
the high-level group, but high enough to yield carcinogenic responses.
Mice were exposed in groups to beryllium metal or to filtered air
(controls) via nose-only inhalation. The specific exposure parameters
are presented in Table 4 below. Mice were sacrificed 7 days post
exposure for ILB analysis, and either at 6 months post exposure (n = 4-
5 mice per group per gender) or when 10 percent or less of the original
population remained (19 months post exposure for p53+/-
knockout and 22.5 months post exposure for p53+/+ wild-type mice). The
sacrifice time was extended in the study because a significant number
of lung tumors were not observed at 6 months post exposure.
Table 4--Summary of Animal Data From Finch Et Al., 1998 b
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of mice
Mean exposure Target be lung Mean daily exposure with 1 or more
Mouse strain concentration burden ([mu]g) Number of mice duration (minutes) Mean ILB ([mu]g) lung tumors/total
([mu]g Be/L) number examined
--------------------------------------------------------------------------------------------------------------------------------------------------------
Knockout (p53+/-)............. 34 15 30 112 (single) NA 0/29
36 60 30 139[Dagger] NA 4/28
Wild-type (p53\+/+\) 34 15 6* 112 (single) 12 4 NA
36 60 36[dagger] 139[Dagger] 54 6 0/28
Knockout (p53+/-)............. NA (air) Control 30 60-180 (single) NA 0/30
--------------------------------------------------------------------------------------------------------------------------------------------------------
ILB = initial lung burden; NA = not applicable
Median aerodynamic diameter of Be aerosol = 1.4 [mu]m ([sigma]g = 1.8)
* Wild-type mice in the low exposure group were not evaluated for carcinogenic effects; however ILB was analyzed in six wild-type mice.
[dagger] Thirty wild-type mice were analyzed for carcinogenic effects; six wild-type mice were analyzed for ILB.
[Dagger] Mice were exposed for 2.3 hours/day for three consecutive days.
Lung burdens of beryllium measured in wild-type mice at 7 days post
exposure were approximately 70-90 percent of target levels. No
exposure-related effects on body weight were observed in mice; however,
lung weights and lung-to-body-weight ratios were somewhat elevated in
60 [mu]g target ILB p53+/- knockout mice compared to
controls (0.05 < p < 0.10). In general, p53+/+ wild-type mice survived
longer than p53+/- knockout mice and beryllium exposure
tended to decrease survival time in both groups. The incidence of
beryllium-induced lung tumors was marginally higher in the 60 [mu]g
target ILB p53+/- knockout mice compared to 60 [mu]g target
ILB p53+/+ wild-type mice (p = 0.056). The incidence of lung tumors in
the 60 [mu]g target ILB p53+/- knockout mice was also
significantly higher than controls (p = 0.048). No tumors developed in
the control mice, 15 [mu]g target ILB p53+/- knockout mice,
or 60 [mu]g target ILB p53+/+ wild-type mice throughout the length of
the study. Most lung tumors in beryllium-exposed mice were squamous
cell carcinomas, three of four of which were poorly circumscribed and
all were associated with at least some degree of granulomatous
pneumonia. The study results suggest that having an inactivated p53
allele is associated with lung tumor progression in p53+/-
knockout mice. This is based on the significant difference seen in the
incidence of beryllium-induced lung neoplasms for the
p53+/-knockout mice compared with the p53\+/+\ wild-type
mice. The authors conclude that since there was a relatively late onset
of tumors in the beryllium-exposed p53+/- knockout mice, a
6-month bioassay in this mouse strain might not be an appropriate model
for lung carcinogenesis (Finch et al., 1998b).
[[Page 47614]]
Nickell-Brady et al. (1994) investigated the development of lung
tumors in 12-week-old F344/N rats after a single nose-only inhalation
exposure to beryllium aerosol, and evaluated whether beryllium lung
tumor induction involves alterations in the K-ras, p53, and c-raf-1
genes. Four groups of rats (30 males and 30 females per group) were
exposed to different mass concentrations of beryllium (Group 1: 500 mg/
m\3\ for 8 min; Group 2: 410 mg/m\3\ for 30 min; Group 3: 830 mg/m\3\
for 48 min; Group 4: 980 mg/m\3\ for 39 min). The beryllium mass median
aerodynamic diameter was 1.4 [mu]m ([sigma]g = 1.9). The
mean beryllium lung burdens for each exposure group were 40, 110, 360,
and 430 [mu]g, respectively.
To examine genetic alterations, DNA isolation and sequencing
techniques (PCR amplification and direct DNA sequence analysis) were
performed on wild-type rat lung tissue (i.e., control samples) along
with two mouse lung tumor cell lines containing known K-ras mutations,
12 carcinomas induced by beryllium (i.e., experimental samples), and 12
other formalin-fixed specimens. Tumors appeared in beryllium-exposed
rats by 14 months, and 64 percent of exposed rats developed lung tumors
during their lifetime. Lungs frequently contained multiple tumor sites,
with some of the tumors greater than 1 cm. A total of 24 tumors were
observed. Most of the tumors (n = 22) were adenocarcinomas exhibiting a
papillary pattern characterized by cuboidal or columnar cells, although
a few had a tubular or solid pattern. Fewer than 10 percent of the
tumors were adenosquamous (n = 1) or squamous cell (n = 1) carcinomas.
No transforming mutations of the K-ras gene (codons 12, 13, or 61)
were detected by direct sequence analysis in any of the lung tumors
induced by beryllium. However, using a more sensitive sequencing
technique (PCR enrichment restriction fragment length polymorphism
(RFLP) analysis) resulted in the detection of K-ras codon 12 GGT to GTT
transversions in 2 of 12 beryllium-induced adenocarcinomas. No p53 and
c-raf-1 alterations were observed in any of the tumors induced by
beryllium exposure (i.e., no differences observed between beryllium-
exposed and control rat tissues). The authors note that the results
suggest that activation of the K-ras proto-oncogene is both a rare and
late event, possibly caused by genomic instability during the
progression of beryllium-induced rat pulmonary adenocarcinomas. It is
unlikely that the K-ras gene plays a role in the carcinogenicity of
beryllium. The results also indicate that p53 mutation is unlikely to
play a role in tumor development in rats exposed to beryllium.
Belinsky et al. (1997) reviewed the findings by Nickell-Brady et
al. (1994) to further examine the role of the K-ras and p53 genes in
lung tumors induced in the F344 rat by non-mutagenic (non-genotoxic)
exposures to beryllium. Their findings are discussed along with the
results of other genomic studies that look at carcinogenic agents that
are either similarly non-mutagenic or, in other cases, mutagenic. The
authors conclude that the identification of non-ras transforming genes
in rat lung tumors induced by non-mutagenic exposures, such as
beryllium, as well as mutagenic exposures will help define some of the
mechanisms underlying cancer induction by different types of DNA
damage.
The inactivation of the p16INK4a (p16) gene is a contributing
factor in disrupting control of the normal cell cycle and may be an
important mechanism of action in beryllium-induced lung tumors.
Swafford et al. (1997) investigated the aberrant methylation and
subsequent inactivation of the p16 gene in primary lung tumors induced
in F344/N rats exposed to known carcinogens via inhalation. The
research involved a total of 18 primary lung tumors that developed
after exposing rats to five agents, one of which was beryllium. In this
study, only one of the 18 lung tumors was induced by beryllium
exposure; the majority of the other tumors were induced by radiation
(x-rays or plutonium-239 oxide). The authors hypothesized that if p16
inactivation plays a central role in development of non-small-cell lung
cancer, then the frequency of gene inactivation in primary tumors
should parallel that observed in the corresponding cell lines. To test
the hypothesis, a rat model for lung cancer was used to determine the
frequency and mechanism for inactivation of p16 in matched primary lung
tumors and derived cell lines. The methylation-specific PCR (MSP)
method was used to detect methylation of p16 alleles. The results
showed that the presence of aberrant p16 methylation in cell lines was
strongly correlated with absent or low expression of the gene. The
findings also demonstrated that aberrant p16 CpG island methylation, an
important mechanism in gene silencing leading to the loss of p16
expression, originates in primary tumors.
Building on the rat model for lung cancer and associated findings
from Swafford et al. (1997), Belinsky et al. (2002) conducted
experiments in 12-week-old F344/N rats (male and female) to determine
whether beryllium-induced lung tumors involve inactivation of the p16
gene and estrogen receptor [alpha] (ER) gene. Rats received a single
nose-only inhalation exposure to beryllium aerosol at four different
exposure levels. The mean lung burdens measured in each exposure group
were 40, 110, 360, and 430 [mu]g. The methylation status of the p16 and
ER genes was determined by MSP. A total of 20 tumors detected in
beryllium-exposed rats were available for analysis of gene-specific
promoter methylation. Three tumors were classified as squamous cell
carcinomas and the others were determined to be adenocarcinomas.
Methylated p16 was present in 80 percent (16/20), and methylated ER was
present in one-half (10/20), of the lung tumors induced by exposure to
beryllium. Additionally, both genes were methylated in 40 percent of
the tumors. The authors noted that four tumors from beryllium-exposed
rats appeared to be partially methylated at the p16 locus. Bisulfite
sequencing of exon 1 of the ER gene was conducted on normal lung DNA
and DNA from three methylated, beryllium-induced tumors to determine
the density of methylation within amplified regions of exon 1 (referred
to as CpG sites). Two of the three methylated, beryllium-induced lung
tumors showed extensive methylation, with more than 80 percent of all
CpG sites methylated.
The overall findings of this study suggest that inactivation of the
p16 and ER genes by promoter hypermethylation are likely to contribute
to the development of lung tumors in beryllium-exposed rats. The
results showed a correlation between changes in p16 methylation and
loss of gene transcription. The authors hypothesize that the mechanism
of action for beryllium-induced p16 gene inactivation in lung tumors
may be inflammatory mediators that result in oxidative stress. The
oxidative stress damages DNA directly through free radicals or
indirectly through the formation of 8-hydroxyguanosine DNA adducts,
resulting primarily in a single-strand DNA break.
Wagner et al. (1969) studied the development of pulmonary tumors
after intermittent daily chronic inhalation exposure to beryllium ores
in three groups of male squirrel monkeys. One group was exposed to
bertrandite ore, a second to beryl ore, and the third served as
unexposed controls. Each of these three exposure groups contained 12
monkeys. Monkeys from each group were sacrificed after 6, 12, or 23
months of exposure. The 12-month sacrificed
[[Page 47615]]
monkeys (n = 4 for bertrandite and control groups; n = 2 for beryl
group) were replaced by a separate replacement group to maintain a
total animal population approximating the original numbers and to
provide a source of confirming data for biologic responses that might
arise following the ore exposures. Animals were exposed to bertrandite
and beryl ore concentrations of 15 mg/m\3\, corresponding to 210 [mu]g
beryllium/m\3\ and 620 [mu]g beryllium/m\3\ in each exposure chamber,
respectively. The parent ores were reduced to particles with geometric
mean diameters of 0.27 [mu]m ( 2.4) for bertrandite and
0.64 [mu]m ( 2.5) for beryl. Animals were exposed for
approximately 6 hours/day, 5 days/week. The histological changes in the
lungs of monkeys exposed to bertrandite and beryl ore exhibited a
similar pattern. The changes generally consisted of aggregates of dust-
laden macrophages, lymphocytes, and plasma cells near respiratory
bronchioles and small blood vessels. There were, however, no consistent
or significant pulmonary lesions or tumors observed in monkeys exposed
to either of the beryllium ores. This is in contrast to the findings in
rats exposed to beryl ore and to a lesser extent bertrandite, where
atypical cell proliferation and tumors were frequently observed in the
lungs. The authors hypothesized that the rats' greater susceptibility
may be attributed to the spontaneous lung disease characteristic of
rats, which might have interfered with lung clearance.
As previously described, Conradi et al. (1971) investigated changes
in the lungs of monkeys and dogs two years after intermittent
inhalation exposure to beryllium oxide calcined at 1,400 [deg]C. Five
adult male and female monkeys (Macaca irus) weighing between 3 and 5.75
kg were used in the study. The study included two control monkeys.
Beryllium concentrations in the atmosphere of whole-body exposed
monkeys varied between 3.30 and 4.38 mg/m\3\. Thirty-minute exposures
occurred once a month for three months, with beryllium oxide
concentrations increasing at each exposure interval. Lung tissue was
investigated using electron microscopy and morphometric methods.
Beryllium content in portions of the lungs of five monkeys was measured
two years following exposure by emission spectrography. The reported
concentrations in monkeys (82.5, 143.0, and 112.7 [mu]g beryllium per
100 gm of wet tissue in the upper lobe, lower lobe, and combined lobes,
respectively) were higher than those in dogs. No neoplastic or
granulomatous lesions were observed in the lungs of any exposed animals
and there was no evidence of chronic proliferative lung changes after
two years.
4. In vitro Studies
The exact mechanism by which beryllium induces pulmonary neoplasms
in animals remains unknown (NAS 2008). Keshava et al. (2001) performed
studies to determine the carcinogenic potential of beryllium sulfate in
cultured mammalian cells. Joseph et al. (2001) investigated
differential gene expression to understand the possible mechanisms of
beryllium-induced cell transformation and tumorigenesis. Both
investigations used cell transformation assays to study the cellular/
molecular mechanisms of beryllium carcinogenesis and assess
carcinogenicity. Cell lines were derived from tumors developed in nude
mice injected subcutaneously with non-transformed BALB/c-3T3 cells that
were morphologically transformed in vitro with 50-200 [mu]g beryllium
sulfate/ml for 72 hours. The non-transformed cells were used as
controls.
Keshava et al. (2001) found that beryllium sulfate is capable of
inducing morphological cell transformation in mammalian cells and that
transformed cells are potentially tumorigenic. A dose-dependent
increase (9-41 fold) in transformation frequency was noted. Using
differential polymerase chain reaction (PCR), gene amplification was
investigated in six proto-oncogenes (K-ras, c-myc, c-fos, c-jun, c-sis,
erb-B2) and one tumor suppressor gene (p53). Gene amplification was
found in c-jun and K-ras. None of the other genes tested showed
amplification. Additionally, Western blot analysis showed no change in
gene expression or protein level in any of the genes examined. Genomic
instability in both the non-transformed and transformed cell lines was
evaluated using random amplified polymorphic DNA fingerprinting (RAPD
analysis). Using different primers, 5 of the 10 transformed cell lines
showed genomic instability when compared to the non-transformed BALB/c-
3T3 cells. The results indicate that beryllium sulfate-induced cell
transformation might, in part, involve gene amplification of K-ras and
c-jun and that some transformed cells possess neoplastic potential
resulting from genomic instability.
Using the Atlas mouse 1.2 cDNA expression microarrays, Joseph et
al. (2001) studied the expression profiles of 1,176 genes belonging to
several different functional categories. Compared to the control cells,
expression of 18 genes belonging to two functional groups (nine cancer-
related genes and nine DNA synthesis, repair, and recombination genes)
was found to be consistently and reproducibly different (at least 2-
fold) in the tumor cells. Differential gene expression profile was
confirmed using reverse transcription-PCR with primers specific to the
differentially expressed genes. Two of the differentially expressed
genes (c-fos and c-jun) were used as model genes to demonstrate that
the beryllium-induced transcriptional activation of these genes was
dependent on pathways of protein kinase C and mitogen-activated protein
kinase and independent of reactive oxygen species in the control cells.
These results indicate that beryllium-induced cell transformation and
tumorigenesis are associated with up-regulated expression of the
cancer-related genes (such as c-fos, c-jun, c-myc, and R-ras) and down-
regulated expression of genes involved in DNA synthesis, repair, and
recombination (such as MCM4, MCM5, PMS2, Rad23, and DNA ligase I).
5. Preliminary Lung Cancer Conclusions
OSHA has preliminarily determined that the weight of evidence
indicates that beryllium compounds should be regarded as potential
occupational lung carcinogens. Other scientific organizations,
including the International Agency for Research on Cancer (IARC), the
National Toxicology Program (NTP), the U.S. Environmental Protection
Agency (EPA), the National Institute for Occupational Safety and Health
(NIOSH), and the American Conference of Governmental Industrial
Hygienists (ACGIH) have reached similar conclusions with respect to the
carcinogenicity of beryllium.
While some evidence exists for direct-acting genotoxicity as a
possible mechanism for beryllium carcinogenesis, the weight of evidence
suggests a possible indirect mechanism may be responsible for most
tumorigenic activity of beryllium in animal models and possibly humans
(EPA, 1998). Inflammation has been postulated to be a key contributor
to many different forms of cancer (Jackson et al., 2006; Pikarsky et
al., 2004; Greten et al., 2004; Leek, 2002). In fact, chronic
inflammation may be a primary factor in the development of up to one-
third of all cancers (Ames et al., 1990; NCI, 2010).
In addition to a T-cell mediated response beryllium has been
demonstrated to produce an inflammatory response in animal models
similar to other particles (Reeves et al., 1967; Swafford et al., 1997;
Wagner et al., 1969) possibly
[[Page 47616]]
contributing to its carcinogenic potential. Animal studies, as
summarized above, have demonstrated a consistent scenario of beryllium
exposure resulting in chronic pulmonary inflammation. Studies conducted
in rats have demonstrated that chronic inhalation of materials similar
in solubility to beryllium result in increased pulmonary inflammation,
fibrosis, epithelial hyperplasia, and, in some cases, pulmonary
adenomas and carcinomas (Heinrich et al., 1995; Nikula et al., 1995;
NTP, 1993; Lee et al., 1985; Warheit et al., 1996). This response is
generally referred to as an ``overload'' response or threshold effect.
Substantial data indicate that tumor formation in the rat after
exposure to some sparingly soluble particles at doses causing marked,
chronic inflammation is due to a secondary mechanism unrelated to the
genotoxicity (or lack thereof) of the particle itself.
It has been hypothesized that the recruitment of neutrophils during
the inflammatory response and subsequent release of oxidants from these
cells have been demonstrated to play an important role in the
pathogenesis of rat lung tumors (Borm et al., 2004; Carter and
Driscoll, 2001; Carter et al., 2006; Johnston et al., 2000; Knaapen et
al., 2004; Mossman, 2000). Inflammatory mediators, as characterized in
many of the studies summarized above, have been shown to play a
significant role in the recruitment of cells responsible for the
release of reactive oxygen and hydrogen species. These species have
been determined to be highly mutagenic themselves as well as mitogenic,
inducing a proliferative response (Feriola and Nettesheim, 1994; Jetten
et al., 1990; Moss et al., 1994; Coussens and Werb, 2002). The
resultant effect is an environment rich for neoplastic transformations
and the progression of fibrosis and tumor formation. This finding does
not imply no risk at levels below an inflammatory response; rather, the
overall weight of evidence is suggestive of a mechanism of an indirect
carcinogen at levels where inflammation is seen. While tumorigenesis
secondary to inflammation is one reasonable mode of action, other
plausible modes of action independent of inflammation (e.g.,
epigenetic, mitogenic, reactive oxygen mediated, indirect genotoxicity,
etc.) may also contribute to the lung cancer associated with beryllium
exposure.
Epidemiological studies indicate excess risk of lung cancer
mortality from occupational beryllium exposure levels at or below the
current OSHA PEL (Schubauer-Berigan et al., 2010; Table 4).
F. Other Health Effects
Past studies on other health effects have been thoroughly reviewed
by several scientific organizations (NTP, 1999; EPA, 1998; ATSDR, 2002;
WHO, 2001; HSDB, 2010). These studies include summaries of animal
studies, in vitro studies, and human epidemiological studies associated
with cardiovascular, hematological, hepatic, renal, endocrine,
reproductive, ocular and mucosal, and developmental effects. High-dose
exposures to beryllium have been shown to have an adverse effect upon a
variety of organs and tissues in the body, particularly the liver. The
adverse systemic effects from human exposures mostly occurred prior to
the introduction of occupational and environmental standards set in
1970-1972 (OSHA, 1971; ACGIH, 1971; ANSI, 1970) and 1974 (EPA, 1974)
and therefore are less relevant today than in the past. The available
data is fairly limited. The hepatic, cardiovascular, renal, and ocular
and mucosal effects are briefly summarized below. Health effects in
other organ systems listed above were only observed in animal studies
at very high exposure levels and are, therefore, not discussed here.
1. Hepatic Effects
Beryllium has been shown to accumulate in the liver and a
correlation has been demonstrated between beryllium content and hepatic
damage. Different compounds have been shown to distribute differently
within the hepatic tissues. For example, beryllium phosphate had
accumulated almost exclusively within sinusoidal (Kupffer) cells of the
liver, while the beryllium derived from beryllium sulfate was found
mainly in parenchymal cells. Conversely, beryllium sulphosalicylic acid
complexes were rapidly excreted (Skillteter and Paine, 1979).
According to a few autopsies, beryllium-laden liver had central
necrosis, mild focal necrosis as well as congestion, and occasionally
beryllium granuloma.
Residents near a beryllium plant may have been exposed by inhaling
trace amounts of beryllium powder, and different beryllium compounds
may have induced different toxicant reactions (Yian and Yin, 1982).
2. Cardiovascular Effects
There is very limited evidence of cardiovascular effects of
beryllium and its compounds in humans. Severe cases of chronic
beryllium disease can result in cor pulmonale, which is hypertrophy of
the right heart ventricle. In a case history study of 17 individuals
exposed to beryllium in a plant that manufactured fluorescent lamps,
autopsies revealed right atrial and ventricular hypertrophy (Hardy and
Tabershaw, 1946). It is not likely that these cardiac effects were due
to direct toxicity to the heart, but rather were a response to impaired
lung function. However, an increase in deaths due to heart disease or
ischemic heart disease was found in workers at a beryllium
manufacturing facility (Ward et al., 1992).
Animal studies performed in monkeys indicate heart enlargement
after acute inhalation exposure to 13 mg beryllium/m\3\ as beryllium
hydrogen phosphate, 0.184 mg beryllium/m\3\ as beryllium fluoride, or
0.198 mg beryllium/m\3\ as beryllium sulfate (Schepers 1964). Decreased
arterial oxygen tension was observed in dogs exposed to 30 mg
beryllium/m\3\ as beryllium oxide for 15 days (HSDB, 2010), 3.6 mg
beryllium/m\3\ as beryllium oxide for 40 days (Hall et al., 1950), or
0.04 mg beryllium/m\3\ as beryllium sulfate for 100 days (Stokinger et
al., 1950). These are expected to be indirect effects on the heart due
to pulmonary fibrosis and toxicity which can increase arterial pressure
and restrict blood flow.
3. Renal Effects
Renal calculi (stones) were unusually prevalent in severe cases
that resulted from high levels of beryllium exposure. Renal stones
containing beryllium occurred in about 10 percent of patients affected
by high exposures (Barnett, et al., 1961). Kidney stones were observed
in 10 percent of the CBD cases collected by the BCR up to 1959 (Hall et
al., 1959). In addition, an excess of calcium in the blood and urine
has been seen frequently in patients with chronic beryllium disease
(ATSDR, 2002).
4. Ocular and Mucosal Effects
Both the soluble, sparingly soluble, and insoluble beryllium
compounds have been shown to cause ocular irritation in humans (Van
Orstrand et al., 1945; De Nardi et al., 1953; Nishimura, 1966; Epstein,
1990; NIOSH, 1994). In addition, beryllium compounds (soluble,
sparingly soluble, or insoluble) have been demonstrated to induce acute
conjunctivitis with corneal maculae and diffuse erythema (HSDB, 2010).
The mucosa (mucosal membrane) is the moist lining of certain
tissues/organs including the eyes, nose, mouth, lungs, and the urinary
and digestive tracts. Soluble beryllium salts have been
[[Page 47617]]
shown to be directly irritating to mucous membranes (HSDB, 2010).
G. Summary of Preliminary Conclusions Regarding Health Effects
Through careful analysis of the current best available scientific
information outlined in this Health Effects Section V, OSHA has
preliminarily determined that beryllium and beryllium-containing
compounds are able to cause sensitization, chronic beryllium disease
(CBD) and lung cancer below the current OSHA PEL of 2 [mu]g/m\3\. The
Agency has preliminarily determined through the studies outlined in
section V.A.2 of this health effects section that skin and inhalation
exposure to beryllium can lead to sensitization; and inhalation
exposure, or skin exposure coupled with inhalation, can cause onset and
progression of CBD. In addition, the Agency has preliminarily
determined through studies outlined in section V.E. of this health
effects section that inhalation exposure to beryllium and beryllium
containing materials causes lung cancer.
1. Beryllium Causes Sensitization Below the Current PEL and
Sensitization is a Precursor to CBD
Through the biological and immunological processes outlined in
section V.B. of the Health Effects, the Agency believes that the
scientific evidence supports the following mechanism for the
development of sensitization and CBD.
Inhaled beryllium and beryllium-containing materials able
to be retained and solubilized in the lungs initiate sensitization and
facilitate CBD development (Section V.B.5).
Beryllium compounds that dissolve in biological fluids,
such as sweat, can penetrate intact skin and initiate sensitization
(section V.A.2; V.B). Phagosomal fluid and lung fluid have been
demonstrated to dissolve beryllium compounds in the lung (section
V.A.2a).
Sensitization occurs through a CD4+ T-cell mediated
process with both soluble and insoluble beryllium and beryllium-
containing compounds through direct antigen presentation or through
further antigen processing (section V.D.1) in the skin or lung. T-cell
mediated responses, such as sensitization, are generally regarded as
long-lasting (e.g., not transient or readily reversible) immune
conditions.
Beryllium sensitization and CBD are adverse events along a
pathological continuum in the disease process with sensitization being
the necessary first step in the progression to CBD (section V.D).
[cir] Animal studies have provided supporting evidence for T-cell
proliferation in the development of granulomatous lung lesions after
beryllium exposure (section V.D.2; V.D.6).
[cir] Since the pathogenesis of CBD involves a beryllium-specific,
cell-mediated immune response, CBD cannot occur in the absence of
beryllium sensitization (V.D.1). While no clinical symptoms are
associated with sensitization, a sensitized worker is at risk of
developing CBD upon subsequent inhalation exposure to beryllium.
[cir] Epidemiological evidence that covers a wide variety of
different beryllium compounds and industrial processes demonstrates
that sensitization and CBD are continuing to occur at present-day
exposures below OSHA's PEL (section V.D.4; V.D.5).
OSHA considers CBD to be a progressive illness with a
continuous spectrum of symptoms ranging from its earliest asymptomatic
stage following sensitization through to full-blown CBD and death
(section V.D.7).
Genetic variabilities may enhance risk for developing
sensitization and CBD in some groups (section V.D.3).
In addition, epidemiological studies outlined in section V.D.5 have
demonstrated that efforts to reduce exposures have succeeded in
reducing the frequency of sensitization and CBD.
2. Evidence Indicates Beryllium is a Human Carcinogen
OSHA has conducted an evaluation of the current available
scientific information of the carcinogenic potential of beryllium and
beryllium-containing compounds (section V.E). Based on weight of
evidence and plausible mechanistic information obtained from in vitro
and in vivo animal studies as well as clinical and epidemiological
investigations, the Agency has preliminarily determined that beryllium
and beryllium-containing materials should be regarded as human
carcinogens. This information is in accordance with findings from IARC,
NTP, EPA, NIOSH, and ACGIH (section V.E).
Lung cancer is an irreversible and frequently fatal
disease with an extremely poor 5-year survival rate (NCI, 2009).
Epidemiological cohort studies have reported statistically
significant excess lung cancer mortality among workers employed in U.S.
beryllium production and processing plants during the 1930s to 1970s
(Section V.E.2).
Significant positive associations were found between lung
cancer mortality and both average and cumulative beryllium exposures
when appropriately adjusted for birth cohort and short-term work status
(Section V.E.2).
Studies in which large amounts of different beryllium
compounds were inhaled or instilled in the respiratory tracts of
experimental animals resulted in an increased incidence of lung tumors
(Section V.E.3).
Authoritative scientific organizations, such as the IARC,
NTP, and EPA, have classified beryllium as a known or probable human
carcinogen.
While OSHA has preliminarily determined there is sufficient
evidence of beryllium carcinogenicity, the exact tumorigenic mechanism
for beryllium is unclear and a number of mechanisms are plausibly
involved, including chronic inflammation, genotoxicity, mitogenicity
oxidative stress, and epigenetic changes (section V.E.3).
Studies of beryllium exposed animals have consistently
demonstrated chronic pulmonary inflammation after exposure (section
V.E.3).
[cir] Substantial data indicate that tumor formation in certain
animal models after inhalation exposure to sparingly soluble particles
at doses causing marked, chronic inflammation is due to a secondary
mechanism unrelated to the genotoxicty of the particle (section V.E.5).
A review conducted by the NAS (2008) found that beryllium
and beryllium-containing compounds tested positive for genotoxicity in
nearly 50 percent of studies without exogenous metabolic activity,
suggesting a possible direct-acting mechanism may exist (section V.E.1)
as well as the potential for epigenetic changes (section V.E.4).
Other health effects have been summarized in sections F of the
Health Effects Section and include hepatic, cardiovascular, renal,
ocular, and mucosal effects. The adverse systemic effects from human
exposures mostly occurred prior to the introduction of occupational and
environmental standards set in 1970-1972 (OSHA, 1971; ACGIH, 1971;
ANSI, 1970) and 1974 (EPA, 1974) and therefore are less relevant today
than in the past.
[[Page 47618]]
APPENDIX
Table A.1--Summary of Beryllium Sensitization and Chronic Beryllium Disease Epidemiological Studies
--------------------------------------------------------------------------------------------------------------------------------------------------------
(%) Prevalence Range of Exposure-
Reference Study type ------------------------------------ exposure response Study Additional
Sensitization CBD measurements relationship limitations comments
--------------------------------------------------------------------------------------------------------------------------------------------------------
Studies Conducted Prior to BeLPT
--------------------------------------------------------------------------------------------------------------------------------------------------------
Hardy and Tabershaw, 1946.... Case-series..... N/A............. N/A............. N/A............. N/A............ Selection bias. Small sample
size.
Hardy, 1980.................. Case-series..... N/A............. N/A............. N/A............. N/A............ Selection bias. Small sample
size.
Machle et al., 1948.......... Case-series..... N/A............. N/A............. Semi- Yes............ Selection bias. Small sample
quantitative. size;
unreliable
exposure data.
Eisenbud et al., 1949........ Case-series..... N/A............. N/A............. Average ............... ............... Non-
concentration: occupational;
350-750 ft from ambient air
plant--0.05-0.1 sampling.
5 [mu]g/m\3\;.
<350 ft from
plant--2.1
[mu]g/m\3\.
Lieben and Metzner, 1959..... ................ N/A............. ................ N/A............. ............... No quantitative Family member
exposure data. contact with
contaminated
clothes.
Hardy et al., 1967........... Case Registry N/A............. N/A............. N/A............. N/A............ Incomplete ...............
Review. exposure
concentration
data.
Hasan and Kazemi, 1974....... ................ N/A............. ................ ................ ............... ............... ...............
Eisenbud and Lisson, 1983.... ................ N/A............. 1-10............ ................ ............... ............... ...............
Stoeckle et al., 1969........ Case-series (60 N/A............. ................ ................ No............. Selection bias. Provided
cases). information
regarding
progression
and
identifying
sarcoidosis
from CBD.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Studies Conducted Following the Development of the BeLPT
--------------------------------------------------------------------------------------------------------------------------------------------------------
Beryllium Mining and Extraction
--------------------------------------------------------------------------------------------------------------------------------------------------------
Deubner et al., 2001b........ Cross-sectional 4.0 (3 cases)... 1.3 (1 case).... Mining, milling-- No............. Small sample Personal
(75 workers). range 0.05-0.8 size. sampling.
[mu]g/m\3\;
Annual maximum
0.04-165.7
[mu]g/m\3\.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Beryllium Metal Processing and Alloy Production
--------------------------------------------------------------------------------------------------------------------------------------------------------
Kreiss et al., 1997.......... Cross-sectional 6.9 (43 cases).. 4.6 (29 cases).. Median--1.4 No............. Inconsistent Short-term
study of 627 [mu]g/m\3\. BeLPT results Breathing Zone
workers. between labs. sampling.
Rosenman et al., 2005........ Cross-sectional 14.5 (83 cases). 5.5 (32 cases).. Mean average No............. ............... Daily weighted
study of 577 range--7.1-8.7 average:
workers. [mu]g/m\3\;. High exposures
Mean peak range-- compared to
53-87 [mu]g/ other studies.
m\3\;.
Mean cumulative
range--100-209
[mu]g/m\3\.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Beryllium Machining Operations
--------------------------------------------------------------------------------------------------------------------------------------------------------
Newman et al., 2001.......... Longitudinal 9.4 (22 cases).. 8.5 (20 cases).. ................ No............. ............... Engineering and
study of 235 administrative
workers. controls
primarily used
to control
exposures.
[[Page 47619]]
Kelleher et al., 2001........ Case-control 11.5 11.5 0.08-0.6 [mu]g/ Yes............ ............... Identified 20
study of 20 (machinists). (machinists). m\3\--lifetime workers with
cases and 206 2.9 (non- 2.9 (non- weighted Sensitization
controls. machinists). machinists). exposures. or CBD.
Madl et al., 2007............ Longitudinal ................ ................ Machining....... Yes............ ............... Personal
study of 27 1980-1995 median sampling:
cases. -0.33 [mu]g/ Required
m\3\; 1996-1999 evidence of
median--0.16 granulomas for
[mu]g/m\3\; CBD diagnosis.
2000-2005
median--0.09
[mu]g/m\3\;.
Non-machining
1980-1995
median--0.12
[mu]g/m\3\;
1996-1999
median--0.08
[mu]g/m\3\;
2000-2005
median--0.06
[mu]g/m\3\.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Beryllium Oxide Ceramics
--------------------------------------------------------------------------------------------------------------------------------------------------------
Kreiss et al., 1993b......... Cross-sectional 3.6 (18 cases).. 1.8 (9 cases)... ................ No ...............
survey of 505
workers.
Kreiss et al., 1996.......... Cross-sectional 5.9 (8 cases)... 4.4 (6 cases)... Machining No............. Small study Breathing Zone
survey of 136 median--0.6 population. Sampling.
workers. [mu]g/m\3\;.
Other Areas
median--<0.3
[mu]g/m\3\;.
Henneberger et al., 2001..... Cross-sectional 9.9 (15 cases).. 5.3 (8 cases)... 6.4% samples >2 Yes............ Small study Breathing zone
survey of 151 [mu]g/m\3\; population. sampling.
workers. 2.4% samples >5
[mu]g/m\3\;.
0.3% samples >25
[mu]g/m\3\.
Cummings et al., 2007........ Longitudinal 0.7-5.6 (4 0.1--7.9 (3 Production...... Yes............ Small sample Personal
study of 93 cases). cases). 1994-1999 size. sampling was
workers. median--0.1[mu] effective in
g/m\3\; 2000- reducing rates
2003 median-- of new cases
0.04[mu]g/m\3\;. of
Administrative sensitization.
1994-1999
median <0.2
[mu]g/m\3\;
2000-2003
median--0.02
[mu]g/m\3\.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Copper-Beryllium Alloy Processing and Distribution
--------------------------------------------------------------------------------------------------------------------------------------------------------
Schuler et al., 2005......... Cross-sectional 7.0 (10 cases).. 4.0 (6 cases)... Rod and Wire ............... Small study Personal
survey of 153 Production population. sampling.
workers. median--0.12
[mu]g/m\3\;
Strip Metal
Production
median--0.02
[mu]g/m\3\;.
Production
Support median--
0.02 [mu]g/
m\3\;.
Administration
median--0.02
[mu]g/m\3\.
[[Page 47620]]
Thomas et al., 2009.......... Cross-sectional 3.8 (3 cases)... 1.9 (1 case).... Used exposure ............... Authors noted Instituted PPE
study of 82 profile from workers may to reduce
workers. Schuler study. have been dermal
sensitized exposures.
prior to
available
screening,
underestimatin
g
sensitization
rate in legacy
workers.
Stanton et al., 2006......... Cross-sectional 1.1 (1 case).... 1.1 (1 case).... Bulk Products ............... Study did not Personal
study of 88 Production report use of sampling.
workers. median 0.04 PPE or
[mu]g/m\3\; respirators.
Strip Metal
Production
median--0.03
[mu]g/m\3\;
Production
support.
median--0.01
[mu]g/m\3\;
Administration
median 0.01
[mu]g/m\3\.
Bailey et al., 2010.......... Cross-sectional 11.0............ 14.5 total...... ................ ............... Study reported ...............
study of 660 prevalence
total workers rates for pre
(258 partial enhanced
program, 290 control-
full program). program,
partial
enhanced
control
program, and
full enhanced
control
program.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Nuclear Weapons Production Facilities and Cleanup of Former Facilities
--------------------------------------------------------------------------------------------------------------------------------------------------------
Kreiss et al., 1989.......... Cross-sectional 11.8 (6 cases).. 7.8 (4 cases)... ................ No............. Small study ...............
survey of 51 population
workers.
Kreiss et al., 1993a......... Cross-sectional 1.9 (18 cases).. 1.7 (15 cases).. ................ No............. Study ...............
survey of 895 population
workers. includes some
workers with
no reported Be
exposure.
Stange et al., 1996.......... Longitudinal 2.4 (76 cases).. 0.7 (29 cases).. Annual mean No............. ............... Personal
Study of 4,397 concentration. sampling.
BHSP 1970-1988 0.016
participants. [mu]g/m\3\;
1984-1987 1.04
[mu]g/m\3\.
Stange et al., 2001.......... Longitudinal 4.5 (154 cases). 1.6 (81 cases).. No quantitative No............. ............... Personal
study of 5,173 information sampling.
workers. presented in
study.
Viet et al., 2000............ Case-control.... 74 workers 50 workers CBD.. Mean exposure Yes............ Likely Fixed airhead
sensitized. range: 0.083- underestimated sampling away
0.622 [mu]g/ exposures. from breathing
m\3\. zone:
Maximum Matched
exposures: 0.54- controls for
36.8 [mu]g/ age, sex,
m.\3\. smoking.
--------------------------------------------------------------------------------------------------------------------------------------------------------
N/A = Information not available from study reports.
[[Page 47621]]
Table A.2--Summary of Mechanistic Animal Studies for Sensitization and CBD
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dose or exposure Type of Other
Reference Species Study length concentration beryllium Study results information
--------------------------------------------------------------------------------------------------------------------------------------------------------
Intratracheal (intrabroncheal) or Nasal Instillation
--------------------------------------------------------------------------------------------------------------------------------------------------------
Barna et al., 1981............ Guinea pig....... 3 month 10 mg-5[mu]m beryllium oxide. Granulomas,
particle size. interstitial
infiltrate with
fibrosis with
thickening of
alveolar septae.
Barna et al., 1984............ Guinea pig....... 3 month 5 mg............. beryllium oxide. Granulomatous
lesions in
strain 2 but
not strain 13
indicating a
genetic
component.
Benson et al., 2000........... Mouse............ ............................ 0, 12.5, 25, beryllium copper Acute pulmonary
100[mu]g; 0, 2, alloy; toxicity
8 [mu]g. beryllium metal. associated with
beryllium/
copper alloy
but not
beryllium metal.
Haley et al., 1994............ Cynomolgus monkey 14, 60, 90 days 0, 1, 50, 150 Beryllium metal, Beryllium oxide
[mu]g. beryllium oxide. particles were
0, 2.5, 12.5, less toxic than
37.5 [mu]g. the beryllium
metal.
Huang et al., 1992............ Mouse............ ............................ 5 [mu]g.......... Beryllium Granulomas ................
1-5 [mu]g........ sulfate produced in A/J
immunization; strain but not
beryllium metal BALB/c or C57BL/
challenge. 6.
Votto et al., 1987............ Rat.............. 3 month 2.4 mg........... Beryllium Granulomas,
8 mg/ml.......... sulfate however, no
immunization; correlation
beryllium between T-cell
sulfate subsets in lung
challenge. and BAL fluid.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Inhalation--Single Exposure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Haley et al., 1989a........... Beagle dog....... Chronic--one dose 0, 6 [mu]g/kg, 18 500 [deg]C; 1000 Positive BeLPT Granulomas
[mu]g/kg. [deg]C results--develo resolved with
beryllium oxide. ped granulomas; time, no full-
low-calcined blown CBD.
beryllium oxide
more toxic than
high-calcined.
Haley et al., 1989b........... Beagle dog....... Chronic--one dose/2 year 0, 17 [mu]g/kg, 500 [deg]C; 1000 Granulomas, Granulomas
recovery 50 [mu]g/kg. [deg]C sensitization, resolved over
beryllium oxide. low-fired more time.
toxic than high
fired.
Robinson et al., 1968......... Dog.............. Chronic 0. 115mg/m\3\.... Beryllium oxide, Foreign body
beryllium reaction in
fluoride, lung.
beryllium
chloride.
Sendelbach et al., 1989....... Rat.............. 2 week 0, 4.05 [mu]g/L.. Beryllium as Interstial
beryllium pneumonitis.
sulfate.
Sendelbach and Witschi, 1987.. Rat.............. 2 week 0, 3.3, 7 [mu]g/L Beryllium as Enzyme changes
beryllium in BAL fluid.
sulfate.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Inhalation--Repeat Exposure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Conradi et al., 1971.......... Beagle dog....... Chronic--2 year 0. 3300 [mu]g/ 1400 [deg]C No changes May have been
m\3\, 4380 [mu]g/ beryllium oxide. detected. due to short
m\3\ once/month exposure time
for 3 months. followed by
long recovery.
[[Page 47622]]
Macaca irus Chronic--2 year 0. 3300 [mu]g/ 1400 [deg]C No changes May have been
Monkey. m\3\, 4380 [mu]g/ beryllium oxide. detected. due to short
m\3\ once/month exposure time
for 3 months. followed by
long recovery.
Haley et al., 1992............ Beagle dog....... Chronic--repeat dose (2.5 17, 50 [mu]g/kg.. 500 [deg]C; 1000 Granulomatous
year intervals) [deg]C pneumonitis.
beryllium oxide.
Harmsen et al., 1985.......... Beagle dog....... Chronic 0, 20 [mu]g/kg, 500[deg]C; 1000
5 dogs per group. 50 [mu]g/kg. [deg]C
beryllium oxide.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dermal or Intradermal
--------------------------------------------------------------------------------------------------------------------------------------------------------
Kang et al., 1977............. Rabbit........... ............................ 10mg............. Beryllium Skin
sulfate. sensitization
and skin
granulomas.
Tinkle et al., 2003........... Mouse............ 3 month 25 [mu]L......... Beryllium Microgranulomas
70 [mu]g......... sulfate. with some
Beryllium oxide. resolution over
time of study.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Intramuscular
--------------------------------------------------------------------------------------------------------------------------------------------------------
Eskenasy, 1979................ Rabbit........... 35 days (injections at 7 day 10mg.ml.......... Beryllium Sensitization,
intervals) sulfate. evidence of CBD.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Intraperitoneal Injection
--------------------------------------------------------------------------------------------------------------------------------------------------------
Marx and Burrell, 1973........ Guinea pig....... 24 weeks (biweekly 2.6 mg + 10 [mu]g Beryllium Sensitization...
injections) dermal sulfate.
injections.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Table A-3--Summary of Beryllium Lung Cancer Epidemiological Studies
--------------------------------------------------------------------------------------------------------------------------------------------------------
Confounding Study Additional
Reference Study type Exposure range Study number Mortality ratio factors limitations comments
--------------------------------------------------------------------------------------------------------------------------------------------------------
Beryllium Case Registry
--------------------------------------------------------------------------------------------------------------------------------------------------------
Infante et al., 1980......... Cohort.......... N/D............. 421 cases from SMR 2.12........ Not reported... Exposure ...............
the BCR. 7 lung cancer concentration
deaths. data or
smoking habits
not reported.
Steenland and Ward, 1991..... Cohort.......... N/D............. 689 cases from SMR 2.00 (95% CI ............... ............... Included women:
the BCR. 1.33-2.89). 93% women
28 lung cancer diagnosed with
deaths. CBD; 50% men
diagnosed with
CBD;
SMR 157 for
those with CBD
and SMR 232
for those with
ABD.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Beryllium Manufacturing and/or Processing Plants (Extraction, Fabrication, and Processing)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Ward et al., 1992............ Retrospective N/D............. 9,225 males..... SMR 1.26........ ............... Lack of job Employment
Mortality (95% CI 1.12- history and period 1940-
Cohort. 1.42). air monitoring 1969.
280 lung cancer data.
deaths.
[[Page 47623]]
Levy et al., 2002............ Cohort.......... N/D............. 9225 males...... Statistically Adjusted for Lack of job Majority of
non-significant smoking. history and workers
elevation in air monitoring studied
lung cancer data. employed for
deaths. less than one
year
Bayliss et al., 1971......... Nested cohort... ................ 8,000 workers... SMR 1.06........ ............... ............... Employed prior
36 lung cancer to 1947 for
deaths. almost half
lung cancer
deaths.
Mancuso, 1970................ Cohort.......... 411-43,300 [mu]g/ 1,222 workers at SMR 1.42........ Only partial Partial smoking Employment
m\3\ annual OH plant; 2,044 (95% CI 1.1-1.8) smoking history; No period from
exposure workers at PA 80 lung cancer history. job analysis 1937-1948.
(reported from plant. deaths. by title or
Zielinsky, exposure
1961). category.
Mancuso, 1980................ Cohort.......... N/D............. Same OH and PA SMR 1.40........ No smoking No adjustment Employment
plant analysis. adjustment. by job title period from
or exposure. 1942-1948;
Used workers
at rayon plant
for
comparison.
Mancuso and El Attar, 1969... Cohort.......... N/D............. 3,685 white SMR 1.49........ Adjusted for No job exposure Employment
males. age and local. data or history from
smoking 1937-1944.
adjustment.
Wagner et al., 1980.......... Cohort.......... N/D............. 3,055 white SMR 1.25........ ............... Inadequately Reanalysis
males PA plant. (95% CI 0.9-1.7) adjusted for using PA lung-
47 lung cancer smoking; Used cancer rate
deaths. national lung- revealed 19%
cancer risk underestimatio
for cancer not n of beryllium
PA. lung cancer
deaths.
Sanderson et al., 2001....... Nested case- -- Average 3,569 males PA SMR 1.22........ Smoking was May not have Found
control. exposure plant. (95% CI 1.03- found not to adjusted association
22.8[mu]g/m\3\. 1.43). be a properly for with 20 year
-- Maximum 142 lung cancer confounding birth-year or latency.
exposure deaths. factor. age at hire.
32.4[mu]g/m\3\.
Levy et al., 2007............ Nested case- Used log Reanalysis of SMR 1.04........ Different ............... Found no
control. transformed Sanderson et (95% CI 0.92- methodology association
exposure data. al., 2001. 1.17). for smoking between
adjustment. beryllium
exposure and
increased risk
of lung
cancer.
Schubauer-Berigan et al., Nested case- Used exposure Reanalysis of Used Odds ratio: Adjusted for ............... -- Controlled
2008. control. data from Sanderson et 1.91 (95% CI smoking, birth for birth-year
Sanderson et al., 2001. 1.06-3.44) cohort, age. and age at
al., 2001, Chen unadjusted;. hire;
2001, and Couch 1.29 (95% CI -- Found
et al., 2010. 0.61-2.71) similar
birth-year results to
adjusted;. Sanderson et
1.24 (95% CI al., 2001;
0.58-2.65) age- -- Found
hire adjusted. association
with 10 year
latency
-- ``0'' = used
minuscule
value at start
to eliminate
the use of 0
in a
logarithmic
analysis
Schubauer-Berigan et al., Cohort.......... N/D............. 9199 workers SMR 1.17 (95%CI Adjusted for ............... Male workers
2010a. from 7 1.08-1.28). smoking. employed at
processing 545 deaths...... least 2 days
plants. between 1940
and 1970.
Schubauer-Berigan et al., Cohort.......... Used exposure 5436 workers OH Evaluated using Adjusted for ............... -- Exposure
2010b. data from and PA plants. hazard ratios age, birth response was
Sanderson et and excess cohort, found between
al., 2001. absolute risk. asbestos 0-10[mu]g/m\3\
293 deaths...... exposure, mean DWA;
short-term -- Increased
work status. with
statistical
significance
at 4[mu]g/
m\3\;
-- 1 in 1000
risk at
0.033[mu]g/
m\3\ mean DWA.
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 47624]]
Re-evaluation of Published Studies
--------------------------------------------------------------------------------------------------------------------------------------------------------
Hollins et al., 2009......... Review.......... Re-examination ................ ................ ............... ............... Found lung
of weight-of- cancer excess
evidence from risk was
more than 50 associated
publications. with higher
levels of
exposure not
relevant in
today's
industrial
settings.
IARC, 2012................... Multiple........ Insufficient ................ Sufficient IARC concluded ............... -- Greater lung
exposure evidence for beryllium lung cancer risk in
concentration. carcinogenicity cancer risk the BCR cohort
Data............ of beryllium. was not -- Correlation
associated between
with smoking. highest lung
cancer rates
and highest
amounts of ABD
or other non-
malignant lung
diseases
-- Increased
risk with
longer latency
-- Greater
excess lung
cancers among
those hired
prior to 1950.
--------------------------------------------------------------------------------------------------------------------------------------------------------
N/D = information not determined for most studies
DWA--daily weighted average
VI. Preliminary Beryllium Risk Assessment
The Occupational Safety and Health (OSH) Act and court cases
arising under it have led OSHA to rely on risk assessment to support
the risk determinations required to set a permissible exposure limit
(PEL) for a toxic substance in standards under the OSH Act. Section
6(b)(5) of the OSH Act states that ``The Secretary [of Labor], in
promulgating standards dealing with toxic materials or harmful physical
agents under this subsection, shall set the standard which most
adequately assures, to the extent feasible, on the basis of the best
available evidence, that no employee will suffer material impairment of
health or functional capacity even if such employee has regular
exposure to the hazard dealt with by such standard for the period of
his working life'' (29 U.S.C. 655(b)(5)).
In Industrial Union Department, AFL-CIO v. American Petroleum
Institute, 448 U.S. 607 (1980) (Benzene), the United States Supreme
Court ruled that the OSH Act requires that, prior to the issuance of a
new standard, a determination must be made that there is a significant
risk of material impairment of health at the existing PEL and that
issuance of a new standard will significantly reduce or eliminate that
risk. The Court stated that ``before [the Secretary] can promulgate any
permanent health or safety standard, the Secretary is required to make
a threshold finding that a place of employment is unsafe--in the sense
that significant risks are present and can be eliminated or lessened by
a change in practices'' (Id. at 642). The Court also stated ``that the
Act does limit the Secretary's power to requiring the elimination of
significant risks'' (488 U.S. at 644 n.49), and that ``OSHA is not
required to support its finding that a significant risk exists with
anything approaching scientific certainty'' (Id. at 656).
OSHA's approach for the risk assessment incorporates both a review
of the recent literature on populations of workers exposed to beryllium
below the current Permissible Exposure Limit (PEL) of 2 [mu]g/m\3\ and
a statistical exposure-response analysis. OSHA evaluated risk at
several alternate PELs under consideration by the Agency: 2 [mu]g/m\3\,
1 [mu]g/m\3\, 0.5 [mu]g/m\3\, 0.2 [mu]g/m\3\, and 0.1 [mu]g/m\3\. A
number of recently published epidemiological studies evaluate the risk
of sensitization and CBD for workers exposed at and below the current
PEL and the effectiveness of exposure control programs in reducing
risk. OSHA also conducted a statistical analysis of the exposure-
response relationship for sensitization and CBD at the current PEL and
alternate PELs the Agency is considering. For this analysis, OSHA used
data provided by National Jewish Medical and Research Center (NJMRC) on
a population of workers employed at a beryllium machining plant in
Cullman, AL. The review of the epidemiological studies and OSHA's own
analysis show substantial risk of sensitization and CBD among workers
exposed at and below the current PEL of 2 [mu]g/m\3\. They also show
substantial reduction in risk where employers have implemented a
combination of controls, including stringent control of airborne
beryllium levels and additional measures such as respirators, dermal
personal protective equipment (PPE), and strict housekeeping to protect
workers against dermal and respiratory beryllium exposure. To evaluate
lung cancer risk, OSHA relied primarily on a quantitative risk
assessment published in 2011 by NIOSH. This risk assessment was based
on an update of the Reading cohort analyzed by Sanderson et al., as
well as workers from two smaller plants (Schubauer-Berigan et al.,
2011) where workers were exposed to lower levels of beryllium and
worked for longer periods than at the Reading plant. The authors found
that lung cancer risk was strongly and significantly related to mean,
cumulative, and maximum measures of workers' exposure; they predicted
substantial risk of lung cancer at the current PEL, and substantial
reductions in risk at the alternate PELs OSHA considered for the
proposed rule (Schubauer-Berigan et al., 2011).
[[Page 47625]]
A. Review of Epidemiological Literature on Sensitization and Chronic
Beryllium Disease From Occupational Exposure
As discussed in the Health Effects section, studies of beryllium-
exposed workers conducted using the beryllium lymphocyte proliferation
test (BeLPT) have found high rates of beryllium sensitization and CBD
among workers in many industries, including at some facilities where
exposures were primarily below OSHA's PEL of 2 [mu]g/m\3\ (Kreiss et
al., 1993; Henneberger et al., 2001; Schuler et al., 2005; Schuler et
al., 2012). In the mid-1990s, some facilities using beryllium began to
aggressively monitor and reduce workplace exposures. Four plants where
several rounds of BeLPT screening were conducted before and after
implementation of new exposure control methods provide the best
currently available evidence on the effectiveness of various exposure
control measures in reducing the risk of sensitization and CBD. The
experiences of these plants--a copper-beryllium processing facility in
Reading, PA, a beryllia ceramics facility in Tucson, AZ; a beryllium
processing facility in Elmore, OH; and a machining facility in Cullman,
AL--show that efforts to prevent sensitization and CBD by using
engineering controls to reduce workers' beryllium exposures to median
levels at or around 0.2 [mu]g/m\3\ and did not emphasize PPE and
stringent housekeeping methods, had only limited impact on risk.
However, exposure control programs implemented more recently, which
drastically reduced respiratory exposure to beryllium via a combination
of engineering controls and respiratory protection, controlled dermal
contact with beryllium using PPE, and employed stringent housekeeping
methods to keep work areas clean and prevent transfer of beryllium
between work areas, sharply curtailed new cases of sensitization among
newly-hired workers. There is additional, but more limited, information
available on the occurrence of sensitization and CBD among aluminum
smelter workers with low-level beryllium exposures (Taiwo et al., 2008;
Taiwo et al., 2010; Nilsen et al., 2010). A discussion of the
experiences at these plants follows.
The Health Effects section also discussed the role of particle
characteristics and beryllium compound solubility in the development of
sensitization and CBD among beryllium-exposed workers. Respirable
particles small enough to reach the deep lung are responsible for CBD.
However, larger inhalable particles that deposit in the upper
respiratory tract may lead to sensitization. The weight of evidence
indicates that both soluble and insoluble forms of beryllium are able
to induce sensitization and CBD. Insoluble forms of beryllium that
persist in the lung for longer periods may pose greater risk of CBD
while soluble forms may more easily trigger immune sensitization.
Although these factors potentially influence the toxicity of beryllium,
the available data are too limited to reliably account for solubility
and particle size in the Agency estimates of risk. The qualitative
impact on conclusions and uncertainties with regard to risk are
discussed in a later section.
1. Reading, PA, Plant
Schuler et al. conducted a study of workers at a copper-beryllium
processing facility in Reading, PA, screening 152 workers with the
BeLPT (Schuler et al., 2005). Exposures at this plant were believed to
be low throughout its history due to the low percentage of beryllium in
the metal alloys used, and the relatively low exposures found in
general area samples collected starting in 1969 (sample median <= 0.1
[mu]g/m\3\, 97% < 0.5 [mu]g/m\3\). The reported prevalences of
sensitization (6.5 percent) and CBD (3.9 percent) showed substantial
risk at this facility, even though airborne exposures were primarily
below OSHA's current PEL of 2 [mu]g/m\3\.
Personal lapel samples were collected in production and production
support jobs between 1995 and May 2000. These samples showed primarily
very low airborne beryllium levels, with a median of 0.073 [mu]g/
m\3\.\6\ The wire annealing and pickling process had the highest
personal lapel sample values, with a median of 0.149 [mu]g/m\3\.
Despite these low exposure levels, cases of sensitization continued to
occur among workers whose first exposures to beryllium occurred in the
1990s. Five (11.5 percent) workers of 43 hired after 1992 who had no
prior beryllium exposure became sensitized, including four in
production work and one in production support (Thomas et al., 2009;
evaluation for CBD not reported). Two (13 percent) of these sensitized
workers were among 15 workers in this group who had been hired less
than a year before the screening.
---------------------------------------------------------------------------
\6\ In their publication, Schuler et al. presented median values
for plant-wide and work-category-specific exposure levels; they did
not present arithmetic or geometric mean values for personal
samples.
---------------------------------------------------------------------------
After the BeLPT screening was conducted in 2000, the company began
implementing new measures to further reduce workers' exposure to
beryllium. Requirements designed to minimize dermal contact with
beryllium, including long-sleeve facility uniforms and polymer gloves,
were instituted in production areas in 2000. In 2001 the company
installed local exhaust ventilation (LEV) in die grinding and
polishing. Personal lapel samples collected between June 2000 and
December 2001 show reduced exposures plant-wide. Of 2,211 exposure
samples collected during this ``pre-enclosure program'' period, 98
percent were below 0.2 [mu]g/m\3\ (Thomas et al., 2009, p. 124).
Median, arithmetic mean, and geometric mean values <= 0.03 [mu]g/m\3\
were reported in this period for all processes except the wire
annealing and pickling process. Samples for this process remained
elevated, with a median of 0.1 [mu]g/m\3\ (arithmetic mean of 0.127
[mu]g/m\3\, geometric mean of 0.083 [mu]g/m\3\). In January 2002, the
plant enclosed the wire annealing and pickling process in a restricted
access zone (RAZ), required respiratory PPE in the RAZ, and implemented
stringent measures to minimize the potential for skin contact and
beryllium transfer out of the zone. While exposure samples collected by
the facility were sparse following the enclosure, they suggest exposure
levels comparable to the 2000-01 samples in areas other than the RAZ.
Within the RAZ, required use of powered air-purifying respirators
(PAPRs) indicates that respiratory exposure was negligible. A 2009
publication on the facility reported that outside the RAZ, ``the vast
majority of employees do not wear any form of respiratory protection
due to very low airborne beryllium concentrations'' (Thomas et al.,
2009, p. 122).
To test the efficacy of the new measures in preventing
sensitization and CBD, in June 2000 the facility began an intensive
BeLPT screening program for all new workers. The company screened
workers at the time of hire; at intervals of 3, 6, 12, 24, and 48
months; and at 3-year intervals thereafter. Among 82 workers hired
after 1999, three cases of sensitization were found (3.7 percent). Two
(5.4 percent) of 37 workers hired prior to enclosure of the wire
annealing and pickling process were found to be sensitized within 3 and
6 months of beginning work at the plant. One (2.2 percent) of 45
workers hired after the enclosure was confirmed as sensitized. Among
these early results, it appears that the greatest reduction in
sensitization risk was achieved after median exposures in all areas of
the plant were reduced to below 0.1 [mu]g/m\3\
[[Page 47626]]
and PPE to prevent dermal contact was instituted.
2. Tucson, AZ, Plant
Kreiss et al. conducted a study of workers at a beryllia ceramics
plant, screening 136 workers with the BeLPT in 1992 (Kreiss et al.,
1996). Full-shift area samples collected between 1983 and 1992 showed
primarily low airborne beryllium levels at this facility. Of 774 area
samples, 76 percent were at or below 0.1 [mu]g/m\3\ and less than 1
percent exceeded 2 [mu]g/m\3\. A small set (75) of personal lapel
samples collected at the plant beginning in 1991 had a median of 0.2
[mu]g/m\3\ and ranged from 0.1 to 1.8 [mu]g/m\3\ (arithmetic and
geometric mean values not reported) (Kreiss et al., 1996, p. 19).
However, area samples and short-term breathing zone samples also showed
occasional instances of very high beryllium exposure levels, with
extreme values of several hundred [mu]g/m\3\ and 3.6 percent of short-
term breathing zone samples in excess of 5 [mu]g/m\3\.
Kreiss et al. reported that eight (5.9 percent) of 136 workers
tested were sensitized, six (4.4 percent) of whom were diagnosed with
CBD. Seven of the eight sensitized employees had worked in machining,
where general area samples collected between October 1985 and March
1988 had a median of 0.3 [mu]g/m\3\, in contrast to a median value of
less than 0.1 [mu]g/m\3\ in other areas of the plant (Kreiss et al.,
1996, p. 20; mean values not reported). Short-term breathing zone
measurements associated with machining had a median of 0.6 [mu]g/m\3\,
double the median of 0.3 [mu]g/m\3\ for breathing zone measurements
associated with other processes (id., p. 20; mean values not reported).
One sensitized worker was one of 13 administrative workers screened,
and was among those diagnosed with CBD. Exposures of administrative
workers were not well-characterized, but were believed to be among the
lowest in the plant. Of three personal lapel samples reported for
administrative staff during the 1990s, all were below the then
detection limit of 0.2 [mu]g/m\3\ (Cummings et al., 2007, p.138).
Following the 1992 screening, the facility reduced exposures in
machining areas by enclosing machines and installing HEPA filter
exhaust systems. Personal samples collected between 1994 and 1999 had a
median of 0.2 [mu]g/m\3\ in production jobs and 0.1 [mu]g/m\3\ in
production support (geometric means 0.21 [mu]g/m\3\ and 0.11 [mu]g/
m\3\, respectively; arithmetic means not reported. Cummings et al.,
2007, p. 138). In 1998, a second screening found that 9 percent of
tested workers hired after the 1992 screening were sensitized, of whom
one was diagnosed with CBD. All of the sensitized workers had been
employed at the plant for less than two years (Henneberger et al.,
2001).
Following the 1998 screening, the company continued efforts to
reduce exposures and risk of sensitization and CBD by implementing
additional engineering and administrative controls and PPE. Respirator
use was required in production areas beginning in 1999, and latex
gloves were required beginning in 2000. The lapping area was enclosed
in 2000, and enclosures were installed for all mechanical presses in
2001. Between 2000 and 2003, water-resistant or water-proof garments,
shoe covers, and taped gloves were incorporated to keep beryllium-
containing fluids from wet machining processes off the skin. The new
engineering measures did not appear to substantially reduce airborne
beryllium levels in the plant. Personal lapel samples collected in
production processes between 2000 and 2003 had a median and geometric
mean of 0.18 [mu]g/m\3\, similar to the 1994-1999 samples (Cummings et
al., 2007, p. 138). However, respiratory protection requirements were
instituted in 2000 to control workers' airborne beryllium exposures.
To test the efficacy of the new measures instituted after 1998, in
January 2000 the company began screening new workers for sensitization
at the time of hire and at 3, 6, 12, 24, and 48 months of employment
(Cummings et al., 2007). These more stringent measures appear to have
substantially reduced the risk of sensitization among new employees. Of
97 workers hired between 2000 and 2004, one case of sensitization was
identified (1 percent). This worker had experienced a rash after an
incident of dermal exposure to lapping fluid through a gap between the
glove and uniform sleeve, indicating that sensitization may have
occurred via skin exposure.
3. Elmore, OH, Plant
Kreiss et al., Schuler et al., and Bailey et al. conducted studies
of workers at a beryllium metal, alloy, and oxide production plant.
Workers participated in BeLPT surveys in 1992 (Kreiss et al., 1997) and
in 1997 and 1999 (Schuler et al., 2012). Exposure levels at the plant
between 1984 and 1993 were characterized by a mixture of general area,
short-term breathing zone, and personal lapel samples. Kreiss et al.
reported that the median area samples for various work areas ranged
from 0.1 to 0.7 [mu]g/m\3\, with the highest values in the alloy arc
furnace and alloy melting-casting areas (other measures of central
tendency not reported). Personal lapel samples were available from
1990-1992, and showed high exposures overall (median value of 1.0
[mu]g/m\3\) with very high exposures for some processes. The authors
reported median sample values of 3.8 [mu]g/m\3\ for beryllium oxide
production, 1.75 [mu]g/m\3\ for alloy melting and casting, and 1.75
[mu]g/m\3\ for the arc furnace.
Kreiss et al. reported that 43 (6.9 percent) of 627 workers tested
in 1992 were sensitized, six of whom were diagnosed with CBD (4.4
percent). Workers with less than one year tenure at the plant were not
tested in this survey (Bailey et al., 2010, p. 511). The work processes
that appeared to carry the highest risk for sensitization and CBD
(e.g., ceramics) were not those with the highest reported exposure
levels (e.g., arc furnace and melting-casting). The authors noted
several possible reasons for this, including factors such as
solubility, particle size/number, and particle surface area that could
not be accounted for in their analysis (Kreiss et al., 1997).
In 1996-1999, the company took steps to reduce workers' beryllium
exposures: some high-exposure processes were enclosed, special
restricted-access zones were set up, HEPA filters were installed in air
handlers, and some ventilation systems were updated. In 1997 workers in
the pebble plant restricted access zone were required to wear half-face
air-purifying respirators, and beginning in 1999 all new employees were
required to wear loose-fitting powered air-purifying respirators (PAPR)
in manufacturing buildings (Bailey et al., 2010, p. 506). Skin
protection became part of the protection program for new employees in
2000, and glove use was required in production areas and for handling
work boots beginning in 2001. Also beginning in 2001, either half-mask
respirators or PAPRs were required in the production facility (type
determined by airborne beryllium levels), and respiratory protection
was required for roof work and during removal of work boots (Bailey et
al., 2010, p. 506). Respirator use was reported to be used on about
half or less of industrial hygiene sample records for most processes in
1990-1992 (Kreiss et al., 1996).
Beginning in 2000, workers were offered periodic BeLPT testing to
evaluate the effectiveness of a new exposure control program
implemented by the company. Bailey et al. (2010) reported on the
results of this surveillance for 290 workers hired between February 21,
2000 and December 18, 2006. They compared the
[[Page 47627]]
occurrence of beryllium sensitization and disease among 258 employees
who began work at the Elmore plant between January 15, 1993 and August
9, 1999 (the `pre-program group') and among 290 employees who were
hired between February 21, 2000 and December 18, 2006 and were tested
at least once after hire (the `program group'). They found that, as of
1999, 23 (8.9 percent) of the pre-program group were sensitized to
beryllium. Six (2.1 percent) of the program group had confirmed
abnormal results on their final round of BeLPTs, which occurred in
different years for different employees. In addition, another five
employees had confirmed abnormal BeLPT results at some point during the
testing period, followed by at least one instance of a normal test
result. One of these employees had a confirmed abnormal baseline BeLPT
at hire, and had two subsequent normal BeLPT results at 6 and 12 months
after hire. Four others had confirmed abnormal BeLPT results at 3 or 6
months after hire, later followed by a normal test. Including these
four in the count of sensitized workers, there were a total of ten (3.5
percent) workers sensitized after hire in the program group. It is not
clear whether the occurrence of a normal result following an abnormal
result reflects an error in one of the test results, a change in the
presence or level of memory T-cells circulating in the worker's blood,
or other possibilities. Because most of the workers in the study had
been employed at the facility for less than two years, Bailey et al.
did not report the incidence of CBD among the sensitized workers
(Bailey et al., 2010, p. 511).
In addition, Bailey et al. divided the program group into the
`partial program subgroup' (206 employees hired between February 21,
2000 and December 31, 2003) and the `full program subgroup' (84
employees hired between January 1, 2004 and December 18, 2006) to
account for the greater effectiveness of the exposure control program
after the first three years of implementation (Bailey et al., pp 506-
507). Four (1.9 percent) of the partial program group were found to be
sensitized on their final BeLPT (excluding one with a confirmed
abnormal BeLPT from their baseline test at hire). Two (2.4 percent) of
the full program group were found to be sensitized on their final BeLPT
(Bailey et al., 2010, p. 509). An additional three employees in the
partial program group and one in the full program group were confirmed
sensitized at 3 or 6 months after hire, then later had a single normal
BeLPT (Bailey et al., 2010, p. 509).
Schuler et al. (2012) published a study examining beryllium
sensitization and CBD among short-term workers at the Elmore, OH plant,
using exposure estimates created by Virji et al. (2012). The study
population included 264 workers employed in 1999 with up to six years
tenure at the plant (91 percent of the 291 eligible workers). By
including only short-term workers, Virji et al. were able to construct
participants' exposures with more precision than was possible in
studies involving workers exposed for longer durations and in time
periods with less exposure sampling. Each participant completed a work
history questionnaire and was tested for beryllium sensitization. The
overall prevalence of sensitization was 9.8 percent (26/264).
Sensitized workers were offered further evaluation for CBD. Twenty-two
sensitized workers consented to clinical testing for CBD via
transbronchial biopsy. Six of those sensitized were diagnosed with CBD
(2.3 percent, 6/264).
Exposure estimates were constructed using two exposure surveys
conducted in 1999: a survey of total mass exposures (4022 full-shift
personal samples) and a survey of size-separated impactor samples (198
samples). The 1999 exposure surveys and work histories were used to
estimate long-term lifetime weighted (LTW) average, cumulative, and
highest-job-worked exposure for total, respirable, and submicron
beryllium mass concentrations. Schuler et al. (2012) found no cases of
sensitization among workers with total mass LTW average exposures below
0.09 [mu]g/m\3\, among workers with total mass cumulative exposures
below 0.08 [mu]g/m\3\-yr, or among workers with total mass highest job
worked exposures below 0.12 [mu]g/m\3\. Twenty-four percent, 16
percent, and 25 percent of the study population were exposed below
those levels, respectively. Both total and respirable beryllium mass
concentration estimates were positively associated with sensitization
(average and highest job), and CBD (cumulative) in logistic regression
models.
4. Cullman, AL, Plant
Newman et al. conducted a series of BeLPT screenings of workers at
a precision machining facility between 1995 and 1999 (Newman et al.,
2001). A small set of personal lapel samples collected in the early
1980s and in 1995 suggests that exposures in the plant varied widely
during this time period. In some processes, such as engineering,
lapping, and electrical discharge machining (EDM), exposures were
apparently low (<= 0.1 [mu]g/m\3\). Madl et al. reported that personal
lapel samples from all machining processes combined had a median of
0.33 [mu]g/m\3\, with a much higher arithmetic mean of 1.63 [mu]g/m\3\
(Madl et al., 2007, Table IV, p. 457). The majority of these samples
were collected in the high-exposure processes of grinding (median of
1.05 [mu]g/m\3\, mean of 8.48 [mu]g/m\3\), milling (median of 0.3
[mu]g/m\3\, mean of 0.82 [mu]g/m\3\), and lathing (median of 0.35
[mu]g/m\3\, mean of 0.88 [mu]g/m\3\) (Madl et al., 2007, Table IV, p.
457). As discussed in greater detail in the background document,\7\ the
data set of machining exposure measurements included a few extremely
high values (41-73 [mu]g/m\3\) that a NIOSH researcher identified as
probable errors, and that appear to be included in Madl et al.'s
arithmetic mean calculations. Because high single-data point exposure
errors influence the arithmetic mean far more than the median value of
a data range, OSHA believes the median values reported by Madl et al.
are more reliable than the arithmetic means they reported.
---------------------------------------------------------------------------
\7\ When used throughout this section, ``background document''
refers to a more comprehensive, companion risk-assessment document
that can be found at www.regulations.gov in OSHA Docket No. ___.
---------------------------------------------------------------------------
After a sentinel case of CBD was diagnosed at the plant in 1995,
the company began BeLPT screenings to identify workers at increased
risk of CBD and implemented engineering and administrative controls and
PPE designed to reduce workers' beryllium exposures in machining
operations. Newman et al. reported 22 (9.4 percent) sensitized workers
among 235 tested, 13 of whom were diagnosed with CBD within the study
period. Between 1995 and 1997, the company built enclosures and
installed or updated local exhaust ventilation (LEV) for several
machining departments, removed pressurized air hoses, and required the
use of company uniforms. Madl et al. reported that historically,
engineering and work process controls, rather than personal protective
equipment, were used to limit workers' exposure to beryllium;
respirators were used only in cases of high exposure, such as during
sandblasting (Madl et al., 2007, p. 450). In contrast to the Reading
and Tucson plants, gloves were not required at this plant.
Personal lapel samples collected extensively between 1996 and 1999
in machining jobs have an overall median of 0.16 [mu]g/m\3\, showing
that the new controls achieved a marked reduction in machinists'
exposures during this
[[Page 47628]]
period. Nearly half of the samples were collected in milling (median =
0.18 [mu]g/m\3\). Exposures in other machining processes were also
reduced, including grinding (median of 0.18 [mu]g/m\3\) and lathing
(median of 0.13 [mu]g/m\3\). However, cases of sensitization and CBD
continued to occur.
At the time that Newman et al. reviewed the results of BeLPT
screenings conducted in 1995-1999, a subset of 60 workers had been
employed at the plant for less than a year. Four (6.7 percent) of these
workers were found to be sensitized, of whom two were diagnosed with
CBD and one with probable CBD (Newman et al., 2001). All four had been
hired in 1996. Two (one CBD case, one sensitized only) had worked only
in milling, and had worked for approximately 3-4 months (0.3-0.4 yrs)
at the time of diagnosis. One of those diagnosed with CBD worked only
in EDM, where lapel samples collected between 1996 and 1999 had a
median of 0.03 [mu]g/m\3\. This worker was diagnosed with CBD in the
same year that he began work at the plant. The last CBD case worked as
a shipper, where exposures in 1996-1999 were similarly low, with a
median of 0.09 [mu]g/m\3\.
Beginning in 2000, exposures in all jobs at the machining facility
were reduced to extremely low levels. Personal lapel samples collected
in machining processes between 2000 and 2005 had a median of 0.09
[mu]g/m\3\, where more than a third of samples came from the milling
process (n = 765, median of 0.09 [mu]g/m\3\). A later publication on
this plant by Madl et al. reported that only one worker hired after
1999 became sensitized. This worker had been employed for 2.7 years in
chemical finishing, where exposures were roughly similar to other
machining processes (n = 153, median of 0.12 [mu]g/m\3\). Madl et al.
did not report whether this worker was evaluated for CBD.
5. Aluminum Smelting Plants
Taiwo et al. (2008) studied a population of 734 employees at four
aluminum smelters located in Canada (2), Italy (1), and the United
States (1). In 2000, a beryllium exposure limit of 0.2 [mu]g/m\3\ 8-
hour TWA (action level 0.1 [mu]g/m\3\) and a short-term exposure limit
(STEL) of 1.0 [mu]g/m\3\ (15-minute sample) were instituted at these
plants. Sampling to determine compliance with the exposure limit began
at all smelters in 2000. Table VI-1 below, adapted from Taiwo et al.
(2008), shows summary information on samples collected from the start
of sampling through 2005.
Table VI-1--Exposure Sampling Data by Plant--2000-2005
----------------------------------------------------------------------------------------------------------------
Arithmetic
Smelter Number of Median ([mu]g/ mean ([mu]g/ Geometric mean
samples m\3\) m\3\) ([mu]g/m\3\)
----------------------------------------------------------------------------------------------------------------
Canadian smelter 1.............................. 246 0.03 0.09 0.03
Canadian smelter 2.............................. 329 0.11 0.29 0.08
Italian smelter................................. 44 0.12 0.14 0.10
U.S. smelter.................................... 346 0.03 0.26 0.04
----------------------------------------------------------------------------------------------------------------
Adapted from Taiwo et al., 2008, Table 1.
All employees potentially exposed to beryllium levels at or above
the action level for at least 12 days per year, or exposed at or above
the STEL 12 or more times per year, were offered medical surveillance
including the BeLPT (Taiwo et al., 2008, p. 158). Table VI-2 below,
adapted from Taiwo et al. (2008), shows test results for each facility
between 2001 and 2005.
Table VI-2--BeLPT Results by Plant--2001-2005
----------------------------------------------------------------------------------------------------------------
Employees Abnormal BeLPT Confirmed
Smelter tested Normal (unconfirmed) Sensitized
----------------------------------------------------------------------------------------------------------------
Canadian smelter 1.............................. 109 107 1 1
Canadian smelter 2.............................. 291 290 1 0
Italian smelter................................. 64 63 0 1
U.S. smelter.................................... 270 268 2 0
----------------------------------------------------------------------------------------------------------------
Adapted from Taiwo et al., 2008, Table 2.
The two workers with confirmed beryllium sensitization were offered
further evaluation for CBD. Both were diagnosed with CBD, based on
broncho-alveolar lavage (BAL) results in one case and pulmony function
tests, respiratory symptoms, and radiographic evidence in the other.
In 2010, Taiwo et al. published a study of beryllium-exposed
workers from smelters at four companies, including some of the workers
from the 2008 publication. 3,185 workers were determined to be
``significantly exposed'' to beryllium and invited to participate in
BeLPT screening. Each company used different criteria to determine
``significant'' exposure, which appeared to vary considerably (p. 570).
About 60 percent of invited workers participated in the program between
2000 and 2006, of whom nine were determined to be sensitized (see Table
VI-3 below). The authors state that all nine workers were referred to a
respiratory physician for further evaluation for CBD. Two were
diagnosed with CBD, as described above (Taiwo et al., 2008). The
authors do not report the details of other sensitized workers'
evaluation for CBD.
[[Page 47629]]
Table VI-3--Medical Surveillance for BeS in ALUMINUM Smelters
----------------------------------------------------------------------------------------------------------------
Number of At-risk Employees
Company smelters employees tested BeS
----------------------------------------------------------------------------------------------------------------
A............................................... 4 1278 734 4
B............................................... 3 423 328 0
C............................................... 1 1100 508 4
D............................................... 1 384 362 1
---------------------------------------------------------------
Total....................................... 9 3185 1932 9
----------------------------------------------------------------------------------------------------------------
Adapted from Taiwo et al., 2011, Table 1.
In general, there appeared to be a low level of sensitization and
CBD among employees at the aluminum smelters studied by Taiwo et al.
This is striking in light of the fact that many of the employees tested
had worked at the smelters long before the institution of exposure
limits for beryllium at some smelters in 2000. However, the authors
note that respiratory protection had long been used at these plants to
protect workers from other hazards. The results are roughly consistent
with the observed prevalence of sensitization following the institution
of respiratory protection at the Tucson beryllium ceramics plant
discussed previously. A study by Nilsen et al. (2010) also found a low
rate of sensitization among aluminum workers in Norway. Three-hundred
sixty-two workers and thirty-one control individuals received BeLPT
testing for beryllium sensitization. The authors found one sensitized
worker (0.28 percent). No borderline results were reported. The authors
reported that current exposures in this plant ranged from 0.1 [micro]g/
m\3\ to 0.31 [micro]g/m\3\ (Nilsen et al., 2010) and that respiratory
protection was in use, as is the case in the smelters studied by Taiwo
et al. (2008, 2010).
B. Preliminary Conclusions
The published literature on beryllium sensitization and CBD shows
that risk of both can be substantial in workplaces in compliance with
OSHA's current PEL (Kreiss et al., 1993; Schuler et al., 2005). The
experiences of several facilities in developing effective industrial
hygiene programs have shown that minimizing both airborne and dermal
exposure, using a combination of engineering and administrative
controls, respiratory protection, and dermal PPE, has substantially
lowered workers' risk of beryllium sensitization. In contrast, risk-
reduction programs that relied primarily on engineering controls to
reduce workers' exposures to median levels in the range of 0.1-0.2
[micro]g/m\3\, such as those implemented in Tucson following the 1992
survey and in Cullman during 1996-1999, had only limited impact on
reducing workers' risk of sensitization. The prevalence of
sensitization among workers hired after such controls were installed at
the Cullman plant remained high (Newman et al. (6.7 percent) and
Henneberger et al. (9 percent)). A similar prevalence of sensitization
was found in the screening conducted in 2000 at the Reading plant,
where the available sampling data show median exposure levels of less
than 0.2 [micro]g/m\3\ (6.5 percent). The risk of sensitization was
found to be particularly high among newly-hired workers (<=1 year of
beryllium exposure) in the Reading 2000 screening (13 percent) and the
Tucson 1998 screening (16 percent).
Cases of CBD have also continued to develop among workers in
facilities and jobs where exposures were below 0.2 [micro]g/m\3\. One
case of CBD was found in the Tucson 1998 screening among nine
sensitized workers hired less than two years previously (Henneberger et
al., 2001). At the Cullman plant, at least two cases of CBD were found
among four sensitized workers screened in 1995-1999 and hired less than
a year previously (Newman et al., 2001). These results suggest a
substantial risk of progression from sensitization to CBD among workers
exposed at levels well below the current PEL, especially considering
the extremely short time of exposure and follow-up for these workers.
Six of 10 sensitized workers identified at Reading in the 2000
screening were diagnosed with CBD. The four sensitized workers who did
not have CBD at their last clinical evaluation had been hired between
one and five years previously; therefore, the time may have been too
short for CBD to develop.
In contrast, more recent exposure control programs that have used a
combination of engineering controls, PPE, and stringent housekeeping
measures to reduce workers' airborne and dermal exposures have
substantially lowered risk of sensitization among newly-hired workers.
Of 97 workers hired between 2000 and 2004 in Tucson, where respiratory
and skin protection was instituted for all workers in production areas,
only one (1 percent) worker became sensitized, and in that case the
worker's dermal protection had failed during wet-machining work (Thomas
et al., 2009). In the aluminum smelters discussed by Taiwo et al.,
where available exposure samples indicated median beryllium levels of
about 0.1 [mu]g/m\3\ or below (measured as an 8-hour TWA) and workers
used respiratory and dermal protection, confirmed cases of
sensitization were rare (zero or one case per location). Sensitization
was also rare among workers at a Norwegian aluminum smelter (Nilsen et
al., 2010), where estimated exposures in the plant ranged from 0.1
[mu]g/m\3\ to 0.3 [mu]g/m\3\ and respiratory protection was regularly
used. In Reading, where in 2000-2001 airborne exposures in all jobs
were reduced to a median of 0.1 [mu]g/m\3\ or below (measured as an 8-
hour TWA) and dermal protection was required for production-area
workers, two (5.4 percent) of 37 newly hired workers became sensitized
(Thomas et al., 2009). After the process with the highest exposures
(median of 0.1 [mu]g/m\3\) was enclosed in 2002 and workers in that
process were required to use respiratory protection, the remaining jobs
had very low exposures (medians ~ 0.03 [mu]g/m\3\). Among 45 workers
hired after the enclosure, one was found to be sensitized (2.2
percent). In Elmore, where all workers were required to wear
respirators and skin PPE in production areas beginning in 2000-2001,
the estimated prevalence of sensitization among workers hired after
these measures were put in place was around 2-3 percent (Bailey et al.,
2010). In addition, Schuler et al. (2012) found no cases of
sensitization among short-term Elmore workers employed in 1999 who had
total mass LTW average exposures below 0.09 [mu]g/m\3\, among workers
with total mass cumulative exposures below 0.08 [mu]g/m\3\-yr, or among
workers with total mass highest job worked exposures below 0.12 [mu]g/
m\3\.
Madl et al. reported one case of sensitization among workers at the
Cullman plant hired after 2000. The median personal exposures were
about
[[Page 47630]]
0.1 [mu]g/m\3\ or below for all jobs during this period. Several
changes in the facility's exposure control methods were instituted in
the late 1990s that were likely to have reduced dermal as well as
respiratory exposure to beryllium. For example, the plant installed
change/locker rooms for workers entering the production facility,
instituted requirements for work uniforms and dedicated work shoes for
production workers, implemented annual beryllium hazard awareness
training that encouraged glove use, and purchased high efficiency
particulate air (HEPA) filter vacuum cleaners for workplace cleanup and
decontamination.
The results of the Reading, Tucson, and Elmore studies show that
reducing airborne exposures to below 0.1 [mu]g/m\3\ and protecting
workers from dermal exposure, in combination, have achieved a
substantial reduction in sensitization risk among newly-hired workers.
Because respirator use, dermal protection, and engineering changes were
often implemented concurrently at these plants, it is difficult to
attribute the reduced risk to any single control measure. The reduction
is particularly evident when comparing newly-hired workers in the most
recent Reading screenings (2.2-5.4 percent), and the rate of
sensitization found among workers hired within the year before the 2000
screening (13 percent). There is a similarly striking difference
between the rate of prevalence found among newly-hired workers in the
most recent Tucson study (1 percent) and the rate found among workers
hired within the year before the 1998 screening at that plant (16
percent). These results are echoed in the Cullman facility, which
combined engineering controls to reduce airborne exposures to below 0.1
[mu]g/m\3\ with measures such as housekeeping improvements and worker
training to reduce dermal exposure.
The studies on recent programs to reduce workers' risk of
sensitization and CBD were conducted on populations with very short
exposure and follow-up time. Therefore, they could not address the
question of how frequently workers who become sensitized in
environments with extremely low airborne exposures (median <0.1 [mu]g/
m\3\) develop CBD. Clinical evaluation for CBD was not reported for
sensitized workers identified in the most recent Tucson, Reading, and
Elmore studies. In Cullman, however, two of the workers with CBD had
been employed for less than a year and worked in jobs with very low
exposures (median 8-hour personal sample values of 0.03-0.09 [mu]g/
m\3\). The body of scientific literature on occupational beryllium
disease also includes case reports of workers with CBD who are known or
believed to have experienced minimal beryllium exposure, such as a
worker employed only in shipping at a copper-beryllium distribution
center (Stanton et al., 2006), and workers employed only in
administration at a beryllium ceramics facility (Kreiss et al., 1996).
Arjomandi et al. published a study of 50 sensitized workers from a
nuclear weapons research and development facility (Arjomandi et al.,
2010). Occupational and medical histories including physical
examination and chest imaging were available for the great majority
(49) of these individuals. Forty underwent testing for CBD via
bronchoscopy and transbronchial biopsies. In contrast to the studies of
low-exposure populations discussed previously, this group had much
longer follow-up time (mean time since first exposure = 32 years) and
length of employment at the facility (mean of 18 years). Quantitative
exposure estimates for the workers were not presented; however, the
authors characterized their probable exposures as ``low'' (13 workers),
``moderate'' (28 workers), or ``high'' (nine workers) based on the jobs
they performed at the facility.
Five of the 50 sensitized workers (10 percent) were diagnosed with
CBD based on histology or high-resolution computed tomography. An
additional three (who had not undergone full clinical evaluation for
CBD) were identified as probable CBD cases, bringing the total
prevalence of CBD and probable CBD in this group to 16 percent. As
discussed in the epidemiology section of the Health Effects chapter,
the prevalence of CBD among worker populations regularly exposed at
higher levels (e.g., median > 0.1 [mu]g/m\3\) is typically much
greater, approaching 80-100% in several studies. The lower prevalence
of CBD in this group of sensitized workers, who were believed to have
primarily low exposure levels, suggests that controlling respiratory
exposure to beryllium may reduce risk of CBD among sensitized workers
as well as reducing risk of CBD via prevention of sensitization.
However, it also demonstrates that some workers in low-exposure
environments can become sensitized and go on to develop CBD. The next
section discusses an additional source of information on low-level
beryllium exposure and CBD: studies of community-acquired CBD in
residential areas surrounding beryllium production facilities.
C. Review of Community-Acquired CBD Literature
The literature on community-acquired chronic beryllium disease (CA-
CBD) documents cases of CBD among individuals exposed to airborne
beryllium at concentrations below the proposed PEL. OSHA notes that
these case studies do not provide information on how frequently
individuals exposed to very low airborne levels develop CBD and that
reconstructed exposure estimates for CA-CBD cases are less reliable
than exposure estimates for working populations reviewed in the
previous sections. In addition, the cumulative exposure that an
occupationally exposed person would accrue at any given exposure
concentration is far less than would typically accrue from long-term
environmental exposure. The literature on CA-CBD thus has important
limitations and is not used as a basis for quantitative risk assessment
for CBD from low-level beryllium exposure. Nevertheless, these case
reports and the broader CA-CBD literature indicate that individuals
exposed to airborne beryllium below the proposed PEL can develop CBD.
Cases of CA-CBD were first reported among residents of Lorain, OH,
and Reading, PA, who lived in the vicinity of beryllium plants. More
recently, BeLPT screening has been used to identify additional cases of
CA-CBD in Reading.
1. Lorain, OH
In 1948, the State of Ohio Department of Public Health conducted an
X-ray program surveying more than 6,000 people who lived within 1.5
miles of a Lorain beryllium plant (Eisenbud, 1949; Eisenbud, 1982;
Eisenbud, 1998). This survey, together with a later review of all
reported cases of CBD in the area, found 13 cases of CBD. All of the
residents who developed CBD lived within 0.75 miles of the plant, and
none had occupational exposure or lived with beryllium-exposed workers.
Among the population of 500 people living within 0.25 miles of the
plant, seven residents (1.4 percent) were diagnosed with CBD. Five
cases were diagnosed among residents living between 0.25 and 0.5 miles
from the plant, one case was diagnosed among residents living between
0.5 and 0.75 miles from the plant, and no cases were found among those
living farther than 0.75 miles from the plant (total populations not
reported) (Eisenbud, 1998).
Beginning in January 1948, air sampling was conducted using a
mobile sampling station to measure
[[Page 47631]]
atmospheric beryllium downwind from the plant. An approximate
concentration of 0.2 [mu]g/m\3\ was measured at 0.25 miles from the
plant's exhaust stack, and concentrations decreased with greater
distance from the plant, to 0.003 [mu]g/m\3\ at a distance of 5 miles
(Eisenbud, 1982). A 10-week sampling program was conducted using three
fixed monitoring stations within 700 feet of the plant and one station
7,000 feet from the plant. Interpolating the measurements collected at
these locations, Eisenbud and colleagues estimated an average airborne
beryllium concentration of between 0.004 and 0.02 [mu]g/m\3\ at a
distance of 0.75 miles from the plant. Accounting for the possibility
that previous exposures may have been higher due to production level
fluctuations and greater use of rooftop emissions, they concluded that
the lowest airborne beryllium level associated with CA-CBD in this
community was somewhere between 0.01 [mu]g/m\3\ and 0.1 [mu]g/m\3\
(Eisenbud, 1982).
2. Reading, PA
Thirty-two cases of CA-CBD were reported in a series of papers
published in 1959-1969 concerning a beryllium refinery in Reading
(Lieben and Metzner, 1959; Metzner and Lieben, 1961; Dattoli et al.,
1964; Lieben and Williams, 1969). The plant, which opened in 1935,
manufactured beryllium oxide, alloys and metal, and beryllium tools and
metal products (Maier et al., 2008; Sanderson et al., 2001b). In a
follow-up study, Maier et al. presented eight additional cases of CA-
CBD who had lived within 1.5 miles of the plant (Maier et al., 2008).
Individuals with a history of occupational beryllium exposure and those
who had resided with occupationally exposed workers were not classified
as having CA-CBD.
The Pennsylvania Department of Health conducted extensive
environmental sampling in the area of the plant beginning in 1958.
Based on samples collected in 1958, Maier et al. stated that most cases
identified in their study would typically have been exposed to airborne
beryllium at levels between 0.0155 and 0.028 [mu]g/m\3\ on average,
with the potential for some excursions over 0.35 [mu]g/m\3\ (Maier et
al 2008, p. 1015). To characterize exposures to cases identified in the
earlier publications, Lieben and Williams cited a sampling program
conducted by the Department of Health between January and July 1962,
using nine sampling stations located between 0.2 and 4.8 miles from the
plant. They reported that 72 percent of 24-hour samples collected were
below 0.01 [mu]g/m\3\. Of samples that exceeded 0.01 [mu]g/m\3\, most
were collected at close proximity to the plant (e.g., 0.2 miles from
the plant).
In the early series of publications, cases of CA-CBD were reported
among people living both close to the plant (Maier et al., 2008; Dutra,
1948) and up to several miles away. Of new cases identified in the 1968
update, all lived between 3 and 7.5 miles from the plant. Lieben and
Williams suggested that some cases of CA-CBD found among more distant
residents might have resulted from working or visiting a graveyard
closer to the plant (Lieben and Williams, 1969). For example, a milkman
who developed CA-CBD had a route in the neighborhood of the plant.
Another resident with CA-CBD had worked as a cleaning woman in the area
of the plant, and a third worked within a half-mile of the plant.
At the time of the final follow-up study (1968), 11 residents
diagnosed with CA-CBD were alive and 21 were deceased. Among those who
had died, berylliosis was listed as the cause of death for three,
including a 10-year-old girl and two women in their sixties. Fibrosis,
granuloma or granulomatosis, and chronic or fibrous pneumonitis were
listed as the cause of death for eight more of those deceased.
Histologic evidence of CBD was reported for nine of 12 deceased
individuals who had been evaluated for it. In addition to showing
radiologic abnormalities associated with CBD, all living cases were
dyspneic.
Following the 1969 publication by Liebman and Williams, no
additional CA-CBD cases were reported in the Reading area until 1999,
when a new case was diagnosed. The individual was a 72-year-old woman
who had had abnormal chest x-rays for the previous six years (Maier et
al., 2008). After the diagnosis of this case, Maier et al. reviewed
medical records and/or performed medical evaluations, including BeLPT
results for 16 community residents who were referred by family members
or an attorney.
Among those referred, eight cases of definite or probable CBD were
identified between 1999 and 2002. All eight were women who lived
between 0.1 and 1.05 miles from the plant, beginning between 1943-1953
and ending between 1956-2001. Five of the women were considered
definite cases of CA-CBD, based on an abnormal blood or lavage cell
BeLPT and granulomatous inflammation on lung biopsy. Three probable
cases of CA-CBD were identified. One had an abnormal BeLPT and
radiography consistent with CBD, but granulomatous disease was not
pathologically proven. Two met Beryllium Case Registry epidemiologic
criteria for CBD based on radiography, pathology and a clinical course
consistent with CBD, but both died before they could be tested for
beryllium sensitization. One of the probable cases, who could not be
definitively diagnosed with CBD because she died before she could be
tested, was the mother of both a definite case and the probable case
who had an abnormal BeLPT but did not show granulomatous disease.
The individuals with CA-CBD identified in this study suffered
significant health impacts from the disease, including obstructive,
restrictive, and gas exchange pulmonary defects in the majority of
cases. All but two had abnormal pulmonary physiology. Those two were
evaluated at early stages of disease following their mother's
diagnosis. Six of the eight women required treatment with prednisone, a
step typically reserved for severe cases due to the adverse side
effects of steroid treatment. Despite treatment, three had died of
respiratory impairment from CBD as of 2002 (Maier et al., 2008). The
authors concluded that ``low levels of exposures with significant
disease latency can result in significant morbidity and mortality''
(id., p. 1017).
OSHA notes that compared with the occupational studies discussed in
the previous section, there is comparatively sparse information on
exposure levels of Lorain and Reading residents. There remains the
possibility that some individuals with CA-CBD may have had higher
exposures than were known and reported in these studies, or have had
unreported exposure to beryllium dust via contact with beryllium-
exposed workers. Nevertheless, the studies conducted in Lorain and
Reading demonstrate that long-term exposure to the apparent low levels
of airborne beryllium, with sufficient disease latency, can lead to
serious or fatal CBD. Genetic susceptibility may play a role in cases
of CBD among individuals with very low or infrequent exposures to
beryllium. The role of genetic susceptibility in the CBD disease
process is discussed in detail in section V.D.3.
D. Exposure-Response Literature on Beryllium Sensitization and CBD
To further examine the relationship between exposure level and risk
of both sensitization and disease, we next review exposure-response
studies in the CBD literature. Many publications have reported that
exposure levels correlate with risk, including a small number of
[[Page 47632]]
exposure-response analyses. Most of these studies examined the
association between job-specific beryllium air measurements and
prevalence of sensitization and CBD. This section focuses on studies at
three facilities that included a more rigorous historical
reconstruction of individual worker exposures in their exposure-
response analyses.
1. Rocky Flats, CO, Facility
In 2000, Viet et al. published a case-control study of participants
in the Rocky Flats Beryllium Health Surveillance Program (BHSP), which
was established in 1991 to screen workers at the Department of Energy's
Rocky Flats, CO, nuclear weapons facility for beryllium sensitization
and evaluate sensitized workers for CBD (Viet et al., 2000). The
program, which at the time of publication had tested over 5,000 current
and former Rocky Flats employees, had identified a total of 127
sensitized individuals as of 1994 when Viet et al. initiated their
study.
Workers were considered sensitized if two BeLPT results were
positive, either from two blood draws or from a single blood draw
analyzed by two different laboratories. All sensitized individuals were
offered clinical evaluation, and 51 were diagnosed with CBD based on
positive lung LPT and evidence of noncaseating granulomas upon lung
biopsy. The number of sensitized individuals who declined clinical
evaluation was not reported. Two cases, one with CBD and one who was
sensitized but not diagnosed with CBD, were excluded from the case-
control analysis due to reported or potential prior beryllium exposure
at a ceramics plant. Another sensitized individual who had not been
diagnosed with CBD was excluded because she could not be matched by the
study's criteria to a non-sensitized control within the BHSP database.
Viet et al. matched a total of 50 CBD cases to 50 controls who were
negative on the BeLPT and had the same age ( 3 years),
gender, race and smoking status, and were otherwise randomly selected
from the database. Using the same matching criteria, 74 sensitized
workers who were not diagnosed with CBD were age-, gender-, race-, and
smoking status-matched to 74 control individuals who tested negative by
the BeLPT from the BHSP database.
Viet et al. developed exposure estimates for the cases and controls
based on daily beryllium air samples collected in one of 36 buildings
where beryllium was used at Rocky Flats, the Building 444 Beryllium
Machine Shop. Over half of the approximately 500,000 industrial hygiene
samples collected at Rocky Flats were taken from this building. Air
monitoring in other buildings was reported to be limited and
inconsistent and, thus, not utilized in the exposure assessment. The
sampling data used to develop worker exposure estimates were
exclusively Building 444 fixed airhead (FAH) area samples collected at
permanent fixtures placed around beryllium work areas and machinery.
Exposure estimates for jobs in Building 444 were constructed for
the years 1960-1988 from this database. Viet et al. worked with Rocky
Flats industrial hygienists and staff to assign a ``building area
factor'' (BAF) to each of the other buildings, indicating the likely
level of exposure in a building relative to exposures in Building 444.
Industrial hygienists and staff similarly assigned a job factor (JF) to
all jobs, representing the likely level of beryllium exposure relative
to the levels experienced by beryllium machinists. A JF of 1 indicated
the lowest exposures, and a JF of 10 indicated the highest exposures.
For example, administrative work and vehicle operation were assigned a
JF of 1, while machining, mill operation, and metallurgical operation
were each assigned a JF of 10. Estimated FAH values for each
combination of job, building and year in the study subjects' work
histories were generated by multiplying together the job and building
factors and the mean annual FAH exposure level. Using data collected by
questionnaire from each BHSP participant, Viet et al. reconstructed
work histories for each case and control, including job title and
building location in each year of their employment at Rocky Flats.
These work histories and the estimated FAH values were used to generate
a cumulative exposure estimate (CEE) for each case and control in the
study. A long-term mean exposure estimate (MEE) was generated by
dividing each CEE by the individual's number of years employed at Rocky
Flats.
Viet et al.'s statistical analysis of the resulting data set
included conditional logistic regression analysis, modeling the
relationship between risk of each health outcome and log-transformed
CEE and MEE. They found highly statistically significant relationships
between log-CEE and risk of CBD (coef = 0.837, p = 0.0006) and between
log-MEE (coef = 0.855, p = 0.0012) and risk of CBD, indicating that
risk of CBD increases with exposure level. These coefficients
correspond to odds ratios of 6.9 and 7.2 per 10-fold increase in
exposure, respectively. Risk of sensitization without CBD did not show
a statistically significant relationship with log-CEE (coef = 0.111, p
= 0.32), but showed a nearly-significant relationship with log-MEE
(coef = 0.230, p = 0.097).
2. Cullman, AL, Facility
The Cullman, AL, precision machining facility discussed previously
was the subject of a case-control study published by Kelleher et al. in
2001. After the diagnosis of an index case of CBD at the plant in 1995,
NJMRC researchers worked with the plant to conduct a medical
surveillance program using the BeLPT to screen workers biennially for
beryllium sensitization and CBD. Of 235 employees screened between 1995
and 1999, 22 (9.4 percent) were found to be sensitized, including 13
diagnosed with CBD (Newman et al., 2001). Concurrently, research was
underway by Martyny et al. to characterize the particle size
distribution of beryllium exposures generated by processes at this
plant (Martyny et al., 2000). The exposure research showed that the
machining operations during this time period generated respirable
particles (10 [mu]m or less) at the worker breathing zone that made up
greater than 50 percent of the beryllium mass. Kelleher et al. used the
dataset of 100 personal lapel samples collected by Martyny et al. and
other NJMRC researchers in 1996, 1997, and 1999 to characterize
exposures for each job in the plant. Following a statistical analysis
comparing the samples collected by NJMRC with earlier samples collected
at the plant, Kelleher et al. concluded that the 1996-1999 data could
be used to represent job-specific exposures from earlier periods.
Detailed work history information gathered from plant data and
worker interviews was used in combination with job exposure estimates
to characterize cumulative and LTW average beryllium exposures for
workers in the surveillance program. In addition to cumulative and LTW
exposure estimates based the total mass of beryllium reported in their
exposure samples, Kelleher et al. calculated cumulative and LTW
estimates based specifically on exposure to particles < 6 [mu]m and
particles < 1 [mu]m in diameter.
To analyze the relationship between exposure level and risk of
sensitization and CBD, Kelleher et al. performed a case-control
analysis using measures of both total beryllium exposure and particle
size-fractionated exposure. The analysis included sensitization cases
identified in the 1995-1999 surveillance and 206 controls from the
group of 215 non-sensitized workers. For nine workers, the researchers
could not
[[Page 47633]]
reconstruct complete job histories. Logistic regression models using
categorical exposure variables showed positive associations between
risk of sensitization and the six exposure measures tested: Total CEE,
total MEE, and variations of CEE and MEE constructed based on particles
< 6 [mu]m and < 1 [mu]m in diameter. None of the associations were
statistically significant (p < 0.05); however, the authors noted that
the dataset was relatively small, with limited power to detect a
statistically significant exposure-response relationship.
Although the Viet et al. and Kelleher et al. exposure-response
analyses provide valuable insight into exposure-response for beryllium
sensitization and CBD, both studies have limitations that affect their
suitability as a basis for quantitative risk assessment. Their
limitations primarily involve the exposure data used to estimate
workers' exposures. Viet et al.'s exposure reconstruction was based on
area samples from a single building within a large, multi-building
facility. Where possible, OSHA prefers to base risk estimates on
exposure data collected in the breathing zone of workers rather than
area samples, because data collected in the breathing zone more
accurately represent workers' exposures. Kelleher's analysis, on the
other hand, was based on personal lapel samples. However, the samples
Kelleher et al. used were collected between 1996 and 1999, after the
facility had initiated new exposure control measures in response to the
diagnosis of a case of CBD in 1995. OSHA believes that industrial
hygiene samples collected at the Cullman plant prior to 1996 better
characterize exposures prior to the new exposure controls. In addition,
since the publication of the Kelleher study, the population has
continued to be screened for sensitization and CBD. Data collected on
workers hired in 2000 and later, after most exposure controls had been
completed, can be used to characterize risk at lower levels of exposure
than have been examined in many previous studies.
To better characterize the relationship between exposure level and
risk of sensitization and CBD, OSHA developed an independent exposure-
response analysis based on a dataset maintained by NJMRC on workers at
the Cullman, AL, machining plant. The dataset includes exposure samples
collected between 1980 and 2005, and has updated work history and
screening information for several hundred workers through 2003. OSHA's
analysis of the NJMRC data set is presented in the next section, E.
OSHA's Exposure-Response Analysis.
3. Elmore, OH, Facility
After OSHA completed its analysis of the NJMRC data set, Schuler et
al. (2012) published a study examining beryllium sensitization and CBD
among 264 short-term workers employed at the previously described
Elmore, OH plant in 1999. The analysis used a high-quality exposure
reconstruction by Virji et al. (2012) and presented a regression
analysis of the relationship between beryllium exposure levels and
beryllium sensitization and CBD in the short-term worker population. By
including only short-term workers, Virji et al. were able to construct
participants' exposures with more precision than was possible in
studies involving workers exposed for longer durations and in time
periods with less exposure sampling. In addition, the focus on short-
term workers allowed more precise knowledge of when sensitization and
CBD occurred than had been the case for previously published cross-
sectional studies of long-term workers. Each participant completed a
work history questionnaire and was tested for beryllium sensitization,
and sensitized workers were offered further evaluation for CBD. The
overall prevalence of sensitization was 9.8 percent (26/264). Twenty-
two sensitized workers consented to clinical testing for CBD via
transbronchial biopsy. Six of those sensitized were diagnosed with CBD
(2.3 percent, 6/264).
Schuler et al. (2012) used logistic regression to explore the
relationship between estimated beryllium exposure and sensitization and
CBD, using estimates of total, respirable, and submicron mass
concentrations. Exposure estimates were constructed using two exposure
surveys conducted in 1999: a survey of total mass exposures (4,022
full-shift personal samples) and a survey of size-separated impactor
samples (198 samples). The 1999 exposure surveys and work histories
were used to estimate long-term lifetime weighted (LTW) average,
cumulative, and highest-job-worked exposure for total, respirable, and
submicron beryllium mass concentrations.
For beryllium sensitization, logistic models showed elevated odds
ratios for average (OR 1.48) and highest job (OR 1.37) exposure for
total mass exposure; the OR for cumulative exposure was smaller (OR
1.23) and borderline statistically significant (95 percent CI barely
included unity). Relationships between sensitization and respirable
exposure estimates were similarly elevated for average (OR 1.37) and
highest job (OR 1.32). Among the submicron exposure estimates, only
highest job (OR 1.24) had a 95 percent CI that just included unity for
sensitization. For CBD, elevated odds ratios were observed only for the
cumulative exposure estimates and were similar for total mass and
respirable exposure (total mass OR 1.66, respirable (OR 1.68).
Cumulative submicron exposure showed an elevated, borderline
significant odds ratio (OR 1.58). The odds ratios for average exposure
and highest-exposed job were not statistically significantly elevated.
Schuler et al. concluded that both total and respirable mass
concentrations of beryllium exposure were relevant predictors of risk
for beryllium sensitization and CBD.
E. OSHA's Exposure-Response Analysis
OSHA evaluated exposure and health outcome data on a population of
workers employed at the Cullman machining facility. NJMRC researchers,
with consent and information provided by the facility, compiled a
dataset containing employee work histories, medical diagnoses, and air
sampling results and provided it to OSHA for analysis. OSHA's
contractors from Eastern Research Group (ERG) gathered additional
information from (1) two surveys of the Cullman plant conducted by
OSHA's contractor (ERG, 2003 and ERG, 2004a), (2) published articles of
investigations conducted at the plant by researchers from NJMRC
(Kelleher et al., 2001; Madl et al., 2007; Martyny et al., 2000; and
Newman et al., 2001), (3) a case file from a 1980 OSHA complaint
inspection at the plant, (4) comments submitted to the OSHA docket
office in 1976 and 1977 by representatives of the metal machining plant
regarding their beryllium control program, and (5) personal
communications with the plant's current industrial hygienist (ERG,
2009b) and an industrial hygiene researcher at NJMRC (ERG, 2009a).
1. Plant Operations
The Cullman plant is a leading fabricator of precision-machined and
processed materials including beryllium and its alloys, titanium,
aluminum, quartz, and glass (ERG, 2009b). The plant has approximately
210 machines, primarily mills and lathes, and processes large
quantities of beryllium on an annual basis. The plant provides complete
fabrication services including ultra-precision machining; ancillary
processing (brazing, ion milling, photo etching, precision cleaning,
heat treating, stress relief, thermal cycling, mechanical assembly, and
chemical
[[Page 47634]]
milling/etching); and coatings (plasma spray, anodizing, chromate
conversion coating, nickel sulfamate plate, nickel plate, gold plate,
black nickel plate, copper plate/strike, passivation, and painting).
Most of the plant's beryllium operations involve machining beryllium
metal and high beryllium content composite materials (beryllium metal/
beryllium oxide metal composites called E-Metal or E-Material), with
occasional machining of beryllium oxide/metal matrix (such as AlBeMet,
aluminum beryllium matrix) and beryllium-containing alloys. E-Materials
such as E-20 and E-60 are currently processed in the E-Cell department.
The 120,000 square-foot plant has two main work areas: a front
office area and a large, open production shop. Operations in the
production shop include inspection of materials, machining, polishing,
and quality assurance. The front office is physically separated from
the production shop. Office workers enter through the front of the
facility and have access to the production shop through a change room
where they must don laboratory coats and shoe covers to enter the
production area. Production workers enter the shop area at the rear of
the facility where a change/locker room is available to change into
company uniforms and work shoes. Support operations are located in
separate areas adjacent to the production shop and include management
and administration, sales, engineering, shipping and receiving, and
maintenance. Management and administrative personnel include two
groups: those primarily working in the front offices (front office
management) and those primarily working on the shop floor (shop
management).
In 1974, the company moved its precision machining operations to
the plant's current location in Cullman. Workplace exposure controls
reportedly did not change much until the diagnosis of an index case of
CBD in 1995. Prior to 1995, exposure controls for machining operations
primarily included a low volume/high velocity (LVHV) central exhaust
system with operator-adjusted exhaust pickups and wet machining
methods. Protective clothing, gloves, and respiratory protection were
not required. After the diagnosis, the facility established an in-house
target exposure level of 0.2 [mu]g/m\3\, installed change/locker rooms
for workers entering the production facility, eliminated pressurized
air hoses, discouraged the use of dry sweeping, initiated biennial
medical surveillance using the BeLPT, and implemented annual beryllium
hazard awareness training.
In 1996, the company instituted requirements for work uniforms and
dedicated work shoes for production workers, eliminated dry sweeping in
all departments, and purchased high-efficiency particulate air (HEPA)
filter vacuum cleaners for workplace cleanup and decontamination. Major
engineering changes were also initiated in 1996, including the purchase
of a new local exhaust ventilation (LEV) system to exhaust machining
operations producing finer aerosols (e.g., dust and fume versus metal
chips). The facility also began installing mist eliminators for each
machine. Departments affected by these changes included cutter grind
(tool and die), E-cell, electrical discharge machining (EDM), flow
lines, grind, lapping, and optics. Dry machining operations producing
chips were exhausted using the existing LVHV exhaust system (ERG,
2004a). In the course of making the ventilation system changes, old
ductwork and baghouses were dismantled and new ductwork and air
cleaning devices were installed. The company also installed Plexiglas
enclosures on machining operations in 1996-1997, including the lapping,
deburring, grinding, EDM, and tool and die operations. In 1998, LEV was
installed in EDM and modified in the lap, deburr, and grind
departments.
Most exposure controls were reportedly in place by 2000 (ERG,
2009a). In 2004, the plant industrial hygienist reported that all
machines had LEV and about 65 percent were also enclosed with either
partial or full enclosures to control the escape of machining coolant
(ERG, 2004b). Over time, the facility has built enclosures for
operations that consistently produce exposures greater than 0.2 [mu]g/
m\3\. The company has never required workers to use gloves or other
PPE.
2. Air Sampling Database and Job Exposure Matrix (JEM)
The NJMRC dataset includes industrial hygiene sampling results
collected by the plant (1980-1984 and 1995-2005) and NJMRC researchers
(June 1996 to February 1997 and September 1999), including 4,370
breathing zone (personal lapel) samples and 712 area samples (ERG,
2004b). Limited air sampling data is available before 1980 and no
exposure data appears to be available for the 10-year time period 1985
through 1994. A review of the NJMRC air sampling database from 1995
through 2005 shows a significant increase in the number of air samples
collected beginning in 2000, which the plant industrial hygienist
attributes to an increase in the number of air sampling pumps (from 5
to 23) and the purchase of an automated atomic absorption
spectrophotometer.
ERG used the personal breathing zone sampling results contained in
the sample database to quantify exposure levels for each year and for
several-year periods. Separate exposure statistics were calculated for
each job included in the job history database. For each job included in
the job history database, ERG estimated the arithmetic mean, geometric
mean, median, minimum, maximum, and 95th percentile value for the
available exposure samples. Prior to generating these statistics ERG
made several adjustments. After consultation with researchers at NJMRC,
four particularly high exposures were identified as probably erroneous
and excluded from calculations. In addition, a 1996 sample for the HS
(Health and Safety) process was removed from the sample calculations
after ERG determined it was for a non-employee researcher visiting the
facility.
Most samples in the sample database for which sampling times were
recorded were long-term samples: 2,503 of the 2,557 (97.9 percent)
breathing zone samples with sampling time recorded had times greater
than or equal to 400 minutes. No adjustments were made for sampling
time, except in the case of four samples for the ``maintenance''
process for 1995. These results show relatively high values and
exceptionally short sampling times consistent with the nature of much
maintenance work, marked by short-term exposures and periods of no
exposure. The four 1995 maintenance samples were adjusted for an eight-
hour sampling time assuming that the maintenance workers received no
further beryllium exposure over the rest of their work shift.
OSHA examined the database for trends in exposure by reviewing
sample statistics for individual years and grouping years into four
time periods that correspond to stages in the plant's approach to
beryllium exposure control. These were: 1980-1995, a period of
relatively minimal control prior to the 1995 discovery of a case of CBD
among the plant's workers; 1996-1997, a period during which some major
engineering controls were in the process of being installed on
machining equipment; 1998-1999, a period during which most engineering
controls on the machining equipment had been installed; and 2000-2003,
a period when installation of all exposure controls on machining
equipment was complete and exposures very low throughout the plant.
Table VI-4 below summarized the available data for each time period. As
the four probable sampling errors identified in
[[Page 47635]]
the original data set are excluded here, arithmetic mean values are
presented.
Table VI-4--Exposure Values for Machining Job Titles, Excluding Probable Sampling Errors ([mu]g/m\3\) in NJMRC Data Set
--------------------------------------------------------------------------------------------------------------------------------------------------------
1980-1995 1996-1997 1998-1999 2000-2003
Job title ---------------------------------------------------------------------------------------
Samples Mean Samples Mean Samples Mean Samples Mean
--------------------------------------------------------------------------------------------------------------------------------------------------------
Deburring....................................................... 27 1.17 19 1.29 0 NA 67 0.1
Electrical Discharge Machining.................................. 2 0.06 2 1.32 16 0.08 63 0.1
Grinding........................................................ 12 3.07 6 0.49 15 0.24 68 0.1
Lapping......................................................... 9 0.15 16 0.24 42 0.21 103 0.1
Lathe........................................................... 18 0.88 8 1.13 40 0.17 200 0.1
Milling......................................................... 43 0.64 15 0.23 95 0.17 434 0.1
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reviewing the revised statistics for individual years for different
groupings, OSHA noted that exposures in the 1996-1997 period were for
some machining jobs equivalent to, or even higher than, exposure levels
recording during the 1980-1995 period. During 1996-1997, major
engineering controls were being installed, but exposure levels were not
yet consistently reduced.
Table VI-5 below summarizes exposures for the four time periods in
jobs other than beryllium machining. These include jobs such as
administrative work, health and safety, inspection, toolmaking (`Tool'
and `Cgrind'), and others. A description of jobs by title is available
in the risk assessment background document.
Table VI-5--Exposure Values for Non-Machining Job Titles ([mu]g/m\3\) in NJMRC Data Set
--------------------------------------------------------------------------------------------------------------------------------------------------------
1980-1995 1996-1997 1998-1999 2000-2003
Job title --------------------------------------------------------------------------------------------------------------------------
Samples mean Samples mean Samples mean Samples mean
--------------------------------------------------------------------------------------------------------------------------------------------------------
Administration............... 0 NA.............. 0 NA.............. 39 0.052........... 74 0.061
Assembly..................... 0 NA.............. 0 NA.............. 8 0.136........... 2 0.051
Cathode...................... 0 NA.............. 0 NA.............. 0 NA.............. 9 0.156
Cgrind....................... 1 0.120........... 0 NA.............. 14 0.105........... 76 0.112
Chem......................... 0 NA.............. 1 0.529........... 21 0.277........... 91 0.152
Ecell........................ 0 NA.............. 13 1.873........... 0 NA.............. 26 0.239
Engineering.................. 1 0.065........... 0 NA.............. 49 0.069........... 125 0.062
Flow Lines................... 0 NA.............. 0 NA.............. 0 NA.............. 113 0.083
Gas.......................... 0 NA.............. 0 NA.............. 0 NA.............. 121 0.058
Glass........................ 0 NA.............. 0 NA.............. 0 NA.............. 38 0.068
Health and Safety \8\........ 0 NA.............. 0 NA.............. 0 NA.............. 5 0.076
Inspection................... 0 NA.............. 0 NA.............. 32 0.101........... 150 0.066
Maintenance.................. 4 1.257........... 1 0.160........... 16 0.200........... 70 0.126
Msupp........................ 0 NA.............. 0 NA.............. 47 0.094........... 68 0.081
Optics....................... 0 NA.............. 0 NA.............. 0 NA.............. 41 0.090
PCIC......................... 1 0.040........... 0 NA.............. 13 0.071........... 42 0.083
Qroom........................ 1 0.280........... 0 NA.............. 0 NA.............. 2 0.130
Shop......................... 0 NA.............. 0 NA.............. 4 0.060........... 0 NA
Spec......................... 3 0.247........... 0 NA.............. 24 0.083........... 19 0.087
Tool......................... 0 NA.............. 0 NA.............. 0 NA.............. 1 0.070
--------------------------------------------------------------------------------------------------------------------------------------------------------
From Table VI-5, it is evident that exposure samples are not
available for many non-machining jobs prior to 2000. Where samples are
available before 2000, sample numbers are small, particularly prior to
1998. In jobs for which exposure values are available in 1998-1999 and
2000-2003, exposures appear either to decline from 1998-1999 to 2000-
2003 (Assembly, Chem, Inspection, Maintenance) or to be roughly
equivalent (Administration, Cgrind, Engineering, Msupp, PCIC, and
Spec). Among the jobs with exposure samples prior to 1998, most had
very few (1-5) samples, with the exception of Ecell (13 samples in
1996-1997). Based on this limited information, it appears that
exposures declined from the period before the first dentification of a
CBD case to the period in which exposure controls were introduced.
---------------------------------------------------------------------------
\8\ An exceptionally high result (0.845 [mu]g/m\3\, not shown in
Table 5) for a 1996 sample for the HS (Health and Safety) process
was removed from the sample calculations. OSHA's contractor
determined this sample to be associated with a non-employee
researcher visiting the facility.
---------------------------------------------------------------------------
Because exposure results from 1996-1997 were not found to be
consistently reduced in comparison to the 1985-1995 period in primary
machining jobs, these two periods were grouped together in the JEM.
Exposure monitoring for jobs other than the primary machining
operations were represented by a single mean exposure value for 1980-
2003. As respiratory protection was not routinely used at the plant,
there was no adjustment for respiratory protection in workers' exposure
estimates. The job exposure matrix is presented in full in the
background document for the quantitative risk assessment.
3. Worker Exposure Reconstruction
The work history database contains job history records for 348
workers, including start years, duration of employment, and percentage
of worktime spent in each job. One hundred ninety-eight of the workers
had been employed at some point in primary machining jobs, including
deburring,
[[Page 47636]]
EDM, grinding, lapping, lathing, and milling. The remainder worked only
in non-primary machining jobs, such as administration, engineering,
quality control, and shop management. The total number of years worked
at each job are presented as integers, leaving some uncertainty
regarding the worker's exact start and end date at the job.
Based on these records and the JEM described previously, ERG
calculated cumulative and average exposure estimates for each worker in
the database. Cumulative exposure was calculated as, [Sigma]i ei t i,
where e(i) is the exposure level for job (i), and t(i) is the time
spent in job (i). Cumulative exposure was divided by total exposure
time to estimate each worker's long-term average exposure. These
exposures were computed in a time-dependent manner for the statistical
modeling. For workers with beryllium sensitization or CBD, exposure
estimates excluded exposures following diagnosis.
Workers who were employed for long time periods in jobs with low-
level exposures tend to have low average and cumulative exposures due
to the way these measures are constructed, incorporating the worker's
entire work history. As discussed in the Health Effects chapter,
higher-level exposures or short-term peak exposures such as those
encountered in machining jobs may be highly relevant to risk of
sensitization. Unfortunately, because it is not possible to
continuously monitor individuals' beryllium exposure levels and
sensitization status, it is not known exactly when workers became
sensitized or what their ``true'' peak exposures leading up to
sensitization were. Only a rough approximation of the upper levels of
exposure a worker experienced is possible. ERG constructed a third type
of exposure estimate reflecting the exposure level associated with the
highest-exposure job (HEJ) and time period experienced by each worker.
This exposure estimate (HEJ), the cumulative exposure estimate, and the
average exposure were used in the quartile analysis and statistical
analyses.
4. Prevalence of Sensitization and CBD
In the database provided to OSHA, seven workers were reported as
sensitized only. Sixteen workers were listed as sensitized and
diagnosed with CBD upon initial clinical evaluation. Three workers,
first shown to be sensitized only, were later diagnosed with CBD.
Tables VI-6, VI-7, and VI-8 below present the prevalence of
sensitization and CBD cases across several categories of lifetime-
weighted (LTW) average, cumulative, and highest-exposed job (HEJ)
exposure. Exposure values were grouped by quartile. Note that all
workers with CBD are also sensitized. Thus, the columns ``Total
Sensitized'' and ``Total %'' refer to all sensitized workers in the
dataset, including workers with and without a diagnosis of CBD.
Table VI-6--Prevalence of Sensitization and CBD by LTW Average Exposure Quartile in NJMRC Data Set
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sensitized Total
Average exposure ([mu]g/m\3\) Group size only CBD sensitized Total % CBD %
--------------------------------------------------------------------------------------------------------------------------------------------------------
0.0-0.080............................................... 91 1 1 2 2.2 1.0
0.081-0.18.............................................. 73 2 4 6 8.2 5.5
0.19-0.51............................................... 77 0 6 6 7.8 7.8
0.51-2.15............................................... 78 4 8 12 15.4 10.3
-----------------------------------------------------------------------------------------------
Total............................................... 319 7 19 26 8.2 6.0
--------------------------------------------------------------------------------------------------------------------------------------------------------
Table VI-7--Prevalence of Sensitization and CBD by Cumulative Exposure Quartile in NJMRC Data Set
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sensitized Total
Cumulative exposure ([mu]g/m\3\-yrs) Group size only CBD sensitized Total % CBD %
--------------------------------------------------------------------------------------------------------------------------------------------------------
0.0-0.147............................................... 81 2 2 4 4.9 2.5
0.148-1.467............................................. 79 0 2 2 2.5 2.5
1.468-7.008............................................. 79 3 8 11 13.9 8.0
7.009-61.86............................................. 80 2 7 9 11.3 8.8
-----------------------------------------------------------------------------------------------
Total............................................... 319 7 19 26 8.2 6.0
--------------------------------------------------------------------------------------------------------------------------------------------------------
Table VI-8--Prevalence of Sensitization and CBD by Highest-Exposed Job Exposure Quartile in NJMRC Data Set
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sensitized Total
HEJ exposure ([mu]g/m\3\) Group size only CBD sensitized Total % CBD %
--------------------------------------------------------------------------------------------------------------------------------------------------------
0.0-0.086............................................... 86 1 0 1 1.2 0.0
0.091-0.214............................................. 81 1 6 7 8.6 7.4
0.387-0.691............................................. 76 2 9 11 14.5 11.8
0.954-2.213............................................. 76 3 4 7 9.2 5.3
-----------------------------------------------------------------------------------------------
Total............................................... 319 7 19 26 8.2 6.0
--------------------------------------------------------------------------------------------------------------------------------------------------------
Table VI-6 shows increasing prevalence of total sensitization and
CBD with increasing LTW average exposure, measured both as average and
cumulative exposure. The lowest prevalence of sensitization and CBD was
observed among workers with average exposure levels less than or equal
to 0.08 [mu]g/m\3\, where two sensitized workers (2.2 percent)
including one case of CBD (1.0 percent) were found. The sensitized
worker in this category without CBD had worked at the facility as an
inspector since 1972, one of the lowest-exposed jobs at the plant.
[[Page 47637]]
Because the job was believed to have very low exposures, it was not
sampled prior to 1998. Thus, estimates of exposures in this job are
based on data from 1998-2003 only. It is possible that exposures
earlier in this worker's employment history were somewhat higher than
reflected in his estimated average exposure. The worker diagnosed with
CBD in this group had been hired in 1996 in production control, and had
an estimated average exposure of 0.08 [mu]g/m\3\. He was diagnosed with
CBD in 1997.
The second quartile of LTW average exposure (0.081--0.18 [mu]g/
m\3\) shows a marked rise in overall prevalence of beryllium-related
health effects, with six workers sensitized (8.2 percent), of whom four
(5.5 percent) were diagnosed with CBD. Among six sensitized workers in
the third quartile (0.19--0.50 [mu]g/m\3\), all were diagnosed with CBD
(7.8 percent). Another increase in prevalence is seen from the third to
the fourth quartile, with 12 cases of sensitization (15.4 percent),
including eight (10.3 percent) diagnosed with CBD.
The quartile analysis of cumulative exposure also shows generally
increasing prevalence of sensitization and CBD with increasing
exposure. As shown in Table VI-7, the lowest prevalences of CBD and
sensitization are in the first two quartiles of cumulative exposure
(0.0-0.147 [mu]g/m\3\-yrs, 0.148-1.467 [mu]g/m\3\-yrs). The upper bound
on this cumulative exposure range, 1.467 [mu]g/m\3\-yrs, is the
cumulative exposure that a worker would have if exposed to beryllium at
a level of 0.03 [mu]g/m\3\ for a working lifetime of 45 years; 0.15
[mu]g/m\3\ for ten years; or 0.3 [mu]g/m\3\ for five years.
A sharp increase in prevalence of sensitization and CBD and total
sensitization occurs in the third quartile (1.468-7.008 [mu]g/m\3\-
yrs), with roughly similar levels of both in the highest group (7.009-
61.86 [mu]g/m\3\-yrs). Cumulative exposures in the third quartile would
be experienced by a worker exposed for 45 years to levels between 0.03
and 0.16 [mu]g/m\3\, for 10 years to levels between 0.15 and 0.7 [mu]g/
m\3\, or for five years to levels between 0.3 and 1.4 [mu]g/m\3\.
When workers' exposures from their highest-exposed job are
considered, the exposure-response pattern is similar to that for LTW
average exposure in the lower quartiles (Table VI-8). The lowest
prevalence is observed in the first quartile (0.0-0.86 [mu]g/m\3\),
with sharply rising prevalence from first to second and second to third
exposure quartiles. The prevalence of sensitization and CBD in the top
quartile (0.954-2.213 [mu]g/m\3\) decreases relative to the third, with
levels similar to the overall prevalence in the dataset. Many workers
in the highest exposure quartiles are long-time employees, who were
hired during the early years of the shop when exposures were highest.
One possible explanation for the drop in prevalence in the highest
exposure quartiles is that highly-exposed workers from early periods
may have developed CBD and left the plant before sensitization testing
began in 1995.
It is of some value to compare the prevalence analysis of the
Cullman (NJMRC) data set with the results of the Reading and Tucson
studies discussed previously. An exact comparison is not possible, in
part because the Reading and Tucson exposure values are associated with
jobs and the NJMRC values are estimates of lifetime weighted average,
cumulative, and highest-exposed job (HEJ) exposures for individuals in
the data set. Nevertheless, OSHA believes it is possible to very
roughly compare the results of the Reading and Tucson studies and the
results of the NJMRC prevalence analysis presented above. As discussed
in detail below, OSHA found a general consistency between the
prevalence of sensitization and CBD in the quartiles of average
exposure in the NJMRC data set and the prevalence of sensitization and
CBD at the Reading and Tucson plants for similar exposure values.
Personal lapel samples collected at the Reading plant between 1995
and 2000 were relatively low overall (median of 0.073 [mu]g/m\3\), with
higher exposures (median of 0.149 [mu]g/m\3\) concentrated in the wire
annealing and pickling process (Schuler et al., 2005). Exposures in the
Reading plant in this time period were similar to the second-quartile
average (Table VI-6-0.081-0.18 [mu]g/m\3\). The prevalence of
sensitization observed in the NJMRC second quartile was 8.2 percent and
appears roughly consistent with the prevalence of sensitization among
Reading workers in the mid-1990s (11.5 percent). The reported
prevalence of CBD (3.9 percent) among the Reading workforce was also
consistent with that observed in the second NJMRC quartile (5.5
percent), After 2000, exposure controls reduced exposures in most
Reading jobs to median levels below 0.03 [mu]g/m\3\, with a median
value of 0.1 [mu]g/m\3\ for the wire annealing and pickling process.
The wire annealing and pickling process was enclosed and stringent
respirator and skin protection requirements were applied for workers in
that area after 2002, essentially eliminating airborne and dermal
exposures for those workers. Thomas et al. (2009) reported that one of
45 workers (2.2 percent) hired after the enclosure in 2002 was
confirmed as sensitized, a value in line with the sensitization
prevalence observed in the lowest quartiles of average exposure (2.2
percent, 0.0-0.08 [mu]g/m\3\).
As with Reading, the prevalence of sensitization observed at Tucson
and in the NJMRC data set are not exactly comparable due to the
different natures of the exposure estimates. Nevertheless, in a rough
sense the results of the Tucson study and the NJMRC prevalence analysis
appear similar. In Tucson, a 1998 BeLPT screening showed that 9.5
percent of workers hired after 1992 were sensitized (Henneberger et
al., 2001). Personal full-shift exposure samples collected in
production jobs between 1994 and 1999 had a median of 0.2 [mu]g/m\3\
(0.1 [mu]g/m\3\ for non-production jobs). In the NJMRC data set, a
sensitization prevalence of 8.2 percent was seen among workers with
average exposures between 0.081 and 0.18 [mu]g/m\3\. At the time of the
1998 screening, workers hired after 1992 had a median one year since
first beryllium exposure and, therefore, CBD prevalence was only 1.4
percent. This prevalence is likely an underestimate since CBD often
requires more than a year to develop. Longer-term workers at the Tucson
plant with a median 14 years since first beryllium exposure had a 9.1
percent prevalence of CBD. There was a 5.5 percent prevalence of CBD
among the entire workforce (Henneberger et al., 2001). As with the
Reading plant employees, this reported prevalence is reasonably
consistent with the 5.5 percent CBD prevalence observed in the second
NJMRC quartile.
Beginning in 1999, the Tucson facility instituted strict
requirements for respiratory protection and other PPE, essentially
eliminating airborne and dermal exposure for most workers. After these
requirements were put in place, Cummings et al. (2007) reported only
one case of sensitization (1 percent; associated with a PPE failure)
among 97 workers hired between 2000 and 2004. This appears roughly in
line with the sensitization prevalence of 2.2 percent observed in the
lowest quartiles of average exposure (0.0-0.08 [mu]g/m\3\) in the NJMRC
data set.
While the literature analysis presented here shows a clear
reduction in risk with well-controlled airborne exposures (<= 0.1
[mu]g/m\3\ on average) and protection from dermal exposure, the level
of detail presented in the published studies limits the Agency's
ability to characterize risk at all the alternate PELs OSHA is
considering. To better understand these risks, OSHA
[[Page 47638]]
used the NJMRC dataset to characterize risk of sensitization and CBD
among workers exposed to each of the alternate PELs under consideration
in the proposed beryllium rule.
F. OSHA's Statistical Modeling
OSHA's contractor performed a complementary log-log proportional
hazards model using the NJMRC data set. The proportional hazards model
is a generalization of logistic regression that allows for time-
dependent exposures and differential time at risk. The proportional
hazards model accounts for the fact that individuals in the dataset are
followed for different amounts of time, and that their exposures change
over time. The proportional hazards model provides hazards ratios,
which estimate the relative risk of disease at a specified time for
someone with exposure level 1 compared to exposure level 2. To perform
this analysis, OSHA's contractor constructed exposure files with time-
dependent cumulative and average exposures for each worker in the data
set in each year that a case of sensitization or CBD was identified.
Workers were included in only those years after they started working at
the plant and continued to be followed. Sensitized cases were not
included in analysis of sensitization after the year in which they were
identified as being sensitized, and CBD cases were not included in
analyses of CBD after the year in which they were diagnosed with CBD.
Follow-up is censored after 2002 because work histories were deemed to
be less reliable after that date.
The results of the discrete proportional hazards analyses are
summarized in Tables VI-9-12 below. All coefficients used in the models
are displayed, including the exposure coefficient, the model constant
for diagnosis in 1995, and additional exposure-independent coefficients
for each succeeding year (1996-1999 for sensitization and 1996-2002 for
CBD) of diagnosis that are fit in the discrete time proportional
hazards modeling procedure. Model equations and variables are explained
more fully in the companion risk assessment background document.
Relative risk of sensitization increased with cumulative exposure
(p = 0.05). A positive, but not statistically significant, association
was observed with LTW average exposure (p = 0.09). The association was
much weaker for exposure duration (p = 0.31), consistent with the
expected biological action of an immune hypersensitivity response where
onset is believed to be more dependent on the concentration of the
sensitizing agent at the target site rather than the number of years of
occupational exposure. The association was also much weaker for
highest-exposed job (HEJ) exposure (p = 0.3).
Table VI-9--Proportional Hazards Model--Cumulative Exposure and Sensitization
----------------------------------------------------------------------------------------------------------------
Variable Coefficient 95% Confidence interval P-value
----------------------------------------------------------------------------------------------------------------
Cumulative Exposure ([mu]g/m\3\-yrs).......... 0.031 0.00 to 0.063................... 0.05
constant...................................... -3.48 -4.27 to -2.69.................. <0.001
1996.......................................... -1.49 -3.04 to 0.06................... 0.06
1997.......................................... -0.29 -1.31 to 0.72................... 0.57
1998.......................................... -1.56 -3.11 to -0.01.................. 0.05
1999.......................................... -1.57 -3.12 to -0.02.................. 0.05
----------------------------------------------------------------------------------------------------------------
Table VI-10--Proportional Hazards Model--LTW Average Exposure and Sensitization
----------------------------------------------------------------------------------------------------------------
Variable Coefficient 95% Confidence interval P-value
----------------------------------------------------------------------------------------------------------------
Average Exposure ([mu]g/m\3\)................. 0.54 -0.09 to 1.17................... 0.09
constant...................................... -3.55 -4.42 to -2.69.................. <0.001
1996.......................................... -1.48 -3.03 to 0.07................... 0.06
1997.......................................... -0.29 -1.31 to 0.72................... 0.57
1998.......................................... -1.54 -3.09 to 0.01................... 0.05
1999.......................................... -1.53 -3.08 to 0.03................... 0.05
----------------------------------------------------------------------------------------------------------------
Table VI-11--Proportional Hazards Model--Exposure Duration and Sensitization
----------------------------------------------------------------------------------------------------------------
Variable Coefficient 95% Confidence interval P-value
----------------------------------------------------------------------------------------------------------------
Exposure Duration (years)..................... 0.03 -0.03 to 0.08................... 0.31
constant...................................... -3.55 -4.57 to -2.53.................. <0.001
1996.......................................... -1.48 -3.03 to 0.70................... 0.06
1997.......................................... -0.30 -1.31 to 0.72................... 0.57
1998.......................................... -1.59 -3.14 to -0.04.................. 0.05
1999.......................................... -1.62 -3.17 to -0.72.................. 0.04
----------------------------------------------------------------------------------------------------------------
Table VI-12--Proportional Hazards Model--HEJ Exposure and Sensitization
----------------------------------------------------------------------------------------------------------------
Variable Coefficient 95% Confidence interval P-value
----------------------------------------------------------------------------------------------------------------
HEJ Exposure ([mu]g/m\3\)..................... 0.31 -0.27 to 0.88................... 0.30
constant...................................... -3.42 -4.27 to -2.56.................. <0.001
1996.......................................... -1.49 -3.04 to 0.06................... 0.06
1997.......................................... -0.31 -1.33 to 0.70................... 0.55
1998.......................................... -1.59 -3.14 to -0.04.................. 0.05
1999.......................................... -1.60 -3.15 to -0.05.................. 0.04
----------------------------------------------------------------------------------------------------------------
[[Page 47639]]
The proportional hazards models for the CBD endpoint (Tables VI-13
through 16 below) showed positive relationships with cumulative
exposure (p = 0.09) and duration of exposure (p = 0.10). However, the
association with the cumulative exposure metric was not as strong as
that for sensitization, probably due to the smaller number of CBD
cases. LTW average exposure and HEJ exposure were not closely related
to relative risk of CBD (p-values > 0.5).
Table VI-13--Proportional Hazards Model--Cumulative Exposure and CBD
----------------------------------------------------------------------------------------------------------------
Variable Coefficient 95% Confidence interval P-value
----------------------------------------------------------------------------------------------------------------
Cumulative Exposure ([mu]g/m\3\-yrs).......... 0.03 .00 to 0.07..................... 0.09
constant...................................... -3.77 -4.67 to -2.86.................. <0.001
1997.......................................... -0.59 -1.86 to 0.68................... 0.36
1998.......................................... -2.01 -4.13 to 0.11................... 0.06
1999.......................................... -0.63 -1.90 to 0.64................... 0.33
2002.......................................... -2.13 -4.25 to -0.01.................. 0.05
----------------------------------------------------------------------------------------------------------------
Table VI-14--Proportional Hazards Model--LTW Average Exposure and CBD
----------------------------------------------------------------------------------------------------------------
Variable Coefficient 95% Confidence interval P-value
----------------------------------------------------------------------------------------------------------------
Average Exposure ([mu]g/m\3\)................. 0.24 -0.59 to 1.06................... 0.58
constant...................................... -3.62 -4.60 to -2.64.................. <0.001
1997.......................................... -0.61 -1.87 to 0.66................... 0.35
1998.......................................... -2.02 -4.14 to 0.10................... 0.06
1999.......................................... -0.64 -1.92 to 0.63................... 0.32
2002.......................................... -2.15 -4.28 to -0.02.................. 0.05
----------------------------------------------------------------------------------------------------------------
Table VI-15--Proportional Hazards Model--Exposure Duration and CBD
----------------------------------------------------------------------------------------------------------------
Variable Coefficient 95% Confidence interval P-value
----------------------------------------------------------------------------------------------------------------
Exposure Duration (yrs)....................... 0.05 -0.01 to 0.11................... 0.10
constant...................................... -4.18 -5.40 to -2.96.................. <0.001
1997.......................................... -0.53 1.84 to 0.69.................... 0.38
1998.......................................... -2.01 -4.13 to 0.11................... 0.06
1999.......................................... -0.67 -1.94 to 0.60................... 0.30
2002.......................................... -2.22 -4.34 to -0.10.................. 0.04
----------------------------------------------------------------------------------------------------------------
Table VI-16--Proportional Hazards Model--HEJ Exposure and CBD
----------------------------------------------------------------------------------------------------------------
Variable Coefficient 95% Confidence interval P-value
----------------------------------------------------------------------------------------------------------------
HEJ Exposure ([mu]g/m\3\)..................... 0.03 -0.70 to 0.77................... 0.93
constant...................................... -3.49 -4.45 to -2.53.................. <0.001
1997.......................................... -0.62 -1.88 to 0.65................... 0.34
1998.......................................... -2.05 -4.16 to 0.07................... 0.06
1999.......................................... -0.68 -1.94 to 0.59................... 0.30
2002.......................................... -2.21 -4.33 to -0.09.................. 0.04
----------------------------------------------------------------------------------------------------------------
In addition to the models reported above, comparable models were
fit to the upper 95 percent confidence interval of the HEJ exposure;
log-transformed cumulative exposure; log-transformed LTW average
exposure; and log-transformed HEJ exposure. Each of these measures was
positively but not significantly associated with sensitization.
OSHA used the proportional hazards models based on cumulative
exposure, shown in Tables VI-9 and VI-13, to derive quantitative risk
estimates. Of the metrics related to exposure level, the cumulative
exposure metric showed the most consistent association with
sensitization and CBD in these models. Table VI-17 summarizes these
risk estimates for sensitization and the corresponding 95 percent
confidence intervals separately for 1995 and 1999, the years with the
highest and lowest baseline rates, respectively. The estimated risks
for CBD are presented in VI-18. The expected number of cases is based
on the estimated conditional probability of being a case in the given
year. The models provide time-specific point estimates of risk for a
worker with any given exposure level, and the corresponding interval is
based on the uncertainty in the exposure coefficient (i.e., the
predicted values based on the 95 percent confidence limits for the
exposure coefficient).
Each estimate represents the number of sensitized workers the model
predicts in a group of 1000 workers at risk during the given year with
an exposure history at the specified level and duration. For example,
in the exposure scenario where 1000 workers are occupationally exposed
to 2 [mu]g/m\3\ for 10 years in 1995, the model predicts that about 56
(55.7) workers would be sensitized that year. The model for CBD
predicts that about 42 (41.9) workers would be diagnosed with CBD that
year.
[[Page 47640]]
Table VI-17a--Predicted Cases of Sensitization per 1000 Workers Exposed at Current and Alternate PELs Based on Proportional Hazards Model, Cumulative
Exposure Metric, With Corresponding Interval Based on the Uncertainty in the Exposure Coefficient
[1995 Baseline]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Exposure duration
-------------------------------------------------------------------------------------------------------
5 years 10 years 20 years 45 years
1995 Exposure level ([mu]g/m\3\) -------------------------------------------------------------------------------------------------------
Cumulative
([mu]g/m\3\- cases/ 1000 [mu]g/m\3\- cases/ 1000 [mu]g/m\3\- cases/ 1000 [mu]g/m\3\- cases/ 1000
yrs) yrs yrs yrs
--------------------------------------------------------------------------------------------------------------------------------------------------------
2.0............................................. 10.0 41.1 20.0 55.7 40.0 101.0 90.0 394.4
30.3-56.2 30.3-102.9 30.3-318.1 30.3-999.9
1.0............................................. 5.0 35.3 10.0 41.1 20.0 55.7 45.0 116.9
30.3-41.3 30.3-56.2 30.3-102.9 30.3-408.2
0.5............................................. 2.5 32.7 5.0 35.3 10.0 41.1 22.5 60.0
30.3-35.4 30.3-41.3 30.3-56.2 30.3-119.4
0.2............................................. 1.0 31.3 2.0 32.2 4.0 34.3 9.0 39.9
30.3-32.3 30.3-34.3 30.3-38.9 30.3-52.9
0.1............................................. 0.5 30.8 1.0 31.3 2.0 32.2 4.5 34.8
30.3-31.3 30.3-32.3 30.3-34.3 30.3-40.1
--------------------------------------------------------------------------------------------------------------------------------------------------------
Table VI-17b--Predicted Cases of Sensitization per 1000 Workers Exposed at Current and Alternate PELs Based on Proportional Hazards Model, Cumulative
Exposure Metric, With Corresponding Interval Based on the Uncertainty in the Exposure Coefficient
[1999 Baseline]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Exposure duration
-------------------------------------------------------------------------------------------------------
5 years 10 years 20 years 45 years
1999 Exposure level ([mu]g/m\3\) -------------------------------------------------------------------------------------------------------
Cumulative
([mu]g/m\3\- cases/ 1000 [mu]g/m\3\- cases/ 1000 [mu]g/m\3\- cases/ 1000 [mu]g/m\3\- cases/ 1000
yrs) yrs yrs yrs
--------------------------------------------------------------------------------------------------------------------------------------------------------
2.0............................................. 10.0 8.4 20.0 11.5 40.0 21.3 90.0 96.3
6.2-11.6 6.2-21.7 6.2-74.4 6.2-835.4
1.0............................................. 5.0 7.2 10.0 8.4 20.0 11.5 45.0 24.8
6.2-8.5 6.2-11.6 6.2-21.7 6.2-100.5
0.5............................................. 2.5 6.7 5.0 7.2 10.0 8.4 22.5 12.4
6.2-7.3 6.2-8.5 6.2-11.6 6.2-25.3
0.2............................................. 1.0 6.4 2.0 6.6 4.0 7.0 9.0 8.2
6.2-6.6 6.2-7.0 6.2-8.0 6.2-10.9
0.1............................................. 0.5 6.3 1.0 6.4 2.0 6.6 4.5 7.1
6.2-6.4 6.2-6.6 6.2-7.0 6.2-8.2
--------------------------------------------------------------------------------------------------------------------------------------------------------
Table VI-18a--Predicted Number of Cases of CBD per 1000 Workers Exposed at Current and Alternative PELs Based on Proportional Hazards Model, Cumulative
Exposure Metric, With Corresponding Interval Based on the Uncertainty in the Exposure Coefficient
[1995 baseline]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Exposure duration
-------------------------------------------------------------------------------------------------------
5 years 10 years 20 years 45 years
1995 Exposure level ([mu]g/m\3\) -------------------------------------------------------------------------------------------------------
Cumulative Estimated Estimated Estimated Estimated
([mu]g/m\3\- cases/1000 [mu]g/m\3\- cases/1000 [mu]g/m\3\- cases/1000 [mu]g/m\3\- cases/1000
yrs) 95% c.i. yrs 95% c.i. yrs 95% c.i. yrs 95% c.i.
--------------------------------------------------------------------------------------------------------------------------------------------------------
........... 30.9 ........... 41.9 ........... 76.6 ........... 312.9
2.0............................................. 10.0 22.8-44.0 20.0 22.8-84.3 40.0 22.8-285.5 90.0 22.8-999.9
........... 26.6 ........... 30.9 ........... 41.9 ........... 88.8
1.0............................................. 5.0 22.8-31.7 10.0 22.8-44.0 20.0 22.8-84.3 45.0 22.8-375.0
........... 24.6 ........... 26.6 ........... 30.9 ........... 45.2
0.5............................................. 2.5 22.8-26.9 5.0 22.8-31.7 10.0 22.8-44.0 22.5 22.8-98.9
........... 23.5 ........... 24.2 ........... 25.8 ........... 30.0
0.2............................................. 1.0 22.8-24.3 2.0 22.8-26.0 4.0 22.8-29.7 9.0 22.8-41.3
........... 23.1 ........... 23.5 ........... 24.2 ........... 26.2
0.1............................................. 0.5 22.8-23.6 1.0 22.8-24.3 2.0 22.8-26.0 4.5 22.8-30.7
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 47641]]
Table VI-18b--Predicted Number of Cases of CBD per 1000 Workers Exposed at Current and Alternative PELs Based on Proportional Hazards Model, Cumulative
Exposure Metric, With Corresponding Interval Based on the Uncertainty in the Exposure Coefficient
[2002 baseline]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Exposure duration
-------------------------------------------------------------------------------------------------------
5 years 10 years 20 years 45 years
2002 Exposure level ([mu]g/m\3\) -------------------------------------------------------------------------------------------------------
Cumulative Estimated Estimated Estimated Estimated
([mu]g/m\3\- cases/1000 [mu]g/m\3\- cases/1000 [mu]g/m\3\- cases/1000 [mu]g/m\3\- cases/1000
yrs) 95% c.i. yrs 95% c.i. yrs 95% c.i. yrs 95% c.i.
--------------------------------------------------------------------------------------------------------------------------------------------------------
........... 3.7 ........... 5.1 ........... 9.4 ........... 43.6
2.0............................................. 10.0 2.7-5.3 20.0 2.7-10.4 40.0 2.7-39.2 90.0 2.7-679.8
........... 3.2 ........... 3.7 ........... 5.1 ........... 11.0
1.0............................................. 5.0 2.7-3.8 10.0 2.7-5.3 20.0 2.7-10.4 45.0 2.7-54.3
........... 3.0 ........... 3.2 ........... 3.7 ........... 5.5
0.5............................................. 2.5 2.7-3.2 5.0 2.7-3.8 10.0 2.7-5.3 22.5 2.7-12.3
........... 2.8 ........... 2.9 ........... 3.1 ........... 3.6
0.2............................................. 1.0 2.7-2.9 2.0 2.7-3.1 4.0 2.7-3.6 9.0 2.7-5.0
........... 2.8 ........... 2.8 ........... 2.9 ........... 3.1
0.1............................................. 0.5 2.7-2.8 1.0 2.7-2.9 2.0 2.7-3.1 4.5 2.7-3.7
--------------------------------------------------------------------------------------------------------------------------------------------------------
The statistical modeling analysis predicts high risk of both
sensitization (96-394 cases per 1000, or 9.6-39.4 percent) and CBD (44-
313 cases per 1000, or 4.4-31.3 percent) at the current PEL of 2 [mu]g/
m\3\ for an exposure duration of 45 years (90 [mu]g/m\3\-yr). The
predicted risks of < 8.2-39.9 per 1000 (0.8-3.9 percent) cases of
sensitization or 3.6 to 30.0 per 1000 (0.4-3 percent) cases of CBD are
substantially less for a 45-year exposure at the proposed PEL, 0.2
[mu]g/m\3\ (9 [mu]g/m\3\-yr).
The model estimates are not directly comparable to prevalence
values discussed in previous sections. They assume a group without
turnover and are based on a comparison of unexposed and hypothetically
exposed workers at specific points in time, whereas the prevalence
analysis simply reports the percentage of workers at the Cullman plant
with sensitization or CBD in each exposure category. Despite the
difficulty of direct comparison, the level of risk seen in the
prevalence analysis and predicted in the modeling analysis appear
roughly similar at low exposures. In the second quartile of cumulative
exposure (0.148-1.467 [mu]g/m\3\-yr), prevalence of sensitization and
CBD was 2.5 percent. This is roughly congruent with the model
predictions for workers with cumulative exposures between 0.5 and 1
[mu]g/m\3\-yr: 6.3-31.3 cases of sensitization per 1000 workers (0.6-
3.1 percent) and 2.8 to 23.5 cases of CBD per 1000 workers (0.28-2.4
percent). As discussed in the background document for this analysis,
most workers in the data set had low cumulative exposures (roughly half
below 1.5 [mu]g/m\3\-years). It is difficult to make any statement
about the results at higher levels, because there were few workers with
high exposure levels and the higher quartiles of cumulative exposure
include an extremely wide range of exposures. For example, the highest
quartile of cumulative exposure was 7.009-61.86 [mu]g/m\3\-yr. This
quartile, which showed an 11.3 percent prevalence of sensitization and
8.8 percent prevalence of CBD, includes the cumulative exposure that a
worker exposed for 45 years at the proposed PEL would experience (9
[mu]g/m\3\-yr) near its lower bound. Its upper bound approaches the
cumulative exposure that a worker exposed for 45 years at the current
PEL would experience (90 [mu]g/m\3\-yr).
Due to limitations including the size of the dataset, relatively
limited exposure data from the plant's early years, study size-related
constraints on the statistical analysis of the dataset, and limited
follow-up time on many workers, OSHA must interpret the model-based
risk estimates presented in Tables VI-17 and VI-18 with caution. The
Cullman study population is a relatively small group and can support
only limited statistical analysis. For example, its size precludes
inclusion of multiple covariates in the exposure-response models or a
two-stage exposure-response analysis to model both sensitization and
the subsequent development of CBD within the subpopulation of
sensitized workers. The limited size of the Cullman dataset is
characteristic of studies on beryllium-exposed workers in modern, low-
exposure environments, which are typically small-scale processing
plants (up to several hundred workers, up to 20-30 cases). However,
these recent studies also have important strengths: They include
workers hired after the institution of stringent exposure controls, and
have extensive exposure sampling using full-shift personal lapel
samples. In contrast, older studies of larger populations tend to have
higher exposures, less exposure data, and exposure data collected in
short-term samples or outside of workers' breathing zones.
Another limitation of the Cullman dataset, which is common to
recent low-exposure studies, is the short follow-up time available for
many of the workers. While in some cases CBD has been known to develop
in short periods (< 2 years), it more typically develops over a longer
time period. Sensitization occurs in a typically shorter time frame,
but new cases of sensitization have been observed in workers exposed to
beryllium for many years. Because the data set is limited to
individuals then working at the plant, the Cullman data set cannot
capture CBD occurring among workers who retire or leave the plant. OSHA
expects that the dataset does not fully represent the risk of
sensitization, and is likely to particularly under-represent CBD among
workers exposed to beryllium at this facility. The Agency believes the
short follow-up time to be a significant source of uncertainty in the
statistical analysis, a factor likely to lead to underestimation of
risk in this population.
A common source of uncertainty in quantitative risk assessment is
the series of choices made in the course of statistical analysis, such
as model type, inclusion or exclusion of additional explanatory
variables, and the assumption of linearity in exposure-response.
Sensitivity analyses and statistical checks were conducted to test the
validity of the choices and
[[Page 47642]]
assumptions in the exposure-response analysis and the impact of
alternative choices on the end results. These analyses did not yield
substantially different results, adding to OSHA's confidence in the
conclusions of its preliminary risk assessment.
OSHA's contractor examined whether smoking and age were confounders
in the exposure-response analysis by adding them as variables in the
discrete proportional hazards model. Neither smoking status nor age was
a statistically significant predictor of sensitization or CBD. The
model coefficients, 95 percent confidence intervals, and p values can
be found in the background document. A sensitivity analysis was done
using the standard Cox model that treats survival time as continuous
rather than discrete. The model coefficients with the standard Cox
using cumulative exposure were 0.025 and very similar to the 0.03
reported in Tables VI-9 and VI-13 above. The interaction between
exposure and follow-up time was not significant in these models,
suggesting that the proportional hazard assumption should not be
rejected. The proportional hazards model assumes a linear relationship
between exposure level and relative risk. The linearity assumption was
assessed using a fractional polynomial approach. For both sensitization
and CBD, the best-fitting fractional polynomial model did not fit
significantly better than the linear model. This result supports OSHA's
use of the linear model to estimate risk. The details of these
statistical analyses can be found in the background document.
The possibility that the number of times a worker has been tested
for sensitization might influence the probability of a positive test
was examined (surveillance bias). Surveillance bias could occur if
workers were tested because they showed some sign of disease, and not
tested otherwise. It is also possible that the original analysis
included erroneous assumptions about the dates of testing for
sensitization and CBD. OSHA's contractor performed a sensitivity
analysis, modifying the original analysis to gauge the effect of
different assumptions about testing dates. In the sensitivity analysis,
the exposure coefficients increased for all four indices of exposure
when the sensitization analysis was restricted to times when cohort
members were assumed to be tested. The exposure coefficient was
statistically significant for duration of exposure but not for
cumulative, LTW average, or HEJ exposure. The increase in exposure
coefficients suggests that the original models may have underestimated
the exposure-response relationship for sensitization and CBD.
Errors in exposure measurement are a common source of uncertainty
in quantitative risk assessments. Because errors in high exposures can
heavily influence modeling results, OSHA's contractor performed
sensitivity analyses excluding the highest 5 percent of cumulative
exposures (those above 25.265 [mu]g/m\3\-yrs) and the highest 10
percent of cumulative exposures (those above 18.723 [mu]g/m\3\-yrs). As
discussed in more detail in the background document, exposure
coefficients were not statistically significant when these exposures
were dropped. This is not surprising, given that the exclusion of high
exposure values reduced the size of the data set. Prior to excluding
high exposure values, the data set was already relatively small and
many of the exposure coefficients were non-significant or weakly
significant in the original analyses. As a result, the sensitivity
analyses did not provide much information about uncertainty due to
exposure measurement error and its effects on the modeling analysis.
Particle size, particle surface area, and beryllium compound
solubility are believed to be important factors influencing the risk of
sensitization and CBD among beryllium-exposed workers. The workers at
the Cullman machining plant were primarily handling insoluble beryllium
compounds, such as beryllium metal and beryllium metal/beryllium oxide
composites. Particle size distributions from a limited number of
airborne beryllium samples collected just after the 1996 installation
of engineering controls indicate worker exposure to a substantial
proportion of respirable particulates. There was no available particle
size data for the 1980 to 1995 period prior to installation of
engineering controls when total beryllium mass exposure levels were
greatest. Particle size data was also lacking from 1998 to 2003 when
additional control measures were in place and total beryllium mass
exposures were lowest. For these reasons, OSHA was not able to
quantitatively account for the influence of particle size and
solubility in developing the risk estimates based on the Cullman data
set. However, it is not unreasonable to expect the CBD experienced by
this cohort to generally reflect the risk from exposure to beryllium
that is relatively insoluble and enriched with respirable particles. As
explained previously, the role of particle size and surface area on
risk of sensitization is more difficult to predict.
Additional uncertainty is introduced when extrapolating the
quantitative estimates presented above to operations that process
beryllium compounds that have different solubility and particle
characteristics than those encountered at the Cullman machining plant.
OSHA does not have sufficient information to quantitatively assess the
degree to which risks of beryllium sensitization and CBD based on the
NJMRC data may be impacted in workplaces where such beryllium forms and
processes are used. However, OSHA does not expect this uncertainty to
alter its qualitative conclusions with regard to the risk at the
current PEL and at alternate PELs as low as 0.1 [mu]g/m\3\. The
existing studies provide clear evidence of sensitization and CBD risk
among workers exposed to a number of beryllium forms as a result of
different processes such as beryllium machining, beryllium-copper alloy
production, and beryllium ceramics production. The Agency believes all
of these forms of beryllium exposure contribute to the overall risk of
sensitization and CBD among beryllium-exposed workers.
G. Lung Cancer
OSHA considers lung cancer to be an important health endpoint for
beryllium-exposed workers. The International Agency for Research on
Cancer (IARC), National Toxicology Program (NTP), and American
Conference of Governmental Industrial Hygienists (ACGIH) have all
classified beryllium as a known human carcinogen. The National Academy
of Sciences (NAS), Environmental Protection Agency, the Agency for
Toxic Substances and Disease Registry (ATSDR), the National Institute
of Occupational Safety and Health (NIOSH), and other reputable
scientific organizations have reviewed the scientific evidence
demonstrating that beryllium is associated with an increased incidence
of cancer. OSHA also has performed an extensive review of the
scientific literature regarding beryllium and cancer. This includes an
evaluation of human epidemiological, animal cancer, and mechanistic
studies described in the Health Effects section of this preamble. Based
on the weight of evidence, the Agency has preliminarily determined
beryllium to be an occupational carcinogen.
Although epidemiological and animal evidence supports a conclusion
of beryllium carcinogenicity, there is considerable uncertainty
surrounding the mechanism of carcinogenesis for beryllium. The evidence
for direct genotoxicity of beryllium and its compounds has been limited
and
[[Page 47643]]
inconsistent (NAS, 2008; IARC, 1993; EPA, 1998; NTP, 2002; ATSDR,
2002). One plausible pathway for beryllium carcinogenicity described in
the Health Effects section of this preamble includes a chronic,
sustained neutrophilic inflammatory response that induces epigenetic
alterations leading to the neoplastic changes necessary for
carcinogenesis. The National Cancer Institute estimates that nearly
one-third of all cancers are caused by chronic inflammation (NCI,
2009). This mechanism of action has also been hypothesized for
crystalline silica and other agents that are known to be human
carcinogens but have limited evidence of genotoxicity.
OSHA's review of epidemiological studies of lung cancer mortality
among beryllium workers found that most did not characterize exposure
levels sufficiently for exposure-response analysis. However, one NIOSH
study evaluated the association between beryllium exposure and lung
cancer mortality based on data from a beryllium processing plant in
Reading, PA (Sanderson et al., 2001a). As discussed in the Health
Effects section of this preamble, this case-control study evaluated
lung cancer incidence in a cohort of workers employed at the plant from
1940 to 1969 and followed through 1992. For each lung cancer victim, 5
age- and race-matched controls were selected by incidence density
sampling, for a total of 142 lung cancer cases and 710 controls.
Between 1971 and 1992, the plant collected close to 7,000 high
volume filter samples consisting of both general area and short-term,
task-based breathing zone measurements for production jobs and
exclusively area measurements for office, lunch, and laboratory areas
(Sanderson et al., 2001b). In addition, a few (< 200) impinger and
high-volume filter samples were collected by other organizations
between 1947 and 1961, and about 200 6-to-8-hour personal samples were
collected in 1972 and 1975. Daily-weighted-average (DWA) exposure
calculations based on the impinger and high-volume samples collected
prior to the 1960s showed that exposures in this period were extremely
high. For example, about half of production jobs had estimated DWAs
ranging between 49 and 131 [mu]g/m\3\ in the period 1935-1960, and many
of the ``lower-exposed'' jobs had DWAs of approximately 20-30 [mu]g/
m\3\ (Table II, Sanderson et al., 2001b). Exposures were reported to
have decreased between 1959 and 1962 with the installation of
ventilation controls and improved housekeeping and following the
passage of the OSH Act in 1970. While no exposure measurements were
available from the period 1961-1970, measurements from the period 1971-
1980 showed a dramatic reduction in exposures plant-wide. Estimated
DWAs for all jobs in this period ranged from 0.1 [mu]g/m\3\ to 1.9
[mu]g/m\3\. Calendar-time-specific beryllium exposure estimates were
made for every job based on the DWA calculations and were used to
estimate workers' cumulative, average, and maximum exposures. Exposure
estimates were lagged by 10 and 20 years in order to account for
exposures that did not contribute to lung cancer because they occurred
after the induction of cancer.
Results of a conditional logistic regression analysis showed an
increased risk of lung cancer in workers with higher exposures when
dose estimates were lagged by 10 and 20 years (Sanderson et al.,
2001a). The authors noted that there was considerable uncertainty in
the estimation of exposure in the 1940s and 1950s and the shape of the
dose-response curve for lung cancer. NIOSH later reanalyzed the data,
adjusting for potential confounders of hire age and birth year
(Schubauer-Berigan et al., 2008). The study reported a significant
increasing trend (p<0.05) in the odds ratio when increasing quartiles
of average (log transformed) exposure were lagged by 10 years. However,
it did not find a significant trend when quartiles of cumulative (log
transformed) exposure were lagged by 0, 10, or 20 years.
OSHA is interested in lung cancer risk estimates from a 45-year
(i.e., working lifetime) exposure to beryllium levels between 0.1
[mu]g/m\3\ and 2 [mu]g/m\3\. The majority of case and control workers
in the Sanderson et al. case-control analysis were first hired during
the 1940s when exposures were extremely high (estimated DWAs > 20
[mu]g/m\3\ for most jobs). The cumulative, average, and maximum
beryllium exposure concentration estimates for the 142 known lung
cancer cases were: 46.06 9.3[mu]g/m\3\-days, 22.8 3.4 [mu]g/m\3\, and 32.4 13.8 [mu]g/m\3\,
respectively. About two-thirds of cases and half of controls worked at
the plant for less than a year. Thus, a risk assessment based on this
exposure-response analysis would need to extrapolate from very high to
very low exposures, based on a working population with extremely short
tenure. While OSHA risk assessments must often make extrapolations to
estimate risk within the range of exposures of interest, the Agency
acknowledges that these issues of short tenure and extremely high
exposures would create substantial uncertainty in a risk assessment
based on this study population.
In addition, the relatively high exposures of even the least-
exposed workers in the NIOSH study may create methodological issues for
the lung cancer case-control study design. Mortality risk is expressed
as an odds ratio that compares higher exposure quartiles to the lowest
quartile. It is preferable that excess risks attributable to
occupational beryllium be determined relative to an unexposed or
minimally exposed reference population. However, in the NIOSH study
workers in the lowest quartile were exposed well above the OSHA PEL
(average exposure <11.2 [mu]g/m\3\) and may have had a significant lung
cancer risk. This issue would introduce further uncertainty in lung
cancer risks estimated from this epidemiological study.
In 2010, researchers at NIOSH published a quantitative risk
assessment based on an update of the Reading cohort analyzed by
Sanderson et al., as well as workers from two smaller plants
(Schubauer-Berigan et al., 2010b). This new risk assessment addresses
several of OSHA's concerns regarding the Sanderson et al. analysis. The
new cohort was exposed, on average, to lower levels of beryllium and
had fewer short-term workers. Finally, the updated cohorts followed the
populations through 2005, increasing the length of follow-up time
overall by an additional 17 years of observation. For these reasons,
OSHA considers the Schubauer-Berigan risk analysis more appropriate
than the Sanderson et al. analysis for its preliminary risk assessment.
The cohort studied by Schubauer-Berigan et al. included 5,436 male
workers who had worked for at least two days at the Reading facility
and beryllium processing plants at Hazleton PA and Elmore OH prior to
1970. The authors developed job-exposure matrices (JEMs) for the three
plants based on extensive historical exposure data, primarily short-
term general area and personal breathing zone samples, collected on a
quarterly basis from a wide variety of operations. These samples were
used to create daily weighted average (DWA) estimates of workers' full-
shift exposures, using records of the nature and duration of tasks
performed by workers during a shift. Details on the JEM and DWA
construction can be found in Sanderson et al. (2001a), Chen et al.
(2001), and Couch et al. (2010).
Workers' cumulative exposures ([mu]g/m\3\-days) were estimated by
summing daily average exposures (assuming five
[[Page 47644]]
workdays per week). To estimate mean exposure ([mu]g/m\3\), cumulative
exposure was divided by exposure time (in days). Maximum exposure
([mu]g/m\3\) was estimated as the highest annual DWA on record for a
worker prior to the study cutoff date of December 31, 2005 and
accounting where appropriate for lag time. Exposure estimates were
lagged by 5, 10, 15, and 20 years in order to account for exposures
that may not have contributed to lung cancer because of the long
latency required for manifestation of the disease. The authors also fit
models with no lag time. As shown in Table VI-19 below, estimated
exposure levels for workers from the Hazleton and Elmore plants were on
average far lower than those for workers from the Reading plant. The
median worker from Hazleton had a mean exposure across his tenure of
less than 2 [micro]g/m\3\, while the median worker from Elmore had a
mean exposure of less than 1 [micro]g/m\3\. The Elmore and Hazleton
worker populations also had fewer short-term workers than the Reading
population. This was particularly evident at Hazleton where the median
value for cumulative exposure among cases was higher than at Reading
despite the much lower mean and maximum exposure levels.
Table VI-19--Cohort Description and Distribution of Cases by Exposure Level
----------------------------------------------------------------------------------------------------------------
All plants Reading plant Hazleton plant Elmore plant
----------------------------------------------------------------------------------------------------------------
Number of cases............... ................ 293 218 30 45
Number of non-cases........... ................ 5143 3337 583 1223
Median value for mean exposure No lag.......... 15.42 25 1.443 0.885
([micro]g/m\3\) among cases... 10-year lag..... 15.15 25 1.443 0.972
Median value for cumulative No lag.......... 2843 2895 3968 1654
exposure.
([micro]g/m\3\-days) among 10-year lag..... 2583 2832 3648 1449
cases.
Median value for maximum No lag.......... 25 25.1 3.15 2.17
exposure.
([micro]g/m\3\) among cases... 10-year lag..... 25 25 3.15 2.17
Number of cases with potential ................ 100 (34%) 68 (31%) 16 (53%) 16 (36%)
asbestos exposure.
Number of cases who were ................ 26 (9%) 21 (10%) 3 (10%) 2 (4%)
professional workers.
----------------------------------------------------------------------------------------------------------------
Table adapted from Schubauer-Berigan et al. 2011, Table 1.
Schubauer-Berigan et al. analyzed the data set using a variety of
exposure-response modeling approaches, including categorical analyses
and continuous-variable piecewise log-linear and power models,
described in Schubauer-Berigan et al. (2011). All models adjusted for
birth cohort and plant. As exposure values were log-transformed for the
power model analyses, the authors added small values to exposures of 0
in lagged analyses (0.05 [micro]g/m\3\ for mean and maximum exposure,
0.05 [micro]g/m\3\-days for cumulative exposure). The authors used
restricted cubic spline models to assess the shape of the exposure-
response curve and suggest appropriate parametric model forms. The
Akaike Information Criterion (AIC) value was used to evaluate the fit
of different model forms and lag times.
Because smoking information was available for only about 25 percent
of the cohort, smoking could not be controlled for directly in the
models. The authors reported that within the subset with smoking
information, there was little difference in smoking by cumulative or
maximum exposure category (p. 6), suggesting that smoking was unlikely
to act as a confounder in the cohort. In addition to models based on
the full cohort, Schubauer-Berigan et al. also prepared risk estimates
based on models excluding professional workers and workers believed to
have asbestos exposure. These models were intended to mitigate the
potential impact of smoking and asbestos as confounders. If
professional workers had both lower beryllium exposures and lower
smoking rates than production workers, smoking could be a confounder in
the cohort comprising both production and professional workers.
However, the authors reasoned that smoking was unlikely to be
correlated with beryllium exposure among production workers, and would
therefore probably not act as a confounder in a cohort excluding
professional workers.
The authors found that lung cancer risk was strongly and
significantly related to mean, cumulative, and maximum measures of
workers' exposure (all models reported in Schubauer-Berigan et al.,
2011). They selected the best-fitting categorical, power, and monotonic
piecewise log-linear (PWL) models with a 10-year lag to generate hazard
ratios for male workers with a mean exposure of 0.5 [micro]g/m\3\ (the
current NIOSH Recommended Exposure Limit for beryllium).\9\ To estimate
excess lifetime risk of cancer, they multiplied this hazard ratio by
the 2004-2006 background lifetime lung cancer rate among U.S. males who
had survived, cancer-free, to age 30. In addition, they estimated the
mean exposure that would be associated with an excess lifetime risk of
one in 1000, a value often used as a benchmark for significant risk in
OSHA regulations. At OSHA's request, they also estimated excess
lifetime risks for workers with mean exposures at the current PEL of 2
[mu]g/m\3\ each of the other alternate PELs under consideration: 1
[mu]g/m\3\, 0.2 [mu]g/m\3\, and 0.1 [mu]g/m\3\ (Schubauer-Berigan, 4/
22/11). The resulting risk estimates are presented in Table VI-20
below.
---------------------------------------------------------------------------
\9\ Here, ``monotonic PWL model'' means a model producing a
monotonic exposure-response curve in the 0-2 ug/m\3\ region.
[[Page 47645]]
Table VI-20--Excess Lifetime Risk per 1000 [95% Confidence Interval] for Male Workers at Alternate PELs
[NIOSH models]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Mean exposure
Exposure-response model ----------------------------------------------------------------------------------------------
0.1 [micro]g/m\3\ 0.2 [micro]g/m\3\ 0.5 [micro]g/m\3\ 1 [micro]g/m\3\ 2 [micro]g/m\3\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Best monotonic PWL--all workers.......................... 7.3[2.0-13] 15[3.3-29] 45[9-98] 120[20-340] 200[29-370]
Best monotonic PWL--excluding professional and asbestos 3.1[<0-11] 6.4[<0-23] 17[<0-74] 39[39-230] 61[<0-280]
workers.................................................
Best categorical--all workers............................ 4.4[1.3-8] 9[2.7-17] 25[6-48] 59[13-130] 170[29-530]
Best categorical--excluding professional and asbestos 1.4[<0-6.0] 2.7[<0-12] 7.1[<0-35] 15[<0-87] 33[<0-290]
workers.................................................
Power model--all workers................................. 12[6-19] 19[9.3-29] 30[15-48] 40[19-66] 52[23-88]
Power model--excluding professional and asbestos workers. 19[8.6-31] 30[13-50] 49[21-87] 68[27-130] 90[34-180]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Schubauer-Berigan et al. discuss several strengths, weaknesses, and
uncertainties of their analysis. Strengths include long (> 30 years)
follow-up time for members of the cohort and the extensive exposure and
work history data available for the development of exposure estimates
for workers in the cohort. Among the weaknesses and uncertainties of
the study are the limited information available on workers' smoking
habits: smoking information was available only for workers employed in
1968, about 25 percent of the cohort. In addition, the JEMs used did
not account for possible respirator use among workers in the cohort.
The authors note that workers' exposures may therefore have been
overestimated, and that overestimation may have been especially severe
for workers with high estimated exposures. They suggest that
overestimation of exposures for workers in highly exposed positions may
have caused attenuation of the exposure-response curve in some models
at higher exposures.
The NIOSH publication did not discuss the reasons for basing risk
estimates on mean exposure rather than cumulative exposure that is more
commonly used for lung cancer risk analysis. OSHA believes the decision
may involve the nonmonotonic relationship NIOSH observed between cancer
risk and cumulative exposure level. As discussed previously, workers
from the Reading plant frequently had very short tenures and high
exposures yielding lower cumulative exposures compared to cohort
workers from other plants with longer employment. Despite the low
estimated cumulative exposures among the short-term Reading workers,
they may be at high risk of lung cancer due to the tendency of
beryllium to persist in the lung for long periods. This exposure
misclassification could lead to the appearance of a nonmonotonic
relationship between cumulative exposure and lung cancer risk. It is
possible that a dose-rate effect may exist for beryllium, such that the
risk from a cumulative exposure gained by long-term, low-level exposure
is not equivalent to the risk from a cumulative exposure gained by very
short-term, high-level exposure. In this case, mean exposure level may
better correlate with the risk of lung cancer than cumulative exposure
level. For these reasons OSHA considers the NIOSH choice of mean
exposure metric to be appropriate and scientifically defensible for
this particular dataset.
H. Preliminary Conclusions
As described above, OSHA's risk assessment for beryllium
sensitization and CBD relied on two approaches: (1) review of the
literature and (2) analysis of a dataset provided by NJRMC. First, the
Agency reviewed the scientific literature to ascertain whether there is
substantial risk to workers exposed at and below the current PEL and to
characterize the expected impact of more stringent controls on workers'
risk of sensitization and CBD. This review focused on facilities where
exposures were primarily below the current PEL, and where several
rounds of BeLPT and CBD screening had been conducted to evaluate the
effectiveness of various exposure control measures. Second, OSHA
investigated the exposure-response relationship for beryllium
sensitization and CBD by analyzing a dataset that NJMRC provided on
workers at a prominent, long-established beryllium machining facility.
Although exposure-response studies have been published on sensitization
and CBD, OSHA believes the nature and quality of their exposure data
significantly limits their value for the Agency's risk assessment.
Therefore, OSHA developed an independent exposure-response analysis
using the NJMRC dataset, which was recently updated, includes workers
exposed at low levels, and includes extensive exposure data collected
in workers' breathing zones, as is preferred by OSHA.
OSHA's review of the scientific literature found substantial risk
of both sensitization and CBD in workplaces in compliance with OSHA's
current PEL (e.g., Kreiss et al., 1992; Schuler et al., 2000; Madl et
al., 2007). At these plants, including a copper-beryllium processing
facility, a beryllia ceramics facility, and a beryllium machining
facility, exposure reduction programs that primarily used engineering
controls to reduce airborne exposures to median levels at or around 0.2
[mu]g/m\3\ had only limited impact on workers' risk. Cases of
sensitization continued to occur frequently among newly hired workers,
and some of these workers developed CBD within the short follow-up
time.
In contrast, industrial hygiene programs that minimized both
airborne and dermal exposure substantially lowered workers' risk of
sensitization in the first years of employment. Programs that
drastically reduced respiratory exposure via a combination of
engineering controls and respiratory protection, minimized the
potential for skin exposure via dermal PPE, and employed stringent
housekeeping methods to keep work areas clean and prevent transfer of
beryllium between areas sharply curtailed new cases of sensitization
among newly-hired workers. For example, studies conducted at copper-
beryllium processing, beryllium production, and beryllia ceramics
facilities show that reduction of exposures to below 0.1 [mu]g/m\3\ and
protection from dermal exposure, in combination, achieved a substantial
reduction in sensitization risk among newly-hired workers. However,
even these stringent measures did not protect all workers from
sensitization.
[[Page 47646]]
The most recent epidemiological literature on programs that have
been successful in reducing workers' risk of sensitization have had
very short follow-up time; therefore, they cannot address the question
of how frequently workers sensitized in very low-exposure environments
develop CBD. Clinical evaluation for CBD was not reported for workers
at the copper-beryllium processing, beryllium production, and ceramics
facilities. However, cases of CBD among workers exposed at low levels
at a machining plant and cases of CA-CBD demonstrate that individuals
exposed to low levels of airborne beryllium can develop CBD, and over
time, can progress to severe disease. This conclusion is also supported
by case reports within the literature of workers with CBD who may have
been minimally exposed to beryllium, such as a worker employed only in
administration at a beryllium ceramics facility (Kreiss et al., 1996).
The Agency's analysis of the Cullman dataset provided by NJMRC
showed strong exposure-response trends using multiple analytical
approaches, including examination of sensitization and disease
prevalence by exposure categories and a proportional hazards modeling
approach. In the prevalence analysis, cases of sensitization and
disease were evident at all levels of exposure. The lowest prevalence
of sensitization (2.0 percent) and CBD (1.0 percent) was observed among
workers with LTW average exposure levels below 0.1 [mu]g/m\3\, while
those with LTW average exposure between 0.1-0.2 [mu]g/m\3\ showed a
marked increase in overall prevalence of sensitization (9.8 percent)
and CBD (7.3 percent). Prevalence of sensitization and CBD also
increased with cumulative exposure.
OSHA's proportional hazards analysis of the Cullman dataset found
increasing risk of sensitization with both cumulative exposure and
average exposure. OSHA also found a positive relationship between risk
of CBD and cumulative exposure, but not between CBD and average
exposure. The Agency used the cumulative exposure model results to
estimate hazards ratios and risk of sensitization and CBD at the
current PEL of 2 [mu]g/m\3\ and each of the alternate PELs under
consideration: 1 [mu]g/m\3\, 0.5 [mu]g/m\3\, 0.2 [mu]g/m\3\, and 0.1
[mu]g/m\3\. To estimate risk of CBD from a working lifetime of
exposure, the Agency calculated the cumulative exposure associated with
45 years of exposure at each level, for total cumulative exposures of
90, 45, 22.5, 9, and 4.5 [mu]g/m\3\-years. The risk estimates for
sensitization and CBD ranged from 100-403 and 40-290 cases,
respectively, per 1000 workers exposed at the current PEL of 2 [mu]g/
m\3\. The risks are projected to be substantially lower for both
sensitization and CBD at 0.1 [mu]g/m\3\ and range from 7.2-35 cases per
1000 and 3.1-26 cases per 1000, respectively. In these ways, the
modeling results are similar to results observed from published studies
of the Reading, Tucson, and Cullman plants and the OSHA analysis of
sensitization and CBD prevalence within the Cullman plant.
OSHA has a high level of confidence in the finding of substantial
risk of sensitization and CBD at the current PEL, and the Agency
believes that a standard requiring a combination of more stringent
controls on beryllium exposure will reduce workers' risk of both
sensitization and CBD. Programs that have reduced median levels to
below 0.1 [mu]g/m\3\, tightly controlled both respiratory and dermal
exposure, and incorporated stringent housekeeping measures have
substantially reduced risk of sensitization within the first years of
exposure. These conclusions are supported by the results of several
studies conducted in state-of-the-art facilities dealing with a variety
of production activities and physical forms of beryllium. In addition,
these conclusions are supported by OSHA's statistical analysis of a
dataset with highly detailed exposure and work history information on
several hundred beryllium workers. While there is uncertainty regarding
the precision of model-derived risk estimates, they provide further
evidence that there is substantial risk of sensitization and CBD
associated with exposure at the current PEL, and that this risk can be
substantially lessened by stringent measures to reduce workers'
beryllium exposure levels.
Furthermore, OSHA believes that beryllium-exposed workers' risk of
lung cancer will be reduced by more stringent control of airborne
beryllium exposures. The risk estimates from NIOSH's recent lung cancer
study, described above, range from 33 to 140 excess lung cancers per
1000 workers exposed at the current PEL of 2 [mu]g/m\3\. The NIOSH risk
assessment's six best-fitting models each predict substantial
reductions in risk with reduced exposure, ranging from 3 to 19 excess
lung cancers per 1000 workers exposed at the proposed PEL of 0.1 [mu]g/
m\3\. The evidence of lung cancer risk from NIOSH's risk assessment
provides additional support for OSHA's preliminary conclusions
regarding the significance of risk to workers exposed to beryllium
levels at and below the current PEL. However, the lung cancer risks
require a sizable low dose extrapolation below beryllium exposure
levels experienced by workers in the NIOSH study. As a result, there is
a greater uncertainty in the lung cancer risk estimates and lesser
confidence in their significance of risk below the current PEL than
with beryllium sensitization and CBD. The preliminary conclusions with
regard to significance of risk are presented and further discussed in
section VIII of the preamble.
VII. Expert Peer Review of Health Effects and Preliminary Risk
Assessment
In 2010, Eastern Research Group, Inc. (ERG), under contract to the
Occupational Safety and Health Administration (OSHA) ,\10\ conducted an
independent, scientific peer review of (1) a draft Preliminary
Beryllium Health Effects Evaluation (OSHA, 2010a), (2) a draft
Preliminary Beryllium Risk Assessment (OSHA, 2010b), and (3) two NIOSH
study manuscripts (Schubauer-Berigan et al., 2011 and 2011a). This
section of the preamble describes the review process and summarizes
peer reviewers' comments and OSHA's responses.
---------------------------------------------------------------------------
\10\ Task Order No. DOLQ59622303, Contract No. GS10F0125P, with
a period of performance from May, 2010 through December, 2010.
---------------------------------------------------------------------------
ERG conducted a search for nationally recognized experts in the
areas of occupational epidemiology, occupational medicine, toxicology,
immunology, industrial hygiene/exposure assessment, and risk
assessment/biostatistics as requested by OSHA. ERG sought experts
familiar with beryllium health effects research and who had no conflict
of interest (COI) or apparent bias in performing the review. Interested
candidates submitted evidence of their qualifications and responded to
detailed COI questions. ERG also searched the Internet to determine
whether qualified candidates had made public statements or declared a
particular bias regarding beryllium regulation.
From the pool of qualified candidates, ERG selected five experts to
conduct the review, based on:
[cir] Their qualifications, including their degrees, years of
relevant experience, number of related peer-reviewed publications,
experience serving as a peer reviewer for OSHA or other government
organizations, and committee and association memberships related to the
review topic;
[cir] Lack of any actual, potential, or perceived conflict of
interest; and
[cir] The need to ensure that the panel collectively was
sufficiently broad and
[[Page 47647]]
diverse to fairly represent the relevant scientific and technical
perspectives and fields of knowledge appropriate to the review.
OSHA reviewed the qualifications of the candidates proposed by ERG
to verify that they collectively represented the technical areas of
interest. ERG then contracted the following experts to perform the
review.
(1) John Balmes, MD, Professor of Medicine, University of
California-San Francisco
Expertise: pulmonary and occupational medicine, CBD,
occupational lung disease, epidemiology, occupational exposures,
medical surveillance.
(2) Patrick Breysse, Ph.D., Professor, Johns Hopkins University
Bloomberg School of Public Health
Expertise: industrial hygiene, occupational/environmental health
engineering, exposure monitoring/analysis, biomarkers, beryllium
exposure assessment
(3) Terry Gordon, Ph.D., Professor, New York University School
of Medicine.
Expertise: inhalation toxicology, pulmonary disease, beryllium
toxicity and carcinogenicity, CBD genetic susceptibility, mode of
action, animal models.
(4) Milton Rossman, MD, Professor of Medicine, Hospital of the
University of Pennsylvania School of Medicine.
Expertise: pulmonary and clinical medicine, immunology,
beryllium sensitization, BeLPT, clinical diagnosis for CBD.
(5) Kyle Steenland, Ph.D., Professor, Emory University, Rollins
School of Public Health.
Expertise: occupational epidemiology, biostatistics, risk and
exposure assessment, lung cancer, CBD, exposure-response models.
Reviewers were provided with the Technical Charge and Instructions
(see ERG, 2010), a Request for Peer Review of NIOSH Manuscripts (see
ERG, 2010), the draft Preliminary OSHA Health Effects Evaluation (OSHA,
2010a), the draft Preliminary Beryllium Risk Assessment (OSHA, 2010b),
and access to relevant references. Each reviewer independently provided
comments on the Health Effects, Risk Assessment, and NIOSH documents. A
briefing call was held early in the review to ensure that reviewers
understood the peer review process. ERG organized the call and OSHA
representatives were available to respond to technical questions of
clarification. Reviewers were invited to submit any subsequent
questions of clarification.
The written comments from each reviewer were received and organized
by ERG by charge questions. The unedited individual and reorganized
comments were submitted to OSHA and the reviewers in preparation for a
follow-up conference call. The conference call, organized and
facilitated by ERG, provided an opportunity for OSHA to clarify
individual reviewer's comments. After the call, reviewers were given
the opportunity to revise their written comments to include the
clarifications or additional information provided on the call. ERG
submitted the revised comments to OSHA organized by both individual
reviewer and by charge question. A final peer review report is
available in the docket (ERG, 2010). Section VII.A of this preamble
summarizes the comments received on the draft health effects document
and OSHA's responses to those comments. Section VII.B summarizes
comments received on the draft Preliminary Risk Assessment and the OSHA
response.
A. Peer Review of Draft Health Effects Evaluation
The Technical Charge to peer reviewers posed general questions on
the draft health effects document as well as specific questions
pertaining to particle/chemical properties, kinetics and metabolism,
acute beryllium disease, development of beryllium sensitization and
CBD, genetic susceptibility, epidemiological studies of sensitization
and CBD, animal models of chronic beryllium disease, genotoxicity, lung
cancer epidemiological studies, animal cancer studies, other health
effects, and preliminary conclusions drawn by OSHA.
OSHA asked the peer reviewers to generally comment on whether the
draft health effects evaluation included the important studies,
appropriately addressed their strengths and limitations, accurately
described the results, and drew scientifically sound conclusions.
Overall, the reviewers felt that the studies were described in
sufficient detail, the interpretations accurate, and the conclusions
reasonable. They agreed that the OSHA document covered the significant
health endpoints related to occupational beryllium exposure. However,
several reviewers requested that additional studies and other specific
information be included in various sections of the document and these
are discussed further below.
The reviewers had similar suggestions to improve the section V.A of
this preamble on physical/chemical properties and section V.B on
kinetics/metabolism. Dr. Balmes requested that physical and chemical
characteristics of beryllium more clearly relate to development of
sensitization and progression to CBD. Dr. Gordon requested greater
consistency in the terminology used to describe particle
characteristics, sampling methodologies, and the particle deposition in
the respiratory tract. Dr. Breysse agreed and requested that the
respiratory deposition discussion be better related to the onset of
sensitization and CBD. Dr. Rossman suggested that the discussion of
particle/chemical characteristics might be better placed after section
V.D on the immunobiology of sensitization and CBD.
OSHA made a number of revisions to sections V.A and V.B to address
the peer review comments above. Terminology used to describe particle
characteristics in various studies was modified to be more consistent
and better reflect the authors' intent in the published research
articles. Section V.B.1 on respiratory kinetics of inhaled beryllium
was modified to more clearly describe particle deposition in the
different regions of the respiratory tract and their influence on CBD.
At the recommendation of Dr. Gordon, a confusing figure was removed
since it did not portray particle deposition in a clear manner. Rather
than relocate the entire discussion of particle/chemical
characteristics, a new section V.B.5 was added to specifically address
the influence of beryllium particle characteristics and chemical form
on the development of sensitization and CBD. Other section areas were
shortened to remove information that was not necessarily relevant to
the overall disease process. Statements were added on the effect of
pre-existing diseases and smoking on beryllium clearance from the lung.
It was made clear that the precise role of dermal exposure in beryllium
sensitization is not completely understood. These smaller changes were
made at the request of individual reviewers.
There were a couple of comments from reviewers pertaining to acute
beryllium disease (ABD). Dr. Rossman commented that ABD did not make
the development of CBD more likely. He requested that the document
include a reference to the Van Ordstrand et al. (1943) article that
first reported ABD in the U.S. Dr. Balmes pointed out that
pathologists, rather than clinicians, interpret ABD pathology from lung
tissue biopsy. Dr. Gordon commented that ABD is of lesser importance
than CBD to the risk assessment and suggested that discussion of ABD be
moved later in the document.
The Van Ordstrand reference was included in section V.C on acute
beryllium diseases and statements were modified to address the peer
review comments above. While OSHA agrees that ABD does not have a great
impact on the Agency risk findings, the Agency believes the current
organization does
[[Page 47648]]
not create confusion on this point and decided not to move the ABD
section later in the document. A statement that ABD is only relevant at
exposures higher than the current PEL has been added to section V.C.
Other reviewers did not feel the ABD discussion needed to be moved to a
later section.
Most reviewers found the description of the development and
pathogenesis of CBD in section V.D to be accurate and understandable.
Dr. Breysse felt the section could better delineate the steps in
disease development (e.g., development of beryllium sensitization, CBD
progression) and recommended the 2008 National Academy of Sciences
report as a model. He and Dr. Gordon felt the section overemphasized
the role of apoptosis in CBD development. Dr. Breysse and Dr. Balmes
recommended avoiding the phrase `subclinical' to describe sensitization
and asymptomatic CBD, preferring the term `early stage' as a more
appropriate description. Dr. Balmes requested clarification regarding
accumulation of inflammatory cells in the bronchoalveolar lavage (BAL)
fluid during CBD development. Dr. Rossman suggested some additional
description of beryllium binding with the HLA-class II receptor and
subsequent interaction with the na[iuml]ve CD4\+\ T cells in the
development of sensitization.
OSHA extensively reorganized section V.D to clearly delineate the
disease process in a more linear fashion starting with the formation of
beryllium antigen complex, its interaction with na[iuml]ve T-cells to
trigger CD4\+\ T-cell proliferation, and development of beryllium
sensitization. This is presented in section V.D.1. A figure has been
added that schematically presents this process in its entirety and the
steps at which dermal exposure and genetic factors are believed to
influence disease development (Figure 2 in section V.D). Section V.D.2
describes how subsequent inhalation and the persistent residual
presence of beryllium in the lung leads to CD4\+\ T cell
differentiation, cytokine production, accumulation of inflammatory
cells in the alveolar region, granuloma formation, and progression of
CBD. The section was modified to present apoptosis as only one of the
plausible mechanisms for development/progression of CBD. The `early
stage' terminology was adopted and the role of inflammatory cells in
BAL was clarified.
While peer reviewers felt genetic susceptibility was adequately
characterized, Dr. Rossman, Dr. Gordon, and Dr. Breysse suggested that
additional study data be discussed to provide more depth on the
subject, particularly the role genetic polymorphisms in providing a
negatively charged HLA protein binding site for the positively charged
beryllium ion. Section V.D.3 on genetic susceptibility now includes
more information on the importance of gene-environment interaction in
the development of CBD in low-exposed workers. The section expands on
HLA-DPB1 alleles that influence beryllium-hapten binding and its impact
on CBD risk.
All reviewers found the definition of CBD to be clear and
understandable. However, several reviewers commented on the document
discussion of the BeLPT which operationally defines beryllium
sensitization. Drs. Balmes and Rossman requested a more clear statement
that two abnormal blood BeLPT results were generally necessary to
confirm sensitization. Dr. Balmes and Dr. Breysse requested more
discussion of historical changes in the BeLPT method that have led to
improvement in test performance and reductions in interlaboratory
variability. These comments were addressed in an expanded document
section V.D.5.b on criteria for sensitization and CBD case definition
following development of the BeLPT.
Reviewers made suggestions to improve presentation of the many
epidemiological studies of sensitization and CBD in the draft health
effects document. Dr. Breysse and Dr. Gordon recommended that common
weaknesses that apply to multiple studies be more rigorously discussed.
Dr. Gordon requested that the discussion of the Beryllium Case Registry
be modified to clarify the case inclusion criteria. Most reviewers
called for the addition of tables to assist in summarizing the
epidemiological study information.
A paragraph has been added near the beginning of section V.D.5 that
identifies the common challenges to interpreting the epidemiological
evidence that supports the occurrence of sensitization and CBD at
occupational beryllium exposures below the current PEL. These include
studies with small numbers of subjects and CBD cases, potential
exposure misclassification resulting from lack of personal and short-
term exposure data prior to the late 1990s, and uncertain dermal
contribution among other issues. Table A.1 summarizing the key
sensitization and CBD epidemiological studies was added to this
preamble in appendix A of section V. Subsection V.D.5.a on studies
conducted prior to the BeLPT has been reorganized to more clearly
present the need for the Registry prior to listing the inclusion
criteria.
Several reviewers requested that the draft health effects document
discuss additional occupational studies on sensitization and CBD. Dr.
Balmes suggested including Bailey et al. (2010) on reduction in
sensitization at a beryllium production plant and Arjomandi et al.
(2010) on CBD among workers in a nuclear weapons facility. Dr. Breysse
recommended adding a brief discussion of Taiwo et al. (2008) on
sensitization in aluminum smelter workers. Dr. Gordon and Dr. Rossman
suggested mention of Curtis, (1951) on cutaneous hypersensitivity to
beryllium as important for the role of dermal exposure. Dr. Rossman
also provided a reference to a number of other sensitization and CBD
articles of historical significance.
The above studies have been incorporated in several subsections of
V.D.5 on human epidemiological evidence. The 1951 Curtis study is
mentioned in the introduction to section V.D.5 as evidence of
sensitization from dermal exposure. The Bailey et al. (2010) study is
discussed in subsection V.D.5.d on beryllium metal processing and alloy
production. The Arjomandi et al. (2010) study is discussed subsection
V.D.5.h on nuclear weapons facilities and cleanup of former facilities.
The Taiwo et al. (2008) study is discussed in subsection V.D.5.i on
aluminum smelting. The other historical studies of historical
significance are referenced in subsection V.D.5.a on studies conducted
prior to the BeLPT.
Dr. Gordon suggested that the draft health effects document make
clear that limitations in study design and lack of an appropriate model
limited extrapolation of animal findings to the human immune-based
respiratory disease. Dr. Rossman also remarked on the lack of a good
animal model that consistently demonstrates a specific cell-mediated
immune response to beryllium. Section V.D.6 was modified to include a
statement that lack of a dependable animal model combined with studies
that used single doses, few animals or abbreviated observation periods
have limited the utility of the data. Table A.2 was added that
summarizes important information on key animal studies of beryllium-
induced immune response and lung inflammation.
In general, peer reviewers considered the preliminary conclusions
with regard to sensitization and CBD to be reasonable and well
presented in the draft health effects evaluation. All reviewers agreed
that the scientific evidence supports sensitization as a necessary
condition and an early endpoint in the development of CBD.
[[Page 47649]]
The peer reviewers did not consider the presented evidence to
convincingly show lung burden to be an important dose metric. Dr.
Gordon explained that some animal studies in dogs have indicated that
lung dose does influence granuloma formation but the importance of dose
relative to genetic susceptibility, and physical/chemical form is
unclear. He suggested the document indicate that many factors,
including lung burden, affect the pulmonary tissue response to
beryllium particles in the workplace.
There were other suggested improvements to the preliminary
conclusion section of the draft document. Dr. Breysse felt that
presenting the range of observed prevalence from occupational studies
would help support the Agency findings. He also recommended that the
preliminary conclusions make clear that CBD is a very complex disease
and certain steps involved in the onset and progression are not yet
clearly understood. Dr. Rossman pointed out that a report from Mroz et
al. (2009) updated information on the rate at which beryllium
sensitized individuals progress to CBD.
A statement has been added to section V.D.7 on the preliminary
sensitization and CBD conclusions to indicate that all facets of
development and progression of sensitization and CBD are not fully
understood. Study references and prevalence ranges were provided to
support the conclusion that epidemiological evidence demonstrates that
sensitization and CBD occur from present-day exposures below OSHA's
PEL. Statements were modified to indicate animal studies provide
important insights into the roles of chemical form, genetic
susceptibility, and residual lung burden in the development of
beryllium lung disease. Updated information on rate of progression from
sensitization to CBD was also included.
Reviewers made suggestions to improve presentation of the
epidemiological studies of lung cancer that were similar to their
comments on the CBD studies. Dr. Steenland requested that a table
summarizing the lung cancer studies be added. He also recommended that
more emphasis be placed on the SMR results from the Ward et al. (1992)
study. Dr. Balmes felt that more detail was presented on the animal
cancer studies than necessary to convey the relevant message. All
reviewers thought that the Schubauer-Berigan et al. (2010) cohort
mortality study that addressed some of the shortcomings of earlier lung
cancer mortality studies should be discussed in the health effects
document.
The recent Schubauer-Berigan et al. (2010) study conducted by the
NIOSH Division of Surveillance, Hazard Evaluations, and Field Studies
is now described and discussed in section V.E.2 on human epidemiology
studies. Table A.3 summarizing the range of exposure measurements,
study strengths and limitations, and other key lung cancer
epidemiological study information was added to the health effects
preamble. Section V.E.3 on the animal cancer studies already contained
several tables that present study data so OSHA decided a summary table
was not needed in this section.
Reviewers were asked two questions regarding the OSHA preliminary
conclusions on beryllium-induced lung cancer: was the inflammation
mechanism presented in the lung cancer section reasonable; and were
there other mechanisms or modes of action to be considered? All
reviewers agreed that inflammation was a reasonable mechanistic
presentation as outlined in the document. Dr. Gordon requested OSHA
clarify that inflammation may not be the sole mechanism for
carcinogenicity. OSHA inserted statements in section V.E.5 on the
preliminary lung cancer conclusions clarifying that tumorigenesis
secondary to inflammation is a reasonable mechanism of action but other
plausible mechanisms independent of inflammation may also contribute to
the lung cancer associated with beryllium exposure.
There were a few comments from reviewers on health effects other
than sensitization/CBD and lung cancer in the draft document. Dr.
Balmes requested that the term ``beryllium poisoning'' not be used when
referring to the hepatic effects of beryllium. He also offered language
to clarify that the cardiovascular mortality among beryllium production
workers in the Ward study cohort was probably due to ischemic heart
disease and not the result of impaired lung function. Dr. Gordon
requested removal of references to hepatic studies from in vitro and
intravenous administration done at very high dose levels of little
relevance to the occupational exposures of interest to OSHA. These
changes were made to section V.F on other health effects.
B. Peer Review of the Draft Preliminary Risk Assessment
The Technical Charge to peer reviewers for review of the draft
preliminary risk assessment was to ensure OSHA selected appropriate
study data, assessed the data in a scientifically credible manner, and
clearly explained its analysis. Specific charge questions were posed
regarding choice of data sets, risk models, and exposure metrics; the
role of dermal exposure and dermal protection; construction of the job
exposure matrix; characterization of the risk estimates and their
uncertainties; and whether a quantitative assessment of lung cancer
risk, in addition to sensitization and CBD, was warranted.
Overall, the peer reviewers were highly supportive of the Agency's
approach and major conclusions. They offered valuable suggestions for
revisions and additional analysis to improve the clarity and certain
technical aspects of the risk assessment. These suggestions and the
steps taken by OSHA to address them are summarized here. A final peer
review report (ERG, 2010c) and a risk assessment background document
(OSHA, 2014a) are available in the docket.
OSHA asked peer reviewers a series of questions regarding its
selection of surveys from a beryllium ceramics facility, a beryllium
machining facility, and a beryllium alloy processing facility as the
critical studies that form the basis of the preliminary risk
assessment. Research showed that these workplaces had well
characterized and relatively low beryllium exposures and underwent
plant-wide screenings for sensitization and CBD before and after
implementation of exposure controls. The reviewers were requested to
comment on whether the study discussions were clearly presented,
whether the role of dermal exposure and dermal protection were
adequately addressed, and whether the preliminary conclusions regarding
the observed exposure-related prevalence and reduction in risk were
reasonable and scientifically credible. They were also asked to
identify other studies that should be reviewed as part of the
sensitization/CBD risk assessment.
Every peer reviewer felt the key studies were appropriate and their
selection clearly explained in the document. Every peer reviewer
regarded the preliminary conclusions from the OSHA review of these
studies to be reasonable and scientifically sound. This conclusion
stated that substantial risk of sensitization and CBD were observed in
facilities where the highest exposed processes had median full-shift
beryllium exposures around 0.2 [mu]g/m\3\ or higher and that the
greatest reduction in risk was achieved when exposures for all
processes were lowered to 0.1 [mu]g/m\3\ or below.
The reviewers suggested that three additional studies be added to
the risk assessment review of the
[[Page 47650]]
epidemiological literature. Dr. Balmes felt the document would be
strengthened by including the Bailey et al. (2010) investigation of
sensitization in a population of workers at the beryllium metal, alloy,
and oxide production plant in Elmore, OH and the Arjomandi et al.
(2010) publication on a group of 50 sensitized workers from a nuclear
plant. Dr. Breysse suggested the study by Taiwo et al. (2008) on
sensitization among workers in four aluminum smelters be considered.
A new subsection VI.A.3 was added to the preliminary risk
assessment that describes the changes in beryllium exposure
measurements, prevalence of sensitization and CBD, and implementation
of exposure controls between 1992 and 2006 at the Elmore plant. This
subsection includes a discussion of the Bailey et al. study. A summary
of the Taiwo et al. (2008) study was added as subsection VI.A.5. A
discussion of the Arjomandi et al. (2010) study was added in subsection
VI.B as evidence that sensitized workers with primarily low beryllium
exposure go on to develop CBD. However, the low rates of CBD among this
group of sensitized workers also suggest that low beryllium exposure
may reduce CBD risk when compared to worker populations with higher
exposure levels.
While the majority of reviewers stated that OSHA adequately
addressed the role of dermal exposure in sensitization and the
importance of dermal protection for workers, a few had additional
suggestions for OSHA's discussion. Dr. Breysse and Dr. Gordon pointed
out that because the beryllium exposure control programs featured steps
to reduce both skin contact and inhalation, it was difficult to
distinguish between the effects of reducing airborne and dermal
exposure. A statement was added to subsection VI.B that concurrent
implementation of respirator use, dermal protection and engineering
changes made it difficult to attribute reduced risk to any single
control measure. Since the Cullman plant did not require glove use,
OSHA believes it to be the best data set available for evaluating the
effects of airborne exposure control on risk of sensitization.
Dr. Breysse requested additional discussion of the role of
respiratory protection in achieving reduction in risk. Dr. Gordon
suggested some additional clarification regarding mean and median
exposure measures. Additional information on respiratory programs and
exposure measures (e.g., median, arithmetic and geometric means), where
available, were presented for each of the studies discussed in
subsection VI.A.
The peer reviewers generally agreed that it was reasonable to
conclude that community-acquired CBD (CA-CBD) resulted from low
beryllium exposures. Drs. Breysse, Balmes and others noted that higher
short-term excursions could not be ruled out. Dr. Gordon suggested that
genetic susceptibility may have a role in cases of CA-CBD. Dr. Rossman
raised the possibility that some CA-CBD cases could occur from contact
with beryllium workers. All these points were added to subsection VI.C.
OSHA asked the peer reviewers to evaluate the choice of the
National Jewish Medical and Research Center (NJMRC) data set on the
Cullman, AL machinist population as a basis for exposure-response
analysis and the reliance on cumulative exposure as the basis for the
exposure-response analysis of sensitization and CBD. All peer reviewers
indicated that the choice of the NJMRC data set for exposure-response
analysis was clearly explained and reasonable and that they knew of no
better data set for the analysis. Dr. Rossman commented that the NJMRC
data set was an excellent source of exposures to different levels of
beryllium and testing and evaluation of the workers. Dr. Steenland and
Dr. Gordon suggested that the results from the OSHA analysis of the
NJMRC data be compared with the available data from the studies of
other beryllium facilities discussed in the epidemiological literature
analysis. While a rigorous quantitative comparison (e.g., meta
analysis) is difficult due to differences in the study designs and data
types available for each study, subsection VI.E.4 compares the results
of OSHA's prevalence analysis from the Cullman data with results from
studies of the Tucson and Reading facilities.
OSHA asked the peer reviewers to evaluate methods used to construct
the job exposure matrix (JEM) and to estimate beryllium exposure for
each worker in the NJMRC data set. The JEM procedure was briefly
summarized in the review document and described in detail as part of a
risk assessment technical background document made available to the
reviewers (OSHA, 2014a). Dr. Balmes felt that a more thorough
discussion of the JEM would strengthen the preamble document. Dr.
Gordon requested information about values assigned exposures below the
limit of detection. Dr. Steenland requested that both the preamble and
technical background document contain additional information on aspects
of the JEM construction such as the job categories, job-specific
exposure values, how jobs were grouped, and how non-machining jobs were
handled in the JEM. He suggested the entire JEM be included in the
technical background document. OSHA greatly expanded subsection VI.E.2
on air sampling and JEM to include more detailed discussion of the JEM
construction. Exposure values for machining and non-machining job
titles were provided in Tables VI-4 and VI-5. The procedures and
rationale for grouping job-specific measurements into four time periods
was explained. Jobs were not grouped in the JEM; rather, individual
exposure estimates were created for each job in the work history data
set. The technical background document further clarifies the JEM
construction and the full JEM is included as an appendix to the revised
background document (OSHA, 2014a). Subsection VI.E.3 on worker exposure
reconstruction contains further detail about the work histories.
Peer reviewers fully supported OSHA's choice of the cumulative
exposure metric to estimate risk of CBD from the NJMRC data set. As
explained by Dr. Steenland, ``cumulative exposure is often the choice
for many chronic diseases as opposed to average or highest exposure.''
He pointed out that the cumulative exposure metric also fit the CBD
data better than other metrics. The reviewers generally felt that
short-term peak exposure was probably the measure of airborne exposure
most relevant to risk of beryllium sensitization. However, peer
reviewers agreed that data required to capture workers' short-term peak
exposures and to relate the peak exposure levels to sensitization were
not available. Dr. Breysse explained that ``short-term (hrs to minutes)
peak exposures may be important to sensitization risk, while long term
averages are more important for CBD risk. Unfortunately data for short-
term peak exposures may not exist.'' Dr. Steenland explained that of
the available metrics ``cumulative exposure fits the sensitization data
better than the two alternatives, and hence is the best metric.''
Statements were added to subsection VI.E.3 to indicate that while
short-term exposures may be highly relevant to risk of sensitization,
the individual peak exposures leading up to onset of sensitization was
not able to be determined in the NJRMC Cullman study.
Peer reviewers found the methods used in the statistical exposure-
response analysis to be clearly described. With the exception of Dr.
Steenland, reviewers believed that a detailed critique of the
statistical approach was
[[Page 47651]]
beyond their level of expertise. Dr. Steenland supported OSHA's overall
approach to the risk modeling and recommended additional analyses to
explore the sensitivity of OSHA's results to alternate choices and to
test the validity of aspects of the analysis. Dr. Steenland recommended
that the logistic regression used by OSHA as a preliminary first
analysis be dropped as an inappropriate model for a situation where it
is important to account for changing exposures and case onset over
time. Instead, he suggested a sensitivity analysis in which exposure-
response coefficients generated using a traditional Cox proportionate
hazards model be compared to the discrete time Cox model analog (i.e.,
complementary log-log Cox model) used by OSHA. The sensitivity analysis
would facilitate examination of the proportional hazard assumption
implied by the use of these models. Dr. Steenland advocated that OSHA
include a table that displayed the mean number of BeLPT tests for the
study population in order to address whether the number of
sensitization tests introduced a potential bias. He inquired about the
possibility of determining a sensitization incidence rate using
cumulative or average exposure. Dr. Steenland suggested that the model
control for additional potential confounders, such as age, smoking
status, race and gender. He wanted a more complete explanation of the
model constant for the year of diagnosis in Tables VI-9 through VI-12
to be included in the preamble as it was in the technical background
document. Dr. Steenland recommended a sensitivity analysis that
excludes the highest 5 to 10 percent of cumulative exposures which
might address potential model uncertainty at the high end exposures. He
requested that the results of statistical tests for non-linearity be
included and confidence intervals for the risk estimates in Tables VI-
17 and VI-18 be determined.
Many of Dr. Steenland's comments were addressed in subsection VI.F
on the statistical modeling. The logistic regression analysis was
removed from the section. A sensitivity analysis using the standard Cox
model that treats survival time as continuous rather than discrete was
added to the risk assessment background document and results were
described in subsection VI.F. The interaction between exposure and
follow-up time was not significant in the models suggesting that the
proportional hazard assumption should not be rejected. The model
coefficients using the standard Cox model were similar to model
coefficients for the discrete model. Given this, OSHA did not feel it
necessary to further estimate risks using the continuous Cox model at
specific exposure levels.
A table of the mean number of BeLPT tests across the study
population was added to the risk assessment background document.
Subsection VI.F describes the table results and its impact on the
statistical modeling. Smoking status and age were included in the
discrete Cox proportional hazards model and not found to be significant
predictors of beryllium sensitization. However, the available study
population composition did not allow a confounder analysis of race and
gender. OSHA chose not to include a detailed explanation of the model
constant for the year of diagnosis in the preamble section. OSHA agrees
with Dr. Steenland that the risk assessment background document
adequately describes the model terms. For that reason, OSHA prefers
that the risk assessment preamble focus on the results and major points
of the analysis and refer the reader to the more technical background
document for an explanation of model parameters. The linearity
assumption was assessed using a fractional polynomial approach. The
best fitting polynomials did not fit significantly better than the
linear model. The details of the analysis were included in the risk
assessment background document. Tables VI-17 and VI-18 now include the
upper 95 percent confidence limits on the model-predicted cases of
sensitization and CBD for the current and alternative PELs.
Most peer reviewers felt the major uncertainties of the risk
assessment were clearly and adequately discussed in the documents they
reviewed. Dr. Breysse requested that the risk assessment cover
potential underestimation of risk from exposure misclassification bias.
He requested further discussion of the degree to which the risk
estimates from the Cullman machining plant could be extrapolated to
workplaces that use other physical (e.g., particle size) and chemical
forms of beryllium. He went on to question the strength of evidence
that insoluble forms of beryllium cause CBD. Dr. Breysse also suggested
that the assumptions used in the risk modeling be consolidated and more
clearly presented. Dr. Steenland felt that there was potential
underestimation of CBD risk resulting from exclusion of former workers
and case status of current workers after employment.
Discussion of these uncertainties was added in the final paragraphs
of section VI.F. The section was modified to more clearly identify
assumptions with regard to the risk modeling such as an assumed
linearity in exposure-response and cumulative dose equivalency when
extrapolating risks over a 45-year working lifetime. Section VI.F
recognizes the uncertainties in risk that can result from
reconstructing individual exposures with very limited sampling data
prior to 1994. The potential exposure misclassification can limit the
strength of exposure-response relationships and result in the
underestimation of risk. A more technical discussion of modeling
assumptions and exposure measurement error are provided in the risk
assessment background document. Section VI.F points out that the NJMRC
data set does not capture CBD that occurred among workers who retired
or left the Cullman plant. This and the short follow-up time is a
source of uncertainty that likely leads to underestimation of risk. The
section indicates that it is not unreasonable to expect the risk
estimates to generally reflect onset of sensitization and CBD from
exposure to beryllium forms that are relatively insoluble and enriched
with respirable particles as encountered at the Cullman machining
plant. Additional uncertainty is introduced when extrapolating the risk
estimates to beryllium compounds of vastly different solubility and
particle characteristics. OSHA does not agree with the comment
suggesting that the association between CBD and insoluble forms of
beryllium is weak. The principle sources of beryllium encountered at
the Cullman machining plant, the Reading copper beryllium processing
plant and the Tucson ceramics plant where excessive CBD was observed
are insoluble forms of beryllium, such as beryllium metal, beryllium
alloy, and beryllium oxide.
Finally, OSHA asked the peer reviewers to evaluate its treatment of
lung cancer in the earlier draft preliminary risk assessment (OSHA,
2010b). When that document was prepared, OSHA had elected not to
conduct a lung cancer risk assessment. The Agency believed that the
exposure-response data available to conduct a lung cancer risk
assessment from a Sanderson et al. study of a Reading, PA beryllium
plant by was highly problematic. The Sanderson study primarily involved
workers with extremely high and short-term exposures above airborne
exposure levels of interest to OSHA (2 [mu]g/m\3\ and below).
Just prior to arranging the peer review, a NIOSH study was
published by Schubauer-Berigan et al. updating the Reading, PA cohort
studied by Sanderson et al. and adding cohorts
[[Page 47652]]
from two additional plants in Elmore, OH and Hazleton, PA (Schubauer-
Berigan, 2011). At OSHA's request, the peer reviewers reviewed this
study to determine whether it could provide a better basis for lung
cancer risk analysis than the Sanderson et al. study. The reviewers
found that the NIOSH update addressed the major concerns OSHA had
expressed about the Sanderson study. In particular, they pointed out
that workers in the Elmore and Hazleton cohorts had longer tenure at
the plants and experienced lower exposures than those at the Reading,
PA plant. Dr. Steenland recommended that ``OSHA consider the new NIOSH
data and develop risk estimates for lung cancer as well as
sensitization and CBD.'' Dr. Breysse believed that the NIOSH data
``suggest that a risk assessment for lung cancer should be conducted by
OSHA and the results be compared to the CBD/sensitization risk
assessment before recommending an appropriate exposure concentration.''
While acknowledging the improvements in the quality of the data, other
reviewers were more restrained in their support for quantitative
estimates of lung cancer risk. Dr. Gordon stated that despite
improvements, there was ``still uncertainty associated with the paucity
of data below the current PEL of 2 [mu]g/m\3\.'' Dr. Rossman noted that
the NIOSH study ``did not address the problem of the uncertainty of the
mechanism of beryllium carcinogenicity.'' He felt that the updated
NIOSH lung cancer mortality data ``should not change the Agency's
rationale for choosing to establish its risk findings for the proposed
rule on its analysis for beryllium sensitization and CBD.'' Dr. Balmes
agreed that ``the agency will be on firmer ground by focusing on
sensitization and CBD.''
The preliminary risk assessment preamble subsection VI.G on lung
cancer includes a discussion of the quantitative lung cancer risk
assessment published by NIOSH researchers in 2010 (Schubauer-Berigan,
2011). The discussion describes the lower exposure levels, longer
tenure, fewer short-term workers and additional years of observation
that make the data more suitable for risk assessment. NIOSH relied on
several modeling approaches to show that lung cancer risk was
significantly related to both mean and cumulative beryllium exposure.
Subsection VI.G provides the excess lifetime lung cancer risks
predicted from several best-fitting NIOSH models at beryllium exposures
of interest to OSHA (Table VI-20). Using the piecewise log-linear
proportional hazards model favored by NIOSH, there is a projected drop
in excess lifetime lung cancer risks from approximately 61 cases per
1000 exposed workers at the current PEL of 2.0 [mu]g/m\3\ to
approximately 6 cases per 1000 at the proposed PEL of 0.2 [mu]g/m\3\.
Subsection VI.H on preliminary conclusions indicates that these
projections support a reduced risk of lung cancer from more stringent
control of beryllium exposures but that the lung cancer risk estimates
are more uncertain than those for sensitization and CBD.
VIII. Significance of Risk
To promulgate a standard that regulates workplace exposure to toxic
materials or harmful physical agents, OSHA must first determine that
the standard reduces a ``significant risk'' of ``material impairment.''
The first part of this requirement, ``significant risk,'' refers to the
likelihood of harm, whereas the second part, ``material impairment,''
refers to the severity of the consequences of exposure.
The Agency's burden to establish significant risk is based on the
requirements of the OSH Act (29 U.S.C. 651 et seq). Section 3(8) of the
Act requires that workplace safety and health standards be ``reasonably
necessary or appropriate to provide safe or healthful employment'' (29
U.S.C. 652(8)). The Supreme Court, in the Benzene decision, interpreted
section 3(8) to mean that ``before promulgating any standard, the
Secretary must make a finding that the workplaces in question are not
safe'' (Industrial Union Department, AFL-CIO v. American Petroleum
Institute, 448 U.S. 607, 642 (1980) (plurality opinion)). Examining
section 3(8) more closely, the Court described OSHA's obligation to
demonstrate significant risk:
``[S]afe'' is not the equivalent of ``risk-free.'' A workplace
can hardly be considered ``unsafe'' unless it threatens the workers
with a significant risk of harm. Therefore, before the Secretary can
promulgate any permanent health or safety standard, he must make a
threshold finding that the place of employment is unsafe in the
sense that significant risks are present and can be eliminated or
lessened by a change in practices (Id).
As the Court made clear, the Agency has considerable latitude in
defining significant risk and in determining the significance of any
particular risk. The Court did not specify a means to distinguish
significant from insignificant risks, but rather instructed OSHA to
develop a reasonable approach to making a significant risk
determination. The Court stated that ``it is the Agency's
responsibility to determine in the first instance what it considers to
be a 'significant' risk,'' (448 U.S. at 655) and it did not express
``any opinion on the . . . difficult question of what factual
determinations would warrant a conclusion that significant risks are
present which make promulgation of a new standard reasonably necessary
or appropriate'' (448 U.S. at 659). The Court also stated that, while
OSHA's significant risk determination must be supported by substantial
evidence, the Agency ``is not required to support the finding that a
significant risk exists with anything approaching scientific
certainty'' (448 U.S. at 656). Furthermore:
A reviewing court [is] to give OSHA some leeway where its
findings must be made on the frontiers of scientific knowledge . . .
. [T]he Agency is free to use conservative assumptions in
interpreting the data with respect to carcinogens, risking error on
the side of overprotection rather than underprotection [so long as
such assumptions are based on] a body of reputable scientific
thought (448 U.S. at 656).
Thus, to make the significance of risk determination for a new or
proposed standard, OSHA uses the best available scientific evidence to
identify material health impairments associated with potentially
hazardous occupational exposures and to evaluate exposed workers' risk
of these impairments.
The OSH Act also requires that the Agency make a finding that the
toxic material or harmful physical agent at issue causes material
impairment to worker health. In that regard, the Act directs the
Secretary of Labor to set standards based on the available evidence
where no employee, over his/her working life time, will suffer from
material impairment of health or functional capacity, even if such
employee has regular exposure to the hazard, to the exent feasible (29
U.S.C. 655(b)(5)).
As with significant risk, what constitutes material impairment in
any given case is a policy determination for which OSHA is given
substantial leeway. ``OSHA is not required to state with scientific
certainty or precision the exact point at which each type of [harm]
becomes a material impairment'' (AFL-CIO v. OSHA, 965 F.2d 962, 975
(11th Cir. 1992)). Courts have also noted that OSHA should consider all
forms and degrees of material impairment--not just death or serious
physical harm--and that OSHA may act with a ``pronounced bias towards
worker safety'' (Id; Bldg & Constr. Trades Dep't v. Brock, 838 F.2d
1258, 1266 (D.C. Cir. 1988)). OSHA's long-standing policy is to
consider 45 years as a ``working life,''
[[Page 47653]]
over which it must evaluate material impairment and risk.
In formulating this proposed beryllium standard, OSHA has reviewed
the best available evidence pertaining to the adverse health effects of
occupational beryllium exposure, including lung cancer and chronic
beryllium disease (CBD), and has evaluated the risk of these effects
from exposures allowed under the current standard as well as the
expected impact of the proposed standard on risk. Based on its review
of extensive epidemiological and experimental research, OSHA has
preliminarily determined that long-term exposure at the current
Permissible Exposure Limit (PEL) would pose a significant risk of
material impairment to workers' health, and that adoption of the new
PEL and other provisions of the proposed rule will substantially reduce
this risk.
A. Material Impairment of Health
In this preamble at section V, Health Effects, OSHA reviewed the
scientific evidence linking occupational beryllium exposure to a
variety of adverse health effects, including CBD and lung cancer. Based
on this review, OSHA preliminarily concludes that beryllium exposure
causes these effects. The Agency's preliminary conclusion was strongly
supported by a panel of independent peer reviewers, as discussed in
section VII.
Here, OSHA discusses its preliminary conclusion that CBD and lung
cancer constitute material impairments of health, and briefly reviews
other adverse health effects that can result from beryllium exposure.
Based on this preliminary conclusion and on the scientific evidence
linking beryllium exposure to both CBD and lung cancer, OSHA concludes
that occupational exposure to beryllium causes ``material impairment of
health or functional capacity'' within the meaning of the OSH Act.
1. Chronic Beryllium Disease
CBD is a respiratory disease in which the body's immune system
reacts to the presence of beryllium in the lung, causing a progression
of pathological changes including chronic inflammation and tissue
scarring. CBD can also impair other organs such as the liver, skin,
spleen, and kidneys and cause adverse health effects such as granulomas
of the skin and lymph nodes and cor pulmonale (i.e., enlargement of the
heart) (Conradi et al., 1971; ACCP, 1965; Kriebel et al., 1988a and b).
In early, asymptomatic stages of CBD, small granulomatous lesions and
mild inflammation occur in the lungs. Early stage CBD among some
workers has been observed to progress to more serious disease even
after the worker is removed from exposure (Mroz, 2009), probably
because common forms of beryllium have slow clearance rates and can
remain in the lung for years after exposure. Sood et al. has reported
that cessation of exposure can sometimes have beneficial effects on
lung function (Sood et al., 2004). However, this was based on a small
study of six patients with CBD, and more research is needed to better
determine the relationship between exposure duration and disease
progression. In general, progression of CBD from early to late stages
is understood to vary widely, responding differently to exposure
cessation and treatment for different individuals (Sood, 2009; Mroz,
2009).
Over time, the granulomas can spread and lead to lung fibrosis
(scarring) and moderate to severe loss of pulmonary function, with
symptoms including a persistent dry cough and shortness of breath
(Saber and Dweik, 2000). Fatigue, night sweats, chest and joint pain,
clubbing of fingers (due to impaired oxygen exchange), loss of
appetite, and unexplained weight loss may occur as the disease
progresses. Corticosteroid therapy, in workers whose beryllium exposure
has ceased, has been shown to control inflammation, ease symptoms
(e.g., difficulty breathing, fever, cough, and weight loss) and in some
cases prevent the development of fibrosis (Marchand-Adam et al., 2008).
Thus early treatment can lead to CBD regression in some patients,
although there is no cure (Sood, 2004). Other patients have shown
short-term improvements from corticosteroid treatment, but then
developed serious fibrotic lesions (Marchand-Adam et al., 2008). Once
fibrosis has developed in the lungs, corticosteroid treatment cannot
reverse the damage (Sood, 2009). Persons with late-stage CBD experience
severe respiratory insufficiency and may require supplemental oxygen
(Rossman, 1991). Historically, late-stage CBD often ended in death
(NAS, 2008).
While the use of steroid therapy has mitigated CBD mortality,
treatment with corticosteroids has side effects that need to be
measured against the possibility of progression of disease
(Trikudanathan and McMahon, 2008; Lipworth, 1999; Gibson et al., 1996;
Zaki et al., 1987). Adverse effects associated with long-term
corticosteroid use include, but are not limited to, increased risk of
opportunistic infections (Lionakis and Kontoyiannis, 2003;
Trikudanathan and McMahon, 2008); accelerated bone loss or osteoporosis
leading to increased risk of fractures or breaks (Hamida et al., 2011;
Lehouck et al., 2011; Silva et al., 2011; Sweiss et al., 2011;
Langhammer et al., 2009); psychiatric effects including depression,
sleep disturbances, and psychosis (Warrington and Bostwick, 2006;
Brown, 2009); adrenal suppression (Lipworth, 1999; Frauman, 1996);
ocular effects including cataracts, ocular hypertension, and glaucoma
(Ballonzolli and Bourchier, 2010; Trikudanathan and McMahon, 2008;
Lipworth, 1999); an increase in glucose intolerance (Trikudanathan and
McMahon, 2008); excessive weight gain (McDonough et al., 2008; Torres
and Nowson, 2007; Dallman et al., 2007; Wolf, 2002; Cheskin et al.,
1999); increased risk of atherosclerosis and other cardiovascular
syndromes (Franchimont et al., 2002); skin fragility (Lipworth, 1999);
and poor wound healing (de Silva and Fellows, 2010). Studies relating
the long-term effect of corticosteroid use for the treatment of CBD
need to be undertaken to evaluate the treatment's overall effectiveness
against the risk of adverse side effects from continued usage.
OSHA considers late-stage CBD to be a material impairment of
health, as it involves permanent damage to the pulmonary system, causes
additional serious adverse health effects, can have adverse
occupational and social consequences, requires treatment associated
with severe and lasting side effects, and may in some cases be life-
threatening. Furthermore, OSHA believes that material impairment begins
prior to the development of symptoms of the disease.
Although there are no symptoms associated with early-stage CBD,
during which small lesions and inflammation appear in the lungs, the
Agency has preliminarily concluded that the earliest stage of CBD is
material impairment of health. OSHA bases this conclusion on evidence
showing that early-stage CBD is a measurable change in the state of
health which, with and sometimes without continued exposure, can
progress to symptomatic disease. Thus, prevention of the earliest
stages of CBD will prevent development of more serious disease. The
OSHA Lead Standard established the Agency's position that a
`subclinical' health effect may be regarded as a material impairment of
health. In the preamble to that standard, the Agency said:
OSHA believes that while incapacitating illness and death
represent one extreme of a spectrum of responses, other biological
effects such as metabolic or physiological changes are precursors or
sentinels of disease which should be prevented . . . Rather than
revealing beginnings of illness the standard must be selected to
prevent an earlier point
[[Page 47654]]
of measurable change in the state of health which is the first
significant indicator of possibly more severe ill health in the
future. The basis for this decision is twofold--first,
pathophysiologic changes are early stages in the disease process
which would grow worse with continued exposure and which may include
early effects which even at early stages are irreversible, and
therefore represent material impairment themselves. Secondly,
prevention of pathophysiologic changes will prevent the onset of the
more serious, irreversible and debilitating manifestations of
disease.\11\ (43 FR 52952, 52954, November 14, 1978)
\11\ Even if asymptomatic CBD were not itself a material
impairment of health, the D.C. Circuit upheld OSHA's authority to
regulate to prevent subclinical health effects as precursors to
disease in United Steelworkers of America, AFL-CIO v. Marshall, 647
F.2d 1189, 1252 (D.C. Cir. 1980), which reviewed the Lead standard.
Without deciding whether the early symptoms of disease were
themselves a material impairment, the court concluded that OSHA may
regulate subclinical effects if it can demonstrate on the basis of
substantial evidence that preventing subclinical effects would help
prevent the clinical phase of disease (Id.).
Since the Lead rulemaking, OSHA has also found other non-
symptomatic health conditions to be material impairments of health. In
the Bloodborne Pathogens (BP) rulemaking, OSHA maintained that material
impairment includes not only workers with clinically ``active''
hepatitis from the hepatitis B virus (HBV) but also includes
asymptomatic HBV ``carriers'' who remain infectious and are able to put
others at risk of serious disease through contact with body fluids
(e.g., blood, sexual contact) (56 FR 64004, December 6, 1991). OSHA
stated: ``Becoming a carrier [of Hepatitis B] is a material impairment
of health even though the carrier may have no symptoms. This is because
the carrier will remain infectious, probably for the rest of his or her
life, and any person who is not immune to HBV who comes in contact with
the carrier's blood or certain other body fluids will be at risk of
becoming infected'' (56 FR 64004, 64036).
OSHA preliminarily finds that early-stage CBD is the type of
asymptomatic health effect the Agency determined to be a material
impairment of health in the lead standard. Early stage CBD involves
lung tissue inflammation without symptomatology that can worsen with--
or without--continued exposure. The lung pathology progresses over time
from a chronic inflammatory response to tissue scarring and fibrosis
accompanied by moderate to severe loss in pulmonary function. Early
stage CBD is clearly a precursor of advanced clinical disease,
prevention of which will prevent symptomatic disease. OSHA argued in
the Lead standard that such precursor effects should be considered
material health impairments in their own right, and that the Agency
should act to prevent them when it is feasible to do so. Therefore,
OSHA preliminarily finds all stages of CBD to be material impairments
of health.
2. Lung Cancer
OSHA considers lung cancer, a frequently fatal disease, to be a
material impairment of health. OSHA's finding that inhaled beryllium
causes lung cancer is based on the best available epidemiological data,
reflects evidence from animal and mechanistic research, and is
consistent with the conclusions of other government and public health
organizations (see this preamble at section V, Health Effects). For
example, the International Agency for Research on Cancer (IARC),
National Toxicology Program (NTP), and American Conference of
Governmental Industrial Hygienists (ACGIH) have all classified
beryllium as a known human carcinogen (IARC, 2009).
The Agency's epidemiological evidence comes from multiple studies
of U.S. beryllium workers (Sanderson et al., 2001a; Ward et al., 1992;
Wagoner et al., 1980; Mancuso et al., 1979). Most recently, a NIOSH
cohort study found significantly increased lung cancer mortality among
workers at seven beryllium processing facilities (Schubauer-Berigan et
al., 2011). The cohort was exposed, on average, to lower levels of
beryllium than those in most previous studies, had fewer short-term
workers, and had sufficient follow-up time to observe lung cancer in
the population. OSHA considers the Schubauer-Berigan study to be the
best available epidemiological evidence regarding the risk of lung
cancer from beryllium at exposure levels near the PEL.\12\
---------------------------------------------------------------------------
\12\ The scientific peer review panel for OSHA's Preliminary
Risk Assessment agreed with the Agency that the Schubauer-Berigan
analysis improves upon the previously available data for lung cancer
risk assessment.
---------------------------------------------------------------------------
Supporting evidence of beryllium carcinogenicity comes from various
animal studies as well as in vitro genotoxicity and other studies (EPA,
1998; ATSDR, 2002; Gordon and Bowser, 2003; NAS, 2008; Nickell-Brady et
al., 1994; NTP, 1999 and 2005; IARC, 1993 and 2009). Multiple
mechanisms may be involved in the carcinogenicity of beryllium, and
factors such as epigenetics, mitogenicity, reactive oxygen-mediated
indirect genotoxicity, and chronic inflammation may contribute to the
lung cancer associated with beryllium exposure, although the results of
studies testing the direct genotoxicity of beryllium are mixed (EPA
summary, 1998). While there is uncertainty regarding the exact
mechanism of carcinogenesis for beryllium, the overall weight of
evidence for the carcinogenicity of beryllium is strong. Therefore, the
Agency has preliminarily determined beryllium to be an occupational
carcinogen.
3. Other Impairments
While OSHA has relied primarily on the relationship between
occupational beryllium exposure and CBD and lung cancer to demonstrate
the necessity of the standard, the Agency has also determined that
several other adverse health effects can result from exposure to
beryllium. Inhalation of high airborne concentrations of beryllium
(well above the 2 [mu]g/m\3\ OSHA PEL) can cause acute beryllium
disease, a severe (sometimes fatal), rapid-onset inflammation of the
lungs. Hepatic necrosis, damage to the heart and circulatory system,
chronic renal disease, mucosal irritation and ulceration, and urinary
tract cancer have also reportedly been associated with occupational
exposures well above the current PEL (see this preamble at section V,
Health Effects, subsection E, Epidemiological Studies, and subsection
F, Other Health Effects). These adverse systemic effects and acute
beryllium disease mostly occurred prior to the introduction of
occupational and environmental standards set in 1970-1972 (OSHA, 1971;
ACGIH, 1971; ANSI, 1970) and 1974 (EPA, 1974) and therefore are less
relevant today than in the past. Because they occur only rarely in
current-day occupational environments, they are not addressed in OSHA's
risk analysis or significance of risk determination.
The Agency has also determined that beryllium sensitization, a
precursor which occurs before early stage CBD and is an essential step
for worker development of the disease, can result from exposure to
beryllium. The Agency takes no position at this time on whether
sensitization constitutes a material impairment of health, because it
was unnecessary to do so as part of this rulemaking. As discussed in
Section V, Health Effects, only sensitized individuals can develop CBD
(NAS, 2008). OSHA's risk assessment for sensitization informs the
Agency's understanding of what exposure control measures have been
successful in preventing sensitization, which in turn prevents
development of CBD. Therefore sensitization is considered in the next
section on significance of risk.
[[Page 47655]]
In AFL-CIO v. Marshall, 617 F.2d 636, 654 n.83 (D.C. Cir. 1979) (Cotton
Dust), the D.C. Circuit upheld OSHA's authority to regulate to prevent
precursors to a material impairment of health without deciding whether
the precursors themselves constituted material impairment of health.
B. Significance of Risk and Risk Reduction
To evaluate the significance of the health risks that result from
exposure to hazardous chemical agents, OSHA relies on the best
available epidemiological, toxicological, and experimental evidence.
The Agency uses both qualitative and quantitative methods to
characterize the risk of disease resulting from workers' exposure to a
given hazard over a working lifetime at levels of exposure reflecting
compliance with current standards and compliance with the new standards
being proposed.
As discussed above, the Agency's characterization of risk is guided
in part by the Benzene decision. In Benzene, the Court broadly
describes the range of risks OSHA might determine to be significant:
It is the Agency's responsibility to determine in the first
instance what it considers to be a ``significant'' risk. Some risks
are plainly acceptable and others are plainly unacceptable. If, for
example, the odds are one in a billion that a person will die from
cancer by taking a drink of chlorinated water, the risk clearly
could not be considered significant. On the other hand, if the odds
are one in a thousand that regular inhalation of gasoline vapors
that are 2 percent benzene will be fatal, a reasonable person might
well consider the risk significant and take the appropriate steps to
decrease or eliminate it (Benzene, 448 U.S. at 655).
The Court further stated, ``The requirement that a 'significant' risk
be identified is not a mathematical straitjacket. . . . Although the
Agency has no duty to calculate the exact probability of harm, it does
have an obligation to find that a significant risk is present before it
can characterize a place of employment as 'unsafe', ``and proceed to
promulgate a regulation (Id.).
In this preamble at section VI, Preliminary Risk Assessment, OSHA
finds that the available epidemiological data are sufficient to
evaluate risk for beryllium sensitization, CBD, and lung cancer among
beryllium-exposed workers. The preliminary findings from this
assessment are summarized below.
1. Risk of Beryllium Sensitization and CBD
OSHA's preliminary risk assessment for CBD and beryllium
sensitization relies on studies conducted at a Tucson, AZ beryllium
ceramics plant (Kreiss et al., 1996; Henneberger et al., 2001; Cummings
et al., 2006); a Reading, PA alloy processing plant (Schuler et al.,
2005; Thomas et al., 2009); a Cullman, AL beryllium machining plant
(Kelleher et al., 2001; Madl et al., 2007); and an Elmore, OH metal,
alloy, and oxide production plant (Kreiss et al., 1997; Bailey et al.,
2010; Schuler et al., 2012). The Agency uses these studies to
demonstrate the significance of risk at the current PEL and the
significant reduction in risk expected with reduction of the PEL. In
addition to the effects OSHA anticipates from reduction of airborne
beryllium exposure, the Agency expects that dermal protection
provisions in the proposed rule will further reduce risk. Studies
conducted in the 1950s by Curtis et al. showed that soluble beryllium
particles could penetrate the skin and cause beryllium sensitization
(Curtis 1951, NAS 2008). Tinkle et al. established that 0.5- and 1.0-
[mu]m particles can penetrate intact human skin surface and reach the
epidermis, where beryllium particles would encounter antigen-presenting
cells and initiate sensitization (Tinkle et al., 2003). Tinkle et al.
further demonstrated that beryllium oxide and beryllium sulfate,
applied to the skin of mice, generate a beryllium-specific, cell-
mediated immune response similar to human beryllium sensitization
(Tinkle et al., 2003). In the epidemiological studies discussed below,
the exposure control programs that most effectively reduced the risk of
beryllium sensitization and CBD incorporated both respiratory and
dermal protection. OSHA has preliminarily determined that an effective
exposure control program should incorporate both airborne exposure
reduction and dermal protection provisions.
In the Tucson ceramics plant, 4,133 short-term breathing zone
measurements collected between 1981 and 1992 had a median of 0.3 [mu]g/
m\3\. Kreiss et al. reported that eight (5.9 percent) of 136 workers
tested for beryllium sensitization in 1992 were sensitized, six (4.4
percent) of whom were diagnosed with CBD. Exposure control programs
were initiated in 1992 to reduce workers' airborne beryllium exposure,
but the programs did not address dermal exposure. Full-shift personal
samples collected between 1994 and 1999 showed a median beryllium
exposure of 0.2 [mu]g/m\3\ in production jobs and 0.1 [mu]g/m\3\ in
production support (Cummings et al., 2007). In 1998, a second screening
found that 6, (9 percent) of 69 tested workers hired after the 1992
screening, were sensitized, of whom 1 was diagnosed with CBD. All of
the sensitized workers had been employed at the plant for less than 2
years (Henneberger et al., 2001), too short a time period for most
people to develop CBD following sensitization. Of the 77 Tucson workers
hired prior to 1992 who were tested in 1998, 8 (10.4 percent) were
sensitized and all but 1 of these (9.7 percent) were diagnosed with CBD
(Henneberger et al., 2001).
Kreiss et al., studied workers at a beryllium metal, alloy, and
oxide production plant in Elmore, OH. Workers participated in a BeLPT
survey in 1992 (Kreiss et al., 1997). Personal lapel samples collected
during 1990-1992 had a median value of 1.0 [mu]g/m\3\. Kreiss et al.
reported that 43 (6.9 percent) of 627 workers tested in 1992 were
sensitized, 6 of whom were diagnosed with CBD (4.4 percent).
Newman et al. conducted a series of BeLPT screenings of workers at
a Cullman, AL precision machining facility between 1995 and 1999
(Newman et al., 2001). Personal lapel samples collected at this plant
in the early 1980s and in 1995 from all machining processes combined
had a median of 0.33 [mu]g/m\3\ (Madl et al., 2007). After a sentinel
case of CBD was diagnosed at the plant in 1995, the company implemented
engineering and administrative controls and PPE designed to reduce
workers' beryllium exposures in machining operations. Personal lapel
samples collected extensively between 1996 and 1999 in machining jobs
have an overall median of 0.16 [mu]g/m\3\, showing that the new
controls reduced machinists' exposures during this period. However, the
results of BeLPT screenings conducted in 1995-1999 showed that the
exposure control program initiated in 1995 did not sufficiently protect
workers from beryllium sensitization and CBD. In a group of 60 workers
who had been employed at the plant for less than a year, and thus would
not have been working there prior to 1995, 4 (6.7 percent) were found
to be sensitized. Two of these workers (3.35 percent) were diagnosed
with CBD. (Newman et al., 2001).
Sensitization and CBD were studied in a population of workers at a
Reading, PA copper beryllium plant, where alloys containing a low level
of beryllium were processed (Schuler et al., 2005). Personal lapel
samples were collected in production and production support jobs
between 1995 and May 2000. These samples showed primarily very low
airborne beryllium levels, with a median of 0.073 [mu]g/m\3\. The wire
[[Page 47656]]
annealing and pickling process had the highest personal lapel sample
values, with a median of 0.149 [mu]g/m\3\. Despite these low exposure
levels, a BeLPT screening conducted in 2000 showed that 5, (11.5
percent) workers of 43 hired after 1992 were sensitized (evaluation for
CBD not reported). Two of the sensitized workers had been hired less
than a year before the screening (Thomas et al., 2009).
In summary, the epidemiological literature on beryllium
sensitization and CBD that OSHA's risk assessment relied on show
sensitization prevalences ranging from 6.5 percent to 11.5 percent and
CBD prevalences ranging from 1.3 percent to 9.7 percent among workers
who had full-shift exposures well below the current PEL and median
full-shift exposures at or below the proposed PEL, and whose follow-up
time was less than 45 years. As referenced earlier, OSHA is interested
in the risk associated with a 45-year (i.e., working lifetime)
exposure. Because CBD often develops over the course of years following
sensitization, the risk of CBD that would result from 45 years'
occupational exposure to airborne beryllium is likely to be higher than
the prevalence of CBD observed among these workers.\13\ In either case,
based on these studies, the risks to workers appear to be significant.
---------------------------------------------------------------------------
\13\ This point was emphasized by members of the scientific peer
review panel for OSHA's Preliminary Risk Assessment (see this
preamble at section VII).
---------------------------------------------------------------------------
The available epidemiological evidence shows that reducing workers'
levels of airborne beryllium exposure can substantially reduce risk of
beryllium sensitization and CBD. The best available evidence on
effective exposure control programs comes partly from studies of
programs introduced around 2000 at Reading, Tucson, and Elmore that
used a combination of engineering controls, dermal and respiratory PPE,
and stringent housekeeping measures to reduce workers' dermal exposures
and airborne exposures to levels well below the proposed PEL of 0.2
[mu]g/m\3\. These programs have substantially lowered the risk of
sensitization among new workers. As discussed earlier, prevention of
beryllium sensitization prevents subsequent development of CBD.
In the Reading, PA copper beryllium plant, full-shift airborne
exposures in all jobs were reduced to a median of 0.1 [mu]g/m\3\ or
below and dermal protection was required for production-area workers
beginning in 2000-2001 (Thomas et al., 2009). After these adjustments
were made, 2 (5.4 percent) of 37 newly hired workers became sensitized.
Thereafter, in 2002, the process with the highest exposures (median 0.1
[mu]g/m\3\) was enclosed and workers involved in that process were
required to use respiratory protection. As a result, the remaining jobs
had very low exposures (medians ~ 0.03 [mu]g/m\3\). Among 45 workers
hired after the enclosure was built and respiratory protection
instituted, 1 was found to be sensitized (2.2 percent). This is a sharp
reduction in sensitization from the 11.5 percent of 43 workers,
discussed above, who were hired after 1992 and had been sensitized by
the time of testing in 2000.
In the Tucson beryllium ceramics plant, respiratory and skin
protection was instituted for all workers in production areas in 2000.
BeLPT testing done in 2000-2004 showed that only 1 (1 percent) worker
had been sensitized out of 97 workers hired during that time period
(Cummings et al., 2007; testing for CBD not reported). This contrasts
with the prevalence of sensitization in the 1998 Tucson BeLPT
screening, which found that 6 (9 percent) of 69 workers hired after
1992 were sensitized (Cummings et al., 2007).
The modern Elmore facility provides further evidence that combined
reductions in respiratory exposure (via respirator use) and dermal
exposure are effective in reducing risk of beryllium sensitization. In
Elmore, historical beryllium exposures were higher than in Tucson,
Reading, and Cullman. Personal lapel samples collected at Elmore in
1990-1992 had a median of 1.0 [micro]g/m\3\. In 1996-1999, the company
took steps to reduce workers' beryllium exposures, including
engineering and process controls (Bailey et al., 2010; exposure levels
not reported). Skin protection was not included in the program until
after 1999. Beginning in 1999 all new employees were required to wear
loose-fitting powered air-purifying respirators (PAPR) in manufacturing
buildings (Bailey et al., 2010). Skin protection became part of the
protection program for new employees in 2000, and glove use was
required in production areas and for handling work boots beginning in
2001. Bailey et al., (2010) compared the occurrence of beryllium
sensitization and CBD in 2 groups of workers: 1) 258 employees who
began work at the Elmore plant between January 15, 1993 and August 9,
1999 (the ``pre-program group'') and were tested in 1997 and 1999, and
2) 290 employees who were hired between February 21, 2000 and December
18, 2006 and underwent BeLPT testing in at least one of frequent rounds
of testing conducted after 2000 (the ``program group''). They found
that, as of 1999, 23 (8.9 percent) of the pre-program group were
sensitized to beryllium. The prevalence of sensitization among the
``program group'' workers, who were hired after the respiratory
protection and PPE measures were put in place, was around 2-3 percent.
Respiratory protection and skin protection substantially reduced, but
did not eliminate, risk of sensitization. Evaluation of sensitized
workers for CBD was not reported.
OSHA's preliminary risk assessment also includes analysis of a data
set provided to OSHA by the National Jewish Research and Medical Center
(NJMRC). The data set describes a population of 319 beryllium-exposed
workers at a Cullman, AL machining facility. It includes exposure
samples collected between 1980 and 2005, and has updated work history
and screening information for over three hundred workers through 2003.
Seven (2.2 percent) workers in the data set were reported as sensitized
only. Sixteen (5.0 percent) workers were listed as sensitized and
diagnosed with CBD upon initial clinical evaluation. Three (1.0
percent) workers, first shown to be sensitized only, were later
diagnosed with CBD. The data set includes workers exposed at airborne
beryllium levels near the proposed PEL, and extensive exposure data
collected in workers' breathing zones, as is preferred by OSHA. Unlike
the Tucson, Reading, and Elmore facilities, respirator use was not
generally required for workers at the Cullman facility. Thus, analysis
of this data set shows the risk associated with varying levels of
airborne exposure, rather than the virtual elimination of airborne
exposure via respiratory PPE. Also unlike the Tucson, Elmore, and
Reading facilities, glove use was not reported to be mandatory in the
Cullman facility. Thus, OSHA believes reductions in risk at the Cullman
facility to be the result of airborne exposure control, rather than the
combination of airborne and dermal exposure controls at the Tucson,
Elmore, and Reading facilities.
OSHA analyzed the prevalence of beryllium sensitization and CBD
among workers at the Cullman facility who were exposed to airborne
beryllium levels at and below the current PEL of 2 [micro]g/m\3\. In
addition, a statistical modeling analysis of the NJMRC Cullman data set
was conducted under contract with Dr. Roslyn Stone of the University of
Pittsburgh Graduate School of Public Heath, Department of
Biostatistics. OSHA summarizes these analyses briefly below, and in
more detail in this preamble at section VI, Preliminary Risk
Assessment.
[[Page 47657]]
Tables 1 and 2 below present the prevalence of sensitization and
CBD cases across several categories of lifetime-weighted (LTW) average
and highest-exposed job (HEJ) exposure at the Cullman facility. The HEJ
exposure is the exposure level associated with the highest-exposure job
and time period experienced by each worker. The columns ``Total'' and
``Total percent'' refer to all sensitized workers in the dataset,
including workers with and without a diagnosis of CBD.
Table 1--Prevalence of Sensitization and CBD by Lifetime Weighted Average Exposure Quartile, Cullman, AL Machining Facility
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sensitized
LTW Average exposure ([mu]g/m\3\) Group size only CBD Total Total % CBD %
--------------------------------------------------------------------------------------------------------------------------------------------------------
0.0-0.080............................................... 91 1 1 2 2.2 1.0
0.081-0.18.............................................. 73 2 4 6 8.2 5.5
0.19-0.51............................................... 77 0 6 6 7.8 7.8
0.51-2.15............................................... 78 4 8 12 15.4 10.3
-----------------------------------------------------------------------------------------------
Total............................................... 319 7 19 26 8.2 6.0
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: Section VI, Preliminary Risk Assessment.
Table 2--Prevalence of Sensitization and CBD by Highest-Exposed Job Exposure Quartile, Cullman, AL Machining Facility
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sensitized
HEJ Exposure ([mu]g/m\3\) Group size only CBD Total Total % CBD %
--------------------------------------------------------------------------------------------------------------------------------------------------------
0.0-0.086............................................... 86 1 0 1 1.2 0.0
0.091-0.214............................................. 81 1 6 7 8.6 7.4
0.387-0.691............................................. 76 2 9 11 14.5 11.8
0.954-2.213............................................. 76 3 4 7 9.2 5.3
-----------------------------------------------------------------------------------------------
Total............................................... 319 7 19 26 8.2 6.0
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: Section VI, Preliminary Risk Assessment.
The current PEL of 2 [mu]g/m\3\ is close to the upper bound of the
highest quartile of LTW average (0.51-2.15 [mu]g/m\3\) and HEJ (0.954-
2.213) exposure levels. In the highest quartile of LTW average
exposure, there were 12 cases of sensitization (15.4 percent),
including 8 (10.3 percent) diagnosed with CBD. Notably, the Cullman
workers had been exposed to beryllium dust for considerably less than
45 years at the time of testing. A high prevalence of sensitization
(9.2 percent) and CBD (5.3 percent) is seen in the top quartile of HEJ
exposure as well, with even higher prevalences in the third quartile
(0.387-0.691 [mu]g/m\3\).\14\
---------------------------------------------------------------------------
\14\ This exposure-response pattern is sometimes attributed to a
``healthy worker effect'' or to exposure misclassification, as
discussed in this preamble at section VI, Preliminary Risk
Assessment.
---------------------------------------------------------------------------
The proposed PEL of 0.2 [mu]g/m\3\ is close to the upper bound of
the second quartile of LTW average (0.81-0.18 [mu]g/m\3\) and HEJ
(0.091-0.214 [mu]g/m\3\) exposure levels and to the lower bound of the
third quartile of LTW average (0.19-0.50 [mu]g/m\3\) exposures. The
second quartile of LTW average exposure shows a high prevalence of
beryllium-related health effects, with six workers sensitized (8.2
percent), of whom four (5.5 percent) were diagnosed with CBD. The
second quartile of HEJ exposure also shows a high prevalence of
beryllium-related health effects, with seven workers sensitized (8.6
percent), of whom 6 (7.4 percent) were diagnosed with CBD. Among six
sensitized workers in the third quartile of LTW average exposures, all
were diagnosed with CBD (7.8 percent). The prevalence of CBD among
workers in these quartiles was approximately 5-8 percent, and overall
sensitization (including workers with and without CBD) was about 8
percent. OSHA considers these rates as evidence that the risk of
developing CBD is significant among workers exposed at and below the
current PEL, even down to the proposed PEL. Much lower prevalences of
sensitization and CBD were found among workers with exposure levels
less than or equal to about 0.08 [mu]g/m\3\. Two sensitized workers
(2.2 percent), including 1 case of CBD (1.0 percent), were found among
workers with LTW average exposure levels and HEJ exposure levels less
than or equal to 0.08 [mu]g/m\3\ and 0.086 [mu]g/m\3\, respectively.
Strict control of airborne exposure to levels below 0.1 [mu]g/m\3\ can,
therefore, significantly reduce risk of sensitization and CBD. Although
OSHA recognizes that maintaining exposure levels below 0.1 [mu]g/m\3\
may not be feasible in some operations (see this preamble at section
IX, Summary of the Preliminary Economic Analysis and Initial Regulatory
Flexibility Analysis), the Agency believes that workers in facilities
that meet the proposed action level of 0.1 [mu]g/m\3\ will be at less
risk of sensitization and CBD than workers in facilities that cannot
meet the action level.
Table 3 below presents the prevalence of sensitization and CBD
cases across cumulative exposure quartiles, based on the same Cullman
data used to derive Tables 1 and 2. Cumulative exposure is the sum of a
worker's exposure across the duration of his employment.
[[Page 47658]]
Table 3--Prevalence of Sensitization and CBD by Cumulative Exposure Quartile Cullman, AL Machining Facility
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sensitized
Cumulative exposure ([mu]g/m\3\ yrs) Group size only CBD Total Total % CBD %
--------------------------------------------------------------------------------------------------------------------------------------------------------
0.0-0.147............................................... 81 2 2 4 4.9 2.5
0.148-1.467............................................. 79 0 2 2 2.5 2.5
1.468-7.008............................................. 79 3 8 11 13.9 8.0
7.009-61.86............................................. 80 2 7 9 11.3 8.8
-----------------------------------------------------------------------------------------------
Total............................................... 319 7 19 26 8.2 6.0
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: Section VI, Preliminary Risk Assessment.
A 45-year working lifetime of occupational exposure at the current
PEL would result in 90 [mu]g/m \3\-years, a value far higher than the
cumulative exposures of workers in this data set, who worked for
periods of time less than 45 years and whose exposure levels were
mostly well below the PEL. Workers with 45 years of exposure to the
proposed PEL would have a cumulative exposure (9 [mu]g/m \3\-years) in
the highest quartile for this worker population. As with the average
and HEJ exposures, the greatest risk of sensitization and CBD appears
at high exposure levels (> 1.468 [mu]g/m \3\-years). The third
cumulative quartile, at which a sharp increase in sensitization and CBD
appears, is bounded by 1.468 and 7.008 [mu]g/m \3\-years. This is
equivalent to 0.73-3.50 years of exposure at the current PEL of 2
[mu]g/m \3\, or 7.34-35.04 years of exposure at the proposed PEL of 0.2
[mu]g/m \3\. Prevalence of both sensitization and CBD is substantially
lower in the second cumulative quartile (0.148-1.467 [mu]g/m \3\-
years). This is equivalent to approximately 0.7 to 7 years at the
proposed PEL of 0.2 [mu]g/m \3\, or 1.5 to 15 years at the proposed
action level of 0.1 [mu]g/m \3\. This supports that maintaining
exposure levels below the proposed PEL, where feasible, will help to
protect long-term workers against risk of beryllium sensitization and
early stage CBD.
As discussed in the Health Effects section (V.D), CBD often worsens
with increased time and level of exposure. In a longitudinal study,
workers initially identified as beryllium sensitized through workplace
surveillance developed early stage CBD defined by granulomatous
inflammation but no apparent physiological abnormalities (Newman et
al., 2005). A study of workers with this early stage CBD showed
significant declines in breathing capacity and gas exchange over the 30
years from first exposure (Mroz et al., 2009). Many of the workers went
on to develop more severe disease that required immunosuppressive
therapy despite being removed from exposure. While precise beryllium
exposure levels were not available on the individuals in these studies,
most started work in the 1980s and 1990s and were likely exposed to
average levels below the current 2 [mu]g/m \3\ PEL. The evidence for
time-dependent disease progression indicates that the CBD risk
estimates for a 45-year lifetime exposure at the current PEL will
include a higher proportion of individuals with advanced clinical CBD
than found among the workers in the NJMRC data set.
Studies of community-acquired (CA) CBD support the occurrence of
advanced clinical CBD from long-term exposure to airborne beryllium
(Eisenbud, 1998; Maier et al., 2008). A discussion of the study
findings can be found in this preamble at section VI.C, Preliminary
Risk Assessment. For example, one study evaluated 16 potential cases of
CA-CBD in individuals that resided near a beryllium production facility
in the years between 1943 and 2001 (Maier et al., 2008). Five cases of
definite CBD and three cases of probable CBD were found. Two of the
subjects with probable cases died before they could be confirmed with
the BeLPT; the third had an abnormal BeLPT and radiography consistent
with CBD, but granulomatous disease was not pathologically proven. The
individuals with CA-CBD identified in this study suffered significant
health impacts from the disease, including obstructive, restrictive,
and gas exchange pulmonary defects. Six of the eight cases required
treatment with prednisone, a step typically reserved for severe cases
due to the adverse side effects of steroid treatment. Despite
treatment, three had died of respiratory impairment as of 2002. There
was insufficient information to estimate exposure to the individuals,
but the limited amount of ambient air sampling in the 1950s suggested
that average beryllium levels in the area where the cases resided were
below 2 [mu]g/m \3\. The authors concluded that ``low levels of
exposures with significant disease latency can result in significant
morbidity and mortality'' (Maier et al., 2008, p. 1017).
OSHA believes that the literature review, prevalence analysis, and
the evidence for time-dependent progression of CBD described above
provide sufficient information to draw preliminary conclusions about
significance of risk, and that further quantitative analysis of the
NJMRC data set is not necessary to support the proposed rule. The
studies OSHA used to support its preliminary conclusions regarding risk
of beryllium sensitization and CBD were conducted at modern industrial
facilities with exposure levels in the range of interest for this
rulemaking, so a model is not needed to extrapolate risk estimates from
high to low exposures, as has often been the case in previous rules.
Nevertheless, the Agency felt further quantitative analysis might
provide additional insight into the exposure-response relationship for
sensitization and CBD.
Using the NJMRC data set, Dr. Stone ran a complementary log-log
proportional hazards model, an extension of logistic regression that
allows for time-dependent exposures and differential time at risk.
Relative risk of sensitization increased with cumulative exposure (p =
0.05). A positive, but not statistically significant association was
observed with LTW average exposure (p = 0.09). There was little
association with highest-exposed job (HEJ) exposure (p = 0.3).
Similarly, the proportional hazards models for the CBD endpoint showed
positive relationships with cumulative exposure (p = 0.09), but LTW
average exposure and HEJ exposure were not closely related to relative
risk of CBD (p-values > 0.5). Dr. Stone used the cumulative exposure
models to generate risk estimates for sensitization and CBD.
Tables 4 and 5 below present risk estimates from these models,
assuming 5, 10, 20, and 45 years of beryllium exposure. The tables
present sensitization and CBD risk estimates based on year-specific
intercepts, as
[[Page 47659]]
explained in the section on Risk Assessment and the accompanying
background document. Each estimate represents the number of sensitized
workers the model predicts in a group of 1000 workers at risk during
the given year with an exposure history at the specified level and
duration. For example, in the exposure scenario for 1995, if 1000
workers were occupationally exposed to 2 [mu]g/m \3\ for 10 years, the
model predicts that about 56 (55.7) workers would be identified as
sensitized. The model for CBD predicts that about 42 (41.9) workers
would be diagnosed with CBD that year. The year 1995 shows the highest
risk estimates generated by the model for both sensitization and CBD,
while 1999 and 2002 show the lowest risk estimates generated by the
model for sensitization and CBD, respectively. The corresponding 95
percent confidence intervals are based on the uncertainty in the
exposure coefficient.
Table 4a--Predicted Cases of Sensitization per 1000 Workers Exposed at Current and Alternate PELs Based on Proportional Hazards Model, Cumulative
Exposure Metric, With Corresponding Interval Based on the Uncertainty in the Exposure Coefficient. 1995 Baseline.
--------------------------------------------------------------------------------------------------------------------------------------------------------
1995 Exposure duration
--------------------------------------------------------------------------------------------------------------------------------------------------------
5 years 10 years 20 years 45 years
-------------------------------------------------------------------------------------------------------
Exposure level ([mu]g/m\3\) Cumulative
([mu]g/m\3\- cases/1000 [mu]g/m\3\- cases/1000 [mu]g/m\3\- cases/1000 [mu]g/m\3\- cases/1000
yrs) yrs yrs yrs
--------------------------------------------------------------------------------------------------------------------------------------------------------
2.0............................................. 10.0 41.1 20.0 55.7 40.0 101.0 90.0 394.4
30.3-56.2 30.3-102.9 30.3-318.1 30.3-999.9
1.0............................................. 5.0 35.3 10.0 41.1 20.0 55.7 45.0 116.9
30.3-41.3 30.3-56.2 30.3-102.9 30.3-408.2
0.5............................................. 2.5 32.7 5.0 35.3 10.0 41.1 22.5 60.0
30.3-35.4 30.3-41.3 30.3-56.2 30.3-119.4
0.2............................................. 1.0 31.3 2.0 32.2 4.0 34.3 9.0 39.9
30.3-32.3 30.3-34.3 30.3-38.9 30.3-52.9
0.1............................................. 0.5 30.8 1.0 31.3 2.0 32.2 4.5 34.8
30.3-31.3 30.3-32.3 30.3-34.3 30.3-40.1
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: Section VI, Preliminary Risk Assessment.
Table 4b--Predicted Cases of Sensitization per 1000 Workers Exposed at Current and Alternate PELs Based on Proportional Hazards Model, Cumulative
Exposure Metric, With Corresponding Interval Based on the Uncertainty in the Exposure Coefficient. 1999 Baseline.
--------------------------------------------------------------------------------------------------------------------------------------------------------
1999 Exposure duration
--------------------------------------------------------------------------------------------------------------------------------------------------------
5 years 10 years 20 years 45 years
-------------------------------------------------------------------------------------------------------
Exposure level ([mu]g/m\3\) Cumulative
([mu]g/m\3\- cases/1000 [mu]g/m\3\- cases/1000 [mu]g/m\3\- cases/1000 [mu]g/m\3\- cases/1000
yrs) yrs yrs yrs
--------------------------------------------------------------------------------------------------------------------------------------------------------
2.0............................................. 10.0 8.4 20.0 11.5 40.0 21.3 90.0 96.3
6.2-11.6 6.2-21.7 6.2-74.4 6.2-835.4
1.0............................................. 5.0 7.2 10.0 8.4 20.0 11.5 45.0 24.8
6.2-8.5 6.2-11.6 6.2-21.7 6.2-100.5
0.5............................................. 2.5 6.7 5.0 7.2 10.0 8.4 22.5 12.4
6.2-7.3 6.2-8.5 6.2-11.6 6.2-25.3
0.2............................................. 1.0 6.4 2.0 6.6 4.0 7.0 9.0 8.2
6.2-6.6 6.2-7.0 6.2-8.0 6.2-10.9
0.1............................................. 0.5 6.3 1.0 6.4 2.0 6.6 4.5 7.1
6.2-6.4 6.2-6.6 6.2-7.0 6.2-8.2
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: Section VI, Preliminary Risk Assessment.
Table 5a--Predicted Number of Cases of CBD per 1000 Workers Exposed at Current and Alternative PELs Based on Proportional Hazards Model, Cumulative
Exposure Metric, With Corresponding Interval Based on the Uncertainty in the Exposure Coefficient. 1995 Baseline.
--------------------------------------------------------------------------------------------------------------------------------------------------------
1995 Exposure duration
--------------------------------------------------------------------------------------------------------------------------------------------------------
5 years 10 years 20 years 45 years
-------------------------------------------------------------------------------------------------------
Exposure level ([mu]g/m\3\) Cumulative Estimated Estimated Estimated Estimated
([mu]g/m\3\- cases/1000 [mu]g/m\3\- cases/1000 [mu]g/m\3\- cases/1000 [mu]g/m\3\- cases/1000
yrs) (95% c.i.) yrs (95% c.i.) yrs (95% c.i.) yrs (95% c.i.)
--------------------------------------------------------------------------------------------------------------------------------------------------------
2.0............................................. 10.0 30.9 20.0 41.9 40.0 76.6 90.0 312.9
22.8-44.0 22.8-84.3 22.8-285.5 22.8-999.9
1.0............................................. 5.0 26.6 10.0 30.9 20.0 41.9 45.0 88.8
22.8-31.7 22.8-44.0 22.8-84.3 22.8-375.0
[[Page 47660]]
0.5............................................. 2.5 24.6 5.0 26.6 10.0 30.9 22.5 45.2
22.8-26.9 22.8-31.7 22.8-44.0 22.8-98.9
0.2............................................. 1.0 23.5 2.0 24.2 4.0 25.8 9.0 30.0
22.8-24.3 22.8-26.0 22.8-29.7 22.8-41.3
0.1............................................. 0.5 23.1 1.0 23.5 2.0 24.2 4.5 26.2
22.8-23.6 22.8-24.3 22.8-26.0 22.8-30.7
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: Section VI, Preliminary Risk Assessment.
Table 5b--Predicted Number of Cases of CBD per 1000 Workers Exposed at Current and Alternative PELs Based on Proportional Hazards Model, Cumulative
Exposure Metric, With Corresponding Interval Based on the Uncertainty in the Exposure Coefficient. 2002 Baseline.
--------------------------------------------------------------------------------------------------------------------------------------------------------
2002 Exposure duration
--------------------------------------------------------------------------------------------------------------------------------------------------------
5 years 10 years 20 years 45 years
-------------------------------------------------------------------------------------------------------
Exposure level ([mu]g/m\3\) Cumulative Estimated Estimated Estimated Estimated
([mu]g/m\3\- cases/1000 [mu]g/m\3\- cases/1000 [mu]g/m\3\- cases/1000 [mu]g/m\3\- cases/1000
yrs) (95% c.i.) yrs (95% c.i.) yrs (95% c.i.) yrs (95% c.i.)
--------------------------------------------------------------------------------------------------------------------------------------------------------
2.0............................................. 10.0 3.7 20.0 5.1 40.0 9.4 90.0 43.6
2.7-5.3 2.7-10.4 2.7-39.2 2.7-679.8
1.0............................................. 5.0 3.2 10.0 3.7 20.0 5.1 45.0 11.0
2.7-3.8 2.7-5.3 2.7-10.4 2.7-54.3
0.5............................................. 2.5 3.0 5.0 3.2 10.0 3.7 22.5 5.5
2.7-3.2 2.7-3.8 2.7-5.3 2.7-12.3
0.2............................................. 1.0 2.8 2.0 2.9 4.0 3.1 9.0 3.6
2.7-2.9 2.7-3.1 2.7-3.6 2.7-5.0
0.1............................................. 0.5 2.8 1.0 2.8 2.0 2.9 4.5 3.1
2.7-2.8 2.7-2.9 2.7-3.1 2.7-3.7
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: Section VI, Preliminary Risk Assessment.
As shown in Tables 4 and 5, the exposure-response models Dr. Stone
developed based on the Cullman data set predict a high risk of both
sensitization (about 96-394 cases per 1000 exposed workers) and CBD
(about 44-313 cases per 1000) at the current PEL of 2 [mu]g/m\3\ for an
exposure duration of 45 years (90 [mu]g/m\3\-yr). For a 45-year
exposure at the proposed PEL of 0.2 [mu]g/m\3\, risk estimates for
sensitization (about 8-40 cases per 1000 exposed workers) and CBD
(about 4-30 per 1000 exposed workers) are substantially reduced. Thus,
the model predicts that the risk of sensitization and CBD at a PEL of
0.2 [mu]g/m\3\ will be about 10 percent of the risk at the current PEL
of 2 [mu]g/m\3\.
OSHA does not believe the risk estimates generated by these
exposure-response models to be highly accurate. Limitations of the
analysis include the size of the dataset, relatively sparse exposure
data from the plant's early years, study size-related constraints on
the statistical analysis of the dataset, and limited follow-up time on
many workers. The Cullman study population is a relatively small group
and can support only limited statistical analysis. For example, its
size precludes inclusion of multiple covariates in the exposure-
response models or a two-stage exposure-response analysis to model both
sensitization and the subsequent development of CBD within the
subpopulation of sensitized workers. The limited size of the Cullman
dataset is characteristic of studies on beryllium-exposed workers in
modern, low-exposure environments, which are typically small-scale
processing plants (up to several hundred workers, up to 20-30 cases).
Despite these issues with the statistical analysis, OSHA believes
its main policy determinations are well supported by the best available
evidence, including the literature review and careful examination of
the prevalence of sensitization and CBD among workers with exposure
levels comparable to the current and proposed PELs in the NJMRC data
set. The previously described literature analysis and prevalence
analysis demonstrate that workers with occupational exposure to
airborne beryllium at the current PEL face a risk of becoming
sensitized to beryllium and progressing to both early and advanced
stages of CBD that far exceeds the value of 1 in 1000 used by OSHA as a
benchmark of clearly significant risk. Furthermore, OSHA's preliminary
risk assessment indicates that risk of beryllium sensitization and CBD
can be significantly reduced by reduction of airborne exposure levels,
along with respiratory and dermal protection measures, as demonstrated
in facilities such as the Tucson ceramics plant, the Elmore beryllium
production facility, and the Reading copper beryllium facility
described in the literature review.
[[Page 47661]]
OSHA's preliminary risk assessment also indicates that despite the
reduction in risk expected with the proposed PEL, the risk to workers
with average exposure levels of 0.2 [mu]g/m\3\ is still clearly
significant (see this preamble at section VI). In the prevalence
analysis, workers with LTW average or HEJ exposures close to 0.2 [mu]g/
m\3\ experienced high levels of sensitization and CBD. This finding is
corroborated by the literature analysis, which showed that workers
exposed to mean plant-wide airborne exposures between 0.1 and 0.5
[mu]g/m\3\ had a similarly high prevalence of sensitization and CBD.
Given the significant risk at these levels of exposure, the Agency
believes that the proposed action level of 0.1 [mu]g/m\3\, dermal
protection requirements, and other ancillary provisions of the proposed
rule are key to reducing the risk of beryllium sensitization and CBD
among exposed workers. OSHA preliminarily concludes that the proposed
standard, including the PEL of 0.2 [mu]g/m\3\, the action level of 0.1
[mu]g/m\3\, and provisions to limit dermal exposure to beryllium,
together will significantly reduce workers' risk of beryllium
sensitization and CBD from occupational beryllium exposure.
2. Risk of Lung Cancer
OSHA's review of epidemiological studies of lung cancer mortality
among beryllium workers found that most did not characterize exposure
levels sufficiently to characterize risk of lung cancer at the current
and proposed PELs. However, as discussed in this preamble at section V,
Health Effects and section VI, Preliminary Risk Assessment, NIOSH
recently published a quantitative risk assessment based on beryllium
exposure and lung cancer mortality among 5436 male workers employed at
beryllium processing plants in Reading, PA; Elmore, OH; and Hazleton,
PA, prior to 1970 (Schubauer-Berigan et al., 2010b). This new risk
assessment addresses important sources of uncertainty for previous lung
cancer analyses, including the sole prior exposure-response analysis
for beryllium and lung cancer, conducted by Sanderson et al. (2001) on
workers from the Reading plant alone. Workers from the Elmore and
Hazleton plants who were added to the analysis by Schubauer-Berigan et
al. were, in general, exposed to lower levels of beryllium than those
at the Reading plant. The median worker from Hazleton had a mean
exposure across his tenure of less than 2 [mu]g/m\3\, while the median
worker from Elmore had a mean exposure of less than 1 [mu]g/m\3\. The
Elmore and Hazleton worker populations also had fewer short-term
workers than the Reading population. Finally, the updated cohorts
followed the worker populations through 2005, increasing the length of
follow-up time compared to the previous exposure-response analysis. For
these reasons, OSHA based its preliminary risk assessment for lung
cancer on the Schubauer-Berigan risk analysis.
Schubauer-Berigan et al. (2011) analyzed the data set using a
variety of exposure-response modeling approaches, described in this
preamble at section VI, Preliminary Risk Assessment. The authors found
that lung cancer mortality risk was strongly and significantly related
to mean, cumulative, and maximum measures of workers' exposure to
beryllium (all models reported in Schubauer-Berigan et al., 2011). They
selected the best-fitting models to generate risk estimates for male
workers with a mean exposure of 0.5 [mu]g/m\3\ (the current NIOSH
Recommended Exposure Limit for beryllium). In addition, they estimated
the mean exposure that would be associated with an excess lung cancer
mortality risk of one in one thousand. At OSHA's request, the authors
also estimated excess risks for workers with mean exposures at each of
the other alternate PELs under consideration: 1 [mu]g/m\3\, 0.2 [mu]g/
m\3\, and 0.1 [mu]g/m\3\. Table 6 presents the estimated excess risk of
lung cancer mortality associated with various levels of beryllium
exposure allowed under the current rule, based on the final models
presented in Schubauer-Berigan et al's risk assessment.
Table 6--Excess Risk of Lung Cancer Mortality per 1000 Male Workers at Alternate PELs (NIOSH Models)
----------------------------------------------------------------------------------------------------------------
Mean exposure
-------------------------------------------------------------------------------
Exposure-response model 0.1 [micro]g/ 0.2 [micro]g/ 0.5 [micro]g/ 1 [micro]g/ 2 [micro]g/
m\3\ m\3\ m\3\ m\3\ m\3\
----------------------------------------------------------------------------------------------------------------
Best monotonic PWL--all workers. 7.3 15 45 120 200
Best monotonic PWL--excluding 3.1 6.4 17 39 61
professional and asbestos
workers........................
Best categorical--all workers... 4.4 9 25 59 170
Best categorical--excluding 1.4 2.7 7.1 15 33
professional and asbestos
workers........................
Power model--all workers........ 12 19 30 40 52
Power model--excluding 19 30 49 68 90
professional and asbestos
workers........................
----------------------------------------------------------------------------------------------------------------
Source: Section VI, Preliminary Risk Assessment.
The lowest estimate of excess lung cancer deaths from the six final
models presented by Schubauer-Berigan et al. is 33 per 1000 workers
exposed at a mean level of 2 [mu]g/m\3\, the current PEL. Risk
estimates as high as 200 lung cancer deaths per 1000 result from the
other five models presented. Regardless of the model chosen, the excess
risk of about 33 to 200 per 1000 workers is clearly significant,
falling well above the level of risk the Supreme Court indicated a
reasonable person might consider acceptable (See Benzene, 448 U.S. at
655). The proposed PEL of 0.2 [mu]g/m\3\ is expected to reduce these
risks significantly, to somewhere between 2.7-30 excess lung cancer
deaths per 1000 workers. These risk estimates still fall above the
threshold of 1 in 1000 that OSHA considers clearly significant.
However, the Agency believes the lung cancer risks should be regarded
with a greater degree of uncertainty than the risk estimates for CBD
discussed previously. While the risk estimates for CBD at the proposed
PEL were determined from exposure levels observed in occupational
studies, the lung cancer risks are extrapolated from much higher
exposure levels.
C. Conclusions
As discussed above, OSHA used the best available scientific
evidence to identify adverse health effects of
[[Page 47662]]
occupational beryllium exposure, and to evaluate exposed workers' risk
of these impairments. The Agency reviewed extensive epidemiological and
experimental research pertaining to adverse health effects of
occupational beryllium exposure, including lung cancer, immunological
sensitization to beryllium, and CBD, and has evaluated the risk of
these effects from exposures allowed under the current and proposed
standards. The Agency has, additionally, reviewed previous policy
determinations and case law regarding material impairment of health,
and has preliminarily determined that CBD, in all stages, and lung
cancer constitute material health impairments. Furthermore, OSHA has
preliminarily determined that long-term exposure to beryllium at the
current PEL would pose a risk of CBD and lung cancer greater than the
risk of 1 per 1000 exposed workers the Agency considers clearly
significant. OSHA's risk assessment for beryllium indicates that
adoption of the new PEL, action level, and dermal protection provisions
of the proposed rule will significantly reduce this risk. OSHA
therefore believes it has met the statutory requirements pertaining to
significance of risk, consistent with the OSH Act, Supreme Court
precedent, and the Agency's previous policy decisions.
IX. Summary of the Preliminary Economic Analysis and Initial Regulatory
Flexibility Analysis
A. Introduction and Summary
OSHA's Preliminary Economic Analysis and Initial Regulatory
Flexibility Analysis (PEA) addresses issues related to the costs,
benefits, technological and economic feasibility, and the economic
impacts (including impacts on small entities) of this proposed
respirable beryllium rule and evaluates regulatory alternatives to the
proposed rule. Executive Orders 13563 and 12866 direct agencies to
assess all costs and benefits of available regulatory alternatives and,
if regulation is necessary, to select regulatory approaches that
maximize net benefits (including potential economic, environmental, and
public health and safety effects; distributive impacts; and equity),
unless a statute requires another regulatory approach. Executive Order
13563 emphasized the importance of quantifying both costs and benefits,
of reducing costs, of harmonizing rules, and of promoting flexibility.
The full PEA has been placed in OSHA rulemaking docket OSHA-H005C-2006-
0870. This rule is an economically significant regulatory action under
Sec. 3(f)(1) of Executive Order 12866 and has been reviewed by the
Office of Information and Regulatory Affairs in the Office of
Management and Budget, as required by executive order.
The purpose of the PEA is to:
Identify the establishments and industries potentially
affected by the proposed rule;
Estimate current exposures and the technologically
feasible methods of controlling these exposures;
Estimate the benefits resulting from employers coming into
compliance with the proposed rule in terms of reductions in cases of
lung cancer and chronic beryllium disease;
Evaluate the costs and economic impacts that
establishments in the regulated community will incur to achieve
compliance with the proposed rule;
Assess the economic feasibility of the proposed rule for
affected industries; and
Assess the impact of the proposed rule on small entities
through an Initial Regulatory Flexibility Analysis (IRFA), to include
an evaluation of significant regulatory alternatives to the proposed
rule that OSHA has considered.
The PEA contains the following chapters:
Chapter I. Introduction
Chapter II. Assessing the Need for Regulation
Chapter III. Profile of Affected Industries
Chapter IV. Technological Feasibility
Chapter V. Costs of Compliance
Chapter VI. Economic Feasibility Analysis and Regulatory Flexibility
Determination
Chapter VII. Benefits and Net Benefits
Chapter VIII. Regulatory Alternatives
Chapter IX. Initial Regulatory Flexibility Analysis
The PEA includes all of the economic analyses OSHA is required to
perform, including the findings of technological and economic
feasibility and their supporting materials required by the OSH Act as
interpreted by the courts (in Chapters III, IV, V, and VI); those
required by EO 12866 and EO 13563 (primarily in Chapters III, V, and
VII, though these depend on material in other chapters); and those
required by the Regulatory Flexibility Act (in Chapters VI, VIII, and
IX, though these depend, in part, on materials presented in other
chapters).
Key findings of these chapters are summarized below and in sections
IX.B through IX.I of this PEA summary.
Profile of Affected Industries
This proposed rule would affect employers and employees in many
different industries across the economy. As described in Section IX.C
and reported in Table IX-2 of this preamble, OSHA estimates that a
total of 35,051 employees in 4,088 establishments are potentially at
risk from exposure to beryllium.
Technological Feasibility
As described in more detail in Section IX.D of this preamble and in
Chapter IV of the PEA, OSHA assessed, for all affected sectors, the
current exposures and the technological feasibility of the proposed PEL
of 0.2 [mu]g/m\3\.
Tables IX-5 in section IX.D of this preamble summarizes all nine
application groups (industry sectors and production processes) studied
in the technological feasibility analysis. The technological
feasibility analysis includes information on current exposures,
descriptions of engineering controls and other measures to reduce
exposures, and a preliminary assessment of the technological
feasibility of compliance with the proposed PELs.
The preliminary technological feasibility analysis shows that for
the majority of the job groups evaluated, exposures are either already
at or below the proposed PEL, or can be adequately controlled with
additional engineering and work practice controls. Therefore, OSHA
preliminarily concludes that the proposed PEL of 0.2 [mu]g/m\3\ is
technologically feasible for most operations most of the time.
Based on the currently available evidence, it is more difficult to
determine whether an alternative PEL of 0.1 [mu]g/m\3\ would also be
feasible in most operations. For some application groups, a PEL of 0.1
[mu]g/m\3\ would almost certainly be feasible. In other application
groups, a PEL of 0.1 [mu]g/m\3\ appears feasible, except for
establishments working with high beryllium content alloys. For
application groups with the highest exposure, the exposure monitoring
data necessary to more fully evaluate the effectiveness of exposure
controls adopted after 2000 are not currently available to OSHA, which
makes it difficult to determine the feasibility of achieving exposure
levels at or below 0.1 [mu]g/m\3\.
OSHA also evaluated the feasibility of a STEL of 2.0 [mu]g/m\3\.
The majority of the available short-term measurements are below 2.0
[mu]g/m\3\; therefore OSHA preliminarily concludes that the proposed
STEL of 2.0 [mu]g/m\3\ can be achieved for most operations most of the
time. OSHA recognizes that for a small number of tasks, short-term
exposures may exceed the proposed STEL, even after feasible control
measures to reduce TWA exposure to below the proposed PEL have been
implemented, and therefore assumes that the use of
[[Page 47663]]
respiratory protection will continue to be required for some short-term
tasks. It is more difficult based on the currently available evidence
to determine whether the alternative STEL of 1.0 [mu]g/m\3\ would also
be feasible in most operations based on lack of detail in the
activities of the workers presented in the data. OSHA expects
additional use of respiratory protection would be required for tasks in
which peak exposures can be reduced to less than 2.0 [mu]g/m\3\ but not
less than 1.0 [mu]g/m\3\. Due to limitations in the available sampling
data and the higher detection limits for short term measurements, OSHA
could not determine the percentage of the STEL measurements that are
less than or equal to 0.5 [mu]g/m\3\.
Costs of Compliance
As described in more detail in Section IX.E and reported, by
application group and NAICS code, in Table IX-7 of this preamble, the
total annualized cost of compliance with the proposed standard is
estimated to be about $37.6 million. The major cost elements associated
with the revisions to the standard are housekeeping ($12.6 million),
engineering controls ($9.5 million), training ($5.8 million), and
medical surveillance ($2.9 million).
The compliance costs are expressed as annualized costs in order to
evaluate economic impacts against annual revenue and annual profits, to
be able to compare the economic impact of the rulemaking with other
OSHA regulatory actions, and to be able to add and track Federal
regulatory compliance costs and economic impacts in a consistent
manner. Annualized costs also represent a better measure for assessing
the longer-term potential impacts of the rulemaking. The annualized
costs were calculated by annualizing the one-time costs over a period
of 10 years and applying a discount rate of 3 percent (and an
alternative discount rate of 7 percent).
The estimated costs for the proposed beryllium standard represent
the additional costs necessary for employers to achieve full
compliance. They do not include costs associated with current
compliance that has already been achieved with regard to the new
requirements or costs necessary to achieve compliance with existing
beryllium requirements, to the extent that some employers may currently
not be fully complying with applicable regulatory requirements.
Economic Impacts
To assess the nature and magnitude of the economic impacts
associated with compliance with the proposed rule, OSHA developed
quantitative estimates of the potential economic impact of the new
requirements on entities in each of the affected industry sectors. The
estimated compliance costs were compared with industry revenues and
profits to provide an assessment of the economic feasibility of
complying with the revised standard and an evaluation of the potential
economic impacts.
As described in greater detail in Section IX.F of this preamble and
in Chapter VI of the PEA, the costs of compliance with the proposed
rulemaking are not large in relation to the corresponding annual
financial flows associated with each of the affected industry sectors.
The estimated annualized costs of compliance represent about 0.11
percent of annual revenues and about 1.52 percent of annual profits, on
average, across all affected firms. Compliance costs do not represent
more than 1 percent of revenues or more than 16.25 percent of profits
in any affected industry.
Based on its analysis of the relative inelasticity of demand for
beryllium-containing inputs and products and of possible international
trade effects, OSHA concluded that most or all costs arising from this
proposed beryllium rule would be passed on in higher prices rather than
absorbed in lost profits and that any price increases would result in
minimal loss of business to foreign competition.
Given the minimal potential impact on prices or profits in the
affected industries, OSHA has preliminarily concluded that compliance
with the requirements of the proposed rulemaking would be economically
feasible in every affected industry sector.
Benefits, Net Benefits, and Cost-Effectiveness
As described in more detail in Section VIII.G of this preamble,
OSHA estimated the benefits, net benefits, and incremental benefits of
the proposed beryllium rule. That section also contains a sensitivity
analysis to show how robust the estimates of net benefits are to
changes in various cost and benefit parameters. A full explanation of
the derivation of the estimates presented there is provided in Chapter
VII of the PEA for the proposed rule.
OSHA estimated the benefits associated with the proposed beryllium
PEL of 0.2 [mu]g/m\3\ and, for analytical purposes to comply with OMB
Circular A-4, with alternative beryllium PELs of .1 [mu]g/m\3\ and .5
[mu]g/m\3\ by applying the dose-response relationship developed in the
Agency's preliminary risk assessment--summarized in Section VI of this
preamble--to current exposure levels. OSHA determined current exposure
levels by first developing an exposure profile for industries with
workers exposed to beryllium, using OSHA inspection and site-visit
data, and then applying this exposure profile to the total current
worker population. The industry-by-industry exposure profile is
summarized in Table IX-3 in Section IX.C of this preamble.
By applying the dose-response relationship to estimates of current
exposure levels across industries, it is possible to project the number
of cases of the following diseases expected to occur in the worker
population given current exposure levels (the ``baseline''):
fatal cases of lung cancer,
fatal cases of chronic beryllium disease (CBD), and
morbidity related to chronic beryllium disease.
Table IX-1 provides a summary of OSHA's best estimate of the costs
and benefits of the proposed rule. As shown, the proposed rule, once it
is fully effective, is estimated to prevent 96 fatalities and 50 non-
fatal beryllium-related illnesses annually, and the monetized
annualized benefits of the proposed rule are estimated to be $575.8
million using a 3-percent discount rate and $255.3 million using a 7-
percent discount rate. Also as shown in Table IX-1, the estimated
annualized cost of the rule is $37.6 million using a 3-percent discount
rate and $39.1 million using a 7-percent discount rate. The proposed
rule is estimated to generate net benefits of $538.2 million annually
using a 3-percent discount rate and $216.2 million annually using a 7-
percent discount rate. The estimated costs and benefits of the proposed
rule, disaggregated by industry sector, were previously presented in
Table I-1 in this preamble.
Table IX-1--Annualized Costs, Benefits and Net Benefits of OSHA's Proposed Beryllium Standard of 0.2 [mu]g/m\3\
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
Discount Rate................................................ 3% 7%
-------------------------------------
[[Page 47664]]
Annualized Costs
Engineering Controls..................................... $9,540,189 $10,334,036
Respirators.............................................. 249,684 252,281
Exposure Assessment...................................... 2,208,950 2,411,851
Regulated Areas and Beryllium Work Areas................. 629,031 652,823
Medical Surveillance..................................... 2,882,076 2,959,448
Medical Removal.......................................... 148,826 166,054
Exposure Control Plan.................................... 1,769,506 1,828,766
Protective Clothing and Equipment........................ 1,407,365 1,407,365
Hygiene Areas and Practices.............................. 389,241 389,891
Housekeeping............................................. 12,574,921 12,917,944
Training................................................. 5,797,535 5,826,975
-------------------------------------
Total Annualized Costs (Point Estimate)...................... 37,597,325 39,147,434
Annual Benefits: Number of Cases Prevented
Fatal Lung Cancer........................................ 4.0
CBD-Related Mortality.................................... 92.0
Total Beryllium Related Mortality........................ 96.0 $572,981,864 $253,743,368
Morbidity................................................ 49.5 2,844,770 1,590,927
Monetized Annual Benefits (midpoint estimate)................ 575,826,633 255,334,295
Net Benefits................................................. 538,229,308 216,186,861
----------------------------------------------------------------------------------------------------------------
Source: OSHA, Directorate of Standards and Guidance, Office of Regulatory Analysis.
Initial Regulatory Flexibility Analysis
OSHA has prepared an Initial Regulatory Flexibility Analysis (IRFA)
in accordance with the requirements of the Regulatory Flexibility Act,
as amended in 1996. Among the contents of the IRFA are an analysis of
the potential impact of the proposed rule on small entities and a
description and discussion of significant alternatives to the proposed
rule that OSHA has considered. The IRFA is presented in its entirety
both in Chapter IX of the PEA and in Section IX.I of this preamble.
The remainder of this section (Section IX) of the preamble is
organized as follows:
B. The Need for Regulation
C. Profile of Affected Industry
D. Technological Feasibility Analysis
E. Costs of Compliance
F. Economic Feasibility Analysis and Regulatory Flexibility
Determination
G. Benefits and Net Benefits
H. Regulatory Alternatives
I. Initial Regulatory Flexibility Analysis.
B. Need for Regulation
Employees in work environments addressed by the proposed beryllium
rule are exposed to a variety of significant hazards that can and do
cause serious injury and death. As described in Chapter II of the PEA
in support of the proposed rule, the risks to employees are excessively
large due to the existence of various types of market failure, and
existing and alternative methods of overcoming these negative
consequences--such as workers' compensation systems, tort liability
options, and information dissemination programs--have been shown to
provide insufficient worker protection.
After carefully weighing the various potential advantages and
disadvantages of using a regulatory approach to improve upon the
current situation, OSHA preliminarily concludes that, in the case of
beryllium exposure, the proposed mandatory standards represent the best
choice for reducing the risks to employees. In addition, rulemaking is
necessary in this case in order to replace older existing standards
with updated, clear, and consistent health standards.
C. Profile of Affected Industries
1. Introduction
Chapter III of the PEA presents a profile of industries that use
beryllium, beryllium oxide, and/or beryllium alloys. The discussion
below summarizes the findings in that chapter. For each industry sector
identified, the Agency describes the uses of beryllium and estimates
the number of establishments and employees that may be affected by this
proposed rulemaking. Employee exposure to beryllium can also occur as a
result of certain processes such as welding that are found in many
industries. OSHA uses the umbrella term ``application group'' to refer
either to an industrial sector or a cross-industry group with a common
process. These groups are all mutually exclusive and are analyzed in
separate sections in Chapter III of the PEA. These sections briefly
describe each application group and then explain how OSHA estimated the
number of establishments working with beryllium and the number of
employees exposed to beryllium. Beryllium is rarely used by all
establishments in any particular application group because its unique
properties and relatively high cost typically result in only very
specific and limited usage within a portion of a group.
The information in Chapter III of the PEA is based on reports
prepared under task order by Eastern Research Group (ERG), an OSHA
contractor; information collected during OSHA's Small Business Advocacy
Review Panel (OSHA 2008b); and Agency research and analysis.
Technological feasibility reports (summarized in Chapter IV of the PEA)
for each beryllium-using application group provide a detailed
presentation of processes and occupations with beryllium exposure,
including available sampling exposure measurements and estimates of how
many employees are affected in each specific occupation.
OSHA has identified nine application groups that would be
potentially affected by the proposed beryllium standard:
1. Beryllium Production
2. Beryllium Oxide Ceramics and Composites
3. Nonferrous Foundries
4. Secondary Smelting, Refining, and Alloying
5. Precision Turned Products
6. Copper Rolling, Drawing, and Extruding
7. Fabrication of Beryllium Alloy Products
8. Welding
9. Dental Laboratories
These application groups are broadly defined, and some include
establishments in several North
[[Page 47665]]
American Industrial Classification System (NAICS) codes. For example,
the Copper Rolling and Drawing, and Extruding application group is made
up both of NAICS 331421 Copper Rolling, Drawing, and Extruding and
NAICS 331422 Copper Wire Drawing. While an application group may
contain numerous NAICS six-digit industry codes, in most cases only a
fraction of the establishments in any individual six-digit NAICS
industry use beryllium and would be affected by the proposed rule. For
example, not all companies in the above application group work with
copper that contains beryllium.
One application group, welding, reflects industrial activities or
processes that take place in various industry sectors. All of the
industries in which a given activity or process may result in worker
exposure to beryllium are identified in the sections on the application
group. The section on each application group describes the production
processes where occupational contact with beryllium can occur and
contains estimates of the total number of firms, employees, affected
establishments, and affected employees.
Chapter III of the PEA presents formulas in the text, usually in
parentheses, to help explain the derivation of estimates. Because the
values used in the formulas shown in the text are sometimes rounded,
while the actual spreadsheet formulas used to create final costs are
not, the calculation using the presented formula will sometimes differ
slightly from the total presented in the text--which is the actual
total as shown in the tables.
At the end of Chapter III in the PEA, OSHA discusses other industry
sectors that have reportedly used beryllium in the past or for which
there are anecdotal or informal reports of beryllium use. The Agency
was unable to verify beryllium use in these sectors that would be
affected by the proposed standard, and seeks further information in
this rulemaking on these or other industries where there may be
significant beryllium use and employee exposure.
2. Summary of Affected Establishments and Employers
As shown in Table IX-2, OSHA estimates that a total of 35,051
workers in 4,088 establishments will be affected by the proposed
beryllium standard. Also shown are the estimated annual revenues for
these entities.
[[Page 47666]]
[GRAPHIC] [TIFF OMITTED] TP07AU15.003
[[Page 47667]]
[GRAPHIC] [TIFF OMITTED] TP07AU15.004
[[Page 47668]]
[GRAPHIC] [TIFF OMITTED] TP07AU15.005
[[Page 47669]]
3. Beryllium Exposure Profile of At-Risk Workers
The technological feasibility analyses presented in Chapter IV of
the PEA contain data and discussion of worker exposures to beryllium
throughout industry. Exposure profiles, by job category, were developed
from individual exposure measurements that were judged to be
substantive and to contain sufficient accompanying description to allow
interpretation of the circumstance of each measurement. The resulting
exposure profiles show the job categories with current overexposures to
beryllium and, thus, the workers for whom beryllium controls would be
implemented under the proposed rule.
Table IX-3 summarizes, from the exposure profiles, the number of
workers at risk from beryllium exposure and the distribution of 8-hour
TWA respirable beryllium exposures by affected job category and sector.
Exposures are grouped into the following ranges: Less than 0.1 [mu]g/
m\3\; >= 0.1 [mu]g/m\3\ and <= 0.2 [mu]g/m\3\; > 0.2 [mu]g/m\3\ and <=
0.5 [mu]g/m\3\; > 0.5 [mu]g/m\3\ and <= 1.0 [mu]g/m\3\; > 1.0 [mu]g/
m\3\ and <= 2.0 [mu]g/m\3\; and greater than 2.0 [mu]g/m\3\. These
frequencies represent the percentages of production employees in each
job category and sector currently exposed at levels within the
indicated range.
Table IX-4 presents data by NAICS code on the estimated number of
workers currently at risk from beryllium exposure, as well as the
estimated number of workers at risk of beryllium exposure above 0
[mu]g/m\3\, at or above 0.1 [mu]g/m\3\, at or above 0.2 [mu]g/m\3\, at
or above 0.5 [mu]g/m\3\, at or above 1.0 [mu]g/m\3\, and at or above
2.0 [mu]g/m\3\. As shown, an estimated 12,101 workers currently have
beryllium exposures at or above the proposed action level of 0.1 [mu]g/
m\3\; and an estimated 8,091 workers currently have beryllium exposures
above the proposed PEL of 0.2 [mu]g/m\3\.
[[Page 47670]]
[GRAPHIC] [TIFF OMITTED] TP07AU15.006
[[Page 47671]]
[GRAPHIC] [TIFF OMITTED] TP07AU15.007
[[Page 47672]]
[GRAPHIC] [TIFF OMITTED] TP07AU15.008
D. Technological Feasibility Analysis of the Proposed Permissible
Exposure Limit to Beryllium Exposures
This section summarizes the technological feasibility analysis
presented in Chapter IV of the PEA (OSHA, 2014). The technological
feasibility analysis includes information on current exposures,
descriptions of engineering controls and other measures to reduce
exposures, and a preliminary assessment of the technological
feasibility of compliance with the proposed standard, including a
reduction in OSHA's permissible exposure limits (PELs) in nine affected
application groups. The current PELs for beryllium are 2.0 [mu]g/m\3\
as an 8-hour time weighted average (TWA), and 5.0 [mu]g/m\3\ as an
acceptable ceiling concentration. OSHA is proposing a PEL of 0.2 [mu]g/
m\3\ as an 8-hour TWA and is additionally considering alternative TWA
PELs of 0.1 and 0.5 [mu]g/m\3\. OSHA is also proposing a 15-minute
short-term exposure limit (STEL) of 2.0 [mu]g/m\3\, and is considering
alternative STELs of 0.5, 1.0 and 2.5 [mu]g/m\3\.
The technological feasibility analysis includes nine application
groups that correspond to specific industries or production processes
that OSHA has preliminarily determined fall within the scope of the
proposed standard. Within each of these application groups, exposure
profiles have been developed
[[Page 47673]]
that characterize the distribution of the available exposure
measurements by job title or group of jobs. Descriptions of existing
engineering controls for operations that create sources of beryllium
exposure, and of additional engineering and work practice controls that
can be used to reduce exposure are also provided. For each application
group, a preliminary determination is made regarding the feasibility of
achieving the proposed permissible exposure limits. For application
groups in which the median exposures for some jobs exceed the proposed
TWA PEL, a more detailed analysis is presented by job or group of jobs
within the application group. The analysis is based on the best
information currently available to the Agency, including a
comprehensive review of the industrial hygiene literature, National
Institute for Occupational Safety and Health (NIOSH) Health Hazard
Evaluations and case studies of beryllium exposure, site visits
conducted by an OSHA contractor (Eastern Research Group (ERG)),
submissions to OSHA's rulemaking docket, and inspection data from
OSHA's Integrated Management Information System (IMIS). OSHA also
obtained information on production processes, worker exposures, and the
effectiveness of existing control measures from the primary beryllium
producer in the United States, Materion Corporation, and from
interviews with industry experts.
The nine application groups included in this analysis were
identified based on information obtained during preliminary rulemaking
activities that included a SBRFA panel, a comprehensive review of the
published literature, stakeholder input, and an analysis of IMIS data
collected during OSHA workplace inspections where detectable airborne
beryllium was found. The nine application groups and their
corresponding section numbers in Chapter IV of the PEA are:
Section 3--Beryllium Production,
Section 4--Beryllium Oxide Ceramics and Composites,
Section 5--Nonferrous Foundries,
Section 6--Secondary Smelting, Refining, and Alloying,
Section 7--Precision Turned Products,
Section 8--Copper Rolling, Drawing, and Extruding,
Section 9--Fabrication of Beryllium Alloy Products,
Section 10--Welding, and
Section 11--Dental Laboratories.
OSHA developed exposure profiles by job or group of jobs using
exposure data at the application, operation or task level to the extent
that such data were available. In those instances where there were
insufficient exposure data to create a profile, OSHA used analogous
operations to characterize the operations. The exposure profiles
represent baseline conditions with existing controls for each operation
with potential exposure. For job groups where exposures were above the
proposed TWA PEL of 0.2 [mu]g/m\3\, OSHA identified additional controls
that could be implemented to reduce employee exposures to beryllium.
These included engineering controls, such as process containment, local
exhaust ventilation and wet methods for dust suppression, and work
practices, such as improved housekeeping and the prohibition of
compressed air for cleaning beryllium-contaminated surfaces.
For the purposes of this technological feasibility assessment,
these nine application groups can be divided into three general
categories based on current exposure levels:
(1) application groups in which current exposures for most jobs are
already below the proposed PEL of 0.2 [mu]g/m\3\;
(2) application groups in which exposures for most jobs are below
the current PEL, but exceed the proposed PEL of 0.2 [mu]g/m\3\, and
therefore additional controls would be required; and
(3) application groups in which exposures in one or more jobs
routinely exceed the current PEL, and therefore substantial reductions
in exposure would be required to achieve the proposed PEL.
The majority of exposure measurements taken in the application
groups in the first category are already at or below the proposed PEL
of 0.2 [mu]g/m\3\, and most of the jobs with exposure to beryllium in
these four application groups have median exposures below the
alternative PEL of 0.1 [mu]g/m\3\ (See Table IX-5). These four
application groups include rolling, drawing, and extruding; fabrication
of beryllium alloy products; welding; and dental laboratories.
The two application groups in the second category include:
precision turned products and secondary smelting. For these two groups,
the median exposures in most jobs are below the current PEL, but the
median exposure levels for some job groups currently exceed the
proposed PEL. Additional exposure controls and work practices could be
implemented that the Agency has preliminarily concluded would reduce
exposures to or below the proposed PEL for most jobs most of the time.
One exception is furnace operations in secondary smelting, in which the
median exposure exceeds the current PEL. Furnace operations involve
high temperatures that produce significant amounts of fumes and
particulate that can be difficult to contain. Therefore, the proposed
PEL may not be feasible for most furnace operations involved with
secondary smelting, and in some cases, respiratory protection would be
required to adequately protect furnace workers when exposures exceed
0.2 [mu]g/m\3\ despite the implementation of all feasible controls.
Exposures in the third category of application groups routinely
exceed the current PEL for several jobs. The three application groups
in this category include: Beryllium production, beryllium oxide
ceramics production, and nonferrous foundries. The individual job
groups for which exposures exceed the current PEL are discussed in the
application group specific sections later in this summary, and
described in greater detail in the PEA. For the jobs that routinely
exceed the current PEL, OSHA identified additional exposure controls
and work practices that the Agency preliminarily concludes would reduce
exposures to or below the proposed PEL most of the time, with three
exceptions: Furnace operations in primary beryllium production and
nonferrous foundries, and shakeout operations at nonferrous foundries.
For these jobs, OSHA recognizes that even after installation of
feasible controls, respiratory protection may be needed to adequately
protect workers.
In conclusion, the preliminary technological feasibility analysis
shows that for the majority of the job groups evaluated, exposures are
either already at or below the proposed PEL, or can be adequately
controlled with additional engineering and work practice controls.
Therefore, OSHA preliminarily concludes that the proposed PEL of 0.2
[mu]g/m\3\ is feasible for most operations most of the time. The
preliminary feasibility determination for the proposed PEL is also
supported by Materion Corporation, the sole primary beryllium
production company in the U.S., and by the United Steelworkers, who
jointly submitted a draft proposed standard that specified an exposure
limit of 0.2 [mu]g/m\3\ to OSHA (Materion and USW, 2012). The
technological feasibility analysis conducted for each application group
is briefly summarized below, and a more detailed discussion is
presented in Sections 3 through 11 of Chapter IV of the PEA (OSHA,
2014).
Based on the currently available evidence, it is more difficult to
determine whether an alternative PEL of
[[Page 47674]]
0.1 [mu]g/m\3\ would also be feasible in most operations. For some
application groups, such as fabrication of beryllium alloy products, a
PEL of 0.1 [mu]g/m\3\ would almost certainly be feasible. In other
application groups, such as precision turned products, a PEL of 0.1
[mu]g/m\3\ appears feasible, except for establishments working with
high beryllium content alloys. For application groups with the highest
exposure, the exposure monitoring data necessary to more fully evaluate
the effectiveness of exposure controls adopted after 2000 are not
currently available to OSHA, which makes it difficult to determine the
feasibility of achieving exposure levels at or below 0.1 [mu]g/m\3\.
OSHA also evaluated the feasibility of a STEL of 2.0 [mu]g/m\3\,
and alternative STELs of 0.5 and 1.0 [mu]g/m\3\. An analysis of the
available short-term exposure measurements indicates that elevated
exposures can occur during short-term tasks such as those associated
with the operation and maintenance of furnaces at primary beryllium
production facilities, at nonferrous foundries, and at secondary
smelting operations. Peak exposure can also occur during the transfer
and handling of beryllium oxide powders. OSHA believes that in many
cases, reducing short-term exposures will be necessary to reduce
workers' TWA exposures to or below the proposed PEL. The majority of
the available short-term measurements are below 2.0 [mu]g/m\3\,
therefore OSHA preliminarily concludes that the proposed STEL of 2.0
[mu]g/m\3\ can be achieved for most operations most of the time. OSHA
recognizes that for a small number of tasks, short-term exposures may
exceed the proposed STEL, even after feasible control measures to
reduce TWA exposure to below the proposed PEL have been implemented,
and therefore assumes that the use of respiratory protection will
continue to be required for some short-term tasks. It is more difficult
based on the currently available evidence to determine whether the
alternative STEL of 1.0 [mu]g/m\3\ would also be feasible in most
operations based on lack of detail in the activities of the workers
presented in the data. OSHA expects additional use of respiratory
protection would be required for tasks in which peak exposures can be
reduced to less than 2.0 [mu]g/m\3\ but not less than 1.0 [mu]g/m\3\.
Due to limitations in the available sampling data and the higher
detection limits for short term measurements, OSHA could not determine
the percentage of the STEL measurements that are less than or equal to
0.5 [mu]g/m\3\. A detailed discussion of the STELs being considered by
OSHA is presented in Section 12 of Chapter IV of the PEA (OSHA, 2014).
OSHA requests available exposure monitoring data and comments
regarding the effectiveness of currently implemented control measures
and the feasibility of the PELs under consideration, particularly the
proposed TWA PEL of 0.2 [mu]g/m\3\, the alternative TWA PEL of 0.1
[mu]g/m\3\, the proposed STEL of 2.0 [mu]g/m\3\, and the alternative
STEL of 1.0 [mu]g/m\3\ to inform the Agency's final feasibility
determinations.
Application Group Summaries
This section summarizes the technological feasibility analysis for
each of the nine application groups affected by the proposed standard.
Chapter IV of the PEA, Technological Feasibility Analysis, identifies
specific jobs or job groups with potential exposure to beryllium, and
presents exposure profiles for each of these job groups (OSHA, 2014).
Control measures and work practices that OSHA believes can reduce
exposures are described along with preliminary conclusions regarding
the feasibility of the proposed PEL. Table IX-5, located at the end of
this summary, presents summary statistics for the personal breathing
zone samples taken to measure full-shift exposures to beryllium in each
application group. For the five application groups in which the median
exposure level for at least one job group exceeds the proposed PEL, the
sampling results are presented by job group. Table IX-5 displays the
number of measurements; the range, the mean and the median of the
measurement results; and the percentage of measurements less than 0.1
[mu]g/m\3\, less than or equal to the proposed PEL of 0.2 [mu]g/m\3\,
and less than or equal to the current PEL of 2.0 [mu]g/m\3\. A more
detailed discussion of exposure levels by job or job group for each
application group is provided in Chapter IV of the PEA, sections 3
through 11, along with a description of the available exposure
measurement data, existing controls, and additional controls that would
be required to achieve the proposed PEL.
Beryllium Production
Only one primary beryllium production facility is currently in
operation in the United States, a plant owned and operated by Materion
Corporation,\15\ located in Elmore, Ohio. OSHA identified eight job
groups at this facility in which workers are exposed to beryllium.
These include: Chemical operations, powdering operations, production
support, cold work, hot work, site support, furnace operations, and
administrative work.
---------------------------------------------------------------------------
\15\ Materion Corporation was previously named Brush Wellman. In
2011, subsequent to the collection of the information presented in
this chapter, the name changed. ``Brush Wellman'' is used whenever
the data being discussed pre-dated the name change.
---------------------------------------------------------------------------
The Agency developed an exposure profile for each of these eight
job groups to analyze the distribution of exposure levels associated
with primary beryllium production. The job exposure profiles are based
primarily on full-shift personal breathing zone (PBZ) (lapel-type)
sample results from air monitoring conducted by Brush Wellman's primary
production facility in 1999 (Brush Wellman, 2004). Starting in 2000,
the company developed the Materion Worker Protection Program (MWPP), a
multi-faceted beryllium exposure control program designed to reduce
airborne exposures for the vast majority of workers to less than an
internally established exposure limit of 0.2 [mu]g/m\3\. According to
information provided by Materion, a combination of engineering
controls, work practices, and housekeeping were used together to reduce
average exposure levels to below 0.2 [mu]g/m\3\ for the majority of
workers (Materion Information Meeting, 2012). Also, two operations with
historically high exposures, the wet plant and pebble plants, were
decommissioned in 2000, thereby reducing average exposure levels.
Therefore, the samples taken prior to 2000 may overestimate current
exposures.
Additional exposure samples were taken by NIOSH at the Elmore
facility from 2007 through 2008 (NIOSH, 2011). This dataset, which was
made available to OSHA by Materion, contains fewer samples than the
1999 survey. OSHA did not incorporate these samples into the exposure
profile due to the limited documentation associated with the sampling
data. The lack of detailed information for individual samples has made
it difficult for OSHA to correlate job classifications and identify the
working conditions associated with the samples. Sampling data provided
by Materion for 2007 and 2008 were not incorporated into the exposure
profiles because the data lacked specific information on jobs and
workplace conditions. In a meeting in May 2012 held between OSHA and
Materion Corporation at the Elmore facility, the Agency was able to
obtain some general information on the exposure control modifications
that Materion Corporation made between 1999 and 2007, but has been
unable to determine what specific
[[Page 47675]]
controls were in place at the time NIOSH conducted sampling (Materion
Information Meeting, 2012).
In five of the primary production job groups (i.e., hot work, cold
work, production support, site support, and administrative work), the
baseline exposure profile indicates that exposures are already lower
than the proposed PEL of 0.2 [mu]g/m\3\. Median exposure values for
these job groups range from nondetectable to 0.08 [mu]g/m\3\.
For three of the job groups involved with primary beryllium
production, (i.e., chemical operations, powdering, and furnace
operations), the median exposure level exceeds the proposed PEL of 0.2
[mu]g/m\3\. Median exposure values for these job groups are 0.47, 0.37,
and 0.68 [mu]g/m\3\ respectively, and only 17 percent to 29 percent of
the available measurements are less than or equal to 0.2 [mu]g/m\3\.
Therefore, additional control measures for these job groups would be
required to achieve compliance with the proposed PEL. OSHA has
identified several engineering controls that the Agency preliminarily
concludes can reduce exposures in chemical processes and powdering
operations to less than or equal to 0.2 [mu]g/m\3\. In chemical
processes, these include fail-safe drum-handling systems, full
enclosure of drum-handling systems, ventilated enclosures around
existing drum positions, automated systems to prevent drum overflow,
and automated systems for container cleaning and disposal such as those
designed for hazardous powders in the pharmaceutical industry. Similar
engineering controls would reduce exposures in powdering operations. In
addition, installing remote viewing equipment (or other equally
effective engineering controls) to eliminate the need for workers to
enter the die-loading hood during die filling will reduce exposures
associated with this powdering task and reduce powder spills. Based on
the availability of control methods to reduce exposures for each of the
major sources of exposure in chemical operations, OSHA preliminarily
concludes that exposures at or below the proposed 0.2 [mu]g/m\3\ PEL
can be achieved in most chemical and powdering operations most of the
time. OSHA believes furnace operators' exposures can be reduced using
appropriate ventilation, including fume capture hoods, and other
controls to reduce overall beryllium levels in foundries, but is not
certain whether the exposures of furnace operators can be reduced to
the proposed PEL with currently available technology. OSHA requests
additional information on current exposure levels and the effectiveness
of potential control measures for primary beryllium production
operations to further refine this analysis.
Beryllium Oxide Ceramics Production
OSHA identified seven job groups involved with beryllium oxide
ceramics production. These include: Material preparation operator,
forming operator, machining operator, kiln operator, production
support, metallization, and administrative work. Four of these jobs
(material preparation, forming operator, machining operator and kiln
operator) work directly with beryllium oxides, and therefore these jobs
have a high potential for exposure. The other three job groups
(production support work, metallization, and administrative work) have
primarily indirect exposure that occurs only when workers in these jobs
groups enter production areas and are exposed to the same sources to
which the material preparation, forming, machining and kiln operators
are directly exposed. However, some production support and
metallization activities do require workers to handle beryllium
directly, and workers performing these tasks may at times be directly
exposed to beryllium.
The Agency developed exposure profiles for these jobs based on air
sampling data from four sources: (1) Samples taken between 1994 and
2003 at a large beryllium oxide ceramics facility, (2) air sampling
data obtained during a site visit to a primary beryllium oxide ceramics
producer, (3) a published report that provides information on beryllium
oxide ceramics product manufacturing for a slightly earlier time
period, and (4) exposure data from OSHA's Integrated Management
Information System (OSHA, 2009). The exposure profile indicates that
the three job groups with mostly indirect exposure (production support
work, metallization, and administrative work) already achieve the
proposed PEL of 0.2 [mu]g/m\3\. Median exposure sample values for these
job groups did not exceed 0.06 [mu]g/m\3\.
The four job groups with direct exposure had higher exposures. In
forming operations and machining operations, the median exposure levels
of 0.18 and 0.15 ug/m\3\, respectively, are below the proposed PEL,
while the median exposure levels for material preparation and kiln
operations of 0.41 [mu]g/m\3\ and 0.25 [mu]g/m\3\, respectively, exceed
the proposed PEL.
The profile for the directly exposed jobs may overestimate
exposures due to the preponderance of data from the mid-1990s, a time
period prior to the implementation of a variety of exposure control
measures introduced after 2000. In forming operations, 44 percent of
sample values in the exposure profile exceeded 0.2 ug/m\3\. However,
the median exposure levels for some tasks, such as small-press and
large-press operation, based on sampling conducted in 2003 were below
0.1 [mu]g/m\3\. The exposure profile for kiln operation was based on
three samples taken from a single facility in 1995, and are all above
0.2 ug/m\3\. Since then, exposures at the facility have declined due to
changes in operations that reduced the amount of time kiln operators
spend in the immediate vicinity of the kilns, as well as the
discontinuation of a nearby high-exposure process. More recent
information communicated to OSHA suggests that current exposures for
kiln operators at the facility are currently below 0.1 ug/m\3\.
Exposures in machining operations, most of which were already below 0.2
ug/m\3\ during the 1990s, may have been further reduced since then
through improved work practices and exposure controls (PEA Chapter IV,
Section 7). For forming, kiln, and machining operations, OSHA
preliminarily concludes that the installation of additional controls
such as machine interlocks (for forming) and improved enclosures and
ventilation will reduce exposures to or below the proposed PEL most of
the time. OSHA requests information on recent exposure levels and
controls in beryllium oxide forming and kiln operations to help the
Agency evaluate the effectiveness of available exposure controls for
this application group.
In the exposure profile for material preparation, 73 percent of
sample values exceeded 0.2 ug/m\3\. As with other parts of the exposure
profile, exposure values from the mid-1990s may overestimate airborne
beryllium levels for current operations. During most material
preparation tasks, such as material loading, transfer, and spray
drying, OSHA preliminarily concludes that exposures can be reduced to
or below 0.2 [mu]g/m\3\ with process enclosures, ventilation hoods, and
improved housekeeping procedures. However, OSHA acknowledges that peak
exposures from some short-term tasks such as servicing of the spray
chamber might continue to drive the TWA exposures above 0.2 [mu]g/m\3\
on days when these material preparation tasks are performed.
Respirators may be needed to protect workers from exposures above the
proposed TWA PEL
[[Page 47676]]
during these tasks.\16\ OSHA notes that material preparation for
production of beryllium oxide ceramics currently takes place at only
two facilities in the United States.
---------------------------------------------------------------------------
\16\ One facility visited by ERG has reportedly modified this
process to reduce worker exposures, but OSHA has no data to quantify
the reduction.
---------------------------------------------------------------------------
Nonferrous Foundries
OSHA identified eight job groups in aluminum and copper foundries
with beryllium exposure: Molding, material handling, furnace operation,
pouring, shakeout operation, abrasive blasting, grinding/finishing, and
maintenance. The Agency developed exposure profiles based on an air
monitoring survey conducted by NIOSH in 2007, a Health Hazard
Evaluation (HHE) conducted by NIOSH in 1975, a site visit by ERG in
2003, a site visit report from 1999 by the California Cast Metals
Association (CCMA); and two sets of data from air monitoring surveys
obtained from Materion in 2004 and 2010.
The exposure profile indicates that in foundries processing
beryllium alloys, six of the eight job groups have median exposures
that exceed the proposed PEL of 0.2 [mu]g/m\3\ with baseline working
conditions. One exception is grinding/finishing operations, where the
median value is 0.12 [mu]g/m\3\ and 73 percent of exposure samples are
below 0.2 [mu]g/m\3\. The other exception is abrasive blasting. The
samples for abrasive blasting used in the exposure profile were
obtained during blasting operations using enclosed cabinets, and all 5
samples were below 0.2 [mu]g/m\3\. Exposures for other job groups
ranged from just below to well above the proposed PEL, including molder
(all samples above 0.2 [mu]g/m\3\), material handler (1 sample total,
above 0.2 [mu]g/m\3\), furnace operator (81.8 percent of samples above
0.2 [mu]g/m\3\), pouring operator (60 percent of samples above 0.2
[mu]g/m\3\), shakeout operator (1 sample total, above 0.2 [mu]g/m\3\),
and maintenance worker (50 percent of samples above 0.2 [mu]g/m\3\).
In some of the foundries at which the air samples included in the
exposure profile were collected, there are indications that the
ventilation systems were not properly used or maintained, and dry
sweeping or brushing and the use of compressed air systems for cleaning
may have contributed to high dust levels. OSHA believes that exposures
in foundries can be substantially reduced by improving and properly
using and maintaining the ventilation systems; switching from dry
brushing, sweeping and compressed air to wet methods and use of HEPA-
filtered vacuums for cleaning molds and work areas; enclosing
processes; automation of high-exposure tasks; and modification of
processes (e.g., switching from sand-based to alternative casting
methods). OSHA preliminarily concludes that these additional
engineering controls and modified work practices can be implemented to
achieve the proposed PEL most of the time for molding, material
handling, maintenance, abrasive blasting, grinding/finishing, and
pouring operations at foundries that produce aluminum and copper
beryllium alloys.
The Agency is less confident that exposure can be reliably reduced
to the proposed PEL for furnace and shakeout operators. Beryllium
concentrations in the proximity of the furnaces are typically higher
than in other areas due to the fumes generated and the difficulty of
controlling emissions during furnace operations. The exposure profile
for furnace operations shows a median beryllium exposure level of 1.14
[mu]g/m\3\. OSHA believes that furnace operators' exposures can be
reduced using local exhaust ventilation and other controls to reduce
overall beryllium levels in foundries, but it is not clear that they
can be reduced to the proposed PEL with currently available technology.
In foundries that use sand molds, the shakeout operation typically
involves removing the freshly cast parts from the sand mold using a
vibrating grate that shakes the sand from castings. The shakeout
equipment generates substantial amounts of airborne dust that can be
difficult to contain, and therefore shakeout operators are typically
exposed to high dust levels. During casting of beryllium alloys, the
dust may contain beryllium and beryllium oxide residues dislodged from
the casting during the shakeout process. The exposure profile for the
shakeout operations contains only one result of 1.3 [mu]g/m\3\. This
suggests that a substantial reduction would be necessary to achieve
compliance with a proposed PEL of 0.2 [mu]g/m\3\. OSHA requests
additional information on recent employee exposure levels and the
effectiveness of dust controls for shakeout operations for copper and
aluminum alloy foundries.
Secondary Smelting, Refining, and Alloying
OSHA identified two job groups in this application group with
exposure to beryllium: Mechanical process operators and furnace
operations workers. Mechanical operators handle and treat source
material, and furnace operators run heating processes for refining,
melting, and casting metal alloy. OSHA developed exposure profiles for
these jobs based on exposure data from ERG site visits to a precious/
base metals recovery facility and a facility that melts and casts
beryllium-containing alloys, both conducted in 2003. The available
exposure data for this application group are limited, and therefore,
the exposure profile is supplemented in part by summary data presented
in secondary sources of information on beryllium exposures in this
application group.
The exposure profile for mechanical processing operators indicates
low exposures (3 samples less than 0.2 [mu]g/m\3\), even though these
samples were collected at a facility where the ventilation system was
allowing visible emissions to escape exhaust hoods. Summary data from
studies and reports published in 2005-2009 showed that mechanical
processing operator exposures averaged between 0.01 and 0.04 [mu]g/m\3\
at facilities where mixed or electronic waste including beryllium alloy
parts were refined. Based on these results, OSHA preliminarily
concludes that the proposed PEL is already achieved for most mechanical
processing operations most of the time, and exposures could be further
reduced through improved ventilation system design and other measures,
such as process enclosures.
As with furnace operations examined in other application groups,
the exposure profile indicates higher worker exposures for furnace
operators in the secondary smelting, refining, and alloying application
group (six samples with a median of 2.15 [mu]g/m\3\, and 83.3 percent
above 0.2 [mu]g/m\3\). The two lowest samples in this job's exposure
profile (0.03 and 0.5 [mu]g/m\3\) were collected at a facility engaged
in recycling and recovery of precious metals where work with beryllium-
containing material is incidental. At this facility, the furnace is
enclosed and fumes are ducted into a filtration system. The four higher
samples, ranging from 1.92 to 14.08 [mu]g/m\3\, were collected at a
facility engaged primarily in beryllium alloying operations, where
beryllium content is significantly higher than in recycling and
precious metal recovery activities, the furnace is not enclosed, and
workers are positioned directly in the path of the exhaust ventilation
over the furnace. OSHA believes these exposures could be reduced by
enclosing the furnace and repositioning the worker, but is not certain
whether the reduction achieved would be enough to bring exposures down
to the proposed PEL. Based on the limited number of samples in the
exposure profile and surrogate data from furnace operations, the
proposed PEL
[[Page 47677]]
may not be feasible for furnace work in beryllium recovery and
alloying, and respirators may be necessary to protect employees
performing these tasks.
Precision Turned Products
OSHA's preliminary feasibility analysis for precision turned
products focuses on machinists who work with beryllium-containing
alloys. The Agency also examined the available exposure data for non-
machinists and has preliminarily concluded that, in most cases,
controlling the sources of exposures for machinists will also reduce
exposures for other job groups with indirect exposure when working in
the vicinity of machining operations.
OSHA developed exposure profiles based on exposure data from four
NIOSH surveys conducted between 1976 and 2008; ERG site visits to
precision machining facilities in 2002, 2003, and 2004; case study
reports from six facilities machining copper-beryllium alloys; and
exposure data collected between 1987 and 2001 by the U.S. Navy
Environmental Health Center (NEHC). Analysis of the exposure data
showed a substantial difference between the median exposure level for
workers machining pure beryllium and/or high-beryllium alloys compared
to workers machining low-beryllium alloys. Most establishments in the
precision turned products application group work only with low-
beryllium alloys, such as copper-beryllium. A relatively small number
of establishments (estimated at 15) specialize in precision machining
of pure beryllium and/or high-beryllium alloys.
The exposure profile indicates that machinists working with low-
beryllium alloys have mostly low exposure to airborne beryllium.
Approximately 85 percent of the 80 exposure results are less than or
equal to 0.2 [mu]g/m\3\, and 74 percent are less than or equal to 0.1
[mu]g/m\3\. Some of the results below 0.1 [mu]g/m\3\ were collected at
a facility where machining operations were enclosed, and metal cutting
fluids were used to control the release of airborne contaminants.
Higher results (0.1 [mu]g/m\3\-1.07 [mu]g/m\3\) were found at a
facility where cutting and grinding operations were conducted in
partially enclosed booths equipped with LEV, but some LEV was not
functioning properly. A few very high results (0.77 [mu]g/m\3\-24
[mu]g/m\3\) were collected at a facility where exposure controls were
reportedly inadequate and poor work practices were observed (e.g.,
improper use of downdraft tables, use of compressed air for cleaning).
Based on these results, OSHA preliminarily concludes that exposures
below 0.2 [mu]g/m\3\ can be achieved most of the time for most
machinists at facilities dealing primarily with low-beryllium alloys.
OSHA recognizes that higher exposures may sometimes occur during some
tasks where exposures are difficult to control with engineering
methods, such as cleaning, and that respiratory protection may be
needed at these times.
Machinists working with high-beryllium alloys have higher exposure
than those working with low-beryllium alloys. This difference is
reflected in the exposure profile for this job, where the median of
exposure is 0.31 [mu]g/m\3\ and 75 percent of samples exceed the
proposed PEL of 0.2 [mu]g/m\3\. The exposure profile was based on two
machining facilities at which LEV was used and machining operations
were performed under a liquid coolant flood. Like most facilities where
pure beryllium and high-beryllium alloys are machined, these facilities
also used some combination of full or partial enclosures, as well as
work practices to minimize exposure such as prohibiting the use of
compressed air and dry sweeping and implementing dust migration control
practices to prevent the spread of beryllium contamination outside
production areas. At one facility machining high-beryllium alloys,
where all machining operations were fully enclosed and ventilated,
exposures were mostly below 0.1 [mu]g/m\3\ (median 0.035 [mu]g/m\3\,
range 0.02-0.11 [mu]g/m\3\). Exposures were initially higher at the
second facility, where some machining operations were not enclosed,
existing LEV system were in need of upgrades, and some exhaust systems
were improperly positioned. Samples collected there in 2003 and 2004
were mostly below the proposed PEL in 2003 (median 0.1 [mu]g/m\3\) but
higher in 2004 (median 0.25 [mu]g/m\3\), and high exposure means in
both years (1.65 and 0.68 [mu]g/m\3\ respectively) show the presence of
high exposure spikes in the facility. However, the facility reported
that measures to reduce exposure brought almost all machining exposures
below 0.2 [mu]g/m\3\ in 2006. With the use of fully enclosed machines
and LEV and work practices that minimize worker exposures, OSHA
preliminarily concludes that the proposed PEL is feasible for the vast
majority of machinists working with pure beryllium and high-beryllium
alloys. OSHA recognizes that higher exposures may sometimes occur
during some tasks where exposures are difficult to control with
engineering methods, such as machine cleaning and maintenance, and that
respiratory protection may be needed at these times.
Copper Rolling, Drawing, and Extruding
OSHA's exposure profile for copper rolling, drawing, and extruding
includes four job groups with beryllium exposure: strip metal
production, rod and wire production, production support, and
administrative work. Exposure profiles for these jobs are based on
personal breathing zone lapel sampling conducted at the Brush Wellman
Reading, Pennsylvania, rolling and drawing facility from 1977 to 2000.
Prior to 2000, the Reading facility had limited engineering
controls in place. Equipment in use included LEV in some operations,
HEPA vacuums for general housekeeping, and wet methods to control loose
dust in some rod and wire production operations. The exposure profile
shows very low exposures for all four job groups. All had median
exposure values below 0.1 [mu]g/m\3\, and in strip metal production,
production support, and administrative work, over 90 percent of samples
were below 0.1 [mu]g/m\3\. In rod and wire production, 70 percent of
samples were below 0.1 [mu]g/m\3\.
To characterize exposures in extrusion, OSHA examined the results
of an industrial hygiene survey of a copper-beryllium extruding process
conducted in 2000 at another facility. The survey reported eight PBZ
samples, which were not included in the exposure profile because of
their short duration (2 hours). Samples for three of the four jobs
involved with the extrusion process (press operator, material handler,
and billet assembler) were below the limit of detection (LOD) (level
not reported). The two samples for the press operator assistant, taken
when the assistant was buffing, sanding, and cleaning extrusion tools,
were very high (1.6 and 1.9 [mu]g/m\3\). Investigators recommended a
ventilated workstation to reduce exposure during these activities.
In summary, exposures at or below 0.2 [mu]g/m\3\ have already been
achieved for most jobs in rolling, drawing, and extruding operations,
and OSHA preliminarily concludes that the proposed PEL of 0.2 [mu]g/
m\3\ is feasible for this application group. For jobs or tasks with
higher exposures, such as tool refinishing, use of exposure controls
such as local exhaust ventilation can help reduce workers' exposures.
The Agency recognizes the limitations of the available data, which were
drawn from two facilities and did not include full-shift PBZ samples
for extrusion. OSHA requests additional exposure data from other
facilities in this application group, especially data from facilities
where extrusion is performed.
[[Page 47678]]
Fabrication of Beryllium Alloy Products
This application group includes the fabrication of beryllium alloy
springs, stampings, and connectors for use in electronics. The exposure
profile is based on a study conducted at four precision stamping
companies; a NIOSH report on a spring and stamping company; an ERG site
visit to a precision stamping, forming, and plating establishment; and
exposure monitoring results from a stamping facility presented at the
American Industrial Hygiene Conference and Exposition in 2007. The
exposure profiles for this application group include three jobs:
chemical processing operators, deburring operators, and assembly
operators. Other jobs for which all samples results were below 0.1
[mu]g/m\3\ are not shown in the profile.
For the three jobs in the profile, the majority of exposure samples
were below 0.1 [mu]g/m\3\ (deburring operators, 79 percent; chemical
processing operators, 81 percent; assembly operators, 93 percent).
Based on these results, OSHA preliminarily concludes that the proposed
PEL is feasible for this application group. The Agency notes that a few
exposures above the proposed PEL were recorded for the chemical
processing operator (in plating and bright cleaning) and for deburring
(during corn cob deburring in an open tumbling mill). OSHA believes the
use of LEV, improved housekeeping, and work practice modifications
would reduce the frequency of excursions above the proposed PEL.
Welding
Most of the samples in OSHA's exposure profile for welders in
general industry were collected between 1994 and 2001 at two of Brush
Wellman's alloy strip distribution centers, and in 1999 at Brush
Wellman's Elmore facility. At these facilities, tungsten inert gas
(TIG) welding was conducted on beryllium alloy strip. Seven samples in
the exposure profile came from a case study conducted at a precision
stamping facility, where airborne beryllium levels were very low (see
previous summary, Fabrication of Beryllium Alloy Products). At this
facility, resistance welding was performed on copper-beryllium parts,
and welding processes were automated and enclosed.
Most of the sample results in the welding exposure profile were
below 0.2 [mu]g/m\3\. Of the 44 welding samples in the profile, 75
percent were below 0.2 [mu]g/m\3\ and 64 percent were below 0.1 [mu]g/
m\3\, with most values between 0.01 and 0.05 [mu]g/m\3\. All but one of
the 16 exposure samples above 0.1 [mu]g/m\3\ were collected in Brush
Wellman's Elmore facility in 1999. According to company
representatives, these higher exposure levels may have been due to
beryllium oxide that can form on the surface of the material as a
result of hot rolling. All seven samples from the precision stamping
facility were below the limit of detection. Based on these results,
OSHA preliminarily concludes that the proposed PEL of 0.2 [mu]g/m\3\ is
feasible for most welding operations in general industry.
Dental Laboratories
OSHA's exposure profile for dental technicians includes sampling
results from a site visit conducted by ERG in 2003; a study of six
dental laboratories published by Rom et al. in 1984; a data set of
exposure samples collected between 1987 and 2001, on dental technicians
working for the U.S. Navy; and a docket submission from CMP Industries
including two samples from a large commercial dental laboratory using
nickel-beryllium alloy. Information on exposure controls in these
facilities suggests that controls in some cases may have been absent or
improperly used.
The exposure profile indicates that 52 percent of samples are less
than or equal to 0.2 [mu]g/m\3\. However, the treatment of
nondetectable samples in the feasibility analysis may overestimate many
of the sample values in the exposure profile. Twelve of the samples in
the profile are nondetectable for beryllium. In the exposure profile,
these were assigned the highest possible value, the limit of detection
(LOD). For eight of the nondetectable samples, the LOD was reported as
0.2 [mu]g/m\3\. For the other four nondetectable samples, the LOD was
between 0.23 and 0.71 [mu]g/m\3\. If the true values for these four
nondetectable samples are actually less than or equal to the assigned
value of 0.2 [mu]g/m\3\, then the true percentage of profile sample
values less than or equal to 0.2 [mu]g/m\3\ is between 52 and 70
percent. Of the sample results with detectable beryllium above 0.2
[mu]g/m\3\, some were collected in 1984 at facilities studied by Rom et
al., who reported that they occurred during grinding with LEV that was
improperly used or, in one case, not used at all. Others were collected
at facilities where little contextual information was available to
determine what control equipment or work practices might have reduced
exposures.
Based on this information, OSHA preliminarily concludes that
beryllium exposures for most dental technicians are already below 0.2
[mu]g/m\3\ most of the time. OSHA furthermore believes that exposure
levels can be reduced to or below 0.1 [mu]g/m\3\ most of the time via
material substitution, engineering controls, and work practices.
Beryllium-free alternatives for casting dental appliances are readily
available from commercial sources, and some alloy suppliers have
stopped carrying alloys that contain beryllium. For those dental
laboratories that continue to use beryllium alloys, exposure control
options include properly designed, installed, and maintained LEV
systems (equipped with HEPA filters) and enclosures; work practices
that optimize LEV system effectiveness; and housekeeping methods that
minimize beryllium contamination in the workplace. In summary, OSHA
preliminarily concludes that the proposed PEL is feasible for dental
laboratories.
[[Page 47679]]
Table IX-5--Beryllium Full-Shift PBZ Samples by Application/Job Group ([mu]g/m\3\)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Application/Job group N Range Mean Median %<0.1 %<=0.2 %<=2.0
--------------------------------------------------------------------------------------------------------------------------------------------------------
Be Production Operations (Section
3)
Furnace Operations........... 172 0.05 to 254 3.80 0.68 5 17 82
Chemical Operations.......... 20 0.05 to 9.6 1.02 0.47 5 15 95
Powdering Operations......... 72 0.06 to 11.5 0.82 0.37 11 29 94
Production Support........... 861 0.02 to 22.7 0.51 0.08 56 71 94
Cold Work.................... 555 0.04 to 24.9 0.31 0.08 61 80 98
Hot Work..................... 297 0.01 to 2.21 0.12 0.06 69 88 99
Site Support................. 879 0.05 to 4.22 0.11 0.05 81 92 99
Administrative............... 981 0.05 to 4.54 0.10 0.05 85 94 99
Be Oxide Ceramics (Section 4)
Material Preparation Operator 77 0.02 to 10.6 1.01 0.41 13 27 90
Forming Operator............. 408 0.02 to 53.2 0.48 0.18 27 56 99
Machining Operator........... 355 0.01 to 5.0 0.32 0.15 37 63 98
Kiln Operator................ 3 0.22 to 0.36 0.28 0.25 0 0 100
Production Support Worker.... 119 0.02 to 7.7 0.21 0.05 68 88 98
Metallization Worker......... 36 0.02 to 0.62 0.15 0.06 55 69 100
Administrative............... 185 0.02 to 1.2 0.06 0.05 93 98 100
Aluminum and Copper Foundries
(Section 5)
Furnace Operator............. 11 0.2 to 19.76 4.41 1.14 0 18 64
Pouring Operator............. 5 0.2 to 2.2 1.21 1.40 0 40 60
Shakeout Operator............ 1 1.3 1.30 1.30 0 0 100
Material Handler............. 1 0.93 0.93 0.93 0 0 100
Molder....................... 8 0.24 to 2.29 0.67 0.45 0 0 88
Maintenance.................. 78 0.05 to 22.71 0.87 0.21 15 50 96
Abrasive Blasting Operator... 5 0.05 to 0.15 0.11 0.12 40 100 100
Grinding/finishing Operator.. 56 0.01 to 4.79 0.31 0.05 59 73 95
Secondary Smelting (Section 6)
Furnace operations worker.... 6 0.03 to 14.1 3.85 2.15 17 17 50
Mechanical processing 3 0.03 to 0.2 0.14 0.20 33 100 100
operator.
Precision Turned Products
(Section 7)
High Be Content Alloys....... 80 0.02 to 7.2 0.72 0.31 14 25 92
Low Be Content Alloys........ 59 0.005 to 24 0.45 0.01 74 85 96
Rolling, Drawing, and Extruding 650 0.006 to 7.8 0.11 0.024 86 93 99
(Section 8)
Alloy Fabrication (Section 9) 71 0.004 to 0.42 0.056 0.025 83 94 100
Welding: Beryllium Alloy (Section 44 0.005 to 2.21 0.19 0.02 64 75 98
10)
Dental Laboratories (Section 11) 23 0.02 to 4.4 0.74 0.2 13 52 87
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: OSHA, Directorate of Standards and Guidance, Office of Regulatory Analysis.
[[Page 47680]]
E. Costs of Compliance
Chapter V of the PEA in support of the proposed beryllium rule
provides a detailed assessment of the costs to establishments in all
affected application groups of reducing worker exposures to beryllium
to an eight-hour time-weighted average (TWA) permissible exposure limit
(PEL) of 0.2 [mu]g/m\3\ and to the proposed short-term exposure limit
(STEL) of 2.0 [mu]g/m\3\, as well as of complying with the proposed
standard's ancillary provisions. OSHA describes its methodology and
sources in more detail in Chapter V. OSHA's preliminary cost assessment
is based on the Agency's technological feasibility analysis presented
in Chapter IV of the PEA; analyses of the costs of the proposed
standard conducted by OSHA's contractor, Eastern Research Group (ERG);
and the comments submitted to the docket in response to the request for
information (RFI) and as part of the SBREFA process.
As shown in Table IX-7 at the end of this section, OSHA estimates
that the proposed standard would have an annualized cost of $37.6
million. All cost estimates are expressed in 2010 dollars and were
annualized using a discount rate of 3 percent, which--along with 7
percent--is one of the discount rates recommended by OMB.\17\
Annualization periods for expenditures on equipment are based on
equipment life, and one-time costs are annualized over a 10-year
period.
---------------------------------------------------------------------------
\17\ Appendix V-A of the PEA presents costs by NAICS industry
and establishment size categories using, as alternatives, a 7
percent discount rate--shown in Table V-A-1--and a 0 percent
discount rate--shown in Table V-A-2.
---------------------------------------------------------------------------
The estimated costs for the proposed beryllium rule represent the
additional costs necessary for employers to achieve full compliance.
They do not include costs associated with current compliance that may
already have been achieved with regard to existing beryllium
requirements or costs necessary to achieve compliance with existing
beryllium requirements, to the extent that some employers may currently
not be fully complying with applicable regulatory requirements.
Throughout this section and in the PEA, OSHA presents cost formulas
in the text, usually in parentheses, to help explain the derivation of
cost estimates for individual provisions. Because the values used in
the formulas shown in the text are shown only to the second decimal
place, while the actual spreadsheet formulas used to create final costs
are not limited to two decimal places, the calculation using the
presented formula will sometimes differ slightly from the presented
total in the text, which is the actual and mathematically correct total
as shown in the tables.
1. Compliance With the Proposed PEL/STEL
OSHA's estimate of the costs for affected employers to comply with
the proposed PEL of 0.2 [mu]g/m\3\ and the proposed STEL of 2.0 [mu]g/
m\3\ consists of two parts. First, costs are estimated for the
engineering controls, additional studies and custom design requirements
to implement those controls, work practices, and specific training
required for those work practices (as opposed to general training in
compliance with the rule) needed for affected employers to meet the
proposed PEL and STEL, as well as opportunity costs (lost productivity)
that may result from working with some of the new controls. In most
cases, the PEA breaks out these costs, but in other instances some or
all of the costs are shortened simply to ``engineering controls'' in
the text, for convenience. Second, for employers unable to meet the
proposed PEL and STEL using engineering controls and work practices
alone, costs are estimated for respiratory protection sufficient to
reduce worker exposure to the proposed PEL and STEL or below.
In the technological feasibility analysis presented in Chapter IV
of the PEA, OSHA concluded that implementing all engineering controls
and work practices necessary to reach the proposed PEL will, except for
a small residual group (accounting for about 6 percent of all exposures
above the STEL), also reduce exposures below the STEL. However, based
on the nature of the processes this residual group is likely to be
engaged in, the Agency expects that employees would already be using
respirators to comply with the PEL under the proposed standard.
Therefore, with the proposed STEL set at ten times the proposed PEL,
the Agency has preliminarily determined that engineering controls, work
practices, and (when needed) respiratory protection sufficient to meet
the proposed PEL are also sufficient to meet the proposed STEL. For
that reason, OSHA has taken no additional costs for affected employers
to meet the proposed STEL. The Agency invites comment and requests that
the public provide data on this issue.
a. Engineering Controls
For this preliminary cost analysis, OSHA estimated the necessary
engineering controls and work practices for each affected application
group according to the exposure profile of current exposures by
occupation presented in Chapter III of the PEA. Under the requirements
of the proposed standard, employers would be required to implement
engineering or work practice controls whenever beryllium exposures
exceed the proposed PEL of 0.2 [mu]g/m\3\ or the proposed STEL of 2.0
[mu]g/m\3\.
In addition, even if employers are not exposed above the proposed
PEL or proposed STEL, paragraph (f)(2) of the proposed standard would
require employers at or above the action level to use at least one
engineering or work practice control to minimize worker exposure. Based
on the technological feasibility analysis presented in Chapter IV of
the PEA, OSHA has determined that, for only two job categories in two
application groups--chemical process operators in the Stamping, Spring
and Connection Manufacture application group and machinists in the
Machining application group--do the majority of facilities at or above
the proposed action level, but below the proposed PEL, lack the
baseline engineering or work controls required by paragraph (f)(2).
Therefore, OSHA has estimated costs, where appropriate, for employers
in these two application groups to comply with paragraph (f)(2).
By assigning controls based on application group, the Agency is
best able to identify those workers with exposures above the proposed
PEL and to design a control strategy for, and attribute costs
specifically to, these groups of workers. By using this approach,
controls are targeting those specific processes, emission points, or
procedures that create beryllium exposures. Moreover, this approach
allows OSHA to assign costs for technologies that are demonstrated to
be the most effective in reducing exposures resulting from a particular
process.
In developing cost estimates, OSHA took into account the wide
variation in the size or scope of the engineering or work practice
changes necessary to minimize beryllium exposures based on technical
literature, judgments of knowledgeable consultants, industry observers,
and other sources. The resulting cost estimates reflect the
representative conditions for the affected workers in each application
group and across all work settings. In all but a handful of cases (with
the exceptions noted in the PEA), all wage costs come from the 2010
Occupational Employment Statistics (OES) of the Bureau of Labor
Statistics (BLS, 2010a) and utilize the median wage for the appropriate
occupation. The wages used include a 30.35 percent markup for fringe
benefits as a percentage of total
[[Page 47681]]
compensation, which is the average percentage markup for fringe
benefits for all civilian workers from the 2010 Employer Costs for
Employee Compensation of the BLS (BLS, 2010b). All descriptions of
production processes are drawn from the relevant sections of Chapter IV
of the PEA.
The specific engineering costs for each of the applications groups,
and the NAICS industries that contain those application groups, are
discussed in Chapter V of the PEA. Like the industry profile and
technological feasibility analysis presented in other PEA chapters,
Chapter V of the PEA presents engineering control costs for the
following application groups:
Beryllium Production
Beryllium Oxide, Ceramics & Composites Production
Nonferrous Foundries
Stamping, Spring and Connection Manufacture
Secondary Smelting, Refining, and Alloying
Copper Rolling, Drawing, and Extruding
Secondary Smelting, Refining, and Alloying
Precision Machining
Welding
Dental Laboratories
The costs within these application groups are estimated by
occupation and/or operation. One application group could have multiple
occupations, operations, or activities where workers are exposed to
levels of beryllium above the proposed PEL, and each will need its own
set of controls. The major types of engineering controls needed to
achieve compliance with the proposed PEL include ventilation equipment,
pharmaceutical-quality high-containment isolators, decontainment
chambers, equipment with controlled water sprays, closed-circuit remote
televisions, enclosed cabs, conveyor enclosures, exhaust hoods, and
portable local-exhaust-ventilation (LEV) systems. Capital costs and
annual operation and maintenance (O&M) costs, as well as any other
annual costs, are estimated for the set of engineering controls
estimated to be necessary for limiting beryllium exposures for each
occupation or operation within each application group.
Tables V-2 through V-10 in Chapter V of the PEA summarize capital,
maintenance, and operating costs for each application group
disaggregated by NAICS code. Table IX-7 at the end of this section
breaks out the costs of engineering controls/work practices by
application group and NAICS code.
Some engineering control costs are estimated on a per-worker basis
and then multiplied by the estimated number of affected workers--as
identified in Chapter III: Profile of Affected Industries in the PEA--
to arrive at a total cost for a particular control within a particular
application group. This worker-based method is necessary because--even
though OSHA has data on the number of firms in each affected industry,
the occupations and industrial activities that result in worker
exposure to beryllium, and the exposure profile of at-risk
occupations--the Agency does not have a way to match up these data at
the firm level. Nor does the Agency have establishment-specific data on
worker exposure to beryllium for all establishments, or even
establishment-specific data on the level of activity involving worker
exposure to beryllium. Thus, OSHA could not always directly estimate
per-affected-establishment costs, but instead first had to estimate
aggregate compliance costs (using an estimated per-worker cost
multiplied by the number of affected workers) and then calculate the
average per-affected-establishment costs by dividing those aggregate
costs by the number of affected establishments. This method, while
correct on average, may under- or over-state costs for certain firms.
For other controls that are implemented on a fixed-cost basis per
establishment (e.g., creating a training program, writing a control
program), the costs are estimated on an establishment basis, and these
costs were multiplied by the number of affected establishments in the
given application group to obtain total control costs.
In developing cost estimates, the Agency sometimes had to make
case-specific judgments about the number of workers affected by each
engineering control. Because work environments vary within occupations
and across establishments, there are no definitive data on how many
workers are likely to have their exposures reduced by a given set of
controls. In the smallest establishments, especially those that might
operate only one shift per day, some controls would limit exposures for
only a single worker in one specific affected occupation. More
commonly, however, several workers are likely to benefit from each
enhanced engineering control. Many controls were judged to reduce
exposure for employees in multi-shift work or where workstations are
used by more than one worker per shift.
In general, improving work practices involves operator training,
actual work practice modifications, and better enforcement or
supervision to minimize potential exposures. The costs of these process
improvements consist of the supervisor and worker time involved and
would include the time spent by supervisors to develop a training
program.
Unless otherwise specified, OSHA viewed the extent to which
exposure controls are already in place to be reflected in the
distribution of exposures at levels above the proposed PEL among
affected workers. Thus, for example, if 50 percent of workers in a
given occupation are found to be exposed to beryllium at levels above
the proposed PEL, OSHA judged this equivalent to 50 percent of
facilities lacking adequate exposure controls. The facilities may have,
for example, the correct equipment installed but without adequate
ventilation to provide protection to workers exposed to beryllium. In
this example, the Agency would expect that the remaining 50 percent of
facilities to either have installed the relevant controls to reduce
beryllium exposures below the PEL or that they engage in activities
that do not require that the exposure controls be in place (for
example, they do not perform any work with beryllium-containing
materials). To estimate the need for incremental controls on a per-
worker basis, OSHA used the exposure profile information as the best
available data. OSHA recognizes that a very small percentage of
facilities might have all the relevant controls in place but are still
unable, for whatever reason, to achieve the proposed PEL through
controls alone. ERG's review of the industrial hygiene literature and
other source materials (ERG, 2007b), however, suggest that the large
majority of workplaces where workers are exposed to high levels of
beryllium lack at least some of the relevant controls. Thus, in
estimating the costs associated with the proposed standard, OSHA has
generally assumed that high levels of exposure to beryllium occur due
to the absence of suitable controls. This assumption likely results in
an overestimate of costs since, in some cases, employers may not need
to install and maintain new controls in order to meet the proposed PEL
but merely need to upgrade or better maintain existing controls, or to
improve work practices.
b. Respiratory Protection Costs
Based on the findings of the technological feasibility analysis, a
small subset of employees working with a few processes in a handful of
application groups will need to use respirators, in addition to
required engineering controls and improved work practices, to reduce
employee exposures to meet the proposed PEL. Specifically, furnace
operators--both in non-ferrous foundries (both sand and non-sand) and
in secondary smelting, refining, and alloying--as well as welders in a
few other processes, will
[[Page 47682]]
need to wear half-mask respirators. In beryllium production, workers
who rebuild or otherwise maintain furnaces and furnace tools will need
to wear full-face powered air-purifying respirators. Finally, the
Agency recognizes the possibility that, after all feasible engineering
and other controls are in place, there may still be a residual group
with potential exposure above the proposed PEL and/or STEL. To account
for these residual cases, OSHA estimates that 10 percent of the
workers, across all application groups and job categories, who are
above the proposed PEL before the beryllium proposed standard is in
place (according to the baseline exposure profile presented in Chapter
III of the PEA), would still be above the PEL after all feasible
controls are implemented and, hence, would need to use half-mask
respirators to achieve compliance with the proposed PEL.
There are five primary costs for respiratory protection. First,
there is a cost per establishment to set up a written respirator
program in accordance with the respiratory protection standard (29 CFR
1910.134). The respiratory protection standard requires written
procedures for the proper selection, use, cleaning, storage, and
maintenance of respirators. As derived in the PEA, OSHA estimates that,
when annualized over 10 years, the annualized per-establishment cost
for a written respirator program is $207.
For reasons unrelated to the proposed standard, certain
establishments will already have a respirator program in place. Table
V-11 in Chapter V of the PEA presents OSHA's estimates, by application
group, of current levels of compliance with the respirator program
provision of the proposed rule.
The four other major costs of respiratory protection are the per-
employee costs for all aspects of respirator use: equipment, training,
fit-testing, and cleaning. Table V-12 of Chapter V in the PEA breaks
out OSHA's estimate of the unit costs for the two types of respirators
needed: A half-mask respirator and a full-face powered air-purifying
respirator. As derived in the PEA, the annualized per-employee cost for
a half-mask respirator would be $524 and the annualized per-employee
cost for a full-face powered air-purifying respirator would be $1,017.
Table V-13 in Chapter V of the PEA presents the number of
additional employees, by application group and NAICS code, that would
need to wear respirators to comply with the proposed standard and the
cost to industry to comply with the respirator protection provisions in
the proposed rule. OSHA judges that only workers in Beryllium
Production work with processes that would require a full-face
respirator and estimates that there are 23 of those workers. Three
hundred and eighteen workers in other assorted application groups are
estimated to need half-mask respirators. A total of 341 employees would
need to wear some type of respirator, resulting in a total annualized
cost of $249,684 for affected industries to comply with the respiratory
protection requirements of the proposed standard. Table IX-7 at the end
of this section breaks out the costs of respiratory protection by
application group and NAICS code.
2. Ancillary Provisions
This section presents OSHA's estimated costs for ancillary
beryllium control programs required under the proposed rule. Based on
the program requirements contained in the proposed standard, OSHA
considered the following cost elements in the following employer
duties: (a) Assess employees' exposure to airborne beryllium, (b)
establish regulated areas, (c) develop a written exposure control plan,
(d) provide protective work clothing, (e) establish hygiene areas and
practices, (f) implement housekeeping measures, (g) provide medical
surveillance, (h) provide medical removal for employees who have
developed CBD or been confirmed positive for beryllium sensitization,
and (i) provide appropriate training.
The worker population affected by each program element varies by
several criteria discussed in detail in each subsection below. In
general, some elements would apply to all workers exposed to beryllium
at or above the action level. Other elements would apply to a smaller
set of workers who are exposed above the PEL. The training requirements
would apply to all employees who work in a beryllium work area (e.g.,
an area with any level of exposure to airborne beryllium). The
regulated area program elements triggered by exposures exceeding the
proposed PEL of 0.2 [mu]g/m\3\ would apply to those workers for whom
feasible controls are not adequate. In the earlier discussion of
respiratory protection, OSHA estimated that 10 percent of all affected
workers with current exposures above the proposed PEL would fall in
this category.
Costs for each program requirement are aggregated by employment and
by industry. For the most part, unit costs do not vary by industry, and
any variations are specifically noted. The estimated compliance rate
for each provision of the proposed standard by application group is
presented in Table V-15 of the PEA.
a. Exposure Assessment
Most establishments wishing to perform exposure monitoring would
require the assistance of an outside consulting industrial hygienist
(IH) to obtain accurate results. While some firms might already employ
or train qualified staff, OSHA judged that the testing protocols are
fairly challenging and that few firms have sufficiently skilled staff
to eliminate the need for outside consultants.
The proposed standard requires that, after receiving the results of
any exposure monitoring where exposures exceed the TWA PEL or STEL, the
employer notify each such affected employee in writing of suspected or
known sources of exposure, and the corrective action(s) being taken to
reduce exposure to or below the PEL. Those workers exposed at or above
the action level and at or below the PEL must have their exposure
levels monitored annually.
For costing purposes, OSHA estimates that, on average, there are
four workers per work area. OSHA interpreted the initial exposure
assessment as requiring first-year testing of at least one worker in
each distinct job classification and work area who is, or may
reasonably be expected to be, exposed to airborne concentrations of
beryllium at or above the action level.
The proposed standard requires that whenever there is a change in
the production, process, control equipment, personnel, or work
practices that may result in new or additional exposures, or when the
employer has any reason to suspect that a change may result in new or
additional exposures, the employer must conduct additional monitoring.
The Agency has estimated that this provision would require an annual
sampling of 10 percent of the affected workers.
OSHA estimates that an industrial hygienist (IH) would spend 1 day
each year to sample 2 workers, for a per worker IH fee of $257. This
exposure monitoring requires that three samples be taken per worker:
One TWA and two STEL for an annual IH fee per sample of $86. Based on
the 2000 EMSL Laboratory Testing Catalog (ERG, 2007b), OSHA estimated
that analysis of each sample would cost $137 in lab fees. When combined
with the IH fee, OSHA estimated the annual cost to obtain a TWA sample
to be $223 per sampled worker and the annual cost to obtain the two
STEL samples to be $445 per sampled worker. The direct exposure
monitoring unit costs are
[[Page 47683]]
summarized in Table V-16 in Chapter V of the PEA.
The cost of the sample also incorporates a productivity loss due to
the additional time for the worker to participate in the sampling (30
minutes per worker sampled) as well as for the associated recordkeeping
time incurred by a manager (15 minutes per worker sampled). The STEL
samples are assumed to be taken along with the TWA sample and, thus,
labor costs were not added to both unit costs. Including the costs
related to lost productivity, OSHA estimates the total annual cost of a
TWA sample to be $251, and 2 STEL samples, $445. The total annual cost
per worker for all sampling taken is then $696. OSHA estimates the
total annualized cost of this provision to be $2,208,950 for all
affected industries. The annualized cost of this provision for each
affected NAICS industry is shown in Table IX-6.
b. Beryllium Work Areas and Regulated Areas
The proposed beryllium standard requires the employer to establish
and maintain a regulated area wherever employees are, or can reasonably
expected to be, exposed to airborne beryllium at levels above the TWA
PEL or STEL. Regulated areas require specific provisions that both
limit employee exposure within its boundaries and curb the migration of
beryllium outside the area. The Agency judged, based on the preliminary
findings of the technological feasibility analysis, that companies can
reduce establishment-wide exposure by ensuring that only authorized
employees wearing proper protective equipment have access to areas of
the establishment where such higher concentrations of beryllium exist,
or can be reasonably expected to exist. Workers in other parts of the
establishment are also likely to see a reduction in beryllium exposures
due to these measures since fewer employees would be traveling through
regulated areas and subsequently carrying beryllium residue to other
work areas on their clothes and shoes.
Requirements in the proposed rule for a regulated area include:
Demarcating the boundaries of the regulated area as separate from the
rest of the workplace, limiting access to the regulated area, providing
an appropriate respirator to each person entering the regulated area
and other protective clothing and equipment as required by paragraph
(g) and paragraph (h), respectively.
OSHA estimated that the total annualized cost per regulated area,
including set-up costs ($76), respirators ($1,768) and protective
clothing ($4,500), is $6,344.
When establishments are in full compliance with the standard,
regulated areas would be required only for those workers for whom
controls could not feasibly reduce their exposures to or below the 0.2
[mu]g/m\3\ TWA PEL and the 2 [mu]g/m\3\ STEL. Based on the findings of
the technological feasibility analysis, OSHA estimated that 10 percent
of the affected workers would be exposed above the TWA PEL or STEL
after implementation of engineering controls and thus would require
regulated areas (with one regulated area, on average, for every four
workers exposed above the proposed TWA PEL or STEL).
The proposed standard requires that all beryllium work areas are
adequately established and demarcated. ERG estimated that one work area
would need to be established for every 12 at-risk workers. OSHA
estimates that the annualized cost would be $33 per work area.
OSHA estimates the total annualized cost of the regulated areas and
work areas is $629,031 for all affected industries. The cost for each
affected application group and NAICS code is shown in Table IX-6.
c. Written Exposure Control Plan
The proposed standard requires that employers must establish and
maintain a written exposure control plan for beryllium work areas. The
written program must contain:
1. An inventory of operations and job titles reasonably expected to
have exposure.
2. An inventory of operations and job titles reasonably expected to
have exposure at or above the action level.
3. An inventory of operations and job titles reasonably expected to
have exposure above the TWA PEL or STEL.
4. Procedures for minimizing cross-contamination, including but not
limited to preventing the transfer of beryllium between surfaces,
equipment, clothing, materials and articles within beryllium work
areas.
5. Procedures for keeping surfaces in the beryllium work area free
as practicable of beryllium.
6. Procedures for minimizing the migration of beryllium from
beryllium work areas to other locations within or outside the
workplace.
7. An inventory of engineering and work practice controls required
by paragraph (f)(2) of this standard.
8. Procedures for removal, laundering, storage, cleaning,
repairing, and disposal of beryllium-contaminated personal protective
clothing and equipment, including respirators.
The unit cost estimates take into account the judgment that (1)
most establishments have an awareness of beryllium risks and, thus,
should be able to develop or modify existing safeguards in an
expeditious fashion, and (2) many operations have limited beryllium
activities and these establishments need to make only modest changes in
procedures to create the necessary exposure control plan. ERG's experts
estimated that managers would spend eight hours per establishment to
develop and implement such a written exposure control plan, yielding a
total cost per establishment to develop and implement the written
control plan of $563.53 and an annualized cost of $66. In addition,
because larger firms with more affected workers will need to develop
more complicated written control plans, the development of a plan would
require an extra thirty minutes of a manager's time per affected
employee, for a cost of $35 per affected employee and an annualized
cost of $4 per employee. Managers would also need 12 minutes (0.2
hours) per affected employee per quarter, or 48 minutes per affected
employee per year to review and update the plan, for a recurring cost
of $56 per affected employee per year to maintain and update the plan.
Five minutes of clerical time would also be needed per employee for
providing each employee with a copy of the written exposure control
plan--yielding an annualized cost of $2 per employee. The total annual
per-employee cost for development, implementation, review, and update
of a written exposure control plan is then $62. The Agency estimates
the total annualized cost of this provision to be $1,769,506 for all
affected establishments. The breakdown of these costs by application
group and NAICS code is presented in Table IX-6.
d. Personal Protective Clothing and Equipment
The proposed standard requires personal protective clothing and
equipment for workers:
1. Whose exposure can reasonably be expected to exceed the TWA PEL
or STEL.
2. When work clothing or skin may become visibly contaminated with
beryllium, including during maintenance and repair activities or during
non-routine tasks.
3. Where employees' skin can reasonably be expected to be exposed
to soluble beryllium compounds.
OSHA has determined that it would be necessary for employers to
provide reusable overalls and/or lab coats at a
[[Page 47684]]
cost of $284 and $86, respectively, for operations in the following
application groups:
Beryllium Production
Beryllium Oxide, Ceramics & Composites
Nonferrous Foundries
Fabrication of Beryllium Alloy Products
Copper Rolling, Drawing & Extruding
Secondary Smelting, Refining and Alloying
Precision Turned Products
Dental Laboratories
Chemical process operators in the spring and stamping application
group would require chemical resistant protective clothing at an annual
cost of $849. Gloves and/or shoe covers would be required when
performing operations in several different application groups,
depending on the process being performed, at an annual cost of $50 and
$78, respectively.
The proposed standard requires that all reusable protective
clothing and equipment be cleaned, laundered, repaired, and replaced as
needed to maintain their effectiveness. This includes such safeguards
as transporting contaminated clothing in sealed and labeled impermeable
bags and informing any third party businesses coming in contact with
such materials of the risks associated with beryllium exposure. OSHA
estimates that the lowest cost alternative to satisfy this provision is
for an employer to rent and launder reusable protective clothing--at an
estimated annual cost per employee of $49. Ten minutes of clerical time
would also be needed per establishment with laundry needs to notify the
cleaners in writing of the potentially harmful effects of beryllium
exposure and how the protective clothing and equipment must be handled
in accordance with this standard--at a per establishment cost of $3.
The Agency estimates the total annualized cost of this provision to
be $1,407,365 for all affected establishments. The breakdown of these
costs by application group and NAICS code is shown in Table IX-6.
e. Hygiene Areas and Practices
The proposed standard requires employers to provide readily
accessible washing facilities to remove beryllium from the hands, face,
and neck of each employee working in a beryllium work area and also to
provide a designated change room in workplaces where employees would
have to remove their personal clothing and don the employer-provided
protective clothing. The proposed standard also requires that employees
shower at the end of the work shift or work activity if the employee
reasonably could have been exposed to beryllium at levels above the PEL
or STEL, and if those exposures could reasonably be expected to have
caused contamination of the employee's hair or body parts other than
hands, face, and neck.
In addition to other forms of PPE costed previously, for processes
where hair may become contaminated, head coverings can be purchased at
an annual cost of $28 per employee. This could satisfy the requirement
to avoid contaminated hair. If workers are covered by protective
clothing such that no body parts (including their hair where necessary,
but not including their hands, face, and neck) could reasonably be
expected to have been contaminated by beryllium, and they could not
reasonably be expected to be exposed to beryllium while removing their
protective clothing, they would not need to shower at the end of a work
shift or work activity. OSHA notes that some facilities already have
showers, and the Agency judges that all employers either already have
showers where needed or will have sufficient measures in place to
ensure that employees could not reasonably be expected to be exposed to
beryllium while removing protective clothing. Therefore, OSHA has
preliminarily determined that employers will not need to provide any
new shower facilities to comply with the standard.
The Agency estimated the costs for the addition of a change room
and segregated lockers based on the costs for acquisition of portable
structures. The change room is presumed to be used in providing a
transition zone from general working areas into beryllium-using
regulated areas. OSHA estimated that portable building, adequate for 10
workers per establishment can be rented annually for $3,251, and that
lockers could be procured for a capital cost of $407--or $48
annualized--per establishment. This results in an annualized cost of
$3,299 per facility to rent a portable change room with lockers. OSHA
estimates that the 10 percent of affected establishments unable to meet
the proposed TWA PEL would require change rooms. The Agency estimated
that a worker using a change room would need 2 minutes per day to
change clothes. Assuming 250 days per year, this annual time cost for
changing clothes is $185 per employee.
The Agency estimates the total annualized cost of the provision on
hygiene areas and practices to be $389,241 for all affected
establishments. The breakdown of these costs by application group and
NAICS code can be seen in Table IX-6.
f. Housekeeping
The proposed rule specifies requirements for cleaning and disposing
of beryllium-contaminated wastes. The employer shall maintain all
surfaces in beryllium work areas as free as practicable of
accumulations of beryllium and shall ensure that all spills and
emergency releases of beryllium are cleaned up promptly, in accordance
with the employer's written exposure control plan and using a HEPA-
filtered vacuum or other methods that minimize the likelihood and level
of exposure. The employer shall not allow dry sweeping or brushing for
cleaning surfaces in beryllium work areas unless HEPA-filtered
vacuuming or other methods that minimize the likelihood and level of
exposure have been tried and were not effective.
ERG's experts estimated that each facility would need to purchase a
single vacuum at a cost of $2,900 for every five affected employees in
order to successfully integrate housekeeping into their daily routine.
The per-employee cost would be $580, resulting in an annualized cost of
$68 per worker. ERG's experts also estimated that all affected workers
would require an additional five minutes per work day (.083 hours) to
complete vacuuming tasks and to label and dispose of beryllium-
contaminated waste. While this allotment is modest, OSHA judged that
the steady application of this incremental additional cleaning, when
combined with currently conducted cleaning, would be sufficient in
average establishments to address dust or surface contamination
hazards. Assuming that these affected workers would be working 250 days
per year, OSHA estimates that the annual labor cost per employee for
additional time spent cleaning in order to comply with this provision
is $462.
The proposed standard requires each disposal bag with contaminated
materials to be properly labeled. ERG estimated a cost of 10 cents per
label with one label needed per day for every five workers. With the
disposal of one labeled bag each day and 250 working days, the per-
employee annual cost would be $5. The annualized cost of a HEPA-
filtered vacuum, combined with the additional time needed to perform
housekeeping and the labeling of disposal bags, results in a total
annualized cost of $535 per employee.
The Agency estimates the total annualized cost of this provision to
be $12,574,921 for all affected establishments. The breakdown of these
costs by application group and NAICS code is shown in Table IX-6.
[[Page 47685]]
g. Medical Surveillance
The proposed standard requires the employer to make medical
surveillance available at no cost to the employee, and at a reasonable
time and place, for the following employees:
1. Employees who have worked in a regulated area for more than 30
days in the last 12 months
2. Employees showing signs or symptoms of chronic beryllium disease
(CBD)
3. Employees exposed to beryllium during an emergency; and
4. Employees exposed to airborne beryllium above 0.2 [mu]g/m\3\ for
more than 30 days in a 12-month period for 5 years or more.
As discussed in the regulated areas section of this analysis of
program costs, the Agency estimates that approximately 10 percent of
affected employees would have exposure in excess of the PEL after the
standard goes into effect and would therefore be placed in regulated
areas. The Agency further estimates that a very small number of
employees will be affected by emergencies in a given year, likely less
than 0.1 percent of the affected population, representing a small
additional cost. The number of workers who would suffer signs and
symptoms of CBD after the rule takes effect is difficult to estimate,
but would likely substantially exceed those with actual cases of CBD.
While the symptoms of CBD vary greatly, the first to appear are
usually chronic dry cough (generally defined as a nonproductive cough,
without phlegm or sputum, lasting two months or more) and shortness of
breath during exertion. Ideally, in developing these costs estimates,
OSHA would first estimate the percent of affected workers who might be
presenting with a chronic cough and/or experiencing shortness of
breath.
Studies have found the prevalence of a chronic cough ranging from
10 to 38 percent across various community populations, with smoking
accounting for up to 18 percent of cough prevalence (Irwin, 1990;
Barbee, 1991). However, these studies are over 20 years old, and the
number of smokers has decreased substantially since then. It's also not
clear whether the various segments of the U.S. population studied are
similar enough to the population of workers exposed to beryllium such
that results of these studies could be generalized to the affected
worker population.
A more recent study from a plant in Cullman, Alabama that works
with beryllium alloy found that about five percent of employees said
they were current smokers, with roughly 52 percent saying they were
previous smokers and approximately 43 percent stating they had never
smoked (Newman et al., 2001). This study does not, however, report on
the prevalence of chronic cough in this workplace.
OSHA was unable to identify any studies on the general prevalence
of the other common early symptom of CBD, shortness of breath. Lacking
any better data to base an estimate on, the Agency used the studies
cited above (Irwin, 1990; Barbee, 1991) showing the prevalence of
chronic cough in the general population, adjusted to account for the
long term decrease in smoking prevalence (and hence, the amount of
overall cases of chronic cough), and estimated that 15 percent of the
worker population with beryllium exposure would exhibit a chronic cough
or other sign or symptom of CBD that would trigger medical
surveillance. The Agency welcomes comment and further data on this
question.
According to the proposed rule, the initial (baseline) medical
examination would consist of the following:
1. A medical and work history, with emphasis on past and present
exposure, smoking history and any history of respiratory system
dysfunction;
2. A physical examination with emphasis on the respiratory tract;
3. A physical examination for skin breaks and wounds;
4. A pulmonary function test;
5. A standardized beryllium lymphocyte proliferation test (BeLPT)
upon the first examination and within every two years from the date of
the first examination until the employee is confirmed positive for
beryllium sensitization;
6. A CT scan, offered every two years for the duration of the
employee's employment, if the employee was exposed to airborne
beryllium at levels above 0.2 [mu]g/m\3\ for more than 30 days in a 12-
month period for at least 5 years. This obligation begins on the start-
up date of this standard, or on the 15th year after the employee's
first exposure above for more than 30 days in a 12-month period,
whichever is later; and
7. Any other test deemed appropriate by the Physician or other
Licensed Health Care Professional (PLHCP).
Table V-17 in Chapter V of the PEA lists the direct unit costs for
initial medical surveillance activities including: Work and medical
history, physical examination, pulmonary function test, BeLPT, CT scan,
and costs of additional tests. In OSHA's cost model, all of the
activities will take place during an employee's initial visit and on an
annual basis thereafter and involve a single set of travel costs,
except that: (1) The BeLPT tests will only be performed at two-year
intervals after the initial test, but will be conducted in conjunction
with the annual general examination (no additional travel costs); and
(2) the CT scans will typically involve different specialists and are
therefore treated as separate visits not encompassed by the general
exams (therefore requiring separate travel costs). Not all employees
would require CT scans, and employers would only be required to offer
them every other year.
In addition to the fees for the annual medical exam, employers may
also incur costs for lost work time when their employees are
unavailable to perform their jobs. This includes time for traveling, a
health history review, the physical exam, and the pulmonary function
test. Each examination would require 15 minutes (or 0.25 hours) of a
human resource manager's time for recording the results of the exam and
tests and the PLHCP's written opinion for each employee and any
necessary post-exam consultation with the employee. There is also a
cost of 15 minutes of supervisor time to provide information to the
physician, five minutes of supervisor time to process a licensed
physician's written medical opinion, and five minutes for an employee
to receive a licensed physician's written medical opinion. The total
unit annual cost for the medical examinations and tests, excluding the
BeLPT test, and the time required for both the employee and the
supervisor is $297.
The estimated fee for the BeLPT is $259. With the addition of the
time incurred by the worker to undergo the test, the total cost for a
BeLPT is $261. The standard requires a biennial BeLPT for each employee
covered by the medical surveillance provision, so most workers would
receive between two and five BeLPT tests over a ten year period
(including the BeLPT performed during the initial examination),
depending on whether the results of these tests were positive. OSHA
therefore estimates a net present value (NPV) of $1,417 for all five
tests. This NPV annualized over a ten year period is $166.
Together, the annualized net present value of the BeLPT and the
annualized cost of the remaining medical surveillance produce an annual
cost of $436 per employee.
The proposed standard requires that a helical tomography (CT scan)
be offered to employees exposed to airborne beryllium above 0.2 [mu]g/
m\3\ for more than 30 days in a 12-month period, for a period of 5
years or more. The five years
[[Page 47686]]
do not need to be consecutive, and the exposure does not need to occur
after the effective date of the standard. The CT scan shall be offered
every 2 years starting on the 15th year after the first year the
employee was exposed above 0.2 [mu]g/m\3\ for more than 30 days in a
12-month period, for the duration of their employment. The total yearly
cost for biennial CT scans consists of medical costs totaling $1,020,
comprised of a $770 fee for the scan and the cost of a specialist to
review the results, which OSHA estimates would cost $250. The Agency
estimates an additional cost of $110 for lost work time, for a total of
$1,131. The annualized yearly cost for biennial CT scans is $574.
Based on OSHA's estimates explained earlier in this section, all
workers in regulated areas, workers exposed in emergencies, and an
estimated 15 percent of workers not in regulated areas who exhibit
signs and symptoms of CBD will be eligible for medical surveillance
other than CT scans. The estimate for the number of workers eligible to
receive CT scans is 25 percent of workers who are exposed above 0.2 in
the exposure profile. The estimate of 25 percent is based on the facts
that roughly this percentage of workers have 15-plus years of job
tenure in the durable manufacturing sector and the estimate that all
those with 15-plus years of job tenure and current exposure over 0.2
would have had at least 5 years of such exposure in the past.
The costs estimated for this provision are likely to be
significantly overestimated, since not all affected employees offered
medical surveillance would necessarily accept the offer. At Department
of Energy facilities, only about 50 percent of eligible employees
participate in the voluntary medical surveillance tests, and a report
on an initial medical surveillance program at four aluminum manufacture
facilities found participation rates to be around 57 percent (Taiwo et
al., 2008). Where employers already offer equivalent health
surveillance screening, no new costs are attributable to the proposed
standard.
Within 30 days after an employer learns that an employee has been
confirmed positive for beryllium sensitization, the employer's
designated licensed physician shall consult with the employee to
discuss referral to a CBD diagnostic center that is mutually agreed
upon by the employer and the employee. If, after this consultation, the
employee wishes to obtain a clinical evaluation at a CBD diagnostic
center, the employer must provide the evaluation at no cost to the
employee. OSHA estimates this consultation will take 15 minutes, with
an estimated total cost of $33.
Table V-18 in Chapter V of the PEA lists the direct unit costs for
a clinical evaluation with a specialist at a CBD diagnostic center. To
estimate these costs, ERG contacted a healthcare provider who commonly
treats patients with beryllium-related disease, and asked them to
provide both the typical tests given and associated costs of an initial
examination for a patient with a positive BeLPT test, presented in
Table V-18 in Chapter V of the PEA. Their typical evaluation includes
bronchoscopy with lung biopsy, a pulmonary stress test, and a chest CAT
scan. The total cost for the entire suite of tests is $6,305.
In addition, there are costs for lost productivity and travel. The
Agency has estimated the clinical evaluation would take three days of
paid time for the worker to travel to and from one of two locations:
Penn Lung Center at the Cleveland Clinic Foundation in Cleveland, Ohio
or National Jewish Medical Center in Denver, Colorado. OSHA estimates
lost work time is 24 hours, yielding total cost for the 3 days of $532.
OSHA estimates that roundtrip air-fare would be available for most
facilities at $400, and the cost of a hotel room would be approximately
$100 per night, for a total cost of $200 for the hotel room. OSHA
estimates a per diem cost of $50 for three days, for a total of $150.
The total cost per trip for traveling expenses is therefore $750.
The total cost of a clinical evaluation with a specialist at a CBD
diagnostic center is equal to the cost of the examination plus the cost
of lost work-time and the cost for the employee to travel to the CBD
diagnostic center, or $7,620.
Based on the data from the exposure profile and the prevalence of
beryllium sensitization observed at various levels of cumulative
exposure,\18\ OSHA estimated the number of workers eligible for BeLPT
testing (4,181) and the percentage of workers who will be confirmed
positive for sensitization (two positive BeLPT tests, as specified in
the proposed standard) and referred to a CBD diagnostic center. During
the first year that the medical surveillance provisions are in effect,
OSHA estimates that 9.4 percent of the workers who are tested for
beryllium sensitization will be identified as sensitized. This
percentage is an average based on: (1) The number of employees in the
baseline exposure profile that are in a given cumulative exposure
range; (2) the expected prevalence for a given cumulative exposure
range (from Table VI-6 in Section VI of the preamble); and (3) an
assumed even distribution of employees by cumulative years of exposure
at a given level--20 percent having exposures at a given level for 5
years, 20 percent for 15 years, 20 percent for 25 years, 20 percent for
30 years, and 20 percent for 40 years.
---------------------------------------------------------------------------
\18\ See Table VI-6 in Section VI of the preamble, Preliminary
Risk Assessment.
---------------------------------------------------------------------------
OSHA did not assume that all workers with confirmed sensitization
would choose to undergo evaluation at a CBD diagnostic center, which
may involve invasive procedures and/or travel. For purposes of this
cost analysis, OSHA estimates that approximately two-thirds of workers
who are confirmed positive for beryllium sensitization will choose to
undergo evaluation for CBD. OSHA requests comment on the CBD evaluation
participation rate. OSHA estimates that about 264 of all non-dental lab
workers will go to a diagnostic center for CBD evaluation in the first
year.
The calculation method described above applies to all workers
except dental technicians, who were analyzed with one modification. The
rates for dental technicians are calculated differently due to the
estimated 75 percent beryllium-substitution rate at dental labs, where
the 75 percent of labs that eliminate all beryllium use are those at
higher exposure levels. None of the remaining labs affected by this
standard had exposures above 0.1 [mu]g/m\3\. For the dental labs, the
same calculation was done as presented in the previous paragraph, but
only the remaining 25 percent of employees (2,314) who would still face
beryllium exposures were included in the baseline cumulative exposure
profile. With that one change, and all other elements of the
calculation the same, OSHA estimates that 9 percent of dental lab
workers tested for beryllium sensitization will be identified as
sensitized. The predicted prevalence of sensitization among those
dental lab workers tested in the first year after the standard takes
effect is slightly lower than the predicted prevalence among all other
tested workers combined. This slightly lower rate is not surprising
because only dental lab workers with exposures below 0.1 [mu]g/m\3\ are
included (after adjusting for substitution), and OSHA's exposure
profile indicates that the vast majority of non-dental workers exposed
to beryllium are also exposed at 0.1 [mu]g/m\3\ or lower. OSHA
estimates that 20 dental lab workers (out of 347 tested for
sensitization) would go to a diagnostic center for CBD evaluation in
the first year.
[[Page 47687]]
In each year after the first year, OSHA relied on a 10 percent
worker turnover rate in a steady state (as discussed in Chapter VII of
the PEA) to estimate that the annual sensitization incidence rate is 10
percent of the first year's incidence rate. Based on that rate and the
number of workers in the medical surveillance program, the CBD
evaluation rate for workers other than those in dental labs would drop
to 0.63 percent (.063 x .10). The evaluation rate for dental labs
technicians is similarly estimated to drop to 0.58 percent (.058 x
.10).
Based on these unit costs and the number of employees requiring
medical surveillance estimated above, OSHA estimates that the medical
surveillance and referral provisions would result in an annualized
total cost of $2,882,706. These costs are presented by application
group and NAICS code in Table IX-7.
h. Medical Removal Provision
Once a licensed physician diagnoses an employee with CBD or the
employee is confirmed positive for sensitization to beryllium, that
employee is eligible for medical removal and has two choices:
(a) Removal from current job, or
(b) Remain in a job with exposure above the action level while
wearing a respirator pursuant to 29 CFR 1910.134.
To be eligible for removal, the employee must accept comparable
work if such is available, but if not available the employer would be
required to place the employee on paid leave for six months or until
such time as comparable work becomes available, whichever comes first.
During that six-month period, whether the employee is re-assigned or
placed on paid leave, the employer must continue to maintain the
employee's base earnings, seniority and other rights, and benefits that
existed at the time of the first test.
For purposes of this analysis, OSHA has conservatively estimated
the costs as if all employees will choose removal, rather than
remaining in the current job while wearing a respirator. In practice,
many workers may prefer to continue working at their current job while
wearing a respirator, and the employer would only incur the respirator
costs identified earlier in this chapter. The removal costs are
significantly higher over the same six-month period, so this analysis
likely overestimates the total costs for this provision.
OSHA estimated that the majority of firms would be able to reassign
the worker to a job at least at the clerical level. The employer will
often incur a cost for re-assigning the worker because this provision
requires that, regardless of the comparable work the medically removed
worker is performing, the employee must be paid the full base earnings
for the previous position for six months. The cost per hour of
reassigning a worker to a clerical job is based on the wage difference
of a production worker of $22.16 and a clerical worker of $19.97, for a
difference of $2.19. Over the six-month period, the incremental cost of
reassigning a worker to a clerical position would be $2,190 per
employee. This estimate is based on the employee remaining in a
clerical position for the entire 6-month period, but the actual cost
would be lower if there is turnover or if the employee is placed in any
alternative position (for any part of the six-month period) that is
compensated at a wage closer to the employee's previous wage.
Some firms may not have the ability to place the worker in an
alternate job. If the employee chooses not to remain in the current
position, the additional cost to the employer would be at most the cost
of equipping that employee with a respirator, which would be required
if the employee would continue to face exposures at or above the action
level. Based on the earlier discussion of respirator costs, that option
would be significantly cheaper than the alternative of providing the
employee with six months of paid leave. Therefore, in order to estimate
the maximum potential economic cost of the remaining alternatives, the
Agency has conservatively estimated the cost per worker based on the
cost of 6 months paid leave.
Using the wage rate of a production worker of $22.16 for 6 months
(or 8 hours a day for 125 days), the total per-worker cost for this
provision when a firm cannot place a worker in an alternate job is
$22,161.
OSHA has estimated an average medical removal cost per worker
assuming 75 percent of firms are able to find the employee an alternate
job, and the remaining 25 percent of firms would not. The weighted
average of these costs is $7,183. Based on these unit costs, OSHA
estimates that the medical removal provision would result in an
annualized total cost of $148,826. The breakdown of these costs by
application group and NAICS code is shown in Table IX-6.
i. Training
As specified in the proposed standard and existing OSHA standard 29
CFR 1910.1200 on hazard communication, training is required for all
employees where there is potential exposure to beryllium. In addition,
newly hired employees would require training before starting work.
OSHA anticipates that training in accordance with the requirements
of the proposed rule, which includes hazard communication training,
would be conducted by in-house safety or supervisory staff with the use
of training modules or videos. ERG estimated that this training would
last, on average, eight hours. (Note that this estimate does not
include the time taken for hazard communication training that is
already required by 29 CFR 1910.1200.) The Agency judged that
establishments could purchase sufficient training materials at an
average cost of $2 per worker, encompassing the cost of handouts, video
presentations, and training manuals and exercises. For initial and
periodic training, ERG estimated an average class size of five workers
with one instructor over an eight hour period. The per-worker cost of
initial training totals to $239.
Annual retraining of workers is also required by the standard. OSHA
estimates the same unit costs as for initial training, so retraining
would require the same per-worker cost of $239.
Finally, to calculate training costs, the Agency needs the turnover
rate of affected workers to know how many workers are receiving initial
training versus retraining. Based on a 26.3 percent new hire rate in
manufacturing, OSHA calculated a total net present value (NPV) of ten
years of initial and annual retraining of $2,101 per employee.
Annualizing this NPV gives a total annual cost for training of $246.
Based on these unit costs, OSHA estimates that the training
requirements in the standard would result in an annualized total cost
of $5,797,535. The breakdown of these costs by application group and
NAICS code is presented in Table IX-6.
[[Page 47688]]
[GRAPHIC] [TIFF OMITTED] TP07AU15.009
[[Page 47689]]
[GRAPHIC] [TIFF OMITTED] TP07AU15.010
[[Page 47690]]
[GRAPHIC] [TIFF OMITTED] TP07AU15.011
[[Page 47691]]
Total Annualized Cost
As shown in Table IX-7, the total annualized cost of the proposed
rule is estimated to be about $37.6 million. As shown, at $27.8
million, the program costs represent about 74 percent of the total
annualized costs of the proposed rule. The annualized cost of complying
with the PEL accounts for the remaining 26 percent, almost all of which
is for engineering controls and work practices. Respiratory protection,
at about $237,600, represents only 3 percent of the annualized cost of
complying with the PEL and less than 1 percent of the annualized cost
of the proposed rule.
[GRAPHIC] [TIFF OMITTED] TP07AU15.012
[[Page 47692]]
[GRAPHIC] [TIFF OMITTED] TP07AU15.013
F. Economic Feasibility Analysis and Regulatory Flexibility
Determination
Chapter VI of the PEA, summarized here, investigates the economic
impacts of the proposed beryllium rule on affected employers. This
impact investigation has two overriding objectives: (1) To establish
whether the proposed rule is economically feasible for all affected
application groups/industries, and (2) to determine if the Agency can
certify that the proposed rule will not have a significant economic
impact on a substantial number of small entities.
In the discussion below, OSHA first presents its approach for
achieving these objectives and next applies this approach to industries
with affected employers. The Agency invites comment on any aspect of
the methods, data, or preliminary findings presented here or in Chapter
VI of the PEA.
1. Analytic Approach
a. Economic Feasibility
Section 6(b)(5) of the OSH Act directs the Secretary of Labor to
set standards based on the available evidence where no employee, over
his/her working life time, will suffer from material impairment of
health or functional capacity, even if such employee has regular
exposure to the hazard, ``to the exent feasible'' (29 U.S.C.
655(b)(5)). OSHA interpreted the phrase ``to the extent feasible'' to
encompass economic feasibility and was supported in this view by the
U.S. Court of Appeals for the D.C. Circuit, which has long held that
OSHA standards would satisfy the economic feasibility criterion even if
they imposed significant costs on regulated industries and forced some
marginal firms out of business, so long as they did not cause massive
economic dislocations within a particular industry or imperil the
existence of that industry. Am. Iron and Steel Inst. v. OSHA, 939 F.2d
975, 980 (D.C. Cir. 1991); United Steelworkers of Am., AFL-CIO-CLC v.
Marshall, 647 F.2d 1189, 1265 (D.C. Cir. 1980); Indus. Union Dep't v.
Hodgson, 499 F.2d 467 (D.C. Cir. 1974).
b. The Price Elasticity of Demand and Its Relationship to Economic
Feasibility
In practice, the economic burden of an OSHA standard on an
industry--and whether the standard is economically feasible for that
industry--depends on
[[Page 47693]]
the magnitude of compliance costs incurred by establishments in that
industry and the extent to which they are able to pass those costs on
to their customers. That, in turn, depends, to a significant degree, on
the price elasticity of demand for the products sold by establishments
in that industry.
The price elasticity of demand refers to the relationship between
the price charged for a product and the demand for that product: The
more elastic the relationship, the less an establishment's compliance
costs can be passed through to customers in the form of a price
increase and the more the establishment has to absorb compliance costs
in the form of reduced profits. When demand is inelastic,
establishments can recover most of the costs of compliance by raising
the prices they charge; under this scenario, profit rates are largely
unchanged and the industry remains largely unaffected. Any impacts are
primarily on those customers using the relevant product. On the other
hand, when demand is elastic, establishments cannot recover all
compliance costs simply by passing the cost increase through in the
form of a price increase; instead, they must absorb some of the
increase from their profits. Commonly, this will mean reductions both
in the quantity of goods and services produced and in total profits,
though the profit rate may remain unchanged. In general, ``[w]hen an
industry is subjected to a higher cost, it does not simply swallow it;
it raises its price and reduces its output, and in this way shifts a
part of the cost to its consumers and a part to its suppliers,'' in the
words of the court in Am. Dental Ass'n v. Sec'y of Labor (984 F.2d 823,
829 (7th Cir. 1993)).
The court's summary is in accord with microeconomic theory. In the
long run, firms can remain in business only if their profits are
adequate to provide a return on investment that ensures that investment
in the industry will continue. Over time, because of rising real
incomes and productivity increases, firms in most industries are able
to ensure an adequate profit. As technology and costs change, however,
the long-run demand for some products naturally increases and the long-
run demand for other products naturally decreases. In the face of
additional compliance costs (or other external costs), firms that
otherwise have a profitable line of business may have to increase
prices to stay viable. Increases in prices typically result in reduced
quantity demanded, but rarely eliminate all demand for the product.
Whether this decrease in the total production of goods and services
results in smaller output for each establishment within the industry or
the closure of some plants within the industry, or a combination of the
two, is dependent on the cost and profit structure of individual firms
within the industry.
If demand is perfectly inelastic (i.e., the price elasticity of
demand is zero), then the impact of compliance costs that are one
percent of revenues for each firm in the industry would be a one
percent increase in the price of the product, with no decline in
quantity demanded. Such a situation represents an extreme case, but
might be observed in situations in which there were few, if any,
substitutes for the product in question, or if the products of the
affected sector account for only a very small portion of the revenue or
income of its customers.
If the demand is perfectly elastic (i.e., the price elasticity of
demand is infinitely large), then no increase in price is possible and
before-tax profits would be reduced by an amount equal to the costs of
compliance (net of any cost savings--such as reduced workers'
compensation insurance premiums--resulting from the proposed standard)
if the industry attempted to maintain production at the same level as
previously. Under this scenario, if the costs of compliance are such a
large percentage of profits that some or all plants in the industry
could no longer operate in the industry with hope of an adequate return
on investment, then some or all of the firms in the industry would
close. This scenario is highly unlikely to occur, however, because it
can only arise when there are other products--unaffected by the
proposed rule--that are, in the eyes of their customers, perfect
substitutes for the products the affected establishments make.
A commonly-discussed intermediate case would be a price elasticity
of demand of one (in absolute terms). In this situation, if the costs
of compliance amount to one percent of revenues, then production would
decline by one percent and prices would rise by one percent. As a
result, industry revenues would remain the same, with somewhat lower
production, but with similar profit rates per unit of output (in most
situations where the marginal costs of production net of regulatory
costs would fall as well). Customers would, however, receive less of
the product for their (same) expenditures, and firms would have lower
total profits; this, as the court described in Am. Dental Ass'n v.
Sec'y of Labor, is the more typical case.
c. Variable Costs Versus Fixed Costs
A decline in output as a result of an increase in price may occur
in a variety of ways: individual establishments could each reduce their
levels of production; some marginal plants could close; or, in the case
of an expanding industry, new entry may be delayed until demand equals
supply. In some situations, there could be a combination of these three
effects. Which possibility is most likely depends on the form that the
costs of the regulation take. If the costs are variable costs (i.e.,
costs that vary with the level of production at a facility), then
economic theory suggests that any reductions in overall output will be
the result of reductions in output at each affected facility, with few,
if any, plant closures. If, on the other hand, the costs of a
regulation primarily take the form of fixed costs (i.e., costs that do
not vary with the level of production at a facility), then reductions
in overall output are more likely to take the form of plant closures or
delays in new entry.
Most of the costs of this regulation, as estimated in Chapter V of
the PEA, are variable costs in the sense that they will tend to vary by
production levels and/or employment levels. Almost all of the major
costs of program elements, such as medical surveillance and training,
will vary in proportion to the number of employees (which is a rough
proxy for the amount of production). Exposure monitoring costs will
vary with the number of employees, but do have some economies of scale
to the extent that a larger firm need only conduct representative
sampling rather than sample every employee. Finally, the costs of
operating and maintaining engineering controls tend to vary by usage--
which typically closely tracks the level of production and are not
fixed costs in the strictest sense.
This leaves two kinds of costs that are, in some sense, fixed
costs--capital costs of engineering controls and certain initial costs.
The capital costs of engineering controls due to the standard--many of
which are scaled to production and/or employment levels--constitute a
relatively small share of the total costs, representing 10 percent of
total annualized costs (or approximately $870 per year per affected
establishment).
Some ancillary provisions require initial costs that are fixed in
the sense that they do not vary by production activity or the number of
employees. Some examples are the costs to develop a training plan for
general training not currently required and to develop a written
exposure control plan.
[[Page 47694]]
As a result of these considerations, OSHA expects it to be quite
likely that any reductions in total industry output would be due to
reductions in output at each affected facility rather than as a result
of plant closures. However, closures of some marginal plants or poorly
performing facilities are always possible.
d. Economic Feasibility Screening Analysis
To determine whether a rule is economically feasible, OSHA begins
with two screening tests to consider minimum threshold effects of the
rule under two extreme cases: (1) All costs are passed through to
customers in the form of higher prices (consistent with a price
elasticity of demand of zero), and (2) all costs are absorbed by the
firm in the form of reduced profits (consistent with an infinite price
elasticity of demand).
In the former case, the immediate impact of the rule would be
observed in increased industry revenues. While there is no hard and
fast rule, in the absence of evidence to the contrary, OSHA generally
considers a standard to be economically feasible for an industry when
the annualized costs of compliance are less than a threshold level of
one percent of annual revenues. Retrospective studies of previous OSHA
regulations have shown that potential impacts of such a small magnitude
are unlikely to eliminate an industry or significantly alter its
competitive structure,\19\ particularly since most industries have at
least some ability to raise prices to reflect increased costs, and
normal price variations for products typically exceed three percent a
year.
---------------------------------------------------------------------------
\19\ See OSHA's Web page, https://www.osha.gov/dea/lookback.html#Completed, for a link to all completed OSHA lookback
reviews.
---------------------------------------------------------------------------
In the latter case, the immediate impact of the rule would be
observed in reduced industry profits. OSHA uses the ratio of annualized
costs to annual profits as a second check on economic feasibility.
Again, while there is no hard and fast rule, in the absence of evidence
to the contrary, OSHA generally considers a standard to be economically
feasible for an industry when the annualized costs of compliance are
less than a threshold level of ten percent of annual profits. In the
context of economic feasibility, the Agency believes this threshold
level to be fairly modest, given that normal year-to-year variations in
profit rates in an industry can exceed 40 percent or more. OSHA also
considered whether this threshold would be adequate to assure that
upfront costs would not create major credit problems for affected
employers. To do this, OSHA examined a worst case scenario in which
annualized costs were ten percent of profits and all of the annualized
costs were the result of upfront costs. In this scenario, assuming a
three percent discount rate and a ten year life of equipment, total
costs would be 85 percent of profits \20\ in the year in which these
upfront costs were incurred. Because upfront costs would be less than
one year's profits in the year they were incurred, this means that an
employer could pay for all of these costs from that year's profits and
would not necessarily have to incur any new borrowing. As a result, it
is unlikely that these costs would create a credit crunch or other
major credit problems. It would be true, however, that paying
regulatory costs from profits might reduce investment from profits in
that year. OSHA's choice of a threshold level of ten percent of annual
profits is low enough that even if, in a hypothetical worst case, all
compliance costs were upfront costs, then upfront costs--assuming a
three percent discount rate and a ten-year time period--would be no
more than 85 percent of first-year profits and thus would be affordable
from profits without resort to credit markets. If the threshold level
were first-year costs of ten percent of annual profits, firms could
even more easily expect to cover first-year costs at the threshold
level out of current profits without having to access capital markets
and otherwise being threatened with short-term insolvency.
---------------------------------------------------------------------------
\20\ At a discount rate of 3 percent over a life of investment
of 10 years, the present value of that stream of annualized costs
would be 8.53 times a single year's annualized costs. Hence, if
yearly annualized costs are 10 percent of profits, upfront costs
would be 85 percent of the profits in that first year. As a simple
example, assume annualized costs are $1 for each of the 10 years. If
annualized costs are 10 percent of profits, this translates to a
yearly profit of $10. The present value of that stream of $1 for
each year is $8.53. (The formula for this calculation is
($1*(1.03[caret]10)-1)/((.03)x(1.03)[caret]10).
---------------------------------------------------------------------------
In general, because it is usually the case that firms would be able
to pass on to their customers some or all of the costs of the proposed
rule in the form of higher prices, OSHA will tend to give much more
weight to the ratio of industry costs to industry revenues than to the
ratio of industry costs to industry profits. However, if costs exceed
either the threshold percentage of revenue or the threshold percentage
of profits for an industry, or if there is other evidence of a threat
to the viability of an industry because of the proposed standard, OSHA
will examine the effect of the rule on that industry more closely. Such
an examination would include market factors specific to the industry,
such as normal variations in prices and profits, and any special
circumstances, such as close domestic substitutes of equal cost, which
might make the industry particularly vulnerable to a regulatory cost
increase.
The preceding discussion focused on the economic viability of the
affected industries in their entirety. However, even if OSHA found that
a proposed standard did not threaten the survival of affected
industries, there is still the question of whether the industries'
competitive structure would be significantly altered. For example, if
the annualized costs of an OSHA standard were equal to 10 percent of an
industry's annual profits, and the price elasticity of demand for the
products in that industry were equal to one, then OSHA would not expect
the industry to go out of business. However, if the increase in costs
were such that most or all small firms in that industry would have to
close, it might reasonably be concluded that the competitive structure
of the industry had been altered. For this reason, OSHA also calculates
compliance costs by size of firm and conducts its economic feasibility
screening analysis for small and very small entities.
e. Regulatory Flexibility Screening Analysis
The Regulatory Flexibility Act (RFA), Public Law 96-354, 94 Stat.
1164 (codified at 5 U.S.C. 601), requires Federal agencies to consider
the economic impact that a proposed rulemaking will have on small
entities. The RFA states that whenever a Federal agency is required to
publish general notice of proposed rulemaking for any proposed rule,
the agency must prepare and make available for public comment an
initial regulatory flexibility analysis (IRFA). 5 U.S.C. 603(a).
Pursuant to section 605(b), in lieu of an IRFA, the head of an agency
may certify that the proposed rule will not have a significant economic
impact on a substantial number of small entities. A certification must
be supported by a factual basis. If the head of an agency makes a
certification, the agency shall publish such certification in the
Federal Register at the time of publication of general notice of
proposed rulemaking or at the time of publication of the final rule. 5
U.S.C. 605(b).
To determine if the Assistant Secretary of Labor for OSHA can
certify that the proposed beryllium rule will not have a significant
economic impact on a substantial number of small entities, the Agency
has developed screening tests to consider minimum threshold effects of
the proposed rule on
[[Page 47695]]
small entities. These screening tests do not constitute hard and fast
rules and are similar in concept to those OSHA developed above to
identify minimum threshold effects for purposes of demonstrating
economic feasibility.
There are, however, two differences. First, for each affected
industry, the screening tests are applied, not to all establishments,
but to small entities (defined as ``small business concerns'' by SBA)
and also to very small entities (as defined by OSHA as businesses with
fewer than 20 employees). Second, although OSHA's regulatory
flexibility screening test for revenues also uses a minimum threshold
level of annualized costs equal to one percent of annual revenues, OSHA
has established a minimum threshold level of annualized costs equal to
five percent of annual profits for the average small entity or very
small entity. The Agency has chosen a lower minimum threshold level for
the profitability screening analysis and has applied its screening
tests to both small entities and very small entities in order to ensure
that certification will be made, and an IRFA will not be prepared, only
if OSHA can be highly confident that a proposed rule will not have a
significant economic impact on a substantial number of small entities
or very small entities in any affected industry.
Furthermore, certification will not be made, and an IRFA will be
prepared, if OSHA believes the proposed rule might otherwise have a
significant economic impact on a substantial number of small entities,
even if the minimum threshold levels are not exceeded for revenues or
profitability for small entities or very small entities in all affected
industries.
2. Impacts on Affected Industries
In this section, OSHA applies its screening criteria and other
analytic methods, as needed, to determine (1) whether the proposed rule
is economically feasible for all affected industries within the scope
of this proposed rule, and (2) whether the Agency can certify that the
proposed rule will not have a significant economic impact on a
substantial number of small entities.
a. Economic Feasibility Screening Analysis: All Establishments
To determine whether the proposed rule's projected costs of
compliance would threaten the economic viability of affected
industries, OSHA first compared, for each affected industry, annualized
compliance costs to annual revenues and profits per (average) affected
establishment. The results for all affected establishments in all
affected industries are presented in Table IX-8. Shown in the table for
each affected industry are the total number of establishments, the
total number of affected establishments, annualized costs per affected
establishment, annual revenues per establishment, the profit rate,
annual profits per establishment, annualized compliance costs as a
percentage of annual revenues, and annualized compliance costs as a
percentage of annual profits.
The annualized costs per affected establishment for each affected
industry were calculated by distributing the industry-level
(incremental) annualized compliance costs among all affected
establishments in the industry, where annualized compliance costs
reflect a 3 percent discount rate. The annualized cost of the proposed
rule for the average affected establishment is estimated at $9,197 in
2010 dollars. It is clear from Table IX-8 that the estimates of the
annualized costs per affected establishment vary widely from industry
to industry. These estimates range from $1,257,214 for NAICS 331419
(Beryllium Production) and $120,372 for NAICS 327113a (Porcelain
Electrical Supply Manufacturing (primary)) to $1,636 for NAICS 621210
(Offices of Dentists) and $1,632 for NAICS 339116 (Dental
Laboratories).
[[Page 47696]]
[GRAPHIC] [TIFF OMITTED] TP07AU15.014
[[Page 47697]]
[GRAPHIC] [TIFF OMITTED] TP07AU15.015
As previously discussed, OSHA has established a minimum threshold
level of annualized costs equal to one percent of annual revenues--and,
secondarily, annualized costs equal to 10 percent of annual profits--
below which the
[[Page 47698]]
Agency has concluded that costs are unlikely to threaten the economic
viability of an affected industry. The results of OSHA's threshold
tests for all affected establishments are displayed in Table IX-8. For
all affected establishments, the estimated annualized cost of the
proposed rule is, on average, equal to 0.11 percent of annual revenue
and 1.52 percent of annual profit.
As Table IX-8 shows, there are no industries in which the
annualized costs of the proposed rule exceed one percent of annual
revenues. However there are three six-digit NAICS industries where
annualized costs exceed ten percent of annual profits.
NAICS 331525 (Copper foundries except die-casting) has the highest
cost impact as a percentage of profits. NAICS 331525 is made up of two
types of copper foundries: sand casting foundries and non-sand casting
foundries, incurring an annualized cost as a percent of profit of 16.25
percent and 14.92 percent, respectively. The other two six-digit NAICS
industries where annualized costs exceed ten percent of annual profits
are NAICS 331534: Aluminum foundries (except die-casting), 13.65
percent; and NAICS 811310: Commercial and industrial machinery and
equipment repair, 10.19 percent.
OSHA believes that the beryllium-containing inputs used by these
industries have a relatively inelastic demand for three reasons. First,
beryllium has rare and unique characteristics, including low mass, high
melting temperature, dimensional stability over a wide temperature
range, strength, stiffness, light weight, and high elasticity
(``springiness'') that can significantly improve the performance of
various alloys. These characteristics cannot easily be replicated by
other materials. In economic terms, this means that the elasticity of
substitution between beryllium and non-beryllium inputs will be low.
Second, products which contain beryllium or beryllium-alloy components
typically have high-performance applications (whose performance depends
on the use of higher-cost beryllium). The lack of available competing
products with these performance characteristics suggests that the price
elasticity of demand for products containing beryllium or beryllium-
alloy components will be low. Third, components made of beryllium or
beryllium-containing alloys typically account for only a small portion
of the overall cost of the finished goods that these parts are used to
make. For example, the cost of brakes made of a beryllium-alloy used in
the production of a jet airplane represents a trivial percentage of the
overall cost to produce that airplane. As economic theory indicates,
the elasticity of derived demand for a factor of production (such as
beryllium) varies directly with the elasticity of substitution between
the input in question and other inputs; the price elasticity of demand
for the final product that the input is used to produce; and, in
general, the share of the cost of the final product that the input
accounts for. Applying these three conditions to beryllium points to
the relative inelastic derived demand for this factor of production and
the likelihood that cost increases resulting from the proposed rule
would be passed on to the consumer in the form of higher prices.
A secondary point is that the establishments in an industry that
use beryllium may be more profitable than those that don't. This
follows from the prior arguments about beryllium's rare and desirable
characteristics and its valuable applications. For example, of the 208
establishments that make up NAICS 331525, OSHA estimated that 45
establishments (or 21 percent) work with beryllium. Of the 394
establishments that make up NAICS 331524, OSHA estimated that only 7
establishments (less than 2 percent) work with beryllium. Of the 21,960
establishments that make up NAICS 811310, OSHA estimated that 143 (0.7
percent) work with beryllium. However, when OSHA calculated the cost-
to-profit ratio, it used the average profit per firm for the entire
NAICs industry, not the average profit per firm for firms working with
beryllium.
(1) Normal Year-to-Year Variations in Prices and Profit Rates
The United States has a dynamic and constantly changing economy in
which an annual percentage increase in industry revenues or prices of
one percent or more are common. Examples of year-to-year changes in an
industry that could cause such an increase in revenues or prices
include increases in fuel, material, real estate, or other costs; tax
increases; and shifts in demand.
To demonstrate the normal year-to-year variation in prices for all
the manufacturers in general industry affected by the proposed rule,
OSHA developed in the PEA year-to-year producer price indices and year-
to-year percentage changes in producer prices, by industry, for the
years 1999-2010. For all of the industries estimated to be affected by
this proposed standard over the 12-year period, the average change in
producer prices was 4.4 percent a year--which is over 4 times as high
as OSHA's 1 percent cost-to-revenue threshold. For the industries found
to have the largest estimated potential annual cost impact as a
percentage of revenue shown in Chapter VI of the PEA are--NAICS 331524:
Aluminum Foundries (except Die-Casting), (0.71 percent); NAICS 331525(a
and b): Copper Foundries (except Die-Casting) (average of 0.81
percent); NAICS 332721a: Precision Turned Product Manufacturing of high
content beryllium (0.49 percent); \21\ and NAICS 811310: Commercial and
Industrial Machinery and Equipment (Except Automotive and Electronic)
Repair and Maintenance (0.55 percent)--the average annual changes in
producer prices in these industries over the 12-year period analyzed
were 3.1 percent, 8.2 percent, 3.6 percent and 2.3 percent,
respectively.
---------------------------------------------------------------------------
\21\ By contrast, NAICS 332721b: Precision Turned Product
Manufacturing of low content beryllium alloys has a cost to revenue
ratio below 0.4 percent.
---------------------------------------------------------------------------
Based on these data, it is clear that the potential price impacts
of the proposed rule in affected industries are all well within normal
year-to-year variations in prices in those industries. The maximum cost
impact of the proposed rule as a percentage of revenue in any affected
industry is 0.84 percent, while, as just noted, the average annual
change in producer prices for affected industries was 4.4 percent for
the period 1999-2010. In fact, Chapter VI of the PEA shows two of the
industries within the secondary smelting, refining, and alloying group,
for example, the prices rose over 60 percent in one year without
imperiling the existence of those industries. Thus, OSHA preliminarily
concludes that the potential price impacts of the proposal would not
threaten the economic viability of any industries affected by this
proposed standard.
Profit rates are also subject to the dynamics of the U.S. economy.
A recession, a downturn in a particular industry, foreign competition,
or the increased competitiveness of producers of close domestic
substitutes are all easily capable of causing a decline in profit rates
in an industry of well in excess of ten percent in one year or for
several years in succession.
To demonstrate the normal year-to-year variation in profit rates
for all the manufacturers affected by the proposed rule, OSHA presented
data in the PEA on year-to-year profit rates and year-to-year
percentage changes in profit rates, by industry, for the years 2002-
2009. For the industries that OSHA has estimated will be affected by
this
[[Page 47699]]
proposed standard over the 8-year period, the average change in profit
rates is calculated to be 39 percent per year. For the industries with
the largest estimated potential annual cost impacts as a percentage of
profit--NAICS 331524: Aluminum foundries (except die-casting), (14
percent); NAICS 331525(a and b): Copper foundries (except die-casting)
(16 percent); NAICS 332721a: Precision Turned Product Manufacturing of
high content beryllium (8 percent); \22\ and NAICS 811310 Commercial
and Industrial Machinery and Equipment (Except Automotive and
Electronic) Repair and Maintenance (10 percent)--the average annual
changes in profit rates in these industries over the eight-year period
were 35 percent, 35 percent, 11 percent, and 5 percent, respectively.
---------------------------------------------------------------------------
\22\ By contrast, NAICS 332721b: Precision Turned Product
Manufacturing of low content beryllium alloys has a cost to profit
ratio of 6 percent.
---------------------------------------------------------------------------
A longer-term loss of profits in excess of 10 percent a year could
be more problematic for some affected industries and might conceivably,
under sufficiently adverse circumstances, threaten an industry's
economic viability. However, as previously discussed, OSHA's analysis
indicates that affected industries would generally not absorb the costs
of the proposed rule in reduced profits but, instead, would be able to
pass on most or all of those costs in the form of higher prices (due to
the relative price inelasticity of demand for beryllium and beryllium-
containing inputs). It is possible that such price increases will
result in some reduction in output, and the reduction in output might
be met through the closure of a small percentage of the plants in the
industry. The only realistic circumstance where an entire industry
would be significantly affected by small potential price increases
would be where there is a very close or perfect substitute product
available not subject to OSHA regulation. In most cases where beryllium
is used, there is no substitute product that could be used in place of
beryllium and achieve the same level of performance. The main potential
concern would be substitution by foreign competition, but the following
discussion reveals why such competition is not likely.
(2) International Trade Effects
World production of beryllium is a thin market, with only a handful
of countries known to process beryllium ores and concentrates into
beryllium products, and characterized by a high degree of variation and
uncertainty. The United States accounts for approximately 65 percent of
world beryllium deposits and 90 percent of world production, but there
is also a significant stockpiling of beryllium materials in Kazakhstan,
Russia, China, and possibly other countries (USGS, 2013a). For the
individual years 2008-2012, the United States' net import reliance as a
percentage of apparent consumption (that is, imports minus exports net
of industry and government stock adjustments) ranged from 10 percent to
61 percent (USGS, 2013b). To assure an adequate stockpile of beryllium
materials to support national defense interests, the U.S. Department of
Defense, in 2005, under the Defense Production Act, Title III, invested
in a public-private partnership with the leading U.S. beryllium
producer to build a new $90.4 million primary beryllium facility in
Elmore, Ohio. Construction of that facility was completed in 2011
(USGS, 2013b).
One factor of importance to firms working with beryllium and
beryllium alloys is to have a reliable supply of beryllium materials.
U.S. manufacturers can have a relatively high confidence in the
availability of beryllium materials relative to manufacturers in many
foreign countries, particularly those that do not have economic or
national security partnerships with the United States.
Firms using beryllium in production must consider not just the cost
of the chemical itself but also the various regulatory costs associated
with the use, transport, and disposal of the material. For example, for
marine transport, metallic beryllium powder and beryllium compounds are
classified by the International Maritime Organization (IMO) as
poisonous substances, presenting medical danger. Beryllium is also
classified as flammable. The United Nations classification of beryllium
and beryllium compounds for the transport of dangerous goods is
``poisonous substance'' and, for packing, a ``substance presenting
medium danger'' (WHO, 1990). Because of beryllium's toxicity, the
material is subject to various workplace restrictions as well as
international, national, and State requirements and guidelines
regarding beryllium content in environmental media (USGS, 2013a).
As the previous discussion indicates, the production and use of
beryllium and beryllium alloys in the United States and foreign markets
appears to depend on the availability of production facilities;
beryllium stockpiles; national defense and political considerations;
regulations limiting the shipping of beryllium and beryllium products;
international, national, and State regulations and guidelines regarding
beryllium content in environmental media; and, of course, the special
performance properties of beryllium and beryllium alloys in various
applications. Relatively small changes in the price of beryllium would
seem to have a minor effect on the location of beryllium production and
use. In particular, as a result of this proposed rule, OSHA would
expect that, if all compliance costs were passed through in the form of
higher prices, a price increase of 0.11 percent, on average, for firms
manufacturing or using beryllium in the United States--and not
exceeding 1 percent in any affected industry--would have a negligible
effect on foreign competition and would therefore not threaten the
economic viability of any affected domestic industries.
(b) Economic Feasibility Screening Analysis: Small and Very Small
Businesses
The preceding discussion focused on the economic viability of the
affected industries in their entirety. Even though OSHA found that the
proposed standard did not threaten the survival of these industries,
there is still the possibility that the competitive structure of these
industries could be significantly altered such as by small entities
exiting from the industry as a result of the proposed standard.
To address this possibility, OSHA examined the annualized costs of
the proposed standard per affected small entity, and per affected very
small entity, for each affected industry. Again, OSHA used a minimum
threshold level of annualized compliance costs equal to one percent of
annual revenues--and, secondarily, annualized compliance costs equal to
ten percent of annual profits--below which the Agency has concluded
that the costs are unlikely to threaten the survival of small entities
or very small entities or, consequently, to alter the competitive
structure of the affected industries.
Based on the results presented in Table IX-9, the annualized cost
of compliance with the proposed rule for the average affected small
entity is estimated to be $8,108 in 2010 dollars. Based on the results
presented in Table IX-10, the annualized cost of compliance with the
proposed rule for the average affected very small entity is estimated
to be $1,955 in 2010 dollars. These tables also show that there are no
industries in which the annualized costs of the proposed rule for small
entities or very small entities exceed one percent of annual revenues.
NAICS 331525b: Sand Copper Foundries (except die-casting) has the
highest estimated cost
[[Page 47700]]
impact as a percentage of revenues for small entities, 0.95 percent,
and NAICS 336322b: Other motor vehicle electrical and electronic
equipment has the highest estimated cost impact as a percentage of
revenues for very small entities, 0.70 percent.
Small entities in four industries--NAICS 331525: Sand and non-sand
foundries (except die-casting); NAICS 331524(a and b): Aluminum
foundries (except die-casting); NAICS 811310: Commercial and Industrial
Machinery and Equipment; and NAICS 331522: Nonferrous (except aluminum)
die-casting foundries--have annualized costs in excess of 10 percent of
annual profits (17.45 percent, 16.12 percent, 11.68 percent, and 10.64
percent, respectively). Very small entities in 7 industries are
estimated to have annualized costs in excess of 10 percent of annual
profit; NAICS 336322b: Other motor vehicle electrical and electronic
equipment (38.49 percent); \23\ NAICS 336322a: Other motor vehicle
electrical and electronic equipment, (18.18 percent); NAICS 327113:
Porcelain electrical Supply Manufacturing (13.82 percent); NAICS
811310: Commercial and Industrial Machinery and Equipment (Except
Automotive and Electronic) Repair and Maintenance (12.76 percent);
NAICS 332721a: Precision turned product manufacturing (10.50 percent);
NAICS 336214: Travel trailer and camper manufacturing (10.75 percent);
and NAICS 336399: All other motor vehicle parts manufacturing (10.38
percent).
---------------------------------------------------------------------------
\23\ NAICS 336322 contains entities that fall into three
separate application groups. NAICS 336322b is in the Beryllium Oxide
Ceramics and Composites application group. NAICS 336322a (which
follows in the text) is in the Fabrication of Beryllium Alloy
Products application group.
---------------------------------------------------------------------------
In general, cost impacts for affected small entities or very small
entities will tend to be somewhat higher, on average, than the cost
impacts for the average business in those affected industries. That is
to be expected. After all, smaller businesses typically suffer from
diseconomies of scale in many aspects of their business, leading to
less revenue per dollar of cost and higher unit costs. Small businesses
are able to overcome these obstacles by providing specialized products
and services, offering local service and better service, or otherwise
creating a market niche for themselves. The higher cost impacts for
smaller businesses estimated for this rule--other than very small
entities in NAICS 336322b: Other motor vehicle electrical and
electronic equipment--generally fall within the range observed in other
OSHA regulations and, as verified by OSHA's lookback reviews, have not
been of such a magnitude to lead to the economic failure of regulated
small businesses.
The ratio of annualized costs to annual profit is a sizable 38.49
percent in NAICS 336322b: Other motor vehicle electrical and electronic
equipment. However, OSHA believes that the actual ratio is
significantly lower. There are 386 very small entities in NAICS 336322,
of which only 6, or 1.5 percent, are affected entities using beryllium.
When OSHA calculated the cost-to-profit ratio, it used the average
profit per firm for the entire NAICs industry, not the average profit
rate for firms working with beryllium. The profit rate for all
establishments in NAICS 336322b was estimated at 1.83 percent. If, for
example, the average profit rate for a very small entity in NAICS
336322b were equal to 5.95 percent, the average profit rate for its
application group, Beryllium Oxide Ceramics and Composites, then the
ratio of the very small entity's annualized cost of the proposed rule
to its annual profit would actually be 11.77 percent. OSHA tentatively
concludes the 6 establishments in the NAICS specializing in beryllium
production will have a higher than average profit rate and will be able
to pass much of the cost onto the consumer for three main reasons: (1)
The absence of substitutes containing the rare performance
characteristics of beryllium; (2) the relative price insensitivity of
(other) motor vehicles containing the special performance
characteristics of beryllium and beryllium alloys; and (3) the fact
that electrical and electronic components made of beryllium or
beryllium-containing alloys typically account for only a small portion
of the overall cost of the finished (other) motor vehicles. The
annualized compliance cost to annual revenue ratio for NAICS 336332b is
0.70 percent, 0.30 percent below the 1 percent threshold. Based on
OSHA's experience, price increases of this magnitude have not
historically been associated with the economic failure of small
businesses.
[[Page 47701]]
[GRAPHIC] [TIFF OMITTED] TP07AU15.016
[[Page 47702]]
[GRAPHIC] [TIFF OMITTED] TP07AU15.017
[[Page 47703]]
[GRAPHIC] [TIFF OMITTED] TP07AU15.018
[[Page 47704]]
[GRAPHIC] [TIFF OMITTED] TP07AU15.019
[[Page 47705]]
[GRAPHIC] [TIFF OMITTED] TP07AU15.020
[[Page 47706]]
[GRAPHIC] [TIFF OMITTED] TP07AU15.021
[[Page 47707]]
(c) Regulatory Flexibility Screening Analysis
To determine if the Assistant Secretary of Labor for OSHA can
certify that the proposed beryllium standard will not have a
significant economic impact on a substantial number of small entities,
the Agency has developed screening tests to consider minimum threshold
effects of the proposed standard on small entities. The minimum
threshold effects for this purpose are annualized costs equal to one
percent of annual revenues, and annualized costs equal to five percent
of annual profits, applied to each affected industry. OSHA has applied
these screening tests both to small entities and to very small
entities. For purposes of certification, the threshold level cannot be
exceeded for affected small entities or very small entities in any
affected industry.
Tables IX-9 and Table IX-10, presented above, show that the
annualized costs of the proposed standard do not exceed one percent of
annual revenues for affected small entities or affected very small
entities in any affected industry. These tables also show that the
annualized costs of the proposed standard exceed five percent of annual
profits for affected small entities in 12 industries and for affected
very small entities in 30 industries. OSHA is therefore unable to
certify that the proposed standard will not have a significant economic
impact on a substantial number of small entities and must prepare an
Initial Regulatory Flexibility Analysis (IRFA). The IRFA is presented
in Chapter IX of the PEA and is reproduced in Section IX.I of this
preamble.
G. Benefits and Net Benefits
In this section, OSHA presents a summary of the estimated benefits
and net benefits of the proposed beryllium rule. This section proceeds
in five steps. The first step estimates the numbers of diseases and
deaths prevented by comparing the current (baseline) situation to a
world in which the proposed PEL is adopted in a final standard to a
world in which employees are exposed at the level of the proposed PEL
throughout their working lives. The second step also assumes that the
proposed PEL is adopted, but uses the results from the first step to
estimate what would happen under a more realistic scenario in which
employees have been exposed for varying periods of time to the baseline
situation and will thereafter be exposed to the new PEL.
The third step covers the monetization of benefits. Then, in the
fourth step, OSHA estimates the net benefits and incremental benefits
of the proposed rule by comparing the monetized benefits to the costs
presented in Chapter V of the PEA. The models underlying each step
inevitably need to make a variety of assumptions based on limited data.
In the fifth step, OSHA provides a sensitivity analysis to explore the
robustness of the estimates of net benefits with respect to many of the
assumptions made in developing and applying the underlying models. A
full explanation of the derivation of the estimates presented here is
provided in Chapter VII of the PEA for the proposed rule. OSHA invites
comments on any aspect of the data and methods used to estimate the
benefits and net benefits of this proposed rule. Because dental labs
constitute a significant source of both costs and benefits to the rule
(over 40 percent), OSHA is particularly interested in comments
regarding the appropriateness of the model, assumptions, and data to
estimating the benefits to workers in that industry.
OSHA has added to the docket the spreadsheets used to calculate the
estimates of benefits outlined below (OSHA, 2015a). Those interested in
exploring the details and methodology of OSHA's benefits analysis, such
as how the life table referred to below was developed and applied,
should consult those spreadsheets.
Step 1--Estimation of the Steady-State Number of Beryllium-Related
Diseases Avoided
Methods of Estimation
The first step in OSHA's development of the benefits analysis
compares the situation in which employees continue to be at baseline
exposure levels for their entire working lives to the situation in
which all employees have been exposed at a given PEL for their entire
working lives. This is a comparison of two steady-state situations. To
do this, OSHA must estimate both the risk associated with the baseline
exposure levels and the risk following the promulgation of a new
beryllium standard. OSHA's approach assumes for inputs such as the
turnover rate and the exposure response function that they are similar
across all workers exposed to beryllium, regardless of industry.
An exposure-response model, discussed below, is used to estimate a
worker's risk of beryllium-related disease based on the worker's
cumulative beryllium exposure. The Agency used a lifetime risk model to
estimate the baseline risk and the associated number of cases for the
various disease endpoints. A lifetime risk model explicitly follows a
worker each year, from work commencement onwards, accumulating the
worker's beryllium exposure in the workplace and estimating outcomes
each year for the competing risks that can occur. To go from exposure
to number of cases, the Agency needs to estimate an exposure-response
relationship, and this is discussed below. The possible outcomes are no
change, or the various health endpoints OSHA has considered (beryllium
sensitization, CBD, lung cancer, and the mortality associated with
these endpoints). As part of the estimation discussion, OSHA will
mention specific parameters used in some of the estimation methods, but
will further discuss how these parameters were derived later in this
section.
The baseline lifetime risk model is the most complicated part of
the analysis. The Agency only needs to make relatively simple
adjustments to this model to reflect changes in activities and
conditions due to the standard, which, working through the model, then
lead to changes in relevant health outcomes. There are three channels
by which the standard generates benefits. First are estimated benefits
due to the lowering of the PEL. Second are estimated benefits with
further exposure reductions from the substitution of non-beryllium for
beryllium-containing materials, ending workers' beryllium exposures
entirely. This potential source of benefits is particularly significant
with respect to OSHA's assumptions for how dental labs are likely to
reduce exposures (see below). Finally, the model estimates benefits due
to the ancillary programs that are required by the proposed standard.
The last channel affects CBD and sensitization, endpoints which may be
mitigated or prevented with the help of ancillary provisions such as
dermal protection and medical surveillance for early detection, and for
which the Agency has some information on the effects on risk of
ancillary provisions. The benefits of ancillary provisions are not
estimated for lung cancer because the benefits from reducing lung
cancer are considered to be the result of reducing airborne exposure
only and thus the ancillary provisions will have no separable effect on
airborne exposures. The discussion here will concentrate on CBD as
being the most important and complex endpoint, and most illustrative of
other endpoints: The structure for other endpoints is the same; only
the exposure response functions are different. Here OSHA will
[[Page 47708]]
discuss first the exposure-response model, then the structure of the
year-to-year changes for a worker, then the estimated exposure
distribution in the affected population and the risk model with the
lowering of the PEL, and, last, the other adjustments for the ancillary
benefits and the substitution benefits.
The exposure response model is designed to translate beryllium
exposure to risk of adverse health endpoints. In the case of beryllium
sensitization and CBD, the Agency uses the cumulative exposure data
from a beryllium manufacturing facility. Specifically, OSHA uses the
quartile data from the Cullman plant that is presented in Table VI-7 of
the Preliminary Risk Assessment in the preamble. The raw data from this
study show cases of CBD with cumulative exposures that would represent
an average exposure level of less than 0.1 [micro]g/m\3\ if exposed for
10 years; show cases of CBD with exposures lasting less than one year;
and show cases of CBD with actual average exposure of less than 0.1
[micro]g/m\3\.
Prevalence is defined as the percentage of persons with a condition
in a population at a given point in time. The quartile data in Table
VI-7 of the Preliminary Risk Assessment are prevalence percentages (the
number of cases of illness documented over several years in the 319
person cohort from the Cullman plant) at different cumulative exposure
levels. The Cullman data do not cover persons who left the work force
or what happened to persons who remained in the workforce after the
study was completed. For the lifetime risk model, the prevalence
percentages will be translated into incidence percentages--the
estimated number of new cases predicted to occur each year. For this
purpose OSHA assumed that the incidence for any given cumulative
exposure level is constant from year to year and continues after
exposure ceases.
To calculate incidence from prevalence, OSHA assumed a steady state
in which both the size of the beryllium-exposed affected population,
exposure concentrations during employment and prevalence are constant
over time. If these conditions are met, and turnover among workers with
a condition is equal to turnover for workers without a condition, then
the incidence rate will be equal to the turnover rate multiplied by the
prevalence rate. If the turnover rate among persons with a condition is
higher than the turnover rate for workers without the condition, then
this assumption will underestimate incidence. This might happen if, in
addition to other reasons for leaving work, persons with a condition
leave a place of employment more frequently because their disabilities
cause them to have difficulty continuing to do the work. If the
turnover rate among persons with a condition is lower than the turnover
rate for workers without the condition, then this assumption will
overestimate incidence. This could happen if an employer provides
special benefits to workers with the condition, and the employer would
cease to provide these benefits if the employee left work.
To illustrate, if 10 percent of the work force (including 10
percent of those with the condition) leave each year and if the overall
prevalence is at 20 percent, then a 2 percent (10 percent times 20
percent) incidence rate will be needed in order to keep a steady 20
percent group prevalence rate each year. OSHA's model assumes a
constant 10 percent turnover rate (see later in this section for the
rationale for this particular turnover rate). While turnover rates are
not available for the specific set of employees in question, for
manufacturing as a whole, the turnover rates are greater than 20
percent, and greater than 30 percent for the economy as a whole (BLS,
2013). For this analysis, OSHA assumed an effective turnover rate of 10
percent. Different turnover rates will result in different incidence
rates. The lower the turnover rate the lower the estimated incidence
rate. This is a conservative assumption for the industries where
turnover rates may be higher. However, some occupations/industries,
such as dental lab technicians, may have lower turnover rates than
manufacturing workers. Additionally, the typical dental technician even
if leaving one workplace, has significant likelihood of continuing to
work as a dental technician and going to another workplace that uses
beryllium. OSHA welcomes comments on its turnover estimates and on
sectors, such as dental laboratories, where turnover may be lower than
ten percent.
Using Table VI-7 of the Preliminary Risk Assessment, when a
worker's cumulative exposure is below 0.147 ([mu]g/m\3\-years), the
prevalence of CBD is 2.5 percent and so the derived annual risk would
be 0.25 percent (0.10 x 2.5 percent). It will stay at this level until
the worker has reached a cumulative exposure of 1.468, where it will
rise to 0.80 percent.
The model assumes a maximum 45-year (250 days per year) working
life (ages 20 through 65 or age of death or onset of CBD, whichever is
earlier) and follows workers after retirement through age 80. The 45-
year working life is based on OSHA's legal requirements and is longer
than the working lives of most exposed workers. A shorter working life
will be examined later in this section. While employed, the worker
accumulates beryllium exposure at a rate depending on where the worker
is in the empirical exposure profile presented in Chapter IV of the PEA
(i.e., OSHA calculates a general risk model which depends on the
exposure level and then plug in our empirical exposure distribution to
estimate the final number of cases of various health outcomes).
Following a worker's retirement, there is no increased exposure, just a
constant annual risk resulting from the worker's final cumulative
exposure.
OSHA's model follows the population of workers each year, keeping
track of cumulative exposure and various health outcomes. Explicitly,
each year the model calculates: The increased cumulative exposure level
for each worker versus last year, the incidence at the new exposure
level, the survival rate for this age bracket, and the percentage of
workers who have not previously developed CBD in earlier years.
For any individual year, the equation for predicting new cases of
CBD for workers at age t is:
New CBD cases rate(t) = modeled incidence rate(t) * survival
rate(t) * (1- currently have CBD rate(t)), where the variables used
are:
New CBD cases rate(t) is the output variable to be calculated;
cumulative exposure(t) = cumulative exposure(t-1) + current
exposure;
modeled incidence rate(t) is a function of cumulative exposure;
and
survival rate(t) is the background survival rate from mortality
due to other causes in the national population.
Then for the next year the model updates the survival rate (due to
an increase in the worker's age), incidence rate (due to any increased
cumulative exposure), and the rate of those currently having CBD, which
increases due to the new CBD case rate of the year before. This process
then repeats for all 60 years.
It is important to note that this model is based on the assumption
that prevalence is explained by an underlying constant incidence, and
as a result, prevalence will be different depending on the average
number of years of exposure in the population examined and (though a
sensitivity analysis is provided later) on the assumption of a maximum
of 45 years of exposure. OSHA also examined (OSHA 2015c) a model in
which prevalence is constant at the levels shown in Table VI-7 of the
preliminary
[[Page 47709]]
risk assessment, with a population age (and thus exposure) distribution
estimated based on an assumed constant turnover rate. OSHA solicits
comment on this and other alternative approaches to using the available
prevalence data to develop an exposure-response function for this
benefits analysis.
In the next step, OSHA uses its model to take into account the
adoption of the lower proposed PEL. OSHA uses the exposure profile for
workers as estimated in Chapter IV of the PEA for each of the various
application groups. These exposure profiles estimate the number of
workers at various exposure levels, specifically the ranges less than
0.1 [mu]g/m\3\, 0.1 to 0.2, 0.2 to 0.5, 0.5 to 1.0, 1.0 to 2.0, and
greater than 2.0 [mu]g/m\3\. Translating these ranges into exposure
levels for the risk model, the model assumes an average exposure equal
to the midpoint of the range, except for the lower end, where it was
assumed to be equal to 0.1 [mu]g/m\3\, and the upper end, where it was
assumed to be equal to 2.0 [mu]g/m\3\.
The model increases the workers' cumulative exposure each year by
these midpoints and then plugs these new values into the new case
equation. This alters the incidence rate as cumulative exposure crosses
a threshold of the quartile data. So then using the exposure profiles
by application group from Chapter IV of the PEA, the baseline exposure
flows through the life time risk model to give us a baseline number of
cases. Next OSHA calculated the number of cases estimated to occur
after the implementation of the proposed PEL of 0.2 [mu]g/m\3\. Here
OSHA simply takes the number of workers with current average exposure
above 0.2 [mu]g/m\3\ and set their exposure level at 0.2 [mu]g/m\3\;
all exposures for workers exposed below 0.2 [mu]g/m\3\ stay the same.
After adjusting the worker exposure profile in this way, OSHA goes
through all the same calculations and obtains a post-standard number of
CBD cases. Subtracting estimated post-standard CBD cases from estimated
pre-standard CBD cases gives us the number of CBD cases that would be
averted due to the proposed change in the PEL.
Based on these methods, OSHA's estimate of benefits associated with
the proposed rule does not include benefits associated with current
compliance that have already been achieved with regard to the new
requirements, or benefits obtained from future compliance with existing
beryllium requirements. However, available exposure data indicate that
few employees are currently exposed above the existing standard's PEL
of 2.0 [mu]g/m\3\. To achieve consistency with the cost estimation
method in chapter V, all employees in the exposure profile that are
above 2.0 [mu]g/m\3\ are assumed to be at the 2.0 [mu]g/m\3\ level.
There is also a component that applies only to dental labs. OSHA
has preliminarily assumed, based on the estimates of higher costs for
engineering controls than using substitutes presented in the cost
chapter, that rather than incur the costs of compliance with the
proposed standard, many dental labs are likely to stop using beryllium-
containing materials after the promulgation of the proposed
standard.\24\ OSHA estimated earlier in this PEA that, for the
baseline, only 25 percent of dental lab workers still work with
beryllium. OSHA estimates that, if OSHA adopts the proposed rule, 75
percent of the 25 percent still using beryllium will stop working with
beryllium; their beryllium exposure level will therefore drop to zero.
OSHA estimates that the 75 percent of workers will not be a random
sample of the dental lab exposure profile but instead will concentrate
among workers who are currently at the highest exposure levels because
it would cost more to reduce those higher exposures into compliance
with the proposed PEL. Under this judgment OSHA is estimating that the
rule would eliminate all cases of CBD in the 75 percent of dental lab
workers with the highest exposure levels. As discussed in the
sensitivity analysis below, dental labs constitute a significant source
of both costs and benefits to the rule (over 40 percent), and the
extent to which dental laboratories substitute other materials for
beryllium has significant effects on the benefits and costs of the
rule. To derive its baseline estimate of cases of CBD in dental
laboratories, OSHA (1) estimated baseline cases of CBD using the
existing rate of beryllium use in dental labs without a projection of
further substitution; (2) estimated cases of CBD with the proposed
regulation using an estimate that 75 percent of the dental labs with
higher exposure would switch to other materials and thus eliminate
exposure to beryllium; and (3) estimated that the turnover rate in the
industry is 10 percent. OSHA welcomes comments on all aspects of the
analysis of substitution away from beryllium in the dental laboratories
sector.
---------------------------------------------------------------------------
\24\ In Chapter V (Costs) of the PEA, OSHA explored the cost of
putting in LEV instead of substitution. The Agency costed an
enclosure for 2 technicians: The Powder Safe Type A Enclosure, 32
inch wide with HEPA filter, AirClean Systems (2011), which including
operating and maintenance, was annualized at $411 per worker. This
is significantly higher than the annual cost for substitution of
$166 per worker, shown later in this section.
---------------------------------------------------------------------------
Estimation results for both dental labs and non-dental workplaces
appear in the table below.
CBD Case Estimates, 45-Year Totals, Baseline and With PEL of 0.2 [mu]g/m\3\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Current beryllium exposure ([mu]g/m\3\)
------------------------------------------------------------------------ Total
< 0.1 0.1-0.2 0.2-0.5 0.5-1.0 1.0-2.0 > 2.0
--------------------------------------------------------------------------------------------------------------------------------------------------------
Baseline................................ Dental labs............... 827 636 432 608 155 466 3,124
Non-dental................ 5,912 631 738 287 112 214 7,893
-----------------------------------------------------------------------------------
Total.................. 6,739 1,267 1,171 895 267 679 11,017
PEL = 0.2 [mu]g/m\3\.................... Dental labs............... 679 0 0 0 0 0 679
Non-dental................ 5,912 631 693 255 98 186 7,774
-----------------------------------------------------------------------------------
Total.................. 6,591 631 693 255 98 186 8,454
Prevented by PEL reduction.............. Dental labs............... 148 636 432 608 155 466 2,444
Non-dental................ 0 0 45 32 14 27 119
-----------------------------------------------------------------------------------
Total.................. 148 636 478 640 169 493 2,563
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 47710]]
In contrast to this PEL component of the benefits, both the
ancillary program benefits calculation and the substitution benefits
calculation are relatively simple. Both are percentages of the
lifetime-risk-model CBD cases that still occur in the post-standard
world. OSHA notes that in the context of existing CBD prevention
programs, some ancillary-provision programs similar to those included
in OSHA's proposal have eliminated a significant percentage of the
remaining CBD cases (discussed later in this chapter). If the ancillary
provisions reduce remaining CBD cases by 90 percent for example, and if
the estimated baseline contains 120 cases of CBD, and post-standard
compliance with a lower PEL reduces the total to 100 cases of CBD, then
90 of those remaining 100 cases of CBD would be averted due to the
ancillary programs.
OSHA assumed, based on the clinical experience discussed further
below, that approximately 65 percent of CBD cases ultimately result in
death. Later in this chapter, OSHA provides a sensitivity analysis of
the effects of different values for assuming this percentage at 50
percent and 80 percent on the number of CBD deaths prevented. OSHA
welcomes comment on this assumption. OSHA's exposure-response model for
lung cancer is based on lung cancer mortality data. Thus, all of the
estimated cases of lung cancer in the benefits analysis are cases of
premature death from beryllium-related lung cancer.
Finally, in recognition of the uncertainty in this aspect of these
models, OSHA presents a ``high'' estimate, a ``low'' estimate, and uses
the midpoint of these two as our ``primary'' estimate. The low estimate
is simply those CBD fatalities prevented due to everything except the
ancillary provisions, i.e., both the reduction in the PEL and the
substitution by dental labs. The high estimate includes both of these
factors plus all the ancillary benefits calculated at an effectiveness
rate of 90 percent in preventing cases of CBD not averted by the
reduction of the PEL. The midpoint is the combination of reductions
attributed to adopting the proposed PEL, substitution by dental labs,
and the ancillary provisions calculated at an effectiveness rate of
only 45 percent.
a. Chronic Beryllium Disease
CBD is a respiratory disease in which the body's immune system
reacts to the presence of beryllium in the lung, causing a progression
of pathological changes including chronic inflammation and tissue
scarring. Immunological sensitization to beryllium (BeS) is a precursor
that occurs before early-stage CBD. Only sensitized individuals can go
on to develop CBD. In early, asymptomatic stages of CBD, small
granulomatous lesions and mild inflammation occur in the lungs. As CBD
progresses, the capacity and function of the lungs decrease, which
eventually affects other organs and bodily functions as well. Over time
the spread of lung fibrosis (scarring) and loss of pulmonary function
cause symptoms such as: A persistent dry cough, shortness of breath,
fatigue, night sweats, chest and join pain, clubbing of fingers due to
impaired oxygen exchange, and loss of appetite. In these later stages
CBD can also impair the liver, spleen, and kidneys, and cause health
effects such as granulomas of the skin and lymph nodes, and cor
pulmonale (enlargement of the heart). The speed and extent of disease
progression may be influenced by the level and duration of exposure,
treatment with corticosteroids, and genetics, but these effects are not
fully understood.
Corticosteroid therapy, in workers whose beryllium exposure has
ceased, has been shown to control inflammation, ease symptoms, and in
some cases prevent the development of fibrosis. However, corticosteroid
use can have adverse effects, including increased risk of infections;
accelerated bone loss or osteoporosis; psychiatric effects such as
depression, sleep disturbances, and psychosis; adrenal suppression;
ocular effects; glucose intolerance; excessive weight gain; increased
risk of cardiovascular disease; and poor wound healing. The effects of
CBD, and of common treatments for CBD, are discussed in detail in this
preamble at Section V, Health Effects, and Section VIII, Significance
of Risk.
OSHA's review of the literature on CBD suggests three broad types
of CBD progression (see this preamble at Section V, Health Effects). In
the first, individuals progress relatively directly toward death
related to CBD. They suffer rapidly advancing disability and their
death is significantly premature. Medical intervention is not applied,
or if it is, does little to slow the progression of disease. In the
second type, individuals live with CBD for an extended period of time.
The progression of CBD in these individuals is naturally slow, or may
be medically stabilized. They may suffer significant disability, in
terms of loss of lung function--and quality of life--and require
medical oversight their remaining years. They would be expected to lose
some years of normal lifespan. As discussed previously, advanced CBD
can involve organs and systems beyond the respiratory system; thus, CBD
can contribute to premature death from other causes. Finally,
individuals with the third type of CBD progression do not die
prematurely from causes related to CBD. The disease is stabilized and
may never progress to a debilitating state. These individuals
nevertheless may experience some disability or loss of lung function,
as well as side effects from medical treatment, and may be affected by
the disease in many areas of their lives: Work, recreation, family,
etc.\25\
---------------------------------------------------------------------------
\25\ As indicated in the Health Effects section of this
preamble: ``It should be noted, however, that treatment with
corticosteroids has side-effects of their own that need to be
measured against the possibility of progression of disease (Gibson
et al., 1996; Zaki et al., 1987). Alternative treatments such as
azathiopurine and infliximab, while successful at treating symptoms
of CBD, have been demonstrated to have side-effects as well
(Pallavicino et al., 2013; Freeman, 2012)''.
---------------------------------------------------------------------------
In the analysis that follows, OSHA assumes, based on the clinical
experience discussed below, that 35 percent of workers who develop CBD
experience the third type of progression and do not die prematurely
from CBD. The remaining 65 percent were estimated to die prematurely,
whether from rapid disease progression (type 1) or slow (type 2).
Although the proportion of CBD patients who die prematurely as a result
of the disease is not well understood or documented at this time, OSHA
believes this assumption is consistent with the information submitted
in response to the RFI. Newman et al. (2003) presented a scenario for
what they considered to be the ``typical'' CBD patient:
We have included an example of a life care plan for a typical
clinical case of CBD. In this example, the hypothetical case is
diagnosed at age 40 and assumed to live an additional 33.7 years
(approximately 5% reduced life expectancy in this model). In this
hypothetical example, this individual would be considered to have
moderate severity of chronic beryllium disease at the time of
initial diagnosis. They require treatment with prednisone and
treatment for early cor pulmonale secondary to CBD. They have
experienced some, but not all, of the side effects of treatment and
only the most common CBD-related health effects.
In short, most workers diagnosed with CBD are expected to have
shortened life expectancy, even if they do not progress rapidly and
directly to death. It should be emphasized that this represents the
Agency's best estimate of the mortality related to CBD based upon the
current available evidence. As described in Section V, Health Effects,
there is a substantial degree of uncertainty as to the prognosis for
those contracting CBD, particularly as the relatively less severe
[[Page 47711]]
cases are likely not to be studied closely for the remainder of their
lives.
As mentioned previously, OSHA used the Cullman data set for
empirical estimates of beryllium sensitization and CBD prevalence in
its exposure response model, which translates beryllium exposure to
risk of adverse health endpoints for the purpose of determining the
benefits that could be achieved by preventing those adverse health
endpoints.
OSHA chose the cumulative exposure quartile data as the basis for
this benefits analysis. The choice of cumulative quartiles was based in
part on the need to use the cumulative exposure forecast developed in
the model, and in part on the fact that in statistically fitted models
for CBD, the cumulative exposure tended to fit the CBD data better than
other exposure variables. OSHA also chose the quartile model because
the outside expert who examined the logistic and proportional hazards
models believed statistical modeling of the data set to be unreliable
due to its small size. In addition, the proportional hazards model with
its dummy variables by year of detection is difficult to interpret for
purposes of this section. Of course regression analyses are often
useful in empirical analysis. They can be a useful compact
representation of a set of data, allow investigations of various
variable interactions and possible causal relationships, have added
flexibility due to covariate transformations, and under certain
conditions can be shown to be statistically ``optimal.'' However, they
are only useful when used in the proper setting. The possibility of
misspecification of functional form, endogeneity, or incorrect
distributional assumptions are just three reasons to be cautious about
using regression analyses.
On the other hand, the use of results produced by a quartile
analysis as inputs in a benefits assessment implies that the analytic
results are being interpreted as evidence of an exposure-response
causal relationship. Regression analysis is a more sophisticated
approach to estimating causal relationships (or even correlations) than
quartile or other quantile analysis, and any data limitations that may
apply to a particular regression-based exposure-response estimation
also apply to exposure-response estimation conducted with a quartile
analysis using the same data set. In this case, OSHA adopted the
quartile analysis because the logistic regression analysis yielded
extremely high prevalence rates for higher level of exposure over long
time periods that some might not find credible. Use of the quartile
analysis serves to show that there are significant benefits even
without using an extremely high estimate of prevalence for long periods
of exposure at high levels. As a check on the quartile model, the
Agency performed the same benefits calculation using the logit model
estimated by the Agency's outside expert, and these benefit results are
presented in a separate OSHA background document (OSHA, 2015b). The
difference in benefits between the two models is slight, and there is
no qualitative change in final outcomes. The Agency solicits comment on
these issues.
(1) Number of CBD Cases Prevented by the Proposed PEL
To examine the effect of simply changing the PEL, including the
effect of the standard on some dental labs to discontinue their use of
beryllium, OSHA compared the number of CBD-related deaths (mortality)
and cases of non-fatal CBD (morbidity) that would occur if workers were
exposed for a 45-year working life to PELs of 0.1, 0.2, or 0.5 [mu]g/
m\3\ to the number of cases that would occur at levels of exposure at
or below the current PEL. The number of avoided cases over a
hypothetical working life of exposure for the current population at a
lower PEL is then equal to the difference between the number of cases
at levels of exposure at or below the current PEL for that population
minus the number of cases at the lower PEL. This approach represents a
steady-state comparison based on what would hypothetically happen to
workers who received a specific average level of occupational exposure
to beryllium during an entire working life. (Chapter VII in the PEA
modifies this approach by introducing a model that takes into account
the timing of benefits before steady state is reached.)
As indicated in Table IX-11, the Agency estimates that there would
be 16,240 cases of beryllium sensitization, from which there would be
11,017, or about 70 percent, progressing to CBD. The Agency arrived at
these estimates by using the CBD and BeS prevalence values from the
Agency's preliminary risk analysis, the exposure profile at current
exposure levels (under an assumption of full, or fixed, compliance with
the existing beryllium PEL), and the model outlined in the previous
methods of estimation section after a working lifetime of exposure.
Applying the prior midpoint estimate, as explained above, that 65
percent of CBD cases cause or contribute to premature death, the Agency
predicts a total of 7,161 cases of mortality and 3,856 cases of
morbidity from exposure at current levels; this translates, annually,
to 165 cases of mortality and 86 cases of morbidity. At the proposed
PEL, OSHA's base model estimates that, due to the airborne factor only,
a total of 2,563 CBD cases would be avoided from exposure at current
levels, including 1,666 cases of mortality and 897 cases of morbidity--
or an average of 37 cases of mortality and 20 cases of morbidity
annually. OSHA has not estimated the quantitative benefits of
sensitization cases avoided.
OSHA requests comment on this analysis, including feedback on the
data relied on and the approach and assumptions used. As discussed
earlier, based on information submitted in response to the RFI, the
Agency estimates that most of the workers with CBD will progress to an
early death, even if it comes after retirement, and has quantified
those cases prevented. However, given the evolving nature of science
and medicine, the Agency invites public comment on the current state of
CBD-related mortality.
The proposed standard also includes provisions for medical
surveillance and removal. The Agency believes that to the extent the
proposal provides medical surveillance sooner and to more workers than
would have been the case in the absence of the proposed standard,
workers will be more likely to receive appropriate treatment and, where
necessary, removal from beryllium exposure. These interventions may
lessen the severity of beryllium-related illnesses, and possibly
prevent premature death. The Agency requests public comment on this
issue.
(2) CBD Cases Prevented by the Ancillary Provisions of the Proposed
Standard
The nature of the chronic beryllium disease process should be
emphasized. As discussed in this preamble at Section V, Heath Effects,
the chronic beryllium disease process involves two steps. First,
workers become sensitized to beryllium. In most epidemiological studies
of CBD conducted to date, a large percentage of sensitized workers have
progressed to CBD. A certain percentage of the population has an
elevated risk of this occurring, even at very low exposure levels, and
sensitization can occur from dermal as well as inhalation exposure to
beryllium. For this reason, the threat of beryllium sensitization and
CBD persist to a substantial degree, even at very low levels of
airborne beryllium exposure. It is therefore desirable not only to
significantly reduce airborne beryllium exposure, but to avoid nearly
any source
[[Page 47712]]
of beryllium exposure, so as to prevent beryllium sensitization.
The analysis presented above accounted only for CBD-prevention
benefits associated with the proposed reduction of the PEL, from 2 ug/
m\3\ to 0.2 ug/m\3\. However, the proposed standard also includes a
variety of ancillary provisions--including requirements for respiratory
protection, personal protective equipment (PPE), housekeeping
procedures, hygiene areas, medical surveillance, medical removal, and
training--that the Agency believes would further reduce workers' risk
of disease from beryllium exposure. These provisions were described in
Chapter I of the PEA and discussed extensively in Section XVIII of this
preamble, Summary and Explanation of the Proposed Standard.
The leading manufacturer of beryllium in the U.S., Materion
Corporation (Materion), has implemented programs including these types
of provisions in several of its plants and has worked with NIOSH to
publish peer-reviewed studies of their effectiveness in reducing
workers' risk of sensitization and CBD. The Agency used the results of
these studies to estimate the health benefits associated with a
comprehensive standard for beryllium.
The best available evidence on comprehensive beryllium programs
comes from studies of programs introduced at Materion plants in
Reading, PA; Tucson, AZ; and Elmore, OH. These studies are discussed in
detail in this preamble at Section VI, Preliminary Risk Assessment, and
Section VIII, Significance of Risk. All three facilities were in
compliance with the current PEL prior to instituting comprehensive
programs, and had taken steps to reduce airborne levels of beryllium
below the PEL, but their medical surveillance programs continued to
identify cases of sensitization and CBD among their workers. Beginning
around 2000, these facilities introduced comprehensive beryllium
programs that used a combination of engineering controls, dermal and
respiratory PPE, and stringent housekeeping measures to reduce workers'
dermal exposures and airborne exposures. These comprehensive beryllium
programs have substantially lowered the risk of sensitization among
workers. At the times that studies of the programs were published,
insufficient follow-up time had elapsed to report directly on the
results for CBD. However, since only sensitized workers can develop
CBD, reduction of sensitization risk necessarily reduces CBD risk as
well.
In the Reading, PA copper beryllium plant, full-shift airborne
exposures in all jobs were reduced to a median of 0.1 ug/m\3\ or below,
and dermal protection was required for production-area workers,
beginning in 2000-2001 (Thomas et al., 2009). In 2002, the process with
the highest exposures (with a median of 0.1 ug/m\3\) was enclosed, and
workers involved in that process were required to use respiratory
protection. Among 45 workers hired after the enclosure was built and
respiratory protection instituted, one was found to be sensitized (2.2
percent). This is more than an 80 percent reduction in sensitization
from a previous group of 43 workers hired after 1992, 11.5 percent of
whom had been sensitized by the time of testing in 2000.
In the Tucson beryllium ceramics plant, respiratory and skin
protection was instituted for all workers in production areas in 2000
(Cummings et al., 2007). BeLPT testing in 2000-2004 showed that only 1
(1 percent) of 97 workers hired during that time period was sensitized
to beryllium. This is a 90 percent reduction from the prevalence of
sensitization in a 1998 BeLPT screening, which found that 6 (9 percent)
of 69 workers hired after 1992 were sensitized.
In the Elmore, OH beryllium production and processing facility, all
new workers were required to wear loose-fitting powered air-purifying
respirators (PAPRs) in manufacturing buildings, beginning in 1999
(Bailey et al., 2010). Skin protection became part of the protection
program for new workers in 2000, and glove use was required in
production areas and for handling work boots, beginning in 2001. Bailey
et al. (2010) found that 23 (8.9 percent) of 258 workers hired between
1993 and 1999, before institution of respiratory and dermal protection,
were sensitized to beryllium. The prevalence of sensitization among the
290 workers who were hired after the respiratory protection and PPE
measures were put in place was about 2 percent, close to an 80 percent
reduction in beryllium sensitization.
In a response to OSHA's 2002 Request for Information (RFI), Lee
Newman et al. from National Jewish Medical and Research Center (NJMRC)
summarized results of beryllium program effectiveness from several
sources. Said Dr. Newman (in response to Question #33):
Q. 33. What are the potential impacts of reducing occupational
exposures to beryllium in terms of costs of controls, costs for
training, benefits from reduction in the number or severity of
illnesses, effects on revenue and profit, changes in worker
productivity, or any other impact measures than you can identify?
A: From experience in [the Tucson, AZ facility discussed above],
one can infer that approximately 90 percent of beryllium
sensitization can be eliminated. Furthermore, the preliminary data
would suggest that potentially 100 percent of CBD can be eliminated
with appropriate workplace control measures.
In a study by Kelleher 2001, Martyny 2000, Newman, JOEM 2001) in
a plant that previously had rates of sensitization as high as 9.7
percent, the data suggests that when lifetime weighted average
exposures were below 0.02 [mu]g per cu meter that the rate of
sensitization fell to zero and the rate of CBD fell to zero as well.
In an unpublished study, we have been conducting serial
surveillance including testing new hires in a precision machining
shop that handles beryllium and beryllium alloys in the Southeast
United States. At the time of the first screening with the blood
BeLPT of people tested within the first year of hire, we had a rate
of 6.7 percent (4/60) sensitization and with 50 percent of these
individuals showing CBD at the time of initial clinical evaluation.
At that time, the median exposures in the machining areas of the
plant was 0.47 [mu]g per cu meter. Subsequently, efforts were made
to reduce exposures, further educate the workforce, and increase
monitoring of exposure in the plant. Ongoing testing of newly hired
workers within the first year of hire demonstrated an incremental
decline in the rate of sensitization and in the rate of CBD. For
example, at the time of most recent testing when the median airborne
exposures in the machining shop were 0.13 [mu]g per cu meter, the
percentage of newly hired workers found to have beryllium
sensitization or CBD was now 0 percent (0/55). Notably, we also saw
an incremental decline in the percentage of longer term workers
being detected with sensitization and disease across this time
period of exposure reduction and improved hygiene practices.
Thus, in calculating the potential economic benefit, it's
reasonable to work with the assumption that with appropriate efforts
to control exposures in the work place, rates of sensitization can
be reduced by over 90 percent. (NJMRC, RFI Ex. 6-20)
OSHA has reviewed these papers and is in agreement with Dr.
Newman's testimony. OSHA judges Dr. Newman's estimate to be an upper
bound of the effectiveness of ancillary programs and examined the
results of using Dr. Newman's estimate that beryllium ancillary
programs can reduce BeS by 90 percent, and potentially eliminate CBD
where sensitization is reduced, because CBD can only occur where there
is sensitization. OSHA applied this 90 percent reduction factor to all
cases of CBD remaining after application of the reductions due to
lowering the PEL alone. OSHA applied this reduction broadly because the
proposed standard would require housekeeping and PPE related to skin
exposure (18,000 of
[[Page 47713]]
28,000 employees will need PPE because of possible skin exposure) to
apply to all or most employees likely to come in contact with beryllium
and not just those with exposure above the action level. Table IX-11
shows that there are 11,017 baseline cases of CBD and that the proposed
PEL of 0.2 [micro]g/m\3\ would prevent 2,563 cases through airborne
prevention alone. The remaining number of cases of CBD is then 8,454
(11,017 minus 2,563). If OSHA applies the full ninety percent reduction
factor to account for prevention of skin exposure (``non-airborne''
protections), then 7,609 (90 percent of 8,454 cases) additional cases
of CBD would be prevented.
The Agency recognizes that there are significant differences
between the comprehensive programs discussed above and the proposed
standard. While the proposed standard includes many of the same
elements, it is generally less stringent. For example, the proposed
standard's requirements for respiratory protection and PPE are
narrower, and many provisions of the standard apply only to workers
exposed above the proposed TWA PEL or STEL. However, many provisions,
such as housekeeping and beryllium work areas, apply to all employers
covered by the proposed standard. To account for these differences,
OSHA has provided a range of benefits estimates (shown in Table IX-11),
first, assuming that there are no ancillary provisions to the standard,
and, second, assuming that the comprehensive standard achieves the full
90-percent reduction in risk documented in existing programs. The
Agency is taking the midpoint of these two numbers as its main estimate
of the benefits of avoided CBD due to the ancillary provisions of the
proposed standard. The results in Table IX-11 suggest that
approximately 60 percent of the beryllium sensitization cases and the
CBD cases avoided would be attributable to the ancillary provisions of
the standard. OSHA solicits comment on all aspects of this approach to
analyzing ancillary provisions and solicits additional data that might
serve to make more accurate estimates of the effects of ancillary
provisions. OSHA is interested in the extent of the effects of
ancillary provisions and whether these apply to all exposed employees
or only those exposed above or below a given exposure level.
(3) Morbidity Only Cases
As previously indicated, the Agency does not believe that all CBD
cases will ultimately result in premature death. While currently strong
empirical data on this are lacking, the Agency estimates that
approximately 35 percent of cases would not ultimately be fatal, but
would result in some pain and suffering related to having CBD, and
possible side effects from steroid treatment, as well as the dread of
not knowing whether the disease will ultimately lead to premature
death. These would be described as ``mild'' cases of CBD relative to
the others. These are the residual cases of CBD after cases with
premature mortality have been counted. As indicated in Table IX-11, the
Agency estimates the standard will prevent 2,228 such cases (midpoint)
over 45 years, or an estimated 50 cases annually.
b. Lung Cancer
In addition to the Agency's determinations with respect to the risk
of chronic beryllium disease, the Agency has preliminarily determined
that chronic beryllium exposure at the current PEL can lead to a
significantly elevated risk of (fatal) lung cancer. OSHA used the
estimation methodology outlined at the beginning of this section.
However, unlike with chronic beryllium disease, the underlying data
were based on incidence of lung cancer and thus there was no need to
address the possible limitations of prevalence data. The Agency also
used lifetime excess risk estimates of lung cancer mortality, presented
in Table VI-20 in Section VI of this preamble, Preliminary Risk
Assessment, to estimate the benefits of avoided lung cancer mortality.
The lung cancer risk estimates are derived from one of the best-fitting
models in a recent, high-quality NIOSH lung cancer study, and are based
on average exposure levels. The estimates of excess lifetime risk of
lung cancer were taken from the line in Table VI-20 in the risk
assessment labeled PWL (piecewise log-linear) not including
professional and asbestos workers. This model avoids possible
confounding from asbestos exposure and reduces the potential for
confounding due to smoking, as smoking rates and beryllium exposures
can be correlated via professional worker status. Of the three
estimates in the NIOSH study that excluded professional workers and
those with asbestos exposure, this model was chosen because it was at
the midpoint of risk results.
Table IX-11 shows the number of avoided fatal lung cancers for PELs
of 0.2 [mu]g/m\3\, 0.1 [mu]g/m\3\, and 0.5 [mu]g/m\3\. At the proposed
PEL of 0.2 [mu]g/m\3\, an estimated 180 lung cancers would be prevented
over the lifetime of the current worker population. This is the
equivalent of 4.0 cases avoided annually, given a 45-year working life
of exposure.
Combining the two major fatal health endpoints--for lung cancer and
CBD-related mortality--OSHA estimates that the proposed PEL would
prevent between 1,846 and 6,791 premature fatalities over the lifetime
of the current worker population, with a midpoint estimate of 4,318
fatalities prevented. This is the equivalent of between 41 and 151
premature fatalities avoided annually, with a midpoint estimate of 96
premature fatalities avoided annually, given a 45-year working life of
exposure.
Note that the Agency based its estimates of reductions in the
number of beryllium-related diseases over a working life of constant
exposure for workers who are employed in a beryllium-exposed occupation
for their entire working lives, from ages 20 to 65. In other words,
workers are assumed not to enter or exit jobs with beryllium exposure
mid-career or to switch to other exposure groups during their working
lives. While the Agency is legally obligated to examine the effect of
exposures from a working lifetime of exposure and set its standard
accordingly,\26\ in an alternative analysis purely for informational
purposes, using the same underlying risk model for CBD, the Agency
examined, in Chapter VII of the PEA, the effect of assuming that
workers are exposed for a maximum of only 25 working years, as opposed
to the 45 years assumed in the main analysis. While all workers are
assumed to have less cumulative exposure under the 25-years-of-exposure
assumption, the effective exposed population over time is
proportionately increased.
---------------------------------------------------------------------------
\26\ Section (6)(b)(5) of the OSH Act states: ``The Secretary,
in promulgating standards dealing with toxic materials or harmful
physical agents under this subsection, shall set the standard which
most adequately assures, to the extent feasible, on the basis of the
best available evidence, that no employee will suffer material
impairment of health or functional capacity even if such employee
has regular exposure to the hazard dealt with by such standard for
the period of his working life.'' Given that it is necessary for
OSHA to reach a determination of significant risk over a working
life, it is a logical extension to estimate what this translates
into in terms of estimated benefits for the affected population over
the same period.
---------------------------------------------------------------------------
A comparison of exposures over a maximum of 25 working years versus
over a potentially 45-year working life shows variations in the number
of estimated prevented cases by health outcome. For chronic beryllium
disease, there is a substantial increase in the number of estimated
baseline and prevented cases if one assumes that the typical maximum
exposure period is 25 years, as opposed to 45. This reflects the
[[Page 47714]]
relatively flat CBD risk function within the relevant exposure range,
given varying levels of airborne beryllium exposure--shortening the
average tenure and increasing the exposed population over time
translates into larger total numbers of people sensitized to beryllium.
This, in turn, results in larger populations of individuals contracting
CBD. Since the lung cancer model itself is based on average, as opposed
to cumulative, exposure, it is not adaptable to estimate exposures over
a shorter period of time. As a practical matter, however, over 90
percent of illness and mortality attributable to beryllium exposure in
this analysis comes from CBD.
Overall, the 45-year-maximum-working-life assumption yields smaller
estimates of the number of cases of avoided fatalities and illnesses
than does the maximum-25-years-of-exposure assumption. For example, the
midpoint estimates of the number of avoided fatalities and illnesses
related to CBD under the proposed PEL of 0.2 [mu]g/m\3\ increases from
92 and 50, respectively, under the maximum-45-year-working-life
assumption to 145 and 78, respectively, under the maximum-25-year-
working-life assumption--or approximately a 57 to 58 percent
increase.\27\
---------------------------------------------------------------------------
\27\ Technically, this analysis assumes that workers receive 25
years' worth of beryllium exposure, but that they receive it over 45
working years, as is assumed by the risk models in the risk
assessment. It also accounts for the turnover implied by 25, as
opposed to 45, years of work. However, it is possible that an
alternate analysis, which accounts for the larger number of post-
exposure worker-years implied by workers departing their jobs before
the end of their working lifetime, might find even larger health
effects for workers receiving 25 years' worth of beryllium exposure.
---------------------------------------------------------------------------
[[Page 47715]]
[GRAPHIC] [TIFF OMITTED] TP07AU15.022
[[Page 47716]]
Step 2--Estimating the Stream of Benefits Over Time
Risk assessments in the occupational environment are generally
designed to estimate the risk of an occupationally related illness over
the course of an individual worker's lifetime. As demonstrated
previously in this section, the current occupational exposure profile
for a particular substance for the current cohort of workers can be
matched up against the expected profile after the proposed standard
takes effect, creating a ``steady state'' estimate of benefits.
However, in order to annualize the benefits for the period of time
after the beryllium rule takes effect, it is necessary to create a
timeline of benefits for an entire active workforce over that period.
While there are various approaches that could be taken for modeling
the workforce, there seem to be two polar extremes. At one extreme, one
could assume that none of the benefits occur until after the worker
retires, or at least 45 years in the future. In the case of lung
cancer, that period would effectively be at least 55 years, since the
45 years of exposure must be added to a 10-year latency period during
which it is assumed that lung cancer does not develop.\28\ At the other
extreme, one could assume that the benefits occur immediately, or at
least immediately after a designated lag. However, based on the various
risk models discussed in this preamble at Section VI, Risk Assessment,
which reflect real-world experience with development of disease over an
extended period of time, it appears that the actual pattern occurs at
some point between these two extremes.
---------------------------------------------------------------------------
\28\ This assumption is consistent with the 10-year lag
incorporated in the lung cancer risk models used in OSHA's
preliminary risk assessment.
---------------------------------------------------------------------------
At first glance, the simplest intermediate approach would be to
follow the pattern of the risk assessments, which are based in part on
life tables, and observe that typically the risk of the illness grows
gradually over the course of a working life and into retirement. Thus,
the older the person exposed to beryllium, the higher the odds that
that person will have developed the disease.
However, while this is a good working model for an individual
exposed over a working life, it is not very descriptive of the effect
of lowering exposures for an entire working population. In the latter
case, in order to estimate the benefits of the standard over time, one
has to consider that workers currently being exposed to beryllium are
going to vary considerably in age. Since the calculated health risks
from beryllium exposure depend on a worker's cumulative exposure over a
working lifetime, the overall benefits of the proposed standard will
phase in over several decades, as the cumulative exposure gradually
falls for all age groups, until those now entering the workforce reach
retirement and the annual stream of beryllium-related illnesses reaches
a new, significantly lowered ``steady state.'' \29\ That said, the
near-term impact of the proposed rule estimated for those workers with
similar current levels of cumulative exposure will be greater for
workers who are now middle-aged or older. This conclusion follows in
part from the structure of the relative risk model used for lung cancer
in this analysis and the fact that the background mortality rates for
lung cancer increase with age.
---------------------------------------------------------------------------
\29\ Technically, the RA lung cancer model is based on average
exposure, Nonetheless, as noted in the RA, the underlying studies
found lung cancer to be significantly related to cumulative
exposure. Particularly since the large majority of the benefits are
related to CBD, the Agency considers this fairly descriptive of the
overall phase-in of benefits from the standard.
---------------------------------------------------------------------------
In order to characterize the magnitude of benefits before the
steady state is reached, OSHA created a linear phase-in model to
reflect the potential timing of benefits. Specifically, OSHA estimated
that, for all non-cancer cases, while the number of cases of beryllium-
related disease would gradually decline as a result of the proposed
rule, they would not reach the steady-state level until 45 years had
passed. The reduction in cases estimated to occur in any given year in
the future was estimated to be equal to the steady-state reduction (the
number of cases in the baseline minus the number of cases in the new
steady state) times the ratio of the number of years since the standard
was implemented and a working life of 45 years. Expressed
mathematically:
Nt = (C-S) x (t/45),
Where Nt is the number of non-malignant beryllium-related
diseases avoided in year t; C is the current annual number of non-
malignant beryllium-related diseases; S is the steady-state annual
number of non-malignant beryllium-related diseases; and t represents
the number of years after the proposed standard takes effect, with t
<= 45.
In the case of lung cancer, the function representing the decline
in the number of beryllium-related cases as a result of the proposed
rule is similar, but there would be a 10-year lag before any reduction
in cancer cases would be achieved. Expressed mathematically, for lung
cancer:
Lt = (Cm-Sm) x ((t-10)/45)),
Where 10 <= t <= 55 and Lt is the number of lung cancer
cases avoided in year t as a result of the proposed rule;
Cm is the current annual number of beryllium-related lung
cancers; and Sm is the steady-state annual number of
beryllium-related lung cancers.
This model was extended to 60 years for all the health effects
previously discussed in order to incorporate the 10-year lag, in the
case of lung cancer, and a maximum-45-year working life, as well as to
capture some occupationally-related disease that manifests itself after
retirement.\30\ As a practical matter, however, there is no overriding
reason for stopping the benefits analysis at 60 years. An internal
analysis by OSHA indicated that, both in terms of cases prevented, and
even with regard to monetized benefits, particularly when lower
discount rates are used, the estimated benefits of the standard are
larger on an annualized basis if the analysis extends further into the
future. The Agency welcomes comment on the merit of extending the
benefits analysis beyond the 60-years analyzed in the PEA.
---------------------------------------------------------------------------
\30\ The left-hand columns in the tables in Appendix VII-A of
the PEA provide estimates using this model of the stream of
prevented fatalities and illnesses due to the proposed beryllium
rule.
---------------------------------------------------------------------------
In order to compare costs to benefits, OSHA assumes that economic
conditions remain constant and that annualized costs--and the
underlying costs--will repeat for the entire 60-year time horizon used
for the benefits analysis (as discussed in Chapter V of the PEA). OSHA
welcomes comments on the assumption for both the benefit and cost
analysis that economic conditions remain constant for sixty years. OSHA
is particularly interested in what assumptions and time horizon should
be used instead and why.
Separating the Timing of Mortality
In previous sections, OSHA modeled the timing and incidence of
morbidity. OSHA's benefit estimates are based on an underlying CBD-
related mortality rate of 65 percent. However, this mortality is not
simultaneous with the onset of morbidity. Although mortality from CBD
has not been well studied, OSHA believes, based on discussions with
experienced clinicians, that the average lag for a larger population
has a range of 10 to 30 years between morbidity and mortality. The
Agency's review of Workers Compensation data related to beryllium
exposure from the Office of Worker Compensation Programs (OWCP)
Division of Energy Employees Occupational Illness Compensation is
consistent with this range. Hence, for the purposes of this
[[Page 47717]]
proposal, OSHA estimates that mortality occurs on average 20 years
after the onset of CBD morbidity. Thus, for example, the prevented
deaths that would have occurred in year 21 after the promulgation of
the rule are associated with the CBD morbidity cases prevented in year
one. OSHA requests comment on this estimate and range.
The Agency invites comment on each of these elements of the
analysis, particularly on the estimates of the expected life expectancy
of a patient with CBD.
Step 3--Monetizing the Benefits of the Proposed Rule
To estimate the monetary value of the reductions in the number of
beryllium-related fatalities, OSHA relied, as OMB recommends, on
estimates developed from the willingness of affected individuals to pay
to avoid a marginal increase in the risk of fatality. While a
willingness-to-pay (WTP) approach clearly has theoretical merit, it
should be noted that an individual's willingness to pay to reduce the
risk of fatality would tend to underestimate the total willingness to
pay, which would include the willingness of others--particularly the
immediate family--to pay to reduce that individual's risk of fatality.
For estimates using the willingness-to-pay concept, OSHA relied on
existing studies of the imputed value of fatalities avoided based on
the theory of compensating wage differentials in the labor market.
These studies rely on certain critical assumptions for their accuracy,
particularly that workers understand the risks to which they are
exposed and that workers have legitimate choices between high- and low-
risk jobs. These assumptions are far from obviously met in actual labor
markets.\31\ A number of academic studies, as summarized in Viscusi &
Aldy (2003), have shown a correlation between higher job risk and
higher wages, suggesting that employees demand monetary compensation in
return for a greater risk of injury or fatality. The estimated trade-
off between lower wages and marginal reductions in fatal occupational
risk--that is, workers' willingness to pay for marginal reductions in
such risk--yields an imputed value of an avoided fatality: The
willingness-to-pay amount for a reduction in risk divided by the
reduction in risk.\32\
---------------------------------------------------------------------------
\31\ On the former assumption, see the discussion in Chapter II
of the PEA on imperfect information. On the latter, see, for
example, the discussion of wage compensation for risk for union
versus nonunion workers in Dorman and Hagstrom (1998).
\32\ For example, if workers are willing to pay $90 each for a
1/100,000 reduction in the probability of dying on the job, then the
imputed value of an avoided fatality would be $90 divided by 1/
100,000, or $9,000,000. Another way to consider this result would be
to assume that 100,000 workers made this trade-off. On average, one
life would be saved at a cost of $9,000,000.
---------------------------------------------------------------------------
OSHA has used this approach in many recent proposed and final
rules. Although this approach has been criticized for yielding results
that are less than statistically robust (see, for example, Hintermann,
Alberini and Markandya, 2010), a more recent WTP analysis, by Kniesner
et al. (2012), of the trade-off between fatal job risks and wages,
using panel data, seems to address many of the earlier econometric
criticisms by controlling for measurement error, endogeneity, and
heterogeneity. In conclusion, the Agency views the WTP approach as the
best available and will rely on it to monetize benefits.\33\ OSHA
welcomes comments on the use of willingness-to-pay measures and
estimates based on compensating wage differentials.
---------------------------------------------------------------------------
\33\ Note that, consistent with the economics literature, these
estimates would be for reducing the risk of an acute (immediate)
fatality. They do not include an individual's willingness to pay to
avoid a higher risk of illness prior to fatality, which is
separately estimated in the following section.
---------------------------------------------------------------------------
Viscusi & Aldy (2003) conducted a meta-analysis of studies in the
economics literature that use a willingness-to-pay methodology to
estimate the imputed value of life-saving programs and found that each
fatality avoided was valued at approximately $7 million in 2000
dollars. Using the GDP Deflator (U.S. BEA, 2010), this $7 million base
number in 2000 dollars yields an estimate of $8.7 million in 2010
dollars for each fatality avoided.\34\
---------------------------------------------------------------------------
\34\ An alternative approach to valuing an avoided fatality is
to monetize, for each year that a life is extended, an estimate from
the economics literature of the value of that statistical life-year
(VSLY). See, for instance, Aldy and Viscusi (2007) for discussion of
VSLY theory and FDA (2003), pp. 41488-9, for an application of VSLY
in rulemaking. OSHA has not investigated this approach, but welcomes
comment on the issue.
---------------------------------------------------------------------------
In addition to the benefits that are based on the implicit value of
fatalities avoided, workers also place an implicit value on
occupational injuries or illnesses avoided, which reflect their
willingness to pay to avoid monetary costs (for medical expenses and
lost wages) and quality-of-life losses as a result of occupational
illness. Chronic beryllium disease and lung cancer can adversely affect
individuals for years, or even decades, in non-fatal cases, or before
ultimately proving fatal. Because measures of the benefits of avoiding
these illnesses are rare and difficult to find, OSHA has included a
range based on a variety of estimation methods.
For both CBD and lung cancer, there is typically some permanent
loss of lung function and disability, on-going medical treatments, side
effects of medicines, and major impacts on one's ability to work,
marry, enjoy family life, and quality of life.
While diagnosis with CBD is evidence of material impairment of
health, placing a precise monetary value on this condition is
difficult, in part because the severity of symptoms may vary
significantly among individuals. For that reason, for this preliminary
analysis, the Agency employed a broad range of valuation, which should
encompass the range of severity these individuals may encounter.
Using the willingness-to-pay approach, discussed in the context of
the imputed value of fatalities avoided, OSHA has estimated a range in
valuations (updated and reported in 2010 dollars) that runs from
approximately $62,000 per case--which reflects estimates developed by
Viscusi and Aldy (2003), based on a series of studies primarily
describing simple accidents--to upwards of $5 million per case--which
reflects work developed by Magat, Viscusi, and Huber (1996) for non-
fatal cancer. The latter number is based on an approach that places a
willingness-to-pay value to avoid serious illness that is calibrated
relative to the value of an avoided fatality. OSHA previously used this
approach in the Preliminary Economic Analysis (PEA) supporting its
respirable crystalline silica proposal (2013) and in the Final Economic
Analysis (FEA) supporting its hexavalent chromium final rule (2006),
and EPA (2003) used this approach in its Stage 2 Disinfection and
Disinfection Byproducts Rule concerning regulation of primary drinking
water. Based on Magat, Viscusi, and Huber (1996), EPA used studies on
the willingness to pay to avoid nonfatal lymphoma and chronic
bronchitis as a basis for valuing a case of nonfatal cancer at 58.3
percent of the value of a fatal cancer. OSHA's estimate of $5 million
for an avoided case of non-fatal cancer is based on this 58.3 percent
figure.
The Agency believes this range of estimates, between $62,000 and $5
million, is descriptive of the value of preventing morbidity associated
with moderate to severe CBD that ultimately results in premature death.
\35\
---------------------------------------------------------------------------
\35\ There are several benchmarks for valuation of health
impairment due to beryllium exposure, using a variety of techniques,
which provide a number of mid-range estimates between OSHA's high
and low estimates. For a fuller discussion of these benchmarks, see
Chapter VII of the PEA.
---------------------------------------------------------------------------
[[Page 47718]]
While the Agency has estimated that 65 percent of CBD cases will
result in premature mortality, the Agency has also estimated that
approximately 35 percent of CBD cases will not result in premature
mortality. However, the Agency acknowledges that it is possible there
have been new developments in medicine and industrial hygiene related
to the benefits of early detection, medical intervention, and greater
control of exposure achieved within the past decade. For that reason,
as elsewhere, the Agency requests comment on these issues.
Also not clear are the negative effects of the illness in terms of
lost productivity, medical costs, and potential side-effects of a
lifetime of immunosuppressive medication. Nonetheless, the Agency is
assigning a valuation of $62,000 per case, to reflect the WTP value of
a prevented injury not estimated to precede premature mortality. The
Agency believes this is conservative, in part because, with any given
case of CBD, the outcome is not known in advance, certainly not at the
point of discovery; indeed much of the psychic value of preventing the
cases may come from removing the threat of premature mortality. In
addition, as previously noted, some of these cases could involve
relatively severe forms of CBD where the worker died of other causes;
however, in those cases, the duration of the disease would be
shortened. While beryllium sensitization is a critical precursor of
CBD, this preliminary analysis does not attempt to assign a separate
value to sensitization itself.
Particularly given the uncertainties in valuation on these
questions, the Agency is interested in public input on the issue of
valuing the cost to society of morbidity associated with CBD, both in
cases preceding mortality, and those that may not result in premature
mortality. The Agency is also interested in comments on whether it is
appropriate to assign a separate valuation to prevented sensitization
cases in their own right, and if so, how such cases should be valued.
a. Summary of Monetized Benefits
Table IX-12 presents the estimated annualized (over 60 years, using
a 0 percent discount rate) benefits from each of these components of
the valuation, and the range of estimates, based on uncertainty of the
prevention factor (i.e., the estimated range of prevented cases,
depending on how large an impact the rule has on cases beyond an
airborne-only effect), and the range of uncertainty regarding valuation
of morbidity. (Mid-point estimates of the undiscounted benefits for
each of the first 60 years are provided in the middle columns of Table
VII-A-1 in Appendix VII-A at the end of Chapter VII in the PEA. The
estimates by year reach a peak of $3.5 billion in the 60th year. Note
that, by using a 60-year time-period, OSHA is not including any
monetized fatality benefits associated with reduced worker CBD cases
originating after year 40 because the 20-year lag takes these CBD
fatalities beyond the 60-year time horizon. To this extent, OSHA will
have underestimated benefits.)
As shown in Table IX-12, the full range of monetized benefits,
undiscounted, for the proposed PEL of 0.2 [micro]g/m\3\ runs from $291
million annually, in the case of the lowest estimate of prevented cases
of CBD, and the lowest valuation for morbidity, up to $2.1 billion
annually, for the highest of both. Note that the value of total
benefits is more sensitive to the prevention factor used (ranging from
$430 million to $1.6 billion, given estimates at the midpoint of the
morbidity valuation) than to the valuation of morbidity (ranging from
$666 million to $1.3 billion, given estimates at the midpoint of
prevention factor).
Also, the analysis illustrates that most of the morbidity benefits
are related to CBD and lung cancer cases that are ultimately fatal. At
the valuation and case frequency midpoint, $663 million in benefits are
related to mortality, $226 million are related to morbidity preceding
mortality, and $4.3 million are related to morbidity not preceding
mortality.
[[Page 47719]]
[GRAPHIC] [TIFF OMITTED] TP07AU15.023
b. Adjustment of WTP Estimates to Reflect Rising Real Income Over Time
OSHA's estimates of the monetized benefits of the proposed rule are
based on the imputed value of each avoided fatality and each avoided
beryllium-related disease. As previously discussed, these, in turn, are
derived from a worker's willingness to pay to avoid a fatality (with an
imputed value per fatality avoided of $8.7 million in 2010 dollars) and
to avoid a beryllium-related disease (with an imputed value per disease
avoided of between $62,000
[[Page 47720]]
and $5 million in 2010 dollars). To this point, these imputed values
have been assumed to remain constant over time. However, two related
factors suggest that these values will tend to increase over time.
First, economic theory indicates that the value of reducing life-
threatening and health-threatening risks--and correspondingly the
willingness of individuals to pay to reduce these risks--will increase
as real per capita income increases. With increased income, an
individual's health and life becomes more valuable relative to other
goods because, unlike other goods, they are without close substitutes
and in relatively fixed or limited supply. Expressed differently, as
income increases, consumption will increase but the marginal utility of
consumption will decrease. In contrast, added years of life (in good
health) is not subject to the same type of diminishing returns--
implying that an effective way to increase lifetime utility is by
extending one's life and maintaining one's good health (Hall and Jones,
2007).
Second, real per capita income has broadly been increasing
throughout U.S. history, including recent periods. For example, for the
period 1950 through 2000, real per capita income grew at an average
rate of 2.31 percent a year (Hall and Jones, 2007),\36\ although real
per capita income for the recent 25-year period 1983 through 2008 grew
at an average rate of only 1.3 percent a year (U.S. Census Bureau,
2010). More important is the fact that real U.S. per capita income is
projected to grow significantly in future years. For example, the
Annual Energy Outlook (AEO) projections, prepared by the Energy
Information Administration (EIA) in the Department of Energy (DOE),
show an average annual growth rate of per capita income in the United
States of 2.7 percent for the period 2011-2035.\37\ The U.S.
Environmental Protection Agency prepared its economic analysis of the
Clean Air Act using the AEO projections. OSHA believes that it is
reasonable to use the same AEO projections employed by DOE and EPA, and
correspondingly projects that per capita income in the United States
will increase by 2.7 percent a year.
---------------------------------------------------------------------------
\36\ The results are similar if the historical period includes a
major economic downturn (such as the United States has recently
experienced). From 1929 through 2003, a period in U.S. history that
includes the Great Depression, real per capita income still grew at
an average rate of 2.22 percent a year (Gomme and Rupert, 2004).
\37\ The EIA used DOE's National Energy Modeling System (NEMS)
to produce the Annual Energy Outlook (AEO) projections (EIA, 2011).
Future per capita GDP was calculated by dividing the projected real
gross domestic product each year by the projected U.S. population
for that year.
---------------------------------------------------------------------------
On the basis of the predicted increase in real per capita income in
the United States over time and the expected resulting increase in the
value of avoided fatalities and diseases, OSHA has adjusted its
estimates of the benefits of the proposed rule to reflect the
anticipated increase in their value over time. This type of adjustment
has been recognized by OMB (2003), supported by EPA's Science Advisory
Board (EPA, 2000), and applied by EPA \38\. OSHA proposes to accomplish
this adjustment by modifying benefits in year i from [Bi] to
[Bi * (1 + k)\i\], where ``k'' is the estimated annual
increase in the magnitude of the benefits of the proposed rule.
---------------------------------------------------------------------------
\38\ See, for example, EPA (2003, 2008).
---------------------------------------------------------------------------
What remains is to estimate a value for ``k'' with which to
increase benefits annually in response to annual increases in real per
capita income, where ``k'' is equal to ``(1+g) * ([eta])'', ``g'' is
the expected annual percentage increase in real per capita income, and
``[eta]'' is the income elasticity of the value of a statistical life.
Probably the most direct evidence of the value of ``k'' comes from the
work of Costa and Kahn (2003, 2004). They estimate repeated labor
market compensating wage differentials from cross-sectional hedonic
regressions using census and fatality data from the Bureau of Labor
Statistics for 1940, 1950, 1960, 1970, and 1980. In addition, with the
imputed income elasticity of the value of life on per capita GNP of 1.7
derived from the 1940-1980 data, they then predict the value of an
avoided fatality in 1900, 1920, and 2000. Given the change in the value
of an avoided fatality over time, it is possible to estimate a value of
``k'' of 3.4 percent a year from 1900-2000; of 4.3 percent a year from
1940-1980; and of 2.5 percent a year from 1980-2000.
Other, more indirect evidence comes from estimates in the economics
literature of ``[eta]'', the income elasticity of the value of a
statistical life. Viscusi and Aldy (2003) performed a meta-analysis on
0.2 wage-risk studies and concluded that the confidence interval upper
bound on the income elasticity did not exceed 1.0 and that the point
estimates across a variety of model specifications ranged between 0.5
and 0.6. Applied to a long-term increase in per capita income of about
2.7 percent a year, this would suggest a value of ``k'' of about 1.5
percent a year.
More recently, Kniesner, Viscusi, and Ziliak (2010), using panel
data quintile regressions, developed an estimate of the overall income
elasticity of the value of a statistical life of 1.44. Applied to a
long-term increase in per capita income of about 2.7 percent a year,
this would suggest a value of ``k'' of about 3.9 percent a year.
Based on the preceding discussion of these three approaches for
estimating the annual increase in the value of the benefits of the
proposed rule and the fact that the projected increase in real per
capita income in the United States has flattened in recent years and
could flatten in the long run, OSHA suggests a conservative value for
``k'' of approximately two percent a year. The Agency invites comment
on this estimate and on estimates of the income elasticity of the value
of a statistical life.
The Agency believes that the rising value, over time, of health
benefits is a real phenomenon that should be taken into account in
estimating the annualized benefits of the proposed rule. Table IX-13,
in the following section on discounting benefits, shows estimates of
the monetized benefits of the proposed rule (under alternative discount
rates) with this estimated increase in monetized benefits over time.
The Agency invites comment on this adjustment to monetized benefits.
c. The Discounting of Monetized Benefits
As previously noted, the estimated stream of benefits arising from
the proposed beryllium rule is not constant from year to year, both
because of the 45-year delay after the rule takes effect until all
active workers obtain reduced beryllium exposure over their entire
working lives and because of, in the case of lung cancer, a 10-year
latency period between reduced exposure and a reduction in the
probability of disease. An appropriate discount rate \39\ is needed to
reflect the timing of benefits over the 60-year period after the rule
takes effect and to allow conversion to an equivalent steady stream of
annualized benefits.
---------------------------------------------------------------------------
\39\ Here and elsewhere throughout this section, unless
otherwise noted, the term ``discount rate'' always refers to the
real discount rate--that is, the discount rate net of any
inflationary effects.
---------------------------------------------------------------------------
1. Alternative Discount Rates for Annualizing Benefits
Following OMB (2003) guidelines, OSHA has estimated the annualized
benefits of the proposed rule using separate discount rates of 3
percent and 7 percent. Consistent with the Agency's own practices in
recent rulemakings, OSHA has also estimated, for benchmarking purposes,
undiscounted benefits--that is, benefits using a zero percent discount
rate.
[[Page 47721]]
The question remains, what is the ``appropriate'' or ``preferred''
discount rate to use to monetize health benefits? The choice of
discount rate is a controversial topic, one that has been the source of
scholarly economic debate for several decades. However, in simplest
terms, the basic choices involve a social opportunity cost of capital
approach or social rate of time preference approach.
The social opportunity cost of capital approach reflects the fact
that private funds spent to comply with government regulations have an
opportunity cost in terms of foregone private investments that could
otherwise have been made. The relevant discount rate in this case is
the pre-tax rate of return on the foregone investments (Lind, 1982, pp.
24-32).
The rate of time preference approach is intended to measure the
tradeoff between current consumption and future consumption, or in the
context of the proposed rule, between current benefits and future
benefits. The individual rate of time preference is influenced by
uncertainty about the availability of the benefits at a future date and
whether the individual will be alive to enjoy the delayed benefits. By
comparison, the social rate of time preference takes a broader view
over a longer time horizon--ignoring individual mortality and the
riskiness of individual investments (which can be accounted for
separately).
The usual method for estimating the social rate of time preference
is to calculate the post-tax real rate of return on long-term, risk-
free assets, such as U.S. Treasury securities (OMB, 2003, p. 33). A
variety of studies have estimated these rates of return over time and
reported them to be in the range of approximately 1-4 percent.
In accordance with OMB Circular A-4 (2003), OSHA presents benefits
and net benefits estimates using discount rates of 3 percent
(representing the social rate of time preference) and 7 percent (a rate
estimated using the social cost of capital approach). The Agency is
interested in any evidence, theoretical or applied, that would inform
the application of discount rates to the costs and benefits of a
regulation.
2. Summary of Annualized Benefits under Alternative Discount Rates
Table IX-13 presents OSHA's estimates of the sum of the annualized
benefits of the proposed rule, using alternative discount rates of 0,
3, and 7 percent, with the suggested adjustment for increasing
monetized benefits in response to annual increases in per capita income
over time.
Given that the stream of benefits extends out 60 years, the value
of future benefits is sensitive to the choice of discount rate. The
undiscounted benefits in Table IX-13 range from $291 million to $2.1
billion annually. Using a 7 percent discount rate, the annualized
benefits range from $60 million to $591 million. As can be seen, going
from undiscounted benefits to a 7 percent discount rate has the effect
of cutting the annualized benefits of the proposed rule by about 74
percent.
Taken as a whole, the Agency's best preliminary estimate of the
total annualized benefits of the proposed rule--using a 3 percent
discount rate with an adjustment for the increasing value of health
benefits over time--is between $158 million and $1.2 billion, with a
mid-point value of $576 million.
[[Page 47722]]
[GRAPHIC] [TIFF OMITTED] TP07AU15.024
Step 4: Net Benefits of the Proposed Rule
OSHA has estimated, in Table IX-14, the monetized and annualized
net benefits of the proposed rule (with a PEL of 0.2 [mu]g/m\3\), based
on the benefits and costs previously presented. Table IX-14 also
provides estimates of annualized net benefits for alternative PELs of
0.1 and 0.5 [mu]g/m\3\. Both the proposed rule and the alternatives PEL
options have the same ancillary provisions and an action level equal to
half of the PEL in both cases.
Table IX-14 is being provided for informational purposes only. As
previously noted, the OSH Act requires the Agency to set standards
based on eliminating significant risk to the extent feasible. An
alternative criterion of maximizing net (monetized) benefits may result
in very different regulatory outcomes. Thus, this analysis of net
benefits has not been used by OSHA as the basis for its decision
concerning the choice of a PEL or of other ancillary requirements for
the proposed beryllium rule.
Table IX-14 shows net benefits using alternative discount rates of
0, 3, and 7 percent for benefits and costs, having previously included
an adjustment to monetized benefits to reflect increases in real per
capita income over time. OSHA has relied on a uniform discount rate
applied to both costs and benefits. The Agency is interested in any
evidence, theoretical or applied, that would support or refute the
application of differential discount rates to the costs and benefits of
a regulation.
As previously noted in this section, the choice of discount rate
for annualizing benefits has a significant effect on annualized
benefits. The same is true for net benefits. For example, the net
benefits using a 7 percent discount rate for benefits are considerably
smaller than the net benefits using a 3 percent discount rate,
declining by over half under all scenarios. (Conversely, as noted in
Chapter V of the PEA, the choice of discount rate for annualizing costs
has a relatively minor effect on annualized costs.)
Based on the results presented in Table IX-14, OSHA finds:
While the net benefits of the proposed rule vary
considerably--depending on the choice of discount rate used to
annualize benefits and on whether the benefits being used are in the
high, midpoint, or low range--benefits exceed costs for the proposed
0.2 [mu]g/m\3\ PEL in all cases that OSHA considered.
[[Page 47723]]
The Agency's best estimate of the net annualized benefits
of the proposed rule--using a uniform discount rate for both benefits
and costs of 3 percent--is between $120 million and $1.2 billion, with
a midpoint value of $538 million.
The alternative of a 0.5 [mu]g/m\3\ PEL has lower net
benefits under all assumptions, whereas the effect on net benefits of
the 0.1 [mu]g/m\3\ PEL is mixed, relative to the proposed 0.2 [mu]g/
m\3\ PEL. However, for these alternative PELs, benefits were also found
to exceed costs in all cases that OSHA considered.
[GRAPHIC] [TIFF OMITTED] TP07AU15.025
Incremental Benefits of the Proposed Rule
Incremental costs and benefits are those that are associated with
increasing the stringency of the standard. A comparison of incremental
benefits and costs provides an indication of the relative efficiency of
the proposed PEL and the alternative PELs. Again, OSHA has conducted
these calculations for informational purposes only and has not used
these results as the basis for selecting the PEL for the proposed rule.
OSHA provides, in Table IX-15, estimates of the net benefits of the
alternative 0.1 and 0.5 [mu]g/m\3\ PELs. The incremental costs,
benefits, and net benefits of meeting a 0.5[mu]g/m\3\ PEL and then
going to a 0.2 [mu]g/m\3\ PEL (as well as meeting a 0.2 [mu]g/m\3\ PEL
and then going to a 0.1 [mu]g/m\3\ PEL--which the Agency has not yet
determined is feasible), for alternative discount rates of 3 and 7
percent, are presented in Table IX-15. Table IX-15 breaks out costs by
provision and benefits by type of disease and by morbidity/mortality.
As Table IX-15 shows, at a discount rate of 3 percent, a PEL of 0.2
[mu]g/m\3\, relative to a PEL of 0.5 [mu]g/m\3\, imposes additional
costs of $4.4 million per year; additional benefits of $172.7 million
per year; and additional net benefits of $168.2 million per year. The
proposed PEL of 0.2 [mu]g/m\3\ also has higher net benefits, relative
to a PEL of 0.5 [mu]g/m\3\, using a 7 percent discount rate.
Table IX-15 demonstrates that, regardless of discount rate, there
are net benefits to be achieved by lowering exposures from the current
PEL of 2.0 [mu]g/m\3\ to 0.5 [mu]g/m\3\ and then, in turn, lowering
them further to 0.2 [mu]g/m\3\. However, the majority of the benefits
and costs attributable to the proposed rule are from the initial effort
to lower exposures to 0.5 [mu]g/m\3\. Consistent with the previous
analysis, net benefits decline across all increments as the discount
rate for annualizing benefits increases. As also shown in Table IX-15,
there is a slight positive net incremental benefit from going from a
PEL of 0.2 [mu]g/m\3\ to 0.1 [mu]g/m\3\ for a discount rate of 3
percent, and a slight negative net increment for a discount rate of 7
percent. (Note that these results are for OSHA's midpoint estimate of
benefits, although as indicated in Table IX-14, this is not universal
across all estimation parameters.)
In addition to examining alternative PELs, OSHA also examined
alternatives to other provisions of the standard. These regulatory
alternatives are discussed Section IX.H of this preamble.
[[Page 47724]]
[GRAPHIC] [TIFF OMITTED] TP07AU15.026
Step 5: Sensitivity Analysis
In this section, OSHA presents the results of two different types
of sensitivity analysis to demonstrate how robust the estimates of net
benefits are to changes in various cost and benefit parameters. In the
first type of sensitivity analysis, OSHA made a series of isolated
changes to individual cost and benefit input parameters in order to
determine their effects on the Agency's estimates of annualized costs,
annualized benefits, and annualized net benefits. In the second type of
[[Page 47725]]
sensitivity analysis--a so-called ``break-even'' analysis--OSHA also
investigated isolated changes to individual cost and benefit input
parameters, but with the objective of determining how much they would
have to change for annualized costs to equal annualized benefits. For
both types of sensitivity analyses, OSHA used the annualized costs and
benefits obtained from a three-percent discount rate as the reference
point.
Again, the Agency has conducted these calculations for
informational purposes only and has not used these results as the basis
for selecting the PEL for the proposed rule.
a. Analysis of Isolated Changes to Inputs
The methodology and calculations underlying the estimation of the
costs and benefits associated with this rulemaking are generally linear
and additive in nature. Thus, the sensitivity of the results and
conclusions of the analysis will generally be proportional to isolated
variations in a particular input parameter. For example, if the
estimated time that employees need to travel to (and from) medical
screenings were doubled, the corresponding labor costs would double as
well.
OSHA evaluated a series of such changes in input parameters to test
whether and to what extent the general conclusions of the economic
analysis held up. OSHA first considered changes to input parameters
that affected only costs and then changes to input parameters that
affected only benefits. Each of the sensitivity tests on cost
parameters had only a very minor effect on total costs or net costs.
Much larger effects were observed when the benefits parameters were
modified; however, in all cases, net benefits remained significantly
positive. On the whole, OSHA found that the conclusions of the analysis
are reasonably robust, as changes in any of the cost or benefit input
parameters still show significant net benefits for the proposed rule.
The results of the individual sensitivity tests are summarized in Table
IX-16 and are described in more detail below.
In the first of these sensitivity tests, where OSHA doubled the
estimated portion of employees in need of protective clothing and
equipment (PPE), essentially doubling the estimated baseline non-
compliance rate (e.g., from 10 to 20 percent), and estimates of other
input parameters remained unchanged, Table IX-16 shows that the
estimated total costs of compliance would increase by $1.4 million
annually, or by about 3.7 percent, while net benefits would also
decline by $1.4 million annually, from $538.2 million to $536.8 million
annually.
In a second sensitivity test, OSHA increased the estimated unit
cost of ventilation from $13.18 per cfm for most sectors to $25 per cfm
for most sectors. As shown in Table IX-16, if OSHA's estimates of other
input parameters remained unchanged, the total estimated costs of
compliance would increase by $2.0 million annually, or by about 5.3
percent, while net benefits would also decline by $2.0 million
annually, from $538.2 million to $536.2 million annually.
[[Page 47726]]
[GRAPHIC] [TIFF OMITTED] TP07AU15.027
In a third sensitivity test, OSHA increased the estimated share of
workers showing signs and symptoms of CBD from 15 to 25 percent,
thereby adding these workers to the group eligible for medical
surveillance and assuming that they would not be otherwise eligible for
another reason (working in a regulated area, exposed during an
emergency, etc.). As shown in Table IX-16, if OSHA's estimates of other
input parameters remained unchanged, the total estimated costs of
compliance would increase by $1.5 million annually, or by about 4.1
percent, while net benefits would also decline by $1.5 million
annually, from $538.2 million to $536.7 million annually.
In a fourth sensitivity test, OSHA increased its estimated
incremental time per workers for housekeeping by 50
[[Page 47727]]
percent. As shown in Table IX-16, if OSHA's estimates of other input
parameters remained unchanged, the total estimated costs of compliance
would increase by $5.4 million annually, or by about 14.4 percent,
while net benefits would also decline by $5.4 million annually, from
$538.2 million to $532.8 million annually.
In a fifth sensitivity test, OSHA increased the estimated number of
establishments needing engineering controls. For this sensitivity test,
if less than 50 percent of the establishments in an industry needed
engineering controls, OSHA doubled the percentage of establishments
needing engineering controls. If more than 50 percent of establishments
in an industry needed engineering controls, then OSHA increased the
percentage of establishment needing engineering control to 100 percent.
The purpose of this sensitivity analysis was to check the importance of
using a methodology that treated 50 percent of workers in a given
occupation exposed above the PEL as equivalent to 50 percent of
facilities lacking adequate exposure controls. As shown in Table IX-16,
if OSHA's estimates of other input parameters remained unchanged, the
total estimated costs of compliance would increase by $4.5 million, or
by about 11.9 percent, while net benefits would also decline by $4.5
million, from $538.2 million to $533.7 million annually.
The Agency also performed sensitivity tests on several input
parameters used to estimate the benefits of the proposed rule. In the
first two tests, in an extension of results previously presented in
Table IX-12, the Agency examined the effect on annualized net benefits
of employing the high-end estimate of the benefits, as well as the low-
end estimate, specifically examining the effect on undiscounted
benefits of varying the valuation of individual morbidity cases. Table
IX-16 presents the effect on annualized net benefits of using the
extreme values of these ranges: the high morbidity valuation case and
the low morbidity valuation case. For the low estimate of valuation,
the benefits decline by 37.7 percent, to $359 million annually,
yielding net benefits of $321 million annually. As shown, using the
high estimate of morbidity valuation, the benefits rise by 77.0 percent
to $1.0 billion annually, yielding net benefits of $982 million
annually.
In a third sensitivity test of benefits, the Agency examined the
effect of removing the component for the estimated rising value of
health and safety over time. This would reduce the benefits by 54.6
percent, or $314 million annually, lowering the net benefits to $224
million annually.
In Chapter VII of the PEA the Agency examined the effect of raising
the discount rate for costs and benefits to 7 percent. Raising the
discount rate to 7 percent would increase costs by $1.5 million
annually and lower benefits by $320.5 million annually, yielding
annualized net benefits of $216.2 million.
Also in Chapter VII of the PEA the Agency performed a sensitivity
analysis of dental lab substitution. In the PEA, OSHA estimates that 75
percent of the dental laboratory industry will react to a new standard
on beryllium by substituting away from using beryllium to the use of
other materials. Substitution is not costless, and Chapter V of the PEA
estimates the increased cost due to the higher costs of using non-
beryllium alloys. These costs are smaller than the avoided costs of the
ancillary provisions and engineering controls. Thus, as indicated in
Table VII-8 of the PEA, the benefits of the proposal would be lower and
the costs higher if there were less substitution out of beryllium in
dental labs. The lowest net benefits would occur if labs were unable to
substitute out beryllium-containing materials at all, and had to use
ventilation to control exposures. In this case, the proposal would
yield only $420 million in net benefits. The highest net benefits,
larger than assumed for OSHA's primary estimate, would be if all dental
labs substituted out of beryllium-containing materials as a result of
the proposal; as a result, the proposal would yield $573 million in net
benefits. Another possibility is a scenario is which technology and the
market move along rapidly away from using beryllium-containing
materials, independently of an OSHA rule, and the proposal itself would
therefore produce neither costs nor benefits in this sector. If dental
labs are removed from the PEA, the net benefits for the proposal--for
the remaining industry sectors--decline to $284 million. This analysis
demonstrates, however, that regardless of any assumption regarding
substitution in dental labs, the proposal would generate substantially
more monetized benefits than costs.
Finally, the Agency examined in Chapter VII of the PEA the effects
of changes in two important inputs to the benefits analysis: the factor
that transforms CBD prevalence rates into incidence rates, needed for
the equilibrium lifetime risk model, and the percentage of CBD cases
that eventually lead to a fatality.
From the Cullman dataset, the Agency has estimated the prevalence
of CBD cases at any point in time as a function of cumulative beryllium
exposure. In order to utilize the lifetime risk model, which tracks
workers over their working life in a job, OSHA has turned these
prevalence rates into an incidence rate, which is the rate of
contracting CBD at a point in time. OSHA's baseline estimate of the
turnover rate in the model is 10 percent. In Table VII-10 in the PEA,
OSHA also presented alternative turnover rates of 5 percent and 20
percent. A higher turnover rate translates into a higher incidence
rate, and the table shows that, from a baseline midpoint estimate with
10 percent turnover the number of CBD cases prevented is 6,367, while
raising the turnover rate to 20 percent causes this midpoint estimate
to rise to 11,751. Conversely, a rate of 5 percent lowers the number of
CBD cases prevented to 3,321. Translated into monetary benefits, the
table shows that the baseline midpoint estimate of $575.8 million now
ranges from $314.4 million to $1,038 million.
Also in TableVII-10 of the PEA, the Agency looked at the effects of
varying the percentage of CBD cases that eventuate in fatality. The
Agency's baseline estimate of this outcome is 65 percent, with half of
this occurring relatively soon, and the other half after an extended
debilitating condition. The Agency judged that a reasonable range to
investigate was a low of 50 percent and a high of 80 percent, while
maintaining the shares of short-term and long-term endpoint fatality.
At a baseline of 65 percent, the midpoint estimate of total CBD cases
prevented is 4,139. At the low end of 50 percent mortality this
estimate lowers to 3,183 while at the high end of 80 percent mortality
this estimate rises to 5,094. Translated into monetary benefits, the
table shows that the baseline midpoint estimate of $575.8 million now
ranges from $500.1 million to $651.5 million.
b. ``Break-Even'' Analysis
OSHA also performed sensitivity tests on several other parameters
used to estimate the net costs and benefits of the proposed rule.
However, for these, the Agency performed a ``break-even'' analysis,
asking how much the various cost and benefits inputs would have to vary
in order for the costs to equal, or break even with, the benefits. The
results are shown in Table IX-17.
In one break-even test on cost estimates, OSHA examined how much
total costs would have to increase in order for costs to equal
benefits. As shown in Table IX-17, this point would
[[Page 47728]]
be reached if costs increased by $538.2 million, or by 1,431 percent.
In a second test, looking specifically at the estimated engineering
control costs, the Agency found that these costs would need to increase
by $566.7 million, or 6,240 percent, for costs to equal benefits.
In a third sensitivity test, on benefits, OSHA examined how much
its estimated monetary valuation of an avoided illness or an avoided
fatality would need to be reduced in order for the costs to equal the
benefits. Since the total valuation of prevented mortality and
morbidity are each estimated to exceed the estimated costs of $38
million, an independent break-even point for each is impossible. In
other words, for example, if no value is attached to an avoided illness
associated with the rule, but the estimated value of an avoided
fatality is held constant, the rule still has substantial net benefits.
Only through a reduction in the estimated net value of both components
is a break-even point possible.
The Agency, therefore, examined how large an across-the-board
reduction in the monetized value of all avoided illnesses and
fatalities would be necessary for the benefits to equal the costs. As
shown in Table IX-17, a 94 percent reduction in the monetized value of
all avoided illnesses and fatalities would be necessary for costs to
equal benefits, reducing the estimated value to $733,303 per fatality
prevented, and an equivalent percentage reduction to about $4,048 per
illness prevented.
In a fourth break-even sensitivity test, OSHA estimated how many
fewer beryllium-related fatalities and illnesses would be required for
benefits to equal costs. Paralleling the previous discussion,
eliminating either the prevented mortality or morbidity cases alone
would be insufficient to lower benefits to the break-even point. The
Agency therefore examined them as a group. As shown in Table IX-17, a
reduction of 96 percent, for both simultaneously, is required to reach
the break-even point--90 fewer fatalities prevented annually, and 46
fewer beryllium-related illnesses-only cases prevented annually.
Taking into account both types of sensitivity analysis the Agency
performed on its point estimates of the annualized costs and annualized
benefits of the proposed rule, the results demonstrate that net
benefits would be positive in all plausible cases tested. In
particular, this finding would hold even with relatively large
variations in individual input parameters. Alternately, one would have
to imagine extremely large changes in costs or benefits for the rule to
fail to produce net benefits. OSHA concludes that its finding of
significant net benefits resulting from the proposed rule is a robust
one.
OSHA welcomes input from the public regarding all aspects of this
sensitivity analysis, including any data or information regarding the
accuracy of the preliminary estimates of compliance costs and benefits
and how the estimates of costs and benefits may be affected by varying
assumptions and methodological approaches. OSHA also invites comment on
the risk analysis and risk estimates from which the benefits estimates
were derived.
[[Page 47729]]
[GRAPHIC] [TIFF OMITTED] TP07AU15.028
H. Regulatory Alternatives
This section discusses various regulatory alternatives to the
proposed OSHA beryllium standard. Executive Order 12866 instructs
agencies to ``select those approaches that maximize net benefits
(including potential economic, environmental, public health and safety,
and other advantages; distributive impacts; and equity), unless a
statute requires another regulatory approach.'' The OSH Act, as
interpreted by the courts, requires health regulations to reduce
significant risk to
[[Page 47730]]
the extent feasible. Nevertheless OSHA has examined possible regulatory
alternatives that may not meet its statutory requirements.
Each regulatory alternative presented here is described and
analyzed relative to the proposed rule. Where appropriate, the Agency
notes whether the regulatory alternative, to be a legitimate candidate
for OSHA consideration, requires evidence contrary to the Agency's
preliminary findings of significant risk and feasibility. To facilitate
comment, OSHA has organized some two dozen specific regulatory
alternatives into five categories: (1) Scope; (2) exposure limits; (3)
methods of compliance; (4) ancillary provisions; and (5) timing.
1. Scope Alternatives
The first set of regulatory alternatives would alter scope of the
proposed standard--that is, the groups of employees and employers
covered by the proposed standard. The scope of the current beryllium
proposal applies only to general industry work, and does not apply to
employers when engaged in construction or maritime activities. In
addition, the proposed rule provides an exemption for those working
with materials that contain beryllium only as a trace contaminant (less
than 0.1percent composition by weight).\40\
---------------------------------------------------------------------------
\40\ Employers engaged in general industry activities exempted
from the proposed rule must still ensure that their employees are
protected from beryllium exposure above the current PEL, as listed
in 29 CFR 1910.1000 Table Z-2.
---------------------------------------------------------------------------
As discussed in the explanation of paragraph (a) in Section XVIII
of this preamble, Summary and Explanation of the Proposed Standard,
OSHA is considering alternatives to the proposed scope that would
increase the range of employers and employees covered by the standard.
OSHA's review of several industries indicates that employees in some
construction and maritime industries, as well as some employees who
deal with materials containing less than 0.1 percent beryllium, may be
at significant risk of CBD and lung cancer as a result of their
occupational exposures. Regulatory Alternatives #1a, #1b, #2a, and #2b
would increase the scope of the proposed standard to provide additional
protection to these workers.
Regulatory Alternative #1a would expand the scope of the proposed
standard to also include all operations in general industry where
beryllium exists only as a trace contaminant; that is, where the
materials used contain less than 0.1 percent beryllium by weight.
Regulatory Alternative #1b is similar to Regulatory Alternative #1a,
but exempts operations where beryllium exists only as a trace
contaminant and the employer can show that employees' exposures will
not meet or exceed the action level or exceed the STEL. Where the
employer has objective data demonstrating that a material containing
beryllium or a specific process, operation, or activity involving
beryllium cannot release beryllium in concentrations at or above the
proposed action level or above the proposed STEL under any expected
conditions of use, that employer would be exempt from the proposed
standard except for recordkeeping requirements pertaining to the
objective data. Alternative #1a and Alternative #1b, like the proposed
rule, would not cover employers or employees in construction or
shipyards.
OSHA has identified two industries with workers engaged in general
industry work that would be excluded under the proposed rule but would
fall within the scope of the standard under Regulatory Alternatives #1a
and #1b: Primary aluminum production and coal-fired power generation.
Beryllium exists as a trace contaminant in aluminum ore and may result
in exposures above the proposed permissible exposure limits (PELs)
during aluminum refining and production. Coal fly ash in coal-powered
power plants is also known to contain trace amounts of beryllium, which
may become airborne during furnace and baghouse operations and might
also result in worker exposures. See Appendices VIII-A and VIII-B at
the end of Chapter VIII in the PEA for a discussion of beryllium
exposures and available controls in these two industries.
As discussed in Appendix IV-B of the PEA, beryllium exposures from
fly ash high enough to exceed the proposed PEL would usually be coupled
with arsenic exposures exceeding the arsenic PEL. Employers would in
that case be required to implement all feasible engineering controls,
work practices, and necessary PPE (including respirators) to comply
with the OSHA Inorganic Arsenic standard (29 CFR 1910.1018)--which
would be sufficient to comply with those aspects of the proposed
beryllium standard as well. The degree of overlap between the
applicability of the two standards and, hence, the increment of costs
attributable to this alternative are difficult to gauge. To account for
this uncertainty, the Agency at this time is presenting a range of
costs for Regulatory Alternative #1a: From no costs being taken for
ancillary provisions under Regulatory Alternative #1a to all such costs
being included. At the low end, the only additional costs under
Regulatory Alternative #1a are due to the engineering control costs
incurred by the aluminum smelters (see Appendix VIII-A).
Similarly, the proposed beryllium standard would not result in
additional benefits from a reduction in the beryllium PEL or from
ancillary provisions similar to those already in place for the arsenic
standard, but OSHA does anticipate some benefits will flow from
ancillary provisions unique to the proposed beryllium standard. To
account for significant uncertainty in the benefits that would result
from the proposed beryllium standard for workers in primary aluminum
production and coal-fired power generation, OSHA estimated a range of
benefits for Regulatory Alternative #1a. The Agency estimated that the
proposed ancillary provisions would avert between 0 and 45 percent \41\
of those baseline CBD cases not averted by the proposed PEL. Though the
Agency is presenting a range for both costs and benefits for this
alternative, the Agency judges the degree of overlap with the arsenic
standard is likely to be substantial, so that the actual costs and
benefits are more likely to be found at the low end of this range. The
Agency invites comment on all these issues.
---------------------------------------------------------------------------
\41\ As discussed in Chapter VII of the PEA, OSHA used 45
percent to develop its best estimate.
---------------------------------------------------------------------------
Table IX-18 presents, for informational purposes, the estimated
costs, benefits, and net benefits of Regulatory Alternative #1a using
alternative discount rates of 3 percent and 7 percent. In addition,
this table presents the incremental costs, incremental benefits, and
incremental net benefits of this alternative relative to the proposed
rule. Table IX-18 also breaks out costs by provision, and benefits by
type of disease and by morbidity/mortality.
As shown in Table IX-18, Regulatory Alternative #1a would increase
the annualized cost of the rule from $37.6 million to between $39.6 and
$56.0 million using a 3 percent discount rate and from $39.1 million to
between $41.3 and $58.1 million using a 7 percent discount rate. OSHA
estimates that regulatory Alternative #1a would prevent as few as an
additional 0.3 (i.e., almost one fatality every 3 years) or as many as
an additional 31.8 beryllium-related fatalities annually, relative to
the proposed rule. OSHA also estimates that Regulatory Alternative #1a
would prevent as few as an additional 0.002 or as many as an additional
9 beryllium-related non-fatal illnesses annually, relative to the
proposed rule. As a result, annualized benefits in monetized
[[Page 47731]]
terms would increase from $575.8 million to between $578.0 and $765.2
million, using a 3 percent discount rate, and from $255.3 million to
between $256.3 and $339.3 million using a 7 percent discount rate. Net
benefits would increase from $538.2 million to between $538.4 and
$709.2 million using a 3 percent discount rate and from $216.2 million
to somewhere between $215.1 to $281.2 million using a 7 percent
discount rate. As noted in Appendix VIII-B of Chapter VIII in the PEA,
the Agency emphasizes that these estimates of benefits are subject to a
significant degree of uncertainty, and the benefits associated with
Regulatory Alternative #1a arguably could be a small fraction of OSHA's
best estimate presented here.
OSHA estimates that the costs and the benefits of Regulatory
Alternative #1b will be somewhat lower than the costs of Regulatory
Alternative #1a, because most--but not all--of the provisions of the
proposed standard are triggered by exposures at the action level, 8-
hour time-weighted average (TWA) PEL, or STEL. For example, where
exposures exist but are below the action level and at or below the
STEL, Alternative #1a would require employers to establish work areas;
develop, maintain, and implement a written exposure control plan;
provide medical surveillance to employees who show signs or symptoms of
CBD; and provide PPE in some instances. Regulatory Alternative #1b
would not require employers to take these measures in operations where
they can produce objective data demonstrating that exposures are below
the action level and at or below the STEL. OSHA only analyzed costs,
not benefits, for this alternative, consistent with the Agency's
treatment of Regulatory Alternatives in the past. Total costs for
Regulatory Alternative #1b versus #1a, assuming full ancillary costs,
drop from to $56.0 million to $49.9 million using a 3 percent discount
rate, and from $58.1 million to $51.8 million using a 7 percent
discount rate.
BILLING CODE 4510-26-P
[[Page 47732]]
[GRAPHIC] [TIFF OMITTED] TP07AU15.029
Regulatory Alternative #2a would expand the scope of the proposed
standard to include employers in construction and maritime. For
example, this alternative would cover abrasive blasters, pot tenders,
and
[[Page 47733]]
cleanup staff working in construction and shipyards who have the
potential for airborne beryllium exposure during blasting operations
and during cleanup of spent media. Regulatory Alternative #2b would
update 29 CFR 1910.1000 Tables Z-1 and Z-2, 1915.1000 Table Z, and
1926.55 Appendix A so that the proposed TWA PEL and STEL would apply to
all employers and employees in general industry, shipyards, and
construction, including occupations where beryllium exists only as a
trace contaminant. For example, this alternative would cover abrasive
blasters, pot tenders, and cleanup staff working in construction and
shipyards who have the potential for significant airborne exposure
during blasting operations and during cleanup of spent media. The
changes to the Z tables would also apply to workers exposed to
beryllium during aluminum refining and production, and workers engaged
in maintenance operations at coal-powered utility facilities. All
provisions of the standard other than the PELs, such as exposure
monitoring, medical removal, and PPE, would be in effect only for
employers and employees that fall within the scope of the proposed
rule.\42\ Alternative #2b would not be as protective as Alternative #1a
or Alternative #1b for employees in aluminum refining and production or
coal-powered utility facilities because the other provisions of the
proposed standard would not apply.
---------------------------------------------------------------------------
\42\ However, many of the occupations excluded from the scope of
the proposed beryllium standard receive some ancillary provision
protections from other rules, such as Personal Protective Equipment
(29 CFR 1910 subpart I, 1915 subpart I, 1926.28, also 1926 subpart
E), Ventilation (including abrasive blasting) (Sec. Sec. 1926.57
and 1915.34), Hazard Communication (Sec. 1910.1200), and specific
provisions for welding (parts 1910 subpart Q, 1915 subpart D, and
1926 subpart J).
---------------------------------------------------------------------------
As discussed in the explanation of proposed paragraph (a) in this
preamble at Section XVIII, Summary and Explanation of the Proposed
Standard, abrasive blasting is the primary application group in
construction and maritime industries where workers may be exposed to
beryllium. OSHA has judged that abrasive blasters and their helpers in
construction and maritime industries have the potential for significant
airborne exposure during blasting operations and during cleanup of
spent media. Airborne concentrations of beryllium have been measured
above the current TWA PEL of 2 [mu]g/m\3\ when blast media containing
beryllium are used as intended (see Appendix IV-C in the PEA for
details).
To address high concentrations of various hazardous chemicals in
abrasive blasting material, employers must already be using engineering
and work practice controls to limit workers' exposures and must be
supplementing these controls with respiratory protection when
necessary. For example, abrasive blasters in the construction industry
fall under the protection of the Ventilation standard (29 CFR 1926.57).
The Ventilation standard includes an abrasive blasting subsection (29
CFR 1926.57(f)), which requires that abrasive blasting respirators be
worn by all abrasive blasting operators when working inside blast-
cleaning rooms (29 CFR 1926.57(f)(5)(ii)(A)), or when using silica sand
in manual blasting operations where the nozzle and blast are not
physically separated from the operator in an exhaust-ventilated
enclosure (29 CFR 1926.57(f)(5)(ii)(B)), or when needed to protect
workers from exposures to hazardous substances in excess of the limits
set in Sec. 1926.55 (29 CFR 1926.57(f)(5)(ii)(C); ACGIH, 1971). For
maritime, standard 29 CFR 1915.34(c) covers similar requirements for
respiratory protection needed in blasting operations. Due to these
requirements, OSHA believes that abrasive blasters already have
controls in place and wear respiratory protection during blasting
operations. Thus, in estimating costs for Regulatory Alternatives #2a
and #2b, OSHA judged that the reduction of the TWA PEL would not impose
costs for additional engineering controls or respiratory protection in
abrasive blasting (see Appendix VIII-C of Chapter VIII in the PEA for
details). OSHA requests comment on this issue--in particular, whether
abrasive blasters using blast material that may contain beryllium as a
trace contaminant are already using all feasible engineering and work
practice controls, respiratory protection, and PPE that would be
required by Regulatory Alternatives #2a and #2b.
In the estimation of benefits for Regulatory Alternative #2a, OSHA
has estimated a range to account for significant uncertainty in the
benefits to this population from some of the ancillary provisions of
the proposed beryllium standard. It is unclear how many of the workers
associated with abrasive blasting work would benefit from dermal
protection, as comprehensive dermal protection may already be used by
most blasting operators. It is also unclear whether the housekeeping
requirements of the proposed standard would be feasible to implement in
the context of abrasive blasting work, and to what extent they would
benefit blasting helpers, who are themselves exposed while performing
cleanup activities. OSHA estimated that the proposed ancillary
provisions would avert between 0 and 45 percent of those baseline CBD
cases not averted by the proposed PEL.
These considerations also lead the Agency to present a range for
the costs of this alternative: From no costs being estimated for
ancillary provisions under Regulatory Alternative #2a to including all
such costs. Based on the considerations discussed above, the Agency
judges that costs and benefits at the low end of this range are more
likely to be correct. The Agency invites comment on these issues.
In addition, OSHA believes that a small number of welders in the
maritime industry may be exposed to beryllium via arc and gas welding
(and none through resistance welding). The number of maritime welders
was estimated using the same methodology as was used to estimate the
number of general industry welders. Brush Wellman's customer survey
estimated 2,000 total welders on beryllium-containing products (Kolanz,
2001). Based on ERG's assumption of 4 welders per establishment, ERG
estimated that a total of 500 establishments would be affected. These
affected establishments were then distributed among the 26 NAICS
industries with the highest number of IMIS samples for welders that
were positive for beryllium. To do this, ERG first consulted the BLS
OES survey to determine what share of establishments in each of the 26
NAICS employed welders and estimated the total number of establishments
that perform welding regardless of beryllium exposure (BLS, 2010a).
Then ERG distributed the 500 affected beryllium welding facilities
among the 26 NAICS based on the relative share of the total number of
establishments performing welding. Finally, to estimate the number of
welders, ERG used the assumption of four welders per establishment.
Based on the information from ERG, OSHA estimated that 30 welders would
be covered in the maritime industry under this regulatory alternative.
For these welders, OSHA used the same controls and exposure profile
that were used to estimate costs for arc and gas welders in Chapter V
of the PEA. ERG judged there to be no construction welders exposed to
beryllium due to a lack of any evidence that the construction sector
uses beryllium-containing products or electrodes in resistance welding.
OSHA solicits comment and any relevant data on beryllium exposures for
welders in construction and maritime employment.
Estimated costs and benefits for Regulatory Alternative #2a are
shown in Table IX-18a. Regulatory Alternative
[[Page 47734]]
#2a would increase costs from $37.6 million to between $37.7 and $55.3
million, using a 3 percent discount rate, and from $39.1 million to
between $39.2 and $57.3 million using a 7 percent discount rate.
Annualized benefits would increase from $575.8 million to between
$575.9 and $675.3 million using a 3 percent discount rate, and from
$255.3 million to between $255.4 and $299.4 million using a 7 percent
discount rate. Net benefits would change from $538.2 million to between
$538.2 and $620.0 million using a 3 percent discount rate, and from
$216.2 million to between $216.1 and $242.1 million using a 7 percent
discount rate.
Table IX-18b presents, for informational purposes, the estimated
costs, benefits, and net benefits, of Regulatory Alternative #2b using
alternative discount rates of 3 percent and 7 percent. In addition,
this table presents the incremental costs, incremental benefits, and
incremental net benefits of this alternative relative to the proposed
rule. Table IX-18b also breaks out costs by provision and benefits by
type of disease and by morbidity/mortality.
As shown in Table IX-18b, this regulatory alternative would
increase the annualized cost of the rule from $37.6 million to $39.6
million, using a 3 percent discount rate, and from $39.1 million to
$41.1 million using a 7 percent discount rate. Regulatory Alternative
#2b would prevent less than one additional beryllium-related fatalities
and less than one beryllium-related illness annually relative to the
proposed rule. As a result, annualized benefits would increase from
$575.8 million to $578.1 million, using a 3 percent discount rate, and
from $255.3 million to $256.3 million using a 7 percent discount rate.
Net benefits would increase from $538.2 million to $538.5 million using
a 3 percent discount rate and slightly decrease from $216.2 million to
$215.2 million using a 7 percent discount rate.
BILLING CODE 4510-26-P
[[Page 47735]]
[GRAPHIC] [TIFF OMITTED] TP07AU15.030
[[Page 47736]]
[GRAPHIC] [TIFF OMITTED] TP07AU15.031
BILLING CODE 4510-26-P
2. Exposure Limit (TWA PEL, STEL, and ACTION LEVEL) Alternatives
OSHA is proposing a new TWA PEL for beryllium of 0.2 [mu]g/m\3\ and
a STEL of 2.0 [mu]g/m\3\ for all application groups covered by the
rule. OSHA's proposal is based on the requirements of the Occupational
Safety and Health Act (OSH Act) and court interpretations of
[[Page 47737]]
the Act. For health standards issued under section 6(b)(5) of the OSH
Act, OSHA is required to promulgate a standard that reduces significant
risk to the extent that it is technologically and economically feasible
to do so. See Section II of this preamble, Pertinent Legal Authority,
for a full discussion of OSHA legal requirements.
Paragraph (c) of the proposed standard establishes two PELs for
beryllium in all forms, compounds, and mixtures: An 8-hour TWA PEL of
0.2 [mu]g/m\3\ (proposed paragraph (c)(1)), and a 15-minute short-term
exposure limit (STEL) of 2.0 [mu]g/m\3\ (proposed paragraph (c)(2)).
OSHA has defined the action level for the proposed standard as an
airborne concentration of beryllium of 0.1 [mu]g/m\3\ calculated as an
eight-hour TWA (proposed paragraph (b)). In this proposal, as in other
standards, the action level has been set at one-half of the TWA PEL.
As discussed in this preamble explanation of paragraph (c) in
Section XVIII, Summary and Explanation of the Proposed Standard, OSHA
is considering three regulatory alternatives that would modify the PELs
for the proposed standard.
Regulatory Alternative #3 would modify the proposed STEL to be five
times the TWA PEL, as is typical for OSHA standards that have STELs. A
STEL five times the TWA PEL has more practical effect because a STEL
ten times the TWA PEL will rarely be exceeded without also driving
exposures above the TWA PEL. For example, assuming a background
exposure level of 0.1 [mu]g/m\3\, a STEL ten times the TWA PEL could
only be exceeded once in a work shift for 15 minutes without driving
exposures above the TWA PEL, whereas a STEL five times the TWA PEL
could be exceeded three times before driving exposures above the TWA
PEL. OSHA's standards for methylene chloride (29 CFR 1910.1052),
acrylonitrile (29 CFR 1910.1045), benzene (29 CFR 1910.1028), ethylene
oxide (29 CFR 1910.1047), and 1,3-Butadiene (29 CFR 1910.1051) all set
STELs at five times the TWA PEL. Thus, if OSHA promulgates the proposed
TWA PEL of 0.2 [mu]g/m\3\, the accompanying STEL under this regulatory
alternative would be set at 1 [mu]g/m\3\.
As discussed in this preamble at Section V, Health Effects,
immunological sensitization can be triggered by short-term exposures.
OSHA believes a STEL for beryllium will help reduce the risk of
sensitization and CBD in beryllium-exposed employees. For instance,
without a STEL, workers' exposures could be as high as 6.4 [mu]g/m\3\
(32 x 0.2 [mu]g/m\3\) for 15 minutes under the proposed TWA PEL, if
exposures during the remainder of the 8-hour work shift are non-
detectable. A STEL serves to minimize high task-based exposures by
requiring feasible controls in these situations, and has the added
effect of further reducing the TWA exposure.
OSHA requests comment on the range of short-term exposures in
covered industries, the types of operations where these are occurring,
and on the proposed and alternative STELs, including any data or
information that may help OSHA choose between them.
OSHA identified two job categories where workers would be expected
to have short-term exposures in the range between the proposed STEL and
the STEL under Regulatory Alternative #3 (that is, between 2.0 and 1.0
[mu]g/m\3\): Furnace operators in nonferrous foundries and material
preparation operators in the beryllium oxide ceramics application
group. To estimate the costs for this alternative, OSHA judged,
conservatively, that all workers in these job categories would need to
wear respirators to meet a STEL of 1.0. OSHA also estimated costs for
additional regulated areas and medical surveillance for workers in
these two job categories. The costs for this alternative are presented
in Table IX-19. Total costs rise from $37.6 million to $37.7 million
using a 3 percent discount rate and from $39.1 million to $39.3 million
using a 7 percent discount rate.
[GRAPHIC] [TIFF OMITTED] TP07AU15.032
Under Regulatory Alternative #4, the TWA PEL would be 0.1 [mu]g/
m\3\ with an action level of 0.05 [mu]g/m\3\. The Agency's preliminary
risk assessment indicates that the risks remaining at the proposed TWA
PEL of 0.2 [mu]g/m\3\--while lower than risks at the current TWA PEL--
are still significant (see this preamble at Section VIII, Significance
of Risk). A
[[Page 47738]]
TWA PEL of 0.1 [mu]g/m\3\ would reduce some of the remaining risks to
workers at the proposed PEL. The OSH Act requires the Agency to set its
standards to address significant risks of harm to the extent
economically and technologically feasible, so OSHA would have very
limited flexibility to adopt a higher PEL if a lower PEL is
technologically and economically feasible.
While OSHA's preliminary analysis indicates that the proposed TWA
PEL of 0.2 [mu]g/m\3\ is economically and technologically feasible,
OSHA has less confidence in the feasibility of a TWA PEL of 0.1 [mu]g/
m\3\. In some industry sectors it is difficult to determine whether a
TWA PEL of 0.1 [mu]g/m\3\ could be achieved in most operations most of
the time (see Section IX.D of this preamble, Technological
Feasibility). OSHA believes that one way this uncertainty could be
resolved would be with additional information on exposure control
technologies and the exposure levels that are currently being achieved
in these industry sectors. OSHA requests additional data and
information to inform its final determinations on feasibility (see
Section IX.D of this preamble, Technological Feasibility) and the
alternative PELs under consideration.
Regulatory Alternative #5, which would set a TWA PEL at 0.5 [mu]g/
m\3\ and an action level at 0.25 [mu]g/m\3\, both higher than in the
proposal, responds to an issue raised during the Small Business
Advocacy Review (SBAR) process conducted in 2007 to consider a draft
OSHA beryllium proposed rule that culminated in an SBAR Panel report
(SBAR, 2008). That report included a recommendation that OSHA consider
both the economic impact of a low TWA PEL and regulatory alternatives
that would ease cost burden for small entities. OSHA has provided a
full analysis of the economic impact of its proposed PELs (see Chapter
VI of the PEA), and Regulatory Alternative #5 addresses the second half
of that recommendation. However, the higher 0.5 [mu]g/m\3\ TWA PEL does
not appear to be consistent with the Agency's mandate under the OSH Act
to promulgate a lower PEL if it is feasible and could prevent
additional fatalities and non-fatal illnesses. The data presented in
Table IX-20 below indicate that the lower TWA PEL would prevent
additional fatalities and non-fatal illnesses, but nevertheless the
Agency solicits comments on this alternative and OSHA's analysis of the
costs and benefits associated with it.
Table IX-20 below presents, for informational purposes, the
estimated costs, benefits, and net benefits of the proposed rule under
the proposed TWA PEL of 0.2 [mu]g/m\3\ and for the regulatory
alternatives of a TWA PEL of 0.1 [mu]g/m\3\ and a TWA PEL of 0.5 [mu]g/
m\3\ (Regulatory Alternatives #4 and #5, respectively), using
alternative discount rates of 3 percent and 7 percent. In addition, the
table presents the incremental costs, the incremental benefits, and the
incremental net benefits, of going from a TWA PEL of 0.5 [mu]g/m\3\ to
the proposed TWA PEL of 0.2 [mu]g/m\3\ and then of going from the
proposed TWA PEL of 0.2 [mu]g/m\3\ to a TWA PEL of 0.1 [mu]g/m\3\.
Table IX-20 also breaks out costs by provision and benefits by type of
disease and by morbidity/mortality.
OSHA has not made a determination that a TWA PEL of 0.1 [mu]g/m\3\
would be feasible for all application groups (that is, engineering and
work practices would be sufficient to reduce and maintain beryllium
exposures to a TWA PEL of 0.1 [mu]g/m\3\ or below in most operations
most of the time in the affected industries). For Regulatory
Alternative #4, the Agency attempted to identify engineering controls
and their costs for those affected application groups where the
technology feasibility analysis in Chapter IV of the PEA indicated that
a TWA PEL of 0.1 [mu]g/m\3\ could be achieved. For those application
groups, OSHA costed out the set of feasible controls necessary to meet
this alternative PEL. For the rest of the affected application groups,
OSHA assumed that all workers exposed between 0.2 [mu]g/m\3\ and 0.1
[mu]g/m\3\ would have to wear respirators to achieve compliance with
the 0.1 [mu]g/m\3\ TWA PEL and estimated the associated additional
costs for respiratory protection. For all affected industries, OSHA
also estimated the costs to satisfy the ancillary requirements
specified in the proposed rule for all affected workers under the
alternative TWA PEL of 0.1 [mu]g/m\3\. For both controls and
respirators, the unit costs were the same as presented in Chapter V of
the PEA.
The estimated benefits for Regulatory Alternative #4 were
calculated based on the number of workers identified with exposures
between 0.1 and 0.2 [mu]g/m\3\, using the methods and unit benefit
values developed in Chapter VII of the PEA.
As Table IX-20 shows, going from a TWA PEL of 0.5 [mu]g/m\3\ to a
TWA PEL of 0.2 [mu]g/m\3\ would prevent, annually, an additional 29
beryllium-related fatalities and an additional 15 non-fatal illnesses.
This is consistent with OSHA's preliminary risk assessment, which
indicates significant risk to workers exposed at a TWA PEL of 0.5
[mu]g/m\3\; furthermore, OSHA's preliminary feasibility analysis
indicates that a lower TWA PEL than 0.5 [mu]g/m\3\ is feasible. Net
benefits of this regulatory alternative versus the proposed TWA PEL of
0.2 [mu]g/m\3\ would decrease from $538.2 million to $370.0 million
using a 3 percent discount rate and from $216.2 million to $144.4
million using 7 percent discount rate.
Table IX-20 also shows the costs and benefits of going from the
proposed TWA PEL of 0.2 [mu]g/m\3\ to a TWA PEL of 0.1 [mu]g/m\3\. As
shown there, going from a TWA PEL of 0.2 [mu]g/m\3\ to a TWA PEL of 0.1
[mu]g/m\3\ would prevent an additional 2 beryllium-related fatalities
and 1 additional non-fatal illness. Net benefits of this regulatory
alternative versus the proposed TWA PEL of 0.2 [mu]g/m\3\ would
increase from $538.2 million to $543.5 million using a 3 percent
discount rate and decrease from $216.2 million to $214.9 million using
a 7 percent discount rate.
BILLING CODE 4510-26-P
[[Page 47739]]
[GRAPHIC] [TIFF OMITTED] TP07AU15.033
[[Page 47740]]
Informational Alternative Featuring Unchanged PEL but Full Ancillary
Provisions
An Informational Analysis: This proposed regulation has the
somewhat unusual feature for an OSHA substance-specific health standard
that most of the quantified benefits would come from the ancillary
provisions rather than from meeting the PEL with engineering controls.
OSHA decided to analyze for informational purposes the effect of
retaining the existing PEL but applying all of the ancillary
provisions, including respiratory protection. Under this approach, the
TWA PEL would remain at 2.0 micrograms per cubic meter, but all of the
other proposed provisions (including respiratory protection, which OSHA
does not consider an ancillary provision) would be required with their
triggers remaining the same as in the proposed rule--either the
presence of airborne beryllium at any level (e.g., initial monitoring,
written exposure control plan), at certain kinds of dermal exposure
(PPE), at the action level of 0.1 [mu]g/m\3\ (e.g., periodic
monitoring, medical removal), or at 0.2 [mu]g/m\3\ (e.g., regulated
areas, respiratory protection, medical surveillance).
Given the record regarding beryllium exposures, this approach is
not one OSHA could legally adopt because the absence of a more
protective requirement for engineering controls would not be consistent
with section 6(b)(5) of the OSH Act, which requires OSHA to ``set the
standard which most adequately assures, to the extent feasible, on the
basis of the best available evidence, that no employee will suffer
material impairment of health or functional capacity even if such
employee has regular exposure to the hazard dealt with by such standard
for the period of his working life.'' For that reason, this additional
analysis is provided strictly for informational purposes. E.O. 12866
and E.O. 13563 direct agencies to identify approaches that maximize net
benefits, and this analysis is purely for the purpose of exploring
whether this approach would hold any real promise to maximize net
benefits if it was permissible under the OSH Act. It does not appear to
hold such promise because an ancillary-provisions-only approach would
not be as protective and thus offers fewer benefits than one that
includes a lower PEL and engineering controls, and OSHA estimates the
costs would be about the same (or slightly lower, depending on certain
assumptions) under that approach as under the traditional proposed
approach.
On an industry by industry basis, OSHA found that some industries
would have lower costs if they could adopt the ancillary-provisions-
only approach. Some employers would use engineering controls where they
are cheaper, even if they are not mandatory. OSHA does not have
sufficient information to do an analysis of the employer-by-employer
situations in which there exist some employers for whom the ancillary-
provisions-only approach might be cheaper. In the majority of affected
industries, the Agency estimates there are no costs saving to the
ancillary-provisions-only approach. However, OSHA estimates a total of
$2,675,828 per year in costs saving for entire industries where the
ancillary-provisions-only approach would be less expensive.
The above discussion does not account for the possibility that the
lack of engineering controls would result in higher beryllium exposures
for workers in adjacent (non-production) work areas due to the
increased level of beryllium in the air. Because of a lack of data, and
because the issue did not arise in the other regulatory alternatives
OSHA considered (all of which have a PEL of less than 2.0 [mu]g/m\3\),
OSHA did not carefully examine exposure levels in non-production areas
for either cost or benefit purposes. To the extent such exposure levels
would be above the action level, there would be additional costs for
respiratory protection.
The ancillary-provisions-only approach adds uncertainty to the
benefits analysis such that the benefits of the rule as proposed may
exceed, and perhaps greatly exceed, the benefits of this ancillary-
provisions-only approach:
(1) Most exposed individuals would be in respirators, which OSHA
considers less effective than engineering controls in preventing
employee exposure to beryllium. OSHA last did an extensive review of
the evidence on effectiveness of respirators for its APFs rulemaking in
2006 (71 FR 50128-45, August 24, 2006). OSHA has not in the past tried
to quantify the size of this effect, but it could partially negate the
estimated benefits of 92 CBD deaths prevented per year and 4 lung
cancer cases prevented per year by the proposed standard.
(2) As noted above, in the proposal OSHA did not consider benefits
caused by reductions in exposure in non-production areas. Unless
employers act to reduce exposures in the production areas, the absence
of a requirement for such controls would largely negate such benefits
from reductions in exposure in the non-productions areas.
(3) OSHA believes that there is a strong possibility that the
benefits of the ancillary provisions (a midpoint estimate of
eliminating 45 percent of all remaining cases of CBD) would be
partially or wholly negated in the absence of engineering controls that
would reduce both airborne and surface dust levels. The measured
reduction in benefits from ancillary provision was in a facility with
average exposure levels of less than 0.2 [mu]g/m\3\.
Based on these considerations, OSHA believes that the ancillary-
provisions-only approach is not one that is likely to maximize net
benefits. The costs saving, if any, are estimated to be small, and the
difficult-to-measure declines in benefits could be substantial.
3. A Method-of-Compliance Alternative
Paragraph (f)(2) of the proposed rule contains requirements for the
implementation of engineering and work practice controls to minimize
beryllium exposures in beryllium work areas. For each operation in a
beryllium work area, employers must ensure that at least one of the
following engineering and work practice controls is in place to
minimize employee exposure: Material and/or process substitution;
ventilated enclosures; local exhaust ventilation; or process controls,
such as wet methods and automation. Employers are exempt from using
engineering and work practice controls only when they can show that
such controls are not feasible or where exposures are below the action
level based on two exposure samples taken seven days apart.
These requirements, which are based on the stakeholders'
recommended beryllium standard that beryllium industry and union
stakeholders submitted to OSHA in 2012 (Materion and United
Steelworkers, 2012), address a concern associated with the proposed TWA
PEL. OSHA expects that day-to-day changes in workplace conditions, such
as workers' positioning or patterns of airflow, may cause frequent
exposures above the TWA PEL in workplaces where periodic sampling
indicates exposures are between the action level and the TWA PEL. As a
result, the default under the standard is that the controls are
required until the employer can demonstrate that exposures have not
exceeded the action level from at least two separate measurements taken
seven days apart.
OSHA believes that substitution or engineering controls such as
those outlined in paragraph (f)(2)(i) provide the most reliable means
to control variability in exposure levels. However, OSHA also
recognizes that the requirements of paragraph (f)(2)(i) are
[[Page 47741]]
not typical of OSHA standards, which usually require engineering
controls only where exposures exceed the TWA PEL or STEL. The Agency is
therefore considering Regulatory Alternative #6, which would drop the
provisions of (f)(2)(i) from the proposed standard and make conforming
edits to paragraphs (f)(2)(ii) and (iii). This regulatory alternative
does not eliminate the need for engineering controls to comply with the
proposed TWA PEL and STEL, but does eliminate the requirement to use
one or more of the specified engineering or work practice controls
where exposures equal or exceed the action level. As shown in Table IX-
21, Regulatory Alternative #6 would decrease the annualized cost of the
proposed rule by about $457,000 using a discount rate of 3 percent and
by about $480,000 using a discount rate of 7 percent. OSHA has not been
able to estimate the change in benefits resulting from Regulatory
Alternative #6 at this time and invites public comment on this issue.
[GRAPHIC] [TIFF OMITTED] TP07AU15.034
4. Regulatory Alternatives That Affect Ancillary Provisions
The proposed standard contains several ancillary provisions
(provisions other than the exposure limits), including requirements for
exposure assessment, medical surveillance, medical removal, training,
and regulated areas or access control. As reported in Chapter V of the
PEA, these ancillary provisions account for $27.8 million (about 72
percent) of the total annualized costs of the rule ($37.6 million)
using a 3 percent discount rate, or $28.6 million (about 73 percent) of
the total annualized costs of the rule ($39.1 million) using a 7
percent discount rate. The most expensive of the ancillary provisions
are the requirements for housekeeping and training, with annualized
costs of $12.6 million and $5.8 million, respectively, at a 3 percent
discount rate ($12.9 million and $5.8 million, respectively, at a 7
percent discount rate).
OSHA's reasons for including each of the proposed ancillary
provisions are explained in Section XVIII of this preamble, Summary and
Explanation of the Standards.
In particular, OSHA is proposing the requirements for exposure
assessment to provide a basis for ensuring that appropriate measures
are in place to limit worker exposures. Medical surveillance is
especially important because workers exposed above the proposed TWA
PEL, as well as many workers exposed below the proposed TWA PEL, are at
significant risk of death and illness. Medical surveillance would allow
for identification of beryllium-related adverse health effects at an
early stage so that appropriate intervention measures can be taken.
OSHA is proposing regulated areas and access control because they serve
to limit exposure to beryllium to as few employees as possible. OSHA is
proposing worker training to ensure that employers inform employees of
the hazards to which they are exposed, along with associated protective
measures, so that employees understand how they can minimize their
exposure to beryllium. Worker training on beryllium-related work
practices is particularly important in controlling beryllium exposures
because engineering controls frequently require action on the part of
workers to function effectively.
OSHA has examined a variety of regulatory alternatives involving
changes to one or more of the proposed ancillary provisions. The
incremental cost of each of these regulatory alternatives and its
impact on the total costs of the proposed rule is summarized in Table
IX-22 at the end of this section. OSHA has preliminarily determined
that several of these ancillary provisions will increase the benefits
of the proposed rule, for example, by helping to ensure the TWA PEL is
not exceeded or by lowering the risks to workers given the significant
risk remaining at the proposed TWA PEL. However, except for Regulatory
Alternative #7 (involving the elimination of all ancillary provisions),
OSHA did not estimate changes in monetized benefits for the regulatory
alternatives that affect ancillary provisions. Two regulatory
alternatives that involve all ancillary provisions are presented below
(#7 and #8), followed by regulatory alternatives for exposure
monitoring (#9, #10, and #11), for regulated areas (#12), for personal
[[Page 47742]]
protective clothing and equipment (#13), for medical surveillance (#14
through #21), and for medical removal (#22).
a. All Ancillary Provisions
The SBAR Panel recommended that OSHA analyze a PEL-only standard as
a regulatory alternative. The Panel also recommended that OSHA consider
not applying ancillary provisions of the standard where exposure levels
are low so as to minimize costs for small businesses (SBAR, 2008). In
response to these recommendations, OSHA analyzed Regulatory Alternative
#7, a PEL-only standard, and Regulatory Alternative #8, which would
apply ancillary provisions of the beryllium standard only where
exposures exceed the proposed TWA PEL of 0.2 [mu]g/m\3\ or the proposed
STEL of 2 [mu]g/m\3\.
Regulatory Alternative #7 would solely update 1910.1000 Tables Z-1
and Z-2, so that the proposed TWA PEL and STEL would apply to all
workers in general industry. This alternative would eliminate all of
the ancillary provisions of the proposed rule, including exposure
assessment, medical surveillance, medical removal, PPE, housekeeping,
training, and regulated areas or access control. Under this regulatory
alternative, OSHA estimates that the costs for the proposed ancillary
provisions of the rule (estimated at $27.8 million annually at a 3
percent discount rate) would be eliminated. In order to meet the PELs,
employers would still commonly need to do monitoring, train workers on
the use of controls, and set up some kind of regulated areas to
indicate where respirator use would be required. It is also likely
that, under this alternative, many employers would follow the
recommendations of Materion and the United Steelworkers to provide
medical surveillance, PPE, and other protective measures for their
workers (Materion and USW, 2012). OSHA has not attempted to estimate
the extent to which these ancillary-provision costs would be incurred
if they were not formally required or whether any of these costs under
Regulatory Alternative #7 would reasonably be attributable to the
proposed rule. OSHA welcomes comment on the issue.
OSHA has also estimated the effect of this regulatory alternative
on the benefits of the rule. As a result of eliminating all of the
ancillary provisions, annualized benefits are estimated to decrease 57
percent, relative to the proposed rule, from $575.8 million to $249.1
million, using a 3 percent discount rate, and from $255.3 million to
$110.4 million using a 7 percent discount rate. This estimate follows
from OSHA's analysis of benefits in Chapter VII of the PEA, which found
that about 57 percent of the benefits of the proposed rule, evaluated
at their mid-point value, were attributable to the combination of the
ancillary provisions. As these estimates show, OSHA expects that the
benefits estimated under the proposed rule will not be fully achieved
if employers do not implement the ancillary provisions of the proposed
rule.
Both industry and worker groups have recognized that a
comprehensive standard is needed to protect workers exposed to
beryllium. The stakeholders' recommended standard that representatives
of the primary beryllium manufacturing industry and the United
Steelworkers union provided to OSHA confirms the importance of
ancillary provisions in protecting workers from the harmful effects of
beryllium exposure (Materion and USW, 2012). Ancillary provisions such
as personal protective clothing and equipment, regulated areas, medical
surveillance, hygiene areas, housekeeping requirements, and hazard
communication all serve to reduce the risks to beryllium-exposed
workers beyond that which the proposed TWA PEL alone could achieve.
Moreover, where there is continuing significant risk at the TWA
PEL, the decision in the Asbestos case (Bldg. and Constr. Trades Dep't,
AFL-CIO v. Brock, 838 F.2d 1258, 1274 (D.C. Cir. 1988)) indicated that
OSHA should use its legal authority to impose additional requirements
on employers to further reduce risk when those requirements will result
in a greater than de minimis incremental benefit to workers' health.
Nevertheless, OSHA requests comment on this alternative.
Under Regulatory Alternative #8, several ancillary provisions that
the current proposal would require under a variety of exposure
conditions (e.g., dermal contact, any airborne exposure, exposure at or
above the action level) would instead only apply where exposure levels
exceed the TWA PEL or STEL. Regulatory Alternative #8 affects the
following provisions of the proposed standard:
--Exposure monitoring: Whereas the proposed standard requires annual
monitoring when exposure levels are at or above the action level and at
or below the TWA PEL, Regulatory Alternative #8 would require annual
exposure monitoring only where exposure levels exceed the TWA PEL or
STEL;
--Written exposure control plan: Whereas the proposed standard requires
written exposure control plans to be maintained in any facility covered
by the standard, Regulatory Alternative #8 would require only
facilities with exposures above the TWA PEL or STEL to maintain a plan;
--Housekeeping: Whereas the proposed standard's housekeeping
requirements apply across a wide variety of beryllium exposure
conditions, Alternative #8 would limit housekeeping requirements to
areas and employees with exposures above the TWA PEL or STEL;
--PPE: Whereas the proposed standard requires PPE for employees under a
variety of conditions, such as exposure to soluble beryllium or visible
contamination with beryllium, Alternative #8 would require PPE only for
employees exposed above the TWA PEL or STEL;
--Medical Surveillance: Whereas the proposed standard's medical
surveillance provisions require employers to offer medical surveillance
to employees with signs or symptoms of beryllium-related health effects
regardless of their exposure level, Alternative #8 would require
surveillance only for those employees exposed above the TWA PEL or
STEL.
To estimate the cost savings for this alternative, OSHA re-
estimated the group of workers that would fall under the above
provisions and the changes to their scope. Combining these various
adjustments along with associated unit costs, OSHA estimates that,
under this regulatory alternative, the costs for the proposed rule
would decline from $37.6 million to $18.9 million using a 3 percent
discount rate and from $39.1 million to $20.0 million using a 7 percent
discount rate.
The Agency has not quantified the impact of this alternative on the
benefits of the rule. However, ancillary provisions that offer
protective measures to workers exposed below the proposed TWA PEL, such
as personal protective clothing and equipment, beryllium work areas,
hygiene areas, housekeeping requirements, and hazard communication, all
serve to reduce the risks to beryllium-exposed workers beyond that
which the proposed TWA PEL and STEL could achieve. OSHA's preliminary
conclusion is that the requirements triggered by the action level and
other exposures below the proposed PELs will result in very real and
necessary, but difficult to quantify, further reduction in risk beyond
that provided by the PELs alone.
The remainder of this section discusses additional regulatory
alternatives that apply to individual
[[Page 47743]]
ancillary provisions. At this time, OSHA is not able to quantify the
effects of these regulatory alternatives on benefits. The Agency
solicits comment on the effects of these regulatory alternatives on the
benefits of the proposed rule.
b. Exposure Monitoring
Paragraph (d) of the proposed standard, Exposure Monitoring,
requires annual monitoring where exposures are at or above the action
level and at or below the TWA PEL. It does not require periodic
monitoring where exposure levels have been determined to be below the
action level, or above the TWA PEL. The rationale for this provision is
provided in this preamble discussion of paragraph (a) in Section XVIII,
Summary and Explanation of the Proposed Standard. Below is a brief
summary, followed by a discussion of three alternatives.
Because of the variable nature of employee exposures to airborne
concentrations of beryllium, maintaining exposures below the action
level provides reasonable assurance that employees will not be exposed
to beryllium at levels above the TWA PEL on days when no exposure
measurements are made. Even when all measurements on a given day fall
at or below the TWA PEL, if those measurements are still at or above
the action level, there is a smaller safety margin and a greater chance
that on another day, when exposures are not measured, the employee's
exposure may exceed the TWA PEL. When exposure measurements are at or
above the action level, the employer cannot be reasonably confident
that employees have not been exposed to beryllium concentrations in
excess of the TWA PEL during at least some part of the work week.
Therefore, requiring periodic exposure measurements when the action
level is met or exceeded provides the employer with a reasonable degree
of confidence in the results of the exposure monitoring. The proposed
action level that would trigger the exposure monitoring is one-half of
the TWA PEL, which reflects the Agency's typical approach to setting
action levels (see, e.g., Inorganic arsenic (29 CFR 1910.1018),
Ethylene oxide (29 CFR 1910.1047), Benzene (29 CFR 1910.1028), and
Methylene Chloride (29 CFR 1910.1052)).
Certain other aspects of the proposed periodic monitoring
requirements, which the Agency based on the stakeholders' recommended
standard submitted by Materion and the United Steelworkers (Materion
and USW, 2012), depart significantly from OSHA's usual exposure
monitoring requirements. The proposed standard only requires annual
monitoring, and does not require periodic monitoring when exposures are
recorded above the TWA PEL, whereas most OSHA standards require
monitoring at least every 6 months when exposure levels exceed the
action level, and every 3 months when exposures are above the TWA PEL.
For example, the standards for vinyl chloride (29 CFR 1910.1017),
inorganic arsenic (29 CFR 1910.1018), lead (29 CFR 1910.1025), cadmium
(29 CFR 1910.1027), methylene chloride (29 CFR 1910.1052),
acrylonitrile (29 CFR 1910.1045), ethylene oxide (29 CFR 1910.1047),
and formaldehyde (29 CFR 1910.1048), all specify periodic monitoring at
least every six months when exposures are at, or above, the action
level. Monitoring is required every three months when exposures exceed
the TWA PEL in the standards for methylene chloride, ethylene oxide,
acrylonitrile, inorganic arsenic, lead, and vinyl chloride. In the
standards for cadmium, 1,3-Butadiene, formaldehyde, benzene and
asbestos (29 CFR 1910.1001), monitoring is required every six months
when exposures exceed the TWA PEL. In these standards, monitoring
workers exposed above the TWA PEL ensures that employers know workers'
exposure levels in order to select appropriate respirators and other
PPE, and that records of their exposures are available if needed for
medical, legal, or epidemiological purposes.
OSHA has examined three regulatory alternatives that would modify
the requirements of paragraph (d) to be more similar to OSHA's typical
periodic monitoring requirements. Under Regulatory Alternative #9,
employers would be required to perform periodic exposure monitoring
every 180 days when exposures are at or above the action level or above
the STEL, but at or below the TWA PEL. As shown in Table IX-22,
Regulatory Alternative #9 would increase the annualized cost of the
proposed rule by about $773,000 using either a 3 percent or 7 percent
discount rate.
Under Regulatory Alternative #10, employers would be required to
perform periodic exposure monitoring every 180 days when exposures are
at or above the action level or above the STEL, including where
exposures exceed the TWA PEL. As shown in Table IX-22, Regulatory
Alternative #10 would increase the annualized cost of the proposed rule
by about $929,000 using either a 3 percent or 7 percent discount rate.
Under Regulatory Alternative #11, employers would be required to
perform periodic exposure monitoring every 180 days when exposures are
at or above the action level, and every 90 days where exposures exceed
the TWA PEL or STEL. This alternative is similar to the periodic
monitoring requirements in the draft proposed rule presented to the
SERs during the 2007 OSHA beryllium SBAR Panel process. Of the exposure
monitoring alternatives, it is also the most similar to the exposure
monitoring provisions of most other 6(b)(5) standards. As shown in
Table IX-22, Regulatory Alternative #11 would increase the annualized
cost of the proposed rule by about $1.07 million using either a 3
percent or 7 percent discount rate.
c. Regulated Areas
Proposed paragraph (e) requires employers to establish and maintain
beryllium work areas wherever employees are exposed to airborne
beryllium, regardless of the level of exposure, and regulated areas
wherever airborne concentrations of beryllium exceed the TWA PEL or
STEL. Employers are required to demarcate beryllium work areas and
regulated areas and limit access to regulated areas to authorized
persons.
The SBAR Panel report recommended that OSHA consider dropping or
limiting the provision for regulated areas (SBAR, 2008). In response to
this recommendation, OSHA examined Regulatory Alternative #12, which
would eliminate the requirement that employers establish regulated
areas. This alternative is meant only to eliminate the requirement to
set up and demarcate specific physical areas: All ancillary provisions
would be triggered by the same conditions as under the standard's
definition of a ``regulated area.'' For example, under the current
proposal, employees who work in regulated areas for at least 30 days
annually are eligible for medical surveillance. If OSHA were to remove
the requirement to establish regulated areas, the medical surveillance
provisions would be altered so that employees who work more than 30
days annually in jobs or areas with exposures that exceed the TWA PEL
or STEL are eligible for medical surveillance. This alternative would
not eliminate the proposed requirement to establish beryllium work
areas. As shown in Table IX-22, Regulatory Alternative #12 would
decrease the annualized cost of the proposed rule by about $522,000
using a 3 percent discount rate, and by about $523,000 using a 7
percent discount rate.
[[Page 47744]]
d. Personal Protective Clothing and Equipment
Regulatory Alternative #13 would modify the requirements for
personal protective equipment (PPE) by requiring appropriate PPE
whenever there is potential for skin contact with beryllium or
beryllium-contaminated surfaces. This alternative would be broader, and
thus more protective, than the PPE requirement in the proposed
standard, which requires PPE to be used in three circumstances: (1)
Where exposure exceeds the TWA PEL or STEL; (2) where employees'
clothing or skin may become visibly contaminated with beryllium; and
(3) where employees may have skin contact with soluble beryllium
compounds. These PPE requirements were based on the stakeholders'
recommended standard that Materion and the United Steelworkers
submitted to the Agency (Materion and USW, 2012).
The proposed rule's requirement to use PPE where work clothing or
skin may become ``visibly contaminated'' with beryllium differs from
prior standards, which do not require contamination to be visible in
order for PPE to be required. While OSHA's language regarding PPE
requirements varies somewhat from standard to standard, previous
standards tend to emphasize potential for contact with a substance that
can trigger health effects via dermal exposure, rather than ``visible
contamination'' with the substance. For example, the standard for
chromium (VI) requires the employer to provide appropriate PPE where a
hazard is present or is likely to be present from skin or eye contact
with chromium (VI) (29 CFR 1910.1026). The lead and cadmium standards
require PPE where employees are exposed above the PEL or where there is
potential for skin or eye irritation, regardless of airborne exposure
level. Under the Methylenedianiline (MDA) standard (29 CFR 1910.1050),
PPE must be provided where employees are subject to dermal exposure to
MDA, where liquids containing MDA can be splashed into the eyes, or
where airborne concentrations of MDA are in excess of the PEL.
OSHA requests comment on the proposed PPE requirements in
Regulatory Alternative #13, which would modify the proposed PPE
requirements to be similar to the chromium (VI), lead, cadmium, and MDA
standards. Because small beryllium particles can pass through intact or
broken skin and cause sensitization, limiting the requirements for PPE
based on surfaces that are ``visibly contaminated'' may not adequately
protect workers from beryllium exposure. Submicron particles (less than
1 [mu]g in diameter) are not visible to the naked eye and yet may pass
through the skin and cause beryllium sensitization. Although solubility
may play a role in the level of sensitization risk, the available
evidence suggests that contact with insoluble, as well as soluble,
beryllium can cause sensitization via dermal contact (see this preamble
at Section V, Health Effects). Sensitized workers are at significant
risk of developing CBD (see this preamble at Section V, Health Effects,
and Section VIII, Significance of Risk).
To estimate the cost of Regulatory Alternative #13, OSHA assumed
that all at-risk workers, except administrative occupations, would
require protective clothing and a pair of work gloves that would need
to be replaced annually. The economic analysis of the proposed standard
already contained costs for protective clothing for all employees whose
clothing might be contaminated by beryllium (the analysis assumed that
all clothing contamination would be visible, or the clothing is already
provided even if not required by this standard) and gloves for many
jobs where workers were expected to be exposed to visible contamination
or soluble beryllium; thus OSHA estimated the cost of this alternative
as the cost of providing gloves for the remainder of the jobs where
workers have potential for skin exposure even in the absence of visible
contamination. As shown in Table IX-22, Regulatory Alternative #13
would increase the annualized cost of the proposed rule by about
$138,000 using either a 3 percent or 7 percent discount rate.
e. Medical Surveillance
The proposed requirements for medical surveillance include: (1)
Medical examinations, including a test for beryllium sensitization, for
employees who are exposed to beryllium in a regulated area (i.e., above
the proposed TWA PEL or STEL) for 30 days or more per year, who are
exposed to beryllium in an emergency, or who show signs or symptoms of
CBD; and (2) CT scans for employees who were exposed above the proposed
TWA PEL or STEL for more than 30 days in a 12-month period for 5 years
or more. The proposed standard would require annual medical exams to be
provided for employees exposed in a regulated area for 30 days or more
per year and for employees showing signs or symptoms of CBD, while
tests for beryllium sensitization and CT scans would be provided to
eligible employees biennially.
OSHA estimated in Chapter V of the PEA that the medical
surveillance requirements would apply to 4,528 workers in general
industry, of whom 387 already receive that surveillance.\43\ In Chapter
V, OSHA estimated the costs of medical surveillance for the remaining
4,141 workers who would now have such protection due to the proposed
standard. The Agency's preliminary analysis indicates that 4 workers
with beryllium sensitization and 6 workers with CBD will be referred to
pulmonary specialists annually as a result of this medical
surveillance. Medical surveillance is particularly important for this
rule because beryllium-exposed workers, including many workers exposed
below the proposed PELs, are at significant risk of illness. OSHA did
not estimate, and the benefits analysis does not include, monetized
benefits resulting from early discovery of illness.
---------------------------------------------------------------------------
\43\ See current compliance rates for medical surveillance in
Chapter V of the PEA, Table V-15.
---------------------------------------------------------------------------
OSHA has examined eight regulatory alternatives (#14 through #21)
that would modify the proposed rule's requirements for employee
eligibility, the tests that must be offered, and the frequency of
periodic exams. Medical surveillance was a subject of special concern
to SERs during the SBAR Panel process, and the SBAR Panel offered many
comments and recommendations related to medical surveillance for OSHA's
consideration. Some of the Panel's concerns have been partially
addressed in this proposal, which was modified since the SBAR Panel was
convened (see this preamble at Section XVIII, Summary and Explanation
of the Proposed Standard, for more detailed discussion). Several of the
regulatory alternatives presented here (#16, #18, and #20) also respond
to recommendations by the SBAR Panel to reduce burdens on small
businesses by dropping or reducing the frequency of medical
surveillance requirements. OSHA is also considering several additional
regulatory alternatives that would increase the frequency of
surveillance or the range of employees covered by medical surveillance
(#14, #15, #17, #19, and #21).
OSHA has preliminarily determined that a significant risk of
beryllium sensitization, CBD, and lung cancer exists at exposure levels
below the proposed TWA PEL and that there is evidence that beryllium
sensitization can occur even from short-term exposures (see this
preamble at Section V, Health Effects, and Section VIII,
[[Page 47745]]
Significance of Risk). The Agency therefore anticipates that more
employees would develop adverse health effects without receiving the
benefits of early intervention in the disease process because they are
not eligible for medical surveillance (see this preamble at Section V,
Health Effects).
OSHA is considering three regulatory alternatives that would expand
eligibility for medical surveillance to a broader group of employees
than those eligible under the proposed standard. Under Regulatory
Alternative #14, medical surveillance would be available to employees
who are exposed to beryllium above the proposed TWA PEL or STEL,
including employees exposed for fewer than 30 days per year. Regulatory
Alternative #15 would expand eligibility for medical surveillance to
employees who are exposed to beryllium above the proposed action level,
including employees exposed for fewer than 30 days per year. Regulatory
Alternative #21 would extend eligibility for medical surveillance as
set forth in proposed paragraph (k) to all employees in shipyards,
construction, and general industry who meet the criteria of proposed
paragraph (k)(1). However, all other provisions of the standard would
be in effect only for employers and employees that fall within the
scope of the proposed rule. Each of these alternatives would provide
surveillance to fewer workers (and cost less to employers) than the
draft proposed rule presented to SERs during the SBAR Panel process,
which included skin contact as a trigger and would therefore cover most
beryllium-exposed workers in general industry, construction, and
maritime. These alternatives would provide more surveillance (and cost
more to employers) than the medical surveillance requirements in the
current proposal.
To estimate the cost of Regulatory Alternative #14, OSHA assumed
that 1 person would enter regulated areas for less than 30 days a year
for every 4 people working in regulated areas on a regular basis. Thus,
this alternative includes costs for an incremental number of annual
medical exams equal to 25 percent of the number of workers estimated to
be working in regulated areas after the standard is promulgated. As
shown in Table IX-22, Regulatory Alternative #14 would increase the
annualized cost of the proposed rule by about $38,000 using either a 3
percent or 7 percent discount rate.
To estimate the cost of Regulatory Alternative #15, OSHA assumed
that all workers exposed above the action level before the standard
would continue to be exposed after the standard is promulgated. OSHA
also assumed that 1 person would enter areas exceeding the action level
for fewer than 30 days a year for every 4 people working in an area
exceeding the action level on a regular basis. Thus, this alternative
includes costs for medical exams for the number of workers exposed
between the action level and the TWA PEL as well as an incremental 25
percent of all workers exposed above the action level. As shown in
Table IX-22, Regulatory Alternative #15 would increase the annualized
cost of the proposed rule by about $3.9 million using a discount rate
of 3 percent, and by about $4.0 million using a discount rate of 7
percent.
For Alternative #21, OSHA is considering two different scenarios to
estimate costs: One where the TWA PEL for the groups outside the scope
of the proposed standard changes from 2 [mu]g/m\3\ to 0.2 [mu]g/m\3\,
as in Regulatory Alternative #2; and one where the TWA PEL remains at
the current level of 2.0 [mu]g/m\3\. For costing purposes, these have
been designated as Regulatory Alternative #21a and Regulatory
Alternative #21b, respectively.
For Regulatory Alternative #21a, medical surveillance above the
proposed TWA PEL of 0.2, OSHA estimated the cost of extending medical
surveillance to workers in aluminum production, abrasive blasting in
construction, maritime abrasive blasting, maritime welding, and coal
fired power plants, assuming that all feasible controls are in place to
reduce exposures to the proposed TWA PEL of 0.2 [mu]g/m\3\ or lower.
OSHA did not include control costs to achieve compliance with a TWA PEL
of 0.2 [mu]g/m\3\, as these costs were addressed in Regulatory
Alternative #2. (For a summary of the estimates of affected workers and
the exposure profile, see the discussion accompanying Regulatory
Alternative # 2.) As shown in Table IX-22, Regulatory Alternative #21a
would increase the annualized cost of the proposed rule by about $4.4
million using a 3-percent discount rate and $4.5 million using a 7-
percent discount rate.
For Alternative #21b, medical surveillance above the current TWA
PEL of 2.0 [mu]g/m\3\, OSHA estimated that all abrasive blasters in
construction and shipyards who are currently above the current TWA PEL
of 2.0 [mu]g/m\3\would be eligible for medical surveillance. As
discussed under alternative #2, outside of abrasive blasting, OSHA has
identified a small group of maritime welders who may be exposed to
beryllium above the current TWA PEL in their work. Of these workers, 90
percent would be below the current TWA PEL if their employers
instituted all feasible engineering and work practice controls to meet
the existing standard. If they came into compliance with the current
PELs, they would not be required to offer employees medical
surveillance under Alternative #21b. OSHA estimated that the other 10
percent of these maritime welders, and 10 percent of workers in primary
aluminum production and coal-fired power generation, with all feasible
engineering controls and work practices in place, would still be
exposed above the current TWA PEL and would be eligible for medical
surveillance under Alternative #21b. OSHA's customary method in
preparing an economic analysis of a new standard is to cost out the
incremental cost of the new standard assuming full compliance with
existing standards. Finally, OSHA estimated that 15 percent of the
workers excluded from the scope of the proposed standard absent the
alternative would show signs and symptoms of CBD or be exposed in
emergencies, and so would be eligible for medical surveillance. As
shown in Table IX-22, under these assumptions Regulatory Alternative
#21b would increase the annualized cost of the proposed rule by about
$3.0 million using a 3-percent discount rate and $3.1 million using a
7-percent discount rate. The Agency notes that, as abrasive blasters
are the primary application group with beryllium exposure in
construction and shipyards, it is unlikely that as many as 15 percent
of other workers would show signs and symptoms of beryllium exposure or
be exposed to beryllium in an emergency. Thus, OSHA believes the stated
cost of about $3.0 million may overestimate the true costs for this
alternative and invites comment on this issue.
In response to concerns raised during the SBAR Panel process about
testing requirements, OSHA is considering two regulatory alternatives
that would provide greater flexibility in the program of tests provided
as part of an employer's medical surveillance program. Under Regulatory
Alternative #16, employers would not be required to offer employees
testing for beryllium sensitization. As shown in Table IX-22, this
alternative would decrease the annualized cost of the proposed rule by
about $710,000 using a discount rate of 3 percent, and by about
$724,000 using a discount rate of 7 percent.
Regulatory Alternative #18 would eliminate the CT scan requirement
from the proposed rule. This alternative would decrease the annualized
cost of
[[Page 47746]]
the proposed rule by about $472,000 using a discount rate of 3 percent,
and by about $481,000 using a discount rate of 7 percent.
OSHA is considering several alternatives to the proposed frequency
of sensitization testing, CT scans, and general medical examinations.
The frequency of periodic medical surveillance is an important factor
in the efficacy of the surveillance in protecting worker health.
Regular, appropriately frequent medical surveillance promotes awareness
of beryllium-related health effects and early intervention in disease
processes among workers. In addition, the longer the time interval
between when a worker becomes sensitized and when the worker's case is
identified in the surveillance program, the more difficult it will be
to identify and address the exposure conditions that led to
sensitization. Therefore, reducing the frequency of sensitization
testing would reduce the usefulness of the surveillance information in
identifying problem areas and reducing risks to other workers. These
concerns must be weighed against the costs and other burdens of
surveillance.
Regulatory alternative #17 would require employers to offer annual
testing for beryllium sensitization to eligible employees, as in the
draft proposal presented to the SBAR Panel. As shown in Table IX-22,
this alternative would increase the annualized cost of the proposed
rule by about $392,000 using a discount rate of 3 percent, and by about
$381,000 using a discount rate of 7 percent.
Regulatory Alternative #19 would similarly increase the frequency
of periodic CT scans from biennial to annual scans, increasing the
annualized cost of the proposed rule by about $459,000 using a discount
rate of 3 percent, and by about $450,000 using a discount rate of 7
percent.
Finally, under Regulatory Alternative #20, employers would only
have to provide all periodic components of the medical surveillance
exams biennially to eligible employees. This alternative would decrease
the annualized cost of the proposed rule by about $446,000 using a
discount rate of 3 percent and by about $433,000 using a discount rate
of 7 percent.
f. Medical Removal
Under paragraph (l) of the proposed standard, Medical Removal,
employees in jobs with exposure at or above the action level become
eligible for medical removal when they are diagnosed with CBD or
confirmed positive for beryllium sensitization. When an employee
chooses removal, the employer is required to remove the employee to
comparable work in an environment where beryllium exposure is below the
action level if such work is available and the employee is either
already qualified or can be trained within one month. If comparable
work is not available, paragraph (l) would require the employer to
place the employee on paid leave for six months or until comparable
work becomes available (whichever comes first). Or, rather than
choosing removal, an eligible employee could choose to remain in a job
with exposure at or above the action level and wear a respirator. The
proposed medical removal protection (MRP) requirements are based on the
stakeholders' recommended beryllium standard that representatives of
the beryllium production industry and the United Steelworkers union
submitted to OSHA in 2012 (Materion and USW, 2012).
The scientific information on effects of exposure cessation is
limited at this time, but the available evidence suggests that removal
from exposure can be beneficial for individuals who are sensitized or
have early-stage CBD (see this preamble at Section VIII, Significance
of Risk). As CBD progresses, symptoms become serious and debilitating.
Steroid treatment is less effective at later stages, once fibrosis has
developed (see this preamble at Section VIII, Significance of Risk).
Given the progressive nature of the disease, OSHA believes it is
reasonable to conclude that removal from exposure to beryllium will
benefit sensitized employees and those with CBD. Physicians at National
Jewish Health, one of the main CBD research and treatment sites in the
US, ``consider it important and prudent for individuals with beryllium
sensitization and CBD to minimize their exposure to airborne
beryllium,'' and ``recommend individuals diagnosed with beryllium
sensitization and CBD who continue to work in a beryllium industry to
have exposure of no more than 0.01 micrograms per cubic meter of
beryllium as an 8-hour time-weighted average'' (NJMRC, 2013). However,
OSHA is aware that MRP may prove costly and burdensome for some
employers and that the scientific literature on the effects of exposure
cessation on the development of CBD among sensitized individuals and
the progression from early-stage to late-stage CBD is limited.
The SBAR Panel report included a recommendation that OSHA give
careful consideration to the impacts that an MRP requirement could have
on small businesses (SBAR, 2008). In response to this recommendation,
OSHA analyzed Regulatory Alternative #22, which would remove the
proposed requirement that employers offer MRP. As shown in Table IX-22,
this alternative would decrease the annualized cost of the proposed
rule by about $149,000 using a discount rate of 3 percent, and by about
$166,000 using a discount rate of 7 percent.
[[Page 47747]]
[GRAPHIC] [TIFF OMITTED] TP07AU15.035
[[Page 47748]]
[GRAPHIC] [TIFF OMITTED] TP07AU15.036
5. Timing
As proposed, the new standard would become effective 60 days
following publication in the Federal Register. The majority of employer
duties in the standard would become enforceable 90 days following the
effective date. Change rooms, however, would not be required until one
year after the effective date, and the deadline for engineering
controls would be no later than two years after the effective date.
OSHA invites suggestions for alternative phase-in schedules for
engineering controls, medical surveillance, and other provisions of the
standard. Although OSHA did not explicitly develop or quantitatively
analyze any other regulatory alternatives involving longer-term or more
complex phase-ins of the standard (possibly involving more delayed
implementation dates for small businesses), some general outcomes are
likely. For example, a longer phase-in time would have several
advantages, such as reducing initial costs of the standard or allowing
employers to coordinate their environmental and occupational safety and
health control strategies to minimize potential costs. However, a
longer phase-in would also postpone and reduce the benefits of the
standard. Suggestions for alternatives may apply to specific industries
(e.g., industries where first-year or annualized cost impacts are
highest), specific size-classes of employers (e.g., employers with
fewer than 20 employees), combinations of these factors, or all firms
covered by the rule.
OSHA requests comments on all these regulatory alternatives,
including the Agency's regulatory alternatives presented above, the
Agency's analysis of these alternatives, and whether there are other
regulatory alternatives the Agency should consider.
I. Initial Regulatory Flexibility Analysis
The Regulatory Flexibility Act, as amended in 1996, requires the
preparation of an Initial Regulatory Flexibility Analysis (IRFA) for
proposed rules where there would be a significant economic impact on a
substantial number of small entities. (5 U.S.C. 601-612). Under the
provisions of the law, each such analysis shall contain:
[[Page 47749]]
1. A description of the impact of the proposed rule on small
entities;
2. A description of the reasons why action by the agency is being
considered;
3. A succinct statement of the objectives of, and legal basis for,
the proposed rule;
4. A description of and, where feasible, an estimate of the number
of small entities to which the proposed rule will apply;
5. A description of the projected reporting, recordkeeping, and
other compliance requirements of the proposed rule, including an
estimate of the classes of small entities which will be subject to the
requirements and the type of professional skills necessary for
preparation of the report or record;
6. An identification, to the extent practicable, of all relevant
Federal rules which may duplicate, overlap, or conflict with the
proposed rule;
7. A description and discussion of any significant alternatives to
the proposed rule which accomplish the stated objectives of applicable
statutes and which minimize any significant economic impact of the
proposed rule on small entities, such as:
(a) The establishment of differing compliance or reporting
requirements or timetables that take into account the resources
available to small entities;
(b) The clarification, consolidation, or simplification of
compliance and reporting requirements under the rule for such small
entities;
(c) The use of performance rather than design standards; and
(d) An exemption from coverage of the rule, or any part thereof,
for such small entities.
5 U.S.C. 603, 607. The Regulatory Flexibility Act further states that
the required elements of the IRFA may be performed in conjunction with,
or as part of, any other agenda or analysis required by any other law
if such other analysis satisfies the provisions of the IRFA. 5 U.S.C.
605.
While a full understanding of OSHA's analysis and conclusions with
respect to costs and economic impacts on small entities requires a
reading of the complete PEA and its supporting materials, the IRFA
summarizes the key aspects of OSHA's analysis as they affect small
entities.
1. A Description of the Impact of the Proposed Rule on Small Entities
Section IX.F of this preamble summarized the impacts of the
proposed rule on small entities. Table IX-9 showed costs as a
percentage of profits and revenues for small entities, classified as
small by the Small Business Administration, and Tables IX-10 showed
costs as a percentage of revenues and profits for business entities
with fewer than 20 employees. (The costs in these tables were
annualized using a discount rate of 3 percent.)
2. A Description of the Reasons Why Action by the Agency Is Being
Considered
Chronic beryllium disease (CBD) is a hypersensitivity, or allergic
reaction, to beryllium that leads to a chronic inflammatory disease of
the lungs. It takes months to years after initial beryllium exposure
before signs and symptoms of CBD occur. Removing an employee with CBD
from the beryllium source does not always lead to recovery. In some
cases CBD continues to progress following removal from beryllium
exposure. CBD is not a chemical pneumonitis but an immune-mediated
granulomatous lung disease. OSHA's preliminary risk assessment,
presented in Section VI of this preamble, indicates that there is
significant risk of beryllium sensitization and chronic beryllium
disease from a 45-year (working life) exposure to beryllium at the
current TWA PEL of 2 [mu]g/m\3\. The risk assessment further indicates
that there is significant risk of lung cancer to workers exposed to
beryllium at the current TWA PEL of 2 [mu]g/m\3\. The proposed
standard, with a lower PEL of .2 [mu]g/m\3\, will help to address these
health concerns.
For CBD to occur, an employee must first become sensitized (i.e.,
allergic) to beryllium. Once an employee is sensitized, inhaled
beryllium that deposits and persists in the lung may trigger a cell-
mediated immune response (i.e., hypersensitivity reaction) that results
in the formation of a type of lung scarring known as a granuloma. The
granuloma consists of a localized mass of immune and inflammatory cells
that have formed around a beryllium particle lodged in the
interstitium, which is tissue between the air sacs that can be affected
by fibrosis or scarring. With time, the granulomas spread and can lead
to chronic cough, shortness of breath (especially upon exertion),
fatigue, abnormal pulmonary function, and lung fibrosis.
While CBD primarily affects the lungs, it can also involve other
organs such as the liver, skin, spleen, and kidneys. As discussed in
more detail in this preamble, some studies demonstrate that
sensitization and CBD cases have occurred in workplaces that use a wide
range of beryllium compounds, including several beryllium salts,
refined beryllium metal, beryllium oxide, and the beryllium alloys.
While water-soluble and insoluble beryllium compounds have the
potential to cause sensitization, it has been suggested that CBD is the
result of occupational exposure to beryllium oxide and other water-
insoluble berylliums rather than exposure to water-soluble beryllium or
beryllium ores. However, there are inadequate data, at this time, on
employees selectively exposed to specific beryllium compounds to
eliminate a potential CBD concern for any particular form of this
metal. Regardless of the type of beryllium compound, in order to cause
respiratory disease the inhaled beryllium must contain particulates
that are small enough to reach the bronchoalveolar region of the lung
where the disease takes place (OSHA, 2007).
Some research suggests that skin exposure to small beryllium
particles or beryllium-containing solutions may also lead to
sensitization (Tinkle et al., 2003). These additional risk factors may
explain why some individuals with seemingly brief, low level exposure
to airborne beryllium become sensitized while others with long-term
high exposures do not. Other studies indicate that even though
employees sensitized to beryllium do not exhibit clinical symptoms,
their immune function is altered such that inhalation to previously
safe levels of beryllium can now trigger serious lung disease (Kreiss
et al., 1996; Kreiss et al., 1997; Kelleher et al., 2001 and Rossman,
2001).
In the 1980s, the laboratory blood test known as the BeLPT was
developed. The test substantially improved identification of beryllium-
sensitized individuals and provides an opportunity to diagnose CBD at
an early stage. The BeLPT measures the ability of immune cells (i.e.,
peripheral blood lymphocytes) to react with beryllium. It has been
reported that the BeLPT can identify 70 to 90 percent of those
sensitized with a high specificity (approximately 1 to 3 percent false
positives) (Newman et al., 2001; Stange et al., 2004).
An employee with an abnormal BeLPT (i.e., the individual is
sensitized) can undergo fiber-optic bronchoscopy to obtain a lung
biopsy sample from which granulomatous lung inflammation can be
pathologically observed prior to the onset of symptoms. The combination
of a confirmed abnormal BeLPT (that is, a second abnormal result from
the BeLPT) and microscopic evidence of granuloma formation is
considered diagnostic for CBD. The BeLPT assists in differentiating CBD
from other granulomatous lung diseases (e.g., sarcoidosis) with similar
lung
[[Page 47750]]
pathology. This pre-clinical diagnostic tool provides opportunities for
early intervention that did not exist when diagnosis relied on clinical
symptoms, chest x-rays, and abnormal pulmonary function (OSHA, 2007).
The BeLPT/lung biopsy diagnostic approach has been utilized in
several occupational surveys and surveillance programs over the last
fifteen years. The findings have expanded scientific awareness of
sensitization and CBD prevalence among beryllium employees and provided
a better understanding of its work-related risk factors. Some of the
more informative studies come from nuclear weapons facilities operated
by the Department of Energy (Viet et al., 2000; Stange et al., 2001;
DOE/HSS Report, 2006), a beryllium ceramics plant in Arizona (Kreiss et
al., 1996; Henneberger et al., 2001; Cummings et al., 2007), a
beryllium production plant in Ohio (Kreiss et al., 1997; Kent et al.,
2001), a beryllium machining facility in Alabama (Kelleher et al.,
2001; Madl et al., 2007), and a beryllium alloy plant (Shuler et al.,
2005) and another beryllium processing plant (Rosenman et al., 2005),
both in Pennsylvania. The prevalence of beryllium sensitization from
these surveyed workforces generally ranged from 1 to 10 percent with a
prevalence of CBD from 0.6 to 8 percent.
In most of the surveys discussed above, 36-100 percent of those
workers who initially tested positive with the BeLPT were diagnosed
with CBD upon pathological evaluation. Most of these workers diagnosed
with CBD had worked four to10 years on the job, although some were
diagnosed within several months of employment. Surveys that found a
high proportion (e.g., larger than 50 percent) of CBD among the
sensitized employees were from facilities with a large number of
employees who had been exposed to respirable beryllium for many years.
It has been estimated from ongoing surveillance of sensitized
individuals, with an average follow-up time of 4.5 years, that 37
percent of beryllium-exposed employees were estimated to progress to
CBD (Newman et al, 2005). Another study of nuclear weapons facility
employees enrolled in an ongoing medical surveillance program found
that only about 20 percent of sensitized individuals employed less than
five years eventually were diagnosed with CBD while 40 percent of
sensitized employees employed ten years or more developed CBD (Stange
et al., 2001). This observation, along with the study findings that CBD
prevalence increases with cumulative exposure (described below),
suggests that sensitized employees who acquire a higher lung burden of
beryllium may be at greater risk of developing CBD than sensitized
employees who have lesser amounts of beryllium in their lungs.
The greatest prevalence of sensitization and CBD were reported for
production processes that involve heating beryllium metal (e.g.,
furnace operations, hot wire pickling, and annealing) or generating and
handling beryllium powder (e.g., machining, forming, firing). For
example, nearly 15 percent of machinists at the Arizona beryllium
ceramics plant were sensitized, compared to just 1 percent of workers
who never worked in machining (Kreiss et al., 1996). A low prevalence
of sensitization and CBD was reported among current employees at the
Department of Energy (DOE) clean-up sites where beryllium was once used
in the production of nuclear weapons (DOE/OSS, 2006). These sites have
been subject to the DOE CBD-prevention programs since 1999. While the
prevalence of sensitization and CBD in non-production jobs was less,
cases of CBD were found among secretaries, office employees, and
security guards. CBD cases have also been reported in downstream uses
of beryllium such as dental laboratories and metal recycling (OSHA,
2007).
The potential importance of respirable and ultrafine beryllium
particulates in the onset of CBD is illustrated in studies of employees
at a large beryllium metal, alloy, and oxide production plant in Ohio.
An initial cross-sectional survey reported that the highest prevalence
of sensitization and CBD occurred among workers employed in beryllium
metal production, even though the highest airborne total mass
concentrations of beryllium were generally among employees operating
the beryllium alloy furnaces in a different area of the plant (Kreiss
et al., 1997). Preliminary follow-up investigations of particle size-
specific sampling at five furnace sites within the plant determined
that the highest respirable (e.g., particles less than10 [mu]m in
diameter) and alveolar-deposited (e.g., particles less than1 [mu]m in
diameter) beryllium mass and particle number concentrations, as
collected by a general area impactor device, were measured at the
beryllium metal production furnaces rather than the beryllium alloy
furnaces (Kent et al., 2001; McCawley et al., 2001). A statistically
significant linear trend was reported between the above alveolar-
deposited particle mass concentration and prevalence of CBD and
sensitization in the furnace production areas. On the other hand, a
linear trend was not found for CBD and sensitization prevalence and
total beryllium mass concentration. The authors concluded that these
findings suggest that alveolar-deposited particles may be a more
relevant exposure metric for predicting the incidence of CBD or
sensitization than the total mass concentration of airborne beryllium
(OSHA, 2007).
Several epidemiological cohort studies have reported excess lung
cancer mortality among workers employed in U.S. beryllium production
and processing plants during the 1930s to 1960s. The largest and most
comprehensive study investigated the mortality experience of over 9,000
workers employed in seven different beryllium processing plants over a
30 year period (Ward et. al., 1992). The employees at the two oldest
facilities (i.e., Lorain, OH and Reading, PA) were found to have
significant excess lung cancer mortality relative to the U.S.
population. These two plants were believed to have the highest exposure
levels to beryllium. A different analysis of the lung cancer mortality
in this cohort using various local reference populations and alternate
adjustments for smoking generally found smaller, non-significant,
excess mortality among the beryllium employees (Levy et al., 2002). All
the cohort studies are limited by a lack of job history and air
monitoring data that would allow investigation of mortality trends with
beryllium exposure.
The weight of evidence indicates that beryllium compounds should be
regarded as potential occupational lung carcinogens, and OSHA has
regulated it since 1974. Other organizations, such as the International
Agency for Research on Cancer (IARC), the National Toxicology Program
(NTP), the U.S. Environmental Protection Agency (EPA), the National
Institute for Occupational Safety and Health (NIOSH), and the American
Conference of Governmental Industrial Hygienists (ACGIH) have reached
similar conclusions with respect to the carcinogenicity of beryllium.
3. A Statement of the Objectives of, and Legal Basis for, the Proposed
Rule
The objective of the proposed beryllium standard is to reduce the
number of fatalities and illnesses occurring among employees exposed to
beryllium. This objective will be achieved by requiring employers to
install engineering controls where appropriate and to provide employees
with the equipment, respirators, training, medical surveillance, and
other protective measures to perform their jobs safely. The legal basis
for the rule is the responsibility given the U.S.
[[Page 47751]]
Department of Labor through the Occupational Safety and Health Act of
1970 (OSH Act). The OSH Act provides that, in promulgating health
standards dealing with toxic materials or harmful physical agents, the
Secretary ``shall set the standard which most adequately assures, to
the extent feasible, on the basis of the best available evidence that
no employee will suffer material impairment of health or functional
capacity even if such employee has regular exposure to the hazard dealt
with by such standard for the period of his working life.'' 29 U.S.C.
655(b)(5). See Section II of this preamble for a more detailed
discussion.
4. A Description of, and an Estimate of, the Number of Small Entities
to Which the Proposed Rule Will Apply
OSHA has completed a preliminary analysis of the impacts associated
with this proposed rule, including an analysis of the type and number
of small entities to which the proposed rule would apply. In order to
determine the number of small entities potentially affected by this
rulemaking, OSHA used the definitions of small entities developed by
the Small Business Administration (SBA) for each industry.
The proposed standard would impact occupational exposures to
beryllium in all forms, compounds, and mixtures in general industry.
Based on the definitions of small entities developed by SBA for each
industry, the proposal is estimated to potentially affect a total of
3,741 small entities as shown in Table IX-1 in Chapter IX of the PEA.
The Agency also estimated costs and conducted a screening analysis
for very small employers (those with fewer than 20 employees). OSHA
estimates that approximately 2,875 very small entities would be
affected by the proposed standard, as shown in Table III-13 in Chapter
III of the PEA.
5. A Description of the Projected Reporting, Recordkeeping, and Other
Compliance Requirements of the Proposed Rule
Tables IX-23 and IX-24 show the average costs of the proposed
standard by NAICS code and by compliance requirement (PEL/STEL or
ancillary provisions) for, respectively, small entities (classified as
small by SBA) and very small entities (those with fewer than 20
employees). Total costs are reported as N/A for NAICS codes with no
affected entities in the relevant size classification. The weighted
average cost per small entity for the proposed rule would be about
$8,638 annually, with PEL/STEL compliance accounting for about 23
percent of the costs and ancillary provisions accounting for about 77
percent of the costs.
The weighted average cost per very small entity for the proposed
rule would be about $2,212 annually, with PEL/STEL compliance
accounting for about 39 percent of the costs and ancillary provisions
accounting for about 61 percent of the costs.
[[Page 47752]]
[GRAPHIC] [TIFF OMITTED] TP07AU15.037
[[Page 47753]]
[GRAPHIC] [TIFF OMITTED] TP07AU15.038
[[Page 47754]]
[GRAPHIC] [TIFF OMITTED] TP07AU15.039
[[Page 47755]]
[GRAPHIC] [TIFF OMITTED] TP07AU15.040
6. Federal Rules Which May Duplicate, Overlap or Conflict With the
Proposed Rule
Section 4(b)(1) of the OSH Act exempts the working conditions for
certain Federal and non-Federal employees from the provisions of the
OSH Act to the extent that other Federal agencies exercise statutory
authority to prescribe and enforce occupational safety and health
standards. The Department of Energy (DOE) issued a regulation in 1999
entitled Chronic Beryllium Disease Prevention Program (CBDPP) (10 CFR
part 850, 64 FR 68854-68914, December 8, 1999). Additionally, DOE
issued 10 CFR part
[[Page 47756]]
851, Worker Safety and Health Program (71 FR 6931-6948, February 9,
2006), which establishes requirements for worker safety and health for
DOE contractors at DOE sites. The CBDPP establishes a beryllium program
for DOE employees and DOE contractor employees. Therefore, under
Section 4(b)(1) of the OSH Act, OSHA's beryllium standard would not
apply to work subject to the CBDPP. DOE has included in its regulations
a requirement for compliance with any more stringent PEL established by
OSHA in rulemaking (10 CFR 850.22). OSHA requests comment on the
potential overlap of DOE's rule with OSHA's proposed rule. (See I.
Issues and Alternatives in this preamble).
There is also a Federal statute addressing the compensation of some
employees with beryllium related illnesses--The Energy Employees
Occupational Illness Compensation Program Act (EEOICPA) of 2000 and its
subsequent amendments. The EEOICPA creates a Federal employees'
compensation program that covers beryllium-related health effects for
DOE employees and its contractor employees, including many private
companies that work away from DOE sites. Several of the private
companies whose employees are covered by the OSH Act, either directly
in amendments to the OSH Act or identified in subsequent Department of
Labor regulations on that Act, would be covered by an OSHA occupational
health standard for beryllium and EEOICPA.
There would be no conflict or duplication, however, between an OSHA
standard and the EEOICPA. In general, the OSHA standard would have
requirements to protect employee health in the future, and the EEOICPA
provides compensation for employees who have developed beryllium-
related illness. There is some overlap between the two in that they may
both require similar medical examinations, or require employers to
provide some compensation to employees, but the proposed OSHA standard
specifically contemplates and addresses that overlap to avoid conflict
and duplication. The explanation for proposed paragraph (k) in Section
XVIII of this preamble, Summary and Explanation, notes that employers
may satisfy the both examination requirements with a single
examination, and the proposed standard specifies that the amount of an
employer's financial obligations will be reduced by the amount of
EEOICPA payments received by that employee (see proposed paragraph
(l)(4)).
7. Alternatives to the Proposed Rule Which Accomplish the Stated
Objectives of Applicable Statutes and Which Minimize Any Significant
Economic Impact of the Proposed Rule on Small Entities
This section first discusses several provisions in the proposed
standard that OSHA has adopted or modified based on comments from small
entity representatives (SERs) during the SBREFA process or on
recommendations made by the SBAR Panel as potentially alleviating
impacts on small entities. Then, the Agency presents various regulatory
alternatives to the proposed OSHA beryllium standard.
a. Elements of the Proposed Rule To Reduce Impacts on Small Entities
During the SBAR Panel, SERs requested a clearer definition of the
triggers for medical surveillance. This concern was rooted in the cost
of BeLPTs and the trigger of potential skin contact. For the proposed
rule, the Agency has removed skin contact as a trigger for medical
surveillance along with providing four clearly defined trigger
mechanisms. The newly defined medical surveillance provision reduces
the number of employees requiring a BeLPT, particularly for small
businesses with low exposures.
Some of the SERs in low-exposure industries wanted to be
``shielded'' from ``expensive'' compliance with a standard they
perceive to be unnecessary and suggested a PEL-only standard that
triggered provisions on the PEL. The alternative of a PEL-only standard
and ancillary provisions triggered only by the PEL are discussed in
Chapter 8 of the PEA (and is repeated in the following section).
Some SERs were already applying many of the protective controls and
practices that would be required by the ancillary provisions of the
standard. However, many SERs objected to the requirements regarding
hygiene facilities. For this proposed rule, OSHA has preliminarily
concluded that all affected employers currently have hand washing
facilities. OSHA has also preliminarily concluded that no affected
employers will be required to install showers. The Agency has
determined that the long-term rental of modular units was
representative of costs for a range of reasonable approaches to comply
with the change room part of the provision. Alternatively, employers
could renovate and rearrange their work areas in order to meet the
requirements of this provision.
b. Regulatory Alternatives
For the convenience of those persons interested only in OSHA's
regulatory flexibility analysis, this section repeats the discussion of
the various regulatory alternatives to the proposed OSHA beryllium
standard presented in Chapter VIII of the PEA, but only for the
regulatory alternatives to the proposed OSHA beryllium standard that
lower costs. OSHA believes that this presentation of specific
regulatory alternatives explores the possibility of less costly ways
(than the proposed rule) to provide an adequate level of worker
protection from exposure to beryllium.
Each regulatory alternative presented here is described and
analyzed relative to the proposed rule. Where appropriate, the Agency
notes whether the regulatory alternative, to be a legitimate candidate
for OSHA consideration, requires evidence contrary to the Agency's
preliminary findings of significant risk and feasibility. As noted
above, for this chapter on the Initial Regulatory Flexibility Analysis,
the Agency is only presenting regulatory alternatives that reduce costs
for small entities. (See Chapter VIII for the full list of all
alternatives analysed.) There are eight regulatory alternatives and an
informational alternative that reduce costs for small entities (and for
all businesses in total). Using the numbering scheme from Chapter VIII,
these are Regulatory Alternatives #5, #6, #7, #8. #12, #16, #18, and
#22. To facilitate comment, OSHA has organized these potentially less
costly regulatory alternatives (and a general discussion of possible
phase-ins of the rule) into four categories: (1) Exposure limits; (2)
methods of compliance; (3) ancillary provisions; and (4) timing.
(1) Exposure limit (TWA PEL, STEL, and ACTION LEVEL) alternatives
Regulatory Alternative #5, which would set a TWA PEL at 0.5 [mu]g/
m\3\ and an action level at 0.25 [mu]g/m\3\, both higher than in the
proposal, responds to an issue raised during the Small Business
Advocacy Review (SBAR) process conducted in 2007 to consider a draft
OSHA beryllium proposed rule that culminated in an SBAR Panel report
(SBAR, 2008). That report included a recommendation that OSHA consider
both the economic impact of a low TWA PEL and regulatory alternatives
that would ease cost burden for small entities. OSHA has provided a
full analysis of the economic impact of its proposed PELs (see Chapter
VI of the PEA), and Regulatory Alternative #5
[[Page 47757]]
addresses the second half of that recommendation. However, the higher
0.5 [mu]g/m\3\ TWA PEL does not appear to be consistent with the
Agency's mandate under the OSH Act to promulgate a lower PEL if it is
feasible and could prevent additional fatalities and non-fatal
illnesses. The data presented in Table IX-25 below indicate that the
lower TWA PEL would prevent additional fatalities and non-fatal
illnesses, but nevertheless the Agency solicits comments on this
alternative and OSHA's analysis of the costs and benefits associated
with it.
Table IX-25 below presents, for informational purposes, the
estimated costs, benefits, and net benefits of the proposed rule under
the proposed TWA PEL of 0.2 [mu]g/m\3\ and for the regulatory
alternative of a TWA PEL of 0.5 [mu]g/m\3\ (Regulatory Alternative #5),
using alternative discount rates of 3 percent and 7 percent. Table IX-
25 also breaks out costs by provision and benefits by type of disease
and by morbidity/mortality. As Table IX-25 shows, going from a TWA PEL
of 0.5 [mu]g/m\3\ to a TWA PEL of 0.2 [mu]g/m\3\ would prevent,
annually, an additional 29 beryllium-related fatalities and an
additional 15 non-fatal illnesses.
BILLING CODE 4510-26-P
[[Page 47758]]
[GRAPHIC] [TIFF OMITTED] TP07AU15.041
[[Page 47759]]
BILLING CODE 4510-26-P
Informational Alternative Featuring Unchanged PEL but Full Ancillary
Provisions
An Informational Analysis: This proposed regulation has the
somewhat unusual feature for an OSHA substance-specific health standard
that most of the quantified benefits would come from the ancillary
provisions rather than from meeting the PEL with engineering controls.
OSHA decided to analyze for informational purposes the effect of
retaining the existing PEL but applying all of the ancillary
provisions, including respiratory protection. Under this approach, the
TWA PEL would remain at 2.0 micrograms per cubic meter, but all of the
other proposed provisions (including respiratory protection, which OSHA
does not consider an ancillary provision) would be required with their
triggers remaining the same as in the proposed rule--either the
presence of airborne beryllium at any level (e.g., initial monitoring,
written exposure control plan), at certain kinds of dermal exposure
(PPE), at the action level of 0.1 [mu]g/m\3\ (e.g., periodic
monitoring, medical removal), or at 0.2 [mu]g/m\3\ (e.g., regulated
areas, respiratory protection, medical surveillance).
Given the record regarding beryllium exposures, this approach is
not one OSHA could legally adopt because the absence of a more
protective requirement for engineering controls would not be consistent
with section 6(b)(5) of the OSH Act, which requires OSHA to ``set the
standard which most adequately assures, to the extent feasible, on the
basis of the best available evidence, that no employee will suffer
material impairment of health or functional capacity even if such
employee has regular exposure to the hazard dealt with by such standard
for the period of his working life.'' For that reason, this additional
analysis is provided strictly for informational purposes. EO 12866 and
EO 13563 direct agencies to identify approaches that maximize net
benefits, and this analysis is purely for the purpose of exploring
whether this approach would hold any real promise to maximize net
benefits if it was permissible under the OSH Act. It does not appear to
hold such promise because an ancillary-provisions-only approach would
not be as protective and thus offers fewer benefits than one that
includes a lower PEL and engineering controls, and OSHA estimates the
costs would be about the same (or slightly lower, depending on certain
assumptions) under that approach as under the traditional proposed
approach.
On an industry by industry basis, OSHA found that some industries
would have lower costs if they could adopt the ancillary-provisions-
only approach. Some employers would use engineering controls where they
are cheaper, even if they are not mandatory. OSHA does not have
sufficient information to do an analysis of the employer-by-employer
situations in which there exist some employers for whom the ancillary-
provisions-only approach might be cheaper. In the majority of affected
industries, the Agency estimates there are no costs saving to the
ancillary-provisions-only approach. However, OSHA estimates a total of
$2,675,828 per year in costs saving for entire industries where the
ancillary-provisions-only approach would be less expensive.
The above discussion does not account for the possibility that the
lack of engineering controls would result in higher beryllium exposures
for workers in adjacent (non-production) work areas due to the
increased level of beryllium in the air. Because of a lack of data, and
because the issue did not arise in the other regulatory alternatives
OSHA considered (all of which have a PEL of less than 2.0 [mu]g/m\3\),
OSHA did not carefully examine exposure levels in non-production areas
for either cost or benefit purposes. To the extent such exposure levels
would be above the action level, there would be additional costs for
respiratory protection.
The ancillary-provisions-only approach adds uncertainty to the
benefits analysis such that the benefits of the rule as proposed may
exceed, and perhaps greatly exceed, the benefits of this ancillary-
provisions-only approach:
(1) Most exposed individuals would be in respirators, which OSHA
considers less effective than engineering controls in preventing
employee exposure to beryllium. OSHA last did an extensive review of
the evidence on effectiveness of respirators for its APFs rulemaking in
2006 (71 FR 50128-45 Aug 24, 2006). OSHA has not in the past tried to
quantify the size of this effect, but it could partially negate the
estimated benefits of 92 CBD deaths prevented per year and 4 lung
cancer cases prevented per year by the proposed standard.
(2) As noted above, in the proposal OSHA did not consider benefits
caused by reductions in exposure in non-production areas. Unless
employers act to reduce exposures in the production areas, the absence
of a requirement for such controls would largely negate such benefits
from reductions in exposure in the non-productions areas.
(3) OSHA believes that there is a strong possibility that the
benefits of the ancillary provisions (a midpoint estimate of
eliminating 45 percent of all remaining cases of CBD) would be
partially or wholly negated in the absence of engineering controls that
would reduce both airborne and surface dust levels. The measured
reduction in benefits from ancillary provision was in a facility with
average exposure levels of less than 0.2 [micro]g/m \3\.
Based on these considerations, OSHA believes that the ancillary-
provisions-only approach is not one that is likely to maximize net
benefits. The costs saving, if any, are estimated to be small, and the
difficult-to-measure declines in benefits could be substantial.
(2) A Method-of-compliance Alternative
Paragraph (f)(2) of the proposed rule contains requirements for the
implementation of engineering and work practice controls to minimize
beryllium exposures in beryllium work areas. For each operation in a
beryllium work area, employers must ensure that at least one of the
following engineering and work practice controls is in place to
minimize employee exposure: Material and/or process substitution;
ventilated enclosures; local exhaust ventilation; or process controls,
such as wet methods and automation. Employers are exempt from using
engineering and work practice controls only when they can show that
such controls are not feasible or where exposures are below the action
level based on two exposure samples taken seven days apart.
These requirements, which are based on the stakeholders'
recommended beryllium standard that beryllium industry and union
stakeholders submitted to OSHA in 2012 (Materion and USW, 2012),
address a concern associated with the proposed TWA PEL. OSHA expects
that day-to-day changes in workplace conditions, such as workers'
positioning or patterns of airflow, may cause frequent exposures above
the TWA PEL in workplaces where periodic sampling indicates exposures
are between the action level and the TWA PEL. As a result, the default
under the standard is that the controls are required until the employer
can demonstrate that exposures have not exceeded the action level from
at least two separate measurements taken seven days apart.
OSHA believes that substitution or engineering controls such as
those outlined in paragraph (f)(2)(i) provide the most reliable means
to control variability in exposure levels. However, OSHA also
recognizes that the requirements of paragraph (f)(2)(i) are
[[Page 47760]]
not typical of OSHA standards, which usually require engineering
controls only where exposures exceed the TWA PEL or STEL. The Agency is
therefore considering Regulatory Alternative #6, which would drop the
provisions of (f)(2)(i) from the proposed standard and make conforming
edits to paragraphs (f)(2)(ii) and (iii). This regulatory alternative
does not eliminate the need for engineering controls to comply with the
proposed TWA PEL and STEL, but does eliminate the requirement to use
one or more of the specified engineering or work practice controls
where exposures equal or exceed the action level. As shown in Table IX-
26, Regulatory Alternative #6 would decrease the annualized cost of the
proposed rule by about $457,000 using a discount rate of 3 percent and
by about $480,000 using a discount rate of 7 percent. OSHA has not been
able to estimate the change in benefits resulting from Regulatory
Alternative #6 at this time and invites public comment on this issue.
[GRAPHIC] [TIFF OMITTED] TP07AU15.042
(3) Regulatory Alternatives That Affect Ancillary Provisions
The proposed standard contains several ancillary provisions
(provisions other than the exposure limits), including requirements for
exposure assessment, medical surveillance, medical removal, training,
and regulated areas or access control. As reported in Chapter V of the
PEA, these ancillary provisions account for $27.8 million (about 72
percent) of the total annualized costs of the rule ($37.6 million)
using a 3 percent discount rate, or $28.6 million (about 73 percent) of
the total annualized costs of the rule ($39.1 million) using a 7
percent discount rate. The most expensive of the ancillary provisions
are the requirements for housekeeping and training, with annualized
costs of $12.6 million and $5.8 million, respectively, at a 3 percent
discount rate ($12.9 million and $5.8 million, respectively, at a 7
percent discount rate).
OSHA's reasons for including each of the proposed ancillary
provisions are explained in Section XVIII of this preamble, Summary and
Explanation of the Standards. In particular, OSHA is proposing the
requirements for exposure assessment to provide a basis for ensuring
that appropriate measures are in place to limit worker exposures.
Medical surveillance is especially important because workers exposed
above the proposed TWA PEL, as well as many workers exposed below the
proposed TWA PEL, are at significant risk of death and illness. Medical
surveillance would allow for identification of beryllium-related
adverse health effects at an early stage so that appropriate
intervention measures can be taken. OSHA is proposing regulated areas
and access control because they serve to limit exposure to beryllium to
as few employees as possible. OSHA is proposing worker training to
ensure that employers inform employees of the hazards to which they are
exposed, along with associated protective measures, so that employees
understand how they can minimize their exposure to beryllium. Worker
training on beryllium-related work practices is particularly important
in controlling beryllium exposures because engineering controls
frequently require action on the part of workers to function
effectively.
OSHA has examined a variety of regulatory alternatives involving
changes to one or more of the proposed ancillary provisions. The
incremental cost of each of these regulatory alternatives and its
impact on the total costs of the proposed rule is summarized in Table
IX-27 at the end of this section. OSHA has preliminarily determined
that several of these ancillary provisions will increase the benefits
of the proposed rule, for example, by helping to ensure the TWA PEL is
not exceeded or by lowering the risks to workers given the significant
risk remaining at the proposed TWA PEL. However, except for Regulatory
Alternative #7 (involving the elimination of all ancillary provisions),
OSHA did not estimate changes in monetized benefits for the regulatory
alternatives that affect ancillary provisions. Two regulatory
alternatives that involve all ancillary provisions are presented below
(#7 and #8), followed
[[Page 47761]]
by regulatory alternatives for regulated areas (#12), for medical
surveillance (#16 and #18), and for medical removal (#22).
(a) All Ancillary Provisions
The SBAR Panel recommended that OSHA analyze a PEL-only standard as
a regulatory alternative. The Panel also recommended that OSHA consider
not applying ancillary provisions of the standard where exposure levels
are low so as to minimize costs for small businesses (SBAR, 2008). In
response to these recommendations, OSHA analyzed Regulatory Alternative
#7, a PEL-only standard, and Regulatory Alternative #8, which would
apply ancillary provisions of the beryllium standard only where
exposures exceed the proposed TWA PEL of 0.2 [mu]g/m\3\ or the proposed
STEL of 2 [mu]g/m\3\.
Regulatory Alternative #7 would solely update 1910.1000 Tables Z-1
and Z-2, so that the proposed TWA PEL and STEL would apply to all
workers in general industry. This alternative would eliminate all of
the ancillary provisions of the proposed rule, including exposure
assessment, medical surveillance, medical removal, PPE, housekeeping,
training, and regulated areas or access control. Under this regulatory
alternative, OSHA estimates that the costs for the proposed ancillary
provisions of the rule (estimated at $27.8 million annually at a 3
percent discount rate) would be eliminated. In order to meet the PELs,
employers would still commonly need to do monitoring, train workers on
the use of controls, and set up some kind of regulated areas to
indicate where respirator use would be required. It is also likely
that, under this alternative, many employers would follow the
recommendations of Materion and the United Steelworkers to provide
medical surveillance, PPE, and other protective measures for their
workers (Materion and USW, 2012). OSHA has not attempted to estimate
the extent to which these ancillary-provision costs would be incurred
if they were not formally required or whether any of these costs under
Regulatory Alternative #7 would reasonably be attributable to the
proposed rule. OSHA welcomes comment on the issue.
OSHA has also estimated the effect of this regulatory alternative
on the benefits of the rule. As a result of eliminating all of the
ancillary provisions, annualized benefits are estimated to decrease 57
percent, relative to the proposed rule, from $575.8 million to $249.1
million, using a 3 percent discount rate, and from $255.3 million to
$110.4 million using a 7 percent discount rate. This estimate follows
from OSHA's analysis of benefits in Chapter VII of the PEA, which found
that about 57 percent of the benefits of the proposed rule, evaluated
at their mid-point value, were attributable to the combination of the
ancillary provisions. As these estimates show, OSHA expects that the
benefits estimated under the proposed rule will not be fully achieved
if employers do not implement the ancillary provisions of the proposed
rule.
Both industry and worker groups have recognized that a
comprehensive standard is needed to protect workers exposed to
beryllium. The stakeholders' recommended standard that representatives
of the primary beryllium manufacturing industry and the United
Steelworkers union provided to OSHA confirms the importance of
ancillary provisions in protecting workers from the harmful effects of
beryllium exposure (Materion and USW, 2012). Ancillary provisions such
as personal protective clothing and equipment, regulated areas, medical
surveillance, hygiene areas, housekeeping requirements, and hazard
communication all serve to reduce the risks to beryllium-exposed
workers beyond that which the proposed TWA PEL alone could achieve.
Moreover, where there is continuing significant risk at the TWA
PEL, the decision in the Asbestos case (Bldg. and Constr. Trades Dep't,
AFL-CIO v. Brock, 838 F.2d 1258, 1274 (D.C. Cir. 1988)) indicated that
OSHA should use its legal authority to impose additional requirements
on employers to further reduce risk when those requirements will result
in a greater than de minimis incremental benefit to workers' health.
Nevertheless, OSHA requests comment on this alternative.
Under Regulatory Alternative #8, several ancillary provisions that
the current proposal would require under a variety of exposure
conditions (e.g., dermal contact, any airborne exposure, exposure at or
above the action level) would instead only apply where exposure levels
exceed the TWA PEL or STEL. Regulatory Alternative #8 affects the
following provisions of the proposed standard:
-- Exposure monitoring: Whereas the proposed standard requires annual
monitoring when exposure levels are at or above the action level and at
or below the TWA PEL, Regulatory Alternative #8 would require annual
exposure monitoring only where exposure levels exceed the TWA PEL or
STEL;
--Written exposure control plan: Whereas the proposed standard requires
written exposure control plans to be maintained in any facility covered
by the standard, Regulatory Alternative #8 would require only
facilities with exposures above the TWA PEL or STEL to maintain a plan;
-- Housekeeping: Whereas the proposed standard's housekeeping
requirements apply across a wide variety of beryllium exposure
conditions, Alternative #8 would limit housekeeping requirements to
areas and employees with exposures above the TWA PEL or STEL;
-- PPE: Whereas the proposed standard requires PPE for employees under
a variety of conditions, such as exposure to soluble beryllium or
visible contamination with beryllium, Alternative #8 would require PPE
only for employees exposed above the TWA PEL or STEL;
-- Medical Surveillance: Whereas the proposed standard's medical
surveillance provisions require employers to offer medical surveillance
to employees with signs or symptoms of beryllium-related health effects
regardless of their exposure level, Alternative #8 would require
surveillance only for those employees exposed above the TWA PEL or
STEL.
To estimate the cost savings for this alternative, OSHA re-
estimated the group of workers that would fall under the above
provisions and the changes to their scope. Combining these various
adjustments along with associated unit costs, OSHA estimates that,
under this regulatory alternative, the costs for the proposed rule
would decline from $37.6 million to $18.9 million using a 3 percent
discount rate and from $39.1 million to $20.0 million using a 7 percent
discount rate.
The Agency has not quantified the impact of this alternative on the
benefits of the rule. However, ancillary provisions that offer
protective measures to workers exposed below the proposed TWA PEL, such
as personal protective clothing and equipment, beryllium work areas,
hygiene areas, housekeeping requirements, and hazard communication, all
serve to reduce the risks to beryllium-exposed workers beyond that
which the proposed TWA PEL and STEL could achieve. OSHA's preliminary
conclusion is that the requirements triggered by the action level and
other exposures below the proposed PELs will result in very real and
necessary, but difficult to quantify, further reduction in risk beyond
that provided by the PELs alone.
The remainder of this section discusses additional regulatory
alternatives that apply to individual
[[Page 47762]]
ancillary provisions. At this time, OSHA is not able to quantify the
effects of these regulatory alternatives on benefits. The Agency
solicits comment on the effects of these regulatory alternatives on the
benefits of the proposed rule.
(b) Regulated Areas
Proposed paragraph (e) requires employers to establish and maintain
beryllium work areas wherever employees are exposed to airborne
beryllium, regardless of the level of exposure, and regulated areas
wherever airborne concentrations of beryllium exceed the TWA PEL or
STEL. Employers are required to demarcate beryllium work areas and
regulated areas and limit access to regulated areas to authorized
persons.
The SBAR Panel report recommended that OSHA consider dropping or
limiting the provision for regulated areas (SBAR, 2008). In response to
this recommendation, OSHA examined Regulatory Alternative #12, which
would eliminate the requirement that employers establish regulated
areas. This alternative is meant only to eliminate the requirement to
set up and demarcate specific physical areas: All ancillary provisions
would be triggered by the same conditions as under the standard's
definition of a ``regulated area.'' For example, under the current
proposal, employees who work in regulated areas for at least 30 days
annually are eligible for medical surveillance. If OSHA were to remove
the requirement to establish regulated areas, the medical surveillance
provisions would be altered so that employees who work more than 30
days annually in jobs or areas with exposures that exceed the TWA PEL
or STEL are eligible for medical surveillance. This alternative would
not eliminate the proposed requirement to establish beryllium work
areas. As shown in Table IX-27, Regulatory Alternative #12 would
decrease the annualized cost of the proposed rule by about $522,000
using a 3 percent discount rate, and by about $523,000 using a 7
percent discount rate.
(e) Medical Surveillance
The proposed requirements for medical surveillance include: (1)
Medical examinations, including a test for beryllium sensitization, for
employees who are exposed to beryllium in a regulated area (i.e., above
the proposed TWA PEL or STEL) for 30 days or more per year, who are
exposed to beryllium in an emergency, or who show signs or symptoms of
CBD; and (2) CT scans for employees who were exposed above the proposed
TWA PEL or STEL for more than 30 days in a 12-month period for 5 years
or more. The proposed standard would require annual medical exams to be
provided for employees exposed in a regulated area for 30 days or more
per year and for employees showing signs or symptoms of CBD, while
tests for beryllium sensitization and CT scans would be provided to
eligible employees biennially.
OSHA estimated in Chapter V of the PEA that the medical
surveillance requirements would apply to 4,528 workers in general
industry, of whom 387 already receive that surveillance.\44\ In Chapter
V, OSHA estimated the costs of medical surveillance for the remaining
4,141 workers who would now have such protection due to the proposed
standard. The Agency's preliminary analysis indicates that four workers
with beryllium sensitization and six workers with CBD will be referred
to pulmonary specialists annually as a result of this medical
surveillance. Medical surveillance is particularly important for this
rule because beryllium-exposed workers, including many workers exposed
below the proposed PELs, are at significant risk of illness. OSHA did
not estimate, and the benefits analysis does not include, monetized
benefits resulting from early discovery of illness.
---------------------------------------------------------------------------
\44\ See current compliance rates for medical surveillance in
Chapter V of the PEA, Table V-15.
---------------------------------------------------------------------------
Medical surveillance was a subject of special concern to SERs
during the SBAR Panel process, and the SBAR Panel offered many comments
and recommendations related to medical surveillance for OSHA's
consideration. Some of the Panel's concerns have been partially
addressed in this proposal, which was modified since the SBAR Panel was
convened (see this preamble at Section XVIII, Summary and Explanation
of the Proposed Standard, for more detailed discussion). The regulatory
alternatives presented in this sub-section (#16, #18, and #20) also
respond to recommendations by the SBAR Panel to reduce burdens on small
businesses by dropping or reducing the frequency of medical
surveillance requirements. OSHA has preliminarily determined that a
significant risk of beryllium sensitization, CBD, and lung cancer
exists at exposure levels below the proposed TWA PEL and that there is
evidence that beryllium sensitization can occur even from short-term
exposures (see this preamble at Section V, Health Effects, and Section
VIII, Significance of Risk). The Agency therefore anticipates that more
employees would develop adverse health effects without receiving the
benefits of early intervention in the disease process because they are
not eligible for medical surveillance (see this preamble at Section V,
Health Effects).
In response to concerns raised during the SBAR Panel process about
testing requirements, OSHA is considering two regulatory alternatives
that would provide greater flexibility in the program of tests provided
as part of an employer's medical surveillance program. Under Regulatory
Alternative #16, employers would not be required to offer employees
testing for beryllium sensitization. As shown in Table IX-27, this
alternative would decrease the annualized cost of the proposed rule by
about $710,000 using a discount rate of 3 percent, and by about
$724,000 using a discount rate of 7 percent.
Regulatory Alternative #18 would eliminate the CT scan requirement
from the proposed rule. This alternative would decrease the annualized
cost of the proposed rule by about $472,000 using a discount rate of 3
percent, and by about $481,000 using a discount rate of 7 percent.
OSHA is considering several alternatives to the proposed frequency
of sensitization testing, CT scans, and general medical examinations.
The frequency of periodic medical surveillance is an important factor
in the efficacy of the surveillance in protecting worker health.
Regular, appropriately frequent medical surveillance promotes awareness
of beryllium-related health effects and early intervention in disease
processes among workers. In addition, the longer the time interval
between when a worker becomes sensitized and when the worker's case is
identified in the surveillance program, the more difficult it will be
to identify and address the exposure conditions that led to
sensitization. Therefore, reducing the frequency of sensitization
testing would reduce the usefulness of the surveillance information in
identifying problem areas and reducing risks to other workers. These
concerns must be weighed against the costs and other burdens of
surveillance.
Finally, under Regulatory Alternative #20, employers would only
have to provide all periodic components of the medical surveillance
exams biennially to eligible employees. This alternative would decrease
the annualized cost of the proposed rule by about $446,000 using a
discount rate of 3 percent and by about $433,000 using a discount rate
of 7 percent.
[[Page 47763]]
(d) Medical Removal
Under paragraph (l) of the proposed standard, Medical Removal,
employees in jobs with exposure at or above the action level become
eligible for medical removal when they are diagnosed with CBD or
confirmed positive for beryllium sensitization. When an employee
chooses removal, the employer is required to remove the employee to
comparable work in an environment where beryllium exposure is below the
action level if such work is available and the employee is either
already qualified or can be trained within one month. If comparable
work is not available, paragraph (l) would require the employer to
place the employee on paid leave for six months or until comparable
work becomes available (whichever comes first). Or, rather than
choosing removal, an eligible employee could choose to remain in a job
with exposure at or above the action level and wear a respirator. The
proposed medical removal protection (MRP) requirements are based on the
stakeholders' recommended beryllium standard that representatives of
the beryllium production industry and the United Steelworkers union
submitted to OSHA in 2012 (Materion and USW, 2012).
The scientific information on effects of exposure cessation is
limited at this time, but the available evidence suggests that removal
from exposure can be beneficial for individuals who are sensitized or
have early-stage CBD (see this preamble at Section VIII, Significance
of Risk). As CBD progresses, symptoms become serious and debilitating.
Steroid treatment is less effective at later stages, once fibrosis has
developed (see this preamble at Section VIII, Significance of Risk).
Given the progressive nature of the disease, OSHA believes it is
reasonable to conclude that removal from exposure to beryllium will
benefit sensitized employees and those with CBD. Physicians at National
Jewish Health, one of the main CBD research and treatment sites in the
US, ``consider it important and prudent for individuals with beryllium
sensitization and CBD to minimize their exposure to airborne
beryllium,'' and ``recommend individuals diagnosed with beryllium
sensitization and CBD who continue to work in a beryllium industry to
have exposure of no more than 0.01 micrograms per cubic meter of
beryllium as an 8-hour time-weighted average'' (NJMRC, 2013). However,
OSHA is aware that MRP may prove costly and burdensome for some
employers and that the scientific literature on the effects of exposure
cessation on the development of CBD among sensitized individuals and
the progression from early-stage to late-stage CBD is limited.
The SBAR Panel report included a recommendation that OSHA give
careful consideration to the impacts that an MRP requirement could have
on small businesses (SBAR, 2008). In response to this recommendation,
OSHA analyzed Regulatory Alternative #22, which would remove the
proposed requirement that employers offer MRP. As shown in Table IX-27,
this alternative would decrease the annualized cost of the proposed
rule by about $149,000 using a discount rate of 3 percent, and by about
$166,000 using a discount rate of 7 percent.
[[Page 47764]]
[GRAPHIC] [TIFF OMITTED] TP07AU15.043
(5) Timing
As proposed, the new standard would become effective 60 days
following publication in the Federal Register. The majority of employer
duties in the standard would become enforceable 90 days following the
effective date. Change rooms, however, would not be required until one
year after the effective date, and the deadline for engineering
controls would be no later than two years after the effective date.
OSHA invites suggestions for alternative phase-in schedules for
engineering controls, medical surveillance, and other provisions of the
standard. Although OSHA did not explicitly develop or quantitatively
analyze any other regulatory alternatives involving longer-term or more
complex phase-ins of the standard (possibly involving more delayed
implementation dates for small businesses), some general outcomes are
likely. For example, a longer phase-in time would have several
advantages, such as reducing initial costs of the standard or allowing
employers to coordinate their environmental and occupational safety and
health control strategies to minimize potential costs. However, a
longer phase-in would also postpone and reduce the benefits of the
standard. Suggestions for alternatives may apply to specific industries
(e.g., industries where first-year or annualized cost impacts are
highest), specific size-classes of employers (e.g., employers with
fewer than 20 employees), combinations of these factors, or all firms
covered by the rule.
OSHA requests comments on all these regulatory alternatives,
including the Agency's regulatory alternatives presented above, the
Agency's analysis of these alternatives, and whether there are other
regulatory alternatives the Agency should consider.
SBAR Panel
Table IX-28 lists all of the SBAR Panel recommendations and OSHA's
response to those recommendations.
[[Page 47765]]
Table IX-28--SBAR Panel Recommendations and OSHA Responses
------------------------------------------------------------------------
Panel recommendation OSHA response
------------------------------------------------------------------------
The Panel recommends that OSHA evaluate OSHA has reviewed its cost
carefully the costs and technological estimates and the
feasibility of engineering controls at technological feasibility of
all PEL options, especially those at engineering controls at
the lowest levels. various PEL levels. These
issues are discussed in the
Regulatory Alternatives
Chapter of the PEA.
The Panel recommends that OSHA consider OSHA has removed the initial
alternatives that would alleviate the exposure monitoring
need for monitoring in operations with requirement for workers likely
exposures far below the PEL. The Panel to be exposed to beryllium by
also recommends that OSHA consider skin or eye contact through
explaining more clearly how employers routine handling of beryllium
may use ``objective data'' to estimate powders or dusts or contact
exposures. Although the draft proposal with contaminated surfaces.
contains a provision allowing The periodic monitoring
employers to initially estimate requirement presented in the
exposures using ``objective data'' SBAR Panel report required
(e.g., data showing that the action monitoring every 6 months for
level is unlikely to be exceeded for airborne levels at or above
the kinds of process or operations an the action level but below the
employer has), the SERs did not appear PEL, and every 3 months for
to have fully understood how this exposures at or above the PEL.
alternative may be used. The proposed standard requires
annual exposure monitoring for
levels at or above the action
level and at or below the PEL.
By reducing the frequency of
periodic monitoring from every
6 months (version submitted to
the SBAR panel) to annually
where exposure levels are at
or below the PEL (the proposed
standard), the Agency has
lessened the need for
monitoring in small business
operations with exposures at
or below the PEL.
In this preamble, OSHA has
clarified the circumstances
under which an employer may
use historical and objective
data in lieu of initial
monitoring.
OSHA is also considering
whether to create a guidance
product on the use of
objective data. These issues
are discussed in this preamble
at Section XVIII, Summary and
Explanation of the Proposed
Standard, (d): Exposure
Monitoring.
The Panel recommends that OSHA consider In this preamble, OSHA has
providing some type of guidance to clarified the circumstances
describe how to use objective data to under which an employer may
estimate exposures in lieu of use historical and objective
conducting personal sampling. data in lieu of initial
Using objective data could provide monitoring. OSHA is also
significant regulatory relief to considering whether to create
several industries where airborne a guidance product on the use
exposures are currently reported by of objective data to satisfy
SERs to be well below even the lowest the requirements of the
PEL option. In particular, since proposed rule.
several ancillary provisions, which These issues are discussed in
may have significant costs for small this preamble at Section
entities may be triggered by the PEL XVIII, Summary and Explanation
or an action level, OSHA should of the Proposed Standard, (d):
consider encouraging and simplifying Exposure Monitoring.
the development of objective data from
a variety of sources.
The Panel recommends that OSHA revisit SERs with very low exposure
its analysis of the costs of regulated levels or only occasional work
areas if a very low PEL is proposed. with beryllium will not be
Drop or limit the provision for required to have regulated
regulated areas: SERs with very low areas unless exposures are
exposure levels or only occasional above the proposed PEL of 0.2
work with beryllium questioned the [mu]g/m\3\.
need for separating areas of work by The proposed standard requires
exposure level. Segregating machines the employer to establish and
or operations, SERs said, would affect maintain a regulated area
productivity and flexibility. Until wherever employees are, or can
the health risks of beryllium are be expected to be exposed to
known in their industries, SERs airborne beryllium at levels
challenged the need for regulated above a PEL of 0.2 [mu]g/m\3\.
areas.
The Panel recommends that OSHA revisit The Agency has removed skin
its cost model for hygiene areas to exposure as a trigger for the
reflect SERs' comments that estimated hygiene provision. The
costs are too low and more carefully requirement for washing
consider the opportunity costs of facilities applies to each
using space for hygiene areas where employee working in a
SERs report they have no unused space beryllium work area. A
in their physical plant for them. The beryllium work area means any
Panel also recommends that OSHA work area where employees are,
consider more clearly defining the or can reasonably be expected
triggers (skin exposure and to be, exposed to airborne
contaminated surfaces) for the hygiene beryllium. OSHA has
areas provisions. In addition, the preliminarily concluded that
Panel recommends that OSHA consider all affected employers
alternative requirements for hygiene currently have hand-washing
areas dependent on airborne exposure facilities.
levels or types of processes. Such OSHA has also preliminarily
alternatives might include, for concluded that no affected
example, hand washing facilities in employers will be required to
lieu of showers in particular cases or install showers.
different hygiene area triggers where Change rooms have only been
exposure levels are very low. costed for regulated areas or
where employees are, or can
reasonably be expected to be,
exposed to airborne beryllium
at levels above the PEL. The
Agency has determined that the
long-term rental of modular
units was representative of
costs for a range of
reasonable approaches to
comply with the change room
part of the provision.
Alternatively, employers could
renovate and rearrange their
work areas in order to meet
the requirements of this
provision.
[[Page 47766]]
The Panel recommends that OSHA consider In this preamble, OSHA has
clearly explaining the purpose of the clarified the purpose of the
housekeeping provision and describing housekeeping provision.
what affected employers must do to However, due to the variety of
achieve it. For example, OSHA should work settings in which
consider explaining more specifically beryllium is used, OSHA has
what surfaces need to be cleaned and preliminarily concluded that a
how frequently they need to be highly specific directive on
cleaned. The Panel recommends that the what surfaces need to be
Agency consider providing guidance in cleaned, and how frequently,
some form so that employers understand would not provide effective
what they must do. The Panel also guidance to businesses.
recommends that once the requirements Instead, at the suggestion of
are clarified that the Agency re- industry and union
analyzes its cost estimates. stakeholders (Materion and
The Panel also recommends that OSHA USW, 2012), OSHA's proposed
reconsider whether the risk and cost standard includes a more
of all parts of the medical flexible requirement for
surveillance provisions are employers to develop a written
appropriate where exposure levels are exposure control plan specific
very low. In that context, the Panel to their facilities. The
recommends that OSHA should also written exposure control plan
consider the special problems and must include documentation of
costs to small businesses that up operations and jobs with
until now may not have had to provide beryllium exposure and
or manage the various parts of an housekeeping procedures,
occupational health standard or including surface cleaning and
program. beryllium migration control.
OSHA requests suggestions for
examples of specific guidance
that could be helpful to
employers preparing written
exposure control plans.
These issues are discussed in
this preamble at Section
XVIII, Summary and Explanation
of the Proposed Standard, (f)
Methods of Compliance and (j)
Housekeeping.
Regulatory Alternative #20
would reduce the frequency of
physical examinations from
annual to biennial, matching
the frequency of BeLPT testing
in the proposed rule.
These alternatives for medical
surveillance are discussed in
the Regulatory Alternatives
Chapter and in this preamble
at section XVIII, Summary and
Explanation of the Proposed
Standard, (k) Medical
Surveillance.
The Panel recommends that OSHA consider Under the proposed standard,
that small entities may lack the employees are only eligible
flexibility and resources to provide for medical removal if they
alternative jobs to employees who test are sensitized or have been
positive for the BeLPT, and whether diagnosed with CBD; skin
MRP achieves its intended purpose exposure is not a trigger for
given the course of beryllium disease. medical removal (unlike the
The Panel also recommends that if MRP version submitted by the SBAR
is implemented, that its effects on Panel). After becoming
the viability of very small firms with eligible for medical removal
a sensitized employee be considered an employee may choose to
carefully. remain in a job with exposure
at or above the action level,
provided that the employee
wears a respirator in
accordance with the
Respiratory Protection
standard (29 CFR 1910.134). If
the employee chooses removal,
the employer is only required
to place the employee in
comparable work with exposure
below the action level if such
work is available; if such
work is not available, the
employer may place the
employee on paid leave for six
months or until such work
becomes available.
OSHA discusses the basis of the
provision and requests
comments on it in this
preamble at Section XVIII,
Summary and Explanation of the
Proposed Standard, (l) Medical
Removal Protection. OSHA
provides an analysis of costs
and economic impacts of the
provision in the PEA in
Chapter 5 and Chapter 6,
respectively.
The Panel recommends that OSHA consider As stated above, the triggers
more clearly defining the trigger for medical surveillance in
mechanisms for medical surveillance the proposed standard have
and also consider additional or changed from those presented
alternative triggers--such as limiting to the SBAR Panel. Whereas the
the BeLPT to a narrower range of draft standard presented at
exposure scenarios and reducing the the SBAR Panel required
frequency of BeLPT tests and physical medical surveillance for
exams. The Panel also recommends that employees with skin contact--
OSHA reconsider whether the risk and potentially applying to
cost of all parts of the medical employees with any level of
surveillance provisions are airborne exposure--the
appropriate where exposure levels are proposed standard ties medical
very low. In that context, the Panel surveillance to exposures
recommends that OSHA should also above the proposed PEL of 0.2
consider the special problems and [mu]g/m\3\ (or signs or
costs to small businesses that up symptoms of beryllium-related
until now may not have had to provide health effects, or emergency
or manage the various parts of an exposure). Thus, small
occupational health standard or businesses with exposures
program. below the proposed PEL would
not need to provide or manage
medical surveillance for their
employees unless employees
develop signs or symptoms of
beryllium-related health
effects or are exposed in
emergencies.
These issues are discussed in
this preamble at section
XVIII, Summary and Explanation
of the Proposed Standard, (k)
Medical Surveillance.
The Panel recommends that the Agency, OSHA has reviewed the possible
in evaluating the economic feasibility effects of the proposed
of a potential regulation, consider regulation on market demand
not only the impacts of estimated and/or foreign production, in
costs on affected establishments, but addition to the Agency's usual
also the effects of the possible measures of economic impact
outcomes cited by SERs: loss of market (costs as a fraction of
demand, the loss of market to foreign revenues and profits). This
competitors, and of U.S. production discussion can be found in
being moved abroad by U.S. firms. The Chapter VI of the PEA
Panel also recommends that OSHA (entitled Economic Feasibility
consider the potential burdens on Analysis and Regulatory
small businesses of dealing with Flexibility Determination).
employees who have a positive test
from the BeLPT. OSHA may wish to
address this issue by examining the
experience of small businesses that
currently provide the BeLPT.
[[Page 47767]]
The Panel recommends that OSHA consider The provisions in the standard
seeking ways of minimizing costs for presented in the SBAR panel
small businesses where the exposure report applied to all
levels may be very low. Clarifying the employees, whereas the
use of objective data, in particular, proposed standard's ancillary
may allow industries and provisions are only applied to
establishments with very low exposures employees in work areas who
to reduce their costs and involvement are, or can reasonably be
with many provisions of a standard. expected to be, exposed to
The Panel also recommends that the airborne beryllium.
Agency consider tiering the In addition, the scope of the
application of ancillary provisions of proposed standard includes
the standard according to exposure several limitations. Whereas
levels and consider a more limited or the standard presented in the
narrowed scope of industries. SBAR panel report covered
beryllium in all forms and
compounds in general industry,
construction, and maritime,
the scope of the proposed
standard (1) applies only to
general industry; (2) does not
apply to beryllium-containing
articles that the employer
does not process; and (3) does
not apply to materials that
contain less than 0.1 percent
beryllium by weight.
In this preamble, OSHA has
clarified the circumstances
under which an employer may
use historical and objective
data in lieu of initial
monitoring (Section XVIII,
Summary and Explanation of
this Proposed Standard, (d)
Exposure Monitoring). OSHA is
also considering whether to
create a guidance product on
the use of objective data to
comply with the requirements
of this proposed standard.
OSHA is considering two
Regulatory Alternatives that
would reduce the impact of
ancillary alternatives on
employers, including small
businesses. Regulatory
Alternative #7, a PEL-only
standard, would drop all
ancillary provisions from the
standard. Regulatory
Alternative #8 would limit the
application of several
ancillary provisions,
including Exposure Monitoring,
the written exposure control
plan section of Method of
Compliance, PPE, Housekeeping,
and Medical Surveillance, to
operations or employees with
exposure levels exceeding the
TWA PEL or STEL. These
alternatives are discussed in
the Regulatory Alternatives
Chapter and in this preamble
at Section I, Issues and
Alternatives.
The Panel recommends that OSHA provide The explanation and analysis
an explanation and analysis for all for all health outcomes (and
health outcomes (and their scientific their scientific basis) are
basis) upon which it is regulating discussed in this preamble at
employee exposure to beryllium. The Section V, Health Effects, and
Panel also recommends that OSHA Section VI, Preliminary Risk
consider to what extent a very low PEL Assessment. They are also
(and lower action level) may result in reviewed in this preamble at
increased costs of ancillary Section VIII, Significance of
provisions to small entities (without Risk, and the Benefits Chapter
affecting airborne employee of the PEA. OSHA requests
exposures). Since in the draft comment on these health
proposal the PEL and action level are outcomes.
critical triggers, the Panel As discussed above, OSHA is
recommends that OSHA consider considering Regulatory
alternate action levels, including an Alternatives #7 and #8, which
action level set at the PEL, if a very would eliminate or reduce the
low PEL is proposed. impact of ancillary provisions
on employers, respectively.
These alternatives are
discussed in the Regulatory
Alternatives Chapter of the
PEA and in this preamble at
Section I, Issues and
Alternatives. OSHA seeks
comment on other ways to avoid
costs of ancillary provisions
when they are not necessary to
protect employees from
exposure to beryllium.
The Panel recommends that OSHA consider OSHA has removed skin exposure
more clearly and thoroughly defining as a trigger for several
the triggers for ancillary provisions, ancillary provisions in this
particularly the skin exposure proposed standard, including
trigger. In addition, the Panel Exposure Monitoring, Hygiene
recommends that OSHA clearly explain Areas and Practices, and
the basis and need for small entities Medical Surveillance. In
to comply with ancillary provisions. addition, the language of this
The Panel also recommends that OSHA proposed standard regarding
consider narrowing the trigger related skin exposure has changed: for
to skin and contamination to capture some ancillary provisions,
only those situations where surfaces including PPE and
and surface dust may contain beryllium Housekeeping, the requirements
in a concentration that is significant are triggered by visible
enough to pose any risk--or limiting contamination with beryllium
the application of the trigger for or dermal contact with soluble
some ancillary provisions. beryllium compounds. These
requirements are discussed in
this preamble at Section
XVIII, Summary and Explanation
of this Proposed Standard. The
Agency has also explained the
basis and need for compliance
with ancillary provisions in
this preamble at Section
XVIII, Summary and
Explanation.
Several SERs said that OSHA should In the Technological
first assume the burden of describing Feasibility Analysis presented
the exposure level in each industry in the PEA, OSHA has described
rather than employers doing so. Others the exposure level in each
said that the Agency should accept industry or application group.
exposure determinations made on an In this preamble, OSHA has
industry-wide basis, especially where clarified the circumstances
exposures were far below the PEL under which an employer may
options under consideration. use historical and objective
As noted above, the Panel recommends data in lieu of initial
that OSHA consider alternatives that monitoring (section XVIII,
would alleviate the need for Summary and Explanation of
monitoring in operations or processes this Proposed Standard, (d)
with exposures far below the PEL. The Exposure Monitoring). Industry-
use of objective data is a principal wide data may be used as
method for industries with low objective data to support an
exposures to satisfy compliance with a employer's case that exposures
proposed standard. The Panel at its facilities are far
recommends that OSHA consider below the PEL. OSHA is also
providing some guidance to small considering whether to create
entities in the use of objective data. a guidance product on the use
of objective data to comply
with requirements in the
proposed standard.
[[Page 47768]]
The Panel recommends that OSHA consider OSHA has provided discussion of
more fully evaluating whether the the BeLPT in Appendix A to the
BeLPT is suitable as a test for regulatory text; in this
beryllium sensitization in an OSHA preamble at section V, Health
standard and respond to the points Effects; and in this preamble
raised by the SERs about its efficacy. at section XVIII, Summary and
In addition, the Agency should Explanation, (k) Medical
consider the availability of other Surveillance. In the
tests under development for detecting regulatory text, OSHA has
beryllium sensitization and not limit clarified that a test for
either employers' choices or new beryllium sensitization other
science and technology in this area. than the BeLPT may be used in
Finally, the Panel recommends that lieu of the BeLPT if a more
OSHA re-consider the trigger for reliable and accurate
medical surveillance where exposures diagnostic test is developed.
are low and consider if there are In this preamble at Section I,
appropriate alternatives. Issues and Alternatives, the
Agency requests comments on
the BeLPT and on the
reliability and accuracy of
alternate tests.
As stated above, the triggers
for medical surveillance in
this proposed standard have
changed from those presented
to the SBAR Panel. Whereas the
draft standard presented
during the SBREFA process
required medical surveillance
for employees with skin
contact--potentially applying
to employees with any level of
airborne exposure--this
proposed standard ties medical
surveillance to exposures
above the proposed PEL of 0.2
[mu]g/m\3\ (or signs or
symptoms of beryllium-related
health effects, or emergency
exposure). The triggers for
medical surveillance are
discussed in this preamble at
section XVIII, Summary and
Explanation, (k) Medical
Surveillance.
OSHA is considering Regulatory
Alternative #16, which would
eliminate BeLPT testing
requirements from this
proposed standard. This
alternative is discussed in
the Regulatory Alternatives
Chapter and in in this
preamble at Section XVIII,
Summary and Explanation of the
Proposed Standard, (k) Medical
Surveillance.
Seeking ways of minimizing costs to low The standard presented in the
risk processes and operations: OSHA SBAR panel report had skin
should consider alternatives for exposure as a trigger. The
minimizing costs to industries, only skin exposure trigger in
operations, or processes that have low this proposed standard is the
exposures. Such alternatives may requirement for PPE when
include, but not be limited to: employees' skin is potentially
encouraging the use of objective data exposed to soluble beryllium
by such mechanisms as providing compounds. OSHA uses an
guidance for objective data; assuring exposure profile to determine
that triggers for skin exposure and which workers will be affected
surface contamination are clear and do by the standard. As a result,
not pull in low risk operations; this proposed standard
providing guidance on least-cost ways establishes regulated work
for low risk facilities to determine areas and exposure monitoring
what provisions of the standard they only with respect to employees
need to comply with; and considering who are, or can reasonably be
ways to limit the scope of 28 the expected to be, exposed to
standard if it can be ascertained that airborne beryllium.
certain processes do not represent a In addition, the scope of this
significant risk. proposed standard includes
several limitations. Whereas
the standard presented in the
SBAR panel report covered
beryllium in all forms and
compounds in general industry,
construction, and maritime,
the scope of this proposed
standard (1) applies only to
general industry; (2) does not
apply to beryllium-containing
articles that the employer
does not process; and (3) does
not apply to materials that
contain less than 0.1 percent
beryllium by weight. In this
preamble, OSHA has clarified
the circumstances under which
an employer may use historical
and objective data in lieu of
initial monitoring (Section
XVIII, Summary and Explanation
of this Proposed Standard, (d)
Exposure Monitoring). OSHA is
also considering whether to
create a guidance product on
the use of objective data.
PEL-only standard: One SER recommended OSHA is considering Regulatory
a PEL-only standard. This would Alternative #7, a PEL-only
protect employees from airborne standard. This alternative is
exposure risks while relieving the discussed in the Regulatory
beryllium industry of the cost of the Alternatives Chapter of the
ancillary provisions. The Panel PEA and in this preamble at
recommends that OSHA, consistent with Section I, Issues and
its statutory obligations, analyze Alternatives.
this alternative.
Alternative triggers for ancillary OSHA has removed skin exposure
provisions: The Panel recommends that as a trigger for several
OSHA clarify and consider eliminating ancillary provisions in this
or narrowing the triggers for proposed standard, including
ancillary provisions associated with Exposure Monitoring, Hygiene
skin exposure or contamination. In Areas and Practices, and
addition, the Panel recommends that Medical Surveillance. In
OSHA should consider trying ancillary addition, the language of this
provisions dependent on exposure proposed standard regarding
rather than have these provisions all skin exposure has changed: for
take effect with the same trigger. If some ancillary provisions,
OSHA does rely on a trigger related to including PPE and
skin exposure, OSHA should thoroughly Housekeeping, the requirements
explain and justify this approach are triggered by visible
based on an analysis of the scientific contamination with beryllium
or research literature that shows a or skin contact with soluble
risk of sensitization via exposure to beryllium compounds. These
skin. If OSHA adopts a relatively low requirements are discussed in
PEL, OSHA should consider the effects this preamble at Section
of alternative airborne action levels XVIII, Summary and
in pulling in many low risk facilities Explanation. OSHA has
that may be unlikely to exceed the explained the scientific basis
PEL--and consider using only the PEL for minimizing skin exposure
as a trigger at very low levels. to beryllium in this preamble
at Section V, Health Effects,
and explains the basis for
specific ancillary provisions
related to skin exposure in
this preamble at Section
XVIII, Summary and
Explanation.
[[Page 47769]]
In this proposed standard, the
application of ancillary
provisions is dependent on
exposure, and not all
provisions take effect with
the same trigger. A number of
requirements are triggered by
exposures (or a reasonable
expectation of exposures)
above the PEL or action level
(AL). As discussed above, OSHA
is considering Regulatory
Alternatives #7 and #8, which
would eliminate or reduce the
impact of ancillary provisions
on employers, respectively.
These alternatives are
discussed in the Regulatory
Alternatives Chapter of the
PEA and in this preamble at
Section I, Issues and
Alternatives.
Revise the medical surveillance Responding to comments from
provisions, including eliminating the SERs, OSHA has revised the
BeLPT: The BeLPT was the most common medical surveillance provision
complaint from SERs. The Panel and removed the skin exposure
recommends that OSHA carefully examine trigger for medical
the value of the BeLPT and consider surveillance. As a result,
whether it should be a requirement of OSHA estimates that the number
a medical surveillance program. The of small-business employees
Panel recommends that OSHA present the requiring a BeLPT will be
scientific evidence that supports the substantially reduced.
use of the BeLPT as several SERs were OSHA has provided discussion of
doubtful of its reliability. The Panel the BeLPT in Appendix A to the
recommends that OSHA also consider regulatory text; in this
reducing the frequency of physicals preamble at section V, Health
and the BeLPT, if these provisions are Effects; and in this preamble
included in a proposal. The Panel at section XVIII, Summary and
recommends that OSHA also consider a Explanation, (k) Medical
performance-based medical surveillance Surveillance. In the
program, permitting employers in regulatory text, OSHA has
consultation with physicians and clarified that a test for
health experts to develop appropriate beryllium sensitization other
tests and their frequency. than the BeLPT may be used in
lieu of the BeLPT if a more
reliable and accurate
diagnostic test is developed.
In this preamble at Section I,
Issues and Alternatives, the
Agency requests comments on
the BeLPT and on the
reliability and accuracy of
alternate tests.
The frequency of periodic BeLPT
testing in this proposed
standard is biennial, whereas
annual testing was included in
the draft standard presented
to the SBAR Panel.
Regulatory Alternative #20
would reduce the frequency of
physical examinations from
annual to biennial, matching
the frequency of BeLPT testing
in this proposed rule.
In response to the suggestion
to allow performance-based
medical surveillance, OSHA is
considering two regulatory
alternatives that would
provide greater flexibility in
the program of tests provided
as part of an employer's
medical surveillance program.
Regulatory Alternative #16
would eliminate BeLPT testing
requirements from this
proposed standard. Regulatory
Alternative #18 would
eliminate the CT scan
requirement from this proposed
standard. These alternatives
are discussed in the
Regulatory Alternatives
Chapter and in this preamble
at Section XVIII, Summary and
Explanation, (k) Medical
Surveillance.
No medical removal protection (MRP): This proposed standard includes
OSHA's draft proposed standard did not an MRP provision. OSHA
include any provision for medical discusses the basis of the
removal protection, but OSHA did ask provision and requests
the SERs to comment on MRP as a comments on it in this
possibility. Based on the SER preamble at Section XVIII,
comments, the Panel recommends that if Summary and Explanation, (l)
OSHA includes an MRP provision, the Medical Removal Protection.
agency provide a thorough analysis of OSHA provides an analysis of
why such a provision is needed, what costs and economic impacts of
it might accomplish, and what its full the provision in the PEA in
costs and economic impacts on those Chapter V and Chapter VI,
small businesses that need to use it respectively.
might be. The Agency is considering
Alternative #22, which would
eliminate the MRP requirement
from the standard. This
alternative is discussed in
the Regulatory Alternatives
Chapter and in in this
preamble at section XVIII,
Summary and Explanation, (l)
Medical Removal Protection.
------------------------------------------------------------------------
X. OMB Review Under the Paperwork Reduction Act of 1995
A. Overview
The proposed general industry standard for occupational exposure to
beryllium contains collection of information (paperwork) requirements
that are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (PRA-95), 44 U.S.C. 3501 et
seq., and OMB's regulations at 5 CFR part 1320. PRA-95 defines
``collection of information'' to mean, ``the obtaining, causing to be
obtained, soliciting, or requiring the disclosure to third parties or
the public, of facts or opinions by or for an agency, regardless of
form or format'' (44 U.S.C. 3502(3)(A)).
Under PRA-95, a Federal agency cannot conduct or sponsor a
collection of information unless OMB approves it, and the agency
displays a currently valid OMB control number. In addition, the public
is not required to respond to a collection of information unless the
collection of information displays a currently valid OMB control
number. Also, notwithstanding any other provision of law, no person
shall be subject to penalty for failing to comply with a collection of
information if the collection of information does not display a
currently valid OMB control number.
B. Solicitation of Comments
OSHA prepared and submitted an Information Collection Request (ICR)
for the collection of information requirements identified in this NPRM
to OMB for review in accordance with 44 U.S.C. 3507(d). The Agency
solicits comments on the proposed collection of information
requirements and the estimated burden hours and costs associated with
these requirements, including comments on the following items:
Whether the proposed collection of information
requirements are necessary for the proper performance of the
[[Page 47770]]
Agency's functions, including whether the information is useful;
The accuracy of OSHA's estimate of the burden (time and
cost) of the information collection requirements, including the
validity of the methodology and assumptions used;
The quality, utility and clarity of the information
collected; and
Ways to minimize the compliance burden on employers, for
example, by using automated or other technological techniques for
collecting and transmitting information.
C. Proposed Collection of Information Requirements
As required by 5 CFR 1320.5(a)(1)(iv) and 1320.8(d)(1), the
following paragraphs provide information about this ICR.
1. Title: Occupational Exposure to Beryllium
2. Description of the ICR: The proposed Beryllium standard contains
collection of information requirements which are essential components
of the occupational safety and health standard that will assist both
employers and their employees in identifying the exposures to beryllium
and beryllium compounds, the medical effects of such exposures, and the
means to reduce the risk of overexposures to beryllium and beryllium
compounds.
3. Brief Summary of the Collection of Information Requirements
Below is a summary of the collection of information requirements
identified in the Beryllium proposal. Specific details contained in the
following collections of information requirements are discussed in
Section XVIII: Summary and Explanation of the Proposed Standard.
Sec. 1910.1024(d) Exposure Monitoring
Under paragraph (d)(5)(i) of the proposed standard, within 15
working days after receiving the results of any exposure monitoring
completed under this standard, employers must notify each employee
whose exposure is characterized by the monitoring in writing. Employers
must either notify each of these employees individually in writing, or
post the exposure monitoring results in an appropriate location
accessible to all of these employees. In this proposed standard, the
following provisions require exposure monitoring: Sec.
1910.1024(d)(1), General; Sec. 1910.1024(d)(2), Initial Exposure
Monitoring; Sec. 1910.1024(d)(3), Periodic Exposure Monitoring; Sec.
1910.1024(d)(4), Additional Monitoring.
Proposed paragraph (d)(5)(ii) details additional information an
employer would need to include in the written notification in
(d)(5)(i), should beryllium exposure exceed the TWA PEL or STEL: a
description of the suspected or known sources of exposure, and the
corrective action(s) the employer has taken or will take to reduce the
employee's exposure to or below the applicable PEL.
Sec. 1910.1024(e)(2)(i) & (ii) Demarcation of Beryllium Work Areas
Proposed paragraph (e)(2)(i) would require employers to identify
each beryllium work area through signs or any other methods that
adequately establish and inform each employee of the boundaries of each
beryllium work area. Paragraph (e)(2)(ii) would require employers to
identify each regulated area in accordance with paragraph (m)(2).
Sec. 1910.1024(f)(1)(i), (ii), and (iii) Written Exposure Control Plan
Proposed paragraph (f)(1)(i) would require employers to establish,
implement, and maintain a written exposure control plan for beryllium
work areas. The plan must contain: (A) An inventory of operations and
job titles reasonably expected to have exposure; (B) an inventory of
operations and job titles reasonably expected to have exposure at or
above the action level; (C) an inventory of operations and job titles
reasonably expected to have exposure above the TWA PEL or STEL; (D)
procedures for minimizing cross-contamination, including but not
limited to preventing the transfer of beryllium between surfaces,
equipment, clothing, materials, and articles within beryllium work
areas; (E) procedures for keeping surfaces in the beryllium work area
as free as practicable of beryllium; (F) procedures for minimizing the
migration of beryllium from beryllium work areas to other locations
within or outside the workplace; (G) an inventory of engineering and
work practice controls; and (H) procedures for removal, laundering,
storage, cleaning, repairing, and disposal of beryllium-contaminated
personal protective clothing and equipment, including respirators.
Proposed paragraph (f)(1)(ii) would require employers to update
their exposure control plans whenever any change in production
processes, materials, equipment, personnel, work practices, or control
methods results or can reasonably be expected to result in new or
additional exposures to beryllium. Paragraph (f)(1)(ii) also requires
employers to update their plans when an employee is confirmed positive
for beryllium sensitization, is diagnosed with CBD, or shows other
signs or symptoms related to beryllium exposure. In addition, this
paragraph requires employers to update their plans if the employer has
any reason to believe that new or additional exposures are occurring or
will occur. Proposed paragraph (f)(1)(iii) would require employers to
make a copy of the exposure control plan accessible to each employee
who is or can reasonably be expected to be exposed to airborne
beryllium in accordance with OSHA's Access to Employee Exposure and
Medical Records (Records Access) standard (29 CFR 1910.1020(e)).
Sec. 1910.1024(g) Respiratory Protection
Proposed paragraph (g)(1) would require employers to provide at no
cost and ensure that each employee uses respiratory protection during
certain periods or operations. Where the proposed standard requires an
employee to use respiratory protection, proposed paragraph (g)(2)
requires such use to be in accordance with the Respiratory Protection
Standard (29 CFR 1910.134).
The Respiratory Protection Standard's collection of information
requirements indicate that employers must: develop a written respirator
program; obtain and maintain employee medical evaluation records;
provide the physician or other licensed health care professional
(PLHCP) with information about the employee's respirator and the
conditions under which the employee will use the respirator; administer
fit tests for employees who will use negative- or positive-pressure,
tight-fitting facepieces; and establish and retain written information
regarding medical evaluations, fit testing, and the respirator program.
Sec. 1910.1024(h) Personal Protective Clothing and Equipment
Sec. 1910.1024(h)(2)(v) Removal and Storage
Proposed paragraph (h)(2)(v) would require employers to ensure that
any protective clothing or equipment required by the standard which is
removed from the workplace for laundering, cleaning, maintenance, or
disposal is labeled in accordance with paragraph (m)(3) of the proposed
standard and the Hazard Communication standard at 29 CFR 1910.1200.
Sec. 1910.1024(h)(3)(iii) Cleaning and Replacement
Proposed paragraph (h)(3)(iii) would require employers to inform in
writing the persons or the business entities who launder, clean or
repair the protective clothing or equipment required by this
[[Page 47771]]
standard of the potentially harmful effects of exposure to airborne
beryllium and contact with soluble beryllium compounds and how the
protective clothing and equipment must be handled in accordance with
the standard.
Sec. 1910.1024(j)(3) Housekeeping
Proposed paragraph (j)(3)(i) requires waste, debris, and materials
visibly contaminated with beryllium and consigned for disposal to be
disposed of in sealed, impermeable enclosures. Proposed paragraph
(j)(3)(ii) requires these enclosures to be labeled in accordance with
proposed paragraph (m)(3) of the standard.
Proposed paragraph (j)(3)(iii) requires materials designated for
recycling that are visibly contaminated with beryllium to be cleaned to
remove the visible particulate or placed in sealed, impermeable
enclosures that are labeled in accordance with proposed paragraph
(m)(3) of the standard.
Sec. 1910.1024(k) Medical Surveillance
Sec. 1910.1024(k)(1), (2), and (3) Employee Medical Surveillance
Proposed paragraph (k)(1) details when and under what conditions an
employer must make medical surveillance available to its employees.
Paragraph (k)(2) of the proposed standard specifies the frequency of
medical examinations that are to be offered to those employees covered
by the medical surveillance program, and proposed paragraph (k)(3)
details the content of the medical examinations.
Sec. 1910.1024(k)(4) Information Provided to the PLHCP
Proposed paragraph (k)(4) would require employers to provide a copy
of this standard and its appendices to the examining PLHCP. In
addition, the proposed paragraph would require employers to provide the
following information, if known, to the PLHCP: (A) A description of the
employee's former and current duties that relate to the employee's
occupational exposure; (B) the employee's former and current levels of
occupational exposure; (C) a description of any protective clothing and
equipment, including respirators, used by the employee, including when
and for how long the employee has used that protective clothing and
equipment; and (D) information from records of employment-related
medical examinations previously provided to the employee, currently
within the control of the employer, after obtaining a medical release
from the employee.
Sec. 1910.1024(k)(5)(i), (ii), and (iii) Licensed Physician's Written
Medical Opinion
Under proposed paragraph (k)(5)(i), the employer must obtain a
written medical opinion from the licensed physician within 30 days of
the employee's medical examination. The written medical opinion must
contain the following information: (A) The licensed physician's opinion
as to whether the employee has any detected medical condition that
would place the employee at increased risk of CBD from further
exposure; (B) any recommended limitations on the employee's exposure,
including the use and limitations of protective clothing or equipment,
including respirators; and (C) a statement that the PLHCP has explained
the results of the medical examination to the employee, including any
tests conducted, any medical conditions related to exposure that
require further evaluation or treatment, and any special provisions for
use of protective clothing or equipment.
Proposed paragraph (k)(5)(ii) would require the employer to ensure
that neither the licensed physician nor any other PLHCP reveals to the
employer findings or diagnoses which are unrelated to beryllium
exposure.
Proposed paragraph (k)(5)(iii) would require the employer to
provide a copy of the licensed physician's written medical opinion to
the employee within two weeks after receiving it.
Sec. 1910.1024(k)(7) Beryllium Sensitization Test Results Research
Proposed paragraph (k)(7) would require employers, upon request by
OSHA, to convey employees' beryllium sensitization test results to OSHA
for evaluation and analysis.
Sec. 1910.1024(m) Communication of Hazards
Proposed paragraph (m)(1)(i) would require chemical manufacturers,
importers, distributors, and employers to comply with all applicable
requirements of the Hazard Communication Standard (HCS) for beryllium
(29 CFR 1910.1200). Proposed paragraph (m)(1)(ii) requires that when
classifying the hazards of beryllium, the employer must address at
least the following: cancer; lung effects (chronic beryllium disease
and acute beryllium disease); beryllium sensitization; skin
sensitization; and skin, eye, and respiratory tract irritation.
Proposed paragraph (m)(1)(iii) would require employers to include
beryllium in the hazard communication program established to comply
with the HCS, and ensure that each employee has access to labels on
containers and safety data sheets for beryllium.
Proposed paragraph (m)(2)(i) would require employers to post
warning signs at each approach to a regulated area so that each
employee is able to read and understand the signs and take necessary
protective steps before entering the area. Proposed paragraph
(m)(2)(ii) would require these signs to be legible and readily visible,
and contains language that would be required to appear on each warning
sign.
Proposed paragraph (m)(3) would require employers to label each bag
and container of clothing, equipment, and materials visibly
contaminated with beryllium consistent with the Hazard Communication
standard at 29 CFR 1910.1200. Proposed paragraph (m)(3) also contains
language that would be required to appear on every such label.
Proposed paragraph (m)(4)(iv) would require employers to make
copies of the standard and its appendices readily available at no cost
to each employee and designated employee representative.
Sec. 1910.1024(m)(4)(iv) Employee Information
Paragraph (m)(4)(iv) requires that employers make copies of the
standard and its appendices readily available at no cost to each
employee and designated employee representative.
Sec. 1910.1024(n) Recordkeeping
Sec. 1910.1024(n)(1)(i), (ii), and (iii) Exposure Measurements.
Proposed paragraph (n)(1)(i) would require employers to keep
records of all measurements taken to monitor employee exposure to
beryllium as required by paragraph (d) of the standard.
Proposed paragraph (n)(1)(ii) would require employers to include at
least the following information in the records: (A) The date of
measurement for each sample taken; (B) the operation that is being
monitored; (C) the sampling and analytical methods used and evidence of
their accuracy; (D) the number, duration, and results of samples taken;
(E) the type of personal protective clothing and equipment, including
respirators, worn by monitored employees at the time of monitoring;
and, (F) the name, social security number, and job classification of
each employee represented by the monitoring, indicating which employees
were actually monitored.
Proposed paragraph (n)(1)(iii) would require employers to maintain
employee exposure monitoring records in
[[Page 47772]]
accordance with 29 CFR 1910.1020(d)(1)(ii).
Sec. 1910.1024(n)(2)(i), (ii), and (iii) Historical Monitoring Data
Proposed paragraph (n)(2)(i) would require employers to establish
an accurate record of any historical monitoring data used to satisfy
the initial monitoring requirements in paragraph (d)(2) of the proposed
standard. Paragraph (n)(2)(ii) would require the employer to
demonstrate that the data comply with the requirements of paragraph
(d)(2) of the standard. Paragraph (n)(2)(iii) would require the
employer to maintain historical monitoring data in accordance with 29
CFR 1910.1020.
Sec. 1910.1024(n)(3)(i), (ii), and (iii) Objective Data
Proposed paragraph (n)(3)(i) would require employers to establish
accurate records of any objective data relied upon to satisfy the
requirement for initial monitoring in proposed paragraph (d)(2).
Proposed paragraph (n)(3)(ii) would require employers to have at least
the following information in such records: (A) The data relied upon;
(B) the beryllium-containing material in question; (C) the source of
the objective data; (D) a description of the operation exempted from
initial monitoring and how the data support the exemption; and (E)
other information demonstrating that the data meet the requirements for
objective data contained in paragraph (d)(2)(ii) of the proposed
standard. Proposed paragraph (n)(3)(iii) would require employers to
maintain objective data records in accordance with 29 CFR 1910.1020.
Sec. 1910.1024(n)(4)(i), (ii), & (iii) Medical Surveillance
Proposed paragraph (n)(4)(i) would require employers to establish
accurate records for each employee covered by the medical surveillance
requirements in proposed paragraph (k). Proposed paragraph (n)(4)(ii)
would require employers to include in employee medical records the
following information about the employee: (A) Name, social security
number, and job classification; (B) a copy of all licensed physicians'
written opinions; and (C) a copy of the information provided to the
PLHCP as required by paragraph (k)(4) of the proposed standard.
Proposed paragraph (n)(4)(iii) would require employers to maintain
medical records in accordance with 29 CFR 1910.1020.
Sec. Sec. 1910.1024(n)(5)(i) & (ii) Training
Proposed paragraph (n)(5)(i) would require employers to prepare an
employee training record at the completion of any training required by
the proposed standard. The training record must contain the following
information: The name, social security number, and job classification
of each employee trained; the date the training was completed; and the
topic of the training. Proposed paragraph (n)(5)(ii) would require
employers to maintain employee training records for three years after
the completion of training. This record maintenance requirement would
also apply to records of annual retraining or additional training as
described in paragraph (m)(4) of the proposed standard.
Sec. 1910.1024(n)(6) Access to Records
Under proposed paragraph (n)(6), employers must make all records
maintained as a requirement of the standard available for examination
and copying to the Assistant Secretary, the Director of NIOSH, each
employee, and each employee's designated representative(s) in
accordance with the Access to employee exposure and medical records
standard (29 CFR 1910.1020).
Sec. 1910.1024(n)(7) Transfer of Records
Paragraph (n)(7) of the proposed standard would require employers
to comply with the transfer requirements contained in the Access to
employee exposure and medical records standard (29 CFR 1910.1020(h)).
That existing standard requires employers either to transfer records to
successor employers or, if there is no successor employer, to inform
employees of their access rights at least three months before the
cessation of the employer's business.
4. Affected Public: Business or other for-profit. This standard
applies to employers in general industry who have employees that may
have occupational exposures to any form of beryllium, including
compounds and mixtures, except those articles and materials exempted by
paragraphs (a)(2) and (a)(3) of the proposed standard. This standard
does not apply to articles, as defined in the Hazard Communication
standard (HCS) (29 CFR 1910.1200(c)), that contain beryllium and that
the employer does not process. Also, this standard does not apply to
materials containing less than 0.1% beryllium by weight.
5. Number of respondents: Employers in general industry that have
employees working in jobs affected by beryllium exposure (4,088
employers).
6. Frequency of responses: Frequency of response varies depending
on the specific collection of information.
7. Number of responses:155,818.
8. Average time per response: Varies from 5 minutes (.08 hours) for
a clerical worker to generate and maintain an employee medical record,
to 8 hours for a human resource manager to develop and implement a
written exposure control plan.
9. Estimated total burden hours: 80,776.
10. Estimated cost (capital-operation and maintenance):
$10,900,579.
D. Submitting Comments
Members of the public who wish to comment on the paperwork
requirements in this proposal must send their written comments to the
Office of Information and Regulatory Affairs, Attn: OMB Desk Officer
for the Department of Labor, OSHA (RIN-1218-AB76), Office of Management
and Budget, Room 10235, Washington, DC 20503, Fax: 202-395-5806 (this
is not a toll-free numbers), email: OIRA_submission@omb.eop.gov. The
Agency encourages commenters also to submit their comments on these
paperwork requirements to the rulemaking docket (Docket Number OSHA-
H005C-2006-0870), along with their comments on other parts of the
proposed rule. For instructions on submitting these comments to the
rulemaking docket, see the sections of this Federal Register notice
titled DATES and ADDRESSES.
E. Docket and Inquiries
To access the docket to read or download comments and other
materials related to this paperwork determination, including the
complete Information Collection Request (ICR) (containing the
Supporting Statement with attachments describing the paperwork
determinations in detail) use the procedures described under the
section of this notice titled ADDRESSES. You also may obtain an
electronic copy of the complete ICR by visiting the Web page at https://www.reginfo.gov/public/do/PRAMain, scroll under ``Currently Under
Review'' to ``Department of Labor (DOL)'' to view all of the DOL's
ICRs, including those ICRs submitted for proposed rulemakings. To make
inquiries, or to request other information, contact Mr. Todd Owen,
Directorate of Standards and Guidance, OSHA, Room N-3609, U.S.
Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210;
telephone (202) 693-2222.
XI. Federalism
The Agency reviewed the proposed beryllium rule according to the
Executive Order (E.O.) on Federalism (E.O. 13132, 64 FR 43255, Aug. 10,
1999), which requires that Federal
[[Page 47773]]
agencies, to the extent possible, refrain from limiting State policy
options, consult with States before taking actions that would restrict
States' policy options and take such actions only when clear
constitutional authority exists and the problem is of national scope.
The E.O. allows Federal agencies to preempt State law only with the
expressed consent of Congress; in such cases, Federal agencies must
limit preemption of State law to the extent possible.
Under Section 18 of the Occupational Safety and Health Act (the
``Act'' or ``OSH Act,'' 29 U.S.C. 667), Congress expressly provides
that States may adopt, with Federal approval, a plan for the
development and enforcement of occupational safety and health
standards; States that obtain Federal approval for such a plan are
referred to as ``State-Plan States.'' (29 U.S.C. 667). Occupational
safety and health standards developed by State-Plan States must be at
least as effective in providing safe and healthful employment and
places of employment as the Federal standards.
While OSHA drafted this proposed rule to protect employees in every
State, Section 18(c)(2) of the OSHA Act permits State-Plan States to
develop and enforce their own standards, provided the requirements in
these standards are at least as safe and healthful as the requirements
specified in this proposed rule if it is promulgated.
In summary, this proposed rule complies with E.O. 13132. In States
without OSHA-approved State plans, Congress expressly provides for OSHA
standards to preempt State occupational safety and health standards in
areas addressed by the Federal standards; in these States, this rule
limits State policy options in the same manner as every standard
promulgated by the Agency. In States with OSHA-approved State plans,
this rulemaking does not significantly limit State policy options.
XII. State-Plan States
When Federal OSHA promulgates a new standard or a more stringent
amendment to an existing standard, the 27 State and U.S. territories
with their own OSHA-approved occupational safety and health plans
(``State-Plan States'') must revise their standards to reflect the new
standard or amendment. The State standard must be at least as effective
as the Federal standard or amendment, and must be promulgated within
six months of the publication date of the final Federal rule. 29 CFR
1953.5(a).
The State may demonstrate that a standard change is not necessary
because, for example, the State standard is already the same as or at
least as effective as the Federal standard change. In order to avoid
delays in worker protection, the effective date of the State standard
and any of its delayed provisions must be the date of State
promulgation or the Federal effective date, whichever is later. The
Assistant Secretary may permit a longer time period if the State makes
a timely demonstration that good cause exists for extending the time
limitation. 29 CFR 1953.5(a).
Of the 27 States and territories with OSHA-approved State plans, 22
cover public and private-sector employees: Alaska, Arizona, California,
Hawaii, Indiana, Iowa, Kentucky, Maryland, Michigan, Minnesota, Nevada,
New Mexico, North Carolina, Oregon, Puerto Rico, South Carolina,
Tennessee, Utah, Vermont, Virginia, Washington, and Wyoming. The five
states and territories whose OSHA-approved State plans cover only
public-sector employees are: Connecticut, Illinois, New Jersey, New
York, and the Virgin Islands.
This proposed beryllium rule applies to general industry. If
adopted as proposed, all State Plan States would be required to revise
their general industry standard appropriately within six months of
Federal promulgation.
XIII. Unfunded Mandates Reform Act
Under Section 202 of the Unfunded Mandates Reform Act of 1995
(UMRA), 2 U.S.C. 1532, an agency must prepare a written ``qualitative
and quantitative assessment'' of any regulation creating a mandate that
``may result in the expenditure by the State, local, and tribal
governments, in the aggregate, or by the private sector, of
$100,000,000 or more'' in any one year before issuing a notice of
proposed rulemaking. OSHA's proposal does not place a mandate on State
or local governments, for purposes of the UMRA, because OSHA cannot
enforce its regulations or standards on State or local governments (see
29 U.S.C. 652(5)). Under voluntary agreement with OSHA, some States
enforce compliance with their State standards on public sector
entities, and these agreements specify that these State standards must
be equivalent to OSHA standards. The OSH Act also does not cover tribal
governments in the performance of traditional governmental functions,
though it does when tribal governments engage in commercial activity.
However, the proposal would not require tribal governments to expend,
in the aggregate, $100,000,000 or more in any one year for their
commercial activities. Thus, although OSHA may include compliance costs
for affected governmental entities in its analysis of the expected
impacts associated with a proposal, the proposal does not trigger the
requirements of UMRA based on its impact on State, local, or tribal
governments.
Based on the analysis presented in the Preliminary Economic
Analysis (see Section IX above), OSHA concludes that the proposal would
impose a Federal mandate on the private sector in excess of $100
million in expenditures in any one year. The Preliminary Economic
Analysis constitutes the written statement containing a qualitative and
quantitative assessment of the anticipated costs and benefits required
under Section 202(a) of the UMRA (2 U.S.C. 1532).
XIV. Protecting Children From Environmental Health and Safety Risks
E.O.13045 (66 FR 19931 (Apr. 23, 2003)) requires that Federal
agencies submitting covered regulatory actions to OMB's Office of
Information and Regulatory Affairs (OIRA) for review pursuant to E.O.
12866 (58 FR 51735 (Oct. 4, 1993)) must provide OIRA with (1) an
evaluation of the environmental health or safety effects that the
planned regulation may have on children, and (2) an explanation of why
the planned regulation is preferable to other potentially effective and
reasonably feasible alternatives considered by the agency. E.O.13045
defines ``covered regulatory actions'' as rules that may (1) be
economically significant under E.O. 12866 (i.e., a rulemaking that has
an annual effect on the economy of $100 million or more, or would
adversely affect in a material way the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety, or State, local, or tribal governments or
communities), and (2) concern an environmental health risk or safety
risk that an agency has reason to believe may disproportionately affect
children. In this context, the term ``environmental health risks and
safety risks'' means risks to health or safety that are attributable to
products or substances that children are likely to come in contact with
or ingest (e.g., through air, food, water, soil, product use).
The proposed beryllium rule is economically significant under E.O.
12866 (see Section IX of this preamble). However, after reviewing the
proposed beryllium rule, OSHA has determined that the rule would not
impose environmental health or safety risks to children as set forth in
E.O. 13045. The proposed rule would require employers to limit employee
exposure to beryllium and take other precautions to protect employees
from adverse health effects
[[Page 47774]]
associated with exposure to beryllium. OSHA is not aware of any studies
showing that exposure to beryllium disproportionately affects children
or that employees under 18 years of age who may be exposed to beryllium
are disproportionately affected by such exposure. Based on this
preliminary determination, OSHA believes that the proposed beryllium
rule does not constitute a covered regulatory action as defined by E.O.
13045. However, if such conditions exist, children who are exposed to
beryllium in the workplace would be better protected from exposure to
beryllium under the proposed rule than they are currently.
XV. Environmental Impacts
OSHA has reviewed the beryllium proposal according to the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321 et seq.), the
regulations of the Council on Environmental Quality (40 CFR part 1500),
and the Department of Labor's NEPA procedures (29 CFR part 11). Based
on that review, OSHA does not expect that the proposed rule, in and of
itself, would create additional environmental issues. OSHA has made a
preliminary determination that the proposed standard will have no
impact on air, water, or soil quality; plant or animal life; the use of
land or aspects of the external environment. Therefore, OSHA concludes
that the proposed beryllium standard would have no significant
environmental impacts.
XVI. Consultation and Coordination With Indian Tribal Governments
OSHA reviewed this proposed rule in accordance with E.O. 13175 on
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000), and determined that it does not have ``tribal
implications'' as defined in that order. The rule, if promulgated,
would not have substantial direct effects on one or more Indian tribes,
on the relationship between the Federal government and Indian tribes,
or on the distribution of power and responsibilities between the
Federal government and Indian tribes.
XVII. Public Participation
OSHA encourages members of the public to participate in this
rulemaking by submitting comments on the proposal.
Written Comments. OSHA invites interested persons to submit written
data, views, and arguments concerning this proposal. In particular,
OSHA encourages interested persons to comment on the issues raised at
the end of each section. When submitting comments, persons must follow
the procedures specified above in the sections titled DATES and
ADDRESSES.
Informal public hearings. The Agency will schedule an informal
public hearing on the proposed rule if requested during the comment
period.
XVIII. Summary and Explanation
Introduction
This section of the preamble explains the requirements that OSHA
proposes to control occupational exposure to beryllium, including the
purpose of these requirements and how they will protect workers from
hazardous beryllium exposures.
OSHA believes, based on currently available information, that the
proposed requirements are necessary and appropriate to protect workers
exposed to beryllium. In developing this proposed rule, OSHA has
considered many sources of data and information, including responses to
the Request for Information (RFI) for ``Occupational Exposure to
Beryllium'' (OSHA, 2002); the responses from Small Entity
Representatives (SERs) who participated in the Small Business
Regulatory Enforcement Fairness Act of 1996 (SBREFA) (5 U.S.C. 601 et
seq.) process (OSHA, 2007a); recommendations of the Small Business
Advocacy Review (SBAR) Panel (OSHA, 2008b); the Department of Energy
(DOE) Chronic Beryllium Disease Prevention Program rule (DOE, 1999);
and numerous scientific studies, professional journal articles, and
other data obtained by the Agency.
The provisions in the proposed standard are generally consistent
with other recent OSHA health standards, such as chromium (VI)(29 CFR
1910.1026) and cadmium (29 CFR 1910.1027). Using a similar approach
across health standards, when possible, makes them more understandable
and easier for employers to follow, and helps to facilitate uniformity
of interpretation. This approach is also consistent with section
6(b)(5) of the OSH Act, which states that health standards shall
consider ``experience gained under this and other health and safety
laws'' (29 U.S.C. 655(b)(5)). However, to the extent that protecting
workers from occupational exposure to beryllium requires different or
unique approaches, the Agency has formulated proposed requirements to
address the specific hazards and working conditions associated with
beryllium exposure.
Also pursuant to section 6(b)(5), OSHA has expressed the proposed
requirements in performance-based language, where possible, to provide
employers with greater flexibility in determining the most effective
strategies for controlling beryllium hazards in their workplaces. OSHA
believes this approach allows employers to incorporate changes and
advancements in control strategy, technology, and industry practice,
thereby reducing the need to revise the rule when those changes occur.
(a) Scope and Application
In paragraph (a)(1), OSHA proposes to apply this standard to
occupational exposure to beryllium in all forms, compounds, and
mixtures in general industry.
For the purpose of the proposed rule, OSHA is treating beryllium
generally, instead of individually addressing specific compounds,
forms, and mixtures. Based on a review of scientific studies, OSHA has
preliminarily determined that the toxicological effects of beryllium
exposure on the human body are similar regardless of the form of
beryllium (see the Health Effects section of this preamble at V.B.5;
V.G). OSHA is not aware of any information that would lead the Agency
to conclude that exposure to different forms of beryllium necessitates
different regulatory approaches or requirements.
OSHA has preliminarily decided to limit the scope of the rulemaking
to general industry. This proposal is modeled on a suggested rule that
was crafted by two major stakeholders in general industry, Materion
Brush and the United Steelworkers Union (Materion and USW, 2012). In
the course of developing this proposal, they provided OSHA with data on
exposure and control measures and information on their experiences with
handling beryllium in general industry settings. At this time, the
information available to OSHA on beryllium exposures outside of general
industry is limited, but suggests that most operations in other sectors
are unlikely to involve beryllium exposure. The Agency hopes to
expedite the rulemaking process by limiting the scope of this proposal
to general industry and relying on already existing standards to
protect workers in those operations outside of general industry where
beryllium exposure may exist.
The proposed rule would not apply to marine terminals, longshoring,
or agriculture. OSHA has not found evidence indicating that beryllium
is used or handled in these sectors in a way that might result in
beryllium exposure. The proposed rule also excludes the construction
and shipyard sectors. OSHA believes that occupational exposures to
beryllium in
[[Page 47775]]
the construction and shipyard sectors occur primarily in abrasive
blasting operations.
Abrasive blasters and ancillary abrasive blasting workers are
exposed to beryllium from coal slag and other abrasive blast material
that may contain beryllium as a trace contaminant. Airborne
concentrations of beryllium have been measured above the current TWA
PEL of 2 [mu]g/m\3\ when blast material containing beryllium is used as
intended (see Appendix IV-C in the PEA, OSHA 2014). Abrasive blasters,
pot tenders, and cleanup workers have the potential for significant
airborne exposure during blasting operations and during cleanup of
spent material that may contain beryllium as a trace contaminant.
To address high concentrations of various hazardous chemicals in
abrasive blasting material, employers must already be using engineering
and work practice controls to limit workers' exposures and must be
supplementing these controls with respiratory protection when
necessary. For example, abrasive blasters in the construction industry
fall under the protection of the Ventilation standard (29 CFR 1926.57).
The Ventilation standard includes an abrasive blasting subsection (29
CFR 1926.57(f)), which requires that abrasive blasting respirators be
worn by all abrasive blasting operators when working inside blast-
cleaning rooms (29 CFR 1926.57(f)(5)(ii)(A)), or when using silica sand
in manual blasting operations where the nozzle and blast are not
physically separated from the operator in an exhaust-ventilated
enclosure (29 CFR 1926.57(f)(5)(ii)(B)), or when needed to protect
workers from exposures to hazardous substances in excess of the limits
set in Sec. 1926.55 (29 CFR 1926.57(f)(5)(ii)(C); ACGIH, 1971)). For
maritime, standard 29 CFR 1915.34(c) covers similar requirements for
respiratory protection needed in blasting operations. Due to these
requirements, OSHA believes that abrasive blasters already have
controls in place and wear respiratory protection during blasting
operations. Thus, in estimating costs for Regulatory Alternatives #2a
and #2b, OSHA judged that the reduction of the TWA PEL would not impose
costs for additional engineering controls or respiratory protection in
abrasive blasting (see Appendix VIII-C in this chapter for details).
OSHA requests comment on this issue--in particular, whether abrasive
blasters using blast material that may contain beryllium as a trace
contaminant are already using all feasible engineering and work
practice controls, respiratory protection, and PPE that would be
required by Regulatory Alternatives #2a and #2b.
OSHA requests comment on the limitation of the scope to general
industry, as well as information on beryllium exposures in all industry
sectors. The Agency requests information on whether employees in the
construction, maritime, longshoring, shipyard, and agricultural sectors
are exposed to beryllium in any form and, if so, their levels of
exposure and what types of exposure controls are currently in place. In
particular, OSHA requests comment on whether abrasive blasters using
blast material that may contain beryllium as a trace contaminant are
already using all feasible engineering and work practice controls,
respiratory protection, and PPE. OSHA also requests comment on
Regulatory Alternatives #2a and #2b, presented at the end of this
section, that would provide protection to workers in sectors outside of
general industry. Regulatory Alternative #2a would expand the scope of
the proposed standard to include employers in construction and
maritime. Regulatory #2b would change the Z tables in 29 CFR 1910.1000
and 29 CFR 1915.1000, and Appendix A of 29 CFR 1926.55, to lower the
permissible exposure limits for beryllium for workers in all beryllium-
exposed occupations. Another regulatory alternative that would impact
the scope of affected industries, extending eligibility for medical
surveillance to employees in shipyards, construction, and parts of
general industry excluded from the scope of the proposed standard, is
discussed along with other medical surveillance alternatives (see this
preamble at Section XVIII, paragraph (k), Regulatory Alternative #21).
Depending on the nature of the data and comments provided, OSHA
envisions possible expansions of its regulation of beryllium either as
part of this rulemaking or at a later time.
Paragraph (a)(2) specifies that the proposed rule would not apply
to articles, as defined in the Hazard Communication standard (HCS) (29
CFR 1910.1200(c)), that contain beryllium and that the employer does
not process. The HCS defines an article as ``a manufactured item other
than a fluid or particle: (i) Which is formed to a specific shape or
design during manufacture; (ii) which has end use function(s) dependent
in whole or in part upon its shape or design during end use; and (iii)
which under normal conditions of use does not release more than very
small quantities e.g., minute or trace amounts of a hazardous chemical
(as determined under paragraph (d) of this section), and does not pose
a physical hazard or health risk to employees.'' For example, items or
parts containing beryllium that employers assemble where the physical
integrity of the item is not compromised are unlikely to release more
than a very small quantity of beryllium that would not pose a physical
or health hazard for workers. These items would be considered articles
that are exempt from the scope of the proposed standard. Similarly,
finished or processed items or parts containing beryllium that
employers are simply packing in containers or affixing with shipping
tags or labels are unlikely to release more than a minute or trace
amount of beryllium. These items would also come within the proposed
exemption. By contrast, if an employer performs operations such as
machining, grinding, blasting, sanding, or other processes that
physically alter an item, these operations would not fall within the
exemption in proposed paragraph (a)(2) because they involve processing
of the item and could result in significant exposure to beryllium-
containing material.
Paragraph (a)(3) specifies that the proposed rule would not apply
to materials containing less than 0.1% beryllium by weight. A similar
exemption is included in several previously promulgated standards,
including Benzene (29 CFR 1910.1028), Methylenedianiline (MDA) (29 CFR
1910.1050), and 1,3-Butadiene (BD) (29 CFR 1910.1051). These exemptions
were established to limit the regulatory burden on employers who do not
use materials containing 0.1 percent or more of the substance in
question, on the premise that workers in exempted industries are not
exposed at levels of concern. In the preamble to the MDA standard, OSHA
states that the Agency relied on data showing that worker exposure to
mixtures or materials of MDA containing less than 0.1 percent MDA did
not create any hazards other than those expected from worker exposure
beneath the action level (57 FR 35630, 35645-46, August 10, 1992). The
exemption in the BD standard does not apply where airborne
concentrations generated by such mixtures can exceed the action level
or STEL. The exemption in the Benzene standard was based on indications
that exposures resulting from substances containing trace amounts of
benzene would generally be below the exposure limit, and on OSHA's
belief that the exemption would encourage employers to reduce the
concentration of benzene in certain
[[Page 47776]]
substances (43 FR 27962, 27968, June 27, 1978).
OSHA is aware of two industries in the general industry sector that
would be exempted from the proposed standard under proposed paragraph
(a)(3): Coal-fired electric power generation and primary aluminum
production. As discussed in the PEA, Chapter IV, Appendices A and B,
most employees' TWA exposures in these industries do not exceed the
proposed action level of 0.1 [mu]g/m\3\. However, exposures above the
proposed PEL of 0.2 [mu]g/m\3\ have been found in some jobs and in
facilities with poor housekeeping and work practices. In coal-fired
electric power generation, these higher exposures are associated with
intermittent exposure to fly ash during maintenance work in and around
baghouses and boilers. Fly ash contains less than 0.01% beryllium;
however, exposures between 0.1 and 0.4 [mu]g/m\3\ were observed among
workers maintaining boilers. Exposures for baghouse cleaning frequently
exceeded the current PEL, reaching as high as 13 [mu]g/m\3\. In
aluminum production, the bauxite ore used as a raw material contains
naturally occurring beryllium in the part per million range (i.e.
<0.0001%); however, a study of four smelters showed that the arithmetic
mean exposure was slightly above the proposed PEL, and the 95th
percentile exposure (of 965 samples) was above 1 [mu]g/m\3\. BeLPT
testing in a group of 734 aluminum workers found two cases of confirmed
beryllium sensitization (0.27%) and an additional few abnormal results
that could not be confirmed, either because the worker was not retested
or the retest appeared normal (Taiwo et al., 2008).
OSHA requests comment on the exemption proposed for the beryllium
standard. Is it appropriate to include an exemption for operations
where beryllium exists only as a trace contaminant, but some workers
can nevertheless be significantly exposed? Should the Agency consider
dropping the exemption, or constraining it to operations where
exposures are below the proposed action level and STEL? OSHA requests
additional data describing the levels of airborne beryllium in
workplaces that fall under this exemption and comments on regulatory
alternatives, discussed at the end of this section, that would
eliminate or modify the exemption.
A number of stakeholders, including SERs who participated in the
SBREFA process, urged OSHA to exempt certain industries or processes
and activities from the proposed standard. In support of this request,
SERs from the stamping industry argued that their exposures are low,
below 0.2 [micro]g/m\3\ (OSHA, 2007a). In addition, some SERs requested
exemptions from particular requirements. SERs from the dental
laboratory industry requested exemptions from all requirements other
than training and the permissible exposure limit (PEL). In support of
this request, they also argued that their exposures are very low,
around 0.02 [mu]g/m\3\ when ventilation is used. They indicated that
they already have sufficient engineering and work practice controls in
place to keep exposures low (OSHA, 2008b). The SBREFA Panel recommended
that OSHA consider a more limited scope of industries (OSHA, 2008b).
The Panel's recommendation is addressed in part in this proposed
standard, which has a much more limited scope than the draft standard
reviewed by the SBREFA Panel. Whereas the draft reviewed by the Panel
covered beryllium in all forms and compounds in general industry,
construction, and maritime, the scope of the current beryllium proposal
includes general industry only, and does not apply to employers in
construction and maritime. In addition, it provides an exemption for
those working with materials that contain beryllium only as a trace
contaminant (less than 0.1 percent composition by weight).
Although much narrower than the scope in the SBREFA draft, the
current proposal's scope includes industries of concern for some SERs.
OSHA's preliminary feasibility analysis indicates that worker exposures
in both dental laboratories and stamping facilities exceed or have the
potential to exceed the proposed TWA PEL where appropriate controls are
not in place (see section IX of this preamble, Summary of the
Preliminary Economic Analysis and Initial Regulatory Flexibility
Analysis). Accordingly, OSHA has not exempted them from the proposed
standard. However, if employers in these industries have historical or
objective data that meet the requirements set forth in proposed
paragraph (d)(2) demonstrating that they have no exposures or that
exposures are below the action level and at or below the STEL, these
employers may be able to satisfy many of their obligations under this
proposed standard by reference to these data.
Some stakeholders, including employers who do stripping operations,
urged that OSHA exempt them from the proposed rule because any
beryllium exposures generated in their facilities were comprised of
larger-sized particles, which they contended were not as harmful as
smaller ones (OSHA, 2008b). OSHA has decided not to exempt operations
based on particle size. As discussed in this preamble at section V,
Health Effects, there is not sufficient evidence to demonstrate that
particle size has a significant bearing on health outcomes.
While acknowledging the concerns raised by SERs that the scope of
the standard might be too broad, OSHA is concerned that the scope of
the current proposal might be too narrow. Exposures have the potential
to exceed the proposed PEL in some blasting operations in construction
and maritime, and in some general industry operations where beryllium
exists as a trace contaminant. Abrasive blasters and ancillary abrasive
blasting workers are exposed to beryllium from coal slags and other
abrasive blast material, which contain beryllium in amounts less than
0.1 percent. Airborne concentrations of beryllium have been measured
above the current TWA PEL of 2 [mu]g/m\3\ when the blast material is
used as intended. Abrasive blasters, pot tenders, and cleanup workers
working primarily in construction and shipyards have the potential for
significant airborne exposure during blasting operations and during
cleanup of spent blast material. Coal fly ash in coal powered utility
facilities is also known to contain trace amounts of beryllium, which
may become airborne during furnace and bag house operations and result
in exposures exceeding the current PELs. Similarly, beryllium exists as
a contaminant in aluminum ore and may result in exposures above the
proposed PELs during aluminum refining and production.
OSHA invites comment on the proposed scope of the standard and on
Regulatory Alternatives 1 and 2 below, which would increase protection
for workers in maritime and construction industries and in occupations
dealing with beryllium as a trace contaminant.
Regulatory Alternatives 1a and 1b
Regulatory Alternative #1a would modify the proposed scope to
eliminate the exemption for materials containing less than 0.1 percent
beryllium by weight. Under this alternative, the scope of the rule
would cover employers in general industry, including industries or
occupations where beryllium exists as a trace contaminant. Regulatory
Alternative #1a would expand the scope of the proposed standard to
include all operations in general industry where beryllium exists only
as a trace contaminant; that is, where the materials used contain no
more than 0.1 percent beryllium by weight. Regulatory
[[Page 47777]]
Alternative #1b is similar to Regulatory Alternative #1a, but exempts
operations where the employer can show that employees' exposures will
not meet or exceed the action level or exceed the STEL. Where the
employer has objective data demonstrating that a material containing
beryllium or a specific process, operation, or activity involving
beryllium cannot release beryllium in concentrations at or above the
proposed action level or above the proposed STEL under any expected
conditions of use, the specific process, operation, or activity would
be exempt from the proposed standard except for recordkeeping
requirements pertaining to the objective data. Alternative #1a and
Alternative #1b, like the proposed rule, would not cover employers or
employees in construction or shipyards.
Regulatory Alternatives 2a and 2b
These two alternatives would increase protections for workers in
the construction and maritime sectors. Regulatory alternative #2a would
expand the scope of the proposed standard to also include employers in
construction and maritime. For example, this alternative would cover
abrasive blasters, pot tenders, and cleanup staff working in
construction and shipyards who have the potential for airborne
beryllium exposure during blasting operations and during cleanup of
spent media. Regulatory alternative #2b would amend 29 CFR 1910.1000
Table Z-1, 29 CFR 1915.1000 Table Z, and 29 CFR 1926.55 Appendix A to
replace the current permissible exposure limits for beryllium and
beryllium compounds (and the reference in 1910.1000 Table Z-1 to Table
Z-2) with the TWA PEL and STEL adopted through this rulemaking. This
alternative would also delete the entry for beryllium and beryllium
compounds in 29 CFR 1910.1000 Table Z-2 because the entry would instead
be listed in Table Z-1 as described above. Note that OSHA is proposing
an 8-hour TWA PEL of 0.2 [mu]g/m\3\ and a 15-minute STEL of 2 [mu]g/
m\3\, and is also considering alternative TWA PELs of 0.1 [mu]g/m\3\
and 0.5 [mu]g/m\3\, and alternative STELs of 0.5 [mu]g/m\3\, 1 [mu]g/
m\3\, and 2.5 [mu]g/m\3\. This alternative would limit permissible
airborne beryllium exposures for workers in all beryllium-exposed
occupations including construction, maritime and other industries where
beryllium is a trace contaminant.
The Z Tables and 1926.55 Appendix A do not incorporate ancillary
provisions such as exposure monitoring, medical surveillance, medical
removal, and PPE. However, many of the occupations excluded from the
scope of the proposed beryllium standard receive some ancillary
provision protections from other rules, such as Personal Protective
Equipment (1910 Subpart I, 1915 Subpart I, 1926.28, also 1926 Subpart
E), Ventilation (1926.57), Hazard Communication (1910.1200), and
specific provisions for welding (1910 Subpart Q, 1915 Subpart D, 1926
Subpart J) and abrasive blasting (1910.109, 1926 Subpart U).
(b) Definitions
Proposed paragraph (b) includes definitions of key terms used in
the proposed standard. To the extent possible, OSHA uses the same terms
and definitions in the proposed standard as the Agency has used in
other OSHA health standards. Using similar terms across health
standards, when possible, makes them more understandable and easier for
employers to follow. In addition, using similar terms and definitions
helps to facilitate uniformity of interpretation.
``Action level'' means an airborne concentration of beryllium of
0.1 micrograms per cubic meter of air ([mu]g/m\3\) calculated as an
eight-hour time-weighted average (TWA). Exposures at or above the
action level but below the TWA PEL trigger the proposed requirements
for periodic exposure monitoring (see paragraph (d)(3)). In addition,
paragraph (f)(1)(i)(B) requires employers to list as part of their
Written Exposure Control Plan the operations and job titles reasonably
expected to have exposure at or above the action level. Paragraph
(f)(2)(i) requires employers to ensure that at least one of the
controls listed in paragraph (f)(2)(i)(A) is in place unless employers
can demonstrate for each operation or process either that such controls
are not feasible, or that employee exposures do not exceed the action
level based on at least two representative personal breathing zone
samples taken seven days apart. Furthermore, whenever an employer
allows employees to consume food or beverages in a beryllium work area,
the employer must ensure that no employee is exposed to beryllium at or
above the action level (paragraph (i)(4)(ii)). The action level is also
relevant to the proposed medical removal requirements. Employees
eligible for removal can chose to remain in environments with exposures
above the action level provided they wear respirators (paragraph
(l)(2)(ii)). These employees may also choose to be transferred to
comparable work in environments with exposures below the action level
(or if comparable work is not available, they may choose to be placed
on paid leave for a period of at least six months (paragraph (l)(3)).
OSHA's preliminary risk assessment indicates that significant risk
remains at the proposed TWA PEL (see this preamble at section VI,
Significance of Risk). When there is a continuing exposure risk at the
PEL, the courts have ruled that OSHA has the legal authority to impose
additional requirements, such as action levels, on employers to further
reduce risk when those requirements will result in a greater than
minimal incremental benefit to workers' health (Asbestos II, 838 F.2d
at 1274). OSHA's preliminary conclusion is that an action level for
beryllium exposure will result in a further reduction in risk beyond
that provided by the PEL alone.
Another important reason for proposing an action level involves the
variable nature of employee exposures to beryllium. Because of this
fact, OSHA believes that maintaining exposures below the action level
provides reasonable assurance that employees will not be exposed to
beryllium above the TWA PEL on days when no exposure measurements are
made. This consideration is discussed later in this section of the
preamble regarding proposed paragraph (d)(3).
OSHA's decision to propose an action level of one-half of the TWA
PEL is consistent with previous standards, including those for
inorganic arsenic (29 CFR 1910.1018), chromium (VI) (29 CFR 1910.1026),
benzene (29 CFR 1910.1028), ethylene oxide (29 CFR 1910.1047), and
methylene chloride (29 CFR 1910.1052).
``Assistant Secretary'' means the Assistant Secretary of Labor for
Occupational Safety and Health, United States Department of Labor, or
designee. Proposed paragraph (k)(7) requires employers to report
employee BeLPT results to OSHA for evaluation and analysis if requested
by the Assistant Secretary. Proposed paragraph (n)(6) requires
employers to make all records required under this section available, if
requested, to the Assistant Secretary for examination and copying.
``Beryllium lymphocyte proliferation test (BeLPT)'' means the
measurement of blood lymphocyte proliferation in a laboratory test when
lymphocytes are challenged with a soluble beryllium salt. A confirmed
positive test result indicates the person has beryllium sensitization.
For additional explanation of the BeLPT, see the Health Effects section
of this preamble (section V), and Appendix A of this proposed standard.
Under paragraph (f)(1)(ii)(B), employers must update the exposure
control plan when an employee is confirmed positive. The BeLPT could be
used to
[[Page 47778]]
determine whether an employee is confirmed positive (see definition of
confirmed positive in paragraph (b) of this proposed standard).
Paragraph (k)(3)(ii)(E) requires the BeLPT unless a more reliable and
accurate test becomes available (see section I of this preamble, Issues
and Alternatives, for discussion and request for comment regarding how
OSHA should determine whether a test is more reliable and accurate than
the BeLPT). Under paragraph (k)(7), employers must convey the results
of medical tests such as the BeLPT to OSHA if requested.
``Beryllium work area'' means any work area where employees are, or
can reasonably be expected to be, exposed to airborne beryllium,
regardless of the level of exposure. OSHA notes both a distinction and
some overlap between the definitions of beryllium work area and
regulated area in this proposal. Beryllium work areas are areas where
employees are or can reasonably be expected to be exposed to airborne
beryllium at any level, whereas an area is a regulated area only if
employees are or can reasonably be expected to be exposed above the TWA
PEL or STEL. Therefore, while not all beryllium work areas are
regulated areas, all regulated areas are beryllium work areas because
they are areas with exposure to beryllium. Accordingly, all
requirements for beryllium work areas also apply in all regulated
areas, but requirements specific to regulated areas apply only to
regulated areas and not to beryllium work areas where exposures do not
exceed the TWA PEL or STEL.
The presence of a beryllium work area triggers a number of the
requirements in this proposal. Under paragraphs (d)(1)(ii) and (iii),
employers must determine exposures for each beryllium work area.
Furthermore, paragraphs (e)(1)(i) and (e)(2)(i) require employers to
establish, maintain, identify, and demarcate the boundaries of each
beryllium work area. Under paragraph (f)(1)(i), employers must
establish and maintain a written exposure control plan for beryllium
work areas. And paragraph (f)(2)(i) requires employers to implement at
least one of the controls listed in (f)(2)(i)(A)(1) through (4) for
each operation in a beryllium work area unless one of the exemptions in
(f)(2)(i)(B) applies. In addition, paragraph (i)(1) requires employers
to provide readily accessible washing facilities to employees working
in a beryllium work area, and to instruct employees to use these
facilities when necessary. Where employees are allowed to eat or drink
in beryllium work areas, employers must ensure that surfaces in these
areas are as free as practicable of beryllium, that exposures are below
the action level, and that these areas comply with the Sanitation
standard (29 CFR 1910.141) (paragraph (i)(4)). Employers must maintain
surfaces in all beryllium work areas as free as practicable of
beryllium (paragraph (j)(1)(i)). Paragraph (j)(2) requires certain
practices and prohibits other practices for cleaning surfaces in
beryllium work areas.
``CBD Diagnostic Center'' means a medical facility that has the
capability of performing an on-site clinical evaluation for the
presence of chronic beryllium disease (CBD) that includes
bronchoalveolar lavage, transbronchial biopsy and interpretation of the
biopsy pathology, and the beryllium bronchoalveolar lavage lymphocyte
proliferation test (BeBALLPT). For purposes of this proposal, the term
``CBD Diagnostic Center'' refers to any medical facility that meets
these criteria, whether or not the medical facility formally refers to
itself as a CBD diagnostic center. For example, if a hospital has all
of the capabilities required by this proposal for CBD diagnostic
centers, the hospital would be considered a CBD diagnostic center for
purposes of this proposal.
Proposed paragraph (k)(6) requires employers to offer employees who
have been confirmed positive a referral to a CBD diagnostic center for
a clinical evaluation.
``Chronic beryllium disease (CBD)'' means a chronic lung disease
associated with exposure to airborne beryllium. The Health Effects
section of this preamble, section V, contains more information on CBD.
CBD is relevant to several provisions of this proposal. Paragraph
(f)(1)(ii)(B) requires employers to update the exposure control plan
whenever an employee is diagnosed with CBD. Under paragraph
(k)(1)(i)(B), employers must make medical surveillance available at no
cost to employees who show signs and symptoms of CBD. Paragraph
(k)(3)(ii)(B) requires medical examinations conducted under this
standard to emphasize screening for respiratory conditions, which would
include CBD. Under paragraph (k)(5)(i)(A), the licensed physician's
opinion must advise the employee on whether or not the employee has any
detected medical condition that would place the employee at an
increased risk of CBD from further exposure to beryllium. Furthermore,
CBD is a criterion for medical removal under paragraph (l)(1). Under
paragraph (m)(1)(ii), employers must address CBD in classifying
beryllium hazards under the HCS. Employers must also train employees on
the signs and symptoms of CBD (see paragraph (m)(4)(ii)(A)).
``Confirmed positive'' means two abnormal test results from
consecutive BeLPTs or a second abnormal BeLPT result within a two-year
period of the first abnormal result. The definition of confirmed
positive also includes a single result of a more reliable test
indicating that a person has been identified as sensitized to
beryllium. OSHA recognizes that diagnostic tests for beryllium
sensitization could eventually be developed that would not require a
second test to confirm sensitization. OSHA requests comment on how best
to determine whether a new method is more reliable and accurate than
the BeLPT for detecting beryllium sensitization (see section I of this
preamble, Issues and Alternatives).
Paragraph (f)(1)(ii)(B) requires employers to update the exposure
control plan whenever an employee is confirmed positive or is diagnosed
with CBD. Under proposed paragraph (k)(3)(ii)(E), employers are
required to ensure that a BeLPT is offered to each eligible employee at
the employee's first medical examination under this proposed standard,
and every two years from the date of the first examination unless the
employee receives an abnormal BeLPT result. If the employee's first
BeLPT result is abnormal, the employer must provide the employee a
second test within one month of the first test. If the employee's
second BeLPT result is also abnormal, the employee is considered
confirmed positive for purposes of this proposed standard. OSHA
requests comment on the methods used to determine when a BeLPT test
result is abnormal, and on standardizing the use and interpretation of
the BeLPT (see section I of this preamble, Issues and Alternatives).
A confirmed positive result will indicate to the licensed physician
that the employee is sensitized to beryllium and is at increased risk
of developing CBD (see paragraph (k)(5)(i)(A)). Employees who are
confirmed positive are eligible for medical removal under proposed
paragraph (l)(1).
``Director'' means the Director of the National Institute for
Occupational Safety and Health (NIOSH), U.S. Department of Health and
Human Services, or designee. The proposed recordkeeping requirements
mandate that, upon request, employers make all records required by this
standard available to the Director (as well as the Assistant Secretary)
for examination and copying (see paragraph (n)(6)). Typically, the
Assistant Secretary sends representatives to review workplace safety
and health records. However, the
[[Page 47779]]
Director may also review these records while conducting studies such as
Health Hazard Evaluations of workplaces, or for other purposes.
``Emergency'' means any uncontrolled release of airborne beryllium.
An emergency could result from equipment failure, rupture of
containers, or failure of control equipment, among other causes.
Emergencies trigger several requirements of this proposed standard.
Under paragraph (g)(1)(iv), respiratory protection is required during
emergencies to protect employees from potential overexposures.
Emergencies also trigger clean-up requirements under paragraph
(j)(1)(ii), and medical surveillance under paragraph (k)(1)(i)(C). In
addition, under paragraph (m)(4)(ii)(D), employers must train employees
in applicable emergency procedures.
``Exposure'' and ``exposure to beryllium'' mean the exposure to
airborne beryllium that would occur if the employee were not using a
respirator. This definition is consistent with the term ``employee
exposure'' in other OSHA standards such as Asbestos (29 CFR 1910.1001),
Benzene (29 CFR 1910.1028), Chromium (VI) (29 CFR 1910.1026), Butadiene
(29 CFR 1910.1051), and Methylene chloride (29 CFR 1910.1052). Many
OSHA standards establish action levels and permissible exposure limits
based on quantitative airborne exposures, and many of these standards'
requirements are tied to exposures at or above the applicable action
level, or above the applicable permissible exposure limit(s). This
definition is also consistent with OSHA's hierarchy of controls policy,
which requires employers to implement engineering and work practices
controls to control exposure before resorting to respiratory
protection. For additional discussion of OSHA's hierarchy of controls
policy, see the discussion of paragraph (f) in this section of the
preamble.
``High-efficiency particulate air (HEPA) filter'' means a filter
that is at least 99.97 percent effective in removing particles 0.3
micrometers in diameter (see Department of Energy Technical Standard
DOE-STD-3020-2005). HEPA filtration is an effective means of removing
hazardous beryllium particles from the air. The proposed standard
requires beryllium-contaminated surfaces to be cleaned by HEPA
vacuuming or other methods that minimize the likelihood of exposure
(see paragraphs (j)(2)(i) and (ii)). Other OSHA health standards also
require the use of vacuum systems equipped with HEPA filtration (see
Chromium (VI) (29 CFR 1910.1026) and Lead in construction (29 CFR
1926.62)).
``Physician or other licensed health care professional (PLHCP)''
means an individual whose legally permitted scope of practice, such as
license, registration, or certification, allows the person to
independently provide or be delegated the responsibility to provide
some or all of the health care services required in proposed paragraph
(k). The Agency recognizes that personnel qualified to provide medical
surveillance may vary from State to State, depending on State licensing
requirements. Whereas all licensed physicians would meet this proposed
definition of PLHCP, not all PLHCPs must be physicians.
Under paragraph (k)(5) of the proposed standard, the written
medical opinion must be completed by a licensed physician. However,
other requirements of paragraph (k) may be performed by a PLHCP under
the supervision of a licensed physician (see paragraphs (k)(1)(ii),
(k)(3)(i), (k)(3)(ii)(G), (k)(5)(i)(C), and (k)(5)(ii)). The proposed
standard also identifies what information must be given to the PLHCP
providing the services listed in this standard, and requires that
employers maintain a record of this information (see paragraphs (k)(4)
and (n)(4)(ii)(C)).
Allowing a PLHCP to provide some of the services required under
this rule is consistent with other recent OSHA health standards, such
as bloodborne pathogens (29 CFR 1910.1030), respiratory protection (29
CFR 1910.134), and methylene chloride (29 CFR 1910.1052).
``Regulated area'' means an area that the employer must demarcate
where employee exposure to airborne concentrations of beryllium
exceeds, or can reasonably be expected to exceed, either the TWA PEL or
STEL. These areas include temporary work areas where maintenance or
non-routine tasks are performed. For an explanation of the distinction
and overlap between beryllium work areas and regulated areas, see the
explanation of beryllium work areas earlier in this section of the
preamble. The requirements triggered by regulated areas are discussed
below.
Paragraphs (e)(1)(ii) and (e)(2)(ii) require employers to establish
and demarcate regulated areas. Note that the demarcation requirements
for regulated areas are more specific than those for other beryllium
work areas (see also proposed paragraph (m)). Paragraph (e)(3) requires
employers to restrict access to regulated areas to authorized persons,
and paragraph (e)(4) requires employers to provide all employees in
regulated areas appropriate respiratory protection and personal
protective clothing and equipment, and to ensure that these employees
use the required respiratory protection and protective clothing and
equipment. Proposed paragraph (i)(5)(i) prohibits employers from
allowing employees to eat, drink, smoke, chew tobacco or gum, or apply
cosmetics in regulated areas.
Under proposed paragraph (k)(1)(i)(A), employees who have worked in
a regulated area for more than 30 days in the previous 12 months are
eligible for medical surveillance. In addition, proposed paragraph
(m)(2) requires warning signs associated with regulated areas to meet
certain specifications. Proposed paragraph (m)(4) requires employers to
train employees in the written exposure control plan required by
paragraph (f)(1), including the location of regulated areas.
This proposed definition of regulated areas is consistent with
other substance-specific health standards, such as Cadmium (29 CFR
1910.1027), Butadiene (29 CFR 1910.1051), and Methylene Chloride (29
CFR 1910.1052).
``This standard'' means this beryllium standard, 29 CFR 1910.1024.
(c) Permissible Exposure Limits (PELs)
Paragraph (c) of the proposed standard establishes two permissible
exposure limits (PELs) for beryllium in all forms, compounds, and
mixtures: An 8-hour time-weighted average (TWA) PEL of 0.2 [mu]g/m\3\
(proposed paragraph (c)(1)), and a 15-minute short-term exposure limit
(STEL) of 2.0 [mu]g/m\3\ (proposed paragraph (c)(2)).
The TWA PEL section of the proposed standard requires employers to
ensure that each employee's exposure to beryllium, averaged over the
course of an 8-hour work shift, does not exceed 0.2 [mu]g/m\3\. The
STEL section of the proposed standard requires employers to ensure that
each employee's exposure sampled over any 15-minute period during the
work shift does not exceed 2.0 [mu]g/m\3\. The existing Air
Contaminants standard (29 CFR 1910.1000 Table Z-2) has two PELs for
``beryllium and beryllium compounds'': (1) a 2 [mu]g/m\3\ TWA PEL, and
(2) a ceiling concentration of 5 [mu]g/m\3\ that employers must ensure
is not exceeded during the 8-hour work shift, except for a maximum peak
of 25 [mu]g/m\3\ over a 30-minute period in an 8-hour work shift. OSHA
adopted the current PELs in 1972 pursuant to section 6(a) of the OSH
Act (29 U.S.C. 655(a)). Section 6(a) permitted OSHA, during the first
two years after the OSH Act became
[[Page 47780]]
effective, to adopt as OSHA standards any established Federal standard
or national consensus standard. The existing PELs were based on the
American National Standards Institute (ANSI) Beryllium and Beryllium
Compounds standard (ANSI, 1970), which in turn was based on a 1949 U.S.
Atomic Energy Commission adoption of a threshold limit for beryllium of
2.0 [mu]/m\3\ and was included in the 1971 American Conference of
Governmental Industrial Hygienists Documentation of the Threshold Limit
Values for Substances in Workroom Air (ACGIH, 1971).
TWA PEL. OSHA is proposing the new TWA PEL because published
studies and more recent exposure data submitted in the record from
industrial facilities involved in beryllium work provide evidence that
occupational exposure to a variety of beryllium compounds at levels
below the current PELs pose a significant risk to workers (see this
preamble at section VIII, Significance of Risk). OSHA's preliminary
risk assessment, presented in section VI of this preamble, indicates
that there is significant risk of beryllium sensitization \45\ and CBD
from a 45-year (working life) exposure to beryllium at the current TWA
PEL of 2 [mu]g/m\3\. The risk assessment further indicates that there
is significant risk of lung cancer to workers exposed to beryllium at
the current TWA PEL of 2 [mu]g/m\3\.
---------------------------------------------------------------------------
\45\ As discussed in section VIII of this preamble, Significance
of Risk, beryllium sensitization is a necessary precursor to
developing CBD.
---------------------------------------------------------------------------
OSHA believes this proposed PEL would be feasible across all
affected industry sectors (see section IX.D of this preamble,
Technological Feasibility) and that compliance with the proposed PEL
would substantially reduce employees' risks of beryllium sensitization,
CBD, and lung cancer (see section VI of this preamble, Preliminary
Beryllium Risk Assessment). OSHA's confidence in the feasibility of the
proposed PEL is high, based both on the preliminary results of the
Agency's feasibility analysis and on the recommendation of the proposed
PEL by Materion Corporation and the United Steelworkers. Materion is
the sole beryllium producer in the U.S., and its facilities include
some of the processes where OSHA expects it will be most challenging to
control beryllium exposures. As with several other provisions of the
proposed standard, OSHA's proposal for the TWA PEL follows the draft
recommended standard submitted to the Agency by Materion and the
Steelworkers Union (see this preamble at section III, Events Leading to
the Proposed Standard).
OSHA's preliminary risk assessment indicates that the risks
remaining at the proposed TWA PEL--while much lower than risks at the
current PEL--are still significant (see this preamble at section VIII,
Significance of Risk). In addition to the proposed PEL, the Agency is
considering an alternative PEL of 0.1 [mu]g/m\3\ that would reduce
risks to workers further than the proposed PEL would, although
significant risk remains at 0.1 [mu]g/m\3\ as well (see section VIII of
this preamble, Significance of Risk, and Regulatory Alternatives
presented at the end of this discussion). Compared with the proposed
PEL, OSHA has less confidence in the feasibility of a PEL of 0.1 [mu]g/
m\3\. In some industry sectors it is difficult to determine whether a
PEL of 0.1 [mu]g/m\3\ could be achieved in most operations, most of the
time. However, OSHA believes this uncertainty could be resolved with
additional information on current exposure levels and exposure control
technologies. OSHA requests additional data and information to inform
its final determinations on feasibility (see section IX.D of this
preamble, Technological Feasibility) and the alternative PELs under
consideration.
Because significant risks of sensitization and CBD remain at both
0.1 [mu]g/m\3\ and 0.2 [mu]g/m\3\, OSHA is also proposing a variety of
ancillary provisions to help reduce risk to workers. These ancillary
provisions include implementation of feasible engineering controls in
beryllium work areas, respiratory protection, personal protective
clothing and equipment, exposure monitoring, regulated areas, medical
surveillance, medical removal, hygiene areas, housekeeping
requirements, and hazard communication. The Agency believes these
provisions will reduce the risk beyond that which the proposed TWA PEL
alone could achieve. These provisions are discussed later in this
section of the preamble.
Other federal agencies and organizations have recommended
occupational exposure limits for beryllium. As mentioned in this
preamble at section III, Events Leading to the Proposed Standard, in
1999 the Department of Energy (DOE) issued its Chronic Beryllium
Disease Prevention Program rule (10 CFR part 850). The DOE rule
established a beryllium action level of 0.2 [mu]g/m\3\. This action
level triggers many of the same requirements found in OSHA's proposed
standard such as regulated areas, periodic exposure monitoring, hygiene
facilities and practices, respiratory protection, and protective
clothing and equipment (10 CFR 850.23(b)). Although the DOE rule
retained OSHA's current TWA PEL, it also stated that employers would be
required to ensure that employees are not exposed above any ``more
stringent TWA PEL'' that OSHA may promulgate (10 CFR 850.22; 64 FR
68873 and 68906, December 8, 1999).
NIOSH has published a Recommended Exposure Limit (REL) of 0.5
[mu]g/m\3\ as a Ceiling Limit and a NIOSH Alert on preventing CBD and
beryllium sensitization (NIOSH, 1977; NIOSH, 2011). The NIOSH Alert
provides guidance to workers and employers on the hazards of exposure
to beryllium and ways to reduce or minimize exposure. In 2009, ACGIH
adopted a revised Threshold Limit Value (TLV) for beryllium that
lowered the TWA to 0.05 [mu]g/m\3\ from 2 [mu]g/m\3\ (ACGIH, 2009).
The SERs who participated in the SBREFA process had few comments
about the proposed PELs (OSHA, 2008b). The major concerns about a
reduced TWA PEL were economic impact and belief that beryllium-related
health effects did not frequently occur in their industries (OSHA,
2008b). The Panel recommended that OSHA consider to what extent a very
low PEL may result in increased costs to small entities. In section V
of the Preliminary Economic Analysis (OSHA, 2014), OSHA considers the
costs of the proposed PEL and ancillary provisions triggered by the PEL
to all affected entities. In addition, the Agency is considering an
alternative PEL of 0.5 [mu]g/m\3\ (see Regulatory Alternative 5 below).
The Agency seeks comment on whether different PELs should be considered
and the justification for the PELs.
STEL. OSHA is also proposing a STEL of 2.0 [mu]g/m\3\, as
determined over a sampling period of 15 minutes. Where a significant
risk of material impairment of health remains at the TWA PEL, OSHA has
the authority to impose a STEL if doing so would further reduce risk
and is feasible to implement. Pub. Citizen Health Research Grp. v.
Tyson, 796 F.2d 1479, 1505 (D.C. Cir. 1986) (Ethylene Oxide).
As discussed in section VIII of this preamble, Significance of
Risk, significant risk of CBD remains at the proposed TWA PEL of 0.2
[mu]g/m\3\ and the proposed alternative TWA PEL of 0.1 [mu]g/m\3\. OSHA
believes the proposed STEL would further reduce this risk. The goal of
a STEL is to protect employees from the risk of harm that can occur as
a result of brief exposures that exceed the TWA PEL. Without a STEL,
the only protection workers would have from high short-duration
[[Page 47781]]
exposures is that, when those exposures are factored in, they cannot
exceed the cumulative 8-hour exposure at the proposed 0.2 [mu]g/m\3\
TWA PEL (i.e., 1.6 [mu]g/m\3\). Since there are 32 15-minute periods in
an 8-hour work shift, exposures could be as high as 6.4 [mu]g/m\3\ (32
x 0.2 [mu]g/m\3\) for 15 minutes under the proposed TWA PEL without a
STEL, if exposures during the remainder of the 8-hour work shift are
non-detectable. A STEL serves to minimize high task-based exposures by
requiring feasible controls in these situations, and has the added
effect of further reducing the TWA exposure.
OSHA believes a STEL for beryllium will help reduce the risk of
sensitization and CBD in beryllium-exposed employees. As discussed in
this preamble at section V, Health Effects, beryllium sensitization is
the initial step in the development of CBD. Sensitization has been
observed in some workers that were only exposed to beryllium for a few
months (see section V.D.1 of this preamble), and tends to be more
strongly associated with `peak' and highest-job-worked exposure metrics
than cumulative exposure (see section V.D.5 of this preamble). Short-
term exposures to beryllium have been shown to contribute to the
development of lung disease in experimental animals. Beagle dogs that
were administered a single short-term perinasal exposure to aerosolized
beryllium oxide developed a granulomatous lung inflammation similar to
CBD, accompanied by an abnormal BeLPT response (Haley et al., 1989).
These study findings indicate that adverse effects to the lung may
occur from beryllium exposures of relatively short duration. OSHA
believes that a STEL in combination with a TWA PEL adds further
protection from risk of harm than that afforded by the proposed 0.2
[mu]g/m\3\ TWA PEL alone.
STEL exposures are typically associated with, and need to be
measured during, the highest-exposure operations that an employee
performs (see proposed paragraph (d)(1)(iii)). OSHA has preliminarily
determined that the proposed STEL of 2.0 [mu]g/m\3\ can be measured for
this brief period of time using OSHA's available sampling and
analytical methodology, and feasible means exist to maintain 15-minute
short-term exposures at or below the proposed STEL (see section IX.D of
this preamble, Technological Feasibility).
The current entry for beryllium and beryllium compounds (as Be) in
29 CFR 1910.1000 Table Z-1 directs the reader to the entry for
beryllium and beryllium compounds in 29 CFR 1910.1000 Table Z-2. Table
Z-2's entry for beryllium and beryllium compounds includes the current
TWA PEL of 2 [mu]g/m\3\, an acceptable ceiling concentration of 5
[mu]g/m\3\, and an acceptable maximum peak above the acceptable ceiling
concentration of 25 [mu]g/m\3\, allowable for 30 minutes in an 8-hour
shift. Table Z in 29 CFR 1915.1000, and 29 CFR 1926.55 Appendix A each
include the current TWA PEL of 2 [mu]g/m\3\ beryllium and beryllium
compounds for construction and maritime industries, but no ceiling or
peak exposure limit.
As discussed in this Summary and Explanation section of the
preamble regarding paragraph (a), the scope of the proposed rule is
limited to general industry. In addition, it provides an exemption for
those working with materials that contain beryllium only as a trace
contaminant (less than 0.1 percent composition by weight). The proposal
would amend the entry for beryllium and beryllium compounds (as Be) in
29 CFR 1910.1000 Table Z-1, to add a cross reference to the new
standard for operations or sectors that fall within the scope of the
proposed standard, and note that industries not covered under the
proposed standard would continue to be covered by the entry in 29 CFR
1910.1000 Table Z-2. The TWA, ceiling, and maximum peak exposure limits
in 29 CFR 1910.1000 Table Z-2 would still apply to general industry
applications and sectors exempted from the proposed standard. Under the
proposed standard, the exposure limits in the current 29 CFR 1915.1000
Table Z and 29 CFR 1926.55 Appendix A would continue to apply in
construction and maritime industries. As discussed previously in this
preamble at Section I, Issues and Alternatives, and Section XVIII,
paragraph (a), OSHA is considering Regulatory Alternative #2b, which
would update 29 CFR 1915.1000 Tables Z-1 and Z-2, 29 CFR 1915.1000
Table Z, and 29 CFR 1926.55 Appendix A to the PEL and STEL adopted
through this rulemaking to the general industry, construction, and
maritime sectors and applications that do not fall within the scope of
the proposed rule. Note that OSHA is proposing a TWA PEL of 0.2 [mu]g/
m\3\ and a STEL of 2 [mu]g/m\3\, and OSHA is also considering
alternative TWA PELs of .1 [mu]g/m\3\ and .5 [mu]g/m\3\, and
alternative STELs of .5 [mu]g/m\3\, 1 [mu]g/m\3\, and 2.5 [mu]g/m\3\.
OSHA invites comment on the proposed TWA PEL and STEL and on
Regulatory Alternatives 3, 4, and 5 below, which specify a lower STEL,
a lower TWA PEL, and a higher TWA PEL than those proposed,
respectively. OSHA also requests comments and data on the range of TWA
and short-term exposures in covered industries and the types of
operations and engineering or work practice controls in place where
these exposures are occurring.
Regulatory Alternative 3
This alternative would modify the proposed STEL to be five times
the TWA PEL, rather than ten times the TWA PEL. Thus, if OSHA
promulgates the proposed TWA PEL of 0.2 [mu]g/m\3\, the STEL would be 1
[mu]g/m\3\; if OSHA promulgates the alternative TWA PEL of 0.1 [mu]g/
m\3\, the STEL would be 0.5 [mu]g/m\3\; and if OSHA promulgates the
alternative TWA PEL of 0.5 [mu]g/m\3\; the STEL would be 2.5 [mu]g/
m\3\.
As discussed above, OSHA has preliminarily determined that short-
term exposures to beryllium can cause beryllium sensitization, and that
therefore a STEL in combination with a TWA PEL adds further protection
from risk of harm than that afforded by the proposed 0.2 [mu]g/m\3\ TWA
PEL alone.
When OSHA regulations in the past have included a STEL, it is
typically five times the PEL. For example, OSHA's standard for
methylene chloride (29 CFR 1910.1052) specifies an 8-hour TWA PEL of 25
ppm, and a short-term limit of 125 ppm averaged over 15 minutes. The
standard for acrylonitrile (29 CFR 1910.1045) sets an 8-hour TWA PEL of
2 ppm, and a short-term limit of 10 ppm averaged over 15 minutes. The
final standards for benzene (29 CFR 1910.1028), for ethylene oxide (29
CFR 1910.1047) and for 1,3-Butadiene (29 CFR 1910.1051) specify an 8-
hour time-weighted average TWA PEL of 1 ppm and short-term limits of 5
ppm averaged over 15 minutes. OSHA has occasionally deviated from its
usual practice of setting a STEL at five times the TWA PEL, as in the
cases of formaldehyde (29 CFR 1910.1048) (TWA PEL 0.75 ppm, STEL 2 ppm)
and methylenedianiline (29 CFR 1910.1050) (TWA PEL 10 ppb, STEL 100
ppb). OSHA requests comment on whether the beryllium standard should
set a STEL at ten times the TWA PEL, as suggested by the Materion-USW
joint proposed rule and specified in this proposal, or should it
maintain its more usual practice of setting a STEL at five times the
PEL.
Regulatory Alternative 4
This alternative would modify the proposed TWA PEL to be 0.1 [mu]g/
m\3\. As discussed above, OSHA believes a PEL of 0.1 [mu]g/m\3\ would
better protect workers from significant risk of CBD and lung cancer
than the proposed TWA PEL of 0.2 [mu]g/m\3\. OSHA's preliminary risk
assessment indicates that the risk of CBD and lung cancer remaining at
the proposed TWA PEL are significant, and
[[Page 47782]]
that an alternative PEL of 0.1 [mu]g/m\3\ would reduce these risks to
workers further than the proposed PEL would. However, compared with the
proposed PEL, OSHA has less confidence in the feasibility of a PEL of
0.1 [mu]g/m\3\ (see section IX.D of this preamble, Technological
Feasibility). This alternative would also lower the action level from
0.1 [mu]g/m\3\ to .05 [mu]g/m\3\.
Regulatory Alternative 5
This alternative would modify the proposed TWA PEL to be 0.5 [mu]g/
m\3\. This alternative would also raise the proposed action level to
2.5 [mu]g/m\3\. As discussed above, the SBREFA Panel recommended that
OSHA consider the economic impact of a reduced PEL and consider
regulatory alternatives that would ease cost burden for small entities.
The economic impact of a reduced PEL is considered in section VIII of
the Preliminary Economic Analysis (OSHA, 2014). However, OSHA's
preliminary risk assessment indicates significant risk to workers
exposed at a PEL of 0.5 [mu]g/m\3\, and OSHA's preliminary feasibility
analysis indicates that a lower PEL is feasible. Unless OSHA receives
new evidence showing that a PEL lower than 0.5 [mu]g/m\3\ is not
feasible or not needed to reduce significant risk, OSHA cannot adopt
this alternative PEL due to its statutory obligation to set the PEL at
the lowest feasible level to reduce or eliminate significant risk.
(d) Exposure Monitoring
Paragraph (d) of the proposed standard imposes monitoring
requirements pursuant to section 6(b)(7) of the OSH Act (29 U.S.C.
655(b)(7)), which mandates that any standard promulgated under section
6(b) shall, where appropriate, ``provide for monitoring or measuring
employee exposure at such locations and intervals, and in such manner
as may be necessary for the protection of employees.''
The purposes of requiring assessment of employee exposures to
beryllium include determination of the extent and degree of exposure at
the worksite; identification and prevention of employee overexposure;
identification of the sources of exposure to beryllium; collection of
exposure data so that the employer can select the proper control
methods to be used; and evaluation of the effectiveness of those
selected methods. Exposure assessment enables employers to meet their
legal obligation to ensure that their employees are not exposed to
beryllium in excess of the permissible exposure limits and to notify
employees of their exposure levels, including any overexposures as
required by section 8(c)(3) of the Act (29 U.S.C. 657(c)(3)). In
addition, the availability of exposure data enables PLHCPs performing
medical examinations to be informed of the extent of an employee's
occupational exposures.
Paragraph (d)(1) contains proposed general requirements for
exposure monitoring. Under paragraph (d)(1)(i), the monitoring
requirements apply whenever there is actual exposure to airborne
beryllium at any level, or a reasonable expectation of such exposure.
As reflected in the definition of ``exposure'' in paragraph (b) of this
standard, exposure monitoring results must reflect the amount of
beryllium an employee would be exposed to without the use of a
respirator.
Under paragraph (d)(1)(ii), monitoring to determine employee time-
weighted average exposures must represent the employee's average
exposure to airborne beryllium over an eight-hour workday. Under
paragraph (d)(1)(iii), short term exposures must be characterized by
sampling periods of 15 minutes for each operation likely to produce
exposures above the STEL.\46\ Samples taken pursuant to paragraphs
(d)(1)(ii) and (d)(1)(iii) must reflect the exposure of employees on
each work shift, for each job classification, in each beryllium work
area. Samples must be taken within an employee's breathing zone.
---------------------------------------------------------------------------
\46\ Although OSHA has used the phrase ``most likely to produce
exposures'' in other standards in the past (e.g., Ethylene Oxide (29
CFR 1910.1047)), OSHA's intended meaning for previous standards and
for the proposed standard is that employers must characterize
exposures for all operations likely to produce exposures above the
STEL. Accordingly, OSHA is using the phrase ``likely to produce
exposures'' rather than ``most likely to produce exposures'' in this
proposed standard to clarify this longstanding intent.
---------------------------------------------------------------------------
Employers must accurately characterize the exposure of each
employee. In some cases, this will entail monitoring all exposed
employees. In other cases, monitoring of ``representative'' employees
is sufficient. Under paragraph (d)(1)(iv), representative exposure
sampling is permitted when a number of employees perform essentially
the same job under the same conditions. For such situations, it may be
sufficient to monitor a fraction of these employees in order to obtain
data that are representative of the remaining employees. Representative
personal sampling for employees engaged in similar work with beryllium
exposure of similar frequency and duration can be achieved by
monitoring the employee(s) reasonably expected to have the highest
exposures. For example, this may involve monitoring the beryllium
exposure of the employee closest to an exposure source. This exposure
result may then be attributed to the remaining employees in the group.
Representative exposure monitoring must at a minimum include one
full-shift sample taken for each job classification, in each beryllium
work area, for each shift. These samples must consist of at least one
sample characteristic of the entire shift or consecutive representative
samples taken over the length of the shift. Where employees are not
performing the same job tasks under the same conditions, representative
sampling will not adequately characterize actual exposures, and
employers must monitor each employee individually.
Under paragraph (d)(1)(v), the employer would be required to use
monitoring and analytical methods that can measure airborne levels of
beryllium to an accuracy of plus or minus 25 percent (+/-25 percent and
can produce accurate measurements at a statistical confidence level of
95 percent for airborne concentrations at or above the action level.
OSHA believes the following methods could meet these criteria: NIOSH
7704 (also ASTM D7202), ASTM D7439, OSHA 206, OSHA 125G, and OSHA 125G
using ICP-MS. All of these methods are available to commercial
laboratories analyzing beryllium samples. It should be noted that most
of these analytical methods were validated using soluble beryllium
compounds and hence the efficacy of the sample preparation
(specifically digestion of particulate beryllium in mineral acids) step
must be verified prior to use (Stefaniak et al., 2008). Verification
can be aided, in part, through use of an appropriate reference
material. However, not all of these methods are appropriate for
measuring beryllium oxide, so employers must verify that the analytical
methods they use are appropriate for measuring the form(s) of beryllium
present in the workplace. A certified reference material consisting of
high-fired beryllium oxide is available from the National Institute of
Standards and Technology as Standard Reference Material 1877: Beryllium
oxide powder. This reference material carries a certified value for
beryllium content and was developed to meet the need to demonstrate
analytical method efficacy for poorly soluble forms of beryllium
(Winchester et al., 2009). OSHA requests comment on whether these
methods would satisfy the requirements of proposed paragraph (d)(1)(v),
and whether other methods would also meet these criteria.
[[Page 47783]]
Rather than specifying a particular method that must be used, OSHA
proposes to take a performance-oriented approach and instead allow the
employer to use the method of its choosing as long as that method meets
the accuracy specifications in paragraph (d)(1)(v), and the reported
results represent the total airborne concentration of beryllium for the
operation and worker being characterized. For example, a respirable
fraction sample or size selective sample would not be directly
comparable to either PEL, and therefore would not be considered valid.
Paragraph (d)(2) contains proposed requirements for initial
monitoring. OSHA proposes that employers characterize the 8-hour TWA
exposure and 15-minute short-term exposure for each employee who is
known to be exposed to airborne beryllium at any level or whose
exposure is reasonably expected. Further obligations under the standard
would be based on the results of this assessment. These obligations may
include periodic monitoring, establishment of regulated areas, and
implementation of control measures.
Initial monitoring need not be conducted in two circumstances.
First, under paragraph (d)(2)(i), initial monitoring is not required
where the employer has previously monitored for beryllium exposure and
the data were obtained during work operations and under workplace
conditions closely resembling the processes, types of material, control
methods, work practices, and environmental conditions used and
prevailing in the employer's current operations. In addition, the
characteristics of the beryllium-containing material being handled when
the employer previously monitored must closely resemble the
characteristics of the beryllium-containing material used in the
employer's current operations. Such historical monitoring must satisfy
all other requirements of this section, including the accuracy and
confidence requirements in paragraph (d)(1)(v). If these requirements
are satisfied, the employer may rely on such earlier monitoring results
to satisfy the initial monitoring requirements of this section. This
provision is designed to make it clear that OSHA does not intend to
require employers who have recently performed appropriate employee
monitoring to conduct initial monitoring. For historical data to
satisfy the employer's obligation to monitor for 8-hour TWA exposures
under paragraph (d)(1)(ii), these data must characterize 8-hour TWA
exposures that satisfy the requirements of paragraph (d)(2)(i). For
historical monitoring to satisfy an employer's obligation to monitor
for 15-minute short-term exposures under paragraph (d)(1)(iii), these
data must reflect 15-minute short-term exposures. OSHA anticipates that
paragraph (d)(2)(i) will reduce the compliance burden on employers,
since redundant monitoring would not be required.
Second, under paragraph (d)(2)(ii), where the employer has
objective data demonstrating that a particular product or material
containing beryllium or a specific process, operation, or activity
involving beryllium cannot release dust, fumes, or mist in
concentrations at or above the action level or STEL under any
reasonably expected conditions of use, the employer may rely upon such
data to satisfy initial monitoring requirements. The data must reflect
workplace conditions closely resembling the processes, types of
material, control methods, work practices, and environmental conditions
in the employer's current operations.
Objective data used in place of initial monitoring under paragraph
(d)(2) must demonstrate that the work operation or the product cannot
reasonably be foreseen to release beryllium in airborne concentrations
at or above the action level or above the STEL under the expected
conditions of use that will cause the greatest possible release. The
data must demonstrate that exposures cannot meet or exceed the action
level and that exposures cannot exceed the STEL; if the data do not
satisfy both of these requirements, they do not meet the criteria of
paragraph (d)(2)(ii) and would not exempt the employer from conducting
initial monitoring. When using the term ``objective data,'' OSHA is
referring to manufacturers' case studies, laboratory studies, and other
research that demonstrates, usually by means of exposure data, that
exposures above the action level or STEL cannot occur. The objective
data may include monitoring data, or mathematical modeling or
calculations based on the chemical and physical properties of a
material. For example, data collected by a trade association from its
members that reflect workplace conditions closely resembling the
processes, material, control methods, work practices, and environmental
conditions in the employer's current operations may be used. OSHA has
allowed employers to use objective data in lieu of initial monitoring
in other standards, such as those for formaldehyde (29 CFR 1910.1048)
and asbestos (29 CFR 1910.1001).
Paragraph (d)(3) contains requirements for periodic monitoring. The
requirement for this continued monitoring depends on the results of
initial monitoring. If the initial monitoring indicates that employee
exposures are below the action level, no further monitoring would be
required unless, under paragraph (d)(4), changes in the workplace could
result in new or additional exposures. If the initial determination
reveals employee exposures to be at or above the action level and at or
below the TWA PEL, the employer must perform periodic monitoring at
least annually. In stating ``at least annually,'' OSHA intends that
employers must monitor at least once during the 12-month period after
initial monitoring is performed, and then at least once in every
subsequent 12-month period. Of course, the proposed requirement for
annual monitoring does not preclude employers from monitoring more
frequently.
OSHA recognizes that exposures in the workplace can vary from day
to day, between shifts, and even within the same operation. Beryllium
exposures for many operations have been shown to be highly variable,
with some exposures exceeding the current TWA PEL. When airborne
concentrations fluctuate in this way, the probability of exceeding the
PELs increases. Periodic monitoring provides the employer with
additional and up-to-date information to use to make informed decisions
on whether additional control measures are necessary.
Periodic monitoring provides the employer with exposure information
for additional use beyond that of determining compliance with the PELs.
Periodic monitoring will provide data to determine whether or not
engineering controls are working properly and work practices are
effective in preventing exposure. Selection of appropriate respiratory
protection also depends on adequate knowledge of employee exposures
obtained through periodic monitoring.
This proposal does not require periodic monitoring where exposures
are above the TWA PEL, which represents a departure from past OSHA
standards such as Chromium (29 CFR 1910.1026) and Cadmium (29 CFR
1910.1027). OSHA has eliminated the requirement for periodic monitoring
where exposures are above the PEL in response to a multi-stakeholder
proposal to this effect (Materion and Steelworkers, 2012). OSHA
anticipates this could be an appropriate way to reduce costs for
employers where exposures are above the TWA PEL after the employer has
implemented all feasible engineering and work practice controls.
However, the employer must continue to assess the status of available
[[Page 47784]]
feasible engineering and work practice controls to ensure that the
employer has reduced exposures to the lowest level feasible. And even
where this standard does not explicitly require periodic monitoring,
employers may need to conduct periodic monitoring to ensure that
controls are working properly, and that employees are adequately
protected and are receiving the services and benefits to which they are
entitled under this standard such as medical surveillance and medical
removal. OSHA requests comment on whether the proposed annual periodic
monitoring for exposures at or above the action level but below the TWA
PEL is sufficiently protective for employees, or whether annual
periodic monitoring should be required when exposures exceed the TWA
PEL (see Section I of this preamble, Issues and Alternatives).
Under paragraph (d)(4), employers are to perform additional
monitoring when there is a change in production processes, materials,
equipment, personnel, work practices, or control methods, that may
result in new or additional exposures to beryllium. In addition, there
may be other situations that can result in new or additional exposures
that are unique to an employer's work situation. In order to cover
those special situations, OSHA requires the employer to perform
additional monitoring whenever the employer has any reason to believe
that a change has occurred that may result in new or additional
exposures. For example, an employer would be required to perform
additional monitoring when an employee has a confirmed positive result
for beryllium sensitization, exhibits signs or symptoms of CBD, or is
diagnosed with CBD. These conditions necessitate additional monitoring
to ascertain if airborne exposures contributed to the positive results
of the medical testing. Another example of a situation requiring
additional monitoring would be a process modification that would
increase the amount of beryllium-containing material used thereby
possibly increasing employee exposure. Once additional monitoring has
been performed and exposures characterized, the employer can take
appropriate action to protect exposed employees.
Under paragraph (d)(5) employers must notify each employee of his
or her monitoring results within 15 working days after receiving the
results. Employees who must be notified include both the employees
whose exposures were monitored directly and those whose exposures are
represented by the monitoring. The employer must either notify each
employee individually in writing, or post the monitoring results in an
appropriate location accessible to all employees required to be
notified. This proposed requirement is consistent with other OSHA
standards, such as those for methylenedianiline (29 CFR 1910.1050),
1,3-butadiene (29 CFR 1910.1051), and methylene chloride (29 CFR
1910.1052). In addition, whenever the TWA PEL or STEL has been
exceeded, the written notification required by paragraph (d)(5)(i) must
contain a description of the suspected or known sources of exposure as
well as the corrective action(s) being taken by the employer to reduce
the employee's exposure to or below the applicable PEL. This
requirement is necessary to assure employees that the employer is
making efforts to furnish them with a safe and healthful work
environment, and is required under section 8(c)(3) of the Act (29
U.S.C. 657(c)(3)).
Paragraph (d)(6) requires the employer to provide employees and
their designated representatives an opportunity to observe any
monitoring of employee exposure to beryllium. Employees who must be
allowed to observe monitoring include both the employees whose
exposures are being monitored and those whose exposures are represented
by the monitoring. When observation of monitoring requires entry into
an area where the use of protective clothing or equipment is required,
the employer must provide the observer with that protective clothing or
equipment, at no cost. The employer must also assure that the observer
uses such clothing or equipment appropriately and complies with all
other applicable safety and health requirements and procedures.
The requirement for employers to provide employees and their
representatives the opportunity to observe monitoring is consistent
with the OSH Act. Section 8(c)(3) of the Act (29 U.S.C. 657(c)(3))
mandates that regulations requiring employers to keep records of
employee exposures to toxic materials or harmful physical agents
provide employees or their representatives with the opportunity to
observe monitoring or measurements. Also, Section 6(b)(7) of the Act
(29 U.S.C. 655(b)(7)) states that, where appropriate, OSHA standards
are to prescribe suitable protective equipment to be used in dealing
with hazards. The provision for observation of monitoring and
protection of the observers is also consistent with OSHA's other
substance-specific health standards, such as those for cadmium (29 CFR
1910.1027) and methylene chloride (29 CFR 1910.1052).
After reviewing commenter responses to the SBREFA inquiry and the
Agency's RFI on beryllium, OSHA has learned that the amount of employer
effort and diligence in assessing exposure levels is proportional to
the presumed degree of exposure (OSHA, 2008b). Commenters whose
companies make products with high-content beryllium are much more
likely to have incorporated considerable sampling into their exposure
assessment protocol. (Brush Wellman, 2003, Honeywell, 2003). In other
instances, where manufacturers use less beryllium or low-content
beryllium alloys, such as in specialty or precision products, sampling
occurs less frequently. (OSHA, 2007a).
Representatives of various stamping firms who are currently
experiencing low levels of exposure felt that their industry as a whole
should be exempt from the initial exposure assessment provision of this
standard and any additional requirements related to exposure
monitoring. (OSHA, 2007a). However, available information demonstrates
that initial exposure assessment needs to be applied to all industries
where beryllium is processed or otherwise handled (see this preamble at
section V, Health Effects). For example, OSHA's technological
feasibility analysis for fabrication of beryllium alloy products
summarizes exposures for workers in the stamped and formed metal
products sector (see this preamble at Section IX.D, Technological
Feasibility). Exposure monitoring data indicate that while for most
production tasks, the median baseline exposure is less than the
proposed action level of 0.1 [mu]g/m\3\, some tasks have the potential
to generate exposures greater than 0.1 [mu]g/m\3\. Initial exposure
monitoring will help identify the areas and job tasks needing
additional controls, or demonstrate that no additional controls are
needed. Initial monitoring also aids the employer in determining
whether controls currently in use to prevent or reduce beryllium
exposure are effective.
To address many of these comments, OSHA has established
performance-oriented language for the exposure assessment provisions of
this standard, allowing employers to choose any method of exposure
monitoring that meets the accuracy specifications in paragraph
(d)(1)(v) of this standard, and that measures the total airborne
concentration of beryllium for the operation and worker exposures being
characterized. In addition, employers may use historical or objective
data in accordance with proposed paragraph (d)(2) of this standard to
satisfy their initial monitoring obligations. OSHA
[[Page 47785]]
believes this flexibility in the proposal accommodates commenters'
concerns without jeopardizing beryllium-exposed workers' health.
SERs also commented that exposure monitoring is costly and that
OSHA should consider alternatives that allow employers with very low
exposures to be exempt from monitoring. As a possible means of
alleviating costs, the Panel recommended that OSHA encourage the use of
objective data and explain more clearly the requirements for its use.
(OSHA, 2008b). OSHA has clarified in this preamble the circumstances
under which an employer may use historical and objective data in lieu
of initial monitoring. OSHA is also considering whether to create a
guidance product on the use of objective data. The Agency requests
comments on whether a guidance product on the use of objective data
would be helpful to businesses seeking to comply with the beryllium
standard, and what questions or areas of information it should address.
In addition, OSHA has reduced to annually the frequency of periodic
monitoring where exposures are at or above the action level and at or
below the TWA PEL, rather than the six-month frequency proposed during
the SBREFA process. OSHA has also removed the requirement for periodic
monitoring every three months where exposures exceed the PEL. The new
provisions were suggested in the Materion-USW recommended standard
submitted to OSHA in 2012 (Materion and USW, 2012). While these changes
to the proposed standard reduce the cost burden of exposure monitoring
for employers, they also may reduce employees' protection from
overexposure to beryllium.
OSHA notes that the frequency and performance of exposure
monitoring in the draft proposal presented to the SBREFA Panel are
similar to OSHA's typical approach to periodic exposure monitoring.
Most OSHA standards require monitoring at least every six months where
exposure levels meet or exceed the action level, and every three months
where exposures are above the TWA PEL. For example, the standards for
vinyl chloride (29 CFR 1910.1017), inorganic arsenic (29 CFR
1910.1018), lead (29 CFR 1910.1025), cadmium (29 CFR 1910.1027),
methylene chloride (29 CFR 1910.1052), acrylonitrile (29 CFR
1910.1045), ethylene oxide (29 CFR 1910.1047), formaldehyde (29 CFR
1910.1048), all specify periodic monitoring at least every six months
where exposures are above the action level. Periodic exposure
monitoring is also required where exposures exceed the PEL in most
health standards issued since OSHA began specifying frequency for
periodic monitoring. In many cases monitoring is required every three
months where exposures exceed the PEL (methylene chloride (29 CFR
1910.1052), ethylene oxide (29 CFR 1910.1047), acrylonitrile (29 CFR
1910.1045), inorganic arsenic (29 CFR 1910.1018), lead (29 CFR
1910.1025), and vinyl chloride (29 CFR 1910.1017)); in other cases, it
is required at least every six months (cadmium (29 CFR 1910.1027), 1,3-
Butadiene (29 CFR 1910.1051), formaldehyde (29 CFR 1910.1048), benzene
(29 CFR 1910.1028) and asbestos (29 CFR 1910.1001)). Thus, the periodic
monitoring requirements outlined in this proposal and in the Materion-
USW recommended standard depart significantly from OSHA's usual
requirements.
OSHA requests comment on the proposed schedule for periodic
monitoring. Are the proposed requirements both practical for employers
and protective for employees? OSHA also requests comment on Regulatory
Alternatives 9, 10, and 11 below, which would modify the frequency and
performance of exposure monitoring to be more similar to previous
standards and to the draft proposal presented to the SBREFA Panel.
Regulatory Alternative 9
This alternative would require employers to perform exposure
monitoring at least every 180 days where exposures are at or above the
action level or above the STEL, and at or below the TWA PEL. If the
initial monitoring required by paragraph (d)(2) of this section reveals
employee 8-hour TWA exposure at or above the action level, the employer
shall repeat such monitoring for each such employee at least every 180
days to evaluate the employee's TWA exposures. If the initial 15-minute
short-term exposure monitoring reveals employee exposure above the
STEL, the employer shall repeat such monitoring for each such employee
at least every 180 days to evaluate the employee's 15-minute short-term
exposures. Where 8-hour TWA exposures are above the TWA PEL, no
monitoring would be required.
Regulatory Alternative 10
This alternative would require employers to perform monitoring at
least every 180 days where exposures are at or above the action level
or above the STEL. Unlike the periodic monitoring requirement in the
current proposal, this alternative would include periodic monitoring
where exposures are above the TWA PEL. If the initial 8-hour TWA
exposure monitoring required by paragraph (d)(2) of this section
reveals employee exposure at or above the action level, the employer
shall repeat such monitoring for each such employee at least every 180
days to evaluate the employee's TWA exposures. If the initial 15-minute
short-term exposure monitoring reveals employee exposure above the
STEL, the employer shall repeat such monitoring for each such employee
at least every 180 days to evaluate the employee's short-term
exposures.
Regulatory Alternative 11
This alternative would require employers to perform monitoring at
least every 180 days where exposures are at or above the action level
and at or below the TWA PEL. It would require employers to perform
monitoring at least every 90 days where exposures are above the TWA PEL
or STEL.
If the initial 8-hour TWA exposure monitoring required by paragraph
(d)(2) of this section reveals employee TWA exposure at or above the
action level and at or below the TWA PEL, the employer shall repeat
such monitoring for each such employee at least every 180 days to
evaluate the employee's TWA exposures. If this initial monitoring
reveals employee exposure above the TWA PEL or STEL, the employer shall
repeat such monitoring for each such employee at least every 90 days to
evaluate the employee's 8-hour TWA and 15-minute short-term exposures.
(e) Beryllium Work Areas and Regulated Areas
Proposed paragraph (e) requires employers to establish and maintain
beryllium work areas wherever employees are, or can reasonably be
expected to be, exposed to airborne beryllium, regardless of the level
of exposure, and regulated areas wherever employees are, or can
reasonably be expected to be, exposed to airborne concentrations of
beryllium in excess of the TWA PEL or STEL. Paragraph (e) would also
require employers to demarcate beryllium work areas and regulated
areas, and limit access to regulated areas to authorized persons.
The proposed requirements for these areas serve several important
purposes. First, requiring employers to establish and demarcate
beryllium work areas and regulated areas ensures that workers and other
persons are aware of the potential presence of airborne beryllium.
Second, the demarcation of regulated areas must include warning signs
describing the dangers of
[[Page 47786]]
beryllium exposure in accordance with paragraph (m) of this standard,
which ensures that persons entering regulated areas will be aware of
these dangers. Third, limiting access to regulated areas restricts the
number of people potentially exposed to beryllium at levels above the
TWA PEL or STEL, and the serious health effects associated with such
exposure. Limiting access to regulated areas has the added benefit of
reducing the employer's obligation to implement certain provisions of
the proposed rule triggered by employee exposure in a regulated area.
Proposed paragraph (e)(1)(i) would require employers to establish
beryllium work areas where employees are, or can reasonably be expected
to be, exposed to airborne beryllium. OSHA intends this provision to
apply to all areas and situations where employees are actually exposed
to airborne beryllium and to areas and situations where the employer
has reason to anticipate or believe that airborne exposures may occur.
The requirements for beryllium work areas under proposed paragraph
(e)(1)(i) are not tied to a particular level of exposure, but rather
are triggered by the presence of airborne beryllium at any exposure
level.
Proposed paragraph (e)(1)(ii) would require employers to establish
regulated areas wherever employees are actually exposed to airborne
beryllium above either the TWA PEL or STEL, and wherever such exposure
can reasonably be expected. This requirement would apply if any
exposure monitoring or historical or objective data indicate that
airborne exposures are in excess of either the TWA PEL or STEL, or if
the employer has reason to anticipate or believe that airborne
exposures may be above the TWA PEL or STEL, even if the employer has
not yet characterized or monitored those exposures. For example, if
newly introduced processes involving beryllium appear to be creating
dust and have not yet been monitored, the employer should reasonably
anticipate that airborne exposures could exceed the TWA PEL or STEL. In
this situation the employer must designate and demarcate the area as a
regulated area to protect workers and other persons until monitoring
results establish that exposures are at or below the TWA PEL and STEL.
The employer may then remove the regulated area designation.
Proposed paragraph (e)(2)(i) requires employers to demarcate each
beryllium work area to distinguish it from the rest of the workplace.
The proposal specifies that employers must identify beryllium work
areas ``through signs or any other methods that adequately establish
and inform each employee of the boundaries of each beryllium work
area.'' This means that the demarcation must effectively alert workers
and other persons that airborne beryllium may be present. Proposed
paragraph (e)(2)(ii) requires employers to identify regulated areas and
post warning signs at each approach to the regulated area in accordance
with proposed paragraph (m)(2) of this standard.
This proposed rule gives employers flexibility in determining the
best means to demarcate beryllium work areas and regulated areas (with
the exception of paragraph (m), which sets forth specific requirements
for warning signs at entry points to regulated areas). OSHA is aware
that employers use various methods to demarcate certain areas in the
workplace, including barricades, textured flooring, roped-off areas,
``No entry''/``No access'' signs, and painted boundary lines (AIA,
2003, Honeywell, 2003, DOD, 2003). Allowing employers to choose the
methods that best demarcate beryllium work areas and regulated areas is
consistent with OSHA's belief that employers are in the best position
to make such determinations, based on the specific conditions in their
workplaces. Whatever demarcation methods the employer selects must be
clear and understandable enough to alert workers to the boundaries of
the beryllium work area or regulated area. This may mean, for example,
including more than one language on a sign, if the inclusion of a
second language would make the sign understandable to workers with
limited English reading skills.
In determining what demarcation might be necessary and effective,
employers should consider factors including:
The configuration of the beryllium work area or regulated
area;
Whether the beryllium work area or regulated area is
permanent or temporary;
The airborne concentrations of beryllium in the beryllium
work area or regulated area;
The number of employees working in areas adjacent to any
beryllium work area or regulated area; and
The period of time the beryllium work area or regulated
area is expected to have hazardous exposures.
OSHA requests comment on the proposed requirement to demarcate
beryllium work areas and regulated areas. OSHA also requests comment on
whether the standard should allow the performance-based approach
indicated in the proposal or whether the rule should specify what types
of demarcation employers must use.
Proposed paragraph (e)(3) requires employers to limit access to
regulated areas. Because of the potentially serious health effects of
exposure to beryllium and the need for persons entering the regulated
area to be properly protected, OSHA believes that the number of persons
allowed to access regulated areas should be limited to those
individuals listed in proposed paragraph (e)(3). Specifically, this
provision would require employers to limit access to regulated areas
to: (i) persons the employer authorizes or requires to be in a
regulated area to perform work duties; (ii) persons entering a
regulated area as designated representatives of employees for the
purposes of exercising the right to observe exposure monitoring
procedures under paragraph (d)(6) of this standard; and (iii) persons
authorized by law to be in a regulated area.
The first group, persons the employer authorizes or requires to be
in a regulated area to perform work duties, may include workers and
other persons whose jobs involve operating machinery, equipment, and
processes located in regulated areas; performing maintenance and repair
operations on machinery, equipment, and processes in those areas;
conducting inspections or quality control tasks; and supervising those
who work in regulated areas.
The second group is made up of persons entering a regulated area as
designated representatives of employees for the purpose of exercising
the right to observe exposure monitoring under paragraph (d)(6). As
explained in this section of the preamble regarding paragraph (d),
providing employees and their representatives with the opportunity to
observe monitoring is consistent with the OSH Act and OSHA's other
substance-specific health standards, such as those for cadmium (29 CFR
1910.1027) and methylene chloride (29 CFR 1910.1052).
The third consists of persons authorized by law to be in a
regulated area. This category includes persons authorized to enter
regulated areas by the OSH Act, OSHA regulations, or any other
applicable law. OSHA compliance officers would fall into this group.
Proposed paragraph (e)(4) requires employers to provide and ensure
that each employee entering a regulated area uses personal protective
clothing and equipment, including respirators, in accordance with
paragraphs (g) and (h) of this standard.
In general, commenters did not oppose the concept of regulated
areas. Stakeholders responding to the RFI supported the need for
regulated areas
[[Page 47787]]
(ASAS, 2002; AFL-CIO, 2003; Honeywell, 2003). For example, the
Department of Defense thought the use of regulated areas was a good way
to limit the number of workers potentially exposed to beryllium (DOD,
2003).
Most small entity representatives (SERs) who participated in the
SBREFA process were not concerned about the impact of tying the
regulated area requirements to one of the PEL options presented in the
SBREFA draft proposed standard (OSHA, 2007b). Only one of the SERs
indicated that it may have a process where typical or average exposures
are above the lowest PEL option of 0.1 [mu]g/m\3\ (OSHA, 2007a), which
is one half the currently proposed TWA PEL.
SERs were divided on the issue of whether it was possible to
isolate or segregate operations to meet the conditions of a regulated
area. Most of the SERs did not currently isolate or segregate their
beryllium processes, and several expressed concern about the difficulty
and costs associated with isolating or segregating their beryllium
processes (OSHA, 2008b). Some SERs said they have large, open plant
floors making it difficult to isolated specific beryllium operations
(OSHA, 2008b). Other SERs said the proposed requirement for a regulated
area would be difficult and costly because they move machinery and
equipment for production purposes. They said that segregating or
restricting processes or machines and equipment to certain areas would
affect productivity to some extent (OSHA, 2008b). SERs who use
beryllium-containing materials only occasionally, frequently as part of
a larger order, said that it would be impractical to isolate specific
areas or machines for beryllium work (OSHA, 2008b). SERs in the
precision metal products industry indicated their beryllium operations
already were well controlled with machine enclosures (e.g., lathes and
forming machines) and therefore would not need to segregate these
operations (OSHA, 2008b). The Panel recommended that OSHA revisit the
cost analysis of regulated areas if the lowest PEL option (0.1 [mu]g/
m\3\) is proposed (OSHA, 2008b). The Panel also recommended that OSHA
consider dropping or limiting the provision for regulated areas (OSHA,
2008b). In response to this recommendation, OSHA analyzed Regulatory
Alternative #12, which would not require employers to establish
regulated areas.
The proposed rule presented during the SBREFA process did not
contain any requirements for beryllium work areas. These requirements
were added by OSHA after the SBREFA process in response to a proposal
OSHA received from a stakeholder group (Materion and USW, 2012).
However, because the proposal presented during the SBREFA process
included a range of proposed TWA PELs down to 0.1 [mu]g/m\3\, SERs had
the opportunity to comment on the requirements for regulated areas at
very low exposure levels. OSHA believes that SER comments about
regulated areas should reflect SER concerns about beryllium work areas
as well. OSHA has also made the establishment and demarcation
requirements for beryllium work areas flexible and performance-based to
address SER concerns. OSHA invites comment on the proposed requirements
for beryllium work areas and regulated areas, and on Regulatory
Alternative 12 below. OSHA also requests comments and information on
work settings where establishing regulated areas could be problematic
or infeasible and what other approaches might be used to warn employees
in such work settings of high risk areas.
Regulatory Alternative 12
This alternative would eliminate the requirement to establish and
demarcate regulated areas within facilities where there is beryllium
exposure. It does not eliminate the proposal's requirement to establish
and demarcate beryllium work areas.
OSHA is aware that eliminating the requirement for regulated areas
may ease the costs and burdens of compliance for some employers.
However, this potential benefit of Alternative #12 must be considered
in light of the reasons regulated areas were included in the proposal,
and are a feature of most OSHA health regulations. As discussed
previously, the proposed requirements for regulated areas serve to
ensure that access to areas where beryllium exposures exceed the TWA
PEL or STEL is restricted, reducing the number of people exposed to
beryllium at levels that create a high risk of adverse health effects.
Second, the requirement for warning signs ensures that persons who
enter areas where exposures exceed the TWA PEL or STEL will be aware of
the hazards present and take appropriate precautions such as the proper
use of personal protective equipment.
OSHA believes the proposed requirements for beryllium work areas
and regulated areas balance commenters' concerns with the need to
reduce the number of employees exposed to beryllium and notify those
exposed of the risks involved. The proposed standard does not require
employers to establish and demarcate beryllium work areas or regulated
areas by permanently segregating and isolating processes generating
airborne beryllium. Instead, the standard allows employers to use
temporary or flexible methods to demarcate beryllium work areas and
regulated areas.
OSHA believes that these flexible, performance-based requirements
could accommodate open work spaces, changeable plant layouts, and
sporadic or occasional beryllium use without imposing undue costs or
burdens. For example, the standard does not prohibit employers from
moving machinery or equipment for production purposes as occurs in the
beryllium-copper alloy industry (OSHA, 2008b). Where employers need to
move machinery and equipment, the proposed rule allows employers to use
methods such as temporary designations and flexible demarcations. OSHA
also notes that some employers have enclosed machines (e.g., lathes) to
prevent the release of airborne beryllium into the workplace, thereby
potentially eliminating the need for the machine to be in a regulated
area (OSHA, 2008b).
(f) Methods of Compliance
Paragraph (f) of the proposed rule establishes methods for reducing
employee exposure to beryllium through the use of a written exposure
control plan and engineering and work practice controls.
Under proposed paragraph (f)(1)(i), employers must establish,
implement, and maintain a written exposure control plan for beryllium
work areas. OSHA believes that adherence to the written exposure
control plan will help reduce skin contact with beryllium, which can
lead to beryllium sensitization, and airborne exposure, which can lead
to beryllium sensitization, CBD, and lung cancer. Because skin contact
and airborne exposure can occur in any workplace within the scope of
the standard, OSHA has made the preliminary determination to require a
written exposure control plan for all employers within the scope of the
standard. In addition, requiring employers to establish and maintain a
written exposure control plan is consistent with other OSHA health
standards, including 1,3 butadiene (29 CFR 1910.1051) and bloodborne
pathogens (29 CFR 1910.1030).
OSHA's proposal to require a written exposure control plan is based
in part on the recommendation of two stakeholders, Materion Corporation
and the Steelworkers Union. Materion and the Steelworkers submitted a
joint proposal for a standard to the Agency (Materion and Steelworkers,
2012) that includes a requirement for a written
[[Page 47788]]
exposure control plan. In the stakeholders' joint proposal, the written
exposure control plan included requiring documentation of operations
and jobs likely to have exposure to beryllium at various levels;
procedures for minimizing the migration of beryllium; procedures for
keeping work surfaces clean; and documentation of engineering and work
practice controls. OSHA's proposed requirements for maintaining and
implementing a written exposure control plan follow the example of the
stakeholders' proposal in most respects.
Under proposed paragraphs (f)(1)(i)(A), (B), and (C), the written
exposure control plan must contain inventories of operations and job
titles reasonably expected to have any exposure to airborne beryllium,
exposure at or above the action level, and exposure above the TWA PEL
or STEL. And, under proposed paragraph (f)(1)(i)(G), the plan must
include an inventory of engineering and work practice controls required
by paragraph (f)(2) of this standard.
A record of which operations and job titles are likely to have
exposures at certain levels and which engineering and work practice
controls the company has selected to control exposures will make it
easier for employers to implement monitoring, hygiene practices,
housekeeping, engineering and work practice controls, and other
measures. These inventories will also help to assure employees'
awareness of the exposures associated with their jobs, their
eligibility for medical surveillance, and the controls that should be
in use throughout the workplace. This will enable employees to work
together with employers to ensure that the appropriate engineering
controls and work practices are in use and functioning and that
provisions such as medical surveillance, housekeeping, and PPE are
properly implemented. In addition, these inventories, like all of the
items required to be included in the written exposure control plan,
will help safety and health personnel, including OSHA Compliance
Officers, carry out their duties. A written plan provides detailed
information to interested parties including employees, employee
representatives, supervisors, and safety consultants of the employer's
determination of the jobs and operations that may place employees at
risk of exposure and the measures the employer has selected to control
exposure.
Under proposed paragraph (f)(1)(D) through (F) and (H), the
exposure control plan must contain procedures for: minimizing cross-
contamination, including preventing the transfer of beryllium between
surfaces, equipment, clothing, materials, and articles within beryllium
work areas; keeping surfaces in the beryllium work area as free as
practicable of beryllium; minimizing the migration of beryllium from
beryllium work areas to other locations within or outside the
workplace; and removal, laundering, storage, cleaning, repairing, and
disposal of beryllium-contaminated personal protective clothing and
equipment, including respirators. Each of these procedures serves to
minimize the spread of beryllium throughout and outside the workplace.
They also work to reduce the likelihood of skin contact and re-
entrainment of beryllium particulate into the workplace atmosphere.
Additional discussion of some of these requirements may be found in
this section of the preamble, Summary and Explanation, at paragraph
(h), Personal Protective Clothing and Equipment; paragraph (i), Hygiene
Areas and Practices; and paragraph (j), Housekeeping.
The requirement to document these procedures in writing, as part of
the exposure control plan, will help to ensure that employees are
advised of their responsibilities and can easily review the procedures
if they have questions. Because employees play an important part in
exposure control through compliance with the rules regarding hygiene
practices, housekeeping, and other measures, employees should have easy
access to documentation detailing the procedures in place in their
workplace. A review of the written exposure control plan should be part
of the hazard communication training for employees as required by
1910.1200 and proposed paragraph (m). Additionally, the documentation
of the procedures will help OSHA Compliance Officers assess employers'
procedures.
Proposed paragraph (f)(1)(ii) requires that employers update their
exposure control plans whenever any change in production processes,
materials, equipment, personnel, work practices, or control methods
results or can reasonably be expected to result in new or additional
exposures to beryllium. Paragraph (f)(1)(ii) also requires employers to
update their plans when an employee is confirmed positive for beryllium
sensitization, is diagnosed with CBD, or shows other signs and symptoms
related to beryllium exposure. In addition, the paragraph requires
employers to update their plans if the employer has any reason to
believe that new or additional exposures are occurring or will occur.
The requirements to update the exposure control plan if changes in
the workplace result in or can be expected to result in new or
additional exposures, or where the employer has any reason to believe
that such exposures are occurring or will occur, ensure that an
employer's plan reflects the current conditions in the workplace. If an
employee becomes sensitized or develops CBD, the employer should
investigate the source(s) of exposure responsible, and must make any
necessary changes to address the source(s) of exposure, and update the
written exposure control plan as necessary to reflect any new
information or corrective action resulting from the employer's
investigation. For example, the employer may find that housekeeping
procedures in the employee's area need improvement, or that more
appropriate PPE could be used. In some cases, the employer may find
that additional engineering or work practice controls are appropriate
to the processes in use. When the employer discovers new sources of
exposure or makes changes in its control strategy, the employer must
update its written exposure control plan to reflect current conditions
in the workplace. Employers such as Materion and Axsys Technologies,
who have worked to identify and document the exposure sources
associated with cases of sensitization and CBD in their facilities,
have used this information to develop and update beryllium exposure
control plans (Bailey et al., 2010; Schuler et al., 2012; Madl et al.,
2007). OSHA believes this proposed process, whereby an employer uses
employee health outcome data to check and improve the effectiveness of
the employer's exposure control plan, is consistent with other
performance-oriented aspects of this proposed standard.
Proposed paragraph (f)(1)(iii) requires employers to make a copy of
the exposure control plan accessible to each employee who is or can
reasonably be expected to be exposed to airborne beryllium in
accordance with OSHA's Access to Employee Exposure and Medical Records
Standard (29 CFR 1910.1020). As mentioned above, access to the exposure
control plan will enable employees to partner with their employers in
keeping the workplace safe.
Paragraph (f)(2) of the proposed rule contains requirements for the
implementation of engineering and work practice controls to minimize
beryllium exposures in beryllium work areas. The proposed rule relies
on engineering and work practice controls as the primary means to
reduce
[[Page 47789]]
exposures. Where, after the implementation of feasible engineering and
work practice controls, exposures exceed or can reasonably be expected
to exceed the TWA PEL or STEL, employers are required to supplement
these controls with respiratory protection, according to the
requirements of paragraph (g) of the proposed rule. OSHA proposes to
require primary reliance on engineering and work practice controls
because reliance on these methods is consistent with good industrial
hygiene practice, with the Agency's experience in ensuring that workers
have a healthy workplace, and with OSHA's traditional adherence to a
hierarchy of controls.
OSHA requires adherence to this hierarchy of controls in a number
of standards, including the Air Contaminants (29 CFR 1910.1000) and
Respiratory Protection (29 CFR 1910.134) standards, as well as other
substance-specific standards. The Agency's adherence to the hierarchy
of controls has been successfully upheld by the courts (see AFL-CIO v.
Marshall, 617 F.2d 636 (D.C. Cir. 1979) (cotton dust standard); United
Steelworkers v. Marshall, 647 F.2d 1189 (D.C. Cir. 1980), cert. denied,
453 U.S. 913 (1981) (lead standard); ASARCO v. OSHA, 746 F.2d 483 (9th
Cir. 1984) (arsenic standard); Am. Iron & Steel v. OSHA, 182 F.3d 1261
(11th Cir. 1999) (respiratory protection standard); Pub. Citizen v.
U.S. Dep't of Labor, 557 F.3d 165 (3rd Cir. 2009) (hexavalent chromium
standard)).
The Agency understands that engineering controls are reliable,
provide consistent levels of protection to a large number of workers,
can be monitored continually and inexpensively, allow for predictable
performance levels, and can efficiently remove toxic substances from
the workplace. Once removed, the toxic substances no longer pose a
threat to employees. The effectiveness of engineering controls does not
generally depend to any substantial degree on human behavior, and the
operation of control equipment is not as vulnerable to human error as
is personal protective equipment. For these reasons, engineering
controls are preferred by OSHA and the safety and health professional
community in general.
The provisions related to engineering and work practice controls
begin in paragraph (f)(2)(i)(A). For each operation in a beryllium work
area, employers must ensure that at least one of the following
engineering and work practice controls is in place to minimize employee
exposure:
(1) Material and/or process substitution;
(2) Ventilated partial or full enclosures;
(3) Local exhaust ventilation at the points of operation, material
handling, and transfer; or
(4) Process control, such as wet methods and automation. OSHA has
included a non-mandatory appendix presenting a non-exhaustive list of
engineering controls employers may use to comply with paragraph
(f)(2)(i) (Appendix B).
Proposed paragraph (f)(2)(i)(B) offers two exemptions from the
engineering and work practice controls requirements. First, under
paragraph (f)(2)(i)(B)(1), an employer is exempt from using engineering
and work practice controls where the employer can establish that the
controls are not feasible.
Second, under paragraph (f)(2)(i)(B)(2), an employer is exempt from
using the controls where the employer can demonstrate that exposures
are below the action level, using no fewer than two representative
personal breathing zone samples taken 7 days apart, for each affected
operation.
The engineering work practice control requirement in paragraph
(f)(2)(i)(A), like the written exposure control plan requirement, was
proposed by the United Steelworkers and Materion as part of their joint
submission to OSHA (Materion and United Steelworkers, 2012). The
inclusion of the engineering work practice control provision in
paragraph (f)(2)(i)(A) addresses a concern regarding the proposed PEL.
OSHA expects that day-to-day changes in workplace conditions may cause
frequent excursions above the PEL in workplaces where periodic sampling
indicates exposures are between the action level and the PEL. Normal
variability in the workplace and work processes, such as workers'
positioning or patterns of airflow, can lead to excursions above the
PEL. OSHA believes that substitution or engineering controls such as
those outlined in paragraph (f)(2)(i)(A) provide the most reliable
means to control variability in exposure levels. OSHA therefore
included this requirement in the proposal. The Agency included the
exemption in paragraph (f)(2)(i)(B)(2) to reduce the cost burden to
employers with operations where measured exposures are below the action
level, and therefore less likely to exceed the PEL in the course of
typical exposure fluctuations. This exemption is similar to a provision
in 1,3 Butadiene (29 CFR 1910.1051), which requires an exposure goal
program where exposures exceed the action level.
OSHA recognizes that the requirements of paragraph (f)(2)(i) are
not typical of OSHA standards, which usually require engineering
controls only where exposures exceed the PEL(s). The Agency is
therefore considering Regulatory Alternative #6, which would drop the
provisions of paragraph (f)(2)(i) from the proposed standard. OSHA
requests comments on the potential benefits of including such a
provision in the beryllium standard, the potential costs and burdens
associated with it, and whether OSHA should include or exclude this
provision in the final standard.
Proposed paragraph (f)(2)(ii) applies when exposures exceed the TWA
PEL or STEL after employers have implemented the control(s) required by
paragraph (f)(2)(i). It requires employers to implement additional or
enhanced engineering and work practice controls to reduce exposures to
or below the PELs. For example, an enhanced engineering control may
entail a redesigned hood on a local ventilation system to more
effectively capture airborne beryllium at the source.
However, under proposed paragraph (f)(2)(iii), wherever the
employer demonstrates that it is not feasible to reduce exposures to or
below the PELs by the engineering and work practice controls required
by paragraphs (f)(2)(i) and (f)(2)(ii), the employer shall implement
and maintain engineering and work practice controls to reduce exposures
to the lowest levels feasible and supplement these controls by using
respiratory protection in accordance with paragraph (g) of this
standard.
Paragraph (f)(3) of the proposed rule would prohibit the employer
from rotating workers to different jobs to achieve compliance with the
PELs. Worker rotation can potentially reduce exposures to individual
employees, but increases the number of employees exposed. Because OSHA
has made a preliminary determination that exposure to beryllium can
result in sensitization, CBD, and cancer, the Agency considers it
inappropriate to place more workers at risk. Since no absolute
threshold has been established for sensitization or resulting CBD or
the carcinogenic effects of beryllium, it is prudent to limit the
number of workers exposed at any concentration.
This provision is not a general prohibition of worker rotation
wherever workers are exposed to beryllium. It is only intended to
restrict its use as a compliance method for the proposed PEL; worker
rotation may be used as deemed appropriate by the employer in
[[Page 47790]]
activities such as to provide cross-training or to allow workers to
alternate physically demanding tasks with less strenuous activities.
This same provision was used for the asbestos (29 CFR 1910.1001 and 29
CFR 1926.1101), chromium (VI) (29 CFR 1910.1026), 1,3 butadiene (29 CFR
1910.1051), methylene chloride (29 CFR 1910.1052), cadmium (29 CFR
1910.1027 and 29 CFR 1926.1127), and methylenedianiline (29 CFR
1926.60) OSHA standards.
The SERs who participated in the SBREFA process did not voice
opposition to a requirement for a written exposure control program or
challenge the utility of a written program in helping to control
exposures (OSHA, 2008b). Several indicated that they already had a
beryllium exposure control program in place. Some SERs suggested that
OSHA should tie the written exposure control program requirement to
exposures exceeding a revised PEL (OSHA, 2008b). The SERs' request to
tie the written exposure control program requirement to the PEL appears
to emerge from their belief that employees exposed below the proposed
PEL are not at risk from beryllium exposure (OSHA, 2008b).
As stated earlier, OSHA's proposed standard would require a written
exposure control plan for all beryllium work areas; i.e., wherever
airborne beryllium is found in the workplace. OSHA believes a written
exposure control plan is needed to reduce employees' risks in low-
exposure areas, where the proposed standard does not require employers
to install engineering controls, as well as in high-risk areas. The
Agency's preliminary risk assessment shows that adverse health effects
from beryllium exposure occur at levels below the proposed PEL, and
even below the proposed action level (see this preamble at Section
VIII, Significance of Risk). In addition, dermal contact with beryllium
can occur in jobs where exposures are below the PEL or the action
level. Dermal exposure to beryllium can cause beryllium sensitization,
a necessary first step in the development of CBD (see this preamble at
Section V, Health Effects, and Section VIII, Significance of Risk).
However, in response to the SERs' comments on the written exposure
control plan and other requirements that may affect workplaces with
exposure levels below the proposed PEL, OSHA is considering Regulatory
Alternative #8 (see chapter VIII of the PEA). Where the proposed
standard requires written exposure control plans to be maintained in
any facility covered by the standard, Regulatory Alternative #8 would
require only facilities with exposures above the TWA PEL or STEL to
maintain a plan. OSHA requests comment on the proposed written exposure
control plan requirement and on Regulatory Alternative #8.
Several SERs expressed doubt that material substitution could be an
effective means of reducing beryllium exposures in their facilities.
One SER stated that substitutes for beryllium alloys are not presently
viable for industrial uses that require certain high-performance
electrical characteristics, or wear resistance (OSHA, 2007a). Another
SER commented that substitutes for beryllium alloys in the dental
appliance industry have also been associated with occupational disease
(OSHA, 2007a).
OSHA recognizes that the use of substitutes for beryllium may not
be feasible or appropriate for some employers. The Agency's intent is
to offer material substitution as one possible means of compliance with
the proposed standard. Employers must determine whether material
substitution is an effective and appropriate means of exposure control
for their facilities. In addition, it is employers' responsibility to
check the toxicity of any material they may use in their facilities,
including potential substitutes for beryllium.
OSHA anticipates that most small businesses will be able to comply
with the proposed standard regardless of whether they choose to
substitute other materials for beryllium in their facilities.
(g) Respiratory Protection
Paragraph (g) of the proposed standard lays out the situations in
which employers are required to protect employees' health through the
use of respiratory protection. Specifically, this paragraph would
require that employers provide respiratory protection at no cost and
ensure that employees utilize the protection during the situations
listed in paragraph (g)(1). As detailed in proposed paragraph (g)(2),
the required respiratory protection must comply with the Respiratory
Protection standard (29 CFR 1910.134).
Proposed paragraph (g)(1) requires employers to ensure that each
employee required to use a respirator does so. Accordingly, simply
providing respirators to employees will not satisfy an employer's
obligations under proposed paragraph (g)(1) unless the employer also
ensures that its employees wear the respirators when required. Proposed
paragraph (g)(1) would also require employers to provide required
respirators at no cost to employees. This requirement is consistent
with OSHA's Respiratory Protection standard, which also requires
employers to provide required respiratory protection to employees at no
cost (29 CFR 1910.134(c)(4)).
Paragraph (g)(1) requires appropriate respiratory protection during
certain enumerated situations. Proposed paragraph (g)(1)(i) requires
respiratory protection during the installation and implementation of
engineering and/or work practice controls where exposures exceed or can
reasonably be expected to exceed the TWA PEL or STEL. The Agency
realizes that changing workplace conditions may require employers to
install new engineering controls, modify existing controls, or make
other workplace changes to reduce employee exposure to beryllium to at
or below the TWA PEL and STEL. In these cases, the proposed standard
recognizes that installing appropriate engineering controls and
implementing proper work practices may take time. During this time,
employers must demonstrate that they are making prompt, good faith
efforts to purchase and install appropriate engineering controls and
implement effective work practices, and to evaluate their effectiveness
for reducing exposure to beryllium to at or below the TWA PEL and STEL.
Proposed paragraph (g)(1)(ii) requires the provision of respiratory
protection during any operations, including maintenance and repair
operations and other non-routine tasks, when engineering and work
practice controls are not feasible and exposures exceed or can
reasonably be expected to exceed the TWA PEL or STEL. OSHA included
this provision because the Agency realizes that certain operations may
take place when engineering and work practice controls are not
operational or capable of controlling exposures to at or below the TWA
PEL and STEL. For example, during maintenance and repair operations,
engineering controls may lose their full effectiveness or require
partial or total breach, bypass, or shutdown. Under these
circumstances, if exposures exceed or can reasonably be expected to
exceed the TWA PEL or STEL, the employer must provide and ensure the
use of respiratory protection.
Proposed paragraph (g)(1)(iii) requires the provision of
respiratory protection where beryllium exposures exceed the TWA PEL or
STEL even after the employer has installed and implemented all feasible
engineering and work practice controls. OSHA anticipates that there
will be very few situations where feasible engineering and work
practice controls are incapable of lowering employee exposure to
beryllium to at or below the TWA PEL
[[Page 47791]]
or STEL (see this preamble at section IX.D, Technological Feasibility).
In such cases, the proposed standard requires that employers install
and implement all feasible engineering and work practice controls and
supplement those controls by providing respiratory protection (proposed
paragraph (f)(2)(iii)). OSHA reiterates that paragraph (f)(2)(iii)
would also require employers to demonstrate that engineering and work
practice controls are not feasible or sufficient to reduce exposure to
levels at or below the TWA PEL and STEL. OSHA requests comment about
the proposed situations during which employers should be required to
provide and ensure the use of respiratory protection.
Proposed paragraph (g)(1)(iv) requires the provision of respiratory
protection in emergencies. At such times, engineering controls may not
be functioning fully or may be overwhelmed or rendered inoperable.
Also, emergencies may occur in areas where there are no engineering
controls. The proposed standard recognizes that the provision of
respiratory protection is critical in emergencies, as beryllium
exposures may be very high and engineering controls may not be adequate
to control an unexpected release of beryllium.
The situations in which respiratory protection is required are
generally consistent with the requirements in other OSHA health
standards, such as those for chromium (VI)(29 CFR 1910.1026), butadiene
(29 CFR 1910.1051), and methylene chloride (29 CFR 1910.1052). Those
standards and this proposed standard also reflect the Agency's
traditional adherence to a hierarchy of controls in which engineering
and work practice controls are preferred to respiratory protection (see
the discussion of proposed paragraph (f) earlier in this section of the
preamble).
Whenever respirators are used to comply with the requirements of
this proposed standard, paragraph (g)(2) requires that the employer
implement a comprehensive written respiratory protection program in
accordance with OSHA's Respiratory Protection standard (29 CFR
1910.134). The Respiratory Protection standard is designed to ensure
that employers properly select and use respiratory protection in a
manner that effectively protects exposed workers. Under 29 CFR
1910.134(c)(1), the employer's respiratory protection program must
include:
Procedures for selecting appropriate respirators for use
in the workplace;
Medical evaluations of employees required to use
respirators;
Respirator fit testing procedures;
Procedures for proper use of respirators in routine and
reasonably foreseeable emergency situations;
Procedures and schedules for maintaining respirators;
Procedures to ensure adequate quality, quantity, and flow
of breathing air for atmosphere-supplying respirators;
Training of employees in the respiratory hazards to which
they are potentially exposed during routine and emergency situations,
and in the proper use of respirators; and
Procedures for evaluating the effectiveness of the
program.
In accordance with the Agency's policy to avoid duplication and to
establish regulatory consistency, proposed paragraph (g)(2)
incorporates by reference the requirements of 29 CFR 1910.134 rather
than reprinting those requirements in this proposed standard. OSHA
notes that the respirator selection provisions in 1910.134 include
requirements for Assigned Protection Factors (APFs) and Maximum Use
Concentrations (MUCs) that OSHA adopted in 2006 (71 FR 50122-50192,
August 24, 2006). The APFs and MUCs provide employers with critical
information for the selection of respirators to protect workers from
exposure to atmospheric workplace contaminants.
OSHA believes that the proposed respiratory protection requirements
are feasible even for small employers. Although none of the SERs who
participated in the SBREFA process made specific recommendations about
respiratory protection, some said that they currently have existing
respiratory protection programs in place as supplemental support to
engineering and work practice controls (OSHA, 2008b).
OSHA requests comment on the proposed requirement to establish and
maintain a respiratory protection program that complies with 29 CFR
1910.134. OSHA would like to hear from companies of all sizes regarding
whether they have respiratory protection programs to protect employees
from beryllium exposures. If so, please explain the parameters of your
program including types of respirators used, when and where respirators
are required, program evaluation, and annual costs.
(h) Personal Protective Clothing and Equipment
Paragraph (h) of the proposed standard requires employers to
provide employees with personal protective clothing and equipment (PPE)
where employee exposure exceeds or can reasonably be expected to exceed
the TWA PEL or STEL; where work clothing or skin may become visibly
contaminated with beryllium, including during maintenance and repair
activities or during non-routine tasks; and where employees are exposed
to soluble beryllium compounds. These PPE requirements are intended to
prevent adverse health effects associated with dermal exposure to
beryllium, and accumulation of beryllium on clothing, shoes, and
equipment that can result in additional inhalation exposure. The
requirements also protect employees in other work areas from exposures
that could occur if contaminated clothing carried beryllium to those
areas, as well as employees and other individuals outside the
workplace. The proposed standard requires the employer to provide PPE
at no cost to employees, and to ensure that employees use the provided
PPE in accordance with the written exposure control plan as described
in paragraph (f)(1) of this proposed standard and OSHA'S Personal
Protective Equipment standards (29 CFR part 1910 subpart I).
Proposed paragraph (h)(1)(i) requires the provision and use of PPE
for employees exposed to airborne beryllium in any form exceeding the
TWA PEL or STEL because such exposure would likely result in skin
contact by means of deposits on employees' skin or clothes or on
surfaces touched by employees. And, OSHA believes that regardless of
the level of exposure, the use of PPE further reduces exposure where
employees' clothing or skin could become visibly contaminated with
beryllium (paragraph (h)(1)(ii)).
The term ``visibly contaminated with beryllium'' means visibly
contaminated with any material that contains beryllium. The proposed
standard does not specify criteria for determining whether work
clothing or skin may become visibly contaminated with beryllium. When
evaluating whether this definition is satisfied, OSHA expects that the
employer will assess the workplace in a manner consistent with the
Agency's general requirements for the use of personal protective
equipment in general industry (29 CFR part 1910 subpart I). These
standards require the employer to assess the workplace to determine if
hazards associated with dermal or inhalation exposure to a substance
such as beryllium are, or are likely to be, present.
The proposed standard also requires the provision and use of PPE
where employees are exposed to soluble
[[Page 47792]]
beryllium compounds, regardless of the level of airborne exposure
(paragraph (h)(1)(iii)). Solubility is a concern because dermal
absorption may occur at a greater rate for soluble beryllium than for
insoluble beryllium. Once absorbed through the skin, beryllium can
induce a sensitization response that is a necessary first step toward
CBD (See the Health Effects section of this preamble, section V.A.2).
However, there is also evidence that beryllium in other forms can be
absorbed through the skin and cause sensitization (see this preamble at
section V.B.2, Health Effects). OSHA requests comment on this
provision, and whether employers should also be required to provide PPE
to limit dermal contact with insoluble forms of beryllium as specified
in Regulatory Alternative #13 below.
Requiring PPE is consistent with section 6(b)(7) of the OSH Act
which states that, where appropriate, standards shall prescribe
suitable protective equipment to be used in connection with hazards.
The proposed requirements for PPE are based upon widely accepted
principles and conventional practices of industrial hygiene, and in
some respects are similar to other OSHA health standards such as those
for chromium (VI) (29 CFR 1910.1026), lead (29 CFR 1910.1025), cadmium
(29 CFR 1910.1027), and methylenedianiline (MDA; 29 CFR 1910.1050).
However, the requirement to use PPE where work clothing or skin may
become ``visibly contaminated'' with beryllium differs from prior
health standards, which do not require contamination to be visible in
order for PPE to be required. For example, the standard for chromium
(VI) requires the employer to provide appropriate PPE where a hazard is
present or is likely to be present from skin or eye contact with
chromium (VI) (29 CFR 1910.1026). The lead (29 CFR 1910.1025) and
cadmium (29 CFR 1910.127) standards require PPE where employees are
exposed above the PEL or where there is potential for skin or eye
irritation, regardless of airborne exposure level. In the case of MDA,
PPE must be provided where employees are subject to dermal exposure to
MDA, where liquids containing MDA can be splashed into the eyes, or
where airborne concentrations of MDA are in excess of the PEL (29 CFR
1910.1050). While OSHA's language regarding PPE requirements varies
somewhat from standard to standard, previous standards tend to
emphasize potential for contact with a substance that can trigger
health effects via dermal exposure, rather than ``visible
contamination'' with the substance.
The employer must exercise reasonable judgment in selecting
appropriate PPE. This requirement is consistent with OSHA's current
standards for provision of personal protective equipment for general
industry (29 CFR part 1910 subpart I). As described in the non-
mandatory appendix providing guidance on conducting a hazard assessment
for OSHA general industry standards (29 CFR 1910 subpart I appendix B),
the employer should ``exercise common sense and appropriate expertise''
in assessing hazards. By ``appropriate expertise,'' OSHA expects
individuals conducting hazard assessments to be familiar the employer's
work processes, materials, and work environment. A thorough hazard
assessment should include a walk-through survey to identify sources of
hazards to employees, wipe sampling to detect beryllium contamination
on surfaces, review of injury and illness data, and employee input on
the hazards to which they are exposed. Information obtained in this
manner provides a basis for the identification and evaluation of
potential hazards. OSHA believes that the implementation of a
comprehensive and thorough program to determine areas of potential
exposure, consistent with the employer's written exposure control plan,
is a sound safety and health practice and a necessary element of
ensuring overall worker protection.
Based on the hazard assessment results, the employer must determine
what PPE is necessary to protect employees. The proposed requirement is
performance-oriented, and is designed to allow the employer flexibility
in selecting the PPE most suitable for each particular workplace. The
type of PPE needed will depend on the potential for exposure, the
physical properties of the beryllium-containing material used, and the
conditions of use in the workplace. For example, shipping and receiving
activities may necessitate only work uniforms and gloves. In other
situations such as when a worker is performing facility maintenance,
gloves, work uniforms, coveralls, and respiratory protection may be
appropriate. Beryllium compounds can exist in acidic or alkaline form,
and these characteristics may influence the choice of PPE. Face shields
may be appropriate in situations where there is a danger of being
splashed in the face with soluble beryllium or a liquid containing
beryllium. Coveralls with a head covering may be appropriate when a
sudden release of airborne beryllium could result in beryllium
contamination of clothing, hair, or skin. Respirators are addressed
separately in the explanation of proposed paragraph (g) earlier in this
section of the preamble.
Note that paragraph (i)(2) of this proposed standard requires
change rooms only where employees are required to remove their personal
clothing. Although some personal protective clothing may be worn over
street clothing, it is not appropriate for workers to wear protective
clothing over street clothing if doing so could reasonably result in
contamination of the workers' street clothes. In situations in which it
is not appropriate for workers to wear protective clothing over their
street clothes, the employer must select and ensure the use of
protective clothing that is worn in lieu of (rather than over) street
clothing.
Paragraph (h)(2) contains proposed requirements for removal and
storage of PPE. This provision is intended to reduce beryllium
contamination in the workplace and limit beryllium exposure outside the
workplace. Wearing contaminated clothing outside the beryllium work
area could lengthen the duration of exposure and carry beryllium from
beryllium work areas to other areas of the workplace. In addition,
contamination of personal clothing could result in beryllium being
carried to employees' cars and homes, increasing employees' exposure as
well as exposing others to beryllium hazards. A National Jewish Medical
and Research Center collaborative study with NIOSH documented
inadvertent transfer of beryllium from the workplace to workers'
automobiles, and stressed the need for separating clean and
contaminated (``dirty'') PPE (Sanderson, 1999). Toxic metals brought by
workers into the home via contaminated clothing and vehicles continue
to result in exposure to children and other household members. A recent
study of battery recycling workers found that lead surface
contamination above the Environmental Protection Agency level of
concern ( 40 [mu]g/ft\2\) was common in the workers' homes
and vehicles (Centers for Disease Control and Prevention, 2012).
Under proposed paragraph (h)(2)(i)(A), beryllium-contaminated PPE
must be removed at the end of the work shift or at the completion of
tasks involving beryllium exposure, whichever comes first. This
language is intended to convey that PPE contaminated with beryllium
should not be worn when tasks involving beryllium exposure have been
completed for the day. For example, if employees perform work tasks
involving beryllium exposure for the first two hours of a
[[Page 47793]]
work shift, and then perform tasks that do not involve exposure, they
should remove their PPE after the exposure period to avoid the
possibility of increasing the duration of exposure and contamination of
the work area from beryllium residues on the PPE (i.e., re-entrainment
of beryllium particulate). If, however, employees are performing tasks
involving exposure intermittently throughout the day, or if employees
are exposed to other contaminants where PPE is needed, this provision
is not intended to prevent them from wearing the PPE until the
completion of their shift, unless it has become visibly contaminated
with beryllium (paragraph (h)(2)(i)(B)).
Paragraph (h)(2)(i)(B) would require employers to ensure that
employees remove PPE that has become visibly contaminated with
beryllium. This language is intended to convey that PPE that is visibly
contaminated with beryllium should be changed at the earliest
reasonable opportunity, for example, at the end of the task during
which it became visibly contaminated. This language is intended to
protect employees working with beryllium and their co-workers from
exposure due to accumulation of beryllium on PPE, and reduces the
likelihood of cross-contamination from beryllium-contaminated PPE.
Proposed paragraph (h)(2)(ii) requires employees to remove PPE
consistent with the written exposure control plan required by proposed
paragraph (f)(1). Paragraph (f)(1) specifies that the employer's
written exposure control plan must contain procedures for minimizing
cross-contamination, and procedures for the storage of beryllium-
contaminated PPE, among other provisions (see (f)(1)(i)(D) & (H)).
Paragraph (h)(2)(iii) would require employers to ensure that protective
clothing is stored separately from employees' street clothing. OSHA
believes these provisions are necessary to prevent the spread of
beryllium throughout and outside the workplace.
To further limit exposures outside the workplace, OSHA proposes in
paragraph (h)(2)(iv) that the employer ensure that beryllium-
contaminated PPE is only removed by employees who are authorized to do
so for the purpose of laundering, cleaning, maintaining, or disposing
of such PPE. These items must be brought to an appropriate location
away from the workplace. To be an appropriate location for purposes of
paragraph (h)(2)(iv), the facility must be equipped to handle
beryllium-contaminated items in accordance with this proposed standard.
The standard would further require in paragraph (h)(2)(v) that PPE
removed from the workplace for laundering, cleaning, maintenance, or
discarding be placed in closed, impermeable bags or containers. These
requirements are intended to minimize cross-contamination and migration
of beryllium, and to protect employees or other individuals who later
handle beryllium-contaminated items. Required warning labels would
alert those handling the contaminated PPE of the potential hazards of
exposure to beryllium. Such labels must conform with the HCS (29 CFR
1910.1200) and paragraph (m)(3) of this proposed standard. These
warning requirements are meant to reduce confusion and ambiguity
regarding critical information communicated in the workplace by
requiring that this information be presented in a clear and uniform
manner.
Proposed paragraph (h)(3)(i) would require the employer to ensure
that reusable PPE is cleaned, laundered, repaired, and replaced as
needed to maintain its effectiveness. These requirements must be
completed at a frequency, and in a manner, necessary to ensure that PPE
continues to serve its intended purpose of protecting workers from
beryllium exposure.
In keeping with the performance-orientation of the proposed
standard, OSHA does not specify how often PPE should be cleaned,
repaired or replaced. The Agency believes that appropriate time
intervals may vary widely based on the types of PPE used, the nature of
the beryllium exposures, and other circumstances in the workplace.
However, even in the absence of a mandated schedule, the employer is
still obligated to keep the PPE in the condition necessary to perform
its protective function. A number of Small Entity Representatives
(SERS) from OSHA's SBREFA panel noted they now use low maintenance
Tyvek disposable protective suits for some high exposure areas to
address potential contamination situations (OSHA, 2007a).
Under paragraph (h)(3)(ii), removal of beryllium from PPE by
blowing, shaking, or any other means which disperses beryllium in the
air would be prohibited as this practice could result in unnecessary
exposure to airborne beryllium.
Paragraph (h)(3)(iii) would require the employer to inform in
writing any person or business entity who launders, cleans, or repairs
PPE required by this standard of the potentially harmful effects of
exposure to airborne beryllium and dermal contact with soluble
beryllium compounds, and of the need to handle the PPE in accordance
with this standard. This provision is intended to limit dermal or
inhalation exposure to beryllium, and to emphasize the need for hazard
awareness and protective measures consistent with the proposed standard
among persons who clean, launder, or repair beryllium-contaminated
items.
Comments from SERs indicate that a number of beryllium-related
businesses already have comprehensive protocols in place for the use
and maintenance of PPE (OSHA, 2007a). One commenter indicated that it
has effectively reduced sensitization and CBD through the use of
respirators, other PPE, and engineering controls (OSHA, 2007a). Another
commenter stated that it utilizes PPE to reduce skin exposure (OSHA,
2007a). These existing PPE programs achieve many of the Agency's goals
and incorporate many of the requirements of this proposed standard.
The primary objections from SERs came from companies that raised
concerns regarding the ``trigger'' (e.g., exposure level or surface
contamination) for PPE in the draft standard, and particularly the use
of such terms as ``anticipated,'' ``routine,'' and ``contaminated
surface area'' in connection with the requirements to protect against
dermal exposure to beryllium (OSHA, 2007a). They also contend that for
certain processes such as stamping, change rooms, PPE, and other
hygiene practices are not necessary (OSHA, 2007a). Much of this
criticism was based on early pre-proposal drafts in circulation to the
SBREFA Panel (OSHA, 2007b). Since that time, OSHA has endeavored to
refine the regulatory text to reflect the concerns and comments
submitted on this topic. ``Contaminated surface area'' is no longer a
trigger for PPE; however, employers must provide PPE if a contaminated
surface presents the potential for workers' skin or clothing to become
visibly contaminated with beryllium (paragraph (h)(1)(ii)). The term
``routine'' has been removed as a trigger, and paragraph (h)(1)(ii)
makes clear that protections are required where skin or clothing may
become visibly contaminated whether during routine or non-routine
tasks. OSHA clarified that dermal protections are required only where
the skin may become visibly contaminated with beryllium. OSHA believes
that this proposed standard addresses commenters' objections with
textual changes and this explanation of the text, which together
provide further guidance to those who would be covered by the standard.
However, OSHA is concerned that the requirement to use PPE where
work clothing or skin may become ``visibly contaminated'' with
beryllium or where
[[Page 47794]]
soluble forms of beryllium are used may not be sufficiently protective
of beryllium-exposed workers. OSHA has preliminarily concluded that
sensitization can occur through dermal exposure. And although
solubility may play a role in the level of sensitization risk, the
available evidence suggests that contact with insoluble as well as
soluble beryllium can cause sensitization via dermal contact (see this
preamble at section V, Health Effects). Furthermore, at exposure levels
below the current or proposed PEL, beryllium surface contamination is
unlikely to be visible yet may still cause sensitization. The
specification of ``visible contamination'' is a departure from most
OSHA standards, which do not specify that contamination must be visible
in order for PPE to be required. OSHA is therefore considering
Regulatory Alternative #13, which would require appropriate PPE
wherever there is potential for skin contact with beryllium or
beryllium-contaminated surfaces. Please provide comments on this
alternative, including the benefits and drawbacks of a comprehensive
PPE requirement, and any relevant data or studies the Agency should
consider.
(i) Hygiene Areas and Practices
Paragraph (i) of the proposed standard requires that, when certain
conditions are met, employers must provide employees with readily
accessible washing facilities, change rooms, and showers. Proposed
paragraph (i) also requires employers to take certain steps to minimize
exposure in eating and drinking areas, and prohibits certain practices
that may contribute to beryllium exposure. OSHA believes that strict
compliance with these provisions would substantially reduce employee
exposure to beryllium.
The proposed standard requires certain hygiene facilities and
procedures in beryllium work areas, and additional hygiene facilities
and procedures when airborne exposures exceed the TWA PEL or STEL. OSHA
believes that skin contact with beryllium can occur even at low
airborne exposures. Skin wipe sample analysis of dental laboratory
technicians performing grinding operations demonstrated that beryllium
was present on the hands of workers even when airborne exposures were
well below the PEL (ERG, 2006).
As discussed in the Health Effects section of this preamble,
section V, respiratory tract, skin, eye, or mucosal contact with
beryllium can result in sensitization, which is a necessary first step
toward the development of CBD. Also, beryllium can contaminate
employees' clothing, shoes, skin, and hair, prolonging workers'
beryllium exposure and exposing others such as family members if proper
hygiene practices are not observed. A study by the National Jewish
Medical and Research Center of Denver, Colorado, measured the levels of
beryllium on workers' skin and vehicle surfaces at a machining plant
where many workers did not change out of their clothes and shoes at the
end of their shifts. The study showed elevated surface levels of
beryllium were present on workers' skin and in their vehicles,
demonstrating that workers carried residual beryllium on their hands
and shoes when leaving work (Sanderson et al., 1999). Paragraph (i) of
the proposed standard would reduce employees' skin contact with
beryllium, the possibility of accidental ingestion and inhalation of
beryllium, and the spread of beryllium within and outside the
workplace.
Paragraph (i)(1) would require the employer to provide readily
accessible washing facilities capable of removing beryllium from the
hands, face, and neck, and to ensure that employees working in
beryllium work areas use these facilities when necessary. This
requirement is performance-oriented, and does not specify any
particular frequency. At a minimum, employees working in a beryllium
work area must wash their hands, faces, and necks at the end of the
shift to remove any residual beryllium. Likewise, washing prior to
eating, drinking, smoking, chewing tobacco or gum, applying cosmetics,
or using the toilet would also protect employees against beryllium
ingestion and inhalation.
Typically, washing facilities would consist of one or more sinks,
soap or another cleaning agent, and a means for employees to dry
themselves after washing. OSHA does not intend to require the use of
any particular soap or cleaning agent. Employers can provide whatever
washing materials and equipment they choose, as long as those materials
and equipment are effective in removing beryllium from the skin and do
not themselves cause skin or eye problems.
Washing reduces exposure by limiting the period of time that
beryllium is in contact with the skin, and helps prevent accidental
ingestion. Although engineering and work practice controls and
protective clothing and equipment are designed to prevent hazardous
skin and eye contact, OSHA realizes that in some circumstances exposure
will nevertheless occur. For example, an employee who wears gloves to
protect against hand contact with beryllium may inadvertently touch his
or her face with the contaminated glove during the course of the day.
The purpose of requiring washing facilities is to mitigate adverse
health effects when skin or eye contact with beryllium occurs.
Under proposed paragraph (i)(2), where employees are required to
remove their personal clothing in order to use personal protective
clothing, the employer must provide designated change rooms with
separate storage facilities for street and work clothing to prevent
cross contamination. Change rooms must be in accordance with the
Sanitation standard (29 CFR 1910.141). OSHA intends the change rooms
requirement to apply to all covered workplaces where employees must
change their clothing (i.e., take off their street clothes) to use
protective clothing. In situations where removal of street clothes is
not necessary (e.g., in a workplace where only gloves are used as
protective clothing), change rooms are not required. Note that
paragraph (h) of this proposed standard requires employers to provide
``appropriate'' personal protective clothing. It is not appropriate for
employees to wear protective clothing over street clothing if doing so
results in contamination of the employee's street clothes. In such
situations, the employer must ensure that employees wear protective
clothing in lieu of (rather than over) street clothing, and provide
change rooms.
Change rooms must be designed in accordance with the written
exposure control plan required by paragraph (f)(1) of this proposed
standard, and with the Sanitation standard (29 CFR 1910.141). These
provisions require change rooms to be equipped with storage facilities
(e.g., lockers) for protective clothing, and separate storage
facilities for street clothes, to prevent cross-contamination.
Minimizing contamination of employees' personal clothes will also
reduce the likelihood that beryllium will contaminate employees' cars
and homes, and other areas outside the workplace.
Because of the risk of beryllium sensitization via the skin as
described in section V of this preamble, Health Effects, OSHA has
determined that employers must provide showers if their employees could
reasonably be expected to be exposed above the TWA PEL or STEL
(paragraph (i)(3)(i)(A)), and if employees' hair or body parts other
than hands, face, and neck could reasonably be expected to be
contaminated with beryllium (paragraph (i)(3)(i)(B)). Employers are
only required to provide showers if paragraphs (i)(3)(i)(A) and (B)
both apply. Other OSHA health standards, such as the standards for
cadmium (29 CFR
[[Page 47795]]
1910.1027) and lead (29 CFR 1910.1025), also require showers when
exposures exceed the PEL. OSHA's standard for coke oven emissions (29
CFR 1910.1029) requires employers to provide showers and ensure that
employees working in a regulated area shower at the end of the work
shift. The standard for methylenedianiline (MDA) (29 CFR 1910.1050)
requires employers to ensure that employees who may potentially be
exposed to MDA above the action level shower at the end of the work
shift.
Paragraph (i)(3)(ii) requires employers to ensure that employees
use the showers at the end of the work activity or shift involving
beryllium if the employees reasonably could have been exposed above the
TWA PEL or STEL, and if beryllium could reasonably have contaminated
the employees' body parts other than hands, face, and neck. This
language is intended to convey that showers are required for employees
who satisfy both paragraphs (i)(3)(ii)(A) and (B) when work activities
involving beryllium exposure have been completed for the day. For
example, if employees perform work activities involving beryllium
exposure for the first two hours of a work shift, and then perform
activities that do not involve exposure, they should shower after the
exposure period to avoid increasing the duration of exposure, potential
of accidental ingestion, and contamination of the work area from
beryllium residue on their hair and body parts other than hands, face,
and neck. If, however, employees are performing tasks involving
exposure intermittently throughout the day, this provision is not
intended to require them to shower before the completion of the last
task involving exposure.
To minimize the possibility of food contamination and the
likelihood of additional exposure to beryllium through inhalation or
ingestion, paragraph (i)(4) would require that employers provide
employees with a place to eat and drink where beryllium exposure is
below the action level, and where the surfaces are maintained as free
as practicable of beryllium. Eating and drinking areas must further
comply with the Sanitation standard (29 CFR 1910.141(g)), which
prohibits consuming food or beverages in a toilet area or in any area
with exposures above an OSHA PEL.
The requirement to maintain surfaces as free as practicable of
beryllium is included in other OSHA health standards such as those for
lead in general industry (29 CFR 1910.1025), lead in construction (29
CFR 1926.62), chromium (IV) (29 CFR 1910.1026), and asbestos (29 CFR
1910.1001). As OSHA explained in a January 13, 2003, letter of
interpretation concerning the meaning of ``as free as practicable'' in
OSHA's Lead in Construction standard (29 CFR 1926.62), OSHA evaluates
whether a surface is ``as free as practicable'' of a contaminant by the
rigor of the employer's program to keep surfaces clean (OSHA, 2003). A
sufficient housekeeping program may be indicated by a routine cleaning
schedule and the use of effective cleaning methods to minimize the
possibility of exposure from accumulation of beryllium on surfaces.
OSHA's compliance directive on Inspection Procedures for Chromium (IV)
Standards provides additional detail on how OSHA interprets ``as free
as practicable'' for enforcement purposes (OSHA, 2008a). As explained
in the directive, if a wipe sample reveals a toxic substance on a
surface, and the employer has not taken practicable measures to keep
the surface clean, the employer has not kept the surface as free as
practicable of the toxic substance.
The proposed standard does not require the employer to provide
separate eating and drinking areas to employees at the worksite.
Employees may consume food or beverages offsite. However, where the
employer chooses to allow employees to consume food or beverages at a
worksite where beryllium is present, the employer would be required to
maintain the area in accordance with paragraph (i)(4) of this proposed
standard.
Paragraph (i)(5)(i) would prohibit eating, drinking, smoking,
chewing tobacco or gum, or applying cosmetics in regulated areas. Where
exposures can reasonably be expected at levels above the proposed TWA
PEL or STEL, there is a greater risk of beryllium contaminating the
food, drink, tobacco, gum, or cosmetics. Prohibiting these activities
would reduce the potential for this manner of exposure.
Under paragraph (i)(5)(ii), employers would also be required to
ensure that employees do not enter eating or drinking areas wearing
contaminated protective clothing or equipment. This is to further
minimize the likelihood that employees will be exposed to beryllium in
eating and drinking areas through inhalation, dermal contact, and
ingestion.
The draft regulatory text presented during the SBREFA process would
have required handwashing facilities and certain other hygiene
provisions when exposures exceeded the TWA PEL, or when there was
``anticipated skin exposure.'' Small Entity Representatives (SERs) from
OSHA's SBREFA panel expressed concern that the phrase ``anticipated
skin exposure'' was vague and lacked definition (OSHA, 2007a).
Commenters suggested that this could require employers at workplaces
with low exposures to make significant modifications to the workplace,
such as installing showers and change rooms. OSHA has evaluated the
hygiene triggers and clarified that change rooms are only required when
employees must remove their street clothes in order to wear protective
clothing. Showers are only required when exposures exceed the TWA PEL
or STEL, and beryllium could reasonably contaminate employees' hair or
body parts other than hands, face, and neck. OSHA has removed the
phrase ``anticipated skin exposure'' from the proposed standard. OSHA
believes these changes address the commenters' concerns.
(j) Housekeeping
Paragraph (j) of the proposed standard requires employers to
maintain surfaces in beryllium work areas as free as practicable of
accumulations of beryllium; promptly clean spills and emergency
releases; use appropriate cleaning methods; and properly dispose of
beryllium-contaminated waste, debris, and materials. These provisions
are especially important because they minimize additional sources of
exposure that engineering controls are not designed to address. Good
housekeeping measures are a cost-effective way to control employee
exposures by removing settled beryllium that could otherwise become re-
entrained into the surrounding atmosphere by physical disturbances or
air currents and could enter an employee's breathing zone. Contact with
contaminated surfaces may also result in dermal exposure to beryllium.
As discussed in this preamble at section V, Health Effects, researchers
have identified skin exposure to beryllium as a pathway to
sensitization. The proposed provisions in this paragraph are consistent
with housekeeping requirements in other OSHA standards for toxic metals
including cadmium (29 CFR 1910.1027), chromium (VI)(29 CFR 1910.1026),
and lead (29 CFR 1910.1025).
Paragraph (j)(1) requires the employer to ensure that all surfaces
in beryllium work areas are maintained as free as practicable of
accumulations of beryllium, and that spills and emergency releases are
cleaned up promptly. Employers must follow the procedures that they
have listed under their exposure control plan required by paragraph
(f)(1) to clean beryllium-
[[Page 47796]]
contaminated surfaces, and use the cleaning methods required by
paragraph (j)(2). Good housekeeping practices are essential in
controlling beryllium exposure. Beryllium-containing material deposited
on ledges, equipment, floors, and other surfaces must be promptly
removed to prevent these deposits from becoming airborne and to
minimize the likelihood of skin contact with beryllium.
Paragraph (j)(1) directs the employer to maintain surfaces where
beryllium may accumulate ``as free as practicable'' of beryllium. In
this context, the phrase ``as free as practicable'' sets forth the
baseline goal in the development of an employer's housekeeping program
to keep work areas free from surface contamination. For a detailed
discussion of the meaning of the phrase ``as free as practicable,'' see
the discussion of proposed paragraph (i) earlier in this section of the
preamble.
Employers must regularly clean surfaces in beryllium work areas to
minimize re-entrainment of dust into the work environment, and to
ensure that accumulations of beryllium do not become sources of
exposure. Although OSHA does not define ``surface'' in the proposed
standard, the term would include surfaces workers come into contact
with such as working surfaces, floors, and storage facilities, as well
as surfaces workers do not directly contact such as rafters. Because
all surfaces in beryllium work areas could potentially accumulate
beryllium that workers could later inhale, touch, or ingest, all
surfaces in beryllium works areas must be kept as free as practicable
of beryllium.
OSHA has preliminarily decided not to require employers to measure
beryllium contamination on surfaces, because the Agency does not have
the necessary data to understand the relationship between surface level
of beryllium and risk of absorption through the skin. The use of wipe
samples, however, remains a useful qualitative tool to detect the
presence of beryllium on surfaces.
As mentioned above, when beryllium is released into the workplace
as a result of a spill or emergency release, paragraph (j)(1)(ii) would
require the employer to ensure prompt and proper cleanup in accordance
with the written exposure control plan required by paragraph (f)(1) and
to use the cleaning methods required by paragraph (j)(2) of this
proposed standard. Spills or emergency releases not attended to
promptly are likely to result in additional employee exposure or skin
contact.
Paragraph (j)(2) provides that clean-up procedures for beryllium-
containing material must minimize employee exposure. OSHA recognizes
that each work environment is unique, so OSHA has established
performance-oriented requirements for housekeeping to allow employers
to determine how best to clean beryllium work areas while minimizing
employee exposure. Paragraph (j)(2)(i) of the proposed standard would
require that surfaces contaminated with beryllium be cleaned by high
efficiency particulate air filter (HEPA) vacuuming or other methods
that minimize the likelihood of beryllium exposure. OSHA believes HEPA
vacuuming is a highly effective method of cleaning beryllium-
contaminated surfaces. However, other cleaning methods equally
effective at minimizing the likelihood of beryllium exposure may be
used.
Paragraph (j)(2)(ii) would permit dry sweeping or brushing in
certain cases only. The employer must demonstrate that it has tried
cleaning with a HEPA-filter vacuum or another method that minimizes the
likelihood of exposure, and that those methods were not effective under
the particular circumstances found in the workplace. OSHA has included
this provision in an attempt to provide employers flexibility when
exposure-minimizing cleaning methods would not be effective, but OSHA
is not aware of any circumstances in which dry sweeping or brushing
would be necessary. OSHA requests comment on whether dry sweeping or
brushing would ever be necessary, and if so, under what circumstances
(see section I of this preamble, Issues and Alternatives).
Paragraph (j)(2)(iii) would prohibit the use of compressed air in
cleaning beryllium-contaminated surfaces unless it is used in
conjunction with a ventilation system designed to capture any resulting
airborne beryllium. This provision is also intended to prevent the
dispersal of beryllium into the air.
Proposed paragraph (j)(2)(iv) details further protections for those
employees who are using certain cleaning methods. Under this provision,
where employees use dry sweeping, brushing, or compressed air to clean
beryllium-contaminated surfaces, the employer must provide respiratory
protection and protective clothing and equipment and ensure that each
employee uses this protection in accordance with paragraphs (g) and (h)
of this standard. The failure to provide proper and adequate protection
to those employees performing cleanup activities would defeat the
purpose of the housekeeping practices required to control beryllium
exposure.
Paragraph (j)(2)(v) would require employers to ensure that
equipment used to clean beryllium from surfaces is handled in a manner
that minimizes employee exposure and the re-entrainment of beryllium
into the workplace environment. For example, cleaning and maintenance
of HEPA-filtered vacuum equipment must be done carefully to avoid
exposure to beryllium. Similarly, filter changes and bag and waste
disposal must be performed in a manner that minimizes the risk of
employee exposure to airborne beryllium. This provision is consistent
with the requirement in proposed paragraph (f)(1)(i)(F) for the written
exposure control plan, under which employers must establish and
implement procedures for minimizing the migration of beryllium. And of
course, employees handling and maintaining cleaning equipment must be
protected in accordance with the other paragraphs of this proposed
standard as well, including the requirements for respiratory protection
and PPE in paragraphs (g) and (h).
Proposed paragraph (j)(3)(i) would require that items visibly
contaminated with beryllium and consigned for disposal be disposed of
in sealed, impermeable bags or other closed impermeable containers.
Proposed paragraph (j)(3)(ii) requires these containers to be marked
with warning labels to inform individuals who handle these items of the
potential hazards associated with beryllium exposure, and the labels
must contain specific language in accordance with paragraph (m)(3) of
the proposed standard. Alerting employers and employees who are
involved in disposal to the potential hazards of beryllium exposure
will better enable them to implement protective measures.
Proposed paragraph (j)(3)(iii) gives employers two options for
materials designated for recycling that are visibly contaminated with
beryllium: Sealing them in impermeable enclosures and labeling them in
accordance with proposed paragraph (m)(3), or cleaning them to remove
visible particulate. Proposed paragraph (j)(3)(iii) allows employers
this flexibility to facilitate the recycling process, and ensures that
employees handling these items for recycling purposes will not be
exposed to visible particulate if the items are not sealed in
impermeable enclosures and labeled with warnings about the dangers of
beryllium exposure.
OSHA believes that the concept and importance of housekeeping
programs in protecting workers from beryllium
[[Page 47797]]
exposure are generally well understood and acknowledged by the affected
employer community. Small Entity Representatives (SERs) on the SBREFA
Advisory Panel indicated that most of the responding small business
entities engaged in regular and routine housekeeping activities in
areas where beryllium-containing material has been used or processed
(OSHA, 2008b). Housekeeping activities included wet mopping, vacuuming,
and sweeping in and around machinery and other surfaces. In performing
these tasks, respirator and PPE usage varied. In some cases, employers
provided the protection, but did not require its usage. In other
instances, no protection was available to workers performing
housekeeping duties. (OSHA, 2007a).
Those companies that did have comprehensive housekeeping policies
provided the Agency with a number of useful practices and examples in
response to the RFI as well as during the SBREFA process. One company
offered its 8-step housekeeping and control strategy into the record as
a comprehensive model (Brush Wellman, 2003). Another company presented
its facility housekeeping program specifying a number of containment
measures such as tack mats, absorbent carpet, and damp disposable
towels to collect any contamination from beryllium operations. Certain
practices were expressly prohibited such as dry sweeping, brushing,
wiping, and the use of compressed air systems to clean machinery
(Honeywell, 2003). Researchers with the National Jewish Hospital and
Research Center found that most of the beryllium facilities that they
visited prohibited the use of compressed air in beryllium areas (NJMRC,
2003).
Several commenters also questioned the vagueness of the term
``contaminated surfaces'' (OSHA, 2008b). The proposed standard no
longer uses this term. Rather, proposed paragraph (j) would require
employers to maintain surfaces in beryllium work areas ``as free as
practicable of accumulations of beryllium,'' which is explained earlier
in this section.
(k) Medical Surveillance
Under paragraph (k)(1) of the proposed standard, OSHA would require
employers to make medical surveillance available at no cost, and at a
reasonable time and place, for all employees who have worked in a
regulated area for more than 30 days in the past 12 months; show signs
and symptoms of CBD; are exposed to beryllium during an emergency; or
were exposed to beryllium in concentrations above 0.2 [mu]g/m\3\ for
more than 30 days in a 12-month period for 5 years or more.
Under paragraph (k)(1)(ii), the required medical surveillance must
be performed by or under the direction of a licensed physician. OSHA
chose to require licensed physicians, as opposed to PLHCPs, to oversee
medical surveillance in this standard, and to provide certain services
required by this standard (see, e.g., paragraphs (k)(1)(ii) and
(k)(5)). OSHA has in the past allowed a PLHCP to perform all aspects of
medical surveillance, regardless of whether the PLHCP is a licensed
physician (see OSHA's standards regulating chromium (VI) (29 CFR
1910.1026) and methylene chloride (29 CFR 1910.1052)). OSHA has
proposed that a licensed physician perform some of the requirements of
paragraph (k) in response to a multi-stakeholder coalition proposal to
this effect. OSHA believes this requirement strikes an appropriate
balance between ensuring that a licensed physician supervises the
overall care of the employee, while giving the employer the flexibility
to retain the services of a variety of qualified licensed health care
professionals to perform certain other services required by paragraph
(k). However, OSHA also believes it may be appropriate to allow a PLHCP
who is not a licensed physician to perform all of the services required
by proposed paragraph (k) (see also section I of this preamble, Issues
and Alternatives). OSHA requests comment on this proposed requirement.
The purpose of medical surveillance for beryllium is, where
reasonably possible, to identify beryllium-related adverse health
effects so that appropriate intervention measures can be taken, and to
determine the employee's fitness to use personal protective equipment
such as respirators. The proposed standard is consistent with Section
6(b)(7) of the OSH Act (29 U.S.C. 655(b)(7)), which requires that,
where appropriate, medical surveillance programs be included in OSHA
health standards to aid in determining whether the health of employees
is adversely affected by exposure to toxic substances. Other OSHA
health standards, such as Chromium (VI) (29 CFR 1910.1026), Methylene
Chloride (29 CFR 1910.1052), and Cadmium (29 CFR 1910.1027), also
include medical surveillance requirements.
The proposed standard is intended to encourage participation in
medical surveillance by requiring at paragraph (k)(1)(i) that the
employer provide medical examinations without cost to employees (also
required by section 6(b)(7) of the Act (29 U.S.C. 655(b)(7)), and at a
reasonable time and place. If participation requires travel away from
the worksite, the employer would be required to bear all travel costs.
Employees must be paid for time away from work spent attending medical
examinations, including travel time.
Paragraph (k)(1)(i)(A) proposes to require employers to make
medical surveillance available to all employees who worked in a
regulated area for more than 30 days in the past 12 months. This
requirement attempts to ensure that those employees who are at most
risk for developing beryllium-related adverse health effects have
access to medical services so that such adverse health effects can be
detected early.
In addition, paragraph (k)(1)(i)(B) would require that employers
provide medical surveillance to any employee who shows signs or
symptoms of CBD. It is expected that employees experiencing signs and
symptoms of exposure will report them to their employers. If an
employer becomes aware that an employee shows signs and symptoms of CBD
either through employee self-reporting or from observation of the
employee, the employer is required to provide medical surveillance to
the employee. However, this provision is not intended to force
employers to survey their workforce, make diagnoses, or determine
causality.
Proposed paragraph (k)(1)(i)(B) recognizes that some employees may
exhibit signs and symptoms of the adverse health effects associated
with beryllium exposure even when not exposed above the TWA PEL or the
STEL for more than 30 days per year. OSHA's preliminary risk assessment
concludes that there is significant risk of adverse health effects from
beryllium exposure below the proposed PEL (see this preamble at section
VI, Preliminary Risk Assessment). In addition, beryllium sensitization
and CBD could develop in employees who are especially sensitive to
beryllium, may have been unknowingly exposed, or may have been exposed
to greater amounts than the exposure assessment suggests.
Self-reporting by employees will be supported by the training
required under proposed paragraph (m)(4)(ii) on the health hazards of
beryllium exposure and the signs and symptoms of CBD, and the medical
surveillance and medical removal requirements of the proposed standard
in paragraphs (k) and (l). Employees have a right under section 11(c)
of the OSH Act to report suspected work-related health effects to their
employers without retaliation. Any employer program or practice that
[[Page 47798]]
discourages employees from reporting or penalizes workers who report
work-related health effects would violate section 11(c). See Memorandum
from Richard E. Fairfax to Regional Administrators (March 12, 2012),
available at https://www.osha.gov/as/opa/whistleblowermemo.html.
As discussed in this preamble at section V, Health Effects, CBD
causes fatigue, weakness, difficulty breathing, and a persistent dry
cough, among other symptoms. In more advanced cases, CBD may also
result in anorexia and weight loss, as well as right side heart
enlargement (cor pulmonale) and heart disease. By requiring covered
employers to make a medical exam available when an employee exhibits
these types of symptoms, the proposed standard would protect all
employees who may have developed CBD, whether or not these employees
have been exposed to beryllium in an emergency or for more than 30 days
in a regulated area.
Paragraph (k)(1)(i)(C) would require that appropriate surveillance
also be made available for employees exposed to beryllium during an
emergency, regardless of the airborne concentrations of beryllium to
which these employees are routinely exposed in the workplace. Emergency
situations involve uncontrolled releases of airborne beryllium, and the
significant exposures that can occur in these situations justify a
requirement for medical surveillance. The proposed requirement for
medical examinations after exposure in an emergency is consistent with
several other OSHA health standards, including the standards for
chromium (VI) (29 CFR 1910.1026), methylenedianiline (29 CFR
1910.1050), butadiene (29 CFR 1910.1051), and methylene chloride (29
CFR 1910.1052).
Paragraph (k)(1)(i)(D) would require medical surveillance to be
provided to employees who have been exposed to beryllium above 0.2
[mu]g/m\3\ for more than 30 days in a 12-month period for 5 years or
more. The five-years of exposure would not need to be consecutive to
satisfy this provision. OSHA included this provision to ensure that
these employees receive the low-dose helical tomography (CT scan, low-
dose computed tomography (LDCT), or CT screening) required by paragraph
(k)(3)(ii)(F) of the proposed standard, even if these employees have
not been exposed above 0.2 [mu]g/m\3\ in the previous 12-month period,
are not exhibiting signs and symptoms of CBD, and have not been exposed
in an emergency. The CT scan is a method of detecting tumors, and is
commonly used to diagnose lung cancer.
Paragraph (k)(2) of the proposed standard specifies how frequently
medical examinations are to be offered to those employees covered by
the medical surveillance program. Under paragraph (k)(2)(i)(A),
employers would be required to provide each employee with a medical
examination within 30 days after the employee has worked in a regulated
area for more than 30 days in the past 12 months, unless the employee
has received a medical examination provided in accordance with this
standard within the previous 12 months. Paragraph (k)(2)(i)(B) requires
employers to provide medical examinations to employees exposed to
beryllium during an emergency, and to those who are showing signs or
symptoms of CBD, within 30 days of the employer becoming aware that
these employees meet the criteria of paragraph (k)(1)(i)(B) or (C).
Paragraph (k)(2)(i)(B) requires an examination without regard to
whether these employees received an exam in the previous 12 months.
Paragraph (k)(2)(ii) of the proposed standard requires that
employers provide an examination annually (after the first examination
is made available) to employees who continue to meet the criteria of
paragraph (k)(1)(i)(A) or (B). This includes employees who have worked
in a regulated area for more than 30 days in the past 12 months and
employees who continue to exhibit signs and symptoms of CBD. The
requirement for annual examinations in paragraph (k)(2)(ii) means that
an examination must be made available at least once every 12 months.
Employees exposed in an emergency, who are covered by paragraph
(k)(1)(i)(C), are not included in the annual examination requirement
unless they also meet the criteria of paragraph (k)(1)(i)(A) or (B),
because OSHA expects that most effects of exposure will be detected
during the medical examination provided within 30 days of the
emergency, pursuant to paragraph (k)(2)(i)(A). An exception to this is
beryllium sensitization, which OSHA believes may result from exposure
in an emergency, but may not be detected within 30 days of the
emergency. Thus, proposed paragraph (k)(3)(ii)(E) requires biennial
testing for beryllium sensitization for employees exposed in
emergencies. This paragraph is discussed in more detail later in this
section of the preamble. Employees covered by paragraph (k)(1)(i)(D)
are also not required to receive exams annually unless they also meet
the criteria of paragraph (k)(1)(i)(A) or (B).
OSHA believes that the annual provision of medical surveillance,
and the biennial provision of beryllium sensitization testing and CT
scans for certain employees, are appropriate frequencies for screening
employees for beryllium-related diseases. The main goals of medical
surveillance for employees are to detect beryllium sensitization before
employees develop CBD, and to detect CBD, lung cancer, and other
adverse health effects at an early stage. The proposed requirement for
annual examinations is consistent with other OSHA health standards,
including those for chromium (VI) (29 CFR 1910.1026) and formaldehyde
(29 CFR 1910.1048). Based on the Agency's experience, OSHA believes
that annual surveillance and biennial tests for beryllium sensitization
and CT scans would strike a reasonable balance between the need to
diagnose health effects at an early stage, while being sufficiently
affordable for employers.
Finally, proposed paragraph (k)(2)(iii) would require the employer
to offer a medical examination at the termination of employment, if the
departing employee meets the criteria of paragraph (k)(1)(i)(A), (B),
or (C) at the time the employee's employment is terminated. This would
apply to employees who worked in a regulated area for more than 30 days
during the previous 12 months, employees showing signs or symptoms of
CBD, and employees who were exposed to beryllium in an emergency at any
time during their employment. This proposed requirement is waived if
the employer provided the departing employee with an exam during the
six months prior to the date of termination. The provision of an exam
at termination is intended to ensure that no employee terminates
employment while carrying a detectable, but undiagnosed, health
condition related to beryllium exposure.
Proposed paragraph (k)(3) details the contents of the examination.
Paragraph (k)(3)(i) would require the employer to ensure that the PLHCP
advises the employee of the risks and benefits of participating in the
medical surveillance program and the employee's right to opt out of any
or all parts of the medical examination. Benefits of participating in
medical surveillance may include early detection of adverse health
effects, and aiding intervention efforts to prevent or treat disease.
However, there may also be risks associated with medical testing for
some conditions, which the PLHCP should communicate to the employee.
Paragraph (k)(3)(ii) then specifies that the medical examination
must consist of a medical and work history; a physical examination with
emphasis on the respiratory tract, skin breaks, and wounds; and
pulmonary function tests.
[[Page 47799]]
Special emphasis is placed on the portions of the medical and work
history focusing on beryllium exposure, health effects associated with
beryllium exposure, and smoking.
The physical exam focuses on organs and systems known to be
susceptible to beryllium toxicity. For example, proposed paragraph
(k)(3)(ii)(C) focuses on the skin, and paragraph (k)(3)(ii)(D) focuses
on the lungs. The information obtained will allow the PLHCP and
supervising physician to assess the employee's health status, identify
adverse health effects related to beryllium exposure, and determine if
limitations should be placed on the employee's exposure to beryllium.
The proposed standard does not include a comprehensive list of specific
tests that must be part of the medical examination. OSHA does not
believe that any particular test--beyond those listed in paragraph
(k)(3)(ii)(D)-(F)--is necessarily applicable to all employees covered
by the medical surveillance requirements. The Agency proposes to give
the PLCHP the flexibility to determine any other appropriate tests to
be selected for a given employee, as provided in paragraph
(k)(3)(ii)(G).
Under paragraph (k)(3)(ii)(E), an employee must be offered a BeLPT
(or a more reliable and accurate test for identifying beryllium
sensitization) at the employee's first examination, and then every two
years after the first examination unless the employee is confirmed
positive. The requirement to test for beryllium sensitization applies
whether or not an employee is otherwise entitled to a medical
examination in a given year. For example, for an employee exposed
during an emergency who would normally be entitled to 1 exam within 30
days of the emergency but not annual exams thereafter, the employer
must still provide this employee with a test for beryllium
sensitization every 2 years. This biennial requirement applies until
the employee is confirmed positive. OSHA believes that the biennial
testing required under paragraph (k)(3)(ii)(E) is adequate to monitor
employees that have the potential to develop sensitization while being
sufficiently affordable for employers.
OSHA considers the BeLPT to be a reliable medical surveillance tool
for the purposes of a medical surveillance program. However, OSHA
considers two abnormal test results necessary to confirm a finding of
beryllium sensitization when using the BeLPT (``confirmed positive'').
Therefore, a BeLPT must also be offered within one month of an employee
receiving a single abnormal result. However, this requirement is waived
if a more reliable and accurate test becomes available that could
confirm beryllium sensitization based on one test result. OSHA requests
comment on how to determine whether a test is more reliable and
accurate than the BeLPT for identifying beryllium sensitization. OSHA
has included a non-mandatory appendix that describes the BeLPT,
discusses several studies of the BeLPT's validity and reliability, and
states criteria OSHA believes are important to judge a new test's
validity and reliability (Appendix A).
Under paragraph (k)(3)(ii)(F), a CT scan must be offered to
employees who have been exposed to beryllium at concentrations above
0.2 [mu]g/m\3\ for more than 30 days in a 12-month period for 5 years
or more. The five years of exposure do not need to be consecutive. As
with the requirement for sensitization testing explained above, the CT
scan must be offered to an employee who meets the criteria of paragraph
(k)(1)(i)(D) without regard to whether the employee is otherwise
required to receive a medical exam in a given year. The CT scan must be
offered to employees who meet the criteria of paragraph (k)(1)(i)(D)
for the first time beginning on the start-up date of this standard, or
15 years after the employee's first exposure to beryllium above 0.2
[mu]g/m\3\ for more than 30 days in a 12-month period, whichever is
later. OSHA proposed the requirement for CT screening based in part on
the Agency's consideration of the draft recommended standard submitted
by industry and union stakeholders (Materion and USW, 2012).
The CT scan requirement may be triggered by exposures that occurred
before or after the effective date of this standard, or a combination
of exposures before and after the effective date. This requirement may
also be triggered by exposures that occurred when the employee was
working for a different employer. An employer is required to offer a CT
scan to employees who meet the criteria of paragraph (k)(1)(i)(D) if
the employer has exposure records demonstrating that the employee meets
the criteria, regardless of whether the exposure records were generated
by the employer or given to the employer by the employee or a third
party.
In a recent systematic review of CT screening trials for lung
cancer, Bach et al. found a significant (20 percent) mortality
reduction in the population studied (26,309 men and women between ages
55 and 74, with at least 30 pack-years of smoking history) (National
Lung Screening Trial, 2011). The benefits of screening for other
populations are less clear at this time. CT screening was not shown to
offer significant reduction in mortality in two other, smaller trial
populations with at least 20 pack-years of smoking history (DANTE,
2009; DLCST, 2012). In addition, there is yet to be agreement on how to
properly compute and set the radiation dose for LDCT. Clarification on
such procedural issues will help inform analyses of LDCT-associated
radiation exposure and its risks as part of a screening protocol for
employees exposed to occupational carcinogens (Christensen, 2014).
OSHA seeks comment on the proposed requirement and whether it is
likely to benefit the beryllium-exposed employee population. As
appropriate, please submit information, studies and data to support
your comments.
OSHA notes that another form of CT scanning, High Resolution
Computed Tomography (HRCT), is available and may be useful in screening
for CBD. In patients with CBD, HRCT scanning of the chest is more
sensitive than plain chest radiography in identifying abnormalities
(NAS, 2008). However, HRCT scans showing no signs consistent with CBD
have been reported in 25 percent of patients with biopsy-proven
noncaseating granulomas (Newman et al., 1994). OSHA seeks comment on
whether HRCT should be included in the list of diagnostic procedures a
CBD Diagnostic Center should be able to provide (see this Preamble at
Section XVIII, paragraph (b), Definitions).
Other types of tests and examinations not mentioned in this
standard, including X-ray, arterial blood gas, diffusing capacity, and
oxygen desaturation during exercise, may also be useful in evaluating
the effects of beryllium exposure. In addition, medical examinations
that include more invasive testing, such as bronchoscopy, alveolar
lavage, and transbronchial biopsy, have been demonstrated to provide
additional valuable medical information. OSHA believes that the PLHCP
is in the best position to decide which medical tests are necessary for
each individual examined. Where specific tests are deemed appropriate
by the PLHCP, the proposed standard, at paragraph (k)(3)(ii)(G), would
require that they be provided.
Proposed paragraph (k)(4) details which information must be
provided to the PHLCP. Specifically, the proposed standard would
require the employer to ensure the examining PLHCP has a copy of the
standard and all the appendices, and to provide to the examining PLHCP
the following information, if known or reasonably available to the
employer: a
[[Page 47800]]
description of the employee's former and current duties as they relate
to beryllium exposure ((k)(4)(i)); the employee's former and current
exposure levels ((k)(4)(ii)); a description of any personal protective
clothing and equipment, including respirators, used or to be used by
the employee, including when and for how long the employee has used
that clothing and equipment ((k)(4)(iii)); and information the employer
has obtained from previous medical examinations provided to the
employee, that is currently within the employer's control ((k)(4)(iv)).
OSHA believes making this information available to the PLHCP will aid
in the PLHCP's evaluation of the employee's health as it relates to the
employee's assigned duties and fitness to use personal protective
equipment, including respirators, when necessary. In order to protect
the employee's privacy, employee medical information may only be
provided to the PLHCP by the employer after the employee has signed a
medical release.
Providing the PLHCP with exposure monitoring results, as required
under paragraph (k)(4)(ii), will assist the physician completing the
written medical opinion in determining if an employee is likely to be
at risk of adverse effects from beryllium exposure at work. A well-
documented exposure history would also assist the PLCHP in determining
if a condition (e.g., dermatitis, decrease in diffusing capacity, or
gradual changes in arterial blood gases) may be related to beryllium
exposure. See this preamble at section V, Health Effects, for a more
detailed discussion of the health effects associated with beryllium
exposure.
Proposed paragraph (k)(5) would require employers to obtain a
written medical opinion from the licensed physician who performed or
directed the exam within 30 days of the examination. The purpose of
requiring the physician to supply a written opinion to the employer is
to provide the employer with a documented medical basis for the
employee's eligibility for medical removal, and to assess the
employee's ability to use protective clothing and equipment, including
respirators. In addition, provision of the written opinion to the
employer may alert the employer to sources of beryllium exposure or
problems with exposure controls at its worksite. OSHA believes the 30-
day period will allow the licensed physician sufficient time to receive
and consider the results of any tests included in the examination, and
allow the employer to take any necessary protective measures in a
timely manner. The proposed requirement that the opinion be in written
form is intended to ensure that employers and employees have the
benefit of the same information and that no information gets lost in
oral communications. OSHA requests comment on the relative merits of
the proposed standard's requirement that employers obtain the PLHCP's
written opinion or an alternative that would provide employees with
greater discretion over the information that goes to employers (see
this preamble at Section 1, Issues and Alternatives, Issue #26).
Paragraphs (k)(5)(i)(A)-(C) of the proposed standard specify what
must be included in the licensed physician's written opinion. The first
item for inclusion is the licensed physician's opinion as to whether
the employee has any detected medical condition that would place the
employee at increased risk of CBD from further exposure. The standard
also proposes that the medical opinion include any recommended
limitations on the employee's exposure, including recommended use of,
and limitations on the use of, personal protective clothing or
equipment such as respirators.
The licensed physician would also need to state in the written
opinion that the PLHCP has explained the results of the medical
examination to the employee, including the results of any tests
conducted, any medical conditions related to exposure that require
further evaluation or treatment, and any special provisions for use of
protective clothing or equipment, including respirators. Under proposed
paragraph (k)(5)(i)(C), OSHA anticipates that the employee will be
informed directly by the PLCHP of all results of his or her medical
examination, including conditions of non-occupational origin. Direct
consultation between the PLHCP and employee ensures that the employee
will receive all information about the employee's health status,
including non-occupationally related conditions that are not
communicated to the employer.
Proposed paragraph (k)(5)(ii) would require the employer to ensure
that neither the licensed physician nor any other PLHCP reveals to the
employer findings or diagnoses which are unrelated to beryllium
exposure. OSHA has proposed this provision to reassure employees
participating in medical surveillance that they will not be penalized
or embarrassed as a result of the employer obtaining information about
them not directly pertinent to beryllium exposure. Paragraph
(k)(5)(iii) would also require the employer to provide a copy of the
licensed physician's written opinion to the employee within two weeks
after receiving it to ensure that the employee has been informed of the
results of the examination in a timely manner.
Proposed paragraph (k)(6)(i) provides for the referral to a CBD
diagnostic center of any employee who is confirmed positive for
beryllium sensitization. Within 30 days after the employer learns of
the confirmed positive result, the employer must ensure that a licensed
physician designated by the employer consults with the employee about
referral to a CBD diagnostic center for further testing, to determine
whether a sensitized employee has CBD. If the employee chooses to
obtain a clinical evaluation at a CBD diagnostic center, the diagnostic
center must be agreed upon by the employer and the employee. The
employer and employee must make a good faith effort to agree on a CBD
diagnostic center that is acceptable to them both. Under paragraph
(k)(6)(ii), the employer is responsible for all costs associated with
testing performed at the center. The term CBD diagnostic center is
defined in proposed paragraph (b), and discussed in this section of the
preamble regarding proposed paragraph (b).
Finally, under paragraph (k)(7), the employer would be required to
convey the results of the medical tests to OSHA for evaluation and
analysis at the request of the Assistant Secretary. The results of the
tests may be used to evaluate the nature, variability, reliability, and
relevance of the beryllium sensitization test results, to evaluate the
effectiveness of the beryllium standard in reducing beryllium-related
occupational disease, or for other scientific purposes. Results
conveyed to OSHA must first be stripped of employees' names, social
security numbers, and other identifying information.
Employees of beryllium vendors who qualify for benefits under the
Energy Employees Occupational Illness Compensation Program Act
(EEOICPA) (42 U.S.C. 7384-7385s-15) and its implementing regulations
(20 CFR part 30) may also qualify for medical surveillance benefits
under this proposed standard. Covered medical surveillance provided to
eligible persons under the EEOICPA program is paid for by the federal
government.
Employees covered by both the EEOICPA program and this proposed
standard would not be required to attend separate medical examinations
for the separate programs. Rather, these dual-coverage employees could
attend consolidated medical examinations at which they would receive
the services
[[Page 47801]]
required under both programs. These examinations would be paid for by
the federal government under the EEOICPA program to the extent that the
services provided are covered under the EEOICPA program. If this
proposed standard requires services that are not covered by the EEOICPA
program, the employer would be required to pay for these additional
services.
As stated in the SBREFA Report, the medical surveillance section
``was the most controversial part of the draft standard for most SERs
and received the most comment'' (OSHA, 2008b). SERs generally were
concerned about the cost of medical surveillance, commenting that
surveillance is unnecessary for employees with low beryllium exposures
(OSHA, 2008b). The requirement of dermal triggers for medical
surveillance was confusing for SERs and led to a number of comments
(OSHA, 2008b). One SER suggested that the medical surveillance
requirements should be performance-based, which would allow employers
to determine which tests were appropriate for their employees (OSHA,
2008b). Use of the BeLPT was also controversial, given SERs' concerns
about its accuracy and costs (OSHA, 2008b). OSHA requests comment on
the proposed requirements for beryllium sensitization testing,
including issues raised in this preamble at section I, Issues and
Alternatives, and on the regulatory alternatives presented later in
this section.
In response to these concerns, OSHA notes several changes made to
the regulatory text since the SBREFA panel was convened. In the
proposed standard, medical surveillance is limited to those employees
who have worked in a regulated area for more than 30 days per year in
the previous 12-month period, employees showing signs and symptoms of
CBD, employees exposed during emergencies, and employees who have been
exposed above 0.2 [mu]g/m\3\ for more than 30 days in a 12-month period
for five years or more. Requiring medical surveillance for employees
with exposures in a regulated area (i.e., with exposures above the TWA
PEL or STEL for more than 30 days in a year) should alleviate some
SERs' concerns that surveillance is not necessary for employees with
low exposures. Employees with exposures at or above the action level
but below the PEL are no longer included in medical surveillance,
unless they show signs or symptoms of CBD or were exposed during an
emergency. Since the SBREFA panel was held, OSHA has also removed the
requirement for medical surveillance based only on dermal exposure to
beryllium, eliminating the confusion caused by the dermal exposure
provision.
These changes will result in fewer employees being eligible for
medical surveillance than were covered in the draft standard presented
to the SBREFA panel. The changes will thereby reduce costs to
employers. However, OSHA has preliminarily determined that a
significant risk of beryllium sensitization, CBD, and lung cancer exist
at exposure levels below the proposed PEL, and there is evidence that
beryllium sensitization can occur from short-term exposures (see this
preamble at Section V, Health Effects, and Section VIII, Significance
of Risk). The Agency therefore anticipates that some employees will
develop adverse health effects and may not receive the benefits of
early intervention in the disease process because they are not eligible
for medical surveillance (see this preamble at Section V, Health
Effects). Thus, OSHA is considering three regulatory alternatives that
would expand eligibility for medical surveillance to a broader group of
employees than those eligible in the proposed standard. Under
Regulatory Alternative #14, medical surveillance would be available to
employees who are exposed to beryllium above the proposed PEL,
including employees exposed for fewer than 30 days per year. Regulatory
Alternative #15 would expand eligibility for medical surveillance to
employees who are exposed to beryllium above the proposed action level,
including employees exposed for fewer than 30 days per year. Regulatory
Alternative #21 would extend eligibility for medical surveillance as
set forth in proposed paragraph (k) to all employees in shipyards,
construction, and general industry who meet the criteria of proposed
paragraph (k)(1). However, all other provisions of the standard would
be in effect only for employers and employees that fall within the
scope of the proposed rule. Most of these alternatives would provide
surveillance to fewer employees (and cost less to employers) than the
draft regulation presented to the SBREFA Panel, but would provide more
surveillance (and cost more to employers) than the medical surveillance
requirements in the current proposal.
The SER who suggested allowing performance-based surveillance
stated that this would permit employers ``to design and determine what
tests were appropriate'' (OSHA, 2008b). OSHA is considering two
regulatory alternatives that would provide greater flexibility in the
program of tests provided as part of an employer's medical surveillance
program. Under Regulatory Alternative #16, employers would not be
required to offer employees testing for beryllium sensitization.
Regulatory Alternative #18 would eliminate the CT scan requirement from
the proposed rule.
OSHA is evaluating these alternatives and has also included some
performance-based elements in its medical surveillance requirements
(e.g., (k)(3)(G)). However, the Agency has preliminarily determined
that the testing required by the proposed standard is necessary and
appropriate for the employees who must be offered medical surveillance.
OSHA believes it is important to detect cases of sensitization, CBD and
other beryllium-related health effects early so that employees can
quickly be removed from exposure, be provided appropriate protective
clothing and equipment, benefit from medical removal, and receive
treatment, as applicable. As discussed in this preamble at section
VIII, Significance of Risk, early intervention in the disease process
may slow or prevent progression to more advanced disease. Further, this
surveillance is particularly necessary in a standard such as this one,
where OSHA has preliminarily found a significant risk of material
impairment of health at the proposed PEL. OSHA requests comments on the
proposed requirements for sensitization testing, CT scans, and medical
examinations, and on Regulatory Alternatives #14 and #15 discussed
above.
Finally, at least one SER commented that providing annual BeLPTs
would result in high costs with no added benefit to employees (OSHA,
2008b). As discussed previously, OSHA would also allow substitution of
a more accurate and reliable test for the BeLPT should such a test
become available. When this occurs, employers can choose to use
whichever test is less expensive. OSHA has also, in its proposed
standard, reduced the frequency of required BeLPTs (or other test
substituted for the BeLPT) to every two years, with follow-up tests for
employees who receive abnormal test results. This change would
significantly reduce the cost of testing, but would also delay early
detection of beryllium-related health effects and intervention to
prevent disease progression among employees in medical surveillance. In
addition, the longer the time interval between when an employee becomes
sensitized and when the employee's case is identified in the
surveillance program, the more difficult it will be to identify and
address the exposure conditions that led to the employee's
sensitization. Therefore, lengthening the time between
[[Page 47802]]
sensitization tests will diminish the usefulness of the surveillance
information in identifying and correcting problem areas and reducing
risks to other employees.
The benefits of regular medical surveillance for beryllium-related
health effects and the costs of surveillance to employers are important
and complex factors in the proposed standard, and OSHA requests
feedback from the regulated and medical communities to help determine
the most appropriate schedule for periodic testing. In particular, the
Agency requests comments on several alternatives to the proposed
frequency of sensitization testing, CT scans, and general medical
examinations. Regulatory alternative #17 would require employers to
offer annual testing for beryllium sensitization to eligible employees,
as in the draft proposal presented to the SBREFA panel. Regulatory
Alternative #19 would similarly increase the frequency of periodic CT
scans from biennial to annual scans. Finally, under Regulatory
Alternative #20, all periodic components of the medical surveillance
exams would be available biennially to eligible employees. Instead of
requiring employers to offer eligible employees a medical examination
every year, employers would be required to offer eligible employees a
medical examination every other year. The frequency of testing for
beryllium sensitization and CT scans would also be biennial for
eligible employees, as in the proposed standard. For all comments on
the medical surveillance provisions of the proposed standard, please
provide an explanation of your position, and supporting data or studies
as appropriate.
(l) Medical Removal Protection
Paragraph (l) of the proposed rule contains the provisions related
to medical removal protection (MRP). Proposed paragraph (l)(1) explains
that employees in jobs with exposure at or above the action level
become eligible for medical removal when they are diagnosed with CBD or
confirmed positive for beryllium sensitization. These medical findings
may be made pursuant to the surveillance requirements of proposed
paragraph (k). The terms ``CBD'' and ``confirmed positive'' are defined
in proposed paragraph (b).
Proposed paragraph (l)(1) is in keeping with OSHA's provisions for
MRP in past standards, where the Agency has specified objective removal
criteria. For example, the Lead standard (29 CFR 1910.1025) requires
that an employee be removed from exposure at or above the action level
when an employee's blood lead concentration exceeds a certain value.
Similarly, the Cadmium standard (29 CFR 1910.1027) includes objective
biological monitoring criteria that trigger removal.
Paragraph (l)(2) lays out the options for employees who are
eligible for MRP. Specifically, paragraph (l)(2)(i) would permit
eligible employees to choose removal as described under proposed
paragraph (l)(3), and proposed paragraph (l)(2)(ii) would permit them
to remain in a job with exposure at or above the action level and wear
a respirator in accordance with the Respiratory Protection standard (29
CFR 1910.134). Eligible employees must choose one of these two options.
OSHA requests comment on whether the standard should establish a
timeframe in which eligible employees must choose one of the options in
paragraph (l)(3) (such as within 7 days, 14 days, or 30 days), and
whether the standard should require the employee to wear a respirator
if the employee fails to choose one of the options within the specified
timeframe.
Proposed paragraph (l)(3) describes eligible employees' removal
options. When an employee chooses removal, the employer is required to
remove the employee to comparable work if such work is available.
Comparable work is a position for which the employee is already
qualified or can be trained within one month, in an environment where
beryllium exposure is below the action level. Comparable work would not
require the employee to use a respirator, although the employee may
choose to use a respirator to minimize beryllium exposure. An employer
is not required to place an employee on paid leave if the employee
refuses comparable work offered under paragraph (l)(3)(i). An employee
must be transferred to comparable work, trained for comparable work, or
placed on paid leave immediately after choosing removal.
If comparable work is not immediately available, paragraph
(l)(3)(ii) would require the employer to place the employee on paid
leave for six months or until comparable work becomes available,
whichever occurs first. If comparable work becomes available before the
end of the six month paid leave period, the employer is obligated to
offer the open position to the employee. Should the employee decline,
the employer has no further obligation to continue the paid leave.
Proposed paragraph (l)(3)(iii) would continue a removed employee's
rights and benefits for six months, regardless of whether the employee
is removed to comparable work or placed on paid leave. The six month
period would begin when the employee is removed, which means either the
day the employer transfers the employee to comparable work, or the day
the employer places the employee on paid leave. For this period, the
provision would require the employer to maintain the employee's base
earnings, seniority, and other rights and benefits of employment as
they existed at the time of removal. This provision is typical of
medical removal provisions in other OSHA standards, such as Cadmium (29
CFR 1910.1027) and Benzene (29 CFR 1910.1028).
Paragraph (l)(4) would reduce an employer's obligation to provide
MRP benefits to a removed employee if, and to the extent that, the
employee receives compensation from a publicly or employer-funded
compensation program for earnings lost during the removal period, or
receives income from another employer made possible by virtue of the
employee's removal. Benefits received under the Energy Employees
Occupational Illness Compensation Program Act (EEOICPA) do not
constitute wage replacement, and therefore would not offset the
employee's medical removal benefits under this proposed standard.
By protecting an employee's rights and benefits during the first
six months of removal, and by reducing in certain circumstances an
employer's obligation to compensate employees for earnings lost, OSHA
emphasizes that MRP is not intended to serve as a workers' compensation
system. The primary reason MRP has been included in this standard is to
provide eligible employees a six-month period to adjust to the
comparable work arrangement or seek alternative employment, without any
further exposure at or above the action level.
The prospect of a medical removal provision concerned some SERS.
Some stated that there is no evidence that removing sensitized
employees will change their health outcomes (OSHA 2008b). Others
commented that they did not believe medical removal was appropriate
because neither sensitization nor CBD is reversible (OSHA 2008b).
OSHA believes that medical removal is an important means of
protecting employees who have become sensitized or developed CBD, and
is an appropriate means to enable them to avoid further exposure. The
scientific information on effects of exposure cessation is limited at
this time, but the available evidence suggests that removal from
exposure can be beneficial for individuals who are
[[Page 47803]]
sensitized or have early-stage CBD (see this preamble at section VIII,
Significance of Risk). As discussed in the Health Effects section of
this preamble, section V, only those who are sensitized can develop
CBD. As CBD progresses, symptoms become serious and debilitating.
Steroid treatment is less effective at later stages, once fibrosis has
developed (see this preamble at section VIII, Significance of Risk).
Given the progressive nature of the disease, OSHA believes it is
reasonable to conclude that removal from exposure to beryllium will
benefit sensitized employees and those with CBD.
There is widespread support for removal of individuals with
sensitization or CBD from further beryllium exposure in the medical
community and among other experts in beryllium disease prevention and
treatment. Physicians at National Jewish, one of the main CBD research
and treatment sites in the US, ``consider it important and prudent for
individuals with beryllium sensitization and CBD to minimize their
exposure to airborne beryllium,'' and ``recommend individuals diagnosed
with beryllium sensitization and CBD who continue to work in a
beryllium industry to have exposure of no more than 0.01 micrograms per
cubic meter of beryllium as an 8-hour time-weighted average'' (National
Jewish site on Chronic Beryllium Disease: Work Environment Management,
accessed May 2013). The Department of Energy included MRP in its
Chronic Beryllium Disease Prevention Program (10 CFR part 850), stating
that without MRP, employers would be ``free to maintain high-risk
workers in their current jobs, which would not be sufficiently
protective of their health'' (64 FR 68894, December 8, 1999). MRP is
included in the recommended beryllium standard that beryllium industry
and union stakeholders submitted to OSHA in 2012 (Materion and United
Steelworkers, 2012).
OSHA believes that MRP also improves the medical surveillance
program described in proposed paragraph (k). Paragraph (k)(1)(i)(B)
requires medical examinations for employees showing signs or symptoms
of CBD. The success of that program will depend in part on employees'
willingness to report their symptoms, submit to examinations, respond
to questions, and comply with instructions. Guaranteeing paid leave or
comparable work can help allay an employee's fear that a CBD diagnosis
will negatively affect earnings or career prospects. MRP encourages
employees to report their symptoms and seek treatment, as OSHA has
previously recognized when including medical removal in regulations
governing the exposure to lead (43 FR 52973, November 14, 1978),
benzene (52 FR 34557, September 11, 1987), and cadmium (57 FR 42367-68,
September 14, 1992). This reasoning was also cited by the Department of
Energy in support of the medical removal provisions of its Chronic
Beryllium Disease Prevention Program, stating that the availability of
medical removal benefits encourages worker participation and
cooperation in medical surveillance (64 FR 68893, December 8, 1999).
MRP also provides an incentive for employers to keep employee
exposures low. The risk of developing CBD or beryllium sensitization
decreases at lower exposures (see this preamble at section VI,
Preliminary Risk Assessment), meaning that employers can improve their
chances of avoiding MRP costs by lowering employee exposure levels.
OSHA previously noted this incentive when describing MRP provisions in
the Lead standard (43 FR 52973, November 14, 1978) and the Cadmium
standard (57 FR 42368, September 14, 1992).
Finally, OSHA's preliminary risk assessment indicates that
significant risk remains at the proposed TWA PEL (see this preamble at
section VI, Preliminary Risk Assessment). MRP offers additional
protection for situations in which workers develop CBD or beryllium
sensitization despite exposures at or below the PEL. As discussed above
regarding the definition of ``action level'' in paragraph (b), if OSHA
finds a continuing exposure risk at the PEL, it has the authority to
impose additional feasible requirements on employers to further reduce
risk when those requirements will result in a greater than minimal
incremental benefit to workers' health (Asbestos II, 838 F.2d at 1274).
During the SBREFA process, SERs commented that small entities may
lack the flexibility and resources to provide comparable positions for
MRP-eligible employees (OSHA 2008b). The SBREFA Panel recommended that
OSHA give careful consideration to the impacts that an MRP requirement
could have on small businesses (OSHA, 2008b). In response to this
recommendation, the Agency has provided flexibility in how employers
may comply with MRP requirements. Where employers have no comparable
positions in environments with exposures below the action level, the
proposed standard permits an employer to place eligible employees on
paid leave for six months, or until comparable work becomes available.
Under proposed paragraph (l)(4), if an employee is placed on paid leave
and receives government or employer-provided compensation, or such paid
leave allows the employee to secure other work, the original employer's
compensation obligations would be offset. Also in response to the
Panel's recommendations, OSHA analyzed Regulatory Alternative #22,
which would eliminate the proposed requirement to offer MRP to
employees with beryllium sensitization or CBD.
Finally, OSHA notes that there is considerable scientific
uncertainty about the effects of exposure cessation on the development
of CBD among sensitized individuals and the progression from early-
stage to late-stage CBD. Members of the medical community support
removal from beryllium exposure as a prudent step in the management of
beryllium sensitization and disease. For example, physicians at
National Jewish Medical Center, a leading organization in CBD research
and treatment, recommend individuals diagnosed with beryllium
sensitization and CBD who continue to work in a beryllium industry to
have exposure of no more than 0.01 micrograms per cubic meter of
beryllium as an 8-hour TWA (https://www.nationaljewish.org/healthinfo/conditions/beryllium-disease/environment-management/). However, the
scientific literature on the effects of exposure cessation is limited.
It suggests that removal from exposure can have beneficial effects for
some individuals, but provides no conclusive evidence on whether
exposure cessation will prevent CBD or CBD progression for most people
(see this preamble at Section V, Health Effects, and Section VIII,
Significance of Risk).
OSHA proposes to include MRP in the beryllium standard, providing
workers with sensitization or CBD the opportunity and means to minimize
their further exposure to beryllium via MRP in keeping with the
recommendation of beryllium specialists in the medical community and
with the draft recommended standard provided by union and industry
stakeholders (Materion and Steelworkers, 2012).
OSHA solicits comments on the health effects of MRP and the
proposed provisions for MRP. Is MRP an appropriate means of
intervention in the disease process for workers with beryllium
sensitization or CBD? Do the proposed MRP provisions appropriately
balance SBREFA commenters' concerns with the need to reduce beryllium
exposure for employees with
[[Page 47804]]
sensitization or CBD? Please comment on whether MRP should be included
in the standard (Regulatory Alternative #22). Please explain your
positions on these issues and provide any relevant data or studies.
(m) Communication of Hazards to Employees
Paragraph (m) of this proposal sets forth the employer's
obligations to comply with OSHA's Hazard Communication standard
(HCS)(29 CFR 1910.1200), and to take additional steps to warn and train
employees about the hazards of beryllium.
Paragraph (m)(1)(i) of this proposal requires chemical
manufacturers, importers, distributors, and employers to comply with
all applicable requirements of the HCS for beryllium. As described in
this preamble at section V, Health Effects, and section VI, Preliminary
Beryllium Risk Assessment, OSHA considers beryllium a hazardous
chemical.
In classifying the hazards of beryllium, the employer must address
at least the following: Cancer; lung effects (chronic beryllium disease
and acute beryllium disease); beryllium sensitization; skin
sensitization; and skin, eye, and respiratory tract irritation
(paragraph (m)(1)(ii)). According to the HCS, employers must classify
hazards if they do not rely on the classifications of chemical
manufacturers, importers, and distributors (see 29 CFR
1910.1200(d)(1)).
Paragraph (m)(1)(iii) requires that employers include beryllium in
the hazard communication program established to comply with the HCS,
and ensure that each employee has access to labels on containers and
safety data sheets for beryllium and is trained in accordance with the
HCS and paragraph (m)(4) of this proposal.
According to paragraph (e)(1)(ii) of this proposal, employers must
establish and maintain regulated areas wherever employees are or can
reasonably be expected to be exposed to beryllium at levels above the
TWA PEL or STEL, and each employee entering a regulated area must wear
a respirator and protective clothing and equipment in accordance with
paragraphs (g) and (h) of this standard. Under paragraph (m)(2) of this
proposal, employers must provide and display warning signs at each
approach to a regulated area so that each employee is able to read and
understand the signs and take necessary protective steps before
entering the area. Employers must ensure that warning signs required by
paragraph (m)(2) are legible and readily visible, and that they bear
the following legend:
Danger; Beryllium; May Cause Cancer; Causes Damage to Lungs;
Authorized Personnel Only; Wear respiratory protection and
protective clothing and equipment in this area.
Some SERs objected to having cancer warnings displayed on the
legends for warning signs and labels. They expressed the opinion that
cancer warnings would unnecessarily scare customers and employees.
Further, they alleged evidence for beryllium causation of cancer was
not sufficient (OSHA, 2008b). OSHA disagrees with these comments. OSHA
has thoroughly reviewed the literature for beryllium carcinogenicity,
and has preliminarily concluded that beryllium is carcinogenic. OSHA's
finding that inhaled beryllium causes lung cancer is based on the best
available epidemiological data, reflects evidence from animal and
mechanistic research, and is consistent with the conclusions of other
government and public health organizations (see this preamble at
section V, Health Effects). For example, the International Agency for
Research on Cancer (IARC), National Toxicology Program (NTP), and
American Conference of Governmental Industrial Hygienists (ACGIH) have
all classified beryllium as a known human carcinogen (IARC, 2009). OSHA
believes that the weight of evidence is sufficient to support the
requirement for cancer warnings on signs and labels.
The signs required by paragraph (m)(2) of this proposal are
intended to serve as a warning to employees and others who may not be
aware that they are entering a regulated area, and to remind them of
the hazards of beryllium so that they take necessary protective steps
before entering the area. These signs are also intended to supplement
the training that employees must receive regarding the hazards of
beryllium, since even trained employees need to be reminded of the
locations of regulated areas and of the precautions necessary before
entering these dangerous areas (see paragraph (m)(4) of this proposal
and 29 CFR 1910.1200(h) for training requirements).
The use of warning signs is important to make employees who are
regularly scheduled to work at these sites aware of beryllium hazards,
to alert employees who have limited access to these sites of beryllium
hazards, and to warn those who do not have access to regulated areas to
avoid the area. Access must be limited to authorized personnel to
ensure that those entering the area are adequately trained and
equipped, and to limit exposure to those whose presence is absolutely
necessary. By limiting access to authorized persons, employers can
minimize employee exposure to beryllium in regulated areas and thereby
minimize the number of employees that may require medical surveillance
or be subject to the other requirements in this proposal associated
with working in a regulated area.
Paragraph (m)(2) specifies the wording of the warning signs for
regulated areas in order to ensure that the proper warning is
consistently given to employees, and to notify employees that
respirators and personal protective clothing and equipment are required
in the regulated area. OSHA believes that the use of the word
``Danger'' is appropriate, based on the evidence of the toxicity of
beryllium. ``Danger'' is used to attract the attention of employees to
alert them to the fact that they are entering an area where the TWA PEL
or STEL may be exceeded, and to emphasize the importance of the message
that follows. The use of the word ``Danger'' is also consistent with
other OSHA health standards dealing with toxins such as cadmium (29 CFR
1910.1027), methylenedianiline (29 CFR 1910.1050), asbestos (29 CFR
1910.1001), and benzene (29 CFR 1910.1028). In addition, use of the
word ``Danger'' for this chemical is consistent with the Globally
Harmonized System of Classification and Labeling of Chemical guidelines
(GHS) (77 FR 17740-48, March 26, 2012). In the Federal Register notice
for the revised HCS, which incorporates the GHS, OSHA explains that for
substance-specific standards, warning signs must be as consistent as
possible with label information for that substance (Id.).
Paragraph (m)(3) requires that labels be affixed to all bags and
containers of clothing, equipment, and materials visibly contaminated
with beryllium. The term ``materials'' includes waste, scrap, debris,
and any other items visibly contaminated with beryllium that are
consigned for disposal or recycling (see paragraphs (h)(2)(iv) and (v)
and (j)(3)(i) through (iii)). The labels must state:
Danger; Contains Beryllium; May Cause Cancer; Causes Damage to
Lungs; Avoid Creating Dust; Do Not Get on Skin.
The purpose of this labeling requirement is to ensure that all
affected employees, not only the employees of a particular employer,
are apprised of the presence of beryllium-containing materials and the
hazardous nature of beryllium exposure. With this knowledge, employees
can take steps to protect themselves through proper work practices
established by their employers. Employees are also better able to alert
their employers if they
[[Page 47805]]
believe exposures or skin contamination can occur.
As discussed previously, these labeling requirements are consistent
with the HCS, which requires classification of hazardous chemicals and
labeling appropriate for the classification (see 77 FR 17740-48, March
26, 2012). In addition, these requirements for labeling are consistent
with the mandate of section (6)(b)(7) of the OSH Act, which requires
that OSHA health standards prescribe the use of labels or other
appropriate forms of warning to apprise employees of the hazards to
which they are exposed.
Paragraph (m)(4) contains requirements for employee information and
training, and applies to all employees who are or can reasonably be
expected to be exposed to airborne beryllium. Employers must ensure
that employees receive information and training in accordance with the
requirements of the HCS (29 CFR 1910.1200(h)), including specific
information on beryllium as well as any other hazards addressed in the
workplace hazard communication program. Under the HCS, employers must
provide their employees with information such as the location and
availability of the written hazard communication program, including
lists of hazardous chemicals and safety data sheets, and the location
of operations in their work areas where hazardous chemicals are
present. The HCS also requires employers to train their employees on
ways to detect the presence or release of hazardous chemicals in the
work area such as any monitoring conducted, the physical and health
hazards of the chemicals in the work area, measures employees can take
to protect themselves, and the details of the employer's hazard
communication program (29 CFR 1910.1200(h)(3)).
Under paragraph (m)(4)(i)(B), training must be provided to each
employee by the time of initial assignment, which means before the
employee's first day of work in a job that could reasonably be expected
to involve exposure to airborne beryllium. This training must be
repeated at least annually thereafter ((m)(4)(i)(C)). OSHA believes
that annual retraining is necessary due to the hazards of beryllium
exposure, and for reinforcement of employees' knowledge of those
hazards. The annual training requirement is consistent with other OSHA
standards such as those for lead (29 CFR 1910.1025), cadmium (29 CFR
1910.1027), benzene (29 CFR 1910.1028), coke oven emissions (29 CFR
1910.1029), cotton dust (29 CFR 1910.1043), and butadiene (29 CFR
1910.1051).
Paragraph (m)(4)(ii) requires the employer to ensure that each
employee who is or can reasonably be expected to be exposed to airborne
beryllium can demonstrate knowledge of nine enumerated categories of
information (see paragraph (m)(4)(ii)(A)--(I)). Providing information
and training on these topics is essential to informing employees of
current hazards and explaining how to minimize potential health hazards
associated with beryllium exposure. As part of an overall hazard
communication program, training serves to explain and reinforce the
information presented on labels and safety data sheets. These written
forms of communication will be most effective when employees understand
the information presented and are aware of how to avoid or minimize
exposures, thereby reducing the possibility of experiencing adverse
health effects. Training should lead to better work practices and
hazard avoidance.
The training requirements in paragraph (m)(4)(ii) are performance-
oriented. This paragraph lists the topics that training must address,
but does not prescribe specific training methods. OSHA believes that
the employer is in the best position to determine how to conduct
training that imparts knowledge and promotes retention. Appropriate
training may include video, DVD or slide presentations; classroom
instruction; hands-on training; informal discussions during safety
meetings; written materials; or a combination of these methods. This
performance-oriented approach is intended to encourage employers to
tailor training to the needs of their workplaces, thereby resulting in
the most effective training program in each individual workplace.
For training to be effective, the employer must ensure that it is
provided in a manner that each employee is able to understand. OSHA
recognizes that employees have varying education levels, literacy
levels, and language skills, and is requiring that they receive
training in a language and at a level of complexity that accounts for
these differences. This may require, for example, providing materials,
instruction, or assistance in Spanish rather than English if the
employees being trained are Spanish-speaking and do not understand
English well. The employer would not be required to provide training in
the employee's preferred language if the employee understands both
languages; as long as the employee is able to understand the language
used, the intent of the proposed standard would be met.
To ensure that employees comprehend the material presented during
training, it is critical that trainees have the opportunity to ask
questions and receive answers if they do not fully understand the
material that is presented to them. When video presentations or
computer-based programs are used, employers may meet this requirement
by having a qualified trainer available to address questions after the
presentation, or providing a telephone hotline so that trainees will
have direct access to a qualified trainer.
In addition to being performance-oriented, these training
requirements are also results-oriented. Paragraph (m)(4)(ii) requires
employers to ensure that affected employees can demonstrate knowledge
of the nine topics enumerated in paragraph (m)(4)(ii)(A) through (I).
Accordingly, employers must ensure that employees participate in and
comprehend the training, and are able to demonstrate knowledge of the
specified topics. Some examples of methods to ensure knowledge are
discussions of the required training subjects, written tests, or oral
quizzes. Although the standard only requires annual retraining,
employers must ensure that employees can demonstrate up-to-date
knowledge of the listed topics at all times.
Paragraph (m)(4)(iii) requires employers to provide additional
training, even if a year has not passed since the previous training,
when workplace changes (such as modification of equipment, tasks, or
procedures) result in new or increased employee exposure that exceeds
or can reasonably be expected to exceed either the TWA PEL or the STEL.
Some examples of changes in work conditions triggering the requirement
for additional training include changes in work production operations
or personnel that affect the way employees operate equipment.
Additional training would also be required if employers introduce new
production or personal protective equipment where employees do not yet
know how to properly use the new equipment. Misuse of either the new
production equipment or PPE could result in new exposures above the TWA
PEL or STEL. As another example, employers must provide additional
training before employees repair or upgrade engineering controls if
exposures during these activities will exceed or can reasonably be
expected to exceed either the TWA PEL or the STEL. OSHA believes the
additional training requirement in this proposal is essential because
it ensures that employees are able to actively participate in
protecting themselves under the conditions found in the workplace, even
if those conditions change.
[[Page 47806]]
Paragraph (m)(5) requires that employers make copies of the
standard and its appendices readily available at no cost to each
employee and designated employee representative. This requirement
ensures that employees and their representatives have direct access to
regulations affecting them, and knowledge of the protective measures
employers must take on employees' behalf.
Commenters to both the RFI and SBREFA recognized the importance of
educating and training their employees about the hazards of beryllium
exposure. In commenting on an earlier OSHA draft standard for beryllium
during the SBREFA process, several companies (e.g., Morgan Bronze
Products, Precision Stamping, and Mid Atlantic Coatings) supported
training that was understandable to the employee. They agreed that
employees should be able to demonstrate knowledge of health hazards
associated with beryllium exposure, and the medical surveillance
program as described in paragraph (k) of this section. They also
supported additional training when exposures exceed the PEL (OSHA
2008b). Most SERs reported already training their employees about
beryllium risks and how employees can protect themselves (OSHA, 2008b).
OSHA agrees with comments supporting the necessity of training, and in
order to assist in the development of training programs, intends to
develop outreach materials and other guidance materials.
(n) Recordkeeping
Paragraph (n) of the proposed standard requires employers to
maintain records of exposure measurements, historical monitoring data,
objective data, medical surveillance, and training. The recordkeeping
requirements are proposed in accordance with section 8(c) of the OSH
Act (29 U.S.C. 657(c)), which authorizes OSHA to require employers to
keep and make available records as necessary or appropriate for the
enforcement of the Act or for developing information regarding the
causes and prevention of occupational injuries and illnesses. The
proposed recordkeeping provisions are also consistent with OSHA's
standard addressing access to employee exposure and medical records (29
CFR 1910.1020).
Proposed paragraph (n)(1)(i) requires employers to keep records of
all measurements taken to monitor employee exposure to beryllium as
required by paragraph (d) of this standard. Paragraph (n)(1)(ii) would
require that such records include the following information: The date
of measurement for each sample taken; the operation involving exposure
to beryllium that was monitored; the sampling and analytical methods
used and evidence of their accuracy; the number, duration, and results
of samples taken; the types of respiratory protection and other
personal protective equipment used; and the name, social security
number, and job classification of each employee represented by the
monitoring, indicating which employees were actually monitored.
These requirements are consistent with those found in other OSHA
standards, such as those for methylene chloride (29 CFR 1910.1052) and
chromium (VI) (29 CFR 1910.1026). These standards, like most of OSHA's
substance-specific standards, require that exposure monitoring and
medical surveillance records include the employee's social security
number. OSHA has included this requirement in the past because social
security numbers are particularly useful in identifying employees,
since each number is unique to an individual for a lifetime and does
not change when an employee changes employers. When employees have
identical or similar names, identifying employees solely by name makes
it difficult to determine to which employee a particular record
pertains. However, based on privacy concerns, OSHA examined
alternatives to requiring social security numbers for employee
identification as part of its Standards Improvement Project-Phase II
(``SIPs'') Final Rule. The Agency analyzed public comment on the
necessity, usefulness, and effectiveness of social security numbers as
a means of identifying employee records. OSHA also analyzed comments
regarding privacy concerns raised by this requirement, as well as the
availability of other effective methods of identifying employees for
OSHA recordkeeping purposes. Comments were divided regarding whether
social security information should be retained for exposure and medical
records. The Agency examined the comments and decided not to take any
action in the SIPs final rule regarding the use of social security
numbers because the conflicting comments all raised significant
concerns, and OSHA wished to study the issue further. (See 70 FR 1112,
1126-27, March 7, 2005).
In this rulemaking, OSHA proposes to continue to require the use of
social security numbers. OSHA emphatically recommends against
distributing or posting employees' social security numbers with
monitoring results. OSHA welcomes comment on this issue.
Proposed paragraph (n)(2) addresses historical monitoring data.
Paragraph (n)(2)(i) would require employers to establish and maintain
an accurate record of any historical monitoring data used to satisfy
the initial monitoring requirements in paragraph (d)(2) of this
standard. As explained earlier in this preamble, paragraph (d)(2)
permits employers to substitute beryllium monitoring results obtained
at an earlier time for the initial monitoring requirements, as long as
employers abide by the criteria specified. Paragraph (n)(2)(ii)
requires the employer to establish and maintain records or documents
showing that the criteria discussed in paragraph (d)(2) are met. This
would mean documenting the workplace conditions present when the
historical data were collected, for purposes of showing that those
conditions closely resemble the conditions present in the employer's
current operations. Employers should also document the dates of
reliance on the historical data as well as the dates on which the
historical data were collected.
Proposed paragraph (n)(3) addresses objective data. Proposed
paragraph (n)(3)(i) requires employers to establish and maintain
accurate records of the objective data relied upon to satisfy the
requirement for initial monitoring in proposed paragraph (d)(2). Under
proposed paragraph (n)(3)(ii), the record must contain the following
information: The data relied upon; the beryllium-containing material in
question; the source of the data; a description of the operation
exempted from initial monitoring and how the data support the
exemption; and other information demonstrating that the data meet the
requirements for objective data in accordance with paragraph (d)(2).
Such other information may include reports of engineering controls,
work area layout and dimensions, and natural air movements pertaining
to the data and current conditions.
Since historical and objective data may be used to exempt the
employer from certain types of monitoring, as specified in paragraph
(d), it is critical that the use of these types of data be carefully
documented. Historical and objective data are intended to provide the
same degree of assurance that employee exposures have been correctly
characterized as would exposure monitoring. The records must
demonstrate a reasonable basis for conclusions drawn from the data.
Under proposed paragraph (n)(4)(i) employers must establish and
maintain accurate medical surveillance records for each employee
covered by the
[[Page 47807]]
medical surveillance requirements of the standard in paragraph (k).
Paragraph (n)(4)(ii) lists the categories of information that an
employer would be required to record: the employee's name, social
security number, and job classification; a copy of all physicians'
written opinions; and a copy of the information provided to the PLHCP
as required by paragraph (k)(4) of this standard.
OSHA believes that medical records, like exposure records, are
necessary and appropriate. Medical records document the results of
medical surveillance and the screening of employees. Employers can use
the information contained in the records to identify and adjust
hazardous workplace conditions and mitigate exposures. Employees can
use these records to make informed decisions regarding medical
surveillance and medical removal. PLHCPs would have the records to use
in any further employee consultations or in making recommendations at a
later time. In sum, medical records play an important part in properly
evaluating the effects of beryllium exposure on employees' health.
Paragraph (n)(5)(i) would require that employers prepare and
maintain records of any training required by this standard. At the
completion of training, the employer would be required to prepare a
record that indicates the name, social security number, and job
classification of each employee trained; the date the training was
completed; and the topic of the training. This record maintenance
requirement would also apply to records of annual retraining or
additional training as described in paragraph (m)(4).
Proposed paragraphs (n)(1) through (4) require employers to
maintain exposure measurements, historical monitoring data, and medical
surveillance records, respectively, in accordance with OSHA's Records
Access standard (29 CFR 1910.1020). That standard, specifically 29 CFR
1910.1020(d), requires employers to ensure the preservation and
retention of exposure and medical records. Exposure measurements and
historical monitoring data are considered employee exposure records
that must be maintained for at least 30 years in accordance with 29 CFR
1910.1020(d)(1)(ii). Medical surveillance records must be maintained
for at least the duration of employment plus 30 years in accordance
with 29 CFR 1910.1020(d)(1)(i).
Proposed paragraph (n)(5)(ii) requires employers to retain training
records, including records of annual retraining or additional training
required under this standard, for a period of three years after the
completion of the training. OSHA believes that the retention period for
training records is reasonable for documentation purposes. The three
year period for the maintenance of training records is consistent with
the Bloodborne Pathogens standard (29 CFR 1910.1030). Other OSHA
standards require training records to be kept for one year beyond the
last date of employment (e.g., Asbestos (29 CFR 1910.1001),
Methylenedianiline in construction (29 CFR 1926.60), and Asbestos in
construction (29 CFR 1926.1101)).
These maintenance provisions, as well as the access requirements
discussed below, ensure that records are available to employees so that
they may examine the employer's exposure measurements, historical
monitoring data, and objective data, as well as medical surveillance
and training records, and evaluate whether employees are being
adequately protected. Moreover, compliance with the requirement to
maintain records of exposure data will enable the employer to show, at
least for the duration of the retention-of-records period, that the
requirements of this standard were carried out appropriately. For
example, maintenance of these types of data could protect employers
from allegations of violating paragraph (d)(2). The lengthy record
retention period is necessitated by the long latency period commonly
associated with diseases such as chronic beryllium disease and cancer
(see this preamble at section V, Health Effects).
Paragraph (n)(6) requires that all records mandated by this
standard must be made available for examination and copying to the
Assistant Secretary, the Director of NIOSH, each employee, and each
employee's designated representative as stipulated by OSHA's Records
Access standard (29 CFR 1910.1020).
Paragraph (n)(7) requires that employers comply with the Records
Access standard regarding the transfer of records. Specifically, the
requirements for the transfer of records are explained in 29 CFR
1910.1020(h), which instructs employers either to transfer records to
successor employers or, if there is no successor employer, to inform
employees of their access rights at least three months before the
cessation of the employer's business.
Commenters to the RFI fully endorsed the need for the collection
and maintenance of health-related records dealing with beryllium
exposure, as well as those for employee hazard training (Brush Wellman,
2003). No comments were received in opposition to the need for such
recordkeeping. However, one commenter suggested that most dental labs
will not have any incentive to comply with the recordkeeping
requirements because they have fewer than ten employees and therefore
would not be subject to OSHA audits of their records. The commenter
noted that OSHA will have difficulty measuring the effectiveness of the
standard if small businesses do not keep accurate records (OSHA,
2007a). OSHA does not intend to exempt small businesses from the
recordkeeping requirements in this proposal because the Agency believes
the severity of disease resulting from beryllium exposure is great
enough to justify requiring small businesses to maintain employee
health records in accordance with this proposal. Also, recordkeeping
for fewer employees should be less resource-intensive than for a larger
organization. OSHA requests comment on the appropriateness of the
proposed recordkeeping requirements.
(o) Dates
According to paragraph (o), this standard will become effective 60
days after the publication of the final rule in the Federal Register.
OSHA intends for this period to allow affected employers the
opportunity to familiarize themselves with the standard and to make
preparations in order to be in compliance by the start-up dates. Under
paragraph (o)(2), employer obligations to comply with most requirements
of the final rule would begin 90 days after the effective date (150
days after publication of the final rule). This additional time period
is designed to allow employers to complete initial exposure assessments
or otherwise make exposure determinations by use of historical or
objective data, to establish regulated areas, to obtain appropriate
work clothing and equipment, and to comply with other provisions of the
rule.
There are two exceptions to the normal start-up intervals--
establishing change rooms and implementing engineering controls--that
provide additional time for employers to comply. Change rooms are
required no later than one year after the effective date of the
standard, and engineering controls need to be in place within two years
after the effective date. The delayed start-up dates allow affected
employers sufficient time to design and construct change rooms where
necessary, and to design, obtain, and install any required control
equipment. In addition, the longer intervals for change rooms and
engineering controls are consistent with other OSHA
[[Page 47808]]
substance-specific standards such as those for chromium (VI) (29 CFR
1910.1026) and cadmium (29 CFR 1910.1027). OSHA solicits comment on the
appropriateness of these proposed start-up dates.
XIX. References
[ACCP] American College of Chest Physicians. (1965). Beryllium
disease: report of the section on nature and prevalence. Dis Chest
48:550-558.
[ACGIH] American Conference of Governmental Industrial Hygienists.
(1949).
[ACGIH] American Conference of Governmental Industrial Hygienists.
(1971). Documentation of the Threshold Limit Values for Substances
in Workroom Air With Supplements for Those Substances Added or
Changed in 1971. American Conference of Governmental Industrial
Hygienists, Cincinnati, OH.
[ACGIH] American Conference of Governmental Industrial Hygienists.
(2009). Threshold limit values for chemical substances and physical
agents and biological exposure indices. American Conference of
Governmental Industrial Hygienists, Cincinnati, OH.
[AFL-CIO] American Federation of Labor and Congress of Industrial
Organizations. (2003). AFL-CIO's response to OSHA's Request for
Information (along with attachments). Dated: February 24, 2003.
[AIA] Aerospace Industries Association. (2003). Aerospace Industries
Association's comments on OSHA's Request for Information. Dated:
February 24, 2003.
AirClean Systems. (2011). Price Quote from AirClean Systems for 32''
Ductless Type A Balance Enclosure. Includes HEPA filter. March 10.
Aldy, J.E., and W.K. Viscusi, 2007. Age Differences in the Value of
Statistical Life, Discussion Paper RFF DP 07005, Resources for the
Future, April 2007.
Alekseeva OG. (1965) Ability of beryllium compounds to cause allergy
of the delayed type. Fed Proc Transl Suppl. Sep-Oct; 25(5):843-6.
[ANSI] American National Standards Institute. (1970). Acceptable
concentrations of beryllium and beryllium compounds. (Z37.29-1970)
New York: American National Standards Institute.
Ames BN and Gold LS. (1990). Chemical Carcinogenesis: Too many
rodent carcinogens. Proc Natl Acad Sci U.S.A. Oct; 87(19):7772-6.
Amicosante M, Berretta F, Franchi A, Rogliani P, Dotti C, Losi M,
Dweik R, Saltini C. (2002). HLA-DP-unrestricted TNF-alpha release in
beryllium-stimulated peripheral blood mononuclear cells. Eur Respir
J Nov 20; 1174-1178.
Amicosante M, Berretta F, Rossman M, Butler RH, Rogliani P, van den
Berg-Loonen E, Saltini C. (2005) Identification of HLA-DRPhe[beta]47
as the susceptibility marker of hypersensitivity to beryllium in
individuals lacking the berylliosis-associated supratypic marker
HLA-DPGlu[beta]69. Respir Res. Aug 14; 6: 94.
Amicosante M, Deubner D, Saltini C. (2005) Role of the berylliosis-
associated HLA-DPGlu69 supratypic variant in determining the
response to beryllium in a blood T-cells beryllium-stimulated
proliferation test. Sarcoidosis Vasc Diffuse Lung Dis. Oct;
22(3):175-9.
Amicosante M, Fontenot AP. (2006) T cell recognition in chronic
beryllium disease. Clin Immunol. Nov; 121(2):134-43.
Andre SM, Metivier H, Lantenois G, Boyer M, Nolibe D, Masse R.
(1987) Beryllium metal solubility in the lung: comparison of metal
hot-pressed forms by in-vivo and in-vitro dissolution bioassays.
Human toxicology, 6(3):233-240.
Arjomandi M, Seward J, Gotway MB, Nishimura S, Fulton GP, Thundiyil
J, King TE Jr, Harber P, Balmes JR. (2010) Low Prevalence of Chronic
Beryllium Disease Among Workers at a Nuclear Weapons Research and
Development Facility. JOEM 52: 647-52.
Arlauskas A, Baker RS, Bonin AM, Tandon RK, Crisp PT, Ellis J.
(1985) Mutagenicity of metal ions in bacteria. Environ Res. 36 (2);
379-388.
Armstrong JL, Day GA, Park JY, Stefaniak AB, Stanton ML, Deubner DC,
Kent MS, Schuler CR, Virji MA. (2014) Migration of beryllium via
multiple exposure pathways among work processes in four different
facilities. J Occup Environ Hyg; 11 (12): 781-792.
[ASAS] Aviation Safety Advisory Services. (2002). ASAS's response to
OSHA's Request for Information (along with attachments) Dated:
December 18, 2002.
Ashby J, Ishidate M, Stoner GD, Morgan MA, Ratpan F, Callander RD.
(1990) Studies on the genotoxicity of beryllium sulphate in vitro
and in vivo. Mutat Res. 240(3); 217-225.
[ATSDR] Agency for Toxic Substance and Disease Registry. (1993)
Toxicological Profile of Beryllium. April, 1993.
[ATSDR] Agency for Toxic Substance and Disease Registry. (2002)
Toxicological Profile of Beryllium. Sept, 2002.
Attia SM, Harisa GI, Hassan MH, Bakheet SA. (2013) Beryllium
chloride-induced oxidative DNA damage and alterations I the
expression patterns of DNA repair-related genes. Mutatgenesis. 28
(5); 555-559.
Bailey RL, Thomas CA, Deubner DC, Kent MS, Kreiss K, Schuler CR.
(2010) Evaluation of a preventive program to reduce sensitization at
a beryllium metal oxide and alloy production plant. J Occup Environ
med. 52(5); 505-512.
Ballonzoli L, Bouchier T. (2010) Ocular side-effects of steroids and
other immunosupproessive agents. Therapie; 65 (2): 115-120.
Barbee RA, Halonen M, Kaltenborn WT, and Burrows B, 1991. ``A
longitudinal study of respiratory symptoms in a community population
sample. Correlations with smoking, allergen skin-test reactivity,
and serum IgE,'' Chest, 1991 Jan;99(1): 20-6.
Bargon J, Kronenberger H, Bergmann L, et al. (1986). Lymphocyte
transformation test in a group of foundry workers exposed to
beryllium and non-exposed controls. Eur J Respir Dis 69:211-215.
Barna BP, Chiang T, Pillarisetti SG, et al. (1981) Immunological
studies of experimental beryllium lung disease in the guinea pig.
Clin Immunol Immunopathol 20:402-411.
Barna BP, Deodhar SD, Chiang T, et al. (1984a) Experimental
beryllium-induced lung disease. I. Differences in immunologic
response to beryllium compounds in strains 2 and 13 guinea pigs. Int
Arch Allergy Appl Immunol 73:42-48.
Barna BP, Deodhar SD, Gautam S, et al. (1984b) Experimental
beryllium-induced lung disease. II. Analyses of bronchial lavage
cells in strains 2 and 13 guinea pigs. Int Arch Allergy Appl Immunol
73:49-55.
Barnett RN, Brown DS, Cadora CB, Baker GP. (1961) Beryllium disease
with death from renal failure. Conn Med. 25; 142-147.
Bayliss DL, Lainhart WS, Crally LJ, et al. (1971) Mortality patterns
in a group of former beryllium workers. In: Proceedings of the
American Conference of Governmental Industrial Hygienists 33rd
Annual Meeting, Toronto, Canada, 94-107.
[BEA] Bureau of Economic Analysis. 2010. National Income and Product
Accounts Table: Table 1.1.9. Implicit Price Deflators for Gross
Domestic Product [Index numbers, 2005=100]. Revised May 27, 2010.
https://www.bea.gov/national/nipaweb/TableView.asp?SelectedTable=13&Freq=Qtr&FrstYear=2006&LastYear=2008.
Belinsky SA, Snow SS, Nikula KJ, Finch GL, Tellez CS, and Palmisano
WA. (2002) Aberrant CpG island methylation of the p16INK4a and
estrogen receptor genes in rat lung tumors induced by particulate
carcinogens. Carcinogenesis 23: 335-339.
Belman S. (1969) Beryllium binding in epidermal constituents. J
Occup Med, Apr;11(4):175-83.
Benson JM, Holmes AM, Barr EB, Nikula KJ, and March TH. (2000)
Particle clearance and histopathology in lungs of C3H/HeJ mice
administered beryllium/copper alloy by intratracheal instillation.
Inhalation Toxicology 12: 733-749.
Bernard A, Torma-Krajewski J, Viet S. (1996) Retrospective beryllium
exposure assessment at the Rocky Flats Environmental Site. Am Ind
Hyg Assoc J 57:804-808.
Beryllium Industry Scientific Advisory Committee. (1997) Is
beryllium carcinogenic in humans. J Occup Environ Med 39:205-208.
Bian Y, Hiraoka S, Tomura M, Zhou XY, Yashiro-Ohtani Y, Mori Y,
Shimizu J, Ono S, Dunussi-Joannopoulos K, Wolf S, Fujiwara H.
(2005). The Capacity of the Natural Ligands for CD28 to Drive IL-4
Expression in Na[iuml]ve And Antigen- Primed CD4\+\ and CD8\+\ T
Cells. Int Immunol; 17(1): 73-83.
Bill JR, Mack DG, Falta MT, Maier LA, Sullivan AK, Joslin FG, Martin
AK, Freed BM, Kotzin BL, Fontenot AP.
[[Page 47809]]
(2005) Beryllium presentation to CD4+ T cells is dependent on a
single amino acid residue of the MHC class II beta-chain. J Immunol;
175(10): 7029-7037.
[BLS] Bureau of Labor Statistics. (2010a). 2010 Occupational
Employment Statistics Survey, U.S. Bureau of Labor Statistics.
Available at https://www.bls.gov/oes/.
[BLS] Bureau of Labor Statistics. (2010b). 2010 Employer Costs for
Employee Compensation, U.S. Bureau of Labor Statistics. Available at
https://www.bls.gov/ncs/ect/.
[BLS] Bureau of Labor Statistics. (2013). BLS Job Openings and Labor
Turnover Survey (JOLTS). Available at: https://www.bls.gov/jlt/.
Boeniger MF. (2003). The significance of skin exposure. Ann Occup
Hyg. Nov;47(8):591-593.
Borak J, Woolf SH, Fields CA. (2006) Use if beryllium lymphocyte
proliferation testing for screening of asymptomatic individuals: an
evidence-based assessment. J Occup Environ Med. 48 (9); 937-947.
Borm PJ, Schins RP, Albrecht C. (2004) Inhaled particles and lung
cancer. Part B: Paradigms and risk assessments. Int J Cancer. May
20;110(1):3-14.
Bost TW, Riches DWH, Schumacher B, et al. (1994) Alveolar
macrophages from patients with beryllium disease and sarcoidosis
express increased levels of mRNA for tumor necrosis factor-alpha and
interleukin-6 but not interleukin-1beta. Am J Respir Cell Mol Biol
10(5):506-513.
Brooks AL, Griffith WC, Johnson NF, Finch GL, Cuddihy RG. (1989) The
induction of chromosome damage in CHO cells by beryllium and
radiation given alone and in combination. Radiat Res. 120 (3); 494-
507.
Brown ES. (2009). Effects of glucocorticoids on mood, memory, and
the hippocampus. Treatment and preventive therapy. Ann NY Acad Sci.
Oct;1179:41-55.
Brush Wellman (2003). Brush Wellman's response to OSHA's Request for
Information.
Brush Wellman (2004). Brush Wellman's 1999 baseline full-shift
personal breathing zone (lapel-type) exposure results for its
Elmore, Ohio, primary beryllium production facility. Data provided
to Eastern Research Group, Inc., Lexington, Massachusetts, on August
23, 2004. [Unpublished].
Cai H, White S, Torney D, Deshpande A, Wang Z, Marrone B, Nolan JP.
(2000) Flow cytometry-based minisequencing: a new platform for high-
throughput single-nucleotide polymorphism scoring. Genomics 66: 135-
143.
Camner P, Hellstrom PA, Lundborg M, Philipson K. (1977). Lung
clearance of 4[mu]m particles coated with silver, carbon or
beryllium. Arch Environ Health, 32:58-62.
Carter JM, Corson N, Driscoll KE, Elder A, Finkelstein JN, Harkema
JR, Gelein R, Wade-Mercer P, Nguyen K, Oberd[ouml]rster G. (2006) A
Comparative Dose-Related Response of Several Key Pro- and Anti-
inflammatory Mediators in the Lungs of Rats, Mice and Hamsters after
Subchronic Inhalation of Carbon Black. J Occup Environ Med. Dec;
48(12): 1265-1278.
Carter JM and Driscoll KE. (2001) The role of inflammation,
oxidative stress, and proliferation in silica-induced disease: a
species comparison. J Environ Pathol Toxicol Oncol. 2001;20 Suppl
1:33-43.
[CCMA] California Cast Metals Association (2000). Ventilation
Control of Airborne Metals and Silica in Foundries. El Dorado Hills,
California. April.
[CDC] Centers for Disease Control and Prevention. (2012). Take-Home
Lead Exposure Among Children with Relatives Employed at a Battery
Recycling Facility--Puerto Rico, 2011, MMWR: 2012; 61 (47): 967-970.
Chen MJ. (2001) Development of beryllium exposure matrices for
workers in a former beryllium manufacturing plant. [Dissertation].
University of Cincinnati, Cincinnati, OH.
Cherry N, Beach J, Burstyn I, Parboosingh J, Schouchen J,
Senthilselvan A, Svenson L, Tamminga J, Yiannakoulias N. (2015)
Genetic susceptibility to beryllium: a case-referent study of men
and women of working age with sarcoisosi or oterh chronic lung
disease. Occup Envion Med; 72: 21-27.
Cheskin LJ, Bartlett SJ, Zayas R, Twiley CH, Allison DB, Contoreggi
C. (1999). Prescription medications: a modifiable contributor to
obesity. South Med J. 1999 Sep;92(9):898-904.
Chiappino G, Cirla A, Vigliani EC. (1969) Delayed-type
hypersensitivity reactions to beryllium compounds. An experimental
Study. Arch Pathol Feb;87(2):131-40.
Cholack J, Schafer L, Yeager D. (1967) Exposures to beryllium in a
beryllium alloying plant. Am Ind Hyg Assoc J 28:399-407.
Chou YK, Edwards DM, Weinberg AD, Vadenbark AA, Kotzin BL, Fontenot
AP, Burrows GG. (2005) Activation pathways implicate anti-HLA-DP and
anti_LFA-1 antibodies as lead candidates for intervention in chronic
berylliosis. J Immunol 174: 4316-4324.
Christensen JD, Tong BC. (2014) Computed Tomography Screening for
Lung Cancer: Where Are We Now? NC Med J; 74(5): 406-410.
Cianciara MJ, Volkova AP, Aizina NL, Alekseeva OG. (1980) A study of
humoral and cellular responsiveness in a population occupationally
exposed to beryllium. Int Arch Occup Environ Health. 1980
Jan;45(1):87-94.
Clary JJ, Bland LS, Stokinger HE. (1975) The effect of reproduction
and lactation on the onset of latent chronic beryllium disease.
Toxicol Appl Pharmacol 33:214-221.
Cohen BS, Harley NH, Martinelli CA, and Lippman M. (1983) Sampling
artifacts in the breathing zone. Proceedings of the International
Symposium on Aerosols in the Mining and Industrial Work Environment
pp 347-360. B. Y. H. Liu and V. A. Maples eds. Minneapolis, MN: Ann
Arbor Press.
Conradi C, Burri PH, Kapanet Y, and Robinson FR. (1971) Lung changes
after beryllium inhalation: Ultrastructural and morphometric study.
Arch Environ Health 23: 348-358.
Cordeiro CR, Jones JC, Alfaro T, Ferriera AJ. (2007) Bronchoalveolar
lavage in occupational lung diseases. Semin Respir Crit Care Med.
Oct;28(5):504-13.
Costa D., and M. Kahn, 2003. ``The Rising Value of Nonmarket
Goods,'' American Economic Review, 93:2, pp. 227-233.
Costa D., and M. Kahn, 2004. ``Changes in the Value of Life, 1940-
1980,'' Journal of Risk and Uncertainty, 29:2, pp. 159-180.
Couch JR, Petersen M, Rice C, Schubauer-Berigan MK. (2011)
Development of Retrospective Quantitative and Qualitative Job-
Exposure Matrices for Exposures at a Beryllium Processing Facility.
Occup Environ Med. May;68(5): 361-5.
Coussens LM, Werb Z. (2002) Inflammation and cancer. Nature.
420(6917); 860-867.
Crowley JF, Hamilton JG, Scott KG. (1949) The metabolism of carrier-
free radioberyllium in the rat. Journal of biological chemistry,
177:975-984.
Cummings KJ, Deubner DC, Day GA, Henneberger PK, Kitt MM, Kent MS,
Kreiss K, Schuler CR. (2007) Enhanced preventive programme at a
beryllium oxide ceramics facility reduces beryllium sensitization
among workers. Occup Environ Med. Feb; 64 2):134-40.
Cummings KJ, Stefaniak AB, Virji MA, Kreiss K. (2009) A
reconsiderationof acute beryllium disease. Environ Health Perspect.
Aug;117(8):1250-6.
Curtis GH. (1951) Cutaneous hypersensitivity due to beryllium; A
study of thirteen cases. AMA Arch Derm Syphiol. Oct; 64(4):470-82.
Curtis GH. (1959) The diagnosis of beryllium disease, with special
reference to the patch test. AMA Arch Ind Health 19 (2): 150-153.
DANTE (2009). The DANTE Trial. A Randomized Study in Lung Cancer
Screening with Low-Dose Spiral Computed Topography.
Dattoli JA, Lieben J, Bisbing J. (1964) Chronic Beryllium Disease. A
Follow-Up Study. J Occup Med. 6:189-94.
Dai H, Guzman J, Costabel U. (1999) Increased expression of
apoptosis signaling receptors by alveolar macrophages in
sarcoidosis. Eur Respir J; 13(6): 1451-1454.
Dai S, Crawford F, Marrack P, Kappler JW. (2008) The structure of
HLA-DR52c: comparison to other HLA-DRB3 Isotypes. Proc Natl Acad Sci
105 (33):11893-7.
Dai S, Murphy GA, Crawford F, Mack DG, Falta MT, Marrack P, Kappler
JW, Fontenot AP. (2010) Crystal structure of HLA-DP2 and
implications for chronic beryllium disease. Proc Natl Acad Sci;
107(16): 7425-7430.
Dai S, Falta MT, Bowerman NA, McKee AS, Fontenot AP. (2013). T Cell
Recognition of Beryllium. Curr Opin Immunol 25(6): 775-780.
[[Page 47810]]
Dallman MF, Akana SF, Pecoraro NC, Warne JP, la Fleur SE., Foster
MT. (2007). Glucocorticoids, the etiology of obesity and the
metabolic syndrome. Curr Alzheimer Res. 2007 Apr;4(2):199-204.
Day GA, Dufresne A, Stefaniak AB, Schuler CR, Stanton ML, Miller WE,
Kent MS, Deubner DC, Kreiss K, Hoover MD. (2007) Exposure assessment
pathway at a copper-beryllium alloy facitilty. Ann Occup Hyg. Jan;
51(1):67-80.
Day GA, Hoover MD, Stefaniak AB, Dickerson RM, Peterson EJ, and
Esmen NA. (2005) Bioavailability of beryllium oxide particles: An in
vitro study in the murine J774A.1 macrophage cell line model. Exp.
Lung Res. 31(3):341-360.
Delic J (1992) Toxicity Review 27 (Part 2): Beryllium and beryllium
compounds. London, Her Majesty's Stationery Office (ISBN 0 11 886343
6).
De Nardi JM, Van Ordstrand HS, Carmody MG. (1949) Acute dermatitis
and pneumonitis in beryllium workers; review of 406 cases in 8-year
period with follow-up on recoveries. Ohio Med. 1949 Jun; 45(6):567-
75.
De Nardi JM, Van Orstrand HS, Curtis GH, Zielinski J. (1953)
Berylliosis: Summary and survey of all clinical types observed in a
twelve-year period. American Medical Association archives of
industrial hygiene and occupational medicine, 8:1-24.
Deodhar SD and BP Barna. (1991) Immune mechanisms in beryllium lung
disease. Cleve Clin J Med. Mar-Apr;58(2):157-60.
de Silva PS, Fellows IW. (2010) Failure in wound healing following
percutaneous gastrostomy insertion in patients on corticosteroids. J
Gastrointestin Liver Dis. Dec;19(4):463.
Deubner D, Kelsh M, Shum M, et al. (2001a) Beryllium sensitization,
chronic beryllium disease, and exposures at a beryllium mining and
extraction facility. Appl Occup Environ Hyg 16(5):579-592.
Deubner DC, Goodman M, Iannuzzi J. (2001b) Variability, predictive
value, and uses of the beryllium blood lymphocyte proliferation test
(BLPT): Preliminary analysis of the ongoing workforce survey. Appl
Occup Environ Hyg 16(5):521-526.
Deubner DC, Sabey P, Huang W, Fernandez D, Rudd A, Johnson WP,
Storrs J, Larson R. (2011) Solubility and Chemistry of Materials
Encountered by Beryllium Mine and Ore Extraction workers: Relation
to Risk. J Occup Environ Med 53 (10) 1187-1193.
Diaconita G and Eskenasy A. (1978) Experimental aerogenic pulmonary
berylliosis in rabbits. Morphol. Embryol. 24:75-79.
Ding J, Lin L, Hang W, Yan X. (2009) Beryllium uptake and related
biological effects studied in THP-1 differentiated macrophages.
Metallomics; 1(6): 471-478.
DLCST (2012). Danish Lung Cancer Screening Trial.
[DOD] Department of Defense. (2003). DOD's response to OSHA's
Request for Information (along with attachments). Dated: February
24, 2003.
[DOE] Department of Energy. (1999) 10 CFR part 850 Chronic Beryllium
Disease Prevention Program; Final Rule. December 8, 1999 https://www.hss.doe.gov/HealthSafety/WSHP/be/docs/berule.pdf.
[DOE] Department of Energy. (2001) Beryllium Lymphocyte
Proliferation Testing. DOE SPEC 1142-2001.
[DOE] Department of Energy. (2006) 10 CFR parts 850 and 851 Chronic
Beryllium Disease Prevention Program; Worker Safety and Health
Program; Final Rule December 9, 2006 https://www.hss.energy.gov/HealthSafety/wshp/be/docs/beryllium_amendments.pdf.
DOE/HSS, 2006. ``Beryllium Current Worker Health Surveillance
Through 2005,'' Publication ORISE 05-1711, https://www3.orau.gov/BAWR/pdf/beregistryrpt_2-13-2007.pdf.
Donovan EP, Kolanz ME, Galbraith DA, Chapman PS, Paustenbach DJ.
(2007) Performance of the beryllium blood lymphocyte proliferation
test based on a long-term occupational surveillance program. Int
Arch Occup Environ Health; 81 (2); 165-178.
Dorman, P., and P. Hagstrom, 1998. ``Wage Compensation for Dangerous
Work Revisited,'' Industrial and Labor Relations Review, 52:1, pp.
116-135.
Dotti C, D'Apice MR, Rogliani P, Novelli G, Saltini C, Amicosante M.
(2004) Analysis of TNF-[alpha] promoter polymorphisms in the
susceptibility to beryllium sensitization. Sarcoidosis Vasc Diffuse
Lung Dis. Mar; 21(1):29-34.
Driscoll KE. (1996) Role of inflammation in the development of rat
lung tumors in response to chronic particle exposure. Inhal Toxicol.
8 (Suppl): 139-153.
Duling MC, Stephaniak AB, Lawrence RB, Chipera SJ, Virji AM. (2012)
Release of beryllium from mineral ores in artificial lung and skin
surface fluids. Environ Geochem Health 34 (3) 313-322.
Dunkel VC, Pienta RJ, Sivak A, Traul KA. (1981) Comparative
Neoplastic Transformation Response of Balb/3T3 Cells, Syrian Hamster
Embryo Cells, and Rauscher Murine Leukemia Virus_infected Fisher 344
Rat Embryo Cells to Chemical Carcinogens. J Nat Cancer Inst. 67(6);
1303-1315.
Dutra FR. (1948) The pneumonitis and granulomatosis peculiar to
beryllium workers. Am J Pathol. 24(6):1137-65.
[EIA] U. S. Energy Information Administration. (2011). Annual Energy
Outlook. Available at: https://www.eia.gov/forecasts/archive/aeo11/.
Eidson, A.F., A. Taya, G.L. Finch, M.D. Hoover, and C. Cook. (1991)
Dosimetry of beryllium in cultured canine pulmonary alveolar
macrophages. J. Toxicol. Environ. Health 34(4):433-448.
Eisenbud M, Berghourt CF, Steadman LT. (1948) Environmental studies
in plants and laboratories using beryllium; the acute disease. J Ind
Hyg Toxicol; 30 (5): 281-285.
Eisenbud M, Wanta RC, Dustan C, Steadman LT, Harris WB, Wolf BS.
(1949) Non-occupational berylliosis. J Ind Hyg Toxicol. 31: 281-294.
Eisenbud M. (1982) Origins of the standards for control of beryllium
disease (1947-1949). Environ Res. 27(1):79-88.
Eisenbud M, Lisson J. (1983) Epidemiological aspects of beryllium-
induced non-malignant lung disease: A 30-year update. J Occup Med 25
(3): 196-202.
Eisenbud M. (1993) Re: Lung cancer incidence among patients with
beryllium disease [Letter]. J Natl Cancer Inst 85:1697-1698.
Eisenbud, M. (1998) The Standard for Control of Chronic Beryllium
Disease. Appl Occup Environ Hyg 13(1): 25-31.
Elder A, Gelein R, Finkelstein JN, Driscoll KE, Harkema J,
Oberd[ouml]rster G. (2005) Effects of subchronically inhaled carbon
black in three species. I. Retention kinetics, lung inflammation,
and histopathology. Toxicol Sci. Dec;88(2):614-29.
[EPA] Environmental Protection Agency. (1974) National emission
standards for hazardous air pollutants. U.S. Environmental
Protection Agency. Code of Federal Regulations 40:61.30-61.34.
[EPA] Environmental Protection Agency. (1987) Health Assessment
Document for Beryllium. U. S. Environmental Protection Agency,
Washington, DC.
[EPA] Environmental Protection Agency. (1998) Toxicological review
of beryllium and compounds. (CASRN 7440-41-7). In Support of Summary
Information on the Integrated Risk Information System (IRIS)U.S.
Environmental Protection Agency, Washington DC EPA/635/R-98/008 Pp.
1-93.
[EPA] Environmental Protection Agency. (2000). ``SAB Report on EPA's
White Paper Valuing the Benefits of Fatal Cancer Risk Reduction,''
EPA-SAB-EEAC-00-013. OSHA Docket OSHA-2010-0034-0652.
[EPA] Environmental Protection Agency. (2003). ``National Primary
Drinking Water Regulations; Stage 2 Disinfectants and Disinfection
Byproducts Rule; National Primary and Secondary Drinking Water
Regulations; Approval of Analytical methods for Chemical
Contaminants; Proposed Rule,'' Federal Register, Volume 68, Number
159, August 18.
[EPA] Environmental Protection Agency. (2008). ``Final Ozone NAAQS
Regulatory Impact Analysis,'' Office of Air Quality Planning and
Standards, Health and Environmental Impacts Division, Air Benefit
and Cost Group, March.
Eastern Research Group (2003). ERG Beryllium Site 5, 2003. Site
visit to a dental laboratory, January 28-29, 2003. Eastern Research
Group, Inc., Lexington, Massachusetts. Attachment 4.
Epstein PE, Daubner JH, Rossman MD, Daniele RP. (1982)
Bronchoalveolar Lavage in a Patient with Chronic Berylliosis:
Evidence for Hypersensitivity Pneumonitis. Annals Int Med; 97 (2):
213-216.
Epstein, W. L. (1991). Cutaneous effects of beryllium. Beryllium
Biomedical and Environmental Aspects.
[ERG] Eastern Research Group. (2003). Survey of the Cullman
machining plant conducted by ERG.
[[Page 47811]]
[ERG] Eastern Research Group. (2004a). Survey of the Cullman
machining plant conducted by ERG.
[ERG] Eastern Research Group. (2004b). ERG personal communication.
``In 2004, the plant industrial hygienist reported that all machines
had LEV and about 65 percent were also enclosed with either partial
or full enclosures to control the escape of machining coolant''.
[ERG] Eastern Research Group. (2007b). Rulemaking Support for
Supplemental Economic Feasibility Data for a Preliminary Economic
Impact Analysis of a Proposed Crystalline Silica Standard; Updated
Cost and Impact Analysis of the Draft Crystalline Silica Standard
for General Industry. Task Report. Eastern Research Group, Inc.
Lexington, MA. Submitted to Occupational Safety And Health
Administration, Directorate of Evaluation and Analysis, Office of
Regulatory Analysis under Task Order 11, Contract No. DOLJ049F10022.
April 20.
[ERG] Eastern Research Group. (2009a). Personal communication with
an industrial hygiene researcher at NJMRC.
[ERG] Eastern Research Group. (2009b). Personal communication with
Cullman machining plant's industrial hygienist.
[ERG] Eastern Research Group. (2010). External Peer Review of OSHA's
Draft ``Preliminary Health Effects Section for Beryllium,''
``Preliminary Risk Assessment for Beryllium,'' and External Peer
Review of NIOSH Papers. Submitted to Occupational Safety and Health
Administration, Directorate of Standards and Guidance under Task
Order 80, Contract No. DOLQ059622303. December 2, 2010.
Eskenasy A. (1979) Experimental pulmonary berylliosis in rabbits
sensitized to beryllium sulfate: Contact hypersensitivity. Morphol.
Embryol. 25(3):257-262.
[FDA] Food and Drug Administration. (2003). ``Food Labeling: Trans
Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and
Health Claims. Final Rule,'' Federal Register, 68 FR 41434.
Ferriola PC, Nettesheim P. (1994) Regulation of normal and
transformed tracheobronchial epithelial cell proliferation by
autocrine growth factors. Crit Rev oncop. 5(2-3); 107-120.
Finch GL et al; (1986) Inhalation Toxicol Research Institute Annual
Report: The Cytotoxicity of Beryllium Compounds to Cultured Canine
Alveolar Macrophages p.286-90.
Finch, G., J. Mewhinney, A. Eidson, M. Hoover, and S. Rothenberg.
(1988) In Vitro Dissolution Characteristics of Beryllium Oxide and
Beryllium Metal Aerosols. J. Aerosol Sci. 19(3):333-342.
Finch GL, Mewhinney JA, Hoover MD, et al. (1990) Clearance,
translocation, and excretion of beryllium following acute inhalation
of beryllium oxide by beagle dogs. Fundam Appl Toxicol 15:231-241.
Finch GL, Finch GL, Lowther WT, Hoover MD, Brooks AL. (1991) Effects
of beryllium metal particles on the viability and function of
cultured rat alveolar macrophages. J Toxicol Environ Health. Sep;
34(1):103-14.
Finch GL, Hahn FF, Carlton WW, Rebar AH, Hoover MD, Griffith WC,
Mewhinney JA, and Cuddihy RG. (1994) Combined exposure of F344 rats
to beryllium metal and \239\PuO2 aerosols. In Inhalation
Toxicology Research Institute Annual Report 1993-1994 (Belinsky SA,
Hoover MD, and Bradley PL, Eds.), pp 77-80. 1TRI-144, National
Technical Information Service, Springfield, VA.
Finch G, March T, Hahn F, Barr E, Belinsky S, Hoover M, Lechner J,
Nikula K, Hobbs C. (1998a) Carcinogenic responses of transgenic
heterozygous p53 knockout mice to inhaled \239\PuO2 or
metallic beryllium. Toxicol Pathol 26:484-491.
Finch GL, Nikula KJ, Hoover MD. (1998b) Dose-response relationships
between inhaled beryllium metal and lung toxicity in C3H mice.
Toxicol Sci 42(1):36-48.
Finch GL, March TH, Hahn FF, Barr EB, Belinsky SA, Hoover, MD,
Lechner JF, Nikula KJ, and Hobbs CH. (1998c) Carcinogenic responses
of transgenic heterozygous p53 knockout mice to inhaled
\239\PuO2 or metallic beryllium. Toxicologic Pathology 26
(4): 484-491.
Fireman E, Haimsky E, Noiderfer M, Priel I, Lerman Y. (2003)
Misdiagnosis of sarcoidosis in patients with chronic beryllium
disease. Sarcoidosis Vasc Diffuse Lung Dis. Jun; 20(2):144-8.
Fodor I. (1977) Histogenesis of beryllium-induced bone tumours. Acta
Morphol Acad Sci Hung. 25(2-3): 99-105.
Fontenot AP, Falta MT, Freed BM, Newman LS, Kotzin BL. (1999)
Identification of pathogenic T cells in patients with beryllium-
induced lung disease. J Immunol; 163(2): 1019-1026.
Fontenot AP, Torres M, Marshall WH, Newman LS, Kotzin BL. (2000)
Beryllium presentation CD4+ T cells underlies disease-susceptibility
HLA-DP alleles in chronic beryllium Disease. Proc Natl Acad Sci. 97
(23): 12717-12722.
Fontenot AP, Canavera SJ, Gharavi L, Newman LS, Kotzin BL. (2002)
Target organ localization of member CD4(+) T cells in patients with
chronic beryllium disease. J Clin Invest. Nov 2002; 110(10): 1473-
1482.
Fontenot AP, Gharavi L, Bennett SR, Canavera SJ, Newman LS, and
Kotzin BL. (2003) CD28 co-stimulation independence of target organ
versus circulating memory antigen-specific CD4+ T cells. J Clin
Invest. 112 (5): 776-784.
Fontenot AP, Palmer BE, Sullivan AK, Joslin FG, Wilson CC, Maier LA,
Newman LS, Kotzin BL. (2005) Frequency of beryllium specific,
central memory CD 4+ T cells in blood determines proliferation
response. J Clin Invest. Oct; 115(10):2886-93.
Fontenot AP, Maier LA. (2005) Genetic susceptibility and immune-
mediated destruction in beryllium-induced disease. Trends Immunol;
26(10): 543-549.
Fontenot AP, Keizer TS, McClesky M, Mack DG, Meza-RomeroR, Huan J,
Edwards DM, Chou YK, Vandenbark AA, Scott B, Burrow GG. (2006)
Recombinant HLA-DP2 binds beryllium and toerizes beryllium-specific
pathogenic CD4+ T cells. J Immunol; 177;3874-3883.
Franchimont D, Kino T, Galon J, Meduri GU. (2002). Glucocorticoids
and inflammation revisited: the state of the art. NIH clinical staff
conference. Neuroimmunomodulation. 2002-2003;10(5):247-60.
Franchimont D, Galon J, Vacchio MS, Fan S, Visconti R, Frucht DM,
Geenen V, Chrousos G, Ashwell JD, O'Shea JJ. (2002). Posititive
effects of glucocorticoids on T cell function by up-regulation of
IL-7 receptor alpha. J Immunol Mar 1:168(5):2212-8.
Frauman AG. (1996). An overview of the adverse reactions to adrenal
corticosteroids. Adverse Drug React Toxicol Rev. Nov;15(4):203-6.
Freeman H. (2012) Colitis associated with biological agents. World J
Gastroenterol; 18 (16): 1871-1874.
Freiman DG, Hardy HL. (1970) Beryllium disease. The relation of
pulmonary pathology to clinical course and prognosis based on a
study of 130 cases from the U.S. beryllium case registry. Hum
Pathol. Mar;1(1):25-44.
Frome EL, Smith MH, Littlefield LG, et al. (1996). Statistical
methods for the blood beryllium lymphocyte proliferation test.
Environ Health Perspect 104(Suppl. 5):957-968.
Frome E, Cragle D, Watkins J, Wing S, Shy C, Tankersley W, West C.
(1997) A mortality study of employees of the nuclear industry in Oak
Ridge, Tennessee. Radiat Res 148:64-80.
Frome EL, Newman LS, Cragle DL, Colyer SP, Wambach PF. (2003)
Identification of an abnormal beryllium lymphocyte proliferation
test. Toxicology 183 (1-3); 39-56. Erratum in Toxicology 188 (2-3);
335-336.
Fuchs B and Protchard DJ. (2002) Etiology of Osteosarcoma. Clin
Orthop Relat Res. 2002 Apr;(397):40-52.
Furchner JE, Richmond CR, London JE. (1973). Comparative metabolism
of radionuclides in mammals.VIII. Retention of beryllium in the
mouse, rat, monkey and dog. Health Phys 24:293-300.
Gaede KI, Amiconsante M, Schurmann M, Fireman E, Saltini C, Muller-
Quernheim. (2005) Function associated transforming growth factor-
beta gene polymorphism in chronic beryllium disease. J Mol Med
(Berl); 83(5): 397-405.
Gelman I. (1936) Poisoning by vapors of beryllium oxyfluoride. J Ind
Hyg Toxicol 18:371379.
Gibson GJ, Prescott RJ, Muers MF, Middleton WG, Mitchell DN,
Connolly CK, Harrison BD (1996). British Thoracic Society
Sarcoidosis Study: effects of long-term corticosteroid treatment.
Thorax. Mar; 51(3):238-47.
Gomme, P., and P. Rupert, 2004. ``Per Capita Income Growth and
Disparity in the United States, 1929-2003,'' Federal Reserve Bank of
Cleveland, August 15.
[[Page 47812]]
Gordon T and Bowser D. (2003) Beryllium: genotoxicity and
carcinogenicity. Mutat Res. Dec 10; 533(1-2):99-105.
Greene TM, Lanzisera DV, Andrews L, Downs AJ (1998) Matrix-isolation
and density functional theory study of the reactions of laser-abated
beryllium, magnesium, and calcium atoms with methane. Journal of the
American Chemical Society, 120 (24):6097-6104.
Greten FR, Karin M. (2004) The IKK/NF-kappa B activation pathway- a
target for prevention and treatment of cancer. Cancer Lett. Apr
8;206(2):193-9.
Groth DH, Kommineni C, and Mackay GR. (1980) Carcinogenicity of
beryllium hydroxide and alloys. Environmental Research 21: 63-84.
Haley PJ, Finch GL, Mewhinney JA, et al. (1989). A canine model of
beryllium-induced granulomatous lung disease. Lab Invest 61:219-227.
Haley PJ, Finch GL, Hoover, MD, et al. (1990) The acute toxicity of
inhaled beryllium metal in rats. Fundam Appl Toxicol 15:767-778.
Haley PJ. (1991) Mechanisms of granulomatous lung disease from
inhaled beryllium: the role of antigenicity in granuloma formation.
Toxicol Pathol, 19(4 Pt 1):514-25.
Haley PJ, Finch GL, Hoover MD, et al. (1992). Beryllium-induced lung
disease in the dog following two exposures to BeO. Environ Res
59:400-415.
Haley P, Pavia KF, Swafford DS, et al. (1994) The comparative
pulmonary toxicity of beryllium metal and beryllium oxide in
cynomolgus monkeys. Immunopharmacol Immunotoxicol 16(4):627-644.
Hall, R.E., and C.I. Jones, 2007. ``The Value of Life and the Rise
in Health Spending,'' Quarterly Journal of Economics, CXXII, pp. 39-
72.
Hall RH, Scott JK, Laskin S, Stroud CA, Stokinger HE. (1950) Acute
toxicity of inhaled beryllium: Observations correlating toxicity
with the physicochemical properties of beryllium oxide dust. Arch
Ind Hyg Occup Med. 2 (1): 25-48.
Hamida, KS, Fajraoui KN, Ben Ghars Amara K, Haouachi R, Sahli H,
Sellami S, Charfi MR, Zouri B. (2011). [Effect of inhaled
corticosteroids on bone mineral density in asthmatic adults: a 20
cases study]. Tunis Med. May;89(5):434-9.
Hanifin JM, Epstein WL and MJ Cline. (1970) In vitro studies on
granulomatous hypersensitivity to beryllium. J Invest Derm. Oct;
55(4):284-8.
Hardy HL, Tabershaw IR. (1946) Delayed chemical pneumonitis
occurring in workers exposed to beryllium compounds. J Ind Hyg
Toxicol 28:197-211.
Hardy HL, Rabe EW, Lorch S. (1967). United States Beryllium Case
Registry: (1952-1966) Review of its methods and utility. J Occup
Med. Jun; 9(6):271-6.
Hardy HL. (1980) Beryllium disease: a clinical perspective. Environ
Res. Feb;21(1):1-9.
Harmsen AG, Finch GL, Mewhinney JA, et al. (1986) Lung cellular
response and lymphocyte blastogenesis in beagle dogs exposed to
beryllium oxide. In: Muggenburg BA, Sun JD, eds. Annual report of
the Inhalation Toxicology Research Institute, October 1, 1985
through September 30, 1986. Lovelace Biomedical and Environmental
Research Institute, Albuquerque, New Mexico, 291-295.
Hart BA, Bickford PC, Whatlen MC, Hemanway D (1980) Distribution and
retention of beryllium in guinea pigs after administration of a
beryllium chloride aerosol. US Department of Energy symposium series
(pulmonary toxicology of respirable particulates), 53:87-102.
Hart BA, Harmsen AG, Low RB, Emerson R. (1984) Biochemical,
cytological, and histological alterations in rat lung following
acute beryllium aerosol exposure. Toxicol Appl Pharmacol. Sep
30;75(3):454-65.
Hasan FM, Kazemi H. (1974) Chronic beryllium diseae: a continued
epidemiolic hazard. Chest. 65 (3); 289-293.
[HSDB] Hazardous Substance Database. (2010). Beryllium and Beryllium
compounds. https://toxnet.nlm.nih.gov/.
Heinrich U, Fuhst R, Rittenhausen S, Creutzenber O, Bellamn B, Koch
W, Levsen K. (1995) Chronic inhalation exposure of Wistar rats and
two different strains of mice to diesel engine exhaust, carbon
black, and titanium dioxide. Inhal Toxicol. 7: 533-556.
Henneberger PK, Cumro D, Deubner DD. (2001) Beryllium sensitization
and disease among long-term and short-term workers in a beryllium
ceramics plant. Int Arch Occup Health 74:167-176.
Hintermann, B., A. Alberini, and A. Markandya, 2010. ``Estimating
the value of safety with labour market data: are the results
trustworthy?'' Applied Economics, 42(9), pp. 1085-1100.
Hollins DM, McKinley MA, Williams C, Wiman A, Fillos D, Chapman PS,
Madl AK. (2009) Beryllium and lung cancer: a weight of evidence
evaluation of the toxicological and epidemiological literature. Crit
Rev Toxicol. 2009;39 Suppl 1:1-32.
Honeywell (2003). Honeywell's comments on OSHA's Request for
Information. Dated: February 24, 2003. Pp. 11.
Hong-Geller. (2006) Chemokine response to beryllium exposure in
human peripheral blood mononuclear and dendritic cells. Toxicology.
Feb 1; 218(2-3):216-28.
Hoover MD, Castorina BT, Finch GL, Rothenberg SJ. (1989)
Determination of oxide layer thickness on beryllium metal particles.
Am Ind Hyg Assoc J. Oct; 50(10):550-3.
Hoover MD, Finch GL, Mewhinney JA, Eidson AF. (1990) Release of
aerosols during sawing and milling of beryllium exposure in human
peripheral blood mononuclear and dendritic cells. Appl Occup Environ
Hyg 5 (11): 787-791.
Hsie AW (1978) Quantitative mammalian cell genetic toxicology.
Environ Sci Res. 15; 291-315.
Huang H, Meyer KC, Kubai L, and Auerbach R. (1992) An immune model
of beryllium-induced pulmonary granulomata in mice: Histopathology,
immune reactivity, and flow-cytometric analysis of bronchoalveolar
lavage-derived cells. Lab Invest 67:138-146.
Huang W, Fernandez D, Rudd A, Johnson WP, Deubner D, Sabey P, Storrs
J, Larsen R. (2011) Dissolution and nanoparticle generation behavior
of Be-associated materials in synthetic lung fluid using inductively
coupled plasma mass spectroscopy and flow field-flow fractionation.
J Chromatogr A 1218 (27) 4149-4159.
[IARC] International Agency for Research on Cancer. (1993).
Beryllium, cadmium, mercury and exposures in the glass manufacturing
industry. Monogr Eval Carcinog Risk Hum 58:41-117.
[IARC] International Agency for Research on Cancer. (2009). Special
Report: Policy A review of human carcinogens--Part C: metals,
arsenic, dusts, and fibres. The Lancet/Oncology. Vol 10 May 2009.
[IARC] International Agency for Research on Cancer. (2012) A review
of the human carcinogens: arsenic, metals, fibres, and dusts.
[ICRP] International Commission on Radiological Protection. (1960)
Report of ICRP Committee II on Permissible Dose for Internal
Radiation. Health physics, 3:154-155.
[ICRP] International Commission on Radiological Protection. (1994).
ICRP Publication 66: Human Respiratory Tract Model for Radiological
Protection (No. 66). ICRP (Ed.). Elsevier Health Sciences.
[ICSC] International Chemical Safety Card 0226 (beryllium metal).
https://www.ilo.org/dyn/icsc/showcard.display?p_lang=en&p_card_id=0226.
[ICSC] International Chemical Safety Card 1325 (beryllium oxide)
https://www.inchem.org/documents/icsc/icsc/eics1325.htm.
[ICSC] International Chemical Safety Card 1351 (beryllium sulfate)
https://www.inchem.org/documents/icsc/icsc/eics1351.htm.
[ICSC] International Chemical Safety Card 1352 (beryllium nitrate)
https://www.inchem.org/documents/icsc/icsc/eics1352.htm.
[ICSC] International Chemical Safety Card 1353 (beryllium carbonate)
https://www.inchem.org/documents/icsc/icsc/eics1353.htm.
[ICSC] International Chemical Safety Card 1354 (beryllium chloride)
https://www.ilo.org/dyn/icsc/showcard.display?p_lang=en&p_card_id=1354.
[ICSC] International Chemical Safety Card 1355 (beryllium fluoride)
https://www.inchem.org/documents/icsc/icsc/eics1355.htm.
Infante P, Wagoner J, Sprince N. (1980) Mortality patterns from lung
cancer and nonneoplastic respiratory disease among white males in
the Beryllium Case Registry. Environ Res 21:35-43.
Invanokov AT, Popov BA, Parfenova IM (1982) Resorption of soluble
beryllium compounds through the injured skin. Gig Tr Prof Zabol 9:
50-52.
[[Page 47813]]
Irwin, R.S., F.J. Curley, and C.L. French, 1990. ``Chronic cough:
the spectrum and frequency of causes, key components of the
diagnostic evaluation, and outcome of specific therapy,'' Am Rev
Respir Dis 1990; 141: 640-7.
Jackson L, Evers BM. (2006) Chronic inflammation and pathogenesis of
GI and pancreatic cancers. Cancer Treat Res. 130:39-65.
Johnson JS, Foote K, McClean M, Cogbill G. (2001) Beryllium exposure
control program at Cardiff Atomic Weapons Establishment in the
United Kingdom. Appl Occup Environ Hyg. May;16(5):619-30.
Johnston CJ, Driscoll KE, Finkelstein JN, Baggs R, O'Reilly MA,
Carter J, Gelein R, Oberd[ouml]rster G. (2000) Pulmonary chemokine
and mutagenic responses in rats after subchronic inhalation of
amorphous and crystalline silica. Toxicol Sci. 2000 Aug;56(2):405-
13.
Joseph, P., T. Muchnok, and T. Ong. (2001) Gene expression profile
in BALB/c-3T3 cells transformed with beryllium sulfate. Mol.
Carcinog. 32(1):28-35.
Kada T. (1980) Mutagenicity of selected chemicals in the rec-assay
in bacillus subtilis. Cmpoarative Chemical Mutagenesis, pp 19-22.
KanematsuN, Hara M, Kada T. (1980) Rec assay and mutagenicity
studies on metal compounds. Mutat Res. Feb;77(2):109-16.
Kang KY, Bice D, Hoffman E, D'Amato R, Ziskind M, Salviggio. (1977)
Experimental studies of sensitization to beryllium, zirconium, and
aluminum compounds in the rabbit. J. Allergy Clin Immunol.
Jun;59(6):425-36.
Keizer TS, Sauer NN, McClesky TM. (2005) Beryllium binding at
neutral pH: the importance of the Be-O-Be motif. J Inorg Biochem;
99(5): 1174-1181.
Kelleher PC, Martyny JW, Mroz MM, Maier LA, Ruttenber AJ, Young DA,
et al. (2001) Beryllium particulate exposure and disease relations
in a beryllium machining plant. J Occup Environ Med 43: 238-249.
Kent MS, Robins TG, Madl AK. (2001) Is total mass or mass of
alveolar -deposited airborne particles of beryllium a better
predictor of the prevalence of disease? A preliminary study of a
beryllium processing facility. Appl Occup Environ Hyg. 16 (5): 539-
558.
Keshava, N, Zhou G, Spruill M, Ensell M, Ong TM. (2001) Carcinogenic
potential and genomic instability of beryllium sulphate in BALB/c-
3T3 cells. Mol. Cell. Biochem. 222(1-2):69-76.
Kimber I, Basketter, DA, Gerberick GF, Ryan CA, Dearman RJ. 2011.
Chemical Allergy: Transplating Biology into Hazard Characterization.
Toxicol. Sci. 120 (S1): S238-S268.
Kittle LA, Sawyer RT, Fadok VA, Maier LA, Newman LS. (2002)
Beryllium induces apoptosis in human lung macrophages. Sarcoidsis
Vasc Diffuse Lung Dis; 19(2): 101-113.
Klemperer FW, Martin AP, Van Riper J. (1951) Beryllium excretion in
humans. A M A Arch Ind Hyg Occup Med. Sep; 4(3):251-6.
Knaapen AM, Borm PJ, Albrecht C, Schins RP. (2004) Inhaled particles
and cancer. Part A: Mechanisms. Int J Cancer. May 10;109(6):799-809.
Kniesner, T.J., W.K. Viscusi, and J.P. Ziliak, 2010. ``Policy
relevant heterogeneity in the value of statistical life: New
evidence from panel data quantile regression,'' Journal of Risk and
Uncertainty, 40, pp. 15-31.
Kniesner, T.J., W.K. Viscusi, C. Woock, and J.P. Ziliak, 2012. ``The
Value of a Statistical Life: Evidence from Panel Data,'' Review of
Economics and Statistics, 94(1), pp. 74-87.
Kolanz, M., 2001. Brush Wellman Customer Data Summary. OSHA
Presentation, July 2, 2001. Washington, DC.
Kreiss K, Newman LS, Mroz MM, Campbell PA. (1989) Screening blood
test identifies subclinical beryllium diease. J Occup Med. 31 (7):
603-608.
Kreiss K, Mroz MM, Zhen B, Martyny JW, Newman LS. (1993a)
Epidemiology of beryllium sensitization and disease in nuclear
workers. Am Rev Respir Dis 148:985-991.
Kreiss K, Wasserman S, Mroz MM, Newman LS. (1993b) Beryllium disease
screening in the ceramics industry. Blood lymphocyte test
performance and exposure-disease relations. J Occup Med 35:267-274.
Kreiss K, Mroz MM, Newman LS, Martyny J, Zhen B. (1996) Machining
Risk of Beryllium Disease and Sensitization With Median Exposures
Below 2 micrograms/m\3\. Am J Ind Med. 30(1):16-25.
Kreiss K, Mroz MM, Zhen B, Wiedemann H, Barna B. (1997) Risks of
beryllium disease related processes at a metal, alloy, and oxide
production plant. Occup Environ Med. 54 (8): 605-612.
Kreiss K, Day GA, Schuler CR. (2007) Beryllium: a modern industrial
hazard. Annu Rev Public Health. 28:259-77.
Kriebel D, Sprince N, Eisen E, Greaves I. (1988a) Pulmonary function
in beryllium workers: assessment of exposure. Br J Ind Med 45:83-92.
Kriebel D, Sprince NL, Eisen EA, et al. (1988b) Beryllium exposure
and pulmonary function: A cross sectional study of beryllium
workers. Br J Ind Med 45:167-173.
Krivanek, Reeves. (1972) The effects of chemical forms of beryllium
on the production of the immunological response. Am Ind Hyg Assoc J.
Jan; 33(1):45-52.
Kuroda K, Endo G, Okamoto A, Yoo YS, Horiguchi S. (1991)
Genotoxicity of beryllium, gallium and antimony in short-term
assays. Mutat Res. Dec;264(4):163-70.
Lang L. (1994) Beryllium: a chronic problem. Environ Health Perspect
102:526-531.
Langhammer A, Forsmo S, Syversen U. (2009). Long-term therapy in
COPD: any evidence of adverse effect on bone? Int J Chron Obstruct
Pulmon Dis. 4:365-80.
Lansdown ABG (1995) Physiological and toxicological changes in the
skin resulting from the action and interaction of metal ions.
Critical reviews in toxicology, 25(5):397-462.
Larramendy ML, Popescu NC, DiPaolo JA. (1981) Induction by inorganic
metal salts of sister chromatid exchanges and chromosome aberrations
in human and Syrian hamster cell strains. Environ Mutagen. 3 (6):
597-606.
Lederer H and J Savage. (1954) Beryllium Granuloma of the Skin. Br J
Ind Med. Jan; 11(1):45-8.
Lee KP, Trochimowicz HJ, Reinhardt CF. (1985) Pulmonary response of
rats exposed to titanium dioxide (TiO2) by inhalation for two years.
Toxicol Appl Pharmacol. Jun 30;79(2):179-92.
Leek RD, Harris AL. (2002) Tumor-associated macrophages in breast
cancer. J Mammary Gland Biol Neoplasia 2002, 7:177-189.
LeFevre ME, Joel DD. (1986) Distribution of label after intragastric
administration of 7Be-labeled carbon to weanling and aged mice. Proc
Soc Exp Biol Med 182:112-119.
Lehouck A, Boonen S, Decramer M, Janssens W. (2011). COPD, bone
metabolism, and osteoporosis. Chest. Mar;139(3):648-57.
Leonard A, Lauwerys R. (1987) Mutagenicity, carcinogenicity and
teratogenicity of beryllium. Mutat Res 186:35-42.
Levy PS, Roth HD, Hwang PMT, Powers TE. (2002) Beryllium and lung
cancer: A reanalysis of a NIOSH cohort mortality study. Inhal
Toxicol. 14 (10): 1003-1015.
Levy, P.S., H.D. Roth, P.M.T. Hwang, and T.E. Powers, 2002.
``Beryllium and Lung Cancer: A Reanalysis of a NIOSH Cohort
Mortality Study,'' Inhalation Toxicology, 14:1003-1015.
Levy PS, Roth HD, Deubner DC. (2007) Exposure to beryllium and
occurrence of lung cancer: A reexamination of findings from a nested
case-control study. J Occup Environ Med. 49 (1): 96-101.
Lieben J, Metzner,F. (1959) Epidemiological findings associated with
beryllium extraction. Am IndHyg Assoc J 20(6):152.
Lieben J, Williams RR. (1969) Respiratory Disease Associated With
Beryllium Refining And Alloy Fabrication. 1968 Follow-up. J Occup
Med. 11(9):480-5.
Lind, R.C. (Ed.), 1982. Discounting for Time and Risk in Energy
Policy, Washington, DC: Resources for the Future.
Lionakis MS and Kontoyiannis DP. (2003). Glucocorticoids and ivasive
fungal infections. Lancet. Nov 29:362(9398):1828-38.
Lipworth BJ. (1999). Systemic adverse effects of inhaled
corticosteroid therapy: A systematic review and meta-analysis. Arch
Intern Med. May 10: 159(9): 941-955.
Machle W, Beyer E, Gregorious F. (1948). Berylliosis; acute
pneumonitis and pulmonary granulomatosis of beryllium workers. Occup
Med (Chic Ill). Jun;5(6):671-83.
Mack DG, Lanham AK, Palmer PE, Maier LA, Watts TH, Fontenot AP.
(2008) 4-4BB enhances proliferation of beryllium-specific T cells in
the lung of subjects with chronic beryllium disease. J Immunol. Sep
15;181(6):4381-8.
MacMahon B. (1994) The epidemiological evidence on the
carcinogenicity of beryllium in humans. J Occup Med 36:15-24.
[[Page 47814]]
Madl AK, Unice K, Brown JL, Kolanz ME, Kent MS. (2007) Exposure-
response analysis for beryllium sensitization and chronic beryllium
disease among workers in a beryllium metal machining plant. J Occup
Environ Hyg. Jun;4(6):448-66.
Magat W., W. Viscusi, and J. Huber, 1996. ``A Reference Lottery
Metric for Valuing Health,'' Management Science, (42: 8), pp. 1118-
1130.
Maier LA. (2001) Beryllium health effects in the era of the
beryllium lymphocyte proliferation test. Appl Occup Environ Hyg
16(5):514-520.
Maier LA, Reynolds MV, Young DA, et al. (1999) Angiotensin-1
converting enzyme polymorphisms in chronic beryllium disease. Am J
Respir Crit Care Med 159(4 Pt 1):1342-1350.
Maier LA, Tinkle SS, Kittie LA, et al. (2001) IL-4 fails to regulate
in vitro beryllium-induced cytokines in berylliosis. Eur Resp J
17:403-415.
Maier LA. (2001) Beryllium health effects in the era of the
beryllium lymphocyte proliferation test. Appl Occup Environ Hyg. 16
(5): 514-520.
Maier LA, McGrath DS, Sato H, Lympany P, Welsh K, Du Bois R,
Silveira L, Fontenot AP, Sawyer RT, Wilcox E, Newman LS. (2003)
Influence of MHC class II in susceptibility to beryllium
sensitization and chronic beryllium disease. J Immunol 171(12):
6910-6918.
Maier LA, Martyny JW, Liang J, Rossman MD. (2008) Recent Chronic
Beryllium Disease in Residents Surrounding a Beryllium Facility. Am
J Respir Crit Care Med. 1;177(9):1012-7.
Maier LA, Barkes BQ, Mroz M, Rossman MD, Barnard J, Gillespie M,
Martin A, Mack DG, Silveira L, Sawyer RT, Newman LS, Fontenot AP.
(2012) Infliximab therapy modulates an antigen-specific immune
response in chronic beryllium disease. Respir Med; 106 (12): 1810-
1813.
Mancuso TF, El-Attar AA. (1969) Epidemiological study of the
beryllium industry. Cohort methodology and mortality studies. J
Occup Med. Aug;11(8):422-34.
Mancuso TF. (1970) Relation of duration of employment and prior
respiratory illness to respiratory cancer among beryllium workers.
Environ. Research 3: 251-275.
Mancuso TF. (1979) Occupational lung cancer among beryllium workers.
Dusts and Diseases, R. Lemen and JM Dement eds. Park Forest South,
Il: Pathotox Publishers. Pp 463-471.
Mancuso T. (1980) Mortality study of beryllium industry workers'
occupational lung cancer. Environ Res 21:48-55.
Mandervelt C, Clottens FL, Demedts M, Nemery B. (1997) Assessment of
the sensitization potential of five metals in the murine local nymph
node assay. Toxicology. Jun 6;120(1):65-73.
Marchand-Adam S, El Khatib A, Guillon F, Brauner MW, Lamberto C,
Lepage V, Naccache JM, Valeyre D. (2008) Short- and long-term
response to corticosteroid therapy in chronic beryllium disease. Eur
Respir J; 32 (3): 683-693.
Martin AK, mack DG, Falta MT, Mroz MM, Newman LS, Maier LA, Fontenot
AP. (2011) Beryllium-specific CD4+ T cells in blood as a biomarker
of disease progression. J Allergy Clin Immunol; 128(5): 1100-1106.
Martyny J, Hoover M, Mroz M, Ellis K, Maier L, Sheff K, Newman L.
(2000) Aerosols generated during beryllium machining. J Occup
Environ Med 42:8-18.
Marx JJ and R Burrell. (1973) Delayed hypersensitivity to beryllium
compounds. J Immunol.l Aug;111(2):590-8.
Materion and USW (2012). Industry and Labor Joint Submission to OSHA
of a Recommended Standard for Beryllium. February, 2012.
Materion Information Meeting, 2012. Personal communication during
meeting between Materion Corporation and the U.S. Occupational
Safety and Health Administration. Elmore, Ohio. May 8-9.
Materion (2004). [previously Brush Wellman, 2004]. Brush Wellman's
1999 Baseline Full-Shift Personal Breathing Zone (Lapel-Type)
Exposure Results for its Elmore, Ohio, Primary Beryllium Production
Facility. Brush Wellman, Inc., Cleveland, Ohio. Data provided to
Eastern Research Group, Inc. August 23. [Unpublished].
McCanlies EC, Ensey JS, Schuler CR, Kreiss K, Weston A. (2004) The
association between HLA-DPB1Glu69 and chronic beryllium disease and
beryllium sensitization. Am J Ind Med. 46 (2): 95-103.
McCanlies EC, Schuler CR, Kreiss K, Frye BL, Ensey JS, Weston A.
(2007) TNF-alpha polymorphism in chronic beryllium disease and
beryllium sensitization. J Occup Environ Med. 49(4): 446-452.
McCanlies EC, YUCesoy B, Mnatsakanova A, Slaven JE, Andrew M, Frye
BL, Schuler CR, Kreiss K, Weston A. (2010) Association between IL-1A
single nucleotide polymorphisms and chronic beryllium disease and
beryllium sensitization. JOEM 52 (7): 680-684.
McCawley MA, Kent MS, Berakis MT. (2001) Ultrafine beryllium number
concentration as a possible metric for chronic beryllium disease
risk. Appl Occup Environ Hyg 16(5):631-638.
McCord DP. (1951) Beryllium as a sensitizing agent. Ind Med Surg.
Jul; 20(7):336-7.
McDonough AK, Curtis JR, Saag KG. (2008). The epidemiology of
glucocorticoid-associated adverse events. Curr Opin Rheumatol.
Mar;20(2):131-7.
Metzner FN, Lieben J. (1961) Respiratory disease associated with
beryllium refining and alloy fabrication; a case study. J Occup Med.
Jul; 3:341-5.
Meyer KC. (1994) Beryllium and Lung Disease. Chest 106; 942-946.
Middleton DC. (1998) Chronic beryllium disease: Uncommon disease,
less common diagnosis. Environ Health Perspect 106(12):765-767.
Middleton DC, Lewin MD, Kowalski PJ, Cox SS, Kleinbaum D. (2006) The
BeLPT: algorithms and implications. Am J Ind Med. Jan; 49(1):36-44.
Middleton DC, Fink J, Kowalski PJ, Lewin MD, Sinks T. (2008)
Optimizing BeLPT criteria for beryllium sensitization. Am J Ind Med.
49 (1); 36-44.
Middleton DC, Mayer AS, Lewin MD, Mroz MM, Maier LA. (2011)
Interpreting borderline BeLPT results. Am J Ind Med. Mar;54(3):205-
9.
Miller FJ, Anjilvel S, Menache MG, Asgharian B, Gerrity T. (1995)
Dosimetric issues relating to particulate toxicity. Inhal Toxicol. 7
(5): 615-632.
Misra, U.K., G. Gawdi, and S.V. Pizzo. (2002) Beryllium fluoride-
induced cell proliferation: A process requiring P21-rasdependent
activated signal transduction and NF-[kappa]B-dependent gene
regulation. J. Leukoc. Biol. 71(3):487-494.
Miyaki M, Akamatsu N, Ono T, Koymam H. (1979) Mutagenicity of metal
cations in cultured cells from Chinese hamster. Mutat Res. 68 (3);
25-263.
Mossman BT. (2000) Mechanisms of action of poorly soluble
particulates in overload-related lung pathology. Inhal Toxicol. Jan-
Feb;12(1-2):141-8.
Mroz MM, Kreiss K, Lezotte DC, Campbell PA, Newman LS. (1991)
Reexamination of the blood lymphocyte transformation test in the
diagnosis of chronic beryllium disease. J allergy Clin Immunol. 88
(1); 54-60.
Mroz MM, Maier LA, Strand M, Silviera L, Newman LS. (2009) Beryllium
lymphocyte proliferation test surveillance identifies clinically
significant beryllium disease. Am J Ind Med. Oct; 52(10):762-73.
Mueller JJ, Adolphson DR. (1979) Corrosion/Electrochemistry of
Beryllium and Beryllium. In Beryllium Science and Technology, Vol 2,
DR Floyd and JN Lowe, eds New York: Plenum Press pp 417-433.
Mullen AL, Stanley RE, Lloyd SR, Moghissi AA. (1972) Radioberyllium
metabolism by the dairy cow. Health physics, 22:17-22.
Muller-Quernheim, J. (2005) Chronic Beryllium Disease. Orphanet
encyclopedia. https://www.orpha.net/consor/cgibin/Disease_Search.php?lng=EN&data_id=1061&Disease_Disease_Search_diseaseGroup=chronic-beryllium-disease&Disease_Disease_Search_diseaseType=Pat&Disease(s)/group of
diseases=Chronic-berylliosis--Chronic-beryllium-disease-
&title=Chronic-berylliosis-Chronic-beryllium-disease-
&search=Disease_Search_Simple.
Muller-Quernheim J, Gaede KI, Fireman E, Zissel G. (2006) Diagnoses
of chronic beryllium disease with cohorts of sarcoidosis patients.
Eur Respir J. Jun; 27(6):1190-5.
[NAS] National Academies of Science (2008) Managing Health Effects
of Beryllium Exposure Committee on Beryllium Alloy Exposures.
National Research Council of the National Academies; The National
Academies Press, Washington, DC.
[NCI] National Cancer Institute. Cancer Trends Progress Report--
2009/2010 Update, National Cancer Institute, NIH, DHHS, Bethesda,
MD, April 2010, https://progressreport.cancer.gov.
[[Page 47815]]
Ndejembi MP, Teijaro JR, Patke DS, Bingaman AW, Chandok MR, Azimadeh
A, Nadler SG, Farber DL. (2006) Control of memory CD4 T cell recall
by the CD28/B7 costimulatory pathway. J Immunol; 177(11): 7698-7706.
[NEHC] Navy Environmental Health Center. (2003a). Navy Response to
Occupational Safety and Health Administration's Occupational
Exposure to Beryllium; Request for Information, February 2003. Navy
Environmental Health Center, Portsmouth, VA.
[NEHC] Navy Environmental Health Center. (2003b). Attachment (1)
Navy Occupational Exposure Database (NOED) Query Report Personal
Breathing Zone Air Sampling Results for Beryllium. Samples taken May
7, 1982 through June 7, 2002. Navy Environmental Health Center,
Portsmouth, VA.
Newman LS, Kreiss K, King TE, Seay S, Campbell PA. (1989) Pathologic
and immunologic alterations in early stages of beryllium disease.
Reexamination of disease definition and natural history. Am Rev
Respir Dis. 139 (6); 1479-1486.
Newman LS, Kreiss K. (1992) Non-occupational beryllium disease
masquerading as sarcoidosis; identification by blood lymphocyte
proliferation response to beryllium. Am Rev Respir Dis.
May;145(5):1212-4.
Newman et al. (1994). Beryllium disease: assessment with CT.
Radiology; 190(3): 835-840.
Newman LS. (1996) Immunology Genetics and Epidemiology of Beryllium
Disease. Chest. 109; 40S-43S.
Newman LS, Llyody J, Daniloff E. (1996) The natural history of
beryllium sensitization and chronic beryllium disease. Environ
Health Perspect. Oct;104 Suppl 5:937-43.
Newman LS, Mroz MM, Maier LA, Daniloff DA, Balkissoon. (2001)
Efficacy of serial medical surveillance from chronic beryllium
disease in a beryllium machining plant. J Occup Environ Health.
43(3): 231-237.
Newman, L.S., L.A. Maier, J.W. Martyny, M.M. Mroz, and E.A. Barker,
2003. National Jewish Medical and Research Center public comment to
``Occupational Exposure to Beryllium: Request for Information,''
OSHA Docket No. OSHA-H005C-2006-0870-0155.
Newman LS, Mroz MM, Balkissoon R, Maier LA. (2005) Beryllium
sensitization progresses to chronic beryllium disease: A
longitudinal study of disease risk. Am J Respir Crit Care Med. 171
(1): 54-60.
Newman LS. (2007) Immunotoxicology of beryllium lung disease.
Environ Health Prev Med; 12 (4): 161-164.
Nicholson W. (1976) Case study 1: asbestos--the TLV approach. Ann NY
Acad Sci 271:152-169.
Nickell-Brady C, Hahn FF, Finch GL, and Belinsky SA. (1994) Analysis
of K-ras, p53, and c-raf-1 mutations in beryllium-induced rat lung
tumors. Carcinogenesis 15:257-262.
Nikula KJ, Swafford DS, Hoover MD, Tohulka MD, and Finch GL. (1997)
Chronic granulomatous pneumonia and lymphocytic responses induced by
inhaled beryllium metal in A/J and C3HlHe J mice. Toxicologic
Pathology 25 (1): 2-12.
Nilsen AM, Vik R, Behrens C, Drablos PA, Espevik T. (2010) Beryllium
sensitivity among workers at a Norwegian aluminum smelter. Am J Ind
Med. 53 (7); 724-732.
[NIOSH] National Institute of Occupational Safety and Health. (1972)
Occupational Exposure to Beryllium; Criteria for a Recommended
Standard. DHEW (HSM) 72-10268. US Department of Health, Education,
and Welfare, Health Services and Mental Health Administration,
National Institute of Occupational Safety and Health, Rockville, MD.
[NIOSH] National Institute of Occupational Safety and Health. HHE
75-87-280. Health Hazard Evaluation Determination Report No. 75-87-
280, Kawecki Berylco Industries, Inc., Reading, Pennsylvania (NTIS
document number PB89-161251). Cincinnati, Ohio. April 1976.
[NIOSH] National Institute of Occupational Safety and Health. HHE
78-17-567. Health Hazard Evaluation Determination Report No. 78-17-
567, Kawecki Berylco Industries, Inc., Reading, Pennsylvania (NTIS
document number PB81-143703). Cincinnati, Ohio. March 1979.
[NIOSH] National Institute for Occupational Safety and Health.
(1994) NIOSH Pocket Guide to Chemical Hazards. DHHS (NIOSH)
Publication No. 94-116. Washington, DC: U.S. Government Printing
Office, June 1994, p. 29.
[NIOSH] National Institute of Occupational Safety and Health. (2005)
NIOSH Pocket Guide to Chemical Hazards.
[NIOSH] National Institute of Occupational Safety and Health. NIOSH
Elmore database, 2011. Spreadsheet containing beryllium exposure
values collected by NIOSH at the Materion Elmore facility in 2007
and 2008; provided by Materion Corporation to OSHA-Directorate of
Standards and Guidance. Fall 2011.
Nishimura M. (1966). Clinical and experimental studies on acute
beryllium disease. Nagoya J Med Sci. Nov; 29(1):17-44.
Nishioka H. (1975). Mutagenic activites pf metal compounds I
bacteria. Mutat Res. 31(3); 185-189.
[NJMRC] National Jewish Medical and Research Center. (2003). NJMRC's
response to OSHA's Request for Information on occupational exposure
to beryllium. Dated: February 20, 2003. Pp. 17.
[NJMRC] National Jewish Medical and Research Center. (2013). Web
page on Chronic Beryllium Disease: Work Environment Management, from
https://www.nationaljewish.org/healthinfo/conditions/beryllium-disease/environment-management/, accessed May 2013.
[NLST] National Lung Screening Trial (2011).--Bach PB (2011).
Inconsistencies in findings from the early lung cancer action
project studies of lung cancer screening. J Natl Cancer Instl
103(13): 1002-1006.
[NTP] National Toxicology Program. (1993). Toxicology and
Carcinogenesis Studies of Talc (CAS No. 14807-96-6)(Non-Asbestiform)
in F344/N Rats and B6C3F1 Mice (Inhalation Studies).
[NTP] National Toxicology Program. (1999). Final Report on
Carcinogens: Background Document for Beryllium and Beryllium
Compounds. https://ntp.niehs.nih.gov/ntp/newhomeroc/roc10/be_no_appendices_508.
[NTP] National Toxicology Program. (2002). Tenth report on
carcinogens. U.S. Department of Health and Human Services, National
Toxicology Program, Research Triangle Park, NC. https://ntp-server.niehs.nih.gov/NewHomeROC/RAHC_list.html. July 12, 2002.
[NTP] National Toxicology Program. (2014). Report on Carcinogens,
Thirteenth Edition. Beryllium and Beryllium compounds. CAS No. 7440-
41-7. https://ntp.niehs.nih.gov/go/roc13.
Oberdorster G. (1996). Significance of particle parameters in the
evaluation of exposure-dose-response relationships of inhaled
particles. Inhal Toxicol. 8 Suppl:73-89.
[OMB] U.S. Office of Management and Budget. (2003). Circular A-4,
Regulatory Analysis, September 17, 2003. Available at: https://www.whitehouse.gov/omb/circulars_a004_a-4/.
[OSHA] U.S. Occupational Safety and Health Administration. (2002).
Request for Information (RFI) for ``Occupational Exposure to
Beryllium'', 67 FR 70707, 70708, 70709, November 26, 2002.
[OSHA] U.S. Occupational Safety and Health Administration. (2003).
Letter of Interpretation. Directorate of Enforcement Programs.
https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=INTERPRETATIONS&p_id=25617.
[OSHA] U.S. Occupational Safety and Health Administration. (2006).
Final Economic and Regulatory Flexibility Analysis for OSHA's Final
Standard for Occupational Exposure to Hexavalent Chromium; Docket
H054A, Exhibit 49, pp. VI-16 to VI-18.
[OSHA] U.S. Occupational Safety and Health Administration. (2007).
Preliminary Initial Regulatory Flexibility Analysis of the
Preliminary Draft Standard for Occupational Exposure to Beryllium,
September 17. OSHA Beryllium Docket Document ID Number: OSHA-H005C-
2006-0870-0338.
[OSHA] U.S. Occupational Safety and Health Administration. (2007a).
Appendix C. Beryllium Small Business Advocacy Review (SBAR) Panel
Report. Written comments from Small Entity Representatives (SERs).
[OSHA] U.S. Occupational Safety and Health Administration. (2007b).
Preliminary Initial Considerations for a Draft Proposed Standard for
General Industries, Construction and Maritime.
[OSHA] U.S. Occupational Safety and Health Administration. (2008a).
Compliance Directive, CPL 02-02-074.
[OSHA] U.S. Occupational Safety and Health Administration. (2008b).
Report of the
[[Page 47816]]
Small Business Advocacy Review Panel on the OSHA Draft Proposed
Standard for Occupational Exposure to Beryllium. January 15, 2008.
[OSHA] U.S. Occupational Safety and Health Administration. (2009).
Integrated Management Information System (IMIS). Beryllium exposure
data, updated April 21, 2009, covering the period 1978 through
September 2008. Data provided to Eastern Research Group, Inc. by the
U.S. Department of Labor, Occupational Safety and Health
Administration, Washington, DC. [Unpublished, electronic files].
[OSHA] Occupational Safety and Health Administration. (2010a).
Occupational Exposure to Beryllium: Preliminary OSHA Health Effects
Evaluation. August 3, 2010.
[OSHA] Occupational Safety and Health Administration. (2010b).
Preliminary Beryllium Risk Assessment. August 3, 2010.
[OSHA] U.S. Occupational Safety and Health Administration. (2013).
Occupational Exposure to Respirable Crystalline Silica, Proposed
Rule, Federal Register, 78 FR 56273.
[OSHA] U.S. Occupational Safety and Health Administration. (2014).
Preliminary Economic Analysis and Initial Regulatory Flexibility
Analysis in support of the Notice of Proposed Rulemaking for
Occupational Exposure to Beryllium.
[OSHA] Occupational Safety and Health Administration. (2014a). Risk
Analysis of a Worker Population at a Beryllium Machining Facility.
[OSHA] Occupational Safety and Health Administration. (2015a).
Spreadsheets in Support of OSHA's Preliminary Economic Analysis for
the Proposed Beryllium Standard.
[OSHA] Occupational Safety and Health Administration. (2015b).
``Comparing Two Models for Beryllium Benefits.''
[OSHA] Occupational Safety and Health Administration. (2015c).
``Spreadsheet for an Alternative Benefit Model.''
Pallavicino F., Pellicano R., Reggiani S., Simondi D., Sguazzini C.,
Bonagura A.G., Cisaro F., Rizzetto M., Astegiano M. (2013).
Inflammatory Bowel Disease And Primary Sclerosing Cholangitis:
Hepatic And Pancreatic Side Effects Due To Azathioprine. Eur Rev Med
Pharma Sci; 17: 84-87.
Palmer B.E., Mack D.G., Martin A.K., Gillespie M., Mroz M.M., Maier
L.A., Fontenot A.P. (2008). Up-regulation of programmed death-1
expression on beryllium-specific CD4+ T cells in chronic beryllium
disease. J Immunol; 180(4): 2704-2712.
Pappas G.P., Newman L.S. (1993). Early pulmonary physiologic
abnormalities in beryllium disease. American review of respiratory
disease, 148:661-666.
Pikarsky E., Porat R.M., Stein I., Abramovitch R., Amit S., Kasem
S., Gutkovich-Pyest E., Urieli-Shoval S., Galun E., Ben-Neriah Y.
(2004). NF-kappaB functions as a tumour promoter in inflammation-
associated cancer. Nature. Sep 23; 431(7007):461-6.
Polak L., Barnes J.M., Turk J.L. (1968). The genetic control of
contact sensitization to inorganic metal compounds in guinea-pigs.
Immunology. 1968 May; 14(5):707-11.
Rana S.V. (2008). Metals and apoptosis: Recent developments. J trace
Elem Biol; 22(4):262-284.
Reeves A.L. (1965). The absorption of beryllium from the
gastrointestinal tract. Arch Environ Health. Aug; 11(2):209-14.
Reeves A.L., Vorwald A.J. (1967). Beryllium carcinogenesis. II.
Pulmonary deposition and clearance of inhaled beryllium sulfate in
the rat. Cancer Res 27:446-451.
Reeves A.L., Deitch D., Vorwald A.J. (1967). Beryllium
carcinogenesis. I. Inhalation exposure of rats to beryllium sulfate
aerosol. Cancer Res 27:439-445.
Reeves A.L., Krivanek N.D., Busby E.K., Swanborg R.H. (1972).
Immunity to pulmonary berylliosis in guinea pigs. Int Arch
Arbeitsmed. 29(3):209-20.
Refsnes M., Hetland R.B., Ovrevik J., Sundfor I., Schwarze P.E., Lag
M. (2006). Different particle determinants induce apoptosis and
cytokine release in primary alveolar macrophage cultures. Part Fibre
Toxicol. Jun 14;3:10.
Rhoads K., Sanders C.L. (1985). Lung clearance, translocation, and
acute toxicity of arsenic, beryllium, cadmium, cobalt, lead,
selenium, vanadium, and ytterbium oxides following deposition in rat
lung.Environ Res 36:359-378.
Richeldi L., Sorrentino R., Saltini C. (1993). HLA-DPB1 glutamate
69: A genetic marker of beryllium disease. Science. Oct
8;262(5131):242-4.
Ritz B., Morgenstern H., Froines J., Young B. (1999). Effects of
exposure to external ionizing radiation on cancer mortality in
nuclear workers monitored for radiation at Rocketdyne/Atomics
International. Am J Ind Med 35:21-31.
Robinson F.R., Schaffner F., and Trachtenburg E. (1968).
Ultrastructure of the lungs of dogs exposed to beryllium-containing
dusts. Arch. Environ. Health 16:374-379.
Rom, W.N., J.E. Lockey, J.S. Lee, A.C. Kimball, K.M. Bang, H.
Leaman, R.E. Johns, D. Perrota, and H.L. Gibbons. (1984).
Pneumoconiosis and Exposures of Dental Laboratory Technicians.
American Journal of Public Health 74(11):1252-1257. November.
Rosenkranz H.S. and Poirer L.A. (1979). Evaluation of the
mutagenicity and DNA-modifying activity of carcinogens and
noncarcinogens in microbial systems. J Natl Cancer Inst. 62(4):873-
891.
Rosenman K., Hertzberg V., Rice C., Reilly M.J., Aronchick J.,
Parker J.E., Regovich J., Rossman M. (2005). Chronic beryllium
disease and sensitization at a beryllium processing facility.
Environ Health Perspect Oct;113(10):1366-72; Erratum (2006).
Rossman T.G., Molina M. (1984). The genetic toxicology of metal
compounds: I. Induction of prophage in E coli WP2. Environ Mut.
6(1); 59-69.
Rossman M.D., Kern J.A., Elias J.A., Cullen M.R., Epstein P.E.,
Preuss O.P., Markham T.N., Daniele R.P. (1988). Proliferative
Response of Bronchoalveolar Lymphocytes to Beryllium: A test for
chronic beryllium disease. Annals Int Med; 108(5):687-693.
Rossman M.D., Preuss O.P., Powers M.B., eds. (1991). Beryllium:
Biomedical and Environmental Aspects. Immunopathogenesis of Chronic
Beryllium Disease. Chapter 10. Baltimore, MD: Williams and Wilkins.
Rossman M. (1996). Chronic beryllium disease; diagnosis and
management. Environ Health Perspect. Oct; 104 Suppl 5:945-7.
Rossman M.D. (2001). Chronic beryllium disease: A hypersensitivity
disorder. Appl Occup Environ Hyg. May; 16(5):615-8.
Rossman M., Kreider. (2003). Is chronic beryllium disease
sarcoidosis of known etiology? Sarcoidosis Vasc Diffuse Lung Dis.
Jun; 20(2):104-9.
Roth H.D. Memorandum to Brush Wellman enclosing a critique of the
EPA health assessment document for beryllium. February 22, 1985.
Saber W., Dweik R.A. (2000). A 65-year-old factory worker with
dyspnea on exertion and a normal chest x-ray. Cleve Clin J Med. Nov;
67(11):791-2, 794, 797-8, 800.
Saltini C., Winestock K., Kirby M., Pinkston P., Crystal R.G.
(1989). Maintenace of alveolitis in patients with chronic beryllium
disease by beryllium-specific helper T cells. N Engl J Med. Apr 27;
320(17):1103-9.
Saltini C., Kirby M., Trapnell B.C., Tamura N., Crystal R.G. (1990).
Biased accumulation of T-lymphocytes with ``memory''-type CD45
leukocyte common antigen gene expression on the epithelial surface
of human lung. J Exp Med. Apr 1; 171(4):1123-40.
Saltini C., Amicosante M. (2001). Beryllium disease. Am J Med Sci
321(1):89-98.
Saltini C., Richeldi L., Losi M., Amicosante M., Voorter C., van den
Berg-Loonen E., Dweik R.A., Wiedmeann H.P., Deubner D.C., Tinelli C.
(2001). Major Histocompatibility Locus Genetic Markers of Beryllium
Sensitization and Disease. Eur Respir J 18(4):677-684.
Salvator H., Gille T., Herve A., Bron C., Lamberto C., Valeyre D.
(2013). Chronic beryllium disease: Azathioprine as a possible
alternative to corticosteroid treatment. Eur Respir J; 41(1):234-
236.
Sanders C.L., Cannon W.C., Powers G.J., et al. (1975). Toxicology of
high-fired beryllium oxide inhaled by rodents. Arch Environ Health
30:546-551.
Sanders, C.L., W.C. Cannon, and G.J. Powers. (1978). Lung
carcinogenesis induced by inhaled high-fired oxides of beryllium and
plutonium. Health Phys. 35(2):193-199.
Sanderson W.T., Henneberger P.K., Martyny J., Ellis K., Mroz M.M.,
Newman L.S. (1999). Beryllium contamination inside vehicles of
machine shop workers. Appl Occup Environ Hyg 14(4):223-230.
Sanderson W.T., Ward E.M., Steenland K., Petersen M.R. (2001a). Lung
Cancer Case Control Study of Beryllium Workers. Am J Ind Med.
39(2):133-44.
[[Page 47817]]
Sanderson W.T., Petersen M.R., Ward E.M. (2001b). Estimating
Historical Exposures Of Workers In A Beryllium Manufacturing Plant.
Am J Ind Med. 39(2):145-57.
Saracci R. (1991) Beryllium and lung cancer: Adding another piece to
the puzzle of epidemiologic evidence. J Natl Cancer Inst 83:1362-
1363.
Sawyer, R.T., V.A. Fadok, L.A. Kittle, L.A. Maier, and L.S. Newman.
(2000). Beryllium-stimulated apoptosis in macrophage cell lines.
Toxicology 149(2-3):129-142.
Sawyer R.T., Parsons C.E., Fontenot A.P., Maier L.A., Gillespie
M.M., Gottschall E.B., Silveira L., Newman L.S. (2004). Beryllium-
induced tumor necrosis factor-alpha production by CD4+ T cells is
mediated by HLA-DP. Am J Respir Cell Mol Biol. Jul; 31(1):122-30.
Sawyer, R.T., D.R. Dobis, M. Goldstein, L. Velsor, L.A. Maier, A.P.
Fontenot, L. Silveira, L.S. Newman, and B.J. Day. (2005). Beryllium-
stimulated reactive oxygen species and macrophage apoptosis. Free
Radic. Biol. Med. 38(7):928-937.
[SBAR] Small Business Advocacy Review. (2008). Report of the Small
Business Advocacy Review (SBAR) Panel on the OSHA Draft Proposed
Standard for Occupational Exposure to Beryllium. Small Business
Advisory Review Panel Report with Appendices A, B, C, and D. Final
version, January 15, 2008. OSHA Beryllium Docket Document ID Number:
OSHA-H005C-2006-0870-0345.
Schepers GW, Durkan TM, Delahant AB, Creedon FT. (1957) The
biological action of inhalaed beryllium sulfate; a preliminary
chronic toxicity study in rats. AMA Arch Ind Health. 15 (1); 32-58.
Schepers GW. (1962) The mineral content of the lung in chronic
berylliosis. Dis Chest. Dec; 42:600-7.
Schlesinger RB, Ben-Jebria A, Dahl AR, Snipes MB, Ultman J 1997.
Chapter 12. Disposition of inhaled toxicants. In: Handbook of Human
Toxicology (Massaro EJ, ed). New York:CRC Press, 493-550.
Schubauer-Berigan MK, Deddens JA, Steenland K, Sanderson WT,
Petersen MR. (2008) Adjustment for temporal confounders in a
reanalysis of a case-control study of beryllium and lung cancer.
Occup Environ Med. Jun; 65(6):379-83.
Schubauer-Berigan MK, Deddens JA, Peterson MR. (2011) Risk of lung
cancer associated with quantitative beryllium exposure metrics
within an occupational cohort. Occup Environ Med 68(5): 354-60.
Schubauer-Berigan, 4-22-2011, NIOSH, personal communication. (table
of lifetime risk estimates, Table VI-20 p. 64 of draft risk doc).
Schuler CR, Kent MS, Deubner DC, Berakis MT, McCawley M, Henneberger
PK, Rossman MD, Kreiss K. (2005) Process-Related Risk of Beryllium
Sensitization and Disease in a Copper-Beryllium Alloy Facility. Am J
Ind Med. 47(3):195-205.
Schuler CR, Kitt MM, Henneberger PK, Deubner, DC, Kreiss K. (2008)
Cumulative Sensitization and Disease in a Beryllium Oxide Ceramics
Worker Cohort. J Occup Environ Med. Dec;50(12):1343-1350.
Schuler CR, Virji MA, Deubner DC, Stanton ML, Stefaniak AB, Day GA,
Park JY, Kent MS, Sparks R, Kreiss K. (2012) Sensitization and
Chronic Beryllium Disease at a Primary Manufacturing Facility, Part
3: Exposure-Response Among Short-Term Workers. Scand J Work Environ
Health. May;38(3): 270-81. Epub 2011 Aug 29.
Scott JK, Neumann WF, Allen R. (1950) The effect of added carrier on
the distribution and excretion of soluble beryllium. J Biol Chem,
182:291-298.
Seidler A, Euler U, Muller-Quernheim J, Gaede KI, Latza U, Groneberg
D, Letzel S. (2012) Systematic review: progression of beryllium
sensitization to chronic beryllium disease. Occup Med; 62 (7): 506-
513.
Seiler D, Rice C, Herrick R, Hertzberg V. (1996) A study of
beryllium exposure measurements: parts 1 and 2. Appl Occup Environ
Hyg 11:89-102.
Sendelbach LE, Witschi HP, Tryka AF. (1986) Acute pulmonary toxicity
of beryllium sulfate inhalation in rats and mice: Cell kinetics and
histopathology. Toxicol Appl Pharmacol 85:248-256.
Sendelbach LE, Witschi HP. (1987) Bronchoalveolar lavage in rats and
mice following beryllium sulfate inhalation. Toxicol Appl Pharmacol
90:322-329.
Sendelbach LE, Tryka AF, Witschi H. (1989) Progressive lung injury
over a one-year period after a single inhalation exposure to
beryllium sulfate. Am Rev Respir Dis 139:1003-1009.
Silva DR, Coelho AC, Dumke A, Valentini JD, de Nunes JN, Stefani CL,
da Silva Mendes LF, Knorst MM (2011) Osteoporosis prevalence and
associated factors in patients with COPD: a cross-sectional study.
Respir Care. 56(7):961-8.
Silveira LJ, McCanlies EC, Fingerlin TE, Van Dyke MV, Mroz MM,
Strand M, Fontenot AP, Bowerman N, Dabelea DM, Schuler CR, Weston A,
Maier LA. (2012) Chronic beryllium disease, HLA-DPB1, and the DP
peptide binding groove. J Immunol 189(8): 4014-4023.
Simmon VF. (1979) In vitro assays for recombinogenic activity of
chemical carcinogens and realted compounds with saccharomyces
cerevisiae D3. Nat Cancer Inst. 62 (4); 901-909.
Skilleter DN, Price RJ. (1978) The uptake and subsequent loss of
beryllium by rat liver parenchymal and non-parenchymal cells after
the intravenous administration of particulate and soluble forms.
Chem Biol Interact. Mar;20(3):383-96.
Skilleter DN, Paine AJ. (1979) Relative toxicities of particulate
and soluble forms of beryllium to a rat liver parenchymal cell line
in culture and possible mechanisms of uptake. Chem Biol Interact.
Jan; 24(1):19-33.
Skilleter DN, Price RJ. (1981) Effects of beryllium compounds on rat
liver Kupffer cells in culture. Toxicol Appl Pharmacol. Jun
30;59(2):279-86.
Skilleter DN, Price RJ. (1988) Effects of beryllium ions on tyrosine
phosphorylation. Biochem SocTrans 16:1047-1048.
Snyder, J. A., Weston, A., Tinkle, S. S., & Demchuk, E. (2003).
Electrostatic potential on human leukocyte antigen: implications for
putative mechanism of chronic beryllium disease. Environmental
health perspectives, 111(15), 1827.
Snyder JA, Demchuk E, McCanlies EC, Schuler CR, Kreiss K, Andrew ME,
Frye BL, Ensey JS, Stanton ML, Weston A. (2008) Impact of negatively
charged patches on the surface of MHC class II antigen-presneting
proteins on risk of chronic beryllium disease. J R Soc Interface;
5(24): 749-758.
Sood A, Beckett WS, Cullen MR. (2004) Variable response to long-term
corticosteroid therapy in chronic beryllium disease. Chest; 126 (6):
2000-2007.
Sood A. (2009) Current treatment of chronic beryllium disease. J
Occup Environ Hyg; 6 (12): 762-765.
Spencer HC, Sadek SE., Jones JC, Hook RH, Blumentshine JA,
McCollister SB. (1967) Toxicological studies on beryllium oxides and
beryllium containing exhaust products, technical report. AMRL-TR-67-
46. Wright Patterson Air Force Base, Aerospace Medical Research
Laboratories. May: 1-53.
Sprince NL, Kazemi H, Hardy HL. (1976) Current (1975) problem of
differentiating between beryllium disease and sarcoidosis. Ann N Y
Acad Sci. 278:654-64.
Sprince NL, Kazemi H. (1980) U.S. beryllium case registry through
1977. Environmental research, 21:44-47.
Stange AW, Hilmas DE, Furman FJ, Gatliffe TR. (2001) Beryllium
sensitization and chronic beryllium disease at a former nuclear
weapons facility. Appl Occup Environ Hyg. 16(3): 405-417.
Stange AW, Furman FJ, Hilmas DE. (2004) The beryllium lymphocyte
proliferation test: Relevant issues in beryllium helath
surveillance. Am J Ind Med. 46 (5): 453-462.
Stanton ML, Henneberger PK, Kent MS, Deubner DC, Kreiss K, Schuler
CR. (2006) Sensitization and chronic berullium disease among workers
in copper-beryllium distribution centers. J Occup Environ Med. 48
(2): 204-211.
Steele VE, Wilkinson BP, Arnold JT, and Kutzman RS. (1989) Study of
beryllium oxide genotoxicity in cultured respiratory epithelial
cells. Inhalation Toxicology 1: 95-110.
Steenland K, Ward E. (1991) Lung cancer incidence among patients
with beryllium disease: A cohort mortality study. J Natl Cancer Inst
83:1380-1385.
Stefaniak AB, Weaver VM, Cadorette M, Puckett LG, Schwartz BS, Wiggs
LD, Jankowski MD, and Breysse PN. (2003) Summary of historical
beryllium uses and airborne concentration levels at Los Alamos
National Laboratory. Appl. Occup. Environ. Hyg. 18(9):708-715.
[[Page 47818]]
Stefaniak AB, Hoover MD, Dickerson RM, Peterson EJ, Day GA, Breysse
PN, Kent MS, Scripsick RC. (2003a) Surface area of respirable
beryllium metal, oxide, and copper alloy aerosols and implications
for assessment of exposure risk of chronic beryllium disease. Am.
Ind. Hyg. Assoc. J. 64(3):297-305.
Stefaniak AB, Guilmette RA, Day GA, Hoover MD, Breysse PN, Scripsick
RC. (2005) Characterization of phagolysomal simulant fluid of
beryllium aerosol particle dissolution. Toxicol In Vitro; 19(1):123-
134.
Stefaniak, AB, Day GA, Hoover MD, Breysse PN, Scripsick RC. (2006)
Differences in dissolution behavior in a phagolysosomal stimulant
fluid for single-constituent and multi-constituent materials
associated with beryllium sensitization and chronic beryllium
disease. Toxicol. In Vitro 20(1):82-95.
Stefaniak AB, Chipera SJ, Day GA, Sabey P, Dickerson RM, Sbarra DC,
Duling MG, Lawrence RB, Stanton ML, Scripsick RC. (2008)
Physicochemical characteristics of aerosol particles generated
during the milling of beryllium silicate ores: Implications for risk
assessment. J Toxicol Environ Health A. 71(22):1468-81.
Stefaniak AB, et al. 2008. Size-selective poorly soluble particulate
reference materials for evaluation of quantitative analytical
methods. Anal. Bioan. Chem. 391:2071-2077.
Stefaniak, A. B., Virji, M. A., & Day, G. A. (2011). Dissolution of
beryllium in artificial lung alveolar macrophage phagolysosomal
fluid. Chemosphere, 83(8), 1181-1187.
Stefaniak AB, Virji A, Day GA. (2012) Release of beryllium into
artificial airway epithelial lining fluid. Arch Environ Occup
Health; 67(4):219-228.
Stiefel T, Schultze K, Zorn H, Tolg G. (1980) Toxicokinetic and
toxicodynamic studies on beryllium. Arch Toxicol. Jul; 45(2):81-92.
Sterner JH and Eisenbud M. (1951) Epidemiology of Beryllium
Intoxification. A M A Arch Ind Hyg Occup Med. Aug; 4(2):123-51.
Stoeckle JD, Hardy HL, Weber AL. (1969) Chronic beryllium disease.
Long-term follow-up of sixty cases and selective review of the
literature. Am J Med. 46 (4); 545-561.
Stokes RF, Rossman MD. (1991) Blood cell proliferation response to
beryllium: Analysis by receiver-operating characteristics. J Occup
Med. Jan; 33(1):23-8.
Stokinger HE, Sprague GF, Hall RH, et al. (1950) Acute inhalation
toxicity of beryllium. I. Four definitive studies of beryllium
sulfate at exposure concentrations of 100, 50, 10 and 1 mg per cubic
meter. Arch Ind Hyg Occup Med 1:379-397.
Stokinger HE, Altman KI, Salomon K. (1953) The effect of various
pathological-conditions on in vivo hemoglobin synthesis. I.
Hemoglobin synthesis in beryllium-induced anemia as studied with
alpha-14C-acetate. Biochim Biophys Acta. Nov; 12(3):439-44.
Stubbs J, Argyris E, Lee CW, Monos D, Rossman MD. (1996) Genetic
markers in beryllium hypersensitization. Chest. Mar; 109 (3 Suppl):
45S.
Sutton M, Burastero SR. (2003) Beryllium chemical speciation in
elemental human biological fluids. Chem Res Toxicol. Sep;
16(9):1145-54.
Swafford DS, Middleton SK, Palmisano WA, Nikula KJ, Tesfaigzi J,
Baylin SB, Herman JG, and Belinsky SJ. (1997) Frequent aberrant
methylation of p16INK4a in primary rat lung tumors. Molecular and
Cellular Biology 17 (3):1366-1374.
Sweiss NJ, Lower EE, Korsten P, Niewold TB, Favus MJ, Baughman RP.
(2011). Bone health issues in sarcoidosis. Curr Rheumatol Rep. Jun;
13(3):265-72.
Taiwo OA, Slade MD, Cantley LF, Fiellin MG, Wesdock JC, Bayer FJ,
Cullen MR. (2008) Beryllium Sensitization in Aluminum Smelter
Workers. JOEM 50(2):157-162.
Taiwo OA, Slade MD, Cantley LF, Kirsche SR, Wesdock JC, Cullen MR.
(2010) Prevalence of beryllium sensitization among aluminum smelter
workers. Occup Med 60:569-571.
Tan MH, Commens CA, Burnett L, Snitch PJ. (1996) A pilot study on
the percutaneous absorption of microfine titanium dioxide from
sunscreens. Australas J Dermatol. Nov; 37(4):185-7.
Tarantino-Hutchison LM, Sorrentino C, Nadas A, Zhu Y, Rubin EM,
Tinkle SS, Weston A, Gordon T (2009). Genetic determinants of
sensitivity to beryllium in mice. J Immunotoxicol. 6 (2):130-135.
Thomas CA, Bailey RL, Kent MS, Deubner DC, Kreiss K, Schuler CR.
(2009) Efficacy of a program to prevent beryllium sensitization
among new employees at a copper-beryllium alloy processing facility.
Public Health Rep. Jul-Aug; 124 Suppl 1:112-24.
Thaler, R., and S. Rosen, 1976. ``The Value of Saving a Life:
Evidence from the Labor Market,'' in Household Production and
Consumption, N E. Terleckyj (ed.), New York: Columbia University
Press, 1976, pp. 265-298.
Thomas CA, Bailey RL, Kent MS, Deubner DC, Kreiss K, Schuler CR.
(2009) Efficacy of a Program to Prevent Beryllium Sensitization
Among New Employees at a Copper-Beryllium Alloy Processing Facility.
Public Health Rep.124 Suppl 1:112-24.
Thorat DD, Mahadevan TN, Ghosh DK. (2003) Particle size distribution
and respiratory deposition estimates of beryllium aerosols in an
extraction and processing plant. Am Ind Hyg Assoc J. 64 (4):522-527.
Tinkle SS, Newman LS. (1997) Beryllium-stimulated release of tumor
necrosis factor-alpha, IL-6 and their soluble receptors in chronic
beryllium disease. Am J Respir Crit Care Med. Dec; 156 (6):1884-91.
Tinkle SS, Kittle LA, Schumacher BA, Newman LS. (1997) Beryllium
induces IL-2 and IFN-gamma in berylliosis. J Immunol. Jan 1;
158(1):518-26.
Tinkle S, Kittle L, Schwitters PW, Addison JR, Newman LS. (1996)
Beryllium stimulates release of T helper 1 cytokines interleukin-2
and interferon gamma from BAL cells in chronic beryllium disease.
Chest; 109 (Suppl 3):5S-6S.
Tinkle SS, Antonini JM, Rich BA, Roberts JR, Salmen R, DePree K,
Adkins EJ. (2003) Skin as a route of exposure and sensitization in
chronic beryllium disease. Environ Health Perspect. Jul;
111(9):1202-8.
Toledo, F., Silvestre, J. F., Cuesta, L., Latorre, N., & Monteagudo,
A. (2011). Contact allergy to beryllium chloride: Report of 12
cases. Contact dermatitis, 64(2), 104-109.
Torres, S.J., & Nowson, C.A. (2007). Relationship between stress,
eating behavior, and obesity. Nutrition, 23, 887-94.
Trikudanathan S, McMahon GT. (2008). Optimum management of
glucocorticoid-treated patients. Nat Clin Pract Endocrinol Metab.
May; 4(5):262-71.
Tso WW, Fung WP. (1981) Mutagencity of metallic cations. Toxicol
Lett. 8 (4-5); 195-200.
Turk J.L. and Polak L. (1969) Experimental studies on metal
dermatitis in guinea pigs. Int Arch Allergy Appl Immunol. 36(1):75-
81.
U.S. Census Bureau. (2010). Income, Poverty, and Health Insurance
Coverage in the United States: 2008, Current Population Reports,
P60-236(RV), and Historical Tables--Table P-1, September 2009.
Internet release date: December 15, 2010. Available at: https://www.census.gov/hhes/www/income/data/historical/people/.
[USGS] United States Geological Survey. (2013a). 2011 Minerals
Yearbook: Beryllium [Advance Release]. Available at: https://minerals.usgs.gov/minerals/pubs/commodity/beryllium/myb1-2011-beryl.pdf.
[USGS] United States Geological Survey. (2013b). Mineral Commodity
Summaries. [Online]. Available at https://minerals.usgs.gov/minerals/pubs/mcs/2013/mcs2013.pdf.
Vacher J. (1972) Immunological response of guinea pigs to beryllium
salts. J Med Microbiol. Feb; 5(1):91-108.
Van Cleave C.D., Kaylor C.T. (1955) Distribution, retention, and
elimination of Be in the rat after intratracheal injection. Archives
of industrial health, 11:375-392.
Van Dyke M.V., Martyny J.W., Mroz M.M., Silveira L.J., Strand M.,
Fingerlin T.E., Sato H., Newman L.S., Maier L.A. (2011) Risk of
chronic beryllium disease by HLA-DPB1 E69 genotype and beryllium
exposure in nuclear workers. Am J Respir Crit Care Med 183
(12):1680-1688.
Van Ordstrand H., Hughes R., Carmody M.G. (1943). Chemical Pneumonia
in Workers Extracting Beryllium Oxide. Archives of the Cleveland
Clinic Quarterly. The Cleveland Clinic Foundation. (1984) 51(2):
431-439. (originally in Cleveland Clinic Quarterly 10:10-18, 1943).
Van Ordstrand H., Hughes R., DeNardi J.M., et al. (1945). Beryllium
poisoning. J Am Med Assoc129:1084-1090.
[[Page 47819]]
Vainio H., Rice J. Beryllium revisted. (1997) J Occup Environ Med
39:203-204.
Vegni-Talluri M. and Guiggiani V. (1967) Action of beryllium ions on
primary cultures of swine cells. Carlogia 20:355-367.
Viet S.M., Torma-Krajewski J., Rogers J. (2000) Chronic beryllium
disease and beryllium sensitization at Rocky Flats: A case-control
study. Am Ind Hyg Assoc J 61:244-254.
Virji M.A., Stefaniak A.B., Day G.A., Stanton M.L., Kent M.S.,
Kreiss K., Schuler C.R. (2011). Characteristics of Beryllium
Exposure to Small Particles At A Beryllium Production Facility. Ann
Occup Hyg; 55 (1):70-85.
Virji M.A., Park J.Y., Stefaniak A.B., Stanton M.L., Day G.A., Kent
M.S., Kreiss K., Schuler C.R. (2012) Sensitization and chronic
beryllium disease at a primary manufacturing facility, part 1:
Historical exposure reconstruction. Scand J Work Environ Health; 38
(3):247-258.
Viscusi, W. and J. Aldy, 2003. ``The Value of a Statistical Life: A
Critical Review of Market Estimates Throughout the World,'' Journal
of Risk and Uncertainty, 27, pp. 5-76.
Votto J.J., Barton R.W., Gionfriddo M.A., Cole S.R., McCormick J.R.,
and Thrall R.S. (1987) A model of pulmonary granulomata induced by
beryllium sulfate in the rat. Sarcoidosis 4(1):71-76.
Vorwald A.J. (1968) Biologic manifestations of toxic inhalants in
monkeys. In: Vagrborg H., ed. Use of Nonhuman primates in drug
evaluation: A symposium. Southwest Foundation for Research and
Education. Austin, Texas: University of Texas Press, 222-228.
Vorwald A.J., Reeves A.L. (1959) Pathologic changes induced by
beryllium compounds. Arch Ind Health 19:190-199.
Vourlekis J.A., R.T. Sawyer, L.S. Newman. (2000) Sarcoidosis:
Developments in etiology, immunology, and therapeutics. Adv Intern
Med; 45:209-257.
Wagoner J., Infante P., Bayliss D. (1980) Beryllium: An etiologic
agent in the induction of lung cancer, nonneoplastic respiratory
disease and heart disease among industrially exposed workers.
Environ Res 21:15-34.
Wagner W.D., Groth D.H., Holtz J.L., Madden G.E., and Stokinger H.E.
(1969) Comparative chronic inhalation toxicity of beryllium ores,
bertrandite and beryl, with production of pulmonary tumors by beryl.
Toxicology and Applied Pharmacology 15:10-29.
Ward E., Okun A., Ruder A., Fingerhut M., Steenland K. (1992) A
mortality study of workers at seven beryllium processing plants. Am
J Ind Med 22:885-904.
Warrington T.P., Bostwick J.M. (2006). Psychiatric adverse effects
of corticosteroids. Mayo Clin Proc. Oct; 81(10):1361-7.
Warheit D.B., Yuen I.S., Kelly D.P., Snajdr S., Hartsky M.A. (1996)
Subchronic inhalation of high concentrations of low toxicity, low
solubility particulates produces sustained pulmonary inflammation
and cellular proliferation. Toxicol Lett. Nov; 88(1-3):249-53.
Weston A., Snyder J., McCanlies E.C., Schuler C.R., Andrew M.E.,
Kreiss K., Demchuk E. (2005) Immunogenetic factors in beryllium
sensitization and chronic beryllium disease. Mutat Res 592 (1-2):68-
78.
Williams W.J. and Williams W.R. (1983) Value of beryllium lymphocyte
transformation tests in chronic beryllium disease and in potentially
exposed workers. Thorax. Jan; 38(1):41-4.
[WHO] World Health Organization. (1990). International Programme on
Chemical Safety (IPCS 1990). Beryllium: Health and safety guide. No.
44. [online]. Available at: https://www.inchem.org/documents/hsg/hsg/hsg044.htm#SectionNumber:7.3.
[WHO] World Health Organization. (2001). Concise International
Chemical Assessment Document (CICAD) 32 Beryllium and Beryllium
compounds.
Winchester M.R., et al. (2009). Certification of beryllium mass
fraction in SRM 1877 Beryllium Oxide Powder using high-performance
inductively-coupled plasma optical emission spectrometry with exact
matching. Analytical Chemistry. 81:2208-2217.
Wolf G. (2002). Glucocorticoids in adipocytes stimulate visceral
obesity. Nutr Rev. May; 60(5 Pt 1):148-51.
Yeh H.C., Cuddihy R.G., Phalen R.F., Chang I.Y. (1996) Comparison of
calculated respiratory tract deposition of particles based on the
proposed NCRP model and the new ICRP 66 model. Aerosol Sci Techn;
25:134-140.
Yoshida T., Shima S., Nagaoka K., Taniwaki H., Wada A., Kurita H.,
Morita K. (1997) A study on the beryllium lymphocyte transformation
test and the beryllium levels in working environment. Ind Health
35:374-379.
Yucesoy B., Johnson V.J. (2011) Genetic variability in
susceptibility to occupational respiratory sensitization. J Allergy;
2011, 346719:1-7.
Zaki M.H., Lyons H.A., Leilop L., Huang C.T. (1987) Corticosteroid
therapy in sarcoidosis. A five-year, controlled follow-up study. NY
State J Med. Sep; 87(9):496-9.
Zakour R.A., Glickman B.W. (1984) Metal-induced mutagenesis in the
lacI gene of Escherichia coli. Mutation research, 126:9-18.
Zissu D., Binet S., Cavelier C. (1996) Patch testing with beryllium
alloy samples in guinea pigs. Contact Dermatitis. Mar; 34(3):196-
200.
Zorn, H., Stiefel, T., & Diem, H. (1977). The importance of
beryllium and its compounds for the industrial physician-2.
communication. Zentralblatt f[uuml]r Arbeitsmedizin, Arbeitsschutz
und Prophylaxe, 27(4), 8.
List of Subjects in 29 CFR Part 1910
Cancer, Chemicals, Hazardous substances, Health, Occupational
safety and health, Reporting and recordkeeping requirements.
Authority and Signature
David Michaels, Ph.D., MPH, Assistant Secretary of Labor for
Occupational Safety and Health, U.S. Department of Labor, 200
Constitution Avenue NW., Washington, DC 20210, directed the preparation
of this notice. OSHA is issuing this notice under Sections 4, 6, and 8
of the Occupational Safety and Health Act of 1970 (29 U.S.C. 653, 655,
657); section 41 of the Longshore and Harbor Worker's Compensation Act
(33 U.S.C. 941); section 107 of the Contract Work Hours and Safety
Standards Act (Construction Safety Act) (40 U.S.C. 3704); Secretary of
Labor's Order 1-2012 (77 FR 3912, January 25, 2012); and 29 CFR part
1911.
Signed at Washington, DC, on July 14, 2015.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.
Proposed Standard
Chapter XVII of Title 29 of the Code of Federal Regulations is
proposed to be amended as follows:
PART 1910--OCCUPATIONAL SAFETY AND HEALTH STANDARDS
Subpart Z--Toxic and Hazardous Substances
0
1. The authority citation for subpart Z of part 1910 is revised to read
as follows:
Authority: Sections 4, 6, 8 of the Occupational Safety and
Health Act of 1970 (29 U.S.C. 653, 655, 657); Secretary of Labor's
Order No. 8-76 (41 FR 25059), 9-83 (48 FR 35736), 1-90 (55 FR 9033),
6-96 (62 FR 111), 3-2000 (65 FR 50017), 5-2002 (67 FR 65008), 5-2007
(72 FR 31159), 4-2010 (75 FR 55355), or 1-2012 (77 FR 3912), as
applicable; and 29 CFR part 1911.
All of subpart Z issued under section 6(b) of the Occupational
Safety and Health Act of 1970, except those substances that have
exposure limits listed in Tables Z-1, Z-2, and Z-3 of 29 CFR
1910.1000. The latter were issued under section 6(a) (29 U.S.C.
655(a)).
Section 1910.1000, Tables Z-1, Z-2 and Z-3 also issued under 5
U.S.C. 553, but not under 29 CFR part 1911 except for the arsenic
(organic compounds), benzene, cotton dust, and chromium (VI)
listings.
Section 1910.1001 also issued under section 107 of the Contract
Work Hours and Safety Standards Act (40 U.S.C. 3704) and 5 U.S.C.
553.
Section 1910.1002 also issued under 5 U.S.C. 553, but not under
29 U.S.C. 655 or 29 CFR part 1911.
Sections 1910.1018, 1910.1029, and 1910.1200 also issued under
29 U.S.C. 653. Section 1910.1030 also issued under Pub. L. 106-430,
114 Stat. 1901.
[[Page 47820]]
Sec. 1910.1000 [Amended]
0
2. In Sec. 1910.1000:
0
a. Table Z-1 is amended by revising the entry for ``Beryllium and
beryllium compounds (as Be)''; and by adding footnote ``W''; and
0
b. Table Z-2 is amended by adding footnote ``Y''.
The revisions and additions read as follows:
Table Z-1--Limits for Air Contaminants
----------------------------------------------------------------------------------------------------------------
ppm (a) mg/m\3\ (b) Skin
Substance CAS No. (c) \1\ \1\ designation
----------------------------------------------------------------------------------------------------------------
* * * * * * *
Beryllium and beryllium compounds (as Be); see
1910.1024 \W\........................................
* * * * * * *
----------------------------------------------------------------------------------------------------------------
\1\ The PELs are 8-hour TWAs unless otherwise noted; a (C) designation denotes a ceiling limit. They are to be
determined from breathing-zone air samples.
a. Parts of vapor or gas per million parts of contaminated air by volume at 25 [deg]C and 760 torr.
b. Milligrams of substance per cubic meter of air. When entry is in this column only, the value is exact; when
listed with a ppm entry, it is approximate.
c. The CAS number is for information only. Enforcement is based on the substance name. For an entry covering
more than one metal compound, measured as the metal, the CAS number for the metal is given--not CAS numbers
for the individual compounds.
d. The final benzene standard in Sec. 1910.1028 applies to all occupational exposures to benzene except in
some circumstances the distribution and sale of fuels, sealed containers and pipelines, coke production, oil
and gas drilling and production, natural gas processing, and the percentage exclusion for liquid mixtures; for
the excepted subsegments, the benzene limits in Table Z-2 apply. See Sec. 1910.1028 for specific
circumstances.
e. This 8-hour TWA applies to respirable dust as measured by a vertical elutriator cotton dust sampler or
equivalent instrument. The time-weighted average applies to the cottom waste processing operations of waste
recycling (sorting, blending, cleaning and willowing) and garnetting. See also Sec. 1910.1043 for cotton
dust limits applicable to other sectors.
f. All inert or nuisance dusts, whether mineral, inorganic, or organic, not listed specifically by substance
name are covered by the Particulates Not Otherwise Regulated (PNOR) limit which is the same as the inert or
nuisance dust limit of Table Z-3.
* * * * * * *
\W\ See Table Z-2 for the exposure limits for any operations or sectors for which the exposure limits in Sec.
1910.1024 are not in effect.
Table Z-2
----------------------------------------------------------------------------------------------------------------
Acceptable maximum peak above the
8-hour time Acceptable acceptable ceiling average concentration
Substance weighted ceiling for an 8-hr shift
average concentration ------------------------------------------
Concentration Maximum duration
----------------------------------------------------------------------------------------------------------------
* * * * * * *
Beryllium and beryllium compounds (as 2 [mu]g/m\3\ 5 [mu]g/m\3\ 25[mu]g/m\3\ 30 minutes
Be) \Y\.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * * *
\Y\ This standard applies to any operations or sectors for which the Beryllium standard, 1910.1024, is not in
effect.
0
3. Section 1910.1024 is added to subpart Z to read as follows:
Sec. 1910.1024 Beryllium
(a) Scope and application. (1) This section applies to occupational
exposures to beryllium in all forms, compounds, and mixtures in general
industry, except those articles and materials exempted by paragraphs
(a)(2) and (3) of this section.
(2) This section does not apply to articles, as defined in the
Hazard Communication standard (HCS) (29 CFR 1910.1200(c)), that contain
beryllium and that the employer does not process.
(3) This section does not apply to materials containing less than
0.1% beryllium by weight.
(b) Definitions.
Action level means a concentration of airborne beryllium of 0.1
micrograms per cubic meter of air ([mu]g/m\3\) calculated as an 8-hour
time-weighted average (TWA).
Assistant Secretary means the Assistant Secretary of Labor for
Occupational Safety and Health, United States Department of Labor, or
designee.
Beryllium lymphocyte proliferation test (BeLPT) means the
measurement of blood lymphocyte proliferation in a laboratory test when
lymphocytes are challenged with a soluble beryllium salt. A confirmed
positive test result indicates the person has beryllium sensitization.
Beryllium work area means any work area where employees are, or can
reasonably be expected to be, exposed to airborne beryllium, regardless
of the level of exposure.
CBD Diagnostic Center means a medical diagnostic center that has
on-site facilities to perform a clinical evaluation for the presence of
chronic beryllium disease (CBD) that includes bronchoalveolar lavage,
transbronchial biopsy and interpretation of the biopsy pathology, and
the beryllium bronchoalveolar lavage lymphocyte proliferation test
(BeBALLPT).
Chronic beryllium disease (CBD) means a chronic lung disease
associated with exposure to airborne beryllium.
Confirmed Positive means two abnormal test results from either
consecutive BeLPTs or a second abnormal BeLPT result within a 2-year
period of the first abnormal test result. It also means the result of a
more reliable and accurate test indicating a
[[Page 47821]]
person has been identified as having beryllium sensitization.
Director means the Director of the National Institute for
Occupational Safety and Health (NIOSH), U.S. Department of Health and
Human Services, or designee.
Emergency means any uncontrolled release of airborne beryllium.
Exposure and exposure to beryllium mean the exposure to airborne
beryllium that would occur if the employee were not using a respirator.
High-efficiency particulate air (HEPA) filter means a filter that
is at least 99.97 percent efficient in removing particles 0.3
micrometers in diameter.
Physician or other licensed health care professional (PLHCP) means
an individual whose legally permitted scope of practice (i.e., license,
registration, or certification) allows the individual to independently
provide or be delegated the responsibility to provide some or all of
the health care services required by paragraph (k) of this standard.
Regulated area means an area that the employer must demarcate,
including temporary work areas where maintenance or non-routine tasks
are performed, where an employee's exposure exceeds, or can reasonably
be expected to exceed, either of the permissible exposure limits
(PELs).
This standard means this beryllium standard, 29 CFR 1910.1024.
(c) Permissible Exposure Limits (PELs). (1) Time-weighted average
(TWA) PEL. The employer shall ensure that each employee's exposure does
not exceed 0.2 [mu]g/m\3\ calculated as an 8-hour TWA.
(2) Short-term exposure limit (STEL). The employer shall ensure
that each employee's exposure does not exceed 2.0 [mu]g/m\3\ as
determined over a sampling period of 15 minutes.
(d) Exposure monitoring--(1) General. (i) These exposure monitoring
requirements apply when employees are, or may reasonably be expected to
be, exposed to airborne beryllium.
(ii) Except as provided in paragraphs (d)(2)(i) and (ii) of this
section, the employer shall determine the 8-hour TWA exposure for each
employee based on one or more breathing zone samples that reflect the
exposure of employees on each work shift, for each job classification,
in each beryllium work area.
(iii) Except as provided in paragraph (d)(2)(i) and (ii) of this
section, the employer shall determine short-term exposure from 15-
minute breathing zone samples measured in operations that are likely to
produce exposures above the STEL for each work shift, for each job
classification, and in each beryllium work area.
(iv) The employer may perform representative sampling to
characterize exposure, provided that the employer:
(A) Performs representative sampling where several employees
perform the same job tasks, in the same job classification, on the same
work shift, and in the same work area, and have similar duration and
frequency of exposure;
(B) Takes sufficient personal breathing zone air samples to
accurately characterize exposure on each work shift, for each job
classification, in each work area; and
(C) Samples those employee(s) who are expected to have the highest
exposure.
(v) Accuracy of measurement. The employer shall use a method of
exposure monitoring and analysis that can measure beryllium to an
accuracy of plus or minus 25 percent within a statistical confidence
level of 95 percent for airborne concentrations at or above the action
level.
(2) Initial exposure monitoring. The employer shall conduct initial
exposure monitoring to determine the 8-hour TWA exposure and 15-minute
short-term exposure for each employee. The employer does not have to
conduct initial exposure monitoring in the following situations:
(i) Where the employer has conducted exposure monitoring for
beryllium and relies on these historical data, provided that:
(A) The work operations and workplace conditions that were in place
when the historical monitoring data were obtained reflect workplace
conditions closely resembling the processes, material, control methods,
work practices, and environmental conditions used and prevailing in the
employer's current operations;
(B) The characteristics of the beryllium-containing material being
handled when the historical monitoring data were obtained closely
resemble the characteristics of the beryllium-containing material used
during the job for which initial monitoring will not be performed; and
(C) The exposure monitoring satisfied all other requirements of
this section, including Accuracy of Measurement in paragraph (d)(1)(v).
(ii) Where the employer relies on objective data to satisfy initial
monitoring requirements, provided that such data:
(A) Demonstrate that any material containing beryllium or any
specific process, operation, or activity involving beryllium cannot
release beryllium dust, fumes, or mist in concentrations at or above
the action level or above the STEL under any expected conditions of
use; and
(B) Reflect workplace conditions closely resembling the processes,
material, control methods, work practices, and environmental conditions
used and prevailing in the employer's current operations.
(3) Periodic exposure monitoring. If initial exposure monitoring
indicates that exposures are at or above the action level and at or
below the TWA PEL, the employer shall conduct periodic exposure
monitoring at least annually in accordance with paragraph (d)(1) of
this section.
(4) Additional monitoring. The employer also shall conduct exposure
monitoring within 30 days after any of the following situations occur:
(i) Any change in production processes, equipment, materials,
personnel, work practices, or control methods that can reasonably be
expected to result in new or additional exposure; or
(ii) The employer has any other reason to believe that new or
additional exposure is occurring.
(5) Employee notification of monitoring results. (i) Within 15
working days after receiving the results of any exposure monitoring
completed under this standard, the employer shall notify each employee
whose exposure is measured or represented by the monitoring
individually in writing of the monitoring results or shall post the
monitoring results in an appropriate location that is accessible to
each of these employees.
(ii) Where exposures exceed the TWA PEL or STEL, the written
notification required by paragraph (d)(5)(i) of this section shall
include suspected or known sources of exposure and the corrective
action(s) the employer has taken or will take to reduce exposure to or
below the PELs, where feasible corrective action exists but had not
been implemented when the monitoring was conducted.
(6) Observation of monitoring. (i) The employer shall provide an
opportunity to observe any exposure monitoring required by this
standard to each employee whose exposures are measured or represented
by the monitoring and each employee's representative(s).
(ii) When observation of monitoring requires entry into an area
where the use of protective clothing or equipment (which may include
respirators) is required, the employer shall provide each observer with
appropriate protective clothing and equipment at no
[[Page 47822]]
cost to the observer and shall ensure that each observer uses such
clothing and equipment.
(iii) The employer shall ensure that each observer complies with
all applicable OSHA requirements and the employer's workplace safety
and health procedures.
(e) Beryllium work areas and regulated areas--(1) Establishment.
(i) The employer shall establish and maintain a beryllium work area
wherever employees are, or can reasonably be expected to be, exposed to
airborne beryllium, regardless of the level of exposure.
(ii) The employer shall establish and maintain a regulated area
wherever employees are, or can reasonably be expected to be, exposed to
airborne beryllium at levels above the TWA PEL or STEL.
(2) Demarcation. (i) The employer shall identify each beryllium
work area through signs or any other methods that adequately establish
and inform each employee of the boundaries of each beryllium work area.
(ii) The employer shall identify each regulated area in accordance
with paragraph (m)(2) of this section.
(3) Access.The employer shall limit access to regulated areas to:
(i) Persons the employer authorizes or requires to be in a
regulated area to perform work duties;
(ii) Persons entering a regulated area as designated
representatives of employees for the purpose of exercising the right to
observe exposure monitoring procedures under paragraph (d)(6) of this
section; and
(iii) Persons authorized by law to be in a regulated area.
(4) Provision of personal protective clothing and equipment,
including respirators. The employer shall provide and ensure that each
employee entering a regulated area uses:
(i) Respiratory protection in accordance with paragraph (g) of this
section; and
(ii) Personal protective clothing and equipment in accordance with
paragraph (h) of this section.
(f) Methods of compliance--(1) Written exposure control plan.
(i) The employer shall establish, implement, and maintain a written
exposure control plan for beryllium work areas, which shall contain:
(A) An inventory of operations and job titles reasonably expected
to have exposure;
(B) An inventory of operations and job titles reasonably expected
to have exposure at or above the action level;
(C) An inventory of operations and job titles reasonably expected
to have exposure above the TWA PEL or STEL;
(D) Procedures for minimizing cross-contamination, including but
not limited to preventing the transfer of beryllium between surfaces,
equipment, clothing, materials, and articles within beryllium work
areas;
(E) Procedures for keeping surfaces in the beryllium work area as
free as practicable of beryllium;
(F) Procedures for minimizing the migration of beryllium from
beryllium work areas to other locations within or outside the
workplace;
(G) An inventory of engineering and work practice controls required
by paragraph (f)(2) of this standard; and
(H) Procedures for removal, laundering, storage, cleaning,
repairing, and disposal of beryllium-contaminated personal protective
clothing and equipment, including respirators.
(ii) The employer shall update the exposure control plan when:
(A) Any change in production processes, materials, equipment,
personnel, work practices, or control methods results or can reasonably
be expected to result in new or additional exposures to beryllium;
(B) An employee is confirmed positive, is diagnosed with CBD, or
shows signs or symptoms associated with exposure; or
(C) The employer has any reason to believe that new or additional
exposures are occurring or will occur.
(iii) The employer shall make a copy of the exposure control plan
accessible to each employee who is or can reasonably be expected to be
exposed to airborne beryllium in accordance with OSHA's Access to
Employee Exposure and Medical Records (Records Access) standard (29 CFR
1910.1020(e)).
(2) Engineering and work practice controls. (i) (A) For each
operation in a beryllium work area, the employer shall ensure that at
least one of the following engineering and work practice controls is in
place to minimize employee exposure:
(1) Material and/or process substitution;
(2) Ventilated partial or full enclosures;
(3) Local exhaust ventilation at the points of operation, material
handling, and transfer; or
(4) Process control, such as wet methods and automation.
(B) An employer is exempt from using the above controls to the
extent that:
(1) The employer can establish that such controls are not feasible;
or
(2) The employer can demonstrate that exposures are below the
action level, using no fewer than two representative personal breathing
zone samples taken 7 days apart, for each affected operation.
(ii) If after implementing the control(s) required by (f)(2)(i)(A)
exposures exceed the TWA PEL or STEL, the employer shall implement
additional or enhanced engineering and work practice controls to reduce
exposures to or below the PELs.
(iii) Wherever the employer demonstrates that it is not feasible to
reduce exposures to or below the PELs by the engineering and work
practice controls required by paragraphs (f)(2)(i) and (ii) of this
section, the employer shall implement and maintain engineering and work
practice controls to reduce exposures to the lowest levels feasible and
supplement these controls by using respiratory protection in accordance
with paragraph (g) of this section.
(3) Prohibition of rotation. The employer shall not rotate
employees to different jobs to achieve compliance with the PELs.
(g) Respiratory protection--(1) General. The employer shall provide
at no cost and ensure that each employee uses respiratory protection
during:
(i) Periods necessary to install or implement feasible engineering
and work practice controls where exposures exceed or can reasonably be
expected to exceed the TWA PEL or STEL;
(ii) Operations, including maintenance and repair activities and
non-routine tasks, when engineering and work practice controls are not
feasible and exposures exceed or can reasonably be expected to exceed
the TWA PEL or STEL;
(iii) Work operations for which an employer has implemented all
feasible engineering and work practice controls when such controls are
not sufficient to reduce exposure to or below the TWA PEL or STEL;
(iv) Emergencies.
(2) Respiratory protection program. Where this standard requires an
employee to use respiratory protection, such use shall be in accordance
with the Respiratory Protection Standard (29 CFR 1910.134).
(h) Personal protective clothing and equipment--(1) Provision and
use. The employer shall provide at no cost and ensure that each
employee uses appropriate personal protective clothing and equipment in
accordance with the written exposure control plan required under
paragraph (f)(1) of this section and OSHA's Personal Protective
Equipment standards (29 CFR part 1910 subpart I):
(i) Where employee exposure exceeds or can reasonably be expected
to exceed the TWA PEL or STEL;
(ii) Where employees' clothing or skin may become visibly
contaminated with
[[Page 47823]]
beryllium including during maintenance and repair activities or during
non-routine tasks; or
(iii) Where employees' skin can reasonably be expected to be
exposed to soluble beryllium compounds.
(2) Removal and storage. (i) The employer shall ensure that each
employee removes all beryllium-contaminated protective clothing and
equipment:
(A) At the end of the work shift or at the completion of tasks
involving beryllium, whichever comes first, or
(B) When protective clothing or equipment becomes visibly
contaminated with beryllium.
(ii) The employer shall ensure that each employee removes
protective clothing visibly contaminated with beryllium as specified in
the exposure control plan required by paragraph (f)(1) of this section.
(iii) The employer shall ensure that each employee stores and keeps
required protective clothing separate from street clothing.
(iv) The employer shall ensure that no employee removes beryllium-
contaminated protective clothing or equipment from the workplace,
except for employees authorized to do so for the purposes of
laundering, cleaning, maintaining or disposing of beryllium-
contaminated protective clothing and equipment at an appropriate
location or facility away from the workplace.
(v) When protective clothing or equipment required by this standard
is removed from the workplace for laundering, cleaning, maintenance or
disposal, the employer shall ensure that protective clothing and
equipment are stored and transported in sealed bags or other closed
containers that are impermeable and are labeled in accordance with
paragraph (m)(3) of this section and the HCS (29 CFR 1910.1200).
(3) Cleaning and replacement. (i) The employer shall ensure that
all reusable protective clothing and equipment required by this
standard is cleaned, laundered, repaired, and replaced as needed to
maintain its effectiveness.
(ii) The employer shall ensure that beryllium is not removed from
protective clothing and equipment by blowing, shaking or any other
means that disperses beryllium into the air.
(iii) The employer shall inform in writing the persons or the
business entities who launder, clean or repair the protective clothing
or equipment required by this standard of the potentially harmful
effects of exposure to airborne beryllium and contact with soluble
beryllium compounds and that the protective clothing and equipment must
be handled in accordance with this standard.
(i) Hygiene areas and practices--(1) General. For each employee
working in a beryllium work area, the employer shall:
(i) Provide readily accessible washing facilities to remove
beryllium from the hands, face, and neck; and
(ii) Ensure each employee exposed to beryllium to use these
facilities when necessary.
(2) Change rooms. In addition to the requirements of paragraph
(i)(1)(i) of this section, the employer shall provide affected
employees with a designated change room and washing facilities in
accordance with this standard and the Sanitation Standard (29 CFR
1910.141) where employees are required to remove their personal
clothing.
(3) Showers. (i) The employer shall provide showers in accordance
with the Sanitation standard (29 CFR 1910.141) where:
(A) Exposure exceeds or can reasonably be expected to exceed the
TWA PEL or STEL; and
(B) Beryllium can reasonably be expected to contaminate employees'
hair or body parts other than hands, face, and neck.
(ii) Employers required to provide showers under paragraph
(i)(3)(i) of this section shall ensure that each employee showers at
the end of the work shift or work activity if:
(A) The employee reasonably could have been exposed above the TWA
PEL or STEL; and
(B) Beryllium could reasonably have contaminated the employee's
hair or body parts other than hands, face, and neck.
(4) Eating and drinking areas. Whenever the employer allows
employees to consume food or beverages in a beryllium work area, the
employer shall ensure that:
(i) Surfaces in eating and drinking areas are as free as
practicable of beryllium;
(ii) No employee in eating and drinking areas is exposed to
airborne beryllium at or above the action level; and
(iii) Eating and drinking facilities provided by the employer are
in accordance with the Sanitation standard (29 CFR 1910.141).
(5) Prohibited activities. (i) The employer shall ensure that no
employees eat, drink, smoke, chew tobacco or gum, or apply cosmetics in
regulated areas.
(ii) The employer shall ensure that no employees enter any eating
or drinking area with protective work clothing or equipment unless
surface beryllium has been removed from the clothing or equipment by
methods that do not disperse beryllium into the air or onto an
employee's body.
(j) Housekeeping--(1) General. (i) The employer shall maintain all
surfaces in beryllium work areas as free as practicable of
accumulations of beryllium and in accordance with the exposure control
plan required under paragraph (f)(1) of this section and the cleaning
methods required under paragraph (j)(2) of this section; and
(ii) The employer shall ensure that all spills and emergency
releases of beryllium are cleaned up promptly and in accordance with
the exposure control plan required under paragraph (f)(1) of this
section and the cleaning methods required under paragraph (j)(2) of
this section.
(2) Cleaning methods. (i) The employer shall ensure that surfaces
in beryllium work areas are cleaned by HEPA-filter vacuuming or other
methods that minimize the likelihood and level of exposure.
(ii) The employer shall not allow dry sweeping or brushing for
cleaning surfaces in beryllium work areas unless HEPA-filtered
vacuuming or other methods that minimize the likelihood and level of
exposure have been tried and were not effective.
(iii) The employer shall not allow the use of compressed air for
cleaning beryllium-contaminated surfaces unless the compressed air is
used in conjunction with a ventilation system designed to capture the
particulates made airborne by the use of compressed air.
(iv) Where employees use dry sweeping, brushing, or compressed air
to clean beryllium-contaminated surfaces, the employer shall provide
and ensure that each employee uses respiratory protection and
protective clothing and equipment in accordance with paragraphs (g) and
(h) of this section.
(v) The employer shall ensure that cleaning equipment is handled
and maintained in a manner that minimizes the likelihood and level of
employee exposure and the re-entrainment of airborne beryllium in the
workplace.
(3) Disposal. The employer shall ensure that:
(i) Waste, debris, and materials visibly contaminated with
beryllium and consigned for disposal are disposed of in sealed,
impermeable enclosures, such as bags or containers;
(ii) Bags or containers of waste, debris, and materials required by
(j)(3)(i) of this section are labeled in accordance with paragraph
(m)(3) of this section; and
[[Page 47824]]
(iii) Materials designated for recycling that are visibly
contaminated with beryllium shall be cleaned to remove visible
particulate, or placed in sealed, impermeable enclosures, such as bags
or containers, that are labeled in accordance with paragraph (m)(3) of
this section.
(k) Medical surveillance--(1) General. (i) The employer shall make
medical surveillance as required by this paragraph available at no cost
to the employee, and at a reasonable time and place, as follows:
(A) For each employee who has worked in a regulated area for more
than 30 days in the last 12 months;
(B) For each employee showing signs or symptoms of CBD, such as
shortness of breath after a short walk or climbing stairs, persistent
dry cough, chest pain, or fatigue;
(C) For each employee exposed to beryllium during an emergency; and
(D) For each employee who was exposed to airborne beryllium above
.2 [mu]g/m\3\ for more than 30 days in a 12-month period for 5 years or
more, limited to the procedures described in paragraph (k)(3)(ii)(F) of
this section unless the employee also qualifies for an examination
under paragraph (k)(1)(i)(A), (B), or (C) of this section.
(ii) The employer shall ensure that all medical examinations and
procedures required by this standard are performed by or under the
direction of a licensed physician.
(2) Frequency. The employer shall provide a medical examination:
(i) Within 30 days after determining that:
(A) An employee meets the criteria of paragraph (k)(1)(i)(A) of
this section, unless the employee has received a medical examination,
provided in accordance with this standard, within the last 12 months;
or
(B) An employee meets the criteria of paragraph (k)(1)(i)(B) or (C)
of this section.
(ii) Annually thereafter for each employee who continues to meet
the criteria of paragraph (k)(1)(i)(A) or (B) of this section; and
(iii) At the termination of employment for each employee who meets
the criteria of paragraph (k)(1)(i)(A), (B), or (C) of this section at
the time the employee's employment is terminated, unless an examination
has been provided in accordance with this standard during the 6 months
prior to the date of termination.
(3) Contents of examination. (i) The employer shall ensure that the
PLHCP advises the employee of the risks and benefits of participating
in the medical surveillance program and the employee's right to opt out
of any or all parts of the medical examination.
(ii) The employer shall ensure that the employee is offered a
medical examination that includes:
(A) A medical and work history, with emphasis on past and present
exposure, smoking history, and any history of respiratory system
dysfunction;
(B) A physical examination with emphasis on the respiratory tract;
(C) A physical examination for skin breaks and wounds;
(D) Pulmonary function tests, performed in accordance with the
guidelines established by the American Thoracic Society including
forced vital capacity and forced expiratory volume at one (1) second
(FEV1);
(E) (1) A standardized BeLPT upon the first examination and within
every 2 years from the date of the first examination until the employee
is confirmed positive. If a more reliable and accurate diagnostic test
is developed after [EFFECTIVE DATE OF FINAL RULE] of this standard such
that beryllium sensitization can be confirmed after one test, a second
confirmation test need not be performed.
(2) If an employee who has not been confirmed positive receives an
abnormal BeLPT result, a second BeLPT is to be performed within 1
month. This requirement for a second test is waived if a more reliable
and accurate test for beryllium sensitization does not need to be
repeated due to variability, repeatability and accuracy of the test
methodology.
(F) Each employee who meets the criteria of paragraph (k)(1)(i)(D)
shall be offered a low dose helical tomography (CT Scan). The CT Scan
shall be offered every 2 years for the duration of the employee's
employment. This obligation begins on the [EFFECTIVE DATE OF FINAL
RULE], or on the 15th year after the employee's first exposure above .2
[mu]g/m\3\ for more than 30 days in a 12-month period, whichever is
later; and
(G) Any other test deemed appropriate by the PLHCP.
(4) Information provided to the PLHCP. The employer shall ensure
that the examining PLHCP has a copy of this standard and all appendices
and shall provide the following information, if known:
(i) A description of the employee's former and current duties that
relate to the employee's occupational exposure;
(ii) The employee's former and current levels of occupational
exposure;
(iii) A description of any protective clothing and equipment,
including respirators, used by the employee, including when and for how
long the employee has used that protective clothing and equipment; and
(iv) Information from records of employment-related medical
examinations previously provided to the employee, currently within the
control of the employer, after obtaining a medical release from the
employee.
(5) Licensed physician's written medical opinion. (i) The employer
shall obtain a written medical opinion from the licensed physician
within 30 days of the examination, which contains:
(A) The licensed physician's opinion as to whether the employee has
any detected medical condition that would place the employee at
increased risk of CBD from further exposure;
(B) Any recommended limitations on the employee's exposure,
including the use and limitations of protective clothing or equipment,
including respirators; and
(C) A statement that the PLHCP has explained the results of the
medical examination to the employee, including any tests conducted, any
medical conditions related to exposure that require further evaluation
or treatment, and any special provisions for use of protective clothing
or equipment.
(ii) The employer shall ensure that neither the licensed physician
nor any other PLHCP reveals to the employer specific findings or
diagnoses unrelated to exposure to airborne beryllium or contact with
soluble beryllium compounds.
(iii) The employer shall provide a copy of the licensed physician's
written medical opinion to the employee within 2 weeks after receiving
it.
(6) Referral to a CBD diagnostic center. (i) Within 30 days after
an employer learns that an employee has been confirmed positive, the
employer's designated licensed physician shall consult with the
employee to discuss referral to a CBD diagnostic center that is
mutually agreed upon by the employer and the employee.
(ii) If, after this consultation, the employee wishes to obtain a
clinical evaluation at a CBD diagnostic center, the employer shall
provide the evaluation at no cost to the employee.
(7) Beryllium sensitization test results research. Upon request by
OSHA, employers must convey employees' beryllium sensitization test
results to OSHA for evaluation and analysis. Employers must remove
employees' names, social security numbers, and other personally
identifying information from the test results before conveying them to
OSHA.
(l) Medical removal. (1) If an employee works in a job with
exposure
[[Page 47825]]
at or above the action level and is diagnosed with CBD or confirmed
positive, the employee is eligible for medical removal.
(2) If an employee is eligible for medical removal, the employee
must choose:
(i) Removal as described in paragraph (l)(3) of this section; or
(ii) To remain in a job with exposure at or above the action level,
provided that the employee wears a respirator in accordance with the
Respiratory Protection standard (29 CFR 1910.134).
(3) If the employee chooses removal:
(i) The employer shall remove the employee to comparable work for
which the employee is qualified or can be trained within 1 month. In
this standard, comparable work must be in a work environment where the
exposure is below the action level. The employee must accept comparable
work if such work is available;
(ii) If comparable work is not available, the employer shall place
the employee on paid leave for 6 months or until such time as
comparable work becomes available, whichever comes first; and
(iii) Whether the employee is removed to comparable work or placed
on paid leave, the employer shall maintain for 6 months the employee's
base earnings, seniority, and other rights and benefits that existed at
the time of removal.
(4) The employer's obligation to provide medical removal protection
benefits to a removed employee shall be reduced to the extent that the
employee receives compensation for earnings lost during the period of
removal from a publicly or employer-funded compensation program, or
receives income from another employer made possible by virtue of the
employee's removal.
(m) Communication of hazards-- (1) General. (i) Chemical
manufacturers, importers, distributors, and employers shall comply with
all requirements of the HCS (29 CFR 1910.1200) for beryllium.
(ii) In classifying the hazards of beryllium, the employer shall
address at least the following hazards: Cancer; lung effects (CBD and
acute beryllium disease); beryllium sensitization; skin sensitization;
and skin, eye, and respiratory tract irritation.
(iii) Employers shall include beryllium in the hazard communication
program established to comply with the HCS. Employers shall ensure that
each employee has access to labels on containers of beryllium and to
safety data sheets, and is trained in accordance with the requirements
of the HCS (29 CFR 1910.1200) and paragraph (m)(4) of this section.
(2) Warning signs--(i) Posting. The employer shall provide and
display warning signs at each approach to a regulated area so that each
employee is able to read and understand the signs and take necessary
protective steps before entering the area.
(ii) Sign specification. (A) The employer shall ensure that the
warning signs required by paragraph (m)(2)(i) of this section are
legible and readily visible.
(B) The employer shall ensure each warning sign required by
paragraph (m)(2)(i) of this section bears the following legend:
DANGER
BERYLLIUM
MAY CAUSE CANCER
CAUSES DAMAGE TO LUNGS
AUTHORIZED PERSONNEL ONLY
WEAR RESPIRATORY PROTECTION AND PROTECTIVE CLOTHING AND EQUIPMENT IN
THIS AREA
(3) Warning labels. The employer shall label each bag and container
of clothing, equipment, and materials visibly contaminated with
beryllium consistent with the HCS (29 CFR 1910.1200), and shall, at a
minimum, include the following on the label:
DANGER
CONTAINS BERYLLIUM
MAY CAUSE CANCER
CAUSES DAMAGE TO LUNGS
AVOID CREATING DUST
DO NOT GET ON SKIN
(4) Employee information and training. (i) For each employee who is
or can reasonably be expected to be exposed to airborne beryllium:
(A) The employer shall provide information and training in
accordance with the HCS (29 CFR 1910.1200(h));
(B) The employer shall provide initial training to each employee by
the time of initial assignment; and
(C) The employer shall repeat the training required under this
section annually for each employee.
(ii) The employer shall ensure that each employee who is or can
reasonably be expected to be exposed to airborne beryllium can
demonstrate knowledge of the following:
(A) The health hazards associated with exposure to beryllium and
contact with soluble beryllium compounds, including the signs and
symptoms of CBD;
(B) The written exposure control plan, with emphasis on the
location(s) of beryllium work areas, including any regulated areas, and
the specific nature of operations that could result in employee
exposure, especially employee exposure above the TWA PEL or STEL;
(C) The purpose, proper selection, fitting, proper use, and
limitations of personal protective clothing and equipment, including
respirators;
(D) Applicable emergency procedures;
(E) Measures employees can take to protect themselves from exposure
to beryllium and contact with soluble beryllium compounds, including
personal hygiene practices;
(F) The purpose and a description of the medical surveillance
program required by paragraph (k) of this section including risks and
benefits of each test to be offered;
(G) The purpose and a description of the medical removal protection
provided under paragraph (l) of this section;
(H) The contents of the standard; and
(I) The employee's right of access to records under the Records
Access standard (29 CFR 1910.1020).
(iii) When a workplace change (such as modification of equipment,
tasks, or procedures) results in new or increased employee exposure
that exceeds, or can reasonably be expected to exceed, either the TWA
PEL or the STEL, the employer shall provide additional training to
those employees affected by the change in exposure.
(iv) Employee information. The employer shall make a copy of this
standard and its appendices readily available at no cost to each
employee and designated employee representative(s).
(n) Recordkeeping--(1) Exposure measurements. (i) The employer
shall maintain a record of all measurements taken to monitor employee
exposure as prescribed in paragraph (d) of this section.
(ii) This record shall include at least the following information:
(A) The date of measurement for each sample taken;
(B) The operation that is being monitored;
(C) The sampling and analytical methods used and evidence of their
accuracy;
(D) The number, duration, and results of samples taken;
(E) The type of personal protective clothing and equipment,
including respirators, worn by monitored employees at the time of
monitoring; and
(F) The name, social security number, and job classification of
each employee represented by the monitoring, indicating which employees
were actually monitored.
(iii) The employer shall maintain this record as required by the
Records
[[Page 47826]]
Access standard (29 CFR 1910.1020(d)(1)(ii)).
(2) Historical monitoring data. (i) The employer shall establish
and maintain an accurate record of any historical data used to satisfy
the initial monitoring requirements of paragraph (d)(2) of this
standard.
(ii) The record shall demonstrate that the data comply with the
requirements of paragraph (d)(2) of this section.
(iii) The employer shall maintain this record as required by the
Records Access standard (29 CFR 1910.1020).
(3) Objective data. (i) Where an employer uses objective data to
satisfy the monitoring requirements under paragraph (d)(2) of this
section, the employer shall establish and maintain a record of the
objective data relied upon.
(ii) This record shall include at least the following information:
(A) The data relied upon;
(B) The beryllium-containing material in question;
(C) The source of the objective data;
(D) A description of the operation exempted from initial monitoring
and how the data support the exemption; and
(E) Other information demonstrating that the data meet the
requirements for objective data contained in paragraph (d)(2)(ii) of
this section.
(iii) The employer shall maintain this record as required by the
Records Access standard (29 CFR 1910.1020).
(4) Medical surveillance. (i) The employer shall establish and
maintain a record for each employee covered by medical surveillance
under paragraph (k) of this section.
(ii) The record shall include the following information about the
employee:
(A) Name, social security number, and job classification;
(B) A copy of all licensed physicians' written opinions; and
(C) A copy of the information provided to the PLHCP as required by
paragraph (k)(4) of this section.
(iii) The employer shall ensure that medical records are maintained
in accordance with the Records Access standard (29 CFR 1910.1020).
(5) Training. (i) At the completion of any training required by
this standard, the employer shall prepare a record that indicates the
name, social security number, and job classification of each employee
trained, the date the training was completed, and the topic of the
training.
(ii) This record shall be maintained for 3 years after the
completion of training.
(6) Access to records. Upon request, the employer shall make all
records maintained as a requirement of this standard available for
examination and copying to the Assistant Secretary, the Director, each
employee, and each employee's designated representative(s) in
accordance the Records Access standard (29 CFR 1910.1020).
(7) Transfer of records. The employer shall comply with the
requirements involving transfer of records set forth in the Records
Access standard (29 CFR 1910.1020).
(o) Dates. (1) Effective date.This standard shall become effective
[DATE 60 DAYS AFTER PUBLICATION OF FINAL RULE IN THE Federal Register].
(2) Start-up dates. All obligations of this standard commence and
become enforceable [DATE 90 DAYS AFTER EFFECTIVE DATE OF FINAL RULE]
except:
(i) Change rooms required by paragraph (i) of this section shall be
provided no later than 1 year after [EFFECTIVE DATE OF FINAL RULE]; and
(ii) Engineering controls required by paragraph (f) of this
standard shall be implemented no later than 2 years after [EFFECTIVE
DATE OF FINAL RULE].
(p) Appendices. Appendices A and B of this section are non-
mandatory.
Appendix A to Sec. 1910.1024--Immunological Testing for the
Determination of Beryllium Sensitization (Non-Mandatory)
I. Background
Exposure to beryllium via inhalation or dermal contact has been
determined to cause an immunological reaction (sensitization) in
some individuals. Beryllium sensitization can progress to chronic
beryllium disease (CBD). Identifying sensitized workers through an
immunological screening program is an essential element in any
monitoring and surveillance program designed to reduce the risk of
developing CBD in the workplace (Kreiss, 1993b, Newman, 2005).
Immunological testing for sensitization to beryllium serves to
identify workers at risk for progression to CBD. The medical
surveillance and medical removal provisions of the proposed standard
provide for clinical evaluation of sensitized workers for early-
stage CBD and intervention before progression to more debilitating
health effects occurs.
2. This appendix provides an overview of the test currently used
to detect beryllium sensitization, the peripheral blood Beryllium
Lymphocyte Proliferation Test (BeLPT) as well as a description of
the test procedure, the best available information on the accuracy
of the test, and several repeat-testing algorithms designed to
improve the predictive value of the test. It is important that this
information be made available to employers, employees, physicians
and other medical personnel to ensure their understanding of the
test and the meaning of test results, and to provide a basis to
compare the reliability and validity (utility) of any other
sensitization tests that may be developed with the utility of the
BeLPT.
II. The Peripheral Blood Beryllium Lymphocyte Proliferation Test
(BeLPT)
1. The BeLPT is an in-vitro blood test that measures the
beryllium antigen-specific T-cell mediated immune response.
Currently, the BeLPT is the most commonly available diagnostic tool
for identifying beryllium sensitization.
2. To perform the BeLPT, venous blood is collected in
heparinized tubes. Lymphocytes are isolated from the blood using
centrifugation and washed in salt solution. The lymphocytes are
counted and evaluated for cell viability. These cells are then
cultured in quadruplicate in the presence or absence of beryllium
sulfate at 1, 10, and 100 [mu]M concentrations for 3-7 days. During
the last 4 hours of the culture, cells are pulsed with a
radiolabeled DNA precursor (tritiated thymidine deoxyriboside),
harvested onto filters and counted in a liquid scintillation
counter. The counts per minute (cpm) from each set of quadruplicates
are averaged and expressed as a ratio of the cpm of the beryllium
stimulated cells to the unstimulated cells. This ratio is called the
stimulation index (SI) (Maier, 2003).
3. The BeLPT is interpreted based on the proportion of SIs that
exceeds a cut-off value, the expected SI for non-sensitized
individuals. Each laboratory sets its own cut-off for the test
(Newman 1996). Traditionally, this cut-off value is determined by
testing cells from control/non-exposed individuals, and must be
determined with each new serum lot that will be used for culturing
the peripheral blood lymphocytes. The cut-off is based on the mean
value of the peak stimulation index among controls plus 2 or 3
standard deviations. This methodology was modeled into a statistical
method known as the ``least absolute values'' (an adaptation of the
``statistical-biological positive'' method) and relies on natural
log modeling of the median stimulation index values (DOE 2001, Frome
2003). This methodology is recommended by the Department of Energy
in guidance (DOE-SPEC-1142-2001) developed by DOE to optimize and
standardize beryllium sensitivity testing. It is recommended, but
not mandated, to be used in all DOE contracts with laboratories for
the purchase of BeLPT services. Other labs have used a standard
ratio of 3.0 (stimulated to unstimulated) as the cut-off for an
abnormal result (Stange 2004, Deubner 2001).
4. BeLPT results are reported as ``normal,'' ``abnormal,'' or
``borderline abnormal.'' According to the DOE a BeLPT result is
considered ``abnormal'' if at least two of the six stimulation
indices are elevated (DOE 2001). If only one of the six stimulation
indices is elevated, the test is considered ``borderline abnormal''
(DOE 2001). If no stimulation index is elevated, the test is normal.
A BeLPT may be considered uninterpretable if there are problems with
the viability of the cells or lack of response to mitogen, or other
problems with the test procedure. (DOE 2001).
5. Due to the nature of the test, issues with variability and
reproducibility of a test can
[[Page 47827]]
arise between and within labs. Potential sources of variability
include: technical problems such as bacterial contamination, cell
death, omission of tritiated thymidine pulse, technician skill,
degree of automation, use of flat- or round-bottom culture plates,
serum concentration, use of beryllium sulfate versus beryllium
fluoride, concentration of the culture serum, and the handling of
outlier SIs (Mroz 1991).
6. Test characteristics and testing algorithms. The utility of
any diagnostic, screening or surveillance test relies on the
capacity of the test to predict whether or not an individual indeed
has the condition intended to be reflected by the test. In the
discussion below, sensitivity refers to the proportion of sensitized
persons who test positive for sensitization using the BeLPT.
Specificity refers to the proportion of non-sensitized persons who
test negative. Positive predictive value (PPV) refers to the
proportion of persons who test positive, who are actually
sensitized. The PPV is related not only to the utility of the test,
but also to the prevalence of the condition in the tested
population. In the remainder of this discussion, we will refer to
the results of a single BeLPT as ``abnormal,'' ``normal,'' and
``borderline,'' and will refer to the outcome of a testing algorithm
as ``positive'' for sensitization or ``negative.''
7. Stange et al. (2004) investigated the utility of BeLPT
testing in a population of employees of 18 United States Department
of Energy (DOE) sites. At these sites, 12,194 current and former
employees were tested for beryllium sensitization at four
laboratories with BeLPT expertise. Stange et al. reported that 68.3
percent of beryllium-sensitized workers tested positive based on a
single abnormal BeLPT result (sensitivity). Thus, the rate of false
negatives (undetected cases of beryllium sensitization) based on one
normal result was 31.7 percent. Stange et al. reported a false
positive rate of 1.09 percent for one abnormal BeLPT result and a
PPV of 0.253, which they found comparable to other widely accepted
medical tests. Middleton et al. (2006) adjusted Stange's parameters
to consider borderline test results and estimated that 59.7 percent
of sensitized persons would test abnormal, 27.7 percent would test
normal, and 12.6 percent would have borderline results. They
estimated that among non-sensitized persons, 97.37 percent would
test normal, 1.09 percent would test abnormal, and 1.58 percent
would have borderline results. Stange et al. recommended repeat
testing to confirm an abnormal BeLPT result to assure appropriate
referral for CBD medical evaluation (Stange et al., 2004).
8. Middleton et al. (2006) studied the characteristics of two
testing algorithms. The more basic algorithm used a single initial
test plus subsequent split specimen confirmation tests. In the
second, enhanced algorithm, an initial test was split and sent to
different laboratories for analysis. The sensitivity, specificity,
and PPV reported by Middleton were 65.7 percent, 99.9 percent, and
93 percent respectively for the basic algorithm, and 86 percent,
99.8 percent, and 90 percent respectively for the enhanced
algorithm. The authors concluded that an algorithm for BeLPT testing
and interpretation is best selected or designed after considering
the (1) likelihood and level of exposure; (2) purpose of testing
(i.e., screening versus medical testing of patients; (3) opportunity
for one-time testing versus serial testing; (4) importance of
getting the right answer the first time; and (5) number of persons
to be tested and the funds available.
9. In April 2006, the Agency for Toxic Substances and Disease
Registry (ATSDR) convened an expert panel of seven physicians and
scientists to discuss the BeLPT and to consider what algorithm
should be used to interpret BeLPT results to establish beryllium
sensitization (Middleton et al., 2008). The three criteria proposed
by panel members were Criteria A (one abnormal BeLPT result
establishes sensitization); Criteria B (one abnormal and one
borderline result establish sensitization); and Criteria C (two
abnormal results establish sensitization).
10. Using the single-test outcome probabilities developed by
Stange et al., the panel convened by ATSDR calculated and compared
the sensitivity, specificity, and positive predictive values (PPVs)
for each algorithm. The characteristics for each algorithm were as
follows:
Table A.1--Characteristics of BeLPT Algorithms
[Adapted from Middleton et al., 2008]
----------------------------------------------------------------------------------------------------------------
Criteria B (1
Criteria A (1 abnormal + 1 Criteria C (2
abnormal) borderline) abnormal)
----------------------------------------------------------------------------------------------------------------
Sensitivity............................................... 68.2% 65.7% 61.2%
Specificity............................................... 98.89% 99.92% 99.98%
PPV at 1% prevalence...................................... 38.3% 89.3% 96.8%
PPV at 10% prevalence..................................... 87.2% 98.9% 99.7%
False positives per 10,000................................ 111 8 2
----------------------------------------------------------------------------------------------------------------
11. The study demonstrated that confirmation of BeLPT results,
whether as one abnormal and one borderline abnormal or as two
abnormals, enhances the test's PPV and protects the persons tested
from unnecessary and invasive medical procedures. In populations
with a high prevalence of beryllium sensitization (i.e., 10 percent
or more), however, a single test may be adequate to predict
sensitization (Middleton et al., 2008).
12. In a later analysis, Middleton et al. (2011) conducted an
evaluation using borderline results from BeLPT testing. Utilizing
the common clinical algorithm with a criterion that accepted 1
abnormal and 1 borderline as establishing beryllium sensitization
resulted in a PPV of 94.4 percent. This study also found that 3
borderline results resulted in a PPV of 91 percent. Both of these
PPVs were based on a population prevalence of 2 percent. This study
further demonstrates borderline results' value in predicting
beryllium sensitization using the BeLPT.
III. New Beryllium-Specific Immunological Test Protocols
1. In the medical surveillance provisions of this standard, OSHA
requires the use of a standardized BeLPT, but states that a ``more
reliable and accurate diagnostic test'' for beryllium sensitization
may be used in lieu of the BeLPT if such a test is developed. The
Agency considers the following criteria to be important in judging a
new test's validity and reliability:
a. A test report prepared by an independent \1\ research
laboratory stating that the laboratory has tested the protocol and
has found it to be valid and reliable; and
b. An article that has been published in a peer-reviewed journal
describing the protocol and explaining how test data support the
protocol's validity and reliability.
c. Sensitivity and specificity that meet or exceed those
reported for the BeLPT in peer-reviewed publications.
---------------------------------------------------------------------------
\1\ An example of an ``independent'' research laboratory would
be a laboratory with no financial interest in the protocol, and no
affiliation with the manufacture or supply of beryllium.
---------------------------------------------------------------------------
Appendix B to Sec. 1910.1024: Control Strategies To Minimize Beryllium
Exposure (Non-Mandatory)
Paragraph (f)(2)(i) of Sec. 1910.1024 requires employers to use
one or more of the control methods listed in paragraph (f)(2)(i)(A)
of Sec. 1910.1024 to minimize worker exposure in each operation in
a beryllium work area, unless the operation is exempt under
paragraph (f)(2)(i)(B) of Sec. 1910.1024. This appendix sets forth
a non-exhaustive list of control options that employers could use to
comply with paragraph (f)(2)(i)(A) of Sec. 1910.1024 for a number
of specific beryllium operations.
[[Page 47828]]
Table B.1--Exposure Control Recommendations
----------------------------------------------------------------------------------------------------------------
Operation Minimal control strategy * Application group
----------------------------------------------------------------------------------------------------------------
Beryllium Oxide Forming (e.g., pressing, For pressing operations:.................. Primary Beryllium
extruding). (1) Install local exhaust ventilation Production; Beryllium
(LEV) on oxide press tables, oxide feed Oxide Ceramics and
drum breaks, press tumblers, powder Composites.
rollers, and die set disassembly
stations;.
(2) Enclose the oxide presses; and........
(3) Install mechanical ventilation (make-
up air) in processing areas..
For extruding operations:.................
(1) Install LEV on extruder powder loading
hoods, oxide supply bottles, rod breaking
operations, centerless grinders, rod
laydown tables, dicing operations,
surface grinders, discharge end of
extrusion presses;.
(2) Enclose the centerless grinders; and..
(3) Install mechanical ventilation (make-
up air) in processing areas..
Chemical Processing Operations (e.g., For medium and high gassing operations.... Primary Beryllium
leaching, pickling, degreasing, (1) Perform operation with a hood having a Production; Beryllium
etching, plating). maximum of one open side; and. Oxide Ceramics and
(2) Design process so as to minimize Composites; Copper
spills; if accidental spills occur, Rolling, Drawing and
perform immediate cleanup.. Extruding.
Finishing (e.g., grinding, sanding, (1) Perform portable finishing operations Secondary Smelting;
polishing, deburring). in a ventilated hood. The hood should Fabrication of Beryllium
include both downdraft and backdraft Alloy Products; Dental
ventilation, and have at least two sides Labs.
and a top.
(2) Perform stationary finishing
operations using a ventilated and
enclosed hood at the point of operation.
The grinding wheel of the stationary unit
should be enclosed and ventilated..
Furnace Operations (e.g., Melting and (1) Use LEV on furnaces, pelletizer; arc Primary Beryllium
Casting). furnace ingot machine discharge; pellet Production; Beryllium
sampling; arc furnace bins and conveyors; Oxide Ceramics and
beryllium hydroxide drum dumper and Composites; Nonferrous
dryer; furnace rebuilding; furnace tool Foundries; Secondary
holders; arc furnace tundish and tundish Smelting.
skimming, tundish preheat hood, and
tundish cleaning hoods; dross handling
equipment and drums; dross recycling; and
tool repair station, charge make-up
station, oxide screener, product sampling
locations, drum changing stations, and
drum cleaning stations.
(2) Use mechanical ventilation (make-up
air) in furnace building..
Machining............................... Use (1) LEV consistent with ACGIH[supreg] Primary Beryllium
ventilation guidelines on deburring Production; Beryllium
hoods, wet surface grinder enclosures, Oxide Ceramics and
belt sanding hoods, and electrical Composites; Copper
discharge machines (for operations such Rolling, Drawing, and
as polishing, lapping, and buffing); Extruding; Precision
(2) high velocity low volume hoods or Turned Products.
ventilated enclosures on lathes, vertical
mills, CNC mills, and tool grinding
operations;.
(3) for beryllium oxide ceramics, LEV on
lapping, dicing, and laser cutting; and.
(4) wet methods (e.g., coolants)..........
Mechanical Processing (e.g., material (1) Enclose and ventilate sources of Primary Beryllium
handling (including scrap), sorting, emission; Production; Beryllium
crushing, screening, pulverizing, (2) Prohibit open handling of materials; Oxide Ceramics and
shredding, pouring, mixing, blending). and. Composites; Aluminum and
(3) Use mechanical ventilation (make-up Copper Foundries;
air) in processing areas.. Secondary Smelting.
Metal Forming (e.g., rolling, drawing, (1) For rolling operations, install LEV on Primary Beryllium
straightening, annealing, extruding). mill stands and reels such that a hood Production; Copper
extends the length of the mill; Rolling, Drawing, and
(2) For point and chamfer operations, Extruding; Fabrication of
install LEV hoods at both ends of the Beryllium Alloy Products.
rod;.
(3) For annealing operations, provide an
inert atmosphere for annealing furnaces,
and LEV hoods at entry and exit points;.
(4) For swaging operations, install LEV on
the cutting head;.
(5) For drawing, straightening, and
extruding operations, install LEV at
entry and exit points; and.
(6) For all metal forming operations,
install mechanical ventilation (make-up
air) for processing areas..
Welding................................. For fixed welding operations: Primary Beryllium
(1) Enclose work locations around the Production; Fabrication
source of fume generation and use local of Beryllium Alloy
exhaust ventilation; and. Products; Welding.
(2) Install close capture hood enclosure
designed so as to minimize fume emission
from the enclosure welding operation..
For manual operations:....................
(1) Use portable local exhaust and general
ventilation..
----------------------------------------------------------------------------------------------------------------
* All LEV specifications should be in accordance with the ACGIH[supreg] Publication No. 2094, ``Industrial
Ventilation--A Manual of Recommended Practice'' wherever applicable.
[FR Doc. 2015-17596 Filed 8-6-15; 8:45 am]
BILLING CODE 4510-26-P
