Revising the Beryllium Standard for General Industry, 42582-42628 [2020-10678]
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XI. Summary and Explanation of the Final
Rule
List of Subjects for 29 CFR Part 1910
Authority
DEPARTMENT OF LABOR
Occupational Safety and Health
Administration
Citation Method
29 CFR Part 1910
[Docket No. OSHA–2018–0003]
RIN 1218–AD20
Revising the Beryllium Standard for
General Industry
Occupational Safety and Health
Administration (OSHA), Labor.
ACTION: Final rule.
AGENCY:
OSHA is amending its
existing general industry standard for
occupational exposure to beryllium and
beryllium compounds to clarify certain
provisions and simplify or improve
compliance. The revisions in this final
rule are designed to maintain or
enhance worker protections overall by
ensuring that the rule is well
understood and compliance is more
straightforward.
DATES: This final rule becomes effective
on September 14, 2020.
ADDRESSES: In accordance with 28
U.S.C. 2112(a)(2), OSHA designates
Edmund C. Baird, Associate Solicitor of
Labor for Occupational Safety and
Health, to receive petitions for review of
the final rule. Contact the Associate
Solicitor at the Office of the Solicitor,
Room S–4004, U.S. Department of
Labor, 200 Constitution Avenue NW,
Washington, DC 20210; telephone: (202)
693–5445.
FOR FURTHER INFORMATION CONTACT:
Press inquiries: Mr. Frank Meilinger,
OSHA Office of Communications,
Occupational Safety and Health
Administration; telephone: (202) 693–
1999; email: meilinger.francis2@dol.gov.
General information and technical
inquiries: Ms. Maureen Ruskin,
Directorate of Standards and Guidance,
Occupational Safety and Health
Administration; telephone: (202) 693–
1950; email: ruskin.maureen@dol.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
Table of Contents
I. Executive Summary
II. Events Leading to the Final Rule
III. Legal Considerations
IV. Final Economic Analysis and Regulatory
Flexibility Act Certification (FEA)
V. Office of Management and Budget (OMB)
Review Under the Paperwork Reduction
Act of 1995
VI. Federalism
VII. State Plans
VIII. Unfunded Mandates Reform Act
IX. Consultation and Coordination With
Indian Tribal Governments
X. Environmental Impacts
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In the docket for this rulemaking
found at https://www.regulations.gov,
every submission was assigned a
document identification (ID) number
that consists of the docket number
(OSHA–2018–0003) followed by an
additional four-digit number. For
example, the document ID number for
the proposed rule is OSHA–2018–0003–
0016. Some document ID numbers
include one or more attachments (see,
e.g., Document ID OSHA–2018–0003–
0026).
When citing exhibits in the OSHA–
2018–0003 docket in this preamble,
OSHA includes the term ‘‘Document
ID’’ followed by the last four digits of
the document number; the attachment
number or other attachment identifier, if
necessary for clarity; and page numbers
(designated ‘‘p.’’ or ‘‘pp.’’). In a citation
that contains two or more document ID
numbers, the document ID numbers are
separated by semi-colons. For example,
a citation referring to National Jewish
Health’s comments and the first
attachment to Materion Brush, Inc.’s
comments would be indicated as
follows: (Document ID 0022, pp. X–X;
0038–A1, p. X).
Occasionally this preamble refers to
documents located in the rulemaking
dockets that were used for previous
beryllium rulemaking activities,
including the 2017 final rule. When
citing exhibits in other dockets, OSHA
includes the term ‘‘Document ID’’
followed by the full document number.
For example, this preamble cites a
publication by Armstrong et al. (2014),
titled ‘‘Migration of beryllium via
multiple exposure pathways among
work processes in four different
facilities,’’ designated Document ID
OSHA–H005C–2006–0870–0502.
The exhibits in the docket (and the
other beryllium-rulemaking dockets
cited in this preamble), including public
comments, supporting materials,
meeting transcripts, and other
documents, are listed on https://
www.regulations.gov. All exhibits are
listed in the docket index on https://
www.regulations.gov, but some exhibits
(e.g., copyrighted material) are not
available to read or download from that
website. All materials in the docket are
available for inspection at the OSHA
Docket Office, Room N–3508, U.S.
Department of Labor, 200 Constitution
Avenue NW, Washington, DC 20210;
telephone (202) 693–2350.
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I. Executive Summary
On January 9, 2017, OSHA published
a final rule on Occupational Exposure to
Beryllium and Beryllium Compounds
(82 FR 2470). This rule created health
standards for beryllium exposure in the
general industry (29 CFR 1910.1024),
construction (29 CFR 1926.1124), and
shipyards (29 CFR 1915.1024) sectors.
On December 11, 2018, OSHA
published a Notice of Proposed
Rulemaking (NPRM) in which the
agency proposed various amendments
to the beryllium standard for general
industry (83 FR 63746). With the
proposed revisions, OSHA sought to
clarify certain provisions and simplify
or improve compliance with the
beryllium standard for general industry.
In this final rule, OSHA is finalizing the
majority of the changes proposed in the
NPRM, with some revisions intended to
address concerns raised by stakeholders
during the comment period. OSHA
believes that these changes to the
standard will maintain safety and health
protections for workers and will further
enhance worker protections by ensuring
that the standard is well-understood.
The changes to the final standard for
general industry are fully discussed in
Section XI, Summary and Explanation
of the Final Rule. Broadly, OSHA
proposed to add one definition and
modify five existing terms in paragraph
(b), Definitions; to amend paragraph (f),
Methods of compliance; paragraph (h),
Personal protective clothing and
equipment; paragraph (i), Hygiene areas
and practices; paragraph (j),
Housekeeping; paragraph (k), Medical
surveillance; paragraph (m),
Communication of hazards; and
paragraph (n), Recordkeeping; and to
replace the 2017 final standard’s
Appendix A with a new appendix
designed to supplement the proposed
definition of beryllium work area.
OSHA is finalizing these provisions as
proposed, with the following
exceptions. First, OSHA is revising the
definition of confirmed positive to state
that the findings of two abnormal, one
abnormal and one borderline, or three
borderline results need to occur from
beryllium lymphocyte proliferation tests
(BeLPTs) conducted within a three-year
period. This differs from the definition
proposed in the 2018 NPRM, which
would have required that any
combination of test results specified in
the definition must be obtained within
the 30-day follow-up test period
required after a first abnormal or
borderline BeLPT test result. Second,
OSHA is modifying the proposed
paragraph (j)(3), which requires
employers to take certain actions when
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transferring materials that contain at
least 0.1 percent beryllium by weight or
that are contaminated with beryllium
outside a plant for the purpose of
disposal, recycling, or reuse, to clarify
that only transfers outside of a plant,
including between facilities owned by
the same employer, are subject to the
labeling requirements of paragraph
(m)(3).
Third, in paragraphs (k)(2)(iii) and
(iv), OSHA is modifying the proposed
provisions pertaining to an employer’s
obligation to offer a medical
examination after an employee is
exposed to beryllium in an emergency.
Fourth, OSHA is amending proposed
paragraph (k)(7)(i) to require that an
examination at a chronic beryllium
disease (CBD) diagnostic center be
scheduled within 30 days of the
employer receiving certain types of
documentation, listed in paragraph
(k)(7)(i)(A) and (B), that trigger
evaluation for CBD. OSHA is further
revising proposed paragraph (k)(7) by
adding a new provision, paragraph
(k)(7)(ii), which clarifies that, as part of
the evaluation at the CBD diagnostic
center, the employer must ensure that
the employee is offered any tests
deemed appropriate by the examining
physician at the CBD diagnostic center
and to state that if any tests deemed
appropriate by the physician are not
available at the CBD diagnostic center,
they may be performed at another
location that is mutually agreed upon by
the employer and the employee. For a
full explanation of comments received
and OSHA’s reasoning for these
revisions, see Section XI, Summary and
Explanation of the Final Rule.
OSHA’s examination of the
technological and economic feasibility
of this final rule is presented in the
Final Economic Analysis and
Regulatory Flexibility Analysis (FEA),
in Section IV of this preamble. As
explained there, OSHA finds that none
of the revisions would impose any new
employer obligations or increase the
overall cost of compliance, while some
of the revisions in this final rule will
clarify and simplify compliance in such
a way that results in cost savings. OSHA
also finds that none of the revisions
would require any new controls or other
technology. OSHA therefore concludes
that the final rule is both economically
and technologically feasible.
Further, this final rule is considered
to be an Executive Order (E.O.) 13771
deregulatory action. Pursuant to the
Congressional Review Act (5 U.S.C. 801
et seq.), the Office of Information and
Regulatory Affairs designated this rule
not a ‘‘major rule,’’ as defined by 5
U.S.C. 804(2).
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II. Events Leading to the Final Rule
On January 9, 2017, OSHA published
the final rule Occupational Exposure to
Beryllium and Beryllium Compounds
(2017 final rule) in the Federal Register
(82 FR 2470).1 Therein, OSHA
concluded that employees exposed to
beryllium and beryllium compounds at
the preceding permissible exposure
limits (PELs) were at significant risk of
material impairment of health,
specifically chronic beryllium disease
(CBD) and lung cancer. The agency
further determined that limiting
employee exposure to an 8-hour timeweighted average (TWA) PEL of 0.2 mg/
m3 would reduce this significant risk to
the maximum extent feasible. Therefore,
the 2017 final rule adopted a TWA PEL
of 0.2 mg/m3. In addition to the revised
PEL, the 2017 final rule established a
new short-term exposure limit (STEL) of
2.0 mg/m3 over a 15-minute sampling
period and an action level of 0.1 mg/m3
as an 8-hour TWA, along with a number
of ancillary provisions intended to
provide additional protections to
employees. The ancillary provisions
included requirements for exposure
assessment, methods for controlling
exposure, respiratory protection,
personal protective clothing and
equipment, housekeeping, medical
surveillance, hazard communication,
and recordkeeping that are similar to
those found in other OSHA health
standards.
The 2017 final rule went into effect on
May 20, 2017, and OSHA began
enforcing the PEL and the general
industry standard’s provisions for
exposure assessment, respiratory
protection, medical surveillance, and
medical removal on May 11, 2018. See
Updated Interim Enforcement Guidance
for the Beryllium Standards, available at
https://www.osha.gov/laws-regs/
standardinterpretations/2018-12-11.
The majority of the general industry
standard’s other provisions became
enforceable on December 12, 2018, with
compliance obligations for showers and
change rooms following on March 11,
2019 (83 FR 39351). OSHA began
enforcing the general industry
requirements for engineering controls
on March 10, 2020.
In response to concerns raised by
stakeholders following the publication
of the 2017 final rule, OSHA published
a direct final rule (DFR) in the Federal
Register on May 7, 2018 (83 FR 19936),
amending the text of the beryllium
standard for general industry to clarify
OSHA’s intent with respect to certain
terms in the standard, including the
definition of beryllium work area
(BWA), the definition of emergency, and
the meaning of the terms dermal contact
and beryllium contamination (see 83 FR
at 19938). The DFR also clarified
OSHA’s intent with respect to
provisions for disposal and recycling
and with respect to provisions that the
agency intended to apply only where
skin can be exposed to materials
containing at least 0.1% beryllium by
weight (83 FR at 19938). Because the
agency did not receive any significant
adverse comments, OSHA published a
Federal Register notice confirming the
effective date of the DFR as July 6, 2018,
and withdrawing the companion NPRM
(83 FR 31045 (July 3, 2018)).
On December 11, 2018, OSHA
published an NPRM in the Federal
Register (83 FR 63746) in which the
agency proposed to further amend the
beryllium standard for general
industry.2 The proposal sought to clarify
certain provisions–with proposed
changes designed to facilitate
application of the standard consistent
with the intent of the 2017 final rule–
and to simplify or improve compliance,
preventing costs that may flow from
misinterpretation or misapplication of
the standard. OSHA requested public
comment on the proposed changes and
provided stakeholders 60 days to submit
comments. OSHA received 22
comments before the comment period
closed on February 11, 2019.
1 In the 2017 final rule, OSHA issued three
separate beryllium standards—general industry,
shipyards, and construction. This final rule amends
only the general industry standard. Therefore,
neither this Events Leading to the Final Rule
section nor the remainder of the preamble will
include information about the other two standards.
2 OSHA stated in the NPRM that the agency
believed that the standard as modified by the
proposal would provide equivalent protection to
the existing standard; and OSHA would therefore
accept compliance with the standard, as modified
by the proposal, as compliance with the standard
while the rulemaking was pending.
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III. Legal Considerations
The purpose of the Occupational
Safety and Health Act of 1970 (‘‘the
OSH Act’’ or ‘‘the Act’’), 29 U.S.C. 651
et seq., 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 occupational safety and
health standards pursuant to notice and
comment rulemaking. See 29 U.S.C.
655(b). An occupational safety or health
standard is a standard which requires
conditions, or the adoption or use of one
or more practices, means, methods,
operations, or processes, reasonably
necessary or appropriate to provide safe
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or healthful employment and places of
employment. 29 U.S.C. 652(8).
The Act also authorizes the Secretary
to ‘‘modify’’ or ‘‘revoke’’ any
occupational safety or health standard,
29 U.S.C. 655(b), and under the
Administrative Procedure Act,
regulatory agencies generally may revise
their rules if the changes are supported
by a reasoned analysis, see Motor
Vehicle Mfrs. Ass’n v. State Farm Mut.
Auto. Ins. Co., 463 U.S. 29, 42 (1983).
‘‘While the removal of a regulation may
not entail the monetary expenditures
and other costs of enacting a new
standard, and accordingly, it may be
easier for an agency to justify a
deregulatory action, the direction in
which an agency chooses to move does
not alter the standard of judicial review
established by law.’’ Id.
The Act provides that in promulgating
health standards dealing with toxic
materials or harmful physical agents,
such as the January 9, 2017, final rule
regulating occupational exposure to
beryllium, the Secretary must set the
standard that most adequately assures,
to the extent feasible and 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).
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. See Indus. Union
Dep’t, AFL–CIO v. Am. Petroleum Inst.
(‘‘Benzene’’), 448 U.S. 607, 641–42
(1980) (plurality opinion). OSHA need
not make additional findings on risk for
this revised rule because OSHA
previously determined that the
beryllium standard addresses a
significant risk that can be eliminated or
lessened by a change in practices, see 82
FR 2545–52, and the changes and
clarifications in this final rule do not
affect that determination. See, e.g., Pub.
Citizen Health Research Grp. v. Tyson,
796 F.2d 1479, 1502 n.16 (D.C. Cir.
1986) (rejecting the argument that
OSHA must ‘‘find that each and every
aspect of its standard eliminates a
significant risk’’).
OSHA standards must also be both
technologically and economically
feasible. See United Steelworkers of
Am., AFL–CIO–CLC v. Marshall (‘‘Lead
I’’), 647 F.2d 1189, 1264 (D.C. Cir. 1980).
The Supreme Court has defined
feasibility as ‘‘capable of being done.’’
Am. Textile Mfrs. Inst. v. Donovan
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(‘‘Cotton Dust’’), 452 U.S. 490, 508–09
(1981). 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 [standard] in most of
its operations.’’ Lead I, 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 (internal
quotation marks and citations omitted).
OSHA exercises significant discretion
in carrying out its responsibilities under
the Act. Indeed, ‘‘[a] number of terms of
the statute give OSHA almost unlimited
discretion to devise means to achieve
the congressionally mandated goal’’ of
ensuring worker safety and health. See
Lead I, 647 F.2d at 1230 (citation
omitted). Thus, where OSHA has
chosen some measures to address a
significant risk over other measures,
parties challenging the OSHA standard
must ‘‘identify evidence that their
proposals would be feasible and
generate more than a de minimis benefit
to worker health.’’ N. Am.’s Bldg.
Trades Unions v. OSHA, 878 F.3d 271,
282 (D.C. Cir. 2017).
Although OSHA is required to set
standards ‘‘on the basis of the best
available evidence,’’ 29 U.S.C. 655(b)(5),
its determinations are ‘‘conclusive’’ if
supported by ‘‘substantial evidence in
the record considered as a whole,’’ 29
U.S.C. 655(f). Similarly, as the Supreme
Court noted in Benzene, OSHA must
look to ‘‘a body of reputable scientific
thought’’ in making determinations, but
a reviewing court must ‘‘give OSHA
some leeway where its findings must be
made on the frontiers of scientific
knowledge.’’ Benzene, 448 U.S. at 656.
When there is disputed scientific
evidence in the record, OSHA must
review the evidence on both sides and
‘‘reasonably resolve’’ the dispute. Tyson,
796 F.2d at 1500. The ‘‘possibility of
drawing two inconsistent conclusions
from the evidence does not prevent the
agency’s finding from being supported
by substantial evidence.’’ N. Am.’s Bldg.
Trades Unions, 878 F.3d at 291 (quoting
Cotton Dust, 452 U.S. at 523)
(alterations omitted). As the D.C. Circuit
has noted, where ‘‘OSHA has the
expertise we lack and it has exercised
that expertise by carefully reviewing the
scientific data,’’ a dispute within the
scientific community is not occasion for
the reviewing court to take sides about
which view is correct. Tyson, 796 F.2d
at 1500.
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Finally, because section 6(b)(5) of the
Act explicitly requires OSHA to set
health standards that eliminate risk ‘‘to
the extent feasible,’’ OSHA uses
feasibility analysis rather than costbenefit analysis to make standardssetting decisions dealing with toxic
materials or harmful physical agents. 29
U.S.C. 655(b)(5). An OSHA standard in
this area must be technologically and
economically feasible–and also cost
effective, which means that the
protective measures it requires are the
least costly of the available alternatives
that achieve the same level of
protection–but OSHA cannot choose an
alternative that provides a lower level of
protection for workers’ health simply
because it is less costly. See Int’l Union,
UAW v. OSHA, 37 F.3d 665, 668 (D.C.
Cir. 1994); see also Cotton Dust, 452
U.S. at 513 n.32. In Cotton Dust, the
Court explained that Congress itself had
defined the appropriate relationship
between costs and benefits by
prioritizing the ‘‘benefit’’ of worker
health above all other considerations,
save those that would make this
‘‘benefit’’ unachievable. The Court
further stated that any standard based
on a balancing of costs and benefits by
the Secretary that strikes a different
balance than that struck by Congress
would be inconsistent with the
command set forth in section 6(b)(5).
See Cotton Dust, 452 U.S. at 509. Thus,
while OSHA estimates the costs and
benefits of its proposed and final rules,
in part to ensure compliance with
requirements such as those in Executive
Orders 12866 and 13771, these
calculations do not form the basis for
the agency’s regulatory decisions.
IV. Final Economic Analysis and
Regulatory Flexibility Act Certification
(FEA)
A. Summary of Economic Impact
This rule amends OSHA’s existing
general industry standard for
occupational exposure to beryllium and
beryllium compounds (29 CFR
1910.1024) to clarify certain provisions
and simplify or improve compliance.
OSHA’s final economic analysis shows
that these changes will result in
unquantifiable cost savings, largely due
to the prevention of misinterpretation
and misapplication of the standard.
In promulgating the 2017 final rule,
OSHA determined that the beryllium
rule was both technologically and
economically feasible. See 82 FR at
2582–86, 2590–96, Summary of the
Final Economic Analysis. The changes
herein are intended to align the rule
more clearly with the intent of the 2017
final rule. Because OSHA has
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determined that this final rule will
decrease the costs of compliance by
preventing misinterpretation and
misapplication of the standard, and
would require no new controls or other
technology, OSHA has also determined
that the rule is both technologically and
economically feasible.
Because this final rule only clarifies
the existing beryllium standard or
makes minor revisions that will
generally aid in compliance, the revised
beryllium standard will maintain safety
and health protections for workers. And,
to the extent this final rule helps
employers avoid misapplication of the
beryllium standard’s requirements and
hence achieves greater compliance with
the standard’s intended meaning, there
will be increased protection for workers.
B. Final Economic Analysis and
Regulatory Flexibility Act Certification
Executive Orders 12866 and 13563,
the Regulatory Flexibility Act (5 U.S.C.
601–612), and the Unfunded Mandates
Reform Act (UMRA) (2 U.S.C. 1532(a))
require that OSHA estimate the benefits,
costs, and net benefits of regulations,
and analyze the impacts of certain rules
that OSHA promulgates. Executive
Order 13563 emphasizes the importance
of quantifying both costs and benefits,
reducing costs, harmonizing rules, and
promoting flexibility.
This final rule is not a ‘‘significant
regulatory action’’ under Executive
Order 12866 or the UMRA. Neither the
benefits nor the costs of this final rule
would exceed $100 million in any given
year. On the contrary, the possible
effects of each provision on costs and
benefits appear to be relatively small,
and OSHA has not been able to quantify
them. Nor has OSHA been able to
quantify the cost savings it expects from
preventing misinterpretation and
misapplication of the standard.
However, OSHA does expect that this
final rule will increase understanding
and compliance with the standard and,
therefore, the agency expects the rule to
result in some, unquantifiable cost
savings. Moreover, and as discussed
above, OSHA expects this final rule will
maintain safety and health protections
for workers.
1. Final Determinations Regarding Costs
and Cost Savings Attributable to the
Final Rule
In the Preliminary Economic Analysis
and Regulatory Flexibility Act
Certification (PEA) in the 2018 NPRM,
OSHA considered whether each of the
proposed changes could affect the costs
and, if so, how those costs might be
affected (83 FR at 63760–65). For the
purposes of the preliminary analysis,
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the agency divided the proposed
changes into two groups: (1) Proposed
clarifications and (2) proposed
revisions. The ‘‘proposed clarifications’’
were those that were solely intended to
clarify provisions and would not alter
the requirements and scope of the rule
(83 FR at 63760–61). The items OSHA
identified as clarifications included the
addition of a definition of beryllium
sensitization to paragraph (b); minor
changes to the definitions of CBD
diagnostic center and chronic beryllium
disease in paragraph (b); minor changes
to the written exposure control plan
provisions in paragraphs (f)(1)(i)(D) and
(f)(1)(ii)(B); a minor change in the PPE
removal provision of paragraph (h)(2)(i);
minor changes to provisions for the
cleaning of PPE in paragraph (h)(3)(iii);
minor changes to the cleaning of PPE
upon entry to eating or drinking areas in
paragraph (i)(4)(ii); and minor changes
to provisions for employee information
and training in paragraphs (m)(4)(ii)(A)
and (m)(4)(ii)(E) (83 FR at 63760–61).
The ‘‘proposed revisions,’’ on the
other hand, were those that would go
beyond clarification and alter certain
requirements of the beryllium standard
(83 FR at 63761). The proposed
provisions that OSHA identified as
revisions included changes to the
definitions of beryllium work area,
confirmed positive, and dermal contact
with beryllium in paragraph (b); a
change to the requirements for washing
facilities in paragraph (i)(1); a change to
the requirements for provision of change
rooms in paragraph (i)(2); changes to the
requirements pertaining to disposal and
recycling in paragraph (j)(3); a change to
the requirements for medical
surveillance following an employee’s
exposure to beryllium in an emergency
in paragraph (k)(2); revision to
provisions for evaluation at a CBD
diagnostic center in paragraph (k)(7)(i);
a change to the requirements for
warning labels in paragraph (m)(3); and
changes to the requirements for
recordkeeping in paragraphs
(n)(1)(ii)(F), (n)(3)(ii)(A), and (n)(4)(i).
After carefully reviewing the
proposed clarifications and revisions,
OSHA preliminarily determined that
their net total effect would result in
potential cost savings, mainly from
improving employer understanding and
facilitating application of the rule (83
FR at 63760–61). OSHA preliminarily
identified a new potential cost, which
would result from the proposed changes
as a whole: A de minimis cost for the
time employers would need to become
familiar with the revised portions of this
final rule (83 FR at 63761, 63765).
Viewing all the proposed changes as a
whole, OSHA explained that it
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preliminarily anticipated that the
proposed provisions’ net effect would
result in some cost savings (83 FR at
63761). OSHA invited comment on all
aspects of the PEA, including these
preliminary determinations (83 FR at
63760–62, 63764–65).
Stakeholders either agreed with or did
not comment on OSHA’s analysis of
potential costs and costs savings
attributable to the vast majority of the
proposed clarifications and revisions
(e.g., Document ID 0026, pp. 1–2; 0038,
pp. 21, 26, 32). The only objections the
agency received related to two of the
four proposed paragraphs that OSHA is
revising from the proposal in the final
rule: (1) The definition of the term
confirmed positive; and (2) the
requirement related to examinations at
CBD diagnostic centers (Document ID
0021, p. 4; 0022, pp. 5–6). Those
comments, and OSHA’s final
determination that each of the four
paragraphs that OSHA is revising from
the proposal will result in small and
unquantifiable cost savings, are
discussed in detail below.
OSHA has also examined the record
concerning the proposed clarifications
and revisions that OSHA has finalized
without change. As noted above,
stakeholders either agreed with or did
not comment on OSHA’s analysis of
potential costs and costs savings
attributable to these proposed changes.
Therefore, after carefully considering all
the comments received and the
remainder of the record, OSHA affirms
its preliminary determination that these
clarifications and revisions are likely to
result in cost savings, largely from
improving employer understanding and
facilitating application of the rule.
OSHA also affirms its preliminary
determination that the only potential
new costs are de minimis costs for the
time employers would need to become
familiar with the revised portions of this
final rule.
In summary, OSHA finds that both
the four paragraphs that OSHA is
revising from the proposal and the
remainder of the proposed clarifications
and revisions that OSHA is finalizing
without change in the final rule will
result in potential cost savings mainly
attributable to improving employer
understanding and facilitating
application of the rule, as well as
preventing costs that would follow from
misunderstanding the standard. OSHA
expects that the cost savings attributable
to these changes will offset the de
minimis employer familiarization costs,
resulting in a net result of cost savings.
Therefore, OSHA finds that this final
rule is likely to result in cost savings.
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2. Analysis of Costs and Costs Savings
Attributable to Provisions in the Final
Rule That Differ From Those in the
Proposal
In this section the agency discusses
the four changes in the final rule that
differ from the proposal: The definition
of confirmed positive in paragraph (b),
Definitions; a clarification to inter-plant
transfers in paragraph (j), Housekeeping;
and two changes to paragraph (k),
Medical Surveillance: Requirements
related to CBD diagnostic centers and
requirements for medical examination at
termination of employment. In all cases,
as stated above, the agency has
determined these will have de minimis
cost or cost savings implications.
Definition of Confirmed Positive.
The 2017 final rule did not specify a
time limit within which the BeLPT tests
that contribute toward a finding of
‘‘confirmed positive’’ must occur. In the
2018 NPRM, OSHA proposed to modify
the definition of confirmed positive to
require that the qualifying test results be
obtained within one testing cycle
(including the 30-day follow-up test
period required after a first abnormal or
borderline BeLPT test result), rather
than arguably over an unlimited time
period that might have led to false
positives that could needlessly concern
workers and their families, could lead
workers to undergo unnecessary testing,
and would not enhance worker
protections. In the PEA, OSHA
explained that the exact effect of the
proposed change was uncertain as it is
unknown how many employees would
have a series of BeLPT results associated
with a confirmed positive finding (two
abnormal results, one abnormal and one
borderline result, or three borderline
results) over an unlimited period of
time, but would not have any such
combination of results within a single
testing cycle (83 FR at 63761–62). OSHA
preliminarily concluded that the
proposed change would not increase
compliance costs and would
incidentally yield some cost savings by
lessening the likelihood of false
positives (83 FR at 63762). The agency
invited comment on its preliminary
conclusion (83 FR at 63762).
As discussed in Section XI, Summary
and Explanation for paragraph (b), a
number of stakeholders commented that
requiring results within a 30-day testing
cycle could create logistical challenges,
for example due to repeat testing
requirements or for businesses in remote
areas with limited healthcare facilities
(Document ID 0022, p. 4; 0021, p. 4;
0024, p. 1; 0033, p. 5; 0027, p. 3).
National Jewish Health (NJH) also
commented that removing the time
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frame of 30 days for confirming
abnormal results would allow for
employee workplace protection and
clinical evaluation referral at a lower
cost and with less logistical burden
(Document ID 0022, p. 5).
Stakeholders’ logistical concerns and
NJH’s comment about costs reflect a
misunderstanding of the proposed
change. As explained in more detail in
the Summary and Explanation for
paragraph (b), OSHA did not intend that
the initial and any follow-up tests had
to be completed and interpreted within
30 days. Rather, the agency intended
that the test results be obtained during
one cycle of testing, that is, an initial or
periodic examination followed by
follow-up testing conducted within 30
days of an abnormal or borderline
result. For example, if an employee
received a borderline BeLPT result at
his or her periodic examination,
paragraph (k)(3)(ii)(E) would require the
employer to offer a follow-up BeLPT
within 30 days of the test results. If the
follow-up BeLPT result was also
borderline, paragraph (k)(3)(ii)(E) would
again require the employer to offer a
follow-up BeLPT within 30 days of the
first follow-up test’s results. If that
second follow-up was borderline or
abnormal, the employee would have
been confirmed positive under the
proposal because all of the tests that
‘‘confirmed’’ the results were triggered
by the initial test. In other words, OSHA
did not intend to suggest that the
proposal would have required
employers to conduct all of the tests or
obtain the confirming results within a
single 30-day period.
In this final rule, OSHA has revised
the definition of confirmed positive to
specify that the findings of two
abnormal, one abnormal and one
borderline, or three borderline results
must be obtained from BeLPTs
conducted within a three-year period.
OSHA determined that this revision
strikes the appropriate balance between
the shorter time period for confirmation
in the proposal and the unspecified,
arguably indefinite, time period of the
original definition. As explained in the
Summary and Explanation section, the
final three-year period will capture the
identification of sensitized workers
enrolled in medical surveillance. OSHA
finds that the addition of a specific time
period to the text of the final rule will
decrease the possibility of a
misinterpretation of the provision’s time
frame that could lead to false positive
results.
As with the proposed revisions to this
definition, OSHA finds that the exact
effect of this change is uncertain
because it is unknown how many
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employees would have a series of
BeLPT results associated with a
confirmed positive finding (two
abnormal results, one abnormal and one
borderline result, or three borderline
results) over an unlimited period of
time, but would not have any such
combination of results within a threeyear testing cycle, though it is likely to
be small. As discussed in Section XI,
Summary and Explanation of the Final
Rule, NJH reported that in a group of
194 CBD patients in their care, the
length of time between abnormal results
ranged from 14 days to 5.8 years, with
a 95th percentile of 2.9 years. This
suggests that the vast majority of
individuals who will have two
abnormal BeLPT tests in the course of
medical surveillance are likely to be
confirmed positive within the three-year
window of time OSHA is establishing in
the definition of confirmed positive. The
Summary and Explanation section notes
further that a three-year testing cycle is
consistent with practices and
recommendations of the medical
community, pointing to the increasing
likelihood that a confirmed positive
finding over longer periods of time will
be a false-positive and lead to costly
further medical exams with no benefit.
Thus, OSHA concludes that this change
will not increase compliance costs and
will incidentally yield some cost
savings by lessening the likelihood of
false positives.
Disposal, Recycling, and Reuse.
Paragraph (j)(3) of the previous
standard (29 CFR 1910.1024(j)(3))
addresses disposal and recycling of
materials that contain beryllium in
concentrations of 0.1 percent by weight
or more or that are contaminated with
beryllium. In the 2018 NPRM, OSHA
proposed to modify this paragraph in a
number of ways—all of which the
agency preliminarily found would not
increase the costs of complying with the
standard and may also result in
unquantifiable savings to employers by
preventing misinterpretation or
misapplication of the rule (83 FR at
63762–63). Stakeholders did not offer
any comments objecting to this
preliminary determination. With the
exception of one minor clarification to
the regulatory text, discussed below,
OSHA is adopting all of the proposed
revisions to paragraph (j)(3) in this final
rule. After reviewing the record as a
whole and having received no evidence
or comment to the contrary, the agency
reaffirms its preliminary determination
that the proposed revisions to paragraph
(j)(3) that are being adopted in this final
rule will result in some cost savings
from increased employer understanding.
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OSHA has made one change to the
proposed provisions in paragraph (j)(3)
in this final rule. When employers
transfer certain materials to another
party for disposal, recycling, or reuse,
proposed paragraph (j)(3)(i) would have
required employers to label the
materials in accordance with paragraph
(m)(3) of the standard. As explained in
the Summary and Explanation for
paragraph (j)(3), a comment alerted the
agency to a potential ambiguity in this
proposed text. Specifically, OSHA
realized that the phrase ‘‘to another
party’’ could be read to suggest that
transfers between two facilities owned
by the same employer are exempted
from the labeling requirements in
paragraph (j)(3)(i). That was not the
agency’s intent in the proposal. To
eliminate any ambiguity on this point,
OSHA revised paragraph (j)(3)(i) in the
final rule to strike the phrase ‘‘to
another party’’ and add the ‘‘except for
intra-plant transfers’’ language that is
found in paragraphs (j)(3)(ii) and (iii).
As with the proposed changes to
paragraphs (j)(3)(ii) and (iii), which
clarified that those paragraphs’
requirements did not apply to intraplant transfers, OSHA finds that this
proposed change is not a substantive
change to the standard. It is simply
clarifying OSHA’s original intent that all
transfers outside of a plant, including
between facilities owned by the same
employer, are subject to the labeling
requirements of paragraph (m)(3). Since
this change does not alter the
requirements of the standard, it will not
affect the costs of compliance with the
standard. Therefore, OSHA finds that
none of the changes this final rule
makes to paragraph (j)(3) will increase
the costs of complying with the
standard.
Medical Surveillance.
In the 2018 NPRM, OSHA proposed
two sets of changes to paragraph (k).
The first set of changes proposed is in
paragraph (k)(2), which specifies when
and how frequently medical
examinations are to be offered to those
employees covered by the medical
surveillance program. Paragraph
(k)(2)(i)(B) of the previous standard
required the employer to provide a
medical examination within 30 days
after determining that the employee
shows signs or symptoms of CBD or
other beryllium-related health effects or
that the employee has been exposed to
beryllium in an emergency.
Based on stakeholder feedback and
other evidence indicating that the 30day period in the previous standard may
be insufficient to detect beryllium
sensitization in individuals exposed one
time in an emergency, OSHA proposed
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removing the requirement for a medical
examination within 30 days of exposure
to beryllium during an emergency,
under paragraph (k)(2)(i)(B), and adding
paragraph (k)(2)(iv), which would
require the employer to offer a medical
examination at least one year after but
no more than two years after the
employee is exposed to beryllium
during an emergency (83 FR at 63757).
In the PEA, OSHA preliminarily
determined that the net cost impact of
these proposed changes would be slight,
with some possible cost savings.
Specifically, OSHA explained that, in
the FEA for the 2017 final rule, the
agency estimated that emergencies
would affect a very small number of
employees in a given year, likely less
than 0.1 percent of the affected
population, representing a small
addition to the costs of medical
surveillance for the standard (Document
ID OSHA–H005C–2006–0870–2042, p.
V–196). Under the 2017 final rule, some
employees might have required two
examinations to be confirmed positive:
A first test cycle within the initial 30day period and a second BeLPT at least
two years later. Under the 2018 NPRM,
OSHA expected that more of the
employees who became sensitized from
exposure in an emergency would be
confirmed positive through a single
testing cycle because that test would
have been administrated one to two
years following the emergency. The
agency anticipated that the proposed
change would result in the elimination
of one premature testing, which would
ensure better detection for more
employees and incidentally trigger some
cost savings (83 FR at 63764).3
To the extent that lengthening the
time period in which the test must be
offered from within 30 days to between
one and two years leads to earlier
confirmed positive results (within two
years, as opposed to within two years
plus 30 days), OSHA preliminarily
found that the proposed change could
slightly accelerate costs to the employer
for earlier CBD diagnostic center referral
and medical removal protection. OSHA
estimated that the proposed change
would affect a very small percentage of
an already very small population. The
agency preliminarily determined that
the proposed revision would only
potentially change the timing of the
already-required BeLPT, CBD diagnostic
center referral, and medical removal
protection (83 FR at 63764, 63764 n.5).
3 Assuming that this initial analysis does not
result in a confirmed positive diagnosis, that
employee would not be confirmed positive until a
second test two years later under the current rule.
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42587
In summary, OSHA preliminarily
found that the end result of the
proposed changes to paragraph (k)(2)
from a cost perspective would be that
the cost savings from the potential
avoidance of a premature BeLPT within
30 days following an emergency would
likely be largely canceled out by the
acceleration of the cost of the CBD
diagnostic center evaluation and
medical removal protection. Therefore,
OSHA preliminarily determined that the
net cost impact of the proposed changes
would be slight, with some possible cost
savings (83 FR at 63764). Stakeholders
did not submit any comments related to
OSHA’s preliminary determinations
regarding potential costs of the
proposed revisions to paragraph (k)(2).
In sum, after considering the record as
a whole, OSHA finds that its
preliminary estimates were correct: A
small change in costs, with possible cost
savings. Nevertheless, as discussed in
more detail in the Summary and
Explanation for paragraph (k), Medical
Surveillance, some stakeholders
expressed concerns about possible
delays in medical consultations and
examinations and lack of employee
knowledge of potential health effects,
and one stakeholder argued that
employees who terminate employment
before receiving the post-emergency
examination might not receive an
examination at all after being exposed in
an emergency (Document ID 0023, pp.
2–3; 0024, p. 2; 0027, p. 4).
OSHA is revising paragraphs (k)(2) in
the final rule in two ways to address
these concerns. First, OSHA has added
two sub-provisions under paragraph
(k)(2)(iv) to provide for post-emergency
examination timing for two separate
groups of employees. Final paragraph
(k)(2)(iv)(A) focuses on the very small
group of employees who are exposed in
an emergency but have not received a
medical examination under paragraph
(k)(1)(i) within the previous two years.
The requirement for these employees is
similar to the requirement contained in
the previous standard; i.e., under the
final standard, the employer must
provide these employees with a medical
examination within 30 days of the date
of the emergency. Because the final
standard treats these employees
similarly to the manner in which the
previous standard treated all employees
exposed in an emergency, OSHA does
not expect that there will be any change
in cost attributable to this change. In
other words, for those employees who
have not had a medical examination
within the past two years there is no
change in protocol and, thus, no change
in costs.
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Final paragraph (k)(2)(iv)(B) focuses
on employees who are exposed during
an emergency, but have recently
received an examination. Under this
new provision, if an employee has
received a medical examination under
paragraph (k)(1)(i) within the previous
two years, then the employer would be
required to offer that employee a
medical examination that meets the
requirements of the standard at least one
year but no more than two years after
the employee was exposed to beryllium
in an emergency. Because this provision
treats employees who have recently
received an examination similarly to the
manner in which the proposal would
have treated all employees exposed in
an emergency, OSHA expects that this
change will result in a fraction of the
small cost savings preliminarily
estimated in the proposal.
Second, to address concerns that
delaying the medical examination to at
least one year and no more than two
years following the emergency may
result in employees not receiving a postemergency examination if their
employment ends soon after exposure
during an emergency, OSHA is revising
paragraph (k)(2)(iii) to require that each
employee who is exposed in an
emergency and has not received an
examination since the emergency
exposure is provided an examination at
the time employment is terminated.
Because paragraph (k)(2)(iii) already
requires an examination at termination
if there has not been one within the last
six months due to any of the standard
medical exam triggers, including
emergency exposure, OSHA expects that
this change will affect an extremely
small group of employees. This revision,
however, will ensure that all employees
with emergency exposure are offered a
medical exam, even under this very
narrow set of circumstances. The
baseline of costs and cost savings of this
analysis is the previous rule, which
already required a medical exam within
30 days of emergency exposure. Thus,
OSHA does not expect that this change
will have any cost implications.
In summary, OSHA finds that this
final rule’s revisions to paragraph (k)(2)
will result in slight cost savings. No
costs or costs savings are attributable to
new paragraph (k)(2)(iv)(A), which
treats employees exposed in an
emergency who have not received a
medical examination within the
previous two years pursuant to
paragraph (k)(1)(i) similarly to how all
employees exposed in an emergency
were treated under the previous
standard. The end result of final
paragraph (k)(2)(iv)(B), however, will be
cost savings from the potential
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avoidance of a premature BeLPT that are
largely offset by the acceleration of the
cost of the CBD diagnostic center
evaluation and medical removal
protection. OSHA does not attribute any
costs or cost savings to result from the
revisions to paragraph (k)(2)(iii).
Therefore, the agency expects the new
result of final paragraph (k)(2) to be a
slight cost savings.
The second set of changes proposed to
the standard’s medical surveillance
requirements is in paragraph (k)(7),
which contains the requirements for
evaluation at a CBD diagnostic center.
Paragraph (k)(7)(i) of the previous rule
required employers to provide an
evaluation at no cost to the employee at
a CBD diagnostic center that is mutually
agreed upon by the employee and
employer within 30 days of the
employer receiving a written medical
opinion that recommends referral to a
CBD diagnostic center, or a written
medical report indicating that the
employee has been confirmed positive
or diagnosed with CBD. To address
stakeholder concerns that scheduling
the appropriate tests with an examining
physician at the CBD diagnostic center
may take longer than 30 days, OSHA
proposed that the employer provide an
initial consultation with the CBD
diagnostic center, rather than the full
evaluation, within 30 days of the
employer receiving one of the types of
documentation listed in paragraph
(k)(7)(i)(A) or (B). The agency noted that
the consultation could occur via
telephone or virtual conferencing
methods and would demonstrate that
the employer made an effort to begin the
process for a medical examination (83
FR at 63758). Evaluation and any testing
would then occur within a reasonable
time after the consultation.
In the PEA, OSHA noted that while
the addition of the consultation would
not result in any additional costs or cost
savings (since the 2017 FEA had already
accounted for a 15-minute discussion
between the employee and a physician
(Document ID OSHA–H005C–2006–
0870–2042, p. V–206)), allowing more
flexibility in scheduling the tests at the
CBD diagnostic center would enable
employers to find more economical
travel and accommodation options. To
the extent that it takes longer than 30
days to schedule the tests at the CBD
diagnostic center, the agency
preliminarily found that employers may
realize a cost savings due to retaining
funds during the delay. OSHA could not
quantify the effect of this flexibility,
however, concluding only that it
expected that the changes would
produce minor, if any, cost savings. The
agency invited comment on its
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preliminary assessment of these
potential effects (83 FR at 63764).
Stakeholders did not offer any
comments on the agency’s preliminary
estimates regarding the cost savings
attributable to these proposed changes.
Several commenters objected to adding
the consultation requirement, however,
arguing that it was an unnecessary step
that would add logistical complications
and costs (see, e.g., Document ID 0021,
p. 3; 022, p. 6). This is discussed in
more detail in the Summary and
Explanation for paragraph (k), Medical
Surveillance. After considering these
comments and the record as a whole,
OSHA decided to modify paragraph
(k)(7)(i) to require that the employer
within 30 days of receiving one of the
types of documentation listed in
paragraph (k)(7)(i)(A) or (B) schedule an
evaluation at a CBD diagnostic center. In
addition, OSHA is adding a requirement
that the evaluation itself must occur
within a reasonable time.
OSHA finds that these changes may
slightly delay the incidence of costs of
an evaluation under paragraph (k)(7)(i),
in that it may occur at a later date in
some cases than under the existing
provision. This would slightly decrease
the costs of compliance with the
standard. The agency also finds that
allowing the evaluation to occur within
a reasonable time, rather than within 30
days, may allow for more cost-effective
travel and accommodation options.
Thus, as with the proposal, OSHA
concludes that these changes may
produce minor cost savings.
To account for a proposed change to
the definition of CBD diagnostic center,
the proposed rule would also have
amended paragraph (k)(7)(i) to clarify
that the employer must provide, at no
cost to the employee and within a
reasonable time after consultation with
the CBD diagnostic center, any of the
following tests that a CBD diagnostic
center must be capable of performing, if
deemed appropriate by the examining
physician at the CBD diagnostic center:
A pulmonary function test as outlined
by American Thoracic Society criteria
testing, bronchoalveolar lavage (BAL),
and transbronchial biopsy. In the PEA,
OSHA explained that this proposed
change would not alter the requirements
of the standard and therefore would not
change the costs of compliance with the
standard (83 FR at 63764).
Stakeholders did not offer any
comments on OSHA’s determination
that these proposed changes would not
affect costs. Some stakeholders argued,
however, that the proposed provision
could be misinterpreted to mean that
the employer does not have to make
available other tests that the examining
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physician deems appropriate for reasons
such as diagnosing or determining the
severity of CBD (Document ID 0021, p.
3; 0022, p. 3; 0028, p. 2). This is
discussed in more detail in the
Summary and Explanation for
paragraph (k), Medical Surveillance. To
address these concerns, OSHA is adding
a new provision, paragraph (k)(7)(ii),
which clarifies that, as part of the
evaluation at the CBD diagnostic center,
the employer must ensure that the
employee is offered any tests deemed
appropriate by the examining physician
at the CBD diagnostic center, such as
pulmonary function testing as outlined
by American Thoracic Society criteria
testing, bronchoalveolar lavage (BAL),
and transbronchial biopsy.4 If any of
these tests deemed appropriate by the
examining physician are not available at
the CBD diagnostic center, the final rule
allows them to be performed at another
location that is mutually agreed upon by
the employer and the employee.
OSHA does not believe that requiring
employers to provide any tests deemed
appropriate by the examining physician
would change the costs of compliance
with the standard because the agency
accounted for such costs in the 2017
final rule.5 Specifically, when
calculating the unit cost for going to a
CBD diagnostic center in the 2017 FEA,
the agency used a typical suite of tests
that would be performed (Document ID
OSHA–H005C–2006–0870–2042, p. V–
205). Consequently, OSHA’s unit cost in
the 2017 final rule for an evaluation at
a CBD diagnostic center was an average
for standard tests that are required. The
agency finds that this average set of tests
by definition is constructed to give the
average cost for the tests deemed
appropriate by the examining physician
and, thus, concludes that there are no
costs or cost savings attributable to this
change.
Paragraph (k)(7)(ii) requires that if any
test deemed appropriate by the
examining physician is not available at
the CBD diagnostic center, the test must
be performed at another location that is
mutually agreed to by the employer and
employee. OSHA believes that such
circumstances would be very rare. CBD
diagnostic centers with the ability to
4 As
discussed in Section XI, Summary and
Explanation of the Final Rule, OSHA also
redesignated previous paragraphs (k)(7)(ii), (iii),
(iv), and (v) as paragraphs (k)(7)(iii), (iv), (v), and
(vi), respectively. This redesignation in paragraph
(k) also affects a reference in paragraph (l)(1)(ii).
These changes are merely administrative and do not
have any substantive or monetary effect.
5 As discussed in the Summary and Explanation
for paragraph (k), Medical Surveillance, OSHA
never intended to limit the required tests to the
three tests listed in the previous definition of the
term CBD diagnostic center.
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perform pulmonary function testing (as
outlined by the American Thoracic
Society criteria), bronchoalveolar lavage
(BAL), and transbronchial biopsy are
most likely to also provide other
medical tests related to CBD.6 As a
result, the CBD diagnostic center in the
vast majority of cases will be able to
offer the additional testing deemed
necessary by the examining physician.
Moreover, because the three tests noted
above are the tests that are commonly
needed to diagnose CBD, OSHA expects
that these are the tests that would most
commonly be performed (see Section XI,
Summary and Explanation of the Final
Rule). Given that this standard requires
CBD diagnostic centers to be able to
perform the three tests that are most
commonly performed to diagnose CBD
and CBD diagnostic centers typically
would be able to offer any additional
tests deemed necessary, OSHA expects
that employees would rarely, if ever,
need to travel to a second location.7 In
those rare cases, the added flexibility of
having the tests performed outside of a
CBD diagnostic center gives more
options for the employer and employee
and should lead to cost savings. Because
this situation should be quite
uncommon, OSHA expects that the cost
savings of allowing employees to have
additional tests outside of a CBD
diagnostic center are likely to be de
minimis.
This change to paragraph (k)(7)
clarifies OSHA’s intent that the
employer provide any tests deemed
appropriate by the examining physician
at the CBD diagnostic center, or at
another location if not available at the
CBD diagnostic center, but does not
substantively change the requirements
of the beryllium standard. OSHA
expects that the changes described here
would maintain safety and health
protections for workers.
6 Document ID OSHA–H005C–2006–0870–0637
provides some information from the NJH website,
which provides an overview of the types of tests
performed.
7 OSHA also notes that it has always intended for
employers to make available any additional tests
deemed appropriate by the examining physician
(see the discussion of paragraph (k), Medical
Surveillance, in Section XI, Summary and
Explanation of the Final Rule, of this preamble).
The economic analysis of the 2017 final rule did not
explicitly account for these rare cases where a test
recommended by the examining physician of the
CBD diagnostic center was not available at the same
center. Hence, there would be a de minimis cost
adjustment increase of the total cost of the 2017
final rule due to this consideration. This is not a
change in people’s behavior, simply a
methodological change. The current final rule could
affect people’s behavior and be a true change
(decrease) in costs. This change merely provides
employers with a more flexible, potentially less
expensive, manner to provide those tests in the rare
situation where they are not available at the original
CBD diagnostic center.
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3. Economic and Technological
Feasibility
In the FEA in support of OSHA’s 2017
Beryllium Final Rule, OSHA concluded
that the general industry beryllium
standard was economically and
technologically feasible (see 82 FR at
2471). In the 2018 NPRM, OSHA
explained that it anticipated that none
of the proposed changes would impose
any new employer obligations or
increase the overall cost of compliance,
while some of the changes would clarify
and simplify compliance in such a way
that results in cost savings. In addition,
OSHA preliminarily anticipated that the
de minimis cost of any time spent
reviewing the proposed changes would
be more than offset by the cost savings
described in the PEA. OSHA further
found that none of the proposed
revisions would require any new
controls or other technology. OSHA
therefore preliminarily determined that
the proposed rule was both
economically and technologically
feasible. OSHA did not receive any
comments objecting to or otherwise
questioning this preliminary
determination.8 Therefore, after
considering the record as a whole,
OSHA finds that the proposed
provisions that are being adopted in this
final rule are economically and
technologically feasible.
OSHA also finds that the few new
changes between the proposal and the
final rule would not require any new
controls or other technology and will
result in cost savings. Therefore, OSHA
finds that these final provisions, and the
final rule as a whole, are economically
and technologically feasible.
4. Effects on Benefits
In the 2017 FEA, OSHA attributed
approximately 67 percent of the
beryllium sensitization cases and the
CBD cases avoided, and none of the
lung cancer cases avoided, solely to the
ancillary provisions of the standard
(Document ID OSHA–H005C–2006–
0870–2042, pp. VII–4 to VII–5, VII–24).
This estimate was based on the ancillary
provisions as a whole, rather than each
provision separately.
8 Although the agency did not receive any
comments questioning the economic or
technological feasibility of the proposed changes, at
least one stakeholder argued that the previous
standard was not economically or technologically
feasible and that the proposed provisions remedied
some of that stakeholder’s concerns with feasibility
(Document ID 0038, pp. 13, 21–22, 43). Because the
feasibility of the January 2017 final rule as a whole
is not at issue in this rulemaking, OSHA considers
these comments indicating that these changes
provide both economic and technological feasibility
relief as support for the economic and technological
feasibility of the proposed revisions.
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In the PEA, OSHA considered the
potential effect of each proposed change
to ancillary provisions on employee
protections. Because the proposed
revisions to the standard would not
remove or change the general nature of
any ancillary provisions, and because
the agency expected the proposed
revisions to maintain safety and health
protections for workers and facilitate
employer understanding and
compliance, OSHA preliminarily
determined that the proposed changes
would increase the standard’s benefits
as a whole by enhancing worker
protections overall and by preventing
costs that follow from misunderstanding
the standard.
OSHA did not receive any comments
related to its preliminary assessment of
the proposed provisions’ effects on
benefits. Having considered the record
as a whole, including all the comments
received, OSHA finds that the changes
in this final rule will maintain safety
and health protections for workers
while aligning the standard with the
intent behind the 2017 final rule and
otherwise preventing costs that could
follow from misinterpretation or
misapplication of the standard. And the
agency reaffirms its determination that
facilitating employer understanding and
compliance has the benefit of enhancing
worker protections overall. Therefore,
OSHA finds that the changes in this
final rule will increase the benefits of
the standard as a whole.
5. Regulatory Flexibility Act
Certification
In accordance with the Regulatory
Flexibility Act, 5 U.S.C. 601 et seq. (as
amended), OSHA has examined the
regulatory requirements of this final rule
to revise the general industry beryllium
standard to determine whether they
would have a significant economic
impact on a substantial number of small
entities. The final rule modifies the
general industry standard to clarify
certain provisions and simplify or
improve compliance. It does not impose
any new duties or increase the overall
cost of compliance, and OSHA expects
it will provide some cost savings. OSHA
therefore expects that this final rule will
not have a significant economic impact
on any small entities. Accordingly,
OSHA certifies that this final rule will
not have a significant economic impact
on a substantial number of small
entities.
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V. Office of Management and Budget
(OMB) Review Under the Paperwork
Reduction Act of 1995
A. Overview
This final rule revises information
collection (paperwork) requirements in
the occupational exposure to beryllium
in general industry (29 CFR 1910.1024)
standard that are subject to Office of
Management and Budget (OMB)
approval under the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C.
3501 et seq.) and its implementing
regulations (5 CFR part 1320). OSHA is
revising the previously approved
paperwork package under OMB control
number 1218–0267, as it pertains to
general industry only. The collection of
information items contained in the
Information Collection Request (ICR)
pertaining to occupational exposure to
beryllium in the construction and
shipyard sectors remain in the ICR
without change.
The PRA generally requires that
agencies consider the impact of
paperwork and other information
collection burdens imposed on the
public, obtain public input, and obtain
approval from OMB before conducting
any collection of information (44 U.S.C.
3507). The PRA defines a collection of
information as ‘‘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)). Federal agencies
generally cannot conduct or sponsor a
collection of information, and the public
is generally not required to respond to
an information collection, unless it is
approved by OMB under the PRA and
displays a valid OMB control number
(44 U.S.C. 3507). 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 valid OMB control number (44
U.S.C. 3512).
B. Solicitation of Comments
On January 9, 2017, OSHA published
a final rule establishing new permissible
exposure limits and other provisions to
protect employees from beryllium
exposure, such as requirements for
exposure assessment, respiratory
protection, personal protective clothing
and equipment, housekeeping, medical
surveillance, hazard communication,
and recordkeeping for the general
industry, construction, and shipyard
sectors. OMB approved the collections
of information contained in the final
rule under OMB Control Number 1218–
0267.
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On December 11, 2018, OSHA
published a Notice of Proposed
Rulemaking (NPRM) to modify the
general industry beryllium standard by
clarifying certain provisions to improve
and simplify compliance (83 FR 63746).
The 2018 NPRM proposed to revise the
collections of information contained in
the general industry standard by
modifying provisions for the written
exposure control plan; the cleaning and
replacement of personal protection
equipment; the disposal, recycling, and
reuse of contaminated materials; certain
aspects of medical surveillance; and the
collection of social security numbers in
recordkeeping. OSHA prepared and
submitted to OMB an ICR for the 2018
proposed rule for review in accordance
with 44 U.S.C. 3507(d). A copy of the
proposed ICR is available to the public
at https://www.reginfo.gov/public/do/
PRAOMBHistory?ombControlNumber=
1218-0267.
In accordance with the PRA (44
U.S.C. 3506(c)(2)), OSHA solicited
public comments on the collection of
information contained in the 2018
proposed rule. OSHA encouraged
commenters to submit their comments
on the information collection
requirements contained in the proposed
rule under docket number OSHA–2018–
0003, along with their comments on
other parts of the proposed rule. In
addition to generally soliciting
comments on the collection of
information requirements, the proposed
rule indicated that OSHA and OMB
were particularly interested in the
following items:
• Whether the proposed collection of
information is necessary for the proper
performance of the agency’s functions,
including whether the information is
useful;
• The accuracy of the agency’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used;
• The quality, utility, and clarity of
the information to be collected; and
• Ways to minimize the compliance
burden on employers, for example,
through the use of automated or other
technological techniques for collecting
and transmitting information (83 FR
63766).
On March 29, 2019, OMB issued a
Notice of Action (NOA) stating, ‘‘Terms
of the previous clearance remain in
effect. OMB is withholding approval at
this time. Prior to publication of the
final rule, the agency should provide a
summary of any comments related to
the information collection and their
response, including any changes made
to the ICR as a result of comments. In
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addition, the agency must enter the
correct burden estimates’’ (see OMB
Conclusion Action on ICR Reference No.
201812–1218–001, dated March 29,
2019, available at: https://www.reginfo.
gov/public/do/PRAOMBHistory?
ombControlNumber=1218-0267).
The agency did not receive any public
comments in response to the proposed
ICR submitted to OMB for review.
Public comments submitted in response
to the NPRM, however, substantively
addressed provisions containing
collection of information. OSHA
considered these comments when it
developed the revised ICR for this final
rule. Summaries of comments received
on the NPRM and OSHA’s responses are
found in Sections XI, Summary and
Explanation of the Final Rule, and IV,
Final Economic Analysis and
Regulatory Flexibility Act Certification.
The Department of Labor submitted
the final ICR concurrent with the
publication of this final rule, containing
the full analysis and description of the
burden hours and costs associated with
the final rule, to OMB for approval. A
copy of this ICR will be available to the
public at https://www.reginfo.gov/public/
do/PRAViewICR?ref_nbr=202006-1218006 (this link will become active on the
day following publication of this
notice). At the conclusion of OMB’s
review, OSHA will publish a separate
notice in the Federal Register to
announce the results.
C. Summary of Information Collection
Requirements
As required by 5 CFR 1320.5(a)(1)(iv)
and 1320.8(d)(2), the following
paragraphs provide information about
the ICR.
1. Title: Beryllium Standard for
General Industry (29 CFR 1910.1024),
Construction (29 CFR 1926.1124), and
Maritime (29 CFR 1915.1024).
2. Type of Review: Revision.
3. OMB Control Number: 1218–0267.
4. Affected Public: Business or Other
For-Profit. This final rule 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).
5. Occupational Exposure to
Beryllium in General Industry only:
a. Number of Respondents: 4,538.
b. Frequency of Responses: On
occasion, quarterly, semi-annually,
annually, biannually.
c. Number of Responses: 134,570.
d. Estimated Total Burden Hours:
82,822.
e. Estimated Cost: $18,741,540.
6. Occupational Exposure to
Beryllium in Construction and Shipyard
Sectors (previously-approved costs not
affected by this rulemaking):
a. Number of Respondents: 2,796.
b. Frequency of responses: On
occasion, quarterly, semi-annually,
annually, biannually.
42591
c. Number of responses: 39,420.
d. Estimated Total Burden Hours:
25,269.
e. Estimated Cost: $8,774,874.
7. Total Estimated Burden Hours and
Cost for All Three Industries:
a. Estimated Total Number of
responses: 173,990.
b. Estimated Total Burden Hours:
108,091.
c. Estimated Cost: $27,516,414.
D. Summary of Changes in the
Collection of Information Requirements
This final standard for occupational
exposure to beryllium and beryllium
compounds in general industry revises
the collection of information
requirements contained in the existing
ICR for general industry, approved
under OMB control number 1218–0267.
OSHA is updating the new ICR to reflect
those changes, which include changes
to the written exposure control plan; the
cleaning and replacement of personal
protection equipment; the disposal,
recycling, and reuse of contaminated
materials; certain aspects of medical
surveillance; and the collection of
Social Security numbers in
recordkeeping (see Table V.1 below).
The majority of these changes were
adopted by the agency as proposed.
However, in response to comments on
the proposed rule, OSHA has revised a
few of the provisions of the final rule
that affect the collection of information.
Those changes are also noted in Table
V.1 below.
TABLE V.1—CHANGES TO COLLECTION OF INFORMATION REQUIREMENTS IN THE FINAL RULE FOR GENERAL INDUSTRY
Information collection requirements in this final rule
Explanation of this final rule’s changes to the
information collection requirements
§ 1910.1024(f)(1)(i), (ii), & (iii)—Methods of Compliance—Written Exposure Control Plan ...........
(i) The employer must establish, implement, and maintain a written exposure control plan,
which must contain:
(A) A list of operations and job titles reasonably expected to involve airborne exposure to
or dermal contact with beryllium;
(B) A list of operations and job titles reasonably expected to involve airborne exposure at
or above the action level;
(C) A list of operations and job titles reasonably expected to involve airborne exposure
above the TWA PEL or STEL;
(D) Procedures for minimizing cross-contamination, including the transfer of beryllium between surfaces, equipment, clothing, materials, and articles within beryllium work areas;
(E) Procedures for keeping surfaces 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) A list of engineering controls, work practices, and respiratory protection required by
paragraph (f)(2) of this standard;
(H) A list of personal protective clothing and equipment required by paragraph (h) of this
standard; and
(I) Procedures for removing, laundering, storing, cleaning, repairing, and disposing of beryllium-contaminated personal protective clothing and equipment, including respirators.
(ii) The employer must review and evaluate the effectiveness of each written exposure control
plan at least annually and update it, as necessary, 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
airborne exposure to beryllium;
This final rule removed the word ‘‘preventing’’
from (f)(i)(D), which previously contained the
phrase ‘‘including preventing the transfer of
beryllium.’’ In addition, the final rule revised
(f)(1)(ii)(B) by replacing the phrase ‘‘airborne
exposure to or dermal contact with beryllium’’ with ‘‘exposure to beryllium.’’ Both of
these changes were adopted as proposed.
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TABLE V.1—CHANGES TO COLLECTION OF INFORMATION REQUIREMENTS IN THE FINAL RULE FOR GENERAL INDUSTRY—
Continued
Explanation of this final rule’s changes to the
information collection requirements
Information collection requirements in this final rule
(B) The employer is notified that an employee is eligible for medical removal in accordance
with paragraph (l)(1) of this standard for evaluation at a CBD diagnostic center, or
shows signs or symptoms associated with exposure to beryllium; or
(C) The employer has any reason to believe that new or additional airborne exposure is
occurring or will occur.
(iii) The employer must make a copy of the written 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(h)(3)(iii)—Personal Protective Clothing and Equipment—Cleaning and Replacement.
(3)(iii) The employer must inform in writing the persons or the business entities who launder,
clean, or repair the personal protective clothing or equipment required by this standard of the
potentially harmful effects of exposure to beryllium and that the personal protective clothing
and equipment must be handled in accordance with this standard.
§ 1910.1024(j)(3)(i), (ii), & (iii)—Housekeeping—Disposal, recycling, and reuse ...........................
(3)(i) Except for intra-plant transfers, when the employer transfers materials that contain at
least 0.1% beryllium by weight or are contaminated with beryllium for disposal, recycling, or
reuse, the employer must label the materials in accordance with paragraph (m)(3) of this
standard;
(ii) Except for intra-plant transfers, materials designated for disposal that contain at least 0.1%
beryllium by weight or are contaminated with beryllium must be cleaned to be as free as
practicable of beryllium or placed in enclosures that prevent the release of beryllium-containing particulate or solutions under normal conditions of use, storage, or transport, such as
bags or containers; and
(iii) Except for intra-plant transfers, materials designated for recycling or reuse that contain at
least 0.1% beryllium by weight or are contaminated with beryllium must be cleaned to be as
free as practicable of beryllium or placed in enclosures that prevent the release of berylliumcontaining particulate or solutions under normal conditions of use, storage, or transport, such
as bags or containers.
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This final rule revised (h)(3)(iii) by replacing the
phrase ‘‘airborne exposure to and dermal
contact with beryllium’’ with ‘‘exposure to beryllium.’’ This change was adopted as proposed.
This final rule revised (j)(3) by explicitly addressing transferring materials for reuse; reorganizing the previous two provisions into
three to allow the agency to incorporate the
new reuse requirements, while also setting
out each distinct obligation clearly; replacing
the phrase materials ‘‘that contain beryllium
in concentrations of 0.1 percent by weight or
more’’ with a shorter, easier to understand
phrase: Materials ‘‘that contain at least 0.1
percent beryllium by weight;’’ clarifying that
the rule’s requirements for disposal, recycling, and reuse do not apply to intra-plant
transfers; clarifying the enclosure requirements by providing more detail on what constitutes an appropriate enclosure; allowing
for the cleaning of materials bound for disposal; and removing the undefined phrase
‘‘surface beryllium contamination.’’
In addition to the above actions, which were all
adopted as proposed, in this final rule,
OSHA revised paragraph (j)(3)(i) to explicitly
incorporate the clarification that the rule’s requirements for disposal, recycling, and reuse
do not apply to intra-plant transfers.
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42593
TABLE V.1—CHANGES TO COLLECTION OF INFORMATION REQUIREMENTS IN THE FINAL RULE FOR GENERAL INDUSTRY—
Continued
Information collection requirements in this final rule
Explanation of this final rule’s changes to the
information collection requirements
§ 1910.1024(k)(2)—Medical Surveillance. (2) Frequency ...............................................................
The employer must provide a medical examination:
(i) Within 30 days after determining that:
(A) An employee meets the criteria of paragraph (k)(1)(i)(A), unless the employee has received a medical examination, provided in accordance with this standard, within the last
two years; or
(B) An employee meets the criteria of paragraph (k)(1)(i)(B) of this standard.
(ii) At least every two years thereafter for each employee who continues to meet the criteria of
paragraph (k)(1)(i)(A), (B), or (D) of this standard.
(iii) At the termination of employment for each employee who meets any of the criteria of paragraph (k)(1)(i) of this standard at the time the employee’s employment terminates, unless an
examination has been provided in accordance with this standard during the six months prior
to the date of termination. Each employee who meets the criteria of paragraph (k)(1)(i)(C) of
this standard and who has not received an examination since exposure to beryllium during
the emergency must be provided an examination at the time the employee’s employment terminates.
(iv) For an employee who meets the criteria of paragraph (k)(1)(i)(C) of this standard:
(A) If that employee has not received a medical examination within the previous two years
pursuant to paragraph (k)(1)(i) of this standard, then within 30 days after the employee
meets the criteria of paragraph (k)(1)(i)(C) of this standard; or
(B) If that employee has received a medical examination within the previous two years pursuant to paragraph (k)(1)(i) of this standard, then at least one year but no more than two
years after the employee meets the criteria of paragraph (k)(1)(i)(C) of this standard.
Paragraph (k)(2)(i)(B) of the 2017 standard
previously required the employer to provide
a medical examination within 30 days after
determining that the employee shows signs
or symptoms of CBD or other beryllium-related health effects or that the employee has
been exposed to beryllium in an emergency.
The 2018 NPRM would have added paragraph (k)(2)(iv) to require employers to offer
an examination to employees exposed to beryllium in an emergency at least one year
after but no more than two years after the
employee is exposed to beryllium in an
emergency. It also would have amended
paragraph (k)(2)(i)(B) to focus only on the
frequency of examinations for employees
who show signs or symptoms of CBD or
other beryllium-related health effects.
This final rule’s provisions differ from those in
the proposal. Specifically, in this final rule,
OSHA removed the requirement for a medical examination within 30 days of exposure
in an emergency and added paragraph
(k)(2)(iv). Final paragraph (k)(2)(iv)(A) requires the employer to offer a medical examination to an employee within 30 days after
the employee was exposed to beryllium in
an emergency, if the employee has not had
an examination under paragraph (k)(1)(i)
within the last two years, while final paragraph (k)(2)(iv)(B) requires the employer to
offer a medical examination to an employee
within one to two years after the employee
was exposed to beryllium in an emergency,
if the employee had an examination under
paragraph (k)(1)(i) of the beryllium standard
within the last two years. In addition, this
final rule revised paragraph (k)(2)(iii) to require that each employee who is exposed in
an emergency and has not received an examination since the emergency exposure
must be provided an examination at the time
employment is terminated.
As proposed in the 2018 NPRM, this final rule
also amended paragraph (k)(2)(i)(B) to focus
only on the frequency of examinations for
employees who show signs or symptoms of
CBD or other beryllium-related health effects.
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TABLE V.1—CHANGES TO COLLECTION OF INFORMATION REQUIREMENTS IN THE FINAL RULE FOR GENERAL INDUSTRY—
Continued
Information collection requirements in this final rule
Explanation of this final rule’s changes to the
information collection requirements
§ 1910.1024(k)(7)—Medical Surveillance—Referral to the CBD Diagnostic Center ......................
(7) CBD diagnostic center. (i) The employer must provide an evaluation at no cost to the employee at a CBD diagnostic center that is mutually agreed upon by the employer and the employee. The evaluation at the CBD diagnostic center must be scheduled within 30 days, and
must occur within a reasonable time, of:
(A) The employer’s receipt of a physician’s written medical opinion to the employer that
recommends referral to a CBD diagnostic center; or
(B) The employee presenting to the employer a physician’s written medical report indicating that the employee has been confirmed positive or diagnosed with CBD, or recommending referral to a CBD diagnostic center.
(ii) The employer must ensure that, as part of the evaluation, the employee is offered any tests
deemed appropriate by the examining physician at the CBD diagnostic center, such as pulmonary function testing (as outlined by the American Thoracic Society criteria),
bronchoalveolar lavage (BAL), and transbronchial biopsy. If any of the tests deemed appropriate by the examining physician are not available at the CBD diagnostic center, they may
be performed at another location that is mutually agreed upon by the employer and the employee.
(iii) The employer must ensure that the employee receives a written medical report from the
CBD diagnostic center that contains all the information required in paragraph (k)(5)(i), (ii),
(iv), and (v) of this standard and that the PLHCP explains the results of the examination to
the employee within 30 days of the examination.
(iv) The employer must obtain a written medical opinion from the CBD diagnostic center within
30 days of the medical examination. The written medical opinion must contain only the information in paragraph (k)(6)(i), as applicable, unless the employee provides written authorization to release additional information. If the employee provides written authorization, the written opinion must also contain the information from paragraphs (k)(6)(ii), (iv), and (v), if applicable.
(v) The employer must ensure that each employee receives a copy of the written medical opinion from the CBD diagnostic center described in paragraph (k)(7) of this standard within 30
days of any medical examination performed for that employee.
(vi) After an employee has received the initial clinical evaluation at a CBD diagnostic center described in paragraphs (k)(7)(i) and (ii) of this standard, the employee may choose to have
any subsequent medical examinations for which the employee is eligible under paragraph (k)
of this standard performed at a CBD diagnostic center mutually agreed upon by the employer and the employee, and the employer must provide such examinations at no cost to
the employee.
The 2018 NPRM would have amended paragraph (k)(7) of the 2017 standard to require
employers to provide, at no cost to the employee and within a reasonable time after the
initial consultation with the CBD diagnostic
center, any of the following tests if deemed
appropriate by the examining physician at
the CBD diagnostic center: Pulmonary function testing (as outlined by the American
Thoracic Society criteria), bronchoalveolar lavage (BAL), and transbronchial biopsy. The
proposal also specified the timing of the initial consultation.
This final rule’s provisions differ from those in
the proposal. Specifically, OSHA revised
paragraph (k)(7)(i) to require that the evaluation must be scheduled within 30 days, and
must occur within a reasonable time, of the
employer receiving one of the types of documentation listed in paragraph (k)(7)(i)(A) or
(B). Previously, the general industry standard
required employers to provide the examination within 30 days of the employer receiving
one of the types of documentation listed in
paragraph (k)(7)(i)(A) or (B).
This final rule also added a provision, in paragraph (k)(7)(ii), which specifies that the employer must ensure that, as part of the evaluation, the employee is offered any tests
deemed appropriate by the examining physician at the CBD diagnostic center, such as
pulmonary function testing (as outlined by
the American Thoracic Society criteria),
bronchoalveolar
lavage
(BAL),
and
transbronchial biopsy. The new provision
also states that if any of the tests deemed
appropriate by the examining physician are
not available at the CBD diagnostic center,
they may be performed at another location
that is mutually agreed upon by the employer and the employee.
This final rule removed the requirement for collection and recording of Social Security numbers from this provision. This change was
adopted as proposed.
§ 1910.1024(n)(1)(i), (ii), & (iii)—Recordkeeping—Air Monitoring Data ..........................................
(i) The employer must make and maintain a record of all exposure measurements taken to assess airborne exposure as prescribed in paragraph (d) of this standard.
(ii) This record must include at least the following information:
(A) The date of measurement for each sample taken;
(B) The task 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 and job classification of each employee represented by the monitoring, indicating which employees were actually monitored.
(iii) The employer must ensure that exposure records are maintained and made available in accordance with the Records Access standard (29 CFR 1910.1020).
§ 1910.1024(n)(3)(i), (ii), & (iii)—Recordkeeping—Medical Surveillance ........................................
(i) The employer must make and maintain a record for each employee covered by medical surveillance under paragraph (k) of this standard.
(ii) The record must include the following information about the employee:
(A) Name and job classification;
(B) A copy of all licensed physicians’ written medical opinions for each employee; and
(C) A copy of the information provided to the PLHCP as required by paragraph (k)(4) of
this standard.
(iii) The employer must ensure that medical records are maintained and made available in accordance with the Records Access standard (29 CFR 1910.1020).
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This final rule removed the requirement for collection and recording of Social Security numbers from this provision. This change was
adopted as proposed.
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TABLE V.1—CHANGES TO COLLECTION OF INFORMATION REQUIREMENTS IN THE FINAL RULE FOR GENERAL INDUSTRY—
Continued
Information collection requirements in this final rule
Explanation of this final rule’s changes to the
information collection requirements
§ 1910.1024(n)(4)(i) & (ii)—Recordkeeping—Training ....................................................................
(4) Training. (i) At the completion of any training required by this standard, the employer must
prepare a record that indicates the name and job classification of each employee trained, the
date the training was completed, and the topic of the training.
(ii) This record must be maintained for three years after the completion of training.
This final rule removed the requirement for collection and recording of Social Security numbers from this provision. This change was
adopted as proposed.
VII. State Plans
When federal OSHA promulgates a
new standard or more stringent
amendment to an existing standard, the
states and U.S. Territories with their
own OSHA-approved occupational
safety and health plans (State Plans)
must promulgate a state standard
adopting such new federal standard, or
more stringent amendment to an
existing federal standard, or an at least
as effective equivalent thereof, within
six months of promulgation of the new
federal standard or more stringent
amendment. The state may demonstrate
that a standard change is not necessary
because the state standard is already the
same or at least as effective as the
federal standard change. Because a state
may include standards and standard
provisions that are equally or more
stringent than federal standards, it
would generally be unnecessary for a
state to revoke a standard when the
comparable federal standard is revoked
or made less stringent. 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 28 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 remaining six states and
territories cover only state and local
government employees: Connecticut,
Illinois, Maine, New Jersey, New York,
and the Virgin Islands.
As discussed in detail below in
Section XI, Summary and Explanation
of the Final Rule, the majority of the
changes made by this final rule will
clarify certain provisions and simplify
or improve employer compliance. After
considering all of the changes made by
this final rule and the record as a whole,
OSHA believes that this final rule
enhances employee safety, in part by
revising provisions that may be
misinterpreted. Therefore, OSHA has
determined that, within six months of
the rule’s promulgation date, State Plans
must review their state standards and
adopt amendments to those standards
that are at least as effective as the
amendments to the beryllium general
industry standard finalized herein, as
required by 29 CFR 1953.5(a), unless the
State Plans demonstrate that such
amendments are not necessary because
their existing standards are already at
least as effective at protecting workers
as this final rule. This decision is also
informed by a comment from Materion
Brush, Inc. (Materion), in which
Materion argued that OSHA should
require states to adopt the proposed
changes (Document ID 0038–A5, p. 2).9
No other stakeholders opined on this
issue.
VI. Federalism
OSHA reviewed this rule in
accordance with the Executive Order on
Federalism (Executive Order 13132, 64
FR 43255, August 10, 1999), which
requires that federal agencies, to the
extent possible, refrain from limiting
state policy options, consult with states
prior to taking any actions that would
restrict state policy options, and take
such actions only when clear
constitutional and statutory authority
exists and the problem is national in
scope. Executive Order 13132 provides
for preemption of state law only with
the expressed consent of Congress. Any
such preemption is to be limited to the
extent possible.
Under Section 18 of the OSH Act,
Congress expressly provides that states
and U.S. territories may adopt, with
federal approval, a plan for the
development and enforcement of
occupational safety and health
standards. OSHA refers to such states
and territories as ‘‘State Plans’’ (29
U.S.C. 667). Occupational safety and
health standards developed by State
Plans must be at least as effective in
providing safe and healthful
employment and places of employment
as the federal standards. Subject to these
requirements, State Plans are free to
develop and enforce under state law
their own requirements for safety and
health standards.
OSHA previously concluded from its
analysis for the 2017 final rule that
promulgation of the beryllium standard
complies with E.O. 13132 (82 FR at
2633). The amendments in this final
rule do not change that conclusion. 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 OSHA. In states with
OSHA-approved State Plans, this
rulemaking does not significantly limit
state policy options.
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VIII. Unfunded Mandates Reform Act
OSHA reviewed this final rule
according to the Unfunded Mandates
Reform Act of 1995 (UMRA) (2 U.S.C.
1501 et seq.) and Executive Order 13132
(64 FR 43255). As discussed above in
Section IV, Final Economic Analysis
and Regulatory Flexibility Act
Certification (FEA), of this preamble, the
agency determined that this final rule
will not impose significant additional
costs on any private- or public-sector
entity. Further, OSHA previously
concluded that the rule will not impose
a federal mandate on the private sector
in excess of $100 million (adjusted
annually for inflation) in expenditures
in any one year (82 FR at 2634).
Accordingly, this final rule will not
require significant additional
9 OSHA notes that Materion also argued that the
State Plans that have already adopted the original
OSHA standard should be required to adopt the
changes OSHA previously adopted in the 2018
direct final rule, as well as the changes that result
from the current rulemaking (Document ID 0038–
A5, p. 1). Whether OSHA should require State Plans
to adopt the changes made in the 2018 direct final
rule is out of the scope of this rulemaking and, thus,
will not be considered here.
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expenditures by either public or private
employers.
As noted above under Section VII,
State Plans, the agency’s standards do
not apply to state and local governments
except in states that have elected
voluntarily to adopt a State Plan
approved by the agency. Consequently,
this final rule does not meet the
definition of a ‘‘federal
intergovernmental mandate’’ (see
Section 421(5) of the UMRA (2 U.S.C.
658(5))). Therefore, for the purposes of
the UMRA, the agency certifies that this
final rule will not mandate that state,
local, or tribal governments adopt new,
unfunded regulatory obligations of, or
increase expenditures by the private
sector by, more than $100 million in any
year.
IX. Consultation and Coordination With
Indian Tribal Governments
OSHA has reviewed this final rule in
accordance with Executive Order 13175
(65 FR 67249) and determined that it
does not have ‘‘tribal implications’’ as
defined in that order. This final rule
does 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.
X. Environmental Impacts
OSHA has reviewed this final rule in
accordance with the requirements of the
National Environmental Policy Act of
1969 (NEPA) (42 U.S.C. 4321 et seq.),
the Council on Environmental Quality
NEPA regulations (40 CFR part 1500–
1508), and the Department of Labor’s
NEPA procedures (29 CFR part 11). As
a result of this review, OSHA has
determined that this final rule will not
have a significant impact on air, water,
or soil quality; plant or animal life; the
use of land; or aspects of the external
environment.
XI. Summary and Explanation of the
Final Rule
On December 11, 2018, OSHA
published a Notice of Proposed
Rulemaking (83 FR 63746) (2018 NPRM)
proposing changes to a number of
provisions in the general industry
beryllium standard. Following
publication of the 2018 NPRM, a variety
of stakeholders, including
representatives of industry, labor,
medical groups, public health
organizations, federal and state
government agencies, academia, trade
associations, and private citizens,
submitted comments on OSHA’s
proposed changes. After reviewing and
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carefully considering these comments
and the remainder of the record, OSHA
has decided to adopt the majority of the
changes proposed, as well as additional
changes that were prompted by the
comments received. These changes
clarify certain provisions and simplify
or improve compliance for the other
provisions of the standard. OSHA
believes that these changes will
maintain safety and health protections
for workers and will further enhance
worker protections by ensuring that the
standard is well understood and
implemented according to the agency’s
intent.
The following discussion summarizes
the comments received on the proposed
changes to the general industry
standard, lays out OSHA’s responses to
and final determinations regarding the
issues in the comments, and explains
each new or revised provision in this
final rule including details on any
modification made from the proposal.
As discussed in detail below, the
changes include the addition of one
definition and modifications to five
existing definitions in paragraph (b) and
revisions to seven of the standard’s
other paragraphs, including paragraph
(f), Methods of compliance; paragraph
(h), Personal protective clothing and
equipment; paragraph (i), Hygiene areas
and practices; paragraph (j),
Housekeeping; paragraph (k), Medical
surveillance; paragraph (m),
Communication of hazards; and
paragraph (n), Recordkeeping. The final
rule also replaces the 2017 standard’s
Appendix A with a new appendix
designed to supplement the final
standard’s definition of beryllium work
area.
Definitions.
Paragraph (b) of the beryllium
standard for general industry provides
definitions of key terms used in the
standard. In this final rule, OSHA is
changing or adding six terms in the
definitions paragraph of the standard.
The terms that OSHA is changing or
adding are beryllium sensitization,
beryllium work area, CBD diagnostic
center, chronic beryllium disease,
confirmed positive, and dermal contact
with beryllium.
Beryllium sensitization.
OSHA is adding the following
definition for beryllium sensitization: ‘‘a
response in the immune system of a
specific individual who has been
exposed to beryllium. There are no
associated physical or clinical
symptoms and no illness or disability
with beryllium sensitization alone, but
the response that occurs through
beryllium sensitization can enable the
immune system to recognize and react
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to beryllium. While not every berylliumsensitized person will develop chronic
beryllium disease (CBD), beryllium
sensitization is essential for
development of CBD.’’ The agency is
adding this definition to clarify other
provisions in the standard, such as the
definitions of chronic beryllium disease
(CBD) and confirmed positive, as well as
the provisions for medical surveillance
in paragraph (k) and hazard
communication in paragraph (m).
This definition of beryllium
sensitization is identical to the
definition proposed in the 2018 NPRM
and is consistent with information
provided in the 2017 final beryllium
rule (82 FR 2470). In the preamble to the
2017 final rule, OSHA found that
individuals sensitized through either
the dermal or inhalation exposure
pathways respond to beryllium through
the formation of a beryllium-protein
complex, which then binds to T-cells
stimulating a beryllium-specific
immune response (82 FR at 2494). The
formation of the T-cell-berylliumprotein complex that results in
beryllium sensitization rarely manifests
in any outward symptoms (such as
coughing or wheezing); most who are
sensitized show no symptoms at all (see
82 FR at 2492, 2527). Once an
individual has been sensitized, any
subsequent beryllium exposures via
inhalation can progress to serious lung
disease through the formation of
granulomas and fibrosis (see 82 FR at
2491–98). Since the pathogenesis of
CBD involves a beryllium-specific, cellmediated immune response, CBD
cannot occur in the absence of
sensitization (82 FR at 2492; see also
NAS, 2008 (Document ID OSHA–
H005C–2006–0870–1355)). Therefore,
this definition’s explanation that
beryllium sensitization is essential for
development of CBD is consistent with
the agency’s findings in the 2017 final
rule.
Several commenters expressed
support for OSHA’s inclusion of a
definition of beryllium sensitization in
the beryllium general industry standard,
including NJH (Document ID 0022, p. 2),
the United Steelworkers (USW)
(Document ID 0033, p. 1), Materion
(Document ID 0038, p. 8), the U.S.
Department of Defense (DOD)
(Document ID 0029, p. 1), and Edison
Electric Institute (EEI) (Document ID
0031, p. 2). According to the USW, the
proposed definition is clear and
accurate, and is necessary because the
beryllium standard includes many
provisions related to the recognition of
and appropriate response to beryllium
sensitization among beryllium-exposed
workers (Document ID 0033, p. 1).
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Materion similarly commented that
inclusion of the proposed definition in
the standard would improve workers’
and employers’ understanding of this
term (Document ID 0038, p. 4).
While OSHA received no objections
to including a definition of beryllium
sensitization in the beryllium standard,
several commenters suggested changes
to the proposed definition. The National
Supplemental Screening Program
(NSSP) and NJH recommended that the
definition of beryllium sensitization
should include the following text, based
on the ATS Statement on Beryllium:
‘‘Beryllium sensitization is a response in
the immune system of an individual
who has been exposed to beryllium. A
diagnosis of [beryllium sensitization]
can be based on two abnormal blood
BeLPTs, one abnormal and one
borderline blood BeLPT, three
borderline BeLPTs, or one abnormal
bronchoalveolar lavage (BAL) BeLPT.
Beryllium sensitization is essential for
development of CBD’’ (Document ID
0027 p. 1; 0022, p. 2; see also Document
ID OSHA–H005C–2006–0870–0364, pp.
1, 44). Neither organization, however,
explained why this definition of
beryllium sensitization should be used
instead of the definition OSHA
proposed.
OSHA disagrees with this
recommendation. The agency is
providing a definition of beryllium
sensitization to give stakeholders a
general understanding of what
beryllium sensitization is and its
relationship to CBD. Information
pertinent to medical identification of
sensitization is provided in the
definition of confirmed positive, which
appears later in this section. OSHA has
determined that the agency’s definitions
of beryllium sensitization and confirmed
positive together provide the
information suggested by NJH and the
NSSP. The definition of confirmed
positive explains how the results of
BeLPT testing should be interpreted in
the context of the standard’s provisions
that refer to that term, such as
evaluation at a CBD diagnostic center
and medical removal protection. The
confirmed positive definition establishes
that these benefits should be extended
to workers who have a pattern of BeLPT
results, obtained in a three-year period,
consistent with the NJH and the NSSP’s
recommended definition of beryllium
sensitization. The remainder of the
information suggested by NJH and the
NSSP, which pertains to the
relationship of beryllium sensitization
to beryllium exposure, the immune
system, and the development of CBD, is
included in the definition of beryllium
sensitization that OSHA proposed and
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is including in this final standard. For
these reasons, OSHA has decided not to
adopt the language suggested by NJH
and the NSSP.
The NSSP objected to the statement
that no physical or clinical symptoms,
illness, or disability are associated with
beryllium sensitization alone, but did
not explain the reason for their concern
with this statement (Document ID 0027,
p. 1). Materion supported the agency’s
inclusion of this information in the
definition, stating that ‘‘employees
deserve to understand that beryllium
sensitization does not involve
symptoms . . .’’ (Document ID 0038, p.
5). The USW also specifically supported
the accuracy of this section of OSHA’s
proposed definition of beryllium
sensitization (Document ID 0033, p. 1).
The agency has decided to retain this
statement in the definition of beryllium
sensitization because it is important that
employers and employees understand
the asymptomatic nature of beryllium
sensitization and the need for
specialized testing such as the BeLPT.
The statement is consistent with
OSHA’s discussion of beryllium
sensitization in the 2017 final rule (82
FR at 2492–99). As OSHA discussed in
the 2017 final rule, sensitization
through dermal contact has sometimes
been associated with skin granulomas,
contact dermatitis, and skin irritation,
but these reactions are rare and those
sensitized through dermal exposure to
beryllium typically do not exhibit any
outward signs or symptoms (see 82 FR
at 2488, 2491–92, 2527). OSHA
determined that while beryllium
sensitization rarely leads to any outward
signs or symptoms, beryllium
sensitization is an adverse health effect
because it is a change to the immune
system that leads to risk of developing
CBD (82 FR at 2498–99). The agency
believes that the asymptomatic nature of
beryllium sensitization, especially in
the lung, should be conveyed to
employers and employees to emphasize
why specialized testing such as the
BeLPT should be provided to workers
who may have no symptoms of illness
associated with beryllium exposure. For
these reasons, OSHA is retaining the
statement ‘‘[t]here are no associated
physical or clinical symptoms and no
illness or disability with beryllium
sensitization alone’’ in the definition of
beryllium sensitization.
The State of Washington Department
of Labor and Industries, Division of
Occupational Safety and Health
(DOSH), commented that OSHA’s
proposed definition of beryllium
sensitization places unnecessary
emphasis on the role that beryllium
sensitization plays in the development
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42597
of CBD. According to DOSH, ‘‘[t]his
language may cause confusion with
proper diagnosis of CBD and application
of the rule requirements for workers
who have developed CBD without a
confirmed beryllium sensitization’’
(Document ID 0023, p. 1). Other
commenters, however, including NJH,
the NSSP, and the USW, supported
including the statement that beryllium
sensitization is necessary for the
development of CBD in OSHA’s
definition of beryllium sensitization
(Document ID 0022, p. 2; 0027, p. 1;
0033, p. 1).
Following consideration of DOSH’s
comment, OSHA has determined that
this information should remain in the
definition of beryllium sensitization (as
well as the definition of chronic
beryllium disease, discussed later).
OSHA believes that an understanding of
the relationship between beryllium
sensitization and CBD is key to workers’
and employers’ understanding of the
beryllium standard. By including the
role that sensitization plays in the
development of CBD in the definition of
beryllium sensitization, OSHA intends
to make a number of things clear to
workers and employers: That beryllium
sensitization, although not itself a
disease, is nevertheless an adverse
health effect that presents a risk for
developing CBD and thus should be
prevented; the need to identify
beryllium sensitization through regular
medical screening; and why workers
who are confirmed positive should be
offered specialized medical evaluation
and medical removal protection. OSHA
notes that DOSH does not dispute the
factual accuracy of OSHA’s statement
regarding the role beryllium
sensitization plays in the development
of CBD, which the agency established in
the Health Effects section of the 2017
final rule (82 FR at 2495–96).
Nevertheless, OSHA agrees with
DOSH that it is not always necessary to
identify a worker as beryllium
sensitized by the BeLPT as part of a
diagnosis of CBD, and the agency
acknowledges that some sensitized
individuals may not be confirmed
positive for beryllium sensitization by
BeLPT testing. OSHA established in the
Health Effects section of the preamble to
the 2017 final rule that while BeLPT
testing is helpful to identify workers at
risk for CBD and to differentiate CBD
from respiratory diseases with similar
clinical presentation, CBD can be
diagnosed in the absence of a confirmed
positive BeLPT (see 82 FR at 2499–
5002) (discussing a number of studies
conducted prior to the development of
the BeLPT). At least one study in the
rulemaking record found that some
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beryllium workers who would not have
been confirmed positive by their BeLPT
results were found to be sensitized via
the BAL BeLPT and went on to develop
CBD (Newman et al., 2001, Document ID
OSHA–H005C–2006–0870–1354, p.
234). Other studies indicate that the
BeLPT has a false-negative rate of
approximately 25–28 percent (that is,
approximately 25–28 percent of
individuals who have a single normal
BeLPT result are in fact sensitized)
(Middleton et al., 2011, Document ID
OSHA–H005C–2006–0870–0399, p. 2
(25 percent); Stange et al., 2004,
Document ID OSHA–H005C–2006–
0870–1402, p. 457 (27.7 percent)).
Because the BeLPT itself may have a
false-negative result and because other
means exist to diagnose CBD apart from
the BeLPT, examining physicians
should have the latitude to diagnose
CBD in the absence of a ‘‘confirmed
positive’’ pattern of BeLPT results.
Moreover, as discussed below, the
determination that an employee is
‘‘confirmed positive’’ under the
beryllium standard acts only as a trigger
for medical monitoring and surveillance
and OSHA does not intend the phrase
‘‘confirmed positive’’ to be
interchangeable with ‘‘beryllium
sensitized.’’
The standard provides a mechanism
for an employee to be referred to a CBD
diagnostic center and diagnosed with
CBD, even in the absence of a confirmed
positive blood BeLPT result. Under
paragraph (k)(5)(iii), the licensed
physician can recommend referral to a
CBD diagnostic center if he or she
deems it appropriate. As OSHA
explained in the preamble to the 2017
final rule, the licensed physician could
recommend an evaluation at a CBD
diagnostic center based on questionable
BeLPT findings (82 FR at 2714). For
example, in a scenario where an
employee has repeating borderline or
abnormal results but does not meet the
definition for confirmed positive,
referral to a CBD diagnostic center may
be appropriate.
Furthermore, the standard does not
specify how CBD is diagnosed and gives
the licensed physician at the CBD
diagnostic center discretion for making
that diagnosis, including by means other
than blood BeLPT results. The
diagnostic criteria for CBD include (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 (82 FR at 2500; see also Newman
et al., 1989 (Document ID OSHA–
H005C–2006–0870–0196, p. 1480)). The
availability of transbronchial lung
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biopsy facilitates the evaluation of the
second criterion, by making
histopathological confirmation possible
in almost all cases (82 FR at 2500). The
ATS has noted that the BAL BeLPT can
be useful in diagnosing CBD in
individuals who have normal blood
BeLPT results and considers one
positive BAL BeLPT sufficient for the
diagnosis of beryllium sensitization
(Document ID OSHA–H005C–2006–
0870–0364, pp. 44–45). OSHA expects
that the licensed physician might apply
such criteria in the diagnosis of CBD,
without relying on a confirmed positive
finding based on blood BeLPT results.
In summary, OSHA believes that
emphasizing the role that beryllium
sensitization plays in the development
of CBD provides employers and
employees with important context for
understanding the beryllium standard.
At the same time, the agency
acknowledges that employees may be
diagnosed with CBD in the absence of
a confirmed positive BeLPT, and the
beryllium standard allows for such a
diagnosis. Thus, following
consideration of the record of comments
on OSHA’s proposed definition of
beryllium sensitization, the agency is
finalizing the definition as proposed in
the 2018 NPRM. The addition of this
definition for beryllium sensitization
does not change employer obligations
under paragraphs (k) and (m) and,
therefore, OSHA expects that the new
definition will maintain safety and
health protections for workers.
Beryllium work area.
Paragraph (b) of the final rule defines
beryllium work area as any work area
where materials that contain at least 0.1
percent beryllium by weight are
processed either: (1) During any of the
operations listed in Appendix A of the
standard; or (2) where employees are, or
can reasonably be expected to be,
exposed to airborne beryllium at or
above the action level. The presence of
a beryllium work area triggers a number
of requirements in the standard. These
include the requirements under
paragraphs (e)(1)(i) and (2)(i) to
establish, maintain, and demarcate the
boundaries of each beryllium work area,
as well as requirements under
paragraphs (f)(1)(i)(D) and (F), written
exposure control plan requirements;
paragraph (f)(2)(ii), required exposure
controls; paragraphs (i)(1) and (2),
general hygiene practices and change
rooms requirements; paragraphs (j)(1)(i)
and (2), housekeeping requirements;
and paragraph (m)(4)(ii)(B), employee
training. The establishment of beryllium
work areas serves to ensure that
employees and other persons are aware
of the potential presence of airborne
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beryllium; to control access to these
areas; and in conjunction with other
provisions such as the written control
plan, hygiene, and housekeeping
requirements, to minimize the transfer
of beryllium to other areas of the facility
and reduce the potential for exposure to
other employees.
The term beryllium work area (as
revised in the 2018 direct final rule) was
defined as any work area (1) containing
a process or operation that can release
beryllium and that involves material
that contains at least 0.1 percent
beryllium by weight; and, (2) where
employees are, or can reasonably be
expected to be, exposed to airborne
beryllium at any level or where there is
the potential for dermal contact with
beryllium. That definition was
developed in response to stakeholder
comments on the 2015 NPRM, which
had proposed to define a beryllium work
area as any work area where there is
potential for exposure to airborne
beryllium at any level, and which did
not include dermal contact as a trigger
for establishment of a beryllium work
area. Some stakeholders argued that the
definition proposed in the 2015 NPRM
was overly broad and could be
interpreted as applying to most or all
areas of a worksite, regardless of the
work processes or operations occurring
in those areas. Commenters also
expressed concern that the definition
was vague and should be triggered on a
measurable threshold of exposure.
NIOSH commented that the proposed
definition’s focus on airborne beryllium
did not account for the potential
contribution of dermal exposures to
total exposure (82 FR at 2659).
In response to these comments, OSHA
modified the definition in the 2017 final
rule to require the presence of a
beryllium-releasing process. The agency
explained in the preamble that
triggering the requirement of creating a
beryllium work area on a specific
threshold level of exposure would be
insufficiently protective of workers, but
also explained that the agency did not
intend for a beryllium work area to be
established in areas where work
processes or operations that release
beryllium do not occur, such as where
employees handle articles containing
beryllium (82 FR at 2659–60). Rather,
the purpose of establishing beryllium
work areas is to identify and demarcate
areas within a facility where processes
or operations release beryllium so that
necessary control measures can be
implemented, such as those designed to
prevent the migration of beryllium to
other areas where beryllium is not
processed or released. OSHA clarified
this intent by defining a beryllium work
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area as an area that contains processes
or operations that release beryllium to
which workers could be exposed.
Additionally, OSHA accounted for
NIOSH’s concern by including the
potential for dermal contact with
beryllium in the definition (see 82 FR at
2658–60).
In the preamble to the 2017 final rule,
however, OSHA disagreed with
commenters who claimed that the
proposed definition of beryllium work
area was impermissibly vague. The
agency explained that, by limiting the
trigger for beryllium work areas to
exposures generated from a berylliumreleasing process or operation within
the area, the definition made clear that
the requirements were not triggered
solely on the fact that an employee may
be handling solid material containing
beryllium. Additionally, any employer
who had doubts about whether a
process was releasing beryllium or
created the potential for dermal contact
with beryllium could use air sampling
or wipe sampling to determine where
the boundary of a beryllium work area
should be established. OSHA reasoned
that, rather than rendering the provision
vague, defining a beryllium work area in
a performance-based manner left
employers flexibility in complying with
the standard (82 FR at 2659).
Nevertheless, following publication of
the 2017 standard, OSHA continued to
hear from stakeholders that the
definition of beryllium work area
remained a source of substantial
uncertainty and confusion. Some
stakeholders expressed concern that
defining a beryllium work area to
include any area where unspecified
processes can reasonably be expected to
generate any level of airborne beryllium,
or where there is a process or operation
that can release beryllium or the
potential for dermal contact with
beryllium, could lead to the designation
of entire facilities as beryllium work
areas because minute quantities of
beryllium can sometimes be detected in
areas of a facility far distant from the
work processes that create beryllium
exposures. Stakeholders requested that
OSHA provide a list of operations that
are known to release airborne beryllium,
which would allow employers to more
accurately identify where beryllium
work areas must be established and
demarcated at their workplaces. As
described in more detail below,
stakeholders also requested that
‘‘dermal contact’’ be removed from the
definition of beryllium work area.
In response to this feedback, OSHA
proposed in this rulemaking to modify
the definition of beryllium work area to
provide clarity for employers on where
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and when to establish a beryllium work
area. First, OSHA proposed a new
appendix to the standard (Appendix A),
containing Table A.1, which includes a
list of operations that are commonly
performed when processing beryllium
materials and are known to generate
airborne beryllium. OSHA proposed to
revise the definition of beryllium work
area so that any work area where an
operation that is listed in proposed
Appendix A occurs, and involves
materials containing at least 0.1 percent
beryllium by weight, is a beryllium
work area. For work areas where no
operations listed in proposed Appendix
A occur, the proposed definition would
require a beryllium work area wherever
materials containing at least 0.1 percent
beryllium by weight are processed and
where employees are, or can be
reasonably expected to be, exposed to
airborne beryllium at or above the
action level. The list of operations in
Table A.1 was compiled based on the
experience of Materion, the primary
beryllium manufacturer in the United
States, and the USW, the primary union
representing employees with beryllium
exposure.10 As noted in the preamble to
the 2018 NPRM, OSHA intends the list
to cover all operations and processes
that have the potential for exposure to
airborne beryllium (83 FR at 63761).
Second, OSHA proposed to remove
the reference to dermal contact from the
definition of the term beryllium work
area. OSHA preliminarily determined
that this change would make it less
likely that the definition could be
misinterpreted as extending to areas of
a facility where work processes or
operations that release beryllium do not
occur or even to entire facilities (83 FR
at 63749). Further, the agency explained
that it was unaware of berylliumreleasing processes or operations that
have a potential for dermal contact that
are not included in the proposed
Appendix A or do not generate airborne
exposures at or above the action level
(83 FR at 63749). Therefore, OSHA
preliminarily determined that the
proposed change would be as protective
as the previous definition, while more
clearly avoiding the erroneous
perception that the standard would
require employers to treat entire
facilities as beryllium work areas.
Comments submitted in response to
the NPRM showed general support from
employers, unions, and public health
experts for OSHA’s proposed approach
10 Table A.1 is divided into three categories: (1)
Beryllium Metal Alloy Operations (generally <10%
beryllium by weight); (2) Beryllium Composite
Operations (generally >10% beryllium by weight)
and Beryllium Metal Operations; and (3) Beryllium
Oxide Operations.
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and for providing better clarity with
respect to beryllium work areas
(Document ID 0017; 0022, pp. 6–7;
0029, p. 1; 0033, pp. 1–4; 0038, pp. 8–
9). For example, the USW agreed with
OSHA that the revisions proposed in the
NPRM would make the definition more
precise and help to ensure that
employers can appropriately comply
with the standard. The USW stated that
the proposed definition ‘‘provides
employers with a clearer means of
understanding when and where
demarcation is required’’ for beryllium
work areas (Document ID 0033, p. 2).
Materion likewise indicated that this
new approach ‘‘greatly improves and
simplifies an understanding of where
beryllium work areas should be in a
facility, allowing employers and
employees to know and understand how
to comply with the requirement to
establish these protective work areas’’
(Document ID 0038, p. 9).
While there was general support for
this proposed approach to beryllium
work areas, several commenters
expressed concerns about various
aspects of the new definition and new
Appendix A. For example, DOSH agreed
that the addition of a new Appendix A
would provide clarity to the beryllium
work area requirements but expressed
concern that removal of the dermal
contact trigger would reduce worker
protections. DOSH suggested the use of
a defined lower limit for beryllium
contamination on surfaces that would
address this concern while maintaining
the protection for workers (Document ID
0023, pp. 1–2).
OSHA does not agree that removing
the reference to dermal contact from the
definition of the term beryllium work
area reduces protections. As noted
above and explained in both the
preambles to the 2017 final rule and the
2018 NPRM, OSHA’s intent was to
capture those areas of a facility where
beryllium-generating processes or
operations are located; OSHA never
intended for dermal contact alone to
trigger the standard’s beryllium work
area requirements (82 FR at 2659; 83 FR
at 63748). Contrary to DOSH’s assertion,
the requirement to establish a beryllium
work area was dependent on the
presence of a process or operation that
can release beryllium and that involves
material that contains at least 0.1
percent beryllium by weight in the area
in question; exposure alone, whether
airborne or dermal, was never a trigger
for the beryllium work area
requirements.
Moreover, again as noted above,
OSHA explained in the 2018 NPRM that
it did not know of any berylliumreleasing processes or operations with
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the potential for dermal contact that are
not included in the proposed Appendix
A or that do not generate airborne
exposures at or above the action level.
Put more simply, OSHA was unaware of
any situation where an employer would
be required to establish a beryllium
work area under the previous definition
but would not be required to do so
under the proposed definition.
However, in the interest of caution,
OSHA asked stakeholders specifically
whether there are any operations or
processes that trigger beryllium work
areas under the previous definition that
would not be covered under the
proposed definition (83 FR at 63749).
Commenters did not point to any such
processes. On the contrary, the only
stakeholder to squarely address this
issue, Materion, noted that it too was
‘‘unaware of work areas containing
beryllium-releasing processes or
operations that have a potential for
dermal contact that are not included in
the proposed Appendix A or generate
airborne exposures at or above the
action level’’ (Document ID 0038 p. 13).
Furthermore, another stakeholder, the
USW commented that it supported
OSHA’s proposed removal of the
reference to dermal contact from the
definition of the term beryllium work
area (Document ID 0033, p. 3). The
USW stated that it does not have
reservations about the proposed change
and explained its belief ‘‘that dermal
exposure is properly addressed
elsewhere in the standard’’ (Document
ID 0033, pp. 1–3). According to the
USW, ‘‘[a]lthough dermal exposure to
beryllium is important and must be
properly addressed, removal of dermal
exposure from this definition will
reduce the confounding factors that
might result in unnecessarily extending
beryllium work areas beyond needed
portions of a workplace’’ (Document ID
0033, p. 3).
In addition, DOSH did not explain
why it believes the change would
reduce worker protections. Given that
DOSH did not point to any particular
loss of worker protection and the lack of
evidence of any differences between the
coverage of the two definitions, OSHA
has decided to adopt the proposed
definition, which commenters have
indicated reduces the confusion caused
by the previous definition. OSHA
expects the revised definition to provide
clarity on the proper boundaries of a
beryllium work area. Employers are
required by paragraph (j)(1), in
conjunction with paragraph (f)(1), to
minimize the migration of beryllium
from beryllium work areas, and clearly
defining the beryllium work area
ensures employees working outside of
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these areas receive the protective
benefits of these requirements. If a
beryllium work area is defined overly
broadly, then more employees may
inadvertently be exposed to beryllium
within the beryllium work area and
would not receive some of these
benefits. Moreover, as stated in the 2018
NPRM, PPE requirements to protect
against dermal exposure to beryllium do
not depend on the existence of a
beryllium work area. The standard
requires employers to provide and
ensure the use of appropriate PPE
whenever there is a reasonable
expectation of dermal contact with
beryllium, regardless of whether or not
the area is a beryllium work area (see 83
FR at 63749).
OSHA also does not agree with DOSH
that a lower limit for beryllium
contamination on surfaces is necessary
as a trigger for establishing a beryllium
work area. In the 2017 final rule, OSHA
chose not to set quantitative limits for
surface contamination because the best
available scientific evidence on adverse
health effects from dermal contact with
beryllium made it difficult to identify an
appropriate limit for surface
contamination (82 FR at 2688). This
remains the case today. OSHA discusses
the limitations of this data more fully
below in the Summary and Explanation
of the definition of dermal contact with
beryllium.
Two commenters objected to the
exemption for materials that contain
less than 0.1 percent beryllium from the
definition of beryllium work area
(Document ID 0022, p. 7; 0027, p. 2).
However, OSHA incorporated this
change in the 2018 direct final rule. At
the time, OSHA explained that it was
never the agency’s intent that the
requirements related to beryllium work
areas apply to these materials (83 FR
19936, 19938 (May 7, 2018)). OSHA did
not receive any adverse comments on
the direct final rule and therefore
finalized the change. The 2018 NPRM
did not propose to amend this portion
of the definition and therefore
comments related to the 0.1 percent
limitation are not within the scope of
this rulemaking.
OSHA also received comments on the
new Appendix A. NJH expressed
concerns that the proposed list of
operations in Appendix A was geared
toward manufacturing and that it ‘‘may
restrict employers’ interpretations of a
beryllium work area and prevent
employees from the protections afforded
by the beryllium standard. Employers
may only consider these featured tasks
as those that dictate a beryllium work
area, when other tasks may be
considered as such’’ (Document ID
PO 00000
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0022, pp. 6–7). OSHA believes NJH’s
concern is misplaced. First, OSHA
requested comment on whether there
were additional operations that should
be included on the list of operations in
Appendix A, and no suggestions for
additional operations were put forth by
commenters. More importantly, the final
standard requires that a beryllium work
area be established if exposures can
reasonably be expected to exceed the
action level where materials that
contain at least 0.1 percent beryllium by
weight are processed, regardless of
whether the operation is listed in
Appendix A. As the USW noted, this
requirement ‘‘provides a backstop for
any unforeseen operation which can
expose employees above the action
level’’ (Document ID 0033, p. 2). Thus,
employees who may be exposed above
the action level during a process not
listed in Appendix A will still receive
the protections afforded by the
beryllium work area requirements.
DOD, while generally supportive of
the proposed definition of beryllium
work area, expressed some concerns
about Appendix A (Document ID 0029,
p. 1). First, DOD suggested, without
explanation, that OSHA remove the
word ‘‘generally’’ from the description
of the table in Appendix A, which
describes beryllium metal alloy
operations as being ‘‘generally < 10%
beryllium by weight’’ and beryllium
composite operations as being
‘‘generally ≤ 10% beryllium by weight.’’
OSHA disagrees with this suggestion.
The table in Appendix A reflects
materials that are on the market today.
However, the inclusion of the word
‘‘generally’’ accounts for the possibility
of beryllium metal alloy operations and
beryllium composite operations
involving different materials. Thus, if
alloys are developed with greater than
10 percent beryllium or composites less
than 10 percent beryllium, these
materials will be covered under Table
A.1. Because OSHA does not intend to
limit Table A.1 to processes involving
only those materials on the market
today, the agency is retaining the word
‘‘generally’’ in the description of the
tables in Appendix A.11
11 The agency notes that DOD’s comment suggests
there might be some confusion as to whether
beryllium alloys and beryllium composites are
analogous. In fact, these materials have different
structures and should be treated differently from a
control strategy point of view. A metal alloy is a
metal which is a homogeneous mixture of two or
more metals or of a metal and another element to
provide unique characteristics or properties (see
https://www.thefreedictionary.com/Metal+alloy). A
‘‘beryllium composite,’’ on the other hand, is a
metal matrix composite or (MMC) which typically
contain at least two distinct constituent parts (see
https://www.azom.com/article.aspx?
ArticleID=9843).
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DOD, along with DOSH, also
questioned the deletion of the Appendix
A published with the 2017 final
beryllium rule. That old appendix
provided non-mandatory general control
strategies for common operations. These
commenters thought that the old
appendix was useful and should be
retained in the standard (Document ID
0029, p. 1; 0023, p. 3). OSHA agrees that
the old appendix contained useful
information, but expects that in time it
would have become either obsolete or
incomplete. Instead, OSHA plans to
provide this information about general
control strategies in guidance materials
tailored to reach the targeted audience.
This will make it easier to update as
new technologies or beryllium processes
become available.
In addition, under paragraph (f)(2),
Engineering and work practices,
employers are obligated to use
engineering controls in beryllium work
areas. OSHA requires employers to use
at least one type of control that is listed
in paragraph (f)(2)(ii) (substitution,
isolation, local exhaust ventilation, or
process controls) unless controls are
infeasible or exposures are
demonstrated to be below the action
level. These general controls are the
same types of controls that were listed
in Appendix A and are required
regardless of whether that appendix is
retained. For these reasons, this final
standard does not retain the old
Appendix A.
Materion fully supported the
proposed changes to the beryllium work
area definition and the proposed
Appendix A. However, it noted a
typographical error in Appendix A for
‘‘High Speed Machining (≤ 10,000
rpm),’’ which should be (≤ 10,000 rpm)
(Document ID 0038, p. 10). OSHA agrees
that the entry in the NPRM’s Appendix
A is incorrect and made the appropriate
correction in this final rule.
After careful consideration of the
record, OSHA has determined that the
revised definition of beryllium work
area will improve compliance with the
standard by providing greater clarity to
employers regarding when and where
beryllium work areas should be
established in the workplace. The
agency further finds that properly
identifying beryllium work areas will
reduce potential exposure for workers
outside of these areas through the
various provisions triggered by
beryllium work areas. In sum, OSHA
has determined that the revision to the
definition of beryllium work area will
ensure that the standard’s requirements
related to beryllium work areas are
workable and properly understood.
Therefore, OSHA has decided to finalize
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the definition of beryllium work area
and the corresponding update to
Appendix A as proposed, with the
exception of correcting the
typographical error in Appendix A
noted by Materion.
CBD diagnostic center.
OSHA is amending the 2017 final
rule’s definition of CBD diagnostic
center to clarify certain requirements
used to qualify an existing medical
facility as a CBD diagnostic center. The
clarification does not change the
requirement for the employer to offer a
follow-up examination at a CBD
diagnostic center to employees meeting
the criteria set forth in paragraph (k).
OSHA is defining CBD diagnostic center
to mean a medical diagnostic center that
has a pulmonologist or pulmonary
specialist on staff and on-site facilities
to perform a clinical evaluation for the
presence of CBD. The revised definition
also states that a CBD diagnostic center
must have the capacity to perform
pulmonary function testing (as outlined
by the American Thoracic Society
criteria), bronchoalveolar lavage (BAL),
and transbronchial biopsy. In the
revised definition, the CBD diagnostic
center must also have the capacity to
transfer BAL samples to a laboratory for
appropriate diagnostic testing within 24
hours and the pulmonologist or
pulmonary specialist must be able to
interpret the biopsy pathology and the
BAL diagnostic test results. This
definition is identical to the definition
of CBD diagnostic center that OSHA
proposed in the 2018 NPRM.
The revised definition of CBD
diagnostic center differs from the former
definition in a number of ways. First,
whereas the 2017 final rule’s definition
specified only that a CBD diagnostic
center must have a pulmonary
specialist, OSHA is adding the term
‘‘pulmonologist’’ to clarify that either
type of specialist is qualified to perform
a clinical evaluation for the presence of
CBD. Additionally, the 2017 definition
required that a CBD diagnostic center
have an on-site pulmonary specialist.
The revised definition states that the
CBD diagnostic center must simply have
a pulmonologist or pulmonary specialist
on staff. This clarifies OSHA’s intent
that a specialist must be available to the
CBD diagnostic center but need not
necessarily be on site at all times.
In their comments on the 2018 NPRM,
two commenters, NJH and the ATS,
recommended that a pulmonologist,
occupational medicine specialist, or
physician with expertise in beryllium
disease should conduct the clinical
evaluation for CBD and that a
pulmonologist should be on staff or
available to perform the bronchoscopy
PO 00000
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(Document ID 0022, p. 2; 0021, p. 2).
According to NJH, clinics that regularly
evaluate patients for CBD have
physicians with experience in
occupational health conduct the clinical
evaluation for CBD, in conjunction with
a pulmonologist who performs a
bronchoscopy (Document ID 0022, pp.
2–3).
OSHA notes that, although the agency
is requiring facilities to have a
pulmonologist or pulmonary specialist
on staff who is able to interpret the
biopsy pathology and the BAL
diagnostic test results, OSHA does not
intend that all aspects of clinical
evaluation for CBD must be performed
by a pulmonologist or pulmonary
specialist. In the preamble to the 2017
final rule, OSHA explained that the
agency was defining a CBD diagnostic
center as a facility with a pulmonary
specialist ‘‘on-site’’ specifically to
indicate that the specialist need not
personally perform the BeLPT testing
(82 FR at 2645). Moreover, paragraph
(k)(7), which sets out the substantive
requirements for the evaluation at the
CBD diagnostic center, refers to
recommendations of the ‘‘examining
physician,’’ not necessarily the
pulmonologist or pulmonary specialist.
Paragraph (b), in turn, defines
physician or other licensed health care
professional (PLHCP) as an individual
licensed to provide some or all of the
services required by paragraph (k). As
such, some parts of the evaluation, such
as lung function tests, might be
performed by a certified medical
professional other than a pulmonologist
or pulmonary specialist. The
arrangement that NJH describes as
typical for clinics treating CBD patients,
in which physicians with experience in
occupational health conduct the clinical
evaluation for CBD in conjunction with
a pulmonologist who performs a
bronchoscopy, is consistent with
OSHA’s intent for the definition of CBD
diagnostic center and other provisions
of the standard related to CBD
diagnosis. Therefore, OSHA has
determined that it is not necessary to
revise the definition of CBD diagnostic
center to require that the clinical
evaluation for CBD be conducted by a
pulmonologist, occupational medicine
specialist, or physician with expertise in
beryllium disease.
An additional change to the definition
of CBD diagnostic center clarifies that
the diagnostic center must have the
capacity to perform pulmonary function
testing (according to American Thoracic
Society criteria), bronchoalveolar lavage
(BAL), and tranbronchial biopsy. OSHA
determined that the former definition—
which stated that the evaluation at the
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diagnostic center ‘‘must include’’ these
tests—could have been misinterpreted
to mean that the examining physician
was required to perform each of these
tests during every clinical evaluation at
a CBD diagnostic center. The agency’s
intent is not to dictate which tests an
evaluation at a CBD diagnostic center
should include, but to ensure that any
CBD diagnostic center has the capacity
to perform any of these tests, which are
commonly needed to diagnose CBD.
OSHA expects that these are the tests
that would most commonly be
requested for a CBD evaluation.
Therefore, the agency is revising the
definition to clarify that the CBD
diagnostic center must simply have the
ability to perform each of these tests
when deemed appropriate. These
changes clarify the definition of CBD
diagnostic center, and OSHA expects
they will maintain safety and health
protections for workers.
Materion submitted comments
supporting OSHA’s intent to specify the
required capacities of a CBD diagnostic
center, rather than the contents of a CBD
evaluation, in the definition of CBD
diagnostic center (Document ID 0038,
pp. 16–17). NJH expressed concern that
this change to the definition may
indicate that the clinical evaluation for
CBD need not include certain aspects of
a CBD evaluation, which NJH, the
Association of Occupational and
Environmental Clinics (AOEC), and the
ATS recommend should typically
include full pulmonary function testing
(lung volumes, spirometry, and
diffusion capacity for carbon
monoxide), chest imaging, and
cardiopulmonary exercise testing, and
may also include bronchoscopy in some
cases (Document ID 0022, p. 3; 0028, p.
2; 0021, pp. 1–2). Similarly, the ATS
commented that not requiring certain
diagnostic tests ‘‘could reduce the
potential to diagnose CBD and
determine disease severity’’ (Document
ID 0021, p. 3). NJH recommended that
OSHA require the ATS
recommendations for diagnostic
evaluation, which the NJH stated
include the BeLPT; pulmonary function
testing and chest imaging; and in some
cases bronchoscopy (Document ID 0022,
p. 3).
As explained below in the Summary
and Explanation of paragraph (k)(7), that
provision—which establishes the
substantive requirements for the
evaluation at the CBD diagnostic
center—makes clear that the employer
must offer any tests that the examining
physician at the CBD diagnostic center
deems appropriate. The definition of
CBD diagnostic center in paragraph (b)
does not alter this requirement. In light
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of paragraph (k), the revised definition
of CBD diagnostic center cannot
reasonably be read to limit the types of
tests available to the employee (see the
Summary and Explanation for
paragraph (k)(7) for a full discussion of
this topic). Thus, after considering these
comments, OSHA has decided to retain
the proposed change to the definition of
CBD diagnostic center.
Chronic beryllium disease (CBD).
OSHA is also amending the definition
of chronic beryllium disease. For the
purposes of this standard, the agency is
using the term chronic beryllium
disease to mean a chronic
granulomatous lung disease caused by
inhalation of airborne beryllium by an
individual who is beryllium sensitized.
OSHA is finalizing the definition as
proposed. It includes several changes to
the 2017 final rule’s definition of
chronic beryllium disease, which was ‘‘a
chronic lung disease associated with
exposure to airborne beryllium’’ (82 FR
at 2645–46). The revisions serve to
differentiate CBD from other respiratory
diseases associated with beryllium
exposure (e.g., lung cancer) and to make
clear that beryllium sensitization and
the presence of beryllium in the lung are
essential in the development of CBD
(see 82 FR at 2492).
First, OSHA is adding the term
‘‘granulomatous’’ to the definition. A
granulomatous lung formation is a focal
collection of inflammatory cells (e.g., Tcells) creating a nodule in the lung (see
Ohshimo et al., 2017, Document ID
OSHA–H005C–2006–0870–2171, p. 2).
The formation of the type of lung
granuloma specific to a beryllium
immune response can occur only in
those with CBD (82 FR at 2492–2502).
Next, OSHA is removing the phrase
‘‘associated with airborne exposure to
beryllium’’ and replacing it with
‘‘caused by inhalation of airborne
beryllium.’’ This change is more
consistent with the findings in the 2017
final rule that beryllium is the causative
agent for CBD and that CBD occurs only
after inhalation of beryllium (82 FR at
2513). Finally, OSHA is clarifying that
CBD is caused by inhalation of airborne
beryllium ‘‘by an individual who is
beryllium sensitized.’’ Along with the
revised definition of beryllium
sensitization discussed above, this
revision emphasizes to employers and
employees the role that beryllium
sensitization plays in the development
of CBD.
NJH, the USW, and Materion agreed
with OSHA that the 2017 final
standard’s definition of chronic
beryllium disease should be clarified.
Materion supported the changes OSHA
proposed, which it characterized as a
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necessary clarification to ensure the
definition provided is specific to
chronic beryllium disease (Document ID
0038, p. 17). The USW similarly
supported the proposed definition,
stating that it clarifies the previous
definition which ‘‘could be read to
apply to any chronic lung disease
caused by beryllium, including lung
cancer’’ (Document ID 0033, p. 5). These
comments reinforce OSHA’s
determination that adding the term
‘‘granulomatous’’ to the definition will
better distinguish CBD from other
occupationally associated chronic
pulmonary diseases. As OSHA
explained in the preamble to the 2017
final rule, the formation of the type of
lung granuloma specific to a beryllium
immune response can occur only in
those with CBD (82 FR at 2492–2502).
Several commenters expressed
concern that the proposed definition of
chronic beryllium disease does not
provide sufficient information to guide
diagnosis of CBD, and specifically that
OSHA’s emphasis on the role of
sensitization in the development of CBD
may confuse diagnostic efforts. The ATS
noted that demonstrating beryllium
sensitization may be challenging in
certain settings and recommended that
OSHA’s definition of chronic beryllium
disease use the diagnostic criteria for
CBD outlined in a 2014 ATS document
on diagnosis and management of
beryllium sensitivity and CBD (‘‘the
ATS Statement’’). These diagnostic
criteria include confirmation of an
immune response to beryllium and
granulomatous lung inflammation using
lung biopsy and emphasize the various
approaches which may be used
‘‘[d]epending on the clinical setting,
feasibility of certain diagnostic tests,
and degree of diagnostic certainty
needed’’ (Document ID 0021, p. 5).
DOSH similarly emphasized that
individuals may be diagnosed with CBD
without a confirmed positive BeLPT
result and advocated that the definition
of chronic beryllium disease ‘‘ensure
employers and medical providers are
given a clear expectation of how
beryllium conditions are properly
identified’’ (Document ID 0023, p. 2).
OSHA notes that the standard’s
definition of chronic beryllium disease
is not intended to provide criteria for
the diagnosis of CBD. The agency’s
intent is to provide readers who may
have little or no familiarity with CBD
with a general understanding of the
term, rather than to provide diagnostic
criteria for healthcare professionals in
addressing CBD.
Due to differences in individual cases
and circumstances, medical specialists
may need to apply somewhat different
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testing regimens and/or diagnostic
criteria to different individuals they
evaluate for CBD. Furthermore, the
diagnostic tools and criteria available to
medical specialists may change over
time. As discussed in the Summary and
Explanation for paragraph (k)(7), OSHA
believes that the physician at the CBD
diagnostic center should have the
latitude to use any tests he or she deems
appropriate for the purpose of
diagnosing or otherwise evaluating CBD
in a patient, and has revised paragraph
(k)(7) to make this clear. Therefore,
OSHA has determined that it is neither
necessary nor appropriate to specify
diagnostic criteria in the beryllium
standard’s definition of chronic
beryllium disease. Instead, OSHA has
decided to retain a definition that
provides the reader with a general
understanding of the term.
NJH suggested that the agency define
chronic beryllium disease as a disease
‘‘characterized by evidence of
granulomatous lung inflammation in an
individual who is sensitized to
beryllium.’’ According to NJH, this
definition would allow for diagnosis
based on different combinations of
clinical evaluation results as detailed
the ATS Statement (Document ID 0022,
p. 3). OSHA believes that the definition
the agency proposed—a chronic
granulomatous lung disease caused by
inhalation of airborne beryllium by an
individual who is beryllium
sensitized—conveys the substance of
NJH’s recommended definition while
also emphasizing that CBD results from
the inhalation of airborne beryllium.
OSHA has therefore decided not to
adopt the definition NJH suggested.
The ATS expressed concern that
OSHA’s proposed changes to the
definition of chronic beryllium disease
could create confusion in the diagnosis
of CBD because it may be challenging in
certain settings to identify sensitization
and granulomatous lung disease based
on lung pathology (Document ID 0021,
p. 5). DOSH similarly commented that
the proposed definition may be
misleading because, although those with
CBD have sensitization to beryllium, the
current testing for sensitization has a
high false-negative rate and individuals
may be diagnosed with CBD without
first being confirmed positive for
beryllium sensitization (Document ID
0023, p. 2).
Although OSHA agrees that
employees may be diagnosed with CBD
without confirmed positive BeLPT
results, the agency does not agree with
these commenters that references to
sensitization should be excluded from
the definition of chronic beryllium
disease. OSHA first notes that neither
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DOSH nor the ATS contend that
OSHA’s definition is inaccurate.
Furthermore, as OSHA explained
previously in its discussion of the
beryllium sensitization definition, the
agency believes that a correct
understanding of the relationship
between beryllium sensitization and
CBD is key to workers’ and employers’
understanding of many provisions of the
beryllium standard. By stating the role
that sensitization plays in the
development of CBD in the standard’s
definition of chronic beryllium disease,
OSHA intends to convey clearly to the
regulated community why protecting
workers from becoming beryllium
sensitized is key to the prevention of
CBD and why workers who are
confirmed positive for beryllium
sensitization should be offered both a
clinical evaluation for CBD and medical
removal protection.
OSHA acknowledges that it is not
always necessary to identify a worker as
confirmed positive for beryllium
sensitization using the BeLPT as part of
a diagnosis of CBD and that the BeLPT
can yield false-negative results in some
individuals. For this reason, an
examining physician should have the
latitude to diagnose CBD even in the
absence of a ‘‘confirmed positive’’
pattern of BeLPT results. As explained
in the Summary and Explanation of
paragraph (k)(7) of the 2017 final rule,
that provision gives the examining
physician this latitude (82 FR 2704,
2709). Because the substantive
provisions of the standard leave the
examining physician discretion in
diagnosing CBD, OSHA does not agree
that acknowledging the role of
beryllium sensitization in the
development of CBD will result in
diagnostic confusion.
The NSSP recommended the
following addition to OSHA’s proposed
definition of chronic beryllium disease:
‘‘The presence of interstitial
mononuclear cell (T cell) infiltrates
(lymphocytosis) is characteristic of
chronic beryllium disease’’ (Document
ID 0027, pp. 3–4). The NSSP argued that
the presence of these infiltrates on lung
biopsy indicates the presence of chronic
beryllium disease, and should therefore
be included in the standard’s definition
(Document ID 0027, p. 4). OSHA
disagrees. The agency believes that the
term ‘‘granulomatous’’ sufficiently
addresses the presence of T-cell
infiltrates, which occur at an early stage
in the development of granulomas (82
FR at 2492–2502). As discussed
previously, OSHA’s intent in defining
chronic beryllium disease is to provide
the reader a general understanding of
what CBD is, rather than provide a
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technical definition for diagnostic use.
The suggested addition is not necessary
to describe the nature of CBD in general
terms. With the addition of the term
‘‘granulomatous,’’ the definition is
sufficiently specific for OSHA’s
purposes in the context of paragraph (b).
In summary, for the purposes of this
standard OSHA is defining chronic
beryllium disease as a chronic
granulomatous lung disease caused by
inhalation of airborne beryllium by an
individual who is beryllium sensitized.
This definition is identical to the
definition of chronic beryllium disease
OSHA proposed in 2018 and includes
only minor changes from the definition
included in the 2017 final standard.
OSHA is providing this definition to
enhance stakeholders’ general
understanding of the beryllium
standard; it is neither intended nor
suitable to provide guidance to medical
professionals on the diagnosis of CBD.
OSHA expects these changes to the 2017
definition of chronic beryllium disease
will clarify the standard, and will
therefore maintain safety and health
protections for workers.
Confirmed positive.
OSHA is amending the definition of
confirmed positive to mean (1) the
person tested has had two abnormal
BeLPT test results, an abnormal and a
borderline test result, or three
borderline test results, obtained from
tests conducted within a three-year
period; or (2) the result of a more
reliable and accurate test indicating a
person has been identified as having
beryllium sensitization. The revised
definition includes several changes to
the 2017 definition of confirmed
positive and one change from the
definition of confirmed positive that
OSHA proposed in the 2018 NPRM.
First, the agency is removing the
phrase ‘‘beryllium sensitization’’ from
the first sentence of the definition,
which previously stated that a person is
confirmed positive if that person has
beryllium sensitization, as indicated by
two abnormal BeLPT test results, an
abnormal and a borderline test result, or
three borderline test results. OSHA
intends that confirmed positive act only
as a trigger for requirements such as
continued medical monitoring and
surveillance for the purposes of this
standard, and not as a general-purpose
definition of beryllium sensitization. By
removing the phrase ‘‘beryllium
sensitization’’ from the first sentence of
the definition, the agency hopes to
avoid confusion resulting from scientific
disagreements over whether certain test
results, such as three borderlines,
necessarily prove that sensitization has
occurred. For purposes of the beryllium
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standard, any worker with the BeLPT
test results specified in the definition of
confirmed positive should be offered an
evaluation for CBD with continued
medical surveillance as well as the
option of medical removal protection,
even though some small percentage of
workers who are confirmed positive by
this definition may not in fact be
sensitized to beryllium, as is the case for
any diagnostic test (Middleton et al.,
2008 (Document ID OSHA–H005C–
2006–0870–0480, p. 4)).12
Both the USW and Materion
supported this proposed revision. The
USW stated that the former definition of
confirmed positive had acted ‘‘as a de
facto definition of sensitization’’ and
that removing the phrase from this
portion of the definition ensures that a
finding of confirmed positive will
trigger medical surveillance and
medical removal protection ‘‘without an
intermediate stop at a finding of
sensitization’’ (Document ID 0033, p. 5).
Similarly, Materion commented that the
revised definition allows individuals
with three borderline BeLPT results to
obtain the protections of the standard,
including evaluation for CBD and
medical removal protection, without
necessarily being ‘‘declared sensitized’’
(Document ID 0038, p. 18). Materion
further asserted that the change
enhances employee protection by
increasing the number of persons
eligible for further testing (Document ID
0038, p. 19).
NJH opposed the revised definition,
asserting that the removal of the phrase
‘‘beryllium sensitization’’ could prevent
individuals who meet the definition of
being confirmed positive from being
identified as sensitized. NJH further
expressed concern that this could make
it difficult for some workers to access
the medical testing and workplace
protections required by the rule
(Document ID 0022, p. 4).
The ATS and the AOEC also
disagreed with the removal of the
phrase ‘‘beryllium sensitization’’ from
the definition of confirmed positive,
stating the medically accepted
interpretation of BeLPT testing results is
that they indicate beryllium
sensitization, and that removing this
phrase may cause confusion about what
condition the term confirmed positive
refers to (Document ID 0021, p. 3; 0028,
12 In the preamble to the 2017 final rule, OSHA
found that three borderline BeLPT results recognize
a change in a person’s immune system with respect
to beryllium exposure based on Middleton et al.’s
2011 finding that three borderline BeLPT results
have a positive predictive value (PPV) of over 90
percent (82 FR at 2501), and therefore the agency
included three borderline results in the criteria for
confirmed positive (82 FR at 2646).
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p. 2). The ATS further stated without
explanation that removing the term
‘‘beryllium sensitization’’ from the
definition of confirmed positive would
reduce worker protections.13 The NSSP
also expressed disagreement with
OSHA’s proposal to remove ‘‘beryllium
sensitization’’ from the first part of the
confirmed positive definition, but did
not state the reasons for their concern
(Document ID 0027, p. 3).
Following consideration of the
concerns raised by these organizations,
OSHA disagrees that removing the
phrase ‘‘beryllium sensitization’’ from
the first sentence of the definition of
confirmed positive will create confusion
or reduce worker protections. The
provisions of the standard intended to
benefit workers who may be sensitized
(evaluation at a CBD diagnostic center
and medical removal protection) are
available to all workers who meet the
definition of confirmed positive.
Therefore, removing the term
‘‘beryllium sensitization’’ from the first
sentence of the definition will not
change the access to these benefits for
any workers. By removing the term
‘‘beryllium sensitization’’ from the first
sentence of the definition, OSHA seeks
to ensure that workers with three
borderline BeLPT results (or other
patterns of test results that some
physician or other licensed health care
professionals (PLHCPs) may consider
ambiguous) will receive the benefits of
the standard regardless of whether their
PLHCP views their results as firm
evidence of sensitization. Furthermore,
OSHA disagrees that removing the
reference to ‘‘beryllium sensitization’’
will lead to confusion about what the
BeLPT results are supposed to indicate
because the second sentence of the
definition of confirmed positive makes
clear that a worker who has been
diagnosed with beryllium sensitization
would also meet the definition of
confirmed positive: ‘‘It [confirmed
positive] also means the result of a more
reliable and accurate test indicating a
person has been identified as having
beryllium sensitization.’’
An additional change to the definition
of confirmed positive provides that the
13 The ATS also asserted that the removal of the
phrase ‘‘beryllium sensitization’’ would reduce
workers’ right to file for worker’s compensation
(Document ID 0021, p. 3). The ATS did not explain
how the definition of confirmed positive in the
beryllium standard could affect worker’s
compensation claims and at least one other
commenter questioned the ATS’s assertion (see
Document ID 0038, p. 19). Regardless, OSHA
intends the definition of confirmed positive to serve
only as a trigger for certain provisions of the
beryllium standard. How OSHA defines this phrase
for purposes of the beryllium standard in no way
limits healthcare professionals’ ability or incentive
to diagnose beryllium sensitization.
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findings of two abnormal, one abnormal
and one borderline, or three borderline
results need to occur from BeLPTs
conducted within a three-year period.
This change in the definition of
confirmed positive differs from the
proposal and is based on comments
submitted to the record following
publication of the 2018 NPRM.
The 2017 final rule did not specify a
time limit within which the BeLPT tests
that contribute toward a finding of
‘‘confirmed positive’’ must occur. After
publication of the 2017 final rule,
stakeholders suggested to OSHA that the
definition of confirmed positive could
be interpreted as meaning that findings
of two abnormal, one abnormal and one
borderline, or three borderline results
over any time period, even as long as 10
years, would result in the employee
being confirmed positive and
automatically referred to a CBD
diagnostic center for evaluation. As
discussed in the preamble to the 2017
standard, clinical evaluation for CBD
involves bronchoalveolar lavage and
biopsy (82 FR at 2497) which, like all
invasive medical procedures, carry risks
of infection and other complications.14
Given such risks, and the possibility
that some repeat abnormal or borderline
results obtained over a long period of
time could be false positives, it was not
the agency’s intent that workers with
rarely recurring abnormal or borderline
BeLPT results should necessarily
proceed to evaluation at a CBD
diagnostic center unless recommended
to do so by their examining physician.
At the same time, OSHA notes that
under paragraph (k)(5)(iii), the licensed
physician performing the BeLPT testing
retains the discretion to refer an
employee to a CBD diagnostic center if
the licensed physician deems it
appropriate, regardless of the BeLPT
result.
In the 2018 NPRM OSHA proposed
that any combination of test results
specified in the definition of confirmed
positive must result from the tests
conducted in one cycle of testing,
including the initial BeLPT and the
follow-up retesting offered within 30
days of an abnormal or borderline result
(paragraph (k)(3)(ii)(E)). As outlined in
proposed paragraph (k)(3)(ii)(E), an
employee would be offered a follow-up
BeLPT within 30 days if the initial test
result is anything other than normal,
unless the employee had been
confirmed positive (e.g., if the initial
14 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 (82 FR at 2497).
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BeLPT was performed on a split sample
and showed two abnormal results).
Thus, for example, if an employee’s
initial test result was abnormal, and the
result of the follow-up testing offered to
confirm the initial test result was
abnormal or borderline, the employee
would be confirmed positive.
Alternatively, if the result of the followup testing offered to confirm the initial
abnormal test result was normal, the
employee would not be confirmed
positive. Any additional abnormal or
borderline results obtained from the
next required BeLPT for that employee
(typically, two years later) would not
identify that employee as confirmed
positive under the proposed
modification to confirmed positive.
OSHA requested comments on the
appropriateness of this proposed time
period.
Several stakeholders, including
Materion, NJH, the ATS, DOSH, the
NSSP, the AOEC, the USW, and The
American College of Occupational and
Environmental Medicine (ACOEM),
submitted comments regarding OSHA’s
proposal to require that the test results
specified in the agency’s definition of
confirmed positive must occur within a
single testing cycle. Commenters
focused on several aspects of the
proposed timing. First, many of the
comments focused on the logistics of
OSHA’s proposed change. Materion
supported the proposed definition of
confirmed positive, stating that a 30-day
allowance for follow-up testing after a
first abnormal or borderline BeLPT
result is appropriate to ensure that
testing is completed in a timely manner
(Document ID 0038, p. 17). However,
NJH, the ATS, ACOEM, the USW, and
the NSSP all indicated that requiring
results with a 30-day testing cycle could
create logistical challenges, for example
due to repeat testing requirements or for
businesses in remote areas with limited
healthcare facilities (Document ID 0022,
p. 4; 0021, p. 4; 0024, p. 1; 0033, p. 5;
0027, p. 3). In this final rule and
preamble, OSHA clarifies that it did not
intend that the initial and follow-up
tests had to be completed and
interpreted within 30 days. It intended
that the test results used to determine if
a worker is confirmed positive be
obtained during one cycle of testing
(i.e., an initial or periodic examination),
including follow-up testing conducted
within 30 days of an abnormal or
borderline result.
Secondly, stakeholders commented
on the appropriateness of limiting the
use of the BeLPT from one test cycle in
determining if a worker is confirmed
positive. Materion agreed with the
proposed timing and commented that
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the change ‘‘increases employee
protections by establishing an employee
as confirmed positive in a shorter time
frame, thus, making the medical
removal benefit option available to the
worker in a more timely manner’’
(Document ID 0038, p. 19). Stakeholders
from the medical community disagreed
and raised concerns that limiting test
results to one test cycle would affect the
ability to identify workers who should
be referred for a CBD evaluation and
receive other protections under the
standard.
The NSSP cited data from healthcare
providers to demonstrate that a 30-day
testing cycle is insufficient to properly
identify sensitized workers. According
to the NSSP, in over 20 years of
conducting BeLPTs in worker
populations, Oak Ridge Associated
Universities observed approximate
median times of 45 days (range of 3 days
to 16 years) between first and second
abnormal tests, 1.5 years (range of 30
days to 11 years) for the abnormal/
borderline test combination, and 1 year
(range of 30 days to 11 years) for three
borderlines (Document ID 0027, p. 3).
Under the proposed 30-day
requirement, the NSSP stated that the
majority of workers who have been
identified as sensitized in the past
would not meet the proposed definition
of confirmed positive (Document ID
0027, p. 3).
NJH reported similar findings in new
evidence submitted to the record
(Document ID 0022, pp. 4–5). The
evidence indicates that many workers
who develop CBD have abnormal or
borderline results that do not
immediately repeat upon retesting. To
the contrary, many CBD patients have a
series of tests which alternate between
normal and abnormal. Data based on
NJH’s extensive experience show that
the BeLPT does not yield consistently
abnormal results among CBD patients.
Of 194 patients diagnosed with CBD at
NJH, the length of time between
abnormal results ranged from 14 days to
5.8 years, with a 95th percentile of 2.9
years. In this group, 150 patients (or 77
percent) would not have been evaluated
for CBD if two abnormal BeLPT results
were required to occur within a 30-day
testing cycle (Document ID 0022, p. 5).
Although the information the NSSP
and NJH submitted to the record is
unpublished, their findings are
consistent with published studies.
Kreiss et al. (1997) reported that nine
individuals had initial abnormal BeLPT
results followed by two normal tests; six
of those individuals were re-tested
approximately one year later and four
were confirmed positive for beryllium
sensitization based on abnormal BeLPT
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42605
results (Document ID OSHA H005C–
2006–0870–1360, pp. 610–12). These
findings suggest a high rate of falsenegative results and are consistent with
results reported in a study by Stange et
al. (2004). That study found an average
false-positive rate of 1.09 percent, and a
false-negative rate of 27.7 percent for the
BeLPT (Document ID OSHA–H005C–
2006–0870–1402, p. 459).
Other public health organizations,
including DOSH, the ATS, the NSSP,
and the AOEC, agreed with NJH that
workers who are sensitized to beryllium
may show varying test results over time;
and restricting the time period for
determining ‘‘confirmed positive’’ status
to 30 days would cause sensitized
individuals to go undetected (Document
ID 0023, p. 2; 0021, p. 2; 0027, p. 3;
0028, p. 2). The ATS and the AOEC
recommended that results from tests
performed up to at least three years after
the initial abnormal or borderline test
result should be used to determine
whether the person tested is confirmed
positive for beryllium sensitization
(Document ID 0021, p. 2; 0028, p. 2).
The ATS stated that a timeframe of at
least three years, which encompasses
two rounds of regularly scheduled
testing required biennially by the
beryllium standard, would adequately
address its concerns regarding logistical
feasibility, would improve diagnostic
accuracy, and help ensure that
sensitized workers are identified
(Document ID 0021, p. 4). The AOEC
agreed that consideration of BeLPT test
results obtained during a time period of
at least three years ‘‘will increase the
potential that workers are accurately
diagnosed with beryllium sensitization
[and] will receive the necessary care’’
(Document ID 0028, p. 2).
The approaches recommended by the
ATS and the AOEC are similar to the
approach NJH used in providing
medical surveillance consultation to
workforces that use beryllium. NJH
stated that, if an individual’s BeLPT
results are abnormal and normal on
their initial round of BeLPT testing, they
will usually request another BeLPT
within a month. If the result of that test
is normal, they do not request further
testing until the next regularly
scheduled BeLPT. If the result of the
next regularly scheduled BeLPT comes
back abnormal, they refer the worker for
clinical evaluation even though the tests
are separated by the two-year testing
cycle (Document ID 0022, p. 5).
Following consideration of the
comments and of the new evidence
submitted to the record following the
proposal, OSHA is convinced that some
workers who are ultimately found to be
sensitized to beryllium or diagnosed
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with CBD may have alternating
abnormal and normal BeLPT results,
and that the time period for abnormal or
borderline results to repeat can be
months or years. OSHA is also
convinced that requiring two abnormal,
an abnormal and borderline, or three
borderline results to occur in one cycle
of an initial or periodic exam before an
employee can be confirmed positive
could result in beryllium sensitization
or CBD going undetected in many
employees. This is demonstrated by the
unpublished data submitted by NJH
showing that a substantial percentage of
individuals with CBD (77 percent) may
not have been referred for further testing
based on results obtained within a 30day cycle of testing and is confirmed by
the experience of the NSSP. Therefore,
OSHA finds that its proposed change
would have the unintended and
unacceptable consequence of reducing
employee protections because some
employees who are sensitized or have
CBD would be deprived of the benefits
available through the standard, such as
a timely evaluation at a CBD diagnostic
center. In addition, requiring that results
be obtained in one test cycle is not
consistent with the approaches
currently applied or supported by the
medical community.
For these reasons, OSHA is revising
the definition of confirmed positive to
specify that the findings of two
abnormal, one abnormal and one
borderline, or three borderline results
must be obtained from BeLPTs
conducted within a three-year period.
OSHA agrees with the ATS and the
AOEC that a three-year period will
facilitate the identification of sensitized
workers enrolled in medical
surveillance (see Document ID 0022, p.
5; 0028, p. 2). In addition, this approach
is consistent with the practices and
recommendations from the medical
community, including NJH, which
provides beryllium-related medical
surveillance consultation. OSHA
believes that allowing a worker to be
confirmed positive based on BeLPT
results obtained over a three-year time
period strikes a reasonable balance that
would allow a timely evaluation for
CBD, while at the same time,
maintaining OSHA’s original intent that
a confirmed positive finding not be
based on results obtained over an
indefinite time period.
OSHA emphasizes that this revision
does not modify the requirements of
paragraph (k)(3)(ii)(E). Under that
paragraph, if the results of the BeLPT
are other than normal, a follow-up
BeLPT must be offered within 30 days
of receiving the results, unless the
employee has been confirmed positive.
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Only other than normal BeLPT results
must be followed up within 30 days of
the same test cycle (i.e., an initial or
periodic medical examination).
As an example, an employee who
receives a borderline result during one
periodic examination conducted in 2020
would be retested within 30 days, and
if the follow-up test is normal, testing
would stop. That employee would be
offered another BeLPT at the next
periodic examination conducted in
2022. However, if the result of the 2022
test is borderline, the employee would
be retested within 30 days of that test
result receipt, and if the follow-up test
is borderline, the employee would be
confirmed positive because of receiving
three borderline tests within three years.
A three-year period for the employee to
be confirmed positive would ensure
sufficient time for such follow-up tests
that may need to be conducted over two
cycles of medical examinations.
DOD recommended changing the term
‘‘confirmed positive’’ to another term
such as ‘‘confirmed non-negative,’’
‘‘confirmed finding of concern,’’ or
‘‘pattern of concern.’’ According to the
DOD, the term ‘‘confirmed positive’’
typically ‘‘implies an initial positive test
that was repeated with another test or
another, more sensitive test, which
confirms the initial positive test result’’
(Document ID 0029, p. 2). The CBD
literature, however, commonly treats
individuals as confirmed positive for
sensitization through sequentially
conducted BeLPTs (see, for example, the
ATS Statement on Diagnosis and
Management of Beryllium Sensitivity
and Chronic Beryllium Disease, ATS
2014, Document ID OSHA–H005C–
2006–0870–0364, p. e41; see also
Document ID OSHA–H005C–2006–
0870–1543, 0603, 0398, 1403, 1449).
Additionally, OSHA again emphasizes
that terms defined in the beryllium
standard are defined only for purposes
of the standard and are not intended as
diagnostic, scientific, or all-purpose
definitions. OSHA believes that its
definition of confirmed positive clearly
indicates what that term means for
purposes of the beryllium standard and
therefore disagrees with DOD’s concern
that the term may cause confusion.
Accordingly, OSHA is retaining the
term ‘‘confirmed positive’’ in this final
standard.
Dermal contact with beryllium.
Paragraph (b) of this final rule defines
dermal contact with beryllium as skin
exposure to (1) soluble beryllium
compounds containing beryllium in
concentrations greater than or equal to
0.1 percent by weight; (2) solutions
containing beryllium in concentrations
greater than or equal to 0.1 percent by
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weight; or (3) visible dust, fumes, or
mists containing beryllium in
concentrations greater than or equal to
0.1 percent by weight. The definition
also states that handling of beryllium
materials in non-particulate solid form
that are free from visible dust containing
beryllium in concentrations greater than
or equal to 0.1 percent by weight is not
considered dermal contact under the
standard. Several of the standard’s
provisions are triggered where an
employee has, or can be reasonably
expected to have, dermal contact with
beryllium. These include provisions in
paragraph (f), Written exposure control
plan; paragraph (h), Personal protective
clothing and equipment (PPE);
paragraph (i), Hygiene areas and
practices; paragraph (k), Medical
surveillance; and paragraph (m),
Communication of hazards.
This final rule makes two changes to
the previous definition, which was
added to the standard through the 2018
direct final rule (83 FR at 19940)
following OSHA’s promulgation of the
final rule in January 2017. That direct
final rule defined dermal contact with
beryllium as skin exposure to soluble
beryllium compounds, beryllium
solutions, or dust, fumes, or mists
containing beryllium, where these
materials contain beryllium in
concentrations greater than or equal to
0.1 percent by weight (83 FR at 19940).
First, this final rule modifies the
definition to refer to ‘‘visible’’ dust,
fumes, or mists containing beryllium in
concentrations greater than or equal to
0.1 percent by weight. Second, OSHA is
adding a sentence to the definition
specifying that handling beryllium
materials in non-particulate solid form
that are free from visible dust containing
beryllium in concentrations greater than
or equal to 0.1 percent by weight is not
considered dermal contact with
beryllium under the standard. This final
rule’s definition of dermal contact with
beryllium is identical to the definition
that OSHA proposed in the 2018 NPRM.
The revisions incorporated in this
definition are intended to help
employers more accurately identify
areas where the provisions triggered by
dermal contact apply. Based on
feedback OSHA received from
stakeholders following publication of
the 2017 final standard, OSHA became
concerned that employers might have
difficulty accurately identifying when
and where the provisions triggered by
dermal contact are required. Berylliumgenerating processes can release
beryllium in varying particle sizes and
amounts, some of which are visible to
the naked eye and some of which are
not. OSHA was concerned that
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employers could reasonably interpret
the provisions triggered by dermal
contact with beryllium (e.g., the use of
PPE) as extending to every employee
who could potentially encounter a
minute and non-visible amount of
beryllium particulate at its facility,
irrespective of the employee’s job duties
and tasks, or who might handle an
object containing beryllium. Such an
interpretation would be contrary to
OSHA’s intent and could prompt
employers to attempt infeasible
compliance measures. Therefore, as
explained in the 2018 NPRM, OSHA
proposed adding the term ‘‘visible’’ to
clarify when skin exposure to
beryllium-containing dust, fumes, or
mist should be considered dermal
contact with beryllium for the purpose
of triggering the standard’s
requirements. OSHA also proposed
adding a sentence to state that handling
of beryllium materials in nonparticulate solid form that are free from
visible dust containing beryllium in
concentrations greater than or equal to
0.1 percent by weight is not considered
‘‘dermal contact with beryllium’’ under
the standard.
Several commenters supported
revising the definition of dermal contact
with beryllium to apply to visible
particulate, agreeing that the revised
definition would facilitate compliance
with the standard. In its submission,
Materion stated that the proposed
change to the definition ‘‘clears up the
ambiguity and eliminates the vagueness
of the [previous] . . . standard,’’ and
that
Revising the standard to provide
employees as well as employers clear lines
will likely immeasurably help not only with
compliance but with enforcement of the
standard. Without the visible cue, employees
will have no idea whether and when they
should be protected by PPE. . . . OSHA has
fixed this problem with a sensible and clear
demarcation threshold for dermal contact,
and has done so in a manner that does not
sacrifice protection against the risk of CBD.
(Document ID 0038, p. 21). Similarly,
the USW stated that dermal exposure to
beryllium needed to be ‘‘properly
addressed,’’ but that triggering
provisions by dermal contact with
materials containing beryllium at any
level ‘‘could extend the application of
the standard far beyond what OSHA
intended or what is necessary to protect
workers’’ (Document ID 0033, p. 4). The
USW referred to non-sparking tools
made from beryllium-copper alloy and
beryllium foil used for x-ray windows as
examples of materials where dermal
contact should not trigger provisions of
the standard (Document ID 0033, p. 4).
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Century Aluminum Company
(Century Aluminum) (Document ID
0026, p. 2) and DOD (Document ID
0029, p. 1) also agreed with the proposal
to add the term ‘‘visible’’ to the
definition. However, DOD
recommended that OSHA revise the
definition to explicitly identify skin
exposure to ‘‘visible dust that has
accumulated on surfaces’’ in addition to
visible dust, fumes, or mists containing
beryllium in concentrations greater than
or equal to 0.1 percent by weight. OSHA
does not believe this added phrase is
necessary. The definition of dermal
contact with beryllium does not
distinguish the exposure routes that
cause the skin exposure and, as
proposed, the phrase ‘‘visible dust’’
encompasses exposures via both air and
surface contamination.
The ATS commented that adding
‘‘visible’’ to the definition to trigger
provisions related to dermal contact
‘‘could be helpful,’’ but cautioned that
inhalation of beryllium particulate that
is not visible is ‘‘the major concern’’ for
developing CBD (Document ID 0021, p.
5). It urged OSHA to ensure that the
revised definition neither undermines
the requirements of the beryllium
standard which limit exposure to
respirable beryllium, nor limits
education on the health effects of
beryllium to only those workers with
exposure to visible dust (Document ID
0021, p. 5).
NJH objected to OSHA’s proposal to
restrict the definition to visible dust,
fumes, and mists, believing that doing
so could reduce employee protections
from beryllium-induced sensitization
and disease (Document ID 0022 p. 7).
NJH commented that the smallest
respirable particles are not visible and
are inhaled into the deepest part of the
lung. It further commented that a
‘‘monitoring program that routinely
samples all departments with air and
wipe samples can accomplish
identifying ‘nonvisible’ dust
contamination and should be part of any
industry that needs to comply with an
exposure limit’’ (Document ID 0022, p.
7). Other commenters voiced similar
concerns about the risk posed by
exposure to ultrafine particles
containing beryllium, including the
NSSP (Document ID 0027, p. 3), the
AOEC (Document ID 0028, p. 2), and
DOSH (Document ID 0023, p. 2).
OSHA agrees that exposure to
airborne beryllium, even when not
visible to the naked eye, is an important
risk factor for developing CBD and that
it would be inappropriate to rely on the
presence of visible airborne particulate
to assess workers’ exposure to airborne
beryllium and the need to implement
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42607
engineering and work practice controls
or respiratory protection. The standard’s
permissible exposure limits and
requirements for quantitative exposure
assessments and use of respiratory
protection are of paramount importance
for ensuring that workers are protected
from CBD, and these requirements are
unaffected by the changes to the dermal
contact with beryllium definition. In
addition, the standard’s requirements to
train workers on the health hazards of
exposure to beryllium and on the
employer’s exposure control plan
(paragraph (m)(4)) apply to all
employees within the scope of the
general industry standard who have, or
can reasonably be expected to have,
airborne exposure (regardless of the size
fraction) to or dermal contact with
beryllium, thus including all workers
that would be considered to be
potentially at risk of beryllium-related
disease.15
DOSH advocated for surface sampling
as being a ‘‘practical method’’ for
assessing exposure and asserted that
adopting a ‘‘specific numerical surface
contamination criterion’’ to assess
dermal contact hazard was a more
protective strategy. DOSH further
suggested that, in establishing this
numerical criterion, OSHA ‘‘consider
levels that could result in uptake of
beryllium by workers at rates similar to
action level airborne exposures’’
(Document ID 0023, p. 2).
With respect to inhalation hazards
associated with beryllium, OSHA agrees
that relying on the visibility of
particulate does not adequately protect
workers from CBD or lung cancer, and
that both conducting routine air
sampling and ensuring no employees
are exposed to airborne beryllium in
excess of the PELs are essential to
minimizing workers’ exposures to
airborne particulate. The TWA PEL for
beryllium is based on robust evidence
from studies of beryllium workers that
permitted the agency to determine that
there is significant risk of sensitization,
CBD, and lung cancer associated with
the previous TWA PEL, and that this
15 NJH also asserted that ‘‘[a]ll workers in a
beryllium using industry should receive beryllium
education with programs tailored to specific jobs
and processes’’ (Document ID 0022, p. 7). Mount
Sinai Selikoff Centers for Occupational Health
similarly advocated for ‘‘intensive training and
protective gear for all workers who may be at risk
of beryllium exposure’’ (Document ID 0032, p. 3).
OSHA notes that the beryllium standard has never
required all workers in a beryllium-using industry
to receive training. Rather, the standard has always
required training for those workers who have or are
reasonably expected to have airborne exposure to
beryllium regardless of the size fraction. The
standard continues to require training for all such
workers.
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risk would be substantially reduced by
the new PEL (82 FR at 2545–52).
Unlike the case for inhalation, the
available data on the effects of dermal
contact with beryllium make it difficult
to establish a reasonably precise,
objective limit on surface contamination
above which protective measures
should be triggered. The most recent
effort to derive a health-based measure
of surface cleanliness for beryllium was
that of Shay et al. (Document ID H005C–
2006–0870–0417), who used models
that accounted for particulate
dissipation, resuspension into air,
transfer efficiency from surface to skin,
dermal absorption of particulate through
intact or damaged skin, and other
factors. The authors used these models
along with both oral and inhalation
toxicity values derived by the
Environmental Protection Agency to
relate the level of surface contamination
to target risk values for cancer and
noncancer effects that would generally
be considered to be de minimis (i.e., an
exposure associated with either a
lifetime cancer risk of one death per
million persons exposed, or no excess
risk of adverse noncancer effects). After
accounting for these factors, the
resulting surface dust cleanup criteria
for each health endpoint ranged over
several orders of magnitude, reflecting a
high degree of uncertainty (for the
noncancer endpoint, the criteria ranged
from 5 to 370 mg/cm2 for damaged skin,
and from 17 to 3,337 mg/cm2 for intact
skin; for cancer, the criteria ranged from
51 to 485 mg/cm2).
This study illustrates the difficulty in
establishing a reliable and objective
risk-based limit on surface
contamination that could be used to
trigger measures that would prevent
dermal contact with beryllium
particulate when such contact is
sufficient to contribute to a significant
risk of disease. Absent an objective
measure, OSHA finds that it is
preferable to base the definition of
dermal contact with beryllium on a
clear, qualitative indicator of when
dermal contact is occurring or is
reasonably anticipated to occur so that
employers can have assurance that they
are in compliance with the provisions
that are triggered by dermal contact.
Accordingly, the final rule’s definition
of dermal contact with beryllium refers
to skin exposure to visible dusts, fumes,
or mists, as well as to soluble
compounds and solutions of beryllium,
as was proposed. As stated above,
OSHA expects that revisions in this
final rule will maintain worker
protections.
NJH also objected to defining dermal
contact with beryllium when handling
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finished beryllium products only by the
presence of visible dust, asserting that
gloves are warranted because beryllium
could oxidize on the surface (Document
ID 0022, p. 7). However, for the reasons
explained below, OSHA considers these
comments to be beyond the scope of the
proposal. The agency also notes that the
revision NJH’s comment refers to merely
clarifies the meaning of the 2017
standard, rather than modifying it
substantively.
OSHA’s revision to the definition of
dermal contact with beryllium clarifies
OSHA’s intent that the provisions in the
standard related to dermal contact with
beryllium do not apply to the handling
of solid beryllium-containing objects
that the employer does not process,
unless visible beryllium particulate has
contaminated the surface of the object.
OSHA explained in the 2017 final rule
that beryllium-containing solid objects,
or ‘‘articles,’’ with uncompromised
physical integrity are unlikely to release
beryllium that would pose a health
hazard for workers (82 FR at 2640). An
article, by definition, ‘‘under normal
conditions of use does not release more
than very small quantities, e.g., minute
or trace amounts of a hazardous
chemical . . . , and does not pose a
physical hazard or health risk to
employees’’ (29 CFR 1910.1200(c)). The
agency therefore excluded articles that
contain beryllium, and that the
employer does not process, from the
scope of the 2017 beryllium standard
(see paragraph (a)(3)). OSHA did not
intend for the 2018 NPRM to open the
agency’s underlying findings on the
handling of beryllium-containing
articles, nor their exclusion from the
scope of the standard, for notice and
comment. To the extent NJH’s comment
challenges the articles exemption, these
comments are beyond the scope of the
proposal.
Nevertheless, even for those solid
beryllium-containing objects that do not
fall under the definition of an article,
such as ingots that might be processed
further, OSHA notes that PPE would be
required if there is a reasonable
expectation that oxidation may result in
visible surface contamination. In its
comments on the 2015 NPRM, Materion
explained that beryllium oxides are
created through particular
manufacturing processes, typically
those involving heating of the
beryllium-containing materials (e.g., hot
forming operations, melting, or heat
treating) (see Document ID OSHA–
H005C–2006–0870–1662, p. 16). These
operations may give rise to a reasonable
expectation of dermal contact due to the
expected oxidization that will occur as
a result of the process. Where there is
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a reasonable expectation that
oxidization may result in visible surface
contamination, an employer must not
wait for the surface to be contaminated
to require PPE for potentially exposed
employees. For example, if the surface
of a solid object must be heat treated,
and the employer has reason to believe
this will result in surface oxidation
absent cleaning the surface, PPE would
be required under this final rule.
After carefully considering the record
of public comments on this topic, OSHA
finds that the revised definition of
dermal contact with beryllium will
provide a clearer and more workable
definition, without reducing worker
protections. The specification of ‘‘visible
dust, fumes, or mists containing
beryllium in concentrations greater than
or equal to 0.1 percent by weight’’ and
clarification regarding berylliumcontaining articles will allow employers
to accurately identify the employees,
particularly those working outside of
beryllium work areas or regulated areas,
to whom the provisions triggered by
dermal contact with beryllium apply,
including the requirement in paragraph
(h) to provide employees with PPE to
protect against reasonably expected
dermal contact with beryllium. The
revised definition will also render more
workable the additional provisions in
the standard that are triggered by dermal
contact with beryllium, which include
provisions in paragraph (f), Written
exposure control plan; paragraph (i),
Hygiene areas and practices; paragraph
(k), Medical surveillance; and paragraph
(m), Communication of hazards.
This final rule better addresses the
practical aspects of a ‘‘reasonable
expectation’’ trigger for PPE than did the
previous rule, which could have been
read as effectively requiring employees
to wear PPE facility-wide, even when
not in proximity to beryllium generating
processes, such as in administrative
offices. OSHA believes that use of PPE
in that circumstance is unwarranted and
would not meaningfully enhance
worker protections against beryllium
exposure. Where an employer has a
reasonable expectation that even very
small amounts of beryllium dust, fume,
or mist might spread outside of
beryllium work areas, they might have
interpreted the language of the previous
rule to require all employees in the
facility to wear PPE all of the time.
OSHA did not intend and did not cost
the previous rule as requiring PPE to
protect against dermal contact with nonvisible beryllium dust, fumes, or mists
outside of beryllium work areas. The
addition of a visual cue will enable
employers to accurately identify the
employees outside of beryllium work
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areas who need to wear PPE due to their
reasonably-expected dermal contact
with beryllium.
As OSHA explained in the 2018
NPRM (83 FR at 63752), the agency
expects that the use of PPE will always
be required in beryllium work areas
because both the operations listed in
Appendix A and those that can be
reasonably expected to generate
exposure at or above the action level
would create a reasonable expectation of
dermal contact with beryllium. This
expectation is based, in part, on a study
conducted by NIOSH and Materion and
published in the Journal of
Occupational and Environmental
Hygiene (Document ID OSHA–H005C–
2006–0870–0502, p. 791). In the 2018
NPRM, OSHA explained that this study
identified a strong correlation between
airborne beryllium concentrations and
the amount measured on gloves worn by
workers at multiple beryllium facilities
and jobs, indicating the potential for
skin exposure where airborne beryllium
is present. The study further concluded
that this correlation implies that one
type of measurement can be indicative
of other exposure pathways (Document
ID OSHA–H005C–2006–0870–0502, p.
791). OSHA further explained that the
expectation of dermal contact within
beryllium work areas is also based on
OSHA’s review of data collected during
site visits conducted by the agency that
cover a wide range of processes (e.g.,
furnace and melting operations, casting,
grinding/deburring, machining and
stamping) and a wide range of materials
including beryllium composite,
beryllium alloy, and beryllium oxide.
The data show that those operations that
would create a reasonable expectation of
dermal contact, either through
beryllium surface contamination or skin
contamination, are covered either by
proposed Appendix A or have
exposures above the action level (see
Document ID OSHA–H005C–2006–
0870–0341).
In its comment, Materion questioned
OSHA’s reliance on the 2007 Day et al.
study (82 FR at 2488–89) and suggested
that, contrary to OSHA’s statement, Day
did not identify a ‘‘strong correlation’’
between airborne concentrations and
skin exposure (Document ID 0038, pp.
13–14). Materion cited Day’s finding of
a potential for greater transfer of
beryllium from surfaces to cotton gloves
that could lead to an overestimation of
the amount of beryllium transferred.
OSHA disagrees with Materion’s
assessment of the Day study. Day
indicates that the underlying
assumption that glove-sampling
techniques actually remove the majority
of the contamination may be overstated
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and that the surface and skin wipe
samples may underestimate the mass of
beryllium that is present. The Day study
demonstrates that there is a correlation
between airborne and potential for skin
exposures (Document ID OSHA–
H005C–2006–0870–1548, p. 79).
As OSHA discussed in the NPRM,
this finding is supported by a follow-up
study by Armstrong et al. (2014)
conducted at four different Materion
manufacturing locations over a wide
variety of jobs. This study also showed
strong positive correlations between air,
dermal, and surface exposures among
the four different facilities that process
beryllium (Document ID OSHA–H005C–
2006–0870–0502, p. 791). The study
further concludes that this correlation
implies that one type of measurement
can be indicative of other exposure
pathways. OSHA finds that these
studies demonstrate a correlation
between airborne exposure and the
reasonable expectation of dermal
contact.16
In the 2018 NPRM, OSHA specifically
requested comments on whether
processes exist that could trigger the
creation of a beryllium work area, but
could be reasonably expected to release
only non-visible beryllium-containing
dusts, fumes, or mists. No commenter
provided evidence of such processes.
Materion asserted that OSHA should not
‘‘automatically classify’’ beryllium work
areas as having a reasonable expectation
of dermal contact because this would
serve as ‘‘a serious disincentive for
employers to eliminate exposure
meeting the definition of dermal
contact’’ (Document ID 0038, p. 15).
However, Materion did not explain how
such a presumption would serve as a
disincentive and, more importantly, did
not identify any process that could
trigger the creation of a beryllium work
area while not also, in fact, creating a
reasonable expectation of dermal
contact.
Accordingly, OSHA reaffirms its
expectation that both the provisions
associated with beryllium work areas
(listed above) and the provisions
associated with dermal contact with
beryllium would apply to employees in
a beryllium work area. OSHA expects
that employers will, for each beryllium
work area, assess the PPE needs as
required by paragraph (f)(1) and OSHA’s
16 Materion also asserted that the evidence in the
record is insufficient to conclude that ‘‘dermal
contact alone is sufficient to create a significant risk
of CBD or even beryllium sensitization’’ (Document
ID 0038, pp. 14–15). However, in the 2017 final
rule, OSHA specifically found that that dermal
exposure can result in sensitization (see 82 FR at
2489). The 2018 NPRM did not propose revisiting
this finding.
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Personal Protective Equipment
standards (subpart I of 29 CFR 1910)
and provide their employees with
appropriate PPE.
Because it will help employers
identify which employees have, or can
be reasonably expected to have, dermal
contact with beryllium, the revised
definition will allow employers to more
accurately comply with the requirement
in paragraph (f)(1)(i)(A) to establish,
implement, and maintain a written
exposure control plan that includes a
list of operations and job titles
reasonably expected to involve airborne
exposure to or dermal contact with
beryllium. OSHA expects that the list
would likely include all operations and
job titles in beryllium work areas, along
with any additional operations or job
titles for employees whose skin could be
exposed to visible beryllium dust,
fumes, or mists in concentrations of 0.1
percent by weight or more. Under the
previous definition, employers could
have reasonably interpreted the
standard as requiring them to list the job
title for every employee at the facility
who could come into contact with a
minute and non-visible amount of
beryllium particulate, including
employees who do not work in
proximity to beryllium-releasing
processes.
Similarly, the revised definition will
facilitate employer compliance with the
requirement to provide information and
training (in accordance with the Hazard
Communication standard (29 CFR
1910.1200(h)) to each employee who
has, or can reasonably be expected to
have, airborne exposure to or dermal
contact with beryllium by the time of
the employee’s initial assignment and
annually thereafter (paragraphs
(m)(4)(i)(A)–(C)). Under this
requirement, employees entitled to
training include all employees who
work in beryllium work areas and any
other employees who may not be
working directly with a berylliumgenerating process, but who may
nonetheless reasonably be expected to
have airborne exposure to and/or skin
contact with soluble beryllium,
beryllium solutions, or visible beryllium
dust, fumes, or mists in concentrations
of 0.1 percent by weight or more. As
discussed previously, OSHA intends the
revised definition of dermal contact
with beryllium to provide employers
with a workable indicator for
determining which employees outside
of beryllium work areas should receive
this information and training.
Because the change would allow
employers to more accurately identify
areas where provisions related to dermal
contact should apply, the revised
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definition would also facilitate proper
compliance with paragraph (i)(1)(ii),
which requires employers to ensure
employees who have dermal contact
with beryllium wash any exposed skin
at the end of the activity, process, or
work shift and prior to eating, drinking,
smoking, chewing tobacco or gum,
applying cosmetics, or using the toilet.
OSHA’s revisions to the definition of
dermal contact with beryllium would
prevent employers from speculating that
all employees in a facility, including
those employees who do not work near
beryllium-releasing processes, must
wash their exposed skin because they
might have come into contact with nonvisible beryllium particulate or handled
articles that contain beryllium. Such an
interpretation would be contrary to
OSHA’s intent.
The revised definition is designed to
further improve employer compliance
with the requirements in paragraph (k)
to offer employees a medical
examination including a medical and
work history that emphasizes past and
present airborne exposure to or dermal
contact with beryllium (paragraph
(k)(3)(ii)(A)), and to provide the
examining physician or other licensed
health care professional (PLHCP) (and
the agreed-upon CBD diagnostic center,
if such an evaluation is required) with
a description of the employee’s former
and current duties that relate to the
employee’s airborne exposure to and
dermal contact with beryllium
(paragraph (k)(4)(i)). Because it would
improve employers’ ability to identify
when dermal contact with beryllium has
occurred or could occur, this change
would permit employers to accurately
complete employee medical and work
histories and the reports that they must
provide to examining PLHCPs or CBD
diagnostic centers. As with the
provisions discussed above, OSHA’s
revisions to the definition of dermal
contact with beryllium will prevent
employers from including superfluous
information in these medical and work
histories and reports because they are
concerned that an employee might have
conceivably had skin contact with
minute, non-visible beryllium
particulate or handled berylliumcontaining articles outside of a
beryllium work area. Such an expansive
interpretation is again contrary to
OSHA’s intent.
OSHA is adding two references to
dermal contact with beryllium in
paragraph (i), Hygiene areas and
practices, to account for the final rule’s
changes to the definition of beryllium
work area in paragraph (b). Paragraph (i)
in the previous rule included
requirements for employers to provide
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each employee working in a beryllium
work area with readily accessible
washing facilities (paragraph (i)(1)(i))
and a designated change room where
employees are required to remove their
personal clothing (paragraph (i)(2)). But,
as explained earlier in this section,
OSHA is revising the definition of
beryllium work area so that the
requirement to establish these areas is
no longer triggered on the potential for
dermal contact with beryllium.
OSHA intends for the washing
facilities and change rooms
requirements to apply where employees
are reasonably expected to have dermal
contact with beryllium, regardless of
whether they work in a beryllium work
area, as now defined in this final rule.
As discussed above, there may be
employees outside of the beryllium
work area that may have a reasonable
expectation of dermal contact with
beryllium. Therefore, as was proposed,
OSHA is adding two additional
references to dermal contact with
beryllium to paragraph (i). First, OSHA
is revising paragraph (i)(1) so that the
requirements would apply to each
employee who works in a beryllium
work area or who can reasonably be
expected to have dermal contact with
beryllium. Paragraph (i)(1)(i) would
then require employers to provide
washing facilities to all employees who
can be reasonably expected to have
dermal contact with beryllium. Second,
OSHA is revising paragraph (i)(2) so that
employers are required to provide
change rooms to employees who are
required to use personal protective
clothing or equipment under paragraph
(h)(1)(ii), if those employees are
required by the employer to remove
their personal clothing. Because
paragraph (h)(1)(ii) requires the use of
PPE where there is a reasonable
expectation of dermal contact with
beryllium, the change to paragraph (i)(2)
ensures that the requirement for change
rooms would continue to protect those
employees who can reasonably be
expected to have dermal contact with
beryllium.
Methods of Compliance.
Paragraph (f) of the beryllium
standard for general industry contains
provisions covering methods for
reducing employee exposure to
beryllium through the use of a written
exposure control plan and engineering
and work practice controls. Paragraph
(f)(1) sets forth the requirements for
written exposure control plans.
Paragraph (f)(1)(i) requires employers to
establish, implement, and maintain
such a plan, and paragraphs (f)(1)(i)(A)–
(H) specifies the information and
procedures that must be included in the
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plan. Paragraph (f)(1)(ii) directs
employers to review and evaluate each
plan at least annually and update it
under specified circumstances.
In the 2018 NPRM, OSHA proposed
two wording changes to paragraph (f)(1)
(83 FR at 63754). The first proposed
change relates to the contents of the
written exposure control plan. Under
paragraph (f)(1)(i)(D), employers were
previously required to include
procedures in their plans for
minimizing cross-contamination,
‘‘including preventing the transfer of
beryllium’’ between surfaces,
equipment, clothing, materials, and
articles within beryllium work areas.
OSHA proposed removing the word
‘‘preventing’’ from the regulatory text to
clarify that these procedures may not
totally eliminate the transfer of
beryllium, but should minimize crosscontamination of beryllium, including
between surfaces, equipment, clothing,
materials, and articles.
The second proposed change involves
one of the circumstance when
employers must update their written
exposure control plans. Paragraph
(f)(1)(ii)(B) of the standard directed
employers to update the written
exposure control plan, as necessary,
when they are notified that an employee
is eligible for medical removal in
accordance with paragraph (l)(1),
referred for evaluation at a CBD
diagnostic center, or shows signs or
symptoms associated with ‘‘airborne
exposure to or dermal contact with
beryllium.’’ In the 2018 NPRM, OSHA
proposed to replace the phrase
‘‘airborne exposure to and dermal
contact with beryllium’’ with ‘‘exposure
to beryllium.’’ The agency explained
that the change would simplify the
language of the provision while still
capturing all potential exposure
scenarios currently covered. Because
these proposed changes are merely
clarifying, OSHA explained that it
expected that they would maintain
safety and health protections for
workers.
All of the stakeholders that submitted
comments related to OSHA’s proposed
changes to the written exposure control
plan provisions supported the changes
(see, e.g., Document ID 0031, p. 2; 0038,
p. 31). For example, EEI observed that
OSHA’s discussion of the proposed
changes were appropriate modifications
to the beryllium standard (Document ID
0031, p. 2). Materion also supported the
proposed changes and agreed with
OSHA that these proposed changes are
merely clarifying, and that they will
maintain safety and health protections
for employees. In addition, Materion
noted that it ‘‘identifie[d] no reduction
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in protection to employees associated
with these clarifying language
revisions’’ (Document ID 0038, p. 31).
After reviewing these comments and
considering the record as a whole,
OSHA has determined that the proposed
changes will clarify for employers the
requirements of the written exposure
control plan without sacrificing safety
and health protections for workers.
Therefore, OSHA is finalizing the
proposed changes to paragraph (f) in
this final rule.
Personal Protective Clothing and
Equipment.
Paragraph (h) of the beryllium
standard for general industry 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, or where there is a reasonable
expectation of dermal contact with
beryllium. Paragraph (h) also contains
provisions for the safe removal, storage,
cleaning, and replacement of the PPE
required by this standard. As explained
in the 2017 final rule preamble, these
PPE requirements are intended to
protect employees by preventing dermal
exposure to beryllium and the
accumulation of airborne beryllium on
PPE, and to protect employees and other
individuals both inside and outside the
workplace from exposures that could
occur if contaminated clothing were to
transfer beryllium (82 FR at 2678).
In the 2018 NPRM, OSHA proposed
two changes to paragraph (h). The first
revision relates to paragraph (h)(2)(i),
which addresses removal and storage of
PPE. Paragraph (h)(2)(i) previously
required employers to ensure that each
employee removes all berylliumcontaminated PPE at the end of the
work shift, ‘‘at the completion of tasks
involving beryllium,’’ or when PPE
becomes visibly contaminated with
beryllium, whichever comes first. OSHA
proposed modifying the phrase ‘‘at the
completion of tasks involving
beryllium’’ by changing ‘‘tasks’’ to ‘‘all
tasks,’’ so that it reads ‘‘at the
completion of all tasks involving
beryllium’’ (83 FR at 63754).
OSHA explained in the 2018 NPRM
that this revision to paragraph (h)(2)(i)
merely clarifies the trigger for when
employees must remove berylliumcontaminated PPE, consistent with the
agency’s original intent (83 FR at
63754). As expressed in the preamble to
the 2017 final rule, OSHA intended that
PPE contaminated with beryllium
should not be worn after tasks involving
beryllium exposure have been
completed for the day (82 FR at 2682).
Thus, when employees perform
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multiple tasks involving beryllium
successively or intermittently
throughout the day, the employer must
ensure that each employee removes all
beryllium-contaminated PPE at the
completion of the set of tasks involving
beryllium, not necessarily after each
separate task. If, however, employees
perform tasks involving beryllium
exposure for only a portion of a work
shift, and then perform tasks that do not
involve exposure to beryllium, the
employer must ensure that employees
remove their PPE after the beryllium
exposure period. Unless the PPE
becomes visibly contaminated with
beryllium, OSHA did not intend this
provision to require multiple PPE
changes throughout the work shift.
Thus, the proposed revision to
paragraph (h)(2)(i) clarifies OSHA’s
original intent.
OSHA received multiple comments in
support of the proposed change to
paragraph (h)(2)(i). The USW
commented that it believes the change
is reasonable and clarifies the intent of
the standard (Document ID 0033, p. 6).
Similarly, Century Aluminum expressed
its support for this ‘‘sensibl[e]’’ revision,
commenting that it is an example of a
logical and workable requirement that
will produce better work practices and
habits and, in turn, improve employee
health and safety outcomes (Document
ID 0026, p. 2). In addition, Century
Aluminum commented that requiring
PPE to be changed after every task
would ‘‘significantly increase costs
without increasing employee health and
safety’’ and could actually increase the
amount of time employees are exposed
to beryllium, thus increasing their risk
of sensitization and disease (Document
ID 0026, p. 2). Materion also expressed
its general support for the ‘‘clarifying
language revisions’’ to paragraph (h)
(Document ID 0038, p. 32).
OSHA also received two comments
opposing the proposed change to
paragraph (h)(2)(i). A private citizen
commented that, although OSHA did
not intend to require continuous PPE
changes throughout a work shift, doing
so seemed necessary to limit
transmission of contaminant between
workers and work areas (Document ID
0017). And another private citizen
commented that if a worker’s suit is
contaminated, the worker should be
required to change even if the suit is not
visibly contaminated (Document ID
0019).
OSHA does not believe it is necessary
for workers to change PPE after each
work task, or after each instance of PPE
contamination, in order to limit the
spread of beryllium particulate between
work areas because, absent visible
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42611
contamination of PPE, any
contamination present will likely be
minute and will not contaminate other
work areas to such a degree as to
materially increase worker exposures.
Furthermore, as explained in the
preamble to the 2017 final rule (82 FR
at 2682), because the purpose of PPE is
to serve as a barrier between an
employee’s body and ambient or surface
beryllium, PPE becomes contaminated
with beryllium immediately as part of
its protective function. Requiring PPE to
be changed upon contamination with
any amount of beryllium is
unreasonable and unnecessary to
protect employees. This is because
contamination of PPE with beryllium
during work processes does not reduce
the effectiveness of PPE or create
hazards to employees unless sufficient
beryllium accumulates on the PPE to
impair its function or create additional
exposures, such as by dispersing
accumulated beryllium into the air.
Moreover, the process of changing
contaminated PPE can create
opportunities for both inhalation
exposure and dermal contact with
beryllium. Accordingly, the use of
‘‘visibly contaminated’’ protects
employees from potential exposures
while changing PPE by limiting the
requirement to change PPE during work
tasks involving beryllium exposure to
those circumstances when changing it is
necessary to maintain its protective
function and prevent deposits of
beryllium from accumulating and
dispersing.
Notably, the USW commented that it
believes including the term ‘‘visibly
contaminated’’ in the provision
provides for employee safety (Document
ID 0033, pp. 6–7), and Materion
similarly stated that ‘‘visibility [of
beryllium-contaminated PPE and
equipment] is a conservative, stringent’’
trigger that ‘‘also has the benefit of
compliance clarity’’ (Document ID 0038,
p. 32). After reviewing these comments
and considering the record as a whole,
OSHA finds that the proposed change in
paragraph (h)(2)(i) is reasonably
necessary and appropriate and has
retained the revised language in the
final rule.
The second proposed revision relates
to paragraph (h)(3)(iii), which addresses
cleaning and replacement of PPE. This
paragraph required employers to inform
in writing the persons or the business
entities who launder, clean, or repair
the PPE required by this standard of the
potentially harmful effects of ‘‘airborne
exposure to and dermal contact with
beryllium.’’ The 2018 NPRM proposed
replacing the phrase ‘‘airborne exposure
to and dermal contact with beryllium’’
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with ‘‘exposure to beryllium’’ (83 FR at
63755). OSHA explained that this
change simplifies the language of the
provision while still capturing all
potential exposure scenarios currently
covered; and, as such, the agency
concluded that the revised language will
maintain safety and health protections
for workers. OSHA received no
comments on this proposed change
beyond Materion’s general support for
the clarifying revisions to paragraph (h)
as a whole (Document ID 0038, p. 32).
OSHA is therefore retaining the
proposed revision to paragraph
(h)(3)(iii) in the final rule.
Hygiene Areas and Practices.
Paragraph (i) of the beryllium general
industry standard requires that the
employer provide employees with
readily accessible washing facilities,
change rooms, and showers when
certain conditions are met; requires the
employer to take certain steps to
minimize exposure in eating and
drinking areas; and prohibits certain
practices that may contribute to
beryllium exposure. As explained in the
2017 final rule, OSHA believes that
strict compliance with these provisions
will reduce the amount and duration of
employees’ airborne exposure and
dermal contact with beryllium (82 FR at
2683–88).
In the 2018 NPRM, OSHA proposed
three changes to paragraph (i) of the
general industry standard. The agency
proposed the first two changes (83 FR at
63755), which apply to paragraphs (i)(1)
and (i)(2), to maintain the protections
included in these paragraphs for
employees who have dermal contact
with beryllium notwithstanding the
proposed change to the definition of
beryllium work area, discussed
previously in this Summary and
Explanation. OSHA proposed the third
change, which applies to paragraph
(i)(4), to clarify the requirements for
cleaning beryllium-contaminated PPE
prior to entering an eating or drinking
area (83 FR at 63755–56).
As explained in the previous
discussion of changes to the definition
of beryllium work area, OSHA proposed
and has finalized these changes to the
definition of beryllium work area to
clarify where a beryllium work area
must be established. One of these
changes removes dermal contact with
beryllium as one of the triggers that
requires an employer to establish a
beryllium work area. As explained in
the 2018 NPRM, OSHA intended for the
hygiene provisions related to washing
facilities and change rooms to continue
to apply to all employees who can
reasonably be expected to have dermal
contact with beryllium, regardless of
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whether they work in beryllium work
areas as defined in the revised
definition (83 FR at 63755). OSHA
accordingly proposed two changes.
First, OSHA proposed a change in the
wording of paragraph (i)(1), which
required that ‘‘[f]or each employee
working in a beryllium work area,’’ the
employer must provide readily
accessible washing facilities to remove
beryllium from the hands, face, and
neck; and ensure that employees who
have dermal contact with beryllium
wash any exposed skin at specific
designated times. The 2018 NPRM
proposed amending the language to
apply to ‘‘each employee . . . who can
reasonably be expected to have dermal
contact with beryllium,’’ in addition to
each employee working in a beryllium
work area (83 FR at 63768).
Second, OSHA proposed a change in
the wording of paragraph (i)(2), which
required employers to provide
‘‘employees who work in a beryllium
work area,’’ with a designated change
room where employees are required to
remove their personal clothing. OSHA
proposed revising paragraph (i)(2) to
require employers to provide a
designated change room to employees
who are required to use personal
protective clothing or equipment under
paragraph (h)(1)(ii) of the beryllium
standard, instead of to employees who
work in a beryllium work area (83 FR
at 63768). Paragraph (h)(1)(ii) of the
beryllium standard requires the
provision and use of appropriate PPE
where there is a reasonable expectation
of dermal contact with beryllium. The
requirement to provide change rooms
would continue to apply only where
employees are required to remove their
personal clothing. As noted above and
explained in the 2018 NPRM, the
proposed changes to paragraphs (i)(1)
and (i)(2) were merely intended to
ensure that the hygiene provisions
related to washing facilities and change
rooms would continue to protect
employees who are reasonably expected
to have dermal contact with beryllium,
if the agency adopted the proposed
revised definition of the term beryllium
work area.
OSHA also proposed a third change,
which applies to paragraph (i)(4), in
order to clarify the requirements for
cleaning beryllium-contaminated PPE
prior to entering an eating or drinking
area. Paragraph (i)(4)(ii) required the
employer to ensure that no employees
enter any eating or drinking area with
beryllium-contaminated personal
protective clothing or equipment unless,
prior to entry, surface beryllium has
been removed from the clothing or
equipment by methods that do not
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disperse beryllium into the air or onto
an employee’s body. In the 2018 NPRM,
OSHA proposed to modify this
paragraph to require the employer to
ensure that, before employees enter an
eating or drinking area, berylliumcontaminated PPE is cleaned, as
necessary, to be as free as practicable of
beryllium by methods that do not
disperse beryllium into the air or onto
an employee’s body (83 FR at 63768).
The agency explained that this proposed
change would clarify that OSHA does
not expect the methods used to clean
PPE prior to entering an eating or
drinking area to completely eliminate
residual beryllium from the surface of
the PPE if complete elimination is not
practicable (83 FR at 63755–56). OSHA
also explained that this is consistent
with its determination, expressed in the
preamble to the 2017 final rule, that ‘‘as
free as practicable’’ is ‘‘the most
appropriate terminology for
requirements pertaining to surface
cleanliness’’ (82 FR at 2687). This
proposed clarification also aligns the
language of paragraph (i)(4)(ii) with the
language of paragraph (i)(4)(i), which
requires employers to ensure that
beryllium-contaminated surfaces in
eating and drinking areas are as free as
practicable of beryllium. Finally, OSHA
explained that requiring cleaning only
‘‘as necessary’’ would clarify that
cleaning would not be required if the
PPE is already as free as practicable of
beryllium. OSHA stated that it expected
these proposed changes to paragraph (i)
would maintain safety and health
protections for workers.
Commenters expressed broad support
for OSHA’s proposed changes to
paragraph (i) (see, e.g., Document ID
0029, p. 1; 0031, p. 2; 0033, p. 6; 0038,
p. 32). For example, EEI observed that
the proposed changes to this paragraph
as a whole were appropriate
modifications to the beryllium standard
(Document ID 0031, p. 2) and DOD
generally agreed with the proposed
changes, commenting that they are
evidence based and provide greater
employee protections (Document ID
0029, p. 1). Materion also supported the
proposed changes to paragraph (i) as a
whole, and agreed with OSHA that
these proposed changes are merely
clarifying, and that they will maintain
safety and health protections for
employees (Document ID 0038, p. 32;
see also Document ID 0034 and 0035, p.
1 (supporting and endorsing the
comments submitted by Materion)).
OSHA did not receive any comments
that specifically addressed the two
proposed changes to paragraphs (i)(1)
and (i)(2). The agency is therefore
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adopting the changes to those
paragraphs as proposed.
Stakeholders also did not submit any
comments on the majority of the
agency’s proposed changes to paragraph
(i)(4). A DOD comment specifically
addressed the term ‘‘as free as
practicable,’’ suggesting that because the
term is not defined, OSHA should
require employers to establish
procedures for cleaning PPE, document
accomplishment of procedures, and
periodically review compliance with
cleaning procedures (Document ID
0029, p. 2). The USW supported the
proposed change for cleaning PPE ‘‘as
necessary,’’ agreeing with OSHA’s
explanation in the 2018 NPRM that
requiring cleaning only as necessary
would clarify that cleaning would not
be required if the PPE is already as free
as practicable of beryllium (Document
ID 0033, p. 6).
The requirement to maintain surfaces
as free as practicable of a regulated
substance is included in other OSHA
health standards, such as those for lead
(29 CFR 1910.1025, 29 CFR 1926.62),
chromium (VI) (29 CFR 1910.1026), and
asbestos (29 CFR 1910.1001), and is
used elsewhere in the beryllium general
industry standard (29 CFR
1910.1024(f)(1)(i)(E), (i)(4)(i), (j)(1)(i),
(j)(3)(ii)). Employers therefore have the
benefit of previous experience
interpreting and developing methods for
compliance with requirements to
maintain surfaces ‘‘as free as
practicable’’ of toxic substances,
including beryllium, as well as guidance
from OSHA on compliance with such
requirements. OSHA discussed the
meaning of this phrase in the Summary
and Explanation of paragraph (j) in the
2017 final rule (82 FR at 2690), as well
as in a 2014 letter of interpretation
explaining the phrase in the context of
the agency’s standard for chromium (VI)
(OSHA, Nov. 5, 2014, Letter of
Interpretation, available at https://
www.osha.gov/laws-regs/
standardinterpretations/2014-11-05). As
OSHA explained in the 2014 letter of
interpretation, OSHA evaluates whether
a surface is ‘‘as free as practicable’’ of a
contaminant by the efficacy of the
employer’s program to keep surfaces
clean. OSHA intends for this term to be
broad and performance-oriented, so as
to allow employers in a variety of
industries flexibility to decide what
type of control methods and procedures
are best suited to their beryllium
operations, and OSHA intends to
evaluate compliance based on employer
efforts under the circumstances present
at each facility. Notably, in its comment,
Materion expressed general support for
use of the phrase ‘‘as free as practicable’’
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in other parts of the standard,
acknowledging that this is the workable
legal standard OSHA relies on in
occupational health standards
(Document ID 0038, pp. 25–26, 33).
Moreover, as to DOD’s
recommendation that OSHA require
employers to establish procedures for
cleaning PPE, document
accomplishment of procedures, and
periodically review compliance with
cleaning procedures (Document ID
0029, p. 2), OSHA agrees that requiring
employers to establish PPE cleaning
procedures is important. To meet this
objective, the written exposure control
plan provision in paragraph (f)(1)(i)
requires employers to establish,
implement, and maintain a written
exposure control plan, which must
contain, among other things, procedures
for removing, laundering, storing,
cleaning, repairing, and disposing of
beryllium-contaminated personal
protective clothing and equipment,
including respirators. Paragraph (f)(1)(ii)
requires employers to review and
evaluate the effectiveness of each
written exposure control plan at least
annually and update it, as necessary, if
certain specified events occur. OSHA
believes that these requirements satisfy
DOD’s concerns while still allowing
employers the flexibility to establish,
implement, and maintain a plan that
works best for their individual
workplaces.
After reviewing these comments and
considering the record as a whole,
OSHA believes that the term ‘‘as free as
practicable’’ is understood by employers
through its use in other standards and
as explained in letters of interpretation
and other guidance, and does not
believe that defining the term in this
standard or establishing specific PPE
cleaning and documentation procedures
is necessary. OSHA also believes the
proposed change is necessary to align
the language of paragraphs (i)(4)(i) and
(i)(4)(ii). OSHA did not receive any
comments objecting to the revised
requirement that PPE be ‘‘cleaned, as
necessary,’’ which makes clear that
cleaning would not be required if PPE
is already as free as practicable of
beryllium. OSHA believes these changes
clarify the agency’s intent without
sacrificing safety and health protection
for workers. The agency is therefore
adopting the changes as proposed to
paragraph (i)(4)(ii) in this final rule.
Disposal, Recycling, and Reuse.
Paragraph (j) of the beryllium general
industry standard requires employers to
adhere to certain housekeeping
practices. Paragraphs (j)(1) and (j)(2)
require employers to maintain all
surfaces in beryllium work areas as free
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42613
as practicable of beryllium, promptly
clean spills and emergency releases of
beryllium, and use appropriate cleaning
methods, while paragraph (j)(3) requires
employers to take certain actions when
transferring materials that contain at
least 0.1 percent beryllium by weight or
that are contaminated with beryllium
outside a plant for the purpose of
disposal, recycling, or reuse.
Specifically, paragraph (j)(3)(i) requires
that, except for intra-plant transfers,
when transferring these materials for
any of these purposes the employer
must label the materials in accordance
with paragraph (m)(3). Paragraph
(j)(3)(ii) further requires that those
materials designated for disposal must
be either cleaned to be as free as
practicable of beryllium or placed in
enclosures that prevent the release of
beryllium-containing particulate or
solutions under normal conditions of
use, storage, or transport, such as bags
or containers. Paragraph (j)(3)(iii)
requires the same for materials
designated for recycling or reuse.
The final rule makes a number of
changes to the previous requirements of
paragraph (j)(3). As originally
promulgated in the 2017 final rule,
paragraph (j)(3)(i) required that
materials designated for disposal be
disposed of in sealed, impermeable
enclosures, such as bags or containers,
that are labeled according to paragraph
(m)(3) of the beryllium standard, but did
not allow employers the alternative
option of cleaning such material to be as
free as practicable of beryllium. Further,
both paragraphs (j)(3)(i) and (j)(3)(ii)
required that materials be transferred in
sealed, impermeable bags, but did not
further define this requirement. Finally,
the original paragraph (j)(3) did not
explicitly address transfers of materials
for the purpose of reuse.17
After the promulgation of the final
rule in 2017, OSHA learned that some
stakeholders were confused about these
requirements. For example, stakeholders
were uncertain about what types of
enclosures would be acceptable under
the standard. To help alleviate
stakeholder confusion, OSHA proposed
a number of changes in the 2018 NPRM
that make explicit what had been
intended in the 2017 final rulemaking.
Specifically, OSHA proposed adding
provisions explicitly addressing
transferring materials for reuse;
clarifying that the rule’s requirements
for disposal, recycling, and reuse do not
apply to intra-plant transfers; and
17 Subsequent to the 2017 final rule, the 2018
direct final rule clarified that the requirements of
paragraph (j)(3) do not apply to materials containing
only trace amounts of beryllium (less than 0.1
percent by weight).
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allowing for the cleaning of materials
bound for disposal. The agency also
proposed reorganizing the paragraph’s
two paragraphs into three that focused
on specific topics and making minor
changes in terminology to improve the
clarity and internal consistency of the
standard. Only one of the changes is
substantive, which is the inclusion of
the option for cleaning instead of
enclosure; the remaining edits merely
clarify OSHA’s original intent. As
discussed in more detail below, OSHA
is retaining the changes proposed in the
2018 NPRM in the final rule with only
one clarifying revision. With these
changes, final paragraph (j)(3) provides
comprehensive, easy to understand
requirements for employers that are
transferring materials outside of their
plants for disposal, recycling, or reuse
that contain at least 0.1 percent
beryllium by weight or are
contaminated with beryllium.
In response to the 2018 NPRM, a
number of commenters, including the
DOD, Materion, the USW, and EEI,
expressed support for the proposed
revisions generally (see, e.g., Document
ID 0029, p. 1; 0038, pp. 32–33; 0033, p.
5; 0031, p. 2). For example, DOD stated
that the revisions ‘‘are evidence based
and provide greater employee
protection’’ (Document ID 0029, p. 1).
Similarly, Materion commented that the
revisions ‘‘will provide improved
understanding and more practical
meaning to manufacturers by improving
the clarity and internal consistency of
the standard’’ (Document ID 0038, p.
32).
Stakeholders also offered specific
comments on the individual changes
OSHA proposed to paragraph (j)(3).
OSHA outlines each of those changes
below, along with any specific
comments received on those changes
and the agency’s final determination as
to whether to retain the proposed
change in the final rule.
OSHA proposed seven changes to the
2017 version of paragraph (j)(3). First,
the agency proposed that the provisions
address reuse (in addition to disposal
and recycling). As noted above,
paragraph (j)(3) of the 2017 final rule
contained requirements for the labeling
and enclosure of certain materials
designated for disposal and the labeling
and either enclosure or cleaning of
materials designated for recycling. The
preamble to the 2017 final rule made
clear that paragraph (j)(3)’s requirements
related to recycling also applied to reuse
(see 82 FR at 2695–96), but the standard
did not explicitly advise employers of
this requirement. To make the agency’s
original intent clear, OSHA proposed in
the 2018 NPRM to include provisions
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addressing reuse. This proposed change
was intended to ensure that workers
who may be exposed to materials
containing or contaminated with
beryllium that are directly reused
without first being processed into a
different form are appropriately
protected. For example, a manufacturer
may sell a by-product from a process to
a downstream manufacturer that would
reuse the by-product as a component of
a new product. Recycling, on the other
hand, typically involves the further
processing of waste materials to separate
and recover various components of
value. OSHA did not receive any
specific comments on the addition
addressing reuse of materials in
paragraph (j)(3). Therefore, OSHA has
finalized the inclusion of requirements
related to the reuse of materials in
paragraph (j)(3).
Second, OSHA proposed reorganizing
paragraph (j)(3)’s original two
paragraphs (one on disposal, one on
recycling—with the labeling
requirements specified in each) into
three new paragraphs with each
paragraph focusing on a different topic.
Proposed paragraph (j)(3)(i) spelled out
the labeling requirements, proposed
paragraph (j)(3)(ii) included the
requirements for cleaning or enclosing
materials bound for disposal, and
proposed paragraph (j)(3)(iii) laid out
the obligations as to materials
designated for recycling or reuse. The
proposed reorganization allowed the
agency to incorporate the new reuse
requirements, while also setting out
each distinct obligation clearly. OSHA
further explained in the proposal that
this is not a substantive change to the
standard, but rather only a
reorganization of the existing provisions
(see 83 FR at 63763). One commenter,
Materion, addressed the reorganization
of paragraph (j)(3), noting that the
change would improve the clarity and
employers’ understanding of the
provisions (Document ID 0038, p. 32).
Having received no comments to the
contrary, OSHA is adopting the new
structure to paragraph (j)(3) in the final
rule.
Third, OSHA proposed a simplifying
change relating to the description of
which materials must be labeled and
cleaned or enclosed prior to transfer for
disposal, recycling, or reuse. The 2018
direct final rule required employers to
label and clean or enclose two groups of
materials: (1) Materials that contain
beryllium in concentrations of 0.1
percent by weight or more, and (2)
materials that are contaminated with
beryllium. In the 2018 NPRM, OSHA
proposed a simplifying edit to the first
group of materials. Specifically, the
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agency proposed replacing the phrase
materials ‘‘that contain beryllium in
concentrations of 0.1 percent by weight
or more’’ with a shorter phrase:
Materials ‘‘that contain at least 0.1
percent beryllium by weight.’’ As the
agency explained in the 2018 NPRM,
this change is meant to simplify the
language and does not change the
meaning. OSHA did not receive any
comments on the proposed
simplification of this language.
Therefore, OSHA is adopting the new
phrase ‘‘that contain at least 0.1 percent
beryllium by weight’’ in paragraph (j)(3)
in the final rule.
Fourth, OSHA proposed adding an
explicit exemption for materials
transferred within a plant from the
cleaning and enclosure requirements in
new paragraphs (j)(3)(ii) and (iii). While
this exemption was not explicitly
included in the regulatory text of the
2017 final rule, its inclusion in this final
rule is not a substantive change. As
OSHA noted in the 2018 NPRM, the
agency never intended the provisions of
paragraph (j)(3) to require employers to
clean or enclose materials to be used in
another location within the same facility
(83 FR at 63756 (citing 82 FR at
2696)).18 Thus, the inclusion of the
exemption in the proposed regulatory
text simply makes the agency’s intent
plain.
The USW supported the proposed
inclusion of the ‘‘intra-plant transfer’’
exemption in the regulatory text
(Document ID 0033, p. 5). Specifically,
the USW pointed to its comments on
OSHA’s 2015 NPRM, which stated that
the agency should not require all
materials to be decontaminated or
sealed in an enclosure (Document ID
0033, p. 5). Rather, the USW explained,
the initial intent of the corresponding
provision of the model standard it
drafted jointly with Materion was ‘‘to
ensure that materials leaving a facility
and designated for recycling be
containerized or visibly clean’’
(Document ID 0033, p. 5) (emphasis
added).
DOD did not submit a comment on
the proposed intra-plant transfer
exception, but its comment on another
part of paragraph (j)(3) suggested that it
understood the paragraph to apply to
intra-plant transfers (see Document ID
18 As OSHA noted in the 2018 NPRM, employees
who may be exposed to these materials during
intra-plant transfers will not go unprotected. On the
contrary, other provisions of the beryllium standard
require employers to communicate possible hazards
to these employees and protect them during such
transfers (see, e.g., paragraph (f), Methods of
compliance; paragraph (g), Respiratory protection;
paragraph (h), Personal protective clothing and
equipment; paragraph (m), Communication of
hazards).
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0029, p. 1 (‘‘To support the proposed
revisions that require surface cleaning of
equipment and materials to remove
beryllium before recycling, re-use, or
intra-plant transfers, we recommend the
use of the Department of Energy’s
(DOE’s) cleanliness standards as
specified in Title 10 Code of Federal
Regulations Part 850.’’)).19 As discussed
below, OSHA does not agree with
DOD’s suggested use of DOE’s surface
limits and, as already stated, OSHA
never intended to require employers to
clean or enclose materials transferred
within a single plant. Rather, the
provisions in paragraph (j)(3) have
always been intended to protect
employees after the materials leave the
facility.
Materion commented that berylliumcontaining scrap metal or wastes are, in
most cases, recycled internally ‘‘either
within or between facilities,’’ but
companies ‘‘also recycle scrap or
purchase scrap on the open market’’
(Document ID 0038, p. 32). Materion
further asserted that OSHA’s regulation
‘‘should not be construed as potentially
limiting the environmentally beneficial
recycling of metals’’ (Document ID 0038,
p. 32). OSHA agrees that paragraph
(j)(3)’s requirements should not be read
to discourage the reuse or recycling of
metals and reads Materion’s statements
regarding the manner in which
companies recycle scrap metal or wastes
(i.e., within or between facilities or on
the open market) as purely
informational. However, the agency
notes that this comment could be read
to suggest that the exception for items
transferred within a facility also applies
to items transferred between two
facilities owned by the same employer.
Such an interpretation would be
incorrect—the intra-plant transfer
exception only exempts transfers within
a single plant; material transfers
between plants are not excluded,
regardless of plant ownership.
This comment also alerted the agency
to a potential ambiguity in the text of
proposed paragraph (j)(3)(i).
Specifically, OSHA realized that the
phrase ‘‘to another party’’ could be read
to suggest that transfers between two
facilities owned by the same employer
are exempted from the labeling
requirements in paragraph (j)(3)(i).
Again, this was not the agency’s intent.
As noted above, the proposed addition
of the explicit intra-plant transfer
exception in paragraphs (j)(3)(ii) and
19 DOD’s suggestion regarding DOE’s cleanliness
standards is addressed below in this section of this
final rule as part of the discussion of the seventh
and final proposed change to paragraph (j)(3)
relating to the cleaning of materials designated for
disposal, recycling, or reuse.
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(iii) was not a substantive change—the
agency never intended to require
employers to clean or enclose materials
transferred within a single plant. The
reorganization of paragraph (j)(3) was
also not a substantive change; it merely
allowed the agency to make clear that
the labeling requirements apply
regardless of whether the employer
transfers materials for the purpose of
disposal, recycling, or reuse (83 FR at
63763, 63756). Because the labeling
requirements were part of paragraphs
(j)(3)(i) and (ii) in the 2017 final rule, to
which the intra-plant exemption
applied, and were simply moved to a
new stand-alone paragraph without
substantive change, the scope of those
activities requiring labeling has not
changed. Put another way, the intraplant exemption continues to apply to
the labeling provision to the same extent
it did prior to the proposal. And, more
to the point, the labeling requirement
continues to apply to all other transfers
for purposes of disposal, recycling, or
reuse, regardless of whether they
involve transfers between two locations
operated by the same employer.
If proposed paragraph (j)(3)(i) was
interpreted to only require the labeling
of materials transferred to another
employer (rather than another facility),
then an employer could place materials
that were designated for reuse in an
enclosure and transfer them to another
facility without a label, so long as the
employer owned the second facility.
This scheme could potentially put both
the transferring and receiving
employees at risk by failing to
appropriately apprise them of the
presence of beryllium-containing
materials and the hazardous nature of
beryllium exposure.
Moreover, such an interpretation
could lead to inconsistencies or
conflicts with the Hazard
Communication standard (HCS) (29 CFR
1910.1200), which requires labeling for
all hazardous chemicals leaving a
worksite regardless of destination. This
is clearly laid out in OSHA’s Hazard
Communication directive (CPL 02–02–
079): ‘‘Manufacturers, importers, and
distributors are required to ensure that
each container of hazardous chemicals
is appropriately labeled. Labeling
requirements apply for shipped
containers leaving the workplace
regardless of whether the intended
destination is interstate or intrastate.’’
Although the agency’s intent was
always to exempt only intra-plant
transfers from the labeling requirement,
OSHA sees value in eliminating any
ambiguity and ensuring that labeling is
consistent with the requirements of the
HCS. Therefore, the agency is revising
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42615
the text of paragraph (j)(3)(i) to more
explicitly match the intent expressed in
both the 2017 rule and the 2018
proposal. Specifically, OSHA is revising
paragraph (j)(3)(i) in the final rule to
strike the phrase ‘‘to another party’’ and
add the ‘‘except for intra-plant
transfers’’ language that is found in
paragraphs (j)(3)(ii) and (iii). Final
paragraph (j)(3)(i), therefore, provides
that except for intra-plant transfers,
when the employer transfers materials
that contain at least 0.1 percent
beryllium by weight or are
contaminated with beryllium for
disposal, recycling, or reuse, the
employer must label the materials in
accordance with paragraph (m)(3) of this
standard.
In summary, OSHA is adopting the
proposed addition of the explicit intraplant exception in final paragraphs
(j)(3)(ii) and (iii). No commenters
opposed these revisions and, therefore,
OSHA has decided to retain them,
unchanged from the proposal (see
Document ID 0038, p. 32; 0033, p. 5).
The agency is also revising proposed
paragraph (j)(3)(i) to explicitly
incorporate the exception. As explained
in detail above, none of these changes
are substantive, but OSHA expects the
clarified language will aid employers in
understanding and, thus, carrying out
their responsibilities under these
provisions.
OSHA’s fifth proposed change to
paragraph (j)(3) focused on the
requirement to place items in ‘‘sealed,
impermeable enclosures.’’ Specifically,
paragraph (j)(3)(i) in the 2017 final rule
required employers to place certain
materials bound for disposal in ‘‘sealed,
impermeable enclosures, such as bags or
containers.’’ Paragraph (j)(3)(ii) in the
2017 final rule also required enclosure
of certain materials that had not been
appropriately cleaned. In the preamble
to the 2017 final rule, OSHA explained
that it intended these requirements to be
broad and performance-oriented and
clarified that the term ‘‘impermeable’’
was not intended to mean absolutely
impervious to rupture but, rather, that
the enclosures would not allow
materials to escape under normal
conditions of use (82 FR at 2695).
Nevertheless, the agency learned that
confusion around the enclosure
requirement remained.
To alleviate the confusion regarding
the enclosure requirements, OSHA
proposed in the 2018 NPRM to clarify
the ‘‘sealed, impermeable bag’’
requirement to make explicit what had
been intended in the 2017 final
rulemaking: That employers must
utilize enclosures that prevent the
release of beryllium-containing
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particulate or solutions under normal
conditions of use, storage, or transport.
The agency further explained that the
proposed change would reinforce the
requirement that employers select the
appropriate type of container to prevent
release based on the form of beryllium
and how it is normally handled. For
example, a container that prevents the
release of a beryllium particulate may
not be effective in preventing the release
of a beryllium solution.
One commenter, Materion, submitted
comments specific to this proposed
change (Document ID 0038, p. 32).
Materion was supportive of the revision,
noting that it will significantly improve
understanding of the requirements for
containerization and transport of
recycled materials and asserting its
belief that without the proposed
changes the disposal and recycling
provision are technologically and
economically infeasible (Document ID
0038, p. 32). According to Materion, the
change appropriately accommodates the
various physical properties of beryllium
materials being recycled, the ‘‘many
different applications resulting in many
types of container configurations,’’ and
the ‘‘many types of transfer mechanisms
and end use processing applications’’
(Document ID 0038, p. 32). No
commenters opposed these revisions
and, therefore, OSHA has decided to
retain them unchanged from the
proposal.
Unlike the previous five proposed
changes, the sixth proposed change was
more than a clarifying change from the
2017 final rule. Under the 2017 final
rule, employers could either clean or
enclose materials designated for
recycling. Materials designated for
disposal, however, could only be
enclosed; the option to clean the
materials was not available. The
difference in the two provisions
stemmed from the concern that
municipal and commercial disposal
workers should be protected from
exposure to beryllium from contact with
materials discarded from beryllium
work areas in general industry by
placing those materials in enclosed
containers. However, as OSHA
explained in the 2018 NPRM, the
agency had not considered situations
where it would be impractical to require
enclosure because the materials in
question were large items, such as
machines or structures, that may
contain at least 0.1 percent beryllium by
weight or be contaminated with
beryllium, rather than more common
items, such as beryllium scrap metal or
shavings.
With that situation in mind, OSHA
reconsidered its earlier determination
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and preliminarily determined that
workers handling items designated for
disposal, like workers handling items
designated for recycling or reuse, would
be just as protected from exposure to
beryllium if the items are cleaned to be
as free as practicable of beryllium as if
the items were placed in containers. In
accordance with this preliminary
determination, OSHA in the 2018
NPRM proposed adding the cleaning
option to paragraph (j)(3)(ii). The agency
explained that, regardless of whether an
employer chooses to clean or enclose
materials designated for disposal, the
labeling requirements under proposed
paragraph (j)(3)(i) would apply and
would require that the materials
designated for disposal be labeled in
accordance with paragraph (m)(3) of this
standard. It further noted its expectation
that these proposed changes would
maintain safety and health protections
for workers.
OSHA received no comments on this
proposed revision and has therefore
finalized it as proposed.
The seventh and final proposed
change also relates to the cleaning of
materials designated for disposal,
recycling, or reuse. Paragraph (j)(3)(ii) in
the 2017 final rule required the
specified materials to be cleaned to be
as free as practicable of surface
beryllium contamination. However, the
2017 final rule did not define the term
‘‘surface beryllium contamination’’ and
other parts of the 2017 final rule used
the term ‘‘as free as practicable’’ without
the ‘‘surface beryllium contamination’’
modifier. To alleviate any potential
confusion stemming from the agency’s
use of this new, undefined term, OSHA
proposed to eliminate any potential
confusion by removing the phrase
‘‘surface beryllium contamination.’’
OSHA did not receive any comments
that directly addressed the removal of
this phrase but one stakeholder, DOD,
offered a suggestion. Specifically, DOD
recommended the use of the Department
of Energy’s (DOE’s) cleanliness
standards as specified in Title 10 Code
of Federal Regulations Part 850
(Document ID 0029, p. 1). According to
DOD, these standards are ‘‘generallyacceptable criteria for surface
contamination and were adopted based
on DOE’s assessment of practical
cleanliness levels and proven
feasibility’’ (Document ID 0029, p. 1).
OSHA agrees that DOE’s standards
might be a useful reference for
employers seeking advice on how to
clean materials prior to transfer for
disposal, reuse, or recycling or how to
determine the effectiveness of existing
cleaning efforts and that wipe sampling
in general can be a useful tool for
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employers to provide feedback on their
cleaning procedures. To the extent that
DOD’s recommendation was intended to
suggest an amendment to the proposed
provisions, however, OSHA does not
believe such an amendment is
appropriate. As discussed in the 2018
NPRM, the ‘‘as free as practicable’’
standard is well-understood by the
regulated community. OSHA has used
the phrase in existing substance-specific
standards, including those for lead (29
CFR 1910.1025, 29 CFR 1926.62),
chromium (VI) (29 CFR 1910.1026), and
asbestos (29 CFR 1910.1001), and has
previously discussed its meaning in a
2014 letter of interpretation explaining
the phrase in the context of the
chromium standard (OSHA, Nov. 5,
2014, Letter of Interpretation, available
at https://www.osha.gov/laws-regs/
standardinterpretations/2014-11-05).
Additionally, as discussed in the
Summary and Explanation of the
definition of the term dermal contact
with beryllium, the best available
scientific evidence on adverse health
effects from dermal contact with
beryllium does not provide sufficient
information to link risk of adverse
health effects with specific levels of
surface contamination. Therefore, the
agency has chosen not to require a
specific target level of surface
contamination for any of the surface
cleanliness requirements of the
beryllium standards. Instead, the agency
has determined that the more
performance-oriented ‘‘as free as
practicable’’ standard for cleaning—
rather than a more prescriptive
requirement—is appropriate. The
agency finds that the use of the broader
standard will better serve employees by
allowing employers in a variety of
industries flexibility to decide what
type of control methods and procedures
are best suited to their beryllium
operations.
Having received no other comments
on this proposed provision, OSHA
strikes the phrase ‘‘surface beryllium
contamination’’ from the regulatory text,
as proposed.
In summary, OSHA is finalizing (j)(3)
as proposed in 2018, except for the
clarifying revision in paragraph (j)(3)(i),
which explicitly incorporates the intraplant exception found in paragraphs
(j)(3)(ii) and (j)(3)(iii). OSHA has based
this decision on the record and has
determined this will maintain or
enhance worker protections.
Medical Surveillance.
Paragraph (k) of the beryllium
standard for general industry (29 CFR
1910.1024) addresses medical
surveillance requirements. The
paragraph specifies which employees
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must be offered medical surveillance, as
well as the frequency and content of
medical examinations. It also sets forth
the information that must be provided
to the employee and employer. The
purposes of medical surveillance for
beryllium are (1) to identify berylliumrelated adverse health effects so that
appropriate intervention measures can
be taken; (2) to determine if an
employee has any condition that might
make him or her more sensitive to
beryllium exposure; and (3) to
determine the employee’s fitness to use
personal protective equipment such as
respirators. The inclusion of medical
surveillance in the beryllium standard
for general industry 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 the hazards
addressed by the standard.
In the 2018 NPRM, OSHA proposed
two sets of changes to paragraph (k).
The first set of changes proposed is in
paragraph (k)(2), which specifies when
and how frequently medical
examinations were to be offered to those
employees covered by the medical
surveillance program. Paragraph
(k)(2)(i)(B) of the standard requires the
employer to provide a medical
examination within 30 days after
determining that the employee shows
signs or symptoms of CBD or other
beryllium-related health effects or that
the employee has been exposed to
beryllium in an emergency. After
publication of the 2017 final rule,
stakeholders suggested to OSHA that,
for individuals exposed one-time during
an emergency, 30 days may be
insufficient to detect beryllium
sensitization, so a longer timeframe for
medical examinations may be more
appropriate (83 FR at 63757).
In the 2018 NPRM, OSHA
acknowledged uncertainty regarding the
time period in which sensitization may
occur following a one-time exposure to
a significant concentration of beryllium
in an emergency (83 FR at 63757). In
fact, beryllium sensitization can occur
several months or more after initial
exposure to beryllium among workers
with regular occupational exposure to
beryllium (see 83 FR at 63757 (citing 82
FR at 2530, 2533)). Based on this
evidence and stakeholder feedback,
OSHA proposed removing the
requirement for a medical examination
within 30 days of exposure in an
emergency, under paragraph (k)(2)(i)(B),
and adding paragraph (k)(2)(iv), which
would require the employer to offer a
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medical examination at least one year
after but no more than two years after
the employee is exposed to beryllium in
an emergency. OSHA requested
comments on the appropriateness of this
change (83 FR at 63757).
Several stakeholders commented on
this issue. NJH supported extending the
time to offer medical surveillance to one
year after an emergency because 30 days
following a high exposure may not be
enough time to detect beryllium
sensitization (Document ID 0022, p. 8).
Materion also agreed with the proposed
one-to-two-year timeframe for
examinations following exposure during
an emergency because 30 days may be
too soon to detect an immunological
change using the BeLPT (Document ID
0038, p. 33). DOSH similarly
commented that delaying the medical
examination to one year might improve
the detection of sensitization because it
may take several months to detect it
(Document ID 0023, p. 2). DOSH also
expressed concern, however, that
workers would not get counseling about
signs and symptoms of berylliumrelated conditions, an occupational
history review, and other medical
advice which may allow for the worker
to identify a developing condition
within the first year after exposure
(Document ID 0023, p. 2). DOSH added
that if the medical examination will be
delayed, it would be appropriate to have
a requirement for additional training or
a brief medical consultation for workers
who are not knowledgeable about
beryllium and the potential medical
conditions that may be triggered by
exposure (Document ID 0023, pp. 2–3).
The ACOEM and NSSP shared
DOSH’s concerns regarding potential
delays in consultations and counseling
(Document ID 0024, p. 2; 0027, p. 4).
The NSSP recommended an earlier
discussion with employees exposed in
an emergency to address their
individual concerns, the medical path
forward, options available, and to
answer any questions the employees
might have (Document ID 0027, p. 4). It
suggested that the medical examination
could then be scheduled in keeping
with the individual employee’s medical
needs (Document ID 0027, p. 4).
ACOEM opposed the change, arguing
that workers who are exposed to
beryllium in an emergency deserve
prompt medical evaluation to
understand the potential health risks,
receive baseline testing, if desired, and
to receive medical counseling
(Document ID 0024, p. 2). ACOEM
maintained that it would be ‘‘an
extremely insensitive and harsh change
in policy’’ to require exposed workers to
wait more than a year to receive
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42617
professional medical advice (Document
ID 0024, p. 2). On the other hand,
Materion argued that the standard
protects workers who may have been
exposed in an emergency, regardless of
when the emergency occurred, by
requiring employers to make medical
surveillance available to any employees
showing signs and symptoms of CBD or
other beryllium-related health effects
(Document ID 0038, p. 33). Specifically,
paragraph (k)(2)(i)(B) requires
employers to provide an examination to
these employees within 30 days of
determining that the employee shows
signs or symptoms of CBD.
After considering these comments and
the record as a whole on this issue,
OSHA reaffirms its preliminary belief
that testing conducted during the
proposed time period of one to two
years is more likely to detect
sensitization than testing conducted 30
days following emergency exposure (82
FR at 63757). Nevertheless, DOSH, the
NSSP, and ACOEM’s concerns about
possible delays in medical consultations
and examinations and lack of employee
knowledge of potential health effects
prompted the agency to reevaluate the
standard’s medical surveillance and
training triggers to determine if any
employees could potentially be exposed
in an emergency but may not be
knowledgeable about symptoms, health
effects, and medical surveillance
because they have not been trained, or
if any employees might be exposed but
have not recently received a medical
examination during which they had the
opportunity to talk with a PLHCP about
exposure to beryllium.
First, OSHA considered the
population of employees affected by
emergencies. As noted in the 2018
NPRM, OSHA estimates that a very
small number of employees, likely less
than 0.1 percent of the affected
population, would be affected by
emergencies in a given year (83 FR at
63764). Second, OSHA considered if
any of the small number of employees
exposed in an emergency in a given year
would not be knowledgeable about
symptoms, health effects, and medical
surveillance through the training
provided under paragraph (m)(4) at the
time of emergency and, thus, might
need such training after exposure during
an emergency. Paragraph (m)(4)(i)
requires the employer to provide
information and training in accordance
with the Hazard Communication
Standard (HCS), 29 CFR 1910.1200(h),
for each employee who has, or can
reasonably be expected to have, airborne
exposure to or dermal contact with
beryllium. Final paragraph (m)(4)(ii)
requires employers to ensure that each
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employee who is, or can reasonably be
expected to be, exposed to airborne
beryllium can demonstrate knowledge
and understanding of a number of
specified topics, including (1) the health
hazards associated with airborne
exposure to and dermal contact with
beryllium, including signs and
symptoms of CBD; (2) the purpose and
a description of the medical
surveillance program under paragraph
(k) of the standard, including risks and
benefits of each test to be offered; (3) the
purpose and a description of the
medical removal protection provided
under paragraph (l) of the standard; and
(4) the contents of the standard.
OSHA expects that the vast majority
of employees who could be exposed to
beryllium in an emergency are those
who are regularly exposed to beryllium
as part of their normal work duties
performed near processes involving
beryllium. Therefore, most of those
employees are already likely to be
trained in accordance with the HCS
under paragraph (m)(4)(i) because the
training requirements under paragraph
(m)(4)(i) are triggered by actual, or
reasonably anticipated, airborne
exposure at any level or dermal contact
with beryllium. In addition, OSHA
anticipates that most of these employees
would also be knowledgeable about
beryllium-related health effects, medical
surveillance, medical removal, and the
remainder of the standard, as required
by paragraph (m)(4)(ii). Nevertheless, if
an employee who had not been trained
in accordance with paragraph (m)(4) or
was not knowledgeable of the subjects
covered in paragraph (m)(4)(ii) was
exposed in an emergency, the standard
would require that the employee be
trained after the emergency because the
exposure during the emergency would
cause them to meet the standard’s
training triggers. In other words, the
standard already provides for training of
the very small number of untrained or
unknowledgeable employees who might
be exposed during an emergency.20
Third, OSHA considered if any
employees exposed during an
emergency would likely not have
received a recent examination under the
standard. Under paragraph (k)(1)(i), the
employer must make medical
surveillance available to four groups of
employees: (A) Employees who are or
20 OSHA notes that the standard would require
additional training for workers who were exposed
during an emergency who had already been trained
if the employer realized that those workers were not
knowledgeable about topics such as the potential
medical conditions which may result from exposure
to beryllium or symptoms that may trigger a
medical examination (see paragraph (m)(4)(ii)(A);
see also additional training requirements under
paragraph (m)(4)(iii)).
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are reasonably expected to be exposed at
or above the action level for more than
30 days per year, (B) employees who
show signs or symptoms of CBD or other
beryllium-related health effects, (C)
employees who are exposed to
beryllium during an emergency, and (D)
employees whose most recent written
medical surveillance opinion required
by paragraph (k)(6) or (k)(7) of the
standard recommends periodic medical
surveillance. Under paragraph (k)(2)(ii),
employees who continue to meet abovetriggers (A), (B), or (D) of the standard
receive examinations at least every two
years after their most recent
examination. Employees previously
exposed in an emergency (and all other
employees who have received an
examination, but no longer meet the
criteria for periodic examinations)
continue to be offered a standardized
BeLPT or equivalent test at least every
two years, unless they are confirmed
positive (paragraph (k)(3)(i)(E); 82 FR at
2705).
As noted above, OSHA expects that
the vast majority of employees who
could be exposed to beryllium in an
emergency are those who are regularly
exposed to beryllium as part of their
normal work duties that are performed
near processes involving beryllium. As
a result, OSHA expects that the majority
of employees who could be exposed to
beryllium in an emergency are likely to
be those who meet the trigger for
periodic medical surveillance under
paragraph (k)(1)(i)(A) (i.e., they are or
are reasonably expected to be exposed at
or above the action level for more than
30 days per year). Thus, they have likely
had an opportunity to consult with a
PLHCP at a minimum of every two years
(paragraph (k)(2)(ii)). Other employees
exposed during an emergency may have
also had a recent examination because
they have recently met one of the other
triggers, such as experiencing signs or
symptoms of CBD or other berylliumrelated health effects. OSHA recognizes,
however, that a much smaller number of
employees, such as office and
warehouse workers, who do not have
regular exposures to beryllium at or
above the action level and have also not
met one of the other medical
surveillance triggers, could potentially
be exposed to beryllium in an
emergency. These employees may have
never received a medical examination or
a BeLPT or equivalent test.
OSHA agrees with ACOEM that it is
unacceptable to have employees who
have not recently been offered a medical
examination under the beryllium
standard wait for a year or more for a
medical consultation and examination
after exposure during an emergency.
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These employees may not have baseline
information on their health status, and
they may not have had the opportunity
to speak to a PLHCP to ask questions
related to their concerns, such as
possible health risks, symptoms, and
medical interventions. In contrast,
employees who had a medical
examination within the previous two
years would have a baseline and have
had the opportunity to speak with a
health professional. Therefore, to
adequately meet the needs of all
employees who may be exposed in an
emergency, OSHA is deleting final
paragraph (k)(2)(iv) and replacing it
with paragraphs (k)(2)(iv)(A) and
(k)(2)(iv)(B).
New paragraph (k)(2)(iv)(A) addresses
the needs of the very small group of
employees who are exposed in an
emergency but have not received a
medical examination under paragraph
(k)(1)(i) within the previous two years.
Specifically, paragraph (k)(2)(iv)(A)
requires that if an employee is exposed
to beryllium during an emergency and
has not received a medical examination
under paragraph (k)(1)(i) within the
previous two years, then the employer
must provide that employee with a
medical examination within 30 days of
the date of the emergency. New
paragraph (k)(2)(iv)(B), on the other
hand, focuses on employees who are
exposed during an emergency, but have
recently received an examination.
Under paragraph (k)(2)(iv)(B), if an
employee has received a medical
examination under paragraph (k)(1)(i)
within the previous two years, then the
employer would be required to offer that
employee a medical examination that
meets the requirements of the standard
at least one year but no more than two
years after the employee was exposed to
beryllium in an emergency.
OSHA concludes that it is appropriate
to provide a medical examination
within 30 days after the employee was
exposed in an emergency, if the
employee has not had an examination
under the beryllium standard within the
last two years. It addresses the concerns
of DOSH, ACOEM, and the NSSP that
employees receive timely medical
consultations and evaluations. If an
employee has not had a previous
examination under the standard, the
examination at 30 days after the
emergency allows for collection of
baseline values on health status, as
recommended by ACOEM. Baseline
information about the employee’s
current health status, such as lung
function, will allow for a comparison
with changes that might occur in the
future. Moreover, if the employee is
confirmed positive by the baseline
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BeLPT and there is a possibility that the
employee could be exposed to beryllium
again in the future, knowledge about the
confirmed positive finding would allow
the employee to consider risks and
options related to employment (82 FR at
2702).
OSHA recognizes, as NJH, DOSH, and
Materion noted, that 30 days following
the emergency is not the best timeframe
for detecting sensitization. However,
paragraph (k)(3)(ii)(E) of the beryllium
standard for general industry already
requires that employees who received a
medical examination because of an
emergency exposure continue to receive
a BeLPT, or an equivalent test, every
two years following that examination,
unless the employee is confirmed
positive. Therefore, the standard already
requires the employers to offer these
employees a BeLPT for the remainder of
their tenure in the workplace where
they were exposed in an emergency,
rather than limiting the opportunity to
detect sensitization to 30 days following
the emergency.
OSHA also concludes that it is
appropriate to require employers to offer
medical surveillance within one to two
years after exposure to beryllium in an
emergency, if that employee had an
examination that meets the
requirements of the beryllium standard
within the last two years. These
employees could include those who
undergo periodic medical surveillance
at least every two years under paragraph
(k)(2)(A) or (D), or who may have
received a medical examination within
the last two years because they were
experiencing symptoms or were
exposed in a previous emergency
(paragraphs (k)(2)(B) and (C)). These
employees would have received a recent
medical consultation and examination
which would have allowed them to ask
questions. In addition, these employees
would have received a baseline
examination. Like the employees
examined within 30 days after exposure
to beryllium in an emergency, all these
employees examined within one to two
years of the emergency will continue to
be offered BeLPT testing every two years
under paragraph (k)(3)(ii)(E) if they have
not been confirmed positive and do not
or no longer meet the criteria for full
periodic medical examinations under
paragraph (k)(2)(ii).
The requirement for continuing
BeLPTs for any employee who has
received an examination under the
beryllium standard, including for an
emergency exposure, addresses another
concern voiced by NJH, which is that
anyone exposed in an emergency should
be provided periodic medical
surveillance (Document ID 0022, p. 8).
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If the employee is confirmed positive, or
if the licensed physician otherwise
deems it appropriate, the licensed
physician is to provide in the written
medical opinion to the employee a
referral to a CBD diagnostic center and
a recommendation for continued
periodic medical surveillance under
paragraph (k)(5)(iii) and (iv). If the
employee authorizes the
recommendation for referral to be
included in the written opinion, the
employer must provide an examination
at a CBD diagnostic center (discussed in
more detail below) (paragraph
(k)(6)(iii)). Once an employee is
evaluated at a CBD diagnostic center, as
described under paragraph (k)(7)(i), the
employee may choose to have any
subsequent medical examinations for
which the employee is eligible,
performed at the CBD diagnostic center
at no cost to the employee (see final
paragraph (k)(7)(vi)). Therefore, the
standard already allows for periodic
BeLPT testing for all employees exposed
in an emergency, and periodic medical
surveillance for any of those employees
who are confirmed positive.
Another concern that was raised by
DOSH is that delaying the medical
examination to at least one year
following the emergency may result in
employees not receiving the
examination if their employment ends
within that one-year period (Document
ID 0023, p. 3). This concern continues
to be relevant to employees who are
receiving the examination for an
emergency exposure at one to two years
after the exposure in the emergency
(paragraph (k)(2)(iv)(B)). If employment
does end before one year after the
emergency, paragraphs (k)(2)(iii) and
(1)(i)(C) require the employer to offer a
medical examination at termination of
employment to any employee exposed
to beryllium in an emergency, unless
the employee received an examination
in accordance with the standard within
the last 6 months. OSHA is concerned
that this provision would not require
employers to offer a medical
examination to some employees who
would receive the emergency
examination at one to two years after the
emergency exposure. For example, if
such an employee, already under
medical surveillance, received a
medical examination one month before
the emergency and then terminated
employment two months after the
emergency, the employer would not be
required to offer a medical examination
to that employee exposed during the
emergency under the proposed changes,
and the employee would not have an
opportunity to have an medical exam
PO 00000
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42619
that could detect any adverse effects
that might have occurred because of the
emergency. OSHA agrees with DOSH
that further revision is necessary to
ensure that every employee who is
exposed in an emergency receives an
examination following the emergency.
Accordingly, OSHA is revising
paragraph (k)(2)(iii) to require that each
employee who is exposed in an
emergency and has not received an
examination since the emergency
exposure is provided an examination at
the time employment is terminated.
OSHA finds that this change better
protects employees because it allows
health effects that could have resulted
from the emergency exposure to be more
readily detected.
In making these decisions on the
appropriate timing for medical
examinations for employees exposed to
beryllium during an emergency, OSHA
considered Materion’s point that
employees experiencing signs or
symptoms or other beryllium-related
health effects after an emergency can
ask for an examination under paragraph
(k)(1)(i)(B) (Document ID 0038, p. 33).
As explained above, all employees who
are exposed in an emergency will either
have previously received training under
paragraph (m)(4) or will need to be
trained within a reasonable time after
exposure. And these employees should
already be knowledgeable or will soon
become knowledgeable about the health
hazards associated with airborne
exposure to and dermal contact with
beryllium, including signs and
symptoms of CBD, as required by
paragraph (m)(4)(ii). Therefore, all
employees exposed during an
emergency should be able to identify
and report signs or symptoms of CBD or
other beryllium-related health effects
either at the time of the emergency or
within a reasonable time after it.
Materion is, thus, correct in pointing out
that if these employees did experience
such signs or symptoms, they could ask
for a medical examination. Other
employees exposed during an
emergency that have not had an
examination and do not experience
these health effects, however, would
still not have had the opportunity for a
timely consultation and medical
examination with a PLHCP.
Consequently, OSHA does not find that
the signs-or-symptoms trigger is
sufficient to resolve the concerns raised
by the other stakeholders.
OSHA also proposed one additional
change to the paragraph involving
emergency exposure. As promulgated in
the 2017 final rule, paragraph (k)(2)(i)(B)
required the employer to provide a
medical examination within 30 days
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after the employer determines that an
employee shows signs or symptoms of
CBD or other beryllium-related health
effects or has been exposed to beryllium
in an emergency. Because OSHA
believes that employers typically will
learn of any emergency resulting in
exposure immediately or soon after it
occurs, OSHA preliminarily determined
that it is appropriate to measure the
time period from the date of exposure.
Therefore, under proposed paragraph
(k)(2)(iv), the time period for providing
a medical examination begins to run
from the date the employee is exposed
during an emergency, regardless of
when the employer discovers that the
exposure occurred. OSHA requested
comments on the appropriateness of
calculating the time period for a medical
examination from the occurrence of the
emergency rather than from the
employer’s determination of eligibility.
Materion agreed with OSHA that most
employers will learn about the
emergency resulting in exposure
immediately or soon after the
occurrence, and it supported measuring
the time period from the date of the
exposure, provided that the employer
determined that the incident can be
defined as an emergency under the
standard (Document ID 0038, pp. 33–
34). OSHA did not receive any
comments objecting to OSHA’s proposal
to measure the time period from the
date of exposure in an emergency;
therefore, OSHA is retaining the
proposed language to measure the time
period from the date of the exposure in
the emergency in final paragraphs
(k)(2)(iv)(A) and (B).
Paragraph (k)(2)(iv)(B) does not
preclude employers from voluntarily
providing a medical examination within
the first year after an emergency.
Providing a medical examination sooner
would not, however, relieve an
employer of the duty to provide an
exam in the one-to-two-year window.
For those employees who are already
eligible for periodic medical
surveillance, the examination for the
emergency exposure could be scheduled
to coincide with the next periodic
examination that is within two years of
the last periodic medical examination
and at least one but no more than two
years after the emergency exposure,
satisfying the requirements of both
paragraphs (k)(2)(ii) and (iv)(B).
In summary, OSHA is modifying
proposed paragraph (k)(2)(iv) to
customize protections for two general
groups of employees who could be
exposed to beryllium in an emergency.
Paragraph (k)(2)(iv)(A) will require the
employer to offer a medical examination
to an employee within 30 days after the
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employee was exposed to beryllium in
an emergency, if the employee has not
had an examination under paragraph
(k)(1)(i) within the last two years. This
requirement improves protections for
what is likely to be a very small group
of employees who have not had a
medical examination under the
beryllium standard within the last two
years because it allows those employees
to have a timely consultation and
examination. Paragraph (k)(2)(iv)(B) will
require the employer to offer a medical
examination to an employee within one
to two years after the employee was
exposed to beryllium in an emergency,
if the employee had an examination
under paragraph (k)(1)(i) of the
beryllium standard within the last two
years. This provision eliminates the
requirement to offer an examination
within 30 days to the majority of
employees who are likely to be exposed
in an emergency and have already
received a recent medical examination.
Thus, these employees would have
received a baseline examination and a
recent consultation regarding beryllium.
And either group will continue to be
offered the BeLPT, or an equivalent test,
every two years under paragraph
(k)(3)(ii)(E), even if they do not or no
longer meet the criteria for full periodic
medical examinations under paragraph
(k)(ii). OSHA is also revising paragraph
(k)(2)(iii) to require that employers offer
a medical examination to any employee
who has not received an examination
since the emergency exposure at the
time the employee’s employment is
terminated. Again, OSHA expects this to
be a very small group of employees that
would have had an exam within six
months of termination but not have had
an exam since exposure during an
emergency. This change ensures that all
employees exposed in an emergency
receive a medical examination for the
emergency exposure before their
employment is terminated.
In addition, other provisions in the
standard ensure that either group of
employees (i.e., those who receive a
medical examination within 30 days or
one to two years after an emergency) are
knowledgeable about the signs and
symptoms of CBD and that if employees
are experiencing signs and symptoms,
they will be provided a medical
examination within 30 days of the
employer determining that they are
experiencing such signs or symptoms.
The second (and final) set of changes
that OSHA proposed to the standard’s
medical surveillance requirements is in
paragraph (k)(7), which contains the
requirements for evaluation at a CBD
diagnostic center. In this final rule,
OSHA is amending paragraph (k)(7) in
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three ways. First, OSHA is revising
paragraph (k)(7)(i) to require that the
evaluation must be scheduled within 30
days, and must occur within a
reasonable time, of the employer
receiving one of the types of
documentation listed in paragraph
(k)(7)(i)(A) or (B). Second, OSHA is
adding a provision, in paragraph
(k)(7)(ii), which clarifies that, as part of
the evaluation at the CBD diagnostic
center, the employer must ensure that
the employee is offered any tests
deemed appropriate by the examining
physician at the CBD diagnostic center,
such as pulmonary function testing (as
outlined by the American Thoracic
Society criteria), bronchoalveolar lavage
(BAL), and transbronchial biopsy. The
new provision also states that if any of
the tests deemed appropriate by the
examining physician are not available at
the CBD diagnostic center, they may be
performed at another location that is
mutually agreed upon by the employer
and the employee. Third, OSHA is
making a handful of minor, nonsubstantive numbering and reference
edits to other provisions in paragraph
(k)(7) to account for the addition of new
paragraph (k)(7)(ii). Specifically, OSHA
is renumbering current paragraphs
(k)(7)(ii), (iii), (iv), and (v) as (k)(7)(iii),
(iv), (v), and (vi), respectively, and is
adding a reference to new paragraph
(k)(7)(ii) to the newly renumbered
paragraph (k)(7)(vi).
Each of these final revisions differ in
some way from the proposed
amendments based on stakeholder
feedback. With regard to the first change
concerning the timing of the exam, the
current standard requires employers to
provide the examination within 30 days
of the employer receiving one of the
types of documentation listed in
paragraph (k)(7)(i)(A) or (B). The
purpose of the 30-day requirement was
to ensure that employees receive the
examination in a timely manner. As
OSHA explained in the proposal,
however, since the publication of the
2017 final rule stakeholders have raised
concerns that the examination and any
required tests could not be scheduled
and completed within 30 days (83 FR at
63758).
To address this concern, OSHA
proposed that the employer provide an
initial consultation with the CBD
diagnostic center, which could occur via
telephone or virtual conferencing
methods, rather than the full evaluation,
within 30 days of the employer
receiving one of the types of
documentation listed in paragraph
(k)(7)(i)(A) or (B). OSHA explained that
providing a consultation before the full
examination at the CBD diagnostic
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center would demonstrate that the
employer made an effort to begin the
process for a medical examination.
OSHA also noted that the proposed
change would also allow (1) the
employee to consult with a physician to
discuss concerns and ask questions
while waiting for a medical
examination, and (2) the physician to
explain the types of tests that are
recommended based on medical
findings about the employee and the
risks and benefits of undergoing such
testing. OSHA requested comments on
the appropriateness of providing the
consultation within 30 days and on the
sufficiency of a consultation via
telephone or virtual conference (83 FR
at 63758).
Several stakeholders offered
comments on this issue (Document ID
0021, p. 3; 0022, p. 6; 0029, p. 2; 0038,
p. 34). The ATS, NJH, and Materion
agreed that an examination at the CBD
diagnostic center should not be required
to occur within 30 days of the referral
because it may take weeks or months
before the CBD diagnostic center has an
opening for an evaluation. In addition,
many of the stakeholders noted that
work responsibilities, personal and
family obligations, or the need to
arrange travel may make it difficult for
employees to have an evaluation done
within that time period.
Materion also supported the proposed
requirement for a telephone or virtual
consultation within 30 days, claiming
that it is a more workable solution that
does not reduce protections, while
allowing employees to consider medical
options available under the standard
and offering the employee more
flexibility in determining when they can
undergo testing based on their
availability and preference (Document
ID 0038, p. 34). In contrast to Materion,
the ATS and NJH opposed the proposed
requirement for a consultation that can
be performed via telephone or virtual
conferencing within 30 days of the
employer receiving documentation
recommending a referral. NJH
commented that a video or phone
consultation would add cost and
logistical difficulty to scheduling, and
that it is not necessary because the
PLHCP who sees the employee for
screening provides information on the
clinical evaluation. Furthermore, they
commented, there are HIPAA privacy
issues of a phone or video conference to
consider (Document ID 0022, p. 6).
The ATS agreed with many of the
concerns expressed by NJH, including
concerns regarding logistical challenges,
the need for an in-person clinical
evaluation and review of medical tests
to provide effective care, and
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redundancy with the PLHCP
consultation (Document ID 0021, p. 3).
The ATS and NJH recommended that
the standard be revised to require that
the employer make an appointment for
the employee to be evaluated at the CBD
diagnostic center within 30 days of
receiving documentation for the referral
(Document ID 0021, p. 3; 0022, p. 6).
DOD also opposed requiring an
evaluation by telephone or virtual
conferencing and stated that an ill
worker should be examined
immediately; it recommended that the
employer make the appointment for
evaluation at a CBD diagnostic center
within seven days of receiving
documentation for a referral (Document
ID 0029, p. 2).
After considering these comments,
OSHA is convinced that scheduling a
phone or virtual consultation with the
CBD diagnostic center is an unnecessary
step that adds logistical complications
and costs. Although the agency
understands Materion’s point that the
additional consultation could provide
employees with more time and
information to make medical decisions,
as well as accommodate other
scheduling logistics, OSHA finds that
the scheduling approach suggested by
the ATS and NJH addresses both the
logistical difficulties cited by
stakeholders with respect to the
requirements in the current standard
and the timing concerns Materion
raised. Moreover, OSHA finds that
employees will have enough
information (through trainings under
paragraph (m) and discussions with the
PLHCP) to allow them to decide
whether to be evaluated at the CBD
diagnostic center.21 OSHA is therefore
amending paragraph (k)(7)(i) to require
that the employer schedule an
examination at a CBD diagnostic center
within 30 days of receiving one of the
types of documentation listed in
paragraph (k)(7)(i)(A) or (B). And to
maintain the intent of the 2017 final
rule and the 2018 NPRM that evaluation
at a CBD diagnostic center occurs in a
timely manner, OSHA is adding that the
evaluation must occur within a
reasonable time. Requiring that the
evaluation occur within a reasonable
time ensures that the evaluation is done
as soon as practicable based upon
availability of openings at the CBD
diagnostic center and the employee’s
preferences. This revision better
addresses OSHA’s original intent that
21 Under paragraph (k)(6)(i)(D), the employer is to
ensure that the PLHCP explains the results of the
medical examination to the employee, including
results of tests conducted and medical conditions
related to airborne beryllium exposure that require
further evaluation or treatment.
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42621
the employee be examined within a
timely period, while providing
employees and employers with
maximum flexibility and convenience.
Although OSHA understands DOD’s
concerns about making a timely
appointment, requiring that an
appointment be made within a sevenday period might not give the employee
enough time to consider his or her
future obligations and possibly have
discussions with family members to
determine the best time period for the
examination. OSHA believes that a 30day period to schedule an appointment
for an examination is a reasonable time
that allows the employee to consider his
or her preferences for an examination
date. In addition, a 30-day period offers
more administrative convenience for
employers because it is consistent with
other triggers in the beryllium standard.
The second change that OSHA
proposed to paragraph (k)(7)(i) relates to
the contents of the examination at the
CBD diagnostic center. As discussed in
more detail above, the former definition
of CBD diagnostic center—which stated
that the evaluation at the diagnostic
center ‘‘must include’’ a pulmonary
function test as outlined by American
Thoracic Society criteria,
bronchoalveolar lavage (BAL), and
transbronchial biopsy—could have been
misinterpreted to mean that the
examining physician was required to
perform each of these tests during every
clinical evaluation at a CBD diagnostic
center. That was not OSHA’s intent.
Rather, the agency merely intended to
ensure that any CBD diagnostic center
has the capacity to perform any of these
tests, which are commonly needed to
diagnose CBD. Therefore, OSHA
proposed revising the definition to
clarify that the CBD diagnostic center
must simply have the ability to perform
each of these tests when deemed
appropriate.
To account for that proposed change
to the definition of CBD diagnostic
center and to ensure that the employer
provides those tests if deemed
appropriate by the examining physician
at the CBD diagnostic center, OSHA
proposed expanding paragraph (k)(7)(i)
to require that the employer provide, at
no cost to the employee and within a
reasonable time after consultation with
the CBD diagnostic center, any of the
three tests mentioned above, if deemed
appropriate by the examining physician
at the CBD diagnostic center (83 FR at
63764). OSHA explained that the
revision would also clarify the agency’s
original intent that, instead of requiring
all three tests to be conducted after
referral to a CBD diagnostic center, the
standard would allow the examining
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physician at the CBD diagnostic center
the discretion to select one or more of
those tests as appropriate (83 FR at
63764).
Several stakeholders offered opinions
on these proposed changes. For
example, Materion agreed with the
proposed changes to align paragraph
(k)(7)(i) with the definition for CBD
diagnostic center (Document ID 0038, p.
34). However, as discussed above in the
Summary and Explanation of paragraph
(b), Definitions, the ATS argued that
‘‘not requiring certain diagnostic tests
(or an equivalent) could reduce the
potential to diagnose CBD and
determine disease severity’’ (Document
ID 0021, p. 3). The ATS further asserted
that ‘‘confirmed positive workers should
have an assessment of lung function and
gas exchange (such as a full set of
pulmonary function tests with
spirometry, lung volumes and diffusion
capacity for carbon monoxide or other
similar tests) and also chest imaging’’
(Document ID 0021, p. 3). NJH and the
AOEC expressed similar concerns,
commenting that lung function and
imaging tests should be included as part
of an evaluation at the CBD diagnostic
center (Document ID 0022, p. 3; 0028, p.
2). After reviewing these comments and
the remainder of the record on this
issue, OSHA agrees that pulmonary
function testing, BAL, and
transbronchial biopsies are important
diagnostic tools, but finds that the
examining physician at the CBD
diagnostic center is in the best position
to determine which diagnostic tests are
appropriate for particular workers. The
agency believes that the modified
definition of the term CBD diagnostic
center, which requires the centers to
have the capacity to perform these three
tests, will serve to ensure that
healthcare providers at the centers are
aware of the importance of and are able
to perform pulmonary function testing,
BAL, and transbronchial biopsies.
Nevertheless, OSHA understands that
the proposed provision could be
misinterpreted to mean that the
employer does not have to make
available additional tests that the
examining physician deems appropriate
for diagnosing or determining severity
of CBD. That was never the agency’s
intent. In fact, OSHA noted the potential
for other tests, as deemed necessary by
the CBD diagnostic center physician,
several times in the preamble to the
2017 final rule (see, e.g., 82 FR at 2709,
2714). Similar to paragraph (k)(3)(ii)(G),
which requires the employer to ensure
that the employee is offered as part of
the initial or periodic medical
examination any test deemed
appropriate by the PLHCP, OSHA
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intends for the employer to ensure the
employee is offered any tests deemed
appropriate by the examining physician
at the CBD diagnostic center, including
tests for diagnosing CBD, for
determining its severity, and for
monitoring progression of CBD
following diagnosis. Allowing the
physician at the CBD diagnostic center
to order additional tests that are deemed
appropriate is also consistent with most
OSHA substance-specific standards,
such as respirable crystalline silica (29
CFR 1910.1053) and chromium (VI) (29
CFR 1910.1026).
To clarify the agency’s intent that the
physician at the CBD diagnostic center
has discretion to order appropriate tests,
and to further respond to stakeholder
concerns regarding the necessity of
pulmonary function testing, BAL, and
transbronchial biopsies, OSHA is
adding a new sub-paragraph (k)(7)(ii),
which focuses on the content of the
examination. This new provision
requires the employer to ensure that, as
part of the evaluation, the employee is
offered any tests deemed appropriate by
the examining physician at the CBD
diagnostic center, such as pulmonary
function testing (as outlined by the
American Thoracic Society criteria),
bronchoalveolar lavage (BAL), and
transbronchial biopsy. OSHA intends
for the new provision to make clear that
the employer must provide additional
tests, such as those noted by the ATS,
NJH, and the AOEC, at no cost to the
employee, if those tests are deemed
necessary by the examining physician.
The agency also believes that explicitly
naming the three examples of tests that
may be appropriate will further
emphasize their importance to
examining physicians at the CBD
diagnostic centers.
Consistent with OSHA’s original
intent, those tests are required to be
offered only if deemed appropriate by
the physician at the CBD diagnostic
center. For example, if lung volume and
diffusion tests were performed
according to the ATS criteria as part of
the periodic medical examination under
paragraph (k)(3) and the physician at the
CBD diagnostic center found them to be
of acceptable quality, those tests would
not have to be repeated as part of a CBD
evaluation. The addition of paragraph
(k)(7)(ii) clarifies that the employer
must, however, offer any test that the
PLHCP deems appropriate. Consistent
with previous health standards and the
meaning of the identical phrase in
paragraph (k)(3)(ii)(G), OSHA intends
the phrase ‘‘deemed appropriate’’ to
mean that additional tests requested by
the physician must be both related to
beryllium exposure and medically
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necessary, based on the findings of the
medical examination (see 82 FR at 2709;
81 FR 16286, 16826 (March 25, 2016)).
New paragraph (k)(7)(ii) also
addresses the possibility that a test that
is deemed appropriate by the examining
physician at the CBD diagnostic center
might not be available at that center.
Although OSHA’s intention has been to
require any testing to be provided by the
same CBD diagnostic center unless the
employer and employee agree to a
different CBD diagnostic center (see 83
FR at 63758), there may be cases where
the CBD diagnostic center does not
perform a type of test deemed
appropriate by the examining physician.
In such a case, OSHA wants to ensure
that the employee can receive the
appropriate test. Therefore, OSHA is
also including in paragraph (k)(7)(ii) a
requirement that if any of those tests
deemed appropriate by the physician
are not available at the CBD diagnostic
center, they may be performed at
another location that is mutually agreed
upon by the employer and the
employee. This other location does not
need to be a CBD diagnostic center as
long as it is able to perform tests
according to requirements under
paragraph (k). OSHA believes that such
circumstances would be very rare
because CBD diagnostic centers with the
ability to perform pulmonary function
testing (as outlined by the ATS criteria),
BAL, and transbronchial biopsy are
likely to also provide other medical tests
related to CBD.22 As a result, the CBD
diagnostic center in the vast majority of
cases will be able to offer the additional
testing deemed necessary by the
examining physician. Given that this
standard requires CBD diagnostic
centers to be able to perform the three
most common tests for diagnosing CBD,
and CBD diagnostic centers typically
would be able to offer any additional
tests deemed necessary, OSHA expects
that employees would rarely, if ever,
need to travel to a second location.
In summary, final paragraph (k)(7)(i)
requires that the employer provide an
evaluation at no cost to the employee at
a CBD diagnostic center that is mutually
agreed to by the employer and the
employee. The evaluation must be
scheduled within 30 days and must
occur within a reasonable time of the
employer receiving one of the types of
documentation listed in paragraph
(k)(7)(i)(A) or (B). Final paragraph
(k)(7)(ii) requires the employer to ensure
that, as part of the evaluation, the
22 Document ID OSHA–H005C–2006–0870–0637
provides information from the NJH website, which
provides an overview of the types of tests
performed.
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employee is offered any tests deemed
appropriate by the examining physician
at the CBD diagnostic center, such as
pulmonary function testing (as outlined
by the American Thoracic Society
criteria), bronchoalveolar lavage (BAL),
and transbronchial biopsy. Paragraph
(k)(7)(ii) further provides that any test
deemed appropriate by the examining
physician that is not available at the
CBD diagnostic center may be
performed at another location that is
agreed upon by the employer and
employee. Such tests must be provided
at no cost to the employee, whether
performed at the CBD diagnostic center
or at another location.
As noted above, OSHA is also making
a handful of minor, non-substantive
numbering and reference edits to other
provisions in paragraph (k)(7) to
account for the addition of new
paragraph (k)(7)(ii). Specifically, OSHA
is renumbering current paragraphs
(k)(7)(ii)–(v) as (k)(7)(iii), (iv), (v), and
(vi), accordingly, and is adding a
reference to new paragraph (k)(7)(ii) to
the newly renumbered paragraph
(k)(7)(vi). Paragraph (k)(7)(vi) provided
that after an employee received the
initial clinical evaluation at the CBD
diagnostic center described in paragraph
(k)(7)(i), the employee could choose to
have any subsequent medical
evaluations for which the employee is
eligible under paragraph (k) performed
at a CBD diagnostic center mutually
agreed upon by the employer and
employee and that the employer must
provide such examinations to the
employee at no cost. OSHA is revising
the paragraph to add the reference to
new paragraph (k)(7)(ii) because the
description of the initial clinical
evaluation is now split between
paragraph (k)(7)(i) and (ii), rather than
appearing solely in paragraph (k)(7)(i).
OSHA does not expect that this
clarifying change will have any
substantive effect. Newly renumbered
paragraph (k)(7)(vi) (previous paragraph
(k)(7)(v)), therefore, continues to require
that, after an employee has received the
initial clinical evaluation at a CBD
diagnostic center, the employee may
choose to have any subsequent medical
examinations for which the employee is
eligible under paragraph (k) of this
standard performed at a CBD diagnostic
center mutually agreed upon by the
employer and the employee, and the
employer must provide such
examinations at no cost to the
employee.
The addition of paragraph (k)(7)(ii)
and consequential renumbering of
current paragraphs (k)(7)(ii)–(v) as
(k)(7)(iii), (iv), (v), and (vi) also affects
two other cross-references in the
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standard. Paragraph (l)(1) of the
standard details the eligibility
requirements for medical removal. Two
of the criteria, those in (l)(1)(i)(B) and
(l)(1)(ii) reference paragraphs (k)(7)(ii)
and (k)(7)(iii), respectively. In this final
rule, OSHA is updating those references
to reflect the renumbering in paragraph
(k)(7). Therefore, final paragraph
(l)(1)(i)(B) references paragraph
(k)(7)(iii) and paragraph (l)(1)(ii)
references paragraph (k)(7)(iv). These
edits, like those noted above in
paragraph (k)(7)(vi), do not change the
substantive meaning of the provisions.
Communication of Hazards.
Paragraph (m) of the beryllium
standard for general industry (29 CFR
1910.1024(m)) sets forth the employer’s
obligation to comply with the Hazard
Communication standard (HCS) (29 CFR
1910.1200) relative to beryllium and to
take additional steps to warn and train
employees about the hazards of
beryllium. Under the HCS, beryllium
manufacturers and importers are
required to evaluate the hazards of
beryllium and prepare labels and safety
data sheets (SDSs) and provide both
documents to downstream users.
Employers whose employees are
exposed to beryllium in their workplace
must develop a hazard communication
program and ensure that employees are
trained on the hazards of beryllium.
These employers must also ensure that
all containers of beryllium are labeled
and that employees are provided access
to the SDSs. In addition to the
requirements under the HCS, paragraph
(m)(1)(ii) of the beryllium standard for
general industry specifies certain
criteria that must be addressed in
classifying the hazards of beryllium.
Paragraph (m)(2) requires employers to
provide and display warning signs with
specified wording at each approach to a
regulated area. Paragraph (m)(3) requires
employers to label each container of
clothing, equipment, and materials
contaminated with beryllium using
specified language. Finally, paragraph
(m)(4) details employers’ duties to
provide information and training to
employees.
In the 2018 NPRM, OSHA proposed
three revisions to paragraph (m) of the
beryllium standard for general industry
(83 FR at 63759–60, 63769). The first
change is related to paragraph (m)(3),
which previously required employers to
label ‘‘each bag and container’’ of
clothing, equipment, and materials
contaminated with beryllium. In the
2018 NPRM, OSHA proposed to replace
the phrase ‘‘each bag and container’’
with the phrase ‘‘each immediate
container,’’ to clarify that the employer
need only label the immediate bag or
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42623
container of beryllium-contaminated
items and not larger containers holding
the labeled bag or container. OSHA
proposed this change to be consistent
with the HCS, which requires only the
primary or immediate container to be
labeled (see 29 CFR 1910.1200(c))
(definition of ‘‘Label’’). OSHA explained
that this proposed change would
effectuate OSHA’s intent, expressed in
the 2017 final rule, that the hazard
communication requirements of the
beryllium standard ‘‘be substantively as
consistent as possible’’ with the HCS (82
FR at 2694, 2724). As such, OSHA
preliminarily determined that the
change would maintain safety and
health protections for workers.
Next, OSHA proposed two revisions
to paragraph (m)(4), which addresses
employee information and training.
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 and
understanding of certain specified
topics. One of the topics specified in the
previous standard was the health
hazards associated with ‘‘airborne
exposure to and contact with
beryllium,’’ including the signs and
symptoms of CBD (83 FR at 63759).
OSHA proposed to modify this language
by adding the word ‘‘dermal’’
immediately prior to ‘‘contact with
beryllium.’’ OSHA explained that the
change would clarify OSHA’s intent that
employers must ensure that exposed
employees can demonstrate knowledge
and understanding of the health hazards
caused by dermal contact with
beryllium.
OSHA also proposed to modify the
language in paragraph (m)(4)(ii)(E),
which required the employer to ensure
that each employee who is, or can
reasonably be expected to be, exposed to
airborne beryllium can demonstrate
knowledge and understanding of
measures employees can take to protect
themselves from ‘‘airborne exposure to
and contact with beryllium,’’ including
personal hygiene practices (83 FR at
63759). As with the previous revision,
OSHA proposed adding the word
‘‘dermal’’ to ‘‘contact with beryllium’’ to
clarify OSHA’s intent that employers
must ensure exposed employees can
demonstrate knowledge and
understanding of measures employees
can take to protect themselves from
dermal contact with beryllium.
Commenters did not object to any of
the changes that OSHA proposed to
paragraph (m). In fact, the only
stakeholder that offered any comments
on these revisions, Materion, generally
supported the proposed changes,
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commenting that the changes will
maintain safety and health protections
for employees (Document ID 0038, p.
34). OSHA agrees with this assessment
and finds that the proposed changes
will clarify employers’ requirements for
the communication of hazards of
beryllium. Therefore, OSHA is
finalizing the proposed changes to
paragraph (m) in this final rule.
Recordkeeping.
Paragraph (n) of the beryllium
standard for general industry requires
employers to make and maintain air
monitoring data, objective data, and
medical surveillance records, and
prepare and maintain training records.
The 2017 final rule required employers’
air monitoring data ((n)(1)(ii)(F)),
medical surveillance ((n)(3)(ii)(A)), and
training ((n)(4)(i)) records to include
employee Social Security Numbers
(SSNs). In the 2018 NPRM, OSHA
proposed to modify paragraph (n) to
remove that requirement. This final rule
adopts the proposed revisions,
eliminating the requirement to include
employee SSNs in these records.
The issue of whether to include
employee SSNs in records under
OSHA’s standards for beryllium dates
back to the 2015 beryllium NPRM. In
that NPRM, OSHA proposed to require
inclusion of employee SSNs in records
related to air monitoring, medical
surveillance, and training, similar to
provisions in previous substancespecific health standards. Some
stakeholders objected to the proposed
requirement based on employee privacy
and identity theft concerns (82 FR at
2730). OSHA recognized the validity of
these concerns, but preliminarily
concluded that due to the agency’s past
consistent practice of requiring an
employee’s SSN on records, any change
to this requirement should be
comprehensive and apply to all OSHA
standards, not just the standards for
beryllium (82 FR at 2730).
In 2016, in its Standards Improvement
Project-Phase IV (SIP–IV) proposed rule
(81 FR 68504, 68526–28 (October 4,
2016)), OSHA proposed to delete the
requirement that employers include
employee SSNs in records required by
the agency’s substance-specific
standards. The 2017 final rule for
beryllium included the SSN
requirements, but, in the preamble,
OSHA recognized that the SIP–IV
rulemaking was ongoing and stated that
it would revisit its decision to require
employers to include SSNs in beryllium
records in light of the SIP–IV
rulemaking, if appropriate (82 FR at
2730).
The SIP–IV rulemaking was still
ongoing when OSHA published the
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2018 NPRM. Consistent with the SIP–IV
proposal, OSHA proposed to modify the
beryllium standard for general industry
by removing the requirement to include
SSNs in the recordkeeping provisions in
paragraphs (n)(1)(ii)(F) (air monitoring
data), (n)(3)(ii)(A) (medical
surveillance), and (n)(4)(i) (training).
OSHA noted that these proposed
revisions would address the privacy
concerns raised in response to the 2015
NPRM, while maintaining safety and
health protection for workers.
Three commenters, Phylmar
Regulatory Roundtable, DOD, and
Materion, expressed general support for
the proposed changes to the
recordkeeping provisions (Document ID
0020, p. 1; 0029, p. 1; 0038, p. 34), and
no commenters expressed opposition to
OSHA’s proposal to remove the
requirement to include each employee’s
SSN in these three sets of records. After
reviewing these comments, OSHA is
finalizing the proposed deletion of the
SSN requirements in this final rule. This
change is also consistent with the
agency’s decision in the SIP–IV
rulemaking, which was finalized in the
months since the publication of the
2018 NPRM (84 FR 21416 (May 14,
2019)). The SIP–IV final rule deletes the
requirement to include employee SSNs
in records employers must maintain
under the substance-specific standards
that existed at the time of OSHA’s 2016
SIP–IV proposal (see 84 FR at 21439–
40).23 The deletion of the SSN
requirements in the beryllium general
industry standard will, thus, bring this
standard into line with the majority of
OSHA’s other substance-specific
standards.
OSHA received one other comment
related to SSNs in this rulemaking. A
private citizen agreed that the proposed
changes were ‘‘necessary and
appropriate,’’ but expressed concerns
that there is no additional requirement
to remove SSNs from existing records
and that allowing employers the option
to continue using SSNs will not
effectively protect employee privacy
(Document ID 0017). OSHA understands
the private citizen’s concerns. The SIP–
IV NPRM did not propose to require
employers to remove employee SSNs
from existing records or to prohibit
employers from using employee SSNs in
their records. The agency did, however,
request comment on whether employers
should be required to use an alternative
identification system rather than SSNs,
23 The beryllium standard for general industry,
which was not published until 2017, was not listed
in the SIP–IV NPRM and, therefore, the SIP–IV final
rule did not affect the 2017 final rule’s requirement
to include employee SSNs in records.
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or to remove SSNs from existing records
(81 FR at 68528).
As discussed in the preamble to the
SIP–IV final rule, the comments that
OSHA received in response to the SIP–
IV NPRM advocated against requiring
employers to use an alternative type of
employee identifier or to remove SSNs
from existing records (84 FR at 21440).
For example, the Construction Industry
Safety Coalition (CISC) supported
OSHA’s statements in the SIP–IV NPRM
that employers would not be required to
delete employee SSNs from existing
records, would not be required to use an
alternative employee identifier on
existing records, and would still be
permitted to use SSNs if they wish to do
so. CISC stated that limiting employers’
flexibility to come up with an
identification system that works best for
their situations would create an undue
compliance burden (84 FR at 21440).
After considering the comments, OSHA
decided in the SIP–IV final rule to
proceed with removing the SSN
collection requirements from previously
published standards, but not to require
employers to delete employee SSNs
from existing records or to use an
alternative employee identifier.
In order to maintain consistency
among OSHA recordkeeping
requirements for substance-specific
standards, the agency has decided not to
require employers to delete employee
SSNs from existing records relating to
beryllium or to use an alternative
employee identifier. The final rule
allows employers the option to still use
SSNs or to use some other alternative
employee identifier system, as
explained in the SIP–IV final rule. This
will give employers the flexibility to
choose the best option for their
particular circumstance and will avoid
unnecessarily increasing employers’
compliance burdens.
Additional Comments.
The scope of the 2018 proposal was
limited to the specific revisions and
clarifications to the beryllium standard
identified in the NPRM. The NPRM did
not invite comment on all of the
agency’s underlying determinations
from the 2017 beryllium final rule. As
such, OSHA determined that some
comments the agency received in
response the 2018 NPRM pertained to
subjects outside the scope of the
proposal. OSHA briefly addresses these
comments below.
Two commenters addressed issues
related to OSHA’s significant risk
finding from the 2017 final rule. One
commenter focused on the risk of health
effects related to beryllium exposure in
the aluminum smelting industry and the
methodologies underlying OSHA’s risk
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assessment of occupational exposure to
beryllium (Document ID 0026,
Attachment 2, pp. 9–16). Another took
issue with OSHA’s risk determination
pertaining to dermal contact with
beryllium and argued that the current
standard did not distinguish between
the chemical forms of beryllium and its
varying risk of injury from dermal
contact (Document ID 0038, pp. 13–15).
OSHA addressed these concerns about
risk in the 2017 final rule and
determined that the beryllium standard
addresses a significant risk (see 82 FR at
2545–52). The changes and
clarifications proposed by the 2018
NPRM do not affect that determination.
Another commenter took issue with
the revised PEL for beryllium set in the
2017 final rule, suggesting that a lower
PEL was needed to protect workers from
CBD and lung cancer (Document ID
0028, p. 1). Although OSHA determined
in the 2017 final rule that there remains
a significant risk of material impairment
of health at the 0.2 mg/m3 PEL and the
2.0 ug/m3 STEL, the agency further
determined that it could not
demonstrate that a lower PEL would be
technologically feasible (82 FR at 2552).
Again, OSHA did not propose to revisit
this finding in this rulemaking.
List of Subjects for 29 CFR Part 1910
Beryllium, General industry, Health,
Occupational safety and health.
Authority
Loren Sweatt, Principal Deputy
Assistant Secretary of Labor for
Occupational Safety and Health, U.S.
Department of Labor, directed the
preparation of this document. The
agency issues the sections under the
following authorities: 29 U.S.C. 653,
655, 657; Secretary of Labor’s Order 1–
2012 (77 FR 3912); 29 CFR part 1911;
and 5 U.S.C. 553, as applicable.
Signed at Washington, DC, on May 13,
2020.
Loren Sweatt,
Principal Deputy Assistant Secretary of Labor
for Occupational Safety and Health.
Amendments to Standards
For the reasons set forth in the
preamble, chapter XVII of title 29, part
1910 is amended to read as follows:
PART 1910—OCCUPATIONAL SAFETY
AND HEALTH STANDARDS
1. The authority section for part 1910,
subpart Z, continues to read as follows:
■
Authority: 29 U.S.C. 653, 655, 657;
Secretary of Labor’s Order No. 12–71 (36 FR
8754), 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),
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5–2007 (72 FR 31160), 4–2010 (75 FR 55355),
or 1–2012 (77 FR 3912); and 29 CFR part
1911.
All of subpart Z issued under 29 U.S.C.
655(b), except those substances that have
exposure limits listed in Tables Z–1, Z–2,
and Z–3 of § 1910.1000. The latter were
issued under 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 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 Public
Law 106–430, 114 Stat. 1901.
Section 1910.1201 also issued under 49
U.S.C. 1801–1819 and 5 U.S.C. 553.
2. Amend § 1910.1024 by:
A. Revising the definitions for
‘‘Beryllium sensitization,’’ ‘‘Beryllium
work area,’’ ‘‘CBD diagnostic center,’’
‘‘Chronic beryllium disease (CBD),’’ and
‘‘Dermal contact with beryllium’’.
■ B. Revise paragraphs (f)(1)(i)(D),
(f)(ii)(B), (h)(2)(i), (h)(3)(iii), (i)(1)
introductory text, (i)(2), (i)(4)(ii), (j)(3),
(k)(2)(i)(B), (k)(2)(iii) and (iv), (k)(7)(i)
introductory text, (k)(7)(ii) through (vi),
(l)(1)(i)(B), (l)(1)(ii), (m)(3), (m)(4)(ii)(A),
(m)(4)(ii)(E), (n)(1)(ii)(F), (n)(3)(ii)(A),
(n)(4)(i), and Appendix A.
The revisions read as follows:
■
■
§ 1910.1024
Beryllium.
*
*
*
*
*
(b) * * *
Beryllium sensitization means a
response in the immune system of a
specific individual who has been
exposed to beryllium. There are no
associated physical or clinical
symptoms and no illness or disability
with beryllium sensitization alone, but
the response that occurs through
beryllium sensitization can enable the
immune system to recognize and react
to beryllium. While not every berylliumsensitized person will develop chronic
beryllium disease (CBD), beryllium
sensitization is essential for
development of CBD.
Beryllium work area means any work
area where materials that contain at
least 0.1 percent beryllium by weight
are processed either:
(1) During any of the operations listed
in Appendix A of this standard; or
(2) Where employees are, or can
reasonably be expected to be, exposed to
airborne beryllium at or above the
action level.
CBD diagnostic center means a
medical diagnostic center that has a
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42625
pulmonologist or pulmonary specialist
on staff and on-site facilities to perform
a clinical evaluation for the presence of
chronic beryllium disease (CBD). The
CBD diagnostic center must have the
capacity to perform pulmonary function
testing (as outlined by the American
Thoracic Society criteria),
bronchoalveolar lavage (BAL), and
transbronchial biopsy. The CBD
diagnostic center must also have the
capacity to transfer BAL samples to a
laboratory for appropriate diagnostic
testing within 24 hours. The
pulmonologist or pulmonary specialist
must be able to interpret the biopsy
pathology and the BAL diagnostic test
results.
Chronic beryllium disease (CBD)
means a chronic granulomatous lung
disease caused by inhalation of airborne
beryllium by an individual who is
beryllium sensitized.
Confirmed positive means the person
tested has had two abnormal BeLPT test
results, an abnormal and a borderline
test result, or three borderline test
results, obtained from tests conducted
within a three-year period. It also means
the result of a more reliable and
accurate test indicating a person has
been identified as having beryllium
sensitization.
*
*
*
*
*
Dermal contact with beryllium means
skin exposure to:
(1) Soluble beryllium compounds
containing beryllium in concentrations
greater than or equal to 0.1 percent by
weight;
(2) Solutions containing beryllium in
concentrations greater than or equal to
0.1 percent by weight; or
(3) Visible dust, fumes, or mists
containing beryllium in concentrations
greater than or equal to 0.1 percent by
weight. The handling of beryllium
materials in non-particulate solid form
that are free from visible dust containing
beryllium in concentrations greater than
or equal to 0.1 percent by weight is not
considered dermal contact under the
standard.
*
*
*
*
*
(f) * * *
(1) * * *
(i) * * *
(D) Procedures for minimizing crosscontamination, including the transfer of
beryllium between surfaces, equipment,
clothing, materials, and articles within
beryllium work areas;
*
*
*
*
*
(ii) * * *
(B) The employer is notified that an
employee is eligible for medical removal
in accordance with paragraph (l)(1) of
this standard, referred for evaluation at
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a CBD diagnostic center, or shows signs
or symptoms associated with exposure
to beryllium; or
*
*
*
*
*
(h) * * *
(2) * * *
(i) The employer must ensure that
each employee removes all berylliumcontaminated personal protective
clothing and equipment at the end of
the work shift, at the completion of all
tasks involving beryllium, or when
personal protective clothing or
equipment becomes visibly
contaminated with beryllium,
whichever comes first.
*
*
*
*
*
(3) * * *
(iii) The employer must inform in
writing the persons or the business
entities who launder, clean, or repair
the personal protective clothing or
equipment required by this standard of
the potentially harmful effects of
exposure to beryllium and that the
personal protective clothing and
equipment must be handled in
accordance with this standard.
*
*
*
*
*
(i) * * *
(1) General. For each employee
working in a beryllium work area or
who can reasonably be expected to have
dermal contact with beryllium, the
employer must:
*
*
*
*
*
(2) Change rooms. In addition to the
requirements of paragraph (i)(1)(i) of
this standard, the employer must
provide employees who are required to
use personal protective clothing or
equipment under paragraph (h)(1)(ii) of
this standard with a designated change
room in accordance with this standard
and the Sanitation standard (§ 1910.141)
where employees are required to remove
their personal clothing.
*
*
*
*
*
(4) * * *
(ii) No employees enter any eating or
drinking area with berylliumcontaminated personal protective
clothing or equipment unless, prior to
entry, it is cleaned, as necessary, to be
as free as practicable of beryllium by
methods that do not disperse beryllium
into the air or onto an employee’s body;
and
*
*
*
*
*
(j) * * *
(3) Disposal, recycling, and reuse. (i)
Except for intra-plant transfers, when
the employer transfers materials that
contain at least 0.1 percent beryllium by
weight or are contaminated with
beryllium for disposal, recycling, or
reuse, the employer must label the
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materials in accordance with paragraph
(m)(3) of this standard;
(ii) Except for intra-plant transfers,
materials designated for disposal that
contain at least 0.1 percent beryllium by
weight or are contaminated with
beryllium must be cleaned to be as free
as practicable of beryllium or placed in
enclosures that prevent the release of
beryllium-containing particulate or
solutions under normal conditions of
use, storage, or transport, such as bags
or containers; and
(iii) Except for intra-plant transfers,
materials designated for recycling or
reuse that contain at least 0.1 percent
beryllium by weight or are
contaminated with beryllium must be
cleaned to be as free as practicable of
beryllium or placed in enclosures that
prevent the release of berylliumcontaining particulate or solutions
under normal conditions of use, storage,
or transport, such as bags or containers.
*
*
*
*
*
(k) * * *
(2) * * *
(i) * * *
(B) An employee meets the criteria of
paragraph (k)(1)(i)(B) of this standard.
*
*
*
*
*
(iii) At the termination of employment
for each employee who meets any of the
criteria of paragraph (k)(1)(i) of this
standard at the time the employee’s
employment terminates, unless an
examination has been provided in
accordance with this standard during
the six months prior to the date of
termination. Each employee who meets
the criteria of paragraph (k)(1)(i)(C) of
this standard and who has not received
an examination since exposure to
beryllium during the emergency must be
provided an examination at the time the
employee’s employment terminates.
(iv) For an employee who meets the
criteria of paragraph (k)(1)(i)(C) of this
standard:
(A) If that employee has not received
a medical examination within the
previous two years pursuant to
paragraph (k)(1)(i) of this standard, then
within 30 days after the employee meets
the criteria of paragraph (k)(1)(i)(C) of
this standard; or
(B) If that employee has received a
medical examination within the
previous two years pursuant to
paragraph (k)(1)(i) of this standard, then
at least one year but no more than two
years after the employee meets the
criteria of paragraph (k)(1)(i)(C) of this
standard.
*
*
*
*
*
(7) * * *
(i) The employer must provide an
evaluation at no cost to the employee at
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a CBD diagnostic center that is mutually
agreed upon by the employer and the
employee. The evaluation at the CBD
diagnostic center must be scheduled
within 30 days, and must occur within
a reasonable time, of:
*
*
*
*
*
(ii) The employer must ensure that, as
part of the evaluation, the employee is
offered any tests deemed appropriate by
the examining physician at the CBD
diagnostic center, such as pulmonary
function testing (as outlined by the
American Thoracic Society criteria),
bronchoalveolar lavage (BAL), and
transbronchial biopsy. If any of the tests
deemed appropriate by the examining
physician are not available at the CBD
diagnostic center, they may be
performed at another location that is
mutually agreed upon by the employer
and the employee.
(iii) The employer must ensure that
the employee receives a written medical
report from the CBD diagnostic center
that contains all the information
required in paragraph (k)(5)(i), (ii), (iv),
and (v) of this standard and that the
PLHCP explains the results of the
examination to the employee within 30
days of the examination.
(iv) The employer must obtain a
written medical opinion from the CBD
diagnostic center within 30 days of the
medical examination. The written
medical opinion must contain only the
information in paragraph (k)(6)(i), as
applicable, unless the employee
provides written authorization to release
additional information. If the employee
provides written authorization, the
written opinion must also contain the
information from paragraphs (k)(6)(ii),
(iv), and (v), if applicable.
(v) The employer must ensure that
each employee receives a copy of the
written medical opinion from the CBD
diagnostic center described in paragraph
(k)(7) of this standard within 30 days of
any medical examination performed for
that employee.
(vi) After an employee has received
the initial clinical evaluation at a CBD
diagnostic center described in
paragraphs (k)(7)(i) and (ii) of this
standard, the employee may choose to
have any subsequent medical
examinations for which the employee is
eligible under paragraph (k) of this
standard performed at a CBD diagnostic
center mutually agreed upon by the
employer and the employee, and the
employer must provide such
examinations at no cost to the
employee.
*
*
*
*
*
(l) * * *
(1) * * *
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(i) * * *
(B) A written medical report
recommending removal from airborne
exposure to beryllium in accordance
with paragraph (k)(5)(v) or (k)(7)(iii) of
this standard; or
(ii) The employer receives a written
medical opinion recommending
removal from airborne exposure to
beryllium in accordance with paragraph
(k)(6)(v) or (k)(7)(iv) of this standard.
*
*
*
*
*
(m) * * *
(3) Warning labels. Consistent with
the HCS (§ 1910.1200), the employer
must label each immediate container of
clothing, equipment, and materials
contaminated with beryllium, and must,
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) * * *
(ii) * * *
(A) The health hazards associated
with airborne exposure to and dermal
contact with beryllium, including the
signs and symptoms of CBD;
*
*
*
*
*
(E) Measures employees can take to
protect themselves from airborne
exposure to and dermal contact with
beryllium, including personal hygiene
practices;
*
*
*
*
*
(n) * * *
(1) * * *
(ii) * * *
(F) The name and job classification of
each employee represented by the
monitoring, indicating which employees
were actually monitored.
*
*
*
*
*
(3) * * *
(ii) * * *
(A) Name and job classification;
*
*
*
*
*
(4) * * *
(i) At the completion of any training
required by this standard, the employer
must prepare a record that indicates the
name and job classification of each
42627
employee trained, the date the training
was completed, and the topic of the
training.
*
*
*
*
*
(p) Appendix. Table A.1 in this
appendix sets forth the operations that,
where performed under the
circumstances described in the column
heading above the particular operations,
trigger the requirement for a beryllium
work area.
Appendix A to § 1910.1024—
Operations for Establishing Beryllium
Work Areas
Paragraph (b) of this standard defines a
beryllium work area as any work area where
materials that contain at least 0.1 percent
beryllium by weight are processed (1) during
any of the operations listed in Appendix A
of this standard, or (2) where employees are,
or can reasonably be expected to be, exposed
to airborne beryllium at or above the action
level. Table A.1 in this appendix sets forth
the operations that, where performed under
the circumstances described in the column
heading above the particular operations,
trigger the requirement for a beryllium work
area.
TABLE A.1—OPERATIONS FOR ESTABLISHING BERYLLIUM WORK AREAS WHERE PROCESSING MATERIALS CONTAINING AT
LEAST 0.1 PERCENT BERYLLIUM BY WEIGHT
Beryllium metal alloy operations
(generally <10% beryllium by weight)
Abrasive Blasting.
Abrasive Processing.
Abrasive Sawing.
Annealing.
Bright Cleaning.
Brushing.
Buffing.
Burnishing.
Casting.
Centerless Grinding.
Chemical Cleaning.
Chemical Etching.
Chemical Milling.
Dross Handling.
Deburring (grinding).
Electrical Chemical Machining (ECM).
Electrical Discharge Machining (EDM).
Extrusion.
Forging.
Grinding.
Heat Treating (in air).
High Speed Machining (>10,000 rpm).
Hot Rolling.
Lapping.
Laser Cutting.
Laser Machining.
Laser Scribing.
Laser Marking.
Melting.
Photo-Etching.
Pickling.
Point and Chamfer.
Polishing.
Torch Cutting (i.e., oxy-acetylene).
Tumbling.
Water-jet Cutting.
Welding.
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Beryllium composite operations
(generally >10% beryllium by weight) and
beryllium metal operations
Abrasive Blasting.
Abrasive Processing.
Abrasive Sawing.
Annealing.
Atomizing.
Attritioning.
Blanking.
Bonding.
Boring.
Breaking.
Bright Cleaning.
Broaching.
Brushing.
Buffing.
Burnishing.
Casting.
Centerless Grinding.
Chemical Cleaning.
Chemical Etching
Chemical Milling.
CNC Machining
Cold Isostatic Pressing.
Cold Pilger.
Crushing.
Cutting.
Deburring.
Dicing.
Drawing.
Drilling.
Dross Handling.
Electrical Chemical Machining (ECM).
Electrical Discharge Machining (EDM).
Extrusion.
Filing by Hand.
Forging.
Grinding.
Heading.
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Beryllium oxide operations
Abrasive Blasting.
Abrasive Processing.
Abrasive Sawing.
Boring.
Brazing (>1,100 °C).
Broaching with green ceramic.
Brushing.
Buffing.
Centerless grinding.
Chemical Cleaning.
Chemical Etching.
CNC Machining.
Cold Isostatic Pressing (CIP).
Crushing.
Cutting.
Deburring (grinding).
Deburring (non-grinding).
Destructive Testing.
Dicing.
Drilling.
Dry/wet Tumbling.
Extrusion.
Filing by Hand.
Firing of Green Ceramic.
Firing of Refractory Metallization (>1,100 °C).
Grinding.
Honing.
Hot Isostatic Pressing (HIP).
Lapping.
Laser Cutting.
Laser Machining.
Laser Scribing.
Laser Marking.
Machining.
Milling.
Piercing.
Mixing.
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TABLE A.1—OPERATIONS FOR ESTABLISHING BERYLLIUM WORK AREAS WHERE PROCESSING MATERIALS CONTAINING AT
LEAST 0.1 PERCENT BERYLLIUM BY WEIGHT—Continued
Beryllium metal alloy operations
(generally <10% beryllium by weight)
Sanding.
Slab Milling.
Beryllium composite operations
(generally >10% beryllium by weight) and
beryllium metal operations
Heat Treating.
Honing.
Hot Isostatic Pressing (HIP).
Lapping.
Laser Cutting.
Laser Machining.
Laser Scribing.
Laser Marking.
Machining.
Melting.
Milling.
Mixing.
Photo-Etching.
Pickling.
Piercing.
Pilger.
Plasma Spray.
Point and Chamfer.
Polishing.
Powder Handling.
Powder Pressing.
Pressing.
Reaming.
Roll Bonding.
Rolling.
Sanding.
Sawing (tooth blade).
Shearing.
Sizing.
Skiving.
Slitting.
Snapping.
Sputtering.
Stamping.
Spray Drying.
Tapping.
Tensile Testing.
Torch Cutting (i.e., oxy acetylene).
Trepanning.
Tumbling
Turning.
Vapor Deposition.
Water-Jet Cutting.
Welding.
Beryllium oxide operations
Plasma Spray.
Polishing.
Powder Handling.
Powder Pressing.
Reaming.
Sanding.
Sectioning.
Shearing.
Sintering of Green Ceramic.
Sintering of Refractory Metallization (>1,100 °C).
Snapping.
Spray Drying.
Tape Casting.
Turning.
Water Jet Cutting.
[FR Doc. 2020–10678 Filed 7–13–20; 8:45 am]
BILLING CODE P
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Agencies
[Federal Register Volume 85, Number 135 (Tuesday, July 14, 2020)]
[Rules and Regulations]
[Pages 42582-42628]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10678]
[[Page 42581]]
Vol. 85
Tuesday,
No. 135
July 14, 2020
Part III
Department of Labor
-----------------------------------------------------------------------
Occupational Safety and Health Administration
-----------------------------------------------------------------------
29 CFR Part 1910
Revising the Beryllium Standard for General Industry; Final Rule
Federal Register / Vol. 85, No. 135 / Tuesday, July 14, 2020 / Rules
and Regulations
[[Page 42582]]
-----------------------------------------------------------------------
DEPARTMENT OF LABOR
Occupational Safety and Health Administration
29 CFR Part 1910
[Docket No. OSHA-2018-0003]
RIN 1218-AD20
Revising the Beryllium Standard for General Industry
AGENCY: Occupational Safety and Health Administration (OSHA), Labor.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: OSHA is amending its existing general industry standard for
occupational exposure to beryllium and beryllium compounds to clarify
certain provisions and simplify or improve compliance. The revisions in
this final rule are designed to maintain or enhance worker protections
overall by ensuring that the rule is well understood and compliance is
more straightforward.
DATES: This final rule becomes effective on September 14, 2020.
ADDRESSES: In accordance with 28 U.S.C. 2112(a)(2), OSHA designates
Edmund C. Baird, Associate Solicitor of Labor for Occupational Safety
and Health, to receive petitions for review of the final rule. Contact
the Associate Solicitor at the Office of the Solicitor, Room S-4004,
U.S. Department of Labor, 200 Constitution Avenue NW, Washington, DC
20210; telephone: (202) 693-5445.
FOR FURTHER INFORMATION CONTACT:
Press inquiries: Mr. Frank Meilinger, OSHA Office of
Communications, Occupational Safety and Health Administration;
telephone: (202) 693-1999; email: [email protected].
General information and technical inquiries: Ms. Maureen Ruskin,
Directorate of Standards and Guidance, Occupational Safety and Health
Administration; telephone: (202) 693-1950; email:
[email protected].
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Executive Summary
II. Events Leading to the Final Rule
III. Legal Considerations
IV. Final Economic Analysis and Regulatory Flexibility Act
Certification (FEA)
V. Office of Management and Budget (OMB) Review Under the Paperwork
Reduction Act of 1995
VI. Federalism
VII. State Plans
VIII. Unfunded Mandates Reform Act
IX. Consultation and Coordination With Indian Tribal Governments
X. Environmental Impacts
XI. Summary and Explanation of the Final Rule
List of Subjects for 29 CFR Part 1910
Authority
Citation Method
In the docket for this rulemaking found at https://www.regulations.gov, every submission was assigned a document
identification (ID) number that consists of the docket number (OSHA-
2018-0003) followed by an additional four-digit number. For example,
the document ID number for the proposed rule is OSHA-2018-0003-0016.
Some document ID numbers include one or more attachments (see, e.g.,
Document ID OSHA-2018-0003-0026).
When citing exhibits in the OSHA-2018-0003 docket in this preamble,
OSHA includes the term ``Document ID'' followed by the last four digits
of the document number; the attachment number or other attachment
identifier, if necessary for clarity; and page numbers (designated
``p.'' or ``pp.''). In a citation that contains two or more document ID
numbers, the document ID numbers are separated by semi-colons. For
example, a citation referring to National Jewish Health's comments and
the first attachment to Materion Brush, Inc.'s comments would be
indicated as follows: (Document ID 0022, pp. X-X; 0038-A1, p. X).
Occasionally this preamble refers to documents located in the
rulemaking dockets that were used for previous beryllium rulemaking
activities, including the 2017 final rule. When citing exhibits in
other dockets, OSHA includes the term ``Document ID'' followed by the
full document number. For example, this preamble cites a publication by
Armstrong et al. (2014), titled ``Migration of beryllium via multiple
exposure pathways among work processes in four different facilities,''
designated Document ID OSHA-H005C-2006-0870-0502.
The exhibits in the docket (and the other beryllium-rulemaking
dockets cited in this preamble), including public comments, supporting
materials, meeting transcripts, and other documents, are listed on
https://www.regulations.gov. All exhibits are listed in the docket index
on https://www.regulations.gov, but some exhibits (e.g., copyrighted
material) are not available to read or download from that website. All
materials in the docket are available for inspection at the OSHA Docket
Office, Room N-3508, U.S. Department of Labor, 200 Constitution Avenue
NW, Washington, DC 20210; telephone (202) 693-2350.
I. Executive Summary
On January 9, 2017, OSHA published a final rule on Occupational
Exposure to Beryllium and Beryllium Compounds (82 FR 2470). This rule
created health standards for beryllium exposure in the general industry
(29 CFR 1910.1024), construction (29 CFR 1926.1124), and shipyards (29
CFR 1915.1024) sectors. On December 11, 2018, OSHA published a Notice
of Proposed Rulemaking (NPRM) in which the agency proposed various
amendments to the beryllium standard for general industry (83 FR
63746). With the proposed revisions, OSHA sought to clarify certain
provisions and simplify or improve compliance with the beryllium
standard for general industry. In this final rule, OSHA is finalizing
the majority of the changes proposed in the NPRM, with some revisions
intended to address concerns raised by stakeholders during the comment
period. OSHA believes that these changes to the standard will maintain
safety and health protections for workers and will further enhance
worker protections by ensuring that the standard is well-understood.
The changes to the final standard for general industry are fully
discussed in Section XI, Summary and Explanation of the Final Rule.
Broadly, OSHA proposed to add one definition and modify five existing
terms in paragraph (b), Definitions; to amend paragraph (f), Methods of
compliance; paragraph (h), Personal protective clothing and equipment;
paragraph (i), Hygiene areas and practices; paragraph (j),
Housekeeping; paragraph (k), Medical surveillance; paragraph (m),
Communication of hazards; and paragraph (n), Recordkeeping; and to
replace the 2017 final standard's Appendix A with a new appendix
designed to supplement the proposed definition of beryllium work area.
OSHA is finalizing these provisions as proposed, with the following
exceptions. First, OSHA is revising the definition of confirmed
positive to state that the findings of two abnormal, one abnormal and
one borderline, or three borderline results need to occur from
beryllium lymphocyte proliferation tests (BeLPTs) conducted within a
three-year period. This differs from the definition proposed in the
2018 NPRM, which would have required that any combination of test
results specified in the definition must be obtained within the 30-day
follow-up test period required after a first abnormal or borderline
BeLPT test result. Second, OSHA is modifying the proposed paragraph
(j)(3), which requires employers to take certain actions when
[[Page 42583]]
transferring materials that contain at least 0.1 percent beryllium by
weight or that are contaminated with beryllium outside a plant for the
purpose of disposal, recycling, or reuse, to clarify that only
transfers outside of a plant, including between facilities owned by the
same employer, are subject to the labeling requirements of paragraph
(m)(3).
Third, in paragraphs (k)(2)(iii) and (iv), OSHA is modifying the
proposed provisions pertaining to an employer's obligation to offer a
medical examination after an employee is exposed to beryllium in an
emergency. Fourth, OSHA is amending proposed paragraph (k)(7)(i) to
require that an examination at a chronic beryllium disease (CBD)
diagnostic center be scheduled within 30 days of the employer receiving
certain types of documentation, listed in paragraph (k)(7)(i)(A) and
(B), that trigger evaluation for CBD. OSHA is further revising proposed
paragraph (k)(7) by adding a new provision, paragraph (k)(7)(ii), which
clarifies that, as part of the evaluation at the CBD diagnostic center,
the employer must ensure that the employee is offered any tests deemed
appropriate by the examining physician at the CBD diagnostic center and
to state that if any tests deemed appropriate by the physician are not
available at the CBD diagnostic center, they may be performed at
another location that is mutually agreed upon by the employer and the
employee. For a full explanation of comments received and OSHA's
reasoning for these revisions, see Section XI, Summary and Explanation
of the Final Rule.
OSHA's examination of the technological and economic feasibility of
this final rule is presented in the Final Economic Analysis and
Regulatory Flexibility Analysis (FEA), in Section IV of this preamble.
As explained there, OSHA finds that none of the revisions would impose
any new employer obligations or increase the overall cost of
compliance, while some of the revisions in this final rule will clarify
and simplify compliance in such a way that results in cost savings.
OSHA also finds that none of the revisions would require any new
controls or other technology. OSHA therefore concludes that the final
rule is both economically and technologically feasible.
Further, this final rule is considered to be an Executive Order
(E.O.) 13771 deregulatory action. Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), the Office of Information and Regulatory
Affairs designated this rule not a ``major rule,'' as defined by 5
U.S.C. 804(2).
II. Events Leading to the Final Rule
On January 9, 2017, OSHA published the final rule Occupational
Exposure to Beryllium and Beryllium Compounds (2017 final rule) in the
Federal Register (82 FR 2470).\1\ Therein, OSHA concluded that
employees exposed to beryllium and beryllium compounds at the preceding
permissible exposure limits (PELs) were at significant risk of material
impairment of health, specifically chronic beryllium disease (CBD) and
lung cancer. The agency further determined that limiting employee
exposure to an 8-hour time-weighted average (TWA) PEL of 0.2 [micro]g/
m\3\ would reduce this significant risk to the maximum extent feasible.
Therefore, the 2017 final rule adopted a TWA PEL of 0.2 [micro]g/m\3\.
In addition to the revised PEL, the 2017 final rule established a new
short-term exposure limit (STEL) of 2.0 [micro]g/m\3\ over a 15-minute
sampling period and an action level of 0.1 [micro]g/m\3\ as an 8-hour
TWA, along with a number of ancillary provisions intended to provide
additional protections to employees. The ancillary provisions included
requirements for exposure assessment, methods for controlling exposure,
respiratory protection, personal protective clothing and equipment,
housekeeping, medical surveillance, hazard communication, and
recordkeeping that are similar to those found in other OSHA health
standards.
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\1\ In the 2017 final rule, OSHA issued three separate beryllium
standards--general industry, shipyards, and construction. This final
rule amends only the general industry standard. Therefore, neither
this Events Leading to the Final Rule section nor the remainder of
the preamble will include information about the other two standards.
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The 2017 final rule went into effect on May 20, 2017, and OSHA
began enforcing the PEL and the general industry standard's provisions
for exposure assessment, respiratory protection, medical surveillance,
and medical removal on May 11, 2018. See Updated Interim Enforcement
Guidance for the Beryllium Standards, available at https://www.osha.gov/laws-regs/standardinterpretations/2018-12-11. The majority
of the general industry standard's other provisions became enforceable
on December 12, 2018, with compliance obligations for showers and
change rooms following on March 11, 2019 (83 FR 39351). OSHA began
enforcing the general industry requirements for engineering controls on
March 10, 2020.
In response to concerns raised by stakeholders following the
publication of the 2017 final rule, OSHA published a direct final rule
(DFR) in the Federal Register on May 7, 2018 (83 FR 19936), amending
the text of the beryllium standard for general industry to clarify
OSHA's intent with respect to certain terms in the standard, including
the definition of beryllium work area (BWA), the definition of
emergency, and the meaning of the terms dermal contact and beryllium
contamination (see 83 FR at 19938). The DFR also clarified OSHA's
intent with respect to provisions for disposal and recycling and with
respect to provisions that the agency intended to apply only where skin
can be exposed to materials containing at least 0.1% beryllium by
weight (83 FR at 19938). Because the agency did not receive any
significant adverse comments, OSHA published a Federal Register notice
confirming the effective date of the DFR as July 6, 2018, and
withdrawing the companion NPRM (83 FR 31045 (July 3, 2018)).
On December 11, 2018, OSHA published an NPRM in the Federal
Register (83 FR 63746) in which the agency proposed to further amend
the beryllium standard for general industry.\2\ The proposal sought to
clarify certain provisions-with proposed changes designed to facilitate
application of the standard consistent with the intent of the 2017
final rule-and to simplify or improve compliance, preventing costs that
may flow from misinterpretation or misapplication of the standard. OSHA
requested public comment on the proposed changes and provided
stakeholders 60 days to submit comments. OSHA received 22 comments
before the comment period closed on February 11, 2019.
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\2\ OSHA stated in the NPRM that the agency believed that the
standard as modified by the proposal would provide equivalent
protection to the existing standard; and OSHA would therefore accept
compliance with the standard, as modified by the proposal, as
compliance with the standard while the rulemaking was pending.
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III. Legal Considerations
The purpose of the Occupational Safety and Health Act of 1970
(``the OSH Act'' or ``the Act''), 29 U.S.C. 651 et seq., 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 occupational safety and
health standards pursuant to notice and comment rulemaking. See 29
U.S.C. 655(b). An occupational safety or health standard is a standard
which requires conditions, or the adoption or use of one or more
practices, means, methods, operations, or processes, reasonably
necessary or appropriate to provide safe
[[Page 42584]]
or healthful employment and places of employment. 29 U.S.C. 652(8).
The Act also authorizes the Secretary to ``modify'' or ``revoke''
any occupational safety or health standard, 29 U.S.C. 655(b), and under
the Administrative Procedure Act, regulatory agencies generally may
revise their rules if the changes are supported by a reasoned analysis,
see Motor Vehicle Mfrs. Ass'n v. State Farm Mut. Auto. Ins. Co., 463
U.S. 29, 42 (1983). ``While the removal of a regulation may not entail
the monetary expenditures and other costs of enacting a new standard,
and accordingly, it may be easier for an agency to justify a
deregulatory action, the direction in which an agency chooses to move
does not alter the standard of judicial review established by law.''
Id.
The Act provides that in promulgating health standards dealing with
toxic materials or harmful physical agents, such as the January 9,
2017, final rule regulating occupational exposure to beryllium, the
Secretary must set the standard that most adequately assures, to the
extent feasible and 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).
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. See Indus. Union
Dep't, AFL-CIO v. Am. Petroleum Inst. (``Benzene''), 448 U.S. 607, 641-
42 (1980) (plurality opinion). OSHA need not make additional findings
on risk for this revised rule because OSHA previously determined that
the beryllium standard addresses a significant risk that can be
eliminated or lessened by a change in practices, see 82 FR 2545-52, and
the changes and clarifications in this final rule do not affect that
determination. See, e.g., Pub. Citizen Health Research Grp. v. Tyson,
796 F.2d 1479, 1502 n.16 (D.C. Cir. 1986) (rejecting the argument that
OSHA must ``find that each and every aspect of its standard eliminates
a significant risk'').
OSHA standards must also be both technologically and economically
feasible. See United Steelworkers of Am., AFL-CIO-CLC v. Marshall
(``Lead I''), 647 F.2d 1189, 1264 (D.C. Cir. 1980). The Supreme Court
has defined feasibility as ``capable of being done.'' Am. Textile Mfrs.
Inst. v. Donovan (``Cotton Dust''), 452 U.S. 490, 508-09 (1981). 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 [standard] in most of its operations.'' Lead I, 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 (internal
quotation marks and citations omitted).
OSHA exercises significant discretion in carrying out its
responsibilities under the Act. Indeed, ``[a] number of terms of the
statute give OSHA almost unlimited discretion to devise means to
achieve the congressionally mandated goal'' of ensuring worker safety
and health. See Lead I, 647 F.2d at 1230 (citation omitted). Thus,
where OSHA has chosen some measures to address a significant risk over
other measures, parties challenging the OSHA standard must ``identify
evidence that their proposals would be feasible and generate more than
a de minimis benefit to worker health.'' N. Am.'s Bldg. Trades Unions
v. OSHA, 878 F.3d 271, 282 (D.C. Cir. 2017).
Although OSHA is required to set standards ``on the basis of the
best available evidence,'' 29 U.S.C. 655(b)(5), its determinations are
``conclusive'' if supported by ``substantial evidence in the record
considered as a whole,'' 29 U.S.C. 655(f). Similarly, as the Supreme
Court noted in Benzene, OSHA must look to ``a body of reputable
scientific thought'' in making determinations, but a reviewing court
must ``give OSHA some leeway where its findings must be made on the
frontiers of scientific knowledge.'' Benzene, 448 U.S. at 656. When
there is disputed scientific evidence in the record, OSHA must review
the evidence on both sides and ``reasonably resolve'' the dispute.
Tyson, 796 F.2d at 1500. The ``possibility of drawing two inconsistent
conclusions from the evidence does not prevent the agency's finding
from being supported by substantial evidence.'' N. Am.'s Bldg. Trades
Unions, 878 F.3d at 291 (quoting Cotton Dust, 452 U.S. at 523)
(alterations omitted). As the D.C. Circuit has noted, where ``OSHA has
the expertise we lack and it has exercised that expertise by carefully
reviewing the scientific data,'' a dispute within the scientific
community is not occasion for the reviewing court to take sides about
which view is correct. Tyson, 796 F.2d at 1500.
Finally, because section 6(b)(5) of the Act explicitly requires
OSHA to set health standards that eliminate risk ``to the extent
feasible,'' OSHA uses feasibility analysis rather than cost-benefit
analysis to make standards-setting decisions dealing with toxic
materials or harmful physical agents. 29 U.S.C. 655(b)(5). An OSHA
standard in this area must be technologically and economically
feasible-and also cost effective, which means that the protective
measures it requires are the least costly of the available alternatives
that achieve the same level of protection-but OSHA cannot choose an
alternative that provides a lower level of protection for workers'
health simply because it is less costly. See Int'l Union, UAW v. OSHA,
37 F.3d 665, 668 (D.C. Cir. 1994); see also Cotton Dust, 452 U.S. at
513 n.32. In Cotton Dust, the Court explained that Congress itself had
defined the appropriate relationship between costs and benefits by
prioritizing the ``benefit'' of worker health above all other
considerations, save those that would make this ``benefit''
unachievable. The Court further stated that any standard based on a
balancing of costs and benefits by the Secretary that strikes a
different balance than that struck by Congress would be inconsistent
with the command set forth in section 6(b)(5). See Cotton Dust, 452
U.S. at 509. Thus, while OSHA estimates the costs and benefits of its
proposed and final rules, in part to ensure compliance with
requirements such as those in Executive Orders 12866 and 13771, these
calculations do not form the basis for the agency's regulatory
decisions.
IV. Final Economic Analysis and Regulatory Flexibility Act
Certification (FEA)
A. Summary of Economic Impact
This rule amends OSHA's existing general industry standard for
occupational exposure to beryllium and beryllium compounds (29 CFR
1910.1024) to clarify certain provisions and simplify or improve
compliance. OSHA's final economic analysis shows that these changes
will result in unquantifiable cost savings, largely due to the
prevention of misinterpretation and misapplication of the standard.
In promulgating the 2017 final rule, OSHA determined that the
beryllium rule was both technologically and economically feasible. See
82 FR at 2582-86, 2590-96, Summary of the Final Economic Analysis. The
changes herein are intended to align the rule more clearly with the
intent of the 2017 final rule. Because OSHA has
[[Page 42585]]
determined that this final rule will decrease the costs of compliance
by preventing misinterpretation and misapplication of the standard, and
would require no new controls or other technology, OSHA has also
determined that the rule is both technologically and economically
feasible.
Because this final rule only clarifies the existing beryllium
standard or makes minor revisions that will generally aid in
compliance, the revised beryllium standard will maintain safety and
health protections for workers. And, to the extent this final rule
helps employers avoid misapplication of the beryllium standard's
requirements and hence achieves greater compliance with the standard's
intended meaning, there will be increased protection for workers.
B. Final Economic Analysis and Regulatory Flexibility Act Certification
Executive Orders 12866 and 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act (UMRA) (2 U.S.C.
1532(a)) require that OSHA estimate the benefits, costs, and net
benefits of regulations, and analyze the impacts of certain rules that
OSHA promulgates. Executive Order 13563 emphasizes the importance of
quantifying both costs and benefits, reducing costs, harmonizing rules,
and promoting flexibility.
This final rule is not a ``significant regulatory action'' under
Executive Order 12866 or the UMRA. Neither the benefits nor the costs
of this final rule would exceed $100 million in any given year. On the
contrary, the possible effects of each provision on costs and benefits
appear to be relatively small, and OSHA has not been able to quantify
them. Nor has OSHA been able to quantify the cost savings it expects
from preventing misinterpretation and misapplication of the standard.
However, OSHA does expect that this final rule will increase
understanding and compliance with the standard and, therefore, the
agency expects the rule to result in some, unquantifiable cost savings.
Moreover, and as discussed above, OSHA expects this final rule will
maintain safety and health protections for workers.
1. Final Determinations Regarding Costs and Cost Savings Attributable
to the Final Rule
In the Preliminary Economic Analysis and Regulatory Flexibility Act
Certification (PEA) in the 2018 NPRM, OSHA considered whether each of
the proposed changes could affect the costs and, if so, how those costs
might be affected (83 FR at 63760-65). For the purposes of the
preliminary analysis, the agency divided the proposed changes into two
groups: (1) Proposed clarifications and (2) proposed revisions. The
``proposed clarifications'' were those that were solely intended to
clarify provisions and would not alter the requirements and scope of
the rule (83 FR at 63760-61). The items OSHA identified as
clarifications included the addition of a definition of beryllium
sensitization to paragraph (b); minor changes to the definitions of CBD
diagnostic center and chronic beryllium disease in paragraph (b); minor
changes to the written exposure control plan provisions in paragraphs
(f)(1)(i)(D) and (f)(1)(ii)(B); a minor change in the PPE removal
provision of paragraph (h)(2)(i); minor changes to provisions for the
cleaning of PPE in paragraph (h)(3)(iii); minor changes to the cleaning
of PPE upon entry to eating or drinking areas in paragraph (i)(4)(ii);
and minor changes to provisions for employee information and training
in paragraphs (m)(4)(ii)(A) and (m)(4)(ii)(E) (83 FR at 63760-61).
The ``proposed revisions,'' on the other hand, were those that
would go beyond clarification and alter certain requirements of the
beryllium standard (83 FR at 63761). The proposed provisions that OSHA
identified as revisions included changes to the definitions of
beryllium work area, confirmed positive, and dermal contact with
beryllium in paragraph (b); a change to the requirements for washing
facilities in paragraph (i)(1); a change to the requirements for
provision of change rooms in paragraph (i)(2); changes to the
requirements pertaining to disposal and recycling in paragraph (j)(3);
a change to the requirements for medical surveillance following an
employee's exposure to beryllium in an emergency in paragraph (k)(2);
revision to provisions for evaluation at a CBD diagnostic center in
paragraph (k)(7)(i); a change to the requirements for warning labels in
paragraph (m)(3); and changes to the requirements for recordkeeping in
paragraphs (n)(1)(ii)(F), (n)(3)(ii)(A), and (n)(4)(i).
After carefully reviewing the proposed clarifications and
revisions, OSHA preliminarily determined that their net total effect
would result in potential cost savings, mainly from improving employer
understanding and facilitating application of the rule (83 FR at 63760-
61). OSHA preliminarily identified a new potential cost, which would
result from the proposed changes as a whole: A de minimis cost for the
time employers would need to become familiar with the revised portions
of this final rule (83 FR at 63761, 63765). Viewing all the proposed
changes as a whole, OSHA explained that it preliminarily anticipated
that the proposed provisions' net effect would result in some cost
savings (83 FR at 63761). OSHA invited comment on all aspects of the
PEA, including these preliminary determinations (83 FR at 63760-62,
63764-65).
Stakeholders either agreed with or did not comment on OSHA's
analysis of potential costs and costs savings attributable to the vast
majority of the proposed clarifications and revisions (e.g., Document
ID 0026, pp. 1-2; 0038, pp. 21, 26, 32). The only objections the agency
received related to two of the four proposed paragraphs that OSHA is
revising from the proposal in the final rule: (1) The definition of the
term confirmed positive; and (2) the requirement related to
examinations at CBD diagnostic centers (Document ID 0021, p. 4; 0022,
pp. 5-6). Those comments, and OSHA's final determination that each of
the four paragraphs that OSHA is revising from the proposal will result
in small and unquantifiable cost savings, are discussed in detail
below.
OSHA has also examined the record concerning the proposed
clarifications and revisions that OSHA has finalized without change. As
noted above, stakeholders either agreed with or did not comment on
OSHA's analysis of potential costs and costs savings attributable to
these proposed changes. Therefore, after carefully considering all the
comments received and the remainder of the record, OSHA affirms its
preliminary determination that these clarifications and revisions are
likely to result in cost savings, largely from improving employer
understanding and facilitating application of the rule. OSHA also
affirms its preliminary determination that the only potential new costs
are de minimis costs for the time employers would need to become
familiar with the revised portions of this final rule.
In summary, OSHA finds that both the four paragraphs that OSHA is
revising from the proposal and the remainder of the proposed
clarifications and revisions that OSHA is finalizing without change in
the final rule will result in potential cost savings mainly
attributable to improving employer understanding and facilitating
application of the rule, as well as preventing costs that would follow
from misunderstanding the standard. OSHA expects that the cost savings
attributable to these changes will offset the de minimis employer
familiarization costs, resulting in a net result of cost savings.
Therefore, OSHA finds that this final rule is likely to result in cost
savings.
[[Page 42586]]
2. Analysis of Costs and Costs Savings Attributable to Provisions in
the Final Rule That Differ From Those in the Proposal
In this section the agency discusses the four changes in the final
rule that differ from the proposal: The definition of confirmed
positive in paragraph (b), Definitions; a clarification to inter-plant
transfers in paragraph (j), Housekeeping; and two changes to paragraph
(k), Medical Surveillance: Requirements related to CBD diagnostic
centers and requirements for medical examination at termination of
employment. In all cases, as stated above, the agency has determined
these will have de minimis cost or cost savings implications.
Definition of Confirmed Positive.
The 2017 final rule did not specify a time limit within which the
BeLPT tests that contribute toward a finding of ``confirmed positive''
must occur. In the 2018 NPRM, OSHA proposed to modify the definition of
confirmed positive to require that the qualifying test results be
obtained within one testing cycle (including the 30-day follow-up test
period required after a first abnormal or borderline BeLPT test
result), rather than arguably over an unlimited time period that might
have led to false positives that could needlessly concern workers and
their families, could lead workers to undergo unnecessary testing, and
would not enhance worker protections. In the PEA, OSHA explained that
the exact effect of the proposed change was uncertain as it is unknown
how many employees would have a series of BeLPT results associated with
a confirmed positive finding (two abnormal results, one abnormal and
one borderline result, or three borderline results) over an unlimited
period of time, but would not have any such combination of results
within a single testing cycle (83 FR at 63761-62). OSHA preliminarily
concluded that the proposed change would not increase compliance costs
and would incidentally yield some cost savings by lessening the
likelihood of false positives (83 FR at 63762). The agency invited
comment on its preliminary conclusion (83 FR at 63762).
As discussed in Section XI, Summary and Explanation for paragraph
(b), a number of stakeholders commented that requiring results within a
30-day testing cycle could create logistical challenges, for example
due to repeat testing requirements or for businesses in remote areas
with limited healthcare facilities (Document ID 0022, p. 4; 0021, p. 4;
0024, p. 1; 0033, p. 5; 0027, p. 3). National Jewish Health (NJH) also
commented that removing the time frame of 30 days for confirming
abnormal results would allow for employee workplace protection and
clinical evaluation referral at a lower cost and with less logistical
burden (Document ID 0022, p. 5).
Stakeholders' logistical concerns and NJH's comment about costs
reflect a misunderstanding of the proposed change. As explained in more
detail in the Summary and Explanation for paragraph (b), OSHA did not
intend that the initial and any follow-up tests had to be completed and
interpreted within 30 days. Rather, the agency intended that the test
results be obtained during one cycle of testing, that is, an initial or
periodic examination followed by follow-up testing conducted within 30
days of an abnormal or borderline result. For example, if an employee
received a borderline BeLPT result at his or her periodic examination,
paragraph (k)(3)(ii)(E) would require the employer to offer a follow-up
BeLPT within 30 days of the test results. If the follow-up BeLPT result
was also borderline, paragraph (k)(3)(ii)(E) would again require the
employer to offer a follow-up BeLPT within 30 days of the first follow-
up test's results. If that second follow-up was borderline or abnormal,
the employee would have been confirmed positive under the proposal
because all of the tests that ``confirmed'' the results were triggered
by the initial test. In other words, OSHA did not intend to suggest
that the proposal would have required employers to conduct all of the
tests or obtain the confirming results within a single 30-day period.
In this final rule, OSHA has revised the definition of confirmed
positive to specify that the findings of two abnormal, one abnormal and
one borderline, or three borderline results must be obtained from
BeLPTs conducted within a three-year period. OSHA determined that this
revision strikes the appropriate balance between the shorter time
period for confirmation in the proposal and the unspecified, arguably
indefinite, time period of the original definition. As explained in the
Summary and Explanation section, the final three-year period will
capture the identification of sensitized workers enrolled in medical
surveillance. OSHA finds that the addition of a specific time period to
the text of the final rule will decrease the possibility of a
misinterpretation of the provision's time frame that could lead to
false positive results.
As with the proposed revisions to this definition, OSHA finds that
the exact effect of this change is uncertain because it is unknown how
many employees would have a series of BeLPT results associated with a
confirmed positive finding (two abnormal results, one abnormal and one
borderline result, or three borderline results) over an unlimited
period of time, but would not have any such combination of results
within a three-year testing cycle, though it is likely to be small. As
discussed in Section XI, Summary and Explanation of the Final Rule, NJH
reported that in a group of 194 CBD patients in their care, the length
of time between abnormal results ranged from 14 days to 5.8 years, with
a 95th percentile of 2.9 years. This suggests that the vast majority of
individuals who will have two abnormal BeLPT tests in the course of
medical surveillance are likely to be confirmed positive within the
three-year window of time OSHA is establishing in the definition of
confirmed positive. The Summary and Explanation section notes further
that a three-year testing cycle is consistent with practices and
recommendations of the medical community, pointing to the increasing
likelihood that a confirmed positive finding over longer periods of
time will be a false-positive and lead to costly further medical exams
with no benefit. Thus, OSHA concludes that this change will not
increase compliance costs and will incidentally yield some cost savings
by lessening the likelihood of false positives.
Disposal, Recycling, and Reuse.
Paragraph (j)(3) of the previous standard (29 CFR 1910.1024(j)(3))
addresses disposal and recycling of materials that contain beryllium in
concentrations of 0.1 percent by weight or more or that are
contaminated with beryllium. In the 2018 NPRM, OSHA proposed to modify
this paragraph in a number of ways--all of which the agency
preliminarily found would not increase the costs of complying with the
standard and may also result in unquantifiable savings to employers by
preventing misinterpretation or misapplication of the rule (83 FR at
63762-63). Stakeholders did not offer any comments objecting to this
preliminary determination. With the exception of one minor
clarification to the regulatory text, discussed below, OSHA is adopting
all of the proposed revisions to paragraph (j)(3) in this final rule.
After reviewing the record as a whole and having received no evidence
or comment to the contrary, the agency reaffirms its preliminary
determination that the proposed revisions to paragraph (j)(3) that are
being adopted in this final rule will result in some cost savings from
increased employer understanding.
[[Page 42587]]
OSHA has made one change to the proposed provisions in paragraph
(j)(3) in this final rule. When employers transfer certain materials to
another party for disposal, recycling, or reuse, proposed paragraph
(j)(3)(i) would have required employers to label the materials in
accordance with paragraph (m)(3) of the standard. As explained in the
Summary and Explanation for paragraph (j)(3), a comment alerted the
agency to a potential ambiguity in this proposed text. Specifically,
OSHA realized that the phrase ``to another party'' could be read to
suggest that transfers between two facilities owned by the same
employer are exempted from the labeling requirements in paragraph
(j)(3)(i). That was not the agency's intent in the proposal. To
eliminate any ambiguity on this point, OSHA revised paragraph (j)(3)(i)
in the final rule to strike the phrase ``to another party'' and add the
``except for intra-plant transfers'' language that is found in
paragraphs (j)(3)(ii) and (iii).
As with the proposed changes to paragraphs (j)(3)(ii) and (iii),
which clarified that those paragraphs' requirements did not apply to
intra-plant transfers, OSHA finds that this proposed change is not a
substantive change to the standard. It is simply clarifying OSHA's
original intent that all transfers outside of a plant, including
between facilities owned by the same employer, are subject to the
labeling requirements of paragraph (m)(3). Since this change does not
alter the requirements of the standard, it will not affect the costs of
compliance with the standard. Therefore, OSHA finds that none of the
changes this final rule makes to paragraph (j)(3) will increase the
costs of complying with the standard.
Medical Surveillance.
In the 2018 NPRM, OSHA proposed two sets of changes to paragraph
(k). The first set of changes proposed is in paragraph (k)(2), which
specifies when and how frequently medical examinations are to be
offered to those employees covered by the medical surveillance program.
Paragraph (k)(2)(i)(B) of the previous standard required the employer
to provide a medical examination within 30 days after determining that
the employee shows signs or symptoms of CBD or other beryllium-related
health effects or that the employee has been exposed to beryllium in an
emergency.
Based on stakeholder feedback and other evidence indicating that
the 30-day period in the previous standard may be insufficient to
detect beryllium sensitization in individuals exposed one time in an
emergency, OSHA proposed removing the requirement for a medical
examination within 30 days of exposure to beryllium during an
emergency, under paragraph (k)(2)(i)(B), and adding paragraph
(k)(2)(iv), which would require the employer to offer a medical
examination at least one year after but no more than two years after
the employee is exposed to beryllium during an emergency (83 FR at
63757).
In the PEA, OSHA preliminarily determined that the net cost impact
of these proposed changes would be slight, with some possible cost
savings. Specifically, OSHA explained that, in the FEA for the 2017
final rule, the agency estimated that emergencies would affect a very
small number of employees in a given year, likely less than 0.1 percent
of the affected population, representing a small addition to the costs
of medical surveillance for the standard (Document ID OSHA-H005C-2006-
0870-2042, p. V-196). Under the 2017 final rule, some employees might
have required two examinations to be confirmed positive: A first test
cycle within the initial 30-day period and a second BeLPT at least two
years later. Under the 2018 NPRM, OSHA expected that more of the
employees who became sensitized from exposure in an emergency would be
confirmed positive through a single testing cycle because that test
would have been administrated one to two years following the emergency.
The agency anticipated that the proposed change would result in the
elimination of one premature testing, which would ensure better
detection for more employees and incidentally trigger some cost savings
(83 FR at 63764).\3\
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\3\ Assuming that this initial analysis does not result in a
confirmed positive diagnosis, that employee would not be confirmed
positive until a second test two years later under the current rule.
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To the extent that lengthening the time period in which the test
must be offered from within 30 days to between one and two years leads
to earlier confirmed positive results (within two years, as opposed to
within two years plus 30 days), OSHA preliminarily found that the
proposed change could slightly accelerate costs to the employer for
earlier CBD diagnostic center referral and medical removal protection.
OSHA estimated that the proposed change would affect a very small
percentage of an already very small population. The agency
preliminarily determined that the proposed revision would only
potentially change the timing of the already-required BeLPT, CBD
diagnostic center referral, and medical removal protection (83 FR at
63764, 63764 n.5).
In summary, OSHA preliminarily found that the end result of the
proposed changes to paragraph (k)(2) from a cost perspective would be
that the cost savings from the potential avoidance of a premature BeLPT
within 30 days following an emergency would likely be largely canceled
out by the acceleration of the cost of the CBD diagnostic center
evaluation and medical removal protection. Therefore, OSHA
preliminarily determined that the net cost impact of the proposed
changes would be slight, with some possible cost savings (83 FR at
63764). Stakeholders did not submit any comments related to OSHA's
preliminary determinations regarding potential costs of the proposed
revisions to paragraph (k)(2).
In sum, after considering the record as a whole, OSHA finds that
its preliminary estimates were correct: A small change in costs, with
possible cost savings. Nevertheless, as discussed in more detail in the
Summary and Explanation for paragraph (k), Medical Surveillance, some
stakeholders expressed concerns about possible delays in medical
consultations and examinations and lack of employee knowledge of
potential health effects, and one stakeholder argued that employees who
terminate employment before receiving the post-emergency examination
might not receive an examination at all after being exposed in an
emergency (Document ID 0023, pp. 2-3; 0024, p. 2; 0027, p. 4).
OSHA is revising paragraphs (k)(2) in the final rule in two ways to
address these concerns. First, OSHA has added two sub-provisions under
paragraph (k)(2)(iv) to provide for post-emergency examination timing
for two separate groups of employees. Final paragraph (k)(2)(iv)(A)
focuses on the very small group of employees who are exposed in an
emergency but have not received a medical examination under paragraph
(k)(1)(i) within the previous two years. The requirement for these
employees is similar to the requirement contained in the previous
standard; i.e., under the final standard, the employer must provide
these employees with a medical examination within 30 days of the date
of the emergency. Because the final standard treats these employees
similarly to the manner in which the previous standard treated all
employees exposed in an emergency, OSHA does not expect that there will
be any change in cost attributable to this change. In other words, for
those employees who have not had a medical examination within the past
two years there is no change in protocol and, thus, no change in costs.
[[Page 42588]]
Final paragraph (k)(2)(iv)(B) focuses on employees who are exposed
during an emergency, but have recently received an examination. Under
this new provision, if an employee has received a medical examination
under paragraph (k)(1)(i) within the previous two years, then the
employer would be required to offer that employee a medical examination
that meets the requirements of the standard at least one year but no
more than two years after the employee was exposed to beryllium in an
emergency. Because this provision treats employees who have recently
received an examination similarly to the manner in which the proposal
would have treated all employees exposed in an emergency, OSHA expects
that this change will result in a fraction of the small cost savings
preliminarily estimated in the proposal.
Second, to address concerns that delaying the medical examination
to at least one year and no more than two years following the emergency
may result in employees not receiving a post-emergency examination if
their employment ends soon after exposure during an emergency, OSHA is
revising paragraph (k)(2)(iii) to require that each employee who is
exposed in an emergency and has not received an examination since the
emergency exposure is provided an examination at the time employment is
terminated. Because paragraph (k)(2)(iii) already requires an
examination at termination if there has not been one within the last
six months due to any of the standard medical exam triggers, including
emergency exposure, OSHA expects that this change will affect an
extremely small group of employees. This revision, however, will ensure
that all employees with emergency exposure are offered a medical exam,
even under this very narrow set of circumstances. The baseline of costs
and cost savings of this analysis is the previous rule, which already
required a medical exam within 30 days of emergency exposure. Thus,
OSHA does not expect that this change will have any cost implications.
In summary, OSHA finds that this final rule's revisions to
paragraph (k)(2) will result in slight cost savings. No costs or costs
savings are attributable to new paragraph (k)(2)(iv)(A), which treats
employees exposed in an emergency who have not received a medical
examination within the previous two years pursuant to paragraph
(k)(1)(i) similarly to how all employees exposed in an emergency were
treated under the previous standard. The end result of final paragraph
(k)(2)(iv)(B), however, will be cost savings from the potential
avoidance of a premature BeLPT that are largely offset by the
acceleration of the cost of the CBD diagnostic center evaluation and
medical removal protection. OSHA does not attribute any costs or cost
savings to result from the revisions to paragraph (k)(2)(iii).
Therefore, the agency expects the new result of final paragraph (k)(2)
to be a slight cost savings.
The second set of changes proposed to the standard's medical
surveillance requirements is in paragraph (k)(7), which contains the
requirements for evaluation at a CBD diagnostic center. Paragraph
(k)(7)(i) of the previous rule required employers to provide an
evaluation at no cost to the employee at a CBD diagnostic center that
is mutually agreed upon by the employee and employer within 30 days of
the employer receiving a written medical opinion that recommends
referral to a CBD diagnostic center, or a written medical report
indicating that the employee has been confirmed positive or diagnosed
with CBD. To address stakeholder concerns that scheduling the
appropriate tests with an examining physician at the CBD diagnostic
center may take longer than 30 days, OSHA proposed that the employer
provide an initial consultation with the CBD diagnostic center, rather
than the full evaluation, within 30 days of the employer receiving one
of the types of documentation listed in paragraph (k)(7)(i)(A) or (B).
The agency noted that the consultation could occur via telephone or
virtual conferencing methods and would demonstrate that the employer
made an effort to begin the process for a medical examination (83 FR at
63758). Evaluation and any testing would then occur within a reasonable
time after the consultation.
In the PEA, OSHA noted that while the addition of the consultation
would not result in any additional costs or cost savings (since the
2017 FEA had already accounted for a 15-minute discussion between the
employee and a physician (Document ID OSHA-H005C-2006-0870-2042, p. V-
206)), allowing more flexibility in scheduling the tests at the CBD
diagnostic center would enable employers to find more economical travel
and accommodation options. To the extent that it takes longer than 30
days to schedule the tests at the CBD diagnostic center, the agency
preliminarily found that employers may realize a cost savings due to
retaining funds during the delay. OSHA could not quantify the effect of
this flexibility, however, concluding only that it expected that the
changes would produce minor, if any, cost savings. The agency invited
comment on its preliminary assessment of these potential effects (83 FR
at 63764).
Stakeholders did not offer any comments on the agency's preliminary
estimates regarding the cost savings attributable to these proposed
changes. Several commenters objected to adding the consultation
requirement, however, arguing that it was an unnecessary step that
would add logistical complications and costs (see, e.g., Document ID
0021, p. 3; 022, p. 6). This is discussed in more detail in the Summary
and Explanation for paragraph (k), Medical Surveillance. After
considering these comments and the record as a whole, OSHA decided to
modify paragraph (k)(7)(i) to require that the employer within 30 days
of receiving one of the types of documentation listed in paragraph
(k)(7)(i)(A) or (B) schedule an evaluation at a CBD diagnostic center.
In addition, OSHA is adding a requirement that the evaluation itself
must occur within a reasonable time.
OSHA finds that these changes may slightly delay the incidence of
costs of an evaluation under paragraph (k)(7)(i), in that it may occur
at a later date in some cases than under the existing provision. This
would slightly decrease the costs of compliance with the standard. The
agency also finds that allowing the evaluation to occur within a
reasonable time, rather than within 30 days, may allow for more cost-
effective travel and accommodation options. Thus, as with the proposal,
OSHA concludes that these changes may produce minor cost savings.
To account for a proposed change to the definition of CBD
diagnostic center, the proposed rule would also have amended paragraph
(k)(7)(i) to clarify that the employer must provide, at no cost to the
employee and within a reasonable time after consultation with the CBD
diagnostic center, any of the following tests that a CBD diagnostic
center must be capable of performing, if deemed appropriate by the
examining physician at the CBD diagnostic center: A pulmonary function
test as outlined by American Thoracic Society criteria testing,
bronchoalveolar lavage (BAL), and transbronchial biopsy. In the PEA,
OSHA explained that this proposed change would not alter the
requirements of the standard and therefore would not change the costs
of compliance with the standard (83 FR at 63764).
Stakeholders did not offer any comments on OSHA's determination
that these proposed changes would not affect costs. Some stakeholders
argued, however, that the proposed provision could be misinterpreted to
mean that the employer does not have to make available other tests that
the examining
[[Page 42589]]
physician deems appropriate for reasons such as diagnosing or
determining the severity of CBD (Document ID 0021, p. 3; 0022, p. 3;
0028, p. 2). This is discussed in more detail in the Summary and
Explanation for paragraph (k), Medical Surveillance. To address these
concerns, OSHA is adding a new provision, paragraph (k)(7)(ii), which
clarifies that, as part of the evaluation at the CBD diagnostic center,
the employer must ensure that the employee is offered any tests deemed
appropriate by the examining physician at the CBD diagnostic center,
such as pulmonary function testing as outlined by American Thoracic
Society criteria testing, bronchoalveolar lavage (BAL), and
transbronchial biopsy.\4\ If any of these tests deemed appropriate by
the examining physician are not available at the CBD diagnostic center,
the final rule allows them to be performed at another location that is
mutually agreed upon by the employer and the employee.
---------------------------------------------------------------------------
\4\ As discussed in Section XI, Summary and Explanation of the
Final Rule, OSHA also redesignated previous paragraphs (k)(7)(ii),
(iii), (iv), and (v) as paragraphs (k)(7)(iii), (iv), (v), and (vi),
respectively. This redesignation in paragraph (k) also affects a
reference in paragraph (l)(1)(ii). These changes are merely
administrative and do not have any substantive or monetary effect.
---------------------------------------------------------------------------
OSHA does not believe that requiring employers to provide any tests
deemed appropriate by the examining physician would change the costs of
compliance with the standard because the agency accounted for such
costs in the 2017 final rule.\5\ Specifically, when calculating the
unit cost for going to a CBD diagnostic center in the 2017 FEA, the
agency used a typical suite of tests that would be performed (Document
ID OSHA-H005C-2006-0870-2042, p. V-205). Consequently, OSHA's unit cost
in the 2017 final rule for an evaluation at a CBD diagnostic center was
an average for standard tests that are required. The agency finds that
this average set of tests by definition is constructed to give the
average cost for the tests deemed appropriate by the examining
physician and, thus, concludes that there are no costs or cost savings
attributable to this change.
---------------------------------------------------------------------------
\5\ As discussed in the Summary and Explanation for paragraph
(k), Medical Surveillance, OSHA never intended to limit the required
tests to the three tests listed in the previous definition of the
term CBD diagnostic center.
---------------------------------------------------------------------------
Paragraph (k)(7)(ii) requires that if any test deemed appropriate
by the examining physician is not available at the CBD diagnostic
center, the test must be performed at another location that is mutually
agreed to by the employer and employee. OSHA believes that such
circumstances would be very rare. CBD diagnostic centers with the
ability to perform pulmonary function testing (as outlined by the
American Thoracic Society criteria), bronchoalveolar lavage (BAL), and
transbronchial biopsy are most likely to also provide other medical
tests related to CBD.\6\ As a result, the CBD diagnostic center in the
vast majority of cases will be able to offer the additional testing
deemed necessary by the examining physician. Moreover, because the
three tests noted above are the tests that are commonly needed to
diagnose CBD, OSHA expects that these are the tests that would most
commonly be performed (see Section XI, Summary and Explanation of the
Final Rule). Given that this standard requires CBD diagnostic centers
to be able to perform the three tests that are most commonly performed
to diagnose CBD and CBD diagnostic centers typically would be able to
offer any additional tests deemed necessary, OSHA expects that
employees would rarely, if ever, need to travel to a second
location.\7\ In those rare cases, the added flexibility of having the
tests performed outside of a CBD diagnostic center gives more options
for the employer and employee and should lead to cost savings. Because
this situation should be quite uncommon, OSHA expects that the cost
savings of allowing employees to have additional tests outside of a CBD
diagnostic center are likely to be de minimis.
---------------------------------------------------------------------------
\6\ Document ID OSHA-H005C-2006-0870-0637 provides some
information from the NJH website, which provides an overview of the
types of tests performed.
\7\ OSHA also notes that it has always intended for employers to
make available any additional tests deemed appropriate by the
examining physician (see the discussion of paragraph (k), Medical
Surveillance, in Section XI, Summary and Explanation of the Final
Rule, of this preamble). The economic analysis of the 2017 final
rule did not explicitly account for these rare cases where a test
recommended by the examining physician of the CBD diagnostic center
was not available at the same center. Hence, there would be a de
minimis cost adjustment increase of the total cost of the 2017 final
rule due to this consideration. This is not a change in people's
behavior, simply a methodological change. The current final rule
could affect people's behavior and be a true change (decrease) in
costs. This change merely provides employers with a more flexible,
potentially less expensive, manner to provide those tests in the
rare situation where they are not available at the original CBD
diagnostic center.
---------------------------------------------------------------------------
This change to paragraph (k)(7) clarifies OSHA's intent that the
employer provide any tests deemed appropriate by the examining
physician at the CBD diagnostic center, or at another location if not
available at the CBD diagnostic center, but does not substantively
change the requirements of the beryllium standard. OSHA expects that
the changes described here would maintain safety and health protections
for workers.
3. Economic and Technological Feasibility
In the FEA in support of OSHA's 2017 Beryllium Final Rule, OSHA
concluded that the general industry beryllium standard was economically
and technologically feasible (see 82 FR at 2471). In the 2018 NPRM,
OSHA explained that it anticipated that none of the proposed changes
would impose any new employer obligations or increase the overall cost
of compliance, while some of the changes would clarify and simplify
compliance in such a way that results in cost savings. In addition,
OSHA preliminarily anticipated that the de minimis cost of any time
spent reviewing the proposed changes would be more than offset by the
cost savings described in the PEA. OSHA further found that none of the
proposed revisions would require any new controls or other technology.
OSHA therefore preliminarily determined that the proposed rule was both
economically and technologically feasible. OSHA did not receive any
comments objecting to or otherwise questioning this preliminary
determination.\8\ Therefore, after considering the record as a whole,
OSHA finds that the proposed provisions that are being adopted in this
final rule are economically and technologically feasible.
---------------------------------------------------------------------------
\8\ Although the agency did not receive any comments questioning
the economic or technological feasibility of the proposed changes,
at least one stakeholder argued that the previous standard was not
economically or technologically feasible and that the proposed
provisions remedied some of that stakeholder's concerns with
feasibility (Document ID 0038, pp. 13, 21-22, 43). Because the
feasibility of the January 2017 final rule as a whole is not at
issue in this rulemaking, OSHA considers these comments indicating
that these changes provide both economic and technological
feasibility relief as support for the economic and technological
feasibility of the proposed revisions.
---------------------------------------------------------------------------
OSHA also finds that the few new changes between the proposal and
the final rule would not require any new controls or other technology
and will result in cost savings. Therefore, OSHA finds that these final
provisions, and the final rule as a whole, are economically and
technologically feasible.
4. Effects on Benefits
In the 2017 FEA, OSHA attributed approximately 67 percent of the
beryllium sensitization cases and the CBD cases avoided, and none of
the lung cancer cases avoided, solely to the ancillary provisions of
the standard (Document ID OSHA-H005C-2006-0870-2042, pp. VII-4 to VII-
5, VII-24). This estimate was based on the ancillary provisions as a
whole, rather than each provision separately.
[[Page 42590]]
In the PEA, OSHA considered the potential effect of each proposed
change to ancillary provisions on employee protections. Because the
proposed revisions to the standard would not remove or change the
general nature of any ancillary provisions, and because the agency
expected the proposed revisions to maintain safety and health
protections for workers and facilitate employer understanding and
compliance, OSHA preliminarily determined that the proposed changes
would increase the standard's benefits as a whole by enhancing worker
protections overall and by preventing costs that follow from
misunderstanding the standard.
OSHA did not receive any comments related to its preliminary
assessment of the proposed provisions' effects on benefits. Having
considered the record as a whole, including all the comments received,
OSHA finds that the changes in this final rule will maintain safety and
health protections for workers while aligning the standard with the
intent behind the 2017 final rule and otherwise preventing costs that
could follow from misinterpretation or misapplication of the standard.
And the agency reaffirms its determination that facilitating employer
understanding and compliance has the benefit of enhancing worker
protections overall. Therefore, OSHA finds that the changes in this
final rule will increase the benefits of the standard as a whole.
5. Regulatory Flexibility Act Certification
In accordance with the Regulatory Flexibility Act, 5 U.S.C. 601 et
seq. (as amended), OSHA has examined the regulatory requirements of
this final rule to revise the general industry beryllium standard to
determine whether they would have a significant economic impact on a
substantial number of small entities. The final rule modifies the
general industry standard to clarify certain provisions and simplify or
improve compliance. It does not impose any new duties or increase the
overall cost of compliance, and OSHA expects it will provide some cost
savings. OSHA therefore expects that this final rule will not have a
significant economic impact on any small entities. Accordingly, OSHA
certifies that this final rule will not have a significant economic
impact on a substantial number of small entities.
V. Office of Management and Budget (OMB) Review Under the Paperwork
Reduction Act of 1995
A. Overview
This final rule revises information collection (paperwork)
requirements in the occupational exposure to beryllium in general
industry (29 CFR 1910.1024) standard that are subject to Office of
Management and Budget (OMB) approval under the Paperwork Reduction Act
of 1995 (PRA) (44 U.S.C. 3501 et seq.) and its implementing regulations
(5 CFR part 1320). OSHA is revising the previously approved paperwork
package under OMB control number 1218-0267, as it pertains to general
industry only. The collection of information items contained in the
Information Collection Request (ICR) pertaining to occupational
exposure to beryllium in the construction and shipyard sectors remain
in the ICR without change.
The PRA generally requires that agencies consider the impact of
paperwork and other information collection burdens imposed on the
public, obtain public input, and obtain approval from OMB before
conducting any collection of information (44 U.S.C. 3507). The PRA
defines a collection of information as ``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)). Federal agencies generally
cannot conduct or sponsor a collection of information, and the public
is generally not required to respond to an information collection,
unless it is approved by OMB under the PRA and displays a valid OMB
control number (44 U.S.C. 3507). 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 valid OMB control number (44 U.S.C.
3512).
B. Solicitation of Comments
On January 9, 2017, OSHA published a final rule establishing new
permissible exposure limits and other provisions to protect employees
from beryllium exposure, such as requirements for exposure assessment,
respiratory protection, personal protective clothing and equipment,
housekeeping, medical surveillance, hazard communication, and
recordkeeping for the general industry, construction, and shipyard
sectors. OMB approved the collections of information contained in the
final rule under OMB Control Number 1218-0267.
On December 11, 2018, OSHA published a Notice of Proposed
Rulemaking (NPRM) to modify the general industry beryllium standard by
clarifying certain provisions to improve and simplify compliance (83 FR
63746). The 2018 NPRM proposed to revise the collections of information
contained in the general industry standard by modifying provisions for
the written exposure control plan; the cleaning and replacement of
personal protection equipment; the disposal, recycling, and reuse of
contaminated materials; certain aspects of medical surveillance; and
the collection of social security numbers in recordkeeping. OSHA
prepared and submitted to OMB an ICR for the 2018 proposed rule for
review in accordance with 44 U.S.C. 3507(d). A copy of the proposed ICR
is available to the public at https://www.reginfo.gov/public/do/PRAOMBHistory?ombControlNumber=1218-0267.
In accordance with the PRA (44 U.S.C. 3506(c)(2)), OSHA solicited
public comments on the collection of information contained in the 2018
proposed rule. OSHA encouraged commenters to submit their comments on
the information collection requirements contained in the proposed rule
under docket number OSHA-2018-0003, along with their comments on other
parts of the proposed rule. In addition to generally soliciting
comments on the collection of information requirements, the proposed
rule indicated that OSHA and OMB were particularly interested in the
following items:
Whether the proposed collection of information is
necessary for the proper performance of the agency's functions,
including whether the information is useful;
The accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used;
The quality, utility, and clarity of the information to be
collected; and
Ways to minimize the compliance burden on employers, for
example, through the use of automated or other technological techniques
for collecting and transmitting information (83 FR 63766).
On March 29, 2019, OMB issued a Notice of Action (NOA) stating,
``Terms of the previous clearance remain in effect. OMB is withholding
approval at this time. Prior to publication of the final rule, the
agency should provide a summary of any comments related to the
information collection and their response, including any changes made
to the ICR as a result of comments. In
[[Page 42591]]
addition, the agency must enter the correct burden estimates'' (see OMB
Conclusion Action on ICR Reference No. 201812-1218-001, dated March 29,
2019, available at: https://www.reginfo.gov/public/do/PRAOMBHistory?ombControlNumber=1218-0267).
The agency did not receive any public comments in response to the
proposed ICR submitted to OMB for review. Public comments submitted in
response to the NPRM, however, substantively addressed provisions
containing collection of information. OSHA considered these comments
when it developed the revised ICR for this final rule. Summaries of
comments received on the NPRM and OSHA's responses are found in
Sections XI, Summary and Explanation of the Final Rule, and IV, Final
Economic Analysis and Regulatory Flexibility Act Certification.
The Department of Labor submitted the final ICR concurrent with the
publication of this final rule, containing the full analysis and
description of the burden hours and costs associated with the final
rule, to OMB for approval. A copy of this ICR will be available to the
public at https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202006-1218-006 (this link will become active on the day following publication
of this notice). At the conclusion of OMB's review, OSHA will publish a
separate notice in the Federal Register to announce the results.
C. Summary of Information Collection Requirements
As required by 5 CFR 1320.5(a)(1)(iv) and 1320.8(d)(2), the
following paragraphs provide information about the ICR.
1. Title: Beryllium Standard for General Industry (29 CFR
1910.1024), Construction (29 CFR 1926.1124), and Maritime (29 CFR
1915.1024).
2. Type of Review: Revision.
3. OMB Control Number: 1218-0267.
4. Affected Public: Business or Other For-Profit. This final rule
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).
5. Occupational Exposure to Beryllium in General Industry only:
a. Number of Respondents: 4,538.
b. Frequency of Responses: On occasion, quarterly, semi-annually,
annually, biannually.
c. Number of Responses: 134,570.
d. Estimated Total Burden Hours: 82,822.
e. Estimated Cost: $18,741,540.
6. Occupational Exposure to Beryllium in Construction and Shipyard
Sectors (previously-approved costs not affected by this rulemaking):
a. Number of Respondents: 2,796.
b. Frequency of responses: On occasion, quarterly, semi-annually,
annually, biannually.
c. Number of responses: 39,420.
d. Estimated Total Burden Hours: 25,269.
e. Estimated Cost: $8,774,874.
7. Total Estimated Burden Hours and Cost for All Three Industries:
a. Estimated Total Number of responses: 173,990.
b. Estimated Total Burden Hours: 108,091.
c. Estimated Cost: $27,516,414.
D. Summary of Changes in the Collection of Information Requirements
This final standard for occupational exposure to beryllium and
beryllium compounds in general industry revises the collection of
information requirements contained in the existing ICR for general
industry, approved under OMB control number 1218-0267. OSHA is updating
the new ICR to reflect those changes, which include changes to the
written exposure control plan; the cleaning and replacement of personal
protection equipment; the disposal, recycling, and reuse of
contaminated materials; certain aspects of medical surveillance; and
the collection of Social Security numbers in recordkeeping (see Table
V.1 below). The majority of these changes were adopted by the agency as
proposed. However, in response to comments on the proposed rule, OSHA
has revised a few of the provisions of the final rule that affect the
collection of information. Those changes are also noted in Table V.1
below.
Table V.1--Changes to Collection of Information Requirements in the
Final Rule for General Industry
------------------------------------------------------------------------
Explanation of this final
Information collection requirements in this rule's changes to the
final rule information collection
requirements
------------------------------------------------------------------------
Sec. 1910.1024(f)(1)(i), (ii), & (iii)-- This final rule removed
Methods of Compliance--Written Exposure the word ``preventing''
Control Plan. from (f)(i)(D), which
(i) The employer must establish, implement, previously contained the
and maintain a written exposure control phrase ``including
plan, which must contain:. preventing the transfer
(A) A list of operations and job titles of beryllium.'' In
reasonably expected to involve airborne addition, the final rule
exposure to or dermal contact with revised (f)(1)(ii)(B) by
beryllium;. replacing the phrase
(B) A list of operations and job titles ``airborne exposure to
reasonably expected to involve airborne or dermal contact with
exposure at or above the action level;. beryllium'' with
(C) A list of operations and job titles ``exposure to
reasonably expected to involve airborne beryllium.'' Both of
exposure above the TWA PEL or STEL;. these changes were
adopted as proposed.
(D) Procedures for minimizing cross-
contamination, including the transfer of
beryllium between surfaces, equipment,
clothing, materials, and articles within
beryllium work areas;
(E) Procedures for keeping surfaces 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) A list of engineering controls, work
practices, and respiratory protection
required by paragraph (f)(2) of this
standard;
(H) A list of personal protective
clothing and equipment required by
paragraph (h) of this standard; and
(I) Procedures for removing, laundering,
storing, cleaning, repairing, and
disposing of beryllium-contaminated
personal protective clothing and
equipment, including respirators.
(ii) The employer must review and evaluate
the effectiveness of each written exposure
control plan at least annually and update
it, as necessary, 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 airborne exposure
to beryllium;
[[Page 42592]]
(B) The employer is notified that an
employee is eligible for medical removal
in accordance with paragraph (l)(1) of
this standard for evaluation at a CBD
diagnostic center, or shows signs or
symptoms associated with exposure to
beryllium; or
(C) The employer has any reason to
believe that new or additional airborne
exposure is occurring or will occur.
(iii) The employer must make a copy of the
written 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(h)(3)(iii)--Personal This final rule revised
Protective Clothing and Equipment--Cleaning (h)(3)(iii) by replacing
and Replacement. the phrase ``airborne
(3)(iii) The employer must inform in writing exposure to and dermal
the persons or the business entities who contact with beryllium''
launder, clean, or repair the personal with ``exposure to
protective clothing or equipment required by beryllium.'' This change
this standard of the potentially harmful was adopted as proposed.
effects of exposure to beryllium and that
the personal protective clothing and
equipment must be handled in accordance with
this standard..
Sec. 1910.1024(j)(3)(i), (ii), & (iii)-- This final rule revised
Housekeeping--Disposal, recycling, and reuse. (j)(3) by explicitly
(3)(i) Except for intra-plant transfers, when addressing transferring
the employer transfers materials that materials for reuse;
contain at least 0.1% beryllium by weight or reorganizing the
are contaminated with beryllium for previous two provisions
disposal, recycling, or reuse, the employer into three to allow the
must label the materials in accordance with agency to incorporate
paragraph (m)(3) of this standard;. the new reuse
(ii) Except for intra-plant transfers, requirements, while also
materials designated for disposal that setting out each
contain at least 0.1% beryllium by weight or distinct obligation
are contaminated with beryllium must be clearly; replacing the
cleaned to be as free as practicable of phrase materials ``that
beryllium or placed in enclosures that contain beryllium in
prevent the release of beryllium-containing concentrations of 0.1
particulate or solutions under normal percent by weight or
conditions of use, storage, or transport, more'' with a shorter,
such as bags or containers; and. easier to understand
(iii) Except for intra-plant transfers, phrase: Materials ``that
materials designated for recycling or reuse contain at least 0.1
that contain at least 0.1% beryllium by percent beryllium by
weight or are contaminated with beryllium weight;'' clarifying
must be cleaned to be as free as practicable that the rule's
of beryllium or placed in enclosures that requirements for
prevent the release of beryllium-containing disposal, recycling, and
particulate or solutions under normal reuse do not apply to
conditions of use, storage, or transport, intra-plant transfers;
such as bags or containers.. clarifying the enclosure
requirements by
providing more detail on
what constitutes an
appropriate enclosure;
allowing for the
cleaning of materials
bound for disposal; and
removing the undefined
phrase ``surface
beryllium
contamination.''
In addition to the above
actions, which were all
adopted as proposed, in
this final rule, OSHA
revised paragraph
(j)(3)(i) to explicitly
incorporate the
clarification that the
rule's requirements for
disposal, recycling, and
reuse do not apply to
intra-plant transfers.
[[Page 42593]]
Sec. 1910.1024(k)(2)--Medical Surveillance. Paragraph (k)(2)(i)(B) of
(2) Frequency. the 2017 standard
The employer must provide a medical previously required the
examination:. employer to provide a
(i) Within 30 days after determining that:... medical examination
(A) An employee meets the criteria of within 30 days after
paragraph (k)(1)(i)(A), unless the employee determining that the
has received a medical examination, provided employee shows signs or
in accordance with this standard, within the symptoms of CBD or other
last two years; or. beryllium-related health
(B) An employee meets the criteria of effects or that the
paragraph (k)(1)(i)(B) of this standard.. employee has been
(ii) At least every two years thereafter for exposed to beryllium in
each employee who continues to meet the an emergency. The 2018
criteria of paragraph (k)(1)(i)(A), (B), or NPRM would have added
(D) of this standard.. paragraph (k)(2)(iv) to
(iii) At the termination of employment for require employers to
each employee who meets any of the criteria offer an examination to
of paragraph (k)(1)(i) of this standard at employees exposed to
the time the employee's employment beryllium in an
terminates, unless an examination has been emergency at least one
provided in accordance with this standard year after but no more
during the six months prior to the date of than two years after the
termination. Each employee who meets the employee is exposed to
criteria of paragraph (k)(1)(i)(C) of this beryllium in an
standard and who has not received an emergency. It also would
examination since exposure to beryllium have amended paragraph
during the emergency must be provided an (k)(2)(i)(B) to focus
examination at the time the employee's only on the frequency of
employment terminates.. examinations for
(iv) For an employee who meets the criteria employees who show signs
of paragraph (k)(1)(i)(C) of this standard:. or symptoms of CBD or
(A) If that employee has not received a other beryllium-related
medical examination within the previous two health effects.
years pursuant to paragraph (k)(1)(i) of This final rule's
this standard, then within 30 days after the provisions differ from
employee meets the criteria of paragraph those in the proposal.
(k)(1)(i)(C) of this standard; or. Specifically, in this
(B) If that employee has received a medical final rule, OSHA removed
examination within the previous two years the requirement for a
pursuant to paragraph (k)(1)(i) of this medical examination
standard, then at least one year but no more within 30 days of
than two years after the employee meets the exposure in an emergency
criteria of paragraph (k)(1)(i)(C) of this and added paragraph
standard.. (k)(2)(iv). Final
paragraph (k)(2)(iv)(A)
requires the employer to
offer a medical
examination to an
employee within 30 days
after the employee was
exposed to beryllium in
an emergency, if the
employee has not had an
examination under
paragraph (k)(1)(i)
within the last two
years, while final
paragraph (k)(2)(iv)(B)
requires the employer to
offer a medical
examination to an
employee within one to
two years after the
employee was exposed to
beryllium in an
emergency, if the
employee had an
examination under
paragraph (k)(1)(i) of
the beryllium standard
within the last two
years. In addition, this
final rule revised
paragraph (k)(2)(iii) to
require that each
employee who is exposed
in an emergency and has
not received an
examination since the
emergency exposure must
be provided an
examination at the time
employment is
terminated.
As proposed in the 2018
NPRM, this final rule
also amended paragraph
(k)(2)(i)(B) to focus
only on the frequency of
examinations for
employees who show signs
or symptoms of CBD or
other beryllium-related
health effects.
[[Page 42594]]
Sec. 1910.1024(k)(7)--Medical Surveillance-- The 2018 NPRM would have
Referral to the CBD Diagnostic Center. amended paragraph (k)(7)
(7) CBD diagnostic center. (i) The employer of the 2017 standard to
must provide an evaluation at no cost to the require employers to
employee at a CBD diagnostic center that is provide, at no cost to
mutually agreed upon by the employer and the the employee and within
employee. The evaluation at the CBD a reasonable time after
diagnostic center must be scheduled within the initial consultation
30 days, and must occur within a reasonable with the CBD diagnostic
time, of:. center, any of the
(A) The employer's receipt of a physician's following tests if
written medical opinion to the employer that deemed appropriate by
recommends referral to a CBD diagnostic the examining physician
center; or. at the CBD diagnostic
(B) The employee presenting to the employer a center: Pulmonary
physician's written medical report function testing (as
indicating that the employee has been outlined by the American
confirmed positive or diagnosed with CBD, or Thoracic Society
recommending referral to a CBD diagnostic criteria),
center.. bronchoalveolar lavage
(ii) The employer must ensure that, as part (BAL), and
of the evaluation, the employee is offered transbronchial biopsy.
any tests deemed appropriate by the The proposal also
examining physician at the CBD diagnostic specified the timing of
center, such as pulmonary function testing the initial
(as outlined by the American Thoracic consultation.
Society criteria), bronchoalveolar lavage This final rule's
(BAL), and transbronchial biopsy. If any of provisions differ from
the tests deemed appropriate by the those in the proposal.
examining physician are not available at the Specifically, OSHA
CBD diagnostic center, they may be performed revised paragraph
at another location that is mutually agreed (k)(7)(i) to require
upon by the employer and the employee.. that the evaluation must
(iii) The employer must ensure that the be scheduled within 30
employee receives a written medical report days, and must occur
from the CBD diagnostic center that contains within a reasonable
all the information required in paragraph time, of the employer
(k)(5)(i), (ii), (iv), and (v) of this receiving one of the
standard and that the PLHCP explains the types of documentation
results of the examination to the employee listed in paragraph
within 30 days of the examination.. (k)(7)(i)(A) or (B).
(iv) The employer must obtain a written Previously, the general
medical opinion from the CBD diagnostic industry standard
center within 30 days of the medical required employers to
examination. The written medical opinion provide the examination
must contain only the information in within 30 days of the
paragraph (k)(6)(i), as applicable, unless employer receiving one
the employee provides written authorization of the types of
to release additional information. If the documentation listed in
employee provides written authorization, the paragraph (k)(7)(i)(A)
written opinion must also contain the or (B).
information from paragraphs (k)(6)(ii), This final rule also
(iv), and (v), if applicable.. added a provision, in
(v) The employer must ensure that each paragraph (k)(7)(ii),
employee receives a copy of the written which specifies that the
medical opinion from the CBD diagnostic employer must ensure
center described in paragraph (k)(7) of this that, as part of the
standard within 30 days of any medical evaluation, the employee
examination performed for that employee.. is offered any tests
(vi) After an employee has received the deemed appropriate by
initial clinical evaluation at a CBD the examining physician
diagnostic center described in paragraphs at the CBD diagnostic
(k)(7)(i) and (ii) of this standard, the center, such as
employee may choose to have any subsequent pulmonary function
medical examinations for which the employee testing (as outlined by
is eligible under paragraph (k) of this the American Thoracic
standard performed at a CBD diagnostic Society criteria),
center mutually agreed upon by the employer bronchoalveolar lavage
and the employee, and the employer must (BAL), and
provide such examinations at no cost to the transbronchial biopsy.
employee.. The new provision also
states that if any of
the tests deemed
appropriate by the
examining physician are
not available at the CBD
diagnostic center, they
may be performed at
another location that is
mutually agreed upon by
the employer and the
employee.
Sec. 1910.1024(n)(1)(i), (ii), & (iii)-- This final rule removed
Recordkeeping--Air Monitoring Data. the requirement for
(i) The employer must make and maintain a collection and recording
record of all exposure measurements taken to of Social Security
assess airborne exposure as prescribed in numbers from this
paragraph (d) of this standard.. provision. This change
(ii) This record must include at least the was adopted as proposed.
following information:.
(A) The date of measurement for each
sample taken;
(B) The task 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 and job classification of
each employee represented by the
monitoring, indicating which employees
were actually monitored.
(iii) The employer must ensure that exposure
records are maintained and made available in
accordance with the Records Access standard
(29 CFR 1910.1020).
Sec. 1910.1024(n)(3)(i), (ii), & (iii)-- This final rule removed
Recordkeeping--Medical Surveillance. the requirement for
(i) The employer must make and maintain a collection and recording
record for each employee covered by medical of Social Security
surveillance under paragraph (k) of this numbers from this
standard.. provision. This change
(ii) The record must include the following was adopted as proposed.
information about the employee:.
(A) Name and job classification;
(B) A copy of all licensed physicians'
written medical opinions for each
employee; and
(C) A copy of the information provided to
the PLHCP as required by paragraph
(k)(4) of this standard.
(iii) The employer must ensure that medical
records are maintained and made available in
accordance with the Records Access standard
(29 CFR 1910.1020).
[[Page 42595]]
Sec. 1910.1024(n)(4)(i) & (ii)-- This final rule removed
Recordkeeping--Training. the requirement for
(4) Training. (i) At the completion of any collection and recording
training required by this standard, the of Social Security
employer must prepare a record that numbers from this
indicates the name and job classification of provision. This change
each employee trained, the date the training was adopted as proposed.
was completed, and the topic of the
training..
(ii) This record must be maintained for three
years after the completion of training.
------------------------------------------------------------------------
VI. Federalism
OSHA reviewed this rule in accordance with the Executive Order on
Federalism (Executive Order 13132, 64 FR 43255, August 10, 1999), which
requires that federal agencies, to the extent possible, refrain from
limiting state policy options, consult with states prior to taking any
actions that would restrict state policy options, and take such actions
only when clear constitutional and statutory authority exists and the
problem is national in scope. Executive Order 13132 provides for
preemption of state law only with the expressed consent of Congress.
Any such preemption is to be limited to the extent possible.
Under Section 18 of the OSH Act, Congress expressly provides that
states and U.S. territories may adopt, with federal approval, a plan
for the development and enforcement of occupational safety and health
standards. OSHA refers to such states and territories as ``State
Plans'' (29 U.S.C. 667). Occupational safety and health standards
developed by State Plans must be at least as effective in providing
safe and healthful employment and places of employment as the federal
standards. Subject to these requirements, State Plans are free to
develop and enforce under state law their own requirements for safety
and health standards.
OSHA previously concluded from its analysis for the 2017 final rule
that promulgation of the beryllium standard complies with E.O. 13132
(82 FR at 2633). The amendments in this final rule do not change that
conclusion. 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 OSHA. In states with
OSHA-approved State Plans, this rulemaking does not significantly limit
state policy options.
VII. State Plans
When federal OSHA promulgates a new standard or more stringent
amendment to an existing standard, the states and U.S. Territories with
their own OSHA-approved occupational safety and health plans (State
Plans) must promulgate a state standard adopting such new federal
standard, or more stringent amendment to an existing federal standard,
or an at least as effective equivalent thereof, within six months of
promulgation of the new federal standard or more stringent amendment.
The state may demonstrate that a standard change is not necessary
because the state standard is already the same or at least as effective
as the federal standard change. Because a state may include standards
and standard provisions that are equally or more stringent than federal
standards, it would generally be unnecessary for a state to revoke a
standard when the comparable federal standard is revoked or made less
stringent. 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 28 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
remaining six states and territories cover only state and local
government employees: Connecticut, Illinois, Maine, New Jersey, New
York, and the Virgin Islands.
As discussed in detail below in Section XI, Summary and Explanation
of the Final Rule, the majority of the changes made by this final rule
will clarify certain provisions and simplify or improve employer
compliance. After considering all of the changes made by this final
rule and the record as a whole, OSHA believes that this final rule
enhances employee safety, in part by revising provisions that may be
misinterpreted. Therefore, OSHA has determined that, within six months
of the rule's promulgation date, State Plans must review their state
standards and adopt amendments to those standards that are at least as
effective as the amendments to the beryllium general industry standard
finalized herein, as required by 29 CFR 1953.5(a), unless the State
Plans demonstrate that such amendments are not necessary because their
existing standards are already at least as effective at protecting
workers as this final rule. This decision is also informed by a comment
from Materion Brush, Inc. (Materion), in which Materion argued that
OSHA should require states to adopt the proposed changes (Document ID
0038-A5, p. 2).\9\ No other stakeholders opined on this issue.
---------------------------------------------------------------------------
\9\ OSHA notes that Materion also argued that the State Plans
that have already adopted the original OSHA standard should be
required to adopt the changes OSHA previously adopted in the 2018
direct final rule, as well as the changes that result from the
current rulemaking (Document ID 0038-A5, p. 1). Whether OSHA should
require State Plans to adopt the changes made in the 2018 direct
final rule is out of the scope of this rulemaking and, thus, will
not be considered here.
---------------------------------------------------------------------------
VIII. Unfunded Mandates Reform Act
OSHA reviewed this final rule according to the Unfunded Mandates
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.) and Executive Order
13132 (64 FR 43255). As discussed above in Section IV, Final Economic
Analysis and Regulatory Flexibility Act Certification (FEA), of this
preamble, the agency determined that this final rule will not impose
significant additional costs on any private- or public-sector entity.
Further, OSHA previously concluded that the rule will not impose a
federal mandate on the private sector in excess of $100 million
(adjusted annually for inflation) in expenditures in any one year (82
FR at 2634). Accordingly, this final rule will not require significant
additional
[[Page 42596]]
expenditures by either public or private employers.
As noted above under Section VII, State Plans, the agency's
standards do not apply to state and local governments except in states
that have elected voluntarily to adopt a State Plan approved by the
agency. Consequently, this final rule does not meet the definition of a
``federal intergovernmental mandate'' (see Section 421(5) of the UMRA
(2 U.S.C. 658(5))). Therefore, for the purposes of the UMRA, the agency
certifies that this final rule will not mandate that state, local, or
tribal governments adopt new, unfunded regulatory obligations of, or
increase expenditures by the private sector by, more than $100 million
in any year.
IX. Consultation and Coordination With Indian Tribal Governments
OSHA has reviewed this final rule in accordance with Executive
Order 13175 (65 FR 67249) and determined that it does not have ``tribal
implications'' as defined in that order. This final rule does 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.
X. Environmental Impacts
OSHA has reviewed this final rule in accordance with the
requirements of the National Environmental Policy Act of 1969 (NEPA)
(42 U.S.C. 4321 et seq.), the Council on Environmental Quality NEPA
regulations (40 CFR part 1500-1508), and the Department of Labor's NEPA
procedures (29 CFR part 11). As a result of this review, OSHA has
determined that this final rule will not have a significant impact on
air, water, or soil quality; plant or animal life; the use of land; or
aspects of the external environment.
XI. Summary and Explanation of the Final Rule
On December 11, 2018, OSHA published a Notice of Proposed
Rulemaking (83 FR 63746) (2018 NPRM) proposing changes to a number of
provisions in the general industry beryllium standard. Following
publication of the 2018 NPRM, a variety of stakeholders, including
representatives of industry, labor, medical groups, public health
organizations, federal and state government agencies, academia, trade
associations, and private citizens, submitted comments on OSHA's
proposed changes. After reviewing and carefully considering these
comments and the remainder of the record, OSHA has decided to adopt the
majority of the changes proposed, as well as additional changes that
were prompted by the comments received. These changes clarify certain
provisions and simplify or improve compliance for the other provisions
of the standard. OSHA believes that these changes will maintain safety
and health protections for workers and will further enhance worker
protections by ensuring that the standard is well understood and
implemented according to the agency's intent.
The following discussion summarizes the comments received on the
proposed changes to the general industry standard, lays out OSHA's
responses to and final determinations regarding the issues in the
comments, and explains each new or revised provision in this final rule
including details on any modification made from the proposal. As
discussed in detail below, the changes include the addition of one
definition and modifications to five existing definitions in paragraph
(b) and revisions to seven of the standard's other paragraphs,
including paragraph (f), Methods of compliance; paragraph (h), Personal
protective clothing and equipment; paragraph (i), Hygiene areas and
practices; paragraph (j), Housekeeping; paragraph (k), Medical
surveillance; paragraph (m), Communication of hazards; and paragraph
(n), Recordkeeping. The final rule also replaces the 2017 standard's
Appendix A with a new appendix designed to supplement the final
standard's definition of beryllium work area.
Definitions.
Paragraph (b) of the beryllium standard for general industry
provides definitions of key terms used in the standard. In this final
rule, OSHA is changing or adding six terms in the definitions paragraph
of the standard. The terms that OSHA is changing or adding are
beryllium sensitization, beryllium work area, CBD diagnostic center,
chronic beryllium disease, confirmed positive, and dermal contact with
beryllium.
Beryllium sensitization.
OSHA is adding the following definition for beryllium
sensitization: ``a response in the immune system of a specific
individual who has been exposed to beryllium. There are no associated
physical or clinical symptoms and no illness or disability with
beryllium sensitization alone, but the response that occurs through
beryllium sensitization can enable the immune system to recognize and
react to beryllium. While not every beryllium-sensitized person will
develop chronic beryllium disease (CBD), beryllium sensitization is
essential for development of CBD.'' The agency is adding this
definition to clarify other provisions in the standard, such as the
definitions of chronic beryllium disease (CBD) and confirmed positive,
as well as the provisions for medical surveillance in paragraph (k) and
hazard communication in paragraph (m).
This definition of beryllium sensitization is identical to the
definition proposed in the 2018 NPRM and is consistent with information
provided in the 2017 final beryllium rule (82 FR 2470). In the preamble
to the 2017 final rule, OSHA found that individuals sensitized through
either the dermal or inhalation exposure pathways respond to beryllium
through the formation of a beryllium-protein complex, which then binds
to T-cells stimulating a beryllium-specific immune response (82 FR at
2494). The formation of the T-cell-beryllium-protein complex that
results in beryllium sensitization rarely manifests in any outward
symptoms (such as coughing or wheezing); most who are sensitized show
no symptoms at all (see 82 FR at 2492, 2527). Once an individual has
been sensitized, any subsequent beryllium exposures via inhalation can
progress to serious lung disease through the formation of granulomas
and fibrosis (see 82 FR at 2491-98). Since the pathogenesis of CBD
involves a beryllium-specific, cell-mediated immune response, CBD
cannot occur in the absence of sensitization (82 FR at 2492; see also
NAS, 2008 (Document ID OSHA-H005C-2006-0870-1355)). Therefore, this
definition's explanation that beryllium sensitization is essential for
development of CBD is consistent with the agency's findings in the 2017
final rule.
Several commenters expressed support for OSHA's inclusion of a
definition of beryllium sensitization in the beryllium general industry
standard, including NJH (Document ID 0022, p. 2), the United
Steelworkers (USW) (Document ID 0033, p. 1), Materion (Document ID
0038, p. 8), the U.S. Department of Defense (DOD) (Document ID 0029, p.
1), and Edison Electric Institute (EEI) (Document ID 0031, p. 2).
According to the USW, the proposed definition is clear and accurate,
and is necessary because the beryllium standard includes many
provisions related to the recognition of and appropriate response to
beryllium sensitization among beryllium-exposed workers (Document ID
0033, p. 1).
[[Page 42597]]
Materion similarly commented that inclusion of the proposed definition
in the standard would improve workers' and employers' understanding of
this term (Document ID 0038, p. 4).
While OSHA received no objections to including a definition of
beryllium sensitization in the beryllium standard, several commenters
suggested changes to the proposed definition. The National Supplemental
Screening Program (NSSP) and NJH recommended that the definition of
beryllium sensitization should include the following text, based on the
ATS Statement on Beryllium: ``Beryllium sensitization is a response in
the immune system of an individual who has been exposed to beryllium. A
diagnosis of [beryllium sensitization] can be based on two abnormal
blood BeLPTs, one abnormal and one borderline blood BeLPT, three
borderline BeLPTs, or one abnormal bronchoalveolar lavage (BAL) BeLPT.
Beryllium sensitization is essential for development of CBD'' (Document
ID 0027 p. 1; 0022, p. 2; see also Document ID OSHA-H005C-2006-0870-
0364, pp. 1, 44). Neither organization, however, explained why this
definition of beryllium sensitization should be used instead of the
definition OSHA proposed.
OSHA disagrees with this recommendation. The agency is providing a
definition of beryllium sensitization to give stakeholders a general
understanding of what beryllium sensitization is and its relationship
to CBD. Information pertinent to medical identification of
sensitization is provided in the definition of confirmed positive,
which appears later in this section. OSHA has determined that the
agency's definitions of beryllium sensitization and confirmed positive
together provide the information suggested by NJH and the NSSP. The
definition of confirmed positive explains how the results of BeLPT
testing should be interpreted in the context of the standard's
provisions that refer to that term, such as evaluation at a CBD
diagnostic center and medical removal protection. The confirmed
positive definition establishes that these benefits should be extended
to workers who have a pattern of BeLPT results, obtained in a three-
year period, consistent with the NJH and the NSSP's recommended
definition of beryllium sensitization. The remainder of the information
suggested by NJH and the NSSP, which pertains to the relationship of
beryllium sensitization to beryllium exposure, the immune system, and
the development of CBD, is included in the definition of beryllium
sensitization that OSHA proposed and is including in this final
standard. For these reasons, OSHA has decided not to adopt the language
suggested by NJH and the NSSP.
The NSSP objected to the statement that no physical or clinical
symptoms, illness, or disability are associated with beryllium
sensitization alone, but did not explain the reason for their concern
with this statement (Document ID 0027, p. 1). Materion supported the
agency's inclusion of this information in the definition, stating that
``employees deserve to understand that beryllium sensitization does not
involve symptoms . . .'' (Document ID 0038, p. 5). The USW also
specifically supported the accuracy of this section of OSHA's proposed
definition of beryllium sensitization (Document ID 0033, p. 1).
The agency has decided to retain this statement in the definition
of beryllium sensitization because it is important that employers and
employees understand the asymptomatic nature of beryllium sensitization
and the need for specialized testing such as the BeLPT. The statement
is consistent with OSHA's discussion of beryllium sensitization in the
2017 final rule (82 FR at 2492-99). As OSHA discussed in the 2017 final
rule, sensitization through dermal contact has sometimes been
associated with skin granulomas, contact dermatitis, and skin
irritation, but these reactions are rare and those sensitized through
dermal exposure to beryllium typically do not exhibit any outward signs
or symptoms (see 82 FR at 2488, 2491-92, 2527). OSHA determined that
while beryllium sensitization rarely leads to any outward signs or
symptoms, beryllium sensitization is an adverse health effect because
it is a change to the immune system that leads to risk of developing
CBD (82 FR at 2498-99). The agency believes that the asymptomatic
nature of beryllium sensitization, especially in the lung, should be
conveyed to employers and employees to emphasize why specialized
testing such as the BeLPT should be provided to workers who may have no
symptoms of illness associated with beryllium exposure. For these
reasons, OSHA is retaining the statement ``[t]here are no associated
physical or clinical symptoms and no illness or disability with
beryllium sensitization alone'' in the definition of beryllium
sensitization.
The State of Washington Department of Labor and Industries,
Division of Occupational Safety and Health (DOSH), commented that
OSHA's proposed definition of beryllium sensitization places
unnecessary emphasis on the role that beryllium sensitization plays in
the development of CBD. According to DOSH, ``[t]his language may cause
confusion with proper diagnosis of CBD and application of the rule
requirements for workers who have developed CBD without a confirmed
beryllium sensitization'' (Document ID 0023, p. 1). Other commenters,
however, including NJH, the NSSP, and the USW, supported including the
statement that beryllium sensitization is necessary for the development
of CBD in OSHA's definition of beryllium sensitization (Document ID
0022, p. 2; 0027, p. 1; 0033, p. 1).
Following consideration of DOSH's comment, OSHA has determined that
this information should remain in the definition of beryllium
sensitization (as well as the definition of chronic beryllium disease,
discussed later). OSHA believes that an understanding of the
relationship between beryllium sensitization and CBD is key to workers'
and employers' understanding of the beryllium standard. By including
the role that sensitization plays in the development of CBD in the
definition of beryllium sensitization, OSHA intends to make a number of
things clear to workers and employers: That beryllium sensitization,
although not itself a disease, is nevertheless an adverse health effect
that presents a risk for developing CBD and thus should be prevented;
the need to identify beryllium sensitization through regular medical
screening; and why workers who are confirmed positive should be offered
specialized medical evaluation and medical removal protection. OSHA
notes that DOSH does not dispute the factual accuracy of OSHA's
statement regarding the role beryllium sensitization plays in the
development of CBD, which the agency established in the Health Effects
section of the 2017 final rule (82 FR at 2495-96).
Nevertheless, OSHA agrees with DOSH that it is not always necessary
to identify a worker as beryllium sensitized by the BeLPT as part of a
diagnosis of CBD, and the agency acknowledges that some sensitized
individuals may not be confirmed positive for beryllium sensitization
by BeLPT testing. OSHA established in the Health Effects section of the
preamble to the 2017 final rule that while BeLPT testing is helpful to
identify workers at risk for CBD and to differentiate CBD from
respiratory diseases with similar clinical presentation, CBD can be
diagnosed in the absence of a confirmed positive BeLPT (see 82 FR at
2499-5002) (discussing a number of studies conducted prior to the
development of the BeLPT). At least one study in the rulemaking record
found that some
[[Page 42598]]
beryllium workers who would not have been confirmed positive by their
BeLPT results were found to be sensitized via the BAL BeLPT and went on
to develop CBD (Newman et al., 2001, Document ID OSHA-H005C-2006-0870-
1354, p. 234). Other studies indicate that the BeLPT has a false-
negative rate of approximately 25-28 percent (that is, approximately
25-28 percent of individuals who have a single normal BeLPT result are
in fact sensitized) (Middleton et al., 2011, Document ID OSHA-H005C-
2006-0870-0399, p. 2 (25 percent); Stange et al., 2004, Document ID
OSHA-H005C-2006-0870-1402, p. 457 (27.7 percent)). Because the BeLPT
itself may have a false-negative result and because other means exist
to diagnose CBD apart from the BeLPT, examining physicians should have
the latitude to diagnose CBD in the absence of a ``confirmed positive''
pattern of BeLPT results. Moreover, as discussed below, the
determination that an employee is ``confirmed positive'' under the
beryllium standard acts only as a trigger for medical monitoring and
surveillance and OSHA does not intend the phrase ``confirmed positive''
to be interchangeable with ``beryllium sensitized.''
The standard provides a mechanism for an employee to be referred to
a CBD diagnostic center and diagnosed with CBD, even in the absence of
a confirmed positive blood BeLPT result. Under paragraph (k)(5)(iii),
the licensed physician can recommend referral to a CBD diagnostic
center if he or she deems it appropriate. As OSHA explained in the
preamble to the 2017 final rule, the licensed physician could recommend
an evaluation at a CBD diagnostic center based on questionable BeLPT
findings (82 FR at 2714). For example, in a scenario where an employee
has repeating borderline or abnormal results but does not meet the
definition for confirmed positive, referral to a CBD diagnostic center
may be appropriate.
Furthermore, the standard does not specify how CBD is diagnosed and
gives the licensed physician at the CBD diagnostic center discretion
for making that diagnosis, including by means other than blood BeLPT
results. The diagnostic criteria for CBD include (1) history of
beryllium exposure; (2) histopathological evidence of non-caseating
granulomas or mononuclear cell infiltrates in the absence of infection;
and (3) positive blood or BAL BeLPT (82 FR at 2500; see also Newman et
al., 1989 (Document ID OSHA-H005C-2006-0870-0196, p. 1480)). The
availability of transbronchial lung biopsy facilitates the evaluation
of the second criterion, by making histopathological confirmation
possible in almost all cases (82 FR at 2500). The ATS has noted that
the BAL BeLPT can be useful in diagnosing CBD in individuals who have
normal blood BeLPT results and considers one positive BAL BeLPT
sufficient for the diagnosis of beryllium sensitization (Document ID
OSHA-H005C-2006-0870-0364, pp. 44-45). OSHA expects that the licensed
physician might apply such criteria in the diagnosis of CBD, without
relying on a confirmed positive finding based on blood BeLPT results.
In summary, OSHA believes that emphasizing the role that beryllium
sensitization plays in the development of CBD provides employers and
employees with important context for understanding the beryllium
standard. At the same time, the agency acknowledges that employees may
be diagnosed with CBD in the absence of a confirmed positive BeLPT, and
the beryllium standard allows for such a diagnosis. Thus, following
consideration of the record of comments on OSHA's proposed definition
of beryllium sensitization, the agency is finalizing the definition as
proposed in the 2018 NPRM. The addition of this definition for
beryllium sensitization does not change employer obligations under
paragraphs (k) and (m) and, therefore, OSHA expects that the new
definition will maintain safety and health protections for workers.
Beryllium work area.
Paragraph (b) of the final rule defines beryllium work area as any
work area where materials that contain at least 0.1 percent beryllium
by weight are processed either: (1) During any of the operations listed
in Appendix A of the standard; or (2) where employees are, or can
reasonably be expected to be, exposed to airborne beryllium at or above
the action level. The presence of a beryllium work area triggers a
number of requirements in the standard. These include the requirements
under paragraphs (e)(1)(i) and (2)(i) to establish, maintain, and
demarcate the boundaries of each beryllium work area, as well as
requirements under paragraphs (f)(1)(i)(D) and (F), written exposure
control plan requirements; paragraph (f)(2)(ii), required exposure
controls; paragraphs (i)(1) and (2), general hygiene practices and
change rooms requirements; paragraphs (j)(1)(i) and (2), housekeeping
requirements; and paragraph (m)(4)(ii)(B), employee training. The
establishment of beryllium work areas serves to ensure that employees
and other persons are aware of the potential presence of airborne
beryllium; to control access to these areas; and in conjunction with
other provisions such as the written control plan, hygiene, and
housekeeping requirements, to minimize the transfer of beryllium to
other areas of the facility and reduce the potential for exposure to
other employees.
The term beryllium work area (as revised in the 2018 direct final
rule) was defined as any work area (1) containing a process or
operation that can release beryllium and that involves material that
contains at least 0.1 percent beryllium by weight; and, (2) where
employees are, or can reasonably be expected to be, exposed to airborne
beryllium at any level or where there is the potential for dermal
contact with beryllium. That definition was developed in response to
stakeholder comments on the 2015 NPRM, which had proposed to define a
beryllium work area as any work area where there is potential for
exposure to airborne beryllium at any level, and which did not include
dermal contact as a trigger for establishment of a beryllium work area.
Some stakeholders argued that the definition proposed in the 2015 NPRM
was overly broad and could be interpreted as applying to most or all
areas of a worksite, regardless of the work processes or operations
occurring in those areas. Commenters also expressed concern that the
definition was vague and should be triggered on a measurable threshold
of exposure. NIOSH commented that the proposed definition's focus on
airborne beryllium did not account for the potential contribution of
dermal exposures to total exposure (82 FR at 2659).
In response to these comments, OSHA modified the definition in the
2017 final rule to require the presence of a beryllium-releasing
process. The agency explained in the preamble that triggering the
requirement of creating a beryllium work area on a specific threshold
level of exposure would be insufficiently protective of workers, but
also explained that the agency did not intend for a beryllium work area
to be established in areas where work processes or operations that
release beryllium do not occur, such as where employees handle articles
containing beryllium (82 FR at 2659-60). Rather, the purpose of
establishing beryllium work areas is to identify and demarcate areas
within a facility where processes or operations release beryllium so
that necessary control measures can be implemented, such as those
designed to prevent the migration of beryllium to other areas where
beryllium is not processed or released. OSHA clarified this intent by
defining a beryllium work
[[Page 42599]]
area as an area that contains processes or operations that release
beryllium to which workers could be exposed. Additionally, OSHA
accounted for NIOSH's concern by including the potential for dermal
contact with beryllium in the definition (see 82 FR at 2658-60).
In the preamble to the 2017 final rule, however, OSHA disagreed
with commenters who claimed that the proposed definition of beryllium
work area was impermissibly vague. The agency explained that, by
limiting the trigger for beryllium work areas to exposures generated
from a beryllium-releasing process or operation within the area, the
definition made clear that the requirements were not triggered solely
on the fact that an employee may be handling solid material containing
beryllium. Additionally, any employer who had doubts about whether a
process was releasing beryllium or created the potential for dermal
contact with beryllium could use air sampling or wipe sampling to
determine where the boundary of a beryllium work area should be
established. OSHA reasoned that, rather than rendering the provision
vague, defining a beryllium work area in a performance-based manner
left employers flexibility in complying with the standard (82 FR at
2659).
Nevertheless, following publication of the 2017 standard, OSHA
continued to hear from stakeholders that the definition of beryllium
work area remained a source of substantial uncertainty and confusion.
Some stakeholders expressed concern that defining a beryllium work area
to include any area where unspecified processes can reasonably be
expected to generate any level of airborne beryllium, or where there is
a process or operation that can release beryllium or the potential for
dermal contact with beryllium, could lead to the designation of entire
facilities as beryllium work areas because minute quantities of
beryllium can sometimes be detected in areas of a facility far distant
from the work processes that create beryllium exposures. Stakeholders
requested that OSHA provide a list of operations that are known to
release airborne beryllium, which would allow employers to more
accurately identify where beryllium work areas must be established and
demarcated at their workplaces. As described in more detail below,
stakeholders also requested that ``dermal contact'' be removed from the
definition of beryllium work area.
In response to this feedback, OSHA proposed in this rulemaking to
modify the definition of beryllium work area to provide clarity for
employers on where and when to establish a beryllium work area. First,
OSHA proposed a new appendix to the standard (Appendix A), containing
Table A.1, which includes a list of operations that are commonly
performed when processing beryllium materials and are known to generate
airborne beryllium. OSHA proposed to revise the definition of beryllium
work area so that any work area where an operation that is listed in
proposed Appendix A occurs, and involves materials containing at least
0.1 percent beryllium by weight, is a beryllium work area. For work
areas where no operations listed in proposed Appendix A occur, the
proposed definition would require a beryllium work area wherever
materials containing at least 0.1 percent beryllium by weight are
processed and where employees are, or can be reasonably expected to be,
exposed to airborne beryllium at or above the action level. The list of
operations in Table A.1 was compiled based on the experience of
Materion, the primary beryllium manufacturer in the United States, and
the USW, the primary union representing employees with beryllium
exposure.\10\ As noted in the preamble to the 2018 NPRM, OSHA intends
the list to cover all operations and processes that have the potential
for exposure to airborne beryllium (83 FR at 63761).
---------------------------------------------------------------------------
\10\ Table A.1 is divided into three categories: (1) Beryllium
Metal Alloy Operations (generally <10% beryllium by weight); (2)
Beryllium Composite Operations (generally >10% beryllium by weight)
and Beryllium Metal Operations; and (3) Beryllium Oxide Operations.
---------------------------------------------------------------------------
Second, OSHA proposed to remove the reference to dermal contact
from the definition of the term beryllium work area. OSHA preliminarily
determined that this change would make it less likely that the
definition could be misinterpreted as extending to areas of a facility
where work processes or operations that release beryllium do not occur
or even to entire facilities (83 FR at 63749). Further, the agency
explained that it was unaware of beryllium-releasing processes or
operations that have a potential for dermal contact that are not
included in the proposed Appendix A or do not generate airborne
exposures at or above the action level (83 FR at 63749). Therefore,
OSHA preliminarily determined that the proposed change would be as
protective as the previous definition, while more clearly avoiding the
erroneous perception that the standard would require employers to treat
entire facilities as beryllium work areas.
Comments submitted in response to the NPRM showed general support
from employers, unions, and public health experts for OSHA's proposed
approach and for providing better clarity with respect to beryllium
work areas (Document ID 0017; 0022, pp. 6-7; 0029, p. 1; 0033, pp. 1-4;
0038, pp. 8-9). For example, the USW agreed with OSHA that the
revisions proposed in the NPRM would make the definition more precise
and help to ensure that employers can appropriately comply with the
standard. The USW stated that the proposed definition ``provides
employers with a clearer means of understanding when and where
demarcation is required'' for beryllium work areas (Document ID 0033,
p. 2). Materion likewise indicated that this new approach ``greatly
improves and simplifies an understanding of where beryllium work areas
should be in a facility, allowing employers and employees to know and
understand how to comply with the requirement to establish these
protective work areas'' (Document ID 0038, p. 9).
While there was general support for this proposed approach to
beryllium work areas, several commenters expressed concerns about
various aspects of the new definition and new Appendix A. For example,
DOSH agreed that the addition of a new Appendix A would provide clarity
to the beryllium work area requirements but expressed concern that
removal of the dermal contact trigger would reduce worker protections.
DOSH suggested the use of a defined lower limit for beryllium
contamination on surfaces that would address this concern while
maintaining the protection for workers (Document ID 0023, pp. 1-2).
OSHA does not agree that removing the reference to dermal contact
from the definition of the term beryllium work area reduces
protections. As noted above and explained in both the preambles to the
2017 final rule and the 2018 NPRM, OSHA's intent was to capture those
areas of a facility where beryllium-generating processes or operations
are located; OSHA never intended for dermal contact alone to trigger
the standard's beryllium work area requirements (82 FR at 2659; 83 FR
at 63748). Contrary to DOSH's assertion, the requirement to establish a
beryllium work area was dependent on the presence of a process or
operation that can release beryllium and that involves material that
contains at least 0.1 percent beryllium by weight in the area in
question; exposure alone, whether airborne or dermal, was never a
trigger for the beryllium work area requirements.
Moreover, again as noted above, OSHA explained in the 2018 NPRM
that it did not know of any beryllium-releasing processes or operations
with
[[Page 42600]]
the potential for dermal contact that are not included in the proposed
Appendix A or that do not generate airborne exposures at or above the
action level. Put more simply, OSHA was unaware of any situation where
an employer would be required to establish a beryllium work area under
the previous definition but would not be required to do so under the
proposed definition. However, in the interest of caution, OSHA asked
stakeholders specifically whether there are any operations or processes
that trigger beryllium work areas under the previous definition that
would not be covered under the proposed definition (83 FR at 63749).
Commenters did not point to any such processes. On the contrary, the
only stakeholder to squarely address this issue, Materion, noted that
it too was ``unaware of work areas containing beryllium-releasing
processes or operations that have a potential for dermal contact that
are not included in the proposed Appendix A or generate airborne
exposures at or above the action level'' (Document ID 0038 p. 13).
Furthermore, another stakeholder, the USW commented that it
supported OSHA's proposed removal of the reference to dermal contact
from the definition of the term beryllium work area (Document ID 0033,
p. 3). The USW stated that it does not have reservations about the
proposed change and explained its belief ``that dermal exposure is
properly addressed elsewhere in the standard'' (Document ID 0033, pp.
1-3). According to the USW, ``[a]lthough dermal exposure to beryllium
is important and must be properly addressed, removal of dermal exposure
from this definition will reduce the confounding factors that might
result in unnecessarily extending beryllium work areas beyond needed
portions of a workplace'' (Document ID 0033, p. 3).
In addition, DOSH did not explain why it believes the change would
reduce worker protections. Given that DOSH did not point to any
particular loss of worker protection and the lack of evidence of any
differences between the coverage of the two definitions, OSHA has
decided to adopt the proposed definition, which commenters have
indicated reduces the confusion caused by the previous definition. OSHA
expects the revised definition to provide clarity on the proper
boundaries of a beryllium work area. Employers are required by
paragraph (j)(1), in conjunction with paragraph (f)(1), to minimize the
migration of beryllium from beryllium work areas, and clearly defining
the beryllium work area ensures employees working outside of these
areas receive the protective benefits of these requirements. If a
beryllium work area is defined overly broadly, then more employees may
inadvertently be exposed to beryllium within the beryllium work area
and would not receive some of these benefits. Moreover, as stated in
the 2018 NPRM, PPE requirements to protect against dermal exposure to
beryllium do not depend on the existence of a beryllium work area. The
standard requires employers to provide and ensure the use of
appropriate PPE whenever there is a reasonable expectation of dermal
contact with beryllium, regardless of whether or not the area is a
beryllium work area (see 83 FR at 63749).
OSHA also does not agree with DOSH that a lower limit for beryllium
contamination on surfaces is necessary as a trigger for establishing a
beryllium work area. In the 2017 final rule, OSHA chose not to set
quantitative limits for surface contamination because the best
available scientific evidence on adverse health effects from dermal
contact with beryllium made it difficult to identify an appropriate
limit for surface contamination (82 FR at 2688). This remains the case
today. OSHA discusses the limitations of this data more fully below in
the Summary and Explanation of the definition of dermal contact with
beryllium.
Two commenters objected to the exemption for materials that contain
less than 0.1 percent beryllium from the definition of beryllium work
area (Document ID 0022, p. 7; 0027, p. 2). However, OSHA incorporated
this change in the 2018 direct final rule. At the time, OSHA explained
that it was never the agency's intent that the requirements related to
beryllium work areas apply to these materials (83 FR 19936, 19938 (May
7, 2018)). OSHA did not receive any adverse comments on the direct
final rule and therefore finalized the change. The 2018 NPRM did not
propose to amend this portion of the definition and therefore comments
related to the 0.1 percent limitation are not within the scope of this
rulemaking.
OSHA also received comments on the new Appendix A. NJH expressed
concerns that the proposed list of operations in Appendix A was geared
toward manufacturing and that it ``may restrict employers'
interpretations of a beryllium work area and prevent employees from the
protections afforded by the beryllium standard. Employers may only
consider these featured tasks as those that dictate a beryllium work
area, when other tasks may be considered as such'' (Document ID 0022,
pp. 6-7). OSHA believes NJH's concern is misplaced. First, OSHA
requested comment on whether there were additional operations that
should be included on the list of operations in Appendix A, and no
suggestions for additional operations were put forth by commenters.
More importantly, the final standard requires that a beryllium work
area be established if exposures can reasonably be expected to exceed
the action level where materials that contain at least 0.1 percent
beryllium by weight are processed, regardless of whether the operation
is listed in Appendix A. As the USW noted, this requirement ``provides
a backstop for any unforeseen operation which can expose employees
above the action level'' (Document ID 0033, p. 2). Thus, employees who
may be exposed above the action level during a process not listed in
Appendix A will still receive the protections afforded by the beryllium
work area requirements.
DOD, while generally supportive of the proposed definition of
beryllium work area, expressed some concerns about Appendix A (Document
ID 0029, p. 1). First, DOD suggested, without explanation, that OSHA
remove the word ``generally'' from the description of the table in
Appendix A, which describes beryllium metal alloy operations as being
``generally < 10% beryllium by weight'' and beryllium composite
operations as being ``generally > 10% beryllium by weight.'' OSHA
disagrees with this suggestion. The table in Appendix A reflects
materials that are on the market today. However, the inclusion of the
word ``generally'' accounts for the possibility of beryllium metal
alloy operations and beryllium composite operations involving different
materials. Thus, if alloys are developed with greater than 10 percent
beryllium or composites less than 10 percent beryllium, these materials
will be covered under Table A.1. Because OSHA does not intend to limit
Table A.1 to processes involving only those materials on the market
today, the agency is retaining the word ``generally'' in the
description of the tables in Appendix A.\11\
---------------------------------------------------------------------------
\11\ The agency notes that DOD's comment suggests there might be
some confusion as to whether beryllium alloys and beryllium
composites are analogous. In fact, these materials have different
structures and should be treated differently from a control strategy
point of view. A metal alloy is a metal which is a homogeneous
mixture of two or more metals or of a metal and another element to
provide unique characteristics or properties (see https://www.thefreedictionary.com/Metal+alloy). A ``beryllium composite,''
on the other hand, is a metal matrix composite or (MMC) which
typically contain at least two distinct constituent parts (see
https://www.azom.com/article.aspx?ArticleID=9843).
---------------------------------------------------------------------------
[[Page 42601]]
DOD, along with DOSH, also questioned the deletion of the Appendix
A published with the 2017 final beryllium rule. That old appendix
provided non-mandatory general control strategies for common
operations. These commenters thought that the old appendix was useful
and should be retained in the standard (Document ID 0029, p. 1; 0023,
p. 3). OSHA agrees that the old appendix contained useful information,
but expects that in time it would have become either obsolete or
incomplete. Instead, OSHA plans to provide this information about
general control strategies in guidance materials tailored to reach the
targeted audience. This will make it easier to update as new
technologies or beryllium processes become available.
In addition, under paragraph (f)(2), Engineering and work
practices, employers are obligated to use engineering controls in
beryllium work areas. OSHA requires employers to use at least one type
of control that is listed in paragraph (f)(2)(ii) (substitution,
isolation, local exhaust ventilation, or process controls) unless
controls are infeasible or exposures are demonstrated to be below the
action level. These general controls are the same types of controls
that were listed in Appendix A and are required regardless of whether
that appendix is retained. For these reasons, this final standard does
not retain the old Appendix A.
Materion fully supported the proposed changes to the beryllium work
area definition and the proposed Appendix A. However, it noted a
typographical error in Appendix A for ``High Speed Machining (<= 10,000
rpm),'' which should be (> 10,000 rpm) (Document ID 0038, p. 10). OSHA
agrees that the entry in the NPRM's Appendix A is incorrect and made
the appropriate correction in this final rule.
After careful consideration of the record, OSHA has determined that
the revised definition of beryllium work area will improve compliance
with the standard by providing greater clarity to employers regarding
when and where beryllium work areas should be established in the
workplace. The agency further finds that properly identifying beryllium
work areas will reduce potential exposure for workers outside of these
areas through the various provisions triggered by beryllium work areas.
In sum, OSHA has determined that the revision to the definition of
beryllium work area will ensure that the standard's requirements
related to beryllium work areas are workable and properly understood.
Therefore, OSHA has decided to finalize the definition of beryllium
work area and the corresponding update to Appendix A as proposed, with
the exception of correcting the typographical error in Appendix A noted
by Materion.
CBD diagnostic center.
OSHA is amending the 2017 final rule's definition of CBD diagnostic
center to clarify certain requirements used to qualify an existing
medical facility as a CBD diagnostic center. The clarification does not
change the requirement for the employer to offer a follow-up
examination at a CBD diagnostic center to employees meeting the
criteria set forth in paragraph (k). OSHA is defining CBD diagnostic
center to mean a medical diagnostic center that has a pulmonologist or
pulmonary specialist on staff and on-site facilities to perform a
clinical evaluation for the presence of CBD. The revised definition
also states that a CBD diagnostic center must have the capacity to
perform pulmonary function testing (as outlined by the American
Thoracic Society criteria), bronchoalveolar lavage (BAL), and
transbronchial biopsy. In the revised definition, the CBD diagnostic
center must also have the capacity to transfer BAL samples to a
laboratory for appropriate diagnostic testing within 24 hours and the
pulmonologist or pulmonary specialist must be able to interpret the
biopsy pathology and the BAL diagnostic test results. This definition
is identical to the definition of CBD diagnostic center that OSHA
proposed in the 2018 NPRM.
The revised definition of CBD diagnostic center differs from the
former definition in a number of ways. First, whereas the 2017 final
rule's definition specified only that a CBD diagnostic center must have
a pulmonary specialist, OSHA is adding the term ``pulmonologist'' to
clarify that either type of specialist is qualified to perform a
clinical evaluation for the presence of CBD. Additionally, the 2017
definition required that a CBD diagnostic center have an on-site
pulmonary specialist. The revised definition states that the CBD
diagnostic center must simply have a pulmonologist or pulmonary
specialist on staff. This clarifies OSHA's intent that a specialist
must be available to the CBD diagnostic center but need not necessarily
be on site at all times.
In their comments on the 2018 NPRM, two commenters, NJH and the
ATS, recommended that a pulmonologist, occupational medicine
specialist, or physician with expertise in beryllium disease should
conduct the clinical evaluation for CBD and that a pulmonologist should
be on staff or available to perform the bronchoscopy (Document ID 0022,
p. 2; 0021, p. 2). According to NJH, clinics that regularly evaluate
patients for CBD have physicians with experience in occupational health
conduct the clinical evaluation for CBD, in conjunction with a
pulmonologist who performs a bronchoscopy (Document ID 0022, pp. 2-3).
OSHA notes that, although the agency is requiring facilities to
have a pulmonologist or pulmonary specialist on staff who is able to
interpret the biopsy pathology and the BAL diagnostic test results,
OSHA does not intend that all aspects of clinical evaluation for CBD
must be performed by a pulmonologist or pulmonary specialist. In the
preamble to the 2017 final rule, OSHA explained that the agency was
defining a CBD diagnostic center as a facility with a pulmonary
specialist ``on-site'' specifically to indicate that the specialist
need not personally perform the BeLPT testing (82 FR at 2645).
Moreover, paragraph (k)(7), which sets out the substantive requirements
for the evaluation at the CBD diagnostic center, refers to
recommendations of the ``examining physician,'' not necessarily the
pulmonologist or pulmonary specialist.
Paragraph (b), in turn, defines physician or other licensed health
care professional (PLHCP) as an individual licensed to provide some or
all of the services required by paragraph (k). As such, some parts of
the evaluation, such as lung function tests, might be performed by a
certified medical professional other than a pulmonologist or pulmonary
specialist. The arrangement that NJH describes as typical for clinics
treating CBD patients, in which physicians with experience in
occupational health conduct the clinical evaluation for CBD in
conjunction with a pulmonologist who performs a bronchoscopy, is
consistent with OSHA's intent for the definition of CBD diagnostic
center and other provisions of the standard related to CBD diagnosis.
Therefore, OSHA has determined that it is not necessary to revise the
definition of CBD diagnostic center to require that the clinical
evaluation for CBD be conducted by a pulmonologist, occupational
medicine specialist, or physician with expertise in beryllium disease.
An additional change to the definition of CBD diagnostic center
clarifies that the diagnostic center must have the capacity to perform
pulmonary function testing (according to American Thoracic Society
criteria), bronchoalveolar lavage (BAL), and tranbronchial biopsy. OSHA
determined that the former definition--which stated that the evaluation
at the
[[Page 42602]]
diagnostic center ``must include'' these tests--could have been
misinterpreted to mean that the examining physician was required to
perform each of these tests during every clinical evaluation at a CBD
diagnostic center. The agency's intent is not to dictate which tests an
evaluation at a CBD diagnostic center should include, but to ensure
that any CBD diagnostic center has the capacity to perform any of these
tests, which are commonly needed to diagnose CBD. OSHA expects that
these are the tests that would most commonly be requested for a CBD
evaluation. Therefore, the agency is revising the definition to clarify
that the CBD diagnostic center must simply have the ability to perform
each of these tests when deemed appropriate. These changes clarify the
definition of CBD diagnostic center, and OSHA expects they will
maintain safety and health protections for workers.
Materion submitted comments supporting OSHA's intent to specify the
required capacities of a CBD diagnostic center, rather than the
contents of a CBD evaluation, in the definition of CBD diagnostic
center (Document ID 0038, pp. 16-17). NJH expressed concern that this
change to the definition may indicate that the clinical evaluation for
CBD need not include certain aspects of a CBD evaluation, which NJH,
the Association of Occupational and Environmental Clinics (AOEC), and
the ATS recommend should typically include full pulmonary function
testing (lung volumes, spirometry, and diffusion capacity for carbon
monoxide), chest imaging, and cardiopulmonary exercise testing, and may
also include bronchoscopy in some cases (Document ID 0022, p. 3; 0028,
p. 2; 0021, pp. 1-2). Similarly, the ATS commented that not requiring
certain diagnostic tests ``could reduce the potential to diagnose CBD
and determine disease severity'' (Document ID 0021, p. 3). NJH
recommended that OSHA require the ATS recommendations for diagnostic
evaluation, which the NJH stated include the BeLPT; pulmonary function
testing and chest imaging; and in some cases bronchoscopy (Document ID
0022, p. 3).
As explained below in the Summary and Explanation of paragraph
(k)(7), that provision--which establishes the substantive requirements
for the evaluation at the CBD diagnostic center--makes clear that the
employer must offer any tests that the examining physician at the CBD
diagnostic center deems appropriate. The definition of CBD diagnostic
center in paragraph (b) does not alter this requirement. In light of
paragraph (k), the revised definition of CBD diagnostic center cannot
reasonably be read to limit the types of tests available to the
employee (see the Summary and Explanation for paragraph (k)(7) for a
full discussion of this topic). Thus, after considering these comments,
OSHA has decided to retain the proposed change to the definition of CBD
diagnostic center.
Chronic beryllium disease (CBD).
OSHA is also amending the definition of chronic beryllium disease.
For the purposes of this standard, the agency is using the term chronic
beryllium disease to mean a chronic granulomatous lung disease caused
by inhalation of airborne beryllium by an individual who is beryllium
sensitized. OSHA is finalizing the definition as proposed. It includes
several changes to the 2017 final rule's definition of chronic
beryllium disease, which was ``a chronic lung disease associated with
exposure to airborne beryllium'' (82 FR at 2645-46). The revisions
serve to differentiate CBD from other respiratory diseases associated
with beryllium exposure (e.g., lung cancer) and to make clear that
beryllium sensitization and the presence of beryllium in the lung are
essential in the development of CBD (see 82 FR at 2492).
First, OSHA is adding the term ``granulomatous'' to the definition.
A granulomatous lung formation is a focal collection of inflammatory
cells (e.g., T-cells) creating a nodule in the lung (see Ohshimo et
al., 2017, Document ID OSHA-H005C-2006-0870-2171, p. 2). The formation
of the type of lung granuloma specific to a beryllium immune response
can occur only in those with CBD (82 FR at 2492-2502). Next, OSHA is
removing the phrase ``associated with airborne exposure to beryllium''
and replacing it with ``caused by inhalation of airborne beryllium.''
This change is more consistent with the findings in the 2017 final rule
that beryllium is the causative agent for CBD and that CBD occurs only
after inhalation of beryllium (82 FR at 2513). Finally, OSHA is
clarifying that CBD is caused by inhalation of airborne beryllium ``by
an individual who is beryllium sensitized.'' Along with the revised
definition of beryllium sensitization discussed above, this revision
emphasizes to employers and employees the role that beryllium
sensitization plays in the development of CBD.
NJH, the USW, and Materion agreed with OSHA that the 2017 final
standard's definition of chronic beryllium disease should be clarified.
Materion supported the changes OSHA proposed, which it characterized as
a necessary clarification to ensure the definition provided is specific
to chronic beryllium disease (Document ID 0038, p. 17). The USW
similarly supported the proposed definition, stating that it clarifies
the previous definition which ``could be read to apply to any chronic
lung disease caused by beryllium, including lung cancer'' (Document ID
0033, p. 5). These comments reinforce OSHA's determination that adding
the term ``granulomatous'' to the definition will better distinguish
CBD from other occupationally associated chronic pulmonary diseases. As
OSHA explained in the preamble to the 2017 final rule, the formation of
the type of lung granuloma specific to a beryllium immune response can
occur only in those with CBD (82 FR at 2492-2502).
Several commenters expressed concern that the proposed definition
of chronic beryllium disease does not provide sufficient information to
guide diagnosis of CBD, and specifically that OSHA's emphasis on the
role of sensitization in the development of CBD may confuse diagnostic
efforts. The ATS noted that demonstrating beryllium sensitization may
be challenging in certain settings and recommended that OSHA's
definition of chronic beryllium disease use the diagnostic criteria for
CBD outlined in a 2014 ATS document on diagnosis and management of
beryllium sensitivity and CBD (``the ATS Statement''). These diagnostic
criteria include confirmation of an immune response to beryllium and
granulomatous lung inflammation using lung biopsy and emphasize the
various approaches which may be used ``[d]epending on the clinical
setting, feasibility of certain diagnostic tests, and degree of
diagnostic certainty needed'' (Document ID 0021, p. 5). DOSH similarly
emphasized that individuals may be diagnosed with CBD without a
confirmed positive BeLPT result and advocated that the definition of
chronic beryllium disease ``ensure employers and medical providers are
given a clear expectation of how beryllium conditions are properly
identified'' (Document ID 0023, p. 2).
OSHA notes that the standard's definition of chronic beryllium
disease is not intended to provide criteria for the diagnosis of CBD.
The agency's intent is to provide readers who may have little or no
familiarity with CBD with a general understanding of the term, rather
than to provide diagnostic criteria for healthcare professionals in
addressing CBD.
Due to differences in individual cases and circumstances, medical
specialists may need to apply somewhat different
[[Page 42603]]
testing regimens and/or diagnostic criteria to different individuals
they evaluate for CBD. Furthermore, the diagnostic tools and criteria
available to medical specialists may change over time. As discussed in
the Summary and Explanation for paragraph (k)(7), OSHA believes that
the physician at the CBD diagnostic center should have the latitude to
use any tests he or she deems appropriate for the purpose of diagnosing
or otherwise evaluating CBD in a patient, and has revised paragraph
(k)(7) to make this clear. Therefore, OSHA has determined that it is
neither necessary nor appropriate to specify diagnostic criteria in the
beryllium standard's definition of chronic beryllium disease. Instead,
OSHA has decided to retain a definition that provides the reader with a
general understanding of the term.
NJH suggested that the agency define chronic beryllium disease as a
disease ``characterized by evidence of granulomatous lung inflammation
in an individual who is sensitized to beryllium.'' According to NJH,
this definition would allow for diagnosis based on different
combinations of clinical evaluation results as detailed the ATS
Statement (Document ID 0022, p. 3). OSHA believes that the definition
the agency proposed--a chronic granulomatous lung disease caused by
inhalation of airborne beryllium by an individual who is beryllium
sensitized--conveys the substance of NJH's recommended definition while
also emphasizing that CBD results from the inhalation of airborne
beryllium. OSHA has therefore decided not to adopt the definition NJH
suggested.
The ATS expressed concern that OSHA's proposed changes to the
definition of chronic beryllium disease could create confusion in the
diagnosis of CBD because it may be challenging in certain settings to
identify sensitization and granulomatous lung disease based on lung
pathology (Document ID 0021, p. 5). DOSH similarly commented that the
proposed definition may be misleading because, although those with CBD
have sensitization to beryllium, the current testing for sensitization
has a high false-negative rate and individuals may be diagnosed with
CBD without first being confirmed positive for beryllium sensitization
(Document ID 0023, p. 2).
Although OSHA agrees that employees may be diagnosed with CBD
without confirmed positive BeLPT results, the agency does not agree
with these commenters that references to sensitization should be
excluded from the definition of chronic beryllium disease. OSHA first
notes that neither DOSH nor the ATS contend that OSHA's definition is
inaccurate. Furthermore, as OSHA explained previously in its discussion
of the beryllium sensitization definition, the agency believes that a
correct understanding of the relationship between beryllium
sensitization and CBD is key to workers' and employers' understanding
of many provisions of the beryllium standard. By stating the role that
sensitization plays in the development of CBD in the standard's
definition of chronic beryllium disease, OSHA intends to convey clearly
to the regulated community why protecting workers from becoming
beryllium sensitized is key to the prevention of CBD and why workers
who are confirmed positive for beryllium sensitization should be
offered both a clinical evaluation for CBD and medical removal
protection.
OSHA acknowledges that it is not always necessary to identify a
worker as confirmed positive for beryllium sensitization using the
BeLPT as part of a diagnosis of CBD and that the BeLPT can yield false-
negative results in some individuals. For this reason, an examining
physician should have the latitude to diagnose CBD even in the absence
of a ``confirmed positive'' pattern of BeLPT results. As explained in
the Summary and Explanation of paragraph (k)(7) of the 2017 final rule,
that provision gives the examining physician this latitude (82 FR 2704,
2709). Because the substantive provisions of the standard leave the
examining physician discretion in diagnosing CBD, OSHA does not agree
that acknowledging the role of beryllium sensitization in the
development of CBD will result in diagnostic confusion.
The NSSP recommended the following addition to OSHA's proposed
definition of chronic beryllium disease: ``The presence of interstitial
mononuclear cell (T cell) infiltrates (lymphocytosis) is characteristic
of chronic beryllium disease'' (Document ID 0027, pp. 3-4). The NSSP
argued that the presence of these infiltrates on lung biopsy indicates
the presence of chronic beryllium disease, and should therefore be
included in the standard's definition (Document ID 0027, p. 4). OSHA
disagrees. The agency believes that the term ``granulomatous''
sufficiently addresses the presence of T-cell infiltrates, which occur
at an early stage in the development of granulomas (82 FR at 2492-
2502). As discussed previously, OSHA's intent in defining chronic
beryllium disease is to provide the reader a general understanding of
what CBD is, rather than provide a technical definition for diagnostic
use. The suggested addition is not necessary to describe the nature of
CBD in general terms. With the addition of the term ``granulomatous,''
the definition is sufficiently specific for OSHA's purposes in the
context of paragraph (b).
In summary, for the purposes of this standard OSHA is defining
chronic beryllium disease as a chronic granulomatous lung disease
caused by inhalation of airborne beryllium by an individual who is
beryllium sensitized. This definition is identical to the definition of
chronic beryllium disease OSHA proposed in 2018 and includes only minor
changes from the definition included in the 2017 final standard. OSHA
is providing this definition to enhance stakeholders' general
understanding of the beryllium standard; it is neither intended nor
suitable to provide guidance to medical professionals on the diagnosis
of CBD. OSHA expects these changes to the 2017 definition of chronic
beryllium disease will clarify the standard, and will therefore
maintain safety and health protections for workers.
Confirmed positive.
OSHA is amending the definition of confirmed positive to mean (1)
the person tested has had two abnormal BeLPT test results, an abnormal
and a borderline test result, or three borderline test results,
obtained from tests conducted within a three-year period; or (2) the
result of a more reliable and accurate test indicating a person has
been identified as having beryllium sensitization. The revised
definition includes several changes to the 2017 definition of confirmed
positive and one change from the definition of confirmed positive that
OSHA proposed in the 2018 NPRM.
First, the agency is removing the phrase ``beryllium
sensitization'' from the first sentence of the definition, which
previously stated that a person is confirmed positive if that person
has beryllium sensitization, as indicated by two abnormal BeLPT test
results, an abnormal and a borderline test result, or three borderline
test results. OSHA intends that confirmed positive act only as a
trigger for requirements such as continued medical monitoring and
surveillance for the purposes of this standard, and not as a general-
purpose definition of beryllium sensitization. By removing the phrase
``beryllium sensitization'' from the first sentence of the definition,
the agency hopes to avoid confusion resulting from scientific
disagreements over whether certain test results, such as three
borderlines, necessarily prove that sensitization has occurred. For
purposes of the beryllium
[[Page 42604]]
standard, any worker with the BeLPT test results specified in the
definition of confirmed positive should be offered an evaluation for
CBD with continued medical surveillance as well as the option of
medical removal protection, even though some small percentage of
workers who are confirmed positive by this definition may not in fact
be sensitized to beryllium, as is the case for any diagnostic test
(Middleton et al., 2008 (Document ID OSHA-H005C-2006-0870-0480, p.
4)).\12\
---------------------------------------------------------------------------
\12\ In the preamble to the 2017 final rule, OSHA found that
three borderline BeLPT results recognize a change in a person's
immune system with respect to beryllium exposure based on Middleton
et al.'s 2011 finding that three borderline BeLPT results have a
positive predictive value (PPV) of over 90 percent (82 FR at 2501),
and therefore the agency included three borderline results in the
criteria for confirmed positive (82 FR at 2646).
---------------------------------------------------------------------------
Both the USW and Materion supported this proposed revision. The USW
stated that the former definition of confirmed positive had acted ``as
a de facto definition of sensitization'' and that removing the phrase
from this portion of the definition ensures that a finding of confirmed
positive will trigger medical surveillance and medical removal
protection ``without an intermediate stop at a finding of
sensitization'' (Document ID 0033, p. 5). Similarly, Materion commented
that the revised definition allows individuals with three borderline
BeLPT results to obtain the protections of the standard, including
evaluation for CBD and medical removal protection, without necessarily
being ``declared sensitized'' (Document ID 0038, p. 18). Materion
further asserted that the change enhances employee protection by
increasing the number of persons eligible for further testing (Document
ID 0038, p. 19).
NJH opposed the revised definition, asserting that the removal of
the phrase ``beryllium sensitization'' could prevent individuals who
meet the definition of being confirmed positive from being identified
as sensitized. NJH further expressed concern that this could make it
difficult for some workers to access the medical testing and workplace
protections required by the rule (Document ID 0022, p. 4).
The ATS and the AOEC also disagreed with the removal of the phrase
``beryllium sensitization'' from the definition of confirmed positive,
stating the medically accepted interpretation of BeLPT testing results
is that they indicate beryllium sensitization, and that removing this
phrase may cause confusion about what condition the term confirmed
positive refers to (Document ID 0021, p. 3; 0028, p. 2). The ATS
further stated without explanation that removing the term ``beryllium
sensitization'' from the definition of confirmed positive would reduce
worker protections.\13\ The NSSP also expressed disagreement with
OSHA's proposal to remove ``beryllium sensitization'' from the first
part of the confirmed positive definition, but did not state the
reasons for their concern (Document ID 0027, p. 3).
---------------------------------------------------------------------------
\13\ The ATS also asserted that the removal of the phrase
``beryllium sensitization'' would reduce workers' right to file for
worker's compensation (Document ID 0021, p. 3). The ATS did not
explain how the definition of confirmed positive in the beryllium
standard could affect worker's compensation claims and at least one
other commenter questioned the ATS's assertion (see Document ID
0038, p. 19). Regardless, OSHA intends the definition of confirmed
positive to serve only as a trigger for certain provisions of the
beryllium standard. How OSHA defines this phrase for purposes of the
beryllium standard in no way limits healthcare professionals'
ability or incentive to diagnose beryllium sensitization.
---------------------------------------------------------------------------
Following consideration of the concerns raised by these
organizations, OSHA disagrees that removing the phrase ``beryllium
sensitization'' from the first sentence of the definition of confirmed
positive will create confusion or reduce worker protections. The
provisions of the standard intended to benefit workers who may be
sensitized (evaluation at a CBD diagnostic center and medical removal
protection) are available to all workers who meet the definition of
confirmed positive. Therefore, removing the term ``beryllium
sensitization'' from the first sentence of the definition will not
change the access to these benefits for any workers. By removing the
term ``beryllium sensitization'' from the first sentence of the
definition, OSHA seeks to ensure that workers with three borderline
BeLPT results (or other patterns of test results that some physician or
other licensed health care professionals (PLHCPs) may consider
ambiguous) will receive the benefits of the standard regardless of
whether their PLHCP views their results as firm evidence of
sensitization. Furthermore, OSHA disagrees that removing the reference
to ``beryllium sensitization'' will lead to confusion about what the
BeLPT results are supposed to indicate because the second sentence of
the definition of confirmed positive makes clear that a worker who has
been diagnosed with beryllium sensitization would also meet the
definition of confirmed positive: ``It [confirmed positive] also means
the result of a more reliable and accurate test indicating a person has
been identified as having beryllium sensitization.''
An additional change to the definition of confirmed positive
provides that the findings of two abnormal, one abnormal and one
borderline, or three borderline results need to occur from BeLPTs
conducted within a three-year period. This change in the definition of
confirmed positive differs from the proposal and is based on comments
submitted to the record following publication of the 2018 NPRM.
The 2017 final rule did not specify a time limit within which the
BeLPT tests that contribute toward a finding of ``confirmed positive''
must occur. After publication of the 2017 final rule, stakeholders
suggested to OSHA that the definition of confirmed positive could be
interpreted as meaning that findings of two abnormal, one abnormal and
one borderline, or three borderline results over any time period, even
as long as 10 years, would result in the employee being confirmed
positive and automatically referred to a CBD diagnostic center for
evaluation. As discussed in the preamble to the 2017 standard, clinical
evaluation for CBD involves bronchoalveolar lavage and biopsy (82 FR at
2497) which, like all invasive medical procedures, carry risks of
infection and other complications.\14\ Given such risks, and the
possibility that some repeat abnormal or borderline results obtained
over a long period of time could be false positives, it was not the
agency's intent that workers with rarely recurring abnormal or
borderline BeLPT results should necessarily proceed to evaluation at a
CBD diagnostic center unless recommended to do so by their examining
physician. At the same time, OSHA notes that under paragraph
(k)(5)(iii), the licensed physician performing the BeLPT testing
retains the discretion to refer an employee to a CBD diagnostic center
if the licensed physician deems it appropriate, regardless of the BeLPT
result.
---------------------------------------------------------------------------
\14\ 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 (82 FR at
2497).
---------------------------------------------------------------------------
In the 2018 NPRM OSHA proposed that any combination of test results
specified in the definition of confirmed positive must result from the
tests conducted in one cycle of testing, including the initial BeLPT
and the follow-up retesting offered within 30 days of an abnormal or
borderline result (paragraph (k)(3)(ii)(E)). As outlined in proposed
paragraph (k)(3)(ii)(E), an employee would be offered a follow-up BeLPT
within 30 days if the initial test result is anything other than
normal, unless the employee had been confirmed positive (e.g., if the
initial
[[Page 42605]]
BeLPT was performed on a split sample and showed two abnormal results).
Thus, for example, if an employee's initial test result was abnormal,
and the result of the follow-up testing offered to confirm the initial
test result was abnormal or borderline, the employee would be confirmed
positive. Alternatively, if the result of the follow-up testing offered
to confirm the initial abnormal test result was normal, the employee
would not be confirmed positive. Any additional abnormal or borderline
results obtained from the next required BeLPT for that employee
(typically, two years later) would not identify that employee as
confirmed positive under the proposed modification to confirmed
positive. OSHA requested comments on the appropriateness of this
proposed time period.
Several stakeholders, including Materion, NJH, the ATS, DOSH, the
NSSP, the AOEC, the USW, and The American College of Occupational and
Environmental Medicine (ACOEM), submitted comments regarding OSHA's
proposal to require that the test results specified in the agency's
definition of confirmed positive must occur within a single testing
cycle. Commenters focused on several aspects of the proposed timing.
First, many of the comments focused on the logistics of OSHA's proposed
change. Materion supported the proposed definition of confirmed
positive, stating that a 30-day allowance for follow-up testing after a
first abnormal or borderline BeLPT result is appropriate to ensure that
testing is completed in a timely manner (Document ID 0038, p. 17).
However, NJH, the ATS, ACOEM, the USW, and the NSSP all indicated that
requiring results with a 30-day testing cycle could create logistical
challenges, for example due to repeat testing requirements or for
businesses in remote areas with limited healthcare facilities (Document
ID 0022, p. 4; 0021, p. 4; 0024, p. 1; 0033, p. 5; 0027, p. 3). In this
final rule and preamble, OSHA clarifies that it did not intend that the
initial and follow-up tests had to be completed and interpreted within
30 days. It intended that the test results used to determine if a
worker is confirmed positive be obtained during one cycle of testing
(i.e., an initial or periodic examination), including follow-up testing
conducted within 30 days of an abnormal or borderline result.
Secondly, stakeholders commented on the appropriateness of limiting
the use of the BeLPT from one test cycle in determining if a worker is
confirmed positive. Materion agreed with the proposed timing and
commented that the change ``increases employee protections by
establishing an employee as confirmed positive in a shorter time frame,
thus, making the medical removal benefit option available to the worker
in a more timely manner'' (Document ID 0038, p. 19). Stakeholders from
the medical community disagreed and raised concerns that limiting test
results to one test cycle would affect the ability to identify workers
who should be referred for a CBD evaluation and receive other
protections under the standard.
The NSSP cited data from healthcare providers to demonstrate that a
30-day testing cycle is insufficient to properly identify sensitized
workers. According to the NSSP, in over 20 years of conducting BeLPTs
in worker populations, Oak Ridge Associated Universities observed
approximate median times of 45 days (range of 3 days to 16 years)
between first and second abnormal tests, 1.5 years (range of 30 days to
11 years) for the abnormal/borderline test combination, and 1 year
(range of 30 days to 11 years) for three borderlines (Document ID 0027,
p. 3). Under the proposed 30-day requirement, the NSSP stated that the
majority of workers who have been identified as sensitized in the past
would not meet the proposed definition of confirmed positive (Document
ID 0027, p. 3).
NJH reported similar findings in new evidence submitted to the
record (Document ID 0022, pp. 4-5). The evidence indicates that many
workers who develop CBD have abnormal or borderline results that do not
immediately repeat upon retesting. To the contrary, many CBD patients
have a series of tests which alternate between normal and abnormal.
Data based on NJH's extensive experience show that the BeLPT does not
yield consistently abnormal results among CBD patients. Of 194 patients
diagnosed with CBD at NJH, the length of time between abnormal results
ranged from 14 days to 5.8 years, with a 95th percentile of 2.9 years.
In this group, 150 patients (or 77 percent) would not have been
evaluated for CBD if two abnormal BeLPT results were required to occur
within a 30-day testing cycle (Document ID 0022, p. 5).
Although the information the NSSP and NJH submitted to the record
is unpublished, their findings are consistent with published studies.
Kreiss et al. (1997) reported that nine individuals had initial
abnormal BeLPT results followed by two normal tests; six of those
individuals were re-tested approximately one year later and four were
confirmed positive for beryllium sensitization based on abnormal BeLPT
results (Document ID OSHA H005C-2006-0870-1360, pp. 610-12). These
findings suggest a high rate of false-negative results and are
consistent with results reported in a study by Stange et al. (2004).
That study found an average false-positive rate of 1.09 percent, and a
false-negative rate of 27.7 percent for the BeLPT (Document ID OSHA-
H005C-2006-0870-1402, p. 459).
Other public health organizations, including DOSH, the ATS, the
NSSP, and the AOEC, agreed with NJH that workers who are sensitized to
beryllium may show varying test results over time; and restricting the
time period for determining ``confirmed positive'' status to 30 days
would cause sensitized individuals to go undetected (Document ID 0023,
p. 2; 0021, p. 2; 0027, p. 3; 0028, p. 2). The ATS and the AOEC
recommended that results from tests performed up to at least three
years after the initial abnormal or borderline test result should be
used to determine whether the person tested is confirmed positive for
beryllium sensitization (Document ID 0021, p. 2; 0028, p. 2). The ATS
stated that a timeframe of at least three years, which encompasses two
rounds of regularly scheduled testing required biennially by the
beryllium standard, would adequately address its concerns regarding
logistical feasibility, would improve diagnostic accuracy, and help
ensure that sensitized workers are identified (Document ID 0021, p. 4).
The AOEC agreed that consideration of BeLPT test results obtained
during a time period of at least three years ``will increase the
potential that workers are accurately diagnosed with beryllium
sensitization [and] will receive the necessary care'' (Document ID
0028, p. 2).
The approaches recommended by the ATS and the AOEC are similar to
the approach NJH used in providing medical surveillance consultation to
workforces that use beryllium. NJH stated that, if an individual's
BeLPT results are abnormal and normal on their initial round of BeLPT
testing, they will usually request another BeLPT within a month. If the
result of that test is normal, they do not request further testing
until the next regularly scheduled BeLPT. If the result of the next
regularly scheduled BeLPT comes back abnormal, they refer the worker
for clinical evaluation even though the tests are separated by the two-
year testing cycle (Document ID 0022, p. 5).
Following consideration of the comments and of the new evidence
submitted to the record following the proposal, OSHA is convinced that
some workers who are ultimately found to be sensitized to beryllium or
diagnosed
[[Page 42606]]
with CBD may have alternating abnormal and normal BeLPT results, and
that the time period for abnormal or borderline results to repeat can
be months or years. OSHA is also convinced that requiring two abnormal,
an abnormal and borderline, or three borderline results to occur in one
cycle of an initial or periodic exam before an employee can be
confirmed positive could result in beryllium sensitization or CBD going
undetected in many employees. This is demonstrated by the unpublished
data submitted by NJH showing that a substantial percentage of
individuals with CBD (77 percent) may not have been referred for
further testing based on results obtained within a 30-day cycle of
testing and is confirmed by the experience of the NSSP. Therefore, OSHA
finds that its proposed change would have the unintended and
unacceptable consequence of reducing employee protections because some
employees who are sensitized or have CBD would be deprived of the
benefits available through the standard, such as a timely evaluation at
a CBD diagnostic center. In addition, requiring that results be
obtained in one test cycle is not consistent with the approaches
currently applied or supported by the medical community.
For these reasons, OSHA is revising the definition of confirmed
positive to specify that the findings of two abnormal, one abnormal and
one borderline, or three borderline results must be obtained from
BeLPTs conducted within a three-year period. OSHA agrees with the ATS
and the AOEC that a three-year period will facilitate the
identification of sensitized workers enrolled in medical surveillance
(see Document ID 0022, p. 5; 0028, p. 2). In addition, this approach is
consistent with the practices and recommendations from the medical
community, including NJH, which provides beryllium-related medical
surveillance consultation. OSHA believes that allowing a worker to be
confirmed positive based on BeLPT results obtained over a three-year
time period strikes a reasonable balance that would allow a timely
evaluation for CBD, while at the same time, maintaining OSHA's original
intent that a confirmed positive finding not be based on results
obtained over an indefinite time period.
OSHA emphasizes that this revision does not modify the requirements
of paragraph (k)(3)(ii)(E). Under that paragraph, if the results of the
BeLPT are other than normal, a follow-up BeLPT must be offered within
30 days of receiving the results, unless the employee has been
confirmed positive. Only other than normal BeLPT results must be
followed up within 30 days of the same test cycle (i.e., an initial or
periodic medical examination).
As an example, an employee who receives a borderline result during
one periodic examination conducted in 2020 would be retested within 30
days, and if the follow-up test is normal, testing would stop. That
employee would be offered another BeLPT at the next periodic
examination conducted in 2022. However, if the result of the 2022 test
is borderline, the employee would be retested within 30 days of that
test result receipt, and if the follow-up test is borderline, the
employee would be confirmed positive because of receiving three
borderline tests within three years. A three-year period for the
employee to be confirmed positive would ensure sufficient time for such
follow-up tests that may need to be conducted over two cycles of
medical examinations.
DOD recommended changing the term ``confirmed positive'' to another
term such as ``confirmed non-negative,'' ``confirmed finding of
concern,'' or ``pattern of concern.'' According to the DOD, the term
``confirmed positive'' typically ``implies an initial positive test
that was repeated with another test or another, more sensitive test,
which confirms the initial positive test result'' (Document ID 0029, p.
2). The CBD literature, however, commonly treats individuals as
confirmed positive for sensitization through sequentially conducted
BeLPTs (see, for example, the ATS Statement on Diagnosis and Management
of Beryllium Sensitivity and Chronic Beryllium Disease, ATS 2014,
Document ID OSHA-H005C-2006-0870-0364, p. e41; see also Document ID
OSHA-H005C-2006-0870-1543, 0603, 0398, 1403, 1449). Additionally, OSHA
again emphasizes that terms defined in the beryllium standard are
defined only for purposes of the standard and are not intended as
diagnostic, scientific, or all-purpose definitions. OSHA believes that
its definition of confirmed positive clearly indicates what that term
means for purposes of the beryllium standard and therefore disagrees
with DOD's concern that the term may cause confusion. Accordingly, OSHA
is retaining the term ``confirmed positive'' in this final standard.
Dermal contact with beryllium.
Paragraph (b) of this final rule defines dermal contact with
beryllium as skin exposure to (1) soluble beryllium compounds
containing beryllium in concentrations greater than or equal to 0.1
percent by weight; (2) solutions containing beryllium in concentrations
greater than or equal to 0.1 percent by weight; or (3) visible dust,
fumes, or mists containing beryllium in concentrations greater than or
equal to 0.1 percent by weight. The definition also states that
handling of beryllium materials in non-particulate solid form that are
free from visible dust containing beryllium in concentrations greater
than or equal to 0.1 percent by weight is not considered dermal contact
under the standard. Several of the standard's provisions are triggered
where an employee has, or can be reasonably expected to have, dermal
contact with beryllium. These include provisions in paragraph (f),
Written exposure control plan; paragraph (h), Personal protective
clothing and equipment (PPE); paragraph (i), Hygiene areas and
practices; paragraph (k), Medical surveillance; and paragraph (m),
Communication of hazards.
This final rule makes two changes to the previous definition, which
was added to the standard through the 2018 direct final rule (83 FR at
19940) following OSHA's promulgation of the final rule in January 2017.
That direct final rule defined dermal contact with beryllium as skin
exposure to soluble beryllium compounds, beryllium solutions, or dust,
fumes, or mists containing beryllium, where these materials contain
beryllium in concentrations greater than or equal to 0.1 percent by
weight (83 FR at 19940). First, this final rule modifies the definition
to refer to ``visible'' dust, fumes, or mists containing beryllium in
concentrations greater than or equal to 0.1 percent by weight. Second,
OSHA is adding a sentence to the definition specifying that handling
beryllium materials in non-particulate solid form that are free from
visible dust containing beryllium in concentrations greater than or
equal to 0.1 percent by weight is not considered dermal contact with
beryllium under the standard. This final rule's definition of dermal
contact with beryllium is identical to the definition that OSHA
proposed in the 2018 NPRM.
The revisions incorporated in this definition are intended to help
employers more accurately identify areas where the provisions triggered
by dermal contact apply. Based on feedback OSHA received from
stakeholders following publication of the 2017 final standard, OSHA
became concerned that employers might have difficulty accurately
identifying when and where the provisions triggered by dermal contact
are required. Beryllium-generating processes can release beryllium in
varying particle sizes and amounts, some of which are visible to the
naked eye and some of which are not. OSHA was concerned that
[[Page 42607]]
employers could reasonably interpret the provisions triggered by dermal
contact with beryllium (e.g., the use of PPE) as extending to every
employee who could potentially encounter a minute and non-visible
amount of beryllium particulate at its facility, irrespective of the
employee's job duties and tasks, or who might handle an object
containing beryllium. Such an interpretation would be contrary to
OSHA's intent and could prompt employers to attempt infeasible
compliance measures. Therefore, as explained in the 2018 NPRM, OSHA
proposed adding the term ``visible'' to clarify when skin exposure to
beryllium-containing dust, fumes, or mist should be considered dermal
contact with beryllium for the purpose of triggering the standard's
requirements. OSHA also proposed adding a sentence to state that
handling of beryllium materials in non-particulate solid form that are
free from visible dust containing beryllium in concentrations greater
than or equal to 0.1 percent by weight is not considered ``dermal
contact with beryllium'' under the standard.
Several commenters supported revising the definition of dermal
contact with beryllium to apply to visible particulate, agreeing that
the revised definition would facilitate compliance with the standard.
In its submission, Materion stated that the proposed change to the
definition ``clears up the ambiguity and eliminates the vagueness of
the [previous] . . . standard,'' and that
Revising the standard to provide employees as well as employers
clear lines will likely immeasurably help not only with compliance
but with enforcement of the standard. Without the visible cue,
employees will have no idea whether and when they should be
protected by PPE. . . . OSHA has fixed this problem with a sensible
and clear demarcation threshold for dermal contact, and has done so
in a manner that does not sacrifice protection against the risk of
CBD.
(Document ID 0038, p. 21). Similarly, the USW stated that dermal
exposure to beryllium needed to be ``properly addressed,'' but that
triggering provisions by dermal contact with materials containing
beryllium at any level ``could extend the application of the standard
far beyond what OSHA intended or what is necessary to protect workers''
(Document ID 0033, p. 4). The USW referred to non-sparking tools made
from beryllium-copper alloy and beryllium foil used for x-ray windows
as examples of materials where dermal contact should not trigger
provisions of the standard (Document ID 0033, p. 4).
Century Aluminum Company (Century Aluminum) (Document ID 0026, p.
2) and DOD (Document ID 0029, p. 1) also agreed with the proposal to
add the term ``visible'' to the definition. However, DOD recommended
that OSHA revise the definition to explicitly identify skin exposure to
``visible dust that has accumulated on surfaces'' in addition to
visible dust, fumes, or mists containing beryllium in concentrations
greater than or equal to 0.1 percent by weight. OSHA does not believe
this added phrase is necessary. The definition of dermal contact with
beryllium does not distinguish the exposure routes that cause the skin
exposure and, as proposed, the phrase ``visible dust'' encompasses
exposures via both air and surface contamination.
The ATS commented that adding ``visible'' to the definition to
trigger provisions related to dermal contact ``could be helpful,'' but
cautioned that inhalation of beryllium particulate that is not visible
is ``the major concern'' for developing CBD (Document ID 0021, p. 5).
It urged OSHA to ensure that the revised definition neither undermines
the requirements of the beryllium standard which limit exposure to
respirable beryllium, nor limits education on the health effects of
beryllium to only those workers with exposure to visible dust (Document
ID 0021, p. 5).
NJH objected to OSHA's proposal to restrict the definition to
visible dust, fumes, and mists, believing that doing so could reduce
employee protections from beryllium-induced sensitization and disease
(Document ID 0022 p. 7). NJH commented that the smallest respirable
particles are not visible and are inhaled into the deepest part of the
lung. It further commented that a ``monitoring program that routinely
samples all departments with air and wipe samples can accomplish
identifying `nonvisible' dust contamination and should be part of any
industry that needs to comply with an exposure limit'' (Document ID
0022, p. 7). Other commenters voiced similar concerns about the risk
posed by exposure to ultrafine particles containing beryllium,
including the NSSP (Document ID 0027, p. 3), the AOEC (Document ID
0028, p. 2), and DOSH (Document ID 0023, p. 2).
OSHA agrees that exposure to airborne beryllium, even when not
visible to the naked eye, is an important risk factor for developing
CBD and that it would be inappropriate to rely on the presence of
visible airborne particulate to assess workers' exposure to airborne
beryllium and the need to implement engineering and work practice
controls or respiratory protection. The standard's permissible exposure
limits and requirements for quantitative exposure assessments and use
of respiratory protection are of paramount importance for ensuring that
workers are protected from CBD, and these requirements are unaffected
by the changes to the dermal contact with beryllium definition. In
addition, the standard's requirements to train workers on the health
hazards of exposure to beryllium and on the employer's exposure control
plan (paragraph (m)(4)) apply to all employees within the scope of the
general industry standard who have, or can reasonably be expected to
have, airborne exposure (regardless of the size fraction) to or dermal
contact with beryllium, thus including all workers that would be
considered to be potentially at risk of beryllium-related disease.\15\
---------------------------------------------------------------------------
\15\ NJH also asserted that ``[a]ll workers in a beryllium using
industry should receive beryllium education with programs tailored
to specific jobs and processes'' (Document ID 0022, p. 7). Mount
Sinai Selikoff Centers for Occupational Health similarly advocated
for ``intensive training and protective gear for all workers who may
be at risk of beryllium exposure'' (Document ID 0032, p. 3). OSHA
notes that the beryllium standard has never required all workers in
a beryllium-using industry to receive training. Rather, the standard
has always required training for those workers who have or are
reasonably expected to have airborne exposure to beryllium
regardless of the size fraction. The standard continues to require
training for all such workers.
---------------------------------------------------------------------------
DOSH advocated for surface sampling as being a ``practical method''
for assessing exposure and asserted that adopting a ``specific
numerical surface contamination criterion'' to assess dermal contact
hazard was a more protective strategy. DOSH further suggested that, in
establishing this numerical criterion, OSHA ``consider levels that
could result in uptake of beryllium by workers at rates similar to
action level airborne exposures'' (Document ID 0023, p. 2).
With respect to inhalation hazards associated with beryllium, OSHA
agrees that relying on the visibility of particulate does not
adequately protect workers from CBD or lung cancer, and that both
conducting routine air sampling and ensuring no employees are exposed
to airborne beryllium in excess of the PELs are essential to minimizing
workers' exposures to airborne particulate. The TWA PEL for beryllium
is based on robust evidence from studies of beryllium workers that
permitted the agency to determine that there is significant risk of
sensitization, CBD, and lung cancer associated with the previous TWA
PEL, and that this
[[Page 42608]]
risk would be substantially reduced by the new PEL (82 FR at 2545-52).
Unlike the case for inhalation, the available data on the effects
of dermal contact with beryllium make it difficult to establish a
reasonably precise, objective limit on surface contamination above
which protective measures should be triggered. The most recent effort
to derive a health-based measure of surface cleanliness for beryllium
was that of Shay et al. (Document ID H005C-2006-0870-0417), who used
models that accounted for particulate dissipation, resuspension into
air, transfer efficiency from surface to skin, dermal absorption of
particulate through intact or damaged skin, and other factors. The
authors used these models along with both oral and inhalation toxicity
values derived by the Environmental Protection Agency to relate the
level of surface contamination to target risk values for cancer and
noncancer effects that would generally be considered to be de minimis
(i.e., an exposure associated with either a lifetime cancer risk of one
death per million persons exposed, or no excess risk of adverse
noncancer effects). After accounting for these factors, the resulting
surface dust cleanup criteria for each health endpoint ranged over
several orders of magnitude, reflecting a high degree of uncertainty
(for the noncancer endpoint, the criteria ranged from 5 to 370
[micro]g/cm\2\ for damaged skin, and from 17 to 3,337 [micro]g/cm\2\
for intact skin; for cancer, the criteria ranged from 51 to 485
[micro]g/cm\2\).
This study illustrates the difficulty in establishing a reliable
and objective risk-based limit on surface contamination that could be
used to trigger measures that would prevent dermal contact with
beryllium particulate when such contact is sufficient to contribute to
a significant risk of disease. Absent an objective measure, OSHA finds
that it is preferable to base the definition of dermal contact with
beryllium on a clear, qualitative indicator of when dermal contact is
occurring or is reasonably anticipated to occur so that employers can
have assurance that they are in compliance with the provisions that are
triggered by dermal contact. Accordingly, the final rule's definition
of dermal contact with beryllium refers to skin exposure to visible
dusts, fumes, or mists, as well as to soluble compounds and solutions
of beryllium, as was proposed. As stated above, OSHA expects that
revisions in this final rule will maintain worker protections.
NJH also objected to defining dermal contact with beryllium when
handling finished beryllium products only by the presence of visible
dust, asserting that gloves are warranted because beryllium could
oxidize on the surface (Document ID 0022, p. 7). However, for the
reasons explained below, OSHA considers these comments to be beyond the
scope of the proposal. The agency also notes that the revision NJH's
comment refers to merely clarifies the meaning of the 2017 standard,
rather than modifying it substantively.
OSHA's revision to the definition of dermal contact with beryllium
clarifies OSHA's intent that the provisions in the standard related to
dermal contact with beryllium do not apply to the handling of solid
beryllium-containing objects that the employer does not process, unless
visible beryllium particulate has contaminated the surface of the
object. OSHA explained in the 2017 final rule that beryllium-containing
solid objects, or ``articles,'' with uncompromised physical integrity
are unlikely to release beryllium that would pose a health hazard for
workers (82 FR at 2640). An article, by definition, ``under normal
conditions of use does not release more than very small quantities,
e.g., minute or trace amounts of a hazardous chemical . . . , and does
not pose a physical hazard or health risk to employees'' (29 CFR
1910.1200(c)). The agency therefore excluded articles that contain
beryllium, and that the employer does not process, from the scope of
the 2017 beryllium standard (see paragraph (a)(3)). OSHA did not intend
for the 2018 NPRM to open the agency's underlying findings on the
handling of beryllium-containing articles, nor their exclusion from the
scope of the standard, for notice and comment. To the extent NJH's
comment challenges the articles exemption, these comments are beyond
the scope of the proposal.
Nevertheless, even for those solid beryllium-containing objects
that do not fall under the definition of an article, such as ingots
that might be processed further, OSHA notes that PPE would be required
if there is a reasonable expectation that oxidation may result in
visible surface contamination. In its comments on the 2015 NPRM,
Materion explained that beryllium oxides are created through particular
manufacturing processes, typically those involving heating of the
beryllium-containing materials (e.g., hot forming operations, melting,
or heat treating) (see Document ID OSHA-H005C-2006-0870-1662, p. 16).
These operations may give rise to a reasonable expectation of dermal
contact due to the expected oxidization that will occur as a result of
the process. Where there is a reasonable expectation that oxidization
may result in visible surface contamination, an employer must not wait
for the surface to be contaminated to require PPE for potentially
exposed employees. For example, if the surface of a solid object must
be heat treated, and the employer has reason to believe this will
result in surface oxidation absent cleaning the surface, PPE would be
required under this final rule.
After carefully considering the record of public comments on this
topic, OSHA finds that the revised definition of dermal contact with
beryllium will provide a clearer and more workable definition, without
reducing worker protections. The specification of ``visible dust,
fumes, or mists containing beryllium in concentrations greater than or
equal to 0.1 percent by weight'' and clarification regarding beryllium-
containing articles will allow employers to accurately identify the
employees, particularly those working outside of beryllium work areas
or regulated areas, to whom the provisions triggered by dermal contact
with beryllium apply, including the requirement in paragraph (h) to
provide employees with PPE to protect against reasonably expected
dermal contact with beryllium. The revised definition will also render
more workable the additional provisions in the standard that are
triggered by dermal contact with beryllium, which include provisions in
paragraph (f), Written exposure control plan; paragraph (i), Hygiene
areas and practices; paragraph (k), Medical surveillance; and paragraph
(m), Communication of hazards.
This final rule better addresses the practical aspects of a
``reasonable expectation'' trigger for PPE than did the previous rule,
which could have been read as effectively requiring employees to wear
PPE facility-wide, even when not in proximity to beryllium generating
processes, such as in administrative offices. OSHA believes that use of
PPE in that circumstance is unwarranted and would not meaningfully
enhance worker protections against beryllium exposure. Where an
employer has a reasonable expectation that even very small amounts of
beryllium dust, fume, or mist might spread outside of beryllium work
areas, they might have interpreted the language of the previous rule to
require all employees in the facility to wear PPE all of the time. OSHA
did not intend and did not cost the previous rule as requiring PPE to
protect against dermal contact with non-visible beryllium dust, fumes,
or mists outside of beryllium work areas. The addition of a visual cue
will enable employers to accurately identify the employees outside of
beryllium work
[[Page 42609]]
areas who need to wear PPE due to their reasonably-expected dermal
contact with beryllium.
As OSHA explained in the 2018 NPRM (83 FR at 63752), the agency
expects that the use of PPE will always be required in beryllium work
areas because both the operations listed in Appendix A and those that
can be reasonably expected to generate exposure at or above the action
level would create a reasonable expectation of dermal contact with
beryllium. This expectation is based, in part, on a study conducted by
NIOSH and Materion and published in the Journal of Occupational and
Environmental Hygiene (Document ID OSHA-H005C-2006-0870-0502, p. 791).
In the 2018 NPRM, OSHA explained that this study identified a strong
correlation between airborne beryllium concentrations and the amount
measured on gloves worn by workers at multiple beryllium facilities and
jobs, indicating the potential for skin exposure where airborne
beryllium is present. The study further concluded that this correlation
implies that one type of measurement can be indicative of other
exposure pathways (Document ID OSHA-H005C-2006-0870-0502, p. 791). OSHA
further explained that the expectation of dermal contact within
beryllium work areas is also based on OSHA's review of data collected
during site visits conducted by the agency that cover a wide range of
processes (e.g., furnace and melting operations, casting, grinding/
deburring, machining and stamping) and a wide range of materials
including beryllium composite, beryllium alloy, and beryllium oxide.
The data show that those operations that would create a reasonable
expectation of dermal contact, either through beryllium surface
contamination or skin contamination, are covered either by proposed
Appendix A or have exposures above the action level (see Document ID
OSHA-H005C-2006-0870-0341).
In its comment, Materion questioned OSHA's reliance on the 2007 Day
et al. study (82 FR at 2488-89) and suggested that, contrary to OSHA's
statement, Day did not identify a ``strong correlation'' between
airborne concentrations and skin exposure (Document ID 0038, pp. 13-
14). Materion cited Day's finding of a potential for greater transfer
of beryllium from surfaces to cotton gloves that could lead to an
overestimation of the amount of beryllium transferred. OSHA disagrees
with Materion's assessment of the Day study. Day indicates that the
underlying assumption that glove-sampling techniques actually remove
the majority of the contamination may be overstated and that the
surface and skin wipe samples may underestimate the mass of beryllium
that is present. The Day study demonstrates that there is a correlation
between airborne and potential for skin exposures (Document ID OSHA-
H005C-2006-0870-1548, p. 79).
As OSHA discussed in the NPRM, this finding is supported by a
follow-up study by Armstrong et al. (2014) conducted at four different
Materion manufacturing locations over a wide variety of jobs. This
study also showed strong positive correlations between air, dermal, and
surface exposures among the four different facilities that process
beryllium (Document ID OSHA-H005C-2006-0870-0502, p. 791). The study
further concludes that this correlation implies that one type of
measurement can be indicative of other exposure pathways. OSHA finds
that these studies demonstrate a correlation between airborne exposure
and the reasonable expectation of dermal contact.\16\
---------------------------------------------------------------------------
\16\ Materion also asserted that the evidence in the record is
insufficient to conclude that ``dermal contact alone is sufficient
to create a significant risk of CBD or even beryllium
sensitization'' (Document ID 0038, pp. 14-15). However, in the 2017
final rule, OSHA specifically found that that dermal exposure can
result in sensitization (see 82 FR at 2489). The 2018 NPRM did not
propose revisiting this finding.
---------------------------------------------------------------------------
In the 2018 NPRM, OSHA specifically requested comments on whether
processes exist that could trigger the creation of a beryllium work
area, but could be reasonably expected to release only non-visible
beryllium-containing dusts, fumes, or mists. No commenter provided
evidence of such processes. Materion asserted that OSHA should not
``automatically classify'' beryllium work areas as having a reasonable
expectation of dermal contact because this would serve as ``a serious
disincentive for employers to eliminate exposure meeting the definition
of dermal contact'' (Document ID 0038, p. 15). However, Materion did
not explain how such a presumption would serve as a disincentive and,
more importantly, did not identify any process that could trigger the
creation of a beryllium work area while not also, in fact, creating a
reasonable expectation of dermal contact.
Accordingly, OSHA reaffirms its expectation that both the
provisions associated with beryllium work areas (listed above) and the
provisions associated with dermal contact with beryllium would apply to
employees in a beryllium work area. OSHA expects that employers will,
for each beryllium work area, assess the PPE needs as required by
paragraph (f)(1) and OSHA's Personal Protective Equipment standards
(subpart I of 29 CFR 1910) and provide their employees with appropriate
PPE.
Because it will help employers identify which employees have, or
can be reasonably expected to have, dermal contact with beryllium, the
revised definition will allow employers to more accurately comply with
the requirement in paragraph (f)(1)(i)(A) to establish, implement, and
maintain a written exposure control plan that includes a list of
operations and job titles reasonably expected to involve airborne
exposure to or dermal contact with beryllium. OSHA expects that the
list would likely include all operations and job titles in beryllium
work areas, along with any additional operations or job titles for
employees whose skin could be exposed to visible beryllium dust, fumes,
or mists in concentrations of 0.1 percent by weight or more. Under the
previous definition, employers could have reasonably interpreted the
standard as requiring them to list the job title for every employee at
the facility who could come into contact with a minute and non-visible
amount of beryllium particulate, including employees who do not work in
proximity to beryllium-releasing processes.
Similarly, the revised definition will facilitate employer
compliance with the requirement to provide information and training (in
accordance with the Hazard Communication standard (29 CFR 1910.1200(h))
to each employee who has, or can reasonably be expected to have,
airborne exposure to or dermal contact with beryllium by the time of
the employee's initial assignment and annually thereafter (paragraphs
(m)(4)(i)(A)-(C)). Under this requirement, employees entitled to
training include all employees who work in beryllium work areas and any
other employees who may not be working directly with a beryllium-
generating process, but who may nonetheless reasonably be expected to
have airborne exposure to and/or skin contact with soluble beryllium,
beryllium solutions, or visible beryllium dust, fumes, or mists in
concentrations of 0.1 percent by weight or more. As discussed
previously, OSHA intends the revised definition of dermal contact with
beryllium to provide employers with a workable indicator for
determining which employees outside of beryllium work areas should
receive this information and training.
Because the change would allow employers to more accurately
identify areas where provisions related to dermal contact should apply,
the revised
[[Page 42610]]
definition would also facilitate proper compliance with paragraph
(i)(1)(ii), which requires employers to ensure employees who have
dermal contact with beryllium wash any exposed skin at the end of the
activity, process, or work shift and prior to eating, drinking,
smoking, chewing tobacco or gum, applying cosmetics, or using the
toilet. OSHA's revisions to the definition of dermal contact with
beryllium would prevent employers from speculating that all employees
in a facility, including those employees who do not work near
beryllium-releasing processes, must wash their exposed skin because
they might have come into contact with non-visible beryllium
particulate or handled articles that contain beryllium. Such an
interpretation would be contrary to OSHA's intent.
The revised definition is designed to further improve employer
compliance with the requirements in paragraph (k) to offer employees a
medical examination including a medical and work history that
emphasizes past and present airborne exposure to or dermal contact with
beryllium (paragraph (k)(3)(ii)(A)), and to provide the examining
physician or other licensed health care professional (PLHCP) (and the
agreed-upon CBD diagnostic center, if such an evaluation is required)
with a description of the employee's former and current duties that
relate to the employee's airborne exposure to and dermal contact with
beryllium (paragraph (k)(4)(i)). Because it would improve employers'
ability to identify when dermal contact with beryllium has occurred or
could occur, this change would permit employers to accurately complete
employee medical and work histories and the reports that they must
provide to examining PLHCPs or CBD diagnostic centers. As with the
provisions discussed above, OSHA's revisions to the definition of
dermal contact with beryllium will prevent employers from including
superfluous information in these medical and work histories and reports
because they are concerned that an employee might have conceivably had
skin contact with minute, non-visible beryllium particulate or handled
beryllium-containing articles outside of a beryllium work area. Such an
expansive interpretation is again contrary to OSHA's intent.
OSHA is adding two references to dermal contact with beryllium in
paragraph (i), Hygiene areas and practices, to account for the final
rule's changes to the definition of beryllium work area in paragraph
(b). Paragraph (i) in the previous rule included requirements for
employers to provide each employee working in a beryllium work area
with readily accessible washing facilities (paragraph (i)(1)(i)) and a
designated change room where employees are required to remove their
personal clothing (paragraph (i)(2)). But, as explained earlier in this
section, OSHA is revising the definition of beryllium work area so that
the requirement to establish these areas is no longer triggered on the
potential for dermal contact with beryllium.
OSHA intends for the washing facilities and change rooms
requirements to apply where employees are reasonably expected to have
dermal contact with beryllium, regardless of whether they work in a
beryllium work area, as now defined in this final rule. As discussed
above, there may be employees outside of the beryllium work area that
may have a reasonable expectation of dermal contact with beryllium.
Therefore, as was proposed, OSHA is adding two additional references to
dermal contact with beryllium to paragraph (i). First, OSHA is revising
paragraph (i)(1) so that the requirements would apply to each employee
who works in a beryllium work area or who can reasonably be expected to
have dermal contact with beryllium. Paragraph (i)(1)(i) would then
require employers to provide washing facilities to all employees who
can be reasonably expected to have dermal contact with beryllium.
Second, OSHA is revising paragraph (i)(2) so that employers are
required to provide change rooms to employees who are required to use
personal protective clothing or equipment under paragraph (h)(1)(ii),
if those employees are required by the employer to remove their
personal clothing. Because paragraph (h)(1)(ii) requires the use of PPE
where there is a reasonable expectation of dermal contact with
beryllium, the change to paragraph (i)(2) ensures that the requirement
for change rooms would continue to protect those employees who can
reasonably be expected to have dermal contact with beryllium.
Methods of Compliance.
Paragraph (f) of the beryllium standard for general industry
contains provisions covering methods for reducing employee exposure to
beryllium through the use of a written exposure control plan and
engineering and work practice controls. Paragraph (f)(1) sets forth the
requirements for written exposure control plans. Paragraph (f)(1)(i)
requires employers to establish, implement, and maintain such a plan,
and paragraphs (f)(1)(i)(A)-(H) specifies the information and
procedures that must be included in the plan. Paragraph (f)(1)(ii)
directs employers to review and evaluate each plan at least annually
and update it under specified circumstances.
In the 2018 NPRM, OSHA proposed two wording changes to paragraph
(f)(1) (83 FR at 63754). The first proposed change relates to the
contents of the written exposure control plan. Under paragraph
(f)(1)(i)(D), employers were previously required to include procedures
in their plans for minimizing cross-contamination, ``including
preventing the transfer of beryllium'' between surfaces, equipment,
clothing, materials, and articles within beryllium work areas. OSHA
proposed removing the word ``preventing'' from the regulatory text to
clarify that these procedures may not totally eliminate the transfer of
beryllium, but should minimize cross-contamination of beryllium,
including between surfaces, equipment, clothing, materials, and
articles.
The second proposed change involves one of the circumstance when
employers must update their written exposure control plans. Paragraph
(f)(1)(ii)(B) of the standard directed employers to update the written
exposure control plan, as necessary, when they are notified that an
employee is eligible for medical removal in accordance with paragraph
(l)(1), referred for evaluation at a CBD diagnostic center, or shows
signs or symptoms associated with ``airborne exposure to or dermal
contact with beryllium.'' In the 2018 NPRM, OSHA proposed to replace
the phrase ``airborne exposure to and dermal contact with beryllium''
with ``exposure to beryllium.'' The agency explained that the change
would simplify the language of the provision while still capturing all
potential exposure scenarios currently covered. Because these proposed
changes are merely clarifying, OSHA explained that it expected that
they would maintain safety and health protections for workers.
All of the stakeholders that submitted comments related to OSHA's
proposed changes to the written exposure control plan provisions
supported the changes (see, e.g., Document ID 0031, p. 2; 0038, p. 31).
For example, EEI observed that OSHA's discussion of the proposed
changes were appropriate modifications to the beryllium standard
(Document ID 0031, p. 2). Materion also supported the proposed changes
and agreed with OSHA that these proposed changes are merely clarifying,
and that they will maintain safety and health protections for
employees. In addition, Materion noted that it ``identifie[d] no
reduction
[[Page 42611]]
in protection to employees associated with these clarifying language
revisions'' (Document ID 0038, p. 31).
After reviewing these comments and considering the record as a
whole, OSHA has determined that the proposed changes will clarify for
employers the requirements of the written exposure control plan without
sacrificing safety and health protections for workers. Therefore, OSHA
is finalizing the proposed changes to paragraph (f) in this final rule.
Personal Protective Clothing and Equipment.
Paragraph (h) of the beryllium standard for general industry
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, or where there
is a reasonable expectation of dermal contact with beryllium. Paragraph
(h) also contains provisions for the safe removal, storage, cleaning,
and replacement of the PPE required by this standard. As explained in
the 2017 final rule preamble, these PPE requirements are intended to
protect employees by preventing dermal exposure to beryllium and the
accumulation of airborne beryllium on PPE, and to protect employees and
other individuals both inside and outside the workplace from exposures
that could occur if contaminated clothing were to transfer beryllium
(82 FR at 2678).
In the 2018 NPRM, OSHA proposed two changes to paragraph (h). The
first revision relates to paragraph (h)(2)(i), which addresses removal
and storage of PPE. Paragraph (h)(2)(i) previously required employers
to ensure that each employee removes all beryllium-contaminated PPE at
the end of the work shift, ``at the completion of tasks involving
beryllium,'' or when PPE becomes visibly contaminated with beryllium,
whichever comes first. OSHA proposed modifying the phrase ``at the
completion of tasks involving beryllium'' by changing ``tasks'' to
``all tasks,'' so that it reads ``at the completion of all tasks
involving beryllium'' (83 FR at 63754).
OSHA explained in the 2018 NPRM that this revision to paragraph
(h)(2)(i) merely clarifies the trigger for when employees must remove
beryllium-contaminated PPE, consistent with the agency's original
intent (83 FR at 63754). As expressed in the preamble to the 2017 final
rule, OSHA intended that PPE contaminated with beryllium should not be
worn after tasks involving beryllium exposure have been completed for
the day (82 FR at 2682). Thus, when employees perform multiple tasks
involving beryllium successively or intermittently throughout the day,
the employer must ensure that each employee removes all beryllium-
contaminated PPE at the completion of the set of tasks involving
beryllium, not necessarily after each separate task. If, however,
employees perform tasks involving beryllium exposure for only a portion
of a work shift, and then perform tasks that do not involve exposure to
beryllium, the employer must ensure that employees remove their PPE
after the beryllium exposure period. Unless the PPE becomes visibly
contaminated with beryllium, OSHA did not intend this provision to
require multiple PPE changes throughout the work shift. Thus, the
proposed revision to paragraph (h)(2)(i) clarifies OSHA's original
intent.
OSHA received multiple comments in support of the proposed change
to paragraph (h)(2)(i). The USW commented that it believes the change
is reasonable and clarifies the intent of the standard (Document ID
0033, p. 6). Similarly, Century Aluminum expressed its support for this
``sensibl[e]'' revision, commenting that it is an example of a logical
and workable requirement that will produce better work practices and
habits and, in turn, improve employee health and safety outcomes
(Document ID 0026, p. 2). In addition, Century Aluminum commented that
requiring PPE to be changed after every task would ``significantly
increase costs without increasing employee health and safety'' and
could actually increase the amount of time employees are exposed to
beryllium, thus increasing their risk of sensitization and disease
(Document ID 0026, p. 2). Materion also expressed its general support
for the ``clarifying language revisions'' to paragraph (h) (Document ID
0038, p. 32).
OSHA also received two comments opposing the proposed change to
paragraph (h)(2)(i). A private citizen commented that, although OSHA
did not intend to require continuous PPE changes throughout a work
shift, doing so seemed necessary to limit transmission of contaminant
between workers and work areas (Document ID 0017). And another private
citizen commented that if a worker's suit is contaminated, the worker
should be required to change even if the suit is not visibly
contaminated (Document ID 0019).
OSHA does not believe it is necessary for workers to change PPE
after each work task, or after each instance of PPE contamination, in
order to limit the spread of beryllium particulate between work areas
because, absent visible contamination of PPE, any contamination present
will likely be minute and will not contaminate other work areas to such
a degree as to materially increase worker exposures. Furthermore, as
explained in the preamble to the 2017 final rule (82 FR at 2682),
because the purpose of PPE is to serve as a barrier between an
employee's body and ambient or surface beryllium, PPE becomes
contaminated with beryllium immediately as part of its protective
function. Requiring PPE to be changed upon contamination with any
amount of beryllium is unreasonable and unnecessary to protect
employees. This is because contamination of PPE with beryllium during
work processes does not reduce the effectiveness of PPE or create
hazards to employees unless sufficient beryllium accumulates on the PPE
to impair its function or create additional exposures, such as by
dispersing accumulated beryllium into the air. Moreover, the process of
changing contaminated PPE can create opportunities for both inhalation
exposure and dermal contact with beryllium. Accordingly, the use of
``visibly contaminated'' protects employees from potential exposures
while changing PPE by limiting the requirement to change PPE during
work tasks involving beryllium exposure to those circumstances when
changing it is necessary to maintain its protective function and
prevent deposits of beryllium from accumulating and dispersing.
Notably, the USW commented that it believes including the term
``visibly contaminated'' in the provision provides for employee safety
(Document ID 0033, pp. 6-7), and Materion similarly stated that
``visibility [of beryllium-contaminated PPE and equipment] is a
conservative, stringent'' trigger that ``also has the benefit of
compliance clarity'' (Document ID 0038, p. 32). After reviewing these
comments and considering the record as a whole, OSHA finds that the
proposed change in paragraph (h)(2)(i) is reasonably necessary and
appropriate and has retained the revised language in the final rule.
The second proposed revision relates to paragraph (h)(3)(iii),
which addresses cleaning and replacement of PPE. This paragraph
required employers to inform in writing the persons or the business
entities who launder, clean, or repair the PPE required by this
standard of the potentially harmful effects of ``airborne exposure to
and dermal contact with beryllium.'' The 2018 NPRM proposed replacing
the phrase ``airborne exposure to and dermal contact with beryllium''
[[Page 42612]]
with ``exposure to beryllium'' (83 FR at 63755). OSHA explained that
this change simplifies the language of the provision while still
capturing all potential exposure scenarios currently covered; and, as
such, the agency concluded that the revised language will maintain
safety and health protections for workers. OSHA received no comments on
this proposed change beyond Materion's general support for the
clarifying revisions to paragraph (h) as a whole (Document ID 0038, p.
32). OSHA is therefore retaining the proposed revision to paragraph
(h)(3)(iii) in the final rule.
Hygiene Areas and Practices.
Paragraph (i) of the beryllium general industry standard requires
that the employer provide employees with readily accessible washing
facilities, change rooms, and showers when certain conditions are met;
requires the employer to take certain steps to minimize exposure in
eating and drinking areas; and prohibits certain practices that may
contribute to beryllium exposure. As explained in the 2017 final rule,
OSHA believes that strict compliance with these provisions will reduce
the amount and duration of employees' airborne exposure and dermal
contact with beryllium (82 FR at 2683-88).
In the 2018 NPRM, OSHA proposed three changes to paragraph (i) of
the general industry standard. The agency proposed the first two
changes (83 FR at 63755), which apply to paragraphs (i)(1) and (i)(2),
to maintain the protections included in these paragraphs for employees
who have dermal contact with beryllium notwithstanding the proposed
change to the definition of beryllium work area, discussed previously
in this Summary and Explanation. OSHA proposed the third change, which
applies to paragraph (i)(4), to clarify the requirements for cleaning
beryllium-contaminated PPE prior to entering an eating or drinking area
(83 FR at 63755-56).
As explained in the previous discussion of changes to the
definition of beryllium work area, OSHA proposed and has finalized
these changes to the definition of beryllium work area to clarify where
a beryllium work area must be established. One of these changes removes
dermal contact with beryllium as one of the triggers that requires an
employer to establish a beryllium work area. As explained in the 2018
NPRM, OSHA intended for the hygiene provisions related to washing
facilities and change rooms to continue to apply to all employees who
can reasonably be expected to have dermal contact with beryllium,
regardless of whether they work in beryllium work areas as defined in
the revised definition (83 FR at 63755). OSHA accordingly proposed two
changes.
First, OSHA proposed a change in the wording of paragraph (i)(1),
which required that ``[f]or each employee working in a beryllium work
area,'' the employer must provide readily accessible washing facilities
to remove beryllium from the hands, face, and neck; and ensure that
employees who have dermal contact with beryllium wash any exposed skin
at specific designated times. The 2018 NPRM proposed amending the
language to apply to ``each employee . . . who can reasonably be
expected to have dermal contact with beryllium,'' in addition to each
employee working in a beryllium work area (83 FR at 63768).
Second, OSHA proposed a change in the wording of paragraph (i)(2),
which required employers to provide ``employees who work in a beryllium
work area,'' with a designated change room where employees are required
to remove their personal clothing. OSHA proposed revising paragraph
(i)(2) to require employers to provide a designated change room to
employees who are required to use personal protective clothing or
equipment under paragraph (h)(1)(ii) of the beryllium standard, instead
of to employees who work in a beryllium work area (83 FR at 63768).
Paragraph (h)(1)(ii) of the beryllium standard requires the provision
and use of appropriate PPE where there is a reasonable expectation of
dermal contact with beryllium. The requirement to provide change rooms
would continue to apply only where employees are required to remove
their personal clothing. As noted above and explained in the 2018 NPRM,
the proposed changes to paragraphs (i)(1) and (i)(2) were merely
intended to ensure that the hygiene provisions related to washing
facilities and change rooms would continue to protect employees who are
reasonably expected to have dermal contact with beryllium, if the
agency adopted the proposed revised definition of the term beryllium
work area.
OSHA also proposed a third change, which applies to paragraph
(i)(4), in order to clarify the requirements for cleaning beryllium-
contaminated PPE prior to entering an eating or drinking area.
Paragraph (i)(4)(ii) required the employer to ensure that no employees
enter any eating or drinking area with beryllium-contaminated personal
protective clothing or equipment unless, prior to entry, 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.
In the 2018 NPRM, OSHA proposed to modify this paragraph to require the
employer to ensure that, before employees enter an eating or drinking
area, beryllium-contaminated PPE is cleaned, as necessary, to be as
free as practicable of beryllium by methods that do not disperse
beryllium into the air or onto an employee's body (83 FR at 63768). The
agency explained that this proposed change would clarify that OSHA does
not expect the methods used to clean PPE prior to entering an eating or
drinking area to completely eliminate residual beryllium from the
surface of the PPE if complete elimination is not practicable (83 FR at
63755-56). OSHA also explained that this is consistent with its
determination, expressed in the preamble to the 2017 final rule, that
``as free as practicable'' is ``the most appropriate terminology for
requirements pertaining to surface cleanliness'' (82 FR at 2687). This
proposed clarification also aligns the language of paragraph (i)(4)(ii)
with the language of paragraph (i)(4)(i), which requires employers to
ensure that beryllium-contaminated surfaces in eating and drinking
areas are as free as practicable of beryllium. Finally, OSHA explained
that requiring cleaning only ``as necessary'' would clarify that
cleaning would not be required if the PPE is already as free as
practicable of beryllium. OSHA stated that it expected these proposed
changes to paragraph (i) would maintain safety and health protections
for workers.
Commenters expressed broad support for OSHA's proposed changes to
paragraph (i) (see, e.g., Document ID 0029, p. 1; 0031, p. 2; 0033, p.
6; 0038, p. 32). For example, EEI observed that the proposed changes to
this paragraph as a whole were appropriate modifications to the
beryllium standard (Document ID 0031, p. 2) and DOD generally agreed
with the proposed changes, commenting that they are evidence based and
provide greater employee protections (Document ID 0029, p. 1). Materion
also supported the proposed changes to paragraph (i) as a whole, and
agreed with OSHA that these proposed changes are merely clarifying, and
that they will maintain safety and health protections for employees
(Document ID 0038, p. 32; see also Document ID 0034 and 0035, p. 1
(supporting and endorsing the comments submitted by Materion)).
OSHA did not receive any comments that specifically addressed the
two proposed changes to paragraphs (i)(1) and (i)(2). The agency is
therefore
[[Page 42613]]
adopting the changes to those paragraphs as proposed.
Stakeholders also did not submit any comments on the majority of
the agency's proposed changes to paragraph (i)(4). A DOD comment
specifically addressed the term ``as free as practicable,'' suggesting
that because the term is not defined, OSHA should require employers to
establish procedures for cleaning PPE, document accomplishment of
procedures, and periodically review compliance with cleaning procedures
(Document ID 0029, p. 2). The USW supported the proposed change for
cleaning PPE ``as necessary,'' agreeing with OSHA's explanation in the
2018 NPRM that requiring cleaning only as necessary would clarify that
cleaning would not be required if the PPE is already as free as
practicable of beryllium (Document ID 0033, p. 6).
The requirement to maintain surfaces as free as practicable of a
regulated substance is included in other OSHA health standards, such as
those for lead (29 CFR 1910.1025, 29 CFR 1926.62), chromium (VI) (29
CFR 1910.1026), and asbestos (29 CFR 1910.1001), and is used elsewhere
in the beryllium general industry standard (29 CFR
1910.1024(f)(1)(i)(E), (i)(4)(i), (j)(1)(i), (j)(3)(ii)). Employers
therefore have the benefit of previous experience interpreting and
developing methods for compliance with requirements to maintain
surfaces ``as free as practicable'' of toxic substances, including
beryllium, as well as guidance from OSHA on compliance with such
requirements. OSHA discussed the meaning of this phrase in the Summary
and Explanation of paragraph (j) in the 2017 final rule (82 FR at
2690), as well as in a 2014 letter of interpretation explaining the
phrase in the context of the agency's standard for chromium (VI) (OSHA,
Nov. 5, 2014, Letter of Interpretation, available at https://www.osha.gov/laws-regs/standardinterpretations/2014-11-05). As OSHA
explained in the 2014 letter of interpretation, OSHA evaluates whether
a surface is ``as free as practicable'' of a contaminant by the
efficacy of the employer's program to keep surfaces clean. OSHA intends
for this term to be broad and performance-oriented, so as to allow
employers in a variety of industries flexibility to decide what type of
control methods and procedures are best suited to their beryllium
operations, and OSHA intends to evaluate compliance based on employer
efforts under the circumstances present at each facility. Notably, in
its comment, Materion expressed general support for use of the phrase
``as free as practicable'' in other parts of the standard,
acknowledging that this is the workable legal standard OSHA relies on
in occupational health standards (Document ID 0038, pp. 25-26, 33).
Moreover, as to DOD's recommendation that OSHA require employers to
establish procedures for cleaning PPE, document accomplishment of
procedures, and periodically review compliance with cleaning procedures
(Document ID 0029, p. 2), OSHA agrees that requiring employers to
establish PPE cleaning procedures is important. To meet this objective,
the written exposure control plan provision in paragraph (f)(1)(i)
requires employers to establish, implement, and maintain a written
exposure control plan, which must contain, among other things,
procedures for removing, laundering, storing, cleaning, repairing, and
disposing of beryllium-contaminated personal protective clothing and
equipment, including respirators. Paragraph (f)(1)(ii) requires
employers to review and evaluate the effectiveness of each written
exposure control plan at least annually and update it, as necessary, if
certain specified events occur. OSHA believes that these requirements
satisfy DOD's concerns while still allowing employers the flexibility
to establish, implement, and maintain a plan that works best for their
individual workplaces.
After reviewing these comments and considering the record as a
whole, OSHA believes that the term ``as free as practicable'' is
understood by employers through its use in other standards and as
explained in letters of interpretation and other guidance, and does not
believe that defining the term in this standard or establishing
specific PPE cleaning and documentation procedures is necessary. OSHA
also believes the proposed change is necessary to align the language of
paragraphs (i)(4)(i) and (i)(4)(ii). OSHA did not receive any comments
objecting to the revised requirement that PPE be ``cleaned, as
necessary,'' which makes clear that cleaning would not be required if
PPE is already as free as practicable of beryllium. OSHA believes these
changes clarify the agency's intent without sacrificing safety and
health protection for workers. The agency is therefore adopting the
changes as proposed to paragraph (i)(4)(ii) in this final rule.
Disposal, Recycling, and Reuse.
Paragraph (j) of the beryllium general industry standard requires
employers to adhere to certain housekeeping practices. Paragraphs
(j)(1) and (j)(2) require employers to maintain all surfaces in
beryllium work areas as free as practicable of beryllium, promptly
clean spills and emergency releases of beryllium, and use appropriate
cleaning methods, while paragraph (j)(3) requires employers to take
certain actions when transferring materials that contain at least 0.1
percent beryllium by weight or that are contaminated with beryllium
outside a plant for the purpose of disposal, recycling, or reuse.
Specifically, paragraph (j)(3)(i) requires that, except for intra-plant
transfers, when transferring these materials for any of these purposes
the employer must label the materials in accordance with paragraph
(m)(3). Paragraph (j)(3)(ii) further requires that those materials
designated for disposal must be either cleaned to be as free as
practicable of beryllium or placed in enclosures that prevent the
release of beryllium-containing particulate or solutions under normal
conditions of use, storage, or transport, such as bags or containers.
Paragraph (j)(3)(iii) requires the same for materials designated for
recycling or reuse.
The final rule makes a number of changes to the previous
requirements of paragraph (j)(3). As originally promulgated in the 2017
final rule, paragraph (j)(3)(i) required that materials designated for
disposal be disposed of in sealed, impermeable enclosures, such as bags
or containers, that are labeled according to paragraph (m)(3) of the
beryllium standard, but did not allow employers the alternative option
of cleaning such material to be as free as practicable of beryllium.
Further, both paragraphs (j)(3)(i) and (j)(3)(ii) required that
materials be transferred in sealed, impermeable bags, but did not
further define this requirement. Finally, the original paragraph (j)(3)
did not explicitly address transfers of materials for the purpose of
reuse.\17\
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\17\ Subsequent to the 2017 final rule, the 2018 direct final
rule clarified that the requirements of paragraph (j)(3) do not
apply to materials containing only trace amounts of beryllium (less
than 0.1 percent by weight).
---------------------------------------------------------------------------
After the promulgation of the final rule in 2017, OSHA learned that
some stakeholders were confused about these requirements. For example,
stakeholders were uncertain about what types of enclosures would be
acceptable under the standard. To help alleviate stakeholder confusion,
OSHA proposed a number of changes in the 2018 NPRM that make explicit
what had been intended in the 2017 final rulemaking. Specifically, OSHA
proposed adding provisions explicitly addressing transferring materials
for reuse; clarifying that the rule's requirements for disposal,
recycling, and reuse do not apply to intra-plant transfers; and
[[Page 42614]]
allowing for the cleaning of materials bound for disposal. The agency
also proposed reorganizing the paragraph's two paragraphs into three
that focused on specific topics and making minor changes in terminology
to improve the clarity and internal consistency of the standard. Only
one of the changes is substantive, which is the inclusion of the option
for cleaning instead of enclosure; the remaining edits merely clarify
OSHA's original intent. As discussed in more detail below, OSHA is
retaining the changes proposed in the 2018 NPRM in the final rule with
only one clarifying revision. With these changes, final paragraph
(j)(3) provides comprehensive, easy to understand requirements for
employers that are transferring materials outside of their plants for
disposal, recycling, or reuse that contain at least 0.1 percent
beryllium by weight or are contaminated with beryllium.
In response to the 2018 NPRM, a number of commenters, including the
DOD, Materion, the USW, and EEI, expressed support for the proposed
revisions generally (see, e.g., Document ID 0029, p. 1; 0038, pp. 32-
33; 0033, p. 5; 0031, p. 2). For example, DOD stated that the revisions
``are evidence based and provide greater employee protection''
(Document ID 0029, p. 1). Similarly, Materion commented that the
revisions ``will provide improved understanding and more practical
meaning to manufacturers by improving the clarity and internal
consistency of the standard'' (Document ID 0038, p. 32).
Stakeholders also offered specific comments on the individual
changes OSHA proposed to paragraph (j)(3). OSHA outlines each of those
changes below, along with any specific comments received on those
changes and the agency's final determination as to whether to retain
the proposed change in the final rule.
OSHA proposed seven changes to the 2017 version of paragraph
(j)(3). First, the agency proposed that the provisions address reuse
(in addition to disposal and recycling). As noted above, paragraph
(j)(3) of the 2017 final rule contained requirements for the labeling
and enclosure of certain materials designated for disposal and the
labeling and either enclosure or cleaning of materials designated for
recycling. The preamble to the 2017 final rule made clear that
paragraph (j)(3)'s requirements related to recycling also applied to
reuse (see 82 FR at 2695-96), but the standard did not explicitly
advise employers of this requirement. To make the agency's original
intent clear, OSHA proposed in the 2018 NPRM to include provisions
addressing reuse. This proposed change was intended to ensure that
workers who may be exposed to materials containing or contaminated with
beryllium that are directly reused without first being processed into a
different form are appropriately protected. For example, a manufacturer
may sell a by-product from a process to a downstream manufacturer that
would reuse the by-product as a component of a new product. Recycling,
on the other hand, typically involves the further processing of waste
materials to separate and recover various components of value. OSHA did
not receive any specific comments on the addition addressing reuse of
materials in paragraph (j)(3). Therefore, OSHA has finalized the
inclusion of requirements related to the reuse of materials in
paragraph (j)(3).
Second, OSHA proposed reorganizing paragraph (j)(3)'s original two
paragraphs (one on disposal, one on recycling--with the labeling
requirements specified in each) into three new paragraphs with each
paragraph focusing on a different topic. Proposed paragraph (j)(3)(i)
spelled out the labeling requirements, proposed paragraph (j)(3)(ii)
included the requirements for cleaning or enclosing materials bound for
disposal, and proposed paragraph (j)(3)(iii) laid out the obligations
as to materials designated for recycling or reuse. The proposed
reorganization allowed the agency to incorporate the new reuse
requirements, while also setting out each distinct obligation clearly.
OSHA further explained in the proposal that this is not a substantive
change to the standard, but rather only a reorganization of the
existing provisions (see 83 FR at 63763). One commenter, Materion,
addressed the reorganization of paragraph (j)(3), noting that the
change would improve the clarity and employers' understanding of the
provisions (Document ID 0038, p. 32). Having received no comments to
the contrary, OSHA is adopting the new structure to paragraph (j)(3) in
the final rule.
Third, OSHA proposed a simplifying change relating to the
description of which materials must be labeled and cleaned or enclosed
prior to transfer for disposal, recycling, or reuse. The 2018 direct
final rule required employers to label and clean or enclose two groups
of materials: (1) Materials that contain beryllium in concentrations of
0.1 percent by weight or more, and (2) materials that are contaminated
with beryllium. In the 2018 NPRM, OSHA proposed a simplifying edit to
the first group of materials. Specifically, the agency proposed
replacing the phrase materials ``that contain beryllium in
concentrations of 0.1 percent by weight or more'' with a shorter
phrase: Materials ``that contain at least 0.1 percent beryllium by
weight.'' As the agency explained in the 2018 NPRM, this change is
meant to simplify the language and does not change the meaning. OSHA
did not receive any comments on the proposed simplification of this
language. Therefore, OSHA is adopting the new phrase ``that contain at
least 0.1 percent beryllium by weight'' in paragraph (j)(3) in the
final rule.
Fourth, OSHA proposed adding an explicit exemption for materials
transferred within a plant from the cleaning and enclosure requirements
in new paragraphs (j)(3)(ii) and (iii). While this exemption was not
explicitly included in the regulatory text of the 2017 final rule, its
inclusion in this final rule is not a substantive change. As OSHA noted
in the 2018 NPRM, the agency never intended the provisions of paragraph
(j)(3) to require employers to clean or enclose materials to be used in
another location within the same facility (83 FR at 63756 (citing 82 FR
at 2696)).\18\ Thus, the inclusion of the exemption in the proposed
regulatory text simply makes the agency's intent plain.
---------------------------------------------------------------------------
\18\ As OSHA noted in the 2018 NPRM, employees who may be
exposed to these materials during intra-plant transfers will not go
unprotected. On the contrary, other provisions of the beryllium
standard require employers to communicate possible hazards to these
employees and protect them during such transfers (see, e.g.,
paragraph (f), Methods of compliance; paragraph (g), Respiratory
protection; paragraph (h), Personal protective clothing and
equipment; paragraph (m), Communication of hazards).
---------------------------------------------------------------------------
The USW supported the proposed inclusion of the ``intra-plant
transfer'' exemption in the regulatory text (Document ID 0033, p. 5).
Specifically, the USW pointed to its comments on OSHA's 2015 NPRM,
which stated that the agency should not require all materials to be
decontaminated or sealed in an enclosure (Document ID 0033, p. 5).
Rather, the USW explained, the initial intent of the corresponding
provision of the model standard it drafted jointly with Materion was
``to ensure that materials leaving a facility and designated for
recycling be containerized or visibly clean'' (Document ID 0033, p. 5)
(emphasis added).
DOD did not submit a comment on the proposed intra-plant transfer
exception, but its comment on another part of paragraph (j)(3)
suggested that it understood the paragraph to apply to intra-plant
transfers (see Document ID
[[Page 42615]]
0029, p. 1 (``To support the proposed revisions that require surface
cleaning of equipment and materials to remove beryllium before
recycling, re-use, or intra-plant transfers, we recommend the use of
the Department of Energy's (DOE's) cleanliness standards as specified
in Title 10 Code of Federal Regulations Part 850.'')).\19\ As discussed
below, OSHA does not agree with DOD's suggested use of DOE's surface
limits and, as already stated, OSHA never intended to require employers
to clean or enclose materials transferred within a single plant.
Rather, the provisions in paragraph (j)(3) have always been intended to
protect employees after the materials leave the facility.
---------------------------------------------------------------------------
\19\ DOD's suggestion regarding DOE's cleanliness standards is
addressed below in this section of this final rule as part of the
discussion of the seventh and final proposed change to paragraph
(j)(3) relating to the cleaning of materials designated for
disposal, recycling, or reuse.
---------------------------------------------------------------------------
Materion commented that beryllium-containing scrap metal or wastes
are, in most cases, recycled internally ``either within or between
facilities,'' but companies ``also recycle scrap or purchase scrap on
the open market'' (Document ID 0038, p. 32). Materion further asserted
that OSHA's regulation ``should not be construed as potentially
limiting the environmentally beneficial recycling of metals'' (Document
ID 0038, p. 32). OSHA agrees that paragraph (j)(3)'s requirements
should not be read to discourage the reuse or recycling of metals and
reads Materion's statements regarding the manner in which companies
recycle scrap metal or wastes (i.e., within or between facilities or on
the open market) as purely informational. However, the agency notes
that this comment could be read to suggest that the exception for items
transferred within a facility also applies to items transferred between
two facilities owned by the same employer. Such an interpretation would
be incorrect--the intra-plant transfer exception only exempts transfers
within a single plant; material transfers between plants are not
excluded, regardless of plant ownership.
This comment also alerted the agency to a potential ambiguity in
the text of proposed paragraph (j)(3)(i). Specifically, OSHA realized
that the phrase ``to another party'' could be read to suggest that
transfers between two facilities owned by the same employer are
exempted from the labeling requirements in paragraph (j)(3)(i). Again,
this was not the agency's intent. As noted above, the proposed addition
of the explicit intra-plant transfer exception in paragraphs (j)(3)(ii)
and (iii) was not a substantive change--the agency never intended to
require employers to clean or enclose materials transferred within a
single plant. The reorganization of paragraph (j)(3) was also not a
substantive change; it merely allowed the agency to make clear that the
labeling requirements apply regardless of whether the employer
transfers materials for the purpose of disposal, recycling, or reuse
(83 FR at 63763, 63756). Because the labeling requirements were part of
paragraphs (j)(3)(i) and (ii) in the 2017 final rule, to which the
intra-plant exemption applied, and were simply moved to a new stand-
alone paragraph without substantive change, the scope of those
activities requiring labeling has not changed. Put another way, the
intra-plant exemption continues to apply to the labeling provision to
the same extent it did prior to the proposal. And, more to the point,
the labeling requirement continues to apply to all other transfers for
purposes of disposal, recycling, or reuse, regardless of whether they
involve transfers between two locations operated by the same employer.
If proposed paragraph (j)(3)(i) was interpreted to only require the
labeling of materials transferred to another employer (rather than
another facility), then an employer could place materials that were
designated for reuse in an enclosure and transfer them to another
facility without a label, so long as the employer owned the second
facility. This scheme could potentially put both the transferring and
receiving employees at risk by failing to appropriately apprise them of
the presence of beryllium-containing materials and the hazardous nature
of beryllium exposure.
Moreover, such an interpretation could lead to inconsistencies or
conflicts with the Hazard Communication standard (HCS) (29 CFR
1910.1200), which requires labeling for all hazardous chemicals leaving
a worksite regardless of destination. This is clearly laid out in
OSHA's Hazard Communication directive (CPL 02-02-079): ``Manufacturers,
importers, and distributors are required to ensure that each container
of hazardous chemicals is appropriately labeled. Labeling requirements
apply for shipped containers leaving the workplace regardless of
whether the intended destination is interstate or intrastate.''
Although the agency's intent was always to exempt only intra-plant
transfers from the labeling requirement, OSHA sees value in eliminating
any ambiguity and ensuring that labeling is consistent with the
requirements of the HCS. Therefore, the agency is revising the text of
paragraph (j)(3)(i) to more explicitly match the intent expressed in
both the 2017 rule and the 2018 proposal. Specifically, OSHA is
revising paragraph (j)(3)(i) in the final rule to strike the phrase
``to another party'' and add the ``except for intra-plant transfers''
language that is found in paragraphs (j)(3)(ii) and (iii). Final
paragraph (j)(3)(i), therefore, provides that except for intra-plant
transfers, when the employer transfers materials that contain at least
0.1 percent beryllium by weight or are contaminated with beryllium for
disposal, recycling, or reuse, the employer must label the materials in
accordance with paragraph (m)(3) of this standard.
In summary, OSHA is adopting the proposed addition of the explicit
intra-plant exception in final paragraphs (j)(3)(ii) and (iii). No
commenters opposed these revisions and, therefore, OSHA has decided to
retain them, unchanged from the proposal (see Document ID 0038, p. 32;
0033, p. 5). The agency is also revising proposed paragraph (j)(3)(i)
to explicitly incorporate the exception. As explained in detail above,
none of these changes are substantive, but OSHA expects the clarified
language will aid employers in understanding and, thus, carrying out
their responsibilities under these provisions.
OSHA's fifth proposed change to paragraph (j)(3) focused on the
requirement to place items in ``sealed, impermeable enclosures.''
Specifically, paragraph (j)(3)(i) in the 2017 final rule required
employers to place certain materials bound for disposal in ``sealed,
impermeable enclosures, such as bags or containers.'' Paragraph
(j)(3)(ii) in the 2017 final rule also required enclosure of certain
materials that had not been appropriately cleaned. In the preamble to
the 2017 final rule, OSHA explained that it intended these requirements
to be broad and performance-oriented and clarified that the term
``impermeable'' was not intended to mean absolutely impervious to
rupture but, rather, that the enclosures would not allow materials to
escape under normal conditions of use (82 FR at 2695). Nevertheless,
the agency learned that confusion around the enclosure requirement
remained.
To alleviate the confusion regarding the enclosure requirements,
OSHA proposed in the 2018 NPRM to clarify the ``sealed, impermeable
bag'' requirement to make explicit what had been intended in the 2017
final rulemaking: That employers must utilize enclosures that prevent
the release of beryllium-containing
[[Page 42616]]
particulate or solutions under normal conditions of use, storage, or
transport. The agency further explained that the proposed change would
reinforce the requirement that employers select the appropriate type of
container to prevent release based on the form of beryllium and how it
is normally handled. For example, a container that prevents the release
of a beryllium particulate may not be effective in preventing the
release of a beryllium solution.
One commenter, Materion, submitted comments specific to this
proposed change (Document ID 0038, p. 32). Materion was supportive of
the revision, noting that it will significantly improve understanding
of the requirements for containerization and transport of recycled
materials and asserting its belief that without the proposed changes
the disposal and recycling provision are technologically and
economically infeasible (Document ID 0038, p. 32). According to
Materion, the change appropriately accommodates the various physical
properties of beryllium materials being recycled, the ``many different
applications resulting in many types of container configurations,'' and
the ``many types of transfer mechanisms and end use processing
applications'' (Document ID 0038, p. 32). No commenters opposed these
revisions and, therefore, OSHA has decided to retain them unchanged
from the proposal.
Unlike the previous five proposed changes, the sixth proposed
change was more than a clarifying change from the 2017 final rule.
Under the 2017 final rule, employers could either clean or enclose
materials designated for recycling. Materials designated for disposal,
however, could only be enclosed; the option to clean the materials was
not available. The difference in the two provisions stemmed from the
concern that municipal and commercial disposal workers should be
protected from exposure to beryllium from contact with materials
discarded from beryllium work areas in general industry by placing
those materials in enclosed containers. However, as OSHA explained in
the 2018 NPRM, the agency had not considered situations where it would
be impractical to require enclosure because the materials in question
were large items, such as machines or structures, that may contain at
least 0.1 percent beryllium by weight or be contaminated with
beryllium, rather than more common items, such as beryllium scrap metal
or shavings.
With that situation in mind, OSHA reconsidered its earlier
determination and preliminarily determined that workers handling items
designated for disposal, like workers handling items designated for
recycling or reuse, would be just as protected from exposure to
beryllium if the items are cleaned to be as free as practicable of
beryllium as if the items were placed in containers. In accordance with
this preliminary determination, OSHA in the 2018 NPRM proposed adding
the cleaning option to paragraph (j)(3)(ii). The agency explained that,
regardless of whether an employer chooses to clean or enclose materials
designated for disposal, the labeling requirements under proposed
paragraph (j)(3)(i) would apply and would require that the materials
designated for disposal be labeled in accordance with paragraph (m)(3)
of this standard. It further noted its expectation that these proposed
changes would maintain safety and health protections for workers.
OSHA received no comments on this proposed revision and has
therefore finalized it as proposed.
The seventh and final proposed change also relates to the cleaning
of materials designated for disposal, recycling, or reuse. Paragraph
(j)(3)(ii) in the 2017 final rule required the specified materials to
be cleaned to be as free as practicable of surface beryllium
contamination. However, the 2017 final rule did not define the term
``surface beryllium contamination'' and other parts of the 2017 final
rule used the term ``as free as practicable'' without the ``surface
beryllium contamination'' modifier. To alleviate any potential
confusion stemming from the agency's use of this new, undefined term,
OSHA proposed to eliminate any potential confusion by removing the
phrase ``surface beryllium contamination.''
OSHA did not receive any comments that directly addressed the
removal of this phrase but one stakeholder, DOD, offered a suggestion.
Specifically, DOD recommended the use of the Department of Energy's
(DOE's) cleanliness standards as specified in Title 10 Code of Federal
Regulations Part 850 (Document ID 0029, p. 1). According to DOD, these
standards are ``generally-acceptable criteria for surface contamination
and were adopted based on DOE's assessment of practical cleanliness
levels and proven feasibility'' (Document ID 0029, p. 1).
OSHA agrees that DOE's standards might be a useful reference for
employers seeking advice on how to clean materials prior to transfer
for disposal, reuse, or recycling or how to determine the effectiveness
of existing cleaning efforts and that wipe sampling in general can be a
useful tool for employers to provide feedback on their cleaning
procedures. To the extent that DOD's recommendation was intended to
suggest an amendment to the proposed provisions, however, OSHA does not
believe such an amendment is appropriate. As discussed in the 2018
NPRM, the ``as free as practicable'' standard is well-understood by the
regulated community. OSHA has used the phrase in existing substance-
specific standards, including those for lead (29 CFR 1910.1025, 29 CFR
1926.62), chromium (VI) (29 CFR 1910.1026), and asbestos (29 CFR
1910.1001), and has previously discussed its meaning in a 2014 letter
of interpretation explaining the phrase in the context of the chromium
standard (OSHA, Nov. 5, 2014, Letter of Interpretation, available at
https://www.osha.gov/laws-regs/standardinterpretations/2014-11-05).
Additionally, as discussed in the Summary and Explanation of the
definition of the term dermal contact with beryllium, the best
available scientific evidence on adverse health effects from dermal
contact with beryllium does not provide sufficient information to link
risk of adverse health effects with specific levels of surface
contamination. Therefore, the agency has chosen not to require a
specific target level of surface contamination for any of the surface
cleanliness requirements of the beryllium standards. Instead, the
agency has determined that the more performance-oriented ``as free as
practicable'' standard for cleaning--rather than a more prescriptive
requirement--is appropriate. The agency finds that the use of the
broader standard will better serve employees by allowing employers in a
variety of industries flexibility to decide what type of control
methods and procedures are best suited to their beryllium operations.
Having received no other comments on this proposed provision, OSHA
strikes the phrase ``surface beryllium contamination'' from the
regulatory text, as proposed.
In summary, OSHA is finalizing (j)(3) as proposed in 2018, except
for the clarifying revision in paragraph (j)(3)(i), which explicitly
incorporates the intra-plant exception found in paragraphs (j)(3)(ii)
and (j)(3)(iii). OSHA has based this decision on the record and has
determined this will maintain or enhance worker protections.
Medical Surveillance.
Paragraph (k) of the beryllium standard for general industry (29
CFR 1910.1024) addresses medical surveillance requirements. The
paragraph specifies which employees
[[Page 42617]]
must be offered medical surveillance, as well as the frequency and
content of medical examinations. It also sets forth the information
that must be provided to the employee and employer. The purposes of
medical surveillance for beryllium are (1) to identify beryllium-
related adverse health effects so that appropriate intervention
measures can be taken; (2) to determine if an employee has any
condition that might make him or her more sensitive to beryllium
exposure; and (3) to determine the employee's fitness to use personal
protective equipment such as respirators. The inclusion of medical
surveillance in the beryllium standard for general industry 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 the hazards
addressed by the standard.
In the 2018 NPRM, OSHA proposed two sets of changes to paragraph
(k). The first set of changes proposed is in paragraph (k)(2), which
specifies when and how frequently medical examinations were to be
offered to those employees covered by the medical surveillance program.
Paragraph (k)(2)(i)(B) of the standard requires the employer to provide
a medical examination within 30 days after determining that the
employee shows signs or symptoms of CBD or other beryllium-related
health effects or that the employee has been exposed to beryllium in an
emergency. After publication of the 2017 final rule, stakeholders
suggested to OSHA that, for individuals exposed one-time during an
emergency, 30 days may be insufficient to detect beryllium
sensitization, so a longer timeframe for medical examinations may be
more appropriate (83 FR at 63757).
In the 2018 NPRM, OSHA acknowledged uncertainty regarding the time
period in which sensitization may occur following a one-time exposure
to a significant concentration of beryllium in an emergency (83 FR at
63757). In fact, beryllium sensitization can occur several months or
more after initial exposure to beryllium among workers with regular
occupational exposure to beryllium (see 83 FR at 63757 (citing 82 FR at
2530, 2533)). Based on this evidence and stakeholder feedback, OSHA
proposed removing the requirement for a medical examination within 30
days of exposure in an emergency, under paragraph (k)(2)(i)(B), and
adding paragraph (k)(2)(iv), which would require the employer to offer
a medical examination at least one year after but no more than two
years after the employee is exposed to beryllium in an emergency. OSHA
requested comments on the appropriateness of this change (83 FR at
63757).
Several stakeholders commented on this issue. NJH supported
extending the time to offer medical surveillance to one year after an
emergency because 30 days following a high exposure may not be enough
time to detect beryllium sensitization (Document ID 0022, p. 8).
Materion also agreed with the proposed one-to-two-year timeframe for
examinations following exposure during an emergency because 30 days may
be too soon to detect an immunological change using the BeLPT (Document
ID 0038, p. 33). DOSH similarly commented that delaying the medical
examination to one year might improve the detection of sensitization
because it may take several months to detect it (Document ID 0023, p.
2). DOSH also expressed concern, however, that workers would not get
counseling about signs and symptoms of beryllium-related conditions, an
occupational history review, and other medical advice which may allow
for the worker to identify a developing condition within the first year
after exposure (Document ID 0023, p. 2). DOSH added that if the medical
examination will be delayed, it would be appropriate to have a
requirement for additional training or a brief medical consultation for
workers who are not knowledgeable about beryllium and the potential
medical conditions that may be triggered by exposure (Document ID 0023,
pp. 2-3).
The ACOEM and NSSP shared DOSH's concerns regarding potential
delays in consultations and counseling (Document ID 0024, p. 2; 0027,
p. 4). The NSSP recommended an earlier discussion with employees
exposed in an emergency to address their individual concerns, the
medical path forward, options available, and to answer any questions
the employees might have (Document ID 0027, p. 4). It suggested that
the medical examination could then be scheduled in keeping with the
individual employee's medical needs (Document ID 0027, p. 4). ACOEM
opposed the change, arguing that workers who are exposed to beryllium
in an emergency deserve prompt medical evaluation to understand the
potential health risks, receive baseline testing, if desired, and to
receive medical counseling (Document ID 0024, p. 2). ACOEM maintained
that it would be ``an extremely insensitive and harsh change in
policy'' to require exposed workers to wait more than a year to receive
professional medical advice (Document ID 0024, p. 2). On the other
hand, Materion argued that the standard protects workers who may have
been exposed in an emergency, regardless of when the emergency
occurred, by requiring employers to make medical surveillance available
to any employees showing signs and symptoms of CBD or other beryllium-
related health effects (Document ID 0038, p. 33). Specifically,
paragraph (k)(2)(i)(B) requires employers to provide an examination to
these employees within 30 days of determining that the employee shows
signs or symptoms of CBD.
After considering these comments and the record as a whole on this
issue, OSHA reaffirms its preliminary belief that testing conducted
during the proposed time period of one to two years is more likely to
detect sensitization than testing conducted 30 days following emergency
exposure (82 FR at 63757). Nevertheless, DOSH, the NSSP, and ACOEM's
concerns about possible delays in medical consultations and
examinations and lack of employee knowledge of potential health effects
prompted the agency to reevaluate the standard's medical surveillance
and training triggers to determine if any employees could potentially
be exposed in an emergency but may not be knowledgeable about symptoms,
health effects, and medical surveillance because they have not been
trained, or if any employees might be exposed but have not recently
received a medical examination during which they had the opportunity to
talk with a PLHCP about exposure to beryllium.
First, OSHA considered the population of employees affected by
emergencies. As noted in the 2018 NPRM, OSHA estimates that a very
small number of employees, likely less than 0.1 percent of the affected
population, would be affected by emergencies in a given year (83 FR at
63764). Second, OSHA considered if any of the small number of employees
exposed in an emergency in a given year would not be knowledgeable
about symptoms, health effects, and medical surveillance through the
training provided under paragraph (m)(4) at the time of emergency and,
thus, might need such training after exposure during an emergency.
Paragraph (m)(4)(i) requires the employer to provide information and
training in accordance with the Hazard Communication Standard (HCS), 29
CFR 1910.1200(h), for each employee who has, or can reasonably be
expected to have, airborne exposure to or dermal contact with
beryllium. Final paragraph (m)(4)(ii) requires employers to ensure that
each
[[Page 42618]]
employee who is, or can reasonably be expected to be, exposed to
airborne beryllium can demonstrate knowledge and understanding of a
number of specified topics, including (1) the health hazards associated
with airborne exposure to and dermal contact with beryllium, including
signs and symptoms of CBD; (2) the purpose and a description of the
medical surveillance program under paragraph (k) of the standard,
including risks and benefits of each test to be offered; (3) the
purpose and a description of the medical removal protection provided
under paragraph (l) of the standard; and (4) the contents of the
standard.
OSHA expects that the vast majority of employees who could be
exposed to beryllium in an emergency are those who are regularly
exposed to beryllium as part of their normal work duties performed near
processes involving beryllium. Therefore, most of those employees are
already likely to be trained in accordance with the HCS under paragraph
(m)(4)(i) because the training requirements under paragraph (m)(4)(i)
are triggered by actual, or reasonably anticipated, airborne exposure
at any level or dermal contact with beryllium. In addition, OSHA
anticipates that most of these employees would also be knowledgeable
about beryllium-related health effects, medical surveillance, medical
removal, and the remainder of the standard, as required by paragraph
(m)(4)(ii). Nevertheless, if an employee who had not been trained in
accordance with paragraph (m)(4) or was not knowledgeable of the
subjects covered in paragraph (m)(4)(ii) was exposed in an emergency,
the standard would require that the employee be trained after the
emergency because the exposure during the emergency would cause them to
meet the standard's training triggers. In other words, the standard
already provides for training of the very small number of untrained or
unknowledgeable employees who might be exposed during an emergency.\20\
---------------------------------------------------------------------------
\20\ OSHA notes that the standard would require additional
training for workers who were exposed during an emergency who had
already been trained if the employer realized that those workers
were not knowledgeable about topics such as the potential medical
conditions which may result from exposure to beryllium or symptoms
that may trigger a medical examination (see paragraph (m)(4)(ii)(A);
see also additional training requirements under paragraph
(m)(4)(iii)).
---------------------------------------------------------------------------
Third, OSHA considered if any employees exposed during an emergency
would likely not have received a recent examination under the standard.
Under paragraph (k)(1)(i), the employer must make medical surveillance
available to four groups of employees: (A) Employees who are or are
reasonably expected to be exposed at or above the action level for more
than 30 days per year, (B) employees who show signs or symptoms of CBD
or other beryllium-related health effects, (C) employees who are
exposed to beryllium during an emergency, and (D) employees whose most
recent written medical surveillance opinion required by paragraph
(k)(6) or (k)(7) of the standard recommends periodic medical
surveillance. Under paragraph (k)(2)(ii), employees who continue to
meet above-triggers (A), (B), or (D) of the standard receive
examinations at least every two years after their most recent
examination. Employees previously exposed in an emergency (and all
other employees who have received an examination, but no longer meet
the criteria for periodic examinations) continue to be offered a
standardized BeLPT or equivalent test at least every two years, unless
they are confirmed positive (paragraph (k)(3)(i)(E); 82 FR at 2705).
As noted above, OSHA expects that the vast majority of employees
who could be exposed to beryllium in an emergency are those who are
regularly exposed to beryllium as part of their normal work duties that
are performed near processes involving beryllium. As a result, OSHA
expects that the majority of employees who could be exposed to
beryllium in an emergency are likely to be those who meet the trigger
for periodic medical surveillance under paragraph (k)(1)(i)(A) (i.e.,
they are or are reasonably expected to be exposed at or above the
action level for more than 30 days per year). Thus, they have likely
had an opportunity to consult with a PLHCP at a minimum of every two
years (paragraph (k)(2)(ii)). Other employees exposed during an
emergency may have also had a recent examination because they have
recently met one of the other triggers, such as experiencing signs or
symptoms of CBD or other beryllium-related health effects. OSHA
recognizes, however, that a much smaller number of employees, such as
office and warehouse workers, who do not have regular exposures to
beryllium at or above the action level and have also not met one of the
other medical surveillance triggers, could potentially be exposed to
beryllium in an emergency. These employees may have never received a
medical examination or a BeLPT or equivalent test.
OSHA agrees with ACOEM that it is unacceptable to have employees
who have not recently been offered a medical examination under the
beryllium standard wait for a year or more for a medical consultation
and examination after exposure during an emergency. These employees may
not have baseline information on their health status, and they may not
have had the opportunity to speak to a PLHCP to ask questions related
to their concerns, such as possible health risks, symptoms, and medical
interventions. In contrast, employees who had a medical examination
within the previous two years would have a baseline and have had the
opportunity to speak with a health professional. Therefore, to
adequately meet the needs of all employees who may be exposed in an
emergency, OSHA is deleting final paragraph (k)(2)(iv) and replacing it
with paragraphs (k)(2)(iv)(A) and (k)(2)(iv)(B).
New paragraph (k)(2)(iv)(A) addresses the needs of the very small
group of employees who are exposed in an emergency but have not
received a medical examination under paragraph (k)(1)(i) within the
previous two years. Specifically, paragraph (k)(2)(iv)(A) requires that
if an employee is exposed to beryllium during an emergency and has not
received a medical examination under paragraph (k)(1)(i) within the
previous two years, then the employer must provide that employee with a
medical examination within 30 days of the date of the emergency. New
paragraph (k)(2)(iv)(B), on the other hand, focuses on employees who
are exposed during an emergency, but have recently received an
examination. Under paragraph (k)(2)(iv)(B), if an employee has received
a medical examination under paragraph (k)(1)(i) within the previous two
years, then the employer would be required to offer that employee a
medical examination that meets the requirements of the standard at
least one year but no more than two years after the employee was
exposed to beryllium in an emergency.
OSHA concludes that it is appropriate to provide a medical
examination within 30 days after the employee was exposed in an
emergency, if the employee has not had an examination under the
beryllium standard within the last two years. It addresses the concerns
of DOSH, ACOEM, and the NSSP that employees receive timely medical
consultations and evaluations. If an employee has not had a previous
examination under the standard, the examination at 30 days after the
emergency allows for collection of baseline values on health status, as
recommended by ACOEM. Baseline information about the employee's current
health status, such as lung function, will allow for a comparison with
changes that might occur in the future. Moreover, if the employee is
confirmed positive by the baseline
[[Page 42619]]
BeLPT and there is a possibility that the employee could be exposed to
beryllium again in the future, knowledge about the confirmed positive
finding would allow the employee to consider risks and options related
to employment (82 FR at 2702).
OSHA recognizes, as NJH, DOSH, and Materion noted, that 30 days
following the emergency is not the best timeframe for detecting
sensitization. However, paragraph (k)(3)(ii)(E) of the beryllium
standard for general industry already requires that employees who
received a medical examination because of an emergency exposure
continue to receive a BeLPT, or an equivalent test, every two years
following that examination, unless the employee is confirmed positive.
Therefore, the standard already requires the employers to offer these
employees a BeLPT for the remainder of their tenure in the workplace
where they were exposed in an emergency, rather than limiting the
opportunity to detect sensitization to 30 days following the emergency.
OSHA also concludes that it is appropriate to require employers to
offer medical surveillance within one to two years after exposure to
beryllium in an emergency, if that employee had an examination that
meets the requirements of the beryllium standard within the last two
years. These employees could include those who undergo periodic medical
surveillance at least every two years under paragraph (k)(2)(A) or (D),
or who may have received a medical examination within the last two
years because they were experiencing symptoms or were exposed in a
previous emergency (paragraphs (k)(2)(B) and (C)). These employees
would have received a recent medical consultation and examination which
would have allowed them to ask questions. In addition, these employees
would have received a baseline examination. Like the employees examined
within 30 days after exposure to beryllium in an emergency, all these
employees examined within one to two years of the emergency will
continue to be offered BeLPT testing every two years under paragraph
(k)(3)(ii)(E) if they have not been confirmed positive and do not or no
longer meet the criteria for full periodic medical examinations under
paragraph (k)(2)(ii).
The requirement for continuing BeLPTs for any employee who has
received an examination under the beryllium standard, including for an
emergency exposure, addresses another concern voiced by NJH, which is
that anyone exposed in an emergency should be provided periodic medical
surveillance (Document ID 0022, p. 8). If the employee is confirmed
positive, or if the licensed physician otherwise deems it appropriate,
the licensed physician is to provide in the written medical opinion to
the employee a referral to a CBD diagnostic center and a recommendation
for continued periodic medical surveillance under paragraph (k)(5)(iii)
and (iv). If the employee authorizes the recommendation for referral to
be included in the written opinion, the employer must provide an
examination at a CBD diagnostic center (discussed in more detail below)
(paragraph (k)(6)(iii)). Once an employee is evaluated at a CBD
diagnostic center, as described under paragraph (k)(7)(i), the employee
may choose to have any subsequent medical examinations for which the
employee is eligible, performed at the CBD diagnostic center at no cost
to the employee (see final paragraph (k)(7)(vi)). Therefore, the
standard already allows for periodic BeLPT testing for all employees
exposed in an emergency, and periodic medical surveillance for any of
those employees who are confirmed positive.
Another concern that was raised by DOSH is that delaying the
medical examination to at least one year following the emergency may
result in employees not receiving the examination if their employment
ends within that one-year period (Document ID 0023, p. 3). This concern
continues to be relevant to employees who are receiving the examination
for an emergency exposure at one to two years after the exposure in the
emergency (paragraph (k)(2)(iv)(B)). If employment does end before one
year after the emergency, paragraphs (k)(2)(iii) and (1)(i)(C) require
the employer to offer a medical examination at termination of
employment to any employee exposed to beryllium in an emergency, unless
the employee received an examination in accordance with the standard
within the last 6 months. OSHA is concerned that this provision would
not require employers to offer a medical examination to some employees
who would receive the emergency examination at one to two years after
the emergency exposure. For example, if such an employee, already under
medical surveillance, received a medical examination one month before
the emergency and then terminated employment two months after the
emergency, the employer would not be required to offer a medical
examination to that employee exposed during the emergency under the
proposed changes, and the employee would not have an opportunity to
have an medical exam that could detect any adverse effects that might
have occurred because of the emergency. OSHA agrees with DOSH that
further revision is necessary to ensure that every employee who is
exposed in an emergency receives an examination following the
emergency.
Accordingly, OSHA is revising paragraph (k)(2)(iii) to require that
each employee who is exposed in an emergency and has not received an
examination since the emergency exposure is provided an examination at
the time employment is terminated. OSHA finds that this change better
protects employees because it allows health effects that could have
resulted from the emergency exposure to be more readily detected.
In making these decisions on the appropriate timing for medical
examinations for employees exposed to beryllium during an emergency,
OSHA considered Materion's point that employees experiencing signs or
symptoms or other beryllium-related health effects after an emergency
can ask for an examination under paragraph (k)(1)(i)(B) (Document ID
0038, p. 33). As explained above, all employees who are exposed in an
emergency will either have previously received training under paragraph
(m)(4) or will need to be trained within a reasonable time after
exposure. And these employees should already be knowledgeable or will
soon become knowledgeable about the health hazards associated with
airborne exposure to and dermal contact with beryllium, including signs
and symptoms of CBD, as required by paragraph (m)(4)(ii). Therefore,
all employees exposed during an emergency should be able to identify
and report signs or symptoms of CBD or other beryllium-related health
effects either at the time of the emergency or within a reasonable time
after it. Materion is, thus, correct in pointing out that if these
employees did experience such signs or symptoms, they could ask for a
medical examination. Other employees exposed during an emergency that
have not had an examination and do not experience these health effects,
however, would still not have had the opportunity for a timely
consultation and medical examination with a PLHCP. Consequently, OSHA
does not find that the signs-or-symptoms trigger is sufficient to
resolve the concerns raised by the other stakeholders.
OSHA also proposed one additional change to the paragraph involving
emergency exposure. As promulgated in the 2017 final rule, paragraph
(k)(2)(i)(B) required the employer to provide a medical examination
within 30 days
[[Page 42620]]
after the employer determines that an employee shows signs or symptoms
of CBD or other beryllium-related health effects or has been exposed to
beryllium in an emergency. Because OSHA believes that employers
typically will learn of any emergency resulting in exposure immediately
or soon after it occurs, OSHA preliminarily determined that it is
appropriate to measure the time period from the date of exposure.
Therefore, under proposed paragraph (k)(2)(iv), the time period for
providing a medical examination begins to run from the date the
employee is exposed during an emergency, regardless of when the
employer discovers that the exposure occurred. OSHA requested comments
on the appropriateness of calculating the time period for a medical
examination from the occurrence of the emergency rather than from the
employer's determination of eligibility.
Materion agreed with OSHA that most employers will learn about the
emergency resulting in exposure immediately or soon after the
occurrence, and it supported measuring the time period from the date of
the exposure, provided that the employer determined that the incident
can be defined as an emergency under the standard (Document ID 0038,
pp. 33-34). OSHA did not receive any comments objecting to OSHA's
proposal to measure the time period from the date of exposure in an
emergency; therefore, OSHA is retaining the proposed language to
measure the time period from the date of the exposure in the emergency
in final paragraphs (k)(2)(iv)(A) and (B).
Paragraph (k)(2)(iv)(B) does not preclude employers from
voluntarily providing a medical examination within the first year after
an emergency. Providing a medical examination sooner would not,
however, relieve an employer of the duty to provide an exam in the one-
to-two-year window. For those employees who are already eligible for
periodic medical surveillance, the examination for the emergency
exposure could be scheduled to coincide with the next periodic
examination that is within two years of the last periodic medical
examination and at least one but no more than two years after the
emergency exposure, satisfying the requirements of both paragraphs
(k)(2)(ii) and (iv)(B).
In summary, OSHA is modifying proposed paragraph (k)(2)(iv) to
customize protections for two general groups of employees who could be
exposed to beryllium in an emergency. Paragraph (k)(2)(iv)(A) will
require the employer to offer a medical examination to an employee
within 30 days after the employee was exposed to beryllium in an
emergency, if the employee has not had an examination under paragraph
(k)(1)(i) within the last two years. This requirement improves
protections for what is likely to be a very small group of employees
who have not had a medical examination under the beryllium standard
within the last two years because it allows those employees to have a
timely consultation and examination. Paragraph (k)(2)(iv)(B) will
require the employer to offer a medical examination to an employee
within one to two years after the employee was exposed to beryllium in
an emergency, if the employee had an examination under paragraph
(k)(1)(i) of the beryllium standard within the last two years. This
provision eliminates the requirement to offer an examination within 30
days to the majority of employees who are likely to be exposed in an
emergency and have already received a recent medical examination. Thus,
these employees would have received a baseline examination and a recent
consultation regarding beryllium. And either group will continue to be
offered the BeLPT, or an equivalent test, every two years under
paragraph (k)(3)(ii)(E), even if they do not or no longer meet the
criteria for full periodic medical examinations under paragraph
(k)(ii). OSHA is also revising paragraph (k)(2)(iii) to require that
employers offer a medical examination to any employee who has not
received an examination since the emergency exposure at the time the
employee's employment is terminated. Again, OSHA expects this to be a
very small group of employees that would have had an exam within six
months of termination but not have had an exam since exposure during an
emergency. This change ensures that all employees exposed in an
emergency receive a medical examination for the emergency exposure
before their employment is terminated.
In addition, other provisions in the standard ensure that either
group of employees (i.e., those who receive a medical examination
within 30 days or one to two years after an emergency) are
knowledgeable about the signs and symptoms of CBD and that if employees
are experiencing signs and symptoms, they will be provided a medical
examination within 30 days of the employer determining that they are
experiencing such signs or symptoms.
The second (and final) set of changes that OSHA proposed to the
standard's medical surveillance requirements is in paragraph (k)(7),
which contains the requirements for evaluation at a CBD diagnostic
center. In this final rule, OSHA is amending paragraph (k)(7) in three
ways. First, OSHA is revising paragraph (k)(7)(i) to require that the
evaluation must be scheduled within 30 days, and must occur within a
reasonable time, of the employer receiving one of the types of
documentation listed in paragraph (k)(7)(i)(A) or (B). Second, OSHA is
adding a provision, in paragraph (k)(7)(ii), which clarifies that, as
part of the evaluation at the CBD diagnostic center, the employer must
ensure that the employee is offered any tests deemed appropriate by the
examining physician at the CBD diagnostic center, such as pulmonary
function testing (as outlined by the American Thoracic Society
criteria), bronchoalveolar lavage (BAL), and transbronchial biopsy. The
new provision also states that if any of the tests deemed appropriate
by the examining physician are not available at the CBD diagnostic
center, they may be performed at another location that is mutually
agreed upon by the employer and the employee. Third, OSHA is making a
handful of minor, non-substantive numbering and reference edits to
other provisions in paragraph (k)(7) to account for the addition of new
paragraph (k)(7)(ii). Specifically, OSHA is renumbering current
paragraphs (k)(7)(ii), (iii), (iv), and (v) as (k)(7)(iii), (iv), (v),
and (vi), respectively, and is adding a reference to new paragraph
(k)(7)(ii) to the newly renumbered paragraph (k)(7)(vi).
Each of these final revisions differ in some way from the proposed
amendments based on stakeholder feedback. With regard to the first
change concerning the timing of the exam, the current standard requires
employers to provide the examination within 30 days of the employer
receiving one of the types of documentation listed in paragraph
(k)(7)(i)(A) or (B). The purpose of the 30-day requirement was to
ensure that employees receive the examination in a timely manner. As
OSHA explained in the proposal, however, since the publication of the
2017 final rule stakeholders have raised concerns that the examination
and any required tests could not be scheduled and completed within 30
days (83 FR at 63758).
To address this concern, OSHA proposed that the employer provide an
initial consultation with the CBD diagnostic center, which could occur
via telephone or virtual conferencing methods, rather than the full
evaluation, within 30 days of the employer receiving one of the types
of documentation listed in paragraph (k)(7)(i)(A) or (B). OSHA
explained that providing a consultation before the full examination at
the CBD diagnostic
[[Page 42621]]
center would demonstrate that the employer made an effort to begin the
process for a medical examination. OSHA also noted that the proposed
change would also allow (1) the employee to consult with a physician to
discuss concerns and ask questions while waiting for a medical
examination, and (2) the physician to explain the types of tests that
are recommended based on medical findings about the employee and the
risks and benefits of undergoing such testing. OSHA requested comments
on the appropriateness of providing the consultation within 30 days and
on the sufficiency of a consultation via telephone or virtual
conference (83 FR at 63758).
Several stakeholders offered comments on this issue (Document ID
0021, p. 3; 0022, p. 6; 0029, p. 2; 0038, p. 34). The ATS, NJH, and
Materion agreed that an examination at the CBD diagnostic center should
not be required to occur within 30 days of the referral because it may
take weeks or months before the CBD diagnostic center has an opening
for an evaluation. In addition, many of the stakeholders noted that
work responsibilities, personal and family obligations, or the need to
arrange travel may make it difficult for employees to have an
evaluation done within that time period.
Materion also supported the proposed requirement for a telephone or
virtual consultation within 30 days, claiming that it is a more
workable solution that does not reduce protections, while allowing
employees to consider medical options available under the standard and
offering the employee more flexibility in determining when they can
undergo testing based on their availability and preference (Document ID
0038, p. 34). In contrast to Materion, the ATS and NJH opposed the
proposed requirement for a consultation that can be performed via
telephone or virtual conferencing within 30 days of the employer
receiving documentation recommending a referral. NJH commented that a
video or phone consultation would add cost and logistical difficulty to
scheduling, and that it is not necessary because the PLHCP who sees the
employee for screening provides information on the clinical evaluation.
Furthermore, they commented, there are HIPAA privacy issues of a phone
or video conference to consider (Document ID 0022, p. 6).
The ATS agreed with many of the concerns expressed by NJH,
including concerns regarding logistical challenges, the need for an in-
person clinical evaluation and review of medical tests to provide
effective care, and redundancy with the PLHCP consultation (Document ID
0021, p. 3). The ATS and NJH recommended that the standard be revised
to require that the employer make an appointment for the employee to be
evaluated at the CBD diagnostic center within 30 days of receiving
documentation for the referral (Document ID 0021, p. 3; 0022, p. 6).
DOD also opposed requiring an evaluation by telephone or virtual
conferencing and stated that an ill worker should be examined
immediately; it recommended that the employer make the appointment for
evaluation at a CBD diagnostic center within seven days of receiving
documentation for a referral (Document ID 0029, p. 2).
After considering these comments, OSHA is convinced that scheduling
a phone or virtual consultation with the CBD diagnostic center is an
unnecessary step that adds logistical complications and costs. Although
the agency understands Materion's point that the additional
consultation could provide employees with more time and information to
make medical decisions, as well as accommodate other scheduling
logistics, OSHA finds that the scheduling approach suggested by the ATS
and NJH addresses both the logistical difficulties cited by
stakeholders with respect to the requirements in the current standard
and the timing concerns Materion raised. Moreover, OSHA finds that
employees will have enough information (through trainings under
paragraph (m) and discussions with the PLHCP) to allow them to decide
whether to be evaluated at the CBD diagnostic center.\21\ OSHA is
therefore amending paragraph (k)(7)(i) to require that the employer
schedule an examination at a CBD diagnostic center within 30 days of
receiving one of the types of documentation listed in paragraph
(k)(7)(i)(A) or (B). And to maintain the intent of the 2017 final rule
and the 2018 NPRM that evaluation at a CBD diagnostic center occurs in
a timely manner, OSHA is adding that the evaluation must occur within a
reasonable time. Requiring that the evaluation occur within a
reasonable time ensures that the evaluation is done as soon as
practicable based upon availability of openings at the CBD diagnostic
center and the employee's preferences. This revision better addresses
OSHA's original intent that the employee be examined within a timely
period, while providing employees and employers with maximum
flexibility and convenience.
---------------------------------------------------------------------------
\21\ Under paragraph (k)(6)(i)(D), the employer is to ensure
that the PLHCP explains the results of the medical examination to
the employee, including results of tests conducted and medical
conditions related to airborne beryllium exposure that require
further evaluation or treatment.
---------------------------------------------------------------------------
Although OSHA understands DOD's concerns about making a timely
appointment, requiring that an appointment be made within a seven-day
period might not give the employee enough time to consider his or her
future obligations and possibly have discussions with family members to
determine the best time period for the examination. OSHA believes that
a 30-day period to schedule an appointment for an examination is a
reasonable time that allows the employee to consider his or her
preferences for an examination date. In addition, a 30-day period
offers more administrative convenience for employers because it is
consistent with other triggers in the beryllium standard.
The second change that OSHA proposed to paragraph (k)(7)(i) relates
to the contents of the examination at the CBD diagnostic center. As
discussed in more detail above, the former definition of CBD diagnostic
center--which stated that the evaluation at the diagnostic center
``must include'' a pulmonary function test as outlined by American
Thoracic Society criteria, bronchoalveolar lavage (BAL), and
transbronchial biopsy--could have been misinterpreted to mean that the
examining physician was required to perform each of these tests during
every clinical evaluation at a CBD diagnostic center. That was not
OSHA's intent. Rather, the agency merely intended to ensure that any
CBD diagnostic center has the capacity to perform any of these tests,
which are commonly needed to diagnose CBD. Therefore, OSHA proposed
revising the definition to clarify that the CBD diagnostic center must
simply have the ability to perform each of these tests when deemed
appropriate.
To account for that proposed change to the definition of CBD
diagnostic center and to ensure that the employer provides those tests
if deemed appropriate by the examining physician at the CBD diagnostic
center, OSHA proposed expanding paragraph (k)(7)(i) to require that the
employer provide, at no cost to the employee and within a reasonable
time after consultation with the CBD diagnostic center, any of the
three tests mentioned above, if deemed appropriate by the examining
physician at the CBD diagnostic center (83 FR at 63764). OSHA explained
that the revision would also clarify the agency's original intent that,
instead of requiring all three tests to be conducted after referral to
a CBD diagnostic center, the standard would allow the examining
[[Page 42622]]
physician at the CBD diagnostic center the discretion to select one or
more of those tests as appropriate (83 FR at 63764).
Several stakeholders offered opinions on these proposed changes.
For example, Materion agreed with the proposed changes to align
paragraph (k)(7)(i) with the definition for CBD diagnostic center
(Document ID 0038, p. 34). However, as discussed above in the Summary
and Explanation of paragraph (b), Definitions, the ATS argued that
``not requiring certain diagnostic tests (or an equivalent) could
reduce the potential to diagnose CBD and determine disease severity''
(Document ID 0021, p. 3). The ATS further asserted that ``confirmed
positive workers should have an assessment of lung function and gas
exchange (such as a full set of pulmonary function tests with
spirometry, lung volumes and diffusion capacity for carbon monoxide or
other similar tests) and also chest imaging'' (Document ID 0021, p. 3).
NJH and the AOEC expressed similar concerns, commenting that lung
function and imaging tests should be included as part of an evaluation
at the CBD diagnostic center (Document ID 0022, p. 3; 0028, p. 2).
After reviewing these comments and the remainder of the record on this
issue, OSHA agrees that pulmonary function testing, BAL, and
transbronchial biopsies are important diagnostic tools, but finds that
the examining physician at the CBD diagnostic center is in the best
position to determine which diagnostic tests are appropriate for
particular workers. The agency believes that the modified definition of
the term CBD diagnostic center, which requires the centers to have the
capacity to perform these three tests, will serve to ensure that
healthcare providers at the centers are aware of the importance of and
are able to perform pulmonary function testing, BAL, and transbronchial
biopsies.
Nevertheless, OSHA understands that the proposed provision could be
misinterpreted to mean that the employer does not have to make
available additional tests that the examining physician deems
appropriate for diagnosing or determining severity of CBD. That was
never the agency's intent. In fact, OSHA noted the potential for other
tests, as deemed necessary by the CBD diagnostic center physician,
several times in the preamble to the 2017 final rule (see, e.g., 82 FR
at 2709, 2714). Similar to paragraph (k)(3)(ii)(G), which requires the
employer to ensure that the employee is offered as part of the initial
or periodic medical examination any test deemed appropriate by the
PLHCP, OSHA intends for the employer to ensure the employee is offered
any tests deemed appropriate by the examining physician at the CBD
diagnostic center, including tests for diagnosing CBD, for determining
its severity, and for monitoring progression of CBD following
diagnosis. Allowing the physician at the CBD diagnostic center to order
additional tests that are deemed appropriate is also consistent with
most OSHA substance-specific standards, such as respirable crystalline
silica (29 CFR 1910.1053) and chromium (VI) (29 CFR 1910.1026).
To clarify the agency's intent that the physician at the CBD
diagnostic center has discretion to order appropriate tests, and to
further respond to stakeholder concerns regarding the necessity of
pulmonary function testing, BAL, and transbronchial biopsies, OSHA is
adding a new sub-paragraph (k)(7)(ii), which focuses on the content of
the examination. This new provision requires the employer to ensure
that, as part of the evaluation, the employee is offered any tests
deemed appropriate by the examining physician at the CBD diagnostic
center, such as pulmonary function testing (as outlined by the American
Thoracic Society criteria), bronchoalveolar lavage (BAL), and
transbronchial biopsy. OSHA intends for the new provision to make clear
that the employer must provide additional tests, such as those noted by
the ATS, NJH, and the AOEC, at no cost to the employee, if those tests
are deemed necessary by the examining physician. The agency also
believes that explicitly naming the three examples of tests that may be
appropriate will further emphasize their importance to examining
physicians at the CBD diagnostic centers.
Consistent with OSHA's original intent, those tests are required to
be offered only if deemed appropriate by the physician at the CBD
diagnostic center. For example, if lung volume and diffusion tests were
performed according to the ATS criteria as part of the periodic medical
examination under paragraph (k)(3) and the physician at the CBD
diagnostic center found them to be of acceptable quality, those tests
would not have to be repeated as part of a CBD evaluation. The addition
of paragraph (k)(7)(ii) clarifies that the employer must, however,
offer any test that the PLHCP deems appropriate. Consistent with
previous health standards and the meaning of the identical phrase in
paragraph (k)(3)(ii)(G), OSHA intends the phrase ``deemed appropriate''
to mean that additional tests requested by the physician must be both
related to beryllium exposure and medically necessary, based on the
findings of the medical examination (see 82 FR at 2709; 81 FR 16286,
16826 (March 25, 2016)).
New paragraph (k)(7)(ii) also addresses the possibility that a test
that is deemed appropriate by the examining physician at the CBD
diagnostic center might not be available at that center. Although
OSHA's intention has been to require any testing to be provided by the
same CBD diagnostic center unless the employer and employee agree to a
different CBD diagnostic center (see 83 FR at 63758), there may be
cases where the CBD diagnostic center does not perform a type of test
deemed appropriate by the examining physician. In such a case, OSHA
wants to ensure that the employee can receive the appropriate test.
Therefore, OSHA is also including in paragraph (k)(7)(ii) a requirement
that if any of those tests deemed appropriate by the physician are not
available at the CBD diagnostic center, they may be performed at
another location that is mutually agreed upon by the employer and the
employee. This other location does not need to be a CBD diagnostic
center as long as it is able to perform tests according to requirements
under paragraph (k). OSHA believes that such circumstances would be
very rare because CBD diagnostic centers with the ability to perform
pulmonary function testing (as outlined by the ATS criteria), BAL, and
transbronchial biopsy are likely to also provide other medical tests
related to CBD.\22\ As a result, the CBD diagnostic center in the vast
majority of cases will be able to offer the additional testing deemed
necessary by the examining physician. Given that this standard requires
CBD diagnostic centers to be able to perform the three most common
tests for diagnosing CBD, and CBD diagnostic centers typically would be
able to offer any additional tests deemed necessary, OSHA expects that
employees would rarely, if ever, need to travel to a second location.
---------------------------------------------------------------------------
\22\ Document ID OSHA-H005C-2006-0870-0637 provides information
from the NJH website, which provides an overview of the types of
tests performed.
---------------------------------------------------------------------------
In summary, final paragraph (k)(7)(i) requires that the employer
provide an evaluation at no cost to the employee at a CBD diagnostic
center that is mutually agreed to by the employer and the employee. The
evaluation must be scheduled within 30 days and must occur within a
reasonable time of the employer receiving one of the types of
documentation listed in paragraph (k)(7)(i)(A) or (B). Final paragraph
(k)(7)(ii) requires the employer to ensure that, as part of the
evaluation, the
[[Page 42623]]
employee is offered any tests deemed appropriate by the examining
physician at the CBD diagnostic center, such as pulmonary function
testing (as outlined by the American Thoracic Society criteria),
bronchoalveolar lavage (BAL), and transbronchial biopsy. Paragraph
(k)(7)(ii) further provides that any test deemed appropriate by the
examining physician that is not available at the CBD diagnostic center
may be performed at another location that is agreed upon by the
employer and employee. Such tests must be provided at no cost to the
employee, whether performed at the CBD diagnostic center or at another
location.
As noted above, OSHA is also making a handful of minor, non-
substantive numbering and reference edits to other provisions in
paragraph (k)(7) to account for the addition of new paragraph
(k)(7)(ii). Specifically, OSHA is renumbering current paragraphs
(k)(7)(ii)-(v) as (k)(7)(iii), (iv), (v), and (vi), accordingly, and is
adding a reference to new paragraph (k)(7)(ii) to the newly renumbered
paragraph (k)(7)(vi). Paragraph (k)(7)(vi) provided that after an
employee received the initial clinical evaluation at the CBD diagnostic
center described in paragraph (k)(7)(i), the employee could choose to
have any subsequent medical evaluations for which the employee is
eligible under paragraph (k) performed at a CBD diagnostic center
mutually agreed upon by the employer and employee and that the employer
must provide such examinations to the employee at no cost. OSHA is
revising the paragraph to add the reference to new paragraph (k)(7)(ii)
because the description of the initial clinical evaluation is now split
between paragraph (k)(7)(i) and (ii), rather than appearing solely in
paragraph (k)(7)(i). OSHA does not expect that this clarifying change
will have any substantive effect. Newly renumbered paragraph (k)(7)(vi)
(previous paragraph (k)(7)(v)), therefore, continues to require that,
after an employee has received the initial clinical evaluation at a CBD
diagnostic center, the employee may choose to have any subsequent
medical examinations for which the employee is eligible under paragraph
(k) of this standard performed at a CBD diagnostic center mutually
agreed upon by the employer and the employee, and the employer must
provide such examinations at no cost to the employee.
The addition of paragraph (k)(7)(ii) and consequential renumbering
of current paragraphs (k)(7)(ii)-(v) as (k)(7)(iii), (iv), (v), and
(vi) also affects two other cross-references in the standard. Paragraph
(l)(1) of the standard details the eligibility requirements for medical
removal. Two of the criteria, those in (l)(1)(i)(B) and (l)(1)(ii)
reference paragraphs (k)(7)(ii) and (k)(7)(iii), respectively. In this
final rule, OSHA is updating those references to reflect the
renumbering in paragraph (k)(7). Therefore, final paragraph
(l)(1)(i)(B) references paragraph (k)(7)(iii) and paragraph (l)(1)(ii)
references paragraph (k)(7)(iv). These edits, like those noted above in
paragraph (k)(7)(vi), do not change the substantive meaning of the
provisions.
Communication of Hazards.
Paragraph (m) of the beryllium standard for general industry (29
CFR 1910.1024(m)) sets forth the employer's obligation to comply with
the Hazard Communication standard (HCS) (29 CFR 1910.1200) relative to
beryllium and to take additional steps to warn and train employees
about the hazards of beryllium. Under the HCS, beryllium manufacturers
and importers are required to evaluate the hazards of beryllium and
prepare labels and safety data sheets (SDSs) and provide both documents
to downstream users. Employers whose employees are exposed to beryllium
in their workplace must develop a hazard communication program and
ensure that employees are trained on the hazards of beryllium. These
employers must also ensure that all containers of beryllium are labeled
and that employees are provided access to the SDSs. In addition to the
requirements under the HCS, paragraph (m)(1)(ii) of the beryllium
standard for general industry specifies certain criteria that must be
addressed in classifying the hazards of beryllium. Paragraph (m)(2)
requires employers to provide and display warning signs with specified
wording at each approach to a regulated area. Paragraph (m)(3) requires
employers to label each container of clothing, equipment, and materials
contaminated with beryllium using specified language. Finally,
paragraph (m)(4) details employers' duties to provide information and
training to employees.
In the 2018 NPRM, OSHA proposed three revisions to paragraph (m) of
the beryllium standard for general industry (83 FR at 63759-60, 63769).
The first change is related to paragraph (m)(3), which previously
required employers to label ``each bag and container'' of clothing,
equipment, and materials contaminated with beryllium. In the 2018 NPRM,
OSHA proposed to replace the phrase ``each bag and container'' with the
phrase ``each immediate container,'' to clarify that the employer need
only label the immediate bag or container of beryllium-contaminated
items and not larger containers holding the labeled bag or container.
OSHA proposed this change to be consistent with the HCS, which requires
only the primary or immediate container to be labeled (see 29 CFR
1910.1200(c)) (definition of ``Label''). OSHA explained that this
proposed change would effectuate OSHA's intent, expressed in the 2017
final rule, that the hazard communication requirements of the beryllium
standard ``be substantively as consistent as possible'' with the HCS
(82 FR at 2694, 2724). As such, OSHA preliminarily determined that the
change would maintain safety and health protections for workers.
Next, OSHA proposed two revisions to paragraph (m)(4), which
addresses employee information and training. 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 and understanding of certain specified topics.
One of the topics specified in the previous standard was the health
hazards associated with ``airborne exposure to and contact with
beryllium,'' including the signs and symptoms of CBD (83 FR at 63759).
OSHA proposed to modify this language by adding the word ``dermal''
immediately prior to ``contact with beryllium.'' OSHA explained that
the change would clarify OSHA's intent that employers must ensure that
exposed employees can demonstrate knowledge and understanding of the
health hazards caused by dermal contact with beryllium.
OSHA also proposed to modify the language in paragraph
(m)(4)(ii)(E), which required the employer to ensure that each employee
who is, or can reasonably be expected to be, exposed to airborne
beryllium can demonstrate knowledge and understanding of measures
employees can take to protect themselves from ``airborne exposure to
and contact with beryllium,'' including personal hygiene practices (83
FR at 63759). As with the previous revision, OSHA proposed adding the
word ``dermal'' to ``contact with beryllium'' to clarify OSHA's intent
that employers must ensure exposed employees can demonstrate knowledge
and understanding of measures employees can take to protect themselves
from dermal contact with beryllium.
Commenters did not object to any of the changes that OSHA proposed
to paragraph (m). In fact, the only stakeholder that offered any
comments on these revisions, Materion, generally supported the proposed
changes,
[[Page 42624]]
commenting that the changes will maintain safety and health protections
for employees (Document ID 0038, p. 34). OSHA agrees with this
assessment and finds that the proposed changes will clarify employers'
requirements for the communication of hazards of beryllium. Therefore,
OSHA is finalizing the proposed changes to paragraph (m) in this final
rule.
Recordkeeping.
Paragraph (n) of the beryllium standard for general industry
requires employers to make and maintain air monitoring data, objective
data, and medical surveillance records, and prepare and maintain
training records. The 2017 final rule required employers' air
monitoring data ((n)(1)(ii)(F)), medical surveillance ((n)(3)(ii)(A)),
and training ((n)(4)(i)) records to include employee Social Security
Numbers (SSNs). In the 2018 NPRM, OSHA proposed to modify paragraph (n)
to remove that requirement. This final rule adopts the proposed
revisions, eliminating the requirement to include employee SSNs in
these records.
The issue of whether to include employee SSNs in records under
OSHA's standards for beryllium dates back to the 2015 beryllium NPRM.
In that NPRM, OSHA proposed to require inclusion of employee SSNs in
records related to air monitoring, medical surveillance, and training,
similar to provisions in previous substance-specific health standards.
Some stakeholders objected to the proposed requirement based on
employee privacy and identity theft concerns (82 FR at 2730). OSHA
recognized the validity of these concerns, but preliminarily concluded
that due to the agency's past consistent practice of requiring an
employee's SSN on records, any change to this requirement should be
comprehensive and apply to all OSHA standards, not just the standards
for beryllium (82 FR at 2730).
In 2016, in its Standards Improvement Project-Phase IV (SIP-IV)
proposed rule (81 FR 68504, 68526-28 (October 4, 2016)), OSHA proposed
to delete the requirement that employers include employee SSNs in
records required by the agency's substance-specific standards. The 2017
final rule for beryllium included the SSN requirements, but, in the
preamble, OSHA recognized that the SIP-IV rulemaking was ongoing and
stated that it would revisit its decision to require employers to
include SSNs in beryllium records in light of the SIP-IV rulemaking, if
appropriate (82 FR at 2730).
The SIP-IV rulemaking was still ongoing when OSHA published the
2018 NPRM. Consistent with the SIP-IV proposal, OSHA proposed to modify
the beryllium standard for general industry by removing the requirement
to include SSNs in the recordkeeping provisions in paragraphs
(n)(1)(ii)(F) (air monitoring data), (n)(3)(ii)(A) (medical
surveillance), and (n)(4)(i) (training). OSHA noted that these proposed
revisions would address the privacy concerns raised in response to the
2015 NPRM, while maintaining safety and health protection for workers.
Three commenters, Phylmar Regulatory Roundtable, DOD, and Materion,
expressed general support for the proposed changes to the recordkeeping
provisions (Document ID 0020, p. 1; 0029, p. 1; 0038, p. 34), and no
commenters expressed opposition to OSHA's proposal to remove the
requirement to include each employee's SSN in these three sets of
records. After reviewing these comments, OSHA is finalizing the
proposed deletion of the SSN requirements in this final rule. This
change is also consistent with the agency's decision in the SIP-IV
rulemaking, which was finalized in the months since the publication of
the 2018 NPRM (84 FR 21416 (May 14, 2019)). The SIP-IV final rule
deletes the requirement to include employee SSNs in records employers
must maintain under the substance-specific standards that existed at
the time of OSHA's 2016 SIP-IV proposal (see 84 FR at 21439-40).\23\
The deletion of the SSN requirements in the beryllium general industry
standard will, thus, bring this standard into line with the majority of
OSHA's other substance-specific standards.
---------------------------------------------------------------------------
\23\ The beryllium standard for general industry, which was not
published until 2017, was not listed in the SIP-IV NPRM and,
therefore, the SIP-IV final rule did not affect the 2017 final
rule's requirement to include employee SSNs in records.
---------------------------------------------------------------------------
OSHA received one other comment related to SSNs in this rulemaking.
A private citizen agreed that the proposed changes were ``necessary and
appropriate,'' but expressed concerns that there is no additional
requirement to remove SSNs from existing records and that allowing
employers the option to continue using SSNs will not effectively
protect employee privacy (Document ID 0017). OSHA understands the
private citizen's concerns. The SIP-IV NPRM did not propose to require
employers to remove employee SSNs from existing records or to prohibit
employers from using employee SSNs in their records. The agency did,
however, request comment on whether employers should be required to use
an alternative identification system rather than SSNs, or to remove
SSNs from existing records (81 FR at 68528).
As discussed in the preamble to the SIP-IV final rule, the comments
that OSHA received in response to the SIP-IV NPRM advocated against
requiring employers to use an alternative type of employee identifier
or to remove SSNs from existing records (84 FR at 21440). For example,
the Construction Industry Safety Coalition (CISC) supported OSHA's
statements in the SIP-IV NPRM that employers would not be required to
delete employee SSNs from existing records, would not be required to
use an alternative employee identifier on existing records, and would
still be permitted to use SSNs if they wish to do so. CISC stated that
limiting employers' flexibility to come up with an identification
system that works best for their situations would create an undue
compliance burden (84 FR at 21440). After considering the comments,
OSHA decided in the SIP-IV final rule to proceed with removing the SSN
collection requirements from previously published standards, but not to
require employers to delete employee SSNs from existing records or to
use an alternative employee identifier.
In order to maintain consistency among OSHA recordkeeping
requirements for substance-specific standards, the agency has decided
not to require employers to delete employee SSNs from existing records
relating to beryllium or to use an alternative employee identifier. The
final rule allows employers the option to still use SSNs or to use some
other alternative employee identifier system, as explained in the SIP-
IV final rule. This will give employers the flexibility to choose the
best option for their particular circumstance and will avoid
unnecessarily increasing employers' compliance burdens.
Additional Comments.
The scope of the 2018 proposal was limited to the specific
revisions and clarifications to the beryllium standard identified in
the NPRM. The NPRM did not invite comment on all of the agency's
underlying determinations from the 2017 beryllium final rule. As such,
OSHA determined that some comments the agency received in response the
2018 NPRM pertained to subjects outside the scope of the proposal. OSHA
briefly addresses these comments below.
Two commenters addressed issues related to OSHA's significant risk
finding from the 2017 final rule. One commenter focused on the risk of
health effects related to beryllium exposure in the aluminum smelting
industry and the methodologies underlying OSHA's risk
[[Page 42625]]
assessment of occupational exposure to beryllium (Document ID 0026,
Attachment 2, pp. 9-16). Another took issue with OSHA's risk
determination pertaining to dermal contact with beryllium and argued
that the current standard did not distinguish between the chemical
forms of beryllium and its varying risk of injury from dermal contact
(Document ID 0038, pp. 13-15). OSHA addressed these concerns about risk
in the 2017 final rule and determined that the beryllium standard
addresses a significant risk (see 82 FR at 2545-52). The changes and
clarifications proposed by the 2018 NPRM do not affect that
determination.
Another commenter took issue with the revised PEL for beryllium set
in the 2017 final rule, suggesting that a lower PEL was needed to
protect workers from CBD and lung cancer (Document ID 0028, p. 1).
Although OSHA determined in the 2017 final rule that there remains a
significant risk of material impairment of health at the 0.2 [micro]g/
m\3\ PEL and the 2.0 ug/m\3\ STEL, the agency further determined that
it could not demonstrate that a lower PEL would be technologically
feasible (82 FR at 2552). Again, OSHA did not propose to revisit this
finding in this rulemaking.
List of Subjects for 29 CFR Part 1910
Beryllium, General industry, Health, Occupational safety and
health.
Authority
Loren Sweatt, Principal Deputy Assistant Secretary of Labor for
Occupational Safety and Health, U.S. Department of Labor, directed the
preparation of this document. The agency issues the sections under the
following authorities: 29 U.S.C. 653, 655, 657; Secretary of Labor's
Order 1-2012 (77 FR 3912); 29 CFR part 1911; and 5 U.S.C. 553, as
applicable.
Signed at Washington, DC, on May 13, 2020.
Loren Sweatt,
Principal Deputy Assistant Secretary of Labor for Occupational Safety
and Health.
Amendments to Standards
For the reasons set forth in the preamble, chapter XVII of title
29, part 1910 is amended to read as follows:
PART 1910--OCCUPATIONAL SAFETY AND HEALTH STANDARDS
0
1. The authority section for part 1910, subpart Z, continues to read as
follows:
Authority: 29 U.S.C. 653, 655, 657; Secretary of Labor's Order
No. 12-71 (36 FR 8754), 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 31160), 4-2010 (75 FR 55355), or 1-2012 (77 FR
3912); and 29 CFR part 1911.
All of subpart Z issued under 29 U.S.C. 655(b), except those
substances that have exposure limits listed in Tables Z-1, Z-2, and
Z-3 of Sec. 1910.1000. The latter were issued under 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 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 Public Law 106-430, 114
Stat. 1901.
Section 1910.1201 also issued under 49 U.S.C. 1801-1819 and 5
U.S.C. 553.
0
2. Amend Sec. 1910.1024 by:
0
A. Revising the definitions for ``Beryllium sensitization,''
``Beryllium work area,'' ``CBD diagnostic center,'' ``Chronic beryllium
disease (CBD),'' and ``Dermal contact with beryllium''.
0
B. Revise paragraphs (f)(1)(i)(D), (f)(ii)(B), (h)(2)(i), (h)(3)(iii),
(i)(1) introductory text, (i)(2), (i)(4)(ii), (j)(3), (k)(2)(i)(B),
(k)(2)(iii) and (iv), (k)(7)(i) introductory text, (k)(7)(ii) through
(vi), (l)(1)(i)(B), (l)(1)(ii), (m)(3), (m)(4)(ii)(A), (m)(4)(ii)(E),
(n)(1)(ii)(F), (n)(3)(ii)(A), (n)(4)(i), and Appendix A.
The revisions read as follows:
Sec. 1910.1024 Beryllium.
* * * * *
(b) * * *
Beryllium sensitization means a response in the immune system of a
specific individual who has been exposed to beryllium. There are no
associated physical or clinical symptoms and no illness or disability
with beryllium sensitization alone, but the response that occurs
through beryllium sensitization can enable the immune system to
recognize and react to beryllium. While not every beryllium-sensitized
person will develop chronic beryllium disease (CBD), beryllium
sensitization is essential for development of CBD.
Beryllium work area means any work area where materials that
contain at least 0.1 percent beryllium by weight are processed either:
(1) During any of the operations listed in Appendix A of this
standard; or
(2) Where employees are, or can reasonably be expected to be,
exposed to airborne beryllium at or above the action level.
CBD diagnostic center means a medical diagnostic center that has a
pulmonologist or pulmonary specialist on staff and on-site facilities
to perform a clinical evaluation for the presence of chronic beryllium
disease (CBD). The CBD diagnostic center must have the capacity to
perform pulmonary function testing (as outlined by the American
Thoracic Society criteria), bronchoalveolar lavage (BAL), and
transbronchial biopsy. The CBD diagnostic center must also have the
capacity to transfer BAL samples to a laboratory for appropriate
diagnostic testing within 24 hours. The pulmonologist or pulmonary
specialist must be able to interpret the biopsy pathology and the BAL
diagnostic test results.
Chronic beryllium disease (CBD) means a chronic granulomatous lung
disease caused by inhalation of airborne beryllium by an individual who
is beryllium sensitized.
Confirmed positive means the person tested has had two abnormal
BeLPT test results, an abnormal and a borderline test result, or three
borderline test results, obtained from tests conducted within a three-
year period. It also means the result of a more reliable and accurate
test indicating a person has been identified as having beryllium
sensitization.
* * * * *
Dermal contact with beryllium means skin exposure to:
(1) Soluble beryllium compounds containing beryllium in
concentrations greater than or equal to 0.1 percent by weight;
(2) Solutions containing beryllium in concentrations greater than
or equal to 0.1 percent by weight; or
(3) Visible dust, fumes, or mists containing beryllium in
concentrations greater than or equal to 0.1 percent by weight. The
handling of beryllium materials in non-particulate solid form that are
free from visible dust containing beryllium in concentrations greater
than or equal to 0.1 percent by weight is not considered dermal contact
under the standard.
* * * * *
(f) * * *
(1) * * *
(i) * * *
(D) Procedures for minimizing cross-contamination, including the
transfer of beryllium between surfaces, equipment, clothing, materials,
and articles within beryllium work areas;
* * * * *
(ii) * * *
(B) The employer is notified that an employee is eligible for
medical removal in accordance with paragraph (l)(1) of this standard,
referred for evaluation at
[[Page 42626]]
a CBD diagnostic center, or shows signs or symptoms associated with
exposure to beryllium; or
* * * * *
(h) * * *
(2) * * *
(i) The employer must ensure that each employee removes all
beryllium-contaminated personal protective clothing and equipment at
the end of the work shift, at the completion of all tasks involving
beryllium, or when personal protective clothing or equipment becomes
visibly contaminated with beryllium, whichever comes first.
* * * * *
(3) * * *
(iii) The employer must inform in writing the persons or the
business entities who launder, clean, or repair the personal protective
clothing or equipment required by this standard of the potentially
harmful effects of exposure to beryllium and that the personal
protective clothing and equipment must be handled in accordance with
this standard.
* * * * *
(i) * * *
(1) General. For each employee working in a beryllium work area or
who can reasonably be expected to have dermal contact with beryllium,
the employer must:
* * * * *
(2) Change rooms. In addition to the requirements of paragraph
(i)(1)(i) of this standard, the employer must provide employees who are
required to use personal protective clothing or equipment under
paragraph (h)(1)(ii) of this standard with a designated change room in
accordance with this standard and the Sanitation standard (Sec.
1910.141) where employees are required to remove their personal
clothing.
* * * * *
(4) * * *
(ii) No employees enter any eating or drinking area with beryllium-
contaminated personal protective clothing or equipment unless, prior to
entry, it is cleaned, as necessary, to be as free as practicable of
beryllium by methods that do not disperse beryllium into the air or
onto an employee's body; and
* * * * *
(j) * * *
(3) Disposal, recycling, and reuse. (i) Except for intra-plant
transfers, when the employer transfers materials that contain at least
0.1 percent beryllium by weight or are contaminated with beryllium for
disposal, recycling, or reuse, the employer must label the materials in
accordance with paragraph (m)(3) of this standard;
(ii) Except for intra-plant transfers, materials designated for
disposal that contain at least 0.1 percent beryllium by weight or are
contaminated with beryllium must be cleaned to be as free as
practicable of beryllium or placed in enclosures that prevent the
release of beryllium-containing particulate or solutions under normal
conditions of use, storage, or transport, such as bags or containers;
and
(iii) Except for intra-plant transfers, materials designated for
recycling or reuse that contain at least 0.1 percent beryllium by
weight or are contaminated with beryllium must be cleaned to be as free
as practicable of beryllium or placed in enclosures that prevent the
release of beryllium-containing particulate or solutions under normal
conditions of use, storage, or transport, such as bags or containers.
* * * * *
(k) * * *
(2) * * *
(i) * * *
(B) An employee meets the criteria of paragraph (k)(1)(i)(B) of
this standard.
* * * * *
(iii) At the termination of employment for each employee who meets
any of the criteria of paragraph (k)(1)(i) of this standard at the time
the employee's employment terminates, unless an examination has been
provided in accordance with this standard during the six months prior
to the date of termination. Each employee who meets the criteria of
paragraph (k)(1)(i)(C) of this standard and who has not received an
examination since exposure to beryllium during the emergency must be
provided an examination at the time the employee's employment
terminates.
(iv) For an employee who meets the criteria of paragraph
(k)(1)(i)(C) of this standard:
(A) If that employee has not received a medical examination within
the previous two years pursuant to paragraph (k)(1)(i) of this
standard, then within 30 days after the employee meets the criteria of
paragraph (k)(1)(i)(C) of this standard; or
(B) If that employee has received a medical examination within the
previous two years pursuant to paragraph (k)(1)(i) of this standard,
then at least one year but no more than two years after the employee
meets the criteria of paragraph (k)(1)(i)(C) of this standard.
* * * * *
(7) * * *
(i) The employer must provide an evaluation at no cost to the
employee at a CBD diagnostic center that is mutually agreed upon by the
employer and the employee. The evaluation at the CBD diagnostic center
must be scheduled within 30 days, and must occur within a reasonable
time, of:
* * * * *
(ii) The employer must ensure that, as part of the evaluation, the
employee is offered any tests deemed appropriate by the examining
physician at the CBD diagnostic center, such as pulmonary function
testing (as outlined by the American Thoracic Society criteria),
bronchoalveolar lavage (BAL), and transbronchial biopsy. If any of the
tests deemed appropriate by the examining physician are not available
at the CBD diagnostic center, they may be performed at another location
that is mutually agreed upon by the employer and the employee.
(iii) The employer must ensure that the employee receives a written
medical report from the CBD diagnostic center that contains all the
information required in paragraph (k)(5)(i), (ii), (iv), and (v) of
this standard and that the PLHCP explains the results of the
examination to the employee within 30 days of the examination.
(iv) The employer must obtain a written medical opinion from the
CBD diagnostic center within 30 days of the medical examination. The
written medical opinion must contain only the information in paragraph
(k)(6)(i), as applicable, unless the employee provides written
authorization to release additional information. If the employee
provides written authorization, the written opinion must also contain
the information from paragraphs (k)(6)(ii), (iv), and (v), if
applicable.
(v) The employer must ensure that each employee receives a copy of
the written medical opinion from the CBD diagnostic center described in
paragraph (k)(7) of this standard within 30 days of any medical
examination performed for that employee.
(vi) After an employee has received the initial clinical evaluation
at a CBD diagnostic center described in paragraphs (k)(7)(i) and (ii)
of this standard, the employee may choose to have any subsequent
medical examinations for which the employee is eligible under paragraph
(k) of this standard performed at a CBD diagnostic center mutually
agreed upon by the employer and the employee, and the employer must
provide such examinations at no cost to the employee.
* * * * *
(l) * * *
(1) * * *
[[Page 42627]]
(i) * * *
(B) A written medical report recommending removal from airborne
exposure to beryllium in accordance with paragraph (k)(5)(v) or
(k)(7)(iii) of this standard; or
(ii) The employer receives a written medical opinion recommending
removal from airborne exposure to beryllium in accordance with
paragraph (k)(6)(v) or (k)(7)(iv) of this standard.
* * * * *
(m) * * *
(3) Warning labels. Consistent with the HCS (Sec. 1910.1200), the
employer must label each immediate container of clothing, equipment,
and materials contaminated with beryllium, and must, 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) * * *
(ii) * * *
(A) The health hazards associated with airborne exposure to and
dermal contact with beryllium, including the signs and symptoms of CBD;
* * * * *
(E) Measures employees can take to protect themselves from airborne
exposure to and dermal contact with beryllium, including personal
hygiene practices;
* * * * *
(n) * * *
(1) * * *
(ii) * * *
(F) The name and job classification of each employee represented by
the monitoring, indicating which employees were actually monitored.
* * * * *
(3) * * *
(ii) * * *
(A) Name and job classification;
* * * * *
(4) * * *
(i) At the completion of any training required by this standard,
the employer must prepare a record that indicates the name and job
classification of each employee trained, the date the training was
completed, and the topic of the training.
* * * * *
(p) Appendix. Table A.1 in this appendix sets forth the operations
that, where performed under the circumstances described in the column
heading above the particular operations, trigger the requirement for a
beryllium work area.
Appendix A to Sec. 1910.1024--Operations for Establishing Beryllium
Work Areas
Paragraph (b) of this standard defines a beryllium work area as
any work area where materials that contain at least 0.1 percent
beryllium by weight are processed (1) during any of the operations
listed in Appendix A of this standard, or (2) where employees are,
or can reasonably be expected to be, exposed to airborne beryllium
at or above the action level. Table A.1 in this appendix sets forth
the operations that, where performed under the circumstances
described in the column heading above the particular operations,
trigger the requirement for a beryllium work area.
Table A.1--Operations for Establishing Beryllium Work Areas Where
Processing Materials Containing at Least 0.1 Percent Beryllium by Weight
------------------------------------------------------------------------
Beryllium composite
Beryllium metal alloy operations (generally
operations (generally >10% beryllium by Beryllium oxide
<10% beryllium by weight) and beryllium operations
weight) metal operations
------------------------------------------------------------------------
Abrasive Blasting. Abrasive Blasting. Abrasive Blasting.
Abrasive Processing. Abrasive Processing. Abrasive Processing.
Abrasive Sawing. Abrasive Sawing. Abrasive Sawing.
Annealing. Annealing. Boring.
Bright Cleaning. Atomizing. Brazing (>1,100 [deg]C).
Brushing. Attritioning. Broaching with green
ceramic.
Buffing. Blanking. Brushing.
Burnishing. Bonding. Buffing.
Casting. Boring. Centerless grinding.
Centerless Grinding. Breaking. Chemical Cleaning.
Chemical Cleaning. Bright Cleaning. Chemical Etching.
Chemical Etching. Broaching. CNC Machining.
Chemical Milling. Brushing. Cold Isostatic Pressing
(CIP).
Dross Handling. Buffing. Crushing.
Deburring (grinding). Burnishing. Cutting.
Electrical Chemical Casting. Deburring (grinding).
Machining (ECM).
Electrical Discharge Centerless Grinding. Deburring (non-
Machining (EDM). grinding).
Extrusion. Chemical Cleaning. Destructive Testing.
Forging. Chemical Etching Dicing.
Grinding. Chemical Milling. Drilling.
Heat Treating (in CNC Machining Dry/wet Tumbling.
air).
High Speed Machining Cold Isostatic Extrusion.
(>10,000 rpm). Pressing.
Hot Rolling. Cold Pilger. Filing by Hand.
Lapping. Crushing. Firing of Green Ceramic.
Laser Cutting. Cutting. Firing of Refractory
Metallization (>1,100
[deg]C).
Laser Machining. Deburring. Grinding.
Laser Scribing. Dicing. Honing.
Laser Marking. Drawing. Hot Isostatic Pressing
(HIP).
Melting. Drilling. Lapping.
Photo-Etching. Dross Handling. Laser Cutting.
Pickling. Electrical Chemical Laser Machining.
Machining (ECM).
Point and Chamfer. Electrical Discharge Laser Scribing.
Machining (EDM).
Polishing. Extrusion. Laser Marking.
Torch Cutting (i.e., Filing by Hand. Machining.
oxy-acetylene).
Tumbling. Forging. Milling.
Water-jet Cutting. Grinding. Piercing.
Welding. Heading. Mixing.
[[Page 42628]]
Sanding. Heat Treating. Plasma Spray.
Slab Milling. Honing. Polishing.
Hot Isostatic Pressing Powder Handling.
(HIP).
Lapping. Powder Pressing.
Laser Cutting. Reaming.
Laser Machining. Sanding.
Laser Scribing. Sectioning.
Laser Marking. Shearing.
Machining. Sintering of Green
Ceramic.
Melting. Sintering of Refractory
Metallization (>1,100
[deg]C).
Milling. Snapping.
Mixing. Spray Drying.
Photo-Etching. Tape Casting.
Pickling. Turning.
Piercing. Water Jet Cutting.
Pilger.
Plasma Spray.
Point and Chamfer.
Polishing.
Powder Handling.
Powder Pressing.
Pressing.
Reaming.
Roll Bonding.
Rolling.
Sanding.
Sawing (tooth blade).
Shearing.
Sizing.
Skiving.
Slitting.
Snapping.
Sputtering.
Stamping.
Spray Drying.
Tapping.
Tensile Testing.
Torch Cutting (i.e.,
oxy acetylene).
Trepanning.
Tumbling
Turning.
Vapor Deposition.
Water-Jet Cutting.
Welding.
------------------------------------------------------------------------
[FR Doc. 2020-10678 Filed 7-13-20; 8:45 am]
BILLING CODE P