Occupational Exposure to Respirable Crystalline Silica, 56273-56504 [2013-20997]
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Vol. 78
Thursday,
No. 177
September 12, 2013
Part II
Department of Labor
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Occupational Safety and Health Administration
29 CFR Parts 1910, 1915, and 1926
Occupational Exposure to Respirable Crystalline Silica; Proposed Rule
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Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules
DEPARTMENT OF LABOR
Occupational Safety and Health
Administration
29 CFR Parts 1910, 1915, and 1926
[Docket No. OSHA–2010–0034]
RIN 1218–AB70
Occupational Exposure to Respirable
Crystalline Silica
Occupational Safety and Health
Administration (OSHA), Department of
Labor.
ACTION: Proposed rule; request for
comments.
AGENCY:
The Occupational Safety and
Health Administration (OSHA) proposes
to amend its existing standards for
occupational exposure to respirable
crystalline silica. The basis for issuance
of this proposal is a preliminary
determination by the Assistant Secretary
of Labor for Occupational Safety and
Health that employees exposed to
respirable crystalline silica face a
significant risk to their health at the
current permissible exposure limits and
that promulgating these proposed
standards will substantially reduce that
risk.
This document proposes a new
permissible exposure limit, calculated
as an 8-hour time-weighted average, of
50 micrograms of respirable crystalline
silica per cubic meter of air (50 mg/m3).
OSHA also proposes other ancillary
provisions for employee protection such
as preferred methods for controlling
exposure, respiratory protection,
medical surveillance, hazard
communication, and recordkeeping.
OSHA is proposing two separate
regulatory texts—one for general
industry and maritime, and the other for
construction—in order to tailor
requirements to the circumstances
found in these sectors.
DATES: Written comments. Written
comments, including comments on the
information collection determination
described in Section IX of the preamble
(OMB Review under the Paperwork
Reduction Act of 1995), must be
submitted (postmarked, sent, or
received) by December 11, 2013.
Informal public hearings. The Agency
plans to hold informal public hearings
beginning on March 4, 2014, in
Washington, DC. OSHA expects the
hearings to last from 9:30 a.m. to 5:30
p.m., local time; a schedule will be
released prior to the start of the
hearings. The exact daily schedule may
be amended at the discretion of the
presiding administrative law judge
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SUMMARY:
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(ALJ). If necessary, the hearings will
continue at the same time on
subsequent days. Peer reviewers of
OSHA’s Health Effects Literature
Review and Preliminary Quantitative
Risk Assessment will be present in
Washington, DC to hear testimony on
the second day of the hearing, March 5,
2014; see Section XV for more
information on the peer review process.
Notice of intention to appear at the
hearings. Interested persons who intend
to present testimony or question
witnesses at the hearings must submit
(transmit, send, postmark, deliver) a
notice of their intention to do so by
November 12, 2013. The notice of intent
must indicate if the submitter requests
to present testimony in the presence of
the peer reviewers.
Hearing testimony and documentary
evidence. Interested persons who
request more than 10 minutes to present
testimony, or who intend to submit
documentary evidence, at the hearings
must submit (transmit, send, postmark,
deliver) the full text of their testimony
and all documentary evidence by
December 11, 2013. See Section XV
below for details on the format and how
to file a notice of intention to appear,
submit documentary evidence at the
hearing, and request an appropriate
amount of time to present testimony.
ADDRESSES: Written comments. You may
submit comments, identified by Docket
No. OSHA–2010–0034, by any of the
following methods:
Electronically: You may submit
comments and attachments
electronically at http://
www.regulations.gov, which is the
Federal e-Rulemaking Portal. Follow the
instructions on-line for making
electronic submissions.
Fax: If your submissions, including
attachments, are not longer than 10
pages, you may fax them to the OSHA
Docket Office at (202) 693–1648.
Mail, hand delivery, express mail,
messenger, or courier service: You must
submit your comments to the OSHA
Docket Office, Docket No. OSHA–2010–
0034, U.S. Department of Labor, Room
N–2625, 200 Constitution Avenue NW.,
Washington, DC 20210, telephone (202)
693–2350 (OSHA’s TTY number is (877)
889–5627). Deliveries (hand, express
mail, messenger, or courier service) are
accepted during the Department of
Labor’s and Docket Office’s normal
business hours, 8:15 a.m.–4:45 p.m.,
E.T.
Instructions: All submissions must
include the Agency name and the
docket number for this rulemaking
(Docket No. OSHA–2010–0034). All
comments, including any personal
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information you provide, are placed in
the public docket without change and
may be made available online at http://
www.regulations.gov. Therefore, OSHA
cautions you about submitting personal
information such as social security
numbers and birthdates.
If you submit scientific or technical
studies or other results of scientific
research, OSHA requests (but is not
requiring) that you also provide the
following information where it is
available: (1) Identification of the
funding source(s) and sponsoring
organization(s) of the research; (2) the
extent to which the research findings
were reviewed by a potentially affected
party prior to publication or submission
to the docket, and identification of any
such parties; and (3) the nature of any
financial relationships (e.g., consulting
agreements, expert witness support, or
research funding) between investigators
who conducted the research and any
organization(s) or entities having an
interest in the rulemaking. If you are
submitting comments or testimony on
the Agency’s scientific and technical
analyses, OSHA requests that you
disclose: (1) The nature of any financial
relationships you may have with any
organization(s) or entities having an
interest in the rulemaking; and (2) the
extent to which your comments or
testimony were reviewed by an
interested party prior to its submission.
Disclosure of such information is
intended to promote transparency and
scientific integrity of data and technical
information submitted to the record.
This request is consistent with
Executive Order 13563, issued on
January 18, 2011, which instructs
agencies to ensure the objectivity of any
scientific and technological information
used to support their regulatory actions.
OSHA emphasizes that all material
submitted to the rulemaking record will
be considered by the Agency to develop
the final rule and supporting analyses.
Informal public hearings. The
Washington, DC hearing will be held in
the auditorium of the U.S. Department
of Labor, 200 Constitution Avenue NW.,
Washington, DC 20210.
Notice of intention to appear, hearing
testimony and documentary evidence.
You may submit (transmit, send,
postmark, deliver) your notice of
intention to appear, hearing testimony,
and documentary evidence, identified
by docket number (OSHA–2010–0034),
by any of the following methods:
Electronically: http://
www.regulations.gov. Follow the
instructions online for electronic
submission of materials, including
attachments.
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Fax: If your written submission does
not exceed 10 pages, including
attachments, you may fax it to the
OSHA Docket Office at (202) 693–1648.
Regular mail, express delivery, hand
delivery, and messenger and courier
service: Submit your materials to the
OSHA Docket Office, Docket No.
OSHA–2010–0034, U.S. Department of
Labor, Room N–2625, 200 Constitution
Avenue NW., Washington, DC 20210;
telephone (202) 693–2350 (TTY number
(877) 889–5627). Deliveries (express
mail, hand delivery, and messenger and
courier service) are accepted during the
Department of Labor’s and OSHA
Docket Office’s normal hours of
operation, 8:15 a.m. to 4:45 p.m., ET.
Instructions: All submissions must
include the Agency name and docket
number for this rulemaking (Docket No.
OSHA–2010–0034). All submissions,
including any personal information, are
placed in the public docket without
change and may be available online at
http://www.regulations.gov. Therefore,
OSHA cautions you about submitting
certain personal information, such as
social security numbers and birthdates.
Because of security-related procedures,
the use of regular mail may cause a
significant delay in the receipt of your
submissions. For information about
security-related procedures for
submitting materials by express
delivery, hand delivery, messenger, or
courier service, please contact the
OSHA Docket Office. For additional
information on submitting notices of
intention to appear, hearing testimony
or documentary evidence, see Section
XV of this preamble, Public
Participation.
Docket: To read or download
comments, notices of intention to
appear, and materials submitted in
response to this Federal Register notice,
go to Docket No. OSHA–2010–0034 at
http://www.regulations.gov or to the
OSHA Docket Office at the address
above. All comments and submissions
are listed in the http://
www.regulations.gov index; however,
some information (e.g., copyrighted
material) is not publicly available to
read or download through that Web site.
All comments and submissions are
available for inspection and, where
permissible, copying at the OSHA
Docket Office.
Electronic copies of this Federal
Register document are available at
http://regulations.gov. Copies also are
available from the OSHA Office of
Publications, Room N–3101, U.S.
Department of Labor, 200 Constitution
Avenue NW., Washington, DC 20210;
telephone (202) 693–1888. This
document, as well as news releases and
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other relevant information, is also
available at OSHA’s Web site at http://
www.osha.gov.
FOR FURTHER INFORMATION CONTACT: For
general information and press inquiries,
contact Frank Meilinger, Director, Office
of Communications, Room N–3647,
OSHA, U.S. Department of Labor, 200
Constitution Avenue NW., Washington,
DC 20210; telephone (202) 693–1999.
For technical inquiries, contact William
Perry or David O’Connor, Directorate of
Standards and Guidance, Room N–3718,
OSHA, U.S. Department of Labor, 200
Constitution Avenue NW., Washington,
DC 20210; telephone (202) 693–1950 or
fax (202) 693–1678. For hearing
inquiries, contact Frank Meilinger,
Director, Office of Communications,
Room N–3647, OSHA, U.S. Department
of Labor, 200 Constitution Avenue NW.,
Washington, DC 20210; telephone (202)
693–1999; email meilinger.francis2@
dol.gov.
SUPPLEMENTARY INFORMATION:
The preamble to the proposed
standard on occupational exposure to
respirable crystalline silica follows this
outline:
I. Issues
II. Pertinent Legal Authority
III. Events Leading to the Proposed Standards
IV. Chemical Properties and Industrial Uses
V. Health Effects Summary
VI. Summary of the Preliminary Quantitative
Risk Assessment
VII. Significance of Risk
VIII. Summary of the Preliminary Economic
Analysis and Initial Regulatory
Flexibility Analysis
IX. OMB Review Under the Paperwork
Reduction Act of 1995
X. Federalism
XI. State Plans
XII. Unfunded Mandates
XIII. Protecting Children From
Environmental Health and Safety Risks
XIV. Environmental Impacts
XV. Public Participation
XVI. Summary and Explanation of the
Standards
(a) Scope and Application
(b) Definitions
(c) Permissible Exposure Limit (PEL)
(d) Exposure Assessment
(e) Regulated Areas and Access Control
(f) Methods of Compliance
(g) Respiratory Protection
(h) Medical Surveillance
(i) Communication of Respirable
Crystalline Silica Hazards to Employees
(j) Recordkeeping
(k) Dates
XVII. References
XVIII. Authority and Signature
OSHA currently enforces permissible
exposure limits (PELs) for respirable
crystalline silica in general industry,
construction, and shipyards. These PELs
were adopted in 1971, shortly after the
Agency was created, and have not been
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updated since then. The PEL for quartz
(the most common form of crystalline
silica) in general industry is a formula
that is approximately equivalent to 100
micrograms per cubic meter of air (mg/
m3) as an 8-hour time-weighted average.
The PEL for quartz in construction and
shipyards is a formula based on a nowobsolete particle count sampling
method that is approximately equivalent
to 250 mg/m3. The current PELs for two
other forms of crystalline silica
(cristobalite and tridymite) are one-half
of the values for quartz in general
industry. OSHA is proposing a new PEL
for respirable crystalline silica (quartz,
cristobalite, and tridymite) of 50 mg/m3
in all industry sectors covered by the
rule. OSHA is also proposing other
elements of a comprehensive health
standard, including requirements for
exposure assessment, preferred methods
for controlling exposure, respiratory
protection, medical surveillance, hazard
communication, and recordkeeping.
OSHA’s proposal is based on the
requirements of the Occupational Safety
and Health Act (OSH Act) and court
interpretations of the Act. For health
standards issued under section 6(b)(5) of
the OSH Act, OSHA is required to
promulgate a standard that reduces
significant risk to the extent that it is
technologically and economically
feasible to do so. See Section II of this
preamble, Pertinent Legal Authority, for
a full discussion of OSHA legal
requirements.
OSHA has conducted an extensive
review of the literature on adverse
health effects associated with exposure
to respirable crystalline silica. The
Agency has also developed estimates of
the risk of silica-related diseases
assuming exposure over a working
lifetime at the proposed PEL and action
level, as well as at OSHA’s current
PELs. These analyses are presented in a
background document entitled
‘‘Respirable Crystalline Silica—Health
Effects Literature Review and
Preliminary Quantitative Risk
Assessment’’ and are summarized in
this preamble in Section V, Health
Effects Summary, and Section VI,
Summary of OSHA’s Preliminary
Quantitative Risk Assessment,
respectively. The available evidence
indicates that employees exposed to
respirable crystalline silica well below
the current PELs are at increased risk of
lung cancer mortality and silicosis
mortality and morbidity. Occupational
exposures to respirable crystalline silica
also may result in the development of
kidney and autoimmune diseases and in
death from other nonmalignant
respiratory diseases, including chronic
obstructive pulmonary disease (COPD).
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As discussed in Section VII,
Significance of Risk, in this preamble,
OSHA preliminarily finds that worker
exposure to respirable crystalline silica
constitutes a significant risk and that the
proposed standard will substantially
reduce this risk.
Section 6(b) of the OSH Act requires
OSHA to determine that its standards
are technologically and economically
feasible. OSHA’s examination of the
technological and economic feasibility
of the proposed rule is presented in the
Preliminary Economic Analysis and
Initial Regulatory Flexibility Analysis
(PEA), and is summarized in Section
VIII of this preamble. For general
industry and maritime, OSHA has
preliminarily concluded that the
proposed PEL of 50 mg/m3 is
technologically feasible for all affected
industries. For construction, OSHA has
preliminarily determined that the
proposed PEL of 50 mg/m3 is feasible in
10 out of 12 of the affected activities.
Thus, OSHA preliminarily concludes
that engineering and work practices will
be sufficient to reduce and maintain
silica exposures to the proposed PEL of
50 mg/m3 or below in most operations
most of the time in the affected
industries. For those few operations
within an industry or activity where the
proposed PEL is not technologically
feasible even when workers use
recommended engineering and work
practice controls, employers can
supplement controls with respirators to
achieve exposure levels at or below the
proposed PEL.
OSHA developed quantitative
estimates of the compliance costs of the
proposed rule for each of the affected
industry sectors. The estimated
compliance costs were compared with
industry revenues and profits to provide
a screening analysis of the economic
feasibility of complying with the revised
standard and an evaluation of the
potential economic impacts. Industries
with unusually high costs as a
percentage of revenues or profits were
further analyzed for possible economic
feasibility issues. After performing these
analyses, OSHA has preliminarily
concluded that compliance with the
requirements of the proposed rule
would be economically feasible in every
affected industry sector.
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OSHA directed Inforum—a not-forprofit corporation (based at the
University of Maryland) well recognized
for its macroeconomic modeling—to run
its LIFT (Long-term Interindustry
Forecasting Tool) model of the U.S.
economy to estimate the industry and
aggregate employment effects of the
proposed silica rule. Inforum developed
estimates of the employment impacts
over the ten-year period from 2014–
2023 by feeding OSHA’s year-by-year
and industry-by-industry estimates of
the compliance costs of the proposed
rule into its LIFT model. Based on the
resulting Inforum estimates of
employment impacts, OSHA has
preliminarily concluded that the
proposed rule would have a negligible—
albeit slightly positive—net impact on
aggregate U.S. employment.
OSHA believes that a new PEL,
expressed as a gravimetric measurement
of respirable crystalline silica, will
improve compliance because the PEL is
simple and relatively easy to
understand. In comparison, the existing
PELs require application of a formula to
account for the crystalline silica content
of the dust sampled and, in the case of
the construction and shipyard PELs, a
conversion from particle count to mg/
m3 as well. OSHA also expects that the
approach to methods of compliance for
construction operations included in this
proposal will improve compliance with
the standard. This approach, which
specifies exposure control methods for
selected construction operations, gives
employers a simple option to identify
the control measures that are
appropriate for these operations.
Alternately, employers could conduct
exposure assessments to determine if
worker exposures are in compliance
with the PEL. In either case, the
proposed rule would provide a basis for
ensuring that appropriate measures are
in place to limit worker exposures.
The Regulatory Flexibility Act, as
amended by the Small Business
Regulatory Enforcement Fairness Act
(SBREFA), requires that OSHA either
certify that a rule would not have a
significant economic impact on a
substantial number of small firms or
prepare a regulatory flexibility analysis
and hold a Small Business Advocacy
Review (SBAR) Panel prior to proposing
the rule. OSHA has determined that a
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regulatory flexibility analysis is needed
and has provided this analysis in
Section VIII.G of this preamble. OSHA
also previously held a SBAR Panel for
this rule. The recommendations of the
Panel and OSHA’s response to them are
summarized in Section VIII.G of this
preamble.
Executive Orders 13563 and 12866
direct agencies to assess all costs and
benefits of available regulatory
alternatives. Executive Order 13563
emphasizes the importance of
quantifying both costs and benefits, of
reducing costs, of harmonizing rules,
and of promoting flexibility. This rule
has been designated an economically
significant regulatory action under
section 3(f)(1) of Executive Order 12866.
Accordingly, the rule has been reviewed
by the Office of Management and
Budget, and the remainder of this
section summarizes the key findings of
the analysis with respect to costs and
benefits of the rule and then presents
several possible alternatives to the rule.
Table SI–1—which, like all the tables
in this section, is derived from material
presented in Section VIII of this
preamble—provides a summary of
OSHA’s best estimate of the costs and
benefits of the proposed rule using a
discount rate of 3 percent. As shown,
the proposed rule is estimated to
prevent 688 fatalities and 1,585 silicarelated illnesses annually once it is fully
effective, and the estimated cost of the
rule is $637 million annually. Also as
shown in Table SI–1, the discounted
monetized benefits of the proposed rule
are estimated to be $5.3 billion
annually, and the proposed rule is
estimated to generate net benefits of
$4.6 billion annually. These estimates
are for informational purposes only and
have not been used by OSHA as the
basis for its decision concerning the
choice of a PEL or of other ancillary
requirements for this proposed silica
rule. The courts have ruled that OSHA
may not use benefit-cost analysis or a
criterion of maximizing net benefits as
a basis for setting OSHA health
standards.1
1 Am. Textile Mfrs. Inst., Inc. v. Nat’l Cotton
Council of Am., 452 U.S. 490, 513 (1981); Pub.
Citizen Health Research Group v. U.S. Dep’t of
Labor, 557 F.3d 165, 177 (3d Cir. 2009); Friends of
the Boundary Waters Wilderness v. Robertson, 978
F.2d 1484, 1487 (8th Cir. 1992).
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Both the costs and benefits of Table
SI–1 reflect the incremental costs and
benefits associated with achieving full
compliance with the proposed rule.
They do not include (a) costs and
benefits associated with current
compliance that have already been
achieved with regard to the new
requirements, or (b) costs and benefits
associated with achieving compliance
with existing requirements, to the extent
that some employers may currently not
be fully complying with applicable
regulatory requirements. They also do
not include costs or benefits associated
with relatively rare, extremely high
exposures that can lead to acute
silicosis.
Subsequent to completion of the PEA,
OSHA identified an industry, hydraulic
fracturing, that would be impacted by
the proposed standard. Hydraulic
fracturing, sometimes called ‘‘fracking,’’
is a process used to extract natural gas
and oil deposits from shale and other
tight geologic formations. A recent
cooperative study by the National
Institute for Occupational Safety and
Health (NIOSH) and industry partners
identified overexposures to silica among
workers conducting hydraulic fracturing
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operations. An industry focus group has
been working with OSHA and NIOSH to
disseminate information about this
hazard, share best practices, and
develop engineering controls to limit
worker exposures to silica. OSHA finds
that there are now sufficient data to
provide the main elements of the
economic analysis for this rapidly
growing industry and has done so in
Appendix A to the PEA.
Based on recent data from the U.S.
Census Bureau and industry sources,
OSHA estimates that roughly 25,000
workers in 444 establishments (operated
by 200 business entities) in hydraulic
fracturing would be affected by the
proposed standard. Annual benefits of
the proposed 50 mg/m3 PEL include
approximately 12 avoided fatalities—2.9
avoided lung cancers (mid-point
estimate), 6.3 prevented non-cancer
respiratory illnesses, and 2.3 prevented
cases of renal failure—and 40.8 avoided
cases of silicosis morbidity. Monetized
benefits are expected to range from
$75.1 million at a seven percent
discount rate to $105.4 million at a three
percent discount rate to undiscounted
benefits of $140.3 million. OSHA
estimates that under the proposed
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standard, annualized compliance costs
for the hydraulic fracturing industry
will total $28.6 million at a discount
rate of 7 percent or $26.4 million at a
discount rate of 3 percent.
In addition to the proposed rule itself,
this preamble discusses several
regulatory alternatives to the proposed
OSHA silica standard. These are
presented below as well as in Section
VIII of this preamble. OSHA believes
that this presentation of regulatory
alternatives serves two important
functions. The first is to explore the
possibility of less costly ways (than the
proposed rule) to provide an adequate
level of worker protection from
exposure to respirable crystalline silica.
The second is tied to the Agency’s
statutory requirement, which underlies
the proposed rule, to reduce significant
risk to the extent feasible. If, based on
evidence presented during notice and
comment, OSHA is unable to justify its
preliminary findings of significant risk
and feasibility as presented in this
preamble to the proposed rule, the
Agency must then consider regulatory
alternatives that do satisfy its statutory
obligations.
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Each regulatory alternative presented
here is described and analyzed relative
to the proposed rule. Where
appropriate, the Agency notes whether
the regulatory alternative, to be a
legitimate candidate for OSHA
consideration, requires evidence
contrary to the Agency’s findings of
significant risk and feasibility. To
facilitate comment, the regulatory
alternatives have been organized into
four categories: (1) Alternative PELs to
the proposed PEL of 50 mg/m3; (2)
regulatory alternatives that affect
proposed ancillary provisions; (3) a
regulatory alternative that would modify
the proposed methods of compliance;
and (4) regulatory alternatives
concerning when different provisions of
the proposed rule would take effect.
In addition, OSHA would like to draw
attention to one possible modification to
the proposed rule, involving methods of
compliance, that the Agency would not
consider to be a legitimate regulatory
alternative: To permit the use of
respiratory protection as an alternative
to engineering and work practice
controls as a primary means to achieve
the PEL.
As described in Section XVI of the
preamble, Summary and Explanation of
the Proposed Standards, OSHA is
proposing to require primary reliance on
engineering controls and work practices
because reliance on these methods is
consistent with long-established good
industrial hygiene practice, with the
Agency’s experience in ensuring that
workers have a healthy workplace, and
with the Agency’s traditional adherence
to a hierarchy of preferred controls. The
Agency’s adherence to the hierarchy of
controls has been successfully upheld
by the courts (see AFL–CIO v. Marshall,
617 F.2d 636 (D.C. Cir. 1979) (cotton
dust standard); United Steelworkers v.
Marshall, 647 F.2d 1189 (D.C. Cir.
1980), cert. denied, 453 U.S. 913 (1981)
(lead standard); ASARCO v. OSHA, 746
F.2d 483 (9th Cir. 1984) (arsenic
standard); Am. Iron & Steel v. OSHA,
182 F.3d 1261 (11th Cir. 1999)
(respiratory protection standard); Pub.
Citizen v. U.S. Dep’t of Labor, 557 F.3d
165 (3rd Cir. 2009) (hexavalent
chromium standard)).
Engineering controls are reliable,
provide consistent levels of protection
to a large number of workers, can be
monitored, allow for predictable
performance levels, and can efficiently
remove a toxic substance from the
workplace. Once removed, the toxic
substance no longer poses a threat to
employees. The effectiveness of
engineering controls does not generally
depend on human behavior to the same
extent as personal protective equipment
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does, and the operation of equipment is
not as vulnerable to human error as is
personal protective equipment.
Respirators are another important
means of protecting workers. However,
to be effective, respirators must be
individually selected; fitted and
periodically refitted; conscientiously
and properly worn; regularly
maintained; and replaced as necessary.
In many workplaces, these conditions
for effective respirator use are difficult
to achieve. The absence of any of these
conditions can reduce or eliminate the
protection that respirators provide to
some or all of the employees who wear
them.
In addition, use of respirators in the
workplace presents other safety and
health concerns. Respirators impose
substantial physiological burdens on
some employees. Certain medical
conditions can compromise an
employee’s ability to tolerate the
physiological burdens imposed by
respirator use, thereby placing the
employee wearing the respirator at an
increased risk of illness, injury, and
even death. Psychological conditions,
such as claustrophobia, can also impair
the effective use of respirators by
employees. These concerns about the
burdens placed on workers by the use
of respirators are the basis for the
requirement that employers provide a
medical evaluation to determine the
employee’s ability to wear a respirator
before the employee is fit tested or
required to use a respirator in the
workplace. Although experience in
industry shows that most healthy
workers do not have physiological
problems wearing properly chosen and
fitted respirators, common health
problems can sometime preclude an
employee from wearing a respirator.
Safety problems created by respirators
that limit vision and communication
must also be considered. In some
difficult or dangerous jobs, effective
vision or communication is vital. Voice
transmission through a respirator can be
difficult and fatiguing.
Because respirators are less reliable
than engineering and work practice
controls and may create additional
problems, OSHA believes that primary
reliance on respirators to protect
workers is generally inappropriate when
feasible engineering and work practice
controls are available. All OSHA
substance-specific health standards
have recognized and required employers
to observe the hierarchy of controls,
favoring engineering and work practice
controls over respirators. OSHA’s PELs,
including the current PELs for
respirable crystalline silica, also
incorporate this hierarchy of controls. In
PO 00000
Frm 00006
Fmt 4701
Sfmt 4702
addition, the industry consensus
standards for crystalline silica (ASTM E
1132–06, Standard Practice for Health
Requirements Relating to Occupational
Exposure to Respirable Crystalline
Silica, and ASTM E 2626–09, Standard
Practice for Controlling Occupational
Exposure to Respirable Crystalline
Silica for Construction and Demolition
Activities) incorporate the hierarchy of
controls.
It is important to note that the very
concept of technological feasibility for
OSHA standards is grounded in the
hierarchy of controls. As indicated in
Section II of this preamble, Pertinent
Legal Authority, the courts have
clarified that a standard is
technologically feasible if OSHA proves
a reasonable possibility,
. . . within the limits of the best available
evidence . . . that the typical firm will be
able to develop and install engineering and
work practice controls that can meet the PEL
in most of its operations. [See United
Steelworkers v. Marshall, 647 F.2d 1189,
1272 (D.C. Cir. 1980)]
Allowing use of respirators instead of
engineering and work practice controls
would be at odds with this framework
for evaluating the technological
feasibility of a PEL.
Alternative PELs
OSHA has examined two regulatory
alternatives (named Regulatory
Alternatives #1 and #2) that would
modify the PEL for the proposed rule.
Under Regulatory Alternative #1, the
proposed PEL would be changed from
50 mg/m3 to 100 mg/m3 for all industry
sectors covered by the rule, and the
action level would be changed from 25
mg/m3 to 50 mg/m3 (thereby keeping the
action level at one-half of the PEL).
Under Regulatory Alternative #2, the
proposed PEL would be lowered from
50 mg/m3 to 25 mg/m3 for all industry
sectors covered by the rule, while the
action level would remain at 25 mg/m3
(because of difficulties in accurately
measuring exposure levels below 25 mg/
m3).
Tables SI–2 and SI–3 present, for
informational purposes, the estimated
costs, benefits, and net benefits of the
proposed rule under the proposed PEL
of 50 mg/m3 and for the regulatory
alternatives of a PEL of 100 mg/m3 and
a PEL of 25 mg/m3 (Regulatory
Alternatives #1 and #2), using
alternative discount rates of 3 and 7
percent. These two tables also present
the incremental costs, the incremental
benefits, and the incremental net
benefits of going from a PEL of 100 mg/
m3 to the proposed PEL of 50 mg/m3 and
then of going from the proposed PEL of
50 mg/m3 to a PEL of 25 mg/m3. Table
E:\FR\FM\12SEP2.SGM
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Jkt 229001
25b!9/m3
~
Discount Rate
Frm 00007
Fmt 4701
Annualized Costs
Engineering Controls (includes Abrasive Blasting)
Respirators
Exposure Assessment
Medical Surveillance
Training
Regulated Area or Access Control
Sfmt 4725
E:\FR\FM\12SEP2.SGM
Siljca~Related
Mortality
Silicosis Morbidity
~
~
50l;!g/m
--EL
3
~
3%
~
$187
$88
$26
$28
$0
$344
$422
$203
$227
$50
$86
$0
$330
$131
$143
$0
$66
$0
$331
$129
$148
$0
$66
$330
$91
$73
$76
$49
$19
~
~
$1,308
$1,332
$670
$674
$637
$658
$339
Cases
Cases
3
Incremental Costs/Benefits
$330
$421
$203
$219
$49
$65
Total Annualized Costs (point estimate)
Annual Benefits: Number of Cases Prevented
Fatal Lung Cancers (midpoint estimate)
Fatal Silicosis & other Non~Malignant
Respiratory Diseases
Fatal Renal Disease
Incremental Costs/Benefits
$344
$91
$74
$79
$50
Cases
100b!g/m
~
~
3%
$197
$88
$26
$29
$0
~
$143
$2
$47
$48
$49
$9
~
$351
$299
$307
Cases
$147
$3
$48
$50
$50
Cases
257
75
162
79
83
527
152
375
186
189
258
108
151
91
1,023
$4,811
$3,160
335
$1,543
$1,028
1,770
$2,219
$1,523
186
$233
$160
60
688
$3,268
$2,132
357
$1,704
$1,116
331
$1,565
$1,016
1,585
$1,986
$1,364
632
$792
$544
953
$1,194
$820
Monetized Annual Benefits (midpoint estimate)
$7,030
$4,684
$1,776
$1,188
$5,254
$3,495
$2,495
$1,659
$2,759
$1,836
Net Benefits
$5722
$3352
$1105
$514
$4617
$2838
$2157
$1308
$2460
$1529
Source: U.S, Department of Labor, Occupational Safety and Health Administration, Directorate of Evaluation and Analysis, Office of Regulatory AnalysIs
breaks out costs and benefits by major
industry sector.
PO 00000
Millions ($2009)
12SEP2
Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules
19:12 Sep 11, 2013
SI–2 breaks out costs by provision and
benefits by type of disease and by
morbidity/mortality, while Table SI–3
VerDate Mar<15>2010
Table 51·2: Annualized Costs, Benefits and Incremental Benefits of OSHA's Proposed Silica Standard of 50 (.191m3 and 100 (.191m3 Alternative
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56280
3
Jkt 229001
251!g/m
~
Discount Rate
3
Incremental Costs/Benefits
~
~
50 l!9!m
~
~
3
3
Incremental Costs/Benefits
~
~
100 I!g/m
~
3%
~
Frm 00008
Fmt 4701
Sfmt 4702
12SEP2
silica exposure (as demonstrated by the
number of silica-related fatalities and
silicosis cases avoided) and is both
technologically and economically
E:\FR\FM\12SEP2.SGM
and an additional 632 cases of silicosis.
Based on its preliminary findings that
the proposed PEL of 50 mg/m3
significantly reduces worker risk from
PO 00000
Annualized Costs
Construction
General Industry/Maritime
$1,043
$264
$1,062
$270
$548
$122
$551
$123
$495
$143
$511
$147
$233
$106
$241
$110
$262
$36
$270
$37
Total Annualized Costs
$1,308
$1,332
$670
$674
$637
$658
$339
$351
$299
$307
Annual Benefits: Number of Cases
Prevented
Silica-Related Mortality
Construction
General Industry/Maritime
Total
Silicosis Morbidity
Construction
General Industry/Maritime
Total
Monetized Annual Benefits (midpoint
estimate)
Construction
General Industry/Maritime
Total
Net Benefits
Construction
General Industry/Maritime
Total
Cases
Cases
Cases
Cases
Cases
802
221
$3,804
$1,007
$2,504
$657
235
100
$1,109
$434
$746
$283
567
121
$2,695
$573
$1,758
$374
242 $1,158
115
$545
$760
$356
325
6
$1,537
$27
$998
$18
1,023
$4,811
$3,160
335
$1,543
$1,028
688
$3,268
$2,132
357 $1,704
$1,116
331
$1,565
$1,016
1,157
613
$1,451
$768
$996
$528
77
109
$96
$136
$66
$94
1,080
504
$1,354
$632
$930
$434
161
471
$202
$590
$139
$405
919
33
$1,152
$42
$791
$29
1,770
$2,219
$1,523
186
$233
$160
1,585
$1,986
$1,364
632
$792
$544
953
$1,194
$820
$5,255
$1,775
$3,500
$1,164
$1,205
$570
$812
$377
$4,049
$1,205
$2,688
$808
$1,360
$1,135
$898
$761
$2,690
$69
$1,789
$47
$7,030
$4,684
$1,776
$1,188
$5,254
$3,495
$2,495
$1,659
$2,759
$1,836
$4,211
$1,511
$2,437
$914
$657
$448
$261
$254
$3,555
$1,062
$2,177
$661
$1,127
$1,029
$658
$651
$2,427
$33
$1,519
$10
$5,722
$3,352
$1,105
$514
$4,617
$2,838
$2,157
$1,308
$2,460
$1,529
Source: U,S, Department of Labor, Occupational Safety and Health Administration, Directorate of Evaluation and AnalYSiS, Office of Regulatory Analysis
Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules
19:12 Sep 11, 2013
As Tables SI–2 and SI–3 show, going
from a PEL of 100 mg/m3 to a PEL of 50
mg/m3 would prevent, annually, an
additional 357 silica-related fatalities
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3
Table SI-3: Annualized Costs, Benefits and Incremental Benefits of OSHA's Proposed Silica Standard of 50 j.lg/m and 100 jJg/m Alternative, by Major Industry Sector
Millions ($2009)
Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules
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feasible, OSHA cannot propose a PEL of
100 mg/m3 (Regulatory Alternative #1)
without violating its statutory
obligations under the OSH Act.
However, the Agency will consider
evidence that challenges its preliminary
findings.
As previously noted, Tables SI–2 and
SI–3 also show the costs and benefits of
a PEL of 25 mg/m3 (Regulatory
Alternative #2), as well as the
incremental costs and benefits of going
from the proposed PEL of 50 mg/m3 to
a PEL of 25 mg/m3. Because OSHA
preliminarily determined that a PEL of
25 mg/m3 would not be feasible (that is,
engineering and work practices would
not be sufficient to reduce and maintain
silica exposures to a PEL of 25 mg/m3 or
below in most operations most of the
time in the affected industries), the
Agency did not attempt to identify
engineering controls or their costs for
affected industries to meet this PEL.
Instead, for purposes of estimating the
costs of going from a PEL of 50 mg/m3
to a PEL of 25 mg/m3, OSHA assumed
that all workers exposed between 50 mg/
m3 and 25 mg/m3 would have to wear
respirators to achieve compliance with
the 25 mg/m3 PEL. OSHA then estimated
the associated additional costs for
respirators, exposure assessments,
medical surveillance, and regulated
areas (the latter three for ancillary
requirements specified in the proposed
rule).
As shown in Tables SI–2 and SI–3,
going from a PEL of 50 mg/m3 to a PEL
of 25 mg/m3 would prevent, annually, an
additional 335 silica-related fatalities
and an additional 186 cases of silicosis.
These estimates support OSHA’s
preliminarily finding that there is
significant risk remaining at the
proposed PEL of 50 mg/m3. However, the
Agency has preliminarily determined
that a PEL of 25 mg/m3 (Regulatory
Alternative #2) is not technologically
feasible, and for that reason, cannot
propose it without violating its statutory
obligations under the OSH Act.
Regulatory Alternatives That Affect
Ancillary Provisions
The proposed rule contains several
ancillary provisions (provisions other
than the PEL), including requirements
for exposure assessment, medical
surveillance, training, and regulated
areas or access control. As shown in
Table SI–2, these ancillary provisions
represent approximately $223 million
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19:12 Sep 11, 2013
Jkt 229001
(or about 34 percent) of the total
annualized costs of the rule of $658
million (using a 7 percent discount
rate). The two most expensive of the
ancillary provisions are the
requirements for medical surveillance,
with annualized costs of $79 million,
and the requirements for exposure
monitoring, with annualized costs of
$74 million.
As proposed, the requirements for
exposure assessment are triggered by the
action level. As described in this
preamble, OSHA has defined the action
level for the proposed standard as an
airborne concentration of respirable
crystalline silica of 25 mg/m3 calculated
as an eight-hour time-weighted average.
In this proposal, as in other standards,
the action level has been set at one-half
of the PEL.
Because of the variable nature of
employee exposures to airborne
concentrations of respirable crystalline
silica, maintaining exposures below the
action level provides reasonable
assurance that employees will not be
exposed to respirable crystalline silica
at levels above the PEL on days when
no exposure measurements are made.
Even when all measurements on a given
day may fall below the PEL (but are
above the action level), there is some
chance that on another day, when
exposures are not measured, the
employee’s actual exposure may exceed
the PEL. When exposure measurements
are above the action level, the employer
cannot be reasonably confident that
employees have not been exposed to
respirable crystalline silica
concentrations in excess of the PEL
during at least some part of the work
week. Therefore, requiring periodic
exposure measurements when the
action level is exceeded provides the
employer with a reasonable degree of
confidence in the results of the exposure
monitoring.
The action level is also intended to
encourage employers to lower exposure
levels in order to avoid the costs
associated with the exposure assessment
provisions. Some employers would be
able to reduce exposures below the
action level in all work areas, and other
employers in some work areas. As
exposures are lowered, the risk of
adverse health effects among workers
decreases.
OSHA’s preliminary risk assessment
indicates that significant risk remains at
the proposed PEL of 50 mg/m3. Where
PO 00000
Frm 00009
Fmt 4701
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56281
there is continuing significant risk, the
decision in the Asbestos case (Bldg. and
Constr. Trades Dep’t, AFL–CIO v. Brock,
838 F.2d 1258, 1274 (D.C. Cir. 1988))
indicated that OSHA should use its
legal authority to impose additional
requirements on employers to further
reduce risk when those requirements
will result in a greater than de minimis
incremental benefit to workers’ health.
OSHA’s preliminary conclusion is that
the requirements triggered by the action
level will result in a very real and
necessary, but non-quantifiable, further
reduction in risk beyond that provided
by the PEL alone. OSHA’s choice of
proposing an action level for exposure
monitoring of one-half of the PEL is
based on the Agency’s successful
experience with other standards,
including those for inorganic arsenic (29
CFR 1910.1018), ethylene oxide (29 CFR
1910.1047), benzene (29 CFR
1910.1028), and methylene chloride (29
CFR 1910.1052).
As specified in the proposed rule, all
workers exposed to respirable
crystalline silica above the PEL of 50 mg/
m3 are subject to the medical
surveillance requirements. This means
that the medical surveillance
requirements would apply to 15,172
workers in general industry and 336,244
workers in construction. OSHA
estimates that 457 possible silicosis
cases will be referred to pulmonary
specialists annually as a result of this
medical surveillance.
OSHA has preliminarily determined
that these ancillary provisions will: (1)
Help ensure that the PEL is not
exceeded, and (2) minimize risk to
workers given the very high level of risk
remaining at the PEL. OSHA did not
estimate, and the benefits analysis does
not include, monetary benefits resulting
from early discovery of illness.
Because medical surveillance and
exposure assessment are the two most
costly ancillary provisions in the
proposed rule, the Agency has
examined four regulatory alternatives
(named Regulatory Alternatives #3, #4,
#5, and #6) involving changes to one or
the other of these ancillary provisions.
These four regulatory alternatives are
defined below and the incremental cost
impact of each is summarized in Table
SI–4. In addition, OSHA is including a
regulatory alternative (named
Regulatory Alternative #7) that would
remove all ancillary provisions.
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12SEP2
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13% Discount Rate I
Cost
Construction
GIIM
Incremental Cost Relative to Proposal
Total
Construction
GIIM
Total
Jkt 229001
Frm 00010
Fmt 4701
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$494,826,699
$142,502,681
$637,329,380
Option 3: PEL=50; AL=50
$457,686,162
$117,680,601
$575,366,763
-$37,140,537
-$24,822,080
-$61,962,617
Option 4: PEL=50; AL =25, with
medical surveillance triggered by AL
$606,697,624
$173,701,827
$780,399,451
$111,870,925
$31,199,146
$143,070,071
Option 5: PEL=50; AL=25, with
medical exams annually
$561,613,766
$145,088,559
$706,702,325
$66,787,067
$2,585,878
$69,372,945
Option 6: PEL=50; AL=25, with
surveillance triggered by AL and
medical exams annually
$775,334,483
$203,665,685
$979,000,168
$280,507,784
$61,163,004
$341,670,788
17% Discount Rate I
Cost
Construction
GIIM
Incremental Cost Relative to Proposal
Total
Construction
GIIM
Total
12SEP2
EP12SE13.003</GPH>
Proposed Rule
$511,165,616
$146,726,595
$657,892,211
Option 3: PEL=50; AL=50
monitoring requirements would be
triggered only if workers were exposed
E:\FR\FM\12SEP2.SGM
m3 to 50 mg/m3 while keeping the PEL
at 50 mg/m3. As a result, exposure
PO 00000
Proposed Rule
$473,638,698
$121,817,396
$595,456,093
-$37,526,918
-$24,909,200
-$62,436,118
Option 4: PEL=50; AL =25, with
medical surveillance triggered by AL
$627,197,794
$179,066,993
$806,264,787
$132,371,095
$36,564,312
$168,935,407
Option 5: PEL=50; AL=25, with
medical exams annually
$575,224,843
$149,204,718
$724,429,561
$64,059,227
$2,478,122
$66,537,350
Option 6: PEL=50; AL=25, with
surveillance triggered by AL and
medical exams annually
$791,806,358
$208,339,741
$1,000,146,099
$280,640,742
$61,613,145
$342,253,887
Source: U.S. Department of Labor, Occupational Safety and Health Administration, Directorate of Evaluation and Analysis, Office of Regulatory Analysis
Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules
19:12 Sep 11, 2013
Under Regulatory Alternative #3, the
action level would be raised from 25 mg/
VerDate Mar<15>2010
Table 51-4: Cost of Regulatory Alternatives Affecting Ancillary Provisions
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Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules
above the proposed PEL of 50 mg/m3. As
shown in Table SI–4, Regulatory Option
#3 would reduce the annualized cost of
the proposed rule by about $62 million,
using a discount rate of either 3 percent
or 7 percent.
Under Regulatory Alternative #4, the
action level would remain at 25 mg/m3
but medical surveillance would now be
triggered by the action level, not the
PEL. As a result, medical surveillance
requirements would be triggered only if
workers were exposed at or above the
proposed action level of 25 mg/m3. As
shown in Table SI–4, Regulatory Option
#4 would increase the annualized cost
of the proposed rule by about $143
million, using a discount rate of 3
percent (and by about $169 million,
using a discount rate of 7 percent).
Under Regulatory Alternative #5, the
only change to the proposed rule would
be to the medical surveillance
requirements. Instead of requiring
workers exposed above the PEL to have
a medical check-up every three years,
those workers would be required to
have a medical check-up annually. As
shown in Table SI–4, Regulatory Option
#5 would increase the annualized cost
of the proposed rule by about $69
million, using a discount rate of 3
percent (and by about $66 million, using
a discount rate of 7 percent).
Regulatory Alternative #6 would
essentially combine the modified
requirements in Regulatory Alternatives
#4 and #5. Under Regulatory Alternative
#6, medical surveillance would be
triggered by the action level, not the
PEL, and workers exposed at or above
the action level would be required to
have a medical check-up annually
rather than triennially. The exposure
monitoring requirements in the
proposed rule would not be affected. As
shown in Table SI–4, Regulatory Option
#6 would increase the annualized cost
of the proposed rule by about $342
million, using a discount rate of either
3 percent or 7 percent.
OSHA is not able to quantify the
effects of these preceding four
regulatory alternatives on protecting
workers exposed to respirable
crystalline silica at levels at or below
the proposed PEL of 50 mg/m3—where
significant risk remains. The Agency
solicits comment on the extent to which
these regulatory options may improve or
reduce the effectiveness of the proposed
rule.
The final regulatory alternative
affecting ancillary provisions,
Regulatory Alternative #7, would
eliminate all of the ancillary provisions
of the proposed rule, including
exposure assessment, medical
surveillance, training, and regulated
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19:12 Sep 11, 2013
Jkt 229001
areas or access control. However, it
should be carefully noted that
elimination of the ancillary provisions
does not mean that all costs for ancillary
provisions would disappear. In order to
meet the PEL, employers would still
commonly need to do monitoring, train
workers on the use of controls, and set
up some kind of regulated areas to
indicate where respirator use would be
required. It is also likely that employers
would increasingly follow the many
recommendations to provide medical
surveillance for employees. OSHA has
not attempted to estimate the extent to
which the costs of these activities would
be reduced if they were not formally
required, but OSHA welcomes comment
on the issue.
As indicated previously, OSHA
preliminarily finds that there is
significant risk remaining at the
proposed PEL of 50 mg/m3. However, the
Agency has also preliminarily
determined that 50 mg/m3 is the lowest
feasible PEL. Therefore, the Agency
believes that it is necessary to include
ancillary provisions in the proposed
rule to further reduce the remaining
risk. OSHA anticipates that these
ancillary provisions will reduce the risk
beyond the reduction that will be
achieved by a new PEL alone.
OSHA’s reasons for including each of
the proposed ancillary provisions are
detailed in Section XVI of this
preamble, Summary and Explanation of
the Standards. In particular, OSHA
believes that requirements for exposure
assessment (or alternately, using
specified exposure control methods for
selected construction operations) would
provide a basis for ensuring that
appropriate measures are in place to
limit worker exposures. Medical
surveillance is particularly important
because individuals exposed above the
PEL (which triggers medical
surveillance in the proposed rule) are at
significant risk of death and illness.
Medical surveillance would allow for
identification of respirable crystalline
silica-related adverse health effects at an
early stage so that appropriate
intervention measures can be taken.
OSHA believes that regulated areas and
access control are important because
they serve to limit exposure to
respirable crystalline silica to as few
employees as possible. Finally, OSHA
believes that worker training is
necessary to inform employees of the
hazards to which they are exposed,
along with associated protective
measures, so that employees understand
how they can minimize potential health
hazards. Worker training on silicarelated work practices is particularly
important in controlling silica
PO 00000
Frm 00011
Fmt 4701
Sfmt 4702
56283
exposures because engineering controls
frequently require action on the part of
workers to function effectively.
OSHA expects that the benefits
estimated under the proposed rule will
not be fully achieved if employers do
not implement the ancillary provisions
of the proposed rule. For example,
OSHA believes that the effectiveness of
the proposed rule depends on regulated
areas or access control to further limit
exposures and on medical surveillance
to identify disease cases when they do
occur.
Both industry and worker groups have
recognized that a comprehensive
standard is needed to protect workers
exposed to respirable crystalline silica.
For example, the industry consensus
standards for crystalline silica, ASTM E
1132–06, Standard Practice for Health
Requirements Relating to Occupational
Exposure to Respirable Crystalline
Silica, and ASTM E 2626–09, Standard
Practice for Controlling Occupational
Exposure to Respirable Crystalline
Silica for Construction and Demolition
Activities, as well as the draft proposed
silica standard for construction
developed by the Building and
Construction Trades Department, AFL–
CIO, have each included comprehensive
programs. These recommended
standards include provisions for
methods of compliance, exposure
monitoring, training, and medical
surveillance (ASTM, 2006; 2009; BCTD
2001). Moreover, as mentioned
previously, where there is continuing
significant risk, the decision in the
Asbestos case (Bldg. and Constr. Trades
Dep’t, AFL–CIO v. Brock, 838 F.2d 1258,
1274 (D.C. Cir. 1988)) indicated that
OSHA should use its legal authority to
impose additional requirements on
employers to further reduce risk when
those requirements will result in a
greater than de minimis incremental
benefit to workers’ health. OSHA
preliminarily concludes that the
additional requirements in the ancillary
provisions of the proposed standard
clearly exceed this threshold.
A Regulatory Alternative That Modifies
the Methods of Compliance
The proposed standard in general
industry and maritime would require
employers to implement engineering
and work practice controls to reduce
employees’ exposures to or below the
PEL. Where engineering and/or work
practice controls are insufficient,
employers would still be required to
implement them to reduce exposure as
much as possible, and to supplement
them with a respiratory protection
program. Under the proposed
construction standard, employers would
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be given two options for compliance.
The first option largely follows
requirements for the general industry
and maritime proposed standard, while
the second option outlines, in Table 1
(Exposure Control Methods for Selected
Construction Operations) of the
proposed rule, specific construction
exposure control methods. Employers
choosing to follow OSHA’s proposed
control methods would be considered to
be in compliance with the engineering
and work practice control requirements
of the proposed standard, and would
not be required to conduct certain
exposure monitoring activities.
One regulatory alternative (Regulatory
Alternative #8) involving methods of
compliance would be to eliminate Table
1 as a compliance option in the
construction sector. Under that
regulatory alternative, OSHA estimates
that there would be no effect on
estimated benefits but that the
annualized costs of complying with the
proposed rule (without the benefit of the
Table 1 option in construction) would
increase by $175 million, totally in
exposure monitoring costs, using a 3
percent discount rate (and by $178
million using a 7 percent discount rate),
so that the total annualized compliance
costs for all affected establishments in
construction would increase from $495
to $670 million using a 3 percent
discount rate (and from $511 to $689
million using a 7 percent discount rate).
Regulatory Alternatives That Affect the
Timing of the Standard
The proposed rule would become
effective 60 days following publication
of the final rule in the Federal Register.
Provisions outlined in the proposed
standard would become enforceable 180
days following the effective date, with
the exceptions of engineering controls
and laboratory requirements. The
proposed rule would require
engineering controls to be implemented
no later than one year after the effective
date, and laboratory requirements
would be required to begin two years
after the effective date.
OSHA will strongly consider
alternatives that would reduce the
economic impact of the rule and
provide additional flexibility for firms
coming into compliance with the
requirements of the rule. The Agency
solicits comment and suggestions from
stakeholders, particularly small
business representatives, on options for
phasing in requirements for engineering
controls, medical surveillance, and
other provisions of the rule (e.g., over 1,
2, 3, or more years). These options will
be considered for specific industries
(e.g., industries where first-year or
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annualized cost impacts are highest),
specific size-classes of employers (e.g.,
employers with fewer than 20
employees), combinations of these
factors, or all firms covered by the rule.
Although OSHA did not explicitly
develop or quantitatively analyze the
multitude of potential regulatory
alternatives involving longer-term or
more complex phase-ins of the standard,
the Agency is soliciting comments on
this issue. Such a particularized, multiyear phase-in could have several
advantages, especially from the
viewpoint of impacts on small
businesses. First, it would reduce the
one-time initial costs of the standard by
spreading them out over time, a
particularly useful mechanism for small
businesses that have trouble borrowing
large amounts of capital in a single year.
Second, a differential phase-in for
smaller firms would aid very small
firms by allowing them to gain from the
control experience of larger firms.
Finally, a phase-in would be useful in
certain industries—such as foundries,
for example—by allowing employers to
coordinate their environmental and
occupational safety and health control
strategies to minimize potential costs.
However a phase-in would also
postpone the benefits of the standard.
OSHA analyzed one regulatory
alternative (Regulatory Alternative #9)
involving the timing of the standard
which would arise if, contrary to
OSHA’s preliminary findings, a PEL of
50 mg/m3 with an action level of 25 mg/
m3 were found to be technologically and
economically feasible some time in the
future (say, in five years), but not
feasible immediately. In that case,
OSHA might issue a final rule with a
PEL of 50 mg/m3 and an action level of
25 mg/m3 to take effect in five years, but
at the same time issue an interim PEL
of 100 mg/m3 and an action level of 50
mg/m3 to be in effect until the final rule
becomes feasible. Under this regulatory
alternative, and consistent with the
public participation and ‘‘look back’’
provisions of Executive Order 13563,
the Agency could monitor compliance
with the interim standard, review
progress toward meeting the feasibility
requirements of the final rule, and
evaluate whether any adjustments to the
timing of the final rule would be
needed. Under Regulatory Alternative
#9, the estimated costs and benefits
would be somewhere between those
estimated for a PEL of 100 mg/m3 with
an action level of 50 mg/m3 and those
estimated for a PEL of 50 mg/m3 with an
action level of 25 mg/m3, the exact
estimates depending on the length of
time until the final rule is phased in.
OSHA emphasizes that this regulatory
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alternative is contrary to the Agency’s
preliminary findings of economic
feasibility and, for the Agency to
consider it, would require specific
evidence introduced on the record to
show that the proposed rule is not now
feasible but would be feasible in the
future.
OSHA requests comments on these
regulatory alternatives, including the
Agency’s choice of regulatory
alternatives (and whether there are other
regulatory alternatives the Agency
should consider) and the Agency’s
analysis of them.
I. Issues
OSHA requests comment on all
relevant issues, including health effects,
risk assessment, significance of risk,
technological and economic feasibility,
and the provisions of the proposed
regulatory text. In addition, OSHA
requests comments on all of the issues
raised by the Small Business Regulatory
Fairness Enforcement Act (SBREFA)
Panel, as summarized in Table VIII–H–
4 in Section VIII.H of this preamble.
OSHA is including Section I on issues
at the beginning of the document to
assist readers as they review the
proposal and consider any comments
they may want to submit. However, to
fully understand the questions in this
section and provide substantive input in
response to them, the parts of the
preamble that address these issues in
detail should be read and reviewed.
These include: Section V, Health Effects
Summary; Section VI, Summary of the
Preliminary Quantitative Risk
Assessment; Section VII, Significance of
Risk; Section VIII, Summary of the
Preliminary Economic Analysis and
Initial Regulatory Flexibility Analysis;
and Section XVI, Summary and
Explanation of the Standards. In
addition, OSHA invites comment on
additional technical questions and
discussions of economic issues
presented in the Preliminary Economic
Analysis (PEA) of the proposed
standards. Section XIX is the text of the
standards and is the final authority on
what is required in them.
OSHA requests that comments be
organized, to the extent possible, around
the following issues and numbered
questions. Comment on particular
provisions should contain a heading
setting forth the section and the
paragraph in the standard that the
comment is addressing. Comments
addressing more than one section or
paragraph will have correspondingly
more headings.
Submitting comments in an organized
manner and with clear reference to the
issue raised will enable all participants
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to easily see what issues the commenter
addressed and how they were
addressed. This is particularly
important in a rulemaking such as
silica, which has multiple adverse
health effects and affects many diverse
processes and industries. Many
commenters, especially small
businesses, are likely to confine their
interest (and comments) to the issues
that affect them, and they will benefit
from being able to quickly identify
comments on these issues in others’
submissions. Of course, the Agency
welcomes comments concerning this
proposal that fall outside the issues
raised in this section. However, OSHA
is especially interested in responses,
supported by evidence and reasons, to
the following questions:
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Health Effects
1. OSHA has described a variety of
studies addressing the major adverse
health effects that have been associated
with exposure to respirable crystalline
silica. Has OSHA adequately identified
and documented all critical health
impairments associated with
occupational exposure to respirable
crystalline silica? If not, what adverse
health effects should be added? Are
there any additional studies, other data,
or information that would affect the
information discussed or significantly
change the determination of material
health impairment? Submit any relevant
information, data, or additional studies
(or the citations), and explain your
reasoning for recommending the
inclusion of any studies you suggest.
2. Using currently available
epidemiologic and experimental
studies, OSHA has made a preliminary
determination that respirable crystalline
silica presents risks of lung cancer,
silicosis, and non-malignant respiratory
disease (NMRD) as well as autoimmune
and renal disease risks to exposed
workers. Is this determination correct?
Are there additional studies or other
data OSHA should consider in
evaluating any of these adverse health
risks? If so, submit the studies (or
citations) and other data and include
your reasons for finding them germane
to determining adverse health effects of
exposure to crystalline silica.
Risk Assessment
3. OSHA has relied upon risk models
using cumulative respirable crystalline
silica exposure to estimate the lifetime
risk of death from occupational lung
cancer, silicosis, and NMRD among
exposed workers. Additionally, OSHA
has estimated the lifetime risk of
silicosis morbidity among exposed
workers. Is cumulative exposure the
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correct metric for exposure for each of
these models? If not, what exposure
measure should be used?
4. Some of the literature OSHA
reviewed indicated that the risk of
contracting accelerated silicosis and
lung cancer may be non-linear at very
high exposures and may be described by
an exposure dose rate health effect
model. OSHA used the more
conservative model of cumulative
exposure that is more protective to the
worker. Are there additional data to
support or rebut any of these models
used by OSHA? Are there other models
that OSHA should consider for
estimating lung cancer, silicosis, or
NMRD risk? If so, describe the models
and the rationale for their use.
5. Are there additional studies or
sources of data that OSHA should have
included in its qualitative and
quantitative risk assessments? What are
these studies and have they been peerreviewed, or are they soon to be peerreviewed? What is the rationale for
recommending the studies or data?
6. Steenland et al. (2001a) pooled data
from 10 cohort studies to conduct an
analysis of lung cancer mortality among
silica-exposed workers. Can you provide
quantitative lung cancer risk estimates
from other data sources? Have or will
the data you submit be peer-reviewed?
OSHA is particularly interested in
quantitative risk analyses that can be
conducted using the industrial sand
worker studies by McDonald, Hughes,
and Rando (2001) and the pooled
center-based case-control study
conducted by Cassidy et al. (2007).
7. OSHA has made a preliminary
determination that the available data are
not sufficient or suitable for quantitative
analysis of the risk of autoimmune
disease, stomach cancer, and other
cancer and non-cancer health effects. Do
you have, or are you aware of, studies,
data, and rationale that would be
suitable for a quantitative risk
assessment for these adverse health
effects? Submit the studies (or citations),
data, and rationale.
Profile of Affected Industries
8. In its PEA of the proposed rule,
summarized in Section VIII of this
preamble, OSHA presents a profile of
the affected worker population. The
profile includes estimates of the number
of affected workers by industry sector or
operation and job category, and the
distribution of exposures by job
category. If your company has potential
worker exposures to respirable
crystalline silica, is your industry
among those listed by North American
Industry Classification System (NAICS)
code as affected industries? Are there
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additional data that will enable the
Agency to refine its profile of the worker
population exposed to respirable
crystalline silica? If so, provide or
reference such data and explain how
OSHA should use these data to revise
the profile.
Technological and Economic Feasibility
of the Proposed PEL
9. What are the job categories in
which employees are potentially
exposed to respirable crystalline silica
in your company or industry? For each
job category, provide a brief description
of the operation and describe the job
activities that may lead to respirable
crystalline silica exposure. How many
employees are exposed, or have the
potential for exposure, to respirable
crystalline silica in each job category in
your company or industry? What are the
frequency, duration, and levels of
exposures to respirable crystalline silica
in each job category in your company or
industry? Where responders are able to
provide exposure data, OSHA requests
that, where available, exposure data be
personal samples with clear
descriptions of the length of the sample,
analytical method, and controls in
place. Exposure data that provide
information concerning the controls in
place are more valuable than exposure
data without such information.
10. Please describe work
environments or processes that may
expose workers to cristobalite. Please
provide supporting evidence, or explain
the basis of your knowledge.
11. Have there been technological
changes within your industry that have
influenced the magnitude, frequency, or
duration of exposure to respirable
crystalline silica or the means by which
employers attempt to control such
exposures? Describe in detail these
technological changes and their effects
on respirable crystalline silica
exposures and methods of control.
12. Has there been a trend within your
industry or an effort in your firm to
reduce or eliminate respirable
crystalline silica from production
processes, products, and services? If so,
please describe the methods used and
provide an estimate of the percentage
reduction in respirable crystalline silica,
and the extent to which respirable
crystalline silica is still necessary in
specific processes within product lines
or production activities. If you have
substituted another substance(s) for
crystalline silica, identify the
substance(s) and any adverse health
effects associated with exposure to the
substitute substances, and the cost
impact of substitution (cost of materials,
productivity impact). OSHA also
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requests that responders describe any
health hazards or technical, economic,
or other deterrents to substitution.
13. Has your industry or firm used
outsourcing or subcontracting, or
concentrated high exposure tasks inhouse, in order to expose fewer workers
to respirable crystalline silica? An
example would be subcontracting for
the removal of hardened concrete from
concrete mixing trucks, a task done
typically 2–4 times a year, to a specialty
subcontractor. What methods have you
used to reduce the number of workers
exposed to respirable crystalline silica
and how were they implemented?
Describe any trends related to
concentration of high exposure tasks
and provide any supporting
information.
14. Does any job category or employee
in your workplace have exposures to
respirable crystalline silica that air
monitoring data do not adequately
portray due to the short duration,
intermittent or non-routine nature, or
other unique characteristics of the
exposure? Explain your response and
indicate peak levels, duration, and
frequency of exposures for employees in
these job categories.
15. OSHA requests the following
information regarding engineering and
work practice controls to control
exposure to crystalline silica in your
workplace or industry:
a. Describe the operations and tasks in
which the proposed PEL is being
achieved most of the time by means of
engineering and work practice controls.
b. What engineering and work
practice controls have been
implemented in these operations and
tasks?
c. For all operations and tasks in
facilities where respirable crystalline
silica is used, what engineering and
work practice controls have been
implemented to control respirable
crystalline silica? If you have installed
engineering controls or adopted work
practices to reduce exposure to
respirable crystalline silica, describe the
exposure reduction achieved and the
cost of these controls.
d. Where current work practices
include the use of regulated areas and
hygiene facilities, provide data on the
implementation of these controls,
including data on the costs of
installation, operation, and maintenance
associated with these controls.
e. Describe additional engineering and
work practice controls that could be
implemented in each operation where
exposure levels are currently above the
proposed PEL to further reduce
exposure levels.
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f. When these additional controls are
implemented, to what levels can
exposure be expected to be reduced, or
what percent reduction is expected to be
achieved?
g. What amount of time is needed to
develop, install, and implement these
additional controls? Will the added
controls affect productivity? If so, how?
h. Are there any processes or
operations for which it is not reasonably
possible to implement engineering and
work practice controls within one year
to achieve the proposed PEL? If so, how
much additional time would be
necessary?
16. OSHA requests information on
whether there are any specific
conditions or job tasks involving
exposure to respirable crystalline silica
where engineering and work practice
controls are not available or are not
capable of reducing exposure levels to
or below the proposed PEL most of the
time. Provide data and evidence to
support your response.
17. OSHA has made a preliminary
determination that compliance with the
proposed PEL can be achieved in most
operations most of the time through the
use of engineering and work practice
controls. OSHA has further made a
preliminary determination that the
proposed rule is technologically
feasible. OSHA solicits comments on
the reasonableness of these preliminary
determinations.
Compliance Costs
18. In its PEA (summarized in Section
VIII.3 of this preamble), OSHA
developed its estimate of the costs of the
proposed rule. The Agency requests
comment on the methodological and
analytical assumptions applied in the
cost analysis. Of particular importance
are the unit cost estimates provided in
tables and text in Chapter V of the PEA
for all major provisions of the proposed
rule. OSHA requests the following
information regarding unit and total
compliance costs:
a. If you have installed engineering
controls or adopted work practices to
reduce exposure to respirable crystalline
silica, describe these controls and their
costs. If you have substituted another
substance(s) for crystalline silica, what
has been the cost impact of substitution
(cost of materials, productivity impact)?
b. OSHA has proposed to limit the
prohibition on dry sweeping to
situations where this activity could
contribute to exposure that exceeds the
PEL and estimated the costs for the use
of wet methods to control dust. OSHA
requests comment on the use of wet
methods as a substitute for dry
sweeping and whether the prohibition
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on dry sweeping is feasible and costeffective.
c. In its PEA, OSHA presents
estimated baseline levels of use of
personal protective equipment (PPE)
and the incremental PPE costs
associated with the proposed rule. Are
OSHA’s estimated PPE compliance rates
reasonable? Are OSHA’s estimates of
PPE costs, and the assumptions
underlying these estimates, consistent
with current industry practice? If not,
provide data and evidence describing
current industry PPE practices.
d. Do you currently conduct exposure
monitoring for respirable crystalline
silica? Are OSHA’s estimates of
exposure assessment costs reasonable?
Would your company require outside
consultants to perform exposure
monitoring?
e. Are OSHA’s estimates for medical
surveillance costs—including direct
medical costs, the opportunity cost of
worker time for offsite travel and for the
health screening, and recordkeeping
costs—reasonable?
f. In its PEA, OSHA presents
estimated baseline levels of training and
information concerning respirable
crystalline silica-related hazards and the
incremental costs associated with the
additional requirements for training and
information in the proposed rule. OSHA
requests information on information and
training programs addressing respirable
crystalline silica that are currently being
implemented by employers and any
necessary additions to those programs
that are anticipated in response to the
proposed rule. Are OSHA’s baseline
estimates and unit costs for training
reasonable and consistent with current
industry practice?
g. Are OSHA’s estimated costs for
regulated areas and written access
control plans reasonable?
h. The cost estimates in the PEA take
the much higher labor turnover rates in
construction into account when
calculating costs. For the proposed rule,
OSHA used the most recent BLS
turnover rate of 64 percent for
construction (versus a turnover rate of
27.2 percent for general industry).
OSHA believes that the estimates in the
PEA capture the effect of high turnover
rates in construction and solicits
comments on this issue.
i. Has OSHA omitted any costs that
would be incurred to comply with the
proposed rule?
Effects on Small Entities
19. OSHA has considered the effects
on small entities raised during its
SBREFA process and addressed these
concerns in Chapter VIII of the PEA. Are
there additional difficulties small
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entities may encounter when attempting
to comply with requirements of the
proposed rule? Can any of the
proposal’s requirements be deleted or
simplified for small entities, while still
providing equivalent protection of the
health of employees? Would allowing
additional time for small entities to
comply make a difference in their
ability to comply? How much additional
time would be necessary?
Economic Impacts
20. OSHA, in its PEA, has estimated
compliance costs per affected entity and
the likely impacts on revenues and
profits. OSHA requests that affected
employers provide comment on OSHA’s
estimate of revenue, profit, and the
impacts of costs for their industry or
application group. The Agency also
requests that employers provide data on
their revenues, profits, and the impacts
of cost, if available. Are there special
circumstances—such as unique cost
factors, foreign competition, or pricing
constraints—that OSHA needs to
consider when evaluating economic
impacts for particular applications and
industry groups?
21. OSHA seeks comment as to
whether establishments will be able to
finance first-year compliance costs from
cash flow, and under what
circumstances a phase-in approach will
assist firms in complying with the
proposed rule.
22. The Agency invites comment on
potential employment impacts of the
proposed silica rule, and on Inforum’s
estimates of the employment impacts of
the proposed silica rule on the U.S.
economy.
c. The choice of discount rate for
annualizing the monetized benefits of
the proposed rule.
d. Increasing the monetary value of a
statistical life over time resulting from
an increase in real per capita income
and the estimated income elasticity of
the value of life.
e. Extending the benefits analysis
beyond the 60-year period used in the
PEA.
f. The magnitude of non-quantified
health benefits arising from the
proposed rule and methods for better
measuring these effects. An example
would be diagnosing latent tuberculosis
(TB) in the silica-exposed population
and thereby reducing the risk of TB
being spread to the population at large.
Overlapping and Duplicative
Regulations
25. Do any federal regulations
duplicate, overlap, or conflict with the
proposed respirable crystalline silica
rule? If so, provide or cite to these
regulations.
Benefits and Net Benefits
Alternatives/Ways to Simplify a New
Standard
26. Comment on the alternative to
new comprehensive standards (which
have ancillary provisions in addition to
a permissible exposure limit) that would
be simply improved outreach and
enforcement of the existing standards
(which is only a permissible exposure
limit with no ancillary provisions). Do
you believe that improved outreach and
enforcement of the existing permissible
exposure limits would be sufficient to
reduce significant risks of material
health impairment in workers exposed
to respirable crystalline silica? Provide
information to support your position.
27. OSHA solicits comments on ways
to simplify the proposed rule without
compromising worker protection from
exposure to respirable crystalline silica.
In particular, provide detailed
recommendations on ways to simplify
the proposed standard for construction.
Provide evidence that your
recommended simplifications would
result in a standard that was effective,
to the extent feasible, in reducing
significant risks of material health
impairment in workers exposed to
respirable crystalline silica.
24. OSHA requests comments on any
aspect of its estimation of benefits and
net benefits from the proposed rule,
including the following:
a. The use of willingness-to-pay
measures and estimates based on
compensating wage differentials.
b. The data and methods used in the
benefits calculations.
Environmental Impacts
28. Submit data, information, or
comments pertaining to possible
environmental impacts of adopting this
proposal, including any positive or
negative environmental effects and any
irreversible commitments of natural
resources that would be involved. In
particular, consideration should be
Outreach and Compliance Assistance
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23. If the proposed rule is
promulgated, OSHA will provide
outreach materials on the provisions of
the standards in order to encourage and
assist employers in complying. Are
there particular materials that would
make compliance easier for your
company or industry? What materials
would be especially useful for small
entities? Submit recommendations or
samples.
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given to the potential direct or indirect
impacts of the proposal on water and air
pollution, energy use, solid waste
disposal, or land use. Would
compliance with the silica rule require
additional actions to comply with
federal, state, or local environmental
requirements?
29. Some small entity representatives
advised OSHA that the use of water as
a control measure is limited at their
work sites due to potential water and
soil contamination. OSHA believes
these limits may only apply in
situations where crystalline silica is
found with other toxic substances such
as during abrasive blasting of metal or
painted metal structures, or in locations
where state and local requirements are
more restrictive than EPA requirements.
OSHA seeks comments on this issue,
including cites to applicable
requirements.
a. Are there limits on the use of water
controls in your operations due to
environmental regulations? If so, are the
limits due to the non-silica components
of the waste stream? What are these
non-silica components?
b. What metals or other toxic
chemicals are in your silica waste
streams and what are the procedures
and costs to filter out these metals or
other toxic chemicals from your waste
streams? Provide documentation to
support your cost estimates.
Provisions of the Standards
Scope
30. OSHA’s Advisory Committee on
Construction Safety and Health
(ACCSH) has historically advised the
Agency to take into consideration the
unique nature of construction work
environments by either setting separate
standards or making accommodations
for the differences in work
environments in construction as
compared to general industry. ASTM,
for example, has separate silica
standards of practice for general
industry and construction, E 1132–06
and E 2625–09, respectively. To account
for differences in the workplace
environments for these different sectors,
OSHA has proposed separate standards
for general industry/maritime and
construction. Is this approach necessary
and appropriate? What other
approaches, if any, should the Agency
consider? Provide a rationale for your
response.
31. OSHA has proposed that the scope
of the construction standard include all
occupational exposures to respirable
crystalline silica in construction work as
defined in 29 CFR 1910.12(b) and
covered under 29 CFR part 1926, rather
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than restricting the application of the
rule to specific construction operations.
Should OSHA modify the scope to limit
what is covered? What should be
included and what should be excluded?
Provide a rationale for your position.
Submit your proposed language for the
scope and application provision.
32. OSHA has not proposed to cover
agriculture because the Agency does not
have data sufficient to determine the
feasibility of the proposed PEL in
agricultural operations. Should OSHA
cover respirable crystalline silica
exposure in agriculture? Provide
evidence to support your position.
OSHA seeks information on agricultural
operations that involve respirable
crystalline silica exposures, including
information that identifies particular
activities or crops (e.g., hand picking
fruit and vegetables, shaking branches
and trees, harvesting with combines,
loading storage silos, planting)
associated with exposure, information
indicating levels of exposure, and
information relating to available control
measures and their effectiveness. OSHA
also seeks information related to the
development of respirable crystalline
silica-related adverse health effects and
diseases among workers in the
agricultural sector.
33. Should OSHA limit coverage of
the rule to materials that contain a
threshold concentration (e.g., 1%) of
crystalline silica? For example, OSHA’s
Asbestos standard defines ‘‘asbestoscontaining material’’ as any material
containing more than 1% asbestos, for
consistency with EPA regulations.
OSHA has not proposed a comparable
limitation to the definition of respirable
crystalline silica. Is this approach
appropriate? Provide the rationale for
your position.
34. OSHA has proposed to cover
shipyards under the general industry
standard. Are there any unique
circumstances in shipyard employment
that would justify development of
different provisions or a separate
standard for the shipyard industry?
What are the circumstances and how
would they not be adequately covered
by the general industry standard?
Definitions
35. Competent person. OSHA has
proposed limited duties for a competent
person relating to establishment of an
access control plan. The Agency did not
propose specific requirements for
training of a competent person. Is this
approach appropriate? Should OSHA
include a competent person provision?
If so, should the Agency add to, modify,
or delete any of the duties of a
competent person as described in the
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proposed standard? Provide the basis for
your recommendations.
36. Has OSHA defined ‘‘respirable
crystalline silica’’ appropriately? If not,
provide the definition that you believe
is appropriate. Explain the basis for
your response, and provide any data
that you believe are relevant.
37. The proposed rule defines
‘‘respirable crystalline silica’’ in part as
‘‘airborne particles that contain quartz,
cristobalite, and/or tridymite.’’ OSHA
believes that tridymite is rarely found in
nature or in the workplace. Please
describe any instances of occupational
exposure to tridymite of which you are
aware. Please provide supporting
evidence, or explain the basis of your
knowledge. Should tridymite be
included in the scope of this proposed
rule? Please provide any evidence to
support your position.
PEL and Action Level
38. OSHA has proposed a TWA PEL
for respirable crystalline silica of 50 mg/
m3 for general industry, maritime, and
construction. The Agency has made a
preliminary determination that this is
the lowest level that is technologically
feasible. The Agency has also
determined that a PEL of 50 mg/m3 will
substantially reduce, but not eliminate,
significant risk of material health
impairment. Is this PEL appropriate,
given the Agency’s obligation to reduce
significant risk of material health
impairment to the extent feasible? If not,
what PEL would be more appropriate?
The Agency also solicits comment on
maintaining the existing PELs for
respirable crystalline silica. Provide
evidence to support your response.
39. OSHA has proposed a single PEL
for respirable crystalline silica (quartz,
cristobalite, and tridymite). Is a single
PEL appropriate, or should the Agency
maintain separate PELs for the different
forms of respirable crystalline silica?
Provide the rationale for your position.
40. OSHA has proposed an action
level for respirable crystalline silica
exposure of 25 mg/m3 in general
industry, maritime, and construction. Is
this an appropriate approach and level,
and if not, what approach or level
would be more appropriate and why?
Should an action level be included in
the final rule? Provide the rationale for
your position.
41. If an action level is included in
the final rule, which provisions, if any,
should be triggered by exposure above
or below the action level? Provide the
basis for your position and include
supporting information.
42. If no action level is included in
the final rule, which provisions should
apply to all workers exposed to
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respirable crystalline silica? Which
provisions should be triggered by the
PEL? Are there any other appropriate
triggers for the requirements of the rule?
Exposure Assessment
43. OSHA is proposing to allow
employers to initially assess employee
exposures using air monitoring or
objective data. Has OSHA defined
‘‘objective data’’ sufficiently for an
employer to know what data may be
used? If not, submit an alternative
definition. Is it appropriate to allow
employers to use objective data to
perform exposure assessments? Explain
why or why not.
44. The proposed rule provides two
options for periodic exposure
assessment: (1) A fixed schedule option,
and (2) a performance option. The
performance option provides employers
flexibility in the methods used to
determine employee exposures, but
requires employers to accurately
characterize employee exposures. The
proposed approach is explained in the
Summary and Explanation for
paragraph (d) Exposure Assessment.
OSHA solicits comments on this
proposed exposure assessment
provision. Is the wording of the
performance option in the regulatory
text understandable and does it clearly
indicate what would constitute
compliance with the provision? If not,
suggest alternative language that would
clarify the provision, enabling
employers to more easily understand
what would constitute compliance.
45. Do you conduct initial air
monitoring or do you rely on objective
data to determine respirable crystalline
silica exposures? If objective data, what
data do you use? Have you conducted
historical exposure monitoring of your
workforce that is representative of
current process technology and
equipment use? Describe any other
approaches you have implemented for
assessing an employee’s initial exposure
to respirable crystalline silica.
46. OSHA is proposing specific
requirements for laboratories that
perform analyses of respirable
crystalline silica samples. The rationale
is to improve the precision in individual
laboratories and reduce the variability of
results between laboratories, so that
sampling results will be more reliable.
Are these proposed requirements
appropriate? Will the laboratory
requirements add necessary reliability
and reduce inter-lab variability, or
might they be overly proscriptive?
Provide the basis for your response.
47. Has OSHA correctly described the
accuracy and precision of existing
methods of sampling and analysis for
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respirable crystalline silica at the
proposed action level and PEL? Can
worker exposures be accurately
measured at the proposed action level
and PEL? Explain the basis for your
response, and provide any data that you
believe are relevant.
48. OSHA has not addressed the
performance of the analytical method
with respect to tridymite since we have
found little available data. Please
comment on the performance of the
analytical method with respect to
tridymite and provide any data to
support your position.
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Regulated Areas and Access Control
49. Where exposures exceed the PEL,
OSHA has proposed to provide
employers with the option of either
establishing a regulated area or
establishing a written access control
plan. For which types of work
operations would employers be likely to
establish a written access control plan?
Will employees be protected by these
options? Provide the basis for your
position and include supporting
information.
50. The Summary and Explanation for
paragraph (e) Regulated Areas and
Access Control clarifies how the
regulated area requirements would
apply to multi-employer worksites in
the proposed standard. OSHA solicits
comments on this issue.
51. OSHA is proposing limited
requirements for protective clothing in
the silica rule. Is this appropriate? Are
you aware of any situations where more
or different protective clothing would be
needed for silica exposures? If so, what
type of protective clothing and
equipment should be required? Are
there additional provisions related to
protective clothing that should be
incorporated into this rule that will
enhance worker protection? Provide the
rationale and data that support your
conclusions.
Methods of Compliance
52. In OSHA’s cadmium standard (29
CFR 1910.1027(f)(1)(ii),(iii), and (iv)),
the Agency established separate
engineering control air limits (SECALs)
for certain processes in selected
industries. SECALs were established
where compliance with the PEL by
means of engineering and work practice
controls was infeasible. For these
industries, a SECAL was established at
the lowest feasible level that could be
achieved by engineering and work
practice controls. The PEL was set at a
lower level, and could be achieved by
any allowable combination of controls,
including respiratory protection. In
OSHA’s chromium (VI) standard (29
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CFR 1910.1026), an exception similar to
SECALs was made for painting
airplanes and airplane parts. Should
OSHA follow this approach for
respirable crystalline silica in any
industries or processes? If so, in what
industries or processes, and at what
exposure levels, should the SECALs be
established? Provide the basis for your
position and include supporting
information.
53. The proposed standards do not
contain a requirement for a written
exposure control program. The two
ASTM standards for general industry
and construction (E 1132–06, section
4.2.6, and E 2626–09, section 4.2.5) state
that, where overexposures are persistent
(such as in regulated areas or abrasive
blasting operations), a written exposure
control plan shall establish engineering
and administrative controls to bring the
area into compliance, if feasible. In
addition, the proposed regulatory
language developed by the Building and
Construction Trades Department, AFL–
CIO contains provisions for a written
program. The ASTM standards
recommend that, where there are
regulated areas with persistent
exposures or tasks, tools, or operations
that tend to cause respirable crystalline
silica exposure, the employer will
conduct a formal analysis and
implement a written control plan (an
abatement plan) on how to bring the
process into compliance. If that is not
feasible, the employer is to indicate the
respiratory protection and other
protective procedures that will be used
to protect employee(s) permanently or
until compliance will be achieved.
Should OSHA require employers to
develop and implement a written
exposure control plan and, if so, what
should be required to be in the plans?
54. Table 1 in the proposed
construction standard specifies
engineering and work practice controls
and respiratory protection for selected
construction operations, and exempts
employers who implement these
controls from exposure assessment
requirements. Is this approach
appropriate? Are there other operations
that should be included, or listed
operations that should not be included?
Are the specified control measures
effective? Should any other changes be
made in Table 1? How should OSHA
update Table 1 in the future to account
for development of new technologies?
Provide data and information to support
your position.
55. OSHA requests comments on the
degree of specificity used for the
engineering and work practice controls
for tasks identified in Table 1, including
maintenance requirements. Should
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OSHA require an evaluation or
inspection checklist for controls? If so,
how frequently should evaluations or
inspections be conducted? Provide any
examples of such checklists, along with
information regarding their frequency of
use and effectiveness.
56. In the proposed construction
standard, when employees perform an
operation listed in Table 1 and the
employer fully implements the
engineering controls, work practices,
and respiratory protection described in
Table 1 for that operation, the employer
is not required to assess the exposure of
the employees performing such
operations. However, the employer must
still ensure compliance with the
proposed PEL for that operation. OSHA
seeks comment on whether employers
fully complying with Table 1 for an
operation should still need to comply
with the proposed PEL for that
operation. Instead, should OSHA treat
compliance with Table 1 as
automatically meeting the requirements
of the proposed PEL?
57. Are the descriptions of the
operations (specific task or tool
descriptions) and control technologies
in Table 1 clear and precise enough so
that employers and workers will know
what controls they should be using for
the listed operations? Identify the
specific operation you are addressing
and whether your assessment is based
on your anecdotal experience or
research. For each operation, are the
data and other supporting information
sufficient to predict the range of
expected exposures under the
controlled conditions? Identify
operations, if any, where you believe the
data are not sufficient. Provide the
reasoning and data that support your
position.
58. In one specific example from
Table 1, OSHA has proposed the option
of using a wet method for hand-operated
grinders, with respirators required only
for operations lasting four hours or
more. Please comment and provide
OSHA with additional information
regarding wet grinding and the
adequacy of this control strategy. OSHA
is also seeking additional information
on the second option (commercially
available shrouds and dust collection
systems) to confirm that this control
strategy (including the use of half-mask
respirators) will reduce workers’
exposure to or below the PEL.
59. For impact drilling operations
lasting four hours or less, OSHA is
proposing in Table 1 to allow workers
to use water delivery systems without
the use of respiratory protection, as the
Agency believes that this dust
suppression method alone will provide
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consistent, sufficient protection. Is this
control strategy appropriate? Please
provide the basis for your position and
any supporting evidence or additional
information that addresses the
appropriateness of this control strategy.
60. In the case of rock drilling, in
order to ensure that workers are
adequately protected from the higher
exposures that they would experience
working under shrouds, OSHA is
proposing in Table 1 that employers
ensure that workers use half-mask
respirators when working under
shrouds at the point of operation. Is this
specification appropriate? Please
provide the basis for your position and
any supporting evidence or additional
information that addresses the
appropriateness of this specification.
61. OSHA has specified a control
strategy for concrete drilling in Table 1
that includes use of a dust collection
system as well as a low-flow water
spray. Please provide to OSHA any data
that you have that describes the efficacy
of these controls. Is the control strategy
in Table 1 adequate? Please provide the
basis for your position and any
supporting evidence or additional
information regarding the adequacy of
this control strategy.
62. One of the control options in
Table 1 in the proposed construction
standard for rock-crushing operations is
local exhaust ventilation. However,
OSHA is aware of difficulties in
applying this control to this operation.
Is this control strategy appropriate and
practical for rock-crushing operations?
Please provide any information that you
have addressing this issue.
63. OSHA has not proposed to
prohibit the use of crystalline silica as
an abrasive blasting agent. Abrasive
blasting, similar to other operations that
involve respirable crystalline silica
exposures, must follow the hierarchy of
controls, which means, if feasible, that
substitution, engineering, or
administrative controls or a
combination of these controls must be
used to minimize or eliminate the
exposure hazard. Is this approach
appropriate? Provide the basis for your
position and any supporting evidence.
64. The technological feasibility study
(PEA, Chapter 4) indicates that
employers use substitutes for crystalline
silica in a variety of operations. If you
are aware of substitutes for crystalline
silica that are currently being used in
any operation not considered in the
feasibility study, please provide to
OSHA relevant information that
contains data supporting the
effectiveness, in reducing exposure to
crystalline silica, of those substitutes.
Provide any information you may have
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on the health hazards associated with
exposure to these substitutes.
65. Information regarding the
effectiveness of dust control kits that
incorporate local exhaust ventilation in
the railroad transportation industry in
reducing worker exposure to crystalline
silica is not available from the
manufacturer. If you have any relevant
information on the effectiveness of such
kits, please provide it to OSHA.
66. The proposed rule prohibits the
use of compressed air and dry brushing
and sweeping for cleaning of surfaces
and clothing in general industry,
maritime, and construction and
promotes the use of wet methods and
HEPA-filter vacuuming as alternatives.
Are there any circumstances in general
industry, maritime, or construction
work where dry sweeping is the only
kind of sweeping that can be done?
Have you done dry sweeping and, if so,
what has been your experience with it?
What methods have you used to
minimize dust when dry sweeping? Can
exposure levels be kept below the
proposed PEL when dry sweeping is
conducted? How? Provide exposure data
for periods when you conducted dry
sweeping. If silica respirable dust
samples are not available, provide real
time respirable dust or gravimetric
respirable dust data. Is water available
at most sites to wet down dust prior to
sweeping? How effective is the use of
water? Does the use of water cause other
problems for the worksite? Are there
other substitutes that are effective?
67. A 30-day exemption from the
requirement to implement engineering
and work practice controls was not
included in the proposed standard for
construction, and has been removed
from the proposed standard for general
industry and maritime. OSHA requests
comment on this issue.
68. The proposed prohibition on
employee rotation is explained in the
Summary and Explanation for
paragraph (f) Methods of Compliance.
OSHA solicits comment on the
prohibition of employee rotation to
achieve compliance when exposure
levels exceed the PEL.
Medical Surveillance
69. Is medical surveillance being
provided for respirable crystalline
silica-exposed employees at your
worksite? If so:
a. How do you determine which
employees receive medical surveillance
(e.g., by exposure level or other factors)?
b. Who administers and implements
the medical surveillance (e.g., company
doctor or nurse, outside doctor or
nurse)?
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c. What examinations, tests, or
evaluations are included in the medical
surveillance program? Does your
medical surveillance program include
testing for latent TB? Do you include
pulmonary function testing in your
medical surveillance program?
d. What benefits (e.g., health,
reduction in absenteeism, or financial)
have been achieved from the medical
surveillance program?
e. What are the costs of your medical
surveillance program? How do your
costs compare with OSHA’s estimated
unit costs for the physical examination
and employee time involved in the
medical surveillance program? Are
OSHA’s baseline assumptions and cost
estimates for medical surveillance
consistent with your experiences
providing medical surveillance to your
employees?
f. How many employees are included
in your medical surveillance program?
g. What NAICS code describes your
workplace?
70. Is the content and frequency of
proposed examinations appropriate? If
not, how should content and frequency
be modified?
71. Is the specified content of the
physician or other licensed health care
professional’s (PLHCP) written medical
opinion sufficiently detailed to enable
the employer to address the employee’s
needs and potential workplace
improvements, and yet appropriately
limited so as to protect the employee’s
medical privacy? If not, how could the
medical opinion be improved?
72. Is the requirement for latent TB
testing appropriate? Does the proposed
rule implement this requirement in a
cost-effective manner? Provide the data
or cite references that support your
position.
73. Is the requirement for pulmonary
function testing initially and at threeyear intervals appropriate? Is there an
alternate strategy or schedule for
conducting follow-up testing that is
better? Provide data or cite references to
support your position.
74. Is the requirement for chest X-rays
initially and at three-year intervals
appropriate? Is there an alternate
strategy or schedule for conducting
follow-up chest X-rays that you believe
would be better? Provide data or cite
references to support your position.
75. Are there other tests that should
be included in medical surveillance?
76. Do you provide medical
surveillance to employees under
another OSHA standard or as a matter
of company policy? If so, describe your
program in terms of what standards the
program addresses and such factors as
content and frequency of examinations
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and referrals, and reports to the
employer.
77. Is exposure for 30 days at or above
the PEL the appropriate number of days
to trigger medical surveillance? Should
the appropriate reference for medical
monitoring be the PEL or the action
level? Is 30 days from initial assignment
a reasonable amount of time to provide
a medical exam? Indicate the basis for
your position.
78. Are PLHCPs available in your
geographic area to provide medical
surveillance to workers who are covered
by the proposed rule? For example, do
you have access to qualified X-ray
technicians, NIOSH-certified B-readers,
and pulmonary specialists? Describe
any difficulties you may have with
regard to access to PLHCPs to provide
surveillance for the rule. Note what you
consider your ‘‘geographic area’’ in
responding to this question.
79. OSHA is proposing to allow an
‘‘equivalent diagnostic study’’ in place
of requirements to use a chest X-ray
(posterior/anterior view; no less than 14
x 17 inches and no more than 16 x 17
inches at full inspiration; interpreted
and classified according to the
International Labour Organization (ILO)
International Classification of
Radiographs of Pneumoconioses by a
NIOSH-certified ‘‘B’’ reader). Two other
radiological test methods, computed
tomography (CT) and high resolution
computed tomography (HRCT), could be
considered ‘‘equivalent diagnostic
studies’’ under paragraph (h)(2)(iii) of
the proposal. However, the benefits of
CT or HRCT should be balanced with
risks, including higher radiation doses.
Also, standardized methods for
interpreting and reporting results of CT
or HRCT are not currently available. The
Agency requests comment on whether
CT and HRCT should be considered
‘‘equivalent diagnostic studies’’ under
the rule. Provide a rationale and
evidence to support your position.
80. OSHA has not included
requirements for medical removal
protection (MRP) in the proposed rule,
because OSHA has made a preliminary
determination that there are few
instances where temporary worker
removal and MRP will be useful. The
Agency requests comment as to whether
the respirable crystalline silica rule
should include provisions for the
temporary removal and extension of
MRP benefits to employees with certain
respirable crystalline silica-related
health conditions. In particular, what
medical conditions or findings should
trigger temporary removal and for what
maximum amount of time should MRP
benefits be extended? OSHA also seeks
information on whether or not MRP is
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currently being used by employers with
respirable crystalline silica-exposed
workers, and the costs of such programs.
Hazard Communication and Training
81. OSHA has proposed that
employers provide hazard information
to employees in accordance with the
Agency’s Hazard Communication
standard (29 CFR 1910.1200).
Compliance with the Hazard
Communication standard would mean
that there would be a requirement for a
warning label for substances that
contain more than 0.1 percent
crystalline silica. Should this
requirement be changed so that warning
labels would only be required of
substances more than 1 percent by
weight of silica? Provide the rationale
for your position. The Agency also has
proposed additional training specific to
work with respirable crystalline silica.
Should OSHA include these additional
requirements in the final rule, or are the
requirements of the Hazard
Communication standard sufficient?
82. OSHA is providing an abbreviated
training section in this proposal as
compared to ASTM consensus
standards (see ASTM E 1132–06,
sections 4.8.1–5). The Hazard
Communication standard is
comprehensive and covers most of the
training requirements traditionally
included in an OSHA health standard.
Do you concur with OSHA that
performance-based training specified in
the Hazard Communication standard,
supplemented by the few training
requirements of this section, is
sufficient in its scope and depth? Are
there any other training provisions you
would add?
83. The proposed rule does not alter
the requirements for substances to have
warning labels, specify wording for
labels, or otherwise modify the
provisions of the OSHA’s Hazard
Communication standard. OSHA invites
comment on these issues.
Recordkeeping
84. OSHA is proposing to require
recordkeeping for air monitoring data,
objective data, and medical surveillance
records. The proposed rule’s
recordkeeping requirements are
discussed in the Summary and
Explanation for paragraph (j)
Recordkeeping. The Agency seeks
comment on the utility of these
recordkeeping requirements as well as
the costs of making and maintaining
these records. Provide evidence to
support your position.
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Dates
85. OSHA requests comment on the
time allowed for compliance with the
provisions of the proposed rule. Is the
time proposed appropriate, or should
there be a longer or shorter phase-in of
requirements? In particular, should
requirements for engineering controls
and/or medical surveillance be phased
in over a longer period of time (e.g., over
1, 2, 3, or more years)? Should an
extended phase-in period be provided
for specific industries (e.g., industries
where first-year or annualized cost
impacts are highest), specific sizeclasses of employers (e.g., employers
with fewer than 20 employees),
combinations of these factors, or all
firms covered by the rule? Identify any
industries, processes, or operations that
have special needs for additional time,
the additional time required, and the
reasons for the request.
86. OSHA is proposing a two-year
start-up period to allow laboratories
time to achieve compliance with the
proposed requirements, particularly
with regard to requirements for
accreditation and round robin testing.
OSHA also recognizes that requirements
for monitoring in the proposed rule will
increase the required capacity for
analysis of respirable crystalline silica
samples. Do you think that this start-up
period is enough time for laboratories to
achieve compliance with the proposed
requirements and to develop sufficient
analytic capacity? If you think that
additional time is needed, please tell
OSHA how much additional time is
required and give your reasons for this
request.
Appendices
87. Some OSHA health standards
include appendices that address topics
such as the hazards associated with the
regulated substance, health screening
considerations, occupational disease
questionnaires, and PLHCP obligations.
In this proposed rule, OSHA has
included a non-mandatory appendix to
clarify the medical surveillance
provisions of the rule. What would be
the advantages and disadvantages of
including such an appendix in the final
rule? If you believe it should be
included, comment on the
appropriateness of the information
included. What additional information,
if any, should be included in the
appendix?
II. Pertinent Legal Authority
The purpose of the Occupational
Safety and Health Act, 29 U.S.C. 651 et
seq. (‘‘the Act’’), is to ‘‘. . . assure so far
as possible every working man and
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woman in the nation safe and healthful
working conditions and to preserve our
human resources.’’ 29 U.S.C. 651(b).
To achieve this goal Congress
authorized the Secretary of Labor (the
Secretary) to promulgate and enforce
occupational safety and health
standards. 29 U.S.C. 654(b) (requiring
employers to comply with OSHA
standards), 655(a) (authorizing summary
adoption of existing consensus and
federal standards within two years of
the Act’s enactment), and 655(b)
(authorizing promulgation, modification
or revocation of standards pursuant to
notice and comment).
The Act provides that in promulgating
health standards dealing with toxic
materials or harmful physical agents,
such as this proposed standard
regulating occupational exposure to
respirable crystalline silica, the
Secretary, shall set the standard which
most adequately assures, to the extent
feasible, on the basis of the best
available evidence that no employee
will suffer material impairment of
health or functional capacity even if
such employee has regular exposure to
the hazard dealt with by such standard
for the period of his working life. 29
U.S.C. 655(b)(5).
The Supreme Court has held that
before the Secretary can promulgate any
permanent health or safety standard, she
must make a threshold finding that
significant risk is present and that such
risk can be eliminated or lessened by a
change in practices. Industrial Union
Dept., AFL–CIO v. American Petroleum
Institute, 448 U.S. 607, 641–42 (1980)
(plurality opinion) (‘‘The Benzene
case’’). Thus, section 6(b)(5) of the Act
requires health standards to reduce
significant risk to the extent feasible. Id.
The Court further observed that what
constitutes ‘‘significant risk’’ is ‘‘not a
mathematical straitjacket’’ and must be
‘‘based largely on policy
considerations.’’ The Benzene case, 448
U.S. at 655. The Court gave the example
that if,
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. . . the odds are one in a billion that a
person will die from cancer . . . the risk
clearly could not be considered significant.
On the other hand, if the odds are one in one
thousand that regular inhalation of gasoline
vapors that are 2% benzene will be fatal, a
reasonable person might well consider the
risk significant. [Id.]
OSHA standards must be both
technologically and economically
feasible. United Steelworkers v.
Marshall, 647 F.2d 1189, 1264 (D.C. Cir.
1980) (‘‘The Lead I case’’). The Supreme
Court has defined feasibility as ‘‘capable
of being done.’’ Am. Textile Mfrs. Inst.
v. Donovan, 452 U.S. 490, 509–510
(1981) (‘‘The Cotton Dust case’’). The
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courts have further clarified that a
standard is technologically feasible if
OSHA proves a reasonable possibility,
. . . within the limits of the best available
evidence . . . that the typical firm will be
able to develop and install engineering and
work practice controls that can meet the PEL
in most of its operations. [See The Lead I
case, 647 F.2d at 1272]
With respect to economic feasibility,
the courts have held that a standard is
feasible if it does not threaten massive
dislocation to or imperil the existence of
the industry. Id. at 1265. A court must
examine the cost of compliance with an
OSHA standard,
. . . in relation to the financial health and
profitability of the industry and the likely
effect of such costs on unit consumer prices
. . . [T]he practical question is whether the
standard threatens the competitive stability
of an industry, . . . or whether any intraindustry or inter-industry discrimination in
the standard might wreck such stability or
lead to undue concentration. [Id. (citing
Indus. Union Dep’t, AFL–CIO v. Hodgson,
499 F.2d 467 (D.C. Cir. 1974))]
The courts have further observed that
granting companies reasonable time to
comply with new PELs may enhance
economic feasibility. The Lead I case at
1265. While a standard must be
economically feasible, the Supreme
Court has held that a cost-benefit
analysis of health standards is not
required by the Act because a feasibility
analysis is required. The Cotton Dust
case, 453 U.S. at 509.
Finally, sections 6(b)(7) and 8(c) of
the Act authorize OSHA to include
among a standard’s requirements
labeling, monitoring, medical testing,
and other information-gathering and
-transmittal provisions. 29 U.S.C.
655(b)(7), 657(c).
III. Events Leading to the Proposed
Standards
OSHA’s current standards for
workplace exposure to respirable
crystalline silica were adopted in 1971,
pursuant to section 6(a) of the OSH Act
(36 FR 10466, May 29, 1971). Section
6(a) provided that in the first two years
after the effective date of the Act, OSHA
had to promulgate ‘‘start-up’’ standards,
on an expedited basis and without
public hearing or comment, based on
national consensus or established
Federal standards that improved
employee safety or health. Pursuant to
that authority, OSHA in 1971
promulgated approximately 425
permissible exposure limits (PELs) for
air contaminants, including silica,
derived principally from Federal
standards applicable to government
contractors under the Walsh-Healey
Public Contracts Act, 41 U.S.C. 35, and
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the Contract Work Hours and Safety
Standards Act (commonly known as the
Construction Safety Act), 40 U.S.C. 333.
The Walsh-Healey Act and Construction
Safety Act standards, in turn, had been
adopted primarily from
recommendations of the American
Conference of Governmental Industrial
Hygienists (ACGIH).
For general industry (see 29 CFR
1910.1000, Table Z–3), the PEL for
crystalline silica in the form of
respirable quartz is based on two
alternative formulas: (1) A particlecount formula, PELmppcf = 250/(% quartz
+ 5); and (2) a mass formula proposed
by ACGIH in 1968, PEL = (10 mg/m3)/
(% quartz + 2). The general industry
PELs for cristobalite and tridymite are
one-half of the value calculated from
either of the above two formulas. For
construction (29 CFR 1926.55,
Appendix A) and shipyards (29 CFR
1915.1000, Table Z), the formula for the
PEL for crystalline silica in the form of
quartz (PELmppcf = 250/(% quartz + 5)),
which requires particle counting, is
derived from the 1970 ACGIH threshold
limit value (TLV).2 The formula based
on particle-counting technology used in
the general industry, construction, and
shipyard PELs is now considered
obsolete.
In 1974, the National Institute for
Occupational Safety and Health
(NIOSH) evaluated crystalline silica as a
workplace hazard and issued criteria for
a recommended standard on
occupational exposure to crystalline
silica (NIOSH, 1974). NIOSH
recommended that occupational
exposure to crystalline silica be
controlled so that no worker is exposed
to a time-weighted average (TWA) of
free (respirable crystalline) silica greater
than 50 mg/m3 as determined by a fullshift sample for up to a 10-hour
workday, 40-hour workweek. The
document also recommended a number
of ancillary provisions for a standard,
such as exposure monitoring and
medical surveillance.
In December 1974, OSHA published
an Advanced Notice of Proposed
Rulemaking (ANPRM) based on the
recommendations in the NIOSH criteria
document (39 FR 44771, Dec. 27, 1974).
In the ANPRM, OSHA solicited ‘‘public
participation on the issues of whether a
new standard for crystalline silica
2 The Mineral Dusts tables that contain the silica
PELs for construction and shipyards do not clearly
express PELs for cristobalite and tridymite. 29 CFR
1926.55; 29 CFR 1915.1000. This lack of textual
clarity likely results from a transcription error in
the Code of Federal Regulations. OSHA’s current
proposal provides the same PEL for quartz,
cristobalite, and tridymite, in general industry,
construction, and shipyards.
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should be issued on the basis of the
[NIOSH] criteria or any other
information, and, if so, what should be
the contents of a proposed standard for
crystalline silica.’’ OSHA also set forth
the particular issues of concern on
which comments were requested. The
Agency did not pursue a final rule for
crystalline silica at that time.
As information developed during the
1980s and 1990s, national and
international classification
organizations came to recognize
crystalline silica as a human carcinogen.
In June 1986, the International Agency
for Research on Cancer (IARC) evaluated
the available evidence regarding
crystalline silica carcinogenicity and
concluded that it was ‘‘probably
carcinogenic to humans’’ (IARC, 1987).
An IARC working group met again in
October 1996 to evaluate the complete
body of research, including research
that had been conducted since the
initial 1986 evaluation. IARC concluded
that ‘‘crystalline silica inhaled in the
form of quartz or cristobalite from
occupational sources is carcinogenic to
humans’’ (IARC, 1997).
In 1991, in the Sixth Annual Report
on Carcinogens, the U.S. National
Toxicology Program (NTP) concluded
that respirable crystalline silica was
‘‘reasonably anticipated to be a human
carcinogen’’ (NTP, 1991). NTP
reevaluated the available evidence and
concluded, in the Ninth Report on
Carcinogens (NTP, 2000), that
‘‘respirable crystalline silica (RCS),
primarily quartz dust occurring in
industrial and occupational settings, is
known to be a human carcinogen, based
on sufficient evidence of carcinogenicity
from studies in humans indicating a
causal relationship between exposure to
RCS and increased lung cancer rates in
workers exposed to crystalline silica
dust’’ (NTP, 2000). ACGIH listed
respirable crystalline silica (in the form
of quartz) as a suspected human
carcinogen in 2000, while lowering the
TLV to 0.05 mg/m3 (ACGIH, 2001).
ACGIH subsequently lowered the TLV
for crystalline silica to 0.025 mg/m3 in
2006, which is the current value
(ACGIH, 2010).
In 1989, OSHA established 8-hour
TWA PELs of 0.1 for quartz and 0.05
mg/m3 for cristobalite and tridymite, as
part of the Air Contaminants final rule
for general industry (54 FR 2332, Jan.
19, 1989). OSHA stated that these limits
presented no substantial change from
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the Agency’s former formula limits, but
would simplify sampling procedures. In
providing comments on the proposed
rule, NIOSH recommended that
crystalline silica be considered a
potential carcinogen.
In 1992, OSHA, as part of the Air
Contaminants proposed rule for
maritime, construction, and agriculture,
proposed the same PELs as for general
industry, to make the PELs consistent
across all the OSHA-regulated sectors
(57 FR 26002, June 12, 1992). However,
on July 7 of the same year, the U.S.
Court of Appeals for the Eleventh
Circuit vacated the 1989 Air
Contaminants final rule for general
industry (Am. Fed’n of Labor and Cong.
of Indus. Orgs. v. OSHA, 965 F.2d 962
(1992)), which also mooted the
proposed rule for maritime,
construction, and agriculture. The
Court’s decision to vacate the rule
forced the Agency to return to the PELs
adopted in the 1970s.
In 1994, OSHA launched a process to
determine which safety and health
hazards in the U.S. needed most
attention. A priority planning
committee included safety and health
experts from OSHA, NIOSH, and the
Mine Safety and Health Administration
(MSHA). The committee reviewed
available information on occupational
deaths, injuries, and illnesses and held
an extensive dialogue with
representatives of labor, industry,
professional and academic
organizations, the States, voluntary
standards organizations, and the public.
The National Advisory Committee on
Occupational Safety and Health and the
Advisory Committee on Construction
Safety and Health also made
recommendations. Rulemaking for
crystalline silica exposure was one of
the priorities designated by this process.
OSHA indicated that crystalline silica
would be added to the Agency’s
regulatory agenda as other standards
were completed and resources became
available.
In August 1996, the Agency initiated
enforcement efforts under a Special
Emphasis Program (SEP) on crystalline
silica. The SEP was intended to reduce
worker silica dust exposures that can
cause silicosis. It included extensive
outreach as well as inspections. Among
the outreach materials available were
slides presenting information on hazard
recognition and crystalline silica control
technology, a video on crystalline silica
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and silicosis, and informational cards
for workers explaining crystalline silica,
health effects related to exposure, and
methods of control. The SEP provided
guidance for targeting inspections of
worksites with employees at risk of
developing silicosis.
As a follow-up to the SEP, OSHA
undertook numerous non-regulatory
actions to address silica exposures. For
example, in October of 1996, OSHA
launched a joint silicosis prevention
effort with MSHA, NIOSH, and the
American Lung Association (DOL,
1996). This public education campaign
involved distribution of materials on
how to prevent silicosis, including a
guide for working safely with silica and
stickers for hard hats to remind workers
of crystalline silica hazards. Spanish
language versions of these materials
were also made available. OSHA and
MSHA inspectors distributed materials
at mines, construction sites, and other
affected workplaces. The joint silicosis
prevention effort included a National
Conference to Eliminate Silicosis in
Washington, DC, in March of 1997,
which brought together approximately
650 participants from labor, business,
government, and the health and safety
professions to exchange ideas and share
solutions to reach the goal of
eliminating silicosis. The conference
highlighted the best methods of
eliminating silicosis and included
problem-solving workshops on how to
prevent the disease in specific
industries and job operations; plenary
sessions with senior government, labor,
and corporate officials; and
opportunities to meet with safety and
health professionals who had
implemented successful silicosis
prevention programs.
In 2003, OSHA examined
enforcement data for the years between
1997 and 2002 and identified high rates
of noncompliance with the OSHA
respirable crystalline silica PEL,
particularly in construction. This period
covers the first five years of the SEP.
These enforcement data, presented in
Table 1, indicate that 24 percent of
silica samples from the construction
industry and 13 percent from general
industry were at least three times the
OSHA PEL. The data indicate that 66
percent of the silica samples obtained
during inspections in general industry
were in compliance with the PEL, while
only 58 percent of the samples collected
in construction were in compliance.
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TABLE III–1—RESULTS OF TIME-WEIGHTED AVERAGE (TWA) EXPOSURE RESPIRABLE CRYSTALLINE SILICA SAMPLES FOR
CONSTRUCTION AND GENERAL INDUSTRY
[January 1, 1997–December 31, 2002]
Construction
Exposure (severity relative to the PEL)
Number of
samples
< 1 PEL ............................................................................................................
1 × PEL to < 2 × PEL ......................................................................................
2 × PEL to < 3 × PEL ......................................................................................
≥ 3 × PEL and higher (3+) ...............................................................................
Number of
samples
Percent
424
86
48
180
Total # of samples ....................................................................................
Other than construction
58
12
6
24
738
Percent
2226
469
215
453
66
14
6
13
3363
Source: OSHA Integrated Management Information System.
In an effort to expand the 1996 SEP,
on January 24, 2008, OSHA
implemented a National Emphasis
Program (NEP) to identify and reduce or
eliminate the health hazards associated
with occupational exposure to
crystalline silica (OSHA, 2008). The
NEP targeted worksites with elevated
exposures to crystalline silica and
included new program evaluation
procedures designed to ensure that the
goals of the NEP were measured as
accurately as possible, detailed
procedures for conducting inspections,
updated information for selecting sites
for inspection, development of outreach
programs by each Regional and Area
Office emphasizing the formation of
voluntary partnerships to share
information, and guidance on
calculating PELs in construction and
shipyards. In each OSHA Region, at
least two percent of inspections every
year are silica-related inspections.
Additionally, the silica-related
inspections are conducted at a range of
facilities reasonably representing the
distribution of general industry and
construction work sites in that region.
A recent analysis of OSHA
enforcement data from January 2003 to
December 2009 (covering the period of
continued implementation of the SEP
and the first two years of the NEP)
shows that considerable noncompliance
with the PEL continues to occur. These
enforcement data, presented in Table 2,
indicate that 14 percent of silica
samples from the construction industry
and 19 percent for general industry were
at least three times the OSHA PEL
during this period. The data indicate
that 70 percent of the silica samples
obtained during inspections in general
industry were in compliance with the
PEL, and 75 percent of the samples
collected in construction were in
compliance.
TABLE III–2—RESULTS OF TIME-WEIGHTED AVERAGE (TWA) EXPOSURE RESPIRABLE CRYSTALLINE SILICA SAMPLES FOR
CONSTRUCTION AND GENERAL INDUSTRY
[January 1, 2003–December 31, 2009]
Construction
Exposure (severity relative to the PEL)
Number of
samples
< 1 PEL ............................................................................................................
1 × PEL to < 2 × PEL ......................................................................................
2 × PEL to < 3 × PEL ......................................................................................
≥ 3 × PEL and higher (3+) ...............................................................................
Number of
samples
Percent
548
49
32
103
Total # of samples ....................................................................................
Other than construction
75
7
4
14
732
948
107
46
254
Percent
70
8
3
19
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Source: OSHA Integrated Management Information System.
Both industry and worker groups have
recognized that a comprehensive
standard is needed to protect workers
exposed to respirable crystalline silica.
For example, ASTM (originally known
as the American Society for Testing and
Materials) has published recommended
standards for addressing the hazards of
crystalline silica, and the Building and
Construction Trades Department, AFL–
CIO also has recommended a
comprehensive program standard. These
recommended standards include
provisions for methods of compliance,
exposure monitoring, training, and
medical surveillance. The National
Industrial Sand Association has also
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developed exposure assessment,
medical surveillance, and training
guidance products.
In 1997, OSHA announced in its
Unified Agenda under Long-Term
Actions that it planned to publish a
proposed rule on crystalline silica
‘‘because the agency has concluded that
there will be no significant progress in
the prevention of silica-related diseases
without the adoption of a full and
comprehensive silica standard,
including provisions for product
substitution, engineering controls,
training and education, respiratory
protection and medical screening and
surveillance. A full standard will
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improve worker protection, ensure
adequate prevention programs, and
further reduce silica-related diseases.’’
(62 FR 57755, 57758, Oct. 29, 1997). In
November 1998, OSHA moved
‘‘Occupational Exposure to Crystalline
Silica’’ to the pre-rule stage in the
Regulatory Plan (63 FR 61284, 61303–
304, Nov. 9, 1998). OSHA held a series
of stakeholder meetings in 1999 and
2000 to get input on the rulemaking.
Stakeholder meetings for all industry
sectors were held in Washington,
Chicago, and San Francisco. A separate
stakeholder meeting for the construction
sector was held in Atlanta.
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OSHA initiated Small Business
Regulatory Enforcement Fairness Act
(SBREFA) proceedings in 2003, seeking
the advice of small business
representatives on the proposed rule (68
FR 30583, 30584, May 27, 2003). The
SBREFA panel, including
representatives from OSHA, the Small
Business Administration (SBA), and the
Office of Management and Budget
(OMB), was convened on October 20,
2003. The panel conferred with small
entity representatives (SERs) from
general industry, maritime, and
construction on November 10 and 12,
2003, and delivered its final report,
which included comments from the
SERs and recommendations to OSHA
for the proposed rule, to OSHA’s
Assistant Secretary on December 19,
2003 (OSHA, 2003).
Throughout the crystalline silica
rulemaking process, OSHA has
presented information to, and has
consulted with, the Advisory Committee
on Construction Safety and Health
(ACCSH) and the Maritime Advisory
Committee on Occupational Safety and
Health (MACOSH). In December of
2009, OSHA representatives met with
ACCSH to discuss the rulemaking and
receive their comments and
recommendations. On December 11,
ACCSH passed motions supporting the
concept of Table 1 in the draft proposed
construction rule and recognizing that
the controls listed in Table 1 are
effective. (As discussed with regard to
paragraph (f) of the proposed rule, Table
1 presents specified control measures
for selected construction operations.)
ACCSH also recommended that OSHA
maintain the protective clothing
provision found in the SBREFA panel
draft regulatory text and restore the
‘‘competent person’’ requirement and
responsibilities to the proposed rule.
Additionally, the group recommended
that OSHA move forward expeditiously
with the rulemaking process.
In January 2010, OSHA completed a
peer review of the draft Health Effects
analysis and Preliminary Quantitative
Risk Assessment following procedures
set forth by OMB in the Final
Information Quality Bulletin for Peer
Review, published on the OMB Web site
on December 16, 2004 (see 70 FR 2664,
Jan. 14, 2005). Each peer reviewer
submitted a written report to OSHA.
The Agency revised its draft documents
as appropriate and made the revised
documents available to the public as
part of this Notice of Proposed
Rulemaking. OSHA also made the
written charge to the peer reviewers, the
peer reviewers’ names, the peer
reviewers’ reports, and the Agency’s
response to the peer reviewers’ reports
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publicly available with publication of
this proposed rule. OSHA will schedule
time during the informal rulemaking
hearing for participants to testify on the
Health Effects analysis and Preliminary
Quantitative Risk Assessment in the
presence of peer reviewers and will
request the peer reviewers to submit any
amended final comments they may wish
to add to the record. The Agency will
consider amended final comments
received from the peer reviewers during
development of a final rule and will
make them publicly available as part of
the silica rulemaking record.
IV. Chemical Properties and Industrial
Uses
Silica is a compound composed of the
elements silicon and oxygen (chemical
formula SiO2). Silica has a molecular
weight of 60.08, and exists in crystalline
and amorphous states, both in the
natural environment and as produced
during manufacturing or other
processes. These substances are odorless
solids, have no vapor pressure, and
create non-explosive dusts when
particles are suspended in air (IARC,
1997).
Silica is classified as part of the
‘‘silicate’’ class of minerals, which
includes compounds that are composed
of silicon and oxygen and which may
also be bonded to metal ions or their
oxides (Hurlbut, 1966). The basic
structural units of silicates are silicon
tetrahedrons (SiO4), pyramidal
structures with four triangular sides
where a silicon atom is located in the
center of the structure and an oxygen
atom is located at each of the four
corners. When silica tetrahedrons bond
exclusively with other silica
tetrahedrons, each oxygen atom is
bonded to the silicon atom of its original
ion, as well as to the silicon atom from
another silica ion. This results in a ratio
of one atom of silicon to two atoms of
oxygen, expressed as SiO2. The siliconoxygen bonds within the tetrahedrons
use only one-half of each oxygen’s total
bonding energy. This leaves negatively
charged oxygen ions available to bond
with available positively charged ions.
When they bond with metal and metal
oxides, commonly of iron, magnesium,
aluminum, sodium, potassium, and
calcium, they form the silicate minerals
commonly found in nature (Bureau of
Mines, 1992).
In crystalline silica, the silicon and
oxygen atoms are arranged in a threedimensional repeating pattern. Silica is
said to be polymorphic, as different
forms are created when the silica
tetrahedrons combine in different
crystalline structures. The primary
forms of crystalline silica are quartz,
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cristobalite, and tridymite. In an
amorphous state, silicon and oxygen
atoms are present in the same
proportions but are not organized in a
repeating pattern. Amorphous silica
includes natural and manufactured
glasses (vitreous and fused silica, quartz
glass), biogenic silica, and opals which
are amorphous silica hydrates (IARC,
1997).
Quartz is the most common form of
crystalline silica and accounts for
almost 12% by volume of the earth’s
crust. Alpha quartz, the quartz form that
is stable below 573 °C, is the most
prevalent form of crystalline silica
found in the workplace. It accounts for
the overwhelming majority of naturally
found silica and is present in varying
amounts in almost every type of
mineral. Alpha quartz is found in
igneous, sedimentary, and metamorphic
rock, and all soils contain at least a trace
amount of quartz (Bureau of Mines,
1992). Alpha quartz is used in many
products throughout various industries
and is a common component of building
materials (Madsen et al., 1995).
Common trade names for commercially
available quartz include: CSQZ, DQ 12,
Min-U-Sil, Sil-Co-Sil, Snowit, Sykron
F300, and Sykron F600 (IARC, 1997).
Cristobalite is a form of crystalline
silica that is formed at high
temperatures (>1470 °C). Although
naturally occurring cristobalite is
relatively rare, volcanic eruptions, such
as Mount St. Helens, can release
cristobalite dust into the air. Cristobalite
can also be created during some
processes conducted in the workplace.
For example, flux-calcined
diatomaceous earth is a material used as
a filtering aid and as a filler in other
products (IARC, 1997). It is produced
when diatomaceous earth (diatomite), a
geological product of decayed
unicellular organisms called diatoms, is
heated with flux. The finished product
can contain between 40 and 60 percent
cristobalite. Also, high temperature
furnaces are often lined with bricks that
contain quartz. When subjected to
prolonged high temperatures, this
quartz can convert to cristobalite.
Tridymite is another material formed
at high temperatures (>870 °C) that is
associated with volcanic activity. The
creation of tridymite requires the
presence of a flux such as sodium oxide.
Tridymite is rarely found in nature and
rarely reported in the workplace (Smith,
1998).
When heated or cooled sufficiently,
crystalline silica can transition between
the polymorphic forms, with specific
transitions occurring at different
temperatures. At higher temperatures
the linkages between the silica
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tetrahedrons break and reform, resulting
in new crystalline structures. Quartz
converts to cristobalite at 1470 °C, and
at 1723 °C cristobalite loses its
crystalline structure and becomes
amorphous fused silica. These high
temperature transitions reverse
themselves at extremely slow rates, with
different forms co-existing for a long
time after the crystal cools.
Other types of transitions occur at
lower temperatures when the silicaoxygen bonds in the silica tetrahedron
rotate or stretch, resulting in a new
crystalline structure. These lowtemperature, or alpha to beta, transitions
are readily and rapidly reversed as the
crystal cools. At temperatures
encountered by workers, only the alpha
form of crystalline silica exists (IARC,
1997).
Crystalline silica minerals produce
distinct X-ray diffraction patterns,
specific to their crystalline structure.
The patterns can be used to distinguish
the crystalline polymorphs from each
other and from amorphous silica (IARC,
1997).
The specific gravity and melting point
of silica vary between polymorphs.
Silica is insoluble in water at 20 °C and
in most acids, but its solubility
increases with higher temperatures and
pH, and it dissolves readily in
hydrofluoric acid. Solubility is also
affected by the presence of trace metals
and by particle size. Under humid
conditions water vapor in the air reacts
with the surface of silica particles to
form an external layer of silinols (SiOH).
When these silinols are present the
crystalline silica becomes more
hydrophilic. Heating or acid washing
reduces the amount of silinols on the
surface area of crystalline silica
particles. There is an external
amorphous layer found in aged quartz,
called the Beilby layer, which is not
found on freshly cut quartz. This
amorphous layer is more water soluble
than the underlying crystalline core.
Etching with hydrofluoric acid removes
the Beilby layer as well as the principal
metal impurities on quartz.
Crystalline silica has limited chemical
reactivity. It reacts with alkaline
aqueous solutions, but does not readily
react with most acids, with the
exception of hydrofluoric acid. In
contrast, amorphous silica and most
silicates react with most mineral acids
and alkaline solutions. Analytical
chemists relied on this difference in
acid reactivity to develop the silica
point count analytical method that was
widely used prior to the current X-ray
diffraction and infrared methods
(Madsen et al., 1995).
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Crystalline silica is used in industry
in a wide variety of applications. Sand
and gravel are used in road building and
concrete construction. Sand with greater
than 98% silica is used in the
manufacture of glass and ceramics.
Silica sand is used to form molds for
metal castings in foundries, and in
abrasive blasting operations. Silica is
also used as a filler in plastics, rubber,
and paint, and as an abrasive in soaps
and scouring cleansers. Silica sand is
used to filter impurities from municipal
water and sewage treatment plants, and
in hydraulic fracturing for oil and gas
recovery. Silica is also used to
manufacture artificial stone products
used as bathroom and kitchen
countertops, and the silica content in
those products can exceed 93 percent
(Kramer et al., 2012).
There are over thirty major industries
and operations where exposures to
crystalline silica can occur. They
include such diverse workplaces as
foundries, dental laboratories, concrete
products and paint and coating
manufacture, as well as construction
activities including masonry cutting,
grinding and tuckpointing, operating
heavy equipment, and road work. A
more detailed discussion of the
industries affected by the proposed
standard is presented in Section VIII of
this preamble. Crystalline silica
exposures can also occur in mining, and
in agriculture during plowing and
harvesting.
V. Health Effects Summary
This section presents a summary of
OSHA’s review of the health effects
literature for respirable crystalline
silica. OSHA’s full analysis is contained
in Section I of the background
document entitled ‘‘Respirable
Crystalline Silica—Health Effects
Literature Review and Preliminary
Quantitative Risk Assessment,’’ which
has been placed in rulemaking docket
OSHA–2010–0034. OSHA’s review of
the literature on the adverse effects
associated with exposure to crystalline
silica covers the following topics:
(1) Silicosis (including relevant data
from U.S. disease surveillance efforts);
(2) Lung cancer and cancer at other
sites;
(3) Non-malignant respiratory disease
(other than silicosis);
(4) Renal and autoimmune effects;
and
(5) Physical factors affecting the
toxicity of crystalline silica.
The purpose of the Agency’s scientific
review is to present OSHA’s preliminary
findings on the nature of the hazards
presented by exposure to respirable
crystalline silica, and to present an
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adequate basis for the quantitative risk
assessment section to follow. OSHA’s
review reflects the relevant literature
identified by the Agency through
previously published reviews, literature
searches, and contact with outside
experts. Most of the evidence that
describes the health risks associated
with exposure to silica consists of
epidemiological studies of worker
populations; in addition, animal and in
vitro studies on mode of action and
molecular toxicology are also described.
OSHA’s review of the silicosis literature
focused on a few particular issues, such
as the factors that affect progression of
the disease and the relationship
between the appearance of radiological
abnormalities indicative of silicosis and
pulmonary function decline. Exposure
to respirable crystalline silica is the only
known cause of silicosis and there are
literally thousands of research papers
and case studies describing silicosis
among working populations. OSHA did
not review every one of these studies,
because many of them do not relate to
the issues that are of interest to OSHA.
OSHA’s health effects literature
review addresses exposure only to
airborne respirable crystalline silica
since there is no evidence that dermal
or oral exposure presents a hazard to
workers. This review is also confined to
issues related to inhalation of respirable
dust, which is generally defined as
particles that are capable of reaching the
gas-exchange region of the lung (i.e.,
particles less than 10 mm in
aerodynamic diameter). The available
studies include populations exposed to
quartz or cristobalite, the two forms of
crystalline silica most often encountered
in the workplace. OSHA was unable to
identify any relevant epidemiological
literature concerning a third polymorph,
tridymite, which is also currently
regulated by OSHA and included in the
scope of OSHA’s proposed crystalline
silica standard.
OSHA’s approach in this review is
based on a weight-of-evidence
approach, in which studies (both
positive and negative) are evaluated for
their overall quality, and causal
inferences are drawn based on a
determination of whether there is
substantial evidence that exposure
increases the risk of a particular effect.
Factors considered in assessing the
quality of studies include size of the
cohort studied and power of the study
to detect a sufficiently low level of
disease risk; duration of follow-up of the
study population; potential for study
bias (such as selection bias in casecontrol studies or survivor effects in
cross-sectional studies); and adequacy
of underlying exposure information for
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examining exposure-response
relationships. Studies were deemed
suitable for inclusion in OSHA’s
Preliminary Quantitative Risk
Assessment where there was adequate
quantitative information on exposure
and disease risks and the study was
judged to be sufficiently high quality
according to the criteria described
above. The Preliminary Quantitative
Risk Assessment is included in Section
II of the background document and is
summarized in Section VI of this
preamble.
A draft health effects review
document was submitted for external
scientific peer review in accordance
with the Office of Management and
Budget’s ‘‘Final Information Quality
Bulletin for Peer Review’’ (OMB, 2004).
A summary of OSHA’s responses to the
peer reviewers’ comments appears in
Section III of the background document.
Since the draft health effects review
document was submitted for external
scientific peer review, new studies or
reviews examining possible associations
between occupational exposure to
respirable crystalline silica and lung
cancer have been published. OSHA’s
analysis of that new information is
presented in a supplemental literature
review and is available in the docket
(OSHA, 2013).
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A. Silicosis and Disease Progression
1. Pathology and Diagnosis
Silicosis is a progressive disease in
which accumulation of respirable
crystalline silica particles causes an
inflammatory reaction in the lung,
leading to lung damage and scarring,
and, in some cases, progresses to
complications resulting in disability and
death. Three types of silicosis have been
described: an acute form following
intense exposure to respirable dust of
high crystalline silica content for a
relatively short period (i.e., a few
months or years); an accelerated form,
resulting from about 5 to 15 years of
heavy exposure to respirable dusts of
high crystalline silica content; and, most
commonly, a chronic form that typically
follows less intense exposure of usually
more than 20 years (Becklake, 1994;
Balaan and Banks, 1992). In both the
accelerated and chronic form of the
disease, lung inflammation leads to the
formation of excess connective tissue, or
fibrosis, in the lung. The hallmark of the
chronic form of silicosis is the silicotic
islet or nodule, one of the few agentspecific lesions in pathology (Balaan
and Banks, 1992). As the disease
progresses, these nodules, or fibrotic
lesions, increase in density and can
develop into large fibrotic masses,
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resulting in progressive massive fibrosis
(PMF). Once established, the fibrotic
process of chronic silicosis is thought to
be irreversible (Becklake, 1994), and
there is no specific treatment for
silicosis (Davis, 1996; Banks, 2005).
Unlike chronic silicosis, the acute form
of the disease almost certainly arises
from exposures well in excess of current
OSHA standards and presents a
different pathological picture, one of
pulmonary alveolar proteinosis.
Chronic silicosis is the most
frequently observed type of silicosis in
the U.S. today. Affected workers may
have a dry chronic cough, sputum
production, shortness of breath, and
reduced pulmonary function. These
symptoms result from airway restriction
and/or obstruction caused by the
development of fibrotic scarring in the
alveolar sacs and lower region of the
lung. The scarring can be detected by
chest x-ray or computerized tomography
(CT) when the lesions become large
enough to appear as visible opacities.
The result is restriction of lung volumes
and decreased pulmonary compliance
with concomitant reduced gas transfer
(Balaan and Banks, 1992). Early stages
of chronic silicosis can be referred to as
either simple or nodular silicosis; later
stages are referred to as either
pulmonary massive fibrosis (PMF),
complicated, or advanced silicosis.
The clinical diagnosis of silicosis has
three requisites (Balaan and Banks,
1992; Banks, 2005). The first is the
recognition by the physician that
exposure to crystalline silica adequate
to cause this disease has occurred. The
second is the presence of chest
radiographic abnormalities consistent
with silicosis. The third is the absence
of other illnesses that could resemble
silicosis on chest radiograph, e.g.,
pulmonary fungal infection or miliary
tuberculosis. To describe the presence
and severity of silicosis from chest x-ray
films or digital radiographic images, a
standardized system exists to classify
the opacities seen on chest radiographs
(the International Labor Organization
(ILO) International Classification of
Radiographs of the Pneumoconioses
(ILO, 1980, 2002, 2011; Merchant and
Schwartz, 1998; NIOSH, 2011). This
system standardizes the description of
chest x-ray films or digital radiographic
images with respect to the size, shape,
and density of opacities, which together
indicate the severity and extent of lung
involvement. The density of opacities
seen on chest x-ray films or digital
radiographic images is classified on a 4point major category scale (0, 1, 2, or 3),
with each major category divided into
three subcategories, giving a 12-point
scale between 0/0 and 3/+. (For each
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subcategory, the top number indicates
the major category that the profusion
most closely resembles, and the bottom
number indicates the major category
that was given secondary
consideration.) Major category 0
indicates the absence of visible opacities
and categories 1 to 3 reflect increasing
profusion of opacities and a
concomitant increase in severity of
disease. Biopsy is not necessary to make
a diagnosis and a diagnosis does not
require that chest x-ray films or digital
radiographic images be rated using the
ILO system (NIOSH, 2002). In addition,
an assessment of pulmonary function,
though not itself necessary to confirm a
diagnosis of silicosis, is important to
evaluate whether the individual has
impaired lung function.
Although chest x-ray is typically used
to examine workers exposed to
respirable crystalline silica for the
presence of silicosis, it is a fairly
insensitive tool for detecting lung
fibrosis (Hnizdo et al., 1993; Craighead
and Vallyathan, 1980; Rosenman et al.,
1997). To address the low sensitivity of
chest x-rays for detecting silicosis,
Hnizdo et al. (1993) recommended that
radiographs consistent with an ILO
category of 0/1 or greater be considered
indicative of silicosis among workers
exposed to a high concentration of
silica-containing dust. In like manner, to
maintain high specificity, chest x-rays
classified as category 1/0 or 1/1 should
be considered as a positive diagnosis of
silicosis.
Newer imaging technologies with
both research and clinical applications
include computed tomography, and
high resolution tomography. Highresolution computed tomography
(HRCT) uses thinner image slices and a
different reconstruction algorithm to
improve spatial resolution over CT.
Recent studies of high-resolution
computerized tomography (HRCT) have
found HRCT to be superior to chest xray imaging for detecting small opacities
and for identifying PMF (Sun et al.,
2008; Lopes et al., 2008; Blum et al.,
2008).
The causal relationship between
exposure to crystalline silica and
silicosis has long been accepted in the
scientific and medical communities. Of
greater interest to OSHA is the
quantitative relationship between
exposure to crystalline silica and
development of silicosis. A large
number of cross-sectional and
retrospective studies have been
conducted to evaluate this relationship
(Kreiss and Zhen, 1996; Love et al.,
1999; Ng and Chan, 1994; Rosenman et
al., 1996; Hughes et al., 1998; Muir et
al., 1989a, 1989b; Park et al., 2002; Chen
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et al., 2001; Hnizdo and Sluis-Cremer,
1993; Miller et al., 1998; Buchanan et
al., 2003; Steenland and Brown, 1995b).
In general, these studies, particularly
those that included retirees, have found
a risk of radiological silicosis (usually
defined as x-ray films classified ILO
major category 1 or greater) among
workers exposed near the range of
cumulative exposure permitted by
current exposure limits. These studies
are presented in detail in OSHA’s
Preliminary Quantitative Risk
Assessment (Section II of the
background document and summarized
in Section VI of this preamble).
2. Silicosis in the United States
Unlike most occupational diseases,
surveillance statistics are available that
provide information on the prevalence
of silicosis mortality and morbidity in
the U.S. The most comprehensive and
current source of surveillance data in
the U.S. related to occupational lung
diseases, including silicosis, is the
National Institute for Occupational
Safety and Health (NIOSH) WorkRelated Lung Disease (WoRLD)
Surveillance System; the WoRLD
Surveillance Report is compiled from
the most recent data from the WoRLD
System (NIOSH, 2008c). National
statistics on mortality associated with
occupational lung diseases are also
compiled in the National Occupational
Respiratory Mortality System (NORMS,
available on the Internet at http://
webappa.cdc.gov/ords/norms.html), a
searchable database administered by
NIOSH. In addition, NIOSH published a
recent review of mortality statistics in
its MMWR Report Silicosis Mortality,
Prevention, and Control—United States,
1968–2002 (CDC, 2005). For each of
these sources, data are compiled from
death certificates reported to state vital
statistics offices, which are collected by
the National Center for Health Statistics
(NCHS). Data on silicosis morbidity are
available from only a few states that
administer occupational disease
surveillance systems, and from data on
hospital discharges. OSHA believes that
the mortality and morbidity statistics
compiled in these sources and
summarized below indicate that
silicosis remains a significant
occupational health problem in the U.S.
today.
From 1968 to 2002, silicosis was
recorded as an underlying or
contributing cause of death on 16,305
death certificates; of these, a total of
15,944 (98 percent) deaths occurred in
males (CDC, 2005). From 1968 to 2002,
the number of silicosis deaths decreased
from 1,157 (8.91 per million persons
aged ≥15 years) to 148 (0.66 per
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million), corresponding to a 93-percent
decline in the overall mortality rate. In
its most recent WoRLD Report (NIOSH,
2008c), NIOSH reported that the number
of silicosis deaths in 2003, 2004, and
2005 were 179, 166, and 161,
respectively, slightly higher than that
reported in 2002. The number of
silicosis deaths identified each year has
remained fairly constant since the late
1990’s.
NIOSH cited two main factors that
were likely responsible for the declining
trend in silicosis mortality since 1968.
First, many of the deaths in the early
part of the study period occurred among
persons whose main exposure to
crystalline silica dust probably occurred
before introduction of national
standards for silica dust exposure
established by OSHA and the Mine
Safety and Health Administration
(MSHA) (i.e., permissible exposure
limits (PELs)) that likely led to reduced
silica dust exposure. Second, there has
been declining employment in heavy
industries (e.g., foundries) where silica
exposure was prevalent (CDC, 2005).
Although the factors described by
NIOSH are reasonable explanations for
the steep reduction in silicosis-related
mortality, it should be emphasized that
the surveillance data are insufficient for
the analysis of residual risk associated
with current occupational exposure
limits for crystalline silica. Analyses
designed to explore this question must
make use of appropriate exposureresponse data, as is presented in
OSHA’s Preliminary Quantitative Risk
Assessment (summarized in Section VI
of this preamble).
Although the number of deaths from
silicosis overall has declined since
1968, the number of silicosis-associated
deaths reported among persons aged 15
to 44 had not declined substantially
prior to 1995 (CDC 1998).
Unfortunately, it is not known to what
extent these deaths among younger
workers were caused by acute or
accelerated forms of silicosis.
Silicosis deaths among workers of all
ages result in significant premature
mortality; between 1996 and 2005, a
total of 1,746 deaths resulted in a total
of 20,234 years of life lost from life
expectancy, with an average of 11.6
years of life lost. For the same period,
among 307 decedents who died before
age 65, or the end of a working life,
there were 3,045 years of life lost to age
65, with an average of 9.9 years of life
lost from a working life (NIOSH, 2008c).
Data on the prevalence of silicosis
morbidity are available from only three
states (Michigan, Ohio, and New Jersey)
that have administered disease
surveillance programs over the past
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several years. These programs rely
primarily on hospital discharge records,
reporting of cases from the medical
community, workers’ compensation
programs, and death certificate data. For
the reporting period 1993–2002, the last
year for which data are available, three
states (Michigan, New Jersey and Ohio)
recorded 879 cases of silicosis (NIOSH
2008c). Hospital discharge records
represent the primary ascertainment
source for all three states. It should be
noted that hospital discharge records
most likely include cases of acute
silicosis or very advance chronic
silicosis since it is unlikely that there
would be a need for hospitalization in
cases with early radiographic signs of
silicosis, such as for an ILO category
1/0 x-ray. Nationwide hospital
discharge data compiled by NIOSH
(2008c) and the Council of State and
Territorial Epidemiologists (CSTE, 2005)
indicates that there are at least 1,000
hospitalizations each year due to
silicosis.
Data on silicosis mortality and
morbidity are likely to understate the
true impact of exposure of U.S. workers
to crystalline silica. This is in part due
to underreporting that is characteristic
of passive case-based disease
surveillance systems that rely on the
health care community to generate
records (Froines et al., 1989). Health
care professionals play the main role in
such surveillance by virtue of their
unique role in recognizing and
diagnosing diseases, but most health
care professionals do not take
occupational histories (Goldman and
Peters, 1981; Rutstein et al., 1983). In
addition to the lack of information about
exposure histories, difficulty in
recognizing occupational illnesses that
have long latency periods, like silicosis,
contributes to under-recognition and
underreporting by health care providers.
Based on an analysis of data from
Michigan’s silicosis surveillance
activities, Rosenman et al. (2003)
estimated that the true incidence of
silicosis mortality and morbidity were
understated by a factor of between 2.5
and 5, and that there were estimated to
be from 3,600 to 7,300 new cases of
silicosis occurring in the U.S. annually
between 1987 and 1996. Taken with the
surveillance data presented above,
OSHA believes that exposure to
crystalline silica remains a cause of
significant mortality and morbidity in
the U.S.
3. Progression of Silicosis and Its
Associated Impairment
As described above, silicosis is a
progressive lung disease that is usually
first detected by the appearance of a
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diffuse nodular fibrosis on chest x-ray
films. To evaluate the clinical
significance of radiographic signs of
silicosis, OSHA reviewed several
studies that have examined how
exposure affects progression of the
disease (as seen by chest radiography) as
well as the relationship between
radiologic findings and pulmonary
function. The following summarizes
OSHA’s preliminary findings from this
review.
Of the several studies reviewed by
OSHA that documented silicosis
progression in populations of workers,
four studies (Hughes et al., 1982; Hessel
et al., 1988; Miller et al., 1998; Ng et al.,
1987a) included quantitative exposure
data that were based on either current
or historical measurements of respirable
quartz. The exposure variable most
strongly associated in these studies with
progression of silicosis was cumulative
respirable quartz (or silica) exposure
(Hessel et al., 1988; Hughes et al., 1982;
Miller et al., 1998; Ng et al., 1987a),
though both average concentration of
respirable silica (Hughes et al., 1982; Ng
et al., 1987a) and duration of
employment in dusty jobs have also
been found to be associated with the
progression of silicosis (Hughes et al.,
1982; Ogawa et al., 2003).
The study reflecting average
exposures most similar to current
exposure conditions is that of Miller et
al. (1998), which followed a group of
547 British coal miners in 1990–1991 to
evaluate chest x-ray changes that had
occurred after the mines closed in 1981.
This study had data available from chest
x-rays taken during health surveys
conducted between 1954 and 1978, as
well as data from extensive exposure
monitoring conducted between 1964
and 1978. The mean and maximum
cumulative exposure reported in the
study correspond to average
concentrations of 0.12 and 0.55 mg/m3,
respectively, over the 15-year sampling
period. However, between 1971 and
1976, workers experienced unusually
high concentrations of respirable quartz
in one of the two coal seams in which
the miners worked. For some
occupations, quarterly mean quartz
concentrations ranged from 1 to 3 mg/
m3, and for a brief period,
concentrations exceeded 10 mg/m3 for
one job. Some of these high exposures
likely contributed to the extent of
disease progression seen in these
workers; in its Preliminary Quantitative
Risk Assessment, OSHA reviewed a
study by Buchanan et al. (2003), who
found that short-term exposures to high
(>2 mg/m3) concentrations of silica can
increase the silicosis risk by 3-fold over
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what would be predicted by cumulative
exposure alone (see Section VI).
Among the 504 workers whose last
chest x-ray was classified as ILO 0/0 or
0/1, 20 percent had experienced onset of
silicosis (i.e., chest x-ray was classified
as ILO 1/0 by the time of follow up in
1990–1991), and 4.8 percent progressed
to at least category 2. However, there are
no data available to continue following
the progression of this group because
there have been no follow-up surveys of
this cohort since 1991.
In three other studies examining the
progression of silicosis, (Hessel et al.,
1988; Hughes et al., 1982; Ng et al.,
1987a) cohorts were comprised of
silicotics (individuals already diagnosed
with silicosis) that were followed
further to evaluate disease progression.
These studies reflect exposures of
workers to generally higher average
concentrations of respirable quartz than
are permitted by OSHA’s current
exposure limit. Some general findings
from this body of literature follow. First,
size of opacities on initial radiograph is
a determinant for further progression.
Individuals with large opacities on
initial chest radiograph have a higher
probability of further disease
progression than those with small
opacities (Hughes et al., 1982; Lee, et al.,
2001; Ogawa et al., 2003). Second,
although silicotics who continue to be
exposed are more likely to progress than
silicotics who are not exposed (Hessel et
al., 1988), once silicosis has been
detected there remains a likelihood of
progression in the absence of additional
exposure to silica (Hessel et al., 1988;
Miller et al., 1998; Ogawa, et al., 2003;
Yang et al., 2006). There is some
evidence in the literature that the
probability of progression is likely to
decline over time following the end of
the exposure, although this observation
may also reflect a survivor effect
(Hughes et al., 1982; Lee et al., 2001). In
addition, of borderline statistical
significance was the association of
tuberculosis with increased likelihood
of silicosis progression (Lee et al., 2001).
Of the four studies reviewed by OSHA
that provided quantitative exposure
information, two studies (Miller et al.,
1998; Ng et al., 1987a) provide the
information most relevant to current
exposure conditions. The range of
average concentration of respirable
crystalline silica to which workers were
exposed in these studies (0.12 to 0.48
mg/m3, respectively) is relatively
narrow and is of particular interest to
OSHA because current enforcement data
indicate that exposures in this range or
not much lower are common today,
especially in construction and
foundries, and sandblasting operations.
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These studies reported the percentage of
workers whose chest x-rays show signs
of progression at the time of follow-up;
the annual rate at which workers
showed disease progression were
similar, 2 percent and 6 percent,
respectively.
Several cross-sectional and
longitudinal studies have examined the
relationship between progressive
changes observed on radiographs and
corresponding declines in lung-function
parameters. In general, the results are
mixed: some studies have found that
pulmonary function losses correlate
with the extent of fibrosis seen on chest
x-ray films, and others have not found
such correlations. The lack of a
correlation in some studies between
degree of fibrotic profusion seen on
chest x-rays and pulmonary function
have led some to suggest that
pulmonary function loss is an
independent effect of exposure to
respirable crystalline silica, or may be a
consequence of emphysematous
changes that have been seen in
conjunction with radiographic silicosis.
Among studies that have reported
finding a relationship between
pulmonary function and x-ray
abnormalities, Ng and Chan (1992)
found that forced expiratory volume
(FEV1) and forced vital capacity (FVC)
were statistically significantly lower for
workers whose x-ray films were
classified as ILO profusion categories 2
and 3, but not among workers with ILO
category 1 profusion compared to those
with a profusion score of 0/0. As
expected, highly significant reductions
in FEV1, FVC, and FEV1/FVC were
noted in subjects with large opacities.
The authors concluded that chronic
simple silicosis, except that classified as
profusion category 1, is associated with
significant lung function impairment
attributable to fibrotic disease.
Similarly, Moore et al. (1988) also
found chronic silicosis to be associated
with significant lung function loss,
especially among workers with chest xrays classified as ILO profusion
categories 2 and 3. For those classified
as category 1, lung function was not
´
diminished. Begin et al. (1988) also
found a correlation between decreased
lung function (FVC and the ratio of
FEV1/FVC) and increased profusion and
coalescence of opacities as determined
by CT scan. This study demonstrated
increased impairment among workers
with higher imaging categories (3 and
4), as expected, but also impairment
(significantly reduced expiratory flow
rates) among persons with more
moderate pulmonary fibrosis (group 2).
In a population of gold miners, Cowie
(1998) found that lung function
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declined more rapidly in men with
silicosis than those without. In addition
to the 24 ml./yr. decrements expected
due to aging, this study found an
additional loss of 8 ml. of FEV1 per year
would be expected from continued
exposure to dust in the mines. An
earlier cross-sectional study by these
authors (Cowie and Mabena, 1991),
which examined 1,197 black
underground gold miners who had
silicosis, found that silicosis (analyzed
as a continuous variable based on chest
x-ray film classification) was associated
with reductions in FVC, FEV1, FEV1/
FVC, and carbon monoxide diffusing
capacity (DLco), and these relationships
persisted after controlling for duration
and intensity of exposure and smoking.
In contrast to these studies, other
investigators have reported finding
pulmonary function decrements in
exposed workers independent of
radiological evidence of silicosis.
Hughes et al. (1982) studied a
representative sample of 83 silicotic
sandblasters, 61 of whom were followed
for one to seven years. A multiple
regression analysis showed that the
annual reductions in FVC, FEV1 and
DLco were related to average silica
concentrations but not duration of
exposure, smoking, stage of silicosis, or
time from initial exposure. Ng et al.
(1987b) found that, among male
gemstone workers in Hong Kong with xrays classified as either Category 0 or 1,
declines in FEV1 and FVC were not
associated with radiographic category of
silicosis after adjustment for years of
employment. The authors concluded
that there was an independent effect of
respirable dust exposure on pulmonary
function. In a population of 61 gold
miners, Wiles et al. (1992) also found
that radiographic silicosis was not
associated with lung function
decrements. In a re-analysis and followup of an earlier study, Hnizdo (1992)
found that silicosis was not a significant
predictor of lung function, except for
FEV1 for non-smokers.
Wang et al. (1997) observed that
silica-exposed workers (both
nonsmokers and smokers), even those
without radiographic evidence of
silicosis, had decreased spirometric
parameters and diffusing capacity
(DLco). Pulmonary function was further
decreased in the presence of silicosis,
even those with mild to moderate
disease (ILO categories 1 and 2). The
authors concluded that functional
abnormalities precede radiographic
changes of silicosis.
A number of studies were conducted
to examine the role of emphysematous
changes in the presence of silicosis in
reducing lung function; these have been
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reviewed by Gamble et al. (2004), who
concluded that there is little evidence
that silicosis is related to development
of emphysema in the absence of PMF.
In addition, Gamble et al. (2004) found
that, in general, studies found that the
lung function of those with radiographic
silicosis in ILO category 1 was
indistinguishable from those in category
0, and that those in category 2 had small
reductions in lung function relative to
those with category 0 and little
difference in the prevalence of
emphysema. There were slightly greater
decrements in lung function with
category 3 and more significant
reductions with progressive massive
fibrosis. In studies for which
information was available on both
silicosis and emphysema, reduced lung
function was more strongly related to
emphysema than to silicosis.
In conclusion, many studies reported
finding an association between
pulmonary function decrements and
ILO category 2 or 3 background
profusion of small opacities; this
appears to be consistent with the
histopathological view, in which
individual fibrotic nodules
conglomerate to form a massive fibrosis
(Ng and Chan, 1992). Emphysema may
also play a role in reducing lung
function in workers with higher grades
of silicosis. Pulmonary function
decrements have not been reported in
some studies among workers with
silicosis scored as ILO category 1.
However, a number of other studies
have documented declines in
pulmonary function in persons exposed
to silica and whose radiograph readings
are in the major ILO category 1 (i.e. 1/
0, 1/1, 1/2), or even before changes were
´
seen on chest x-ray (Begin et al., 1988;
Cowie, 1998; Cowie and Mabena, 1991;
Ng et al., 1987a; Wang et al., 1997). It
may also be that studies designed to
relate x-ray findings with pulmonary
function declines are further
confounded by pulmonary function
declines caused by chronic obstructive
pulmonary disease (COPD) seen among
silica-exposed workers absent
radiological silicosis, as has been seen
in many investigations of COPD.
OSHA’s review of the literature on
crystalline silica exposure and
development of COPD appears in
section II.D of the background document
and is summarized in section V.D
below.
OSHA believes that the literature
reviewed above demonstrates decreased
lung function among workers with
radiological evidence of silicosis
consistent with an ILO classification of
major category 2 or higher. Also, given
the evidence of functional impairment
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in some workers prior to radiological
evidence of silicosis, and given the low
sensitivity of radiography, particularly
in detecting early silicosis, OSHA
believes that exposure to silica impairs
lung function in at least some
individuals before silicosis can be
detected on chest radiograph.
4. Pulmonary Tuberculosis
As silicosis progresses, it may be
complicated by severe mycobacterial
infections, the most common of which
is pulmonary tuberculosis (TB). Active
tuberculosis infection is a wellrecognized complication of chronic
silicosis, and such infections are known
as silicotuberculosis (IARC, 1997;
NIOSH, 2002). The risk of developing
TB infection is higher in silicotics than
non-silicotics (Balmes, 1990; Cowie,
1994; Hnizdo and Murray, 1998;
Kleinschmidt and Churchyard, 1997;
and Murray et al., 1996). There also is
evidence that exposure to silica
increases the risk for pulmonary
tuberculosis independent of the
presence of silicosis (Cowie, 1994;
Hnizdo and Murray, 1998;
teWaterNaude et al., 2006). In a
summary of the literature on silicarelated disease mechanisms, Ding et al.
(2002) noted that it is well documented
that exposure to silica can lead to
impaired cell-mediated immunity,
increasing susceptibility to
mycobacterial infection. Reduced
numbers of T-cells, increased numbers
of B-cells, and alterations of serum
immunoglobulin levels have been
observed in workers with silicosis. In
addition, according to Ng and Chan
(1991), silicosis and TB act
synergistically to increase fibrotic scar
tissue (leading to massive fibrosis) or to
enhance susceptibility to active
mycobacterial infection. Lung fibrosis is
common to both diseases and both
diseases decrease the ability of alveolar
macrophages to aid in the clearance of
dust or infectious particles.
B. Carcinogenic Effects of Silica (Cancer
of the Lung and Other Sites)
OSHA conducted an independent
review of the epidemiological literature
on exposure to respirable crystalline
silica and lung cancer, covering more
than 30 occupational groups in over a
dozen industrial sectors. In addition,
OSHA reviewed a pooled case-control
study, a large national death certificate
study, two national cancer registry
studies, and six meta-analyses. In all,
OSHA’s review included approximately
60 primary epidemiological studies.
Based on its review, OSHA
preliminarily concludes that the human
data summarized in this section
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provides ample evidence that exposure
to respirable crystalline silica increases
the risk of lung cancer among workers.
The strongest evidence comes from the
worldwide cohort and case-control
studies reporting excess lung cancer
mortality among workers exposed to
respirable crystalline silica dust as
quartz in various industrial sectors,
including the granite/stone quarrying
and processing, industrial sand, mining,
and pottery and ceramic industries, as
well as to cristobalite in diatomaceous
earth and refractory brick industries.
The 10-cohort pooled case-control
analysis by Steenland et al. (2001a)
confirms these findings. A more recent
clinic-based pooled case-control
analysis of seven European countries by
Cassidy et al. (2007) as well as two
national death certificate registry
studies (Pukkala et al., 2005 in Finland;
Calvert et al., 2003 in the United States)
support the findings from the cohort
and case-control analysis.
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1. Overall and Industry Sector-Specific
Findings
Associations between exposure to
respirable crystalline silica and lung
cancer have been reported in worker
populations from many different
industrial sectors. IARC (1997)
concluded that crystalline silica is a
confirmed human carcinogen based
largely on nine studies of cohorts in four
industry sectors that IARC considered to
be the least influenced by confounding
factors (sectors included quarries and
granite works, gold mining, ceramic/
pottery/refractory brick industries, and
the diatomaceous earth industry). IARC
(2012) recently reaffirmed that
crystalline silica is a confirmed human
carcinogen. NIOSH (2002) also
determined that crystalline silica is a
human carcinogen after evaluating
updated literature.
OSHA believes that the strongest
evidence for carcinogenicity comes from
studies in five industry sectors. These
are:
• Diatomaceous Earth Workers
(Checkoway et al., 1993, 1996, 1997,
and 1999; Seixas et al., 1997);
• British Pottery Workers (Cherry et
al., 1998; McDonald et al., 1995);
• Vermont Granite Workers (Attfield
and Costello, 2004; Graham et al., 2004;
Costello and Graham, 1988; Davis et al.,
1983);
• North American Industrial Sand
Workers (Hughes et al., 2001; McDonald
et al., 2001, 2005; Rando et al., 2001;
Sanderson et al., 2000; Steenland and
Sanderson, 2001); and
• British Coal Mining (Miller et al.,
2007; Miller and MacCalman, 2009).
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The studies above were all
retrospective cohort or case-control
studies that demonstrated positive,
statistically significant exposureresponse relationships between
exposure to crystalline silica and lung
cancer mortality. Except for the British
pottery studies, where exposureresponse trends were noted for average
exposure only, lung cancer risk was
found to be related to cumulative
exposure. OSHA credits these studies
because in general, they are of sufficient
size and have adequate years of follow
up, and have sufficient quantitative
exposure data to reliably estimate
exposures of cohort members. As part of
their analyses, the authors of these
studies also found positive exposureresponse relationships for silicosis,
indicating that underlying estimates of
worker exposures were not likely to be
substantially misclassified.
Furthermore, the authors of these
studies addressed potential confounding
due to other carcinogenic exposures
through study design or data analysis.
A series of studies of the
diatomaceous earth industry
(Checkoway et al., 1993, 1996, 1997,
1999) demonstrated positive exposureresponse trends between cristobalite
exposures and lung cancer as well as
non-malignant respiratory disease
mortality (NMRD). Checkoway et al.
(1993) developed a ‘‘semi-quantitative’’
cumulative exposure estimate that
demonstrated a statistically significant
positive exposure-response trend (p =
0.026) between duration of employment
or cumulative exposure and lung cancer
mortality. The quartile analysis showed
a monotonic increase in lung cancer
mortality, with the highest exposure
quartile having a RR of 2.74 for lung
cancer mortality. Checkoway et al.
(1996) conducted a re-analysis to
address criticisms of potential
confounding due to asbestos and again
demonstrated a positive exposure
response risk gradient when controlling
for asbestos exposure and other
variables. Rice et al. (2001) conducted a
re-analysis and quantitative risk
assessment of the Checkoway et al.
(1997) study, which OSHA has included
as part of its assessment of lung cancer
mortality risk (See Section II,
Preliminary Quantitative Risk
Assessment).
In the British pottery industry, excess
lung cancer risk was found to be
associated with crystalline silica
exposure among workers in a PMR
study (McDonald et al., 1995) and in a
cohort and nested case-control study
(Cherry et al., 1998). In the PMR study,
elevated PMRs for lung cancer were
found after adjusting for potential
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confounding by asbestos exposure. In
the study by Cherry et al., odds ratios
for lung cancer mortality were
statistically significantly elevated after
adjusting for smoking. Odds ratios were
related to average, but not cumulative,
exposure to crystalline silica. The
findings of the British pottery studies
are supported by other studies within
their industrial sector. Studies by
Winter et al. (1990) of British pottery
workers and by McLaughlin et al. (1992)
both reported finding suggestive trends
of increased lung cancer mortality with
increasing exposure to respirable
crystalline silica.
Costello and Graham (1988) and
Graham et al. (2004) in a follow-up
study found that Vermont granite
workers employed prior to 1930 had an
excess risk of lung cancer, but lung
cancer mortality among granite workers
hired after 1940 (post-implementation of
controls) was not elevated in the
Costello and Graham (1988) study and
was only somewhat elevated (not
statistically significant) in the Graham et
al. (2004) study. Graham et al. (2004)
concluded that their results did not
support a causal relationship between
granite dust exposure and lung cancer
mortality. Looking at the same
population, Attfield and Costello (2004)
developed a quantitative estimate of
cumulative exposure (8 exposure
categories) adapted from a job exposure
matrix developed by Davis et al. (1983).
They found a statistically significant
trend with log-transformed cumulative
exposure. Lung cancer mortality rose
reasonably consistently through the first
seven increasing exposure groups, but
fell in the highest cumulative exposure
group. With the highest exposure group
omitted, a strong positive dose-response
trend was found for both untransformed
and log-transformed cumulative
exposures. Attfield and Costello (2004)
concluded that exposure to crystalline
silica in the range of cumulative
exposures typically experienced by
contemporarily exposed workers causes
an increased risk of lung cancer
mortality. The authors explained that
the highest exposure group would have
included the most unreliable exposure
estimates being reconstructed from
exposures 20 years prior to study
initiation when exposure estimation
was less precise. Also, even though the
highest exposure group consisted of
only 15 percent of the study population,
it had a disproportionate effect on
dampening the exposure-response
relationship.
OSHA believes that the study by
Attfield and Costello (2004) is of
superior design in that it was a
categorical analysis that used
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quantitative estimates of exposure and
evaluated lung cancer mortality rates by
exposure group. In contrast, the findings
by Graham et al. (2004) are based on a
dichotomous comparison of risk among
high- versus low-exposure groups,
where date-of-hire before and after
implementation of ventilation controls
is used as a surrogate for exposure.
Consequently, OSHA believes that the
study by Attfield and Costello is the
more convincing study, and is one of
the studies used by OSHA for
quantitative risk assessment of lung
cancer mortality due to crystalline silica
exposure.
The conclusions of the Vermont
granite worker study (Attfield and
Costello, 2004) are supported by the
findings in studies of workers in the
U.S. crushed stone industry (Costello et
al., 1995) and Danish stone industry
´
(Guenel et al., 1989a, 1989b). Costello et
al. (1995) found a non-statistically
significant increase in lung cancer
mortality among limestone quarry
workers and a statistically significant
increased lung cancer mortality in
granite quarry workers who worked 20
years or more since first exposure.
´
Guenel et al. (1989b), in a Danish cohort
study, found statistically significant
increases in lung cancer incidence
among skilled stone workers and skilled
granite stone cutters. A study of Finnish
granite workers that initially showed
increasing risk of lung cancer with
increasing silica exposure, upon
extended follow-up, did not show an
association and is therefore considered
a negative study (Toxichemica, Inc.,
2004).
Studies of two overlapping cohorts in
the industrial sand industry (Hughes et
al., 2001; McDonald et al., 2001, 2005;
Rando et al., 2001; Sanderson et al.,
2000; Steenland and Sanderson, 2001)
reported comparable results. These
studies found a statistically significantly
increased risk of lung cancer mortality
with increased cumulative exposure in
both categorical and continuous
analyses. McDonald et al. (2001)
examined a cohort that entered the
workforce, on average, a decade earlier
than the cohorts that Steenland and
Sanderson (2001) examined. The
McDonald cohort, drawn from eight
plants, had more years of exposure in
the industry (19 versus 8.8 years). The
Steenland and Sanderson (2001) cohort
worked in 16 plants, 7 of which
overlapped with the McDonald, et al.
(2001) cohort. McDonald et al. (2001),
Hughes et al. (2001), and Rando et al.
(2001) had access to smoking histories,
plant records, and exposure
measurements that allowed for
historical reconstruction and the
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development of a job exposure matrix.
Steenland and Sanderson (2001) had
limited access to plant facilities, less
detailed historic exposure data, and
used MSHA enforcement records for
estimates of recent exposure. These
studies (Hughes et al., 2001; McDonald
et al., 2005; Steenland and Sanderson,
2001) show very similar exposure
response patterns of increased lung
cancer mortality with increased
exposure. OSHA included the
quantitative exposure-response analysis
from the Hughes et al. (2001) study in
its Preliminary Quantitative Risk
Assessment (Section II).
Brown and Rushton (2005a, 2005b)
found no association between risk of
lung cancer mortality and exposure to
respirable crystalline silica among
British industrial sand workers.
However, the small sample size and
number of years of follow-up limited the
statistical power of the analysis.
Additionally, as Steenland noted in a
letter review (2005a), the cumulative
exposures of workers in the Brown and
Ruston (2005b) study were over 10
times lower than the cumulative
exposures experienced by the cohorts in
the pooled analysis that Steenland et al.
(2001b) performed. The low exposures
experienced by this cohort would have
made detecting a positive association
with lung cancer mortality even more
difficult.
Excess lung cancer mortality was
reported in a large cohort study of
British coal miners (Miller et al., 2007;
Miller and MacCalman, 2009). These
studies examined the mortality
experience of 17,800 miners through the
end of 2005. By that time, the cohort
had accumulated 516,431 person years
of observation (an average of 29 years
per miner), with 10,698 deaths from all
causes. Overall lung cancer mortality
was elevated (SMR=115.7, 95% C.I.
104.8–127.7), and a positive exposureresponse relationship with crystalline
silica exposure was determined from
Cox regression after adjusting for
smoking history. Three of the strengths
of this study are the detailed timeexposure measurements of both quartz
and total mine dust, detailed individual
work histories, and individual smoking
histories. For lung cancer, analyses
based on the Cox regression provide
strong evidence that, for these coal
miners, quartz exposures were
associated with increased lung cancer
risk but that simultaneous exposures to
coal dust did not cause increased lung
cancer risk. Because of these strengths,
OSHA included the quantitative
analysis from this study in its
Preliminary Quantitative Risk
Assessment (Section II).
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Studies of lung cancer mortality in
metal ore mining populations reflect
mixed results. Many of these mining
studies were subject to confounding due
to exposure to other potential
carcinogens such as radon and arsenic.
IARC (1997) noted that in only a few ore
mining studies was confounding from
other occupational carcinogens taken
into account. IARC (1997) also noted
that, where confounding was absent or
accounted for in the analysis (gold
miners in the U.S., tungsten miners in
China, and zinc and lead miners in
Sardinia, Italy), an association between
silica exposure and lung cancer was
absent. Many of the studies conducted
since IARC’s (1997) review more
strongly implicate crystalline silica as a
human carcinogen. Pelucchi et al.
(2006), in a meta-analysis of studies
conducted since IARC’s (1997) review,
reported statistically significantly
elevated relative risks of lung cancer
mortality in underground and surface
miners in three cohort and four casecontrol studies (See Table I–15). Cassidy
et al. (2007), in a pooled case-control
analysis, showed a statistically
significant increased risk of lung cancer
mortality among miners (OR = 1.48).
Cassidy et al. (2007) also demonstrated
a clear linear trend of increasing odds
ratios for lung cancer with increasing
exposures.
Among workers in Chinese tungsten
and iron mines, mortality from lung
cancer was not found to be statistically
significantly increased (Chen et al.,
1992; McLaughlin et al., 1992). In
contrast, studies of Chinese tin miners
found increased lung cancer mortality
rates and positive exposure-response
associations with increased silica
exposure (Chen et al., 1992).
Unfortunately, in many of these Chinese
tin mines, there was potential
confounding from arsenic exposure,
which was highly correlated with
exposure to crystalline silica (Chen and
Chen, 2002; Chen et al., 2006). Two
other studies (Carta et al. (2001) of
Sardinian miners and stone quarrymen;
Finkelstein (1998) primarily of
Canadian miners) were limited to
silicotics. The Sardinian study found a
non-statistically significant association
between crystalline silica exposure and
lung cancer mortality but no apparent
exposure-response trend with silica
exposure. The authors attributed the
increased lung cancer to increased
radon exposure and smoking among
cases as compared to controls.
Finkelstein (1998) found a positive
association between silica exposure and
lung cancer.
Gold mining has been extensively
studied in the United States, South
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Africa, and Australia in four cohort and
associated nested case-control studies,
and in two separate case-control studies
conducted in South Africa. As with
metal ore mining, gold mining involves
exposure to radon and other
carcinogenic agents, which may
confound the relationship between
silica exposure and lung cancer. The
U.S. gold miner study (Steenland and
Brown, 1995a) did not find an increased
risk of lung cancer, while the western
Australian gold miner study (de Klerk
and Musk, 1998) showed a SMR of 149
(95% CI 1.26–1.76) for lung cancer.
Logistic regression analysis of the
western Australian case control data
showed that lung cancer mortality was
statistically significantly associated with
log cumulative silica exposure after
adjusting for smoking and bronchitis.
After additionally adjusting for silicosis,
the relative risk remained elevated but
was no longer statistically significant.
The authors concluded that their
findings showed statistically
significantly increased lung cancer
mortality in this cohort but that the
increase in lung cancer mortality was
restricted to silicotic members of the
cohort.
Four studies of gold miners were
conducted in South Africa. Two case
control studies (Hessel et al., 1986,
1990) reported no significant association
between silica exposure and lung
cancer, but these two studies may have
underestimated risk, according to
Hnizdo and Sluis-Cremer (1991). Two
cohort studies (Reid and Sluis-Cremer,
1996; Hnizdo and Sluis-Cremer, 1991)
and their associated nested case-control
studies found elevated SMRs and odds
ratios, respectively, for lung cancer.
Reid and Sluis-Cremer (1996) attributed
the increased mortality due to lung
cancer and other non-malignant
respiratory diseases to cohort members’
lifestyle choices (particularly smoking
and alcohol consumption). However,
OSHA notes that the study reported
finding a positive, though not
statistically significant, association
between cumulative crystalline silica
exposure and lung cancer, as well as
statistically significant association with
renal failure, COPD, and other
respiratory diseases that have been
implicated with silica exposure.
In contrast, Hnizdo and Sluis-Cremer
(1991) found a positive exposureresponse relationship between
cumulative exposure and lung cancer
mortality among South African gold
miners after accounting for smoking. In
a nested case-control study from the
same cohort, Hnizdo et al. (1997) found
a statistically significant increase in
lung cancer mortality that was
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associated with increased cumulative
dust exposure and time spent
underground. Of the studies examining
silica and lung cancer among South
African gold miners, these two studies
were the least likely to have been
affected by exposure misclassification,
given their rigorous methodologies and
exposure measurements. Although not
conclusive in isolation, OSHA considers
the mining study results, particularly
the gold mining and the newer mining
studies, as supporting evidence of a
causal relationship between exposure to
silica and lung cancer risk.
OSHA has preliminarily determined
that the results of the studies conducted
in three industry sectors (foundry,
silicon carbide, and construction
sectors) were confounded by the
presence of exposures to other
carcinogens. Exposure data from these
studies were not sufficient to
distinguish between exposure to silica
dust and exposure to other occupational
carcinogens. Thus, elevated rates of lung
cancer found in these industries could
not be attributed to silica. IARC
previously made a similar
determination in reference to the
foundry industry. However, with
respect to the construction industry,
Cassidy et al. (2007), in a large,
European community-based casecontrol study, reported finding a clear
linear trend of increasing odds ratio
with increasing cumulative exposure to
crystalline silica (estimated semiquantitatively) after adjusting for
smoking and exposure to insulation and
wood dusts. Similar trends were found
for workers in the manufacturing and
mining industries as well. This study
was a very large multi-national study
that utilized information on smoking
histories and exposure to silica and
other occupational carcinogens. OSHA
believes that this study provides further
evidence that exposure to crystalline
silica increases the risk of lung cancer
mortality and, in particular, in the
construction industry.
In addition, a recent analysis of 4.8
million death certificates from 27 states
within the U.S. for the years 1982 to
1995 showed statistically significant
excesses in lung cancer mortality,
silicosis mortality, tuberculosis, and
NMRD among persons with occupations
involving medium and high exposure to
respirable crystalline silica (Calvert et
al., 2003). A national records and death
certificate study was also conducted in
Finland by Pukkala et al. (2005), who
found a statistically significant excess of
lung cancer incidence among men and
women with estimated medium and
heavy exposures. OSHA believes that
these large national death certificate
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studies and the pooled European
community-based case-control study are
strongly supportive of the previously
reviewed epidemiologic data and
supports the conclusion that
occupational exposure to crystalline
silica is a risk factor for lung cancer
mortality.
One of the more compelling studies
evaluated by OSHA is the pooled
analysis of 10 occupational cohorts (5
mines and 5 industrial facilities)
conducted by Steenland et al. (2001a),
which demonstrated an overall positive
exposure-response relationship between
cumulative exposure to silica and lung
cancer mortality. These ten cohorts
included 65,980 workers and 1,072 lung
cancer deaths, and were selected
because of the availability of raw data
on exposure to crystalline silica and
health outcomes. The investigators used
a nested case control design and found
lung cancer risk increased with
increasing cumulative exposure, log
cumulative exposure, and average
exposure. Exposure-response trends
were similar between mining and nonmining cohorts. From their analysis, the
authors concluded that ‘‘[d]espite this
relatively shallow exposure–response
trend, overall our results tend to support
the recent conclusion by IARC (1997)
that inhaled crystalline silica in
occupational settings is a human
carcinogen, and suggest that existing
permissible exposure limits for silica
need to be lowered (Steenland et al.,
2001a). To evaluate the potential effect
of random and systematic errors in the
underlying exposure data from these 10
cohort studies, Steenland and Bartell
(Toxichemica, Inc., 2004) conducted a
series of sensitivity analyses at OSHA’s
request. OSHA’s Preliminary
Quantitative Risk Assessment (Section
II) presents additional information on
the Steenland et al. (2001a) pooled
cohort study and the sensitivity analysis
performed by Steenland and Bartell
(Toxichemica, Inc., 2004).
2. Smoking, Silica Exposure, and Lung
Cancer
Smoking is known to be a major risk
factor for lung cancer. However, OSHA
believes it is unlikely that smoking
explains the observed exposureresponse trends in the studies described
above, particularly the retrospective
cohort or nested case-control studies of
diatomaceous earth, British pottery,
Vermont granite, British coal, South
African gold, and industrial sand
workers. Also, the positive associations
between silica exposure and lung cancer
in multiple studies in multiple sectors
indicates that exposure to crystalline
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silica independently increases the risk
of lung cancer.
Studies by Hnizdo et al. (1997),
McLaughlin et al. (1992), Hughes et al.
(2001), McDonald et al. (2001, 2005),
Miller and MacCalman (2009), and
Cassidy et al. (2007) had detailed
smoking histories with sufficiently large
populations and a sufficient number of
years of follow-up time to quantify the
interaction between crystalline silica
exposure and cigarette smoking. In a
cohort of white South African gold
miners (Hnizdo and Sluis-Cremer, 1991)
and in the follow-up nested case-control
study (Hnizdo et al., 1997) found that
the combined effect of exposure to
respirable crystalline silica and smoking
was greater than additive, suggesting a
multiplicative effect. This synergy
appeared to be greatest for miners with
greater than 35 pack-years of smoking
and higher cumulative exposure to
silica. In the Chinese nested casecontrol studies reported by McLaughlin
et al. (1992), cigarette smoking was
associated with lung cancer, but control
for smoking did not influence the
association between silica and lung
cancer in the mining and pottery
cohorts studied. The studies of
industrial sand workers by Hughes et al.
(2001) and British coal workers by
Miller and MacCalman (2009) found
positive exposure-response trends after
adjusting for smoking histories, as did
Cassidy et al. (2007) in their
community-based case-control study of
exposed European workers.
In reference to control of potential
confounding by cigarette smoking in
crystalline silica studies, Stayner (2007),
in an invited journal commentary,
stated:
Of particular concern in occupational
cohort studies is the difficulty in adequately
controlling for confounding by cigarette
smoking. Several of the cohort studies that
adjusted for smoking have demonstrated an
excess of lung cancer, although the control
for smoking in many of these studies was less
than optimal. The results of the article by
Cassidy et al. presented in this journal appear
to have been well controlled for smoking and
other workplace exposures. It is quite
implausible that residual confounding by
smoking or other risk factors for lung cancer
in this or other studies could explain the
observed excess of lung cancer in the wide
variety of populations and study designs that
have been used. Also, it is generally
considered very unlikely that confounding by
smoking could explain the positive exposureresponse relationships observed in these
studies, which largely rely on comparisons
between workers with similar socioeconomic
backgrounds.
Given the findings of investigators
who have accounted for the impact of
smoking, the weight of the evidence
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reviewed here implicates respirable
crystalline silica as an independent risk
factor for lung cancer mortality. This
finding is further supported by animal
studies demonstrating that exposure to
silica alone can cause lung cancer (e.g.,
Muhle et al., 1995).
3. Silicosis and Lung Cancer Risk
In general, studies of workers with
silicosis, as well as meta-analyses that
include these studies, have shown that
workers with radiologic evidence of
silicosis have higher lung cancer risk
than those without radiologic
abnormalities or mixed cohorts. Three
meta-analyses attempted to look at the
association of increasing ILO
radiographic categories of silicosis with
increasing lung cancer mortality. Two of
these analyses (Kurihara and Wada,
2004; Tsuda et al., 1997) showed no
association with increasing lung cancer
mortality, while Lacasse et al. (2005)
demonstrated a positive dose-response
for lung cancer with increasing ILO
radiographic category. A number of
other studies, discussed above, found
increased lung cancer risk among
exposed workers absent radiological
evidence of silicosis (Cassidy et al.,
2007; Checkoway et al., 1999; Cherry et
al., 1998; Hnizdo et al., 1997;
McLaughlin et al., 1992). For example,
the diatomaceous earth study by
Checkoway et al. (1999) showed a
statistically significant exposureresponse for lung cancer among nonsilicotics. Checkoway and Franzblau
(2000), reviewing the international
literature, found all epidemiological
studies conducted to that date were
insufficient to conclusively determine
the role of silicosis in the etiology of
lung cancer. OSHA preliminarily
concludes that the more recent pooled
and meta-analyses do not provide
compelling evidence that silicosis is a
necessary precursor to lung cancer. The
analyses that do suggest an association
between silicosis and lung cancer may
simply reflect that more highly exposed
individuals are at a higher risk for lung
cancer.
Animal and in vitro studies have
demonstrated that the early steps in the
proposed mechanistic pathways that
lead to silicosis and lung cancer seem to
share some common features. This has
led some of these researchers to also
suggest that silicosis is a prerequisite to
lung cancer. Some have suggested that
any increased lung cancer risk
associated with silica may be a
consequence of the inflammation (and
concomitant oxidative stress) and
increased epithelial cell proliferation
associated with the development of
silicosis. However, other researchers
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have noted that other key factors and
proposed mechanisms, such as direct
damage to DNA by silica, inhibition of
p53, loss of cell cycle regulation,
stimulation of growth factors, and
production of oncogenes, may also be
involved in carcinogenesis induced by
silica (see Section II.F of the background
document for more information on these
studies). Thus, OSHA preliminarily
concludes that available animal and in
vitro studies do not support the
hypothesis that development of silicosis
is necessary for silica exposure to cause
lung cancer.
4. Relationship Between Silica
Polymorphs and Lung Cancer Risk
OSHA’s current PELs for respirable
crystalline silica reflects a once-held
belief that cristobalite is more toxic than
quartz (i.e., the existing general industry
PEL for cristobalite is one-half the
general industry PEL for quartz).
Available evidence indicates that this
does not appear to be the case with
respect to the carcinogenicity of
crystalline silica. A comparison between
cohorts having principally been exposed
to cristobalite (the diatomaceous earth
study and the Italian refractory brick
study) with other well conducted
studies of quartz-exposed cohorts
suggests no difference in the toxicity of
cristobalite versus quartz. The data
indicates that the SMRs for lung cancer
mortality among workers in the
diatomaceous earth (SMR = 141) and
refractory brick (SMR=151) cohort
studies are within the range of the SMR
point estimates of other cohort studies
with principally quartz exposures
(quartz exposure of Vermont granite
workers yielding an SMR of 117; quartz
and possible post-firing cristobalite
exposure of British pottery workers
yielding an SMR of 129; quartz exposure
among industrial sand workers yielding
SMRs of 129, (McDonald et al., 2001)
and 160 (Steenland and Sanderson,
2001)). Also, the SMR point estimates
for the diatomaceous earth and
refractory brick studies are similar to,
and fall within the 95 percent
confidence interval of, the odds ratio
(OR=1.37, 95% CI 1.14–1.65) of the
recently conducted multi-center casecontrol study in Europe (Cassidy et al.,
2007).
OSHA believes that the current
epidemiological literature provides
little, if any, support for treating
cristobalite as presenting a greater lung
cancer risk than comparable exposure to
respirable quartz. Furthermore, the
weight of the available toxicological
literature no longer supports the
hypothesis that cristobalite has a higher
toxicity than quartz, and quantitative
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estimates of lung cancer risk do not
suggest that cristobalite is more
carcinogenic than quartz. (See Section
I.F of the background document,
Physical Factors that May Influence
Toxicity of Crystalline Silica, for a fuller
discussion of this issue.) OSHA
preliminary concludes that respirable
cristobalite and quartz dust have similar
potencies for increasing lung cancer
risk. Both IARC (1997) and NIOSH
(2002) reached similar conclusions.
5. Cancers of Other Sites
Respirable crystalline silica exposure
has also been investigated as a potential
risk factor for cancer at other sites such
as the larynx, nasopharynx and the
digestive system including the
esophagus and stomach. Although many
of these studies suggest an association
between exposure to crystalline silica
and an excess risk of cancer mortality,
most are too limited in terms of size,
study design, or potential for
confounding to be conclusive. Other
than for lung cancer, cancer mortality
studies demonstrating a dose-response
relationship are quite limited. In their
silica hazard review, NIOSH (2002)
concluded that, exclusive of the lung, an
association has not been established
between silica exposure and excess
mortality from cancer at other sites. A
brief summary of the relevant literature
is presented below.
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a. Cancer of the Larynx and
Nasopharynx
Several studies, including three of the
better-quality lung cancer studies
(Checkoway et al., 1997; Davis et al.,
1983; McDonald et al., 2001) suggest an
association between exposure to
crystalline silica and increased
mortality from laryngeal cancer.
However, the evidence for an
association is not strong due to the
small number of cases reported and lack
of statistical significance of most of the
findings.
b. Gastric (Stomach) Cancer
In their 2002 hazard review of
respirable crystalline silica, NIOSH
identified numerous epidemiological
studies and reported statistically
significant increases in death rates due
to gastric or stomach cancer. OSHA
preliminarily concurs with observations
made previously by Cocco et al. (1996)
and the NIOSH (2002) crystalline silica
hazard review that the vast majority of
epidemiology studies of silica and
stomach cancer have not sufficiently
adjusted for the effects of confounding
factors or have not been sufficiently
designed to assess a dose-response
relationship (e.g., Finkelstein and
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Verma, 2005; Moshammer and
Neuberger, 2004; Selikoff, 1978, Stern et
al., 2001). Other studies did not
demonstrate a statistically significant
dose-response relationship (e.g., Calvert
et al., 2003; Tsuda et al., 2001).
Therefore, OSHA believes the evidence
is insufficient to conclude that silica is
a gastric carcinogen.
c. Esophageal Cancer
Three well-conducted nested casecontrol studies of Chinese workers
indicated an increased risk of
esophageal cancer mortality attributed
by the study’s authors to respirable
crystalline silica exposure in refractory
brick production, boiler repair, and
foundry workers (Pan et al., 1999;
Wernli et al., 2006) and caisson
construction work (Yu et al., 2005).
Each study demonstrated a doseresponse association with some
surrogate measure of exposure, but
confounding due to other occupational
exposures is possible in all three work
settings (heavy metal exposure in the
repair of boilers in steel plants, PAH
exposure in foundry workers, radon and
radon daughter exposure in Hong Kong
caisson workers). Other less wellconstructed studies also indicated
elevated rates of esophageal cancer
mortality with silica exposure (Tsuda et
al., 2001; Xu et al., 1996a).
In contrast, two large national
mortality studies in Finland and the
United States, using qualitatively
ranked exposure estimates, did not
show a positive association between
silica exposure and esophageal cancer
mortality (Calvert et al., 2003;
Weiderpass et al., 2003). OSHA
preliminarily concludes that the
epidemiological literature is not
sufficiently robust to attribute increased
esophageal cancer mortality to exposure
to respirable crystalline silica.
d. Other Miscellaneous Cancers
In 2002, NIOSH conducted a thorough
literature review of the health effects
potentially associated with crystalline
silica exposure including a review of
lung cancer and other carcinogens.
NIOSH noted that for workers who may
have been exposed to crystalline silica,
there have been infrequent reports of
statistically significant excesses of
deaths for other cancers. A summary of
these cancer studies as cited in NIOSH
(2002) have been reported in the
following organ systems (see NIOSH,
2002 for full bibliographic references):
salivary gland; liver; bone; pancreatic;
skin; lymphopoetic or hematopoietic;
brain; and bladder.
According to NIOSH (2002), an
association has not been established
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between these cancers and exposure to
crystalline silica. OSHA believes that
these isolated reports of excess cancer
mortality at these sites are not sufficient
to draw any inferences about the role of
silica exposure. The findings have not
been consistently seen among
epidemiological studies and there is no
evidence of an exposure response
relationship.
C. Other Nonmalignant Respiratory
Disease
In addition to causing silicosis,
exposure to crystalline silica has been
associated with increased risks of other
non-malignant respiratory diseases
(NMRD), primarily chronic obstructive
pulmonary disease (COPD). COPD is a
disease state characterized by airflow
limitation that is not fully reversible.
The airflow limitation is usually
progressive and is associated with an
abnormal inflammatory response of the
lungs to noxious particles or gases. In
patients with COPD, either chronic
bronchitis or emphysema may be
present or both conditions may be
present together. The following presents
OSHA’s discussion of the literature
describing the relationships between
silica exposure and non-malignant
respiratory disease.
1. Emphysema
OSHA has considered a series of
longitudinal studies of white South
African gold miners conducted by
Hnizdo and co-workers. Hnizdo et al.
(1991) found a significant association
between emphysema (both panacinar
and centriacinar) and years of
employment in a high dust occupation
(respirable dust was estimated to
contain 30 percent free silica). There
was no such association found for nonsmokers, as there were only four nonsmokers with a significant degree of
emphysema found in the cohort. A
further study by Hnizdo et al. (1994)
looked at only life-long non-smoking
South African gold miners. In this
population, no significant degree of
emphysema or association with years of
exposure or cumulative dust exposure
was found. However, the degree of
emphysema was significantly associated
with the degree of hilar gland nodules,
which the authors suggested might act
as a surrogate for exposure to silica. The
authors concluded that the minimal
degree of emphysema seen in nonsmoking miners exposed to the
cumulative dust levels found in this
study (mean 6.8 mg/m3, SD 2.4, range
0.5 to 20.2, 30 percent crystalline silica)
was unlikely to cause meaningful
impairment of lung function.
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From the two studies above, Hnizdo
et al. (1994) concluded that the
statistically significant association
between exposure to silica dust and the
degree of emphysema in smokers
suggests that tobacco smoking
potentiates the effect of silica dust. In
contrast to their previous studies, a later
study by Hnizdo et al. (2000) of South
African gold miners found that
emphysema prevalence was decreased
in relation to dust exposure. The
authors suggested that selection bias
was responsible for this finding.
The findings of several cross-sectional
and case-control studies were more
mixed. Becklake et al. (1987), in an
unmatched case-control study of white
South African gold miners, determined
that a miner who had worked in high
dust for 20 years had a greater chance
of getting emphysema than a miner who
had never worked in high dust. A
reanalysis of this data (de Beer et al.,
1992) including added-back cases and
controls (because of possible selection
bias in the original study), still found an
increased risk for emphysema, although
the reported odds ratio was smaller than
previously reported by Becklake et al.
(1987). Begin et al. (1995), in a study of
the prevalence of emphysema in silicaexposed workers with and without
silicosis, found that silica-exposed
smokers without silicosis had a higher
prevalence of emphysema than a group
of asbestos-exposed workers with
similar smoking history. In nonsmokers, the prevalence of emphysema
was much higher in those with silicosis
than in those without silicosis. A study
of black underground gold miners found
that the presence and grade of
emphysema were statistically
significantly associated with the
presence of silicosis but not with years
of mining (Cowie et al., 1993).
Several of the above studies (Becklake
et al., 1987; Begin et al., 1995; Hnizdo
et al., 1994) found that emphysema can
occur in silica-exposed workers who do
not have silicosis and suggest that a
causal relationship may exist between
exposure to silica and emphysema. The
findings of experimental (animal)
studies that emphysema occurs at lower
silica doses than does fibrosis in the
airways or the appearance of early
silicotic nodules (e.g., Wright et al.,
1988) tend to support the findings in
human studies that silica-induced
emphysema can occur absent signs of
silicosis.
Others have also concluded that there
is a relationship between emphysema
and exposure to crystalline silica. Green
and Vallyathan (1996) reviewed several
studies of emphysema in workers
exposed to silica. The authors stated
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that these studies show an association
between cumulative dust exposure and
death from emphysema. IARC (1997)
has also briefly reviewed studies on
emphysema in its monograph on
crystalline silica carcinogenicity and
concluded that exposure to crystalline
silica increases the risk of emphysema.
In their 2002 Hazard Review, NIOSH
concluded that occupational exposure
to respirable crystalline silica is
associated with emphysema but that
some epidemiologic studies suggested
that this effect may be less frequent or
absent in non-smokers.
Hnizdo and Vallyathan (2003) also
conducted a review of studies
addressing COPD due to occupational
silica exposure and concluded that
chronic exposure to silica dust at levels
that do not cause silicosis may cause
emphysema.
Based on these findings, OSHA
preliminarily concludes that exposure
to respirable crystalline silica or silicacontaining dust can increase the risk of
emphysema, regardless of whether
silicosis is present. This appears to be
clearly the case for smokers. It is less
clear whether nonsmokers exposed to
silica would also be at higher risk and
if so, at what levels of exposure. It is
also possible that smoking potentiates
the effect of silica dust in increasing
emphysema risk.
2. Chronic Bronchitis
There were no longitudinal studies
available designed to investigate the
relationship between silica exposure
and bronchitis. However, several crosssectional studies provide useful
information. Studies are about equally
divided between those that have
reported a relationship between silica
exposure and bronchitis and those that
have not. Several studies demonstrated
a qualitative or semiquantitative
relationship between silica exposure
and chronic bronchitis. Sluis-Cremer et
al. (1967) found a significant difference
between the prevalence of chronic
bronchitis in dust-exposed and non-dust
exposed male residents of a South
African gold mining town who smoked,
but found no increased prevalence
among non-smokers. In contrast, a
different study of South African gold
miners found that the prevalence of
chronic bronchitis increased
significantly with increasing dust
concentration and cumulative dust
exposure in smokers, nonsmokers, and
ex-smokers (Wiles and Faure, 1977).
Similarly, a study of Western Australia
gold miners found that the prevalence of
chronic bronchitis, as indicated by odds
ratios (controlled for age and smoking),
was significantly increased in those that
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had worked in the mines for 1 to 9
years, 10 to 19 years, and more than 20
years, as compared to lifetime nonminers (Holman et al., 1987). Chronic
bronchitis was present in 62 percent of
black South African gold miners and 45
percent of those who had never smoked
in a study by Cowie and Mabena (1991).
The prevalence of what the researchers
called ‘‘chronic bronchitic symptom
complex’’ reflected the intensity of dust
exposure. A higher prevalence of
respiratory symptoms, independent of
smoking and age, was also found for
granite quarry workers in Singapore in
a high exposure group as compared to
low exposure and control groups, even
after excluding those with silicosis from
the analysis (Ng et al., 1992b).
Other studies found no relationship
between silica exposure and the
prevalence of chronic bronchitis. Irwig
and Rocks (1978) compared silicotic and
non-silicotic South African gold miners
and found no significant difference in
symptoms of chronic bronchitis. The
prevalence of symptoms of chronic
bronchitis were also not found to be
associated with years of mining, after
adjusting for smoking, in a population
of current underground uranium miners
(Samet et al., 1984). Silica exposure was
described in the study to be ‘‘on
occasion’’ above the TLV. It was not
possible to determine, however,
whether miners with respiratory
diseases had left the workforce, making
the remaining population
unrepresentative. Hard-rock
(molybdenum) miners, with 27 and 49
percent of personal silica samples
greater than 100 and 55 mg/m3,
respectively, also showed no increase in
prevalence of chronic bronchitis in
association with work in that industry
(Kreiss et al., 1989). However, the
authors thought that differential outmigration of symptomatic miners and
retired miners from the industry and
town might explain that finding.
Finally, grinders of agate stones (with
resulting dust containing 70.4 percent
silica) in India also had no increase in
the prevalence of chronic bronchitis
compared to controls matched by
socioeconomic status, age and smoking,
although there was a significantly
higher prevalence of acute bronchitis in
female grinders. A significantly higher
prevalence and increasing trend with
exposure duration for pneumoconiosis
in the agate workers indicated that had
an increased prevalence in chronic
bronchitis been present, it would have
been detected (Rastogi et al., 1991).
However, control workers in this study
may also have been exposed to silica
and the study and control workers both
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had high tuberculosis prevalence,
possibly masking an association of
exposure with bronchitis (NIOSH,
2002). Furthermore, exposure durations
were very short.
Thus, some prevalence studies
supported a finding of increased
bronchitis in workers exposed to silicacontaining dust, while other studies did
not support such a finding. However,
OSHA believes that many of the studies
that did not find such a relationship
were likely to be biased towards the
null. For example, some of the
molybdenum miners studied by Kreiss
et al. (1989), particularly retired and
symptomatic miners, may have left the
town and the industry before the time
that the cross-sectional study was
conducted, resulting in a survivor effect
that could have interfered with
detection of a possible association
between silica exposure and bronchitis.
This survivor effect may also have been
operating in the study of uranium
miners in New Mexico (Samet et al.,
1984). In two of the negative studies,
members of comparison and control
groups were also exposed to crystalline
silica (Irwig and Rocks, 1978; Rastogi et
al., 1991), creating a potential bias
toward the null. Additionally,
tuberculosis in both exposed and
control groups in the agate worker study
(Rastogi et al., 1991)) may have masked
an effect (NIOSH, 2002), and the
exposure durations were very short.
Several of the positive studies
demonstrated a qualitative or semiquantitative relationship between silica
exposure and chronic bronchitis.
Others have reviewed relevant studies
and also concluded that there is a
relationship between exposure to
crystalline silica and the development
of bronchitis. The American Thoracic
Society (ATS) (1997) published an
official statement on the adverse effects
of crystalline silica exposure that
included a section that discussed
studies on chronic bronchitis (defined
by chronic sputum production).
According to the ATS review, chronic
bronchitis was found to be common
among worker groups exposed to dusty
environments contaminated with silica.
In support of this conclusion, ATS cited
studies with what they viewed as
positive findings of South African
(Hnizdo et al., 1990) and Australian
(Holman et al., 1987) gold miners,
Indonesian granite workers (Ng et al.,
1992b), and Indian agate workers
(Rastogi et al., 1991). ATS did not
mention studies with negative findings.
A review published by NIOSH in
2002 discussed studies related to silica
exposure and development of chronic
bronchitis. NIOSH concluded, based on
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the same studies reviewed by OSHA,
that occupational exposure to respirable
crystalline silica is associated with
bronchitis, but that some epidemiologic
studies suggested that this effect may be
less frequent or absent in non-smokers.
Hnizdo and Vallyathan (2003) also
reviewed studies addressing COPD due
to occupational silica exposure and
concluded that chronic exposure to
silica dust at levels that do not cause
silicosis may cause chronic bronchitis.
They based this conclusion on studies
that they cited as showing that the
prevalence of chronic bronchitis
increases with intensity of exposure.
The cited studies were also reviewed by
OSHA (Cowie and Mabena, 1991;
Holman et al., 1987; Kreiss et al., 1989;
Sluis-Cremer et al., 1967; Wiles and
Faure, 1977).
OSHA preliminarily concludes that
exposure to respirable crystalline silica
may cause chronic bronchitis and an
exposure-response relationship may
exist. Smokers may be at increased risk
as compared to non-smokers. Chronic
bronchitis may occur in silica-exposed
workers who do not have silicosis.
3. Pulmonary Function Impairment
OSHA has reviewed numerous
studies on the relationship of silica
exposure to pulmonary function
impairment as measured by spirometry.
There were several longitudinal studies
available. Two groups of researchers
conducted longitudinal studies of lung
function impairment in Vermont granite
workers and reached opposite
conclusions. Graham et al (1981, 1994)
examined stone shed workers, who had
the highest exposures to respirable
crystalline silica (between 50 and 100
mg/m3), along with quarry workers
(presumed to have lower exposure) and
office workers (expected to have
negligible exposure). The longitudinal
losses of FVC and FEV1 were not
correlated with years employed, did not
differ among shed, quarry, and office
workers, and were similar, according to
the authors, to other blue collar workers
not exposed to occupational dust.
Eisen et al. (1983, 1995) found the
opposite. They looked at lung function
in two groups of granite workers:
‘‘survivors’’, who participated in each of
five annual physical exams, and
‘‘dropouts’’, who did not participate in
the final exam. There was a significant
exposure-response relationship between
exposure to crystalline silica and FEV1
decline among the dropouts but not
among the survivors. The dropout group
had a steeper FEV1 loss, and this was
true for each smoking category. The
authors concluded that exposures of
about 50 ug/m3 produced a measurable
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effect on pulmonary function in the
dropouts. Eisen et al. (1995) felt that the
‘‘healthy worker effect’’ was apparent in
this study and that studies that only
looked at ‘‘survivors’’ would be less
likely to see any effect of silica on
pulmonary function.
A 12-year follow-up of age- and
smoking-matched granite crushers and
referents in Sweden found that over the
follow-up period, the granite crushers
had significantly greater decreases in
FEV1, FEV1/FVC, maximum expiratory
flow, and FEF50 than the referents
(Malmberg et al., 1993). A longitudinal
study of South African gold miners
conducted by Hnizdo (1992) found that
cumulative dust exposure was a
significant predictor of most indices of
decreases in lung function, including
FEV1 and FVC. A multiple linear
regression analysis showed that the
effects of silica exposure and smoking
were additive. Another study of South
African gold miners (Cowie, 1998) also
found a loss of FEV1 in those without
silicosis. Finally, a study of U.S.
automotive foundry workers (Hertzberg
et al., 2002) found a consistent
association with increased pulmonary
function abnormalities and estimated
measures of cumulative silica exposure
within 0.1 mg/m3. The Hnizdo (1992),
Cowie et al. (1993), and Cowie (1998)
studies of South African gold miners
and the Malmberg et al. (1993) study of
Swedish granite workers found very
similar reductions in FEV1 attributable
to silica dust exposure.
A number of prevalence studies have
described relationships between lung
function loss and silica exposure or
exposure measurement surrogates (e.g.,
duration of exposure). These findings
support those of the longitudinal
studies. Such results have been found in
studies of white South African gold
miners (Hnizdo et al., 1990; Irwig and
Rocks, 1978), black South African gold
miners (Cowie and Mabena, 1991),
Quebec silica-exposed workers (Begin,
et al., 1995), Singapore rock drilling and
crushing workers (Ng et al., 1992b),
Vermont granite shed workers
(Theriault et al., 1974a, 1974b),
aggregate quarry workers and coal
miners in Spain (Montes et al., 2004a,
2004b), concrete workers in The
Netherlands (Meijer et al., 2001),
Chinese refractory brick manufacturing
workers in an iron-steel plant (Wang et
al., 1997), Chinese gemstone workers
(Ng et al., 1987b), hard-rock miners in
Manitoba, Canada (Manfreda et al.,
1982) and Colorado (Kreiss et al., 1989),
pottery workers in France (Neukirch et
al., 1994), potato sorters exposed to
diatomaceous earth containing
crystalline silica in The Netherlands
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(Jorna et al., 1994), slate workers in
Norway (Suhr et al., 2003), and men in
a Norwegian community (Humerfelt et
al., 1998). Two of these prevalence
studies also addressed the role of
smoking in lung function impairment
associated with silica exposure. In
contrast to the longitudinal study of
South African gold miners discussed
above (Hnizdo, 1992), another study of
South African gold miners (Hnizdo et
al., 1990) found that the joint effect of
dust and tobacco smoking on lung
function impairment was synergistic,
rather than additive. Also, Montes et al.
(2004b) found that the criteria for dusttobacco interactions were satisfied for
FEV1 decline in a study of Spanish
aggregate quarry workers.
One of the longitudinal studies and
many of the prevalence studies
discussed above directly addressed the
question of whether silica-exposed
workers can develop pulmonary
function impairment in the absence of
silicosis. These studies found that
pulmonary function impairment: (1)
Can occur in silica-exposed workers in
the absence of silicosis, (2) was still
evident when silicosis was controlled
for in the analysis, and (3) was related
to the magnitude and duration of silica
exposure rather than to the presence or
severity of silicosis.
Many researchers have concluded that
a relationship exists between exposure
to silica and lung function impairment.
IARC (1997) has briefly reviewed
studies on airways disease (i.e., chronic
airflow limitation and obstructive
impairment of lung function) in its
monograph on crystalline silica
carcinogenicity and concluded that
exposure to crystalline silica causes
these effects. In its official statement on
the adverse effects of crystalline silica
exposure, the American Thoracic
Society (ATS) (1997) included a section
on airflow obstruction. The ATS noted
that, in most of the studies reviewed,
airflow limitation was associated with
chronic bronchitis. The review of
Hnizdo and Vallyathan (2003) also
addressed COPD due to occupational
silica exposure. They examined the
epidemiological evidence for an
exposure-response relationship for
airflow obstruction in studies where
silicosis was present or absent. Hnizdo
and Vallyathan (2003) concluded that
chronic exposure to silica dust at levels
that do not cause silicosis may cause
airflow obstruction.
Based on the evidence discussed
above from a number of longitudinal
studies and numerous cross-sectional
studies, OSHA preliminarily concludes
that there is an exposure-response
relationship between exposure to
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respirable crystalline silica and the
development of impaired lung function.
The effect of tobacco smoking on this
relationship may be additive or
synergistic. Also, pulmonary function
impairment has been shown to occur
among silica-exposed workers who do
not show signs of silicosis.
4. Non-malignant Respiratory Disease
Mortality
In this section, OSHA reviews studies
on NMRD mortality that focused on
causes of death other than from
silicosis. Two studies of gold miners, a
study of diatomaceous earth workers,
and a case-control analysis of death
certificate data provide useful
information.
Wyndham et al. (1986) found a
significant excess mortality for chronic
respiratory diseases in a cohort of white
South African gold miners. Although
these data did include silicosis
mortality, the authors found evidence
demonstrating that none of the miners
certified on the death certificate as
dying from silicosis actually died from
that disease. Instead, pneumoconiosis
was always an incidental finding in
those dying from some other cause, the
most common of which was chronic
obstructive lung disease. A case-referent
analysis found that, although the major
risk factor for chronic respiratory
disease was smoking, there was a
statistically significant additional effect
of cumulative dust exposure, with the
relative risk estimated to be 2.48 per ten
units of 1000 particle years of exposure.
A synergistic effect of smoking and
cumulative dust exposure on mortality
from COPD was found in another study
of white South African gold miners
(Hnizdo, 1990). Analysis of various
combinations of dust exposure and
smoking found a trend in odds ratios
that indicated this synergism. There was
a statistically significant increasing
trend for dust particle-years and for
cigarette-years of smoking. For
cumulative dust exposure, an exposureresponse relationship was found, with
the analysis estimating that those with
exposures of 10,000, 17,500, or 20,000
particle-years of exposure had a 2.5-,
5.06-, or 6.4-times higher mortality risk
for COPD, respectively, than those with
the lowest dust exposure of less than
5000 particle-years. The authors
concluded that dust alone would not
lead to increased COPD mortality but
that dust and smoking act
synergistically to cause COPD and were
thus the main risk factor for death from
COPD in their study.
Park et al. (2002) analyzed the
California diatomaceous earth cohort
data originally studied by Checkoway et
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al. (1997), consisting of 2,570
diatomaceous earth workers employed
for 12 months or more from 1942 to
1994, to quantify the relationship
between exposure to cristobalite and
mortality from chronic lung disease
other than cancer (LDOC). Diseases in
this category included pneumoconiosis
(which included silicosis), chronic
bronchitis, and emphysema, but
excluded pneumonia and other
infectious diseases. Smoking
information was available for about 50
percent of the cohort and for 22 of the
67 LDOC deaths available for analysis,
permitting Park et al. (2002) to at least
partially adjust for smoking. Using the
exposure estimates developed for the
cohort by Rice et al. (2001) in their
exposure-response study of lung cancer
risks, Park et al. (2002) evaluated the
quantitative exposure-response
relationship for LDOC mortality and
found a strong positive relationship
with exposure to respirable crystalline
silica. OSHA finds this study
particularly compelling because of the
strengths of the study design and
availability of smoking history data on
part of the cohort and high-quality
exposure and job history data;
consequently, OSHA has included this
study in its Preliminary Quantitative
Risk Assessment.
In a case-control analysis of death
certificate data drawn from 27 U.S.
states, Calvert et al. (2003) found
increased mortality odds ratios among
those in the medium and higher
crystalline silica exposure categories, a
significant trend of increased risk for
COPD mortality with increasing silica
exposures, and a significantly increased
odds ratio for COPD mortality in
silicotics as compared to those without
silicosis.
Green and Vallyathan (1996) also
reviewed several studies of NMRD
mortality in workers exposed to silica.
The authors stated that these studies
showed an association between
cumulative dust exposure and death
from the chronic respiratory diseases.
Based on the evidence presented in
the studies above, OSHA preliminarily
concludes that respirable crystalline
silica increases the risk for mortality
from non-malignant respiratory disease
(not including silicosis) in an exposurerelated manner. However, it appears
that the risk is strongly influenced by
smoking, and the effects of smoking and
silica exposure may be synergistic.
D. Renal and Autoimmune Effects
In recent years, evidence has
accumulated that suggests an
association between exposure to
crystalline silica and an increased risk
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of renal disease. Over the past 10 years,
epidemiologic studies have been
conducted that provide evidence of
exposure-response trends to support
this association. There is also suggestive
evidence that silica can increase the risk
of rheumatoid arthritis and other
autoimmune diseases (Steenland,
2005b). In fact, an autoimmune
mechanism has been postulated for
some silica-associated renal disease
(Calvert et al., 1997). This section will
discuss the evidence supporting an
association of silica exposure with renal
and autoimmune diseases.
Overall, there is substantial evidence
suggesting an association between
exposure to crystalline silica and
increased risks of renal and
autoimmune diseases. In addition to a
number of case reports, epidemiologic
studies have found statistically
significant associations between
occupational exposure to silica dust and
chronic renal disease (e.g., Calvert et al.,
1997), subclinical renal changes (e.g.,
Ng et al., 1992c), end-stage renal disease
morbidity (e.g., Steenland et al., 1990),
chronic renal disease mortality
(Steenland et al., 2001b, 2002a), and
Wegener’s granulomatosis (Nuyts et al.,
1995). In other findings, silica-exposed
individuals, both with and without
silicosis, had an increased prevalence of
abnormal renal function (Hotz et al.,
1995), and renal effects have been
reported to persist after cessation of
silica exposure (Ng et al., 1992c).
Possible mechanisms suggested for
silica-induced renal disease include a
direct toxic effect on the kidney,
deposition in the kidney of immune
complexes (IgA) following silica-related
pulmonary inflammation, or an
autoimmune mechanism (Calvert et al.,
1997; Gregorini et al., 1993).
Several studies of exposed worker
populations reported finding excess
renal disease mortality and morbidity.
Wyndham et al. (1986) reported finding
excess mortality from acute and chronic
nephritis among South African
goldminers that had been followed for 9
years. Italian ceramic workers
experienced an overall increase in the
prevalence of end-stage renal disease
(ESRD) cases compared to regional rates;
the six cases that occurred among the
workers had cumulative exposures to
crystalline silica of between 0.2 and 3.8
mg/m3-years (Rapiti et al., 1999).
Calvert et al. (1997) found an
increased incidence of non-systemic
ESRD cases among 2,412 South Dakota
gold miners exposed to a median
crystalline silica concentration of 0.09
mg/m3. In another study of South
Dakota gold miners, Steenland and
Brown (1995a) reported a positive trend
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of chronic renal disease mortality risk
and cumulative exposure to respirable
crystalline silica, but most of the excess
deaths were concentrated among
workers hired before 1930 when
exposures were likely higher than in
more recent years.
Excess renal disease mortality has
also been described among North
American industrial sand workers.
McDonald et al., (2001, 2005) found that
nephritis/nephrosis mortality was
elevated overall among 2,670 industrial
sand workers hired 20 or more years
prior to follow-up, but there was no
apparent relationship with either
cumulative or average exposure to
crystalline silica. However, Steenland et
al. (2001b) did find that increased
mortality from acute and chronic renal
disease was related to increasing
quartiles of cumulative exposure among
a larger cohort of 4,626 industrial sand
workers. In addition, they also found a
positive trend for ESRD case incidence
and quartiles of cumulative exposure.
In a pooled cohort analysis, Steenland
et al. (2002a) combined the industrial
sand cohort from Steenland et al.
(2001b), gold mining cohort from
Steenland and Brown (1995a), and the
Vermont granite cohort studies by
Costello and Graham (1988). In all, the
combined cohort consisted of 13,382
workers with exposure information
available for 12,783. The exposure
estimates were validated by the
monotonically increasing exposureresponse trends seen in analyses of
silicosis, since cumulative silica levels
are known to predict silicosis risk. The
mean duration of exposure, cumulative
exposure, and concentration of
respirable silica for the cohort were 13.6
years, 1.2 mg/m3-years, and 0.07 mg/m3,
respectively.
The analysis demonstrated
statistically significant exposureresponse trends for acute and chronic
renal disease mortality with quartiles of
cumulative exposure to respirable
crystalline silica. In a nested casecontrol study design, a positive
exposure-response relationship was
found across the three cohorts for both
multiple-cause mortality (i.e., any
mention of renal disease on the death
certificate) and underlying cause
mortality. Renal disease risk was most
prevalent among workers with
cumulative exposures of 0.5 mg/m3 or
more (Steenland et al., 2002a).
Other studies failed to find an excess
renal disease risk among silica-exposed
workers. Davis et al. (1983) found an
elevated, but not a statistically
significant increase, in mortality from
diseases of the genitourinary system
among Vermont granite shed workers.
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There was no observed relationship
between mortality from this cause and
cumulative exposure. A similar finding
was reported by Koskela et al. (1987)
among Finnish granite workers, where
there were 4 deaths due to urinary tract
disease compared to 1.8 expected. Both
Carta et al. (1994) and Cocco et al.
(1994) reported finding no increased
mortality from urinary tract disease
among workers in an Italian lead mine
and a zinc mine. However, Cocco et al.
(1994) commented that exposures to
respirable crystalline silica were low,
averaging 0.007 and 0.09 mg/m3 in the
two mines, respectively, and that their
study in particular had low statistical
power to detect excess mortality.
There are many case series, casecontrol, and cohort studies that provide
support for a causal relationship
between exposure to respirable
crystalline silica and an increased renal
disease risk (Kolev et al., 1970; Osorio
et al., 1987; Steenland et al., 1990;
Gregorini et al., 1993; Nuyts et al.,
1995). In addition, a number of studies
have demonstrated early clinical signs
of renal dysfunction (i.e., urinary
excretion of low- and high-molecular
weight proteins and other markers of
renal glomerular and tubular disruption)
in workers exposed to crystalline silica,
both with and without silicosis (Ng et
al., 1992c; Hotz et al., 1995; Boujemaa,
1994; Rosenman et al., 2000).
OSHA believes that there is
substantial evidence on which to base a
finding that exposure to respirable
crystalline silica increases the risk of
renal disease mortality and morbidity.
In particular, OSHA believes that the 3cohort pooled analysis conducted by
Steenland et al. (2002a) is particularly
convincing. OSHA believes that the
findings of this pooled analysis seem
credible because the analysis involved a
large number of workers from three
cohorts with well-documented,
validated job-exposure matrices and
found a positive and monotonic
increase in renal disease risk with
increasing exposure for both underlying
and multiple cause data. However, there
are considerably less data, and thus the
findings based on them are less robust,
than what is available for silicosis
mortality or lung cancer mortality.
Nevertheless, OSHA preliminarily
concludes that the underlying data are
sufficient to provide useful estimates of
risk and has included the Steenland et
al. (2002a) analysis in its Preliminary
Quantitative Risk Assessment.
Several studies of different designs,
including case series, cohort, registry
linkage and case-control, conducted in a
variety of exposed groups suggest an
association between silica exposure and
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increased risk of systemic autoimmune
disease (Parks et al., 1999). Studies have
found that the most common
autoimmune diseases associated with
silica exposure are scleroderma (e.g.,
Sluis-Cremer et al., 1985); rheumatoid
arthritis (e.g. Klockars et al., 1987;
Rosenman and Zhu, 1995); and systemic
lupus erythematosus (e.g., Brown et al.,
1997). Mechanisms suggested for silicarelated autoimmune disease include an
adjuvant effect of silica (Parks et al.,
1999), activation of the immune system
by the fibrogenic proteins and growth
factors released as a result of the
interaction of silica particles with
macrophages (e.g., Haustein and
Anderegg, 1998), and a direct local
effect of non-respirable silica particles
penetrating the skin and producing
scleroderma (Green and Vallyathan,
1996). However, there are no
quantitative exposure-response data
available at this time on which to base
a quantitative risk assessment for
autoimmune diseases.
Therefore, OSHA preliminarily
concludes that there is substantial
evidence that silica exposure increases
the risks of renal and autoimmune
disease. The positive and monotonic
exposure-response trends demonstrated
for silica exposure and renal disease risk
more strongly suggest a causal link. The
studies by Steenland et al. (2001b,
2002a) and Steenland and Brown
(1995a) provide evidence of a positive
exposure-response relationship. For
autoimmune diseases, the available data
did not provide an adequate basis for
assessing exposure-response
relationships. However, OSHA believes
that the available exposure-response
data on silica exposure and renal
disease is sufficient to allow for
quantitative estimates of risk.
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E. Physical Factors That May Influence
Toxicity of Crystalline Silica
Much research has been conducted to
investigate the influence of various
physical factors on the toxicologic
potency of crystalline silica. Such
factors examined include crystal
polymorphism; the age of fractured
surfaces of the crystal particle; the
presence of impurities, particularly
metals, on particle surfaces; and clay
occlusion of the particle. These factors
likely vary among different workplace
settings suggesting that the risk to
workers exposed to a given level of
respirable crystalline silica may not be
equivalent in different work
environments. In this section, OSHA
examines the research demonstrating
the effects of these factors on the
toxicologic potency of silica.
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The modification of surface
characteristics by the physical factors
noted above may alter the toxicity of
silica by affecting the physical and
biochemical pathways of the
mechanistic process. Thus, OSHA has
reviewed the proposed mechanisms by
which silica exposure leads to silicosis
and lung cancer. It has been proposed
that silicosis results from a cycle of cell
damage, oxidant generation,
inflammation, scarring and fibrosis. A
silica particle entering the lung can
cause lung damage by two major
mechanisms: direct damage to lung cells
due to the silica particle’s unique
surface properties or by the activation or
stimulation of alveolar macrophages
(after phagocytosis) and/or alveolar
epithelial cells. In either case, an
elevated production of reactive oxygen
and nitrogen species (ROS/RNS) results
in oxidant damage to lung cells. The
oxidative stress and lung injury
stimulates alveolar macrophages and/or
alveolar epithelial cells to produce
growth factors and fibrogenic mediators,
resulting in fibroblast activation and
pulmonary fibrosis. A continuous
ingestion-reingestion cycle, with cell
activation and death, is established.
OSHA has examined evidence on the
comparative toxicity of the silica
polymorphs (quartz, cristobalite, and
tridymite). A number of animal studies
appear to suggest that cristobalite and
tridymite are more toxic to the lung than
quartz and more tumorigenic (e.g., King
et al., 1953; Wagner et al., 1980).
However, in contrast to these findings,
several authors have reviewed the
studies done in this area and concluded
that cristobalite and tridymite are not
more toxic than quartz (e.g., Bolsaitis
and Wallace, 1996; Guthrie and Heaney,
1995). Furthermore, a difference in
toxicity between cristobalite and quartz
has not been observed in epidemiologic
studies (tridymite has not been studied)
(NIOSH, 2002). In an analysis of
exposure-response for lung cancer,
Steenland et al. (2001a) found similar
exposure-response trends between
cristobalite-exposed workers and other
cohorts exposed to quartz.
A number of studies have compared
the toxicity of freshly fractured versus
aged silica. Although animal studies
have demonstrated that freshly fractured
silica is more toxic than aged silica,
aged silica still retains significant
toxicity (Porter et al., 2002; Shoemaker
et al., 1995; Vallyathan et al., 1995).
Studies of workers exposed to freshly
fractured silica have demonstrated that
these workers exhibit the same cellular
effects as seen in animals exposed to
freshly fractured silica (Castranova et
al., 1998; Goodman et al., 1992). There
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have been no studies, however,
comparing workers exposed to freshly
fractured silica to those exposed to aged
silica. Animal studies also suggest that
pulmonary reactions of rats to shortduration exposure to freshly fractured
silica mimic those seen in acute silicosis
in humans (Vallyathan et al., 1995).
Surface impurities, particularly
metals, have been shown to alter silica
toxicity. Iron, depending on its state and
quantity, has been shown to either
increase or decrease toxicity. Aluminum
has been shown to decrease toxicity
(Castranova et al., 1997; Donaldson and
Borm, 1998; Fubini, 1998). Silica coated
with aluminosilicate clay exhibits lower
toxicity, possibly as a result of reduced
bioavailability of the silica particle
surface (Donaldson and Borm, 1998;
Fubini, 1998). This reduced
bioavailability may be due to aluminum
ions left on the silica surface by the clay
(Bruch et al., 2004; Cakmak et al., 2004;
Fubini et al., 2004). Aluminum and
other metal ions are thought to modify
silanol groups on the silica surface, thus
decreasing the membranolytic and
cytotoxic potency and resulting in
enhanced particle clearance from the
lung before damage can take place
(Fubini, 1998). An epidemiologic study
found that the risk of silicosis was less
in pottery workers than in tin and
tungsten miners (Chen et al., 2005;
Harrison et al., 2005), possibly reflecting
that pottery workers were exposed to
silica particles having less biologically
available, non-clay-occluded surface
area than was the case for miners. The
authors concluded that clay occlusion of
silica particles can be a factor in
reducing disease risk.
Although it is evident that a number
of factors can act to mediate the
toxicological potency of crystalline
silica, it is not clear how such
considerations should be taken into
account to evaluate lung cancer and
silicosis risks to exposed workers. After
evaluating many in vitro studies that
had been conducted to investigate the
surface characteristics of crystalline
silica particles and their influence on
fibrogenic activity, NIOSH (2002)
concluded that further research is
needed to associate specific surface
characteristics that can affect toxicity
with specific occupational exposure
situations and consequent health risks
to workers. According to NIOSH (2002),
such exposures may include work
processes that produce freshly fractured
silica surfaces or that involve quartz
contaminated with trace elements such
as iron. NIOSH called for further in vitro
and in vivo studies of the toxicity and
pathogenicity of alpha quartz compared
with its polymorphs, quartz
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contaminated with trace elements, and
further research on the association of
surface properties with specific work
practices and health effects.
In discussing the ‘‘considerable’’
heterogeneity shown across the 10
studies used in the pooled lung cancer
risk analysis, Steenland et al. (2001a)
pointed to hypotheses that physical
differences in silica exposure (e.g.,
freshness of particle cleavage) between
cohorts may be a partial explanation of
observed differences in exposureresponse coefficients derived from those
cohort studies. However, the authors
did not have specific information on
whether or how these factors might have
actually influenced the observed
differences. Similarly, in the pooled
analysis and risk assessments for
silicosis mortality conducted by
Mannetje et al. (2002b), differences in
biological activity of different types of
silica dust could not be specifically
taken into account. Mannetje et al.
(2002b) determined that the exposureresponse relationship between silicosis
and log-transformed cumulative
exposure to crystalline silica was
comparable between studies and no
significant heterogeneity was found.
The authors therefore concluded that
their findings were relevant for different
circumstances of occupational exposure
to crystalline silica. Both the Steenland
et al. (2001a) and Mannetje et al. (2002b)
studies are discussed in detail in
OSHA’s Preliminary Quantitative Risk
Assessment (section II of the
background document and summarized
in section VI of this preamble).
OSHA preliminarily concludes that
there is considerable evidence to
support the hypothesis that surface
activity of crystalline silica particles
plays an important role in producing
disease, and that several environmental
influences can modify surface activity to
either enhance or diminish the toxicity
of silica. However, OSHA believes that
the available information is insufficient
to determine in any quantitative way
how these influences may affect disease
risk to workers in any particular
workplace setting.
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VI. Summary of OSHA’s Preliminary
Quantitative Risk Assessment
A. Introduction
The Occupational Safety and Health
Act (OSH Act or Act) and some
landmark court cases have led OSHA to
rely on quantitative risk assessment, to
the extent possible, to support the risk
determinations required to set a
permissible exposure limit (PEL) for a
toxic substance in standards under the
OSH Act. A determining factor in the
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decision to perform a quantitative risk
assessment is the availability of suitable
data for such an assessment. In the case
of crystalline silica, there has been
extensive research on its health effects,
and several quantitative risk
assessments have been published in the
peer-reviewed scientific literature that
describe the risk to exposed workers of
lung cancer mortality, silicosis mortality
and morbidity, non-malignant
respiratory disease mortality, and renal
disease mortality. These assessments
were based on several studies of
occupational cohorts in a variety of
industry sectors, the underlying studies
of which are described in OSHA’s
review of the health effects literature
(see section V of this preamble). In this
section, OSHA summarizes its
Preliminary Quantitative Risk
Assessment (QRA) for crystalline silica,
which is presented in Section II of the
background document entitled
‘‘Respirable Crystalline Silica—Health
Effects Literature Review and
Preliminary Quantitative Risk
Assessment’’ (placed in Docket OSHA–
2010–0034).
OSHA has done what it believes to be
a comprehensive review of the literature
to provide quantitative estimates of risk
for crystalline silica-related diseases.
Quantitative risk assessments for lung
cancer and silicosis mortality were
published after the International Agency
for Research on Cancer (IARC)
determined more than a decade ago that
there was sufficient evidence to regard
crystalline silica as a human carcinogen
(IARC, 1997). This finding was based on
several studies of worker cohorts
demonstrating associations between
exposure to crystalline silica and an
increased risk of lung cancer. Although
IARC judged the overall evidence as
being sufficient to support this
conclusion, IARC also noted that some
studies of crystalline silica-exposed
workers did not demonstrate an excess
risk of lung cancer and that exposureresponse trends were not always
consistent among studies that were able
to describe such trends. These findings
led Steenland et al. (2001a) and
Mannetje et al. (2002b) to conduct
comprehensive exposure-response
analyses of the risk of lung cancer and
silicosis mortality associated with
exposure to crystalline silica. These
studies, referred to as the IARC multicenter studies of lung cancer and
silicosis mortality, relied on all
available cohort data from previously
published epidemiological studies for
which there were adequate quantitative
data on worker exposures to crystalline
silica to derive pooled estimates of
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disease risk. In addition, OSHA
identified four single-cohort studies of
lung cancer mortality that it judged
suitable for quantitative risk assessment;
two of these cohorts (Attfield and
Costello, 2004; Rice et al., 2001) were
included among the 10 used in the IARC
multi-center study and studies of two
other cohorts appeared later (Hughes et
al., 2001; McDonald et al., 2001, 2005;
Miller and MacCalman, 2009). For nonmalignant respiratory disease mortality,
in addition to the silicosis mortality
study by Mannetje et al. (2002b), Park et
al. (2002) conducted an exposureresponse analysis of non-malignant
respiratory disease mortality (including
silicosis and other chronic obstructive
pulmonary diseases) among
diatomaceous earth workers. Exposureresponse analyses for silicosis morbidity
have been published in several singlecohort studies (Chen et al., 2005;
Hnizdo and Sluis-Cremer, 1993;
Steenland and Brown, 1995b; Miller et
al., 1998; Buchanan et al., 2003).
Finally, a quantitative assessment of
end-stage renal disease mortality based
on data from three worker cohorts was
developed by Steenland et al. (2002a).
In addition to these published studies,
OSHA’s contractor, Toxichemica, Inc.,
commissioned Drs. Kyle Steenland and
Scott Bartell of Emory University to
perform an uncertainty analysis to
examine the effect on lung cancer and
silicosis mortality risk estimates of
uncertainties that exist in the exposure
assessments underlying the two IARC
multi-center analyses (Toxichemica,
Inc., 2004).
OSHA’s Preliminary QRA presents
estimates of the risk of silica-related
diseases assuming exposure over a
working life (45 years) to the proposed
8-hour time-weighted average (TWA)
PEL and action level of 0.05 and 0.025
mg/m3, respectively, of respirable
crystalline silica, as well as to OSHA’s
current PELs. OSHA’s current general
industry PEL for respirable quartz is
expressed both in terms of a particle
count formula and a gravimetric
concentration formula, while the
current construction and shipyard
employment PELs for respirable quartz
are only expressed in terms of a particle
count formula. The current PELs limit
exposure to respirable dust; the specific
limit in any given instance depends on
the concentration of crystalline silica in
the dust. For quartz, the gravimetric
general industry PEL approaches a limit
of 0.1 mg/m3 as respirable quartz as the
quartz content increases (see discussion
in Section XVI of this preamble,
Summary and Explanation for
paragraph (c)). OSHA’s Preliminary
QRA presents risk estimates for
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exposure over a working lifetime to 0.1
mg/m3 to represent the risk associated
with exposure to the current general
industry PEL. OSHA’s current PEL for
construction and shipyard employment
is a formula PEL that limits exposure to
respirable dust expressed as a respirable
particle count concentration. As with
the gravimetric general industry PEL,
the limit varies depending on quartz
content of the dust. There is no single
mass concentration equivalent for the
construction and shipyard PELs;
OSHA’s Preliminary QRA reviews
several studies that suggest that the
current construction/shipyard PEL
likely lies in the range between 0.25 and
0.5 mg/m3 respirable quartz, and OSHA
presents risk estimates for this range of
exposure to represent the risks
associated with exposure to the current
construction/shipyard PEL. In general
industry, for both the gravimetric and
particle count PELs, OSHA’s current
PEL for cristobalite and tridymite are
half the value for quartz. Thus, OSHA’s
Preliminary QRA presents risk estimates
associated with exposure over a working
lifetime to 0.025, 0.05, 0.1, 0.25, and 0.5
mg/m3 respirable silica (corresponding
to cumulative exposures over 45 years
to 1.125, 2.25, 4.5, 11.25, and 22.5 mg/
m3-years).
Risk estimates for lung cancer
mortality, silicosis and non-malignant
respiratory disease mortality, and renal
disease mortality are presented in terms
of lifetime (up to age 85) excess risk per
1,000 workers for exposure over an 8hour working day, 250 days per year,
and a 45-year working life. For silicosis
morbidity, OSHA based its risk
estimates on cumulative risk models
used by the various investigators to
develop quantitative exposure-response
relationships. These models
characterized the risk of developing
silicosis (as detected by chest
radiography) up to the time that cohort
members (including both active and
retired workers) were last examined.
Thus, risk estimates derived from these
studies represent less-than-lifetime risks
of developing radiographic silicosis.
OSHA did not attempt to estimate
lifetime risk (i.e., up to age 85) for
silicosis morbidity because the
relationships between age, time, and
disease onset post-exposure have not
been well characterized.
A draft preliminary quantitative risk
assessment document was submitted for
external scientific peer review in
accordance with the Office of
Management and Budget’s ‘‘Final
Information Quality Bulletin for Peer
Review’’ (OMB, 2004). A summary of
OSHA’s responses to the peer reviewers’
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comments appears in Section III of the
background document.
In the sections below, OSHA
describes the studies and the published
risk assessments it uses to estimate the
occupational risk of crystalline silicarelated disease. (The Preliminary QRA
itself also discusses several other
available studies that OSHA does not
include and OSHA’s reasons for not
including these studies.)
B. Lung Cancer Mortality
1. Summary of Studies
In its Preliminary QRA, OSHA
discusses risk assessments from six
published studies that quantitatively
analyzed exposure-response
relationships for crystalline silica and
lung cancer; some of these also provided
estimates of risks associated with
exposure to OSHA’s current PEL or
NIOSH’s Recommended Exposure Limit
(REL) of 0.05 mg/m3. These studies
include: (1) A quantitative analysis by
Steenland et al. (2001a) of worker cohort
data pooled from ten studies; (2) an
exposure-response analysis by Rice et
al. (2001) of a cohort of diatomaceous
earth workers primarily exposed to
cristobalite; (3) an analysis by Attfield
and Costello (2004) of U.S. granite
workers; (4) a risk assessment by
Kuempel et al. (2001), who employed a
kinetic rat lung model to describe the
relationship between quartz lung
burden and cancer risk, then calibrated
and validated that model using the
diatomaceous earth worker and granite
worker cohort mortality data; (5) an
exposure-response analysis by Hughes
et al., (2001) of U.S. industrial sand
workers; and (6) a risk analysis by
Miller et al. (2007) and Miller and
MacCalman (2009) of British coal
miners. These six studies are described
briefly below and are followed by a
summary of the lung cancer risk
estimates derived from these studies.
a. Steenland et al. (2001a) Pooled Cohort
Analysis
OSHA considers the lung cancer
analysis conducted by Steenland et al.
(2001a) to be of prime importance for
risk estimation because of its size,
incorporation of data from multiple
cohorts, and availability of detailed
exposure and job history data.
Subsequent to its publication, Steenland
and Bartell (Toxichemica, Inc., 2004)
conducted a quantitative uncertainty
analysis on the pooled data set to
evaluate the potential impact on the risk
estimates of random and systematic
exposure misclassification, and
Steenland (personal communication,
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2010) conducted additional exposureresponse modeling.
The original study consisted of a
pooled exposure-response analysis and
risk assessment based on raw data
obtained from ten cohorts of silicaexposed workers (65,980 workers, 1,072
lung cancer deaths). Steenland et al.
(2001a) initially identified 13 cohort
studies as containing exposure
information sufficient to develop a
quantitative exposure assessment; the
10 studies included in the pooled
analysis were those for which data on
exposure and health outcome could be
obtained for individual workers. The
cohorts in the pooled analysis included
U.S. gold miners (Steenland and Brown,
1995a), U.S. diatomaceous earth
workers (Checkoway et al., 1997),
Australian gold miners (de Klerk and
Musk, 1998), Finnish granite workers
(Koskela et al., 1994), U.S. industrial
sand employees (Steenland and
Sanderson, 2001), Vermont granite
workers (Costello and Graham, 1988),
South African gold miners (Hnizdo and
Sluis-Cremer, 1991; Hnizdo et al., 1997),
and Chinese pottery workers, tin
miners, and tungsten miners (Chen et
al., 1992).
The exposure assessments developed
for the pooled analysis are described by
Mannetje et al. (2002a). The exposure
information and measurement methods
used to assess exposure from each of the
10 cohort studies varied by cohort and
by time and included dust
measurements representing particle
counts, mass of total dust, and
respirable dust mass. All exposure
information was converted to units of
mg/m3 respirable crystalline silica by
generating cohort-specific conversion
factors based on the silica content of the
dust to which workers were exposed.
A case-control study design was
employed for which cases and controls
were matched for race, sex, age (within
5 years) and study; 100 controls were
matched to each case. To test the
reasonableness of the cumulative
exposure estimates for cohort members,
Mannetje et al. (2002a) examined
exposure-response relationships for
silicosis mortality by performing a
nested case-control analysis for silicosis
or unspecified pneumoconiosis using
conditional logistic regression. Each
cohort was stratified into quartiles by
cumulative exposure, and standardized
rate ratios (SRR) for silicosis were
calculated using the lowest-exposure
quartile as the baseline. Odds ratios
(OR) for silicosis were also calculated
for the pooled data set overall, which
was stratified into quintiles based on
cumulative exposure.
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For the pooled data set, the
relationship between odds ratio for
silicosis mortality and increasing
cumulative exposure was ‘‘positive and
reasonably monotonic’’, ranging from
3.1 for the lowest quartile of exposure
to 4.8 for the highest. In addition, in
seven of the ten individual cohorts,
there were statistically significant trends
between silicosis mortality rate ratios
(SRR) and cumulative exposure. For two
of the cohorts (U.S. granite workers and
U.S. gold miners), the trend test was not
statistically significant (p=0.10). A trend
analysis could not be performed on the
South African gold miner cohort since
silicosis was not coded as an underlying
cause of death in that country. A more
rigorous analysis of silicosis mortality
on pooled data from six of these cohorts
also showed a strong, statistically
significant increasing trend with
increasing decile of cumulative
exposure (Mannetje et al., 2002b),
providing additional evidence for the
reasonableness of the exposure
assessment used for the Steenland et al
(2001a) lung cancer analysis.
For the pooled lung cancer mortality
analysis, Steenland et al. (2001a)
conducted a nested case-control
analysis via Cox regression, in which
there were 100 controls chosen for each
case randomly selected from among
cohort members who survived past the
age at which the case died, and matched
on age (the time variable in Cox
regression), study, race/ethnicity, sex,
and date of birth within 5 years (which,
in effect, matched on calendar time
given the matching on age). Using
alternative continuous exposure
variables in a log-linear relative risk
model (log RR=bx, where x represents
the exposure variable and b the
coefficient to be estimated), Steenland et
al. (2001a) found that the use of either
1) cumulative exposure with a 15-year
lag, 2) the log of cumulative exposure
with a 15-year lag, or 3) average
exposure resulted in positive
statistically significant (p≤0.05)
exposure-response coefficients. The
models that provided the best fit to the
data were those that used cumulative
exposure and log-transformed
cumulative exposure. The fit of the loglinear model with average exposure was
clearly inferior to those using
cumulative and log-cumulative
exposure metrics.
There was significant heterogeneity
among studies (cohorts) using either
cumulative exposure or average
exposure. The authors suggested a
number of possible reasons for such
heterogeneity, including errors in
measurement of high exposures (which
tends to have strong influence on the
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exposure-response curve when
untransformed exposure measures are
used), the differential toxicity of silica
depending on the crystalline
polymorph, the presence of coatings or
trace minerals that alter the reactivity of
the crystal surfaces, and the age of the
fractured surfaces. Models that used the
log transform of cumulative exposure
showed no statistically significant
heterogeneity among cohorts (p=0.36),
possibly because they are less
influenced by very high exposures than
models using untransformed cumulative
exposure. For this reason, as well as the
good fit of the model using logcumulative exposure, Steenland et al.
(2001a) conducted much of their
analysis using log-transformed
cumulative exposure. The sensitivity
analysis by Toxichemica, Inc. (2004)
repeated this analysis after correcting
some errors in the original coding of the
data set. At OSHA’s request, Steenland
(2010) also conducted a categorical
analysis of the pooled data set and
additional analyses using linear relative
risk models (with and without logtransformation of cumulative exposure)
as well as a 2-piece spline model.
The cohort studies included in the
pooled analysis relied in part on particle
count data and the use of conversion
factors to estimate exposures of workers
to mass respirable quartz. A few studies
were able to include at least some
respirable mass sampling data. OSHA
believes that uncertainty in the
exposure assessments that underlie each
of the 10 studies included in the pooled
analysis is likely to represent one of the
most important sources of uncertainty
in the risk estimates. To evaluate the
potential impact of uncertainties in the
underlying exposure assessments on
estimates of the risk, OSHA’s contractor,
Toxichemica, Inc. (2004), commissioned
Drs. Kyle Steenland and Scott Bartell of
Emory University to conduct an
uncertainty analysis using the raw data
from the pooled cancer risk assessment.
The uncertainty analysis employed a
Monte Carlo technique in which two
kinds of random exposure measurement
error were considered; these were (1)
random variation in respirable dust
measurements and (2) random error in
estimating respirable quartz exposures
from historical data on particle count
concentration, total dust mass
concentration, and respirable dust mass
concentration measurements. Based on
the results of this uncertainty analysis,
OSHA does not have reason to believe
that random error in the underlying
exposure estimates in the Steenland et
al. (2001a) pooled cohort study of lung
cancer is likely to have substantially
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influenced the original findings,
although a few individual cohorts
(particularly the South African and
Australian gold miner cohorts) appeared
to be sensitive to measurement errors.
The sensitivity analysis also
examined the potential effect of
systematic bias in the use of conversion
factors to estimate respirable crystalline
silica exposures from historical data.
Absent a priori reasons to suspect bias
in a specific direction (with the possible
exception of the South African cohort),
Toxichemica, Inc. (2004) considered
possible biases in either direction by
assuming that exposure was underestimated by 100% (i.e., the true
exposure was twice the estimated) or
over-estimated by 100% (i.e., the true
exposure was half the estimated) for any
given cohort in the original pooled
dataset. For the conditional logistic
regression model using log cumulative
exposure with a 15-year lag, doubling or
halving the exposure for a specific study
resulted in virtually no change in the
exposure-response coefficient for that
study or for the pooled analysis overall.
Therefore, based on the results of the
uncertainty analysis, OSHA believes
that misclassification errors of a
reasonable magnitude in the estimation
of historical exposures for the 10 cohort
studies were not likely to have
substantially biased risk estimates
derived from the exposure-response
model used by Steenland et al. (2001a).
b. Rice et al. (2001) Analysis of
Diatomaceous Earth Workers
Rice et al. (2001) applied a variety of
exposure-response models to the same
California diatomaceous earth cohort
data originally reported on by
Checkoway et al. (1993, 1996, 1997) and
included in the pooled analysis
conducted by Steenland et al. (2001a)
described above. The cohort consisted
of 2,342 white males employed for at
least one year between 1942 and 1987
in a California diatomaceous earth
mining and processing plant. The cohort
was followed until 1994, and included
77 lung cancer deaths. Rice et al. (2001)
relied on the dust exposure assessment
developed by Seixas et al. (1997) from
company records of over 6,000 samples
collected from 1948 to 1988; cristobalite
was the predominate form of crystalline
silica to which the cohort was exposed.
Analysis was based on both Poisson
regression models Cox’s proportional
hazards models with various functions
of cumulative silica exposure in mg/m3years to estimate the relationship
between silica exposure and lung cancer
mortality rate. Rice et al. (2001) reported
that exposure to crystalline silica was a
significant predictor of lung cancer
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mortality for nearly all of the models
employed, with the linear relative risk
model providing the best fit to the data
in the Poisson regression analysis.
c. Attfield and Costello (2004) Analysis
of Granite Workers
Attfield and Costello (2004) analyzed
the same U.S. granite cohort originally
studied by Costello and Graham (1988)
and Davis et al. (1983) and included in
the Steenland et al. (2001a) pooled
analysis, consisting of 5,414 male
granite workers who were employed in
the Vermont granite industry between
1950 and 1982 and who had received at
least one chest x-ray from the
surveillance program of the Vermont
Department of Industrial Hygiene. Their
2004 report extended follow-up from
1982 to 1994, and found 201 deaths.
Workers’ cumulative exposures were
estimated by Davis et al. (1983) based on
historical exposure data collected in six
environmental surveys conducted
between 1924 and 1977, plus work
history information.
Using Poisson regression models and
seven cumulative exposure categories,
the authors reported that the results of
the categorical analysis showed a
generally increasing trend of lung
cancer rate ratios with increasing
cumulative exposure, with seven lung
cancer death rate ratios ranging from
1.18 to 2.6. A complication of this
analysis was that the rate ratio for the
highest exposure group in the analysis
(cumulative exposures of 6.0 mg/m3years or higher) was substantially lower
than those for other exposure groups.
Attfield and Costello (2004) reported
that the best-fitting model was based on
a 15-year lag, use of untransformed
cumulative exposure, and omission of
the highest exposure group.
The authors argued that it was
appropriate to base their risk estimates
on a model that was fitted without the
highest exposure group for several
reasons. They believed the underlying
exposure data for the high-exposure
group was weaker than for the others,
and that there was a greater likelihood
that competing causes of death and
misdiagnoses of causes of death
attenuated the lung cancer death rate.
Second, all of the remaining groups
comprised 85 percent of the deaths in
the cohort and showed a strong linear
increase in lung cancer mortality with
increasing exposure. Third, Attfield and
Costello (2004) believed that the
exposure-response relationship seen in
the lower exposure groups was more
relevant given that the exposures of
these groups were within the range of
current occupational standards. Finally,
the authors stated that risk estimates
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derived from the model after excluding
the highest exposure group were more
consistent with other published risk
estimates than was the case for
estimates derived from the model using
all exposure groups. Because of these
reasons, OSHA believes it is appropriate
to rely on the model employed by
Attfield and Costello (2004) after
omitting the highest exposure group.
d. Kuempel et al. (2001) Rat-Based
Model for Human Lung Cancer
Kuempel et al. (2001) published a ratbased toxicokinetic/toxicodynamic
model for silica exposure for predicting
human lung cancer, based on lung
burden concentrations necessary to
cause the precursor events that can lead
to adverse physiological effects in the
lung. These adverse physiological
effects can then lead to lung fibrosis and
an indirect genotoxic cause of lung
cancer. The hypothesized first step, or
earliest expected response, in these
disease processes is chronic lung
inflammation, which the authors
consider as a disease limiting step.
Since the NOAEL of lung burden
associated with this inflammation,
based on the authors’ rat-to-human lung
model conversion, is the equivalent of
exposure to 0.036 mg/m3 (Mcrit) for 45
years, exposures below this level would
presumably not lead to (based on an
indirect genotoxic mechanism) lung
cancer, at least in the ‘‘average
individual.’’ Since silicosis also is
inflammation mediated, this exposure
could also be considered to be an
average threshold level for that disease
as well.
Kuempel et al. (2001) have used their
rat-based lung cancer model with
human data, both to validate their
model and to estimate the lung cancer
risk as a function of quartz lung burden.
First they ‘‘calibrated’’ human lung
burdens from those in rats based on
exposure estimates and lung autopsy
reports of U.S. coal miners. Then they
validated these lung burden estimates
using quartz exposure data from U.K.
coal miners. Using these human lung
burden/exposure concentration
equivalence relationships, they then
converted the cumulative exposure-lung
cancer response slope estimates from
both the California diatomaceous earth
workers (Rice et al., 2001) and Vermont
granite workers (Attfield and Costello,
2001) to lung burden-lung cancer
response slope estimates. Finally, they
used these latter slope estimates in a life
table program to estimate lung cancer
risk associated with their ‘‘threshold’’
exposure of 0.036 mg/m3 and to the
OSHA PEL and NIOSH REL. Comparing
the estimates from the two
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epidemiology studies with those based
on a male rat chronic silica exposure
study the authors found that, ’’ the lung
cancer excess risk estimates based on
male rat data are approximately three
times higher than those based on the
male human data.’’ Based on this
modeling and validation exercise,
Keumpel et al. concluded, ‘‘the ratbased estimates of excess lung cancer
risk in humans exposed to crystalline
silica are reasonably similar to those
based on two human occupational
epidemiology studies.’’
Toxichemica, Inc. (2004) investigated
whether use of the dosimetry model
would substantially affect the results of
the pooled lung cancer data analysis
initially conducted by Steenland et al.
(2001a). They replicated the lung
dosimetry model using Kuempel et al.’s
(2001) reported median fit parameter
values, and compared the relationship
between log cumulative exposure and
15-year lagged lung burden at the age of
death in case subjects selected for the
pooled case-control analysis. The two
dose metrics were found to be highly
correlated (r=0.99), and models based
on either log silica lung burden or log
cumulative exposure were similarly
good predictors of lung cancer risk in
the pooled analysis (nearly identical
log-likelihoods of –4843.96 and—
4843.996, respectively). OSHA believes
that the Kuempel et al. (2001) analysis
is a credible attempt to quantitatively
describe the retention and accumulation
of quartz in the lung, and to relate the
external exposure and its associated
lung burden to the inflammatory
process. However, using the lung
burden model to convert the cumulative
exposure coefficients to a different
exposure metric appears to add little
additional information or insight to the
risk assessments conducted on the
diatomaceous earth and granite cohort
studies. Therefore, for the purpose of
quantitatively evaluating lung cancer
risk in exposed workers, OSHA has
chosen to rely on the epidemiology
studies themselves and the cumulative
exposure metrics used in those studies.
e. Hughes et al. (2001), McDonald et al.
(2001), and McDonald et al. (2005)
Study of North American Industrial
Sand Workers
McDonald et al. (2001), Hughes et al.
(2001) and McDonald et al. (2005)
followed up on a cohort study of North
American industrial sand workers that
overlapped with the industrial sand
cohort (18 plants, 4,626 workers)
studied by Steenland and Sanderson
(2001) and included in Steenland et al.’s
(2001a) pooled cohort analysis. The
McDonald et al. (2001) follow-up cohort
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included 2,670 men employed before
1980 for three years or more in one of
nine North American (8 U.S. and 1
Canadian) sand-producing plants,
including 1 large associated office
complex. Information on cause of death
was obtained, from 1960 through 1994,
for 99 percent of the deceased workers
for a total 1,025 deaths representing 38
percent of the cohort. A nested casecontrol study and analysis based on 90
lung cancer deaths from this cohort was
also conducted by Hughes et al. (2001).
A later update through 2000, of both the
cohort and nested case-control studies
by McDonald et al. (2005), eliminated
the Canadian plant, following 2,452
men from the eight U.S. plants. For the
lung cancer case-control part of the
study the update included 105 lung
cancer deaths. Both the initial and
updated case control studies used up to
two controls per case.
Although the cohort studies provided
evidence of increased risk of lung
cancer (SMR = 150, p = 0.001, based on
U.S. rates) for deaths occurring 20 or
more years from hire, the nested casecontrol studies, Hughes et al. (2001) and
McDonald et al. (2005), allowed for
individual job, exposure, and smoking
histories to be taken into account in the
exposure-response analysis for lung
cancer. Both of these case-control
analyses relied on an analysis of
exposure information reported by
Sanderson et al. (2000) and by Rando et
al. (2001) to provide individual
estimates of average and cumulative
exposure. Statistically significant
positive exposure-response trends for
lung cancer were found for both
cumulative exposure (lagged 15 years)
and average exposure concentration, but
not for duration of employment, after
controlling for smoking. A monotonic
increase was seen for both lagged and
unlagged cumulative exposure when the
four upper exposure categories were
collapsed into two. With exposure
lagged 15 years and after adjusting for
smoking, increasing quartiles of
cumulative silica exposure were
associated with lung cancer mortality
(odds ratios of 1.00, 0.84, 2.02 and 2.07,
p-value for trend=0.04). There was no
indication of an interaction effect of
smoking and cumulative silica exposure
(Hughes et al., 2001).
OSHA considers this Hughes et al.
(2001) study and analysis to be of high
enough quality to provide risk estimates
for excess lung cancer for silica
exposure to industrial sand workers.
Using the median cumulative exposure
levels of 0, 0.758, 2.229 and 6.183 mg/
m3-years, Hughes et al. estimated lung
cancer odds ratios, ORs (no. of deaths),
for these categories of 1.00 (14), 0.84
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(15), 2.02 (31), and 2.07 (30),
respectively, on a 15-year lag basis (pvalue for trend=0.04.) For the updated
nested case control analysis, McDonald
et al. (2005) found very similar results,
with exposure lagged 15 years and, after
adjusting for smoking, increasing
quartiles of cumulative silica exposure
were associated with lung cancer ORs
(no. of deaths) of 1.00 (13), 0.94 (17),
2.24 (38), and 2.66 (37) (p-value for
trend=0.006). Because the Hughes et al.
(2001) report contained information that
allowed OSHA to better calculate
exposure-response estimates and
because of otherwise very similar results
in the two papers, OSHA has chosen to
base its lifetime excess lung cancer risk
estimate for these industrial sand
workers on the Hughes et al. (2001)
case-control study. Using the median
exposure levels of 0, 0.758, 2.229 and
6.183 mg-years/m3, respectively, for
each of the four categories described
above, and using the model: ln OR = a
+ b × Cumulative Exposure, the
coefficient for the exposure estimate
was b = 0.13 per (mg/m3-years), with a
standard error of b = 0.074 (calculated
from the trend test p-value in the same
paper). In this model, with background
lung cancer risks of about 5 percent, the
OR provides a suitable estimate of the
relative risk.
f. Miller et al. (2007) and Miller and
MacCalman (2009) Study of British Coal
Workers Exposed to Respirable Quartz
Miller et al. (2007) and Miller and
MacCalman (2009) continued a followup mortality study, begun in 1970, of
18,166 coalminers from 10 British
coalmines initially followed through the
end of 1992 (Miller et al., 1997). The
two recent reports on mortality analyzed
the cohort of 17,800 miners and
extended the analysis through the end
of 2005. By that time there were 516,431
person years of observation, an average
of 29 years per miner, with 10,698
deaths from all causes. Causes of deaths
of interest included pneumoconiosis,
other non-malignant respiratory
diseases (NMRD), lung cancer, stomach
cancer, and tuberculosis. Three of the
strengths of this study are its use of
detailed time-exposure measurements of
both quartz and total mine dust,
detailed individual work histories, and
individual smoking histories. However,
the authors noted that no additional
exposure measurements were included
in the updated analysis, since all the
mines had closed by the mid 1980’s.
For this cohort mortality study there
were analyses using both external
(regional age-time and cause specific
mortality rates) internal controls. For
the analysis from external mortality
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rates, the all-cause mortality SMR from
1959 through 2005 was 100.9 (95% C.I.,
99.0–102.8), based on all 10,698 deaths.
However, these death ratios were not
uniform over time. For the period from
1990 to 2005, the all-cause SMR was
109.6 (95% C.I., 106.5–112.8), while the
ratios for previous periods were less
than 100. This pattern of recent
increasing SMRs was also seen in the
recent cause-specific death rate for lung
cancer, SMR=115.7 (95% C.I., 104.8–
127.7). For the analysis based on
internal rates and using Cox regression
methods, the relative risk for lung
cancer risk based on a cumulative
quartz exposure equivalent to
approximately 0.055 mg/m3 for 45 years
was RR = 1.14 (95% C.I., 1.04 to 1.25).
This risk is adjusted for concurrent coal
dust exposure and smoking status, and
incorporated a 15-year lag in quartz
exposures. The analysis showed a strong
effect for smoking (independent of
quartz exposure) on lung cancer. For
lung cancer, OSHA believes that the
analyses based on the Cox regression
method provides strong evidence that
for these coal miners’ quartz exposures
were associated with increased lung
cancer risk, but that simultaneous
exposures to coal dust did not cause
increased lung cancer risk. To estimate
lung cancer risk from this study, OSHA
estimated the regression slope for a loglinear relative risk model based on the
Miller and MacCalman’s (2009) finding
of a relative risk of 1.14 for a cumulative
exposure of 0.055 mg/m3-years.
2. Summary of OSHA’s Estimates of
Lung Cancer Mortality Risk
Tables VI–1 and VI–2 summarize the
excess lung cancer risk estimates from
occupational exposure to crystalline
silica, based on five of the six lung
cancer risk assessments discussed
above. OSHA’s estimates of lifetime
excess lung cancer risk associated with
45 years of exposure to crystalline silica
at 0.1 mg/m3 (approximately the current
general industry PEL) range from 13 to
60 deaths per 1,000 workers. For
exposure to the proposed PEL of 0.05
mg/m3, the lifetime risk estimates
calculated by OSHA are in the range of
6 to 26 deaths per 1,000 workers. For a
45-year exposure at the proposed action
level of 0.025 mg/m3, OSHA estimates
the risk to range from 3 to 23 deaths per
1,000 workers. The results from these
assessments are reasonably consistent
despite the use of data from different
cohorts and the reliance on different
analytical techniques for evaluating
dose-response relationships.
Furthermore, OSHA notes that in this
range of exposure, 0.025—0.1 mg/m3,
there is statistical consistency between
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the risk estimates, as evidenced by the
considerable overlap in the 95-percent
confidence intervals of the risk
estimates presented in Table VI–1.
OSHA also estimates the lung cancer
risk associated with 45 years of
exposure to the current construction/
shipyard PEL (in the range of 0.25 to 0.5
mg/m3) to range from 37 to 653 deaths
per 1,000 workers. Exposure to 0.25 or
0.5 mg/m3 over 45 years represents
cumulative exposures of 11.25 and 22.5
mg-years/m3, respectively. This range of
cumulative exposure is well above the
median cumulative exposure for most of
the cohorts used in the risk assessment,
primarily because most of the
individuals in these cohorts had not
been exposed for as long as 45 years.
Thus, estimating lung cancer excess
risks over this higher range of
cumulative exposures of interest to
OSHA required some degree of
extrapolation and adds uncertainty to
the estimates.
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C. Silicosis and Non-Malignant
Respiratory Disease Mortality
There are two published quantitative
risk assessment studies of silicosis and
non-malignant respiratory disease
(NMRD) mortality; a pooled analysis of
silicosis mortality by Mannetje et al.
(2002b) of data from six epidemiological
studies, and an exposure-response
analysis of NMRD mortality among
diatomaceous earth workers (Park et al.,
2002).
1. Mannetje et al. (2002b) Six Cohort
Pooled Analysis
The Mannetje et al. (2002b) silicosis
analysis was part of the IARC ten cohort
pooled study included in the Steenland
et al. (2001a) lung cancer mortality
analysis above. These studies included
18,634 subjects and 170 silicosis deaths
(n = 150 for silicosis, and n = 20
unspecified pneumoconiosis). The
silicosis deaths had a median duration
of exposure of 28 years, a median
cumulative exposure of 7.2 mg/m3years, and a median average exposure of
0.26 mg/m3, while the respective values
of the whole cohort were 10 years, 0.62
mg/m3-years, and 0.07 mg/m3. Rates for
silicosis adjusted for age, calendar time,
and study were estimated by Poisson
regression; rates increased nearly
monotonically with deciles of
cumulative exposure, from a mortality
rate of 5/100,000 person-years in the
lowest exposure category (0–0.99 mg/
m3-years) to 299/100,000 person-years
in the highest category (>28.10 mg/m3years). Quantitative estimates of
exposure to respirable silica (mg/m3)
were available for all six cohorts
(Mannetje et al. 2002a). Lifetime risk of
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silicosis mortality was estimated by
accumulating mortality rates over time
using the formula
Risk = 1 ¥ exp(¥ètime * rate).
To estimate the risk of silicosis
mortality at the current and proposed
PELs, OSHA used the model described
by Mannetje et al. (2002b) to estimate
risk to age 85 but used rate ratios that
were estimated from a nested casecontrol design that was part of a
sensitivity analysis conducted by
Toxichemica, Inc. (2004), rather than
the Poisson regression originally
conducted by Mannetje et al. (2002b).
The case-control design was selected
because it was expected to better control
for age; in addition, the rate ratios
derived from the case-control study
reflect exposure measurement
uncertainty via conduct of a Monte
Carlo analysis (Toxichemica, Inc., 2004).
2. Park et al. (2002) Study of
Diatomaceous Earth Workers
Park et al. (2002) analyzed the
California diatomaceous earth cohort
data originally studied by Checkoway et
al. (1997), consisting of 2,570
diatomaceous earth workers employed
for 12 months or more from 1942 to
1994, to quantify the relationship
between exposure to cristobalite and
mortality from chronic lung disease
other than cancer (LDOC). Diseases in
this category included pneumoconiosis
(which included silicosis), chronic
bronchitis, and emphysema, but
excluded pneumonia and other
infectious diseases. Industrial hygiene
data for the cohort were available from
the employer for total dust, silica
(mostly cristobalite), and asbestos. Park
et al. (2002) used the exposure
assessment previously reported by
Seixas et al. (1997) and used by Rice et
al. (2001) to estimate cumulative
crystalline silica exposures for each
worker in the cohort based on detailed
work history files. The mean silica
concentration for the cohort overall was
0.29 mg/m3 over the period of
employment (Seixas et al., 1997). The
mean cumulative exposure values for
total respirable dust and respirable
crystalline silica were 7.31 and 2.16 mg/
m3-year, respectively. Similar
cumulative exposure estimates were
made for asbestos. Smoking information
was available for about 50 percent of the
cohort and for 22 of the 67 LDOC deaths
available for analysis, permitting Park et
al. (2002) to at least partially adjust for
smoking. Estimates of LDOC mortality
risks were derived via Poisson and
Cox’s proportional hazards models; a
variety of relative rate model forms were
fit to the data, with a linear relative rate
model being selected for risk estimation.
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3. Summary Risk Estimates for Silicosis
and NMRD Mortality
Table VI–2 presents OSHA’s risk
estimates for silicosis and NMRD
mortality derived from the Mannetje et
al. (2002b) and Park et al. (2002) studies,
respectively. For 45 years of exposure to
the current general industry PEL
(approximately 0.1 mg/m3 respirable
crystalline silica), OSHA’s estimates of
excess lifetime risk are 11 deaths per
1,000 workers for the pooled analysis
and 83 deaths per 1,000 workers based
on Park et al.’s (2002) estimates. At the
proposed PEL, estimates of silicosis and
NMRD mortality are 7 and 43 deaths per
1,000, respectively. For exposures up to
0.25 mg/m3, the estimates based on Park
et al. are about 5 to 11 times as great as
those calculated for the pooled analysis
of silicosis mortality (Mannetje et al.,
2002b). However, these two sets of risk
estimates are not directly comparable.
First, the Park et al. analysis used
untransformed cumulative exposure as
the exposure metric, whereas the
Mannertje et al. analysis used log
cumulative exposure, which causes the
exposure-response to flatten out in the
higher exposure ranges. Second, the
mortality endpoint for the Park et al.
(2002) analysis is death from all noncancer lung diseases, including
pneumoconiosis, emphysema, and
chronic bronchitis, whereas the pooled
analysis by Mannetje et al. (2002b)
included only deaths coded as silicosis
or other pneumoconiosis. Less than 25
percent of the LDOC deaths in the Park
et al. (2002) analysis were coded as
silicosis or other pneumoconiosis (15 of
67). As noted by Park et al. (2002), it is
likely that silicosis as a cause of death
is often misclassified as emphysema or
chronic bronchitis; thus, Mannetje et
al.’s (2002b) selection of deaths may
tend to underestimate the true risk of
silicosis mortality, and Park et al.’s
(2002) analysis would more fairly
capture the total respiratory mortality
risk from all non-malignant causes,
including silicosis and chronic
obstructive pulmonary disease.
D. Renal Disease Mortality
Steenland et al. (2002a) examined
renal disease mortality in three cohorts
and evaluated exposure-response
relationships from the pooled cohort
data. The three cohorts included U.S.
gold miners (Steenland and Brown,
1995a), U.S. industrial sand workers
(Steenland et al., 2001b), and Vermont
granite workers (Costello and Graham,
1988), all three of which are included in
both the lung cancer mortality and
silicosis mortality pooled analyses
reported above. Follow up for the U.S.
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gold miners study was extended six
years from that in the other pooled
analyses. Steenland et al. (2002a)
reported that these cohorts were chosen
because data were available for both
underlying cause mortality and multiple
cause mortality; this was believed
important because renal disease is often
listed on death certificates without
being identified as an underlying cause
of death. In the three cohorts, there were
51 total renal disease deaths using
underlying cause, and 204 total renal
deaths using multiple cause mortality.
The combined cohort for the pooled
analysis (Steenland et al., 2002a)
consisted of 13,382 workers with
exposure information available for
12,783 (95 percent). Exposure matrices
for the three cohorts had been used in
previous studies (Steenland and Brown,
1995a; Attfield and Costello, 2001;
Steenland et al., 2001b). The mean
duration of exposure, the mean
cumulative exposure, and the mean
concentration of respirable silica for the
pooled cohort were 13.6 years, 1.2 mg/
m3-years, and 0.07 mg/m3, respectively.
SMRs (compared to the U.S. population)
for renal disease (acute and chronic
glomerulonephritis, nephrotic
syndrome, acute and chronic renal
failure, renal sclerosis, and nephritis/
nephropathy) were statistically
significantly elevated using multiple
cause data (SMR 1.29, 95% CI 1.10–
1.47, 193 deaths) and underlying cause
data (SMR 1.41, 95% CI 1.05–1.85, 51
observed deaths).
OSHA’s estimates of renal disease
mortality appear in Table VI–2. Based
on the life table analysis, OSHA
estimates that exposure to the current
(0.10 mg/m3) and proposed general
industry PEL (0.0.05 mg/m3) over a
working life would result in a lifetime
excess renal disease risk of 39 (95% CI
2–200) and 32 (95% CI 1.7–147) deaths
per 1,000, respectively. For exposure to
the current construction/shipyard PEL,
OSHA estimates the excess lifetime risk
to range from 52 (95% CI 2.2–289) to 63
(95% CI 2.5–368) deaths per 1,000
workers.
E. Silicosis Morbidity
OSHA’s Preliminary QRA summarizes
the principal cross-sectional and cohort
studies that have quantitatively
characterized relationships between
exposure to crystalline silica and
development of radiographic evidence
of silicosis. Each of these studies relied
on estimates of cumulative exposure to
evaluate the relationship between
exposure and silicosis prevalence in the
worker populations examined. The
health endpoint of interest in these
studies is the appearance of opacities on
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chest roentgenograms indicative of
pulmonary fibrosis.
The International Labour
Organization’s (ILO) 1980 International
Classification of Radiographs of the
Pneumoconioses is accepted as the
standard against which chest
radiographs are measured in
epidemiologic studies, for medical
surveillance and for clinical evaluation.
According to this standard, if
radiographic findings are or may be
consistent with pneumoconiosis, then
the size, shape, and extent of profusion
of opacities are characterized by
comparing the radiograph to standard
films. Classification by shape (rounded
vs. irregular) and size involves
identifying primary and secondary types
of small opacities on the radiograph and
classifying them into one of six size/
shape categories. The extent of
profusion is judged from the
concentrations of opacities as compared
with that on the standard radiographs
and is graded on a 12-point scale of four
major categories (0–3, with Category 0
representing absence of opacities), each
with three subcategories. Most of the
studies reviewed by OSHA considered a
finding consistent with an ILO
classification of 1/1 to be a positive
diagnosis of silicosis, although some
also considered an x-ray classification of
1/0 or 0/1 to be positive.
Chest radiography is not the most
sensitive tool used to diagnose or detect
silicosis. In 1993, Hnizdo et al. reported
the results of a study that compared
autopsy and radiological findings of
silicosis in a cohort of 557 white South
African gold miners. The average period
from last x-ray to autopsy was 2.7 years.
Silicosis was not diagnosed
radiographically for over 60 percent of
the miners for whom pathological
examination of lung tissue showed
slight to marked silicosis. The
likelihood of false negatives (negative by
x-ray, but silicosis is actually present)
increased with years of mining and
average dust exposure of the miners.
The low sensitivity seen for
radiographic evaluation suggests that
risk estimates derived from radiographic
evidence likely understate the true risk
of developing fibrotic lesions as a result
of exposure to crystalline silica.
OSHA’s Preliminary QRA examines
multiple studies from which silicosis
occupational morbidity risks can be
estimated. The studies evaluated fall
into three major types. Some are crosssectional studies in which radiographs
taken at a point in time were examined
to ascertain cases (Kreiss and Zhen,
1996; Love et al., 1999; Ng and Chan,
1994; Rosenman et al., 1996;
Churchyard et al., 2003, 2004); these
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radiographs may have been taken as part
of a health survey conducted by the
investigators or represent the most
recent chest x-ray available for study
subjects. Other studies were designed to
examine radiographs over time in an
effort to determine onset of disease.
Some of these studies examined
primarily active, or current, workers
(Hughes et al., 1998; Muir et al., 1989a,
1989b; Park et al., 2002), while others
included both active and retired
workers (Chen et al., 2001, 2005; Hnizdo
and Sluis-Cremer, 1993; Miller et al.,
1998; Buchanan et al., 2003; Steenland
and Brown, 1995b).
Even though OSHA has presented
silicosis risk estimates for all of the
studies identified, the Agency is relying
primarily on those studies that
examined radiographs over time and
included both active and retired
workers. It has been pointed out by
others (Chen et al., 2001; Finkelstein,
2000; NIOSH, 2002) that lack of followup of retired workers consistently
resulted in lower risk estimates
compared to studies that included
retired workers. OSHA believes that the
most reliable estimates of silicosis
morbidity, as detected by chest
radiographs, come from the studies that
evaluated radiographs over time,
included radiographic evaluation of
workers after they left employment, and
derived cumulative or lifetime estimates
of silicosis disease risk. Brief
descriptions of these cumulative risk
studies used to estimate silicosis
morbidity risks are presented below.
1. Hnizdo and Sluis Cremer (1993)
Study of South African White Gold
Miners
Hnizdo and Sluis-Cremer (1993)
described the results of a retrospective
cohort study of 2,235 white gold miners
in South Africa. These workers had
received annual examinations and chest
x-rays while employed; most returned
for occasional examinations after
employment. A case was defined as one
with an x-ray classification of ILO 1/1
or greater. A total of 313 miners had
developed silicosis and had been
exposed for an average of 27 years at the
time of diagnosis. Forty-three percent of
the cases were diagnosed while
employed and the remaining 57 percent
were diagnosed an average of 7.4 years
after leaving the mines. The average
latency for the cohort was 35 years
(range of 18–50 years) from start of
exposure to diagnosis.
The average respirable dust exposure
for the cohort overall was 0.29 mg/m3
(range 0.11–0.47), corresponding to an
estimated average respirable silica
concentration of 0.09 mg/m3 (range
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0.033–0.14). The average cumulative
dust exposure for the overall cohort was
6.6 mg/m3-years (range 1.2–18.7), or an
average cumulative silica exposure of
1.98 mg/m3-years (range 0.36–5.61).
OSHA believes that the exposure
estimates for the cohort are uncertain
given the need to rely on particle count
data generated over a fairly narrow
production period.
Silicosis risk increased exponentially
with cumulative exposure to respirable
dust and was modeled using log-logistic
regression. Using the exposure-response
relationship developed by Hnizdo and
Sluis-Cremer (1993), and assuming a
quartz content of 30 percent in
respirable dust, Rice and Stayner (1995)
and NIOSH (2002) estimated the risk of
silicosis to be 70 percent and 13 percent
for a 45-year exposure to 0.1 and 0.05
mg/m3 respirable crystalline silica,
respectively.
2. Steenland and Brown (1995b) Study
of South Dakota Gold Miners
Three thousand three hundred thirty
South Dakota gold miners who had
worked at least a year underground
between 1940 and 1965 were studied by
Steenland and Brown (1995b). Workers
were followed though 1990 with 1,551
having died; loss to follow up was low
(2 percent). Chest x-rays taken in crosssectional surveys in 1960 and 1976 and
death certificates were used to ascertain
cases of silicosis. One hundred twenty
eight cases were found via death
certificate, 29 by x-ray (defined as ILO
1/1 or greater), and 13 by both. Nine
percent of deaths had silicosis
mentioned on the death certificate.
Inclusion of death certificate diagnoses
probably increases the risk estimates
from this study compared to those that
rely exclusively on radiographic
findings to evaluate silicosis morbidity
risk (see discussion of Hnizdo et al.
(1993) above).
Exposure was estimated by
conversion of impinger (particle count)
data and was based on measurements
indicating an average of 13 percent
silica in the dust. Based on these data,
the authors estimated the mean
exposure concentration to be 0.05 mg/
m3 for the overall cohort, with those
hired before 1930 exposed to an average
of 0.15 mg/m3. The average duration of
exposure for cases was 20 years (s.d =
8.7) compared to 8.2 years (s.d = 7.9) for
the rest of the cohort. This study found
that cumulative exposure was the best
disease predictor, followed by duration
of exposure and average exposure.
Lifetime risks were estimated from
Poisson regression models using
standard life table techniques. The
authors estimated a risk of 47 percent
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associated with 45 years of exposure to
0.09 mg/m3 respirable crystalline silica,
which reduced to 35 percent after
adjustment for age and calendar time.
3. Miller et al. (1995, 1998) and
Buchanan et al. (2003) Study of Scottish
Coal Miners
Miller et al. (1995, 1998) and
Buchanan et al. (2003) reported on a
1990/1991 follow-up study of 547
survivors of a 1,416 member cohort of
Scottish coal workers from a single
mine. These men had all worked in the
mine during a period between early
1971 and mid 1976, during which they
had experienced ‘‘unusually high
concentrations of freshly cut quartz in
mixed coalmine dust. The population’s
exposures to both coal and quartz dust
had been measured in unique detail, for
a substantial proportion of the men’s
working lives.’’ Thus, this cohort
allowed for the study of the effects of
both higher and lower silica
concentrations, and exposure-rate
effects on the development of silicosis.
The 1,416 men had all had previous
radiographs dating from before, during,
or just after this high concentration
period, and the 547 participating
survivors received their follow-up chest
x-rays between November 1990 and
April 1991. Follow-up interviews
consisted of questions on current and
past smoking habits, and occupational
history since leaving the coal mine,
which closed in 1981.
Silicosis cases were identified as such
if the median classification of the three
readers indicated an ILO (1980)
classification of 1/0 or greater, plus a
progression from the earlier reading. Of
the 547 men, 203 (38 percent) showed
progression of at least one ILO category
from the 1970’s surveys to the 1990–91
survey; in 128 of these (24 percent)
there was progression of two or more
steps. In the 1970’s survey 504 men had
a profusion score of 0; of these, 120 (24
percent) progressed to an ILO
classification of 1/0 or greater. Of the 36
men who had shown earlier profusions
of 1/0 or greater, 27 (75 percent) showed
further progression at the 1990/1991
follow-up. Only one subject showed a
regression from any earlier reading, and
that was slight, from ILO 1/0 to 0/1.
To study the effects of exposure to
high concentrations of quartz dust, the
Buchanan et al. (2003) analysis
presented the results of logistic
regression modeling that incorporated
two independent terms for cumulative
exposure, one arising from exposure to
concentrations less than 2 mg/m3
respirable quartz and the other from
exposure to concentrations greater than
or equal to 2 mg/m3. Both of the
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cumulative quartz exposure
concentration variables were ‘‘highly
statistically significant in the presence
of the other,’’ and independent of the
presence of coal dust. Since these quartz
variables were in the same units, g–hr/
m3, the authors noted that coefficient for
exposure concentrations equal to or
above 2.0 mg/m3 was 3 times that of the
coefficient for concentrations less than
2.0 mg/m3. From this, the authors
concluded that their analysis showed
that ‘‘the risk of silicosis over a working
lifetime can rise dramatically with
exposure to such high concentrations
over a timescale of merely a few
months.’’
Buchanan et al., (2003) provided
analysis and risk estimates only for
silicosis cases defined as having an xray classified as ILO 2/1+, after
adjusting for the disproportionately
severe effect of exposure to high
concentrations on silicosis risk.
Estimating the risk of acquiring a chest
x-ray classified as ILO 1/0+ from the
Buchanan (2003) or the earlier Miller et
al. (1995, 1998) publications can only be
roughly approximated because of the
limited summary information included;
this information suggests that the risk of
silicosis defined as an ILO classification
of 1/0+ could be about three times
higher than the risk of silicosis defined
as an ILO 2/1+ x-ray. OSHA has a high
degree of confidence in the estimates of
progression to stages 2/1+ from this
Scotland coal mine study, mainly
because of the highly detailed and
extensive exposure measurements, the
radiographic records, and the detailed
analyses of high exposure-rate effects.
4. Chen et al. (2001) Study of Tin
Miners
Chen et al. (2001) reported the results
of a retrospective study of a Chinese
cohort of 3,010 underground miners
who had worked in tin mines at least
one year between 1960 and 1965. They
were followed through 1994, by which
time 2,426 (80.6%) workers had either
retired or died, and only 400 (13.3%)
remained employed at the mines.
The study incorporated occupational
histories, dust measurements and
medical examination records. Exposure
data consisted of high-flow, short-term
gravimetric total dust measurements
made routinely since 1950; the authors
used data from 1950 to represent earlier
exposures since dust control measures
were not implemented until 1958.
Results from a 1998–1999 survey
indicated that respirable silica
measurements were 3.6 percent (s.d =
2.5 percent) of total dust measurements.
Annual radiographs were taken since
1963 and all cohort members continued
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to have chest x-rays taken every 2 or 3
years after leaving work. Silicosis was
diagnosed when at least 2 of 3
radiologists classified a radiograph as
being a ‘‘suspected case’’ or at Stage I,
II, or III under the 1986 Chinese
pneumoconiosis roentgen diagnostic
criteria. According to Chen et al. (2001),
these four categories under the Chinese
system were found to agree closely with
ILO categories 0/1, Category 1, Category
2, and Category 3, respectively, based on
studies comparing the Chinese and ILO
classification systems. Silicosis was
observed in 33.7 percent of the group;
67.4 percent of the cases developed after
exposure ended.
5. Chen et al. (2005) Study of Chinese
Pottery Workers, Tin Miners, and
Tungsten Miners
In a later study, Chen et al. (2005)
investigated silicosis morbidity risks
among three cohorts to determine if the
risk varied among workers exposed to
silica dust having different
characteristics. The cohorts consisted of
4,547 pottery workers, 4,028 tin miners,
and 14,427 tungsten miners selected
from a total of 20 workplaces. Cohort
members included all males employed
after January 1, 1950 and who worked
for at least one year between 1960 and
1974. Radiological follow-up was
through December 31, 1994 and x-rays
were scored according to the Chinese
classification system as described above
by Chen et al. (2001) for the tin miner
study. Exposure estimates of cohort
members to respirable crystalline silica
were based on the same data as
described by Chen et al. (2001). In
addition, the investigators measured the
extent of surface occlusion of crystalline
silica particles by alumino-silicate from
47 dust samples taken at 13 worksites
using multiple-voltage scanning
electron microscopy and energy
dispersive X-ray spectroscopy (Harrison
et al., 2005); this method yielded
estimates of the percent of particle
surface that is occluded.
Compared to tin and tungsten miners,
pottery workers were exposed to
significantly higher mean total dust
concentrations (8.2 mg/m3, compared to
3.9 mg/m3 for tin miners and 4.0 mg/m3
for tungsten miners), worked more net
years in dusty occupations (mean of
24.9 years compared to 16.4 years for tin
miners and 16.5 years for tungsten
miners), and had higher mean
cumulative dust exposures (205.6 mg/
m3-years compared to 62.3 mg/m3-years
for tin miners and 64.9 mg/m3-years for
tungsten miners) (Chen et al., 2005).
Applying the authors’ conversion
factors to estimate respirable crystalline
silica from Chinese total dust
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measurements, the approximate mean
cumulative exposures to respirable
silica for pottery, tin, and tungsten
workers are 6.4 mg/m3-years, 2.4 mg/
m3-years, and 3.2 mg/m3-years,
respectively. Measurement of particle
surface occlusion indicated that, on
average, 45 percent of the surface area
of respirable particles collected from
pottery factory samples was occluded,
compared to 18 percent of the particle
surface area for tin mine samples and 13
percent of particle surface area for
tungsten mines.
Based on Chen et al. (2005), OSHA
estimated the cumulative silicosis risk
associated with 45 years of exposure to
0.1 mg/m3 respirable crystalline silica (a
cumulative exposure of 4.5 mg/m3years) to be 6 percent for pottery
workers, 12 percent for tungsten miners,
and 40 percent for tin miners. For a
cumulative exposure of 2.25 mg/m3years (i.e., 45 years of exposure to 0.05
mg/m3), cumulative silicosis morbidity
risks were estimated to be 2, 2, and 10
percent for pottery workers, tungsten
miners, and tin miners, respectively.
When cumulative silica exposure was
adjusted to reflect exposure to surfaceactive quartz particles (i.e., not
occluded), the estimated cumulative
risk among pottery workers more closely
approximated those of the tin and
tungsten miners, suggesting to the
authors that alumino-silicate occlusion
of the crystalline particles in pottery
factories at least partially explained the
lower risk seen among workers, despite
their having been more heavily exposed.
6. Summary of Silicosis Morbidity Risk
Estimates.
Table VI–2 presents OSHA’s risk
estimates for silicosis morbidity that are
derived from each of the studies
described above. Estimates of silicosis
morbidity derived from the seven
cohorts in cumulative risk studies with
post-employment follow-up range from
60 to 773 per 1,000 workers for 45-year
exposures to the current general
industry PEL of 0.10 mg/m3, and from
20 to 170 per 1,000 workers for a 45year exposure to the proposed PEL of
0.05 mg/m3. The study results provide
substantial evidence that the disease can
progress for years after exposure ends.
Results from an autopsy study (Hnizdo
et al., 1993), which found pathological
evidence of silicosis absent radiological
signs, suggest that silicosis cases based
on radiographic diagnosis alone tend to
underestimate risk since pathological
evidence of silicosis. Other results
(Chen et al., 2005) suggest that surface
properties among various types of silica
dusts can have different silicosis
potencies. Results from the Buchanan et
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al. (2003) study of Scottish coal miners
suggest that short-term exposures to >2
mg/m3 silica can cause a
disproportionately higher risk of
silicosis than would be predicted by
cumulative exposure alone, suggesting a
dose-rate effect for exposures to
concentrations above this level. OSHA
believes that, given the consistent
finding of a monotonic exposureresponse relationship for silicosis
morbidity with cumulative exposure in
the studies reviewed, that cumulative
exposure is a reasonable exposure
metric upon which to base risk
estimates in the exposure range of
interest to OSHA (i.e., between 0.025
and 0.5 mg/m3 respirable crystalline
silica).
F. Other Considerations in OSHA’s Risk
Analysis
Uncertainties are inherent to any risk
modeling process and analysis;
assessing risk and associated
complexities of silica exposure among
workers is no different. However, the
Agency has a high level of confidence
that the preliminary risk assessment
results reasonably reflect the range of
risks experienced by workers exposed to
silica in all occupational settings. First,
the preliminary assessment is based on
an analysis of a wide range of studies,
conducted in multiple industries across
a wide range of exposure distributions,
which included cumulative exposures
equivalent to 45 years of exposure to
and below the current PEL.
Second, risk models employed in this
assessment are based on a cumulative
exposure metric, which is the product of
average daily silica concentration and
duration of worker exposure for a
specific job. Consequently, these models
predict the same risk for a given
cumulative exposure regardless of the
pattern of exposure. For example, a
manufacturing plant worker exposed to
silica at 0.05 mg/m3 for eight hours per
day will have the same cumulative
exposure over a given period of time as
a construction worker who is exposed
each day to silica at 0.1 mg/m3 for one
hour, at 0.075 mg/m3 for four hours and
not exposed to silica for three hours.
The cumulative exposure metric thus
reflects a worker’s long-term average
exposure without regard to the pattern
of exposure experienced by the worker,
and is therefore generally applicable to
all workers who are exposed to silica in
the various industries. For example, at
construction sites, conditions may
change often since the nature of work
can be intermittent and involve working
with a variety of materials that contain
different concentrations of quartz.
Additionally, workers may perform
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cumulative exposures exhibited in these
studies are equivalent to the cumulative
exposure that would result from 45
years of exposure to the current and
proposed PELs (i.e., 4.5 and 2,25 mg/m3,
respectively). For this reason, OSHA has
a high degree of confidence in the risk
estimates associated with exposure to
the current and proposed PELs;
additionally, the risk assessment does
not require significant low-dose
extrapolation of the model beyond the
observed range of exposures. OSHA
acknowledges there is greater
uncertainty in the risk estimates for the
proposed action level of 0.025 mg/m3,
particularly given some evidence of a
threshold for silicosis between the
proposed PEL and action level. Given
the Agency’s findings that controlling
exposures below the proposed PEL
would not be technologically feasible
for employers, OSHA believes that
estimating risk for exposures below the
proposed action level, which becomes
increasingly more uncertain, is not
construction operations for relatively
short periods of time where they are
exposed to concentrations of silica that
may be significantly higher than many
continuous operations in general
industry. However, these differences are
taken into account by the use of the
cumulative exposure metric that relates
exposure to disease risk. OSHA believes
that use of cumulative exposure is the
most appropriate dose-metric because
each of the studies that provide the
basis for the risk assessment
demonstrated strong exposure-response
relationships between cumulative
exposure and disease risk. This metric
is especially important in terms of
progression of silica-related disease, as
discussed in Section VII of the
preamble, Significance of Risk, in
section B.1.a.
OSHA’s risk assessment relied upon
many studies that utilized cumulative
exposures of cohort members. Table VI–
3 summarizes these lung cancer studies,
including worker exposure quartile data
across a number of industry sectors. The
necessary to further inform the Agency’s
regulatory action.
Although the Agency believes that the
results of its risk assessment are broadly
relevant to all occupational exposure
situations involving crystalline silica,
OSHA acknowledges that differences
exist in the relative toxicity of
crystalline silica particles present in
different work settings due to factors
such as the presence of mineral or metal
impurities on quartz particle surfaces,
whether the particles have been freshly
fractured or are aged, and size
distribution of particles. At this time,
however, OSHA preliminarily
concludes that it is not yet possible to
use available information on factors that
mediate the potency of silica to refine
available quantitative estimates of the
lung cancer and silicosis mortality risks,
and that the estimates from the studies
and analyses relied upon are fairly
representative of a wide range of
workplaces reflecting differences in
silica polymorphism, surface properties,
and impurities.
TABLE VI–1—ESTIMATES OF LIFETIME A LUNG CANCER MORTALITY RISK RESULTING FROM 45-YEARS OF EXPOSURE TO
CRYSTALLINE SILICA
[Deaths per 1,000 workers (95% confidence interval)]
Cohort
Exposure
lag
(years)
Model
Exposure level (mg/m3)
Model parameters
(standard error)
0.025
0.05
0.10
0.25
0.50
............
15
b = 0.60 (0.015) ....
22 (11–36)
26 (12–41)
29 (13–48)
34 (15–56)
38 (17–63)
..................
15
23 (9–38)
26 (10–43)
29 (11–47)
33 (12–53)
36 (14–58)
Linear ....................
Ten pooled cohorts
(see Table II–1).
15
9 (2–16)
18 (4–31)
22 (6–38)
27 (12–43)
36 (20–51)
0.21–13
0.41–28
0.83–69
2.1–298
4.2–687
Log-linear b
...........................
15
b = 0.074950
(0.024121).
b1 = 0.16498
(0.0653) and.
b2 = ¥0.1493
(0.0657).
Various ..................
Log-linear c ............
Linear c ..................
10
b = 0.1441 e ...........
9 (2–21)
17 (5–41)
34 (10–79)
81 (24–180)
152 (46–312)
Log-linear c ............
15
b = 0.19 e ...............
11 (4–18)
25 (9–42)
60 (19–111)
250 (59–502)
653 (167–760)
Log-linear c ............
15
b = 0.13 (0.074) f ...
7 (0–16)
15 (0–37)
34 (0–93)
120 (0–425)
387 (0–750)
Log-linear c ............
15
B = 0.0524
(0.0188).
3 (1–5)
6 (2–11)
13 (4–23)
37 (9–75)
95 (20–224)
Linear b
Spline§c d
Range from 10 cohorts.
Diatomaceous
earth workers.
U.S.Granite workers.
North American industrial sand
workers.
British coal miners
...............
a Risk
to age 85 and based on 2006 background mortality rates for all males (see Appendix for life table method).
with log cumulative exposure (mg/m3-days + 1).
with cumulative exposure (mg/m3-years).
d 95% confidence interval calculated as follows (where CE = cumulative exposure in mg/m3-years and SE is standard error of the parameter estimate):
For CE ≤ 2.19: 1 + [(b1 ± (1.96*SE1)) * CE].
For CE > 2.19: 1 + [(b1 * CE) + (b2 * (CE–2.19))] ± 1.96 * SQRT[ (CE2 * SE12) + ((CE–2.19)2* SE22) + (2*CE*(CE–3.29)*-0.00429)].
e Standard error not reported, upper and lower confidence limit on beta estimated from confidence interval of risk estimate reported in original article.
f Standard error of the coefficient was estimated from the p-value for trend.
b Model
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c Model
TABLE VI–2—SUMMARY OF LIFETIME OR CUMULATIVE RISK ESTIMATES FOR CRYSTALLINE SILICA
Risk associated with 45 years of occupational exposure
(per 1,000 workers)
Health endpoint (source)
Respirable crystalline silica exposure level (mg/m3)
0.025
Lung Cancer Mortality (Lifetime Risk):
Pooled Analysis, Toxichemica, Inc (2004) a b ...............
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9–23
Fmt 4701
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18–26
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27–34
0.500
36–38
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TABLE VI–2—SUMMARY OF LIFETIME OR CUMULATIVE RISK ESTIMATES FOR CRYSTALLINE SILICA—Continued
Risk associated with 45 years of occupational exposure
(per 1,000 workers)
Health endpoint (source)
Respirable crystalline silica exposure level (mg/m3)
0.025
Diatomaceous Earth Worker study (Rice et al.,
2001) a c .....................................................................
U.S. Granite Worker study (Attfield and Costello,
2004) a d .....................................................................
North American Industrial Sand Worker study
(Hughes et al., 2001) a e ............................................
British Coal Miner study (Miller and MacCalman,
2009) a f ......................................................................
Silicosis and Non-Malignant Lung Disease Mortality
(Lifetime Risk):
Pooled Analysis (Toxichemica, Inc., 2004) (silicosis) g
Diatomaceous Earth Worker study (Park et al., 2002)
(NMRD) h ...................................................................
Renal Disease Mortality (Lifetime Risk):
Pooled Cohort study (Steenland et al., 2002a) ............
Silicosis Morbidity (Cumulative Risk):
Chest x-ray category of 2/1 or greater (Buchanan et
al., 2003) j ..................................................................
Silicosis mortality and/or x-ray of 1/1 or greater
(Steenland and Brown, 1995b) k ...............................
Chest x-ray category of 1/1 or greater (Hnizdo and
Sluis-Cremer, 1993) l .................................................
Chest x-ray category of 1 or greater (Chen et al.,
2001) m ......................................................................
Chest x-ray category of 1 or greater (Chen et al.,
2005) n
Tin miners ..............................................................
Tungsten miners ....................................................
Pottery workers ......................................................
0.05
0.100
0.250
0.500
9
17
34
81
152
11
25
60
250
653
7
15
34
120
387
3
6
13
37
95
4
7
11
17
22
22
43
83
188
321
25
32
39
52
63
21
55
301
994
1000
31
74
431
593
626
6
127
773
995
1000
40
170
590
1000
1000
40
5
5
100
20
20
400
120
60
950
750
300
1000
1000
700
From Table II–12, ‘‘Respirable Crystalline Silica—Health Effects Literature Review and Preliminary Quantitative Risk Assessment’’
(Docket OSHA–2010–0034).
TABLE VI–3—EXPOSURE DISTRIBUTION IN LUNG CANCER STUDIES
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Study
U.S. diatomaceous earth
workers 1
(Checkoway
et al., 1997).
S. African gold
miners 1
(Hnizdo and
Sluis-cremer,
1991 &
Hnizdo et al.,
1997).
U.S. gold miners 1
(Steenland
and Brown,
1995a).
Australian gold
miners 1 (de
Klerk and
Musk, 1998).
U.S. granite
workers
(Costello and
Graham,
1988).
Finnish granite
workers
(Koskela et
al., 1994).
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Cum(exp) (mg/m3-y)
Primary
exposure
(as
described
in study)
No. of
deaths
from lung
cancer
2,342
cristobalite
77
0.37
1.05
2.48
2,260
quartz and
other silicates.
77
n/a
4.23
3,328
silica dust
156
0.1
2,297
silica dust
135
5,414
silica dust
from
granite.
1,026
quartz dust
Average* exposure (mg/m3)
n
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25th (q1)
median
(q2)
75th (q3)
62.52
0.11
0.18
0.46
2.43
n/a
n/a
n/a
0.15
0.19
0.22
0.31
n/a
0.23
0.74
6.2
0.02
0.05
0.1
0.24
n/a
6.52
11.37
17.31
50.22
0.25
0.43
0.65
1.55
n/a
124
0.14
0.71
2.19
50
0.02
0.05
0.08
1.01
n/a
38
0.84
4.63
15.42
100.98
0.39
0.59
1.29
3.6
n/a
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median
(q2)
Mean respirable
crystalline
silica exposure
over employment
period
(mg/m∧3)
q1
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TABLE VI–3—EXPOSURE DISTRIBUTION IN LUNG CANCER STUDIES—Continued
Study
U.S. industrial
sand workers 1
(Steenland
et al., 2001b).
North American industrial sand
workers 1
(Hughes et
al., 2001).
Ch. Tungsten
(Chen et al.,
1992).
Ch. Pottery
(Chen et al.,
1992).
Ch. Tin (Chen
et al., 1992).
British coal
workers 1
(Miller and
MacCalman,
2009).
Cum(exp) (mg/m3-y)
Primary
exposure
(as
described
in study)
No. of
deaths
from lung
cancer
4,626
silica dust
85
0.03
0.13
5.2
90
crystalline
silica.
95
1.11
2.73
28,442
silica dust
174
3.49
13,719
silica dust
81
7,849
silica dust
quartz .......
Average* exposure (mg/m3)
n
17,820
Mean respirable
crystalline
silica exposure
over employment
period
(mg/m∧3)
25th (q1)
median
(q2)
75th (q3)
8.265
0.02
0.04
0.06
0.4
n/a
5.20
n/a
0.069
0.15
0.025
n/a
n/a
8.56
29.79
232.26
0.15
0.32
1.28
4.98
6.1
3.89
6.07
9.44
63.15
0.18
0.22
0.34
2.1
11.4
119
2.79
5.27
5.29
83.09
0.12
0.19
0.49
1.95
7.7
973
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
median
(q2)
q1
q3
max
max
1 Study
adjusted for effects smoking.
* Average exposure is cumulative exposure averaged over the entire exposure period.
n/a Data not available.
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VII. Significance of Risk
A. Legal Requirements
To promulgate a standard that
regulates workplace exposure to toxic
materials or harmful physical agents,
OSHA must first determine that the
standard reduces a ‘‘significant risk’’ of
‘‘material impairment.’’ The first part of
this requirement, ‘‘significant risk,’’
refers to the likelihood of harm, whereas
the second part, ‘‘material impairment,’’
refers to the severity of the
consequences of exposure.
The Agency’s burden to establish
significant risk derives from the OSH
Act, 29 U.S.C. 651 et seq. Section 3(8)
of the Act requires that workplace safety
and health standards be ‘‘reasonably
necessary and appropriate to provide
safe or healthful employment.’’ 29
U.S.C. 652(8). The Supreme Court, in
the ‘‘benzene’’ decision, stated that
section 3(8) ‘‘implies that, before
promulgating any standard, the
Secretary must make a finding that the
workplaces in question are not safe.’’
Indus. Union Dep’t, AFL–CIO v. Am.
Petroleum Inst., 448 U.S. 607, 642
(1980). Examining section 3(8) more
closely, the Court described OSHA’s
obligation to demonstrate significant
risk:
‘‘[S]afe’’ is not the equivalent of ‘‘risk-free.’’
A workplace can hardly be considered
‘‘unsafe’’ unless it threatens the workers with
a significant risk of harm. Therefore, before
the Secretary can promulgate any permanent
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health or safety standard, he must make a
threshold finding that the place of
employment is unsafe in the sense that
significant risks are present and can be
eliminated or lessened by a change in
practices.
Id. While clarifying OSHA’s
responsibilities, the Court emphasized
the Agency’s discretion in determining
what constitutes significant risk, stating,
‘‘[the Agency’s] determination that a
particular level of risk is ‘significant’
will be based largely on policy
considerations.’’ Benzene, 448 U.S. at
655, n. 62. The Court explained that
significant risk is not a ‘‘mathematical
straitjacket,’’ and maintained that OSHA
could meet its burden without
‘‘wait[ing] for deaths to occur before
taking any action.’’ Benzene, 448 U.S. at
655.
Because section 6(b)(5) of the Act
requires that the Agency base its
findings on the ‘‘best available
evidence,’’ 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. Thus, while OSHA’s
significant risk determination must be
supported by substantial evidence, the
Agency ‘‘is not required to support the
finding that a significant risk exists with
anything approaching scientific
certainty.’’ Id. Furthermore, ‘‘the
Agency is free to use conservative
assumptions in interpreting the data
with respect to carcinogens, risking
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error on the side of over protection
rather than under protection,’’ so long as
such assumptions are based in ‘‘a body
of reputable scientific thought.’’ Id.
The Act also requires that the Agency
make a finding that the toxic material or
harmful physical agent at issue causes
material impairment to workers’ health.
Section 6(b)(5) of the Act directs the
Secretary of Labor to ‘‘set the standard
which most adequately assures, to the
extent feasible, on the basis of the best
available evidence, that no employee
will suffer material impairment of
health or functional capacity even if
such employee has regular exposure to
the hazard . . . for the period of his
working life.’’ 29 U.S.C. 655(b)(5). As
with significant risk, what constitutes
material impairment in any given case
is a policy determination for which
OSHA is given substantial leeway.
‘‘OSHA is not required to state with
scientific certainty or precision the
exact point at which each type of [harm]
becomes a material impairment.’’ AFL–
CIO v. OSHA, 965 F.2d 962, 975 (11th
Cir. 1992). Courts have also noted that
OSHA should consider all forms and
degrees of material impairment—not
just death or serious physical harm—
and that OSHA may act with a
‘‘pronounced bias towards worker
safety.’’ Id; Bldg & Constr. Trades Dep’t
v. Brock, 838 F.2d 1258, 1266 (D.C. Cir.
1988).
It is the Agency’s practice to estimate
risk to workers by using quantitative
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risk assessment and determining the
significance of that risk based on
judicial guidance, the language of the
OSH Act, and Agency policy
considerations. Thus, using the best
available evidence, OSHA identifies
material health impairments associated
with potentially hazardous occupational
exposures, and, when possible, provides
a quantitative assessment of exposed
workers’ risk of these impairments. The
Agency then evaluates whether these
risks are severe enough to warrant
regulatory action and determines
whether a new or revised rule will
substantially reduce these risks.
In this case, OSHA has reviewed
extensive toxicological,
epidemiological, and experimental
research pertaining to adverse health
effects of occupational exposure to
respirable crystalline silica, including
silicosis, other non-malignant
respiratory disease, lung cancer, and
autoimmune and renal diseases. As a
result of this review, the Agency has
developed preliminary quantitative
estimates of the excess risk of mortality
and morbidity that is attributable to
currently allowable respirable
crystalline silica exposure
concentrations. The Agency is
proposing a new PEL of 0.05 mg/m3
because exposures at and above this
level present a significant risk to
workers’ health. Even though OSHA’s
preliminary risk assessment indicates
that a significant risk exists at the
proposed action level of 0.025 mg/m3,
the Agency is not proposing a PEL
below the proposed 0.05 mg/m3 limit
because OSHA must also consider
technological and economic feasibility
in determining exposure limits. As
explained in the Summary and
Explanation for paragraph (c),
Permissible Exposure Limit (PEL),
OSHA has preliminary determined that
the proposed PEL of 0.05 mg/m3 is
technologically and economically
feasible, but that a lower PEL of 0.025
mg/m3 is not technologically feasible.
OSHA has preliminarily determined
that long-term exposure at the current
PEL presents a significant risk of
material harm to workers’ health, and
that adoption of the proposed PEL will
substantially reduce this risk to the
extent feasible.
As discussed in Section V of this
preamble (Health Effects Summary),
inhalation exposure to respirable
crystalline silica increases the risk of a
variety of adverse health effects,
including silicosis, chronic obstructive
pulmonary disease (COPD), lung cancer,
immunological effects, kidney disease,
and infectious tuberculosis (TB). OSHA
considers each of these conditions to be
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a material impairment of health. These
diseases result in significant discomfort,
permanent functional limitations
including permanent disability or
reduced ability to work, reduced quality
of life, and decreased life expectancy.
When these diseases coexist, as is
common, the effects are particularly
debilitating (Rice and Stayner, 1995;
Rosenman et al., 1999). Based on these
findings and on the scientific evidence
that respirable crystalline silica
substantially increases the risk of each
of these conditions, OSHA preliminarily
concludes that workers who are exposed
to respirable crystalline silica at the
current PEL are at significant risk of
material impairment of health or
functional capacity.
B. OSHA’s Preliminary Findings
1. Material Impairments of Health
Section I of OSHA’s Health Effects
Literature Review and Preliminary
Quantitative Risk Assessment (available
in Docket OSHA–2010–0034) describes
in detail the adverse health conditions
that workers who are exposed to
respirable crystalline silica are at risk of
developing. The Agency’s findings are
summarized in Section V of this
preamble (Health Effects Summary). The
adverse health effects discussed include
lung cancer, silicosis, other nonmalignant respiratory disease (NMRD),
and immunological and renal effects.
a. Silicosis
Silicosis refers to a spectrum of lung
diseases attributable to the inhalation of
respirable crystalline silica. As
described in Section V (Health Effects
Summary), the three types of silicosis
are acute, accelerated, and chronic.
Acute silicosis can occur within a few
weeks to months after inhalation
exposure to extremely high levels of
respirable crystalline silica. Death from
acute silicosis can occur within months
to a few years of disease onset, with the
exposed person drowning in their own
lung fluid (NIOSH, 1996). Accelerated
silicosis results from exposure to high
levels of airborne respirable crystalline
silica, and disease usually occurs within
5 to 10 years of initial exposure (NIOSH,
1996). Both acute and accelerated
silicosis are associated with exposures
that are substantially above the current
general industry PEL, although precise
information on the relationships
between exposure and occurrence of
disease are not available.
Chronic silicosis is the most common
form of silicosis seen today, and is a
progressive and irreversible condition
characterized as a diffuse nodular
pulmonary fibrosis (NIOSH, 1996).
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Chronic silicosis generally occurs after
10 years or more of inhalation exposure
to respirable crystalline silica at levels
below those associated with acute and
accelerated silicosis. Affected workers
may have a dry chronic cough, sputum
production, shortness of breath, and
reduced pulmonary function. These
symptoms result from airway restriction
caused by the development of fibrotic
scarring in the alveolar sacs and the
ends of the lung tissue. The scarring can
be detected in chest x-ray films when
the lesions become large enough to
appear as visible opacities. The result is
restriction of lung volumes and
decreased pulmonary compliance with
concomitant reduced gas transfer
(Balaan and Banks, 1992). Chronic
silicosis is characterized by small,
rounded opacities that are
symmetrically distributed in the upper
lung zones on chest radiograph.
The diagnosis of silicosis is based on
a history of exposure to respirable
crystalline silica, chest radiograph
findings, and the exclusion of other
conditions, including tuberculosis (TB).
Because workers affected by early stages
of chronic silicosis are often
asymptomatic, the finding of opacities
in the lung is key to detecting silicosis
and characterizing its severity. The
International Labour Organization (ILO)
International Classification of
Radiographs of Pneumoconioses (ILO,
1980, 2002, 2011) is the currently
accepted standard against which chest
radiographs are evaluated in
epidemiologic studies, for medical
surveillance, and for clinical evaluation.
The ILO system standardizes the
description of chest x-rays, and is based
on a 12-step scale of severity and extent
of silicosis as evidenced by the size,
shape, and density of opacities seen on
the x-ray film. Profusion (frequency) of
small opacities is classified on a 4-point
major category scale (0–3), with each
major category divided into three, giving
a 12-point scale between 0/¥ and 3/+.
Large opacities are defined as any
opacity greater than 1 cm that is present
in a film.
The small rounded opacities seen in
early stage chronic silicosis (i.e., ILO
major category 1 profusion) may
progress (through ILO major categories 2
and/or 3) and develop into large fibrotic
masses that destroy the lung
architecture, resulting in progressive
massive fibrosis (PMF). This stage of
advanced silicosis is usually
characterized by impaired pulmonary
function, disability, and premature
death. In cases involving PMF, death is
commonly attributable to progressive
respiratory insufficiency (Balaan and
Banks, 1992).
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The appearance of ILO category 2 or
3 background profusion of small
opacities has been shown to increase the
risk of developing large opacities
characteristic of PMF. In one study of
silicosis patients in Hong Kong, Ng and
Chan (1991) found the risk of PMF
increased by 42 and 64 percent among
patients whose chest x-ray films were
classified as ILO major category 2 or 3,
respectively. Research has shown that
people with silicosis advanced beyond
ILO major category 1 have reduced
median survival times compared to the
general population (Infante-Rivard et al.,
1991; Ng et al., 1992a; Westerholm,
1980).
Silicosis is the oldest known
occupational lung disease and is still
today the cause of significant premature
mortality. In 2005, there were 161
deaths in the U.S. where silicosis was
recorded as an underlying or
contributing cause of death on a death
certificate (NIOSH, 2008c). Between
1996 and 2005, deaths attributed to
silicosis resulted in an average of 11.6
years of life lost by affected workers
(NIOSH, 2007). In addition, exposure to
respirable crystalline silica remains an
important cause of morbidity and
hospitalizations. State-based hospital
discharge data show that in the year
2000, 1,128 silicosis-related
hospitalizations occurred, indicating
that silicosis continues to be a
significant health issue in the U.S.
(CSTE, 2005). Although there is no
national silicosis disease surveillance
system in the U.S., a published analysis
of state-based surveillance data from the
time period 1987–1996 estimated that
between 3,600–7,000 new cases of
silicosis occurred in the U.S. each year
(Rosenman et al., 2003). It has been
widely reported that available statistics
on silicosis-related mortality and
morbidity are likely to be understated
due to misclassification of causes of
death (for example, as tuberculosis,
chronic bronchitis, emphysema, or cor
pulmonale), errors in recording
occupation on death certificates, or
misdiagnosis of disease by health care
providers (Goodwin, 2003; Windau et
al., 1991; Rosenman et al., 2003).
Furthermore, reliance on chest x-ray
findings may miss cases of silicosis
because fibrotic changes in the lung may
not be visible on chest radiograph; thus,
silicosis may be present absent x-ray
signs or may be more severe than
indicated by x-ray (Hnizdo et al., 1993;
Craighead and Vallyathan, 1980;
Rosenman et al., 1997).
Although most workers with earlystage silicosis (ILO categories 0/1 or 1/
0) typically do not experience
respiratory symptoms, the primary risk
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to the affected worker is progression of
disease with progressive decline of lung
function. Several studies of workers
exposed to crystalline silica have shown
that, once silicosis is detected by x-ray,
a substantial proportion of affected
workers can progress beyond ILO
category 1 silicosis, even after exposure
has ceased (for example, Hughes et al.,
1982; Hessel et al., 1988; Miller et al.,
1998; Ng et al., 1987a; Yang et al., 2006).
In a population of coal miners whose
last chest x-ray while employed was
classified as major category 0, and who
were examined again 10 years after the
mine had closed, 20 percent had
developed opacities consistent with a
classification of at least 1/0, and 4
percent progressed further to at least 2/
1 (Miller et al., 1998). Although there
were periods of extremely high
exposure to respirable quartz in the
mine (greater than 2 mg/m3 in some jobs
between 1972 and 1976, and more than
10 percent of exposures between 1969
and 1977 were greater than 1 mg/m3),
the mean cumulative exposure for the
cohort over the period 1964–1978 was
1.8 mg/m3-years, corresponding to an
average silica concentration of 0.12 mg/
m3. In a population of granite quarry
workers exposed to an average
respirable silica concentration of 0.48
mg/m3 (mean length of employment was
23.4 years), 45 percent of those
diagnosed with simple silicosis showed
radiological progression of disease after
2 to 10 years of follow up (Ng et al.,
1987a). Among a population of gold
miners, 92 percent progressed in 14
years; exposures of high-, medium-, and
low-exposure groups were 0.97, 0.45,
and 0.24 mg/m3, respectively (Hessel et
al., 1988). Chinese mine and factory
workers categorized under the Chinese
system of x-ray classification as
‘‘suspected’’ silicosis cases (analogous
to ILO 0/1) had a progression rate to
stage I (analogous to ILO major category
1) of 48.7 percent and the average
interval was about 5.1 years (Yang et al.,
2006). These and other studies
discussed in the Health Effects section
are of populations of workers exposed to
average concentrations of respirable
crystalline silica above those permitted
by OSHA’s current general industry
PEL. The studies, however, are of
interest to OSHA because the Agency’s
current enforcement data indicate that
exposures in this range are still common
in some industry sectors. Furthermore,
the Agency’s preliminary risk
assessment is based on use of an
exposure metric that is less influenced
by exposure pattern and, instead,
characterizes the accumulated exposure
of workers over time. Further, the use of
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Sfmt 4702
a cumulative exposure metric reflects
the progression of silica-related
diseases: While it is not known that
silicosis is a precursor to lung cancer,
continued exposure to respirable
crystalline silica among workers with
silicosis has been shown to be
associated with malignant respiratory
disease (Chen et al., 1992). The Chinese
pottery workers study offers an example
of silicosis-associated lung cancer
among workers in the clay industry,
reflecting the variety of health outcomes
associated with diverse silica exposures
across industrial settings.
The risk of silicosis, and particularly
its progression, carries with it an
increased risk of reduced lung function.
There is strong evidence in the literature
for the finding that lung function
deteriorates more rapidly in workers
exposed to silica, especially those with
silicosis, than what is expected from a
normal aging process (Cowie 1998;
Hughes et al., 1982; Malmberg et al.,
1993; Ng and Chan, 1992). The rates of
decline in lung function are greater in
those whose disease showed evidence of
´
radiologic progression (Begin et al.,
1987a; Cowie 1998; Ng and Chan, 1992;
Ng et al., 1987a). Additionally, the
average deterioration of lung function
exceeds that in smokers (Hughes et al.,
1982).
Several studies have reported no
decrease in pulmonary function with an
ILO category 1 level of profusion of
small opacities but found declines in
pulmonary function with categories 2
and 3 (Ng et al., 1987a; Begin et al.,
1988; Moore et al., 1988). A study by
Cowie (1998), however, found a
statistically significantly greater annual
loss in FVC and FEV1 among those with
category 1 profusion compared to
category 0. In another study, Cowie and
Mabena (1991) found that the degree of
profusion of opacities was associated
with reductions in several pulmonary
function metrics. Still, other studies
have reported no associations between
radiographic silicosis and decreases in
pulmonary function (Ng et al., 1987a;
Wiles et al., 1992; Hnizdo, 1992), with
some studies (Ng et al., 1987a; Wang et
al., 1997) finding that measurable
changes in pulmonary function are
evident well before the changes seen on
chest x-ray. This may reflect the general
insensitivity of chest radiography in
detecting lung fibrosis, and/or may
reflect that exposure to respirable silica
has also been shown to increase the risk
of chronic obstructive pulmonary
disease (COPD) (see Section V, Health
Effects Summary).
Finally, silicosis, and exposure to
respirable crystalline silica in and of
itself, increases the risk that latent
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tuberculosis infection can convert to
active disease. Early descriptions of dust
diseases of the lung did not distinguish
between TB and silicosis, and most fatal
cases described in the first half of this
century were a combination of silicosis
and TB (Castranova et al., 1996). More
recent findings demonstrate that
exposure to silica, even without
silicosis, increases the risk of infectious
(i.e., active) pulmonary TB (Sherson et
al., 1990; Cowie, 1994; Hnizdo and
Murray, 1998; WaterNaude et al., 2006).
Both conditions together can hasten the
development of respiratory impairment
and increase mortality risk even beyond
that experienced by unexposed persons
with active TB (Banks, 2005).
Based on the information presented
above and in its review of the health
literature, OSHA preliminarily
concludes that silicosis remains a
significant cause of early mortality and
of serious morbidity, despite the
existence of an enforceable exposure
limit over the past 40 years. Silicosis in
its later stages of progression (i.e., with
chest x-ray findings of ILO category 2 or
3 profusion of small opacities, or the
presence of large opacities) is
characterized by the likely appearance
of respiratory symptoms and decreased
pulmonary function, as well as
increased risk of progression to PMF,
disability, and early mortality. Earlystage silicosis, although without
symptoms among many who are
affected, nevertheless reflects the
formation of fibrotic lesions in the lung
and increases the risk of progression to
later stages, even after exposure to
respirable crystalline silica ceases. In
addition, the presence of silicosis
increases the risk of pulmonary
infections, including conversion of
latent TB infection to active TB.
Silicosis is not a reversible condition
and there is no specific treatment for the
disease, other than administration of
drugs to alleviate inflammation and
maintain open airways, or
administration of oxygen therapy in
severe cases. Based on these
considerations, OSHA preliminarily
finds that silicosis of any form, and at
any stage, is a material impairment of
health and that fibrotic scarring of the
lungs represents loss of functional
respiratory capacity.
b. Lung Cancer
OSHA considers lung cancer, an
irreversible and usually fatal disease, to
be a clear material impairment of health.
According to the National Cancer
Institute (Horner et al., 2009), the fiveyear survival rate for all forms of lung
cancer is only 15.6 percent, a rate that
has not improved in nearly two decades.
OSHA’s preliminary finding that
respirable crystalline silica exposure
substantially increases the risk of lung
cancer mortality is based on the best
available toxicological and
epidemiological data, reflects
substantial supportive evidence from
56325
animal and mechanistic research, and is
consistent with the conclusions of other
government and public health
organizations, including the
International Agency for Research on
Cancer (IARC, 1997), the National
Toxicology Program (NTP, 2000), the
National Institute for Occupational
Safety and Health (NIOSH, 2002), the
American Thoracic Society (1997), and
the American Conference of
Governmental Industrial Hygienists
(ACGIH, 2001). The Agency’s primary
evidence comes from evaluation of more
than 50 studies of occupational cohorts
from many different industry sectors in
which exposure to respirable crystalline
silica occurs, including granite and
stone quarrying; the refractory brick
industry; gold, tin, and tungsten mining;
the diatomaceous earth industry; the
industrial sand industry; and
construction. Studies key to OSHA’s
risk assessment are outlined in Table
VII–1, which summarizes exposure
characterization and related lung cancer
risk across several different industries.
In addition, the association between
exposure to respirable crystalline silica
and lung cancer risk was reported in a
national mortality surveillance study
(Calvert et al., 2003) and in two
community-based studies (Pukkala et
al., 2005; Cassidy et al., 2007), as well
as in a pooled analysis of 10
occupational cohort studies (Steenland
et al., 2001a).
TABLE VII–1— SUMMARY OF KEY LUNG CANCER STUDIES
Industry sector/population
Type of study and description of population
Exposure characterization
No. of lung cancer
deaths/cases
Risk ratios (95% CI)
Additional information
U.S. Diatomaceous
earth workers.
Cohort study. Same as
Checkoway et al.,
1993, excluding 317
workers whose exposures could not
be characterized,
and including 89
workers with asbestos exposure who
were previously excluded from the
1993 study. Follow
up through 1994.
Cohort study. N=2,209
white male miners
employed between
1936 and 1943. Followed from 1968–
1986.
Assessment based on
almost 6,400 samples taken from
1948–1988; about
57 percent of samples represented
particle counts, 17
percent were personal respirable dust
samples. JEM included 135 jobs
over 4 time periods
(Seixas et al., 1997).
Particle count data
from Beadle (1971).
77 ................................
SMR 129 (CI 101–
161) based on national rates, and
SMR 144 (CI 114–
180) based on local
rates. Risk ratios by
exposure quintile
were 1.00, 0.96,
0.77, 1.26, and 2.15,
with the latter being
stat. sig. RR= 2.15
and 1.67.
Smoking history available for half cohort.
Under worst-case
assumptions, the
risk ratio for the
high-exposure group
would be reduced to
1.67 after accounting for smoking.
Checkoway et al.,
1997.
77 ................................
RR 1.023 (CI 1.005–
1.042) per 1,000
particle-years of exposure based on
Cox proportional
hazards model.
Model adjusted for
smoking and year of
birth. Lung cancer
was associated with
silicosis of the hilar
glands not silicosis
of lung or pleura.
Possible confounding by radon
exposure among
miners with 20 or
more years experience.
Hnizdo and SluisCremer, 1991.
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South African
gold miners.
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TABLE VII–1— SUMMARY OF KEY LUNG CANCER STUDIES—Continued
Industry sector/population
Type of study and description of population
Exposure characterization
South African
gold miners.
Nested case-control
study from population study by
Hnizdo and SluisCremer,1991. N=78
cases, 386 controls.
Particle count data
converted to respirable dust mass
(Beadle and Bradley, 1970, and
Page-Shipp and
Harris, 1972).
78 ................................
RR 2.45 (CI 1.2–5.2)
when silicosis was
included in model.
US gold miners.
Cohort and nested
case-control study,
same population as
Brown et al. (1986);
workers with at least
1 year underground
work between 1940
and 1965. Follow up
through 1990.
115 ..............................
Australian
gold miners.
Cohort and nested
case-control study.
N=2,297, follow up
of Armstrong et al.
(1979). Follow up
through 1993.
Particle count data,
conversion to mass
concentration based
on Vt. Granite study,
construction of JEM.
Median quartz exposures were 0.15,
0.07, and 0.02 mg/
m3 prior to 1930,
from 1930–1950,
and after 1950 respectively.
Expert ranking of
dustiness by job.
SMR 113 (CI 94–136)
overall. SMRs increased for workers
with 30 or more
years of latency,
and when local cancer rates used as
referents. Case-control study showed no
relationship of risk to
cumulative exposure
to dust.
SMR 126 (CI 107–
159) lower bound;
SMR 149 (CI 126–
176) upper bound.
From case-control,
RR 1.31 (CI 1.10–
1.7) per unit exposure score.
U.S.
(Vermont)
granite
shed and
quarry
workers –.
Cohort study. N=5,414
employed at least 1
year between 1950
and 1982.
Exposure data not
used in analysis.
53 deaths among
those hired before
1930; 43 deaths
among those hired
after 1940.
Finnish granite workers.
Cohort and nested
case-control studies.
N=1,026, follow up
from 1972–1981, extended to 1985
(Koskella et al.,
1990) and 1989
(Koskella et al.,
1994).
Case-control study
from McDonald et
al. (2001) cohort.
Personal sampling
data collected from
1970–1972 included
total and respirable
dust and respirable
silica sampling. Average silica concentrations ranged
form 0.3–4.9 mg/m3.
Assessment based on
14,249 respirable
dust and silica samples taken from
1974 to 1998. Exposures prior to this
based on particle
count data. Adjustments made for respirator use (Rando
et al., 2001).
31 through 1989 .........
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North American industrial sand
workers.
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No. of lung cancer
deaths/cases
Nested case control of
138 lung cancer
deaths.
95 cases, two controls
per case.
Frm 00054
Fmt 4701
Risk ratios (95% CI)
SMR 129 for pre-1930
hires (not stat. sig.);
SMR 95 for post1940 hires (not stat.
sig). SMR 181 (stat.
sig) for shed workers hired before
1930 and with long
tenure and latency.
Through 1989, SMR
140 (CI 98–193).
For workers in two
regions where silica
content of rock was
highest, SMRs were
126 (CI 71–208) and
211 (CI 120–342),
respectively.
OR 1.00, 0.84, 2.02
and 2.07 for increasing quartiles of exposure p for
trend=0.04).
Sfmt 4702
Additional information
Source
Lung cancer mortality
Hnizdo et al., 1997.
associated with
smoking, cumulative
dust exposure, and
duration of underground work. Latter
two factors were
most significantly
associated with lung
cancer with exposure lagged 20
years.
Smoking data availSteenland and Brown,
able for part of co1995a, 1995b
hort, habits comparable to general
US population; attributable smokingrelated cancer risk
estimated to be 1.07.
Association between
exposure and lung
cancer mortality not
stat. sig. after adjusting for smoking,
bronchitis, and silicosis. Authors concluded lung cancer
restricted to miners
who received compensation for silicosis..
Dust controls employed between
1938 and 1940 with
continuing improvement afterwards.
de Klerk and Musk,
1998
Smoking habits similar
to other Finnish occupational groups.
Minimal work-related
exposures to other
carcinogens.
Koskela et al., 1987,
1990, 1994.
Adjusted for smoking.
Positive association
between silica exposure and lung cancer. Median exposure for cases and
controls were 0.148
and 0.110 mg/m3
respirable silica, respectively.
Hughes et al., 2001.
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Costello and Graham,
1988.
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56327
TABLE VII–1— SUMMARY OF KEY LUNG CANCER STUDIES—Continued
Type of study and description of population
Exposure characterization
No. of lung cancer
deaths/cases
Risk ratios (95% CI)
Additional information
U.S. industrial sand
workers.
Cohort and nested
case-control study.
N=4,626 workers.
Follow up from
1960–1996.
SMR 160 (CI 131–
193) overall. Positive trends seen with
cumulative silica exposure (p=0.04 for
unlagged, p=0.08 for
lagged).
Smoking data from
358 workers suggested that smoking
could not explain the
observed increase in
lung cancer mortality
rates.
Steenland and
Sanderson, 2001.
Cohort study.
N=54,522 workers
employed 1 yr. or
more between 1972
and 1974. Follow up
through 1989.
.....................................
SMRs 198 for tin
workers (no CI reported but stat. sig.).
No stat. sig. increased SMR for
tungsten or copper
miners.
Non-statistically significantly increased risk
ratio for lung cancer
among silicotics. No
increased gradient
in risk observed with
exposure.
Chen et al., 1992.
Chinese Pottery workers.
Cohort study.
N=13,719 workers
employed in 1972–
1974. Follow up
through 1989.
.....................................
SMR 58 (p<0.05) overall. RR 1.63 (CI 0.8–
3.4) among silicotics
compared to nonsilicotics.
No reported increase
in lung cancer with
increasing exposure.
Chen et al., 1992.
British Coal
workers.
Cohort study.
N=17,820 miners
from 10 collieries..
Exposure assessment
based on 4,269
compliance dust
samples taken from
1974–1996 and analyzed for respirable
quartz. Exposures
prior to 1974 based
on particle count
data and quartz
analysis of settled
dust and dust collected by high-volume air samplers,
and use of a conversion factor (1
mppcf=0.1 mg/m3).
Measurements for total
dust, quartz content,
and particle size
taken from 1950’s1980’s. Exposures
categorized as high,
medium, low, or
non-exposed.
Measurements of jobspecific total dust
and quartz content
of settled dust used
to classify workers
into one of four total
dust exposure
groups.
Quartz exposure assessed from personal respirable dust
samples.
109 deaths overall ......
Chinese Tin,
Tungsten,
and Copper miners.
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Industry sector/population
973 ..............................
Significant relationship
between cumulative
silica exposure
(lagged 15 years)
and lung cancer
mortality VIA Cox
regression.
Adjusted for smoking ..
Miller et al, 2007; Miller and MacCalman,
2009
Toxicity studies provide additional
evidence of the carcinogenic potential of
crystalline silica (Health Effects
Summary, Section V). Acellular studies
using DNA exposed directly to freshly
fractured crystalline silica demonstrate
the direct effect silica has on DNA
breakage. Cell culture research has
investigated the processes by which
crystalline silica disrupts normal gene
expression and replication (Section V).
Studies demonstrate that chronic
inflammatory and fibrotic processes
resulting in oxidative and cellular
damage set up another possible
mechanism that leads to neoplastic
changes in the lung (Goldsmith, 1997;
see also Health Effects discussion in
Section V). In addition, the biologically
damaging physical characteristics of
crystalline silica, and the direct and
indirect genotoxicity of crystalline silica
(Schins, 2002; Borm and Driscoll, 1996),
support the Agency’s preliminary
position that respirable crystalline silica
should be considered as an occupational
carcinogen that causes lung cancer, a
clear material impairment of health.
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c. Non-Malignant Respiratory Disease
(Other Than Silicosis)
Exposure to respirable crystalline
silica increases the risk of developing
chronic obstructive pulmonary disease
(COPD), in particular chronic bronchitis
and emphysema. COPD results in loss of
pulmonary function that restricts
normal activity in individuals afflicted
with these conditions (ATS, 2003). Both
chronic bronchitis and emphysema can
occur in conjunction with development
of silicosis. Several studies have
documented increased prevalence of
chronic bronchitis and emphysema
among silica-exposed workers even
absent evidence of silicosis (see Section
I of the Health Effects Literature Review
and Preliminary Quantitative Risk
Assessment; NIOSH, 2002; ATS, 1997).
There is evidence that smoking may
have an additive or synergistic effect on
silica-related COPD morbidity or
mortality (Hnizdo, 1990; Hnizdo et al.,
1990; Wyndham et al., 1986; NIOSH,
2002). In a study of diatomaceous earth
workers, Park et al. (2002) found a
positive exposure-response relationship
between exposure to respirable
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Source
cristobalite and increased mortality
from non-malignant respiratory disease.
Decrements in pulmonary function
have often been found among workers
exposed to respirable crystalline silica
absent radiologic evidence of silicosis.
Several cross-sectional studies have
reported such findings among granite
workers (Theriault, 1974a, 1974b; Ng et
al., 1992b; Montes et al., 2004b), South
African gold miners (Irwig and Rocks,
1978; Hnizdo et al., 1990; Cowie and
Mabena, 1991), gemstone cutters (Ng et
al., 1987b), concrete workers (Meijer et
al., 2001), refractory brick workers
(Wang et al., 1997), hard rock miners
(Manfreda et al., 1982; Kreiss et al.,
1989), pottery workers (Neukirch et al.,
1994), slate workers (Suhr et al., 2003),
and potato sorters (Jorna et al., 1994).
OSHA also evaluated several
longitudinal studies where exposed
workers were examined over a period of
time to track changes in pulmonary
function. Among both active and retired
Vermont granite workers exposed to an
average of 60 mg/m3, Graham did not
find exposure-related decrements in
pulmonary function (Graham et al.,
1981, 1994). However, Eisen et al.
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(1995) did find significant pulmonary
decrements among a subset of granite
workers (termed ‘‘dropouts’’) who left
work and consequently did not
voluntarily participate in the last of a
series of annual pulmonary function
tests. This group of workers experienced
steeper declines in FEV1 compared to
the subset of workers who remained at
work and participated in all tests
(termed ‘‘survivors’’), and these declines
were significantly related to dust
exposure. Thus, in this study, workers
who had left work had exposure-related
declines in pulmonary function to a
greater extent than did workers who
remained on the job, clearly
demonstrating a survivor effect among
the active workers. Exposure-related
changes in lung function were also
reported in a 12-year study of granite
workers (Malmberg et al., 1993), in two
5-year studies of South African miners
(Hnizdo, 1992; Cowie, 1998), and in a
study of foundry workers whose lung
function was assessed between 1978
and 1992 (Hertzberg et al., 2002).
Each of these studies reported their
findings in terms of rates of decline in
any of several pulmonary function
measures, such as FVC, FEV1, and FEV1/
FVC. To put these declines in
perspective, Eisen et al. (1995), reported
that the rate of decline in FEV1 seen
among the dropout subgroup of
Vermont granite workers was 4 ml per
mg/m3-year of exposure to respirable
granite dust; by comparison, FEV1
declines at a rate of 10 ml/year from
smoking one pack of cigarettes daily.
From their study of foundry workers,
Hertzberg et al., (2002) reported finding
a 1.1 ml/year decline in FEV1 and a 1.6
ml/year decline in FVC for each mg/m3year of respirable silica exposure after
controlling for ethnicity and smoking.
From these rates of decline, they
estimated that exposure to the current
OSHA quartz standard of 0.1 mg/m3 for
40 years would result in a total loss of
FEV1 and FVC that is less than but still
comparable to smoking a pack of
cigarettes daily for 40 years. Hertzberg et
al. (2002) also estimated that exposure
to the current standard for 40 years
would increase the risk of developing
abnormal FEV1 or FVC by factors of 1.68
and 1.42, respectively. OSHA believes
that this magnitude of reduced
pulmonary function, as well as the
increased morbidity and mortality from
non-malignant respiratory disease that
has been documented in the studies
summarized above, constitute material
impairments of health and loss of
functional respiratory capacity.
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d. Renal and Autoimmune Effects
OSHA’s review of the literature
summarized in Section V, Health Effects
Summary, reflects substantial evidence
that exposure to crystalline silica
increases the risk of renal and
autoimmune diseases. Epidemiologic
studies have found statistically
significant associations between
occupational exposure to silica dust and
chronic renal disease (e.g., Calvert et al.,
1997), subclinical renal changes
including proteinurea and elevated
serum creatinine (e.g., Ng et al., 1992c;
Rosenman et al., 2000; Hotz et al., 1995),
end-stage renal disease morbidity (e.g.,
Steenland et al., 1990), chronic renal
disease mortality (Steenland et al.,
2001b, 2002a), and Wegener’s
granulomatosis (Nuyts et al., 1995), the
latter of which represents severe injury
to the glomeruli that, if untreated,
rapidly leads to renal failure. Possible
mechanisms suggested for silicainduced renal disease include a direct
toxic effect on the kidney, deposition in
the kidney of immune complexes (IgA)
following silica-related pulmonary
inflammation, or an autoimmune
mechanism (Calvert et al., 1997;
Gregorini et al., 1993). Steenland et al.
(2002a) demonstrated a positive
exposure-response relationship between
exposure to respirable crystalline silica
and end-stage renal disease mortality.
In addition, there are a number of
studies that show exposure to be related
to increased risks of autoimmune
disease, including scleroderma (e.g.,
Sluis-Cremer et al., 1985), rheumatoid
arthritis (e.g. Klockars et al., 1987;
Rosenman and Zhu, 1995), and systemic
lupus erythematosus (e.g., Brown et al.,
1997). Scleroderma is a degenerative
disorder that leads to over-production of
collagen in connective tissue that can
cause a wide variety of symptoms
including skin discoloration and
ulceration, joint pain, swelling and
discomfort in the extremities, breathing
problems, and digestive problems.
Rheumatoid arthritis is characterized by
joint pain and tenderness, fatigue, fever,
and weight loss. Systemic lupus
erythematosus is a chronic disease of
connective tissue that can present a
wide range of symptoms including skin
rash, fever, malaise, joint pain, and, in
many cases, anemia and iron deficiency.
OSHA believes that chronic renal
disease, end-stage renal disease
mortality, Wegener’s granulomatosis,
scleroderma, rheumatoid arthritis, and
systemic lupus erythematosus clearly
represent material impairments of
health.
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2. Significance of Risk
To evaluate the significance of the
health risks that result from exposure to
hazardous chemical agents, OSHA relies
on toxicological, epidemiological, and
experimental data, as well as statistical
methods. The Agency uses these data
and methods to characterize the risk of
disease resulting from workers’
exposure to a given hazard over a
working lifetime at levels of exposure
reflecting both compliance with current
standards and compliance with the new
standard being proposed. In the case of
crystalline silica, the current general
industry, construction, and shipyard
PELs are formulas that limit 8-hour
TWA exposures to respirable dust; the
limit on exposure decreases with
increasing crystalline silica content of
the dust. OSHA’s current general
industry PEL for respirable quartz is
expressed both in terms of a particle
count as well as a gravimetric
concentration, while the current
construction and shipyard employment
PELs for respirable quartz are only
expressed in terms of a particle count
formula. For general industry, the
gravimetric formula PEL for quartz
approaches 0.1 mg/m3 (100 mg/m3) of
respirable crystalline silica when the
quartz content of the dust is about 10
percent or greater. For the construction
and shipyard industries, the current PEL
is a formula that is based on
concentration of respirable particles in
the air; on a mass concentration basis,
it is believed by OSHA to lie within a
range of between about 0.25 mg/m3 (250
mg/m3) to 0.5 mg/m3 (500 mg/m3)
expressed as respirable quartz (see
Section VI). In general industry, the
current PELs for cristobalite and
tridymite are one-half the PEL for
quartz.
OSHA is proposing to revise the
current PELs for general industry,
construction, and shipyards to 0.05 mg/
m3 (50 mg/m3) of respirable crystalline
silica. OSHA is also proposing an action
level of 0.025 mg/m3 (25 mg/m3). In the
Summary of the Preliminary
Quantitative Risk Assessment (Section
VI of the preamble), OSHA presents
estimates of health risks associated with
45 years of exposure to 0.025, 0.05, and
0.1 mg/m3 respirable crystalline silica to
represent the risks associated with
exposure over a working lifetime to the
proposed action level, proposed PEL,
and current general industry PEL,
respectively. OSHA also presents
estimates associated with exposure to
0.25 and 0.5 mg/m3 to represent a range
of risks likely to be associated with
exposure to the current construction
and shipyard PELs. Risk estimates are
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presented for mortality due to lung
cancer, silicosis and other nonmalignant lung disease, and end-stage
renal disease, as well as silicosis
morbidity. The preliminary findings
from this assessment are summarized
below.
a. Summary of Excess Risk Estimates for
Excess Lung Cancer Mortality
For preliminary estimates of lung
cancer risk from crystalline silica
exposure, OSHA has relied upon studies
of exposure-response relationships
presented in a pooled analysis of 10
cohort studies (Steenland, et al. 2001a;
Toxichemica, Inc., 2004) as well as on
individual studies of granite (Attfield
and Costello, 2004), diatomaceous earth
(Rice et al., 2001), and industrial sand
(Hughes et al., 2001) worker cohorts,
and a study of coal miners exposed to
respirable quartz (Miller et al., 2007;
Miller and MacCalman, 2009). OSHA
believes these studies are suitable for
use to quantitatively characterize health
risks to exposed workers because (1)
study populations were of sufficient size
to provide adequate power to detect low
levels of risk, (2) sufficient quantitative
exposure data were available to
characterize cumulative exposures of
cohort members to respirable crystalline
silica, (3) the studies either adjusted for
or otherwise adequately addressed
confounding factors such as smoking
and exposure to other carcinogens, and
(4) investigators developed quantitative
assessments of exposure-response
relationships using appropriate
statistical models or otherwise provided
sufficient information that permits
OSHA to do so. Where investigators
estimated excess lung cancer risks
associated with exposure to the current
PEL or NIOSH recommended exposure
limit, OSHA provided these estimates in
its Preliminary Quantitative Risk
Assessment. However, OSHA
implemented all risk models in its own
life table analysis so that the use of
background lung cancer rates and
assumptions regarding length of
exposure and lifetime were constant
across each of the models, and so OSHA
could estimate lung cancer risks
associated with exposure to specific
levels of silica of interest to the Agency.
The Steenland et al. (2001a) study
consisted of a pooled exposure-response
analysis and risk assessment based on
raw data obtained for ten cohorts of
silica-exposed workers (65,980 workers,
1,072 lung cancer deaths). The cohorts
in this pooled analysis include U.S. gold
miners (Steenland and Brown, 1995a),
U.S. diatomaceous earth workers
(Checkoway et al., 1997), Australian
gold miners (deKlerk and Musk, 1998),
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Finnish granite workers (Koskela et al.,
1994), South African gold miners
(Hnizdo et al., 1997), U.S. industrial
sand employees (Steenland et al.,
2001b), Vermont granite workers
(Costello and Graham, 1988), and
Chinese pottery workers, tin miners,
and tungsten miners (Chen et al., 1992).
The investigators used a nested casecontrol design with cases and controls
matched for race, sex, age (within five
years) and study; 100 controls were
matched for each case. An extensive
exposure assessment for this pooled
analysis was developed and published
by Mannetje et al. (2002a). Exposure
measurement data were available for all
10 cohorts and included measurements
of particle counts, total dust mass,
respirable dust mass, and, for one
cohort, respirable quartz. Cohortspecific conversion factors were used to
estimate cumulative exposures to
respirable crystalline silica. A casecontrol analysis of silicosis mortality
(Mannetje et al., 2002b) showed a strong
positive exposure-response trend,
indicating that cumulative exposure
estimates for the cohorts were not
subject to random misclassification
errors of such a magnitude so as to
obscure observing an exposure-response
relationship between silica and silicosis
despite the variety of dust measurement
metrics relied upon and the need to
make assumptions to convert the data to
a single exposure metric (i.e., mass
concentration of respirable crystalline
silica). In effect, the known relationship
between exposure to respirable silica
and silicosis served as a positive control
to assess the validity of exposure
estimates. Quantitative assessment of
lung cancer risks were based on use of
a log-linear model (log RR = bx, where
x represents the exposure variable and
b the coefficient to be estimated) with a
15-year exposure lag providing the best
fit. Models based on untransformed or
log-transformed cumulative dose
metrics provided an acceptable fit to the
pooled data, with the model using
untransformed cumulative dose
providing a slightly better fit. However,
there was substantial heterogeneity
among the exposure-response
coefficients derived from the individual
cohorts when untransformed
cumulative dose was used, which could
result in one or a few of the cohorts
unduly influencing the pooled
exposure-response coefficient. For this
reason, the authors preferred the use of
log-transformed cumulative exposure in
the model to derive the pooled
coefficient since heterogeneity was
substantially reduced.
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OSHA’s implementation of this model
is based on a re-analysis conducted by
Steenland and Bartow (Toxichemica,
2004), which corrected small errors in
the assignment of exposure estimates in
the original analysis. In addition,
subsequent to the Toxichemica report,
and in response to suggestions made by
external peer reviewers, Steenland and
Bartow conducted additional analyses
based on use of a linear relative risk
model having the general form RR = 1
+ bx, as well as a categorical analysis
(personal communication, Steenland
2010). The linear model was
implemented with both untransformed
and log-transformed cumulative
exposure metrics, and was also
implemented as a 2-piece spline model.
The categorical analysis indicates
that, for the pooled data set, lung cancer
relative risks increase steeply at low
exposures, after which the rate of
increase in relative risk declines and the
exposure-response curve becomes flat
(see Figure II–2 of the Preliminary
Quantitative Risk Assessment). Use of
either the linear relative risk or loglinear relative risk model with
untransformed cumulative exposure
(with or without a 15-year lag) failed to
capture this initial steep slope, resulting
in an underestimate of the relative risk
compared to that suggested by the
categorical analysis. In contrast, use of
log-transformed cumulative exposure
with the linear or log-linear model, and
use of the 2-piece linear spline model
with untransformed exposure, better
reflected the initial rise and subsequent
leveling out of the exposure-response
curve, with the spline model fitting
somewhat better than either the linear
or log-linear models (all models
incorporated a 15-year exposure lag). Of
the three models that best reflect the
shape of the underlying exposureresponse curve suggested by the
categorical analysis, there is no clear
rationale to prefer one over the other.
Use of log-transformed cumulative
exposure in either the linear or loglinear models has the advantage of
reducing heterogeneity among the 10
pooled studies, lessening the likelihood
that the pooled coefficient would be
overtly influenced by outliers; however,
use of a log-transformed exposure
metric complicates comparing results
with those from other risk analyses
considered by OSHA that are based on
untransformed exposure metrics. Since
all three of these models yield
comparable estimates of risk the choice
of model is not critical for the purpose
of assessing significance of the risk, and
therefore OSHA believes that the risk
estimates derived from the pooled study
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are best represented as a range of
estimates based on all three of these
models.
From these models, the estimated
lung cancer risk associated with 45
years of exposure to 0.1 mg/m3 (about
equal to the current general industry
PEL) is between 22 and 29 deaths per
1,000 workers. The estimated risk
associated with exposure to silica
concentrations in the range of 0.25 and
0.5 mg/m3 (about equal to the current
construction and shipyard PELs) is
between 27 and 38 deaths per 1,000. At
the proposed PEL of 0.05 mg/m3, the
estimated excess risk ranges from 18 to
26 deaths per 1,000, and, at the
proposed action level of 0.025 mg/m3,
from 9 to 23 deaths per 1,000.
As previously discussed, the
exposure-response coefficients derived
from each of the 10 cohorts exhibited
significant heterogeneity; risk estimates
based on the coefficients derived from
the individual studies for
untransformed cumulative exposure
varied by almost two orders of
magnitude, with estimated risks
associated with exposure over a working
lifetime to the current general industry
PEL ranging from a low of 0.8 deaths per
1,000 (from the Chinese pottery worker
study) to a high of 69 deaths per 1,000
(from the South African miner study). It
is possible that the differences seen in
the slopes of the exposure-response
relationships reflect physical differences
in the nature of crystalline silica
particles generated in these workplaces
and/or the presence of different
substances on the crystal surfaces that
could mitigate or enhance their toxicity
(see Section V, Health Effects
Summary). It may also be that exposure
estimates for some cohorts were subject
to systematic misclassification errors
resulting in under- or over-estimation of
exposures due to the use of assumptions
and conversion factors that were
necessary to estimate mass respirable
crystalline silica concentrations from
exposure samples analyzed as particle
counts or total and respirable dust mass.
OSHA believes that, given the wide
range of risk estimates derived from
these 10 studies, use of log-transformed
cumulative exposure or the 2-piece
spline model is a reasonable approach
for deriving a single summary statistic
that represents the lung cancer risk
across the range of workplaces and
exposure conditions represented by the
studies. However, use of these
approaches results in a non-linear
exposure-response and suggests that the
relative risk of silica-related lung cancer
begins to attenuate at cumulative
exposures in the range of those
represented by the current PELs.
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Although such exposure-response
relationships have been described for
some carcinogens (for example, from
metabolic saturation or a healthy worker
survivor effect, see Staynor et al., 2003),
OSHA is not aware of any specific
evidence that would suggest that such a
result is biologically plausible for silica,
except perhaps the possibility that lung
cancer risks increase more slowly with
increasing exposure because of
competing risks from other silica-related
diseases. Attenuation of the exposureresponse can also result from
misclassification of exposure estimates
for the more highly-exposed cohort
members (Staynor et al., 2003). OSHA’s
evaluation of individual cohort studies
discussed below indicates that, with the
exception of the Vermont granite cohort,
attenuation of exposure-related lung
cancer response has not been directly
observed.
In addition to the pooled cohort
study, OSHA’s Preliminary Quantitative
Risk Assessment presents risk estimates
derived from four individual studies
where investigators presented either
lung cancer risk estimates or exposureresponse coefficients. Two of these
studies, one on diatomaceous earth
workers (Rice et al., 2001) and one on
Vermont granite workers (Attfield and
Costello, 2004), were included in the 10cohort pooled study (Steenland et al.,
2001a; Toxichemica, 2004). The other
two were of British coal miners (Miller
et al., 2007; Miller and MacCalman,
2010) and North American industrial
sand workers (Hughes et al., 2001).
Rice et al. (2001) presents an
exposure-response analysis of the
diatomaceous worker cohort studied by
Checkoway et al. (1993, 1996, 1997),
who found a significant relationship
between exposure to respirable
cristobalite and increased lung cancer
mortality. The cohort consisted of 2,342
white males employed for at least one
year between 1942 and 1987 in a
California diatomaceous earth mining
and processing plant. The cohort was
followed until 1994, and included 77
lung cancer deaths. The risk analysis
relied on an extensive job-specific
exposure assessment developed by
Sexias et al. (1997), which included use
of over 6,000 samples taken during the
period 1948 through 1988. The mean
cumulative exposure for the cohort was
2.16 mg/m3-years for respirable
crystalline silica dust. Rice et al. (2001)
evaluated several model forms for the
exposure-response analysis and found
exposure to respirable cristobalite to be
a significant predictor of lung cancer
mortality with the best-fitting model
being a linear relative risk model (with
a 15-year exposure lag). From this
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model, the estimates of the excess risk
of lung cancer mortality are 34, 17, and
9 deaths per 1,000 workers for 45-years
of exposure to 0.1, 0.05, and 0.025 mg/
m3, respectively. For exposures in the
range of the current construction and
shipyard PELs over 45 years, estimated
risks lie in a range between 81 and 152
deaths per 1,000 workers.
Somewhat higher risk estimates are
derived from the analysis presented by
Attfield and Costello (2004) of Vermont
granite workers. This study involved a
cohort of 5,414 male granite workers
who were employed in the Vermont
granite industry between 1950 and 1982
and who were followed through 1994.
Workers’ cumulative exposures were
estimated by Davis et al. (1983) based on
historical exposure data collected in six
environmental surveys conducted
between 1924 and 1977. A categorical
analysis showed an increasing trend of
lung cancer risk ratios with increasing
exposure, and Poisson regression was
used to evaluate several exposureresponse models with varying exposure
lags and use of either untransformed or
log-transformed exposure metrics. The
best-fitting model was based on use of
a 15-year lag, use of untransformed
cumulative exposure, and omission of
the highest exposure group. The
investigators believed that the omission
of the highest exposure group was
appropriate since: (1) The underlying
exposure data for the high-exposure
group was weaker than for the others;
(2) there was a greater likelihood that
competing causes of death and
misdiagnoses of causes of death
attenuated the lung cancer death rate in
the highest exposure group; (3) all of the
remaining groups comprised 85 percent
of the deaths in the cohort and showed
a strong linear increase in lung cancer
mortality with increasing exposure; and
(4) the exposure-response relationship
seen in the lower exposure groups was
more relevant given that the exposures
of these groups were within the range of
current occupational standards. OSHA’s
use of the exposure coefficient from this
analysis in a log-linear relative risk
model yielded a risk estimate of 60
deaths per 1,000 workers for 45 years of
exposure to the current general industry
PEL of 0.1 mg/m3, 25 deaths per 1,000
for 45 years of exposure to the proposed
PEL of 0.05 mg/m3, and 11 deaths per
1,000 for 45 years of exposure at the
proposed action level of 0.025 mg/m3.
Estimated risks associated with 45 years
of exposure at the current construction
PEL range from 250 to 653 deaths per
1,000.
Hughes et al. (2001) conducted a
nested case-control study of 95 lung
cancer deaths from a cohort of 2,670
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industrial sand workers in the U.S. and
Canada studied by McDonald et al.
(2001). (This cohort overlaps with the
cohort studied by Steenland and
Sanderson (2001), which was included
in the 10-cohort pooled study by
Steenland et al., 2001a). Both categorical
analyses and conditional logistic
regression were used to examine
relationships with cumulative exposure,
log of cumulative exposure, and average
exposure. Exposure levels over time
were estimated via a job-exposure
matrix developed for this study (Rando
et al., 2001). The 50th percentile
(median) exposure level of cases and
controls for lung cancer were 0.149 and
0.110 mg/m3 respirable crystalline
silica, respectively, slightly above the
current OSHA general industry
standard. There did not appear to be
substantial misclassification of
exposures, as evidenced by silicosis
mortality showing a positive exposureresponse trend with cumulative
exposure and average exposure
concentration. Statistically significant
positive exposure-response trends for
lung cancer were found for both
cumulative exposure (lagged 15 years)
and average exposure concentration, but
not for duration of employment, after
controlling for smoking. There was no
indication of an interaction effect of
smoking and cumulative silica
exposure. Hughes et al. (2001) reported
the exposure coefficients for both lagged
and unlagged cumulative exposure;
there was no significant difference
between the two (0.13 per mg/m3-year
for lagged vs. 0.14 per mg/m3-year for
unlagged). Use of the coefficient from
Hughes et al. (2001) that incorporated a
15-year lag generates estimated cancer
risks of 34, 15, and 7 deaths per 1,000
for 45 years exposure to the current
general industry PEL of 0.1, the
proposed PEL of 0.05 mg/m3, and the
proposed action level of 0.025 mg/m3
respirable silica, respectively. For 45
years of exposure to the construction
PEL, estimated risks range from 120 to
387 deaths per 1,000 workers.
Miller and MacCalman (2010, also
reported in Miller et al., 2007) extended
the follow-up of a previously published
cohort mortality study (Miller and
Buchanan, 1997). The follow-up study
included 17,800 miners from 10 coal
mines in the U.K. who were followed
through the end of 2005; observation in
the original study began in 1970. By
2005, there were 516,431 person years
of observation, an average of 29 years
per miner, with 10,698 deaths from all
causes. Exposure estimates of cohort
members were not updated from the
earlier study since the mines closed in
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the 1980s; however, some of these men
might have had additional exposure at
other mines or facilities. An analysis of
cause-specific mortality was performed
using external controls; it demonstrated
that lung cancer mortality was
statistically significantly elevated for
coal miners exposed to silica. An
analysis using internal controls was
performed via Cox proportional hazards
regression methods, which allowed for
each individual miner’s measurements
of age and smoking status, as well as the
individual’s detailed dust and quartz
time-dependent exposure
measurements. From the Cox regression,
Miller and MacCalman (2009) estimated
that cumulative exposure of 5 g-h/m3
respirable quartz (incorporating a 15year lag) was associated with a relative
risk of 1.14 for lung cancer. This
cumulative exposure is about equivalent
to 45 years of exposure to 0.055 mg/m3
respirable quartz, or a cumulative
exposure of 2.25 mg/m3-yr, assuming
2,000 hours of exposure per year. OSHA
applied this slope factor in a log-relative
risk model and estimated the lifetime
lung cancer mortality risk to be 13 per
1,000 for 45 years of exposure to 0.1 mg/
m3 respirable crystalline silica. For the
proposed PEL of 0.05 mg/m3 and
proposed action level of 0.025 mg/m3,
the lifetime risks are estimated to be 6
and 3 deaths per 1,000, respectively.
The range of risks estimated to result
from 45 years of exposure to the current
construction and shipyard PELs is from
37 to 95 deaths per 1,000 workers.
The analysis from the Miller and
MacCalman (2009) study yields risk
estimates that are lower than those
obtained from the other cohort studies
described above. Possible explanations
for this include: (1) Unlike the studies
on diatomaceous earth workers and
granite workers, the mortality analysis
of the coal miners was adjusted for
smoking; (2) lung cancer risks might
have been lower among the coal miners
due to high competing mortality risks
observed in the cohort (mortality was
significantly increased for several
diseases, including tuberculosis,
chronic bronchitis, and non-malignant
respiratory disease); and (3) the lower
risk estimates derived from the coal
miner study could reflect an actual
difference in the cancer potency of the
quartz dust in the coal mines compared
to that present in the work
environments studied elsewhere. OSHA
believes that the risk estimates derived
from this study are credible. In terms of
design, the cohort was based on union
rolls with very good participation rates
and good reporting. The study group
was the largest of any of the individual
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cohort studies reviewed here (over
17,000 workers) and there was an
average of nearly 30 years of follow-up,
with about 60 percent of the cohort
having died by the end of follow-up.
Just as important were the high quality
and detail of the exposure
measurements, both of total dust and
quartz.
b. Summary of Risk Estimates for
Silicosis and Other Chronic Lung
Disease Mortality
OSHA based its quantitative
assessment of silicosis mortality risks on
a pooled analysis conducted by
Mannetje et al. (2002b) of data from six
of the ten epidemiological studies in the
Steenland et al. (2001a) pooled analysis
of lung cancer mortality. Cohorts
included in the silicosis study were U.S.
diatomaceous earth workers
(Checkoway et al., 1997); Finnish
granite workers (Koskela et al., 1994);
U.S. granite workers (Costello and
Graham, 1988); U.S. industrial sand
workers (Steenland and Sanderson,
2001); U.S. gold miners (Steenland and
Brown, 1995b); and Australian gold
miners (deKlerk and Musk, 1998). These
six cohorts contained 18,634 subjects
and 170 silicosis deaths, where silicosis
mortality was defined as death from
silicosis (ICD–9 502, n=150) or from
unspecified pneumoconiosis (ICD–9
505, n = 20). Analysis of exposureresponse was performed in a categorical
analysis where the cohort was divided
into cumulative exposure deciles and
Poisson regression was used to estimate
silicosis rate ratios for each category,
adjusted for age, calendar period, and
study. Exposure-response was examined
in more detail using a nested casecontrol design and logistic regression.
Although Mannetje et al. (2002b)
estimated silicosis risks at the current
OSHA PEL from the Poisson regression,
a subsequent analysis based on the casecontrol design was conducted by
Steenland and Bartow (Toxichemica,
2004), which resulted in slightly lower
estimates of risk. Based on the
Toxichemica analysis, OSHA estimates
that the lifetime risk (over 85 years) of
silicosis mortality associated with 45
years of exposure to the current general
industry PEL of 0.1 mg/m3 is 11 deaths
per 1,000 workers. Exposure for 45 years
to the proposed PEL of 0.05 mg/m3 and
action level of 0.025 mg/m3 results in an
estimated 7 and 4 silicosis deaths per
1,000, respectively. Lifetime risks
associated with exposure at the current
construction and shipyard PELs range
from 17 to 22 deaths per 1,000 workers.
To study non-malignant respiratory
diseases, of which silicosis is one, Park
et al. (2002) analyzed the California
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diatomaceous earth cohort data
originally studied by Checkoway et al.
(1997), consisting of 2,570 diatomaceous
earth workers employed for 12 months
or more from 1942 to 1994. The authors
quantified the relationship between
exposure to cristobalite and mortality
from chronic lung disease other than
cancer (LDOC). Diseases in this category
included pneumoconiosis (which
included silicosis), chronic bronchitis,
and emphysema, but excluded
pneumonia and other infectious
diseases. Less than 25 percent of the
LDOC deaths in the analysis were coded
as silicosis or other pneumoconiosis (15
of 67). As noted by Park et al. (2002), it
is likely that silicosis as a cause of death
is often misclassified as emphysema or
chronic bronchitis. Exposure-response
relationships were explored using both
Poisson regression models and Cox’s
proportional hazards models fit to the
same series of relative rate exposureresponse models that were evaluated by
Rice et al. (2001) for lung cancer (i.e.,
log-linear, log-square root, log-quadratic,
linear relative rate, a power function,
and a shape function). Relative or excess
rates were modeled using internal
controls and adjusting for age, calendar
time, ethnicity (Hispanic versus white),
and time since first entry into the
cohort, or using age- and calendar timeadjusted external standardization to
U.S. population mortality rates. There
were no LDOC deaths recorded among
workers having cumulative exposures
above 32 mg/m3-years, causing the
response to level off or decline in the
highest exposure range; possible
explanations considered included
survivor selection, depletion of
susceptible populations in high dust
areas, and/or a higher degree of
misclassification of exposures in the
earlier years where exposure data were
lacking and when exposures were
presumably the highest. Therefore, Park
et al. (2002) performed exposureresponse analyses that restricted the
dataset to observations where
cumulative exposures were below 10
mg/m3-years, a level more than four
times higher than that resulting from 45
years of exposure to the current general
industry PEL for cristobalite (which is
about 0.05 mg/m3), as well as analyses
using the full dataset. Among the
models based on the restricted dataset,
the best-fitting model with a single
exposure term was the linear relative
rate model using external adjustment.
OSHA’s estimates of the lifetime
chronic lung disease mortality risk
based on this model are substantially
higher than those that OSHA derived
from the Mannetje et al. (2002b) silicosis
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analysis. For the current general
industry PEL of 0.1 mg/m3, exposure for
45 years is estimated to result in 83
deaths per 1,000 workers. At the
proposed PEL of 0.05 mg/m3 and action
level of 0.025 mg/m3, OSHA estimates
the lifetime risk from 45 years of
exposure to be 43 and 22 deaths per
1,000, respectively. The range of risks
associated with exposure at the
construction and shipyard PELs over a
working lifetime is from 188 to 321
deaths per 1,000 workers. It should be
noted that the Mannetje study (2002b)
was not adjusted for smoking while the
Park study (2002) had data on smoking
habits for about one-third of the workers
who died from LDOC and about half of
the entire cohort. The Poisson
regression on which the risk model is
based was partially stratified on
smoking. Furthermore, analyses without
adjustment for smoking suggested to the
authors that smoking was acting as a
negative confounder.
c. Summary of Risk Estimates for Renal
Disease Mortality
OSHA’s analysis of the health effects
literature included several studies that
have demonstrated that exposure to
crystalline silica increases the risk of
renal and autoimmune disease (see
Section V, Health Effects Summary).
Studies have found statistically
significant associations between
occupational exposure to silica dust and
chronic renal disease, sub-clinical renal
changes, end-stage renal disease
morbidity, chronic renal disease
mortality, and Wegener’s
granulomatosis. A strong exposureresponse association for renal disease
mortality and silica exposure has also
been demonstrated.
OSHA’s assessment of the renal
disease risks that result from exposure
to respirable crystalline silica are based
on an analysis of pooled data from three
cohort studies (Steenland et al., 2002a).
The combined cohort for the pooled
analysis (Steenland et al., 2002a)
consisted of 13,382 workers and
included industrial sand workers
(Steenland et al., 2001b), U.S. gold
miners (Steenland and Brown, 1995a),
and Vermont granite workers (Costello
and Graham, 1998). Exposure data were
available for 12,783 workers and
analyses conducted by the original
investigators demonstrated
monotonically increasing exposureresponse trends for silicosis, indicating
that exposure estimates were not likely
subject to significant random
misclassification. The mean duration of
exposure, cumulative exposure, and
concentration of respirable silica for the
combined cohort were 13.6 years, 1.2
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mg/m3-years, and 0.07 mg/m3,
respectively. There were highly
statistically significant trends for
increasing renal disease mortality with
increasing cumulative exposure for both
multiple cause analysis of mortality
(p<0.000001) and underlying cause
analysis (p = 0.0007). Exposureresponse analysis was also conducted as
part of a nested case-control study,
which showed statistically significant
monotonic trends of increasing risk with
increasing exposure again for both
multiple cause (p = 0.004 linear trend,
0.0002 log trend) and underlying cause
(p = 0.21 linear trend, 0.03 log trend)
analysis. The authors found that use of
log-cumulative dose in a log relative risk
model fit the pooled data better than
cumulative exposure, average exposure,
or lagged exposure. OSHA’s estimates of
renal disease mortality risk, which are
based on the log relative risk model
with log cumulative exposure, are 39
deaths per 1,000 for 45 years of
exposure at the current general industry
PEL of 0.1 mg/m3, 32 deaths per 1,000
for exposure at the proposed PEL of 0.05
mg/m3, and 25 deaths per 1,000 at the
proposed action level of 0.025 mg/m3.
OSHA also estimates that 45 years of
exposure at the current construction and
shipyard PELs would result in a renal
disease mortality risk ranging from 52 to
63 deaths per 1,000 workers.
d. Summary of Risk Estimates for
Silicosis Morbidity
OSHA’s Preliminary Quantitative Risk
Assessment reviewed several crosssectional studies designed to
characterize relationships between
exposure to respirable crystalline silica
and development of silicosis as
determined by chest radiography.
Several of these studies could not
provide information on exposure or
length of employment prior to disease
onset. Others did have access to
sufficient historical medical data to
retrospectively determine time of
disease onset but included medical
examination at follow up of primarily
active workers with little or no postemployment follow-up. Although OSHA
presents silicosis risk estimates that
were reported by the investigators of
these studies, OSHA believes that such
estimates are likely to understate
lifetime risk of developing radiological
silicosis; in fact, the risk estimates
reported in these studies are generally
lower than those derived from studies
that included retired workers in follow
up medical examinations.
Therefore, OSHA believes that the
most useful studies for characterizing
lifetime risk of silicosis morbidity are
retrospective cohort studies that
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Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules
included a large proportion of retired
workers in the cohort and that were able
to evaluate disease status over time,
including post-retirement. OSHA
identified studies of six cohorts for
which the inclusion of retirees was
deemed sufficient to adequately
characterize silicosis morbidity risks
well past employment (Hnizdo and
Sluis-Cremer, 1993; Steenland and
Brown, 1995b; Miller et al., 1998;
Buchanan et al., 2003; Chen et al., 2001;
Chen et al., 2005). Study populations
included five mining cohorts and a
Chinese pottery worker cohort. Except
for the Chinese studies (Chen et al.,
2001; Chen et al., 2005), chest
radiographs were interpreted in
accordance with the ILO system
described earlier in this section, and xray films were read by panels of Breaders. In the Chinese studies, films
were evaluated using a Chinese system
of classification that is analogous to the
ILO system. In addition, the Steenland
and Brown (1995b) study of U.S. gold
miners included silicosis mortality as
well as morbidity in its analysis.
OSHA’s estimates of silicosis morbidity
risks are based on implementing the
various exposure-response models
reported by the investigators; these are
considered to be cumulative risk models
in the sense that they represent the risk
observed in the cohort at the time of the
last medical evaluation and do not
reflect all of the risk that may become
manifest over a lifetime. With the
exception of a coal miner study
(Buchanan et al., 2003), risk estimates
reflect the risk that a worker will
acquire an abnormal chest x-ray
classified as ILO major category 1 or
greater; the coal miner study evaluated
the risk of acquiring an abnormal chest
x-ray classified as major category 2 or
higher.
For miners exposed to freshly cut
crystalline silica, the estimated risk of
developing lesions consistent with an
ILO classification of category 1 or
greater is estimated to range from 120 to
773 cases per 1,000 workers exposed at
the current general industry PEL of 0.1
mg/m3 for 45 years. For 45 years of
exposure to the proposed PEL of 0.05
mg/m3, the range in estimated risk is
from 20 to 170 cases per 1,000 workers.
The risk predicted from exposure to the
proposed action level of 0.025 mg/m3
ranges from 5 to 40 cases per 1,000.
From the coal miner study of Buchanan
et al. (2003), the estimated risks of
acquiring an abnormal chest x-ray
classified as ILO category 2 or higher are
301, 55, and 21 cases per 1,000 workers
exposed for 45 years to 0.1, 0.05, and
0.025 mg/m3, respectively. These
estimates are within the range of risks
obtained from the other mining studies.
At exposures at or above 0.25 mg/m3 for
45 years (equivalent to the current
construction and shipyard PELs), the
risk of acquiring an abnormal chest xray approaches unity. Risk estimates
based on the pottery cohort are 60, 20,
and 5 cases per 1,000 workers exposed
for 45 years to 0.1, 0.05, and 0.025 mg/
m3, respectively, which is generally
below the range of risks estimated from
the other studies and may reflect a
lower toxicity of quartz particles in that
work environment due to the presence
of alumino-silicates on the particle
surfaces. According to Chen et al.
(2005), adjustment of the exposure
metric to reflect the unoccluded surface
area of silica particles resulted in an
exposure-response of pottery workers
that was similar to the mining cohorts.
The finding of a reduced silicosis risk
among pottery workers is consistent
with other studies of clay and brick
industries that have reported finding a
lower prevalence of silicosis compared
to that experienced in other industry
sectors (Love et al., 1999; Hessel, 2006;
Miller and Soutar, 2007) as well as a
lower silicosis risk per unit of
cumulative exposure (Love et al., 1999;
Miller and Soutar, 2007).
3. Significance of Risk and Risk
Reduction
The Supreme Court’s benzene
decision of 1980, discussed above in
this section, states that ‘‘before he can
promulgate any permanent health or
safety standard, the Secretary [of Labor]
is required to make a threshold finding
that a place of employment is unsafe—
56333
in the sense that significant risks are
present and can be eliminated or
lessened by a change in practices.’’
Benzene, 448 U.S. at 642. While making
it clear that it is up to the Agency to
determine what constitutes a significant
risk, the Court offered general guidance
on the level of risk OSHA might
determine to be significant.
It is the Agency’s responsibility to
determine in the first instance what it
considers to be a ‘‘significant’’ risk. Some
risks are plainly acceptable and others are
plainly unacceptable. If, for example, the
odds are one in a billion that a person will
die from cancer by taking a drink of
chlorinated water, the risk clearly could not
be considered significant. On the other hand,
if the odds are one in a thousand that regular
inhalation of gasoline vapors that are 2%
benzene will be fatal, a reasonable person
might well consider the risk significant and
take appropriate steps to decrease or
eliminate it.
Benzene, 448 U.S. at 655. The Court
further stated that the determination of
significant risk is not a mathematical
straitjacket and that ‘‘the Agency has no
duty to calculate the exact probability of
harm.’’ Id.
In this section, OSHA presents its
preliminary findings with respect to the
significance of the risks summarized
above, and the potential of the proposed
standard to reduce those risks. Findings
related to mortality risk will be
presented first, followed by silicosis
morbidity risks.
a. Mortality Risks
OSHA’s Preliminary Quantitative Risk
Assessment (and the Summary of the
Preliminary Quantitative Risk
Assessment in section VI) presents risk
estimates for four causes of excess
mortality: Lung cancer, silicosis, nonmalignant respiratory disease (including
silicosis and COPD), and renal disease.
Table VII–2 presents the estimated
excess lifetime risks (i.e., to age 85) of
these fatal diseases associated with
various levels of crystalline silica
exposure allowed under the current
rule, based on OSHA’s risk assessment
and assuming 45 years of occupational
exposure to crystalline silica.
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TABLE VII–2—EXPECTED EXCESS DEATHS PER 1,000 WORKERS
Current general
industry PEL
(0.1 mg/m3)
Fatal health outcome
Lung Cancer:
10-cohort pooled analysis ........................................................................................
Single cohort study-lowest estimate .........................................................................
Single cohort study-highest estimate .......................................................................
Silicosis ............................................................................................................................
Non-Malignant Respiratory Disease (including silicosis) ................................................
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Current
construction/
shipyard PEL
(0.25–0.5 mg/m3)
22–29
13
60
11
83
E:\FR\FM\12SEP2.SGM
27–38
37–95
250–653
17–22
188–321
12SEP2
Proposed PEL
(0.05 mg/m3)
18–26
6
25
7
43
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Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules
TABLE VII–2—EXPECTED EXCESS DEATHS PER 1,000 WORKERS—Continued
Current general
industry PEL
(0.1 mg/m3)
Fatal health outcome
Renal Disease .................................................................................................................
The purpose of the OSH Act, as stated
in Section 6(b), is to ensure ‘‘that no
employee will suffer material
impairment of health or functional
capacity even if such employee has
regular exposure to the hazard . . . for
the period of his working life.’’ 29
U.S.C. 655(b)(5). Assuming a 45-year
working life, as OSHA has done in
significant risk determinations for
previous standards, the Agency
preliminarily finds that the excess risk
of disease mortality related to exposure
to respirable crystalline silica at levels
permitted by current OSHA standards is
clearly significant. The Agency’s
estimate of such risk falls well above the
level of risk the Supreme Court
indicated a reasonable person might
consider unacceptable. Benzene, 448
U.S. at 655. For lung cancer, OSHA
estimates the range of risk at the current
general industry PEL to be between 13
and 60 deaths per 1,000 workers. The
estimated risk for silicosis mortality is
lower, at 11 deaths per 1,000 workers;
however, the estimated lifetime risk for
non-malignant respiratory disease
mortality, including silicosis, is about 8fold higher than that for silicosis alone,
at 83 deaths per 1,000. OSHA believes
that the estimate for non-malignant
respiratory disease mortality is better
than the estimate for silicosis mortality
at capturing the total respiratory disease
burden associated with exposure to
crystalline silica dust. The former
captures deaths related to COPD, for
which there is strong evidence of a
causal relationship with exposure to
silica, and is also more likely to capture
those deaths where silicosis was a
contributing factor but where the cause
of death was misclassified. Finally,
there is an estimated lifetime risk of
renal disease mortality of 39 deaths per
1,000. Exposure for 45 years at levels of
respirable crystalline silica in the range
of the current limits for construction
and shipyards result in even higher risk
estimates, as presented in Table VII–2.
To further demonstrate significant
risk, OSHA compares the risk from
currently permissible crystalline silica
exposures to risks found across a broad
variety of occupations. The Agency has
used similar occupational risk
comparisons in the significant risk
determination for substance-specific
standards promulgated since the
benzene decision. This approach is
supported by evidence in the legislative
record, with regard to Section 6(b)(5) of
the Act (29 U.S.C. 655(b)(5)), that
Congress intended the Agency to
regulate unacceptably severe
occupational hazards, and not ‘‘to
establish a utopia free from any
hazards’’ or to address risks comparable
to those that exist in virtually any
occupation or workplace. 116 Cong.
Rec. 37614 (1970), Leg. Hist. 480–82. It
is also consistent with Section 6(g) of
the OSH Act, which states: ‘‘In
determining the priority for establishing
standards under this section, the
Secretary shall give due regard to the
urgency of the need for mandatory
safety and health standards for
particular industries, trades, crafts,
occupations, businesses, workplaces or
work environments.’’ 29 U.S.C. 655(g).
Fatal injury rates for most U.S.
industries and occupations may be
obtained from data collected by the
Bureau of Labor Statistics. Table VII–3
shows annual fatality rates per 1,000
employees for several industries for
Current
construction/
shipyard PEL
(0.25–0.5 mg/m3)
39
52–63
Proposed PEL
(0.05 mg/m3)
32
2007, as well as projected fatalities per
1,000 employees assuming exposure to
workplace hazards for 45 years based on
these annual rates (BLS, 2010). While it
is difficult to meaningfully compare
aggregate industry fatality rates to the
risks estimated in the quantitative risk
assessment for crystalline silica, which
address one specific hazard (inhalation
exposure to respirable crystalline silica)
and several health outcomes (lung
cancer, silicosis, NMRD, renal disease
mortality), these rates provide a useful
frame of reference for considering risk
from inhalation exposure to crystalline
silica. For example, OSHA’s estimated
range of 6–60 excess lung cancer deaths
per 1,000 workers from regular
occupational exposure to respirable
crystalline silica in the range of 0.05—
0.1 mg/m3 is roughly comparable to, or
higher than, the expected risk of fatal
injuries over a working life in high-risk
occupations such as mining and
construction (see Table VII–3). Regular
exposures at higher levels, including the
current construction and shipyard PELs
for respirable crystalline silica, are
expected to cause substantially more
deaths per 1,000 workers from lung
cancer (ranging from 37 to 653 per
1,000) than result from occupational
injuries in most private industry. At the
proposed PEL of 0.05 mg/m3 respirable
crystalline silica, the Agency’s estimate
of excess lung cancer mortality, from 6
to 26 deaths per 1,000 workers, is still
3- to10-fold or more higher than private
industry’s average fatal injury rate,
given the same employment time, and
substantially exceeds those rates found
in lower-risk industries such as finance
and educational and health services.
TABLE VII–3—FATAL INJURIES PER 1000 EMPLOYEES, BY INDUSTRY OR SECTOR
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Over 1 year
All Private Industry ...................................................................................................................................................
Mining (General) ......................................................................................................................................................
Construction .............................................................................................................................................................
Manufacturing ..........................................................................................................................................................
Wholesale Trade ......................................................................................................................................................
Transportation and Warehousing ............................................................................................................................
Financial Activities ...................................................................................................................................................
Educational and Health Services ............................................................................................................................
Source: BLS (2010).
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0.043
0.214
0.108
0.024
0.045
0.165
0.012
0.008
Over 45 years
1.9
9.6
4.8
1.1
2.0
7.4
0.5
0.4
Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules
Because there is little available
information on the incidence of
occupational cancer across all
industries, risk from crystalline silica
exposure cannot be compared with
overall risk from other workplace
carcinogens. However, OSHA’s previous
risk assessments provide estimates of
56335
from 45 years of occupational exposure
to several carcinogens, as published in
the preambles to final rules promulgated
since the benzene decision in 1980.
These risks were judged by the Agency
to be significant.
risk from exposure to certain
carcinogens. These risk assessments, as
with the current assessment for
crystalline silica, were based on animal
or human data of reasonable or high
quality and used the best information
then available. Table VII–4 shows the
Agency’s best estimates of cancer risk
TABLE VII–4—SELECTED OSHA RISK ESTIMATES FOR PRIOR AND CURRENT PELS
[Excess Cancers per 1000 workers]
Standard
Risk at prior PEL
Risk at current PEL
Federal Register date
Ethylene Oxide ..................................................................
Asbestos ............................................................................
Benzene .............................................................................
Formaldehyde ....................................................................
Methylenedianiline .............................................................
Cadmium ............................................................................
1,3-Butadiene .....................................................................
Methylene Chloride ............................................................
Chromium VI ......................................................................
Crystalline Silica:
General Industry PEL .................................................
Construction/Shipyard PEL ........................................
63–109 per 1000 .................
64 per 1000 .........................
95 per 1000 .........................
0.4–6.2 per 1000 .................
*6–30 per 1000 ...................
58–157 per 1000 .................
11.2–59.4 per 1000 .............
126 per 1000 .......................
101–351 per 1000 ...............
1.2–2.3 per 1000 .................
6.7 per 1000 ........................
10 per 1000 .........................
0.0056 per 1000 ..................
0.8 per 1000 ........................
3–15 per 1000 .....................
1.3–8.1 per 1000 .................
3.6 per 1000 ........................
10–45 per 1000 ...................
June 22, 1984.
June 20, 1986.
September 11, 1987.
December 4, 1987.
August 10, 1992.
September 14, 1992.
November 4, 1996.
January 10, 1997.
February 28, 2006
**13–60 per 1000 ................
**27–653 per 1000 ..............
***6–26 per 1000 .................
***6–26 per 1000 .................
N/A
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* no prior standard; reported risk is based on estimated exposures at the time of the rulemaking
** estimated excess lung cancer risks at the current PEL
*** estimated excess lung cancer risks at the proposed new PEL
The estimated excess lung cancer
risks associated with respirable
crystalline silica at the current general
industry PEL, 13–60 deaths per 1,000
workers, are comparable to, and in some
cases higher than, the estimated excess
cancer risks for many other workplace
carcinogens for which OSHA made a
determination of significant risk (see
Table VII–4, ‘‘Selected OSHA Risk
Estimates for Prior and Current PELs’’).
The estimated excess lung cancer risks
associated with exposure to the current
construction and shipyard PELs are
even higher. The estimated risk from
lifetime occupational exposure to
respirable crystalline silica at the
proposed PEL is 6–26 excess lung
cancer deaths per 1,000 workers, a range
still higher than the risks from exposure
to many other carcinogens regulated by
OSHA (see Table VII–4, ‘‘Selected
OSHA Risk Estimates for Prior and
Current PELs’’).
OSHA’s preliminary risk assessment
also shows that reduction of the current
PELs to the proposed level of 0.05 mg/
m3 will result in substantial reduction
in risk, although quantification of that
reduction is subject to model
uncertainty. Risk models that reflect
attenuation of the risk with increasing
exposure, such as those relating risk to
a log transformation of cumulative
exposure, will result in lower estimates
of risk reduction compared to linear risk
models. Thus, for lung cancer risks, the
assessment based on the 10-cohort
pooled analysis by Steenland et al.
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(2001; also Toxichemica, 2004;
Steenland 2010) suggests risk will be
reduced by about 14 percent from the
current general industry PEL and by 28–
41 percent from the current
construction/shipyard PEL (based on
the midpoint of the ranges of estimated
risk derived from the three models used
for the pooled cohort data). These risk
reduction estimates, however, are much
lower than those derived from the single
cohort studies (Rice et al., 2001; Attfield
and Costello, 2004; Hughes et al., 2001;
Miller and MacCalman, 2009), which
used linear or log-linear relative risk
models with untransformed cumulative
exposure as the dose metric. These
single cohort studies suggest that
reducing the current PELs to the
proposed PEL will reduce lung cancer
risk by more than 50 percent in general
industry and by more than 80 percent in
construction and shipyards.
For silicosis mortality, OSHA’s
assessment indicates that risk will be
reduced by 36 percent and by 58–68
percent as a result of reducing the
current general industry and
construction/shipyard PELs,
respectively. Non-malignant respiratory
disease mortality risks will be reduced
by 48 percent and by 77–87 percent
from reducing the general industry and
construction/shipyard PELs,
respectively, to the proposed PEL. There
is also a substantial reduction in renal
disease mortality risks; an 18-percent
reduction associated with reducing the
general industry PEL and a 38- to 49-
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percent reduction associated with
reducing the construction/shipyard PEL.
Thus, OSHA believes that the
proposed PEL of 0.05 mg/m3 respirable
crystalline silica will substantially
reduce the risk of material health
impairments associated with exposure
to silica. However, even at the proposed
PEL, as well as the action level of 0.025
mg/m3, the risk posed to workers with
45 years of regular exposure to
respirable crystalline silica is greater
than 1 per 1,000 workers and is still
clearly significant.
b. Silicosis Morbidity Risks
OSHA’s Preliminary Risk Assessment
characterizes the risk of developing lung
fibrosis as detected by chest x-ray. For
45 years of exposure at the current
general industry PEL, OSHA estimates
that the risk of developing lung fibrosis
consistent with an ILO category 1+
degree of small opacity profusion ranges
from 60 to 773 cases per 1,000. For
exposure at the construction and
shipyard PELs, the risk approaches
unity. The wide range of risk estimates
derived from the underlying studies
relied on for the risk assessment may
reflect differences in the relative toxicity
of quartz particles in different
workplaces; nevertheless, OSHA
believes that each of these risk estimates
clearly represent a significant risk of
developing fibrotic lesions in the lung.
Exposure to the proposed PEL of 0.05
mg/m3 respirable crystalline silica for
45 years yields an estimated risk of
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Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules
between 20 and 170 cases per 1,000 for
developing fibrotic lesions consistent
with an ILO category of 1+. These risk
estimates indicate that promulgation of
the proposed PEL would result in a
reduction in risk by about two-thirds or
more, which the Agency believes is a
substantial reduction of the risk of
developing abnormal chest x-ray
findings consistent with silicosis.
One study of coal miners also
permitted the agency to evaluate the risk
of developing lung fibrosis consistent
with an ILO category 2+ degree of
profusion of small opacities (Buchanan
et al., 2003). This level of profusion has
been shown to be associated with a
higher prevalence of lung function
decrement and an increased rate of early
mortality (Ng et al., 1987a; Begin et al.,
1998; Moore et al., 1988; Ng et al.,
1992a; Infante-Rivard et al., 1991). From
this study, OSHA estimates that the risk
associated with 45 years of exposure to
the current general industry PEL is 301
cases per 1,000 workers, again a clearly
significant risk. Exposure to the
proposed PEL of 0.05 mg/m3 respirable
crystalline silica for 45 years yields an
estimated risk of 55 cases per 1,000 for
developing lesions consistent with an
ILO category 2+ degree of small opacity
profusion. This represents a reduction
in risk of over 80 percent, again a clearly
substantial reduction of the risk of
developing radiologic silicosis
consistent with ILO category 2+ degree
of small opacity profusion.
As is the case for other health effects
addressed in the preliminary risk
assessment (i.e., lung cancer, silicosis
morbidity defined as ILO 1+ level of
profusion), there is some evidence that
this risk will vary according to the
nature of quartz particles present in
different workplaces. In particular, risk
may vary depending on whether quartz
is freshly fractured during work
operations and the co-existence of other
minerals and substances that could alter
the biological activity of quartz. Using
medical and exposure data taken from a
cohort of heavy clay workers first
studied by Love et al. (1999), Miller and
Soutar (2007) compared the silicosis
prevalence within the cohort to that
predicted by the exposure-response
model derived by Buchanan et al. (2003)
and used by OSHA to estimate the risk
of radiologic silicosis with a
classification of ILO 2+. They found that
the model predicted about a 4-fold
higher prevalence of workers having an
abnormal x-ray than was actually seen
in the clay cohort (31 cases predicted vs.
8 observed). Unlike the coal miner
study, the clay worker cohort included
only active workers and not retirees
(Love et al., 1999); however, Miller and
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Soutar believed this could not explain
the magnitude of the difference between
the model prediction and observed
silicosis prevalence in the clay worker
cohort. OSHA believes that the result
obtained by Miller and Soutar (2007)
likely does reflect differences in the
toxic potency of quartz particles in
different work settings. Nevertheless,
even if the risk estimates predicted by
the model derived from the coal worker
study were reduced substantially, even
by more than a factor of 10, the resulting
risk estimate would still reflect the
presence of a significant risk.
The Preliminary Quantitative Risk
Assessment also discusses the question
of a threshold exposure level for
silicosis. There is little quantitative data
available with which to estimate a
threshold exposure level for silicosis or
any of the other silica-related diseases
addressed in the risk assessment. The
risk assessment discussed one study
that perhaps provides the best
information. This is an analysis by
Kuempel et al. (2001) who used a ratbased toxicokinetic/toxicodynamic
model along with a human lung
deposition/clearance model to estimate
a minimum lung burden necessary to
cause the initial inflammatory events
that can lead to lung fibrosis and an
indirect genotoxic cause of lung cancer.
They estimated that the threshold effect
level of lung burden associated with this
inflammation (Mcrit) is the equivalent of
exposure to 0.036 mg/m3 for 45 years;
thus, exposures below this level would
presumably not lead to an excess lung
cancer risk (based on an indirect
genotoxic mechanism) nor to silicosis,
at least in the ‘‘average individual.’’
This might suggest that exposures to a
concentration of silica at the proposed
action level would not be associated
with a risk of silicosis, and possibly not
of lung cancer. However, OSHA does
not believe that the analysis by Kuemple
et al. is definitive with respect to a
threshold for silica-related disease.
First, since the critical quartz burden is
a mean value derived from the model,
the authors estimated that a 45-year
exposure to a concentration as low as
0.005 mg/m3, or 5 times below the
proposed action level, would result in a
lung quartz burden that was equal to the
95-percent lower confidence limit on
Mcrit. Due to the statistical uncertainty in
Kuemple et al.’s estimate of critical lung
burden, OSHA cannot rule out the
existence of a threshold lung burden
that is below that resulting from
exposure to the proposed action level.
In addition, with respect to silicarelated lung cancer, if at least some of
the risk is from a direct genotoxic
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mechanism (see section II.F of the
Health Effects Literature Review), then
this threshold value is not relevant to
the risk of lung cancer. Supporting
evidence comes from Steenland and
Deddens (2002), who found that, for the
10-cohort pooled data set, a risk model
that incorporated a threshold did fit
better than a no-threshold model, but
the estimated threshold was very low,
0.010 mg/m3 (10 mg/m3). OSHA
acknowledges that a threshold exposure
level might lie within the range of the
proposed action level, as suggested by
the work of Kuempel et al. (2001) and
that this possibility adds uncertainty to
the estimated risks associated with
exposure to the action level. However,
OSHA believes that available
information cannot firmly establish a
threshold exposure level for silicarelated effects, and there is no empirical
evidence that a threshold exists at or
above the proposed PEL of 0.05 mg/m3
for respirable crystalline silica.
VIII. Summary of the Preliminary
Economic Analysis and Initial
Regulatory Flexibility Analysis
A. Introduction and Summary
OSHA’s Preliminary Economic
Analysis and Initial Regulatory
Flexibility Analysis (PEA) addresses
issues related to the costs, benefits,
technological and economic feasibility,
and the economic impacts (including
impacts on small entities) of this
proposed respirable crystalline silica
rule and evaluates regulatory
alternatives to the proposed rule.
Executive Orders 13563 and 12866
direct agencies to assess all costs and
benefits of available regulatory
alternatives and, if regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, and public health and
safety effects; distributive impacts; and
equity). Executive Order 13563
emphasized the importance of
quantifying both costs and benefits, of
reducing costs, of harmonizing rules,
and of promoting flexibility. The full
PEA has been placed in OSHA
rulemaking docket OSHA–2010–0034.
This rule is an economically significant
regulatory action under Sec. 3(f)(1) of
Executive Order 12866 and has been
reviewed by the Office of Information
and Regulatory Affairs in the Office of
Management and Budget, as required by
executive order.
The purpose of the PEA is to:
• Identify the establishments and
industries potentially affected by the
proposed rule;
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• Estimate current exposures and the
technologically feasible methods of
controlling these exposures;
• Estimate the benefits resulting from
employers coming into compliance with
the proposed rule in terms of reductions
in cases of silicosis, lung cancer, other
forms of chronic obstructive pulmonary
disease, and renal failure;
• Evaluate the costs and economic
impacts that establishments in the
regulated community will incur to
achieve compliance with the proposed
rule;
• Assess the economic feasibility of
the proposed rule for affected
industries; and
• Assess the impact of the proposed
rule on small entities through an Initial
Regulatory Flexibility Analysis (IRFA),
to include an evaluation of significant
regulatory alternatives to the proposed
rule that OSHA has considered.
The Preliminary Economic Analysis
contains the following chapters:
Chapter I. Introduction
Chapter II. Assessing the Need for Regulation
Chapter III. Profile of Affected Industries
Chapter IV. Technological Feasibility
Chapter V. Costs of Compliance
Chapter VI. Economic Impacts
Chapter VII. Benefits and Net Benefits
Chapter VIII. Regulatory Alternatives
Chapter IX. Initial Regulatory Flexibility
Analysis
Chapter X. Environmental Impacts
Key findings of these chapters are
summarized below and in sections
VIII.B through VIII.I of this PEA
summary.
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Profile of Affected Industries
The proposed rule would affect
employers and employees in many
different industries across the economy.
As described in Section VIII.C and
reported in Table VIII–3 of this
preamble, OSHA estimates that a total of
2.1 million employees in 550,000
establishments and 533,000 firms
(entities) are potentially at risk from
exposure to respirable crystalline silica.
This total includes 1.8 million
employees in 477,000 establishments
and 486,000 firms in the construction
industry and 295,000 employees in
56,000 establishments and 47,000 firms
in general industry and maritime.
Technological Feasibility
As described in more detail in Section
VIII.D of this preamble and in Chapter
IV of the PEA, OSHA assessed, for all
affected sectors, the current exposures
and the technological feasibility of the
proposed PEL of 50 mg/m3 and, for
analytic purposes, an alternative PEL of
25 mg/m3.
Tables VIII–6 and VIII–7 in section
VIII.D of this preamble summarize all
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the industry sectors and construction
activities studied in the technological
feasibility analysis and show how many
operations within each can achieve
levels of 50 mg/m3 through the
implementation of engineering and
work practice controls. The table also
summarizes the overall feasibility
finding for each industry sector or
construction activity based on the
number of feasible versus infeasible
operations. For the general industry
sector, OSHA has preliminarily
concluded that the proposed PEL of 50
mg/m3 is technologically feasible for all
affected industries. For the construction
activities, OSHA has determined that
the proposed PEL of 50 mg/m3 is feasible
in 10 out of 12 of the affected activities.
Thus, OSHA preliminarily concludes
that engineering and work practices will
be sufficient to reduce and maintain
silica exposures to the proposed PEL of
50 mg/m3 or below in most operations
most of the time in the affected
industries. For those few operations
within an industry or activity where the
proposed PEL is not technologically
feasible even when workers use
recommended engineering and work
practice controls (seven out of 108
operations, see Tables VIII–6 and VIII–
7), employers can supplement controls
with respirators to achieve exposure
levels at or below the proposed PEL.
Based on the information presented in
the technological feasibility analysis,
the Agency believes that 50 mg/m3 is the
lowest feasible PEL. An alternative PEL
of 25 mg/m3 would not be feasible
because the engineering and work
practice controls identified to date will
not be sufficient to consistently reduce
exposures to levels below 25 mg/m3 in
most operations most of the time. OSHA
believes that an alternative PEL of 25
mg/m3 would not be feasible for many
industries, and that the use of
respiratory protection would be
necessary in most operations most of the
time to achieve compliance.
Additionally, the current methods of
sampling analysis create higher errors
and lower precision in measurement as
concentrations of silica lower than the
proposed PEL are analyzed. However,
the Agency preliminarily concludes that
these sampling and analytical methods
are adequate to permit employers to
comply with all applicable requirements
triggered by the proposed action level
and PEL.
Costs of Compliance
As described in more detail in Section
VIII.E and reported by industry in Table
VIII–8 of this preamble, the total
annualized cost of compliance with the
proposed standard is estimated to be
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about $658 million. The major cost
elements associated with the revisions
to the standard are costs for engineering
controls, including controls for abrasive
blasting ($344 million); medical
surveillance ($79 million); exposure
monitoring ($74 million); respiratory
protection ($91 million); training ($50
million) and regulated areas or access
control ($19 million). Of the total cost,
$511 million would be borne by firms
in the construction industry and $147
million would be borne by firms in
general industry and maritime.
The compliance costs are expressed as
annualized costs in order to evaluate
economic impacts against annual
revenue and annual profits, to be able to
compare the economic impact of the
rulemaking with other OSHA regulatory
actions, and to be able to add and track
Federal regulatory compliance costs and
economic impacts in a consistent
manner. Annualized costs also represent
a better measure for assessing the
longer-term potential impacts of the
rulemaking. The annualized costs were
calculated by annualizing the one-time
costs over a period of 10 years and
applying discount rates of 7 and 3
percent as appropriate.
The estimated costs for the proposed
silica standard rule include the
additional costs necessary for employers
to achieve full compliance. They do not
include costs associated with current
compliance that has already been
achieved with regard to the new
requirements or costs necessary to
achieve compliance with existing silica
requirements, to the extent that some
employers may currently not be fully
complying with applicable regulatory
requirements.
OSHA’s exposure profile represents
the Agency’s best estimate of current
exposures (i.e., baseline exposures).
OSHA did not attempt to determine the
extent to which current exposures in
compliance with the current silica PELs
are the result of baseline engineering
controls or the result of circumstances
leading to low exposures. This
information is not needed to estimate
the costs of (additional) engineering
controls needed to comply with the
proposed standard.
Because of the severe health hazards
involved, the Agency expects that the
estimated 15,446 abrasive blasters in the
construction sector and the estimated
4,550 abrasive blasters in the maritime
sector are currently wearing respirators
in compliance with OSHA’s abrasive
blasting provisions. Furthermore, for the
construction baseline, an estimated
241,269 workers, including abrasive
blasters, will need to use respirators to
achieve compliance with the proposed
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rule, and, based on the NIOSH/BLS
respirator use survey (NIOSH/BLS,
2003), an estimated 56 percent of
construction employers currently
require such respiratory use and have
respirator programs that meet OSHA’s
respirator standard. OSHA has not taken
any costs for employers and their
workers currently in compliance with
the respiratory provisions in the
proposed rule.
In addition, under both the general
industry and construction baselines, an
estimated 50 percent of employers have
pre-existing training programs that
address silica-related risks (as required
under OSHA’s hazard communication
standard) and partially satisfy the
proposed rule’s training requirements
(for costing purposes, estimated to
satisfy 50 percent of the training
requirements in the proposed rule).
These employers will need fewer
resources to achieve full compliance
with the proposed rule than those
employers without pre-existing training
programs that address silica-related
risks.
Other than respiratory protection and
worker training concerning silicarelated risks, OSHA did not assume
baseline compliance with any ancillary
provisions, even though some
employers have reported that they do
currently monitor silica exposure and
some employers have reported
conducting medical surveillance.
Economic Impacts
To assess the nature and magnitude of
the economic impacts associated with
compliance with the proposed rule,
OSHA developed quantitative estimates
of the potential economic impact of the
new requirements on entities in each of
the affected industry sectors. The
estimated compliance costs were
compared with industry revenues and
profits to provide an assessment of the
economic feasibility of complying with
the revised standard and an evaluation
of the potential economic impacts.
As described in greater detail in
Section VIII.F of this preamble, the costs
of compliance with the proposed
rulemaking are not large in relation to
the corresponding annual financial
flows associated with each of the
affected industry sectors. The estimated
annualized costs of compliance
represent about 0.02 percent of annual
revenues and about 0.5 percent of
annual profits, on average, across all
firms in general industry and maritime,
and about 0.05 percent of annual
revenues and about 1.0 percent of
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annual profits, on average, across all
firms in construction. Compliance costs
do not represent more than 0.39 percent
of revenues or more than 8.8 percent of
profits in any affected industry in
general industry or maritime, or more
than 0.13 percent of revenues or more
than 3 percent of profits in any affected
industry in construction.
Based on its analysis of international
trade effects, OSHA concluded that
most or all costs arising from this
proposed silica rule would be passed on
in higher prices rather than absorbed in
lost profits and that any price increases
would result in minimal loss of business
to foreign competition.
Given the minimal potential impact
on prices or profits in the affected
industries, OSHA has preliminarily
concluded that compliance with the
requirements of the proposed
rulemaking would be economically
feasible in every affected industry
sector.
In addition, OSHA directed Inforum—
a not-for-profit corporation with over 40
years of experience in the design and
application of macroeconomic models—
to run its LIFT (Long-term Interindustry
Forecasting Tool) model of the U.S.
economy to estimate the industry and
aggregate employment effects of the
proposed silica rule. Inforum developed
estimates of the employment impacts
over the ten-year period from 2014–
2023 by feeding OSHA’s year-by-year
and industry-by-industry estimates of
the compliance costs of the proposed
rule into its LIFT model. The most
important Inforum result is that the
proposed silica rule would have a
negligible—albeit slightly positive—net
effect on aggregate U.S. employment.
Based on its analysis of the costs and
economic impacts associated with this
rulemaking and on Inforum’s estimates
of associated employment and other
macroeconomic impacts, OSHA
preliminarily concludes that the effect
of the proposed standard on
employment, wages, and economic
growth for the United States would be
negligible.
Benefits, Net Benefits, and CostEffectiveness
As described in more detail in Section
VIII.G of this preamble, OSHA estimated
the benefits, net benefits, and
incremental benefits of the proposed
silica rule. That section also contains a
sensitivity analysis to show how robust
the estimates of net benefits are to
changes in various cost and benefit
parameters. A full explanation of the
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derivation of the estimates presented
there is provided in Chapter VII of the
PEA for the proposed rule. OSHA
invites comments on any aspect of its
estimation of the benefits and net
benefits of the proposed rule.
OSHA estimated the benefits
associated with the proposed PEL of 50
mg/m3 and, for analytical purposes to
comply with OMB Circular A–4, with
an alternative PEL of 100 mg/m3 for
respirable crystalline silica by applying
the dose-response relationship
developed in the Agency’s quantitative
risk assessment—summarized in
Section VI of this preamble—to current
exposure levels. OSHA determined
current exposure levels by first
developing an exposure profile
(presented in Chapter IV of the PEA) for
industries with workers exposed to
respirable crystalline silica, using OSHA
inspection and site-visit data, and then
applying this exposure profile to the
total current worker population. The
industry-by-industry exposure profile is
summarized in Table VIII–5 in Section
VIII.C of this preamble.
By applying the dose-response
relationship to estimates of current
exposure levels across industries, it is
possible to project the number of cases
of the following diseases expected to
occur in the worker population given
current exposure levels (the ‘‘baseline’’):
• Fatal cases of lung cancer,
• fatal cases of non-malignant
respiratory disease (including silicosis),
• fatal cases of end-stage renal
disease, and
• cases of silicosis morbidity.
Table VIII–1 provides a summary of
OSHA’s best estimate of the costs and
benefits of the proposed rule using a
discount rate of 3 percent. As shown,
the proposed rule is estimated to
prevent 688 fatalities and 1,585 silicarelated illnesses annually once it is fully
effective, and the estimated cost of the
rule is $637 million annually. Also as
shown in Table VIII–1, the discounted
monetized benefits of the proposed rule
are estimated to be $5.3 billion
annually, and the proposed rule is
estimated to generate net benefits of
$4.6 billion annually. Table VIII–1 also
presents the estimated costs and
benefits of the proposed rule using a
discount rate of 7 percent. The
estimated costs and benefits of the
proposed rule, disaggregated by
industry sector, were previously
presented in Table SI–3 in this
preamble.
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TABLE VIII–1—ANNUALIZED BENEFITS, COSTS AND NET BENEFITS OF OSHA’S PROPOSED SILICA STANDARD OF 50 μG/M3
Discount rate
3%
Annualized Costs
Engineering Controls (includes Abrasive Blasting) ..................................................
Respirators ...............................................................................................................
Exposure Assessment ..............................................................................................
Medical Surveillance .................................................................................................
Training .....................................................................................................................
Regulated Area or Access Control ...........................................................................
$329,994,068
90,573,449
72,504,999
76,233,932
48,779,433
19,243,500
3,203,485,869
1,986,214,921
2,101,980,475
1,363,727,104
5,189,700,790
4,552,371,410
688
1,585
657,892,211
3,465,707,579
2,807,815,368
162
375
151
Silica-Related Mortality .............................................................................................
Silicosis Morbidity .....................................................................................................
$343,818,700
90,918,741
74,421,757
79,069,527
50,266,744
19,396,743
637,329,380
Total Annualized Costs (point estimate) ...........................................................
Annual Benefits: Number of Cases Prevented
Fatal Lung Cancers (midpoint estimate) ..................................................................
Fatal Silicosis & other Non-Malignant Respiratory Diseases ..................................
Fatal Renal Disease .................................................................................................
Monetized Annual Benefits (midpoint estimate) ...............................................
Net Benefits .......................................................................................................
Initial Regulatory Flexibility Analysis
OSHA has prepared an Initial
Regulatory Flexibility Analysis (IRFA)
in accordance with the requirements of
the Regulatory Flexibility Act, as
amended in 1996. Among the contents
of the IRFA are an analysis of the
potential impact of the proposed rule on
small entities and a description and
discussion of significant alternatives to
the proposed rule that OSHA has
considered. The IRFA is presented in its
entirety both in Chapter IX of the PEA
and in Section VIII.I of this preamble.
The remainder of this section (Section
VIII) of the preamble is organized as
follows:
B. The Need for Regulation
C. Profile of Affected Industry
D. Technological Feasibility
E. Costs of Compliance
F. Economic Feasibility Analysis and
Regulatory Flexibility Determination
G. Benefits and Net Benefits
H. Regulatory Alternatives
I. Initial Regulatory Flexibility Analysis.
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7%
B. Need for Regulation
Employees in work environments
addressed by the proposed silica rule
are exposed to a variety of significant
hazards that can and do cause serious
injury and death. As described in
Chapter II of the PEA in support of the
proposed rule, the risks to employees
are excessively large due to the
existence of various types of market
failure, and existing and alternative
methods of overcoming these negative
consequences—such as workers’
compensation systems, tort liability
options, and information dissemination
programs—have been shown to provide
insufficient worker protection.
After carefully weighing the various
potential advantages and disadvantages
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of using a regulatory approach to
improve upon the current situation,
OSHA concludes that, in the case of
silica exposure, the proposed mandatory
standards represent the best choice for
reducing the risks to employees. In
addition, rulemaking is necessary in this
case in order to replace older existing
standards with updated, clear, and
consistent health standards.
C. Profile of Affected Industries
1. Introduction
Chapter III of the PEA presents profile
data for industries potentially affected
by the proposed silica rule. The
discussion below summarizes the
findings in that chapter. As a first step,
OSHA identifies the North American
Industrial Classification System
(NAICS) industries, both in general
industry and maritime and in the
construction sector, with potential
worker exposure to silica. Next, OSHA
provides summary statistics for the
affected industries, including the
number of affected entities and
establishments, the number of at-risk
workers, and the average revenue for
affected entities and establishments. 3
Finally, OSHA presents silica exposure
profiles for at-risk workers. These data
are presented by sector and job category.
Summary data are also provided for the
number of workers in each affected
industry who are currently exposed
above the proposed silica PEL of 50 mg/
m3, as well as above an alternative PEL
3 An establishment is a single physical location at
which business is conducted or services or
industrial operations are performed. An entity is an
aggregation of all establishments owned by a parent
company within an industry with some annual
payroll.
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of 100 mg/m3 for economic analysis
purposes.
The methodological basis for the
industry and at-risk worker data
presented here comes from ERG (2007a,
2007b, 2008a, and 2008b). The actual
data presented here comes from the
technological feasibility analyses
presented in Chapter IV of the PEA and
from ERG (2013), which updated ERG’s
earlier spreadsheets to reflect the most
recent industry data available. The
technological feasibility analyses
identified the job categories with
potential worker exposure to silica. ERG
(2007a, 2007b) matched the BLS
Occupational Employment Survey
(OES) occupational titles in NAICS
industries with the at-risk job categories
and then calculated the percentages of
production employment represented by
each at-risk job title.4 These percentages
were then used to project the number of
employees in the at-risk job categories
by NAICS industry. OSHA welcomes
additional information and data that
might help improve the accuracy and
usefulness of the industry profile
presented here and in Chapter III of the
PEA.
2. Selection of NAICS Industries for
Analysis
The technological feasibility analyses
presented in Chapter IV of the PEA
identify the general industry and
maritime sectors and the construction
activities potentially affected by the
proposed silica standard.
4 Production employment includes workers in
building and grounds maintenance; forestry,
fishing, and farming; installation and maintenance;
construction; production; and material handling
occupations.
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a. General Industry and Maritime
Employees engaged in various
activities in general industry and
maritime routinely encounter crystalline
silica as a molding material, as an inert
mineral additive, as a refractory
material, as a sandblasting abrasive, or
as a natural component of the base
materials with which they work. Some
industries use various forms of silica for
multiple purposes. As a result,
employers are challenged to limit
worker exposure to silica in dozens of
job categories throughout the general
industry and maritime sectors.
Job categories in general industry and
maritime were selected for analysis
based on data from the technical
industrial hygiene literature, evidence
from OSHA Special Emphasis Program
(SEP) results, and, in several cases,
information from ERG site visit reports.
These data sources provided evidence of
silica exposures in numerous sectors.
While the available data are not entirely
comprehensive, OSHA believes that
silica exposures in other sectors are
quite limited.
The 25 industry subsectors in the
overall general industry and maritime
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sectors that OSHA identified as being
potentially affected by the proposed
silica standard are as follows:
• Asphalt Paving Products
• Asphalt Roofing Materials
• Industries with Captive Foundries
• Concrete Products
• Cut Stone
• Dental Equipment and Supplies
• Dental Laboratories
• Flat Glass
• Iron Foundries
• Jewelry
• Mineral Processing
• Mineral Wool
• Nonferrous Sand Casting Foundries
• Non-Sand Casting Foundries
• Other Ferrous Sand Casting Foundries
• Other Glass Products
• Paint and Coatings
• Porcelain Enameling
• Pottery
• Railroads
• Ready-Mix Concrete
• Refractories
• Refractory Repair
• Shipyards
• Structural Clay
In some cases, affected industries
presented in the technological
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feasibility analysis have been
disaggregated to facilitate the cost and
economic impact analysis. In particular,
flat glass, mineral wool, and other glass
products are subsectors of the glass
industry described in Chapter IV of the
PEA, and captive foundries,5 iron
foundries, nonferrous sand casting
foundries, non-sand cast foundries, and
other ferrous sand casting foundries are
subsectors of the overall foundries
industry presented in Chapter IV of the
PEA.
As described in ERG (2008b), OSHA
identified the six-digit NAICS codes for
these subsectors to develop a list of
industries potentially affected by the
proposed silica standard. Table VIII–2
presents the sectors listed above with
their corresponding six-digit NAICS
industries.
BILLING CODE 4510–26–P
5 Captive foundries include establishments in
other industries with foundry processes incidental
to the primary products manufactured. ERG (2008b)
provides a discussion of the methodological issues
involved in estimating the number of captive
foundries and in identifying the industries in which
they are found.
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Table VIII-2
General Industry and Martime Sectors and Industries Potentially Affected by OSHA's Proposed Silica Rule
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NAICS
Industry
324121
324122
331111
331112
331210
331221
331222
331314
331423
331492
332111
332112
332115
332116
332117
332211
332212
332213
332214
332439
332510
332611
332612
332618
332710
332911
332912
332913
332919
332991
332996
332997
332998
332999
333319
333411
333412
333414
333511
333512
333513
333514
333515
333516
333518
333612
333613
333911
333912
333991
333992
333993
333994
333995
333996
333997
333999
334518
336111
336112
336120
336211
336212
Asphalt paving mixture and block mfg
Asphalt shingle and roofing materials
Iron & steel mills
Electrometallurgical ferroalloy product mfg
Iron & steel pipes & tubes mfg from purchased steel
Cold-rolled steel shape mfg
Steel wire drawing
Secondary smelting & alloying of aluminum
Secondary smelting, refining, & alloying of copper
Other nonferrous metal secondary smelting, refining, & alloying
Iron & steel forging
Nonferrous forging
Crown & closure mfg
Metal stamping
Powder metallurgy part mfg
Cutlery & flatware (except precious) mfg
Hand & edge tool mfg
Saw blade & handsaw mfg
Kitchen utensil, pot, & pan mfg
Other metal container mfg
Hardware mfg
Spring (heavy gauge) mfg
Spring (light gauge) mfg
Other fabricated wire product mfg
Machine shops
Industrial valve mfg
Fluid power valve & hose fitting mfg
Plumbing fixture fitting & trim mfg
Other metal valve & pipe fitting mfg
Ball & roller bearing mfg
Fabricated pipe & pipe fitting mfg
Industrial pattern mfg
Enameled iron & metal sanitary ware mfg
All other miscellaneous fabricated metal product mfg
Other commercial & service industry machinery mfg
Air purification equipment mfg
Industrial & commercial fan & blower mfg
Heating equipment (except warm air furnaces) mfg
Industrial mold mfg
Machine tool (metal cutting types) mfg
Machine tool (metal forming types) mfg
Special die & tool, die set, jig, & fixture mfg
Cutting tool & machine tool accessory mfg
Rolling mill machinery & equipment mfg
Other metalworking machinery mfg
Speed changer, industrial high-speed drive, & gear mfg
Mechanical power transmission equipment mfg
Pump & pumping equipment mfg
Air & gas compressor mfg
Power-driven handtool mfg
Welding & soldering equipment mfg
Packaging machinery mfg
Industrial process furnace & oven mfg
Fluid power cylinder & actuator mfg
Fluid power pump & motor mfg
Scale & balance (except laboratory) mfg
All other miscellaneous general-purpose machinery mfg
Watch, clock, & part mfg
Automobile mfg
Light truck & utility vehicle mfg
Heavy duty truck mfg
Motor vehicle body mfg
Truck trailer mfg
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Sector
Asphalt Paving Products
Asphalt Roofing Materials
Captive Foundries
56342
Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules
Table VIII-2
General Industry and Martime Sectors and Industries Potentially Affected by OSHA's Proposed Silica Rule
(Continued)
Concrete Products
Cut Stone
Dental Equipment and Supplies
Dental Laboratories
Flat Glass
Iron Foundries
Jewelry
Mineral Processing
Mineral Wool
Nonferrous Sand Casting Foundries
Non-Sand Casting Foundries
Other Ferrous Sand Casting Foundries
Other Glass Products
Paint and Coatings
Porcelain Enameling
Pottery
Railraods
Ready-Mix Concrete
Refractories
Refractory Repair
Shipyards
Carburetor, piston, piston ring, & vallA3 mfg
Gasoline engine & engine parts mfg
Other motor IA3hicle electrical & electronic equipment mfg
Motor IA3hicle steering & suspension component (except spring) mfg
Motor IA3hicie brake system mfg
Motor IA3hicie transmission & power train parts mfg
Motor IA3hicie metal stamping
All other motor IA3hicie parts mfg
Military armored IA3hicle, tank, & tank component mfg
Showcase, partition, shellhng, & locker mfg
Costume jewelry & nOlA3lty mfg
Concrete block & brick mfg
Concrete pipe mfg
Other concrete product mfg
All other miscellaneous nonmetallic mineral product mfg
Cut stone & stone product mfg
Dental equipment and supplies, manufacturing
Dental laboratories
Offices of dentists
Flat glass mfg
Iron foundries
Jewelry (except costume) mfg
Jewelers' material & lapidary work mfg
Costume jewelry & nOlA3lty mfg
Ground or treated mineral and earth manufacturing
Mineral wool mfg
Aluminum foundries (except die-casting)
Copper foundries (except die-casting)
Other nonferrous foundries (except die-casting)
Steel inlA3stment foundries
Aluminum foundries (except die-casting)
Copper foundries (except die-casting)
Other nonferrous foundries (except die-casting)
Steel foundries (except inlA3stment)
Other pressed & blown glass & glassware mfg
Glass container mfg
Paint & coating mfg tel
Metal coating and allied serlhces
Enameled iron & metal sanitary ware mfg
Electric housewares and household fans
Household cooking appliance manufactruing
Household refrigerator and home freezer manufacturing
Ornamental and architectural metal work
Household laundry equipment manufacturing
Other major household appliance manufacturing
Sign manufacturing
Vitreous china plumbing fixture & bathroom accessories mfg
Vitreous china, fine earthenware, & other pottery product mfg
Porcelain electrical supply mfg
Rail transportation
Ready-mix concrete mfg
Clay refractory mfg
Nonclay refractory mfg
Industrial supplies - wholesale
Ship building & repairing
Boat building
Brick & structural clay tile mfg
Ceramic wall & floor tile mfg
Other structural clay product mfg
Source: ERG, 2013
BILLING CODE 4510–26–C
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Structural Clay
336311
336312
336322
336330
336340
336350
336370
336399
336992
337215
339914
327331
327332
327390
327999
327991
339114
339116
621210
327211
331511
339911
339913
339914
327992
327993
331524
331525
331528
331512
331524
331525
331528
331513
327212
327213
325510
332812
332998
335211
335221
335222
332323
335224
335228
339950
327111
327112
327113
482110
327320
327124
327125
423840
336611
336612
327121
327122
327123
Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules
b. Construction
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
The construction sector is an integral
part of the nation’s economy,
accounting for almost 6 percent of total
employment. Establishments in this
industry are involved in a wide variety
of activities, including land
development and subdivision,
homebuilding, construction of
nonresidential buildings and other
structures, heavy construction work
(including roadways and bridges), and a
myriad of special trades such as
plumbing, roofing, electrical,
excavation, and demolition work.
Construction activities were selected
for analysis based on historical data of
recorded samples of construction
worker exposures from the OSHA
Integrated Management Information
System (IMIS) and the National Institute
for Occupational Safety and Health
(NIOSH). In addition, OSHA reviewed
the industrial hygiene literature across
the full range of construction activities,
and focused on dusty operations where
silica sand was most likely to be
fractured or abraded by work
operations. These physical processes
have been found to cause the silica
exposures that pose the greatest risk of
silicosis for workers.
The 12 construction activities, by job
category, that OSHA identified as being
potentially affected by the proposed
silica standard are as follows:
• Abrasive Blasters
• Drywall Finishers
• Heavy Equipment Operators
• Hole Drillers Using Hand-Held Drills
• Jackhammer and Impact Drillers
• Masonry Cutters Using Portable Saws
• Masonry Cutters Using Stationary
Saws
• Millers Using Portable or Mobile
Machines
• Rock and Concrete Drillers
• Rock-Crushing Machine Operators
and Tenders
• Tuckpointers and Grinders
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• Underground Construction Workers
As shown in ERG (2008a) and in
Chapter IV of the PEA, these
construction activities occur in the
following construction industries,
accompanied by their four-digit NAICS
codes: 6 7
• 2361 Residential Building
Construction
• 2362 Nonresidential Building
Construction
• 2371 Utility System Construction
• 2372 Land Subdivision
• 2373 Highway, Street, and Bridge
Construction
• 2379 Other Heavy and Civil
Engineering Construction
• 2381 Foundation, Structure, and
Building Exterior Contractors
• 2382 Building Equipment Contractors
• 2383 Building Finishing Contractors
• 2389 Other Specialty Trade
Contractors
Characteristics of Affected Industries
Table VIII–3 provides an overview of
the industries and estimated number of
workers affected by the proposed rule.
Included in Table VIII–3 are summary
statistics for each of the affected
industries, subtotals for construction
and for general industry and maritime,
and grand totals for all affected
industries combined.
The first five columns in Table VIII–
3 identify each industry in which
workers are routinely exposed to
6 ERG and OSHA used the four-digit NAICS codes
for the construction sector both because the BLS’s
Occupational Employment Statistics survey only
provides data at this level of detail and because,
unlike the case in general industry and maritime,
job categories in the construction sector are taskspecific, not industry-specific. Furthermore, as far
as economic impacts are concerned, IRS data on
profitability are reported only at the four-digit
NAICS code level of detail.
7 In addition, some public employees in state and
local governments are exposed to elevated levels of
respirable crystalline silica. These exposures are
included in the construction sector because they are
the result of construction activities.
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56343
respirable crystalline silica (preceded by
the industry’s NAICS code) and the total
number of entities, establishments, and
employees for that industry. Note that
not all entities, establishments, and
employees in these affected industries
necessarily engage in activities
involving silica exposure.
The next three columns in Table VIII–
3 show, for each affected industry,
OSHA’s estimate of the number of
affected entities, establishments, and
workers—that is, the number of entities
and establishments in which workers
are actually exposed to silica and the
total number of workers exposed to
silica. Based on ERG (2007a, 2007b),
OSHA’s methodology focused on
estimation of the number of affected
workers. The number of affected
establishments was set equal to the total
number of establishments in an industry
(based on Census data) unless the
number of affected establishments
would exceed the number of affected
employees in the industry. In that case,
the number of affected establishments in
the industry was set equal to the
number of affected employees, and the
number of affected entities in the
industry was reduced so as to maintain
the same ratio of entities to
establishments in the industry.8
8 OSHA determined that removing this
assumption would have a negligible impact on total
costs and would reduce the cost and economic
impact on the average affected establishment or
entity.
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........
........
........
........
........
........
........
........
........
........
........
........
........
........
........
........
........
........
........
........
........
........
........
........
........
........
........
........
........
327113
327121
327122
327123
327124
327125
327211
327212
327213
327320
327331
327332
327390
327991
327992
327993
327999
331111
331112
331210
331221
331222
331314
331423
331492
331511
331512
331513
331524
331525
331528
332111
332112
332115
332116
332117
332211
332212
332213
332214
332323
332439
327112 ........
324121
324122
325510
327111
236100
236200
237100
237200
237300
237900
238100
238200
238300
238900
999000
NAICS
197,600
43,634
20,236
12,383
11,081
5,326
116,836
179,051
132,219
73,922
14,397
Total entities a
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12SEP2
457
115
208
441
251
119
358
67
50
1,556
111
138
1,056
127
64
2,408
364
150
232
119
29
195
110
104
180
45
108
81
56
457
32
2,470
599
194
1,934
1,885
171
195
350
686
22
186
728
480
121
1,093
31
Subtotals—Construction ....................................................
Asphalt paving mixture and block manufacturing ....................
Asphalt shingle and roofing materials ......................................
Paint and coating manufacturing e ...........................................
Vitreous china plumbing fixtures & bathroom accessories
manufacturing.
Vitreous china, fine earthenware, & other pottery product
manufacturing.
Porcelain electrical supply mfg .................................................
Brick and structural clay mfg ....................................................
Ceramic wall and floor tile mfg .................................................
Other structural clay product mfg .............................................
Clay refractory manufacturing ..................................................
Nonclay refractory manufacturing ............................................
Flat glass manufacturing ..........................................................
Other pressed and blown glass and glassware manufacturing
Glass container manufacturing .................................................
Ready-mixed concrete manufacturing ......................................
Concrete block and brick mfg ..................................................
Concrete pipe mfg ....................................................................
Other concrete product mfg .....................................................
Cut stone and stone product manufacturing ............................
Ground or treated mineral and earth manufacturing ...............
Mineral wool manufacturing .....................................................
All other misc. nonmetallic mineral product mfg ......................
Iron and steel mills ...................................................................
Electrometallurgical ferroalloy product manufacturing .............
Iron and steel pipe and tube manufacturing from purchased
steel.
Rolled steel shape manufacturing ............................................
Steel wire drawing ....................................................................
Secondary smelting and alloying of aluminum ........................
Secondary smelting, refining, and alloying of copper ..............
Secondary smelting, refining, and alloying of nonferrous
metal (except cu & al).
Iron foundries ............................................................................
Steel investment foundries .......................................................
Steel foundries (except investment) .........................................
Aluminum foundries (except die-casting) .................................
Copper foundries (except die-casting) .....................................
Other nonferrous foundries (except die-casting) ......................
Iron and steel forging ...............................................................
Nonferrous forging ....................................................................
Crown and closure manufacturing ...........................................
Metal stamping .........................................................................
Powder metallurgy part manufacturing ....................................
Cutlery and flatware (except precious) manufacturing ............
Hand and edge tool manufacturing ..........................................
Saw blade and handsaw manufacturing ..................................
Kitchen utensil, pot, and pan manufacturing ............................
Ornamental and architectural metal work ................................
Other metal container manufacturing .......................................
806,685
Residential Building Construction .............................................
Nonresidential Building Construction .......................................
Utility System Construction ......................................................
Land Subdivision ......................................................................
Highway, Street, and Bridge Construction ...............................
Other Heavy and Civil Engineering Construction ....................
Foundation, Structure, and Building Exterior Contractors .......
Building Equipment Contractors ...............................................
Building Finishing Contractors ..................................................
Other Specialty Trade Contractors ...........................................
State and local governments d .................................................
Industry
13,101,738
966,198
741,978
496,628
77,406
325,182
90,167
1,167,986
1,940,281
975,335
557,638
5,762,939
485,859
54,973
43,634
20,236
6,466
11,081
5,326
116,836
19,988
119,000
73,922
14,397
Total affected
entities b
Construction
Total employment a
527
132
222
466
256
124
398
77
59
1,641
129
141
1,155
136
70
2,450
401
170
288
150
31
217
125
204
193
49
129
105
83
499
72
6,064
951
385
2,281
1,943
271
321
465
805
22
240
731
1,431
224
1,344
41
59,209
16,429
17,722
26,565
6,120
4,710
26,596
8,814
3,243
64,724
8,362
5,779
36,622
7,304
3,928
39,947
15,195
10,857
14,669
7,381
1,278
9,383
6,168
13,509
7,094
1,603
4,475
5,640
11,003
20,625
14,392
107,190
22,738
14,077
66,095
30,633
6,629
19,241
10,028
108,592
2,198
21,543
9,178
14,471
12,631
46,209
5,854
457
115
208
441
251
119
135
43
15
347
41
32
189
39
20
53
78
54
67
33
7
48
110
104
180
45
108
81
56
457
32
2,470
599
194
1,934
1,885
171
195
350
523
12
94
728
480
121
1,093
31
General Industry and Maritime
802,349
198,912
44,702
21,232
12,469
11,860
5,561
117,456
182,368
133,343
74,446
N/A
Total establish-ments a
527
132
222
466
256
124
150
50
18
366
47
33
207
41
22
54
86
61
83
42
7
53
125
204
193
49
129
105
83
499
72
6,064
951
385
2,281
1,943
271
321
465
614
12
122
731
1,431
224
1,344
41
477,476
55,338
44,702
21,232
6,511
11,860
5,561
117,456
20,358
120,012
74,446
NA
Total affected
establishments b
22,111
5,934
6,618
9,633
2,219
1,708
150
50
18
366
47
33
207
41
22
54
86
61
83
42
7
53
2,953
5,132
2,695
609
1,646
2,075
271
1,034
722
43,920
10,962
6,787
31,865
12,085
5,051
1,090
4,835
614
12
122
4,394
5,043
4,395
3,285
2,802
1,849,175
55,338
173,939
217,070
6,511
204,899
46,813
559,729
20,358
120,012
274,439
170,068
Total affected
employment b
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
652,029
27,669
34,788
96,181
3,255
66,916
18,835
111,946
10,179
60,006
137,219
85,034
Total FTE
affected
employees b
9,753,093
2,290,472
3,640,441
3,614,233
747,437
821,327
5,702,872
2,080,000
905,206
10,418,233
1,178,698
1,198,675
6,382,593
1,450,781
1,226,230
6,402,565
2,817,120
4,494,254
3,496,143
4,139,263
765,196
3,012,985
951,475
2,195,641
1,217,597
227,406
955,377
1,453,869
3,421,674
3,395,635
4,365,673
27,904,708
5,127,518
2,861,038
10,336,178
3,507,209
2,205,910
5,734,226
2,538,560
53,496,748
1,027,769
7,014,894
827,296
8,909,030
7,168,591
24,113,682
818,725
1,548,247,709
$374,724,410
313,592,140
98,129,343
24,449,519
96,655,241
19,456,230
157,513,197
267,537,377
112,005,298
84,184,953
N/A
Total revenues
($1,000) c
21,341,560
19,917,147
17,502,121
8,195,541
2,977,835
6,901,910
15,929,811
31,044,783
18,104,119
6,695,523
10,618,900
8,686,049
6,044,123
11,423,474
19,159,850
2,658,873
7,739,340
29,961,696
15,069,584
34,783,724
26,386,082
15,451,203
8,649,776
21,111,931
6,764,429
5,053,461
8,846,082
17,948,999
61,101,328
7,430,274
136,427,289
11,297,453
8,560,131
14,747,620
5,344,456
1,860,588
12,900,061
29,406,287
7,253,028
77,983,597
46,716,774
37,714,484
1,136,395
18,560,480
59,244,556
22,061,923
26,410,479
1,954,148
$1,896,379
7,186,876
4,849,246
1,974,442
8,722,610
3,653,066
1,348,156
1,494,196
847,120
1,138,835
N/A
Revenues per
entity
TABLE VIII–3—CHARACTERISTICS OF INDUSTRIES AFFECTED BY OSHA’S PROPOSED STANDARD FOR SILICA—ALL ENTITIES
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
18,506,818
17,352,060
16,398,383
7,755,866
2,919,674
6,623,607
14,328,825
27,012,993
15,342,473
6,348,710
9,137,193
8,501,240
5,526,055
10,667,509
17,517,577
2,613,292
7,025,236
26,436,790
12,139,387
27,595,088
24,683,755
13,884,721
7,611,802
10,762,945
6,308,794
4,640,933
7,406,022
13,846,371
41,224,993
6,804,880
60,634,351
4,601,700
5,391,712
7,431,268
4,531,424
1,805,048
8,139,891
17,863,633
5,459,268
66,455,587
46,716,774
29,228,725
1,131,731
6,225,737
32,002,640
17,941,728
19,968,899
1,929,644
$1,883,870
7,015,170
4,621,766
1,960,824
8,149,683
3,498,693
1,341,040
1,467,019
839,979
1,130,819
N/A
Revenues per
establishment
56344
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333992
333993
333994
333995
333996
333997
333999
334518
335211
335221
335222
335224
335228
336111
336112
336120
336211
336212
336213
336311
336312
336322
........
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........
336370
336399
336611
336612
336992
337215
339114
339116
339911
339913
339914
336340 ........
336350 ........
336330 ........
........
........
........
........
........
........
........
........
........
........
........
333411
333412
333414
333511
333512
333513
333514
333515
333516
333518
333612
333319 ........
332510
332611
332612
332618
332710
332812
332911
332912
332913
332919
332991
332996
332997
332998
332999
Hardware manufacturing ..........................................................
Spring (heavy gauge) manufacturing .......................................
Spring (light gauge) manufacturing ..........................................
Other fabricated wire product manufacturing ...........................
Machine shops .........................................................................
Metal coating and allied services .............................................
Industrial valve manufacturing ..................................................
Fluid power valve and hose fitting manufacturing ...................
Plumbing fixture fitting and trim manufacturing ........................
Other metal valve and pipe fitting manufacturing ....................
Ball and roller bearing manufacturing ......................................
Fabricated pipe and pipe fitting manufacturing ........................
Industrial pattern manufacturing ...............................................
Enameled iron and metal sanitary ware manufacturing ..........
All other miscellaneous fabricated metal product manufacturing.
Other commercial and service industry machinery manufacturing.
Air purification equipment manufacturing .................................
Industrial and commercial fan and blower manufacturing .......
Heating equipment (except warm air furnaces) manufacturing
Industrial mold manufacturing ..................................................
Machine tool (metal cutting types) manufacturing ...................
Machine tool (metal forming types) manufacturing ..................
Special die and tool, die set, jig, and fixture manufacturing ....
Cutting tool and machine tool accessory manufacturing .........
Rolling mill machinery and equipment manufacturing .............
Other metalworking machinery manufacturing .........................
Speed changer, industrial high-speed drive, and gear manufacturing.
Mechanical power transmission equipment manufacturing .....
Pump and pumping equipment manufacturing ........................
Air and gas compressor manufacturing ...................................
Power-driven handtool manufacturing ......................................
Welding and soldering equipment manufacturing ....................
Packaging machinery manufacturing .......................................
Industrial process furnace and oven manufacturing ................
Fluid power cylinder and actuator manufacturing ....................
Fluid power pump and motor manufacturing ...........................
Scale and balance (except laboratory) manufacturing ............
All other miscellaneous general purpose machinery manufacturing.
Watch, clock, and part manufacturing ......................................
Electric housewares and household fans ................................
Household cooking appliance manufacturing ..........................
Household refrigerator and home freezer manufacturing ........
Household laundry equipment manufacturing ..........................
Other major household appliance manufacturing ....................
Automobile manufacturing ........................................................
Light truck and utility vehicle manufacturing ............................
Heavy duty truck manufacturing ...............................................
Motor vehicle body manufacturing ...........................................
Truck trailer manufacturing .......................................................
Motor home manufacturing ......................................................
Carburetor, piston, piston ring, and valve manufacturing ........
Gasoline engine and engine parts manufacturing ...................
Other motor vehicle electrical and electronic equipment manufacturing.
Motor vehicle steering and suspension components (except
spring) manufacturing.
Motor vehicle brake system manufacturing .............................
Motor vehicle transmission and power train parts manufacturing.
Motor vehicle metal stamping ..................................................
All other motor vehicle parts manufacturing ............................
Ship building and repair ...........................................................
Boat building .............................................................................
Military armored vehicle, tank, and tank component manufacturing.
Showcase, partition, shelving, and locker manufacturing ........
Dental equipment and supplies manufacturing ........................
Dental laboratories ...................................................................
Jewelry (except costume) manufacturing .................................
Jewelers’ materials and lapidary work manufacturing .............
Costume jewelry and novelty manufacturing ...........................
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
1,647
740
7,028
1,760
261
590
635
1,189
575
1,066
47
188
432
214
104
99
116
18
17
39
167
63
77
728
353
79
102
810
643
196
413
272
137
250
583
312
269
146
95
1,630
303
142
377
2,084
514
274
3,172
1,482
70
362
197
1,253
734
109
270
1,103
21,135
2,363
394
306
126
240
107
711
459
72
3,043
1,733
763
7,261
1,777
264
590
781
1,458
635
1,129
57
241
535
257
106
105
125
26
23
45
181
94
95
820
394
91
116
876
697
231
490
318
150
275
619
335
319
178
102
1,725
351
163
407
2,126
530
285
3,232
1,552
73
383
226
1,349
828
113
340
1,198
21,356
2,599
488
381
144
268
180
765
461
76
3,123
59,080
15,550
47,088
25,280
5,199
6,775
110,578
149,251
87,352
54,705
6,899
33,782
83,756
39,390
2,188
7,425
16,033
17,121
16,269
12,806
75,225
103,815
32,122
47,566
32,260
21,533
10,537
66,112
62,016
15,645
30,764
21,417
8,714
15,853
21,179
10,720
19,887
13,631
3,748
52,454
14,883
10,506
20,577
39,917
17,220
8,556
57,576
34,922
3,020
12,470
12,374
53,012
45,282
4,059
15,336
36,364
266,597
56,978
38,330
35,519
11,513
18,112
27,197
27,201
5,281
5,655
72,201
317
399
7,028
1,760
261
590
508
687
575
1,066
32
149
382
185
12
20
43
18
17
32
167
63
77
239
163
79
52
345
323
75
147
104
45
82
113
56
95
63
20
280
72
52
108
221
94
46
319
188
17
67
61
278
227
22
69
189
1,490
2,363
175
161
57
91
91
143
30
72
397
334
411
7,261
1,777
264
590
624
843
635
1,129
39
191
473
223
12
22
47
26
23
37
181
94
95
269
182
91
60
373
350
88
174
121
49
90
120
61
112
77
21
296
84
59
116
226
97
48
325
197
17
70
70
299
256
23
87
205
1,506
2,599
216
201
65
102
154
154
30
76
408
334
411
33,214
7,813
1,607
1,088
624
843
2,798
1,752
39
191
473
223
12
22
47
50
47
37
425
587
181
269
182
122
60
373
350
88
174
121
49
90
120
61
112
77
21
296
84
59
116
226
97
48
325
197
17
70
70
299
256
23
87
205
1,506
4,695
216
201
65
102
154
154
30
96
408
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
8,059,533
3,397,252
3,852,293
6,160,238
934,387
751,192
24,461,822
42,936,991
14,650,189
10,062,908
2,406,966
11,675,801
31,710,273
10,244,934
491,114
2,175,398
4,461,008
4,601,594
4,792,444
4,549,859
87,308,106
139,827,543
17,387,065
11,581,029
6,313,133
5,600,569
2,327,226
30,440,351
22,222,133
3,256,010
7,872,517
6,305,944
3,115,514
4,257,678
4,294,579
1,759,938
3,991,832
3,019,188
694,419
9,791,511
2,428,159
1,962,040
4,266,536
4,963,915
3,675,264
1,398,993
7,232,706
4,941,932
652,141
2,605,582
2,280,825
12,744,730
9,268,800
825,444
2,618,283
5,770,701
32,643,382
11,010,624
8,446,768
8,044,008
3,276,413
3,787,626
6,198,871
4,879,023
486,947
1,036,508
12,944,345
4,893,462
4,590,881
548,135
3,500,135
3,580,028
1,273,206
38,522,554
36,111,851
25,478,589
9,439,876
51,212,047
62,105,323
73,403,409
47,873,524
4,722,250
21,973,717
38,456,968
255,644,105
281,908,445
116,663,058
522,803,033
2,219,484,812
225,806,042
15,908,007
17,884,229
70,893,283
22,815,945
37,580,680
34,560,082
16,612,294
19,061,785
23,183,616
22,740,979
17,030,713
7,366,345
5,640,828
14,839,523
20,679,367
7,309,671
6,007,062
8,013,727
13,817,181
11,317,071
2,381,917
7,150,320
5,105,812
2,280,172
3,334,637
9,316,299
7,197,740
11,577,790
10,171,373
12,627,793
7,572,882
9,697,344
5,231,823
1,544,518
4,659,595
21,438,497
26,287,608
26,003,281
15,781,773
57,933,374
6,862,198
1,060,887
14,395,940
4,253,811
4,650,625
4,452,493
530,546
3,466,650
3,539,346
1,273,206
31,321,154
29,449,239
23,071,163
8,913,116
42,227,477
48,447,306
59,271,538
39,863,557
4,633,151
20,718,076
35,688,066
176,984,380
208,367,112
101,107,984
482,365,229
1,487,527,055
183,021,739
14,123,206
16,023,179
61,544,718
20,062,296
34,749,259
31,882,544
14,095,280
16,066,362
19,830,011
20,770,094
15,482,466
6,937,931
5,253,548
12,513,579
16,961,728
6,808,027
5,676,238
6,917,833
12,037,053
10,482,888
2,334,861
6,934,461
4,908,746
2,237,842
3,184,235
8,933,437
6,803,086
10,092,145
9,447,539
11,194,203
7,304,815
7,700,832
4,816,946
1,528,534
4,236,485
17,308,951
21,112,882
22,752,871
14,132,931
34,438,172
6,377,808
1,056,285
13,638,259
4,144,843
Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules
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........
........
........
........
6,291
7,016
N/A
119,471
219,203
1,025,888
Subtotals—General Industry and maritime .......................
Totals—All Industries ........................................................
Total entities a
Sign manufacturing ...................................................................
Industrial supplies, wholesalers ................................................
Rail transportation ....................................................................
Dental offices ............................................................................
Industry
1,041,291
238,942
6,415
10,742
N/A
124,553
Total establish-ments a
17,508,728
4,406,990
89,360
111,198
N/A
817,396
Total employment a
532,866
47,007
487
250
N/A
7,655
Total affected
entities b
533,597
56,121
496
383
N/A
7,980
Total affected
establishments b
2,144,061
294,886
496
383
16,895
7,980
Total affected
employment b
652,029
........................
........................
........................
........................
........................
Total FTE
affected
employees b
$2,649,803,698
1,101,555,989
11,299,429
19,335,522
N/A
88,473,742
Total revenues
($1,000) c
$2,619,701
5,025,278
1,796,126
2,755,918
N/A
740,546
Revenues per
entity
$2,544,729
4,610,140
1,761,407
1,799,993
N/A
710,330
Revenues per
establishment
a U.S. Census Bureau, Statistics of U.S. Businesses, 2006.
b OSHA estimates of employees potentially exposed to silica and associated entities and establishments. Affected entities and establishments constrained to be less than or equal to the number of affected employees.
c Estimates based on 2002 receipts and payroll data from U.S. Census Bureau, Statistics of U.S. Businesses, 2002, and payroll data from the U.S. Census Bureau, Statistics of U.S. Businesses, 2006. Receipts are not reported for 2006, but were estimated assuming the ratio of receipts to payroll remained unchanged from 2002 to 2006.
d State-plan states only. State and local governments are included under the construction sector because the silica risks for public employees are the result of construction-related activities.
e OSHA estimates that only one-third of the entities and establishments in this industry, as reported above, use silica-containing inputs.
Source: U.S. Dept. of Labor, OSHA, Directorate of Standards and Guidance, Office of Regulatory Analysis, based on ERG, 2013.
339950
423840
482110
621210
NAICS
TABLE VIII–3—CHARACTERISTICS OF INDUSTRIES AFFECTED BY OSHA’S PROPOSED STANDARD FOR SILICA—ALL ENTITIES—Continued
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As shown in Table VIII–3, OSHA
estimates that a total of 533,000 entities
(486,000 in construction; 47,000 in
general industry and maritime), 534,000
establishments (477,500 in construction;
56,100 in general industry and
maritime), and 2.1 million workers (1.8
million in construction; 0.3 million in
general industry and maritime) would
be affected by the proposed silica rule.
Note that only slightly more than 50
percent of the entities and
establishments, and about 12 percent of
the workers in affected industries,
actually engage in activities involving
silica exposure.9
The ninth column in Table VIII–3,
with data only for construction, shows
for each affected NAICS construction
industry the number of full-timeequivalent (FTE) affected workers that
corresponds to the total number of
affected construction workers in the
previous column.10 This distinction is
necessary because affected construction
workers may spend large amounts of
time working on tasks with no risk of
silica exposure. As shown in Table VIII–
3, the 1.8 million affected workers in
construction converts to approximately
652,000 FTE affected workers. In
contrast, OSHA based its analysis of the
affected workers in general industry and
maritime on the assumption that they
were engaged full time in activities with
some silica exposure.
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9 It should be emphasized that these percentages
vary significantly depending on the industry sector
and, within an industry sector, depending on the
NAICS industry. For example, about 14 percent of
the workers in construction, but only 7 percent of
workers in general industry, actually engage in
activities involving silica exposure. As an example
within construction, about 63 percent of workers in
highway, street, and bridge construction, but only
3 percent of workers in state and local governments,
actually engage in activities involving silica
exposure.
10 FTE affected workers becomes a relevant
variable in the estimation of control costs in the
construction industry. The reason is that, consistent
with the costing methodology, control costs depend
only on how many worker-days there are in which
exposures are above the PEL. These are the workerdays in which controls are required. For the
derivation of FTEs, see Tables IV–8 and IV–22 and
the associated text in ERG (2007a).
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The last three columns in Table VIII–
3 show combined total revenues for all
entities (not just affected entities) in
each affected industry, and the average
revenue per entity and per
establishment in each affected industry.
Because OSHA did not have data to
distinguish revenues for affected entities
and establishments in any industry,
average revenue per entity and average
revenue per affected entity (as well as
average revenue per establishment and
average revenue per affected
establishment) are estimated to be equal
in value.
Silica Exposure Profile of At-Risk
Workers
The technological feasibility analyses
presented in Chapter IV of the PEA
contain data and discussion of worker
exposures to silica throughout industry.
Exposure profiles, by job category, were
developed from individual exposure
measurements that were judged to be
substantive and to contain sufficient
accompanying description to allow
interpretation of the circumstance of
each measurement. The resulting
exposure profiles show the job
categories with current overexposures to
silica and, thus, the workers for whom
silica controls would be implemented
under the proposed rule.
Chapter IV of the PEA includes a
section with a detailed description of
the methods used to develop the
exposure profile and to assess the
technological feasibility of the proposed
standard. That section documents how
OSHA selected and used the data to
establish the exposure profiles for each
operation in the affected industry
sectors, and discusses sources of
uncertainly including the following:
• Data Selection—OSHA discusses
how exposure samples with sample
durations of less than 480 minutes (an
8-hour shift) are used in the analysis.
• Use of IMIS data—OSHA discusses
the limitations of data from its
Integrated Management Information
System.
• Use of analogous information—
OSHA discusses how information from
one industry or operation is used to
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56347
describe exposures in other industries
or operations with similar
characteristics.
• Non-Detects—OSHA discusses how
exposure data that is identified as ‘‘less
than the LOD (limit of detection)’’ is
used in the analysis.
OSHA seeks comment on the
assumptions and data selection criteria
the Agency used to develop the
exposure profiles shown in Chapter IV
of the PEA.
Table VIII–4 summarizes, from the
exposure profiles, the total number of
workers at risk from silica exposure at
any level, and the distribution of 8-hour
TWA respirable crystalline silica
exposures by job category for general
industry and maritime sectors and for
construction activities. Exposures are
grouped into the following ranges: less
than 25 mg/m3; ≥ 25 mg/m3 and ≤ 50 mg/
m3; > 50 mg/m3 and ≤ 100 mg/m3; > 100
mg/m3 and ≤ 250 mg/m3; and greater than
250 mg/m3. These frequencies represent
the percentages of production
employees in each job category and
sector currently exposed at levels within
the indicated range.
Table VIII–5 presents data by NAICS
code—for each affected general,
maritime, and construction industry—
on the estimated number of workers
currently at risk from silica exposure, as
well as the estimated number of workers
at risk of silica exposure at or above 25
mg/m3, above 50 mg/m3, and above 100
mg/m3. As shown, an estimated
1,026,000 workers (851,000 in
construction; 176,000 in general
industry and maritime) currently have
silica exposures at or above the
proposed action level of 25 mg/m3; an
estimated 770,000 workers (648,000 in
construction; 122,000 in general
industry and maritime) currently have
silica exposures above the proposed PEL
of 50 mg/m3; and an estimated 501,000
workers (420,000 in construction;
81,000 in general industry and
maritime) currently have silica
exposures above 100 mg/m3—an
alternative PEL investigated by OSHA
for economic analysis purposes.
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Table VIII-4
Distribution of Silica Exposures by Sector and Job Category or Activity
Silica Exposure Range
<25
Job Category/Activity
Sector
~g/m3
25-50
~g/m3
50-100
~g/m3
100-250 >250
~g/m3
~g/m3
Total
Construction
18.6%
86.7%
79.2%
14.3%
18.3%
24.2%
11.9%
6.7%
8.3%
28.6%
8.3%
9.9%
16.9%
6.7%
8.3%
35.7%
15.6%
12.1%
20.3%
0.0%
4.2%
14.3%
24.8%
38.5%
32.2%
0.0%
0.0%
7.1%
33.0%
15.4%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
Masonry Cutters Using Stationary Saws
21.4%
25.0%
25.0%
3.6%
25.0%
100.0%
Millers Using Portable or Mobile Machines
Rock and Concrete Drillers
54.3%
35.9%
20.0%
17.9%
200%
17.9%
2.9%
17.9%
2.9%
10.3%
100.0%
100.0%
Rock-Crushing Machine Operators and Tenders
Tuckpointers and Grinders
Underground Construction Workers
0.0%
10.0%
59.3%
0.0%
8.5%
18.5%
0.0%
11.9%
11.1%
20.0%
18.4%
7.4%
80.0%
51.2%
3.7%
100.0%
100.0%
100.0%
50.0%
100.0%
100.0%
0.0%
16.7%
28.1%
26.3%
25.0%
172%
14.4%
13.3%
45.9%
83.3%
41.9%
46.2%
33.3%
14.3%
16.7%
11.8%
17.4%
17.2%
33.3%
83.9%
50.0%
0.0%
6.6%
15.5%
25.5 0/0
37.5%
14.3%
10.8%
16.7%
28.1%
26.3%
25.0%
17.2%
14.4%
37.5%
0.0%
50.0%
0.0%
6.6%
0.0%
0.0%
0.0%
28.6%
60.0%
24.6%
21.6%
32.1%
25.0%
14.3%
35.1%
25.0%
18.8%
24.3%
25.0%
15.5%
25.8%
6.7%
16.2%
7.1%
22.6%
15.4%
0.0%
28.6%
33.3%
17.6%
26.1%
13.8%
0.0%
12.9%
0.0%
16,7%
24.6%
21.6%
32.1%
25.0%
14.3%
35.1%
25.0%
18.8%
24.3%
25.0%
15.5%
25.8%
18.8%
82.4%
0<0%
16.7%
24.6%
50.0%
0.0%
0.0%
42.9%
200%
27.9%
19.2%
29.2%
0.0%
429%
18.9%
25.0%
31.3%
28.9%
16.7%
25.9%
29.9%
20.0%
10.8%
7.1%
19.4%
0.0%
33.3%
14.3%
8.3%
23.5%
39.1%
20.7%
33.3%
3.2%
33.3%
33.3%
27.9%
19.2%
29.2%
0.0%
42.9%
18.9%
25.0%
31.3%
28.9%
16.7%
25.9%
29.9%
12.5%
11.8%
33.3%
33.3%
27.9%
0.0%
0.0%
0.0%
28.6%
20.0%
27.9%
21.1%
9.4%
12.5%
14.3%
24.3%
12.5%
21.9%
19.1%
29.2%
27.6%
17.5%
26.7%
16.2%
2.4%
9.7%
30.8%
16.7%
14.3%
25.0%
35.3%
17.4%
48.3%
33.3%
0.0%
0.0%
33.3%
27.9%
21.1%
9.4%
12.5%
14.3%
24.3%
12.5%
21.9%
19.1%
29.2%
27.6%
17.5%
18.8%
5.9%
0.0%
33.3%
27.9%
0.0%
0.0%
0.0%
0.0%
0.0%
13.1%
22.5%
3.8%
25.0%
14.3%
10.8%
20.8%
0.0%
1.3%
4.2%
13.8%
12.4%
33.3%
10.8%
0.0%
6.5%
7.7%
16.7%
28.6%
16.7%
11.8%
0.0%
0.0%
0.0%
0.0%
16.7%
16.7%
13.1%
22.5%
3.8%
25.0%
14.3%
10.8%
20.8%
0.0%
1.3%
4.2%
13.8%
12.4%
12.5%
0.0%
16.7%
16.7%
13.1%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
1000%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
1000%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
1000%
100.0%
100.0%
100.0%
15.5%
25.5%
21.6%
321%
19.2%
29.2%
21.1%
9.4%
22.5%
3.8%
100.0%
100.0%
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
General Industry/Maritime
Asphalt Paving Products
Front-end loader operator
Maintenance worker
Plant operator
Asphalt Roofing Materials
Material handler
Production operator
Abrasive blasting operator
Captive Foundries
Cleaning/Finishing operator
Coremaker
Furnace operator
Housekeeping worker
Knockout operator
Maintenance operator
Material handler
Molder
Pouring operator
Sand systems operator
Shakeout operator
Abrasive blasting operator
Concrete Products
Finishing operator
Forming Line operator
Material handler
Mixer Operator
Packaging operator
Abrasive blasting ops
Cut Stone
Fabricator
Machine operator
Sawyer
Splitter/chipper
Production operator
Dental Equipment
Dental technician
Dental Laboratories
Batch operator
FlalGlass
Material handler
Abrasive blasting operator
Iron Foundries
Cleaning/Finishing operator
Coremaker
Furnace operator
Housekeeping worker
Knockout operator
Maintenance operator
Material handler
Molder
Pouring operator
Sand systems operator
Shakeout operator
Jewelry workers
Jewelry
Production worker
Mineral Processing
Batch operator
Mineral Wool
Materia! handler
Abrasive blasting operator
Nonferrous Sand Casling
Foundries
Cleaning/Finishing operator
Coremaker
VerDate Mar<15>2010
19:12 Sep 11, 2013
Jkt 229001
PO 00000
Frm 00076
0.0%
6.6%
15.5%
25.5%
37.5%
14.3%
10.8%
Fmt 4701
Sfmt 4725
E:\FR\FM\12SEP2.SGM
12SEP2
EP12SE13.006</GPH>
Abrasive Blasters
Drywall Finishers
Heavy Equipment Operators
Hole Drillers Using Hand-Held Drills
Jackhammer and Impact Drillers
Masonry Cutters Using Portable Saws
Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules
56349
Table VIII-4
Distribution of Silica Exposures by Sector and Job Category or Activity
(Continued)
Silica Exposure Range
Sector
<25
~g/m3
~g/m3
100-250 >250 ~g/m3
Total
~g/m3
37.5%
14.3%
10.8%
16.7%
28.1%
26.3%
25.0%
17.2%
14.4%
6.6%
Maintenance operator
Materia! handler
Molder
Pouring operator
Sand systems operator
Shakeout operator
Non-Sand Casting Foundries Abrasive blasting operator
Cleaning/Finishing operator
Coremaker
Furnace operator
Housekeeping worker
Knockout operator
Maintenance operator
Material handler
Molder
Pouring operator
Sand systems operator
Shakeout operator
Abrasive blasting operator
0.0%
42.9%
18.9%
25.0%
31.3%
28.9%
16.7%
25.9%
29.9%
27.9%
12.5%
14.3%
24.3%
12.5%
21.9%
19.1%
29.2%
27.6%
17.5%
27.9%
25.0%
14.3%
10.8%
20.8%
0.0%
1.3%
4.2%
13.8%
12.4%
13.1%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
1000%
100.0%
100.0%
21.6%
32.1%
25.0%
14.3%
35.1%
25.0%
18.8%
24.3%
25.0%
15.5%
25.8%
24.6%
19.2%
29.2%
0.0%
42.9%
18.9%
25.0%
31.3%
28.9%
16.7%
25.9%
29.9%
27.9%
21.1%
9.4%
12.5%
14.3%
24.3%
12.5%
21.9%
19.1%
29.2%
27.6%
17.5%
27.9%
22.5%
3.8%
25.0%
14.3%
10.8%
20.8%
0.0%
1.3%
42%
13.8%
12.4%
13.1%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
15.5%
25.5%
37.5%
14.3%
10.8%
16.7%
28.1%
26.3%
25.0%
17.2%
14.4%
50.0%
0.0%
100.0%
800%
33.3%
52.2%
18.9%
5.3%
15.4%
25.6%
38.1%
50.0%
21.0%
100.0%
60.0%
75.0%
100.0%
0.0%
100.0%
100.0%
45.5%
33.3%
50.0%
20.0%
0.0%
10.0%
27.0%
0.0%
21.4%
42.9%
70.3%
30.0%
Knockout operator
25.0%
14.3%
35.1%
25.0%
18.8%
24.3%
25.0%
15.5%
25.8%
24.6%
15.5%
25.5%
37.5%
14.3%
10.8%
16.7%
28.1%
26.3%
25.0%
172%
14.4%
6.6%
Furnace operator
Housekeeping worker
Other Ferrous Sand Casting
50-100
~glm3
Job Category/Activity
25-50
21.6%
32.1%
25.0%
14.3%
35.1%
250%
18.8%
24.3%
25.0%
15.5%
25.8%
0.0%
16.7%
0.0%
0.0%
33.3%
13.0%
10.8%
5.3%
34.6%
40.0%
19.0%
26.9%
380%
0.0%
20.0%
0.0%
0.0%
0.0%
0.0%
0.0%
27.3%
22.2%
41.7%
40.0%
28.6%
10.0%
16.2%
14.3%
7.1%
0.0%
16.2%
20.0%
19.2%
29.2%
0.0%
42.9%
18.9%
25.0%
31.3%
28.9%
16.7%
25.9%
29.9%
33.3%
33.3%
0.0%
0.0%
33.3%
21.7%
16.2%
31.6%
19.2%
14.4%
19.0%
7.7%
23.0%
0.0%
20.0%
25.0%
0.0%
0.0%
0.0%
0.0%
13.6%
22.2%
0.0%
20.0%
14.3%
50.0%
16.2%
14.3%
21.4%
28.6%
10.8%
30.0%
21.1%
9.4%
12.5%
14.3%
24.3%
12.5%
21.9%
19.1%
29.2%
27.6%
17.5%
0.0%
33.3%
0.0%
0.0%
0.0%
0.0%
32.4%
26.3%
30.8%
20.0%
9.5%
7.7%
11.0%
0.0%
0.0%
0.0%
0.0%
0.0%
0.0%
0.0%
13.6%
18.5%
8.3%
20.0%
14.3%
30.0%
29.7%
28.6%
28.6%
28.6%
2.7%
15.0%
22.5%
3.8%
25.0%
14.3%
10.8%
20.8%
0.0%
1.3%
4.2%
13.8%
12.4%
16.7%
16.7%
0.0%
20.0%
0.0%
13.0%
21.6%
31.6%
0.0%
0.0%
14.3%
7.7%
7.0%
0.0%
0.0%
0.0%
0.0%
100.0%
0.0%
0.0%
0.0%
3.7%
0.0%
0.0%
42.9%
0.0%
10.8%
42.9%
21.4%
0.0%
0.0%
5.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
100.0%
Foundries
Cleaning/Finishing operator
Coremaker
Furnace operator
Housekeeping worker
Knockout operator
Maintenance operator
Material handler
Molder
Other Glass Products
Paint and Coatings
Porcelain Enameling
Pottery
Railroads
Ready mix
Refractories
Refractory Repair
Shipyards
Structural Clay
Pouring operator
Sand systems operator
Shakeout operator
Batch operator
Material handler
Material handler
Mixer operator
Enamel preparer
Porcelain applicator
Coatings operator
Coatings preparer
Finishing operator
Forming line operator
Material handler
Ballast dumper
Machine operator
Batch operator
Maintenance operator
Materia! handler
Quality control technician
Truck driver
Ceramic fiber furnace operator
Finishing operator
Forming operator
Material handler
Packaging operator
Production operator
Abrasive blasters
Forming line operator/Coatings blender
Forming line operator/Formers
Forming line operator/Pug mill operator
Grinding operator
Material handler/Loader operator
Materia! handler/post-production
Material handler/production
Source: Technological feasibillty analysis in Chapter IV of the PEA
BILLING CODE 4510–26–C
NAICS
Number of
establishments
Industry
Number of
employees
Numbers exposed to Silica
>=0
>=25
>=50
>=100
>=250
Construction
236100
236200
237100
237200
..............
..............
..............
..............
VerDate Mar<15>2010
Residential Building Construction ..........
Nonresidential Building Construction .....
Utility System Construction ....................
Land Subdivision ....................................
19:12 Sep 11, 2013
Jkt 229001
PO 00000
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44,702
21,232
12,469
Frm 00077
Fmt 4701
966,198
741,978
496,628
77,406
Sfmt 4702
55,338
173,939
217,070
6,511
32,260
83,003
76,687
1,745
E:\FR\FM\12SEP2.SGM
12SEP2
24,445
63,198
53,073
1,172
14,652
39,632
28,667
560
7,502
20,504
9,783
186
EP12SE13.007</GPH>
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
TABLE VIII–5—NUMBERS OF WORKERS EXPOSED TO SILICA (BY AFFECTED INDUSTRY AND EXPOSURE LEVEL (μg/m3))
56350
Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules
TABLE VIII–5—NUMBERS OF WORKERS EXPOSED TO SILICA (BY AFFECTED INDUSTRY AND EXPOSURE LEVEL (μg/m3))—
Continued
NAICS
237300 ..............
237900 ..............
238100 ..............
238200
238300
238900
999000
..............
..............
..............
..............
Subtotals—
Construction.
Number of
establishments
Industry
Highway, Street, and Bridge Construction.
Other Heavy and Civil Engineering Construction.
Foundation, Structure, and Building Exterior Contractors.
Building Equipment Contractors ............
Building Finishing Contractors ...............
Other Specialty Trade Contractors ........
State and local governments [d] ............
................................................................
Number of
employees
Numbers exposed to Silica
>=0
>=25
>=50
>=100
>=250
11,860
325,182
204,899
58,441
39,273
19,347
7,441
5,561
90,167
46,813
12,904
8,655
4,221
1,369
117,456
1,167,986
559,729
396,582
323,119
237,537
134,355
182,368
133,343
74,446
NA
1,940,281
975,335
557,638
5,762,939
20,358
120,012
274,439
170,068
6,752
49,202
87,267
45,847
4,947
37,952
60,894
31,080
2,876
24,662
32,871
15,254
1,222
14,762
13,718
5,161
802,349
13,101,738
1,849,175
850,690
647,807
420,278
216,003
General Industry and Maritime
324121 ..............
324122 ..............
325510 ..............
327111 ..............
327112 ..............
327113
327121
327122
327123
327124
327125
327211
327212
..............
..............
..............
..............
..............
..............
..............
..............
327213
327320
327331
327332
327390
327991
..............
..............
..............
..............
..............
..............
327992 ..............
327993 ..............
327999 ..............
331111 ..............
331112 ..............
331210 ..............
331221 ..............
331222 ..............
331314 ..............
331423 ..............
331492 ..............
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
331511
331512
331513
331524
331525
331528
..............
..............
..............
..............
..............
..............
332111
332112
332115
332116
332117
332211
..............
..............
..............
..............
..............
..............
332212 ..............
332213 ..............
332214 ..............
VerDate Mar<15>2010
Asphalt paving mixture and block manufacturing.
Asphalt shingle and roofing materials ....
Paint and coating manufacturing ...........
Vitreous china plumbing fixtures & bathroom accessories manufacturing.
Vitreous china, fine earthenware, &
other pottery product manufacturing.
Porcelain electrical supply mfg ..............
Brick and structural clay mfg .................
Ceramic wall and floor tile mfg ..............
Other structural clay product mfg ..........
Clay refractory manufacturing ................
Nonclay refractory manufacturing ..........
Flat glass manufacturing ........................
Other pressed and blown glass and
glassware manufacturing.
Glass container manufacturing ..............
Ready-mixed concrete manufacturing ...
Concrete block and brick mfg ................
Concrete pipe mfg ..................................
Other concrete product mfg ...................
Cut stone and stone product manufacturing.
Ground or treated mineral and earth
manufacturing.
Mineral wool manufacturing ...................
All other misc. nonmetallic mineral product mfg.
Iron and steel mills .................................
Electrometallurgical ferroalloy product
manufacturing.
Iron and steel pipe and tube manufacturing from purchased steel.
Rolled steel shape manufacturing .........
Steel wire drawing ..................................
Secondary smelting and alloying of aluminum.
Secondary smelting, refining, and
alloying of copper.
Secondary smelting, refining, and
alloying of nonferrous metal (except
cu & al).
Iron foundries .........................................
Steel investment foundries .....................
Steel foundries (except investment) ......
Aluminum foundries (except die-casting)
Copper foundries (except die-casting) ...
Other nonferrous foundries (except diecasting).
Iron and steel forging .............................
Nonferrous forging .................................
Crown and closure manufacturing .........
Metal stamping .......................................
Powder metallurgy part manufacturing ..
Cutlery and flatware (except precious)
manufacturing.
Hand and edge tool manufacturing .......
Saw blade and handsaw manufacturing
Kitchen utensil, pot, and pan manufacturing.
19:12 Sep 11, 2013
Jkt 229001
PO 00000
1,431
14,471
5,043
48
48
0
0
224
1,344
41
12,631
46,209
5,854
4,395
3,285
2,802
4,395
404
2,128
1,963
404
1,319
935
404
853
0
404
227
731
9,178
4,394
3,336
2,068
1,337
356
125
204
193
49
129
105
83
499
6,168
13,509
7,094
1,603
4,475
5,640
11,003
20,625
2,953
5,132
2,695
609
1,646
2,075
271
1,034
2,242
3,476
1,826
412
722
910
164
631
1,390
2,663
1,398
316
364
459
154
593
898
1,538
808
182
191
241
64
248
239
461
242
55
13
17
45
172
72
6,064
951
385
2,281
1,943
14,392
107,190
22,738
14,077
66,095
30,633
722
43,920
10,962
6,787
31,865
12,085
440
32,713
5,489
3,398
15,957
10,298
414
32,110
3,866
2,394
11,239
7,441
173
29,526
2,329
1,442
6,769
4,577
120
29,526
929
575
2,700
1,240
271
6,629
5,051
5,051
891
297
0
321
465
19,241
10,028
1,090
4,835
675
2,421
632
1,705
268
1,027
182
410
805
22
108,592
2,198
614
12
456
9
309
6
167
3
57
1
240
21,543
122
90
61
33
11
170
288
150
10,857
14,669
7,381
61
83
42
46
62
31
31
42
21
17
23
11
6
8
4
31
1,278
7
5
4
2
1
217
9,383
53
39
27
14
5
527
132
222
466
256
124
59,209
16,429
17,722
26,565
6,120
4,710
22,111
5,934
6,618
9,633
2,219
1,708
16,417
4,570
4,914
7,418
1,709
1,315
11,140
3,100
3,334
5,032
1,159
892
6,005
1,671
1,797
2,712
625
481
2,071
573
620
931
214
165
398
77
59
1,641
129
141
26,596
8,814
3,243
64,724
8,362
5,779
150
50
18
366
47
33
112
37
14
272
35
24
76
25
9
184
24
16
41
13
5
99
13
9
14
5
2
34
4
3
1,155
136
70
36,622
7,304
3,928
207
41
22
154
31
17
104
21
11
56
11
6
19
4
2
Frm 00078
Fmt 4701
Sfmt 4702
E:\FR\FM\12SEP2.SGM
12SEP2
56351
Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules
TABLE VIII–5—NUMBERS OF WORKERS EXPOSED TO SILICA (BY AFFECTED INDUSTRY AND EXPOSURE LEVEL (μg/m3))—
Continued
NAICS
332323 ..............
332439
332510
332611
332612
332618
..............
..............
..............
..............
..............
332710
332812
332911
332912
..............
..............
..............
..............
332913 ..............
332919 ..............
332991 ..............
332996 ..............
332997 ..............
332998 ..............
332999 ..............
333319 ..............
333411 ..............
333412 ..............
333414 ..............
333511 ..............
333512 ..............
333513 ..............
333514 ..............
333515 ..............
333516 ..............
333518 ..............
333612 ..............
333613 ..............
333911 ..............
333912 ..............
333991 ..............
333992 ..............
333993 ..............
333994 ..............
333995 ..............
333996 ..............
333997 ..............
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
333999 ..............
334518 ..............
335211 ..............
335221 ..............
335222 ..............
335224 ..............
335228 ..............
336111 ..............
VerDate Mar<15>2010
Number of
establishments
Industry
Ornamental and architectural metal
work.
Other metal container manufacturing ....
Hardware manufacturing ........................
Spring (heavy gauge) manufacturing .....
Spring (light gauge) manufacturing ........
Other fabricated wire product manufacturing.
Machine shops .......................................
Metal coating and allied services ...........
Industrial valve manufacturing ...............
Fluid power valve and hose fitting manufacturing.
Plumbing fixture fitting and trim manufacturing.
Other metal valve and pipe fitting manufacturing.
Ball and roller bearing manufacturing ....
Fabricated pipe and pipe fitting manufacturing.
Industrial pattern manufacturing ............
Enameled iron and metal sanitary ware
manufacturing.
All other miscellaneous fabricated metal
product manufacturing.
Other commercial and service industry
machinery manufacturing.
Air purification equipment manufacturing
Industrial and commercial fan and blower manufacturing.
Heating equipment (except warm air
furnaces) manufacturing.
Industrial mold manufacturing ................
Machine tool (metal cutting types) manufacturing.
Machine tool (metal forming types)
manufacturing.
Special die and tool, die set, jig, and fixture manufacturing.
Cutting tool and machine tool accessory
manufacturing.
Rolling mill machinery and equipment
manufacturing.
Other metalworking machinery manufacturing.
Speed changer, industrial high-speed
drive, and gear manufacturing.
Mechanical power transmission equipment manufacturing.
Pump and pumping equipment manufacturing.
Air and gas compressor manufacturing
Power-driven handtool manufacturing ...
Welding and soldering equipment manufacturing.
Packaging machinery manufacturing .....
Industrial process furnace and oven
manufacturing.
Fluid power cylinder and actuator manufacturing.
Fluid power pump and motor manufacturing.
Scale and balance (except laboratory)
manufacturing.
All other miscellaneous general purpose
machinery manufacturing.
Watch, clock, and part manufacturing ...
Electric housewares and household
fans.
Household cooking appliance manufacturing.
Household refrigerator and home freezer manufacturing.
Household laundry equipment manufacturing.
Other major household appliance manufacturing.
Automobile manufacturing .....................
19:12 Sep 11, 2013
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PO 00000
Number of
employees
Numbers exposed to Silica
>=0
>=25
>=50
>=100
>=250
2,450
39,947
54
26
19
7
7
401
828
113
340
1,198
15,195
45,282
4,059
15,336
36,364
86
256
23
87
205
64
190
17
64
153
43
129
12
44
104
23
69
6
24
56
8
24
2
8
19
21,356
2,599
488
381
266,597
56,978
38,330
35,519
1,506
4,695
216
201
1,118
2,255
161
149
759
1,632
109
101
409
606
59
55
141
606
20
19
144
11,513
65
48
33
18
6
268
18,112
102
76
51
28
10
180
765
27,197
27,201
154
154
114
114
77
77
42
42
14
14
461
76
5,281
5,655
30
96
22
56
15
38
8
16
3
11
3,123
72,201
408
303
205
111
38
1,349
53,012
299
222
151
81
28
351
163
14,883
10,506
84
59
62
44
42
30
23
16
8
6
407
20,577
116
86
59
32
11
2,126
530
39,917
17,220
226
97
168
72
114
49
61
26
21
9
285
8,556
48
36
24
13
5
3,232
57,576
325
241
164
88
30
1,552
34,922
197
146
99
54
18
73
3,020
17
13
9
5
2
383
12,470
70
52
35
19
7
226
12,374
70
52
35
19
7
231
15,645
88
66
44
24
8
490
30,764
174
129
88
47
16
318
150
275
21,417
8,714
15,853
121
49
90
90
37
67
61
25
45
33
13
24
11
5
8
619
335
21,179
10,720
120
61
89
45
60
31
32
16
11
6
319
19,887
112
83
57
31
11
178
13,631
77
57
39
21
7
102
3,748
21
16
11
6
2
1,725
52,454
296
220
149
80
28
106
105
2,188
7,425
12
22
9
10
6
8
3
3
1
3
125
16,033
47
22
16
6
6
26
17,121
50
24
17
7
7
23
16,269
47
23
17
6
6
45
12,806
37
18
13
5
5
181
75,225
425
316
214
115
40
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TABLE VIII–5—NUMBERS OF WORKERS EXPOSED TO SILICA (BY AFFECTED INDUSTRY AND EXPOSURE LEVEL (μg/m3))—
Continued
NAICS
336112 ..............
336120
336211
336212
336213
336311
..............
..............
..............
..............
..............
336312 ..............
336322 ..............
336330 ..............
336340 ..............
336350 ..............
336370 ..............
336399 ..............
336611 ..............
336612 ..............
336992 ..............
337215 ..............
339114 ..............
339116 ..............
339911 ..............
339913 ..............
339914 ..............
339950
423840
482110
621210
..............
..............
..............
..............
Subtotals—
General
Industry
and Maritime.
Totals
Number of
establishments
Industry
Light truck and utility vehicle manufacturing.
Heavy duty truck manufacturing ............
Motor vehicle body manufacturing .........
Truck trailer manufacturing ....................
Motor home manufacturing ....................
Carburetor, piston, piston ring, and
valve manufacturing.
Gasoline engine and engine parts manufacturing.
Other motor vehicle electrical and electronic equipment manufacturing.
Motor vehicle steering and suspension
components (except spring) manufacturing.
Motor vehicle brake system manufacturing.
Motor vehicle transmission and power
train parts manufacturing.
Motor vehicle metal stamping ................
All other motor vehicle parts manufacturing.
Ship building and repair .........................
Boat building ..........................................
Military armored vehicle, tank, and tank
component manufacturing.
Showcase, partition, shelving, and locker manufacturing.
Dental equipment and supplies manufacturing.
Dental laboratories .................................
Jewelry (except costume) manufacturing.
Jewelers’ materials and lapidary work
manufacturing.
Costume jewelry and novelty manufacturing.
Sign manufacturing ................................
Industrial supplies, wholesalers .............
Rail transportation ..................................
Dental offices .........................................
Number of
employees
Numbers exposed to Silica
>=0
>=25
>=50
>=100
>=250
94
103,815
587
436
296
159
55
95
820
394
91
116
32,122
47,566
32,260
21,533
10,537
181
269
182
122
60
135
200
135
90
44
91
135
92
61
30
49
73
50
33
16
17
25
17
11
6
876
66,112
373
277
188
101
35
697
62,016
350
260
176
95
33
257
39,390
223
165
112
60
21
241
33,782
191
142
96
52
18
535
83,756
473
351
238
128
44
781
1,458
110,578
149,251
624
843
464
626
315
425
170
229
58
79
635
1,129
57
87,352
54,705
6,899
2,798
1,752
39
2,798
1,752
29
1,998
1,252
20
1,599
1,001
11
1,199
751
4
1,733
59,080
334
248
168
91
31
763
15,550
411
274
274
137
0
7,261
1,777
47,088
25,280
33,214
7,813
5,357
4,883
1,071
3,418
0
2,442
0
977
264
5,199
1,607
1,004
703
502
201
590
6,775
1,088
685
479
338
135
6,415
10,742
NA
124,553
89,360
111,198
NA
817,396
496
383
16,895
7,980
249
306
11,248
1,287
172
153
5,629
257
57
77
2,852
0
57
0
1,233
0
................................................................
238,942
4,406,990
294,886
175,801
122,472
80,731
48,956
................................................................
1,041,291
17,508,728
2,144,061
1,026,491
770,280
501,009
264,959
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Source: U.S. Dept. of Labor, OSHA, Directorate of Standards and Guidance, Office of Regulatory Analysis, based on Table III–5 and the technological feasibility
analysis presented in Chapter IV of the PEA.
D. Technological Feasibility Analysis of
the Proposed Permissible Exposure
Limit to Crystalline Silica Exposures
Chapter IV of the Preliminary
Economic Analysis (PEA) provides the
technological feasibility analysis that
guided OSHA’s selection of the
proposed PEL, consistent with the
requirements of the Occupational Safety
and Health Act (‘‘OSH Act’’), 29 U.S.C.
651 et seq. Section 6(b)(5) of the OSH
Act requires that OSHA ‘‘set the
standard which most adequately
assures, to the extent feasible, on the
basis of the best available evidence, that
no employee will suffer material
impairment of health or functional
capacity.’’ 29 U.S.C. 655(b)(5) (emphasis
added). The Court of Appeals for the
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D.C. Circuit has clarified the Agency’s
obligation to demonstrate the
technological feasibility of reducing
occupational exposure to a hazardous
substance:
OSHA must prove a reasonable possibility
that the typical firm will be able to develop
and install engineering and work practice
controls that can meet the PEL in most of its
operations . . . The effect of such proof is to
establish a presumption that industry can
meet the PEL without relying on respirators
. . . Insufficient proof of technological
feasibility for a few isolated operations
within an industry, or even OSHA’s
concession that respirators will be necessary
in a few such operations, will not undermine
this general presumption in favor of
feasibility. Rather, in such operations firms
will remain responsible for installing
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engineering and work practice controls to the
extent feasible, and for using them to reduce
. . . exposure as far as these controls can do
so.
United Steelworkers of America, AFL–
CIO–CIC v. Marshall, 647 F.2d 1189,
1272 (D.C. Cir. 1980).
Additionally, the D.C. Circuit has
explained that ‘‘[f]easibility of
compliance turns on whether exposure
levels at or below [the PEL] can be met
in most operations most of the time.
. . .’’ American Iron & Steel Inst. v.
OSHA, 939 F.2d 975, 990 (D.C. Cir.
1991).
To demonstrate the limits of
feasibility, OSHA’s analysis examines
the technological feasibility of the
proposed PEL of 50 mg/m3, as well as
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the technological feasibility of an
alternative PEL of 25 mg/m3. In total,
OSHA analyzed technological feasibility
in 108 operations in general industry,
maritime, and construction industries.
This analysis addresses two different
aspects of technological feasibility: (1)
The extent to which engineering
controls can reduce and maintain
exposures; and (2) the capability of
existing sampling and analytical
methods to measure silica exposures.
The discussion below summarizes the
findings in Chapter IV of the PEA (see
Docket No. OSHA–2010–0034).
Methodology
The technological feasibility analysis
relies on information from a wide
variety of sources. These sources
include published literature, OSHA
inspection reports, NIOSH reports and
engineering control feasibility studies,
and information from other federal
agencies, state agencies, labor
organizations, industry associations,
and other groups. OSHA has limited the
analysis to job categories that are
associated with substantial direct silica
exposure. The technological feasibility
analyses group the general industry and
maritime workplaces into 23 industry
sectors.11 The Agency has divided each
industry sector into specific job
categories on the basis of common
materials, work processes, equipment,
and available exposure control methods.
OSHA notes that these job categories are
intended to represent job functions;
actual job titles and responsibilities
might differ depending on the facility.
OSHA has organized the construction
industry by grouping workers into 12
general construction activities. The
Agency organized construction workers
into general activities that create silica
exposures rather than organizing them
by job titles because construction
workers often perform multiple
activities and job titles do not always
coincide with the sources of exposure.
In organizing construction worker
activity this way, OSHA was able to
create a more accurate exposure profile
and apply control methods to workers
who perform these activities in any
segment of the construction industry.
The exposure profiles include silica
exposure data only for workers in the
United States. Information on
international exposure levels is
occasionally referenced for perspective
11 Note that OSHA’s technological feasibility
analysis contains 21 general industry sections. The
number is expanded to 23 in this summary because
Table VIII.D–1 describes the foundry industry as
three different sectors (ferrous, nonferrous, and
non-sand casting foundries) to provide a more
detailed analysis of exposures.
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or in discussions of control options. It
is important to note that the vast
majority of crystalline silica
encountered by workers in the United
States is in the quartz form, and the
terms crystalline silica and quartz are
often used interchangeably. Unless
specifically indicated otherwise, all
silica exposure data, samples, and
results discussed in the technological
feasibility analysis refer to
measurements of personal breathing
zone (PBZ) respirable crystalline silica.
In general and maritime industries,
the exposure profiles in the
technological feasibility analysis consist
mainly of full-shift samples, collected
over periods of 360 minutes or more. By
using full-shift sampling results, OSHA
minimizes the number of results that are
less than the limit of detection (LOD)
and eliminates the ambiguity associated
with the LOD for low air volume
samples. Thus, results that are reported
in the original data source as below the
LOD are included without contributing
substantial uncertainty regarding their
relationship to the proposed PEL. This
is particularly important for general
industry samples, which on average
have lower silica levels than typical
results for many tasks in the
construction industry.
In general and maritime industries,
the exposure level for the period
sampled is assumed to have continued
over any unsampled portion of the
worker’s shift. OSHA has preliminarily
determined that this sample criterion is
valid because workers in these
industries are likely to work at the same
general task or same repeating set of
tasks over most of their shift; thus,
unsampled periods generally are likely
to be similar to the sampled periods.
In the construction industry, much of
the data analyzed for the defined
activities consisted of full-shift samples
collected over periods of 360 minutes or
more. Construction workers are likely to
spend a shift working at multiple
discrete tasks, independent of
occupational titles, and do not normally
engage in those discrete tasks for the
entire duration of a shift. Therefore, the
Agency occasionally included partialshift samples (periods of less than 360
minutes), but has limited the use of
partial-shift samples with results below
the LOD, giving preference to data
covering a greater part of the workers’
shifts.
OSHA believes that the partial-shift
samples were collected for the entire
duration of the task and that the
exposure to silica ended when the task
was completed. Therefore, OSHA
assumes that the exposure to silica was
zero for the remaining unsampled time.
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OSHA understands that this may not
always be the case, and that there may
be activities other than the sampled
tasks that affect overall worker
exposures, but the documentation
regarding these factors is insufficient to
use in calculating a time-weighted
average. It is important to note,
however, that the Agency has identified
to the best of its ability the construction
activities that create significant
exposures to respirable crystalline
silica.
In cases where exposure information
from a specific job category is not
available, OSHA has based that portion
of the exposure profile on surrogate data
from one or more similar job categories
in related industries. The surrogate data
is selected based on strong similarities
of raw materials, equipment, worker
activities, and exposure duration
between the job categories. When used,
OSHA has clearly identified the
surrogate data and the relationship
between the industries or job categories.
1. Feasibility Determination of Sampling
and Analytical Methods
As part of its technological feasibility
analysis, OSHA examined the capability
of currently available sampling methods
and sensitivity 12 and precision of
currently available analytical methods
to measure respirable crystalline silica
(please refer to the ‘‘Feasibility of
Measuring Respirable Crystalline Silica
Exposures at The Proposed PEL’’ section
in Chapter IV of the PEA). The Agency
understands that several commercially
available personal sampling cyclones
exist that can be operated at flow rates
that conform to the ISO/CEN particle
size selection criteria with an acceptable
level of bias. Some of these sampling
devices are the Dorr-Oliver, HiggensDowel, BGI GK 2.69, and the SKC G–3
cyclones. Bias against the ISO/CEN
criteria will fall within ±20 percent, and
often is within ±10 percent.
Additionally, the Agency
preliminarily concludes that all of the
mentioned cyclones are capable of
allowing a sufficient quantity of quartz
to be collected from atmospheric
concentrations as low as 25 mg/m3 to
exceed the limit of quantification for the
OSHA ID–142 analytical method,
provided that a sample duration is at
least 4 hours. Furthermore, OSHA
believes that these devices are also
capable of collecting more than the
minimum amount of cristobalite at the
proposed PEL and action level
12 Note that sensitivity refers to the smallest
quantity that can be measured with a specified level
of accuracy, expressed either as the limit of
detection or limit of quantification.
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necessary for quantification with
OSHA’s method ID–142 for a full shift.
One of these cyclones (GK 2.69) can also
collect an amount of cristobalite
exceeding OSHA’s limit of
quantification (LOQ) with a 4-hour
sample at the proposed PEL and action
level.
Regarding analytical methods to
measure silica, OSHA investigated the
sensitivity and precision of available
methods. The Agency preliminarily
concludes that the X-Ray Diffraction
(XRD) and Infrared Spectroscopy (IR)
methods of analysis are both sufficiently
sensitive to quantify levels of quartz and
cristobalite that would be collected on
air samples taken from concentrations at
the proposed PEL and action level.
Available information shows that poor
inter-laboratory agreement and lack of
specificity render colorimetric
spectrophotometry (another analytical
method) inferior to XRD or IR
techniques. As such, OSHA is proposing
not to permit employers to rely on
exposure monitoring results based on
analytical methods that use colorimetric
methods.
For the OSHA XRD Method ID–142
(revised December 1996), precision is
±23 percent at a working range of 50 to
160 mg crystalline silica, and the SAE
(sampling and analytical error) is ±19
percent. The NIOSH and MSHA XRD
and IR methods report a similar degree
of precision. OSHA’s Salt Lake
Technical Center (SLTC) evaluated the
precision of ID–142 at lower filter
loadings and has shown an acceptable
level of precision is achieved at filter
loadings of approximately 40 mg and 20
mg corresponding to the amounts
collected from full-shift sampling at the
proposed PEL and action level,
respectively. This analysis showed that
at filter loadings corresponding to the
proposed PEL, the precision and SAE
for quartz are ±17 and ±14 percent,
respectively. For cristobalite, the
precision and SAE are ±19 and ±16
percent, respectively. These results
indicate that employers can have
confidence in sampling results for the
purpose of assessing compliance with
the PEL and identifying when
additional engineering and work
practice controls and/or respiratory
protection are needed.
For example, given an SAE for quartz
of 0.14 at a filter load of 40 mg,
employers can be virtually certain that
the PEL is not exceeded where
exposures are less than 43 mg/m3, which
represents the lower 95-percent
confidence limit (i.e., 50 mg/m3 minus
50*0.14). At 43 mg/m3, a full-shift
sample that collects 816 L of air will
result in a filter load of 35 mg of quartz,
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or more than twice the LOQ for Method
ID–142. Thus, OSHA believes that the
method is sufficiently sensitive and
precise to allow employers to
distinguish between operations that
have sufficient dust control to comply
with the PEL from those that do not.
Finally, OSHA’s analysis of PAT data
indicates that most laboratories achieve
good agreement in results for samples
having filter loads just above 40 mg
quartz (49–70 mg).
At the proposed action level, the
study by SLTC found the precision and
SAE of the method for quartz at 20 mg
to be ±19 and ±16 percent, respectively.
For cristobalite, the precision and SAE
at 20 mg were also ±19 and ±16 percent,
respectively. OSHA believes that these
results show that Method ID–142 can
achieve a sufficient degree of precision
for the purpose of identifying those
operations where routine exposure
monitoring should be conducted.
However, OSHA also believes that
limitations in the characterization of the
precision of the analytical method in
this range of filter load preclude the
Agency from proposing a PEL of 25 mg/
m3 at this time. First, the measurement
error increases by about 4 to 5 percent
for a full-shift sample taken at 25 mg/m3
compared to one taken at 50 mg/m3, and
the error would be expected to increase
further as filter loads approach the limit
of detection. Second, for an employer to
be virtually certain that an exposure to
quartz did not exceed 25 mg/m3 as an
exposure limit, the exposure would
have to be below 21 mg/m3 given the
SAE of ±16 percent calculated from the
SLTC study. For a full-shift sample of
0.816 L of air, only about 17 mg of quartz
would be collected at 21 mg/m3, which
is near the LOQ for Method ID–142 and
at the maximum acceptable LOD that
would be required by the proposed rule.
Thus, given a sample result that is
below a laboratory’s reported LOD,
employers might not be able to rule out
whether a PEL of 25 mg/m3 was
exceeded.
Finally, there are no available data
that describe the total variability seen
between laboratories at filter loadings in
the range of 20 mg crystalline silica since
the lowest filter loading used in PAT
samples is about 50 mg. Given these
considerations, OSHA believes that a
PEL of 50 mg/m3 is more appropriate in
that employers will have more
confidence that sampling results are
properly informing them where
additional dust controls and respiratory
protection is needed.
Based on the evaluation of the
nationally recognized sampling and
analytical methods for measuring
respirable crystalline silica presented in
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the section titled ‘‘Feasibility of
Measuring Respirable Crystalline Silica
Exposures at The Proposed PEL’’ in
Chapter IV of the PEA, OSHA
preliminarily concludes that it is
technologically feasible to reliably
measure exposures of workers at the
proposed PEL of 50 mg/m3 and action
level of 25 mg/m3. OSHA notes that the
sampling and analytical error is larger at
the proposed action level than that for
the proposed PEL. In the ‘‘Issues’’
section of this preamble (see Provisions
of the Standards—Exposure
Assessment), OSHA solicits comments
on whether measurements of exposures
at the proposed action level and PEL are
sufficiently precise to permit employers
to adequately determine when
additional exposure monitoring is
necessary under the standard, when to
provide workers with the required
medical surveillance, and when to
comply with all other requirements of
the proposed standard. OSHA also
solicits comments on the
appropriateness of specific requirements
in the proposed standard for
laboratories that perform analyses of
respirable crystalline silica samples to
reduce the variability between
laboratories.
2. Feasibility Determination of Control
Technologies
The Agency has conducted a
feasibility analysis for each of the
identified 23 general industry sectors
and 12 construction industry activities
that are potentially affected by the
proposed silica standard. Additionally,
the Agency identified 108 operations
within those sectors/activities and
developed exposure profiles for each
operation, except for two industries,
engineered stone products and
landscape contracting industries. For
these two industries, data satisfying
OSHA’s criteria for inclusion in the
exposure profile were unavailable (refer
to the Methodology section in Chapter
4 of the PEA for criteria). However, the
Agency obtained sufficient information
in both of these industries to make
feasibility determinations (see Chapter
IV Sections C.7 and C.11 of the PEA).
Each feasibility analysis contains a
description of the applicable operations,
the baseline conditions for each
operation (including the respirable
silica samples collected), additional
controls necessary to reduce exposures,
and final feasibility determinations for
each operation.
3. Feasibility Findings for the Proposed
Permissible Exposure Limit of 50 mg/m3
Tables VIII–6 and VIII–7 summarize
all the industry sectors and construction
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activities studied in the technological
feasibility analysis and show how many
operations within each can achieve
levels of 50 mg/m3 through the
implementation of engineering and
work practice controls. The tables also
summarize the overall feasibility finding
for each industry sector or construction
activity based on the number of feasible
versus not feasible operations. For the
general industry sector, OSHA has
preliminarily concluded that the
proposed PEL of 50 mg/m3 is
technologically feasible for all affected
industries. For the construction
activities, OSHA has determined that
the proposed PEL of 50 mg/m3 is feasible
in 10 out of 12 of the affected activities.
Thus, OSHA preliminarily concludes
that engineering and work practices will
be sufficient to reduce and maintain
silica exposures to the proposed PEL of
50 mg/m3 or below in most operations
most of the time in the affected
industries. For those few operations
within an industry or activity where the
proposed PEL is not technologically
feasible even when workers use
recommended engineering and work
practice controls (seven out of 108
operations, see Tables VIII–6 and VIII–
7), employers can supplement controls
with respirators to achieve exposure
levels at or below the proposed PEL.
4. Feasibility Findings for an Alternative
Permissible Exposure Limit of 25 mg/m3
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Based on the information presented in
the technological feasibility analysis,
OSHA believes that engineering and
work practice controls identified to date
will not be sufficient to consistently
reduce exposures to PELs lower than 50
mg/m3. The Agency believes that a
proposed PEL of 25 mg/m3, for example,
would not be feasible for many
industries, and to use respiratory
protection would have to be required in
most operations and most of the time to
achieve compliance.
However, OSHA has data indicating
that an alternative PEL of 25 mg/m3 has
already been achieved in several
industries (e.g. asphalt paving products,
dental laboratories, mineral processing,
and paint and coatings manufacturing in
general industry, and drywall finishers
and heavy equipment operators in
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construction). In these industries,
airborne respirable silica concentrations
are inherently low because either small
amounts of silica containing materials
are handled or these materials are not
subjected to high energy processes that
generate large amounts of respirable
dust.
For many of the other industries,
OSHA believes that engineering and
work practice controls will not be able
to reduce and maintain exposures to an
alternative PEL of 25 mg/m3 in most
operations and most of the time. This is
especially the case in industries that use
silica containing material in substantial
quantities and industries with high
energy operations. For example, in
general industry, the ferrous foundry
industry would not be able to comply
with an alternative PEL of 25 mg/m3
without widespread respirator use. In
this industry, silica containing sand is
transported, used, and recycled in
significant quantities to create castings,
and as a result, workers can be exposed
to high levels of silica in all steps of the
production line. Additionally, some
high energy operations in foundries
create airborne dust that causes high
worker exposures to silica. One of these
operations is the shakeout process,
where operators monitor equipment that
separates castings from mold materials
by mechanically vibrating or tumbling
the casting. The dust generated from
this process causes elevated silica
exposures for shakeout operators and
often contributes to exposures for other
workers in a foundry. For small,
medium, and large castings, exposure
information with engineering controls
in place show that exposures below 50
mg/m3 can be consistently achieved, but
exposures above an alternative PEL of
25 mg/m3 still occur. With engineering
controls in place, exposure data for
these operations range from 13 mg/m3 to
53 mg/m3, with many of the reported
exposures above 25 mg/m3.
In the construction industry, OSHA
estimates that an alternative PEL of 25
mg/m3 would be infeasible in most
operations because most of them are
high energy operations that produce
significant levels of dust, causing
workers to have elevated exposures, and
available engineering controls would
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56355
not be able to maintain exposures at or
below the alternative PEL most of the
time. For example, jackhammering is a
high energy operation that creates a
large volume of silica containing dust,
which disburses rapidly in highly
disturbed air. OSHA estimates that the
exposure levels of most workers
operating jackhammers outdoors will be
reduced to less that 100 mg/m3 as an 8hour TWA, by using either wet methods
or LEV paired with a suitable vacuum.
OSHA believes that typically, the
majority of jackhammering is performed
for less than four hours of a worker’s
shift, and in these circumstances the
Agency estimates that most workers will
experience levels below 50 mg/m3.
Jackhammer operators who work
indoors or with multiple jackhammers
will achieve similar results granted that
the same engineering controls are used
and that fresh air circulation is provided
to prevent accumulation of respirable
dust in a worker’s vicinity. OSHA does
not have any data indicating that these
control strategies would reduce
exposures of most workers to levels of
25 mg/m3 or less.
5. Overall Feasibility Determination
Based on the information presented in
the technological feasibility analysis,
the Agency believes that 50 mg/m3 is the
lowest feasible PEL. An alternative PEL
of 25 mg/m3 would not be feasible
because the engineering and work
practice controls identified to date will
not be sufficient to consistently reduce
exposures to levels below 25 mg/m3 in
most operations most of the time. OSHA
believes that an alternative PEL of 25
mg/m3 would not be feasible for many
industries, and that the use of
respiratory protection would be
necessary in most operations most of the
time to achieve compliance.
Additionally, the current methods of
sampling analysis create higher errors
and lower precision in measurement as
concentrations of silica lower than the
proposed PEL are analyzed. However,
the Agency preliminarily concludes that
these sampling and analytical methods
are adequate to permit employers to
comply with all applicable requirements
triggered by the proposed action level
and PEL.
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TABLE VIII–6—SUMMARY OF TECHNOLOGICAL FEASIBILITY OF CONTROL TECHNOLOGIES IN GENERAL AND MARITIME
INDUSTRIES AFFECTED BY SILICA EXPOSURES
Total number
of affected
operations
Industry sector
Number of operations for which
the proposed PEL
is achievable with
engineering controls and work
practice controls
Number of operations for which
the proposed PEL
is NOT achievable
with engineering
controls and work
practice controls
Asphalt Paving Products .........................................................
Asphalt Roofing Materials ........................................................
Concrete Products ...................................................................
Cut Stone .................................................................................
Dental Equipment and Suppliers .............................................
Dental Laboratories .................................................................
Engineered Stone Products .....................................................
Foundries: Ferrous* .................................................................
Foundries: Nonferrous* ............................................................
Foundries: Non-Sand Casting* ................................................
Glass ........................................................................................
Jewelry .....................................................................................
Landscape Contracting ............................................................
Mineral Processing ..................................................................
Paint and Coatings ..................................................................
Porcelain Enameling ................................................................
Pottery ......................................................................................
Railroads ..................................................................................
Ready-Mix Concrete ................................................................
Refractories ..............................................................................
Refractory Repair .....................................................................
Shipyards (Maritime Industry) ..................................................
Structural Clay .........................................................................
3
2
6
5
1
1
1
12
12
11
2
1
1
1
2
2
5
5
5
5
1
2
3
3
2
5
5
1
1
1
12
12
11
2
1
1
1
2
2
5
5
4
5
1
1
3
0
0
1
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1
0
0
1
0
Totals ................................................................................
89
96.6%
Overall feasibility finding for industry sector
Feasible.
Feasible.
Feasible.
Feasible.
Feasible.
Feasible.
Feasible.
Feasible.
Feasible.
Feasible.
Feasible.
Feasible.
Feasible.
Feasible.
Feasible.
Feasible.
Feasible.
Feasible.
Feasible.
Feasible.
Feasible.
Feasible.
Feasible.
3.4%
* Section 8 of the Technological Feasibility Analysis includes four subsectors of the foundry industry. Each subsector includes its own exposure
profile and feasibility analysis in that section. This table lists three of those four subsectors individually based on the difference in casting processes used and subsequent potential for silica exposure. The table does not include captive foundries because the captive foundry operations
are incorporated into the larger manufacturing process of the parent foundry.
TABLE VIII–7—SUMMARY OF TECHNOLOGICAL FEASIBILITY OF CONTROL TECHNOLOGIES IN CONSTRUCTION ACTIVITIES
AFFECTED BY SILICA EXPOSURES
Total number
of affected
operations
Construction activity
Number of
operations for
which the proposed PEL is
achievable with
engineering controls and work
practice controls
Number of
operations for
which the proposed PEL is
NOT achievable
with engineering
controls and work
practice controls
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Abrasive Blasters .....................................................................
Drywall Finishers ......................................................................
Heavy Equipment Operators ...................................................
Hole Drillers Using Hand-Held Drills .......................................
Jackhammer and Impact Drillers .............................................
Masonry Cutters Using Portable Saws ....................................
Masonry Cutters Using Stationary Saws .................................
Millers Using Portable and Mobile Machines ..........................
Rock and Concrete Drillers ......................................................
Rock-Crushing Machine Operators and Tenders ....................
Tuckpointers and Grinders ......................................................
Underground Construction Workers ........................................
2
1
1
1
1
3
1
3
1
1
3
1
0
1
1
1
1
3
1
3
1
1
1
1
2
0
0
0
0
0
0
0
0
0
2
0
Totals ................................................................................
19
78.9%
Overall feasibility finding for activity
21.1%
E. Costs of Compliance
Chapter V of the PEA in support of
the proposed silica rule provides a
detailed assessment of the costs to
establishments in all affected industry
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sectors of reducing worker exposures to
silica to an eight-hour time-weighted
average (TWA) permissible exposure
limit (PEL) of 50 mg/m3 and of
complying with the proposed standard’s
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Not Feasible.
Feasible.
Feasible.
Feasible.
Feasible.
Feasible.
Feasible.
Feasible.
Feasible.
Feasible.
Not Feasible.
Feasible.
ancillary requirements. The discussion
below summarizes the findings in the
PEA cost chapter. OSHA’s preliminary
cost assessment is based on the
Agency’s technological feasibility
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analysis presented in Chapter IV of the
PEA (2013); analyses of the costs of the
proposed standard conducted by
OSHA’s contractor, Eastern Research
Group (ERG, 2007a, 2007b, and 2013);
and the comments submitted to the
docket as part of the SBREFA panel
process.
OSHA estimates that the proposed
rule will cost $657.9 million per year in
2009 dollars. Costs originally estimated
for earlier years were adjusted to 2009
dollars using the appropriate price
indices. All costs are annualized using
a discount rate of 7 percent. (A
sensitivity analysis using discount rates
of 3 percent and 0 percent is presented
in the discussion of net benefits.) Onetime costs are annualized over 10-year
annualization period, and capital goods
are annualized over the life of the
equipment. OSHA has historically
annualized one-time costs over at least
a 10-year period, which approximately
reflects the average life of a business in
the United States. (The Agency has
chosen a longer annualization period
under special circumstances, such as
when a rule involves longer and more
complex phase-in periods. In general, a
longer annualization period, in such
cases, will tend to reduce annualized
costs slightly.)
The estimated costs for the proposed
silica standard rule include the
additional costs necessary for employers
to achieve full compliance. They do not
include costs associated with current
compliance that has already been
achieved with regard to the new
requirements or costs necessary to
achieve compliance with existing silica
requirements, to the extent that some
employers may currently not be fully
complying with applicable regulatory
requirements.
Table VIII–8 provides the annualized
costs of the proposed rule by cost
category for general industry, maritime,
and construction. As shown in Table
VIII–8, of the total annualized costs of
the proposed rule, $132.5 million would
be incurred by general industry, $14.2
million by maritime, and $511.2 million
by construction.
Table VIII–9 shows the annualized
costs of the proposed rule by cost
category and by industry for general
industry and maritime, and Table VIII–
10 shows the annualized costs similarly
disaggregated for construction. These
tables show that engineering control
costs represent 69 percent of the costs
of the proposed standard for general
industry and maritime and 47 percent of
the costs of the proposed standard for
construction. Considering other leading
cost categories, costs for exposure
assessment and respirators represent,
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respectively, 20 percent and 5 percent of
the costs of the proposed standard for
general industry and maritime; costs for
respirators and medical surveillance
represent, respectively, 16 percent and
15 percent of the costs of the proposed
standard for construction.
While the costs presented here
represent the Agency’s best estimate of
the costs to industry of complying with
the proposed rule under static
conditions (that is, using existing
technology and the current deployment
of workers), OSHA recognizes that the
actual costs could be somewhat higher
or lower, depending on the Agency’s
possible overestimation or
underestimation of various cost factors.
In Chapter VII of the PEA, OSHA
provides a sensitivity analysis of its cost
estimates by modifying certain critical
unit cost factors. Beyond the sensitivity
analysis, however, OSHA believes its
cost estimates may significantly
overstate the actual costs of the
proposed rule because, in response to
the rule, industry may be able to take
two types of actions to reduce
compliance costs.
First, in construction, 53 percent of
the estimated costs of the proposed rule
(all costs except engineering controls)
vary directly with the number of
workers exposed to silica. However, as
shown in Table VIII–3 of this preamble,
almost three times as many construction
workers would be affected by the
proposed rule as would the number of
full-time-equivalent construction
workers necessary to do the work. This
is because most construction workers
currently do work involving silica
exposure for only a portion of their
workday. In response to the proposed
rule, many employers are likely to
assign work so that fewer construction
workers perform tasks involving silica
exposure; correspondingly, construction
work involving silica exposure will tend
to become a full-time job for some
construction workers.13 Were this
approach fully implemented in
construction, the actual cost of the
proposed rule would decline by over 25
percent, or by $180 million annually, to
under $480 million annually.14
13 There are numerous instances of job
reassignments and job specialties arising in
response to OSHA regulation. For example, asbestos
removal and confined space work in construction
have become activities performed by well-trained
specialized employees, not general laborers (whose
only responsibility is to identify the presence of
asbestos or a confined space situation and then to
notify the appropriate specialist).
14 OSHA expected that such a structural change
in construction work assignments would not have
a significant effect on the benefits of the proposed
rule. As discussed in Chapter VII of the PEA, the
benefits of the proposed rule are relatively
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56357
Second, the costs presented here do
not take into account the likely
development and dissemination of costreducing compliance technology in
response to the proposed rule.15 One
possible example is the development of
safe substitutes for silica sand in
abrasive blasting operations, repair and
replacement of refractory materials,
foundry operations, and the railroad
transportation industry. Another is
expanded uses of automated processes,
which would allow workers to be
isolated from the points of operation
that involve silica exposure (such as
tasks between the furnace and the
pouring machine in foundries and at
sand transfer stations in structural clay
production facilities). Yet another
example is the further development and
use of bags with valves that seal
effectively when filled, thereby
preventing product leakage and worker
exposure (for example, in mineral
processing and concrete products
industries). Probably the most pervasive
and significant technological advances,
however, will likely come from the
integration of compliant control
technology into production equipment
as standard equipment. Such advances
would both increase the effectiveness
and reduce the costs of silica controls
retrofitted to production equipment.
Possible examples include local exhaust
ventilation (LEV) systems attached to
portable tools used by grinders and
tuckpointers; enclosed operator cabs
equipped with air filtration and air
conditioning in industries that
mechanically transfer silica or silicacontaining materials; and machineintegrated wet dust suppression systems
used, for example, in road milling
operations. Of course, all the possible
technological advances in response to
the proposed rule and their effects on
costs are difficult to predict.16
OSHA has decided at this time not to
create a more dynamic and predictive
analysis of possible cost-reducing
insensitive to changes in average occupational
tenure or how total silica exposure in an industry
is distributed among individual workers.
15 Evidence of such technological responses to
regulation is widespread (see for example Ashford,
Ayers, and Stone (1985), OTA (1995), and OSHA’s
regulatory reviews of existing standards under § 610
of the Regulatory Flexibility Act (‘‘610 lookback
reviews’’)).
16 A dramatic example from OSHA’s 610
lookback review of its 1984 ethylene oxide (EtO)
standard is the use of EtO as a sterilant. OSHA
estimated the costs of add-on controls for EtO
sterilization, but in response to the standard,
improved EtO sterilizers with built-in controls were
developed and widely disseminated at about half
the cost of the equipment with add-on controls.
(See OSHA, 2005.) Lower-cost EtO sterilizers with
built-in controls did not exist, and their
development had not been predicted by OSHA, at
the time the final rule was published in 1984.
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technological advances or worker
specialization because the technological
and economic feasibility of the
proposed rule can easily be
demonstrated using existing technology
and employment patterns. However,
OSHA believes that actual costs, if
future developments of this type were
fully accounted for, would be lower
than those estimated here.
OSHA invites comment on this
discussion concerning the costs of the
proposed rule.
TABLE VIII–8—ANNUALIZED COMPLIANCE COSTS FOR EMPLOYERS IN GENERAL INDUSTRY, MARITIME, AND CONSTRUCTION
AFFECTED BY OSHA’S PROPOSED SILICA STANDARD
[2009 dollars]
Industry
Engineering
controls (includes abrasive blasting)
Respirators
Exposure
assessment
Medical
surveillance
Regulated
areas or
access control
Training
Total
General Industry ..........
Maritime .......................
Construction .................
$88,442,480
12,797,027
242,579,193
$6,914,225
NA
84,004,516
$29,197,633
671,175
44,552,948
$2,410,253
646,824
76,012,451
$2,952,035
43,865
47,270,844
$2,580,728
70,352
16,745,663
$132,497,353
14,229,242
511,165,616
Total ......................
343,818,700
90,918,741
74,421,757
79,069,527
50,266,744
19,396,743
657,892,211
U.S. Source: U.S. Dept. of Labor, OSHA, Directorate of Standards and Guidance, Office of Regulatory Analysis, based on ERG (2007a,
2007b, and 2013).
TABLE VIII–9—ANNUALIZED COMPLIANCE COSTS FOR ALL GENERAL INDUSTRY AND MARITIME ESTABLISHMENTS
AFFECTED BY THE PROPOSED SILICA STANDARD
Engineering
controls (includes abrasive blasting)
NAICS
Industry
324121 .....
Asphalt paving mixture and block manufacturing.
Asphalt shingle and roofing materials ..
Paint and coating manufacturing ..........
Vitreous china plumbing fixtures &
bathroom accessories manufacturing.
Vitreous china, fine earthenware, &
other pottery product manufacturing.
Porcelain electrical supply mfg .............
Brick and structural clay mfg ................
Ceramic wall and floor tile mfg .............
Other structural clay product mfg .........
Clay refractory manufacturing ..............
Nonclay refractory manufacturing ........
Flat glass manufacturing ......................
Other pressed and blown glass and
glassware manufacturing.
Glass container manufacturing .............
Ready-mixed concrete manufacturing ..
Concrete block and brick mfg ..............
Concrete pipe mfg ................................
Other concrete product mfg .................
Cut stone and stone product manufacturing.
Ground or treated mineral and earth
manufacturing.
Mineral wool manufacturing .................
All other misc. nonmetallic mineral
product mfg.
Iron and steel mills ...............................
Electrometallurgical ferroalloy product
manufacturing.
Iron and steel pipe and tube manufacturing from purchased steel.
Rolled steel shape manufacturing ........
Steel wire drawing ................................
Secondary smelting and alloying of
aluminum.
Secondary smelting, refining, and
alloying of copper.
Secondary smelting, refining, and
alloying of nonferrous metal (except
cu & al).
Iron foundries ........................................
Steel investment foundries ...................
Steel foundries (except investment) .....
Aluminum foundries (except die-casting).
Copper foundries (except die-casting)
324122 .....
325510 .....
327111 .....
327112 .....
327113
327121
327122
327123
327124
327125
327211
327212
.....
.....
.....
.....
.....
.....
.....
.....
327213
327320
327331
327332
327390
327991
.....
.....
.....
.....
.....
.....
327992 .....
327993 .....
327999 .....
331111 .....
331112 .....
331210 .....
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
331221 .....
331222 .....
331314 .....
331423 .....
331492 .....
331511
331512
331513
331524
.....
.....
.....
.....
331525 .....
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Exposure
assessment
Respirators
Medical
surveillance
Regulated
areas
Training
Total
$179,111
$2,784
$8,195
$962
$49,979
$1,038
$242,070
2,194,150
0
1,128,859
113,924
23,445
76,502
723,761
70,423
369,478
39,364
8,179
26,795
43,563
33,482
29,006
42,495
8,752
28,554
3,157,257
144,281
1,659,194
1,769,953
119,948
579,309
42,012
45,479
44,770
2,601,471
1,189,482
6,966,654
3,658,389
826,511
304,625
383,919
227,805
902,802
80,610
154,040
80,982
18,320
21,108
26,602
8,960
34,398
389,320
554,322
306,500
72,312
124,390
156,769
29,108
111,912
28,234
53,831
28,371
6,417
7,393
9,318
3,138
12,048
30,564
51,566
27,599
6,302
17,043
21,479
2,800
10,708
30,087
57,636
30,266
6,838
7,878
9,929
3,344
12,839
1,748,297
7,838,050
4,132,107
936,699
482,438
608,017
275,155
1,084,706
629,986
7,029,710
2,979,495
1,844,576
8,660,830
5,894,506
24,003
1,862,221
224,227
138,817
651,785
431,758
78,093
5,817,205
958,517
593,408
2,786,227
1,835,498
8,374
652,249
78,536
48,621
228,290
151,392
7,472
454,630
113,473
70,250
329,844
126,064
8,959
695,065
83,692
51,813
243,276
161,080
756,888
16,511,080
4,437,939
2,747,484
12,900,251
8,600,298
3,585,439
51,718
867,728
18,134
52,692
19,295
4,595,006
897,980
1,314,066
36,654
98,936
122,015
431,012
12,852
34,691
11,376
50,435
13,675
36,911
1,094,552
1,966,052
315,559
6,375
17,939
362
72,403
1,463
6,129
124
5,836
118
6,691
135
424,557
8,577
62,639
3,552
14,556
1,239
1,222
1,328
84,537
31,618
42,648
21,359
1,793
2,419
1,213
7,348
9,911
4,908
625
843
419
617
832
406
670
904
453
42,672
57,557
28,757
3,655
207
857
72
71
78
4,940
27,338
1,551
6,407
539
531
580
36,946
11,372,127
3,175,862
3,403,790
5,155,172
645,546
179,639
193,194
291,571
2,612,775
739,312
794,973
1,220,879
223,005
62,324
67,027
101,588
216,228
58,892
65,679
97,006
241,133
67,110
72,174
108,935
15,310,815
4,283,138
4,596,837
6,975,150
1,187,578
67,272
309,403
23,668
23,448
25,095
1,636,463
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TABLE VIII–9—ANNUALIZED COMPLIANCE COSTS FOR ALL GENERAL INDUSTRY AND MARITIME ESTABLISHMENTS
AFFECTED BY THE PROPOSED SILICA STANDARD—Continued
Engineering
controls (includes abrasive blasting)
NAICS
Industry
331528 .....
Other nonferrous foundries (except
die-casting).
Iron and steel forging ...........................
Nonferrous forging ................................
Crown and closure manufacturing .......
Metal stamping .....................................
Powder metallurgy part manufacturing
Cutlery and flatware (except precious)
manufacturing.
Hand and edge tool manufacturing ......
Saw blade and handsaw manufacturing.
Kitchen utensil, pot, and pan manufacturing.
Ornamental and architectural metal
work.
Other metal container manufacturing ...
Hardware manufacturing ......................
Spring (heavy gauge) manufacturing ...
Spring (light gauge) manufacturing ......
Other fabricated wire product manufacturing.
Machine shops .....................................
Metal coating and allied services .........
Industrial valve manufacturing ..............
Fluid power valve and hose fitting
manufacturing.
Plumbing fixture fitting and trim manufacturing.
Other metal valve and pipe fitting manufacturing.
Ball and roller bearing manufacturing ..
Fabricated pipe and pipe fitting manufacturing.
Industrial pattern manufacturing ...........
Enameled iron and metal sanitary ware
manufacturing.
All other miscellaneous fabricated
metal product manufacturing.
Other commercial and service industry
machinery manufacturing.
Air purification equipment manufacturing.
Industrial and commercial fan and
blower manufacturing.
Heating equipment (except warm air
furnaces) manufacturing.
Industrial mold manufacturing ..............
Machine tool (metal cutting types)
manufacturing.
Machine tool (metal forming types)
manufacturing.
Special die and tool, die set, jig, and
fixture manufacturing.
Cutting tool and machine tool accessory manufacturing.
Rolling mill machinery and equipment
manufacturing.
Other metalworking machinery manufacturing.
Speed changer, industrial high-speed
drive, and gear manufacturing.
Mechanical power transmission equipment manufacturing.
Pump and pumping equipment manufacturing.
Air and gas compressor manufacturing
Power-driven handtool manufacturing ..
Welding and soldering equipment manufacturing.
Packaging machinery manufacturing ...
Industrial process furnace and oven
manufacturing.
Fluid power cylinder and actuator manufacturing.
Fluid power pump and motor manufacturing.
332111
332112
332115
332116
332117
332211
.....
.....
.....
.....
.....
.....
332212 .....
332213 .....
332214 .....
332323 .....
332439
332510
332611
332612
332618
.....
.....
.....
.....
.....
332710
332812
332911
332912
.....
.....
.....
.....
332913 .....
332919 .....
332991 .....
332996 .....
332997 .....
332998 .....
332999 .....
333319 .....
333411 .....
333412 .....
333414 .....
333511 .....
333512 .....
333513 .....
333514 .....
333515 .....
333516 .....
333518 .....
333612 .....
333613 .....
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
333911 .....
333912 .....
333991 .....
333992 .....
333993 .....
333994 .....
333995 .....
333996 .....
VerDate Mar<15>2010
19:12 Sep 11, 2013
Jkt 229001
PO 00000
Exposure
assessment
Respirators
Medical
surveillance
Training
Regulated
areas
Total
914,028
51,701
212,778
17,937
16,949
19,314
1,232,708
77,324
25,529
9,381
188,102
24,250
16,763
4,393
1,451
532
10,676
1,375
952
19,505
6,440
2,236
45,595
5,727
4,229
1,538
508
186
3,734
481
333
1,555
513
186
3,736
479
337
1,640
541
199
3,988
514
355
105,955
34,982
12,720
255,832
32,828
22,970
106,344
21,272
6,041
1,209
26,356
5,090
2,110
418
2,118
411
2,255
451
145,223
28,851
11,442
650
2,886
228
230
243
15,678
28,010
1,089
4,808
383
572
406
35,267
44,028
131,574
11,792
44,511
105,686
2,502
7,476
670
2,529
6,005
11,106
33,190
2,974
11,228
26,659
876
2,617
235
885
2,102
885
2,646
237
895
2,125
934
2,790
250
944
2,241
60,330
180,292
16,158
60,992
144,819
774,529
2,431,996
111,334
103,246
44,074
94,689
6,316
5,863
211,043
395,206
25,894
24,854
15,533
33,145
2,197
2,040
16,157
48,563
2,159
2,021
16,423
35,337
2,361
2,189
1,077,759
3,038,935
150,261
140,213
33,484
1,901
8,060
661
655
710
45,472
52,542
2,984
12,648
1,038
1,028
1,114
71,354
79,038
78,951
4,488
4,483
19,027
19,006
1,561
1,560
1,547
1,545
1,676
1,674
107,338
107,219
15,383
46,581
874
2,225
3,703
9,304
304
774
301
969
326
831
20,891
60,684
209,692
11,915
53,603
4,181
4,256
4,446
288,093
154,006
8,741
37,161
3,053
3,046
3,266
209,273
43,190
2,453
10,037
847
823
916
58,265
30,549
1,735
7,099
599
582
648
41,212
59,860
3,399
13,911
1,174
1,141
1,269
80,754
116,034
49,965
6,597
2,839
30,348
12,313
2,317
988
2,375
985
2,460
1,059
160,131
68,151
24,850
1,411
6,157
495
500
527
33,940
167,204
9,513
44,922
3,346
3,458
3,545
231,988
101,385
5,764
26,517
2,025
2,075
2,150
139,916
8,897
506
2,327
178
182
189
12,279
36,232
2,060
9,476
724
742
768
50,002
35,962
2,043
8,308
702
674
763
48,452
45,422
2,581
10,493
886
852
963
61,197
89,460
5,077
21,139
1,767
1,746
1,897
121,086
62,241
25,377
46,136
3,534
1,441
2,622
14,975
6,105
10,882
1,230
501
904
1,219
497
879
1,320
538
978
84,518
34,459
62,401
61,479
31,154
3,491
1,768
15,004
7,694
1,219
620
1,218
626
1,304
661
83,714
42,523
57,771
3,280
13,532
1,137
1,113
1,225
78,057
39,598
2,247
9,296
782
772
840
53,535
Frm 00087
Fmt 4701
Sfmt 4702
E:\FR\FM\12SEP2.SGM
12SEP2
56360
Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules
TABLE VIII–9—ANNUALIZED COMPLIANCE COSTS FOR ALL GENERAL INDUSTRY AND MARITIME ESTABLISHMENTS
AFFECTED BY THE PROPOSED SILICA STANDARD—Continued
Engineering
controls (includes abrasive blasting)
NAICS
Industry
333997 .....
Scale and balance (except laboratory)
manufacturing.
All other miscellaneous general purpose machinery manufacturing.
Watch, clock, and part manufacturing ..
Electric housewares and household
fans.
Household cooking appliance manufacturing.
Household refrigerator and home
freezer manufacturing.
Household laundry equipment manufacturing.
Other major household appliance manufacturing.
Automobile manufacturing ....................
Light truck and utility vehicle manufacturing.
Heavy duty truck manufacturing ...........
Motor vehicle body manufacturing .......
Truck trailer manufacturing ...................
Motor home manufacturing ..................
Carburetor, piston, piston ring, and
valve manufacturing.
Gasoline engine and engine parts
manufacturing.
Other motor vehicle electrical and electronic equipment manufacturing.
Motor vehicle steering and suspension
components (except spring) manufacturing.
Motor vehicle brake system manufacturing.
Motor vehicle transmission and power
train parts manufacturing.
Motor vehicle metal stamping ..............
All other motor vehicle parts manufacturing.
Ship building and repair .......................
Boat building .........................................
Military armored vehicle, tank, and
tank component manufacturing.
Showcase, partition, shelving, and
locker manufacturing.
Dental equipment and supplies manufacturing.
Dental laboratories ...............................
Jewelry (except costume) manufacturing.
Jewelers’ materials and lapidary work
manufacturing.
Costume jewelry and novelty manufacturing.
Sign manufacturing ...............................
Industrial supplies, wholesalers ............
Rail transportation ................................
Dental offices ........................................
333999 .....
334518 .....
335211 .....
335221 .....
335222 .....
335224 .....
335228 .....
336111 .....
336112 .....
336120
336211
336212
336213
336311
.....
.....
.....
.....
.....
336312 .....
336322 .....
336330 .....
336340 .....
336350 .....
336370 .....
336399 .....
336611 .....
336612 .....
336992 .....
337215 .....
339114 .....
339116 .....
339911 .....
339913 .....
339914 .....
339950
423840
482110
621210
.....
.....
.....
.....
Total ......................................................
Exposure
assessment
Respirators
Medical
surveillance
Training
Regulated
areas
Total
10,853
616
2,688
216
218
230
14,822
152,444
8,657
36,677
3,012
2,985
3,232
207,006
6,389
11,336
363
437
1,596
1,641
127
149
129
203
135
163
8,740
13,928
24,478
944
3,543
321
438
352
30,077
26,139
1,009
3,784
343
468
376
32,118
24,839
958
3,596
326
444
357
30,521
19,551
754
2,830
256
350
281
24,023
218,635
301,676
12,444
17,170
49,525
68,335
4,203
5,799
3,914
5,400
4,636
6,397
293,357
404,778
93,229
138,218
93,781
62,548
30,612
5,303
7,849
5,325
3,557
1,739
21,179
32,738
21,786
14,284
7,044
1,800
2,722
1,841
1,212
598
1,692
2,674
1,791
1,147
576
1,977
2,931
1,989
1,326
649
125,181
187,131
126,512
84,073
41,219
192,076
10,910
44,198
3,753
3,616
4,073
258,625
180,164
10,233
41,457
3,520
3,392
3,820
242,586
114,457
6,504
26,216
2,228
2,128
2,427
153,960
98,118
5,573
22,578
1,917
1,847
2,080
132,114
243,348
13,832
55,796
4,730
4,510
5,160
327,377
321,190
433,579
18,237
24,628
73,408
99,769
6,282
8,472
6,057
8,162
6,810
9,194
431,985
583,803
7,868,944
4,928,083
20,097
NA
NA
1,142
412,708
258,467
4,786
397,735
249,089
394
26,973
16,892
383
43,259
27,092
426
8,749,619
5,479,624
27,227
171,563
9,741
41,962
3,405
3,412
3,638
233,720
272,308
15,901
48,135
5,524
4,157
5,930
351,955
103,876
260,378
62,183
198,421
892,167
876,676
21,602
69,472
335,984
81,414
23,193
73,992
1,439,004
1,560,353
53,545
40,804
180,284
14,287
16,742
15,216
320,878
54,734
27,779
122,885
9,726
11,337
10,359
236,821
227,905
97,304
0
24,957
9,972
8,910
327,176
14,985
44,660
60,422
1,738,398
251,046
3,491
3,149
110,229
5,286
5,173
4,199
154,412
87,408
3,718
3,315
121,858
5,572
294,919
177,299
2,452,073
389,256
101,239,507
6,914,225
29,868,808
3,057,076
2,995,900
2,651,079
146,726,595
Source: U.S. Dept. of Labor, OSHA, Directorate of Standards and Guidance, Office of Regulatory Analysis, based on ERG (2013).
TABLE VIII–10—ANNUALIZED COMPLIANCE COSTS FOR CONSTRUCTION EMPLOYERS AFFECTED BY OSHA’S PROPOSED
SILICA STANDARD
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
[2009 dollars]
NAICS
236100
236200
237100
237200
237300
.....
.....
.....
.....
.....
Engineering
controls (includes abrasive blasting)
Industry
Residential Building Construction .........
Nonresidential Building Construction ...
Utility System Construction ..................
Land Subdivision ..................................
Highway, Street, and Bridge Construction.
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19:12 Sep 11, 2013
Jkt 229001
$14,610,121
16,597,147
30,877,799
676,046
16,771,688
PO 00000
Frm 00088
Exposure
assessment
Respirators
$2,356,507
7,339,394
2,808,570
59,606
2,654,815
Fmt 4701
$1,949,685
4,153,899
4,458,900
128,183
3,538,146
Sfmt 4702
Medical
surveillance
$2,031,866
6,202,842
2,386,139
51,327
2,245,164
E:\FR\FM\12SEP2.SGM
Training
$1,515,047
4,349,517
5,245,721
173,183
4,960,966
12SEP2
Regulated
areas and
access control
$825,654
1,022,115
941,034
22,443
637,082
Total
$23,288,881
39,664,913
46,718,162
1,110,789
30,807,861
Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules
56361
TABLE VIII–10—ANNUALIZED COMPLIANCE COSTS FOR CONSTRUCTION EMPLOYERS AFFECTED BY OSHA’S PROPOSED
SILICA STANDARD—Continued
[2009 dollars]
Engineering
controls (includes abrasive blasting)
NAICS
Industry
237900 .....
Other Heavy and Civil Engineering
Construction.
Foundation, Structure, and Building
Exterior Contractors.
Building Equipment Contractors ...........
Building Finishing Contractors ..............
Other Specialty Trade Contractors .......
State and Local Governments [c] .........
Total—Construction ..............................
238100 .....
238200
238300
238900
999000
.....
.....
.....
.....
Exposure
assessment
Respirators
Medical
surveillance
Training
Regulated
areas and
access control
Total
4,247,372
430,127
825,247
367,517
1,162,105
131,843
7,164,210
66,484,670
59,427,878
17,345,127
50,179,152
14,435,854
8,034,530
215,907,211
3,165,237
34,628,392
43,159,424
11,361,299
366,310
2,874,918
4,044,680
1,641,712
394,270
2,623,763
5,878,597
3,257,131
316,655
5,950,757
4,854,336
1,426,696
526,555
3,156,004
7,251,924
4,493,968
133,113
1,025,405
2,815,017
1,157,427
4,902,138
50,259,239
68,003,978
23,338,234
242,579,193
84,004,516
44,552,948
76,012,451
47,270,844
16,745,663
511,165,616
Source: U.S. Dept. of Labor, OSHA, Directorate of Standards and Guidance, Office of Regulatory Analysis, based on ERG (2013).
1. Unit Costs, Other Cost Parameters,
and Methodological Assumptions by
Major Provision
Below, OSHA summarizes its
methodology for estimating unit and
total costs for the major provisions
required under the proposed silica
standard. For a full presentation of the
cost analysis, see Chapter V of the PEA
and ERG (2007a, 2007b, 2011, 2013).
OSHA invites comment on all aspects of
its preliminary cost analysis.
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
a. Engineering Controls
Engineering controls include such
measures as local exhaust ventilation,
equipment hoods and enclosures, dust
suppressants, spray booths and other
forms of wet methods, high efficient
particulate air (HEPA) vacuums, and
control rooms.
Following ERG’s (2011) methodology,
OSHA estimated silica control costs on
a per-worker basis, allowing the costs to
be related directly to the estimates of the
number of overexposed workers. OSHA
then multiplied the estimated control
cost per worker by the numbers of
overexposed workers for both the
proposed PEL of 50 mg/m3 and the
alternative PEL of 100 mg/m3,
introduced for economic analysis
purposes. The numbers of workers
needing controls (i.e., workers
overexposed) are based on the exposure
profiles for at-risk occupations
developed in the technological
feasibility analysis in Chapter IV of the
PEA and estimates of the number of
workers employed in these occupations
developed in the industry profile in
Chapter III of the PEA. This workerbased method is necessary because,
even though the Agency has data on the
number of firms in each affected
industry, on the occupations and
industrial activities with worker
exposure to silica, on exposure profiles
of at-risk occupations, and on the costs
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of controlling silica exposure for
specific industrial activities, OSHA does
not have a way to match up these data
at the firm level. Nor does OSHA have
facility-specific data on worker
exposure to silica or even facilityspecific data on the level of activity
involving worker exposure to silica.
Thus, OSHA could not directly estimate
per-affected-facility costs, but instead,
first had to estimate aggregate
compliance costs and then calculate the
average per-affected-facility costs by
dividing aggregate costs by the number
of affected facilities.
In general, OSHA viewed the extent to
which exposure controls are already in
place to be reflected in the distribution
of overexposures among the affected
workers. Thus, for example, if 50
percent of workers in a given
occupation are found to be overexposed
relative to the proposed silica PEL,
OSHA judged this equivalent to 50
percent of facilities lacking the relevant
exposure controls. The remaining 50
percent of facilities are expected either
to have installed the relevant controls or
to engage in activities that do not
require that the exposure controls be in
place. OSHA recognizes that some
facilities might have the relevant
controls in place but are still unable, for
whatever reason, to achieve the PEL
under consideration. ERG’s review of
the industrial hygiene literature and
other source materials (as noted in ERG,
2007b), however, suggest that the large
majority of overexposed workers lack
relevant controls. Thus, OSHA has
generally assumed that overexposures
occur due to the absence of suitable
controls. This assumption results in an
overestimate of costs since, in some
cases, employers may merely need to
upgrade or better maintain existing
controls or to improve work practices
rather than to install and maintain new
controls.
PO 00000
Frm 00089
Fmt 4701
Sfmt 4702
There are two situations in which the
proportionality assumption may
oversimplify the estimation of the costs
of the needed controls. First, some
facilities may have the relevant controls
in place but are still unable, for
whatever reason, to achieve the PEL
under consideration for all employees.
ERG’s review of the industrial hygiene
literature and other source materials (as
noted in ERG, 2007b, pg. 3–4), however,
suggest that the large majority of
overexposed workers lack relevant
controls. Thus, OSHA has generally
assumed that overexposures occur due
to the absence of suitable controls. This
assumption could, in some cases, result
in an overestimate of costs where
employers merely need to upgrade or
better maintain existing controls or to
improve work practices rather than to
install and maintain new controls.
Second, there may be situations where
facilities do not have the relevant
controls in place but nevertheless have
only a fraction of all affected employees
above the PEL. If, in such situations, an
employer would have to install all the
controls necessary to meet the PEL,
OSHA may have underestimated the
control costs. However, OSHA believes
that, in general, employers could come
into compliance by such methods as
checking the work practices of the
employee who is above the PEL or
installing smaller amounts of LEV at
costs that would be more or less
proportional to the costs for all
employees. Nevertheless there may be
situations in which a complete set of
controls would be necessary if even one
employee in a work area is above the
PEL. OSHA welcomes comment on the
extent to which this approach may yield
underestimates or overestimates of
costs.
At many workstations, employers
must improve ventilation to reduce
silica exposures. Ventilation
improvements will take a variety of
E:\FR\FM\12SEP2.SGM
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mstockstill on DSK4VPTVN1PROD with PROPOSALS2
56362
Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules
forms at different workstations and in
different facilities and industries. The
cost of ventilation enhancements
generally reflects the expense of
ductwork and other equipment for the
immediate workstation or individual
location and, potentially, the cost of
incremental capacity system-wide
enhancements and increased operation
costs for the heating, ventilation, and air
conditioning (HVAC) system for the
facility.
For a number of occupations, the
technological feasibility analysis
indicates that, in addition to ventilation,
the use of wet methods, improved
housekeeping practices, and enclosure
of process equipment are needed to
reduce silica exposures. The degree of
incremental housekeeping depends
upon how dusty the operations are and
the applicability of HEPA vacuums or
other equipment to the dust problem.
The incremental costs for most such
occupations arise due to the labor
required for these additional
housekeeping efforts. Because
additional labor for housekeeping will
be required on virtually every work shift
by most of the affected occupations, the
costs of housekeeping are substantial.
Employers also need to purchase HEPA
vacuums and must incur the ongoing
costs of HEPA vacuum filters. To reduce
silica exposures by enclosure of process
equipment, such as in the use of
conveyors near production workers in
mineral processing, covers can be
particularly effective where silicacontaining materials are transferred (and
notable quantities of dust become
airborne), or, as another example, where
dust is generated, such as in sawing or
grinding operations.
For construction, ERG (2007a) defined
silica dust control measures for each
representative job as specified in Table
1 of the proposed rule. Generally, these
controls involve either a dust collection
system or a water-spray approach (wet
method) to capture and suppress the
release of respirable silica dust. Wetmethod controls require a water source
(e.g., tank) and hoses. The size of the
tank varies with the nature of the job
and ranges from a small handpressurized tank to a large tank for earth
drilling operations. Depending on the
tool, dust collection methods entail
vacuum equipment, including a vacuum
unit and hoses, and either a dust shroud
or an extractor. For example, concrete
grinding operations using hand-held
tools require dust shroud adapters for
each tool and a vacuum. The capacity of
the vacuum depends on the type and
size of tool being used. Some
equipment, such as concrete floor
grinders, comes with a dust collection
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Jkt 229001
system and a port for a vacuum hose.
The estimates of control costs for those
jobs using dust collection methods
assume that an HEPA filter will be
required.
For each job, ERG estimated the
annual cost of the appropriate controls
and translated this cost to a daily
charge. The unit costs for control
equipment were based on price
information collected from
manufacturers and vendors. In some
cases, control equipment costs were
based on data on equipment rental
charges.
As noted above, included among the
engineering controls in OSHA’s cost
model are housekeeping and dustsuppression controls in general
industry. For the maritime industry and
for construction, abrasive blasting
operations are expected to require the
use of wet methods to control silica
dust.
Tables V–3, V–4, V–21, V–22, and V–
31 in Chapter V of the PEA and Tables
V–A–1 and V–A–2 in Appendix V–A
provide details on the unit costs, other
unit parameters, and methodological
assumptions applied by OSHA to
estimate engineering control costs.
OSHA’s cost estimates assume that
implementation of the recommended
silica controls prevents workers in
general industry and maritime from
being exposed over the PEL in most
cases. Specifically, based on its
technological feasibility analysis, OSHA
expects that the technical controls are
adequate to keep silica exposures at or
below the PEL for an alternative PEL of
100 mg/m3 (introduced for economic
analysis purposes).17 For the proposed
50 mg/m3 PEL, OSHA’s feasibility
analysis suggests that the controls that
employers use, either because of
technical limitations or imperfect
implementation, might not be adequate
in all cases to ensure that worker
exposures in all affected job categories
are at or below 50 mg/m3. For this
preliminary cost analysis, OSHA
estimates that ten percent of the at-risk
workers in general industry would
require respirators, at least occasionally,
after the implementation of engineering
controls to achieve compliance with the
proposed PEL of 50 mg/m3. For workers
in maritime, the only activity with silica
exposures above the proposed PEL of 50
mg/m3 is abrasive blasting, and maritime
workers engaged in abrasive blasting are
already required to use respirators
under the existing OSHA ventilation
standard (29 CFR 1910.94(a)). Therefore,
OSHA has estimated no additional costs
for maritime workers to use respirators
as a result of the proposed silica rule.
For construction, employers whose
workers receive exposures above the
PEL are assumed to adopt the
appropriate task-specific engineering
controls and, where required,
respirators prescribed in Table 1 and
under paragraph (g)(1) in the proposed
standard. Respirator costs in the
construction industry have been
adjusted to take into account OSHA’s
estimate (consistent with the findings
from the NIOSH Respiratory Survey,
2003) that 56 percent of establishments
in the construction industry are already
using respirators that would be in
compliance with the proposed silica
rule.
ERG (2013) used respirator cost
information from a 2003 OSHA
respirator study to estimate the annual
cost of $570 (in 2009 dollars) for a halfmask, non-powered, air-purifying
respirator and $638 per year (in 2009
dollars) for a full-face non-powered airpurifying respirator (ERG, 2003). These
unit costs reflect the annualized cost of
respirator use, including accessories
(e.g., filters), training, fit testing, and
cleaning.
In addition to bearing the costs
associated with the provision of
respirators, employers will incur a cost
burden to establish respirator programs.
OSHA projects that this expense will
involve an initial 8 hours for
establishments with 500 or more
employees and 4 hours for all other
firms. After the first year, OSHA
estimates that 20 percent of
establishments would revise their
respirator program every year, with the
largest establishments (500 or more
employees) expending 4 hours for
program revision, and all other
employers expending two hours for
program revision. Consistent with the
findings from the NIOSH Respiratory
Survey (2003), OSHA estimates that 56
percent of establishments in the
construction industry that would
require respirators to achieve
compliance with the proposed PEL
already have a respirator program.18
OSHA further estimates that 50 percent
of firms in general industry and all
maritime firms that would require
17 As a result, OSHA expects that establishments
in general industry do not currently use respirators
to comply with the current OSHA PEL for quartz
of approximately 100 mg/m3.
18 OSHA’s derivation of the 56 percent current
compliance rate in construction, in the context of
the proposed silica rule, is described in Chapter V
in the PEA.
b. Respiratory Protection
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respirators to achieve compliance
already have a respirator program.
c. Exposure Assessment
Most establishments wishing to
perform exposure monitoring will
require the assistance of an outside
consulting industrial hygienist (IH) to
obtain accurate results. While some
firms might already employ or train
qualified staff, ERG (2007b) judged that
the testing protocols are fairly
challenging and that few firms have
sufficiently skilled staff to eliminate the
need for outside consultants.
Table V–8 in the PEA shows the unit
costs and associated assumptions used
to estimate exposure assessment costs.
Unit costs for exposure sampling
include direct sampling costs, the costs
of productivity losses, and
recordkeeping costs, and, depending on
establishment size, range from $225 to
$412 per sample in general industry and
maritime and from $228 to $415 per
sample in construction.
For costing purposes, based on ERG
(2007b), OSHA estimated that there are
four workers per work area. OSHA
interpreted the initial exposure
assessment as requiring first-year testing
of at least one worker in each distinct
job classification and work area who is,
or may reasonably be expected to be,
exposed to airborne concentrations of
respirable crystalline silica at or above
the action level. This may result in
overestimated exposure assessment
costs in construction because OSHA
anticipates that many employers, aware
that their operations currently expose
their workers to silica levels above the
PEL, will simply choose to comply with
Table 1 and avoid the costs of
conducting exposure assessments.
For periodic monitoring, the proposed
standard provides employers an option
of assessing employee exposures either
under a fixed schedule (paragraph
(d)(3)(i)) or a performance-based
schedule (paragraph (d)(3)(ii)). Under
the fixed schedule, the proposed
standard requires semi-annual sampling
for exposures at or above the action
level and quarterly sampling for
exposures above the 50 mg/m3 PEL.
Monitoring must be continued until the
employer can demonstrate that
exposures are no longer at or above the
action level. OSHA used the fixed
schedule option under the frequency-ofmonitoring requirements to estimate, for
costing purposes, that exposure
monitoring will be conducted (a) twice
a year where initial or subsequent
exposure monitoring reveals that
employee exposures are at or above the
action level but at or below the PEL, and
(b) four times a year where initial or
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subsequent exposure monitoring reveals
that employee exposures are above the
PEL.
As required under paragraph (d)(4) of
the proposed rule, whenever there is a
change in the production, process,
control equipment, personnel, or work
practices that may result in new or
additional exposures at or above the
action level or when the employer has
any reason to suspect that a change may
result in new or additional exposures at
or above the action level, the employer
must conduct additional monitoring.
Based on ERG (2007a, 2007b), OSHA
estimated that approximately 15 percent
of workers whose initial exposure or
subsequent monitoring was at or above
the action level would undertake
additional monitoring.
A more detailed description of unit
costs, other unit parameters, and
methodological assumptions for
exposure assessments is presented in
Chapter V of the PEA.
d. Medical Surveillance
Paragraph (h) of the proposed
standard requires an initial health
screening and then triennial periodic
screenings for workers exposed above
the proposed PEL of 50 mg/m3 for 30
days or more per year. ERG (2013)
assembled information on
representative unit costs for initial and
periodic medical surveillance. Separate
costs were estimated for current
employees and for new hires as a
function of the employment size (i.e., 1–
19, 20–499, or 500+ employees) of
affected establishments. Table V–10 in
the PEA presents ERG’s unit cost data
and modeling assumptions used by
OSHA to estimate medical surveillance
costs.
In accordance with the paragraph
(h)(2) of the proposed rule, the initial
(baseline) medical examination would
consist of (1) a medical and work
history, (2) a physical examination with
special emphasis on the respiratory
system, (3) a chest X-ray that is
interpreted according to guidelines of
the International Labour Organization,
(4) a pulmonary function test that meets
certain criteria and is administered by
spirometry technician with current
certification from a NIOSH-approved
spirometry course, (5) testing for latent
tuberculosis (TB) infection, and (6) any
other tests deemed appropriate by the
physician or licensed health care
professional (PLHCP).
As shown in Table V–10 in the PEA,
the estimated unit cost of the initial
health screening for current employees
in general industry and maritime ranges
from approximately $378 to $397 and
includes direct medical costs, the
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opportunity cost of worker time (i.e.,
lost work time, evaluated at the worker’s
2009 hourly wage, including fringe
benefits) for offsite travel and for the
initial health screening itself, and
recordkeeping costs. The variation in
the unit cost of the initial health
screening is due entirely to differences
in the percentage of workers expected to
travel offsite for the health screening. In
OSHA’s experience, the larger the
establishment the more likely it is that
the selected PLHCP would provide the
health screening services at the
establishment’s worksite. OSHA
estimates that 20 percent of
establishments with fewer than 20
employees, 75 percent of establishments
with 20–499 employees, and 100
percent of establishments with 500 or
more employees would have the initial
health screening for current employees
conducted onsite.
The unit cost components of the
initial health screening for new hires in
general industry and maritime are
identical to those for existing employees
with the exception that the percentage
of workers expected to travel offsite for
the health screening would be
somewhat larger (due to fewer workers
being screened annually, in the case of
new hires, and therefore yielding fewer
economies of onsite screening). OSHA
estimates that 10 percent of
establishments with fewer than 20
employees, 50 percent of establishments
with 20–499 employees, and 90 percent
of establishments with 500 or more
employees would have the initial health
screening for new hires conducted
onsite. As shown in Chapter V in the
PEA, the estimated unit cost of the
initial health screening for new hires in
general industry and maritime ranges
from approximately $380 to $399.
The unit costs of medical surveillance
in construction were derived using
identical methods. As shown in Table
V–39 of the PEA, the estimated unit
costs of the initial health screening for
current employees in construction range
from approximately $389 to $425; the
estimated unit costs of the initial health
screening for new hires in construction
range from approximately $394 to $429.
In accordance with paragraph (h)(3) of
the proposed rule, the periodic medical
examination (every third year after the
initial health screening) would consist
of (1) a medical and work history review
and update, (2) a physical examination
with special emphasis on the respiratory
system, (3) a chest X-ray that meets
certain standards of the International
Labour Organization, (4) a pulmonary
function test that meets certain criteria
and is administered by a spirometry
technician with current certification
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from a NIOSH-approved spirometry
course, (5) testing for latent TB
infection, if recommended by the
PLHCP, and (6) any other tests deemed
appropriate by the PLHCP.
The estimated unit cost of periodic
health screening also includes direct
medical costs, the opportunity cost of
worker time, and recordkeeping costs.
As shown in Table V–10 in the PEA,
these triennial unit costs in general
industry and maritime vary from $378
to $397. For construction, as shown in
Table V–39 in the PEA, the triennial
unit costs for periodic health screening
vary from roughly $389 to $425. The
variation in the unit cost (with or
without the chest X-ray and pulmonary
function test) is due entirely to
differences in the percentage of workers
expected to travel offsite for the periodic
health screening. OSHA estimated that
the share of workers traveling offsite, as
a function of establishment size, would
be the same for the periodic health
screening as for the initial health
screening for existing employees.
ERG (2013) estimated a turnover rate
of 27.2 percent in general industry and
maritime and 64.0 percent in
construction, based on estimates of the
separations rate (layoffs, quits, and
retirements) provided by the Bureau of
Labor Statistics (BLS, 2007). However,
not all new hires would require initial
medical testing. As specified in
paragraph (h)(2) of the proposed rule,
employees who had received a
qualifying medical examination within
the previous twelve months would be
exempt from the initial medical
examination. OSHA estimates that 25
percent of new hires in general industry
and maritime and 60 percent of new
hires in construction would be exempt
from the initial medical examination.
Although OSHA believes that some
affected establishments in general
industry, maritime, and construction
currently provide some medical testing
to their silica-exposed employees, the
Agency doubts that many provide the
comprehensive health screening
required under the proposed rule.
Therefore for costing purposes for the
proposed rule, OSHA has assumed no
current compliance with the proposed
health screening requirements. OSHA
requests information from interested
parties on the current levels and the
comprehensiveness of health screening
in general industry, maritime, and
construction.
Finally, OSHA estimated the unit cost
of a medical examination by a
pulmonary specialist for those
employees found to have signs or
symptoms of silica-related disease or are
otherwise referred by the PLHCP. OSHA
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estimates that a medical examination by
a pulmonary specialist costs
approximately $307 for workers in
general industry and maritime and $333
for workers in construction. This cost
includes direct medical costs, the
opportunity cost of worker time, and
recordkeeping costs. In all cases, OSHA
anticipates that the worker will travel
offsite to receive the medical
examination by a pulmonary specialist.
See Chapter V in the PEA for a full
discussion of OSHA’s analysis of
medical surveillance costs under the
proposed standard.
e. Information and Training
As specified in paragraph (i) of the
proposed rule and 29 CFR 1910.1200,
training is required for all employees in
jobs where there is potential exposure to
respirable crystalline silica. In addition,
new hires would require training before
starting work. As previously noted, ERG
(2013) provided an estimate of the newhire rate in general industry and
maritime, based on the BLS-estimated
separations rate of 27.2 percent in
manufacturing, and an estimate of the
new-hire rate in construction, based on
the BLS-estimated separations rate in
construction of 64.0 percent.
OSHA estimated separate costs for
initial training of current employees and
for training new hires. Given that newhire training might need to be
performed frequently during the year,
OSHA estimated a smaller class size for
new hires. OSHA anticipates that
training, in accordance with the
requirements of the proposed rule, will
be conducted by in-house safety or
supervisory staff with the use of training
modules or videos and will last, on
average, one hour. ERG (2007b) judged
that establishments could purchase
sufficient training materials at an
average cost of $2 per worker,
encompassing the cost of handouts,
video presentations, and training
manuals and exercises. ERG (2013)
included in the cost estimates for
training the value of worker and trainer
time as measured by 2009 hourly wage
rates (to include fringe benefits). ERG
also developed estimates of average
class sizes as a function of
establishment size. For initial training,
ERG estimated an average class size of
5 workers for establishments with fewer
than 20 employees, 10 workers for
establishments with 20 to 499
employees, and 20 workers for
establishments with 500 or more
employees. For new hire training, ERG
estimated an average class size of 2
workers for establishments with fewer
than 20 employees, 5 workers for
establishments with 20 to 499
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employees, and 10 workers for
establishments with 500 or more
employees.
The unit costs of training are
presented in Tables V–14 (for general
industry/maritime) and V–43 (for
construction) in the PEA. Based on
ERG’s work, OSHA estimated the
annualized cost (annualized over 10
years) of initial training per current
employee at between $3.02 and $3.57
and the annual cost of new-hire training
at between $22.50 and $32.72 per
employee in general industry and
maritime, depending on establishment
size. For construction, OSHA estimated
the annualized cost of initial training
per employee at between $3.68 and
$4.37 and the annual cost of new hire
training at between $27.46 and $40.39
per employee, depending on
establishment size.
OSHA recognizes that many affected
establishments currently provide
training on the hazards of respirable
crystalline silica in the workplace.
Consistent with some estimates
developed by ERG (2007a and 2007b),
OSHA estimates that 50 percent of
affected establishments already provide
such training. However, some of the
training specified in the proposed rule
requires that workers be familiar with
the training and medical surveillance
provisions in the rule. OSHA expects
that these training requirements in the
proposed rule are not currently being
provided. Therefore, for costing
purposes for the proposed rule, OSHA
has estimated that 50 percent of affected
establishments currently provide their
workers, and would provide new hires,
with training that would comply with
approximately 50 percent of the training
requirements. In other words, OSHA
estimates that those 50 percent of
establishments currently providing
training on workplace silica hazards
would provide an additional 30 minutes
of training to comply with the proposed
rule; the remaining 50 percent of
establishments would provide 60
minutes of training to comply with the
proposed rule. OSHA also recognizes
that many new hires may have been
previously employed in the same
industry, and in some cases by the same
establishment, so that they might have
already received (partial) silica training.
However, for purposes of cost
estimation, OSHA estimates that all new
hires will receive the full silica training
from the new employer. OSHA requests
comments from interested parties on the
reasonableness of these assumptions.
f. Regulated Areas and Access Control
Paragraph (e)(1) of the proposed
standard requires that wherever an
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employee’s exposure to airborne
concentrations of respirable crystalline
silica is, or can reasonably be expected
to be, in excess of the PEL, each
employer shall establish and implement
either a regulated area in accordance
with paragraph (e)(2) or an access
control plan in accordance with
paragraph (e)(3). For costing purposes,
OSHA estimated that employers in
general industry and maritime would
typically prefer and choose option (e)(2)
and would therefore establish regulated
areas when an employee’s exposure to
airborne concentrations of silica
exceeds, or can reasonably be expected
to exceed, the PEL. OSHA believes that
general industry and maritime
employers will prefer this option as it is
expected to be the most practical
alternative in fixed worksites.
Requirements in the proposed rule for a
regulated area include demarcating the
boundaries of the regulated area (as
separate from the rest of the workplace),
limiting access to the regulated area,
providing an appropriate respirator to
each employee entering the regulated
area, and providing protective clothing
as needed in the regulated area.
Based on ERG (2007b), OSHA derived
unit cost estimates for establishing and
maintaining regulated areas to comply
with these requirements and estimated
that one area would be necessary for
every eight workers in general industry
and maritime exposed above the PEL.
Unit costs include planning time
(estimated at eight hours of supervisor
time annually); material costs for signs
and boundary markers (annualized at
$63.64 in 2009 dollars); and costs of
$500 annually for two disposable
respirators per day to be used by
authorized persons (other than those
who regularly work in the regulated
area) who might need to enter the area
in the course of their job duties. In
addition, for costing purposes, OSHA
estimates that, in response to the
protective work clothing requirements
in regulated areas, ten percent of
employees in regulated areas would
wear disposable protective clothing
daily, estimated at $5.50 per suit, for an
annual clothing cost of $1,100 per
regulated area. Tables V–16 in the PEA
shows the cost assumptions and unit
costs applied in OSHA’s cost model for
regulated areas in general industry and
maritime. Overall, OSHA estimates that
each regulated area would, on average,
cost employers $1,732 annually in
general industry and maritime.
For construction, OSHA estimated
that some employers would select the
(e)(2) option concerning regulated areas
while other employers would prefer the
(e)(3) option concerning written access
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control plans whenever an employee’s
exposure to airborne concentrations of
respirable crystalline silica exceeds, or
can reasonably be expected to exceed,
the PEL.
Based on the respirator specifications
developed by ERG (2007a) and shown in
Table V–34 in the PEA, ERG derived the
full-time-equivalent number of workers
engaged in construction tasks where
respirators are required and estimated
the costs of establishing a regulated area
for these workers.
Under the second option for written
access control plans, the employer must
include the following elements in the
plan: competent person provisions;
notification and demarcation
procedures; multi-employer workplace
procedures; provisions for limiting
access; provisions for supplying
respirators; and protective clothing
procedures. OSHA anticipates that
employers will incur costs for labor,
materials, respiratory protection, and
protective clothing to comply with the
proposed access control plan
requirements.
Table V–45 in the PEA shows the unit
costs and assumptions for developing
costs for regulated areas and for access
control plans in construction. ERG
estimated separate development and
implementation costs. ERG judged that
developing either a regulated area or an
access control plan would take
approximately 4 hours of a supervisor’s
time. The time allowed to set up a
regulated area or an access control plan
is intended to allow for the
communication of access restrictions
and locations at multi-employer
worksites. ERG estimated a cost of $116
per job based on job frequency and the
costs for hazard tape and warning signs
(which are reusable). ERG estimated a
labor cost of $27 per job for
implementing a written access control
plan (covering the time expended for
revision of the access control plan for
individual jobs and communication of
the plan). In addition, OSHA estimated
that there would be annual disposable
clothing costs of $333 per crew for
employers who implement either
regulated areas or the access control
plan option. In addition, OSHA
estimated that there would be annual
respirator costs of $60 per crew for
employers who implement either
option.
ERG aggregated costs by estimating an
average crew size of four in construction
and an average job length of ten days.
ERG judged that employers would
choose to establish regulated areas in 75
percent of the instances where either
regulated areas or an access control plan
is required, and that written access
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control plans would be established for
the remaining 25 percent.
See Chapter V in the PEA for a full
discussion of OSHA’s analysis of costs
for regulated areas and written access
control plans under the proposed
standard.
F. Economic Feasibility Analysis and
Regulatory Flexibility Determination
Chapter VI of the PEA presents
OSHA’s analysis of the economic
impacts of its proposed silica rule on
affected employers in general industry,
maritime, and construction. The
discussion below summarizes the
findings in that chapter.
As a first step, the Agency explains its
approach for achieving the two major
objectives of its economic impact
analysis: (1) To establish whether the
proposed rule is economically feasible
for all affected industries, and (2) to
determine if the Agency can certify that
the proposed rule will not have a
significant economic impact on a
substantial number of small entities.
Next, this approach is applied to
industries with affected employers in
general industry and maritime and then
to industries with affected employers in
construction. Finally, OSHA directed
Inforum—a not-for-profit corporation
(based at the University of Maryland)
specializing in the design and
application of macroeconomic models
of the United States (and other
countries)—to estimate the industry and
aggregate employment effects of the
proposed silica rule. The Agency invites
comment on any aspect of the methods
and data presented here or in Chapter VI
of the PEA.
1. Analytic Approach
a. Economic Feasibility
The Court of Appeals for the D.C.
Circuit has long held that OSHA
standards are economically feasible so
long as their costs do not threaten the
existence of, or cause massive economic
dislocations within, a particular
industry or alter the competitive
structure of that industry. American
Iron and Steel Institute. v. OSHA, 939
F.2d 975, 980 (D.C. Cir. 1991); United
Steelworkers of America, AFL–CIO–CLC
v. Marshall, 647 F.2d 1189, 1265 (D.C.
Cir. 1980); Industrial Union Department
v. Hodgson, 499 F.2d 467, 478 (D.C. Cir.
1974).
In practice, the economic burden of
an OSHA standard on an industry—and
whether the standard is economically
feasible for that industry—depends on
the magnitude of compliance costs
incurred by establishments in that
industry and the extent to which they
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are able to pass those costs on to their
customers. That, in turn, depends, to a
significant degree, on the price elasticity
of demand for the products sold by
establishments in that industry.
The price elasticity of demand refers
to the relationship between the price
charged for a product and the demand
for that product: the more elastic the
relationship, the less an establishment’s
compliance costs can be passed through
to customers in the form of a price
increase and the more it has to absorb
compliance costs in the form of reduced
profits. When demand is inelastic,
establishments can recover most of the
costs of compliance by raising the prices
they charge; under this scenario, profit
rates are largely unchanged and the
industry remains largely unaffected.
Any impacts are primarily on those
customers using the relevant product.
On the other hand, when demand is
elastic, establishments cannot recover
all compliance costs simply by passing
the cost increase through in the form of
a price increase; instead, they must
absorb some of the increase from their
profits. Commonly, this will mean
reductions both in the quantity of goods
and services produced and in total
profits, though the profit rate may
remain unchanged. In general, ‘‘[w]hen
an industry is subjected to a higher cost,
it does not simply swallow it; it raises
its price and reduces its output, and in
this way shifts a part of the cost to its
consumers and a part to its suppliers,’’
in the words of the court in American
Dental Association v. Secretary of Labor
(984 F.2d 823, 829 (7th Cir. 1993)).
The court’s summary is in accord
with microeconomic theory. In the long
run, firms can remain in business only
if their profits are adequate to provide
a return on investment that ensures that
investment in the industry will
continue. Over time, because of rising
real incomes and productivity increases,
firms in most industries are able to
ensure an adequate profit. As
technology and costs change, however,
the long-run demand for some products
naturally increases and the long-run
demand for other products naturally
decreases. In the face of additional
compliance costs (or other external
costs), firms that otherwise have a
profitable line of business may have to
increase prices to stay viable. Increases
in prices typically result in reduced
quantity demanded, but rarely eliminate
all demand for the product. Whether
this decrease in the total production of
goods and services results in smaller
output for each establishment within
the industry or the closure of some
plants within the industry, or a
combination of the two, is dependent on
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the cost and profit structure of
individual firms within the industry.
If demand is perfectly inelastic (i.e.,
the price elasticity of demand is zero),
then the impact of compliance costs that
are 1 percent of revenues for each firm
in the industry would result in a 1
percent increase in the price of the
product, with no decline in quantity
demanded. Such a situation represents
an extreme case, but might be observed
in situations in which there were few if
any substitutes for the product in
question, or if the products of the
affected sector account for only a very
small portion of the revenue or income
of its customers.
If the demand is perfectly elastic (i.e.,
the price elasticity of demand is
infinitely large), then no increase in
price is possible and before-tax profits
would be reduced by an amount equal
to the costs of compliance (net of any
cost savings—such as reduced workers’
compensation insurance premiums—
resulting from the proposed standard) if
the industry attempted to maintain
production at the same level as
previously. Under this scenario, if the
costs of compliance are such a large
percentage of profits that some or all
plants in the industry could no longer
operate in the industry with hope of an
adequate return on investment, then
some or all of the firms in the industry
would close. This scenario is highly
unlikely to occur, however, because it
can only arise when there are other
products—unaffected by the proposed
rule—that are, in the eyes of their
customers, perfect substitutes for the
products the affected establishments
make.
A common intermediate case would
be a price elasticity of demand of one
(in absolute terms). In this situation, if
the costs of compliance amount to 1
percent of revenues, then production
would decline by 1 percent and prices
would rise by 1 percent. As a result,
industry revenues would remain the
same, with somewhat lower production,
but with similar profit rates (in most
situations where the marginal costs of
production net of regulatory costs
would fall as well). Customers would,
however, receive less of the product for
their (same) expenditures, and firms
would have lower total profits; this, as
the court described in American Dental
Association v. Secretary of Labor, is the
more typical case.
A decline in output as a result of an
increase in price may occur in a variety
of ways: individual establishments
could each reduce their levels of
production; some marginal plants could
close; or, in the case of an expanding
industry, new entry may be delayed
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until demand equals supply. In many
cases it will be a combination of all
three kinds of reductions in output.
Which possibility is most likely
depends on the form that the costs of
the regulation take. If the costs are
variable costs (i.e., costs that vary with
the level of production at a facility),
then economic theory suggests that any
reductions in output will take the form
of reductions in output at each affected
facility, with few if any plant closures.
If, on the other hand, the costs of a
regulation primarily take the form of
fixed costs (i.e., costs that do not vary
with the level of production at a
facility), then reductions in output are
more likely to take the form of plant
closures or delays in new entry.
Most of the costs of this regulation, as
estimated in Chapter V of the PEA, are
variable costs. Almost all of the major
costs of program elements, such as
medical surveillance and training, will
vary in proportion to the number of
employees (which is a rough proxy for
the amount of production). Exposure
monitoring costs will vary with the
number of employees, but do have some
economies of scale to the extent that a
larger firm need only conduct
representative sampling rather than
sample every employee. The costs of
engineering controls in construction
also vary by level of production because
almost all necessary equipment can
readily be rented and the productivity
costs of using some of these controls
vary proportionally to the level of
production. Finally, the costs of
operating engineering controls in
general industry (the majority of the
annualized costs of engineering controls
in general industry) vary by the number
of hours the establishment works, and
thus vary by the level of production and
are not fixed costs in the strictest sense.
This leaves two kinds of costs that
are, in some sense, fixed costs—capital
costs of engineering controls in general
industry and certain initial costs that
new entries to the industry will not
have to bear.
Capital costs of engineering controls
in general industry due to this standard
are relatively small as compared to the
total costs, representing less than 8
percent of total annualized costs and
approximately $362 per year per
affected establishment in general
industry.
Some initial costs are fixed in the
sense that they will only be borne by
firms in the industry today—these
include initial costs for general training
not currently required and initial costs
of medical surveillance. Both of these
costs will disappear after the initial year
of the standard and thus would be
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difficult to pass on. These costs,
however, represent less than 4 percent
of total costs and less than $55 per
affected establishment.
As a result of these considerations,
OSHA expects that it is somewhat more
likely that reductions in industry output
will be met by reductions in output at
each affected facility rather than as a
result of plant closures. However,
closures of some marginal plants or
poorly performing facilities are always
possible.
To determine whether a rule is
economically feasible, OSHA begins
with two screening tests to consider
minimum threshold effects of the rule
under two extreme cases: (1) all costs
are passed through to customers in the
form of higher prices (consistent with a
price elasticity of demand of zero), and
(2) all costs are absorbed by the firm in
the form of reduced profits (consistent
with an infinite price elasticity of
demand).
In the former case, the immediate
impact of the rule would be observed in
increased industry revenues. While
there is no hard and fast rule, in the
absence of evidence to the contrary,
OSHA generally considers a standard to
be economically feasible for an industry
when the annualized costs of
compliance are less than a threshold
level of one percent of annual revenues.
Retrospective studies of previous OSHA
regulations have shown that potential
impacts of such a small magnitude are
unlikely to eliminate an industry or
significantly alter its competitive
structure,19 particularly since most
industries have at least some ability to
raise prices to reflect increased costs
and, as shown in the PEA, normal price
variations for products typically exceed
three percent a year. Of course, OSHA
recognizes that even when costs are
within this range, there could be
unusual circumstances requiring further
analysis.
In the latter case, the immediate
impact of the rule would be observed in
reduced industry profits. OSHA uses the
ratio of annualized costs to annual
profits as a second check on economic
feasibility. Again, while there is no hard
and fast rule, in the absence of evidence
to the contrary, OSHA has historically
considered a standard to be
economically feasible for an industry
when the annualized costs of
compliance are less than a threshold
level of ten percent of annual profits. In
the context of economic feasibility, the
Agency believes this threshold level to
19 See OSHA’s Web page, http://www.osha.gov/
dea/lookback.html#Completed, for a link to all
completed OSHA lookback reviews.
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be fairly modest, given that—as shown
in the PEA—normal year-to-year
variations in profit rates in an industry
can exceed 40 percent or more. OSHA’s
choice of a threshold level of ten
percent of annual profits is low enough
that even if, in a hypothetical worst
case, all compliance costs were upfront
costs, then upfront costs would still
equal seventy-one percent of profits and
thus would be affordable from profits
without resort to credit markets. If the
threshold level were first-year costs of
ten percent of annual profits, firms
could even more easily expect to cover
first-year costs at the threshold level out
of current profits without having to
access capital markets and otherwise
being threatened with short-term
insolvency.
In general, because it is usually the
case that firms would able to pass on
some or all of the costs of the proposed
rule, OSHA will tend to give much more
weight to the ratio of industry costs to
industry revenues than to the ratio of
industry costs to industry profits.
However, if costs exceed either the
threshold percentage of revenue or the
threshold percentage of profits for an
industry, or if there is other evidence of
a threat to the viability of an industry
because of the standard, OSHA will
examine the effect of the rule on that
industry more closely. Such an
examination would include market
factors specific to the industry, such as
normal variations in prices and profits,
international trade and foreign
competition, and any special
circumstances, such as close domestic
substitutes of equal cost, which might
make the industry particularly
vulnerable to a regulatory cost increase.
The preceding discussion focused on
the economic viability of the affected
industries in their entirety. However,
even if OSHA found that a proposed
standard did not threaten the survival of
affected industries, there is still the
question of whether the industries’
competitive structure would be
significantly altered. For this reason,
OSHA also examines the differential
costs by size of firm.
b. Regulatory Flexibility Screening
Analysis
The Regulatory Flexibility Act (RFA),
Pub. L. No. 96–354, 94 Stat. 1164
(codified at 5 U.S.C. 601), requires
Federal agencies to consider the
economic impact that a proposed
rulemaking will have on small entities.
The RFA states that whenever a Federal
agency is required to publish general
notice of proposed rulemaking for any
proposed rule, the agency must prepare
and make available for public comment
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56367
an initial regulatory flexibility analysis
(IRFA). 5 U.S.C. 603(a). Pursuant to
section 605(b), in lieu of an IRFA, the
head of an agency may certify that the
proposed rule will not have a significant
economic impact on a substantial
number of small entities. A certification
must be supported by a factual basis. If
the head of an agency makes a
certification, the agency shall publish
such certification in the Federal
Register at the time of publication of
general notice of proposed rulemaking
or at the time of publication of the final
rule. 5 U.S.C. 605(b).
To determine if the Assistant
Secretary of Labor for OSHA can certify
that the proposed silica rule will not
have a significant economic impact on
a substantial number of small entities,
the Agency has developed screening
tests to consider minimum threshold
effects of the proposed rule on small
entities. These screening tests are
similar in concept to those OSHA
developed above to identify minimum
threshold effects for purposes of
demonstrating economic feasibility.
There are, however, two differences.
First, for each affected industry, the
screening tests are applied, not to all
establishments, but to small entities
(defined as ‘‘small business concerns’’
by SBA) and also to very small entities
(defined by OSHA as entities with fewer
than 20 employees). Second, although
OSHA’s regulatory flexibility screening
test for revenues also uses a minimum
threshold level of annualized costs
equal to one percent of annual revenues,
OSHA has established a minimum
threshold level of annualized costs
equal to five percent of annual profits
for the average small entity or very
small entity. The Agency has chosen a
lower minimum threshold level for the
profitability screening analysis and has
applied its screening tests to both small
entities and very small entities in order
to ensure that certification will be made,
and an IRFA will not be prepared, only
if OSHA can be highly confident that a
proposed rule will not have a significant
economic impact on a substantial
number of small entities in any affected
industry.
2. Impacts in General Industry and
Maritime
a. Economic Feasibility Screening
Analysis: All Establishments
To determine whether the proposed
rule’s projected costs of compliance
would threaten the economic viability
of affected industries, OSHA first
compared, for each affected industry,
annualized compliance costs to annual
revenues and profits per (average)
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affected establishment. The results for
all affected establishments in all
affected industries in general industry
and maritime are presented in Table
VIII–11, using annualized costs per
establishment for the proposed 50 mg/m3
PEL. Shown in the table for each
affected industry are total annualized
costs, the total number of affected
establishments, annualized costs per
affected establishment, annual revenues
per establishment, the profit rate,
annual profits per establishment,
annualized compliance costs as a
percentage of annual revenues, and
annualized compliance costs as a
percentage of annual profits.
The annualized costs per affected
establishment for each affected industry
were calculated by distributing the
industry-level (incremental) annualized
compliance costs among all affected
establishments in the industry, where
costs were annualized using a 7 percent
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discount rate. The annualized cost of
the proposed rule for the average
establishment in all of general industry
and maritime is estimated at $2,571 in
2009 dollars. It is clear from Table VIII–
11 that the estimates of the annualized
costs per affected establishment in
general industry and maritime vary
widely from industry to industry. These
estimates range from $40,468 for NAICS
327111 (Vitreous china plumbing
fixtures and bathroom accessories
manufacturing) and $38,422 for NAICS
327121 (Brick and structural clay
manufacturing) to $107 for NAICS
325510 (Paint and coating
manufacturing) and $49 for NAICS
621210 (Dental offices).
Table VIII–11 also shows that, within
the general industry and maritime
sectors, there are no industries in which
the annualized costs of the proposed
rule exceed 1 percent of annual
revenues or 10 percent of annual profits.
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NAICS 327123 (Other structural clay
product manufacturing) has both the
highest cost impact as a percentage of
revenues, of 0.39 percent, and the
highest cost impact as a percentage of
profits, of 8.78 percent. Based on these
results, even if the costs of the proposed
rule were 50 percent higher than OSHA
has estimated, the highest cost impact as
a percentage of revenues in any affected
industry in general industry or maritime
would be less than 0.6 percent.
Furthermore, the costs of the proposed
rule would have to be more than 150
percent higher than OSHA has
estimated for the cost impact as a
percentage of revenues to equal 1
percent in any affected industry. For all
affected establishments in general
industry and maritime, the estimated
annualized cost of the proposed rule is,
on average, equal to 0.02 percent of
annual revenue and 0.5 percent of
annual profit.
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.....
.....
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.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
327113
327121
327122
327123
327124
327125
327211
327212
327213
327320
327331
327332
327390
327991
327992
327993
327999
331111
331112
331210
331221
331222
331314
331423
331492
331511
331512
331513
331524
331525
331528
332111
332112
332115
332116
332117
332211
332212
332213
332214
332323
332439
332510
332611
332612
332618
332710
332812
332911
327112 .....
324121
324122
325510
327111
NAICS
Asphalt paving mixture and block manufacturing ........
Asphalt shingle and roofing materials ..........................
Paint and coating manufacturing .................................
Vitreous china plumbing fixtures & bathroom accessories manufacturing.
Vitreous china, fine earthenware, & other pottery
product manufacturing.
Porcelain electrical supply mfg ....................................
Brick and structural clay mfg .......................................
Ceramic wall and floor tile mfg ....................................
Other structural clay product mfg ................................
Clay refractory manufacturing ......................................
Nonclay refractory manufacturing ................................
Flat glass manufacturing ..............................................
Other pressed and blown glass and glassware manufacturing.
Glass container manufacturing ....................................
Ready-mixed concrete manufacturing .........................
Concrete block and brick mfg ......................................
Concrete pipe mfg ........................................................
Other concrete product mfg .........................................
Cut stone and stone product manufacturing ...............
Ground or treated mineral and earth manufacturing ...
Mineral wool manufacturing .........................................
All other misc. nonmetallic mineral product mfg ..........
Iron and steel mills .......................................................
Electrometallurgical ferroalloy product manufacturing
Iron and steel pipe and tube manufacturing from purchased steel.
Rolled steel shape manufacturing ...............................
Steel wire drawing ........................................................
Secondary smelting and alloying of aluminum ............
Secondary smelting, refining, and alloying of copper ..
Secondary smelting, refining, and alloying of nonferrous metal (except cu & al).
Iron foundries ...............................................................
Steel investment foundries ...........................................
Steel foundries (except investment) ............................
Aluminum foundries (except die-casting) .....................
Copper foundries (except die-casting) .........................
Other nonferrous foundries (except die-casting) .........
Iron and steel forging ...................................................
Nonferrous forging .......................................................
Crown and closure manufacturing ...............................
Metal stamping .............................................................
Powder metallurgy part manufacturing ........................
Cutlery and flatware (except precious) manufacturing
Hand and edge tool manufacturing .............................
Saw blade and handsaw manufacturing ......................
Kitchen utensil, pot, and pan manufacturing ...............
Ornamental and architectural metal work ....................
Other metal container manufacturing ..........................
Hardware manufacturing ..............................................
Spring (heavy gauge) manufacturing ...........................
Spring (light gauge) manufacturing ..............................
Other fabricated wire product manufacturing ..............
Machine shops .............................................................
Metal coating and allied services .................................
Industrial valve manufacturing .....................................
Industry
Jkt 229001
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15,310,815
4,283,138
4,596,837
6,975,150
1,636,463
1,232,708
105,955
34,982
12,720
255,832
32,828
22,970
145,223
28,851
15,678
35,267
60,330
180,292
16,158
60,992
144,819
1,077,759
3,038,935
150,261
42,672
57,557
28,757
4,940
36,946
756,888
16,511,080
4,437,939
2,747,484
12,900,251
8,600,298
4,595,006
1,094,552
1,966,052
424,557
8,577
84,537
1,748,297
7,838,050
4,132,107
936,699
482,438
608,017
275,155
1,084,706
2,601,471
$242,070
3,157,257
144,281
1,659,194
Total
annualized
costs
527
132
222
466
256
124
150
50
18
366
47
33
207
41
22
54
86
256
23
87
205
1,506
2,599
216
61
83
42
7
53
72
6,064
951
385
2,281
1,943
271
321
465
614
12
122
125
204
193
49
129
105
83
499
731
1,431
224
1,344
41
Number of affected establishments
29,053
32,448
20,706
14,968
6,392
9,941
705
705
697
700
696
705
702
698
705
654
705
705
705
705
705
716
1,169
694
694
694
692
695
695
10,512
2,723
4,667
7,136
5,656
4,426
16,956
3,410
4,228
692
692
694
13,986
38,422
21,410
19,116
3,740
5,791
3,315
2,174
3,559
$169
14,095
107
40,468
Annualized
costs per affected establishment
19,672,534
18,445,040
17,431,292
8,244,396
3,103,580
7,040,818
15,231,376
28,714,500
16,308,872
6,748,606
9,712,731
9,036,720
5,874,133
11,339,439
18,620,983
2,777,899
7,467,745
11,899,309
7,764,934
8,185,896
5,120,358
1,624,814
4,503,334
18,399,215
28,102,003
12,904,028
29,333,260
26,238,546
14,759,299
64,453,615
4,891,554
5,731,328
7,899,352
4,816,851
1,918,745
8,652,610
18,988,835
5,803,139
70,641,523
49,659,392
31,069,797
8,091,258
11,440,887
6,706,175
4,933,258
7,872,516
14,718,533
43,821,692
7,233,509
1,203,017
$6,617,887
34,018,437
19,071,850
21,226,709
Revenues per
establishment
4.11
4.11
4.11
4.11
4.11
4.11
4.71
4.71
4.71
4.71
4.71
5.22
5.22
5.22
5.22
4.70
3.58
5.22
5.22
5.22
5.22
5.80
4.85
6.81
4.49
4.49
4.46
4.42
4.42
3.42
6.64
6.64
6.64
6.64
5.49
5.49
5.49
5.49
4.49
4.49
4.49
4.41
4.41
4.41
4.41
4.41
4.41
3.42
3.42
4.41
7.50
7.50
5.38
4.41
Profit rate a
(percent)
809,290
758,794
717,090
339,159
127,675
289,646
716,646
1,351,035
767,343
317,526
456,990
472,045
306,843
592,331
972,693
130,669
267,613
621,577
405,612
427,602
267,469
94,209
218,618
1,252,418
1,262,339
579,647
1,309,709
1,158,438
651,626
2,204,903
324,706
380,451
524,366
319,747
105,320
474,944
1,042,303
318,536
3,173,209
2,230,694
1,395,652
357,222
505,105
296,072
217,799
347,565
649,810
1,499,102
247,452
53,112
$496,420
2,551,788
1,026,902
937,141
Profits per establishment
0.15
0.18
0.12
0.18
0.21
0.14
0.00
0.00
0.00
0.01
0.01
0.01
0.01
0.01
0.00
0.02
0.01
0.01
0.01
0.01
0.01
0.04
0.03
0.00
0.00
0.01
0.00
0.00
0.00
0.02
0.06
0.08
0.09
0.12
0.23
0.20
0.02
0.07
0.00
0.00
0.00
0.17
0.34
0.32
0.39
0.05
0.04
0.01
0.03
0.30
0.00
0.04
0.00
0.19
Costs as a percentage of revenues
3.59
4.28
2.89
4.41
5.01
3.43
0.10
0.05
0.09
0.22
0.15
0.15
0.23
0.12
0.07
0.50
0.26
0.11
0.17
0.16
0.26
0.76
0.53
0.06
0.05
0.12
0.05
0.06
0.11
0.48
0.84
1.23
1.36
1.77
4.20
3.57
0.33
1.33
0.02
0.03
0.05
3.92
7.61
7.23
8.78
1.08
0.89
0.22
0.88
6.70
0.03
0.55
0.01
4.32
Costs as a percentage of profits
TABLE VIII–11—SCREENING ANALYSIS FOR ESTABLISHMENTS IN GENERAL INDUSTRY AND MARITIME AFFECTED BY OSHA’S PROPOSED SILICA STANDARD
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334518
335211
335221
335222
335224
335228
336111
336112
336120
336211
336212
336213
336311
336312 .....
.....
.....
.....
.....
333911
333912
333991
333992
333993
333994
333995
333996
333997
333999
333613 .....
333516 .....
333518 .....
333612 .....
333515 .....
333511
333512
333513
333514
333414 .....
333411 .....
333412 .....
333319 .....
332999 .....
332912
332913
332919
332991
332996
332997
332998
NAICS
Fluid power valve and hose fitting manufacturing .......
Plumbing fixture fitting and trim manufacturing ...........
Other metal valve and pipe fitting manufacturing ........
Ball and roller bearing manufacturing ..........................
Fabricated pipe and pipe fitting manufacturing ...........
Industrial pattern manufacturing ..................................
Enameled iron and metal sanitary ware manufacturing.
All other miscellaneous fabricated metal product manufacturing.
Other commercial and service industry machinery
manufacturing.
Air purification equipment manufacturing ....................
Industrial and commercial fan and blower manufacturing.
Heating equipment (except warm air furnaces) manufacturing.
Industrial mold manufacturing ......................................
Machine tool (metal cutting types) manufacturing .......
Machine tool (metal forming types) manufacturing .....
Special die and tool, die set, jig, and fixture manufacturing.
Cutting tool and machine tool accessory manufacturing.
Rolling mill machinery and equipment manufacturing
Other metalworking machinery manufacturing ............
Speed changer, industrial high-speed drive, and gear
manufacturing.
Mechanical power transmission equipment manufacturing.
Pump and pumping equipment manufacturing ............
Air and gas compressor manufacturing .......................
Power-driven handtool manufacturing .........................
Welding and soldering equipment manufacturing .......
Packaging machinery manufacturing ...........................
Industrial process furnace and oven manufacturing ....
Fluid power cylinder and actuator manufacturing ........
Fluid power pump and motor manufacturing ...............
Scale and balance (except laboratory) manufacturing
All other miscellaneous general purpose machinery
manufacturing.
Watch, clock, and part manufacturing .........................
Electric housewares and household fans ....................
Household cooking appliance manufacturing ..............
Household refrigerator and home freezer manufacturing.
Household laundry equipment manufacturing .............
Other major household appliance manufacturing ........
Automobile manufacturing ...........................................
Light truck and utility vehicle manufacturing ................
Heavy duty truck manufacturing ..................................
Motor vehicle body manufacturing ...............................
Truck trailer manufacturing ..........................................
Motor home manufacturing ..........................................
Carburetor, piston, piston ring, and valve manufacturing.
Gasoline engine and engine parts manufacturing .......
Industry
258,625
30,521
24,023
293,357
404,778
125,181
187,131
126,512
84,073
41,219
8,740
13,928
30,077
32,118
121,086
84,518
34,459
62,401
83,714
42,523
78,057
53,535
14,822
207,006
61,197
12,279
50,002
48,452
139,916
160,131
68,151
33,940
231,988
80,754
58,265
41,212
209,273
288,093
140,213
45,472
71,354
107,338
107,219
20,891
60,684
Total
annualized
costs
373
23
37
181
94
95
269
182
91
60
12
22
47
26
174
121
49
90
120
61
112
77
21
296
88
17
70
70
197
226
97
48
325
116
84
59
299
408
201
65
102
154
154
30
76
Number of affected establishments
693
1,327
643
1,621
4,306
1,318
696
694
924
693
703
643
643
1,235
696
698
698
696
700
702
695
695
702
698
693
710
710
693
710
710
702
702
714
694
694
694
699
707
698
698
698
698
698
698
798
Annualized
costs per affected establishment
36,938,061
221,491,837
107,476,620
512,748,675
1,581,224,101
194,549,998
15,012,805
17,032,455
65,421,325
21,325,990
4,924,986
22,023,076
37,936,003
188,132,355
17,078,357
21,079,073
22,078,371
16,457,683
7,374,940
5,584,460
13,301,790
18,030,122
7,236,854
6,033,776
14,983,120
9,496,141
7,231,602
10,727,834
3,384,805
2,481,931
7,371,252
5,217,940
2,378,801
11,143,189
7,353,577
12,795,249
10,042,625
4,405,921
22,442,750
24,186,039
15,023,143
36,607,380
6,779,536
1,122,819
14,497,312
Revenues per
establishment
2.04
4.21
4.21
2.04
2.04
2.04
2.04
2.04
2.04
2.04
5.94
4.21
4.21
4.21
4.58
4.58
4.58
4.58
4.58
4.58
4.58
4.58
4.58
4.58
2.63
5.29
5.29
2.63
5.29
5.29
5.29
5.29
5.29
4.55
4.55
4.55
4.86
6.81
6.81
6.81
6.81
6.81
6.81
6.81
6.81
Profit rate a
(percent)
753,709
9,331,875
4,528,196
10,462,470
32,264,364
3,969,729
306,331
347,542
1,334,901
435,150
292,667
927,874
1,598,316
7,926,376
781,566
964,653
1,010,384
753,162
337,503
255,565
608,737
825,122
331,184
276,127
393,597
502,283
382,504
281,813
179,034
131,278
389,890
275,994
125,823
507,342
334,804
582,559
487,919
299,907
1,527,658
1,646,322
1,022,612
2,491,832
461,477
76,429
986,819
Profits per establishment
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.01
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.01
0.01
0.01
0.00
0.01
0.01
0.00
0.01
0.01
0.01
0.02
0.03
0.01
0.01
0.03
0.01
0.01
0.01
0.01
0.02
0.00
0.00
0.00
0.00
0.01
0.06
0.01
Costs as a percentage of revenues
0.09
0.01
0.01
0.02
0.01
0.03
0.23
0.20
0.07
0.16
0.24
0.07
0.04
0.02
0.09
0.07
0.07
0.09
0.21
0.27
0.11
0.08
0.21
0.25
0.18
0.14
0.19
0.25
0.40
0.54
0.18
0.25
0.57
0.14
0.21
0.12
0.14
0.24
0.05
0.04
0.07
0.03
0.15
0.91
0.08
Costs as a percentage of profits
TABLE VIII–11—SCREENING ANALYSIS FOR ESTABLISHMENTS IN GENERAL INDUSTRY AND MARITIME AFFECTED BY OSHA’S PROPOSED SILICA STANDARD—
Continued
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242,586
146,726,595
Total .............................................................................
233,720
431,985
583,803
8,749,619
5,479,624
27,227
132,114
327,377
153,960
351,955
1,439,004
1,560,353
320,878
236,821
294,919
177,299
2,452,073
389,256
Other motor vehicle electrical and electronic equipment manufacturing.
Motor vehicle steering and suspension components
(except spring) manufacturing.
Motor vehicle brake system manufacturing .................
Motor vehicle transmission and power train parts
manufacturing.
Motor vehicle metal stamping ......................................
All other motor vehicle parts manufacturing ................
Ship building and repair ...............................................
Boat building ................................................................
Military armored vehicle, tank, and tank component
manufacturing.
Showcase, partition, shelving, and locker manufacturing.
Dental equipment and supplies manufacturing ...........
Dental laboratories .......................................................
Jewelry (except costume) manufacturing ....................
Jewelers’ materials and lapidary work manufacturing
Costume jewelry and novelty manufacturing ...............
Sign manufacturing ......................................................
Industrial supplies, wholesalers ...................................
Rail transportation ........................................................
Dental offices ...............................................................
56,121
411
7,261
1,777
264
590
496
383
N/A
7,980
334
624
843
635
1,129
39
191
473
223
350
2,571
856
198
878
1,215
401
594
463
N/A
49
701
692
693
13,779
4,854
697
693
692
692
693
..........................
4,732,949
563,964
3,685,009
3,762,284
1,353,403
1,872,356
1,913,371
N/A
755,073
4,943,560
33,294,026
31,304,202
24,524,381
9,474,540
44,887,321
51,498,927
63,004,961
42,374,501
33,890,776
..........................
10.77
10.77
5.80
5.80
5.80
5.80
3.44
N/A
7.34
4.54
2.04
2.04
5.86
5.86
6.31
2.04
2.04
2.04
2.04
..........................
509,695
60,734
213,566
218,045
78,437
108,513
65,736
N/A
55,429
224,593
679,354
638,752
1,437,564
555,376
2,832,073
1,050,819
1,285,596
864,638
691,530
..........................
0.02
0.04
0.02
0.03
0.03
0.03
0.02
N/A
0.01
0.01
0.00
0.00
0.06
0.05
0.00
0.00
0.00
0.00
0.00
..........................
0.17
0.33
0.41
0.56
0.51
0.55
0.70
N/A
0.09
0.31
0.10
0.11
0.96
0.87
0.02
0.07
0.05
0.08
0.10
rates were calculated by ERG (2013) as the average of profit rates for 2000 through 2006, based on balance sheet data reported in the Internal Revenue Service’s Corporation Source Book (IRS, 2007).
Source: U.S. Dept. of Labor, OSHA, Office of Regulatory Analysis, based on ERG (2013).
[a] Profit
339114
339116
339911
339913
339914
339950
423840
482110
621210
337215 .....
336370
336399
336611
336612
336992
336340 .....
336350 .....
336330 .....
336322 .....
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b. Normal Year-to-Year Variations in
Prices and Profit Rates
The United States has a dynamic and
constantly changing economy in which
an annual percentage increase in
industry revenues or prices of one
percent or more are common. Examples
of year-to-year changes in an industry
that could cause such an increase in
revenues or prices include increases in
fuel, material, real estate, or other costs;
tax increases; and shifts in demand.
To demonstrate the normal year-toyear variation in prices for all the
manufacturers in general industry and
maritime affected by the proposed rule,
OSHA developed in the PEA year-toyear producer price indices and year-toyear percentage changes in producer
prices, by industry, for the years 1998–
2009. For the combined affected
manufacturing industries in general
industry and maritime over the 12-year
period, the average change in producer
prices was 3.8 percent a year. For the
three industries in general industry and
maritime with the largest estimated
potential annual cost impact as a
percentage of revenue (of approximately
0.35 percent, on average), the average
annual changes in producer prices in
these industries over the 12-year period
averaged 3.5 percent.
Based on these data, it is clear that the
potential price impacts of the proposed
rule in general industry and maritime
are all well within normal year-to-year
variations in prices in those industries.
Thus, OSHA preliminarily concludes
that the potential price impacts of the
proposed would not threaten the
economic viability of any industries in
general industry and maritime.
Changes in profit rates are also subject
to the dynamics of the U.S. economy. A
recession, a downturn in a particular
industry, foreign competition, or the
increased competitiveness of producers
of close domestic substitutes are all
easily capable of causing a decline in
profit rates in an industry of well in
excess of ten percent in one year or for
several years in succession.
To demonstrate the normal year-toyear variation in profit rates for all the
manufacturers in general industry and
maritime affected by the proposed rule,
OSHA presented data in the PEA on
year-to-year profit rates and year-to-year
percentage changes in profit rates, by
industry, for the years 2000–2006. For
the combined affected manufacturing
industries in general industry and
maritime over the 7-year period, the
average change in profit rates was 38.9
percent a year. For the 7 industries in
general industry and maritime with the
largest estimated potential annual cost
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impacts as a percentage of profit—
ranging from 4 percent to 9 percent—the
average annual changes in profit rates in
these industries over the 7-year period
averaged 35 percent.
Nevertheless, a longer-term reduction
in profit rates in excess of 10 percent a
year could be problematic for some
affected industries and might
conceivably, under sufficiently adverse
circumstances, threaten an industry’s
economic viability. In OSHA’s view,
however, affected industries would
generally be able to pass on most or all
of the costs of the proposed rule in the
form of higher prices rather than to bear
the costs of the proposed rule in
reduced profits. After all, it defies
common sense to suggest that the
demanded quantities of brick and
structural clay, vitreous china, ceramic
wall and floor tile, other structural clay
products (such as clay sewer pipe), and
the various other products
manufactured by affected industries
would significantly contract in response
to a 0.4 percent (or lower) price increase
for these products. It is of course
possible that such price changes will
result in some reduction in output, and
the reduction in output might be met
through the closure of a small
percentage of the plants in the industry.
However, the only realistic
circumstance such that an entire
industry would be significantly affected
by small potential price increases would
be the availability in the market of a
very close or perfect substitute product
not subject to OSHA regulation. The
classic example, in theory, would be
foreign competition. Below, OSHA
examines the threat of foreign
competition for affected U.S.
establishments in general industry and
maritime.
c. International Trade Effects
The magnitude and strength of foreign
competition is a critical factor in
determining the ability of firms in the
U.S. to pass on (part or all of) the costs
of the proposed rule. If firms are unable
to do so, they would likely absorb the
costs of the proposed rule out of profits,
possibly resulting in the business failure
of individual firms or even, if the cost
impacts are sufficiently large and
pervasive, causing significant
dislocations within an affected industry.
In the PEA, OSHA examined how
likely such an outcome is. The analysis
there included a review of trade theory
and empirical evidence and the
estimation of impacts. Throughout, the
Agency drew on ERG (2007c), which
was prepared specifically to help
analyze the international trade impacts
of OSHA’s proposed silica rule. A
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summary of the PEA results is presented
below.
ERG (2007c) focused its analysis on
eight of the industries likely to be most
affected by the proposed silica rule and
for which import and export data were
available. ERG combined econometric
estimates of the elasticity of substitution
between foreign and domestic products,
Annual Survey of Manufactures data,
and assumptions concerning the values
for key parameters to estimate the effect
of a range of hypothetical price
increases on total domestic production.
In particular, ERG estimated the
domestic production that would be
replaced by imported products and the
decrease in exported products that
would result from a 1 percent increase
in prices—under the assumption that
firms would attempt to pass on all of a
1 percent increase in costs arising from
the proposed rule. The sum of the
increase in imports and decrease in
exports represents the total loss to
industry attributable to the rule. These
projected losses are presented as a
percentage of baseline domestic
production to provide some context for
evaluating the relative size of these
impacts.
The effect of a 1 percent increase in
the price of a domestic product is
derived from the baseline level of U.S.
domestic production and the baseline
level of imports. The baseline ratio of
import values to domestic production
for the eight affected industries ranges
from 0.04 for iron foundries to 0.547 for
ceramic wall and floor tile
manufacturing—that is, baseline import
values range from 4 percent to more
than 50 percent of domestic production
in these eight industries. ERG’s
estimates of the percentage reduction in
U.S. production for the eight affected
industries due to increased domestic
imports (arising from a 1 percent
increase in the price of domestic
products) range from 0.013 percent for
iron foundries to 0.237 percent for cut
stone and stone product manufacturing.
ERG also estimated baseline ratio of
U.S. exports to consumption in the rest
of the world for the sample of eight
affected industries. The ratios range
from 0.001 for other concrete
manufacturing to 0.035 percent for
nonclay refractory manufacturing. The
estimated percentage reductions in U.S.
production due to reduced U.S. exports
(arising from a 1 percent increase in the
price of domestic products) range from
0.014 percent for ceramic wall and floor
tile manufacturing to 0.201 percent for
nonclay refractory manufacturing.
The total percentage change in U.S.
production for the eight affected
industries is the sum of the loss of
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increased imports and the loss of
exports. The total percentage reduction
in U.S. production arising from a 1
percent increase in the price of domestic
products range from a low of 0.085
percent for other concrete product
manufacturing to a high of 0.299 percent
for porcelain electrical supply
manufacturing.
These estimates suggest that the
proposed rule would have only modest
international trade effects. It was
previously hypothesized that if price
increases resulted in a substantial loss
of revenue to foreign competition, then
the increased costs of the proposed rule
would have to come out of profits. That
possibility has been contradicted by the
results reported in this section. The
maximum loss to foreign competition in
any affected industry due to a 1 percent
price increase was estimated at
approximately 0.3 percent of industry
revenue. Because, as reported earlier in
this section, the maximum cost impact
of the proposed rule for any affected
industry would be 0.39 percent of
revenue, this means that the maximum
loss to foreign competition in any
affected industry as a result of the
proposed rule would be 0.12 percent of
industry revenue—which, even for the
most affected industry, would hardly
qualify as a substantial loss to foreign
competition. This analysis cannot tell us
whether the resulting change in
revenues will lead to a small decline in
the number of establishments in the
industry or slightly less revenue for
each establishment. However it can
reasonably be concluded that revenue
changes of this magnitude will not lead
to the elimination of industries or
significantly alter their competitive
structure.
Based on the Agency’s preceding
analysis of economic impacts on
revenues, profits, and international
trade, OSHA preliminarily concludes
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that the annualized costs of the
proposed rule are below the threshold
level that could threaten the economic
viability of any industry in general
industry or maritime. OSHA further
notes that while there would be
additional costs (not attributable to the
proposed rule) for some employers in
general industry and maritime to come
into compliance with the current silica
standard, these costs would not affect
the Agency’s preliminary determination
of the economic feasibility of the
proposed rule.
d. Economic Feasibility Screening
Analysis: Small and Very Small
Businesses
The preceding discussion focused on
the economic viability of the affected
industries in their entirety and found
that the proposed standard did not
threaten the survival of these industries.
Now OSHA wishes to demonstrate that
the competitive structure of these
industries would not be significantly
altered.
To address this issue, OSHA
examined the annualized costs per
affected small entity and per very small
entity for each affected industry in
general industry and maritime. Again,
OSHA used a minimum threshold level
of annualized costs equal to one percent
of annual revenues—and, secondarily,
annualized costs equal to ten percent of
annual profits—below which the
Agency has concluded that the costs are
unlikely to threaten the survival of
small entities or very small entities or,
consequently, to alter the competitive
structure of the affected industries.
As shown in Table VIII–12 and Table
VIII–13, the annualized cost of the
proposed rule is estimated to be $2,103
for the average small entity in general
industry and maritime and $616 for the
average very small entity in general
industry and maritime. These tables also
show that there are no industries in
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general industry and maritime in which
the annualized costs of the proposed
rule for small entities or very small
entities exceed one percent of annual
revenues. NAICS 327111 (Vitreous
china plumbing fixtures & bathroom
accessories manufacturing) has the
highest potential cost impact as a
percentage of revenues, of 0.61 percent,
for small entities, and NAICS 327112
(Vitreous china, fine earthenware, &
other pottery product manufacturing)
has the highest potential cost impact as
a percentage of revenues, of 0.75
percent, for very small entities. Small
entities in two industries in general
industry and maritime—NAICS 327111
and NAICS 327123 (Other structural
clay product mfg.)—have annualized
costs in excess of 10 percent of annual
profits (13.91 percent and 10.63 percent,
respectively). NAICS 327112 is the only
industry in general industry and
maritime in which the annualized costs
of the proposed rule for very small
entities exceed ten percent of annual
profits (16.92 percent).
In general, cost impacts for affected
small entities or very small entities will
tend to be somewhat higher, on average,
than the cost impacts for the average
business in those affected industries.
That is to be expected. After all, smaller
businesses typically suffer from
diseconomies of scale in many aspects
of their business, leading to less revenue
per dollar of cost and higher unit costs.
Small businesses are able to overcome
these obstacles by providing specialized
products and services, offering local
service and better service, or otherwise
creating a market niche for themselves.
The higher cost impacts for smaller
businesses estimated for this rule
generally fall within the range observed
in other OSHA regulations and, as
verified by OSHA’s lookback reviews,
have not been of such a magnitude to
lead to their economic failure.
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.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
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.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
327113
327121
327122
327123
327124
327125
327211
327212
327213
327320
327331
327332
327390
327991
327992
327993
327999
331111
331112
331210
331221
331222
331314
331423
331492
331511
331512
331513
331524
331525
331528
332111
332112
332115
332116
332117
332211
332212
332213
332214
332323
332439
332510
332611
332612
332618
332710
332812
332911
332912
327112 .....
324121
324122
325510
327111
NAICS
Asphalt paving mixture and block manufacturing ........
Asphalt shingle and roofing materials ..........................
Paint and coating manufacturing .................................
Vitreous china plumbing fixtures & bathroom accessories manufacturing.
Vitreous china, fine earthenware, & other pottery
product manufacturing.
Porcelain electrical supply mfg ....................................
Brick and structural clay mfg ........................................
Ceramic wall and floor tile mfg ....................................
Other structural clay product mfg .................................
Clay refractory manufacturing ......................................
Nonclay refractory manufacturing ................................
Flat glass manufacturing ..............................................
Other pressed and blown glass and glassware manufacturing.
Glass container manufacturing ....................................
Ready-mixed concrete manufacturing .........................
Concrete block and brick mfg ......................................
Concrete pipe mfg ........................................................
Other concrete product mfg .........................................
Cut stone and stone product manufacturing ................
Ground or treated mineral and earth manufacturing ...
Mineral wool manufacturing .........................................
All other misc. nonmetallic mineral product mfg ..........
Iron and steel mills .......................................................
Electrometallurgical ferroalloy product manufacturing
Iron and steel pipe and tube manufacturing from purchased steel.
Rolled steel shape manufacturing ................................
Steel wire drawing ........................................................
Secondary smelting and alloying of aluminum ............
Secondary smelting, refining, and alloying of copper ..
Secondary smelting, refining, and alloying of nonferrous metal (except cu & al).
Iron foundries ...............................................................
Steel investment foundries ...........................................
Steel foundries (except investment) .............................
Aluminum foundries (except die-casting) .....................
Copper foundries (except die-casting) .........................
Other nonferrous foundries (except die-casting) .........
Iron and steel forging ...................................................
Nonferrous forging ........................................................
Crown and closure manufacturing ...............................
Metal stamping .............................................................
Powder metallurgy part manufacturing ........................
Cutlery and flatware (except precious) manufacturing
Hand and edge tool manufacturing ..............................
Saw blade and handsaw manufacturing ......................
Kitchen utensil, pot, and pan manufacturing ...............
Ornamental and architectural metal work ....................
Other metal container manufacturing ...........................
Hardware manufacturing ..............................................
Spring (heavy gauge) manufacturing ...........................
Spring (light gauge) manufacturing ..............................
Other fabricated wire product manufacturing ...............
Machine shops .............................................................
Metal coating and allied services .................................
Industrial valve manufacturing .....................................
Fluid power valve and hose fitting manufacturing .......
Industry
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5,312,382
1,705,373
2,521,998
4,316,135
1,596,288
620,344
47,376
13,056
5,080
212,110
17,537
10,419
87,599
9,221
10,475
28,608
43,857
78,538
14,071
36,826
113,603
1,032,483
2,492,357
53,520
41,712
42,672
57,557
15,277
4,206
18,357
57,797
10,490,561
2,862,910
1,441,766
8,826,516
8,028,431
2,108,649
291,145
1,130,230
424,557
4,987
84,537
1,004,480
3,062,272
2,189,278
510,811
212,965
211,512
275,155
243,132
1,854,472
$140,305
872,614
71,718
231,845
Total
annualized
costs
408
101
192
412
246
112
63
17
7
279
23
14
113
12
13
42
56
104
19
44
148
1,399
2,301
71
55
54
67
20
6
25
24
2,401
567
181
1,876
1,874
132
175
326
523
7
94
97
93
173
42
96
68
56
228
717
431
106
1,042
25
Number of
affected small
entities
13,021
16,885
13,135
10,476
6,489
5,539
756
760
732
759
762
738
772
752
798
673
784
756
754
834
765
738
1,083
752
757
787
862
777
722
741
2,408
4,369
5,049
7,966
4,705
4,284
15,975
1,664
3,467
812
692
896
10,355
32,928
12,655
12,162
2,218
3,110
4,913
1,068
2,586
$326
8,232
69
9,274
Annualized cost
per affected
entity
5,865,357
8,489,826
11,977,647
4,039,244
2,847,376
2,640,180
8,310,925
21,892,338
6,697,995
5,360,428
6,328,522
2,852,835
3,399,782
5,385,465
10,355,293
2,069,492
5,260,693
4,442,699
6,621,896
4,500,760
3,440,489
1,464,380
2,904,851
5,841,019
6,486,405
31,848,937
16,018,794
18,496,524
20,561,614
9,513,728
10,181,980
7,245,974
6,318,185
7,852,099
3,521,965
1,730,741
6,288,188
6,181,590
4,299,551
82,895,665
24,121,503
40,090,061
4,574,464
9,265,846
3,236,635
2,592,114
6,026,297
7,346,739
64,950,007
935,353
693,637
$10,428,583
14,067,491
6,392,803
1,509,677
Revenues per
entity
4.11
4.11
4.11
4.11
4.11
4.11
4.71
4.71
4.71
4.71
4.71
5.22
5.22
5.22
5.22
4.70
3.58
5.22
5.22
5.22
5.22
5.80
4.85
6.81
6.81
4.49
4.49
4.46
4.42
4.42
3.42
6.64
6.64
6.64
6.64
5.49
5.49
5.49
5.49
4.49
4.49
4.49
4.41
4.41
4.41
4.41
4.41
4.41
3.42
3.42
4.41
7.50
7.50
5.38
4.41
Profit rate [a]
(percent)
241,290
349,255
492,738
166,167
117,136
108,612
391,034
1,030,048
315,145
252,211
297,761
149,022
177,592
281,317
540,923
97,346
188,521
232,070
345,904
235,103
179,719
84,907
141,018
397,593
441,524
1,430,651
719,562
825,857
907,800
420,033
348,317
480,994
419,407
521,229
233,791
95,001
345,160
339,309
236,004
3,723,664
1,083,535
1,800,841
201,959
409,079
142,895
114,440
266,056
324,352
2,221,884
31,998
30,623
$782,268
1,055,229
344,213
66,651
Profits per
entity
0.22
0.20
0.11
0.26
0.23
0.21
0.01
0.00
0.01
0.01
0.01
0.03
0.02
0.01
0.01
0.03
0.01
0.02
0.01
0.02
0.02
0.05
0.04
0.01
0.01
0.00
0.01
0.00
0.00
0.01
0.02
0.06
0.08
0.10
0.13
0.25
0.25
0.03
0.08
0.00
0.00
0.00
0.23
0.36
0.39
0.47
0.04
0.04
0.01
0.11
0.37
0.00
0.06
0.00
0.61
Costs as a
percentage
of revenues
5.40
4.83
2.67
6.30
5.54
5.10
0.19
0.07
0.23
0.30
0.26
0.50
0.43
0.27
0.15
0.69
0.42
0.33
0.22
0.35
0.43
0.87
0.77
0.19
0.17
0.05
0.12
0.09
0.08
0.18
0.69
0.91
1.20
1.53
2.01
4.51
4.63
0.49
1.47
0.02
0.06
0.05
5.13
8.05
8.86
10.63
0.83
0.96
0.22
3.34
8.45
0.04
0.78
0.02
13.91
Costs as a
percentage
of profits
TABLE VIII–12—SCREENING ANALYSIS FOR SMALL ENTITIES IN GENERAL INDUSTRY AND MARITIME AFFECTED BY OSHA’S PROPOSED SILICA STANDARD
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336120
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333992
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333999
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333513
333514
333414 .....
333411 .....
333412 .....
333319 .....
332999 .....
332913
332919
332991
332996
332997
332998
Plumbing fixture fitting and trim manufacturing ...........
Other metal valve and pipe fitting manufacturing ........
Ball and roller bearing manufacturing ..........................
Fabricated pipe and pipe fitting manufacturing ............
Industrial pattern manufacturing ...................................
Enameled iron and metal sanitary ware manufacturing.
All other miscellaneous fabricated metal product manufacturing.
Other commercial and service industry machinery
manufacturing.
Air purification equipment manufacturing .....................
Industrial and commercial fan and blower manufacturing.
Heating equipment (except warm air furnaces) manufacturing.
Industrial mold manufacturing ......................................
Machine tool (metal cutting types) manufacturing .......
Machine tool (metal forming types) manufacturing ......
Special die and tool, die set, jig, and fixture manufacturing.
Cutting tool and machine tool accessory manufacturing.
Rolling mill machinery and equipment manufacturing
Other metalworking machinery manufacturing ............
Speed changer, industrial high-speed drive, and gear
manufacturing.
Mechanical power transmission equipment manufacturing.
Pump and pumping equipment manufacturing ............
Air and gas compressor manufacturing .......................
Power-driven handtool manufacturing .........................
Welding and soldering equipment manufacturing ........
Packaging machinery manufacturing ...........................
Industrial process furnace and oven manufacturing ....
Fluid power cylinder and actuator manufacturing ........
Fluid power pump and motor manufacturing ...............
Scale and balance (except laboratory) manufacturing
All other miscellaneous general purpose machinery
manufacturing.
Watch, clock, and part manufacturing .........................
Electric housewares and household fans ....................
Household cooking appliance manufacturing ..............
Household refrigerator and home freezer manufacturing.
Household laundry equipment manufacturing .............
Other major household appliance manufacturing ........
Automobile manufacturing ............................................
Light truck and utility vehicle manufacturing ................
Heavy duty truck manufacturing ..................................
Motor vehicle body manufacturing ...............................
Truck trailer manufacturing ..........................................
Motor home manufacturing ..........................................
Carburetor, piston, piston ring, and valve manufacturing.
Gasoline engine and engine parts manufacturing .......
Other motor vehicle electrical and electronic equipment manufacturing.
Motor vehicle steering and suspension components
(except spring) manufacturing.
Motor vehicle brake system manufacturing .................
Motor vehicle transmission and power train parts
manufacturing.
Motor vehicle metal stamping ......................................
All other motor vehicle parts manufacturing ................
Ship building and repair ...............................................
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
159,156
169,401
8,749,619
32,886
46,869
25,492
65,767
71,423
30,521
1,917
293,357
404,778
125,181
187,131
54,137
84,073
10,269
6,646
3,326
6,521
32,118
41,360
23,948
9,867
23,144
54,872
34,418
32,249
15,258
12,129
123,384
26,182
9,604
38,359
25,087
104,313
143,216
44,845
30,365
203,742
45,308
27,021
27,149
123,816
230,825
19,037
30,618
13,624
74,633
20,767
13,779
201
235
575
46
66
36
94
101
17
3
167
63
77
239
72
79
14
9
5
10
18
54
32
13
31
74
45
43
20
16
166
35
13
50
32
140
193
60
40
274
61
36
34
165
311
25
40
18
99
28
22
792
721
15,217
710
710
708
703
706
1,795
671
1,757
6,425
1,626
784
748
1,064
748
732
643
649
1,784
762
758
732
745
742
757
756
772
764
745
754
744
765
777
746
743
746
758
743
741
748
791
750
742
752
764
741
754
736
630
11,477,248
6,985,145
27,083,446
6,554,128
6,058,947
7,742,773
4,245,230
6,746,386
299,665,426
8,269,046
555,733,594
2,359,286,755
240,029,218
16,910,028
9,018,164
75,358,742
2,242,044
2,878,581
6,088,365
10,460,359
271,746,735
6,220,799
6,290,845
3,816,319
5,635,771
4,240,165
4,470,378
5,830,077
4,401,836
4,987,858
3,262,128
9,094,798
8,330,543
5,680,062
6,028,137
2,082,357
2,121,298
4,136,962
4,358,035
2,083,166
5,667,272
4,449,669
7,928,953
4,960,861
2,904,500
9,183,477
9,432,914
5,892,239
4,377,576
1,127,301
3,195,173
2.04
2.04
5.86
2.04
2.04
2.04
2.04
2.04
4.21
4.21
2.04
2.04
2.04
2.04
2.04
2.04
2.04
5.94
4.21
4.21
4.21
4.58
4.58
4.58
4.58
4.58
4.58
4.58
4.58
4.58
4.58
2.63
5.29
5.29
2.63
5.29
5.29
5.29
5.29
5.29
4.55
4.55
4.55
4.86
6.81
6.81
6.81
6.81
6.81
6.81
6.81
234,190
142,530
1,587,570
133,735
123,631
157,989
86,623
137,658
12,625,478
348,391
11,339,563
48,140,479
4,897,718
345,044
184,013
1,537,671
45,748
171,059
256,514
440,715
11,449,210
284,686
287,891
174,648
257,913
194,045
204,580
266,805
201,444
228,262
149,287
238,915
440,630
300,438
158,355
110,143
112,203
218,818
230,511
110,186
258,027
202,591
361,000
241,023
197,707
625,111
642,090
401,079
297,978
76,734
217,493
0.01
0.01
0.06
0.01
0.01
0.01
0.02
0.01
0.00
0.01
0.00
0.00
0.00
0.00
0.01
0.00
0.03
0.03
0.01
0.01
0.00
0.01
0.01
0.02
0.01
0.02
0.02
0.01
0.02
0.02
0.02
0.01
0.01
0.01
0.01
0.04
0.04
0.02
0.02
0.04
0.01
0.02
0.01
0.02
0.03
0.01
0.01
0.01
0.02
0.07
0.02
0.34
0.51
0.96
0.53
0.57
0.45
0.81
0.51
0.01
0.19
0.02
0.01
0.03
0.23
0.41
0.07
1.64
0.43
0.25
0.15
0.02
0.27
0.26
0.42
0.29
0.38
0.37
0.28
0.38
0.33
0.50
0.32
0.17
0.25
0.49
0.68
0.66
0.34
0.33
0.67
0.29
0.37
0.22
0.31
0.38
0.12
0.12
0.18
0.25
0.96
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Total .............................................................................
176,800
261,393
1,397,271
1,392,054
257,285
242,158
264,810
143,614
N/A
370,174
2,612,088
27,227
Total
annualized
costs
Boat building .................................................................
Military armored vehicle, tank, and tank component
manufacturing.
Showcase, partition, shelving, and locker manufacturing.
Dental equipment and supplies manufacturing ............
Dental laboratories .......................................................
Jewelry (except costume) manufacturing ....................
Jewelers’ materials and lapidary work manufacturing
Costume jewelry and novelty manufacturing ...............
Sign manufacturing ......................................................
Industrial supplies, wholesalers ...................................
Rail transportation ........................................................
Dental offices ................................................................
Industry
41,136
292
7,011
1,751
258
588
428
226
N/A
7,423
235
814
32
Number of
affected small
entities
2,103
895
199
795
997
412
618
636
N/A
50
751
3,209
845
Annualized cost
per affected
entity
2,619,222
532,828
2,615,940
2,775,717
971,681
1,642,826
5,001,467
N/A
663,948
3,637,716
5,304,212
54,437,815
Revenues per
entity
10.77
10.77
5.80
5.80
5.80
5.80
3.44
N/A
7.34
4.54
5.86
6.31
Profit rate [a]
(percent)
282,066
57,381
151,608
160,868
56,314
95,211
171,830
N/A
48,739
165,266
310,921
3,434,642
Profits per
entity
0.03
0.04
0.03
0.04
0.04
0.04
0.01
N/A
0.01
0.02
0.06
0.00
Costs as a
percentage
of revenues
0.32
0.35
0.52
0.62
0.73
0.65
0.37
N/A
0.10
0.45
1.03
0.02
Costs as a
percentage
of profits
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327992
327993
327999
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331112
331210
331221 .....
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327113
327121
327122
327123
327124
327125
327211
327212
327112 .....
324121
324122
325510
327111
NAICS
Asphalt paving mixture and block manufacturing ........
Asphalt shingle and roofing materials ..........................
Paint and coating manufacturing .................................
Vitreous china plumbing fixtures & bathroom accessories manufacturing.
Vitreous china, fine earthenware, & other pottery
product manufacturing.
Porcelain electrical supply mfg ....................................
Brick and structural clay mfg ........................................
Ceramic wall and floor tile mfg ....................................
Other structural clay product mfg .................................
Clay refractory manufacturing ......................................
Nonclay refractory manufacturing ................................
Flat glass manufacturing ..............................................
Other pressed and blown glass and glassware manufacturing.
Glass container manufacturing ....................................
Ready-mixed concrete manufacturing .........................
Concrete block and brick mfg ......................................
Concrete pipe mfg ........................................................
Other concrete product mfg .........................................
Cut stone and stone product manufacturing ................
Ground or treated mineral and earth manufacturing ...
Mineral wool manufacturing .........................................
All other misc. nonmetallic mineral product mfg ..........
Iron and steel mills .......................................................
Electrometallurgical ferroalloy product manufacturing
Iron and steel pipe and tube manufacturing from purchased steel.
Rolled steel shape manufacturing ................................
Industry
1,612
4,798
1,897,131
544,975
116,670
1,885,496
2,753,051
389,745
48,575
311,859
9,342
0
1,706
79,824
76,696
382,871
67,176
29,861
34,061
4,450
87,895
747,902
$27,770
85,253
18,910
26,606
Total
annualized
costs
2
4
1,429
339
67
1,326
1,471
78
46
235
12
0
2
57
31
136
25
55
40
4
79
645
260
57
324
19
Number of affected entities
with <20 employees
774
1,107
1,328
1,608
1,741
1,422
1,872
4,997
1,061
1,327
777
N/A
774
1,400
2,474
2,815
2,687
543
852
1,075
1,107
1,160
$107
1,496
58
1,400
Annualized
costs per affected entities
2,108,498
2,690,032
1,922,659
1,995,833
2,375,117
974,563
946,566
1,635,092
1,398,274
1,457,181
4,177,841
1,202,610
2,113,379
601,316
715,098
807,291
782,505
1,521,469
1,506,151
905,562
370,782
155,258
$4,335,678
4,013,780
1,871,296
327,368
Revenues per
entity
4.49
3.42
6.64
6.64
6.64
6.64
5.49
5.49
5.49
5.49
4.49
4.49
4.49
4.41
4.41
4.41
4.41
4.41
4.41
3.42
3.42
4.41
7.50
7.50
5.38
4.41
Profit rate [a]
(percent)
94,713
92,024
127,628
132,485
157,662
64,692
51,957
89,751
76,752
79,985
187,668
54,021
94,933
26,548
31,571
35,641
34,547
67,172
66,495
30,978
12,684
6,855
$325,227
301,081
100,758
14,453
Profits per entity
0.04
0.04
0.07
0.08
0.07
0.15
0.20
0.31
0.08
0.09
0.02
N/A
0.04
0.23
0.35
0.35
0.34
0.04
0.06
0.12
0.30
0.75
0.00
0.04
0.00
0.43
Costs as a percentage of revenues
0.82
1.20
1.04
1.21
1.10
2.20
3.60
5.57
1.38
1.66
0.41
N/A
0.82
5.28
7.84
7.90
7.78
0.81
1.28
3.47
8.73
16.92
0.03
0.50
0.06
9.69
Costs as a percentage of profits
TABLE VIII–13—SCREENING ANALYSIS FOR VERY SMALL ENTITIES (FEWER THAN 20 EMPLOYEES) IN GENERAL INDUSTRY AND MARITIME AFFECTED BY OSHA’S
PROPOSED SILICA STANDARD
[a] Profit rates were calculated by ERG, 2013, as the average of profit rates for 2000 through 2006, based on balance sheet data reported in the Internal Revenue Service’s Corporation Source Book (IRS, 2007).
Source: U.S. Dept. of Labor, OSHA, Office of Regulatory Analysis, based on ERG (2013).
339114
339116
339911
339913
339914
339950
423840
482110
621210
337215 .....
336612 .....
336992 .....
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TABLE VIII–12—SCREENING ANALYSIS FOR SMALL ENTITIES IN GENERAL INDUSTRY AND MARITIME AFFECTED BY OSHA’S PROPOSED SILICA STANDARD—
Continued
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332115
332116
332117
332211
332212
332213
332214
332323
332439
332510
332611
332612
332618
332710
332812
332911
332912
332913
332919
332991
332996
332997
332998
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333911
333912
333991
333992
333993
333994
333995
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.....
.....
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.....
.....
333613 .....
333516 .....
333518 .....
333612 .....
333515 .....
333511
333512
333513
333514
333414 .....
333411 .....
333412 .....
333319 .....
332999 .....
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.....
331222
331314
331423
331492
Steel wire drawing ........................................................
Secondary smelting and alloying of aluminum ............
Secondary smelting, refining, and alloying of copper ..
Secondary smelting, refining, and alloying of nonferrous metal (except cu & al).
Iron foundries ...............................................................
Steel investment foundries ...........................................
Steel foundries (except investment) .............................
Aluminum foundries (except die-casting) .....................
Copper foundries (except die-casting) .........................
Other nonferrous foundries (except die-casting) .........
Iron and steel forging ...................................................
Nonferrous forging ........................................................
Crown and closure manufacturing ...............................
Metal stamping .............................................................
Powder metallurgy part manufacturing ........................
Cutlery and flatware (except precious) manufacturing
Hand and edge tool manufacturing ..............................
Saw blade and handsaw manufacturing ......................
Kitchen utensil, pot, and pan manufacturing ...............
Ornamental and architectural metal work ....................
Other metal container manufacturing ...........................
Hardware manufacturing ..............................................
Spring (heavy gauge) manufacturing ...........................
Spring (light gauge) manufacturing ..............................
Other fabricated wire product manufacturing ...............
Machine shops .............................................................
Metal coating and allied services .................................
Industrial valve manufacturing .....................................
Fluid power valve and hose fitting manufacturing .......
Plumbing fixture fitting and trim manufacturing ...........
Other metal valve and pipe fitting manufacturing ........
Ball and roller bearing manufacturing ..........................
Fabricated pipe and pipe fitting manufacturing ............
Industrial pattern manufacturing ...................................
Enameled iron and metal sanitary ware manufacturing.
All other miscellaneous fabricated metal product manufacturing.
Other commercial and service industry machinery
manufacturing.
Air purification equipment manufacturing .....................
Industrial and commercial fan and blower manufacturing.
Heating equipment (except warm air furnaces) manufacturing.
Industrial mold manufacturing ......................................
Machine tool (metal cutting types) manufacturing .......
Machine tool (metal forming types) manufacturing ......
Special die and tool, die set, jig, and fixture manufacturing.
Cutting tool and machine tool accessory manufacturing.
Rolling mill machinery and equipment manufacturing
Other metalworking machinery manufacturing ............
Speed changer, industrial high-speed drive, and gear
manufacturing.
Mechanical power transmission equipment manufacturing.
Pump and pumping equipment manufacturing ............
Air and gas compressor manufacturing .......................
Power-driven handtool manufacturing .........................
Welding and soldering equipment manufacturing ........
Packaging machinery manufacturing ...........................
Industrial process furnace and oven manufacturing ....
Fluid power cylinder and actuator manufacturing ........
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
7,209
4,228
2,212
3,835
9,742
5,631
3,955
3,114
1,361
6,766
3,318
31,406
43,738
8,756
4,666
65,867
6,087
4,745
1,675
19,776
55,981
330,543
47,902
162,670
503,027
370,110
162,043
4,089
784
992
27,154
2,072
2,217
19,535
2,296
0
9,527
5,279
11,863
1,927
4,960
19,946
416,115
613,903
5,886
4,491
1,505
2,710
1,132
12,453
8,917
3,287
2,939
1,254
0
2,897
9
5
3
5
13
7
5
4
2
9
4
41
56
11
6
85
8
6
2
26
72
201
27
102
235
164
77
5
1
1
35
3
3
25
3
0
14
7
15
2
6
26
537
885
8
6
2
3
1
16
12
5
4
2
0
4
774
774
774
774
774
774
774
774
774
774
774
775
774
776
774
774
777
774
774
774
774
1,644
1,774
1,595
2,141
2,257
2,104
774
774
774
775
774
774
774
774
N/A
694
788
777
786
774
774
774
694
774
774
774
781
774
774
774
690
774
774
N/A
774
1,343,868
1,644,664
2,158,268
1,331,521
809,474
1,324,790
916,613
2,113,156
2,243,812
965,694
1,393,898
771,162
716,506
911,891
1,308,768
816,990
901,560
1,152,661
1,454,305
1,127,993
933,734
1,031,210
1,831,394
1,577,667
874,058
814,575
837,457
1,175,666
1,431,874
1,715,882
1,146,408
1,580,975
391,981
770,858
975,698
826,410
695,970
1,027,511
776,986
1,774,584
1,085,302
778,870
649,804
602,598
1,294,943
1,350,501
811,318
2,164,960
1,808,246
1,237,265
503,294
725,491
835,444
2,039,338
2,729,146
1,546,332
4.58
4.58
4.58
4.58
4.58
4.58
4.58
2.63
5.29
5.29
2.63
5.29
5.29
5.29
5.29
5.29
4.55
4.55
4.55
4.86
6.81
4.11
4.11
4.11
4.11
4.11
4.11
4.71
4.71
4.71
4.71
4.71
5.22
5.22
5.22
5.22
4.70
3.58
5.22
5.22
5.22
5.22
5.80
4.85
6.81
6.81
6.81
6.81
6.81
6.81
6.81
6.81
4.49
4.46
4.42
4.42
61,500
75,266
98,770
60,935
37,044
60,627
41,947
55,511
118,683
51,079
36,617
40,789
37,898
48,233
69,225
43,213
41,047
52,480
66,214
54,803
63,558
42,422
75,340
64,902
35,957
33,510
34,451
55,316
67,371
80,733
53,939
74,386
20,476
40,267
50,967
43,169
32,737
36,822
40,587
92,698
56,692
40,685
37,677
29,254
88,146
91,927
55,226
147,367
123,086
84,220
34,259
49,384
37,528
91,055
120,492
68,271
0.06
0.05
0.04
0.06
0.10
0.06
0.08
0.04
0.03
0.08
0.06
0.10
0.11
0.09
0.06
0.09
0.09
0.07
0.05
0.07
0.08
0.16
0.10
0.10
0.24
0.28
0.25
0.07
0.05
0.05
0.07
0.05
0.20
0.10
0.08
N/A
0.10
0.08
0.10
0.04
0.07
0.10
0.12
0.12
0.06
0.06
0.10
0.04
0.04
0.06
0.15
0.10
0.09
0.04
N/A
0.05
1.26
1.03
0.78
1.27
2.09
1.28
1.84
1.39
0.65
1.51
2.11
1.90
2.04
1.61
1.12
1.79
1.89
1.47
1.17
1.41
1.22
3.88
2.35
2.46
5.95
6.73
6.11
1.40
1.15
0.96
1.44
1.04
3.78
1.92
1.52
N/A
2.12
2.14
1.92
0.85
1.36
1.90
2.06
2.37
0.88
0.84
1.40
0.53
0.63
0.92
2.26
1.40
2.06
0.85
N/A
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Total
annualized
costs
79,876
1,040,112
533,353
86,465
100,556
89,586
50,612
N/A
320,986
15,745,425
Total .............................................................................
28,216
5,759
16,021
212,021
391,950
0
2,386
6,390
2,876
11,683
8,618
0
0
2,147
795
943
12,371
5,147
1,193
1,329
1,322
0
722
0
2,670
1,947
32,637
Fluid power pump and motor manufacturing ...............
Scale and balance (except laboratory) manufacturing
All other miscellaneous general purpose machinery
manufacturing.
Watch, clock, and part manufacturing .........................
Electric housewares and household fans ....................
Household cooking appliance manufacturing ..............
Household refrigerator and home freezer manufacturing.
Household laundry equipment manufacturing .............
Other major household appliance manufacturing ........
Automobile manufacturing ............................................
Light truck and utility vehicle manufacturing ................
Heavy duty truck manufacturing ..................................
Motor vehicle body manufacturing ...............................
Truck trailer manufacturing ..........................................
Motor home manufacturing ..........................................
Carburetor, piston, piston ring, and valve manufacturing.
Gasoline engine and engine parts manufacturing .......
Other motor vehicle electrical and electronic equipment manufacturing.
Motor vehicle steering and suspension components
(except spring) manufacturing.
Motor vehicle brake system manufacturing .................
Motor vehicle transmission and power train parts
manufacturing.
Motor vehicle metal stamping ......................................
All other motor vehicle parts manufacturing ................
Ship building and repair ...............................................
Boat building .................................................................
Military armored vehicle, tank, and tank component
manufacturing.
Showcase, partition, shelving, and locker manufacturing.
Dental equipment and supplies manufacturing ............
Dental laboratories .......................................................
Jewelry (except costume) manufacturing ....................
Jewelers’ materials and lapidary work manufacturing
Costume jewelry and novelty manufacturing ...............
Sign manufacturing ......................................................
Industrial supplies, wholesalers ...................................
Rail transportation ........................................................
Dental offices ................................................................
Industry
25,544
87
6,664
1,532
218
368
140
95
N/A
6,506
36
7
21
65
121
0
3
8
4
15
11
0
0
3
1
1
16
7
2
2
2
0
1
0
3
3
42
Number of affected entities
with <20 employees
616
922
156
348
397
274
639
531
N/A
49
774
778
774
3,252
3,247
N/A
774
774
774
774
774
N/A
N/A
774
774
774
774
774
774
774
774
N/A
698
N/A
774
774
774
Annualized
costs per affected entities
657,192
326,740
673,857
919,422
454,292
521,518
2,432,392
N/A
562,983
866,964
1,519,875
1,369,097
770,896
1,101,324
1,145,870
1,378,684
864,746
1,543,436
867,703
1,383,831
1,767,776
1,706,991
1,507,110
1,089,801
4,371,350
1,720,545
2,706,375
2,184,388
870,496
586,350
847,408
2,228,319
4,917,513
1,417,549
1,527,651
871,700
Revenues per
entity
10.77
10.77
5.80
5.80
5.80
5.80
3.44
N/A
7.34
4.54
2.04
2.04
5.86
5.86
6.31
2.04
2.04
2.04
2.04
2.04
4.21
4.21
2.04
2.04
2.04
2.04
2.04
2.04
2.04
5.94
4.21
4.21
4.21
4.58
4.58
4.58
Profit rate [a]
(percent)
70,773
35,187
39,054
53,285
26,329
30,225
83,567
N/A
41,328
39,387
31,013
27,936
45,188
64,557
72,296
28,132
17,645
31,493
17,705
28,237
74,480
71,919
30,752
22,237
89,196
35,107
55,223
44,572
17,762
34,844
35,703
93,883
207,184
64,872
69,911
39,892
Profits per entity
0.14
0.05
0.05
0.04
0.06
0.12
0.02
N/A
0.01
0.09
0.05
0.06
0.42
0.29
N/A
0.06
0.09
0.05
0.09
0.06
N/A
N/A
0.05
0.07
0.02
0.04
0.03
0.04
0.09
0.13
N/A
0.03
N/A
0.05
0.05
0.09
Costs as a percentage of revenues
1.30
0.44
0.89
0.74
1.04
2.12
0.64
N/A
0.12
1.96
2.51
2.77
7.20
5.03
N/A
2.75
4.38
2.46
4.37
2.74
N/A
N/A
2.52
3.48
0.87
2.20
1.40
1.74
4.36
2.22
N/A
0.74
N/A
1.19
1.11
1.94
Costs as a percentage of profits
rates were calculated by ERG, 2013, as the average of profit rates for 2000 through 2006, based on balance sheet data reported in the Internal Revenue Service’s Corporation Source Book (IRS, 2007).
Source: U.S. Dept. of Labor, OSHA, Office of Regulatory Analysis, based on ERG (2013).
a Profit
339114
339116
339911
339913
339914
339950
423840
482110
621210
337215 .....
336370
336399
336611
336612
336992
336340 .....
336350 .....
336330 .....
336312 .....
336322 .....
.....
.....
.....
.....
334518
335211
335221
335222
333996 .....
333997 .....
333999 .....
NAICS
TABLE VIII–13—SCREENING ANALYSIS FOR VERY SMALL ENTITIES (FEWER THAN 20 EMPLOYEES) IN GENERAL INDUSTRY AND MARITIME AFFECTED BY OSHA’S
PROPOSED SILICA STANDARD—Continued
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As a point of clarification, OSHA
would like to draw attention to
industries with captive foundries. There
are three industries with captive
foundries whose annualized costs for
very small entities approach five
percent of annual profits: NAICS 336311
(Carburetor, piston ring, and valve
manufacturing); NAICS 336312
(Gasoline engine and engine parts
manufacturing); and NAICS 336350
(Motor vehicle transmission and power
train parts manufacturing). For very
small entities in all three of these
industries, the annualized costs as a
percentage of annual profits are
approximately 4.4 percent. OSHA
believes, however, that very small
entities in industries with captive
foundries are unlikely to actually have
captive foundries and that the captive
foundries allocated to very small
entities in fact belong in larger entities.
This would have the result that the costs
as percentage of profits for these larger
entities would be lower than the 4.4
percent reported above. Instead, OSHA
assumed that the affected employees
would be distributed among entities of
different size according to each entity
size class’s share of total employment.
In other words, if 15 percent of
employees in an industry worked in
very small entities (those with fewer
than 20 employees), then OSHA
assumed that 15 percent of affected
employees in the industry would work
in very small entities. However, in
reality, OSHA anticipates that in
industries with captive foundries, none
of the entities with fewer than 20
employees have captive foundries or, if
they do, that the impacts are much
smaller than estimated here. OSHA
invites comment about whether and to
what extent very small entities have
captive foundries (in industries with
captive foundries).
Regardless of whether the cost
estimates have been inflated for very
small entities in the three industries
with captive foundries listed above,
there are two reasons why OSHA is
confident that the competitive structure
of these industries would not be
threatened by adverse competitive
conditions for very small entities. First,
as shown in Appendix VI–B of the PEA,
very small entities in NAICS 336311,
NAICS 336312, and NAICS 336350
account for 3 percent, 2 percent, and 3
percent, respectively, of the total
number of establishments in the
industry. Although it is possible that
some of these very small entities could
exit the industry in response to the
proposed rule, courts interpreting the
OSH Act have historically taken the
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view that losing at most 3 percent of the
establishments in an industry would
alter the competitive structure of that
industry. Second, very small entities in
industries with captive foundries, when
confronted with higher foundry costs as
a result of the proposed rule, have the
option of dropping foundry activities,
purchasing foundry products and
services from businesses directly in the
foundry industry, and focusing on the
main goods and services produced in
the industry. This, after all, is precisely
what the rest of the establishments in
these industries do.
e. Regulatory Flexibility Screening
Analysis
To determine if the Assistant
Secretary of Labor for OSHA can certify
that the proposed silica rule will not
have a significant economic impact on
a substantial number of small entities,
the Agency has developed screening
tests to consider minimum threshold
effects of the proposed rule on small
entities. The minimum threshold effects
for this purpose are annualized costs
equal to one percent of annual revenues
and annualized costs equal to five
percent of annual profits applied to each
affected industry. OSHA has applied
these screening tests both to small
entities and to very small entities. For
purposes of certification, the threshold
level cannot be exceeded for affected
small entities or very small entities in
any affected industry.
Table VIII–12 and Table VIII–13 show
that, in general industry and maritime,
the annualized costs of the proposed
rule do not exceed one percent of
annual revenues for small entities or for
very small entities in any industry.
These tables also show that the
annualized costs of the proposed rule
exceed five percent of annual profits for
small entities in 10 industries and for
very small entities in 13 industries.
OSHA is therefore unable to certify that
the proposed rule will not have a
significant economic impact on a
substantial number of small entities in
general industry and maritime and must
prepare an Initial Regulatory Flexibility
Analysis (IRFA). The IRFA is presented
in Section VIII.I of this preamble.
3. Impacts in Construction
a. Economic Feasibility Screening
Analysis: All Establishments
To determine whether the proposed
rule’s projected costs of compliance
would threaten the economic viability
of affected construction industries,
OSHA used the same data sources and
methodological approach that were used
earlier in this chapter for general
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industry and maritime. OSHA first
compared, for each affected
construction industry, annualized
compliance costs to annual revenues
and profits per (average) affected
establishment. The results for all
affected establishments in all affected
construction industries are presented in
Table VIII–14, using annualized costs
per establishment for the proposed 50
mg/m3 PEL. The annualized cost of the
proposed rule for the average
establishment in construction,
encompassing all construction
industries, is estimated at $1,022 in
2009 dollars. It is clear from Table VIII–
14 that the estimates of the annualized
costs per affected establishment in the
10 construction industries vary widely.
These estimates range from $2,598 for
NAICS 237300 (Highway, street, and
bridge construction) and $2,200 for
NAICS 237100 (Utility system
construction) to $241 for NAICS 238200
(Building finishing contractors) and
$171 for NAICS 237200 (Land
subdivision).
Table VIII–14 shows that in no
construction industry do the annualized
costs of the proposed rule exceed one
percent of annual revenues or ten
percent of annual profits. NAICS 238100
(Foundation, structure, and building
exterior contractors) has both the
highest cost impact as a percentage of
revenues, of 0.13 percent, and the
highest cost impact as a percentage of
profits, of 2.97 percent. Based on these
results, even if the costs of the proposed
rule were 50 percent higher than OSHA
has estimated, the highest cost impact as
a percentage of revenues in any affected
construction industry would be less
than 0.2 percent. Furthermore, the costs
of the proposed rule would have to be
more than 650 percent higher than
OSHA has estimated for the cost impact
as a percentage of revenues to equal 1
percent in any affected construction
industry. For all affected establishments
in construction, the estimated
annualized cost of the proposed rule is,
on average, equal to 0.05 percent of
annual revenue and 1.0 percent of
annual profit.
Therefore, even though the
annualized costs of the proposed rule
incurred by the construction industry as
a whole are almost four times the
combined annualized costs incurred by
general industry and maritime, OSHA
preliminarily concludes, based on its
screening analysis, that the annualized
costs as a percentage of annual revenues
and as a percentage of annual profits are
below the threshold level that could
threaten the economic viability of any of
the construction industries. OSHA
further notes that while there would be
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additional costs (not attributable to the
proposed rule) for some employers in
construction industries to come into
compliance with the current silica
standard, these costs would not affect
the Agency’s preliminary determination
of the economic feasibility of the
proposed rule.
Below, OSHA provides additional
information to further support the
Agency’s conclusion that the proposed
rule would not threaten the economic
viability of any construction industry.
TABLE VIII–14—SCREENING ANALYSIS FOR ESTABLISHMENTS IN CONSTRUCTION AFFECTED BY OSHA’S PROPOSED SILICA
STANDARD
NAICS
Industry
236100 .....
Residential Building
Construction.
Nonresidential Building
Construction.
Utility System Construction.
Land Subdivision ........
Highway, Street, and
Bridge Construction.
Other Heavy and Civil
Engineering Construction.
Foundation, Structure,
and Building Exterior
Contractors.
Building Equipment
Contractors.
Building Finishing Contractors.
Other Specialty Trade
Contractors.
State and local governments d.
Total ............................
236200 .....
237100 .....
237200 .....
237300 .....
237900 .....
238100 .....
238200 .....
238300 .....
238900 .....
999000 .....
Affected establishments
Annualized
costs per
affected
establishment
Revenues
per establishment
$23,288,881
55,338
$421
$2,002,532
39,664,913
44,702
887
46,718,162
21,232
1,110,789
30,807,861
Total
annualized
costs
Profits per
establishment
Costs as a
percentage of
revenues
Costs as a
percentage of
profits
4.87
$97,456
0.02
0.43
7,457,045
4.87
362,908
0.01
0.24
2,200
4,912,884
5.36
263,227
0.04
0.84
6,511
11,860
171
2,598
2,084,334
8,663,019
11.04
5.36
230,214
464,156
0.01
0.03
0.07
0.56
7,164,210
5,561
1,288
3,719,070
5.36
199,264
0.03
0.65
215,907,211
117,456
1,838
1,425,510
4.34
61,832
0.13
2.97
4,902,138
20,358
241
1,559,425
4.34
67,640
0.02
0.36
50,259,239
120,012
419
892,888
4.34
38,729
0.05
1.08
68,003,978
74,446
913
1,202,048
4.48
53,826
0.08
1.70
23,338,234
N/A
N/A
N/A
N/A
N/A
N/A
N/A
511,165,616
477,476
1,022
......................
......................
......................
......................
......................
Profit rate a
(percent)
a Profit
rates were calculated by ERG, 2013, as the average of profit rates for 2000 through 2006, based on balance sheet data reported in the Internal Revenue
Service’s Corporation Source Book (IRS, 2007).
Source: U.S. Dept. of Labor, OSHA, Office of Regulatory Analysis, based on ERG (2013).
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b. Normal Year-to-Year Variations in
Profit Rates
As previously noted, the United
States has a dynamic and constantly
changing economy in which large yearto-year changes in industry profit rates
are commonplace. A recession, a
downturn in a particular industry,
foreign competition, or the increased
competitiveness of producers of close
domestic substitutes are all easily
capable of causing a decline in profit
rates in an industry of well in excess of
ten percent in one year or for several
years in succession.
To demonstrate the normal year-toyear variation in profit rates for all the
manufacturers in construction affected
by the proposed rule, OSHA presented
data in the PEA on year-to-year profit
rates and year-to-year percentage
changes in profit rates, by industry, for
the years 2000—2006. For the combined
affected manufacturing industries in
general industry and maritime over the
7-year period, the average change in
profit rates was 15.4 percent a year.
What these data indicate is that, even
if, theoretically, the annualized costs of
the proposed rule for the most
significantly affected construction
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industries were completely absorbed in
reduced annual profits, the magnitude
of reduced annual profit rates are well
within normal year-to-year variations in
profit rates in those industries and do
not threaten their economic viability. Of
course, a permanent loss of profits
would present a greater problem than a
temporary loss, but it is unlikely that all
costs of the proposed rule would be
absorbed in lost profits. Given that, as
discussed in Chapter VI of the PEA, the
overall price elasticity of demand for the
outputs of the construction industry is
fairly low and that almost all of the
costs estimated in Chapter V of the PEA
are variable costs, there is a reasonable
chance that most firms will see small
declines in output rather than that any
but the most extremely marginal firms
would close.
Considering the costs of the proposed
rule relative to the size of construction
activity in the United States, OSHA
preliminarily concludes that the price
and profit impacts of the proposed rule
on construction industries would, in
practice, be quite limited. Based on ERG
(2007a), on an annual basis, the cost of
the proposed rule would be equal to
approximately 2 percent of the value of
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affected, silica-generating construction
activity, and silica-generating
construction activity accounts for
approximately 4.8 percent of all
construction spending in the U.S. Thus,
the annualized cost of the proposed rule
would be equal to approximately 0.1
percent of the value of annual
construction activity in the U.S. On top
of that, construction activity in the U.S.
is not subject to any meaningful foreign
competition, and any foreign firms
performing construction activities in the
United States would be subject to OSHA
regulations.
c. Impacts by Type of Construction
Demand
The demand for construction services
originates in three independent sectors:
residential building construction,
nonresidential building construction,
and nonbuilding construction.
Residential Building Construction:
Residential housing demand is derived
from the household demand for housing
services. These services are provided by
the stock of single and multi-unit
residential housing units. Residential
housing construction represents changes
to the housing stock and includes
construction of new units and
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modifications, renovations, and repairs
to existing units. A number of studies
have examined the price sensitivity of
the demand for housing services.
Depending on the data source and
estimation methodologies, these studies
have estimated the demand for housing
services at price elasticity values
ranging from –0.40 to –1.0, with the
smaller (in absolute value) less elastic
values estimated for short-run periods.
In the long run, it is reasonable to
expect the demand for the stock of
housing to reflect similar levels of price
sensitivity. Since housing investments
include changes in the existing stock
(renovations, depreciation, etc.) as well
as new construction, it is likely that the
price elasticity of demand for new
residential construction will be lower
than that for residential construction as
a whole.
OSHA judges that many of the silicagenerating construction activities
affected by the proposed rule are not
widely used in single-family
construction. This assessment is
consistent with the cost estimates that
show relatively low impacts for
residential building contractors. Multifamily residential construction might
have more substantial impacts, but,
based on census data, this type of
construction represents a relatively
small share of net investment in
residential buildings.
Nonresidential Building Construction:
Nonresidential building construction
consists of industrial, commercial, and
other nonresidential structures. As such,
construction demand is derived from
the demand for the output of the
industries that use the buildings. For
example, the demand for commercial
office space is derived from the demand
for the output produced by the users of
the office space. The price elasticity of
demand for this construction category
will depend, among other things, on the
price elasticity of demand for the final
products produced, the importance of
the costs of construction in the total cost
of the final product, and the elasticity of
substitution of other inputs that could
substitute for nonresidential building
construction. ERG (2007c) found no
studies that attempted to quantify these
relationships. But given the costs of the
proposed rule relative to the size of
construction spending in the United
States, the resultant price or revenue
effects are likely to be so small as to be
barely detectable.
Nonbuilding Construction:
Nonbuilding construction includes
roads, bridges, and other infrastructure
projects. Utility construction (power
lines, sewers, water mains, etc.) and a
variety of other construction types are
also included. A large share of this
construction (63.8 percent) is publicly
financed (ERG, 2007a). For this reason,
a large percentage of the decisions
regarding the appropriate level of such
investments is not made in a private
market setting. The relationship
between the costs and price of such
investments and the level of demand
might depend more on political
considerations than the factors that
determine the demand for privately
produced goods and services.
While a number of studies have
examined the factors that determine the
demand for publicly financed
construction projects, these studies have
focused on the ability to finance such
projects (e.g., tax receipts) and sociodemographic factors (e.g., population
growth) to the exclusion of cost or price
factors. In the absence of budgetary
constraints, OSHA believes, therefore,
that the price elasticity of demand for
public investment is probably quite low.
On the other hand, budget-imposed
limits might constrain public
construction spending. If the dollar
value of public investments were fixed,
a price elasticity of demand of 1 (in
absolute terms) would be implied. Any
percentage increase in construction
costs would be offset with an equal
percentage reduction in investment
(measured in physical units), keeping
public construction expenditures
constant.
Public utility construction comprises
the remainder of nonbuilding
construction. This type of construction
is subject to the same derived-demand
considerations discussed for
nonresidential building construction,
and for the same reasons, OSHA expects
the price and profit impacts to be quite
small.
d. Economic Feasibility Screening
Analysis: Small and Very Small
Businesses
The preceding discussion focused on
the economic viability of the affected
construction industries in their entirety
and found that the proposed standard
did not threaten the survival of these
construction industries. Now OSHA
wishes to demonstrate that the
competitive structure of these industries
would not be significantly altered.
To address this issue, OSHA
examined the annualized costs per
affected small and very small entity for
each affected construction industry.
Table VIII–15 and Table VIII–16 show
that in no construction industries do the
annualized costs of the proposed rule
exceed one percent of annual revenues
or ten percent of annual profits either
for small entities or for very small
entities. Therefore, OSHA preliminarily
concludes, based on its screening
analysis, that the annualized costs as a
percentage of annual revenues and as a
percentage of annual profits are below
the threshold level that could threaten
the competitive structure of any of the
construction industries.
TABLE VIII–15—SCREENING ANALYSIS FOR SMALL ENTITIES IN CONSTRUCTION AFFECTED BY OSHA’S PROPOSED SILICA
STANDARD
NAICS
Industry
236100 .....
Residential Building
Construction.
Nonresidential Building
Construction.
Utility System Construction.
Land Subdivision ........
Highway, Street, and
Bridge Construction.
Other Heavy and Civil
Engineering Construction.
Foundation, Structure,
and Building Exterior
Contractors.
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236200 .....
237100 .....
237200 .....
237300 .....
237900 .....
238100 .....
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Total
annualized
costs
Affected
small entities
Annualized
costs per
affected
entities
Revenues
per entities
Profit rate a
(percent)
Profits per
entities
Costs as a
percentage of
revenues
Costs as a
percentage of
profits
$18,527,934
44,212
$419
$1,303,262
4.87
$67,420
0.03
0.62
24,443,185
42,536
575
4,117,755
4.87
200,396
0.01
0.29
30,733,201
20,069
1,531
3,248,053
5.36
174,027
0.05
0.88
546,331
13,756,992
3,036
10,350
180
1,329
1,215,688
3,851,971
11.04
5.36
134,272
206,385
0.01
0.03
0.13
0.64
5,427,484
5,260
1,032
2,585,858
5.36
138,548
0.04
0.74
152,160,159
115,345
1,319
991,258
4.34
42,996
0.13
3.07
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TABLE VIII–15—SCREENING ANALYSIS FOR SMALL ENTITIES IN CONSTRUCTION AFFECTED BY OSHA’S PROPOSED SILICA
STANDARD—Continued
NAICS
Industry
238200 .....
Building Equipment
Contractors.
Building Finishing Contractors.
Other Specialty Trade
Contractors.
State and local governments [d].
238300 .....
238900 .....
999000 .....
Total ............................
Total
annualized
costs
Affected
small entities
Annualized
costs per
affected
entities
Revenues
per entities
Profit rate a
(percent)
Profits per
entities
Costs as a
percentage of
revenues
Costs as a
percentage of
profits
3,399,252
13,933
244
1,092,405
4.34
47,383
0.02
0.51
36,777,673
87,362
421
737,930
4.34
32,008
0.06
1.32
53,432,213
73,291
729
1,006,640
4.48
45,076
0.07
1.62
2,995,955
13,482
222
N/A
N/A
N/A
N/A
N/A
342,200,381
428,876
798
......................
......................
......................
......................
......................
a Profit
rates were calculated by ERG, 2013, as the average of profit rates for 2000 through 2006, based on balance sheet data reported in the Internal Revenue
Service’s Corporation Source Book (IRS, 2007).
Source: U.S. Dept. of Labor, OSHA, Office of Regulatory Analysis, based on ERG (2013).
TABLE VIII–16—SCREENING ANALYSIS FOR VERY SMALL ENTITIES (FEWER THAN 20 EMPLOYEES) IN CONSTRUCTION
AFFECTED BY OSHA’S PROPOSED SILICA STANDARD
NAICS
Industry
236100 .....
Residential Building
Construction.
Nonresidential Building
Construction.
Utility System Construction.
Land Subdivision ........
Highway, Street, and
Bridge Construction.
Other Heavy and Civil
Engineering Construction.
Foundation, Structure,
and Building Exterior
Contractors.
Building Equipment
Contractors.
Building Finishing Contractors.
Other Specialty Trade
Contractors.
State and local governments [d].
Total ............................
236200 .....
237100 .....
237200 .....
237300 .....
237900 .....
238100 .....
238200 .....
238300 .....
238900 .....
999000 .....
Affected entities with <20
employees
Annualized
costs per affected entities
$13,837,293
32,042
$432
$922,275
4.87
10,777,269
35,746
301
1,902,892
8,578,771
16,113
532
546,331
4,518,038
3,036
8,080
1,650,007
Total
annualized
costs
Costs as a
percentage of
revenues
Costs as a
percentage of
profits
$44,884
0.05
0.96
4.87
92,607
0.02
0.33
991,776
5.36
53,138
0.05
1.00
180
559
1,215,688
1,649,324
11.04
5.36
134,272
88,369
0.01
0.03
0.13
0.63
4,436
372
834,051
5.36
44,688
0.04
0.83
81,822,550
105,227
778
596,296
4.34
25,864
0.13
3.01
1,839,588
7,283
253
579,724
4.34
25,146
0.04
1.00
21,884,973
50,749
431
429,154
4.34
18,615
0.10
2.32
30,936,078
68,075
454
600,658
4.48
26,897
0.08
1.69
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
176,390,899
330,786
533
......................
......................
......................
......................
......................
Revenues
per entities
Profit rate [a]
(percent)
Profits per
entities
a Profit
rates were calculated by ERG, 2013, as the average of profit rates for 2000 through 2006, based on balance sheet data reported in the Internal Revenue
Service’s Corporation Source Book (IRS, 2007).
Source: U.S. Dept. of Labor, OSHA, Office of Regulatory Analysis, based on ERG (2013).
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e. Differential Impacts on Small Entities
and Very Small Entities
Below, OSHA provides some
additional information about differential
compliance costs for small and very
small entities that might influence the
magnitude of differential impacts for
these smaller businesses.
The distribution of impacts by size of
business is affected by the
characteristics of the compliance
measures. For silica controls in
construction, the dust control measures
consist primarily of equipment
modifications and additions made to
individual tools, rather than large,
discrete investments, such as might be
applied in a manufacturing setting. As
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a result, compliance advantages for large
firms through economies of scale are
limited. It is possible that some large
construction firms might derive
purchasing power by buying dust
control measures in bulk. Given the
simplicity of many control measures,
however, such as the use of wet
methods on machines already
manufactured to accommodate them,
such differential purchasing power
appears to be of limited consequence.
The greater capital resources of large
firms will give them some advantage in
making the relatively large investments
for some control measures. For example,
cab enclosures on heavy construction
equipment or foam-based dust control
systems on rock crushers might be
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particularly expensive for some small
entities with an unusual number of
heavy equipment pieces. Nevertheless,
where differential investment
capabilities might exist, small
construction firms might also have the
capability to achieve compliance with
lower-cost measures, such as by
modifying work practices. In the case of
rock crushing, for example, simple
water spray systems can be arranged
without large-scale investments in the
best commercially available systems.
In the program area, large firms might
have a slight advantage in the delivery
of training or in arranging for health
screenings. Given the likelihood that
small firms can, under most
circumstances, call upon independent
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training specialists at competitive
prices, and the widespread availability
of medical services for health
screenings, the advantage for large firms
is, again, expected to be fairly modest.
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f. Regulatory Flexibility Screening
Analysis
To determine if the Assistant
Secretary of Labor for OSHA can certify
that the proposed silica rule will not
have a significant economic impact on
a substantial number of small entities,
the Agency has developed screening
tests to consider minimum threshold
effects of the proposed rule on small
entities. The minimum threshold effects
for this purpose are annualized costs
equal to one percent of annual revenues
and annualized costs equal to five
percent of annual profits applied to each
affected industry. OSHA has applied
these screening tests both to small
entities and to very small entities. For
purposes of certification, the threshold
levels cannot be exceeded for affected
small or very small entities in any
affected industry.
Table VIII–15 and Table VIII–16 show
that in no construction industries do the
annualized costs of the proposed rule
exceed one percent of annual revenues
or five percent of annual profits either
for small entities or for very small
entities. However, as previously noted
in this section, OSHA is unable to
certify that the proposed rule will not
have a significant economic impact on
a substantial number of small entities in
general industry and maritime and must
prepare an Initial Regulatory Flexibility
Analysis (IRFA). The IRFA is presented
in Section VIII.I of this preamble.
4. Employment Impacts on the U.S.
Economy
In October 2011, OSHA directed
Inforum—a not-for-profit Maryland
corporation (based at the University of
Maryland)—to run its macroeconomic
model to estimate the employment
impacts of the costs of the proposed
silica rule.20 The specific model of the
U.S. economy that Inforum used—called
the LIFT model—is particularly suitable
for this work because it combines the
industry detail of a pure input-output
model (which shows, in matrix form,
how the output of each industry serves
as inputs in other industries) with
macroeconomic modeling of demand,
investment, and other macroeconomic
parameters.21 The Inforum model can
20 Inforum has over 40 years experience designing
and using macroeconomic models of the United
States (and other countries).
21 LIFT stands for Long-Term Interindustry
Forecasting Tool. This model combines a dynamic
input-output core for 97 productive sectors with a
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thus both trace changes in particular
industries through their effect on other
industries and also examine the effects
of these changes on aggregate demand,
imports, exports, and investment, and in
turn determine net changes to GDP,
employment, prices, etc.
In order to estimate the possible
macroeconomic impacts of the proposed
rule, Inforum had to run its model
twice: once to establish a baseline and
then again with changes in industry
expenditures to reflect the year-by-year
costs of the proposed silica rule as
estimated by OSHA in its Preliminary
Economic Analysis (PEA).22 The
difference in employment, GDP, etc.
between the two runs of the model
revealed the estimated economic
impacts of the proposed rule.23
OSHA selected 2014 as the starting
year for running the Inforum model
under the assumption that that would
be the earliest that a final silica rule
could take effect. Inforum ran the model
through the year 2023 and reported its
annual and cumulative results for the
ten-year period 2014–2023. The most
important Inforum result is that the
proposed silica rule cumulatively
generates an additional 8,625 job-years
over the period 2014–2023, or an
additional 862.5 job-years annually, on
full macroeconomic model with more than 800
macroeconomic variables. LIFT employs a
‘‘bottoms-up’’ regression approach to
macroeconomic modeling (so that aggregate
investment, employment, and exports, for example,
are the sum of investment and employment by
industry and exports by commodity). Unlike some
simpler forecasting models, price effects are
embedded in the model and the results are timedependent (that is, they are not static or steadystate, but present year-by-year estimates of impacts
consistent with economic conditions at the time).
22 OSHA worked with Inforum to disaggregate
compliance costs into categories that mapped into
specific LIFT production sectors. Inforum also
established a mapping between OSHA’s NAICSbased industries and the LIFT production sectors.
OSHA’s compliance cost estimates were based on
production and employment levels in affected
industries in 2006 (although the costs were then
inflated to 2009 dollars). Therefore, Inforum
benchmarked compliance cost estimates in future
years to production and employment conditions in
2006 (that is, compliance costs in a future year were
proportionately adjusted to production and
employment changes from 2006 to that future year).
See Inforum (2011) for a discussion of these and
other transformations of OSHA’s cost estimates to
conform to the specifications of the LIFT model.
23 Because OSHA’s analysis of the hydraulic
fracturing industry for the proposed silica rule was
not conducted until after the draft PEA had been
completed, OSHA’s estimates of the compliance
costs for this industry were not included in
Inforum’s analysis of the rule’s employment and
other macroeconomic impacts on the U.S. economy.
It should be noted that, according to the Agency’s
estimates, compliance costs for the hydraulic
fracturing industry represent only about 4 percent
of the total compliance costs for all affected
industries.
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average, over the period (Inforum,
2011).24
For a fuller discussion of the
employment and other macroeconomic
impacts of the silica rule, see Inforum
(2011) and Chapter VI of the PEA for the
proposed rule.
G. Benefits and Net Benefits
In this section, OSHA presents a
summary of the estimated benefits, net
benefits, and incremental benefits of the
proposed silica rule. This section also
contains a sensitivity analysis to show
how robust the estimates of net benefits
are to changes in various cost and
benefit parameters. A full explanation of
the derivation of the estimates presented
here is provided in Chapter VII of the
PEA for the proposed rule. OSHA
invites comments on any aspect of its
estimation of the benefits and net
benefits of the proposed rule.
1. Estimation of the Number of SilicaRelated Diseases Avoided
OSHA estimated the benefits
associated with the proposed PEL of 50
mg/m3 and, for economic analysis
purposes, with an alternative PEL of 100
mg/m3 for respirable crystalline silica by
applying the dose-response relationship
developed in the Agency’s quantitative
risk assessment (QRA)—summarized in
Section VI of this preamble—to
exposures at or below the current PELs.
OSHA determined exposures at or
below the current PELs by first
developing an exposure profile
(presented in Chapter IV of the PEA) for
industries with workers exposed to
respirable crystalline silica, using OSHA
inspection and site-visit data, and then
applying this exposure profile to the
total current worker population. The
industry-by-industry exposure profile
was previously presented in Section
VIII.C of this preamble.
By applying the dose-response
relationship to estimates of exposures at
or below the current PELs across
industries, it is possible to project the
number of cases of the following
diseases expected to occur in the worker
population given exposures at or below
the current PELs (the ‘‘baseline’’):
• Fatal cases of lung cancer,
• fatal cases of non-malignant
respiratory disease (including silicosis),
• fatal cases of end-stage renal
disease, and
• cases of silicosis morbidity.
In addition, it is possible to project
the number of these cases that would be
avoided under alternative, lower PELs.
24 A ‘‘job-year’’ is the term of art used to reflect
the fact that an additional person is employed for
a year, not that a new job has necessarily been
permanently created.
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As a simplified example, suppose that
the risk per worker of a given health
endpoint is 2 in 1,000 at 100 mg/m3 and
1 in 1,000 at 50 mg/m3 and that there are
100,000 workers currently exposed at
100 mg/m3. In this example, the
proposed PEL would lower exposures to
50 mg/m3, thereby cutting the risk in half
and lowering the number of expected
cases in the future from 200 to 100.
The estimated benefits for the
proposed silica rule represent the
additional benefits derived from
employers achieving full compliance
with the proposed PEL relative to the
current PELs. They do not include
benefits associated with current
compliance that has already been
achieved with regard to the new
requirements or benefits obtained from
future compliance with existing silica
requirements, to the extent that some
employers may currently not be fully
complying with applicable regulatory
requirements.
The technological feasibility analysis,
described earlier in this section of the
preamble, demonstrated the
effectiveness of controls in meeting or
exceeding the proposed OSHA PEL. For
purposes of estimating the benefit of
reducing the PEL, OSHA has made some
simplifying assumptions. On the one
hand, given the lack of background
information on respirator use related to
existing exposure data, OSHA used
existing personal exposure
measurement information, unadjusted
for potential respirator use.25 On the
other hand, OSHA assumed that
compliance with the existing and
proposed rule would result in
reductions in exposure levels to exactly
the existing standard and proposed PEL,
respectively. However, in many cases,
indivisibilities in the application of
respirators, as well as certain types of
engineering controls, may cause
employers to reduce exposures to some
point below the existing standard or the
proposed PEL. This is particularly true
in the construction sector for employers
who opt to follow Table 1, which
specifies particular controls.
In order to examine the effect of
simply changing the PEL, OSHA
compared the number of various kinds
of cases that would occur if a worker
were exposed for an entire working life
to PELs of 50 mg/m3 or 100 mg/m3 to the
number of cases that would occur at
levels of exposure at or below the
25 Based on available data, the Agency estimated
the weighted average for the relevant exposure
groups to match up with the quantitative risk
assessment. For the 50–100 mg/m3 exposure range,
the Agency estimated an average exposure of 62.5
mg/m3. For the 100–250 mg/m3 range, the Agency
estimated an average exposure of 125 mg/m3.
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current PELs. The number of avoided
cases over a hypothetical working life of
exposure for the current population at a
lower PEL is then equal to the difference
between the number of cases at levels of
exposure at or below the current PEL for
that population minus the number of
cases at the lower PEL. This approach
represents a steady-state comparison
based on what would hypothetically
happen to workers who received a
specific average level of occupational
exposure to silica during an entire
working life. (In order to incorporate the
element of timing to assess the
economic value of the health benefits,
OSHA presents a modified approach
later in this section.)
Based on OSHA’s application of the
Steenland et al. (2001) log-linear and the
Attfield and Costello (2004) models,
Table VIII–17 shows the estimated
number of avoided fatal lung cancers for
PELs of 50 mg/m3 and 100 mg/m3. At the
proposed PEL of 50 mg/m3, an estimated
2,404 to 12,173 lung cancers would be
prevented over the lifetime of the
current worker population, with a
midpoint estimate of 7,289 fatal cancers
prevented. This is the equivalent of
between 53 and 271 cases avoided
annually, with a midpoint estimate of
162 cases avoided annually, given a 45year working life of exposure.
Following Park (2002), as discussed in
summary of the Agency’s QRA in
Section VI of this preamble, OSHA also
estimates that the proposed PEL of 50
mg/m3 would prevent an estimated
16,878 fatalities over a lifetime from
non-malignant respiratory diseases
arising from silica exposure. This is
equivalent to 375 fatal cases prevented
annually. Some of these fatalities would
be classified as silicosis, but most would
be classified as other pneumoconioses
and chronic obstructive pulmonary
disease (COPD), which includes chronic
bronchitis and emphysema.
As also discussed in the summary of
the Agency’s QRA in Section VI of this
preamble, OSHA finds that workers
with large exposures to silica are at
elevated risk of end-stage renal disease
(ESRD). Based on Steenland, Attfield,
and Mannetje (2002), OSHA estimates
that the proposed PEL of 50 mg/m3
would prevent 6,774 cases of end-stage
renal disease over a working life of
exposure, or about 151 cases annually.
Combining the three major fatal
health endpoints—for lung cancer, nonmalignant respiratory diseases, and endstage renal disease—OSHA estimates
that the proposed PEL would prevent
between 26,055 and 35,825 premature
fatalities over a lifetime, with a
midpoint estimate of 30,940 fatalities
prevented. This is the equivalent of
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between 579 and 796 premature
fatalities avoided annually, with a
midpoint estimate of 688 premature
fatalities avoided annually, given a 45year working life of exposure.
In addition, the rule would prevent a
large number of cases of silicosis
morbidity. Based on Rosenman et al.
(2003), the Agency estimates that
between 2,700 and 5,475 new cases of
silicosis, at an ILO X-ray rating of 1/0 or
higher, occur annually at the present
PELs as a result of silica exposure at
establishments within OSHA’s
jurisdiction. Based on the studies
summarized in OSHA’s QRA, OSHA
expects that the proposed rule will
eliminate the large majority of these
cases.
The Agency has not included the
elimination of the less severe silicosis
cases in its estimates of the monetized
benefits and net benefits of the proposed
rule. Instead, OSHA separately
estimated the number of silicosis cases
reaching the more severe levels of 2/1
and above. Based on a study by
Buchannan et al. (2003) of a cohort of
coal miners (as discussed in the
Agency’s QRA), OSHA estimates that
the proposed PEL of 50 mg/m3 would
prevent 71,307 cases of moderate-tosevere silicosis (registering 2/1 or more,
using the ILO method for assessing
severity) over a working life, or about
1,585 cases of moderate-to-severe
silicosis prevented annually.
Note that the Agency based its
estimates of reductions in the number of
silica-related diseases over a working
life of constant exposure for workers
who are employed in a respirable
crystalline silica-exposed occupation for
their entire working lives, from ages 20
to 65. While the Agency is legally
obligated to examine the effect of
exposures from a working lifetime of
exposure,26 in an alternative analysis
purely for informational purposes, the
Agency examined, in Chapter VII of the
PEA, the effect of assuming that workers
are exposed for only 25 working years,
as opposed to the 45 years assumed in
the main analysis. While all workers are
assumed to have less cumulative
exposure under the 25-years-of26 Section (6)(b)(5) of the OSH Act states: ‘‘The
Secretary, in promulgating standards dealing with
toxic materials or harmful physical agents under
this subsection, shall set the standard which most
adequately assures, to the extent feasible, on the
basis of the best available evidence, that no
employee will suffer material impairment of health
or functional capacity even if such employee has
regular exposure to the hazard dealt with by such
standard for the period of his working life.’’ Given
that it is necessary for OSHA to reach a
determination of significant risk over a working life,
it is a logical extension to estimate what this
translates into in terms of estimated benefits for the
affected population over the same period.
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exposure assumption, the effective
exposed population over time is
proportionately increased. Estimated
prevented cases of end-stage renal
disease and silicosis morbidity are
lower in the 25-year model, whereas
cases of fatal non-malignant lung
disease are higher. In the case of lung
cancer, the effect varies by model, with
a lower high-end estimate (Attfield &
Costello, 2004) and a higher low-end
estimate (Steenland et. al., 2001 loglinear model). Overall, however, the 45year-working-life assumption yields
larger estimates of the number of cases
of avoided fatalities and illnesses than
does the 25-years-of-exposure
assumption. For example, the midpoint
estimates of the number of avoided
fatalities and illnesses under the
proposed PEL of 50 mg/m3 would
decline from 688 and 1,585,
respectively, under the 45-year-workinglife assumption to 683 and 642,
respectively, under the 25-year-workinglife assumption. Note the effect, in this
case, of going from a 45-year-workinglife assumption to a 25-year-working-life
assumption would be a 1 percent
reduction in the number of avoided
fatalities and a 59 percent reduction in
the number of avoided illnesses. The
divergence reflects differences in the
mathematical structure of the risk
assessment models that are the basis for
these estimates.27
OSHA believes that 25 years of
worker exposure to respirable
crystalline silica may be a reasonable
alternative estimate for informational
purposes. However, to accommodate the
possibility that average worker exposure
to silica over a working life may be
shorter, at least in certain industries (see
the following paragraph), the Agency
also examined the effect of assuming
only 13 years of exposure for the
average worker. The results were
broadly similar to the 25 years of
exposure—annual fatalities prevented
were higher (788), but illnesses
prevented lower (399), with the lower
average cumulative exposure being
offset to a substantial degree by a larger
exposed population. The same effect is
seen if one assumes only 6.6 years of
cumulative exposure to silica for the
average worker: estimated fatalities rise
to 832 cases annually, with 385 cases of
27 Technically, this analysis assumes that workers
receive 25 years worth of silica exposure, but that
they receive it over 45 working years, as is assumed
by the risk models in the QRA. It also accounts for
the turnover implied by 25, as opposed to 45, years
of work. However, it is possible that an alternate
analysis, which accounts for the larger number of
post-exposure worker-years implied by workers
departing their jobs before the end of their working
lifetime, might find larger health effects for workers
receiving 25 years worth of silica exposure.
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silicosis morbidity. In short, the
aggregate estimated benefits of the rule
appear to be relatively insensitive to
implicit assumptions of average
occupational tenure. Nonetheless, the
Agency is confident that the typical
affected worker sustains an extended
period of exposure to silica.
Even in the construction industry,
which has an extremely high rate of job
turnover, the mean job tenure with one’s
current employer is 6.6 years (BLS,
2010a), and the median age of
construction workers in the U.S. is 41.6
years (BLS, 2010b). OSHA is unaware of
any data on job tenure within an
industry, but the Agency would expect
job tenure in the construction industry
would be at least twice the job tenure
with one’s current employer.
Furthermore, many workers may return
to the construction industry after
unemployment or work in another
industry. Of course, job tenure is longer
in the other industries affected by the
proposed rule.
The proposed rule also contains
specific provisions for diagnosing latent
tuberculosis (TB) in the silica-exposed
population and thereby reducing the
risk of TB being spread to the
population at large. The Agency
currently lacks good methods for
quantifying these benefits. Nor has the
Agency attempted to assess benefits
directly stemming from enhanced
medical surveillance in terms of
reducing the severity of symptoms from
the illnesses that do result from present
or future exposure to silica. However,
the Agency welcomes comment on the
likely magnitude of these currently nonquantified health benefits arising from
the proposed rule and on methods for
better measuring these effects.
OSHA’s risk estimates are based on
application of exposure-response
models derived from several individual
epidemiological studies as well as the
pooled cohort studies of Steenland et al.
(2001) and Mannetje et al. (2002). OSHA
recognizes that there is uncertainty
around any of the point estimates of risk
derived from any single study. In its
preliminary risk assessment
(summarized in Section VI of this
preamble), OSHA has made efforts to
characterize some of the more important
sources of uncertainty to the extent that
available data permit. This specifically
includes characterizing statistical
uncertainty by reporting the confidence
intervals around each of the risk
estimates; by quantitatively evaluating
the impact of uncertainties in
underlying exposure data used in the
cohort studies; and by exploring the use
of alternative exposure-response model
forms. OSHA believes that these efforts
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56385
reflect much, but not necessarily all, of
the uncertainties associated with the
approaches taken by investigators in
their respective risk analyses. However,
OSHA believes that characterizing the
risks and benefits as a range of estimates
derived from the full set of available
studies, rather than relying on any
single study as the basis for its
estimates, better reflects the
uncertainties in the estimates and more
fairly captures the range of risks likely
to exist across a wide range of industries
and exposure situations.
Another source of uncertainty
involves the degree to which OSHA’s
risk estimates reflect the risk of disease
among workers with widely varying
exposure patterns. Some workers are
exposed to fairly high concentrations of
crystalline silica only intermittently,
while others experience more regular
and constant exposure. Risk models
employed in the quantitative assessment
are based on a cumulative exposure
metric, which is the product of average
daily silica concentration and duration
of worker exposure for a specific job.
Consequently, these models predict the
same risk for a given cumulative
exposure regardless of the pattern of
exposure, reflecting a worker’s longterm average exposure without regard to
intermittencies or other variances in
exposure, and are therefore generally
applicable to all workers who are
exposed to silica in the various
industries. Section VI of this preamble
provides evidence supporting the use of
cumulative exposure as the preferred
dose metric. Although the Agency
believes that the results of its risk
assessment are broadly relevant to all
occupational exposure situations
involving crystalline silica, OSHA
acknowledges that differences exist in
the relative toxicity of crystalline silica
particles present in different work
settings due to factors such as the
presence of mineral or metal impurities
on quartz particle surfaces, whether the
particles have been freshly fractured or
are aged, and size distribution of
particles. However, in its preliminary
risk assessment, OSHA preliminarily
concludes that the estimates from the
studies and analyses relied upon are
fairly representative of a wide range of
workplaces reflecting differences in
silica polymorphism, surface properties,
and impurities.
Thus, OSHA has a high degree of
confidence in the risk estimates
associated with exposure to the current
and proposed PELs. OSHA
acknowledges there is greater
uncertainty in the risk estimates for the
proposed action level of 0.025 mg/m3
than exists at the current (0.1 mg/m3)
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and proposed (0.05 mg/m3) PELs,
particularly given some evidence of a
threshold for silicosis between the
proposed PEL and action level. Given
the Agency’s findings that controlling
exposures below the proposed PEL
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would not be technologically feasible
for employers, OSHA believes that a
precise estimate of the risk for
exposures below the proposed action
level is not necessary to further inform
the Agency’s regulatory action. OSHA
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requests comment on remaining sources
of uncertainties in its risk and benefits
estimates that have not been specifically
characterized by OSHA in its analysis.
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Estimated Number of Avoided Fatal & Nonfatal Illnesses Resulting from a Reduction in Crystalline Silica Exposure of At-Risk Workers over a 45-Year Working Life Due to Proposed PEL of 50
3
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IJg/m and Alternative PEL of 100 IJg/m
3
Total Number of Avoided Cases
Frm 00115
50
Fmt 4701
Sfmt 4725
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Construction
2,636
1,437
238
6,563
3,719
875
6,277
3,573
869
13,944
2,934
8,490
6,774
5,722
1,052
35,825
30,940
26,055
29,203
25,517
21,831
71,307
48,617
Construction
12,173
7,289
2,404
9,537
5,852
2,166
Silicosis & Other Non-Malignant Respiratory
Diseases
16,878
End Stage Renal Disease
Total Number of Fatal Illnesses Prevented
High
Midpoint
Low
Total Number of Silicosis Morbidity Cases
Prevented'
GI&
Total
Total
Lung Cancers
High
Midpoint
Low
100
50
GI&
Annual Number of Avoided Cases
100
Total
Construction
286
146
6
271
162
53
212
130
48
8,403
87
375
2,684
2,655
29
6,622
5,423
4,224
17,737
14,893
12,049
17,335
14,631
11,927
22,689
42,881
41,375
Maritime
GI&
GI&
Total
Construction
59
32
5
146
83
19
139
79
19
6
3
0
310
65
189
187
2
151
127
23
60
59
1
402
262
122
796
688
579
649
567
485
147
121
94
394
331
268
385
325
265
9
6
3
1,506
1,585
1,080
504
953
919
33
Maritime
*Assessed at 2/1 or higher X-ray, following ILO criteria
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Maritime
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Table VIII-17
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2. Estimating the Stream of Benefits
Over Time
Risk assessments in the occupational
environment are generally designed to
estimate the risk of an occupationally
related illness over the course of an
individual worker’s lifetime. As
previously discussed, the current
occupational exposure profile for a
particular substance for the current
cohort of workers can be matched up
against the expected profile after the
proposed standard takes effect, creating
a ‘‘steady state’’ estimate of benefits.
However, in order to annualize the
benefits for the period of time after the
silica rule takes effect, it is necessary to
create a timeline of benefits for an entire
active workforce over that period.
In order to characterize the magnitude
of benefits before the steady state is
reached, OSHA created a linear phasein model to reflect the potential timing
of benefits. Specifically, OSHA
estimated that, for all non-cancer cases,
while the number of cases would
gradually decline as a result of the
proposed rule, they would not reach the
steady-state level until 45 years had
passed. The reduction in cases
estimated to occur in any given year in
the future was estimated to be equal to
the steady-state reduction (the number
of cases in the baseline minus the
number of cases in the new steady state)
times the ratio of the number of years
since the standard was implemented
and a working life of 45 years.
Expressed mathematically:
Nt=(C—S) × (t/45),
where Nt is the number of nonmalignant silica-related diseases
avoided in year t; C is the current
annual number of non-malignant silicarelated diseases; S is the steady-state
annual number of non-malignant silicarelated diseases; and t represents the
number of years after the proposed
standard takes effect, with t≤45.
In the case of lung cancer, the
function representing the decline in the
number of cases as a result of the
proposed rule is similar, but there
would be a 15-year lag before any
reduction in cancer cases would be
achieved. Expressed mathematically, for
lung cancer:
Lt=(Cm—Sm) x ((t-15)/45)),
where 15 ≤ t ≤ 60 and Lt is the number
of lung cancer cases avoided in year t
as a result of the proposed rule; Cm is
the current annual number of silicarelated lung cancers; and Sm is the
steady-state annual number of silicarelated lung cancers.
A more complete discussion of the
functioning and results of this model is
presented in Chapter VII of the PEA.
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This model was extended to 60 years
for all the health effects previously
discussed in order to incorporate the 15year lag, in the case of lung cancer, and
a 45-year working life. As a practical
matter, however, there is no overriding
reason for stopping the benefits analysis
at 60 years. An internal analysis by
OSHA indicated that, both in terms of
cases prevented, and even with regard
to monetized benefits, particularly when
lower discount rates are used, the
estimated benefits of the standard are
noticeably larger on an annualized basis
if the analysis extends further into the
future. The Agency welcomes comment
on the merit of extending the benefits
analysis beyond the 60 years analyzed
in the PEA.
In order to compare costs to benefits,
OSHA assumes that economic
conditions remain constant and that
annualized costs—and the underlying
costs—will repeat for the entire 60-year
time horizon used for the benefits
analysis (as discussed in Chapter V of
the PEA). OSHA welcomes comments
on the assumption for both the benefit
and cost analysis that economic
conditions remain constant for sixty
years. OSHA is particularly interested in
what assumptions and time horizon
should be used instead and why.
3. Monetizing the Benefits
To estimate the monetary value of the
reductions in the number of silicarelated fatalities, OSHA relied, as OMB
recommends, on estimates developed
from the willingness of affected
individuals to pay to avoid a marginal
increase in the risk of fatality. While a
willingness-to-pay (WTP) approach
clearly has theoretical merit, it should
be noted that an individual’s
willingness to pay to reduce the risk of
fatality would tend to underestimate the
total willingness to pay, which would
include the willingness of others—
particularly the immediate family—to
pay to reduce that individual’s risk of
fatality.28
For estimates using the willingnessto-pay concept, OSHA relied on existing
studies of the imputed value of fatalities
avoided based on the theory of
compensating wage differentials in the
labor market. These studies rely on
certain critical assumptions for their
accuracy, particularly that workers
28 See, for example, Thaler and Rosen (1976), pp.
265–266. In addition, see Sunstein (2004), p. 433.
‘‘This point demonstrates a general and badly
neglected problem for WTP as it is currently used:
agencies consider people’s WTP to eliminate
statistical risks, without taking account of the fact
that others—especially family members and close
friends—would also be willing to pay something to
eliminate those risks.’’
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understand the risks to which they are
exposed and that workers have
legitimate choices between high- and
low-risk jobs. These assumptions are far
from obviously met in actual labor
markets.29 A number of academic
studies, as summarized in Viscusi &
Aldy (2003), have shown a correlation
between higher job risk and higher
wages, suggesting that employees
demand monetary compensation in
return for a greater risk of injury or
fatality. The estimated trade-off between
lower wages and marginal reductions in
fatal occupational risk—that is, workers’
willingness to pay for marginal
reductions in such risk—yields an
imputed value of an avoided fatality: the
willingness-to-pay amount for a
reduction in risk divided by the
reduction in risk.30 OSHA has used this
approach in many recent proposed and
final rules. Although this approach has
been found to yield results that are less
than statistically robust (see, for
example, Hintermann, Alberini and
Markandya, 2010), OSHA views these
estimates as the best available, and will
use them for its basic estimates. OSHA
welcomes comments on the use of
willingness-to-pay measures and
estimates based on compensating wage
differentials.
Viscusi & Aldy (2003) conducted a
meta-analysis of studies in the
economics literature that use a
willingness-to-pay methodology to
estimate the imputed value of lifesaving programs and found that each
fatality avoided was valued at
approximately $7 million in 2000
dollars. This $7 million base number in
2000 dollars yields an estimate of $8.7
million in 2009 dollars for each fatality
avoided.31
In addition to the benefits that are
based on the implicit value of fatalities
avoided, workers also place an implicit
value on occupational injuries or
illnesses avoided, which reflect their
29 On the former assumption, see the discussion
in Chapter II of the PEA on imperfect information.
On the latter, see, for example, the discussion of
wage compensation for risk for union versus
nonunion workers in Dorman and Hagstrom (1998).
30 For example, if workers are willing to pay $50
each for a 1/100,000 reduction in the probability of
dying on the job, then the imputed value of an
avoided fatality would be $50 divided by 1/100,000,
or $5,000,000. Another way to consider this result
would be to assume that 100,000 workers made this
trade-off. On average, one life would be saved at a
cost of $5,000,000.
31 An alternative approach to valuing an avoided
fatality is to monetize, for each year that a life is
extended, an estimate from the economics literature
of the value of that statistical life-year (VSLY). See,
for instance, Aldy and Viscusi (2007) for discussion
of VSLY theory and FDA (2003), pp. 41488–9, for
an application of VSLY in rulemaking. OSHA has
not investigated this approach, but welcomes
comment on the issue.
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willingness to pay to avoid monetary
costs (for medical expenses and lost
wages) and quality-of-life losses as a
result of occupational illness. Silicosis,
lung cancer, and renal disease can
adversely affect individuals for years or
even decades in non-fatal cases, or
before ultimately proving fatal. Because
measures of the benefits of avoiding
these illnesses are rare and difficult to
find, OSHA has included a range based
on a variety of estimation methods.
Consistent with Buchannan et al.
(2003), OSHA estimated the total
number of moderate to severe silicosis
cases prevented by the proposed rule, as
measured by 2/1 or more severe X-rays
(based on the ILO rating system).
However, while radiological evidence of
moderate to severe silicosis is evidence
of significant material impairment of
health, placing a precise monetary value
on this condition is difficult, in part
because the severity of symptoms may
vary significantly among individuals.
For that reason, for this preliminary
analysis, the Agency employed a broad
range of valuation, which should
encompass the range of severity these
individuals may encounter. Using the
willingness-to-pay approach, discussed
in the context of the imputed value of
fatalities avoided, OSHA has estimated
a range in valuations (updated and
reported in 2009 dollars) that runs from
approximately $62,000 per case—which
reflects estimates developed by Viscusi
and Aldy (2003), based on a series of
studies primarily describing simple
accidents—to upwards of $5.1 million
per case—which reflects work
developed by Magat, Viscusi & Huber
(1996) for non-fatal cancer. The latter
number is based on an approach that
places a willingness-to-pay value to
avoid serious illness that is calibrated
relative to the value of an avoided
fatality. OSHA (2006) previously used
this approach in the Final Economic
Analysis (FEA) supporting its
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hexavalent chromium final rule, and
EPA (2003) used this approach in its
Stage 2 Disinfection and Disinfection
Byproducts Rule concerning regulation
of primary drinking water. Based on
Magat, Viscusi & Huber (1996), EPA
used studies on the willingness-to-pay
to avoid nonfatal lymphoma and
chronic bronchitis as a basis for valuing
a case of nonfatal cancer at 58.3 percent
of the value of a fatal cancer. OSHA’s
estimate of $5.1 million for an avoided
case of non-fatal cancer is based on this
58.3 percent figure.
The Agency believes this range of
estimates is descriptive of the value of
preventing morbidity associated with
moderate to severe silicosis, as well as
the morbidity preceding mortality due
to other causes enumerated here—lung
cancer, lung diseases other than cancer,
and renal disease.32 OSHA therefore is
applying these values to those situations
as well.
The Agency is interested in public
input on the issue of valuing the cost to
society of non-fatal cases of moderate to
severe silicosis, as well as the morbidity
associated with other related diseases of
the lung, and with renal disease.
a. The Monetized Benefits of the
Proposed Rule
Table VIII–18 presents the estimated
annualized (over 60 years, using a 0
percent discount rate) benefits from
each of these components of the
valuation, and the range of estimates,
based on risk model uncertainty
(notably in the case of lung cancer), and
the range of uncertainty regarding
valuation of morbidity. (Mid-point
estimates of the undiscounted benefits
for each of the first 60 years are
32 There are several benchmarks for valuation of
health impairment due to silica exposure, using a
variety of techniques, which provide a number of
mid-range estimates between OSHA’s high and low
estimates. For a fuller discussion of these estimates,
see Chapter VII of the PEA.
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56389
provided in the middle columns of
Table VII–A–1 in Appendix VII–A in
the PEA. The estimates by year reach a
peak of $11.9 billion in the 60th year.)
As shown, the full range of monetized
benefits, undiscounted, for the proposed
PEL of 50 mg/m3 runs from $3.2 billion
annually, in the case of the lowest
estimate of lung cancer risk and the
lowest valuation for morbidity, up to
$10.9 billion annually, for the highest of
both. Note that the value of total
benefits is more sensitive to the
valuation of morbidity (ranging from
$3.5 billion to $10.3 billion, given
estimates at the midpoint of the lung
cancer models) than to the lung cancer
model used (ranging from $6.4 to $7.4
billion, given estimates at the midpoint
of the morbidity valuation).33
This comports with the very wide
range of valuation for morbidity. At the
low end of the valuation range, the total
value of benefits is dominated by
mortality ($3.4 billion out of $3.5 billion
at the case frequency midpoint),
whereas at the high end the majority of
the benefits are related to morbidity
($6.9 billion out of $10.3 billion at the
case frequency midpoint). Also, the
analysis illustrates that most of the
morbidity benefits are related to
silicosis cases that are not ultimately
fatal. At the valuation and case
frequency midpoint, $3.4 billion in
benefits are related to mortality, $1.0
billion are related to morbidity
preceding mortality, and $2.4 billion are
related to morbidity not preceding
mortality.
33 As previously indicated, these valuations
include all the various estimated health endpoints.
In the case of mortality this includes lung cancer,
non-malignant respiratory disease and end-stage
renal disease. The Agency highlighted lung cancers
in this discussion due to the model uncertainty. In
calculating the monetized benefits, the Agency is
typically referring to the midpoint of the high and
low ends of potential valuation—in this case, the
undiscounted midpoint of $3.2 billion and $10.9
billion..
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Estimated Annualized Undiscounted Monetized Benefits of the Silica Proposal for Morbidity and Mortality
Low
3
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12SEP2
imputed value of avoided fatalities and
avoided diseases will tend to increase
over time. Two related factors suggest
such an increase in value over time.
First, economic theory suggests that
the value of reducing life-threatening
E:\FR\FM\12SEP2.SGM
disease. To this point, these imputed
values have been assumed to remain
constant over time.
OSHA now would like to suggest that
an adjustment be made to monetized
benefits to reflect the fact that the
PO 00000
Hi h
Low
100 j.Jg/m
Valuation
Midpoint
$3,074,165,270
$3,436,186,835
$3,798,208,401
$3,074,165,270
$3,436,186,835
$3,798,208,401
$1,433,022,347
$1,643,786,936
$1,643,786,936
$1,433,022,347
$1,643,786,936
$1,643,786,936
$1,433,022,347
$1,643,786,936
$1,643,786,936
$912,002,363
$1,019,402,094
$1,126,801,826
$1,802,096,882
$2,014,316,421
$2,226,535,959
$10,212,343
$11,714,344
$11,714,344
$425,129,963
$487,656,791
$487,656,791
$840,047,583
$963,599,238
$963,599,238
$2,449,641,696
$4,840,438,842
$35,733,901
$1,487,567,728
$2,939,401,554
$6,435,809,329 $9,716,700,994
$6,905,230,626 $10,290,942,098
$7,374,651,923 $10,865,183,202
$1,478,968,592
$1,691,235,181
$1,691,235,181
$3,345,720,038
$3,619,011,454
$3,619,011,454
$5,212,471,484
$5,546,787,728
$5,546,787,728
50 j.Jg/m
Valuation
Mid oint
Hiah
Cases
Fatalities - Total
Low
Midpoint
High
$3,074,165,270
$3,436,186,835
$3,798,208,401
Morbidity Preceding Mortality
Low
Midpoint
High
$21,907,844
$24,487,768
$27,067,692
Morbidity Not Preceding Mortality
Total
EP12SE13.009</GPH>
3
PEL
TOTAL
Low
Midpoint
High
$58,844,551
$3,154,917,665
$3,519,519,154
$3,884,120,643
Source: U.S. Department of Labor, Occupational Safety and Health Administration, Directorate of Evaluation and Analysis, Office of
Regulatory Analysis
Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules
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b. A Suggested Adjustment to
Monetized Benefits
19:12 Sep 11, 2013
OSHA’s estimates of the monetized
benefits of the proposed rule are based
on the imputed value of each avoided
fatality and each avoided silica-related
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TABLE VIII-18
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and health-threatening risks will
increase as real per capita income
increases. With increased income, an
individual’s health and life become
more valuable relative to other goods
because, unlike other goods, they are
without close substitutes and in
relatively fixed or limited supply.
Expressed differently, as income
increases, consumption will increase
but the marginal utility of consumption
will decrease. In contrast, added years
of life (in good health) is not subject to
the same type of diminishing returns—
implying that an effective way to
increase lifetime utility is by extending
one’s life and maintaining one’s good
health (Hall and Jones, 2007).
Second, real per capita income has
broadly been increasing throughout U.S.
history, including recent periods. For
example, for the period 1950 through
2000, real per capita income grew at an
average rate of 2.31 percent a year (Hall
and Jones, 2007) 34 although real per
capita income for the recent 25 year
period 1983 through 2008 grew at an
average rate of only 1.3 percent a year
(U.S. Census Bureau, 2010). More
important is the fact that real U.S. per
capita income is projected to grow
significantly in future years. For
example, the Annual Energy Outlook
(AEO) projections, prepared by the
Energy Information Administration
(EIA) in the Department of Energy
(DOE), show an average annual growth
rate of per capita income in the United
States of 2.7 percent for the period
2011–2035.35 The U.S. Environmental
Protection Agency prepared its
economic analysis of the Clean Air Act
using the AEO projections. Although
these estimates may turn out to be
somewhat higher or lower than
predicted, OSHA believes that it is
reasonable to use the same AEO
projections employed by DOE and EPA,
and correspondingly projects that per
capita income in the United States will
increase by 2.7 percent a year.
On the basis of the predicted increase
in real per capita income in the United
States over time and the expected
resulting increase in the value of
avoided fatalities and diseases, OSHA is
considering adjusting its estimates of
34 The results are similar if the historical period
includes a major economic downturn (such as the
United States has recently experienced). From 1929
through 2003, a period in U.S. history that includes
the Great Depression, real per capita income still
grew at an average rate of 2.22 percent a year
(Gomme and Rupert, 2004).
35 The EIA used DOE’s National Energy Modeling
System (NEMS) to produce the Annual Energy
Outlook (AEO) projections (EIA, 2011). Future per
capita GDP was calculated by dividing the projected
real gross domestic product each year by the
projected U.S. population for that year.
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the benefits of the proposed rule to
reflect the anticipated increase in their
value over time. This type of adjustment
has been recognized by OMB (2003),
supported by EPA’s Science Advisory
Board (EPA, 2000), and applied by
EPA.36 OSHA proposes to accomplish
this adjustment by modifying benefits in
year i from [Bi] to [Bi * (1 + h)i], where
‘‘h’’ is the estimated annual increase in
the magnitude of the benefits of the
proposed rule.
What remains is to estimate a value
for ‘‘h’’ with which to increase benefits
annually in response to annual
increases in real per capita income.
Probably the most direct evidence of the
value of ‘‘h’’ comes from the work of
Costa and Kahn (2003, 2004). They
estimate repeated labor market
compensating wage differentials from
cross-sectional hedonic regressions
using census and fatality data from the
Bureau of Labor Statistics for 1940,
1950, 1960, 1970, and 1980. In addition,
with the imputed income elasticity of
the value of life on per capita GNP of
1.7 derived from the 1940–1980 data,
they then predict the value of an
avoided fatality in 1900, 1920, and
2000. Given the change in the value of
an avoided fatality over time, it is
possible to estimate a value of ‘‘h’’ of 3.4
percent a year from 1900–2000; of 4.3
percent a year from 1940–1980; and of
2.5 percent a year from 1980–2000.
Other, more indirect evidence comes
from estimates in the economics
literature on the income elasticity for
the value of a statistical life. Viscusi and
Aldy (2003) performed a meta-analysis
on 50 wage-risk studies and concluded
that the point estimates across a variety
of model specifications ranged between
0.5 and 0.6. Applied to a long-term
increase in per capita income of about
2.7 percent a year, this would suggest a
value of ‘‘h’’ of about 1.5 percent a year.
More recently, Kniesner, Viscusi, and
Ziliak (2010), using panel data quintile
regressions, developed an estimate of
the overall income elasticity of the value
of a statistical life of 1.44. Applied to a
long-term increase in per capita income
of about 2.7 percent a year, this would
suggest a value of ‘‘h’’ of about 3.9
percent a year.
Based on the preceding discussion of
these two approaches for estimating the
annual increase in the value of the
benefits of the proposed rule and the
fact that, as previously noted, the
projected increase in real per capita
income in the United States has
flattened in the most recent 25 year
period, OSHA suggests a value of ‘‘h’’ of
approximately 2 percent a year. The
36 See,
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for example, EPA (2003, 2008).
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56391
Agency invites comment on this
estimate and on estimates of the income
elasticity of the value of a statistical life.
While the Agency believes that the
rising value, over time, of health
benefits is a real phenomenon that
should be taken into account in
estimating the annualized benefits of the
proposed rule, OSHA is at this time
only offering these adjusted monetized
benefits as analytic alternatives for
consideration. Table VIII–19, which
follows the discussion on discounting
monetized benefits, shows estimates of
the monetized benefits of the proposed
rule (under alternative discount rates)
both with and without this suggested
increase in monetized benefits over
time. The Agency invites comment on
this suggested adjustment to monetized
benefits.
4. Discounting of Monetized Benefits
As previously noted, the estimated
stream of benefits arising from the
proposed silica rule is not constant from
year to year, both because of the 45-year
delay after the rule takes effect until all
active workers obtain reduced silica
exposure over their entire working lives
and because of, in the case of lung
cancer, a 15-year latency period
between reduced exposure and a
reduction in the probability of disease.
An appropriate discount rate 37 is
needed to reflect the timing of benefits
over the 60-year period after the rule
takes effect and to allow conversion to
an equivalent steady stream of
annualized benefits.
a. Alternative Discount Rates for
Annualizing Benefits
Following OMB (2003) guidelines,
OSHA has estimated the annualized
benefits of the proposed rule using
separate discount rates of 3 percent and
7 percent. Consistent with the Agency’s
own practices in recent proposed and
final rules, OSHA has also estimated, for
benchmarking purposes, undiscounted
benefits—that is, benefits using a zero
percent discount rate.
The question remains, what is the
‘‘appropriate’’ or ‘‘preferred’’ discount
rate to use to monetize health benefits?
The choice of discount rate is a
controversial topic, one that has been
the source of scholarly economic debate
for several decades. However, in
simplest terms, the basic choices
involve a social opportunity cost of
capital approach or social rate of time
preference approach.
37 Here and elsewhere throughout this section,
unless otherwise noted, the term ‘‘discount rate’’
always refers to the real discount rate—that is, the
discount rate net of any inflationary effects.
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The social opportunity cost of capital
approach reflects the fact that private
funds spent to comply with government
regulations have an opportunity cost in
terms of foregone private investments
that could otherwise have been made.
The relevant discount rate in this case
is the pre-tax rate of return on the
foregone investments (Lind, 1982b, pp.
24–32). The rate of time preference
approach is intended to measure the
tradeoff between current consumption
and future consumption, or in the
context of the proposed rule, between
current benefits and future benefits. The
individual rate of time preference is
influenced by uncertainty about the
availability of the benefits at a future
date and whether the individual will be
alive to enjoy the delayed benefits. By
comparison, the social rate of time
preference takes a broader view over a
longer time horizon—ignoring
individual mortality and the riskiness of
individual investments (which can be
accounted for separately) .
The usual method for estimating the
social rate of time preference is to
calculate the post-tax real rate of return
on long-term, risk-free assets, such as
U.S. Treasury securities (OMB, 2003). A
variety of studies have estimated these
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19:12 Sep 11, 2013
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rates of return over time and reported
them to be in the range of approximately
1–4 percent.
In accordance with OMB Circular A–
4 (2003), OSHA presents benefits and
net benefits estimates using discount
rates of 3 percent (representing the
social rate of time preference) and 7
percent (a rate estimated using the
social cost of capital approach). The
Agency is interested in any evidence,
theoretical or applied, that would
inform the application of discount rates
to the costs and benefits of a regulation.
b. Summary of Annualized Benefits
Under Alternative Discount Rates
Table VIII–19 presents OSHA’s
estimates of the sum of the annualized
benefits of the proposed rule, using
alternative discount rates at 0, 3, and 7
percent, with a breakout between
construction and general industry, and
including the possible alternative of
increasing monetized benefits in
response to annual increases in per
capita income over time.
Given that the stream of benefits
extends out 60 years, the value of future
benefits is sensitive to the choice of
discount rate. As previously established
in Table VIII–18, the undiscounted
benefits range from $3.2 billion to $10.9
PO 00000
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billion annually. Using a 7 percent
discount rate, the annualized benefits
range from $1.6 billion to $5.4 billion.
As can be seen, going from
undiscounted benefits to a 7 percent
discount rate has the effect of cutting
the annualized benefits of the proposed
rule approximately in half.
The Agency’s best estimate of the total
annualized benefits of the proposed
rule—using a 3 percent discount rate
with no adjustment for the increasing
value of health benefits over time— is
between $2.4 and $8.1 billion, with a
mid-point value of $5.3 billion.
As previously mentioned, OSHA has
not attempted to estimate the monetary
value of less severe silicosis cases,
measured at 1/0 to 1/2 on the ILO scale.
The Agency believes the economic loss
to individuals with less severe cases of
silicosis could be substantial, insofar as
they may be accompanied by a lifetime
of medical surveillance and lung
damage, and potentially may require a
change in career. However, many of
these effects can be difficult to isolate
and measure in economic terms,
particularly in those cases where there
is no obvious effect yet on physiological
function or performance. The Agency
invites public comment on this issue.
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Total Annual Monetized Benefits Resulting from a Reduction in Exposure to Crystalline Silica
Jkt 229001
Due to Proposed PEL of 50 Ilg/m3 and Alternative PEL of 100 Ilg/m3
($Billions)
PO 00000
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E:\FR\FM\12SEP2.SGM
12SEP2
Discount Rate
Range
Total
Construction
UndiscOlmted (0%)
Low
Midpoint
High
Low
Midpoint
High
Low
Midpoint
High
Low
Midpoint
High
Low
Midpoint
High
$3.2
$7.0
$lO.9
$2.9
$6.4
$9.9
$2.4
$5.3
$8.1
$2.0
$4.3
$6.6
$1.6
$3.5
$5.4
$2.6
$5.4
$8.2
$2.4
$5.0
$7.5
$2.0
$4.1
$6.1
$1.6
$3.3
$5.0
$1.3
$2.7
$4.1
Discounted at 3%, with a
suggested increased in
monetized benefits over time
Discounted at 3%
Discounted at 7%, with a
suggested increased in
monetized benefits over time
Discounted at 7%
100
50
PEL
GI&
Maritime
$0.5
$1.6
$2.7
$0.5
$1.5
$2.4
$0.4
$1.2
$2.0
$0.3
$1.0
$1.6
$0.3
$0.8
$1.3
Total
Construction
G I & Maritime
$1.5
$3.7
$5.9
$1.4
$3.4
$5.4
$1.1
$2.8
$4.4
$0.9
$2.2
$3.6
$0.8
$1.8
$2.9
$1.5
$3.6
$5.7
$1.3
$3.3
$5.2
$1.1
$2.7
$4.3
$0.9
$2.2
$3.5
$0.8
$1.8
$2.8
$0.0
$0.1
$0.2
$0.0
$0.1
$0.1
$0.0
$0.1
$0.1
$0.0
$0.1
$0.1
$0.0
$0.0
$0.1
Source: U.S. Department of Labor, Occupational Safety and Health Administration, Directorate of Evaluation and Analysis, Office of Regulatory
Analysis
Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules
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Table VIII-19
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Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules
5. Net Benefits of the Proposed Rule
OSHA has estimated, in Table VIII–
20, the net benefits of the proposed rule
(with a PEL of 50 mg/m3), based on the
benefits and costs previously presented.
Table VIII–20 also provides estimates of
annualized net benefits for an
alternative PEL of 100 mg/m3. Both the
proposed rule and the alternative rule
have the same ancillary provisions and
an action level equal to half of the PEL
in both cases.
Table VIII–20 is being provided for
informational purposes only. As
previously noted, the OSH Act requires
the Agency to set standards based on
eliminating significant risk to the extent
feasible. An alternative criterion of
maximizing net (monetized) benefits
may result in very different regulatory
outcomes. Thus, this analysis of net
benefits has not been used by OSHA as
the basis for its decision concerning the
choice of a PEL or of other ancillary
requirements for this proposed silica
rule.
Table VIII–20 shows net benefits
using alternative discount rates of 0, 3,
and 7 percent for benefits and costs and
includes a possible adjustment to
monetized benefits to reflect increases
in real per capita income over time. (An
expanded version of Tables VIII–20,
with a breakout of net benefits between
construction and general industry/
maritime, is provided in Table VII–B–1
in Appendix B, of the PEA.) OSHA has
relied on a uniform discount rate
applied to both costs and benefits. The
Agency is interested in any evidence,
theoretical or applied, that would
support or refute the application of
differential discount rates to the costs
and benefits of a regulation.
As previously noted, the choice of
discount rate for annualizing benefits
has a significant effect on annualized
benefits. The same is true for net
benefits. For example, the net benefits
using a 7 percent discount rate for
benefits are considerably smaller than
the net benefits using a 0 percent
discount rate, declining by more than
half under all scenarios. (Conversely, as
noted in Chapter V of the PEA, the
choice of discount rate for annualizing
costs has only a very minor effect on
annualized costs.)
Based on the results presented in
Table VIII–20, OSHA finds:
• While the net benefits of the
proposed rule vary considerably—
depending on the choice of discount
rate used to annualize benefits and on
whether the benefits being used are in
the high, midpoint, or low range—
benefits exceed costs for the proposed
50 mg/m3 PEL in all cases that OSHA
considered.
• The Agency’s best estimate of the
net annualized benefits of the proposed
rule—using a uniform discount rate for
both benefits and costs of 3 percent—is
between $1.8 billion and $7.5 billion,
with a midpoint value of $4.6 billion.
• The alternative of a 100 mg/m3 PEL
was found to have lower net benefits
under all assumptions, relative to the
proposed 50 mg/m3 PEL. However, for
this alternative PEL, benefits were found
to exceed costs in all cases that OSHA
considered.
6. Incremental Benefits of the Proposed
Rule
Incremental costs and benefits are
those that are associated with increasing
the stringency of the standard. A
comparison of incremental benefits and
costs provides an indication of the
relative efficiency of the proposed PEL
and the alternative PEL. Again, OSHA
has conducted these calculations for
informational purposes only and has not
used this information as the basis for
selecting the PEL for the proposed rule.
OSHA provided, in Table VIII–20,
estimates of the net benefits of an
alternative 100 mg/m3 PEL. The
incremental costs, benefits, and net
benefits of going from a 100 mg/m3 PEL
to a 50 mg/m3 PEL (as well as meeting
a 50 mg/m3 PEL and then going to a 25
mg/m3 PEL—which the Agency has
determined is not feasible), for
alternative discount rates of 3 and 7
percent, are presented in Tables VIII–21
and VIII–22. Table VIII–21 breaks out
costs by provision and benefits by type
of disease and by morbidity/mortality,
while Table VIII–22 breaks out costs and
benefits by major industry sector. As
Table VIII–21 shows, at a discount rate
of 3 percent, a PEL of 50 mg/m3, relative
to a PEL of 100 mg/m3, imposes
additional costs of $339 million per
year; additional benefits of $2.5 billion
per year, and additional net benefits of
$2.16 billion per year. The proposed
PEL of 50 mg/m3 also has higher net
benefits using either a 3 percent or 7
percent discount rate.
Table VIII–22 continues this
incremental analysis but with
breakdowns between construction and
general industry/maritime. This table
shows that construction provides most
of the incremental costs, but the
incremental benefits are more evenly
divided between the two sectors.
Nevertheless, both sectors show strong
positive net benefits, which are greater
for the proposed PEL of 50 mg/m3 than
the alternative of 100 mg/m3.
Tables VIII–21 and VIII–22
demonstrate that, across all discount
rates, there are net benefits to be
achieved by lowering exposures to 100
mg/m3 and then, in turn, lowering them
further to 50 mg/m3. However, the
majority of the benefits and costs
attributable to the proposed rule are
from the initial effort to lower exposures
to 100 mg/m3. Consistent with the
previous analysis, net benefits decline
across all increments as the discount
rate for annualizing benefits increases.
In addition to examining alternative
PELs, OSHA also examined alternatives
to other provisions of the standard.
These alternatives are discussed in
Section VIII.H of this preamble.
TABLE VIII–20—ANNUAL MONETIZED NET BENEFITS RESULTING FROM A REDUCTION IN EXPOSURE TO CRYSTALLINE
SILICA DUE TO PROPOSED PEL OF 50 μg/m3 AND ALTERNATIVE PEL OF 100 μg/m3
[$Billions]
PEL
50
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Discount rate
Undiscounted (0%) ...................................................
Low ...........................................................................
Midpoint ....................................................................
High ..........................................................................
Low ...........................................................................
Midpoint ....................................................................
High ..........................................................................
Low ...........................................................................
Midpoint ....................................................................
High ..........................................................................
100
Range
Discounted at 3%, with a suggested increased in
monetized benefits over time.
3% .............................................................................
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$2.5
6.4
10.2
2.3
5.8
9.3
1.8
4.6
7.5
12SEP2
$1.2
3.4
5.6
1.1
3.1
5.1
0.8
2.5
4.1
Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules
56395
TABLE VIII–20—ANNUAL MONETIZED NET BENEFITS RESULTING FROM A REDUCTION IN EXPOSURE TO CRYSTALLINE
SILICA DUE TO PROPOSED PEL OF 50 μg/m3 AND ALTERNATIVE PEL OF 100 μg/m3—Continued
[$Billions]
PEL
50
Discount rate
Discounted at 7%, with a suggested increased in
monetized benefits over time.
Low ...........................................................................
Midpoint ....................................................................
High ..........................................................................
Low ...........................................................................
Midpoint ....................................................................
High ..........................................................................
100
Range
7% .............................................................................
1.3
3.6
5.9
1.0
2.8
4.7
0.6
1.9
3.3
0.5
1.5
2.6
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Source: U.S. Department of Labor, Occupational Safety and Health Administration, Directorate of Standards and Guidance, Office of Regulatory Analysis.
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~
Discount Rate
Annualized Costs
Engineering Controls (includes Abrasive Blasting)
Respirators
Exposure Assessment
Medical Surveillance
Training
Regulated Area or Access Control
~
~
~
~
$344
$422
$203
$227
$50
$86
$0
$330
$131
$143
$0
$66
$0
$331
$129
$148
$0
$66
$330
$91
$73
$76
$49
$19
~
~
$1,308
$1,332
$670
$674
$637
$658
$339
Cases
Cases
100 ~gfm'
Incremental Costs/Benefits
~
3%
$330
$421
$203
$219
$49
$85
Total Annualized Costs (point estimate)
Annual Benefits: Number of Cases Prevented
Fatal Lung Cancers (midpoint estimate)
Fatal Silicosis & other Non-Malignant
Respiratory Diseases
Fatal Renal Disease
5Ol!g/m3
Incremental Costs/Benefits
$344
$91
$74
$79
$50
Cases
$187
$88
$26
$28
$0
~
~
3%
$197
$88
$26
$29
$0
$143
$2
$47
$48
$147
$3
$48
$50
$50
$49
$9
$351
~
$299
~
$307
Cases
Cases
"""237
75
""""162
~
83
527
152
375
186
189
258
~
108
Silica-Related Mortality
1,023
$4,811
$3,160
335
$1,543
$1,028
Silicosis Morbidity
1,770
$2,219
$1,523
186
$233
$160
91
60
688
$3,268
$2,132
357
$1,704
$1,116
331
$1,565
$1,016
1,585
$1,986
$1,364
632
$792
$544
953
$1,194
$820
Monetized Annual Benefds (midpoint estimate)
$7,030
$4,684
$1,776
$1,188
$5,254
$3,495
$2,495
$1,659
$2,759
$1,836
Net Benefits
$5722
$3352
$1105
$514
$4617
$2838
$2157
$1308
$2460
$1529
Source: U.S. Department of Labor, Occupational Safety and Health Administration, Directorate of Evaluation and Analysis, Office of Regulatory Analysis
* Benefits are assessed over a 50-year time horizon, during which it is assumed that economic conditions remain constant. Costs are annualized over ten years, with the exception of
equipment expenditures, which are annualized over the life of the equipment. Annualized costs are assumed to continue at the same level for sixty years, which is consistent with
assuming that economic conditions remain constant for the sixty year time horizon,
Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules
19:12 Sep 11, 2013
Table VIII·21: Annualized Costs, Benefits and Incremental Benefds of OSHA's Proposed Silica Standard of 50 ~gfm3 and 100 ~gfm3 AUernative
Millions ($2009)
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Annualized Costs
Construction
General Industry/Maritime
$1,043
$264
Total Annualized Costs
$1,308
~
~
$1,062
$270
$548
$122
$1,332
~
$551
$123
$670
Incremental Costs/Benefits
50 (!s/m'
Incremental Costs/Benefits
$495
$143
$674
~
~
100 (!s/m'
~
3%
~
$511
$147
$233
$106
$241
$110
$262
$36
$270
$37
$658
$339
$351
$299
$307
----
Annual Benefits: Number of Cases
Prevented
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Construction
Generallndustry/Maritime
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Monetized Annual Benefits (midpoint
estimate)
Construction
General Industry/Maritime
Total
Net Benefits
Construction
General Industry/Maritime
12SEP2
Total
Cases
Cases
$637
Cases
Cases
Cases
802
221
$3,804
$1,007
$2,504
$657
235
100
$1,109
$434
$746
$283
567
121
$2,695
$573
$1,758
$374
242
115
$1,158
$545
$760
$356
325
6
$1,537
$27
$998
$18
1,023
$4,811
$3,160
335
$1,543
$1,028
688
$3,268
$2,132
357
$1,704
$1,116
331
$1,565
$1,016
1,157
613
$1,451
$768
$996
$528
77
109
$96
$136
$66
$94
1,080
504
$1,354
$632
$930
$434
161
471
$202
$590
$139
$405
919
33
$1,152
$42
$791
$29
1,770
$2,219
$1,523
186
$233
$160
1,585
$1,986
$1,364
632
$792
$544
953
$1,194
$820
$5,255
$1,775
$3,500
$1,164
$1,205
$570
$812
$377
$4,049
$1,205
$2,688
$808
$1,360
$1,135
$898
$761
$2,690
$69
$1,789
$47
$7,030
$4,684
$1,776
$1,188
$5,254
$3,495
$2,495
$1,659
$2,759
$1,836
$4,211
$1,511
$2,437
$914
$657
$448
$261
$254
$3,555
$1,062
$2,177
$661
$1,127
$1,029
$658
$651
$2,427
$33
$1,519
$10
$5,722
$3,352
$1,105
$514
$4,617
$2,838
$2,157
$1,308
$2,460
$1,529
Source: U,S, Department of Labor, Occupational Safety and Health Administration, Directorate of Evaluation and Analysis, Office of Regulatory Analysis
* Benefits are assessed over a 60-year time horizon, during which it is assumed that economic conditions remain constant Costs are annualized over ten years, with the exception of
equipment expenditures, which are annualized over the life of the equipment Annualized costs are assumed to continue at the same level for sixty years, which is consistent with
assuming that economic conditions remain constant for the sixty year time horizon,
Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules
19:12 Sep 11, 2013
Table VIII-22: Annualized Costs, Benefits and Incremental Benefits of OSHA's Proposed Silica Standard of 50 1l9/m' and 100 1l9/m' Alternative, by Major Industry Sector
Millions ($2009)
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7. Sensitivity Analysis
In this section, OSHA presents the
results of two different types of
sensitivity analysis to demonstrate how
robust the estimates of net benefits are
to changes in various cost and benefit
parameters. In the first type of
sensitivity analysis, OSHA made a
series of isolated changes to individual
cost and benefit input parameters in
order to determine their effects on the
Agency’s estimates of annualized costs,
annualized benefits, and annualized net
benefits. In the second type of
sensitivity analysis—a so-called ‘‘breakeven’’ analysis—OSHA also investigated
isolated changes to individual cost and
benefit input parameters, but with the
objective of determining how much they
would have to change for annualized
costs to equal annualized benefits.
Again, the Agency has conducted
these calculations for informational
purposes only and has not used these
results as the basis for selecting the PEL
for the proposed rule.
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Analysis of Isolated Changes to Inputs
The methodology and calculations
underlying the estimation of the costs
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and benefits associated with this
rulemaking are generally linear and
additive in nature. Thus, the sensitivity
of the results and conclusions of the
analysis will generally be proportional
to isolated variations a particular input
parameter. For example, if the estimated
time that employees need to travel to
(and from) medical screenings were
doubled, the corresponding labor costs
would double as well.
OSHA evaluated a series of such
changes in input parameters to test
whether and to what extent the general
conclusions of the economic analysis
held up. OSHA first considered changes
to input parameters that affected only
costs and then changes to input
parameters that affected only benefits.
Each of the sensitivity tests on cost
parameters had only a very minor effect
on total costs or net costs. Much larger
effects were observed when the benefits
parameters were modified; however, in
all cases, net benefits remained
significantly positive. On the whole,
OSHA found that the conclusions of the
analysis are reasonably robust, as
changes in any of the cost or benefit
input parameters still show significant
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net benefits for the proposed rule. The
results of the individual sensitivity tests
are summarized in Table VIII–23 and
are described in more detail below.
In the first of these sensitivity test
where OSHA doubled the estimated
portion of employees in regulated areas
requiring disposable clothing, from 10
to 20 percent, and estimates of other
input parameters remained unchanged,
Table VIII–23 shows that the estimated
total costs of compliance would increase
by $3.6 million annually, or by about
0.54 percent, while net benefits would
also decline by $3.6 million, from
$4,582 million to $4,528 million
annually.
In a second sensitivity test, OSHA
decreased the estimated current
prevalence of baseline silica training by
half, from 50 percent to 25 percent. As
shown in Table VIII–23, if OSHA’s
estimates of other input parameters
remained unchanged, the total
estimated costs of compliance would
increase by $7.9 million annually, or by
about 1.19 percent, while net benefits
would also decline by $7.9 million
annually, from $4,532 million to $4,524
million annually.
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In a third sensitivity test, OSHA
doubled the estimated travel time for
employees to and from medical exams
from 60 to 120 minutes. As shown in
Table VIII–23, if OSHA’s estimates of
other input parameters remained
unchanged, the total estimated costs of
compliance would increase by $1.4
million annually, or by about 0.22
percent, while net benefits would also
decline by $1.4 million annually, from
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$4,532 million to $4,530 million
annually.
In a fourth sensitivity test, OSHA
reduced its estimate of the number of
workers who could be represented by an
exposure monitoring sample from four
to three. This would have the effect of
increasing such costs by one-third. As
shown in Table VIII–23, if OSHA’s
estimates of other input parameters
remained unchanged, the total
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estimated costs of compliance would
increase by $24.8 million annually, or
by about 3.77 percent, while net benefits
would also decline by $24.8 million
annually, from $4,532 million to $4,507
million annually.
In a fifth sensitivity test, OSHA
increased by 50 percent the size of the
productivity penalty arising from the
use of engineering controls in
construction. As shown in Table VIII–
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23, if OSHA’s estimates of other input
parameters remained unchanged, the
total estimated costs of compliance
would increase by $35.8 million
annually, or by about 5.44 percent (and
by 7.0 percent in construction), while
net benefits would also decline by $35.8
million annually, from $4,532 million to
$4,496 million annually.
In a sixth sensitivity test, based on the
discussion in Chapter V of this PEA,
OSHA reduced the costs of respirator
cartridges to reflect possible reductions
in costs since the original costs per filter
were developed in 2003, and inflated to
current dollars. For this purpose, OSHA
reduced respirator filter costs by 40
percent to reflect the recent lowerquartile estimates of costs relative to the
costs used in OSHA’s primary analysis.
As shown in Table VIII–23, the total
estimated costs of compliance would be
reduced by $21.2 million annually, or
by about 3.23 percent, while net benefits
would also increase by $21.2 million
annually, from $4,532 million to $4,553
million annually.
In a seventh sensitivity test, OSHA
reduced the average crew size in general
industry and maritime subject to a
‘‘unit’’ of engineering controls from 4 to
3. This would have the effect of
increasing such costs by one-third. As
shown in Table VIII–23, if OSHA’s
estimates of other input parameters
remained unchanged, the total
estimated costs of compliance would
increase by $20.8 million annually, or
by about 3.16 percent (and by 14.2
percent in general industry and
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maritime), while net benefits would also
decline by $20.8 million annually, from
$4,532 million to $4,511 million
annually.
In an eighth sensitivity test, OSHA
considered the effect on annualized net
benefits of varying the discount rate for
costs and the discount rate for benefits
separately. In particular, the Agency
examined the effect of reducing the
discount rate for costs from 7 percent to
3 percent. As indicated in Table VIII–23,
this parameter change lowers the
estimated annualized cost by $20.6
million, or 3.13 percent. Total
annualized net benefits would increase
from $4,532 million annually to $4,552
million annually.
The Agency also performed
sensitivity tests on several input
parameters used to estimate the benefits
of the proposed rule. In the first two
tests, in an extension of results
previously presented in Table VIII–21,
the Agency examined the effect on
annualized net benefits of employing
the high-end estimate of the benefits, as
well as the low-end estimate. As
discussed previously, the Agency
examined the sensitivity of the benefits
to both the number of different fatal
lung cancer cases prevented, as well as
the valuation of individual morbidity
cases. Table VIII–23 presents the effect
on annualized net benefits of using the
extreme values of these ranges, the high
mortality count and high morbidity
valuation case, and the low mortality
count and low morbidity valuation case.
As indicated, using the high estimate of
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mortality cases prevented and morbidity
valuation, the benefits rise by 56% to
$8.1 billion, yielding net benefits of $7.5
billion. For the low estimate of both
cases and valuation, the benefits decline
by 54 percent, to $2.4 billion, yielding
net benefits of $1.7 billion.
In the third sensitivity test of benefits,
the Agency examined the effect of
raising the discount rate for benefits to
7 percent. The fourth sensitivity test of
benefits examines the effect of adjusting
monetized benefits to reflect increases
in real per capita income over time. The
results of these two sensitivity tests
were previously shown in Table VIII–20
and are repeated in Table VIII–23.
Raising the interest rate to 7 percent
lowers the estimated benefits by 33
percent, to $3.5 billion, yielding
annualized net benefits of $2.8 billion.
Adjusting monetized benefits to reflect
increases in real per capita income over
time raises the benefits by 22 percent, to
$6.3 billion, yielding net benefits of $5.7
billion.
‘‘Break-Even’’ Analysis
OSHA also performed sensitivity tests
on several other parameters used to
estimate the net costs and benefits of the
proposed rule. However, for these, the
Agency performed a ‘‘break-even’’
analysis, asking how much the various
cost and benefits inputs would have to
vary in order for the costs to equal, or
break even with, the benefits. The
results are shown in Table VIII–24.
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$657,892,211
$5,189,700,790
$4,531,808,579
688.8%
Engineering Control Costs
$343,818,700
$4,875,627,279
$4,531,808,579
1318.1 %
$8,700,000
$2,575,000
$1,102,889
$326,430
-$7,597, III
-$2,248,570
-87.3%
-87.3%
688
1,585
87
201
-600
-1,384
-87.3%
-87.3%
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*Note: The total estimated value of prevented mortality or morbidity alone exceeds the estimated cost of the rule, providing no break-even point.
Accordingly, these numbers represent a reduction in the composite valuation of an avoided fatality or illness or in the composite number of cases avoided.
Source: U.S. Department of Labor, Occupational Safety and Health Administration, Directorate of Evaluation and Analysis, Office of Regulatory Analysis
12SEP2
56401
and morbidity are each estimated to
exceed $1.9 billion, while the estimated
costs are $0.6 billion, an independent
break-even point for each is impossible.
In other words, for example, if no value
is attached to an avoided illness
associated with the rule, but the
estimated value of an avoided fatality is
held constant, the rule still has
substantial net benefits. Only through a
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would need to increase by $4.5 billion,
or 1,318 percent, for costs to equal
benefits.
In a third sensitivity test, on benefits,
OSHA examined how much its
estimated monetary valuation of an
avoided illness or an avoided fatality
would need to be reduced in order for
the costs to equal the benefits. Since the
total valuation of prevented mortality
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Illnesses Avoided*
Factor Value at which
Benefits Equal Costs
OSHA's Best Estimate
of Annualized Cost or
Benefit Factor
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Cases Avoided
Total Costs
Benefits Valuation per Case Avoided
Monetized Benefit per Fatality Avoided*
Monetized Benefit per Illness Avoided*
Required Factor
Dollar/N umber
Change
Percentage Factor
Change
Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules
Break-Even Sensitivity Analysis
In one break-even test on cost
estimates, OSHA examined how much
costs would have to increase in order for
costs to equal benefits. As shown in
Table VIII–24, this point would be
reached if costs increased by $4.5
billion, or 689 percent.
In a second test, looking specifically
at the estimated engineering control
costs, the Agency found that these costs
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reduction in the estimated net value of
both components is a break-even point
possible.
The Agency, therefore, examined how
large an across-the-board reduction in
the monetized value of all avoided
illnesses and fatalities would be
necessary for the benefits to equal the
costs. As shown in Table VIII–24, an 87
percent reduction in the monetized
value of all avoided illnesses and
fatalities would be necessary for costs to
equal benefits, reducing the estimated
value to $1.1 million per life saved, and
an equivalent percentage reduction to
about $0.3 million per illness prevented.
In a fourth break-even sensitivity test,
OSHA estimated how many fewer silicarelated fatalities and illnesses would be
required for benefits to equal costs.
Paralleling the previous discussion,
eliminating either the prevented
mortality or morbidity cases alone
would be insufficient to lower benefits
to the break-even point. The Agency
therefore examined them as a group. As
shown in Table VIII–24, a reduction of
87 percent, for both simultaneously, is
required to reach the break-even point—
600 fewer mortality cases prevented
annually, and 1,384 fewer morbidity
cases prevented annually.
Taking into account both types of
sensitivity analysis the Agency
performed on its point estimates of the
annualized costs and annualized
benefits of the proposed rule, the results
demonstrate that net benefits would be
positive in all plausible cases tested. In
particular, this finding would hold even
with relatively large variations in
individual input parameters.
Alternately, one would have to imagine
extremely large changes in costs or
benefits for the rule to fail to produce
net benefits. OSHA concludes that its
finding of significant net benefits
resulting from the proposed rule is a
robust one.
OSHA welcomes input from the
public regarding all aspects of this
sensitivity analysis, including any data
or information regarding the accuracy of
the preliminary estimates of compliance
costs and benefits and how the
estimates of costs and benefits may be
affected by varying assumptions and
methodological approaches.
H. Regulatory Alternatives
This section discusses various
regulatory alternatives to the proposed
OSHA silica standard. OSHA believes
that this presentation of regulatory
alternatives serves two important
functions. The first is to explore the
possibility of less costly ways (than the
proposed rule) to provide an adequate
level of worker protection from
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exposure to respirable crystalline silica.
The second is tied to the Agency’s
statutory requirement, which underlies
the proposed rule, to reduce significant
risk to the extent feasible. If, based on
evidence presented during notice and
comment, OSHA is unable to justify its
preliminary findings of significant risk
and feasibility as presented in this
preamble to the proposed rule, the
Agency must then consider regulatory
alternatives that do satisfy its statutory
obligations.
Each regulatory alternative presented
here is described and analyzed relative
to the proposed rule. Where
appropriate, the Agency notes whether
the regulatory alternative, to be a
legitimate candidate for OSHA
consideration, requires evidence
contrary to the Agency’s findings of
significant risk and feasibility. To
facilitate comment, the regulatory
alternatives have been organized into
four categories: (1) Alternative PELs to
the proposed PEL of 50 mg/m3; (2)
regulatory alternatives that affect
proposed ancillary provisions; (3) a
regulatory alternative that would modify
the proposed methods of compliance;
and (4) regulatory alternatives
concerning when different provisions of
the proposed rule would take effect.
Alternative PELs
OSHA is proposing a new PEL for
respirable crystalline silica of 50 mg/m3
for all industry sectors covered by the
rule. OSHA’s proposal is based on the
requirements of the Occupational Safety
and Health Act (OSH Act) and court
interpretations of the Act. For health
standards issued under section 6(b)(5) of
the OSH Act, OSHA is required to
promulgate a standard that reduces
significant risk to the extent that it is
technologically and economically
feasible to do so. See Section II of this
preamble, Pertinent Legal Authority, for
a full discussion of OSHA legal
requirements.
OSHA has conducted an extensive
review of the literature on adverse
health effects associated with exposure
to respirable crystalline silica. The
Agency has also developed estimates of
the risk of silica-related diseases
assuming exposure over a working
lifetime at the proposed PEL and action
level, as well as at OSHA’s current
PELs. These analyses are presented in a
background document entitled
‘‘Respirable Crystalline Silica—Health
Effects Literature Review and
Preliminary Quantitative Risk
Assessment’’ and are summarized in
this preamble in Section V, Health
Effects Summary, and Section VI,
Summary of OSHA’s Preliminary
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Quantitative Risk Assessment,
respectively. The available evidence
indicates that employees exposed to
respirable crystalline silica well below
the current PELs are at increased risk of
lung cancer mortality and silicosis
mortality and morbidity. Occupational
exposures to respirable crystalline silica
also may result in the development of
kidney and autoimmune diseases and in
death from other nonmalignant
respiratory diseases. As discussed in
Section VII, Significance of Risk, in this
preamble, OSHA preliminarily finds
that worker exposure to respirable
crystalline silica constitutes a
significant risk and that the proposed
standard will substantially reduce this
risk.
Section 6(b) of the OSH Act (29 U.S.C.
655(b)) requires OSHA to determine that
its standards are technologically and
economically feasible. OSHA’s
examination of the technological and
economic feasibility of the proposed
rule is presented in the Preliminary
Economic Analysis and Initial
Regulatory Flexibility Analysis (PEA),
and is summarized in this section
(Section VIII) of this preamble. For
general industry and maritime, OSHA
has preliminarily concluded that the
proposed PEL of 50 mg/m3 is
technologically feasible for all affected
industries. For construction, OSHA has
preliminarily determined that the
proposed PEL of 50 mg/m3 is feasible in
10 out of 12 of the affected activities.
Thus, OSHA preliminarily concludes
that engineering and work practices will
be sufficient to reduce and maintain
silica exposures to the proposed PEL of
50 mg/m3 or below in most operations
most of the time in the affected
industries. For those few operations
within an industry or activity where the
proposed PEL is not technologically
feasible even when workers use
recommended engineering and work
practice controls, employers can
supplement controls with respirators to
achieve exposure levels at or below the
proposed PEL.
OSHA developed quantitative
estimates of the compliance costs of the
proposed rule for each of the affected
industry sectors. The estimated
compliance costs were compared with
industry revenues and profits to provide
a screening analysis of the economic
feasibility of complying with the revised
standard and an evaluation of the
potential economic impacts. Industries
with unusually high costs as a
percentage of revenues or profits were
further analyzed for possible economic
feasibility issues. After performing these
analyses, OSHA has preliminarily
concluded that compliance with the
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requirements of the proposed rule
would be economically feasible in every
affected industry sector.
OSHA has examined two regulatory
alternatives (named Regulatory
Alternatives #1 and #2) that would
modify the PEL for the proposed rule.
Under Regulatory Alternative #1, the
proposed PEL would be changed from
50 mg/m3 to 100 mg/m3 for all industry
sectors covered by the rule, and the
action level would be changed from 25
mg/m3 to 50 mg/m3 (thereby keeping the
action level at one-half of the PEL).
Under Regulatory Alternative #2, the
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19:12 Sep 11, 2013
Jkt 229001
proposed PEL would be lowered from
50 mg/m3 to 25 mg/m3 for all industry
sectors covered by the rule, while the
action level would remain at 25 mg/m3
(because of difficulties in accurately
measuring exposure levels below 25 mg/
m3).
Tables VIII–25 and VIII–26 present,
for informational purposes, the
estimated costs, benefits, and net
benefits of the proposed rule under the
proposed PEL of 50 mg/m3 and for the
regulatory alternatives of a PEL of 100
mg/m3 and a PEL of 25 mg/m3
(Regulatory Alternatives # 1 and #2),
PO 00000
Frm 00131
Fmt 4701
Sfmt 4702
56403
using alternative discount rates of 3 and
7 percent. These two tables also present
the incremental costs, the incremental
benefits, and the incremental net
benefits of going from a PEL of 100 mg/
m3 to the proposed PEL of 50 mg/m3 and
then of going from the proposed PEL of
50 mg/m3 to a PEL of 25 mg/m3. Table
VIII–25 breaks out costs by provision
and benefits by type of disease and by
morbidity/mortality, while Table VIII–
26 breaks out costs and benefits by
major industry sector.
E:\FR\FM\12SEP2.SGM
12SEP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
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VerDate Mar<15>2010
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Millions ($2009)
25 ~g/m3
PO 00000
~
Discount Rate
50 ~g/m3
Incremental Costs/Benefits
~
~
~
~
3%
100 ~g/m3
Incremental Costs/Benefits
~
~
~
3%
Annualized Costs
Frm 00132
Engineering Controls (includes Abrasive Blastlng)
Respirators
Exposure Assessment
Medical Surveillance
Training
Regulated Area or Access Control
Fmt 4701
$330
$421
$203
$219
$49
$85
Annual Benefits: Number of Cases Prevented
Sfmt 4725
Fatal Lung Cancers (midpoint estimate)
Fatal Silicosis & other Non-Malignant
Respiratory Diseases
Fatal Renal Disease
$0
$330
$131
$143
$0
$66
$0
$331
$129
$148
$0
$66
$330
$91
$73
$76
$49
$19
~
~
$1,308
Total Annualized Costs (point estimate)
$344
$422
$203
$227
$50
$86
$1,332
$670
$674
$637
$658
$339
Cases
Cases
$344
$91
$74
$79
$50
Cases
$187
$88
$26
$28
$0
$197
$88
$26
$29
$0
$143
$2
$47
$48
$49
$9
$351
Cases
~
$299
~
$147
$3
$48
$50
$50
$307
Cases
237
----ys
---w2
79
83
527
152
375
186
189
258
108
151
E:\FR\FM\12SEP2.SGM
Silica-Related Mortality
1,023
$4,811
$3,160
335
$1,543
$1,028
Silicosis Morbidity
1,770
$2,219
$1,523
186
$233
$160
Monetized Annual Benefits (midpoint estimate)
$7,030
$4,664
$1,776
Net Benefits
$5722
$3352
$1105
91
60
688
$3,268
$2,132
357
$1,704
$1,116
331
$1,565
$1,016
1,585
$1,986
$1,364
632
$792
$544
953
$1,194
$820
$1,188
$5,254
$3,495
$2,495
$1,659
$2,759
$1,836
$514
$4617
$2838
$2157
$1308
$2460
$1529
Source: U.S. Department of Labor, Occupational Safety and Health Administration, Directorate of Evaluation and Analysis, Office of Regulatory Analysis
12SEP2
* Benefits are assessed over a 60-year time horizon, during which it is assumed that economic conditions remain constant. Costs are annualized over ten years, with the
exception of equipment expenditures, which are annualized over the life of the equipment. Annualized costs are assumed to continue at the same level for sixty years, which
is consistent with assuming that economic conditions remain constant for the sixty year time horizon,
Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules
19:12 Sep 11, 2013
EP12SE13.015</GPH>
Table VIII-25: Annualized Costs, Benefits and Incremental Benefits of OSHA's Proposed Silica Standard of 50 !-191m3 and 100 !-191m3 Alternative
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
25!:19/m3
~ ~
Discount Rate
Jkt 229001
Annualized Costs
Construction
General Industry/Maritime
$1,043
$264
Frm 00133
Fmt 4701
Sfmt 4702
12SEP2
$1,062
$270
$548
$122
Annual Benefits: Number of Cases
Prevented
Silica-Related Mortality
Construction
General Industry/Maritime
Total
Silicosis Morbidity
Construction
General Industry/Maritime
Total
Monetized Annual Benefits (midpoint
estimate)
Construction
General Industry/Maritime
Total
Net Benefits
Construction
General Industry/Maritime
Total
$1,308
~
$551
$123
$495
$143
---- ---
$1,332
Cases
~
$670
~
~
$511
$147
$233
$106
---- --$637
$674
Cases
Incremental Costs/Benefits
~
3%
$241
$110
$262
$36
--- ---
$658
Cases
100 !:I9/m'
$339
$270
$37
---
$351
Cases
~
$299
$307
Cases
802
221
$3,804
$1,007
$2,504
$657
235
100
$1,109
$434
$746
$283
567
121
$2,695
$573
$1,758
$374
242
115
$1,158
$545
$760
$356
325
6
$1,537
$27
$998
$18
1,023
$4,811
$3,160
335
$1,543
$1,028
688
$3,268
$2,132
357
$1,704
$1,116
331
$1,565
$1,016
1,157
613
$1,451
$768
$996
$528
77
109
$96
$136
$66
$94
1,080
504
$1,354
$632
$930
$434
161
471
$202
$590
$139
$405
919
33
$1,152
$42
$791
$29
1,770
$2,219
$1,523
186
$233
$160
1,585
$1,986
$1,364
632
$792
$544
953
$1,194
$820
$5,255
$1,775
$3,500
$1,184
$1,205
$570
$812
$377
$4,049
$1,205
$2,688
$808
$1,360
$1,135
$898
$761
$2,690
$69
$1,789
$47
$7,030
$4,684
$1,776
$1,188
$5,254
$3,495
$2,495
$1,659
$2,759
$1,836
$4,211
$1,511
$2,437
$914
$657
$448
$261
$254
$3,555
$1,062
$2,177
$661
$1,127
$1,029
$658
$651
$2,427
$33
$1,519
$10
$5,722
$3352
$1.105
$514
$4,617
ill38
~157
$1,308
$2~iM~L
Source: U,S, Department of Labor, Occupational Safety and Health Administration, Directorate of Evaluation and Analysis, Office of Regulatory Analysis
* Benefits are assessed over a 60-year time horizon, during which it is assumed that economic conditions remain constant. Costs are annualized over ten years, with the
exception of equipment expenditures, which are annualized over the life of the equipment. Annualized costs are assumed to continue at the same level for sixty years, which
is consistent with assuming that economic conditions remain constant for the sixty year time horizon.
56405
and an additional 632 cases of silicosis.
Based on its preliminary findings that
E:\FR\FM\12SEP2.SGM
of 50 mg/m3 would prevent, annually, an
additional 357 silica-related fatalities
PO 00000
EP12SE13.016</GPH>
~
---- --Total Annualized Costs
50 !:I9/m3
Incremental Costs/Benefits
Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules
19:12 Sep 11, 2013
As Tables VIII–25 and VIII–26 show,
going from a PEL of 100 mg/m3 to a PEL
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Table VIII-26: Annualized Costs, Benefits and Incremental Benefits of OSHA's Proposed Silica Standard of 50 I'g/m' and 100 I'g/m' Alternative, by Major Industry Sector
Millions ($2009)
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the proposed PEL of 50 mg/m3
significantly reduces worker risk from
silica exposure (as demonstrated by the
number of silica-related fatalities and
silicosis cases avoided) and is both
technologically and economically
feasible, OSHA cannot propose a PEL of
100 mg/m3 (Regulatory Alternative #1)
without violating its statutory
obligations under the OSH Act.
However, the Agency will consider
evidence that challenges its preliminary
findings.
As previously noted, Tables VIII–25
and VIII–26 also show the costs and
benefits of a PEL of 25 mg/m3
(Regulatory Alternative #2), as well as
the incremental costs and benefits of
going from the proposed PEL of 50 mg/
m3 to a PEL of 25 mg/m3. Because OSHA
determined that a PEL of 25 mg/m3
would not be feasible (that is,
engineering and work practices would
not be sufficient to reduce and maintain
silica exposures to a PEL of 25 mg/m3 or
below in most operations most of the
time in the affected industries), the
Agency did not attempt to identify
engineering controls or their costs for
affected industries to meet this PEL.
Instead, for purposes of estimating the
costs of going from a PEL of 50 mg/m3
to a PEL of 25 mg/m3, OSHA assumed
that all workers exposed between 50 mg/
m3 and 25 mg/m3 would have to wear
respirators to achieve compliance with
the 25 mg/m3 PEL. OSHA then estimated
the associated additional costs for
respirators, exposure assessments,
medical surveillance, and regulated
areas (the latter three for ancillary
requirements specified in the proposed
rule).
As shown in Tables VIII–25 and VIII–
26, going from a PEL of 50 mg/m3 to a
PEL of 25 mg/m3 would prevent,
annually, an additional 335 silicarelated fatalities and an additional 186
cases of silicosis. These estimates
support OSHA’s preliminarily finding
that there is significant risk remaining at
the proposed PEL of 50 mg/m3. However,
the Agency has preliminarily
determined that a PEL of 25 mg/m3
(Regulatory Alternative #2) is not
technologically feasible, and for that
reason, cannot propose it without
violating its statutory obligations under
the OSH Act.
Regulatory Alternatives That Affect
Ancillary Provisions
The proposed rule contains several
ancillary provisions (provisions other
the PEL), including requirements for
exposure assessment, medical
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surveillance, silica training, and
regulated areas or access control. As
shown in Table VIII–25, these ancillary
provisions represent approximately
$223 million (or about 34 percent) of the
total annualized costs of the rule of $658
million (using a 7 percent discount
rate). The two most expensive of the
ancillary provisions are the
requirements for medical surveillance,
with annualized costs of $79 million,
and the requirements for exposure
monitoring, with annualized costs of
$74 million.
As proposed, the requirements for
exposure assessment are triggered by the
action level. As described in this
preamble, OSHA has defined the action
level for the proposed standard as an
airborne concentration of respirable
crystalline silica of 25 mg/m3 calculated
as an eight-hour time-weighted average.
In this proposal, as in other standards,
the action level has been set at one-half
of the PEL.
Because of the variable nature of
employee exposures to airborne
concentrations of respirable crystalline
silica, maintaining exposures below the
action level provides reasonable
assurance that employees will not be
exposed to respirable crystalline silica
at levels above the PEL on days when
no exposure measurements are made.
Even when all measurements on a given
day may fall below the PEL (but are
above the action level), there is some
chance that on another day, when
exposures are not measured, the
employee’s actual exposure may exceed
the PEL. When exposure measurements
are above the action level, the employer
cannot be reasonably confident that
employees have not been exposed to
respirable crystalline silica
concentrations in excess of the PEL
during at least some part of the work
week. Therefore, requiring periodic
exposure measurements when the
action level is exceeded provides the
employer with a reasonable degree of
confidence in the results of the exposure
monitoring.
The action level is also intended to
encourage employers to lower exposure
levels in order to avoid the costs
associated with the exposure assessment
provisions. Some employers would be
able to reduce exposures below the
action level in all work areas, and other
employers in some work areas. As
exposures are lowered, the risk of
adverse health effects among workers
decreases.
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Frm 00134
Fmt 4701
Sfmt 4702
OSHA’s preliminary risk assessment
indicates that significant risk remains at
the proposed PEL of 50 mg/m3. Where
there is continuing significant risk, the
decision in the Asbestos case (Bldg. and
Constr.Trades Dep’t, AFL–CIO v. Brock,
838 F.2d 1258, 1274 (DC Cir. 1988))
indicated that OSHA should use its
legal authority to impose additional
requirements on employers to further
reduce risk when those requirements
will result in a greater than de minimis
incremental benefit to workers’ health.
OSHA’s preliminary conclusion is that
the requirements triggered by the action
level will result in a very real and
necessary, but non-quantifiable, further
reduction in risk beyond that provided
by the PEL alone. OSHA’s choice of
proposing an action level for exposure
monitoring of one-half of the PEL is
based on the Agency’s successful
experience with other standards,
including those for inorganic arsenic (29
CFR 1910.1018), ethylene oxide (29 CFR
1910.1047), benzene (29 CFR
1910.1028), and methylene chloride (29
CFR 1910.1052).
As specified in the proposed rule, all
workers exposed to respirable
crystalline silica above the PEL of 50 mg/
m3 are subject to the medical
surveillance requirements. This means
that the medical surveillance
requirements would apply to 15,172
workers in general industry and 336,244
workers in construction. OSHA
estimates that 457 possible silicosis
cases will be referred to pulmonary
specialists annually as a result of this
medical surveillance.
OSHA has preliminarily determined
that these ancillary provisions will: (1)
help to ensure the PEL is not exceeded,
and (2) minimize risk to workers given
the very high level of risk remaining at
the PEL. OSHA did not estimate, and
the benefits analysis does not include,
monetary benefits resulting from early
discovery of illness.
Because medical surveillance and
exposure assessment are the two most
costly ancillary provisions in the
proposed rule, the Agency has
examined four regulatory alternatives
(named Regulatory Alternatives #3, #4,
#5, and #6) involving changes to one or
the other of these ancillary provisions.
These four regulatory alternatives are
defined below and the incremental cost
impact of each is summarized in Table
VIII–27. In addition, OSHA is including
a regulatory alternative (named
Regulatory Alternative #7) that would
remove all ancillary provisions.
E:\FR\FM\12SEP2.SGM
12SEP2
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13% Discount Rate I
Cost
Construction
GIIM
Incremental Cost Relative to Proposal
Total
Construction
GIIM
Total
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Frm 00135
Fmt 4701
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12SEP2
$494,826,699
$142,502,681
$637,329,380
Option 3: PEL=50; AL=50
$457,686,162
$117,680,601
$575,366,763
-$37,140,537
-$24,822,080
-$61,962,617
Option 4: PEL=50; AL =25, with
medical surveillance triggered by AL
$606,697,624
$173,701,827
$780,399,451
$111,870,925
$31,199,146
$143,070,071
Option 5: PEL=50; AL=25, with
medical exams annually
$561,613,766
$145,088,559
$706,702,325
$66,787,067
$2,585,878
$69,372,945
Option 6: PEL=50; AL=25, with
surveillance triggered by AL and
medical exams annually
$775,334,483
$203,665,685
$979,000,168
$280,507,784
$61,163,004
$341,670,788
f7°7~bisc6unfRatel
Cost
Construction
GIIM
Incremental Cost Relative to Proposal
Total
Construction
GIIM
Total
Proposed Rule
$511,165,616
$146,726,595
$657,892,211
Option 3: PEL=50; AL=50
$473,638,698
$121,817,396
$595,456,093
-$37,526,918
-$24,909,200
-$62,436,118
Option 4: PEL=50; AL =25, with
medical surveillance triggered by AL
$627,197,794
$179,066,993
$806,264,787
$132,371,095
$36,564,312
$168,935,407
Option 5: PEL=50; AL=25, with
medical exams annually
$575,224,843
$149,204,718
$724,429,561
$64,059,227
$2,478,122
$66,537,350
Option 6: PEL=50; AL=25, with
surveillance triggered by AL and
medical exams annually
$791,806,358
$208,339,741
$1,000,146,099
$280,640,742
$61,613,145
$342,253,887
Source: U.S. Department of Labor, Occupational Safety and Health Administration, Directorate of Evaluation and Analysis, Office of Regulatory Analysis
56407
monitoring requirements would be
triggered only if workers were exposed
E:\FR\FM\12SEP2.SGM
m3 to 50 mg/m3 while keeping the PEL
at 50 mg/m3. As a result, exposure
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Proposed Rule
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19:12 Sep 11, 2013
Under Regulatory Alternative #3, the
action level would be raised from 25 mg/
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EP12SE13.017</GPH>
Table VIII-27: Cost of Regulatory Alternatives Affecting Ancillary Provisions
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Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules
above the proposed PEL of 50 mg/m3. As
shown in Table VIII–27, Regulatory
Option #3 would reduce the annualized
cost of the proposed rule by about $62
million, using a discount rate of either
3 percent or 7 percent.
Under Regulatory Alternative #4, the
action level would remain at 25 mg/m3
but medical surveillance would now be
triggered by the action level, not the
PEL. As a result, medical surveillance
requirements would be triggered only if
workers were exposed at or above the
proposed action level of 25 mg/m3. As
shown in Table VIII–27, Regulatory
Option #4 would increase the
annualized cost of the proposed rule by
about $143 million, using a discount
rate of 3 percent (and by about $169
million, using a discount rate of 7
percent).
Under Regulatory Alternative #5, the
only change to the proposed rule would
be to the medical surveillance
requirements. Instead of requiring
workers exposed above the PEL to have
a medical check-up every three years,
those workers would be required to
have a medical check-up annually. As
shown in Table VIII–27, Regulatory
Option #5 would increase the
annualized cost of the proposed rule by
about $69 million, using a discount rate
of 3 percent (and by about $66 million,
using a discount rate of 7 percent).
Regulatory Alternative #6 would
essentially combine the modified
requirements in Regulatory Alternatives
#4 and #5. Under Regulatory Alternative
#6, medical surveillance would be
triggered by the action level, not the
PEL, and workers exposed at or above
the action level would be required to
have a medical check-up annually
rather than triennially. The exposure
monitoring requirements in the
proposed rule would not be affected. As
shown in Table VIII–27, Regulatory
Option #6 would increase the
annualized cost of the proposed rule by
about $342 million, using a discount
rate of either 3 percent or 7 percent.
OSHA is not able to quantify the
effects of these preceding four
regulatory alternatives on protecting
workers exposed to respirable
crystalline silica at levels at or below
the proposed PEL of 50 mg/m3—where
significant risk remains. The Agency
solicits comment on the extent to which
these regulatory options may improve or
reduce the effectiveness of the proposed
rule.
The final regulatory alternative
affecting ancillary provisions,
Regulatory Alternative #7, would
eliminate all of the ancillary provisions
of the proposed rule, including
exposure assessment, medical
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19:12 Sep 11, 2013
Jkt 229001
surveillance, training, and regulated
areas or access control. However, it
should be carefully noted that
elimination of the ancillary provisions
does not mean that all costs for ancillary
provisions would disappear. In order to
meet the PEL, employers would still
commonly need to do monitoring, train
workers on the use of controls, and set
up some kind of regulated areas to
indicate where respirator use would be
required. It is also likely that employers
would increasingly follow the many
recommendations to provide medical
surveillance for employees. OSHA has
not attempted to estimate the extent to
which the costs of these activities would
be reduced if they were not formally
required, but OSHA welcomes comment
on the issue.
As indicated previously, OSHA
preliminarily finds that there is
significant risk remaining at the
proposed PEL of 50 mg/m3. However, the
Agency has also preliminarily
determined that 50 mg/m3 is the lowest
feasible PEL. Therefore, the Agency
believes that it is necessary to include
ancillary provisions in the proposed
rule to further reduce the remaining
risk. OSHA anticipates that these
ancillary provisions will reduce the risk
beyond the reduction that will be
achieved by a new PEL alone.
OSHA’s reasons for including each of
the proposed ancillary provisions are
detailed in Section XVI of this
preamble, Summary and Explanation of
the Standards. In particular, OSHA
believes that requirements for exposure
assessment (or alternately, using
specified exposure control methods for
selected construction operations) would
provide a basis for ensuring that
appropriate measures are in place to
limit worker exposures. Medical
surveillance is particularly important
because individuals exposed above the
PEL (which triggers medical
surveillance in the proposed rule) are at
significant risk of death and illness.
Medical surveillance would allow for
identification of respirable crystalline
silica-related adverse health effects at an
early stage so that appropriate
intervention measures can be taken.
OSHA believes that regulated areas and
access control are important because
they serve to limit exposure to
respirable crystalline silica to as few
employees as possible. Finally, OSHA
believes that worker training is
necessary to inform employees of the
hazards to which they are exposed,
along with associated protective
measures, so that employees understand
how they can minimize potential health
hazards. Worker training on silicarelated work practices is particularly
PO 00000
Frm 00136
Fmt 4701
Sfmt 4702
important in controlling silica
exposures because engineering controls
frequently require action on the part of
workers to function effectively.
OSHA expects that the benefits
estimated under the proposed rule will
not be fully achieved if employers do
not implement the ancillary provisions
of the proposed rule. For example,
OSHA believes that the effectiveness of
the proposed rule depends on regulated
areas or access control to further limit
exposures and on medical surveillance
to identify disease cases when they do
occur.
Both industry and worker groups have
recognized that a comprehensive
standard is needed to protect workers
exposed to respirable crystalline silica.
For example, the industry consensus
standards for crystalline silica, ASTM E
1132–06, Standard Practice for Health
Requirements Relating to Occupational
Exposure to Respirable Crystalline
Silica, and ASTM E 2626–09, Standard
Practice for Controlling Occupational
Exposure to Respirable Crystalline
Silica for Construction and Demolition
Activities, as well as the draft proposed
silica standard for construction
developed by the Building and
Construction Trades Department, AFL–
CIO, have each included comprehensive
programs. These recommended
standards include provisions for
methods of compliance, exposure
monitoring, training, and medical
surveillance (ASTM, 2006; 2009; BCTD
2001). Moreover, as mentioned
previously, where there is continuing
significant risk, the decision in the
Asbestos case (Bldg. and Constr. Trades
Dep’t, AFL–CIO v. Brock, 838 F.2d 1258,
1274 (DC Cir. 1988)) indicated that
OSHA should use its legal authority to
impose additional requirements on
employers to further reduce risk when
those requirements will result in a
greater than de minimis incremental
benefit to workers’ health. OSHA
preliminarily concludes that the
additional requirements in the ancillary
provisions of the proposed standard
clearly exceed this threshold.
A Regulatory Alternative That Modifies
the Methods of Compliance
The proposed standard in general
industry and maritime would require
employers to implement engineering
and work practice controls to reduce
employees’ exposures to or below the
PEL. Where engineering and/or work
practice controls are insufficient,
employers would still be required to
implement them to reduce exposure as
much as possible, and to supplement
them with a respiratory protection
program. Under the proposed
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construction standard, employers would
be given two options for compliance.
The first option largely follows
requirements for the general industry
and maritime proposed standard, while
the second option outlines, in Table 1
(Exposure Control Methods for Selected
Construction Operations) of the
proposed rule, specific construction
exposure control methods. Employers
choosing to follow OSHA’s proposed
control methods would be considered to
be in compliance with the engineering
and work practice control requirements
of the proposed standard, and would
not be required to conduct certain
exposure monitoring activities.
One regulatory alternative (Regulatory
Alternative #8) involving methods of
compliance would be to eliminate Table
1 as a compliance option in the
construction sector. Under this
regulatory alternative, OSHA estimates
that there would be no effect on
estimated benefits but that the
annualized costs of complying with the
proposed rule (without the benefit of the
Table 1 option in construction) would
increase by $175 million, totally in
exposure monitoring costs, using a 3
percent discount rate (and by $178
million using a 7 percent discount rate),
so that the total annualized compliance
costs for all affected establishments in
construction would increase from $495
to $670 million using a 3 percent
discount rate (and from $511 to $689
million using a 7 percent discount rate).
Regulatory Alternatives That Affect the
Timing of the Standard
The proposed rule would become
effective 60 days following publication
of the final rule in the Federal Register.
Provisions outlined in the proposed
standard would become enforceable 180
days following the effective date, with
the exceptions of engineering controls
and laboratory requirements. The
proposed rule would require
engineering controls to be implemented
no later than one year after the effective
date, and laboratory requirements
would be required to begin two years
after the effective date.
One regulatory alternative (Regulatory
Alternative #9) involving the timing of
the standard would arise if, contrary to
OSHA’s preliminary findings, a PEL of
50 mg/m3 with an action level of 25 mg/
m3 were found to be technologically and
economically feasible some time in the
future (say, in five years), but not
feasible immediately. In that case,
OSHA might issue a final rule with a
PEL of 50 mg/m3 and an action level of
25 mg/m3 to take effect in five years, but
at the same time issue an interim PEL
of 100 mg/m3 and an action level of 50
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mg/m3 to be in effect until the final rule
becomes feasible. Under this regulatory
alternative, and consistent with the
public participation and ‘‘look back’’
provisions of Executive Order 13563,
the Agency could monitor compliance
with the interim standard, review
progress toward meeting the feasibility
requirements of the final rule, and
evaluate whether any adjustments to the
timing of the final rule would be
needed. Under Regulatory Alternative
#9, the estimated costs and benefits
would be somewhere between those
estimated for a PEL of 100 mg/m3 with
an action level of 50 mg/m3 and those
estimated for a PEL of 50 mg/m3 with an
action level of 25 mg/m3, the exact
estimates depending on the length of
time until the final rule is phased in.
OSHA emphasizes that this regulatory
alternative is contrary to the Agency’s
preliminary findings of economic
feasibility and, for the Agency to
consider it, would require specific
evidence introduced on the record to
show that the proposed rule is not now
feasible but would be feasible in the
future.
Although OSHA did not explicitly
develop or quantitatively analyze any
other regulatory alternatives involving
longer-term or more complex phase-ins
of the standard (possibly involving more
delayed implementation dates for small
businesses), OSHA is soliciting
comments on this issue. Such a
particularized, multi-year phase-in
would have several advantages,
especially from the viewpoint of
impacts on small businesses. First, it
would reduce the one-time initial costs
of the standard by spreading them out
over time, a particularly useful
mechanism for small businesses that
have trouble borrowing large amounts of
capital in a single year. A differential
phase-in for smaller firms would also
aid very small firms by allowing them
to gain from the control experience of
larger firms. A phase-in would also be
useful in certain industries—such as
foundries, for example—by allowing
employers to coordinate their
environmental and occupational safety
and health control strategies to
minimize potential costs. However a
phase-in would also postpone the
benefits of the standard, recognizing, as
described in Chapter VII of the PEA,
that the full benefits of the proposal
would take a number of years to fully
materialize even in the absence of a
phase-in.
As previously discussed in the
Introduction to this preamble, OSHA
requests comments on these regulatory
alternatives, including the Agency’s
choice of regulatory alternatives (and
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56409
whether there are other regulatory
alternatives the Agency should
consider) and the Agency’s analysis of
them.
I. Initial Regulatory Flexibility Analysis
The Regulatory Flexibility Act, as
amended in 1996, requires the
preparation of an Initial Regulatory
Flexibility Analysis (IRFA) for proposed
rules where there would be a significant
economic impact on a substantial
number of small entities. (5 U.S.C. 601–
612). Under the provisions of the law,
each such analysis shall contain:
1. A description of the impact of the
proposed rule on small entities;
2. A description of the reasons why
action by the agency is being
considered;
3. A succinct statement of the
objectives of, and legal basis for, the
proposed rule;
4. A description of and, where
feasible, an estimate of the number of
small entities to which the proposed
rule will apply;
5. A description of the projected
reporting, recordkeeping, and other
compliance requirements of the
proposed rule, including an estimate of
the classes of small entities which will
be subject to the requirements and the
type of professional skills necessary for
preparation of the report or record;
6. An identification, to the extent
practicable, of all relevant Federal rules
which may duplicate, overlap, or
conflict with the proposed rule; and
7. A description and discussion of any
significant alternatives to the proposed
rule which accomplish the stated
objectives of applicable statutes and
which minimize any significant
economic impact of the proposed rule
on small entities, such as
(a) The establishment of differing
compliance or reporting requirements or
timetables that take into account the
resources available to small entities;
(b) The clarification, consolidation, or
simplification of compliance and
reporting requirements under the rule
for such small entities;
(c) The use of performance rather than
design standards; and
(d) An exemption from coverage of
the rule, or any part thereof, for such
small entities.
5 U.S.C. 603, 607.
The Regulatory Flexibility Act further
states that the required elements of the
IRFA may be performed in conjunction
with or as part of any other agenda or
analysis required by any other law if
such other analysis satisfies the
provisions of the IRFA. 5 U.S.C. 605.
While a full understanding of OSHA’s
analysis and conclusions with respect to
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costs and economic impacts on small
entities requires a reading of the
complete PEA and its supporting
materials, this IRFA will summarize the
key aspects of OSHA’s analysis as they
affect small entities.
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
A Description of the Impact of the
Proposed Rule on Small Entities
Section VIII.F of this preamble
summarized the impacts of the
proposed rule on small entities. Tables
VIII–12 and VIII–15 showed costs as a
percentage of profits and revenues for
small entities in general industry and
maritime and in construction,
respectively, classified as small by the
Small Business Administration, and
Tables VIII–13 and VIII–16 showed
costs as a percentage of revenues and
profits for business entities with fewer
than 20 employees in general industry
and maritime and in construction,
respectively. (The costs in these tables
were annualized using a discount rate of
7 percent.)
A Description of the Reasons Why
Action by the Agency Is Being
Considered
Exposure to crystalline silica has been
shown to increase the risk of several
serious diseases. Crystalline silica is the
only known cause of silicosis, which is
a progressive respiratory disease in
which respirable crystalline silica
particles cause an inflammatory reaction
in the lung, leading to lung damage and
scarring, and, in some cases, to
complications resulting in disability and
death. In addition, many wellconducted investigations of exposed
workers have shown that exposure
increases the risk of mortality from lung
cancer, chronic obstructive pulmonary
disease (COPD), and renal disease.
OSHA’s detailed analysis of the
scientific literature and silica-related
health risks are presented in the
background document entitled
‘‘Respirable Crystalline Silica—Health
Effects Literature Review and
Preliminary Quantitative Risk
Assessment’’ (placed in Docket OSHA–
2010–0034).
Based on a review of over 60
epidemiological studies covering more
than 30 occupational groups, OSHA
preliminarily concludes that crystalline
silica is a human carcinogen. Most of
these studies documented that exposed
workers experience higher lung cancer
mortality rates than do unexposed
workers or the general population, and
that the increase in lung cancer
mortality is related to cumulative
exposure to crystalline silica. These
exposure-related trends strongly
implicate crystalline silica as a likely
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causative agent. This is consistent with
the conclusions of other government
and public health organizations,
including the International Agency for
Research on Cancer (IARC), the Agency
for Toxic Substance and Disease
Registry (ATSDR), the World Health
Organization (WHO), the U.S.
Environmental Protection Agency
(EPA), the National Toxicology Program
(NTP), the National Academies of
Science (NAS), the National Institute for
Occupational Safety and Health
(NIOSH), and the American Conference
of Governmental Industrial Hygienists
(ACGIH).
OSHA believes that the strongest
evidence for carcinogenicity comes from
studies in five industry sectors
(diatomaceous earth, pottery, granite,
industrial sand, and coal mining) as
well as a study by Steenland et al.
(2001) that analyzed pooled data from
10 occupational cohort studies; each of
these studies found a positive
relationship between exposure to
crystalline silica and lung cancer
mortality. Based on a variety of relative
risk models fit to these data sets, OSHA
estimates that the excess lifetime risk to
workers exposed over a working life of
45 years at the current general industry
permissible exposure limit (PEL)
(approximately 100 mg/m3 respirable
crystalline silica) is between 13 and 60
deaths per 1,000 workers. For exposure
over a working life at the current
construction and shipyard employment
PELs (estimated to range between 250
and 500 mg/m3), the estimated risk lies
between 37 and 653 deaths per 1,000.
Reducing these PELs to the proposed
PEL of 50 mg/m3 respirable crystalline
silica results in a substantial reduction
of these risks, to a range estimated to be
between 6 and 26 deaths per 1,000
workers.
OSHA has also quantitatively
evaluated the mortality risk from nonmalignant respiratory disease, including
silicosis and COPD. Risk estimates for
silicosis mortality are based on a study
by Mannetje et al. (2002), which pooled
data from six worker cohort studies to
derive a quantitative relationship
between exposure and death rate for
silicosis. For non-malignant respiratory
disease, risk estimates are based on an
epidemiologic study of diatomaceous
earth workers, which included a
quantitative exposure-response analysis
(Park et al., 2002). For 45 years of
exposure to the current general industry
PEL, OSHA’s estimates of excess
lifetime risk are 11 deaths per 1,000
workers for the pooled analysis and 83
deaths per 1,000 workers based on Park
et al.’s (2002) estimates. At the proposed
PEL, estimates of silicosis and non-
PO 00000
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Fmt 4701
Sfmt 4702
malignant respiratory disease mortality
are 7 and 43 deaths per 1,000,
respectively. As noted by Park et al.
(2002), it is likely that silicosis as a
cause of death is often misclassified as
emphysema or chronic bronchitis; thus,
Mannetje et al.’s selection of deaths may
tend to underestimate the true risk of
silicosis mortality, while Park et al.’s
(2002) analysis would more fairly
capture the total respiratory mortality
risk from all non-malignant causes,
including silicosis and COPD.
OSHA also identified seven studies
that quantitatively described
relationships between exposure to
respirable crystalline silica and silicosis
morbidity, as diagnosed from chest
radiography (i.e., chest x-rays or
computerized tomography). Estimates of
silicosis morbidity derived from these
cohort studies range from 60 to 773
cases per 1,000 workers for a 45-year
exposure to the current general industry
PEL, and approach unity for a 45-year
exposure to the current construction/
shipyard PEL. Estimated risks of
silicosis morbidity range from 20 to 170
cases per 1,000 workers for a 45-year
exposure to the proposed PEL, reflecting
a substantial reduction in the risk
associated with exposure to the current
PELs.
OSHA’s estimates of crystalline silicarelated renal disease mortality risk are
derived from an analysis by Steenland
et al. (2002), in which data from three
cohort studies were pooled to derive a
quantitative relationship between
exposure to silica and the relative risk
of end-stage renal disease mortality. The
cohorts included workers in the U.S.
gold mining, industrial sand, and
granite industries. From this study,
OSHA estimates that exposure to the
current general industry and proposed
PELs over a working life would result in
a lifetime excess renal disease risk of 39
and 32 deaths per 1,000 workers,
respectively. For exposure to the current
construction/shipyard PEL, OSHA
estimates the excess lifetime risk to
range from 52 to 63 deaths per 1,000
workers.
A Statement of the Objectives of, and
Legal Basis for, the Proposed Rule
The objective of the proposed rule is
to reduce the numbers of fatalities and
illnesses occurring among employees
exposed to respirable crystalline silica
in general industry, maritime, and
construction sectors. This objective will
be achieved by requiring employers to
install engineering controls where
appropriate and to provide employees
with the equipment, respirators,
training, exposure monitoring, medical
surveillance, and other protective
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measures to perform their jobs safely.
The legal basis for the rule is the
responsibility given the U.S.
Department of Labor through the
Occupational Safety and Health Act of
1970 (OSH Act). The OSH Act provides
that, in promulgating health standards
dealing with toxic materials or harmful
physical agents, the Secretary ‘‘shall set
the standard which most adequately
assures, to the extent feasible, on the
basis of the best available evidence that
no employee will suffer material
impairment of health or functional
capacity even if such employee has
regular exposure to the hazard dealt
with by such standard for the period of
his working life.’’ 29 U.S.C. Sec.
655(b)(5). See Section II of this preamble
for a more detailed discussion of the
Secretary’s legal authority to promulgate
standards.
A Description of and Estimate of the
Number of Small Entities To Which the
Proposed Rule Will Apply
OSHA has completed a preliminary
analysis of the impacts associated with
this proposal, including an analysis of
the type and number of small entities to
which the proposed rule would apply,
as described above. In order to
determine the number of small entities
potentially affected by this rulemaking,
OSHA used the definitions of small
entities developed by the Small
Business Administration (SBA) for each
industry.
OSHA estimates that approximately
470,000 small business or government
entities would be affected by the
proposed standard. Within these small
entities, roughly 1.3 million workers are
exposed to crystalline silica and would
be protected by the proposed standard.
A breakdown, by industry, of the
number of affected small entities is
provided in Table III–3 in Chapter III of
the PEA.
OSHA estimates that approximately
356,000 very small entities would be
affected by the proposed standard.
Within these very small entities,
roughly 580,000 workers are exposed to
crystalline silica and would be
protected by the proposed standard. A
breakdown, by industry, of the number
of affected very small entities is
provided in Table III–4 in Chapter III of
the PEA.
A Description of the Projected
Reporting, Recordkeeping, and Other
Compliance Requirements of the
Proposed Rule
Tables VIII–28 and VIII–29 show the
average costs of the proposed standard
by NAICS code and by compliance
requirement for, respectively, small
entities (classified as small by SBA) and
very small entities (fewer than 20
employees). For the average small entity
in general industry and maritime, the
estimated cost of the proposed rule
would be about $2,103 annually, with
engineering controls accounting for 67
percent of the costs and exposure
monitoring accounting for 23 percent of
the costs. For the average small entity in
construction, the estimate cost of the
proposed rule would be about $798
annually, with engineering controls
accounting for 47 percent of the costs,
exposure monitoring accounting for 17
percent of the costs, and medical
surveillance accounting for 15 percent
of the costs.
For the average very small entity in
general industry and maritime, the
estimate cost of the proposed rule
would be about $616 annually, with
engineering controls accounting for 55
percent of the costs and exposure
monitoring accounting for 33 percent of
the costs. For the average very small
entity in construction, the estimate cost
of the proposed rule would be about
$533 annually, with engineering
controls accounting for 45 percent of the
costs, exposure monitoring accounting
for 16 percent of the costs, and medical
surveillance accounting for 16 percent
of the costs.
Table VIII–30 shows the unit costs
which form the basis for these cost
estimates for the average small entity
and very small entity.
TABLE VIII–28—AVERAGE COSTS FOR SMALL ENTITIES AFFECTED BY THE PROPOSED SILICA STANDARD FOR GENERAL
INDUSTRY, MARITIME, AND CONSTRUCTION
[2009 dollars]
Engineering
controls (includes abrasive blasting)
NAICS
Industry
324121 .....
Asphalt paving mixture and block manufacturing.
Asphalt shingle and roofing materials ..
Paint and coating manufacturing ..........
Vitreous china plumbing fixtures &
bathroom accessories manufacturing.
Vitreous china, fine earthenware, &
other pottery product manufacturing.
Porcelain electrical supply mfg .............
Brick and structural clay mfg ................
Ceramic wall and floor tile mfg .............
Other structural clay product mfg .........
Clay refractory manufacturing ..............
Nonclay refractory manufacturing ........
Flat glass manufacturing ......................
Other pressed and blown glass and
glassware manufacturing.
Glass container manufacturing .............
Ready-mixed concrete manufacturing ..
Concrete block and brick mfg ..............
Concrete pipe mfg ................................
Other concrete product mfg .................
Cut stone and stone product manufacturing.
Ground or treated mineral and earth
manufacturing.
Mineral wool manufacturing .................
All other misc. nonmetallic mineral
product mfg.
Iron and steel mills ...............................
324122 .....
325510 .....
327111 .....
327112 .....
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
327113
327121
327122
327123
327124
327125
327211
327212
.....
.....
.....
.....
.....
.....
.....
.....
327213
327320
327331
327332
327390
327991
.....
.....
.....
.....
.....
.....
327992 .....
327993 .....
327999 .....
331111 .....
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PO 00000
Exposure
monitoring
Respirators
Medical surveillance
Regulated
areas or access control
Training
Total
$232
$4
$13
$1
$74
$1
$326
5,721
0
6,310
297
10
428
1,887
36
2,065
103
3
150
114
15
162
111
4
160
8,232
69
9,274
1,679
114
663
41
47
42
2,586
6,722
28,574
10,982
10,554
1,325
1,964
4,068
889
458
636
245
235
92
136
160
34
2,656
3,018
1,160
1,115
653
802
520
110
162
226
87
83
33
48
56
12
188
237
91
87
81
110
50
11
170
236
91
87
34
51
60
13
10,355
32,928
12,655
12,162
2,218
3,110
4,913
1,068
2,004
1,728
3,236
5,105
3,016
2,821
76
460
245
386
228
207
248
1,726
1,257
1,983
1,171
1,040
27
163
87
137
81
74
24
121
134
211
125
65
29
171
91
143
85
77
2,408
4,369
5,049
7,966
4,705
4,284
12,034
174
3,449
62
191
65
15,975
1,365
2,222
56
168
185
863
20
60
17
92
21
62
1,664
3,467
604
34
138
12
11
13
812
Frm 00139
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TABLE VIII–28—AVERAGE COSTS FOR SMALL ENTITIES AFFECTED BY THE PROPOSED SILICA STANDARD FOR GENERAL
INDUSTRY, MARITIME, AND CONSTRUCTION—Continued
[2009 dollars]
Engineering
controls (includes abrasive blasting)
NAICS
Industry
331112 .....
Electrometallurgical ferroalloy product
manufacturing.
Iron and steel pipe and tube manufacturing from purchased steel.
Rolled steel shape manufacturing ........
Steel wire drawing ................................
Secondary smelting and alloying of
aluminum.
Secondary smelting, refining, and
alloying of copper.
Secondary smelting, refining, and
alloying of nonferrous metal (except
cu & al).
Iron foundries ........................................
Steel investment foundries ...................
Steel foundries (except investment) .....
Aluminum foundries (except die-casting).
Copper foundries (except die-casting)
Other nonferrous foundries (except
die-casting).
Iron and steel forging ...........................
Nonferrous forging ................................
Crown and closure manufacturing .......
Metal stamping .....................................
Powder metallurgy part manufacturing
Cutlery and flatware (except precious)
manufacturing.
Hand and edge tool manufacturing ......
Saw blade and handsaw manufacturing.
Kitchen utensil, pot, and pan manufacturing.
Ornamental and architectural metal
work.
Other metal container manufacturing ...
Hardware manufacturing ......................
Spring (heavy gauge) manufacturing ...
Spring (light gauge) manufacturing ......
Other fabricated wire product manufacturing.
Machine shops .....................................
Metal coating and allied services .........
Industrial valve manufacturing ..............
Fluid power valve and hose fitting
manufacturing.
Plumbing fixture fitting and trim manufacturing.
Other metal valve and pipe fitting manufacturing.
Ball and roller bearing manufacturing ..
Fabricated pipe and pipe fitting manufacturing.
Industrial pattern manufacturing ...........
Enameled iron and metal sanitary ware
manufacturing.
All other miscellaneous fabricated
metal product manufacturing.
Other commercial and service industry
machinery manufacturing.
Air purification equipment manufacturing.
Industrial and commercial fan and
blower manufacturing.
Heating equipment (except warm air
furnaces) manufacturing.
Industrial mold manufacturing ..............
Machine tool (metal cutting types)
manufacturing.
Machine tool (metal forming types)
manufacturing.
Special die and tool, die set, jig, and
fixture manufacturing.
Cutting tool and machine tool accessory manufacturing.
331210 .....
331221 .....
331222 .....
331314 .....
331423 .....
331492 .....
331511
331512
331513
331524
.....
.....
.....
.....
331525 .....
331528 .....
332111
332112
332115
332116
332117
332211
.....
.....
.....
.....
.....
.....
332212 .....
332213 .....
332214 .....
332323 .....
332439
332510
332611
332612
332618
.....
.....
.....
.....
.....
332710
332812
332911
332912
.....
.....
.....
.....
332913 .....
332919 .....
332991 .....
332996 .....
332997 .....
332998 .....
332999 .....
333319 .....
333411 .....
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
333412 .....
333414 .....
333511 .....
333512 .....
333513 .....
333514 .....
333515 .....
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PO 00000
Exposure
monitoring
Respirators
Medical surveillance
Regulated
areas or access control
Training
Total
514
29
118
10
10
11
692
664
38
154
13
13
14
896
583
638
577
33
36
33
135
148
133
12
13
11
11
12
11
12
14
12
787
862
777
534
30
125
11
10
11
722
548
31
128
11
11
12
741
9,143
11,874
9,223
7,367
522
675
526
419
2,777
3,596
2,802
2,231
185
240
187
149
200
249
202
155
194
251
196
156
13,021
16,885
13,135
10,476
4,563
3,895
260
222
1,382
1,179
92
79
96
82
96
82
6,489
5,539
531
533
514
533
535
518
30
30
29
30
31
30
161
162
156
162
163
157
11
11
10
11
11
10
12
12
11
12
12
11
11
11
11
11
11
11
756
760
732
759
762
738
542
528
31
30
165
160
11
11
12
12
12
11
772
752
560
32
170
11
12
12
798
524
20
102
7
11
8
673
550
531
529
585
537
31
30
30
33
31
167
161
161
178
163
11
11
11
12
11
12
12
12
13
12
12
11
11
12
11
784
756
754
834
765
518
843
528
532
30
33
30
30
157
165
160
162
10
12
11
11
11
18
12
12
11
12
11
11
738
1,083
752
757
528
30
160
11
12
11
752
536
31
163
11
12
11
764
545
529
31
30
131
161
11
11
11
12
12
11
741
754
517
484
29
23
157
97
10
8
11
10
11
9
736
630
521
30
158
11
11
11
742
526
30
160
11
12
11
750
525
30
160
11
11
11
748
555
32
169
11
12
12
791
520
30
158
11
11
11
741
522
524
30
30
159
159
11
11
11
11
11
11
743
746
532
30
162
11
12
11
758
522
30
158
11
11
11
743
524
30
159
11
11
11
746
Frm 00140
Fmt 4701
Sfmt 4702
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12SEP2
56413
Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules
TABLE VIII–28—AVERAGE COSTS FOR SMALL ENTITIES AFFECTED BY THE PROPOSED SILICA STANDARD FOR GENERAL
INDUSTRY, MARITIME, AND CONSTRUCTION—Continued
[2009 dollars]
Engineering
controls (includes abrasive blasting)
NAICS
Industry
333516 .....
Rolling mill machinery and equipment
manufacturing.
Other metalworking machinery manufacturing.
Speed changer, industrial high-speed
drive, and gear manufacturing.
Mechanical power transmission equipment manufacturing.
Pump and pumping equipment manufacturing.
Air and gas compressor manufacturing
Power-driven handtool manufacturing ..
Welding and soldering equipment manufacturing.
Packaging machinery manufacturing ...
Industrial process furnace and oven
manufacturing.
Fluid power cylinder and actuator manufacturing.
Fluid power pump and motor manufacturing.
Scale and balance (except laboratory)
manufacturing.
All other miscellaneous general purpose machinery manufacturing.
Watch, clock, and part manufacturing ..
Electric housewares and household
fans.
Household cooking appliance manufacturing.
Household refrigerator and home
freezer manufacturing.
Household laundry equipment manufacturing.
Other major household appliance manufacturing.
Automobile manufacturing ....................
Light truck and utility vehicle manufacturing.
Heavy duty truck manufacturing ...........
Motor vehicle body manufacturing .......
Truck trailer manufacturing ...................
Motor home manufacturing ..................
Carburetor, piston, piston ring, and
valve manufacturing.
Gasoline engine and engine parts
manufacturing.
Other motor vehicle electrical and electronic equipment manufacturing.
Motor vehicle steering and suspension
components (except spring) manufacturing.
Motor vehicle brake system manufacturing.
Motor vehicle transmission and power
train parts manufacturing.
Motor vehicle metal stamping ..............
All other motor vehicle parts manufacturing.
Ship building and repair .......................
Boat building .........................................
Military armored vehicle, tank, and
tank component manufacturing.
Showcase, partition, shelving, and
locker manufacturing.
Dental equipment and supplies manufacturing.
Dental laboratories ...............................
Jewelry (except costume) manufacturing.
Jewelers’ materials and lapidary work
manufacturing.
Costume jewelry and novelty manufacturing.
Sign manufacturing ...............................
Industrial supplies, wholesalers ............
333518 .....
333612 .....
333613 .....
333911 .....
333912 .....
333991 .....
333992 .....
333993 .....
333994 .....
333995 .....
333996 .....
333997 .....
333999 .....
334518 .....
335211 .....
335221 .....
335222 .....
335224 .....
335228 .....
336111 .....
336112 .....
336120
336211
336212
336213
336311
.....
.....
.....
.....
.....
336312 .....
336322 .....
336330 .....
336340 .....
336350 .....
336370 .....
336399 .....
336611 .....
336612 .....
336992 .....
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
337215 .....
339114 .....
339116 .....
339911 .....
339913 .....
339914 .....
339950 .....
423840 .....
VerDate Mar<15>2010
19:12 Sep 11, 2013
Jkt 229001
PO 00000
Exposure
monitoring
Respirators
Medical surveillance
Regulated
areas or access control
Training
Total
522
30
159
11
11
11
744
537
31
163
11
12
11
765
546
31
166
11
12
12
777
529
30
161
11
12
11
754
535
31
163
11
12
11
762
532
514
523
30
29
30
162
156
159
11
10
11
12
11
11
11
11
11
758
732
745
521
531
30
30
158
161
11
11
11
12
11
11
742
757
531
30
161
11
12
11
756
542
31
165
11
12
11
772
537
31
163
11
12
11
764
523
30
159
11
11
11
745
514
523
29
20
156
76
10
7
11
9
11
8
732
643
529
20
77
7
9
8
649
1,452
56
210
19
26
21
1,784
1,461
56
212
19
26
21
1,795
523
20
101
7
11
8
671
1,309
4,789
75
273
297
1,085
25
92
23
86
28
102
1,757
6,425
1,211
579
525
792
525
69
33
30
45
30
275
137
160
181
160
23
11
11
15
11
22
11
11
15
11
26
12
11
17
11
1,626
784
748
1,064
748
522
30
120
10
10
11
703
524
30
121
10
10
11
706
526
30
120
10
10
11
708
527
30
121
10
10
11
710
528
30
121
10
10
11
710
556
535
32
30
169
123
11
10
12
10
12
11
792
721
13,685
2,831
624
0
0
35
718
202
149
692
149
12
47
11
12
75
16
13
15,217
3,209
845
527
30
160
11
12
11
751
671
39
145
14
11
15
895
12
120
7
92
130
475
3
33
44
41
3
34
199
795
151
115
596
41
51
43
997
87
44
229
16
19
16
412
465
313
20
29
107
257
7
10
11
15
8
11
618
636
Frm 00141
Fmt 4701
Sfmt 4702
E:\FR\FM\12SEP2.SGM
12SEP2
56414
Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules
TABLE VIII–28—AVERAGE COSTS FOR SMALL ENTITIES AFFECTED BY THE PROPOSED SILICA STANDARD FOR GENERAL
INDUSTRY, MARITIME, AND CONSTRUCTION—Continued
[2009 dollars]
Engineering
controls (includes abrasive blasting)
NAICS
Industry
482110 .....
621210 .....
Rail transportation ................................
Dental offices ........................................
Total—General Industry and Maritime
Residential Building Construction .........
Nonresidential Building Construction ...
Utility System Construction ..................
Land Subdivision ..................................
Highway, Street, and Bridge Construction.
Other Heavy and Civil Engineering
Construction.
Foundation, Structure, and Building
Exterior Contractors.
Building Equipment Contractors ...........
Building Finishing Contractors ..............
Other Specialty Trade Contractors .......
State and Local Governments [c] .........
Total—Construction ..............................
236100
236200
237100
237200
237300
.....
.....
.....
.....
.....
237900 .....
238100 .....
238200
238300
238900
999000
.....
.....
.....
.....
Respirators
Exposure
monitoring
Medical surveillance
Training
Regulated
areas or access control
Total
......................
3
1,399
264
234
978
104
692
......................
2
93
43
104
89
9
109
......................
32
483
34
67
172
25
179
......................
1
46
37
89
78
8
95
......................
11
46
27
66
185
30
227
......................
1
36
15
14
30
3
26
......................
50
2,103
419
575
1,531
180
1,329
592
60
134
52
175
18
1,032
401
359
113
307
91
49
1,319
156
289
460
108
375
18
24
43
16
132
21
23
65
31
72
16
50
52
14
122
27
27
79
43
71
7
9
30
11
26
244
421
729
222
798
Source: U.S. Dept. of Labor, OSHA, Directorate of Standards and Guidance, Office of Regulatory Analysis, based on ERG (2013).
TABLE VIII–29—AVERAGE COSTS FOR VERY SMALL ENTITIES (<20 EMPLOYEES) AFFECTED BY THE PROPOSED SILICA
STANDARD FOR GENERAL INDUSTRY, MARITIME, AND CONSTRUCTION
[2009 dollars]
Engineering
controls (includes abrasive blasting)
NAICS
Industry
324121 .....
Asphalt paving mixture and block manufacturing.
Asphalt shingle and roofing materials ..
Paint and coating manufacturing ..........
Vitreous china plumbing fixtures &
bathroom accessories manufacturing.
Vitreous china, fine earthenware, &
other pottery product manufacturing.
Porcelain electrical supply mfg .............
Brick and structural clay mfg ................
Ceramic wall and floor tile mfg .............
Other structural clay product mfg .........
Clay refractory manufacturing ..............
Nonclay refractory manufacturing ........
Flat glass manufacturing ......................
Other pressed and blown glass and
glassware manufacturing.
Glass container manufacturing .............
Ready-mixed concrete manufacturing ..
Concrete block and brick mfg ..............
Concrete pipe mfg ................................
Other concrete product mfg .................
Cut stone and stone product manufacturing.
Ground or treated mineral and earth
manufacturing.
Mineral wool manufacturing .................
All other misc. nonmetallic mineral
product mfg.
Iron and steel mills ...............................
Electrometallurgical ferroalloy product
manufacturing.
Iron and steel pipe and tube manufacturing from purchased steel.
Rolled steel shape manufacturing ........
Steel wire drawing ................................
Secondary smelting and alloying of
aluminum.
Secondary smelting, refining, and
alloying of copper.
Secondary smelting, refining, and
alloying of nonferrous metal (except
cu & al).
Iron foundries ........................................
Steel investment foundries ...................
Steel foundries (except investment) .....
324122 .....
325510 .....
327111 .....
327112 .....
327113
327121
327122
327123
327124
327125
327211
327212
.....
.....
.....
.....
.....
.....
.....
.....
327213
327320
327331
327332
327390
327991
.....
.....
.....
.....
.....
.....
327992 .....
327993 .....
327999 .....
331111 .....
331112 .....
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
331210 .....
331221 .....
331222 .....
331314 .....
331423 .....
331492 .....
331511 .....
331512 .....
331513 .....
VerDate Mar<15>2010
19:12 Sep 11, 2013
Jkt 229001
PO 00000
Exposure
monitoring
Respirators
Medical surveillance
Regulated
areas or access control
Training
Total
$74
$1
$5
$0
$26
$0
$107
914
0
851
48
7
58
476
33
422
17
3
21
23
13
26
18
3
22
1,496
58
1,400
705
48
349
17
22
18
1,160
851
2,096
2,385
2,277
301
471
842
873
58
47
53
51
21
33
34
34
422
277
316
301
186
291
163
164
21
17
19
18
8
12
12
12
26
19
22
21
20
32
12
12
22
17
20
19
8
12
12
12
1,400
2,474
2,815
2,687
543
852
1,075
1,107
873
475
966
1,046
854
1,158
34
127
74
80
65
86
164
595
470
509
416
535
12
46
27
29
23
31
12
37
44
48
39
30
12
47
27
29
24
32
1,107
1,328
1,608
1,741
1,422
1,872
3,564
52
1,280
19
63
19
4,997
823
797
34
61
166
388
12
22
12
37
13
22
1,061
1,327
517
0
30
0
197
0
11
0
13
0
11
0
777
0
514
30
196
11
12
11
774
514
514
514
30
30
30
196
196
196
11
11
11
12
12
12
11
11
11
774
774
774
0
0
0
0
0
0
0
514
30
196
11
12
11
774
1,093
1,181
1,060
63
68
61
416
448
404
23
24
22
26
28
26
23
25
22
1,644
1,774
1,595
Frm 00142
Fmt 4701
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E:\FR\FM\12SEP2.SGM
12SEP2
56415
Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules
TABLE VIII–29—AVERAGE COSTS FOR VERY SMALL ENTITIES (<20 EMPLOYEES) AFFECTED BY THE PROPOSED SILICA
STANDARD FOR GENERAL INDUSTRY, MARITIME, AND CONSTRUCTION—Continued
[2009 dollars]
Engineering
controls (includes abrasive blasting)
NAICS
Industry
331524 .....
Aluminum foundries (except die-casting).
Copper foundries (except die-casting)
Other nonferrous foundries (except
die-casting).
Iron and steel forging ...........................
Nonferrous forging ................................
Crown and closure manufacturing .......
Metal stamping .....................................
Powder metallurgy part manufacturing
Cutlery and flatware (except precious)
manufacturing.
Hand and edge tool manufacturing ......
Saw blade and handsaw manufacturing.
Kitchen utensil, pot, and pan manufacturing.
Ornamental and architectural metal
work.
Other metal container manufacturing ...
Hardware manufacturing ......................
Spring (heavy gauge) manufacturing ...
Spring (light gauge) manufacturing ......
Other fabricated wire product manufacturing.
Machine shops .....................................
Metal coating and allied services .........
Industrial valve manufacturing ..............
Fluid power valve and hose fitting
manufacturing.
Plumbing fixture fitting and trim manufacturing.
Other metal valve and pipe fitting manufacturing.
Ball and roller bearing manufacturing ..
Fabricated pipe and pipe fitting manufacturing.
Industrial pattern manufacturing ...........
Enameled iron and metal sanitary ware
manufacturing.
All other miscellaneous fabricated
metal product manufacturing.
Other commercial and service industry
machinery manufacturing.
Air purification equipment manufacturing.
Industrial and commercial fan and
blower manufacturing.
Heating equipment (except warm air
furnaces) manufacturing.
Industrial mold manufacturing ..............
Machine tool (metal cutting types)
manufacturing.
Machine tool (metal forming types)
manufacturing.
Special die and tool, die set, jig, and
fixture manufacturing.
Cutting tool and machine tool accessory manufacturing.
Rolling mill machinery and equipment
manufacturing.
Other metalworking machinery manufacturing.
Speed changer, industrial high-speed
drive, and gear manufacturing.
Mechanical power transmission equipment manufacturing.
Pump and pumping equipment manufacturing.
Air and gas compressor manufacturing
Power-driven handtool manufacturing ..
Welding and soldering equipment manufacturing.
Packaging machinery manufacturing ...
Industrial process furnace and oven
manufacturing.
331525 .....
331528 .....
332111
332112
332115
332116
332117
332211
.....
.....
.....
.....
.....
.....
332212 .....
332213 .....
332214 .....
332323 .....
332439
332510
332611
332612
332618
.....
.....
.....
.....
.....
332710
332812
332911
332912
.....
.....
.....
.....
332913 .....
332919 .....
332991 .....
332996 .....
332997 .....
332998 .....
332999 .....
333319 .....
333411 .....
333412 .....
333414 .....
333511 .....
333512 .....
333513 .....
333514 .....
333515 .....
333516 .....
333518 .....
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
333612 .....
333613 .....
333911 .....
333912 .....
333991 .....
333992 .....
333993 .....
333994 .....
VerDate Mar<15>2010
19:12 Sep 11, 2013
Jkt 229001
PO 00000
Exposure
monitoring
Respirators
Medical surveillance
Regulated
areas or access control
Training
Total
1,425
82
541
29
33
30
2,141
1,503
1,401
86
80
570
532
31
29
35
33
32
30
2,257
2,104
514
514
514
515
514
514
30
30
30
30
30
30
196
196
196
196
196
196
11
11
11
11
11
11
12
12
12
12
12
12
11
11
11
11
11
11
774
774
774
775
774
774
514
514
30
30
196
196
11
11
12
12
11
11
774
774
0
0
0
0
0
0
0
520
20
127
7
12
8
694
524
517
523
514
514
30
30
30
30
30
199
197
199
196
196
11
11
11
11
11
13
13
13
12
12
11
11
11
11
11
788
777
786
774
774
515
519
514
514
30
20
30
30
196
127
196
196
11
7
11
11
12
12
12
12
11
8
11
11
774
694
774
774
514
30
196
11
12
11
774
519
30
198
11
13
11
781
514
514
30
30
196
196
11
11
12
12
11
11
774
774
514
484
30
23
196
153
11
8
12
12
11
9
774
690
514
30
196
11
12
11
774
514
30
196
11
12
11
774
514
30
196
11
12
11
774
514
30
196
11
12
11
774
517
30
197
11
13
11
777
515
516
30
30
196
196
11
11
12
13
11
11
774
776
514
30
196
11
12
11
774
515
30
196
11
12
11
774
515
30
196
11
12
11
775
514
30
196
11
12
11
774
514
30
196
11
12
11
774
514
30
196
11
12
11
774
514
30
196
11
12
11
774
514
30
196
11
12
11
774
514
514
514
30
30
30
196
196
196
11
11
11
12
12
12
11
11
11
774
774
774
514
514
30
30
196
196
11
11
12
12
11
11
774
774
Frm 00143
Fmt 4701
Sfmt 4702
E:\FR\FM\12SEP2.SGM
12SEP2
56416
Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules
TABLE VIII–29—AVERAGE COSTS FOR VERY SMALL ENTITIES (<20 EMPLOYEES) AFFECTED BY THE PROPOSED SILICA
STANDARD FOR GENERAL INDUSTRY, MARITIME, AND CONSTRUCTION—Continued
[2009 dollars]
Engineering
controls (includes abrasive blasting)
NAICS
Industry
333995 .....
Fluid power cylinder and actuator manufacturing.
Fluid power pump and motor manufacturing.
Scale and balance (except laboratory)
manufacturing.
All other miscellaneous general purpose machinery manufacturing.
Watch, clock, and part manufacturing ..
Electric housewares and household
fans.
Household cooking appliance manufacturing.
Household refrigerator and home
freezer manufacturing.
Household laundry equipment manufacturing.
Other major household appliance manufacturing.
Automobile manufacturing ....................
Light truck and utility vehicle manufacturing.
Heavy duty truck manufacturing ...........
Motor vehicle body manufacturing .......
Truck trailer manufacturing ...................
Motor home manufacturing ..................
Carburetor, piston, piston ring, and
valve manufacturing.
Gasoline engine and engine parts
manufacturing.
Other motor vehicle electrical and electronic equipment manufacturing.
Motor vehicle steering and suspension
components (except spring) manufacturing.
Motor vehicle brake system manufacturing.
Motor vehicle transmission and power
train parts manufacturing.
Motor vehicle metal stamping ..............
All other motor vehicle parts manufacturing.
Ship building and repair .......................
Boat building .........................................
Military armored vehicle, tank, and
tank component manufacturing.
Showcase, partition, shelving, and
locker manufacturing.
Dental equipment and supplies manufacturing.
Dental laboratories ...............................
Jewelry (except costume) manufacturing.
Jewelers’ materials and lapidary work
manufacturing.
Costume jewelry and novelty manufacturing.
Sign manufacturing ...............................
Industrial supplies, wholesalers ............
Rail transportation ................................
Dental offices ........................................
Total—General Industry and Maritime
Residential Building Construction .........
Nonresidential Building Construction ...
Utility System Construction ..................
Land Subdivision ..................................
Highway, Street, and Bridge Construction.
Other Heavy and Civil Engineering
Construction.
Foundation, Structure, and Building
Exterior Contractors.
Building Equipment Contractors ...........
Building Finishing Contractors ..............
Other Specialty Trade Contractors .......
State and Local Governments [c] .........
333996 .....
333997 .....
333999 .....
334518 .....
335211 .....
335221 .....
335222 .....
335224 .....
335228 .....
336111 .....
336112 .....
336120
336211
336212
336213
336311
.....
.....
.....
.....
.....
336312 .....
336322 .....
336330 .....
336340 .....
336350 .....
336370 .....
336399 .....
336611 .....
336612 .....
336992 .....
337215 .....
339114 .....
339116 .....
339911 .....
339913 .....
339914 .....
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
339950
423840
482110
621210
.....
.....
.....
.....
236100
236200
237100
237200
237300
.....
.....
.....
.....
.....
237900 .....
238100 .....
238200
238300
238900
999000
.....
.....
.....
.....
VerDate Mar<15>2010
19:12 Sep 11, 2013
Jkt 229001
PO 00000
Exposure
monitoring
Respirators
Medical surveillance
Regulated
areas or access control
Training
Total
514
30
196
11
12
11
774
514
30
196
11
12
11
774
514
30
196
11
12
11
774
514
30
196
11
12
11
774
514
0
30
0
196
0
11
0
12
0
11
0
774
0
523
20
127
7
12
8
698
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
514
514
30
30
196
196
11
11
12
12
11
11
774
774
514
514
514
514
514
30
30
30
30
30
196
196
196
196
196
11
11
11
11
11
12
12
12
12
12
11
11
11
11
11
774
774
774
774
774
514
30
196
11
12
11
774
514
30
196
11
12
11
774
514
30
196
11
12
11
774
514
30
196
11
12
11
774
514
30
196
11
12
11
774
517
514
30
30
197
196
11
11
13
12
11
11
778
774
2,820
2,816
0
0
0
0
253
252
0
151
151
0
13
12
0
16
15
0
3,252
3,247
0
514
30
196
11
12
11
774
663
39
180
14
12
14
922
8
45
5
35
107
225
2
13
32
17
2
13
156
348
52
40
256
14
19
15
397
50
26
166
9
12
10
274
459
262
20
24
132
215
7
9
12
13
7
9
639
531
3
337
264
117
326
104
275
2
29
43
52
30
9
44
32
205
42
42
71
25
89
1
12
38
46
27
8
39
11
23
30
37
69
30
102
1
11
15
7
10
3
10
49
616
432
301
532
180
559
202
20
57
18
67
6
372
228
204
80
180
58
28
778
156
289
276
N/A
18
24
26
N/A
26
28
49
N/A
16
51
32
N/A
30
30
53
N/A
7
9
18
N/A
253
431
454
N/A
Frm 00144
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E:\FR\FM\12SEP2.SGM
12SEP2
56417
Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules
TABLE VIII–29—AVERAGE COSTS FOR VERY SMALL ENTITIES (<20 EMPLOYEES) AFFECTED BY THE PROPOSED SILICA
STANDARD FOR GENERAL INDUSTRY, MARITIME, AND CONSTRUCTION—Continued
[2009 dollars]
NAICS
Engineering
controls (includes abrasive blasting)
Industry
Total—Construction ..............................
Exposure
monitoring
Respirators
242
87
56
Medical surveillance
Regulated
areas or access control
Training
83
49
17
Total
533
Source: U.S. Dept. of Labor, OSHA, Directorate of Standards and Guidance, Office of Regulatory Analysis, based on ERG (2013).
TABLE VIII–30—SOURCE INFORMATION FOR THE UNIT COST ESTIMATES USED IN OSHA’S PRELIMINARY COST ANALYSIS
FOR GENERAL INDUSTRY, MARITIME, AND CONSTRUCTION
Ventilation
airflow (cfm)
Description
Saw enclosure ............
8′ x 8′ x 8′ wood/plastic.
N/A
$487.70
$48.77
$118.95
Cab enclosures ..........
Enclosed cabs ............
N/A
15,164.82
5,307.69
3,698.56
LEV for hand held
grinders.
Shrouds + vacuum .....
N/A
1,671.63
585.07
407.70
Upgraded abrasive
blast cabinet.
Improved maintenance
and purchases for
some.
N/A
4,666.10
1,000.00
664.35
Improved spray booth
for pottery.
Maintenance time &
materials.
N/A
116.65
114.68
231.33
Improved LEV for ceramics spray booth.
Exhaust for saw, cut
stone industry.
Increased air flow; per
cfm.
Based on saw LEV
(e.g., pg. 10–158,
159, 160, ACGIH,
2001).
Granite cutting and finishing; (pg. 10–94,
ACGIH, 2001).
Based on abrasive
cut-off saw; (pg. 10–
134) (ACGIH, 2001).
Bag opening station;
(pg. 10–19, ACGIH,
2001).
Conveyor belt ventilation; (pg. 10–70,
ACGIH, 2001).
Bucket elevator ventilation (pg. 10–68;
ACGIH, 2001).
N/A
3.21
0.88
3.21
450
5,774.30
1,577.35
822.13
600
7,699.06
2,103.14
1,096.17
500
6,415.89
1,752.61
913.48
1,513
19,414.48
5,303.41
2,764.18
700
8,982.24
2,453.66
1,278.87
1,600
20,530.84
5,608.36
2,923.13
1,050
13,473.36
3,680.49
1,918.30
1,200
15,398.13
4,206.27
2,192.35
4′ x 6′ screen; 50 cfm
per ft2.
1,050
13,473.36
3,680.49
1,918.30
ERG estimate of cfm
requirements.
3,750
48,119.16
13,144.60
6,851.09
ERG estimate of cfm
requirements.
LEV for hand chipping
in cut stone.
Exhaust trimming machine.
Bag opening ...............
Conveyor ventilation ...
Bucket elevator ventilation.
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Bin and hopper ventilation.
Screen ventilation .......
Batch operator
workstation.
LEV for hand grinding
operator (pottery).
VerDate Mar<15>2010
Bin and hopper ventilation (pg. 10–69;
ACGIH, 2001).
Ventilated screen (pg.
10–173, ACGIH,
2001).
Bin & hopper ventilation for unvented
mixers (pg. 10–69,
ACGIH, 2001).
Hand grinding bench
(pg. 10–135,
ACGIH, 2001).
19:12 Sep 11, 2013
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Capital cost [b]
Annualized
capital cost
Control [a]
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Operating cost
E:\FR\FM\12SEP2.SGM
12SEP2
Comment or source
Fabrication costs estimated by ERG, assuming in-plant
work. Five-year life.
ERG estimate based
on vendor interviews.
Vacuum plus shroud
adapter (http://www.
proventilation.com/
products/productDetail.asp?id=15); 35%
for maintenance and
operating costs.
Assumes add. maintenance (of up to
$2,000) or new cabinets ($8,000) (Norton, 2003).
Annual: $100 materials plus 4 hours
maintenance time.
25% of installed CFM
price.
ERG based on typical
saw cfm requirements.
ERG estimate of cfm
requirements.
Opening of 2 sq ft assumed, with 250
cfm/sq.ft.
3.5′ x 1.5′ opening;
with ventilated bag
crusher (200 cfm).
Per take-off point, 2′
wide belt.
2′ x 3′ x 30′ casing; 4
take-offs @250 cfm;
100 cfm per sq ft of
cross section.
350 cfm per ft2; 3’ belt
width.
56418
Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules
TABLE VIII–30—SOURCE INFORMATION FOR THE UNIT COST ESTIMATES USED IN OSHA’S PRELIMINARY COST ANALYSIS
FOR GENERAL INDUSTRY, MARITIME, AND CONSTRUCTION—Continued
Ventilation
airflow (cfm)
Capital cost [b]
Annualized
capital cost
Control [a]
Description
LEV, mixer and muller
hood.
Mixer & muller hood
(pg. 10–87, ACGIH,
2001).
Bag filling station (pg.
10–15, ACGIH,
2001).
Manual controls, system covers 100 ft of
conveyor.
1,050
13,473.36
3,680.49
1,918.30
ERG estimate of cfm
requirements.
1,500
19,247.66
5,257.84
2,740.43
Includes costs for air
shower.
N/A
10,207.09
1,020.71
1,453.26
Plumbing for hose installations, floor resloping and troughs.
Ventilated shakeout
conveyor enclosure.
Shakeout double sidedraft table (pg. 10–
23, ACGIH, 2001).
Ventilated enclosing
hood (pg. 10–23,
ACGIH, 2001); 4′ x
4′ openings.
Portable grinding table
pg. 10–136),
ACGIH, 2001), 3′ x
3′ opening.
Hand grinding table
pg. 10–135),
ACGIH, 2001), 4′ x
6′ surface.
Ventilated cut-off saw
(pg. 10–134,
ACGIH, 2001, 2′ x
3′ opening.
Bench with LEV (pg.
10–135, ACGIH,
2001); 3′ x 5′.
Bench with LEV (pg.
10–149, ACGIH,
2001), 3′ x 4′.
Bench with LEV (pg.
10–135, ACGIH,
2001); 3′ x 4′.
Retrofit suction attachment.
Clean air supplied directly to worker.
N/A
36,412.40
3,258.87
5,184.31
10,000
128,317.75
35,052.26
18,269.56
National Environmental Services
Company (Kestner,
2003).
ERG estimate. Includes cost of water
and labor time.
ERG estimate.
28,800
369,555.11
100,950.52
52,616.33
ERG estimate of cfm
requirements.
7,040
90,335.69
24,676.79
12,861.77
ERG estimate of
opening size required.
1,350
17,322.90
4,732.06
2,466.39
ERG estimate of
opening size required.
4,800
61,592.52
16,825.09
8,769.39
ERG estimate of
bench surface area.
1,500
19,247.66
5,257.84
2,740.43
ERG estimate of
opening size required.
3,750
48,119.16
13,144.60
6,851.09
1,400
17,964.48
4,907.32
2,557.74
2,400
30,796.26
8,412.54
4,384.69
200
464.21
701.05
66.09
2,500
32,079.44
8,763.07
4,567.39
ERG estimate of cfm
requirements; 250
cfm/sq. ft.
ERG estimate of cfm
requirements; 125
cfm per linear foot.
ERG estimate of cfm
requirements; 200
cfm/sq. ft.
ERG estimate of cfm
requirements.
ERG estimate of cfm
requirements; 125
cfm/sq. ft. for 20
square feet.
ERG estimate. $100 in
annual costs.
LEV for bag filling stations.
Installed manual spray
mister.
Install cleaning hoses,
reslope floor, drainage.
Shakeout conveyor
enclosure.
Shakeout side-draft
ventilation.
Shakeout enclosing
hood.
Small knockout table ..
Large knockout table ..
Ventilated abrasive
cutoff saw.
Hand grinding bench
(foundry).
Forming operator
bench (pottery).
Hand grinding bench
(pottery).
Hand tool hardware ....
Clean air island ..........
Operating cost
Shop-built water feed
equipment.
N/A
116.65
0.00
116.65
Ventilation blower and
ducting.
N/A
792.74
198.18
193.34
Control room ..............
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Water fed chipping
equipment drum
cleaning.
Ventilation for drum
cleaning.
10′ x 10′ ventilated
control room with
HEPA filter.
200
19,556.79
701.05
2,784.45
Control room improvement.
Repair and improve
control room enclosure.
N/A
2,240.00
N/A
318.93
Improved bag valves ..
Bags with extended
polyethylene valve,
incremental cost per
bag.
N/A
0.01
N/A
N/A
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Comment or source
Electric blower (1,277
cfm) and 25 ft. of
duct. Northern Safety Co. (p. 193).
ERG estimate based
on RSMeans
(2003), ACGIH
(2001).
ERG estimate. Assumes repairs are
20% of new control
room cost.
Cecala et. al., (1986).
Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules
56419
TABLE VIII–30—SOURCE INFORMATION FOR THE UNIT COST ESTIMATES USED IN OSHA’S PRELIMINARY COST ANALYSIS
FOR GENERAL INDUSTRY, MARITIME, AND CONSTRUCTION—Continued
Ventilation
airflow (cfm)
Capital cost [b]
Annualized
capital cost
Control [a]
Description
Dust suppressants .....
Kleen Products 50 lb
poly bag green
sweeping compound.
NILFISK VT60 wet/dry
hepa vac, 15 gal.
N/A
N/A
634.54
0.00
N/A
3,494.85
511.20
852.36
HEPA vacuum for
housekeeping.
Yard dust suppression
NILFISK, large capacity.
100 ft, 1’’ contractor
hose and nozzle.
N/A
7,699.06
988.90
1,877.73
N/A
204.14
0.00
112.91
Wet methods to clean
concrete mixing
equip..
HEPA vacuum substitute for compressed air.
Spray system for wet
concrete finishing.
10 mins per day per
operator.
N/A
0.00
916.82
0.00
Incremental time to remove dust by vacuum.
Shop-built sprayer
system.
N/A
N/A
494.54
0.00
5 min per day per affected worker.
N/A
204.67
20.47
113.20
Substitute alt., non-silica, blasting media.
Alternative media estimated to cost 22
percent more.
N/A
0.00
33,646.00
0.00
Abrasive blasting cost
per square foot (dry
blasting).
Half-mask, non-powered, air-purifying
respirator.
125 blasting days per
year.
N/A
N/A
2.00
N/A
Assumes $100 in materials and 4 hours
to fabricate. Also
10% for maintenance.
Based on 212,000
square feet of coverage per year per
crew.
ERG estimate based
on RSMeans
(2009).
Unit cost includes expenses for accessories, training, fit
testing, and cleaning.
Unit cost includes expenses for accessories, training, fit
testing, and cleaning.
Unit cost includes expenses for accessories, training, fit
testing, and cleaning.
Consulting IH technician—rate per sample. Assumes IH
rate of $500 per day
and samples per
day of 2, 6, and 8
for small, medium,
and large establishments, respectively.
.....................................
N/A
N/A
570.13
N/A
N/A
N/A
637.94
N/A
N/A
N/A
468.74
N/A
N/A
N/A
500
N/A
N/A
N/A
133.38
N/A
Evaluation and office
consultation including detailed examination.
Tri-annual radiologic
examination, chest;
stereo, frontal.
Costs include consultation and written
report.
N/A
N/A
100.00
N/A
N/A
N/A
79.61
N/A
HEPA vacuum for
housekeeping.
Full-face nonpowered
air-purifying respirator.
Half-face respirator
(construction).
Industrial Hygiene
Fees/personal
breathing zone.
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Exposure assessment
lab fees and shipping cost.
Physical examination
by knowledgeable
Health Care Practitioner.
Chest X-ray ................
VerDate Mar<15>2010
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Operating cost
E:\FR\FM\12SEP2.SGM
12SEP2
Comment or source
0.28/lb, 2 lbs/day; 5
minutes/day
(www.fastenal.com).
Nilfisk, HEPA vacuum
(http://www.sylvane.
com/nilfisk.html).
Nilfisk, HEPA vacuum
(McCarthy, 2003).
Contactor hose and
nozzle; 2 year life;
(www.pwmall.com).
10 mins per day per
mixer operator.
Lab fees (EMSL Laboratory, 2000) and
OSHA estimates. Inflated to 2009 values.
ERG, 2013.
56420
Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules
TABLE VIII–30—SOURCE INFORMATION FOR THE UNIT COST ESTIMATES USED IN OSHA’S PRELIMINARY COST ANALYSIS
FOR GENERAL INDUSTRY, MARITIME, AND CONSTRUCTION—Continued
Control [a]
Pulmonary function
test.
Ventilation
airflow (cfm)
Description
Operating cost
Annualized
capital cost
Comment or source
N/A
N/A
54.69
N/A
N/A
N/A
190.28
N/A
N/A
N/A
34.09
N/A
Estimated cost of $2
per worker for the
training/reading materials.
.....................................
N/A
N/A
2.00
N/A
N/A
N/A
17.94
N/A
1.00 per respirator per
day, typical cost for
N95 disposable respirator.
Per suit, daily clothing
costs for 10% of
workers.
Per regulated area for
annual set-up (300
ft).
25.30 per sign ............
N/A
N/A
1.00
N/A
N/A
N/A
5.50
N/A
Lab Safety Supply,
2010.
N/A
N/A
5.80
N/A
Lab Safety Supply,
2010.
N/A
N/A
151.80
N/A
.....................................
N/A
226.73
[d] 0.18
125.40
Dust shrouds: grinder
.....................................
N/A
97.33
[d] 0.14
97.33
Water tank, portable
(unspecified capacity).
Water tank, small capacity (hand pressurized).
Hose (water), 20′, 2″
diameter.
Custom water spray
nozzle and attachments.
Hose (water), 200′, 2″
diameter.
Vacuum, 10–15 gal
with HEPA.
.....................................
N/A
[e] 15.50
N/A
Lab Safety Supply,
2010.
Contractors Direct
(2009); Berland
House of Tools
(2009); mytoolstore
(2009).
Contractors Direct
(2009); Berland
House of Tools
(2009); Dust-Buddy
(2009); Martin
(2008).
RSMeans—based on
monthly rental cost.
.....................................
N/A
[d] 0.11
79.04
.....................................
N/A
N/A
[e] 1.65
N/A
.....................................
N/A
363
[d] 0.54
388.68
.....................................
N/A
N/A
[e] 16.45
N/A
.....................................
N/A
725
[d] 0.56
400.99
Vacuum, large capacity with HEPA.
.....................................
N/A
2,108
[d] 1.63
1,165.92
Examination by a pulmonary specialist [c].
Training instructor cost
per hour.
Training materials for
class per attendee.
Value of worker time
spent in class.
Cost—disposable particulate respirator
(N95).
Disposable clothing ....
Hazard tape ................
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Warning signs (6 per
regulated area).
Wet kit, with water
tank.
VerDate Mar<15>2010
Tri-annual spirometry,
including graphic
record, total and
timed vital capacity,
expiratory flow rate
measurements(s),
and/or maximal voluntary ventilation.
Office consultation and
evaluation by a pulmonary specialist.
.....................................
Capital cost [b]
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12SEP2
Based on supervisor
wage, adjusted for
fringe benefits (BLS,
2008, updated to
2009 dollars).
Based on worker
wage, adjusted for
fringe benefits (BLS,
2008, updated to
2009 dollars).
Lab Safety Supply,
2010.
Contractors Direct
(2009); mytoolstore
(2009).
RSMeans—based on
monthly cost.
New Jersey Laborers’
Health and Safety
Fund (2007).
RSMeans—based on
monthly rental cost.
ICS (2009); Dust Collection (2009);
EDCO (2009); CS
Unitec (2009).
ICS (2009); EDCO
(2009); Aramsco
(2009).
Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules
56421
TABLE VIII–30—SOURCE INFORMATION FOR THE UNIT COST ESTIMATES USED IN OSHA’S PRELIMINARY COST ANALYSIS
FOR GENERAL INDUSTRY, MARITIME, AND CONSTRUCTION—Continued
Ventilation
airflow (cfm)
Capital cost [b]
Annualized
capital cost
Control [a]
Description
Dust extraction kit (rotary hammers).
.....................................
N/A
215
[d] 0.30
214.81
Dust control/quarry
drill.
.....................................
N/A
N/A
[e] 17.33
N/A
Dustless drywall sander.
.....................................
N/A
133
[d] 0.19
133.33
Cab enclosure/w ventilation and air conditioning.
Foam dust suppression system.
Water tank, engine
driven discharge,
5000 gal..
Tunnel dust suppression system supplement.
Training instructor cost
per hour (Construction).
.....................................
N/A
13,000
[d] 2.59
1,850.91
.....................................
N/A
14,550
[e] 162.07
2,071.59
.....................................
N/A
N/A
[d] 121.50
N/A
.....................................
N/A
7,928
[e] 2.71
1,933.47
.....................................
N/A
N/A
43.12
N/A
Value of worker time
spent in class (Construction).
.....................................
N/A
N/A
22.22
N/A
Warning signs (3 per
regulated area)
(Construction).
Per-worker costs for
written access control plan or regulated area setup implementation (Construction).
25.30 per sign ............
N/A
N/A
75.90
N/A
Weighted average annual cost per worker; Applies to workers with exposures
above the PEL.
Operating cost
Comment or source
Grainger (2009);
mytoolstore (2009);
Toolmart (2009).
RSMeans Heavy Construction Cost Data
(2008).
Home Depot (2009);
LSS (2009); Dustless Tech (2009).
Estimates from equipment suppliers and
retrofitters.
Midyette (2003).
RSMeans (2008)—
based on monthly
rental cost.
Raring (2003).
Based on supervisor
wage, adjusted for
fringe benefits (BLS,
2008, updated to
2009 dollars).
Based on worker
wage, adjusted for
fringe benefits (BLS,
2008, updated to
2009 dollars).
Lab Safety Supply,
2010.
175.56
[a] For
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
local exhaust ventilation (LEV), maintenance, and conveyor covers, OSHA applied the following estimates:
LEV: capital cost = $12.83 per cfm; operating cost = $3.51 per cfm; annualized capital cost = $1.83 per cfm; based on current energy prices
and the estimates of consultants to ERG (2013).
Maintenance: estimated as 10% of capital cost.
Conveyor Covers: estimated as $17.10 per linear foot for 100 ft. (Landola, 2003); capital cost = $19.95 per linear ft., including all hardware;
annualized capital cost = $2.84 per linear ft.
[b] Adjusted from 2003 price levels using an inflation factor of 1.166, calculated as the ratio of average annual GDP Implicit Price Deflator for
2009 and 2003.
[c] Mean expense per office-based physician visit to a pulmonary specialist for diagnosis and treatment, based on data from the 2004 Medical
Expenditure Panel Survey. Inflated to 2009 dollars using the consumer price inflator for medical services.
Costs for physical exams and tests, chest X-ray, and pulmonary tests are direct medical costs used in bundling services under Medicare
(Intellimed International, 2003). Costs are inflated by 30% to eliminate the effect of Medicare discounts that are unlikely to apply to occupational
medicine environments.
[d] Daily maintenance and operating cost.
[e] Daily equipment costs derived from RS Means (2008) monthly rental rates, which include maintenance and operating costs.
Source: U.S. Dept. of Labor, OSHA, Directorate of Standards and Guidance, Office of Regulatory Analysis, based on ERG (2013).
Federal Rules Which May Duplicate,
Overlap, or Conflict With the Proposed
Rule.
OSHA has not identified any other
Federal rules which may duplicate,
overlap, or conflict with the proposal,
and requests comments from the public
regarding this issue.
VerDate Mar<15>2010
19:12 Sep 11, 2013
Jkt 229001
1. Alternatives to the Proposed Rule
which Accomplish the Stated Objectives
of Applicable Statutes and which
Minimize any Significant Economic
Impact of the Proposed Rule on Small
Entities
SBREFA Panel process or on
recommendations made by the SBREFA
Panel as potentially alleviating impacts
on small entities. Then, the Agency
presents various regulatory alternatives
to the proposed OSHA silica standard.
This section first discusses several
provisions in the proposed standard that
OSHA has adopted or modified based
on comments from small entity
representatives (SERs) during the
a. Elements of Proposed Rule To Reduce
Impacts on Small Entities
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The SBREFA Panel was concerned
that changing work conditions in the
construction industry would make it
E:\FR\FM\12SEP2.SGM
12SEP2
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
56422
Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules
difficult to apply some of the provisions
that OSHA suggested at the time of the
Panel. OSHA has preliminarily decided
to change its approach in this sector.
OSHA is proposing two separate
standards, one for general industry and
maritime and one for construction. As
described earlier in this preamble, in
construction, OSHA has provided a
table—labeled Table 1, Exposure
Control Methods for Selected
Construction Operations—that for
special operations enables the employer
to implement engineering controls,
work practices, and respiratory
protection without the need for
exposure assessment. Table 1 in the
proposed construction standard
presents engineering and work practice
controls and respiratory protection
options for special operations. Where
employees perform the special
operations listed in the table and the
employer has fully implemented the
engineering controls, work practices,
and respiratory protection specified in
the table, the employer is not required
to assess the exposure of employees
performing such operations.
As an alternative to the regulated area
provision, OSHA is proposing that
employers be permitted the option of
establishing written access control plans
that must contain provisions for a
competent person; procedures for
notifying employees of the presence of
exposure to respirable crystalline silica
and demarcating such areas from the
rest of the workplace; in multi-employer
workplaces, the methods for informing
other employers of the presence and
location of areas where silica exposures
may exceed the PEL; provisions for
limiting access to areas where silica
exposures are likely; and procedures for
providing respiratory protection to
employees entering areas with
controlled access. Further discussion on
this alternative is found in the Summary
and Explanation for paragraph (e)
Regulated Areas and Access Control.
OSHA believes that, although the
estimated per-worker cost for written
access control plans averages somewhat
higher than the per-worker cost for
regulated areas ($199.29 per worker for
the control plans vs. $167.65 per worker
for the regulated area), access control
plans may be significantly less costly
and more protective than regulated
areas in certain work situations.
Some SERs were already applying
many of the protective controls and
practices that would be required by the
ancillary provisions of the standard.
However, many SERs objected to the
provisions regarding housekeeping,
protective clothing, and hygiene
facilities. For this proposed rule, OSHA
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removed the requirement for hygiene
facilities, which has resulted in the
elimination of compliance costs for
change rooms, shower facilities, lunch
rooms, and hygiene-specific
housekeeping requirements. OSHA also
restricted the provision for protective
clothing (or, alternatively, any other
means to remove excessive silica dust
from work clothing) to situations where
there is the potential for employees’
work clothing to become grossly
contaminated with finely divided
material containing crystalline silica.
b. Regulatory Alternatives
For the convenience of those persons
interested only in OSHA’s regulatory
flexibility analysis, this section repeats
the discussion of the various regulatory
alternatives to the proposed OSHA
silica standard presented in the
Introduction and in Section VIII.H of
this preamble.
Each regulatory alternative presented
here is described and analyzed relative
to the proposed rule. Where
appropriate, the Agency notes whether
the regulatory alternative, to be a
legitimate candidate for OSHA
consideration, requires evidence
contrary to the Agency’s findings of
significant risk and feasibility. To
facilitate comment, the regulatory
alternatives have been organized into
four categories: (1) Alternative PELs to
the proposed PEL of 50 mg/m3; (2)
regulatory alternatives that affect
proposed ancillary provisions; (3) a
regulatory alternative that would modify
the proposed methods of compliance;
and (4) regulatory alternatives
concerning when different provisions of
the proposed rule would take effect.
Alternative PELs
OSHA is proposing a new PEL for
respirable crystalline silica of 50 mg/m3
for all industry sectors covered by the
rule. OSHA’s proposal is based on the
requirements of the Occupational Safety
and Health Act (OSH Act) and court
interpretations of the Act. For health
standards issued under section 6(b)(5) of
the OSH Act, OSHA is required to
promulgate a standard that reduces
significant risk to the extent that it is
technologically and economically
feasible to do so. See Section II of this
preamble, Pertinent Legal Authority, for
a full discussion of OSHA legal
requirements.
OSHA has conducted an extensive
review of the literature on adverse
health effects associated with exposure
to respirable crystalline silica. The
Agency has also developed estimates of
the risk of silica-related diseases
assuming exposure over a working
PO 00000
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lifetime at the proposed PEL and action
level, as well as at OSHA’s current
PELs. These analyses are presented in a
background document entitled
‘‘Respirable Crystalline Silica—Health
Effects Literature Review and
Preliminary Quantitative Risk
Assessment’’ and are summarized in
this preamble in Section V, Health
Effects Summary, and Section VI,
Summary of OSHA’s Preliminary
Quantitative Risk Assessment,
respectively. The available evidence
indicates that employees exposed to
respirable crystalline silica well below
the current PELs are at increased risk of
lung cancer mortality and silicosis
mortality and morbidity. Occupational
exposures to respirable crystalline silica
also may result in the development of
kidney and autoimmune diseases and in
death from other nonmalignant
respiratory diseases. As discussed in
Section VII, Significance of Risk, in this
preamble, OSHA preliminarily finds
that worker exposure to respirable
crystalline silica constitutes a
significant risk and that the proposed
standard will substantially reduce this
risk.
Section 6(b) of the OSH Act (29 U.S.C.
655(b)) requires OSHA to determine that
its standards are technologically and
economically feasible. OSHA’s
examination of the technological and
economic feasibility of the proposed
rule is presented in the Preliminary
Economic Analysis and Initial
Regulatory Flexibility Analysis (PEA),
and is summarized in this section
(Section VIII) of this preamble. For
general industry and maritime, OSHA
has preliminarily concluded that the
proposed PEL of 50 mg/m3 is
technologically feasible for all affected
industries. For construction, OSHA has
preliminarily determined that the
proposed PEL of 50 mg/m3 is feasible in
10 out of 12 of the affected activities.
Thus, OSHA preliminarily concludes
that engineering and work practices will
be sufficient to reduce and maintain
silica exposures to the proposed PEL of
50 mg/m3 or below in most operations
most of the time in the affected
industries. For those few operations
within an industry or activity where the
proposed PEL is not technologically
feasible even when workers use
recommended engineering and work
practice controls, employers can
supplement controls with respirators to
achieve exposure levels at or below the
proposed PEL.
OSHA developed quantitative
estimates of the compliance costs of the
proposed rule for each of the affected
industry sectors. The estimated
compliance costs were compared with
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industry revenues and profits to provide
a screening analysis of the economic
feasibility of complying with the revised
standard and an evaluation of the
potential economic impacts. Industries
with unusually high costs as a
percentage of revenues or profits were
further analyzed for possible economic
feasibility issues. After performing these
analyses, OSHA has preliminarily
concluded that compliance with the
requirements of the proposed rule
would be economically feasible in every
affected industry sector.
OSHA has examined two regulatory
alternatives (named Regulatory
Alternatives #1 and #2) that would
modify the PEL for the proposed rule.
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Under Regulatory Alternative #1, the
proposed PEL would be changed from
50 mg/m3 to 100 mg/m3 for all industry
sectors covered by the rule, and the
action level would be changed from 25
mg/m3 to 50 mg/m3 (thereby keeping the
action level at one-half of the PEL).
Under Regulatory Alternative #2, the
proposed PEL would be lowered from
50 mg/m3 to 25 mg/m3 for all industry
sectors covered by the rule, while the
action level would remain at 25 mg/m3
(because of difficulties in accurately
measuring exposure levels below 25 mg/
m3).
Tables VIII–31A and VIII–31B
present, for informational purposes, the
estimated costs, benefits, and net
PO 00000
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56423
benefits of the proposed rule under the
proposed PEL of 50 mg/m3 and for the
regulatory alternatives of a PEL of 100
mg/m3 and a PEL of 25 mg/m3
(Regulatory Alternatives # 1 and #2),
using alternative discount rates of 3 and
7 percent. These two tables also present
the incremental costs, the incremental
benefits, and the incremental net
benefits of going from a PEL of 100 mg/
m3 to the proposed PEL of 50 mg/m3 and
then of going from the proposed PEL of
50 mg/m3 to a PEL of 25 mg/m3. Table
VIII–31A breaks out costs by provision
and benefits by type of disease and by
morbidity/mortality, while Table VIII–
31B breaks out costs and benefits by
major industry sector.
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56424
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PO 00000
25~!!1m3
~
Discount Rate
3
Incremental Costs/Benefits
~
~
~
~
3%
100~!!1m3
Incremental Costs/Benefits
501!g/m
~
~
~
3%
Frm 00152
Annualized Costs
Fmt 4701
$330
$421
$203
$219
$49
$85
Total Annualized Costs (point estimate)
Sfmt 4725
Annual Benefits: Number of Cases Prevented
E:\FR\FM\12SEP2.SGM
Fatal Lung Cancers (midpoint estimate)
Fatal Silicosis & other Non-Malignant
Respiratory Diseases
Fatal Renal Disease
$344
$422
$203
$227
$50
$86
$0
$330
$131
$143
$0
$66
$0
$331
$129
$148
$0
$66
$330
$91
$73
$76
$49
$1,308
Engineering Controls (includes Abrasive Blasting)
Respirators
Exposure Assessment
Medical Surveillance
Training
Regulated Area or Access Control
$1,332
$670
$674
$637
Cases
Cases
$344
$91
$74
$79
$50
$187
$88
$26
$28
$0
~
~
$658
$339
Cases
$197
$88
$26
$29
$0
$143
$2
$47
$48
$49
~
Cases
$147
$3
$48
$50
$50
~
$351
$299
$307
Cases
23'7
75
"""""i62
79
83
527
152
375
186
189
258
108
151
91
Silica-Related Mortality
1,023
$4,811
$3,160
335
Silicosis Morbidity
1,770
186
$1,543
$1,028
688
$3,268
$2,132
357
1,585
632
60
$1,704
$1,116
331
$1.565
953
$1,016
$2,219
$1,523
$233
$160
$1,986
$1,364
$792
$544
$1,194
$820
Monetized Annual Benefits (midpoint estimate)
$7,030
$4,684
$1,776
$1,188
$5,254
$3,495
$2,495
$1,659
$2,759
$1,836
Net Benefits
$5,722
$3,352
$1,105
$514
$4,617
$2,838
$2,157
$1,308
$2,460
$1,529
Source: U.S. Department of Labor, Occupational Safety and Health Administration, Directorate of Evaluation and Analysis, Office of Regulatory Analysis
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Table VIII-31A: Annualized Costs, Benefits and Incremental Benefits of OSHA's Proposed Silica Standard of 50 J.lg/m and 100 J.lg/m Alternative
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~ ~
Discount Rate
3
Incremental Costs/Benefits
251!g/m
~
Frm 00153
Fmt 4701
Sfmt 4702
12SEP2
$1,062
$270
$548
$122
$551
$123
Total Annualized Costs
$1,308
$1,332
$670
$674
$495
$143
~
~
100 I!g/m
~
3%
~
$511
$147
$233
$106
$241
$110
$262
$36
$270
$37
$658
$339
$351
$299
$307
----
Annual Benefits: Number of Cases
Prevented
Silica-Related Mortality
Construction
General Industry/Maritime
Total
Silicosis Morbidity
Construction
General Industry/Maritime
Total
Total
Net Benefits
Construction
General Industry/Maritime
Total
Cases
Cases
$637
Cases
Cases
Cases
802
221
$3,804
$1,007
$2,504
$657
235
100
$1,109
$434
$746
$283
567
121
$2,695
$573
$1,758
$374
242
115
$1,158
$545
$760
$356
325
6
$1,537
$27
$998
$18
1,023
$4,811
$3,160
335
$1,543
$1,028
688
$3,268
$2,132
357
$1,704
$1,116
331
$1,565
$1,016
1,157
613
$1,451
$768
$996
$528
77
109
$96
$136
$66
$94
1,080
504
$1,354
$632
$930
$434
161
471
$202
$590
$139
$405
919
33
$1,152
$42
$791
$29
1,770
$2,219
$1,523
186
$233
$160
1,585
$1,986
$1,364
632
$792
$544
953
$1,194
$820
$5,255
$1,775
$3,500
$1.184
$1,205
$570
$812
$377
$4,049
$1,205
$2,688
$808
$1,360
$1,135
$898
$761
$2,690
$69
$1,789
$47
$7,030
$4,684
$1,776
$1,188
$5,254
$3,495
$2,495
$1,659
$2,759
$1,836
$4,211
$1,511
$2,437
$914
$657
$448
$261
$254
$3,555
$1,062
$2,177
$661
$1,127
$1,029
$658
$651
$2,427
$33
$1,519
$10
$5,722
$3,352
$1,105
$514
$4,617
$2,838
$2,157
$1,308
$2,460
$1,529
Source: U.S. Department of Labor, Occupational Safety and Health Administration, Directorate of Evaluation and Analysis, Office of Regulatory Analysis
56425
related fatalities and an additional 632
cases of silicosis. Based on its
E:\FR\FM\12SEP2.SGM
a PEL of 50 mg/m3 would prevent,
annually, an additional 357 silica-
PO 00000
$1,043
$264
~
3
Incremental Costs/Benefits
50 I!g/m
~
Annualized Costs
Construction
General Industry/Maritime
Monetized Annual Benefits (midpoint
estimate)
Construction
Generallndustry/Maritime
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As Tables VIII–31A and VIII–31B
show, going from a PEL of 100 mg/m3 to
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3
Table VIII-31B: Annualized Costs, Benefits and Incremental Benefits of OSHA's Proposed Silica Standard of 50 I'g/m and 100 I'g/m Alternative, by Major Industry Sector
Millions ($2009)
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preliminary findings that the proposed
PEL of 50 mg/m3 significantly reduces
worker risk from silica exposure (as
demonstrated by the number of silicarelated fatalities and silicosis cases
avoided) and is both technologically
and economically feasible, OSHA
cannot propose a PEL of 100 mg/m3
(Regulatory Alternative #1) without
violating its statutory obligations under
the OSH Act. However, the Agency will
consider evidence that challenges its
preliminary findings.
As previously noted, Tables VIII–31A
and VIII–31B also show the costs and
benefits of a PEL of 25 mg/m3
(Regulatory Alternative #2), as well as
the incremental costs and benefits of
going from the proposed PEL of 50 mg/
m3 to a PEL of 25 mg/m3. Because OSHA
determined that a PEL of 25 mg/m3
would not be feasible (that is,
engineering and work practices would
not be sufficient to reduce and maintain
silica exposures to a PEL of 25 mg/m3 or
below in most operations most of the
time in the affected industries), the
Agency did not attempt to identify
engineering controls or their costs for
affected industries to meet this PEL.
Instead, for purposes of estimating the
costs of going from a PEL of 50 mg/m3
to a PEL of 25 mg/m3, OSHA assumed
that all workers exposed between 50 mg/
m3 and 25 mg/m3 would have to wear
respirators to achieve compliance with
the 25 mg/m3 PEL. OSHA then estimated
the associated additional costs for
respirators, exposure assessments,
medical surveillance, and regulated
areas (the latter three for ancillary
requirements specified in the proposed
rule).
As shown in Tables VIII–31A and
VIII–31B, going from a PEL of 50 mg/m3
to a PEL of 25 mg/m3 would prevent,
annually, an additional 335 silicarelated fatalities and an additional 186
cases of silicosis. These estimates
support OSHA’s preliminarily finding
that there is significant risk remaining at
the proposed PEL of 50 mg/m3. However,
the Agency has preliminarily
determined that a PEL of 25 mg/m3
(Regulatory Alternative #2) is not
technologically feasible, and for that
reason, cannot propose it without
violating its statutory obligations under
the OSH Act.
Regulatory Alternatives That Affect
Ancillary Provisions
The proposed rule contains several
ancillary provisions (provisions other
the PEL), including requirements for
exposure assessment, medical
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surveillance, silica training, and
regulated areas or access control. As
shown in Table VIII–31A, these
ancillary provisions represent
approximately $223 million (or about 34
percent) of the total annualized costs of
the rule of $658 million (using a 7
percent discount rate). The two most
expensive of the ancillary provisions are
the requirements for medical
surveillance, with annualized costs of
$79 million, and the requirements for
exposure monitoring, with annualized
costs of $74 million.
As proposed, the requirements for
exposure assessment are triggered by the
action level. As described in the
preamble, OSHA has defined the action
level for the proposed standard as an
airborne concentration of respirable
crystalline silica of 25 mg/m3 calculated
as an eight-hour time-weighted average.
In this proposal, as in other standards,
the action level has been set at one-half
of the PEL.
Because of the variable nature of
employee exposures to airborne
concentrations of respirable crystalline
silica, maintaining exposures below the
action level provides reasonable
assurance that employees will not be
exposed to respirable crystalline silica
at levels above the PEL on days when
no exposure measurements are made.
Even when all measurements on a given
day may fall below the PEL (but are
above the action level), there is some
chance that on another day, when
exposures are not measured, the
employee’s actual exposure may exceed
the PEL. When exposure measurements
are above the action level, the employer
cannot be reasonably confident that
employees have not been exposed to
respirable crystalline silica
concentrations in excess of the PEL
during at least some part of the work
week. Therefore, requiring periodic
exposure measurements when the
action level is exceeded provides the
employer with a reasonable degree of
confidence in the results of the exposure
monitoring.
The action level is also intended to
encourage employers to lower exposure
levels in order to avoid the costs
associated with the exposure assessment
provisions. Some employers would be
able to reduce exposures below the
action level in all work areas, and other
employers in some work areas. As
exposures are lowered, the risk of
adverse health effects among workers
decreases.
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OSHA’s preliminary risk assessment
indicates that significant risk remains at
the proposed PEL of 50 mg/m3. Where
there is continuing significant risk, the
decision in the Asbestos case (Bldg. and
Constr.Trades Dep’t, AFL–CIO v. Brock,
838 F.2d 1258, 1274 (D.C. Cir. 1988))
indicated that OSHA should use its
legal authority to impose additional
requirements on employers to further
reduce risk when those requirements
will result in a greater than de minimis
incremental benefit to workers’ health.
OSHA’s preliminary conclusion is that
the requirements triggered by the action
level will result in a very real and
necessary, but non-quantifiable, further
reduction in risk beyond that provided
by the PEL alone. OSHA’s choice of
proposing an action level for exposure
monitoring of one-half of the PEL is
based on the Agency’s successful
experience with other standards,
including those for inorganic arsenic (29
CFR 1910.1018), ethylene oxide (29 CFR
1910.1047), benzene (29 CFR
1910.1028), and methylene chloride (29
CFR 1910.1052).
As specified in the proposed rule, all
workers exposed to respirable
crystalline silica above the PEL of 50 mg/
m3 are subject to the medical
surveillance requirements. This means
that the medical surveillance
requirements would apply to 15,172
workers in general industry and 336,244
workers in construction. OSHA
estimates that 457 possible silicosis
cases will be referred to pulmonary
specialists annually as a result of this
medical surveillance.
OSHA has preliminarily determined
that these ancillary provisions will: (1)
Help to ensure the PEL is not exceeded,
and (2) minimize risk to workers given
the very high level of risk remaining at
the PEL. OSHA did not estimate, and
the benefits analysis does not include,
monetary benefits resulting from early
discovery of illness.
Because medical surveillance and
exposure assessment are the two most
costly ancillary provisions in the
proposed rule, the Agency has
examined four regulatory alternatives
(named Regulatory Alternatives #3, #4,
#5, and #6) involving changes to one or
the other of these ancillary provisions.
These four regulatory alternatives are
defined below and the incremental cost
impact of each is summarized in Table
VIII–32. In addition, OSHA is including
a regulatory alternative (named
Regulatory Alternative #7) that would
remove all ancillary provisions.
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13% Discount Rate I
Cost
Construction
GIIM
Incremental Cost Relative to Proposal
Total
Construction
GIIM
Total
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12SEP2
$494,826,699
$142,502,681
$637,329,380
Option 3: PEL=50; AL=50
$457,686,162
$117,680,601
$575,366,763
-$37,140,537
-$24,822,080
-$61,962,617
Option 4: PEL=50; AL =25, with
medical surveillance triggered by AL
$606,697,624
$173,701,827
$780,399,451
$111,870,925
$31,199,146
$143,070,071
Option 5: PEL=50; AL=25, with
medical exams annually
$561,613,766
$145,088,559
$706,702,325
$66,787,067
$2,585,878
$69,372,945
Option 6: PEL=50; AL=25, with
surveillance triggered by AL and
medical exams annually
$775,334,483
$203,665,685
$979,000,168
$280,507,784
$61,163,004
$341,670,788
(7%·biscountRatel
Cost
Construction
GIIM
Incremental Cost Relative to Proposal
Total
Construction
GI/M
Total
Proposed Rule
$511,165,616
$146,726,595
$657,892,211
Option 3: PEL=50; AL=50
$473,638,698
$121,817,396
$595,456,093
-$37,526,918
-$24,909,200
-$62,436,118
Option 4: PEL=50; AL =25, with
medical surveillance triggered by AL
$627,197,794
$179,066,993
$806,264,787
$132,371,095
$36,564,312
$168,935,407
Option 5: PEL=50; AL=25, with
medical exams annually
$575,224,843
$149,204,718
$724,429,561
$64,059,227
$2,478,122
$66,537,350
Option 6: PEL=50; AL=25, with
surveillance triggered by AL and
medical exams annually
$791,806,358
$208,339,741
$1,000,146,099
$280,640,742
$61,613,145
$342,253,887
Source: U.S. Department of Labor, Occupational Safety and Health Administration, Directorate of Evaluation and Analysis, Office of Regulatory Analysis
56427
monitoring requirements would be
triggered only if workers were exposed
E:\FR\FM\12SEP2.SGM
m3 to 50 mg/m3 while keeping the PEL
at 50 mg/m3. As a result, exposure
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Under Regulatory Alternative #3, the
action level would be raised from 25 mg/
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above the proposed PEL of 50 mg/m3. As
shown in Table VIII–32, Regulatory
Option #3 would reduce the annualized
cost of the proposed rule by about $62
million, using a discount rate of either
3 percent or 7 percent.
Under Regulatory Alternative #4, the
action level would remain at 25 mg/m3
but medical surveillance would now be
triggered by the action level, not the
PEL. As a result, medical surveillance
requirements would be triggered only if
workers were exposed at or above the
proposed action level of 25 mg/m3. As
shown in Table VIII–32, Regulatory
Option #4 would increase the
annualized cost of the proposed rule by
about $143 million, using a discount
rate of 3 percent (and by about $169
million, using a discount rate of 7
percent).
Under Regulatory Alternative #5, the
only change to the proposed rule would
be to the medical surveillance
requirements. Instead of requiring
workers exposed above the PEL to have
a medical check-up every three years,
those workers would be required to
have a medical check-up annually. As
shown in Table VIII–32, Regulatory
Option #5 would increase the
annualized cost of the proposed rule by
about $69 million, using a discount rate
of 3 percent (and by about $66 million,
using a discount rate of 7 percent).
Regulatory Alternative #6 would
essentially combine the modified
requirements in Regulatory Alternatives
#4 and #5. Under Regulatory Alternative
#6, medical surveillance would be
triggered by the action level, not the
PEL, and workers exposed at or above
the action level would be required to
have a medical check-up annually
rather than triennially. The exposure
monitoring requirements in the
proposed rule would not be affected. As
shown in Table VIII–32, Regulatory
Option #6 would increase the
annualized cost of the proposed rule by
about $342 million, using a discount
rate of either 3 percent or 7 percent.
OSHA is not able to quantify the
effects of these preceding four
regulatory alternatives on protecting
workers exposed to respirable
crystalline silica at levels at or below
the proposed PEL of 50 mg/m3—where
significant risk remains. The Agency
solicits comment on the extent to which
these regulatory options may improve or
reduce the effectiveness of the proposed
rule.
The final regulatory alternative
affecting ancillary provisions,
Regulatory Alternative #7, would
eliminate all of the ancillary provisions
of the proposed rule, including
exposure assessment, medical
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surveillance, training, and regulated
areas or access control. However, it
should be carefully noted that
elimination of the ancillary provisions
does not mean that all costs for ancillary
provisions would disappear. In order to
meet the PEL, employers would still
commonly need to do monitoring, train
workers on the use of controls, and set
up some kind of regulated areas to
indicate where respirator use would be
required. It is also likely that employers
would increasingly follow the many
recommendations to provide medical
surveillance for employees. OSHA has
not attempted to estimate the extent to
which the costs of these activities would
be reduced if they were not formally
required, but OSHA welcomes comment
on the issue.
As indicated previously, OSHA
preliminarily finds that there is
significant risk remaining at the
proposed PEL of 50 mg/m3. However, the
Agency has also preliminarily
determined that 50 mg/m3 is the lowest
feasible PEL. Therefore, the Agency
believes that it is necessary to include
ancillary provisions in the proposed
rule to further reduce the remaining
risk. OSHA anticipates that these
ancillary provisions will reduce the risk
beyond the reduction that will be
achieved by a new PEL alone.
OSHA’s reasons for including each of
the proposed ancillary provisions are
detailed in Section XVI of this
preamble, Summary and Explanation of
the Standards. In particular, OSHA
believes that requirements for exposure
assessment (or alternately, using
specified exposure control methods for
selected construction operations) would
provide a basis for ensuring that
appropriate measures are in place to
limit worker exposures. Medical
surveillance is particularly important
because individuals exposed above the
PEL (which triggers medical
surveillance in the proposed rule) are at
significant risk of death and illness.
Medical surveillance would allow for
identification of respirable crystalline
silica-related adverse health effects at an
early stage so that appropriate
intervention measures can be taken.
OSHA believes that regulated areas and
access control are important because
they serve to limit exposure to
respirable crystalline silica to as few
employees as possible. Finally, OSHA
believes that worker training is
necessary to inform employees of the
hazards to which they are exposed,
along with associated protective
measures, so that employees understand
how they can minimize potential health
hazards. Worker training on silicarelated work practices is particularly
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important in controlling silica
exposures because engineering controls
frequently require action on the part of
workers to function effectively.
OSHA expects that the benefits
estimated under the proposed rule will
not be fully achieved if employers do
not implement the ancillary provisions
of the proposed rule. For example,
OSHA believes that the effectiveness of
the proposed rule depends on regulated
areas or access control to further limit
exposures and on medical surveillance
to identify disease cases when they do
occur.
Both industry and worker groups have
recognized that a comprehensive
standard is needed to protect workers
exposed to respirable crystalline silica.
For example, the industry consensus
standards for crystalline silica, ASTM E
1132–06, Standard Practice for Health
Requirements Relating to Occupational
Exposure to Respirable Crystalline
Silica, and ASTM E 2626–09, Standard
Practice for Controlling Occupational
Exposure to Respirable Crystalline
Silica for Construction and Demolition
Activities, as well as the draft proposed
silica standard for construction
developed by the Building and
Construction Trades Department, AFL–
CIO, have each included comprehensive
programs. These recommended
standards include provisions for
methods of compliance, exposure
monitoring, training, and medical
surveillance (ASTM, 2006; 2009; BCTD
2001). Moreover, as mentioned
previously, where there is continuing
significant risk, the decision in the
Asbestos case (Bldg. and Constr. Trades
Dep’t, AFL–CIO v. Brock, 838 F.2d 1258,
1274 (DC Cir. 1988)) indicated that
OSHA should use its legal authority to
impose additional requirements on
employers to further reduce risk when
those requirements will result in a
greater than de minimis incremental
benefit to workers’ health. OSHA
preliminarily concludes that the
additional requirements in the ancillary
provisions of the proposed standard
clearly exceed this threshold.
A Regulatory Alternative That Modifies
the Methods of Compliance
The proposed standard in general
industry and maritime would require
employers to implement engineering
and work practice controls to reduce
employees’ exposures to or below the
PEL. Where engineering and/or work
practice controls are insufficient,
employers would still be required to
implement them to reduce exposure as
much as possible, and to supplement
them with a respiratory protection
program. Under the proposed
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construction standard, employers would
be given two options for compliance.
The first option largely follows
requirements for the general industry
and maritime proposed standard, while
the second option outlines, in Table 1
(Exposure Control Methods for Selected
Construction Operations) of the
proposed rule, specific construction
exposure control methods. Employers
choosing to follow OSHA’s proposed
control methods would be considered to
be in compliance with the engineering
and work practice control requirements
of the proposed standard, and would
not be required to conduct certain
exposure monitoring activities.
One regulatory alternative (Regulatory
Alternative #8) involving methods of
compliance would be to eliminate Table
1 as a compliance option in the
construction sector. Under this
regulatory alternative, OSHA estimates
that there would be no effect on
estimated benefits but that the
annualized costs of complying with the
proposed rule (without the benefit of the
Table 1 option in construction) would
increase by $175 million, totally in
exposure monitoring costs, using a 3
percent discount rate (and by $178
million using a 7 percent discount rate),
so that the total annualized compliance
costs for all affected establishments in
construction would increase from $495
to $670 million using a 3 percent
discount rate (and from $511 to $689
million using a 7 percent discount rate).
Regulatory Alternatives That Affect the
Timing of the Standard
The proposed rule would become
effective 60 days following publication
of the final rule in the Federal Register.
Provisions outlined in the proposed
standard would become enforceable 180
days following the effective date, with
the exceptions of engineering controls
and laboratory requirements. The
proposed rule would require
engineering controls to be implemented
no later than one year after the effective
date, and laboratory requirements
would be required to begin two years
after the effective date.
One regulatory alternative (Regulatory
Alternative #9) involving the timing of
the standard would arise if, contrary to
OSHA’s preliminary findings, a PEL of
50 mg/m3 with an action level of 25 mg/
m3 were found to be technologically and
economically feasible some time in the
future (say, in five years), but not
feasible immediately. In that case,
OSHA might issue a final rule with a
PEL of 50 mg/m3 and an action level of
25 mg/m3 to take effect in five years, but
at the same time issue an interim PEL
of 100 mg/m3 and an action level of 50
mg/m3 to be in effect until the final rule
becomes feasible. Under this regulatory
alternative, and consistent with the
public participation and ‘‘look back’’
provisions of Executive Order 13563,
the Agency could monitor compliance
with the interim standard, review
progress toward meeting the feasibility
requirements of the final rule, and
evaluate whether any adjustments to the
timing of the final rule would be
needed. Under Regulatory Alternative
#9, the estimated costs and benefits
would be somewhere between those
estimated for a PEL of 100 mg/m3 with
an action level of 50 mg/m3 and those
estimated for a PEL of 50 mg/m3 with an
action level of 25 mg/m3, the exact
estimates depending on the length of
time until the final rule is phased in.
OSHA emphasizes that this regulatory
alternative is contrary to the Agency’s
preliminary findings of economic
feasibility and, for the Agency to
consider it, would require specific
evidence introduced on the record to
show that the proposed rule is not now
56429
feasible but would be feasible in the
future.
Although OSHA did not explicitly
develop or quantitatively analyze any
other regulatory alternatives involving
longer-term or more complex phase-ins
of the standard (possibly involving more
delayed implementation dates for small
businesses), OSHA is soliciting
comments on this issue. Such a
particularized, multi-year phase-in
would have several advantages,
especially from the viewpoint of
impacts on small businesses. First, it
would reduce the one-time initial costs
of the standard by spreading them out
over time, a particularly useful
mechanism for small businesses that
have trouble borrowing large amounts of
capital in a single year. A differential
phase-in for smaller firms would also
aid very small firms by allowing them
to gain from the control experience of
larger firms. A phase-in would also be
useful in certain industries—such as
foundries, for example—by allowing
employers to coordinate their
environmental and occupational safety
and health control strategies to
minimize potential costs. However a
phase-in would also postpone the
benefits of the standard.
As previous discussed in the
Introduction and in Section VIII.H of
this preamble, OSHA requests
comments on these regulatory
alternatives, including the Agency’s
choice of regulatory alternatives (and
whether there are other regulatory
alternatives the Agency should
consider) and the Agency’s analysis of
them.
SBREFA Panel
Table VIII–33 lists all of the SBREFA
Panel recommendations and OSHA’s
responses to these recommendations.
TABLE VIII–33—SBREFA PANEL RECOMMENDATIONS AND OSHA RESPONSES
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SBREFA Panel recommendation
OSHA response
The Panel recommended that OSHA give consideration to the alternative of improved enforcement of and expanded outreach for the
existing rule rather than a new rule. In addition, the Panel recommended that OSHA carefully study the effects of existing compliance and outreach efforts, such as the Special Emphasis Program
on silica, with a view to better delineating the effects of such efforts.
This examination should include (1) a year-by-year analysis of the
extent of noncompliance discovered in OSHA compliance inspections, and (2) the kinds of efforts OSHA made to improve enforcement and outreach.
As discussed in Chapter II of the PEA, Need for Regulation (and summarized in Section VIII.B of this Preamble), OSHA has reviewed existing enforcement and outreach programs, as well as other legal
and administrative remedies, and believes that a standard would be
the most effective means to protect workers from exposure to silica.
A review of OSHA’s compliance assistance efforts and an analysis of
compliance with the current PELs for respirable crystalline silica are
discussed in Section III of the preamble, Events Leading to the Proposed Standard.
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TABLE VIII–33—SBREFA PANEL RECOMMENDATIONS AND OSHA RESPONSES—Continued
SBREFA Panel recommendation
OSHA response
(General Industry) The Panel recommended that OSHA revise its economic and regulatory flexibility analyses as appropriate to reflect the
SERs’ comments on underestimation of costs, and that the Agency
compare OSHA’s revised estimates to alternative estimates provided
and methodologies suggested by the SERs. For those SER estimates and methodological suggestions that OSHA does not adopt,
the Panel recommends that OSHA explain its reasons for preferring
an alternative estimate and solicit comment on the issue.
OSHA has reviewed its cost estimates in response to the comments
received from the SERs and evaluated the alternative estimates and
methodologies suggested by the SERs. In some cases (such as for
exposure monitoring and training) OSHA has revised its cost estimates in response to SER comments. However, OSHA has not
made all cost changes suggested by the SERs, but has retained (or
simply updated) those cost estimates that OSHA determined reflect
sound methodology and reliable data. OSHA requests comments on
the Agency’s estimated costs and on the assumptions applied in the
cost analysis, and has included this topic in Section I. Issues (See
Compliance Costs) and in Chapter V of the PEA.
OSHA has extensively reviewed its costs estimates, changed many of
them in response to SER comments, and solicits comments on these
revised cost estimates. A few examples of OSHA’s cost changes are
given in the responses to specific issues below (e.g., exposure monitoring, medical exams, training and familiarization). OSHA requests
comments on the Agency’s estimated costs and on the assumptions
applied in the cost analysis, and has included this topic in Section I.
Issues (See Compliance Costs) and in Chapter V of the PEA.
The PEA reflects OSHA’s judgment on technological feasibility and includes responses to specific issues raised by the Panel and SERs.
OSHA solicits comment on the accuracy and reasonableness of
these judgments and has included this topic in Section I. Issues (See
Technological and Economic Feasibility of the Proposed PEL and
Compliance Costs).
Table 1 in the proposed standard is designed to relieve establishments
in construction from requirements for exposure assessment when
certain controls are established. OSHA developed cost estimates in
the PEA for exposure monitoring as a function of the size of the establishment. OSHA’s cost estimates now reflect the fact that smaller
entities will tend to experience larger unit costs. OSHA estimated
higher exposure monitoring costs for small entities because an industrial hygienist could not take as many samples a day in a small
establishment as in a large one. OSHA believes that its unit cost estimates for exposure monitoring are realistic but will raise that as an
issue. See Chapter V of the PEA for details of OSHA’s unit costs for
exposure monitoring in general industry and maritime.
OSHA’s cost estimates for health screening are a function of the size
of the establishment. OSHA’s cost estimates now reflect the fact that
smaller entities will tend to experience larger unit costs. OSHA estimated higher medical surveillance costs (than was estimated in the
Preliminary Initial Regulatory Flexibility Analysis (PIRFA)) for small
entities because smaller establishments would be more likely to send
the workers off-site for medical testing. In addition, OSHA significantly increased the total costs of exposure sampling and x-rays in
medical surveillance by assuming no existing compliance with the
those provisions in the proposed rule (as compared to an average of
32.6 percent and 34.8 percent existing compliance, respectively, in
the PIRFA).
OSHA removed the specific hygiene provisions in the proposed rule,
which has resulted in the elimination of compliance costs for changing rooms, shower facilities, lunch rooms, and hygiene-specific
housekeeping requirements. However, OSHA has retained requirements and cost estimates for disposable clothing (in regulated areas)
where there is the potential for employees’ work clothing to become
grossly contaminated with finely divided material containing crystalline silica.
Dry sweeping remains a prohibited activity in the proposed standard
and OSHA has estimated the costs for the use of wet methods to
control dust (see Table VIII–30, above). OSHA requests comment on
the use of wet methods as a substitute for dry sweeping and has included this topic in Section I. Issues (See Compliance Costs and
Provisions of the Standards—Methods of compliance).
The Panel recommended that, as time permits, OSHA revise its economic and regulatory flexibility analyses as appropriate to reflect the
SERs’ comments on underestimation of costs and that the Agency
compare the OSHA revised estimates to alternative estimates provided and methodologies suggested by the SERs. For those SER
estimates and methodological suggestions that OSHA does not
adopt, the Panel recommends that OSHA explain its reasons for preferring an alternative estimate and solicit comment on the issue.
The Panel recommended that prior to publishing a proposed standard,
OSHA should carefully consider the ability of each potentially affected industry to meet any proposed PEL for silica, and that OSHA
should recognize, and incorporate in its cost estimates, specific
issues or hindrances that different industries may have in implementing effective controls.
The Panel recommended that OSHA carefully review the basis for its
estimated exposure monitoring costs, consider the concerns raised
by the SERs, and ensure that its estimates are revised, as appropriate, to fully reflect the costs likely to be incurred by potentially affected establishments.
The Panel recommended that OSHA carefully review the basis for its
estimated health screening compliance costs, consider the concerns
raised by the SERs, and ensure that its estimates are revised, as appropriate, to fully reflect the costs likely to be incurred by potentially
affected establishments.
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(Construction) The Panel recommended that OSHA carefully review the
basis for its estimated hygiene compliance costs, consider the concerns raised by the SERs, and ensure that its estimates are revised,
as appropriate, to fully reflect the costs likely to be incurred by potentially affected establishments.
The Panel recommended that OSHA carefully review the issue of dry
sweeping in the analysis, consider the concerns raised by the SERs,
and ensure that its estimates are revised, as appropriate, to fully reflect the costs likely to be incurred by potentially affected establishments.
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56431
TABLE VIII–33—SBREFA PANEL RECOMMENDATIONS AND OSHA RESPONSES—Continued
SBREFA Panel recommendation
OSHA response
The Panel recommended that OSHA carefully review the basis for its
training costs, consider the concerns raised by the SERs, and ensure that its estimates are revised, as appropriate, to fully reflect the
costs likely to be incurred by potentially affected establishments.
One participant in the silica SBREFA process objected to ERG’s analytical assumption (used in OSHA’s Preliminary Initial Regulatory
Flexibility Analysis) that training is needed only for those workers exposed above the action level and suggested that training might be
necessary for all at-risk workers. For the proposed rule, the scope of
this requirement was revised so that the provision now would apply
to workers with any potential occupational exposure to respirable
crystalline silica; OSHA has estimated training costs in the PEA accordingly.
OSHA estimated higher training costs for small entities because of
smaller-sized training classes and significantly increased training
costs by assuming only half compliance for half of the affected establishments (compared to an average of 56 percent existing compliance for all establishments in the PIRFA).
The cost estimates in the PEA reflect OSHA’s best judgment and take
the much higher labor turnover rates in construction into account
when calculating costs. For the proposed rule, OSHA used the most
recent BLS turnover rate of 64 percent for construction (versus a
turnover rate of 27.2 percent for general industry). OSHA believes
that the estimates in the PEA capture the effect of high turnover
rates in construction and solicits comments on this issue in Section I.
Issues (See Compliance Costs).
OSHA used the exposure profiles to estimate the number of full-timeequivalent (FTE) workers in construction who are exposed above the
PEL. This would be the exposure profile if all exposed workers
worked full-time only at the specified silica-generating tasks. In
OSHA’s analysis, the actual number of workers exposed above the
PEL is represented by two to five times the number of FTE workers,
depending on the activity. The estimate of the total number of at-risk
workers takes into account the fact that most workers, regardless of
construction occupation, spend some time working on jobs where no
silica contamination is present. For the control cost analysis, however, it matters only how many worker-days there are in which exposures are above the PEL. These are the worker-days in which controls are required. The control costs (as opposed to the program
costs) are independent of the number of at-risk workers associated
with these worker-days. OSHA emphasizes that the use of FTEs
does not ‘‘discount’’ its estimates of aggregate control costs.
A 30-day exemption from the requirement to implement engineering
and work practice controls was not included in the proposed standard for construction, and has been removed from the proposed
standard for general industry. OSHA requests comment on a 30-day
exemption, and has included this topic in Section I. Issues (See Provisions of the Standards—Methods of compliance).
(Construction) SERs raised cost issues similar to those in general industry, but were particularly concerned about the impact in construction, given the high turnover rates in the industry.
The Panel recommended that OSHA carefully review the basis for its
estimated compliance costs, consider the concerns raised by the
SERs, and ensure that its estimates are revised, as appropriate, to
fully reflect the costs likely to be incurred by potentially affected establishments.
(Construction) The Panel recommended that OSHA (1) carefully review
the basis for its estimated labor costs, and issues related to the use
of FTEs in the analysis, (2) consider the concerns raised by the
SERs, and (3) ensure that its estimates are revised, as appropriate,
to fully reflect the costs likely to be incurred by potentially affected
establishments.
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(Construction) Some SERs requested that OSHA apply a 30-day exclusion for implementing engineering and work practice controls, as was
reflected in the draft standard for general industry and maritime.
The Panel recommended that OSHA consider this change and request
comment on the appropriateness of exempting operations that are
conducted fewer than 30 days per year from the hierarchy requirement.
(Construction) The Panel recommended that OSHA consider and seek
comment on the need to prohibit employee rotation as a means of
complying with the PEL and the likelihood that employees would be
exposed to other serious hazards if the Agency were to retain this
provision.
(Construction) Some SERs questioned the scientific and legal basis for
the draft prohibitions on the use of compressed air, brushing, and dry
sweeping of silica-containing debris. Others raised feasibility concerns such as in instances where water or electric power was unavailable or where use of wet methods could damage construction
materials.
The Panel recommended that OSHA carefully consider the need for
and feasibility of these prohibitions given these concerns, and that
OSHA seek comment on the appropriateness of such prohibitions.
(Construction) The Panel recommended that OSHA carefully consider
whether regulated area provisions should be included in the draft
proposed standard, and, if so, where and how regulated areas are to
be established. OSHA should also clarify in the preamble and in its
compliance assistance materials how compliance is expected to be
achieved in the various circumstances raised by the SERs.
(Construction) The Panel recommended that OSHA clarify how the regulated area requirements would apply to multi-employer worksites in
the draft standard or preamble, and solicit comments on site control
issues.
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The proposed prohibition on rotation is explained in the Summary and
Explanation for paragraph (f) Methods of Compliance. OSHA solicits
comment on the prohibition of employee rotation to achieve compliance when exposure levels exceed the PEL, and has included this
topic in Section I. Issues (See Provisions of the Standards—Methods
of compliance).
As discussed in the Summary and Explanation of paragraph (f) Methods of Compliance, the prohibition against the use of compressed
air, brushing, and dry sweeping applies to situations where such activities could contribute to employee exposure that exceeds the PEL.
OSHA solicits comment on this issue, and has included this topic in
Section I. Issues (See Provisions of the Standards—Methods of
compliance).
As described in the Summary and Explanation for paragraph (e) Regulated Areas and Access Control, the proposed standard includes a
provision for implementation of ‘‘access control plans’’ in lieu of establishing regulated areas. Clarification for establishing either a regulated area or an access control plan is provided in the Summary and
Explanation.
The Summary and Explanation for paragraph (e) Regulated Areas and
Access Control clarifies this requirement. OSHA requests comment
on this topic, and has included this topic in Section I. Issues (See
Compliance Costs and Provisions of the Standards—Methods of
compliance).
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TABLE VIII–33—SBREFA PANEL RECOMMENDATIONS AND OSHA RESPONSES—Continued
SBREFA Panel recommendation
OSHA response
(Construction) Many SERs were concerned with the extent to which
they felt the draft proposed standard would require the use of respirators in construction activities.
The Panel recommended that OSHA carefully consider its respiratory
protection requirements, the respiratory protection requirements in
Table 1, and the PEL in light of this concern.
OSHA has made a preliminary determination that compliance with the
proposed PEL can be achieved in most operations most of the time
through the use of engineering and work practice controls. However,
as described in the Summary and Explanation of paragraphs (f)
Methods of Compliance and (g) Respiratory Protection and in the
Technological Feasibility chapter of the PEA, use of respiratory protection will be required for some operations. OSHA solicits comment
on this issue in Section I. Issues (See Technological and Economic
Feasibility of the Proposed PEL).
OSHA discusses the reliability of measuring respirable crystalline silica
in the Technological Feasibility chapter of the PEA. An exemption for
monitoring is also provided where the employer uses Table 1. As
discussed in the Summary and Explanation for paragraph (d) Exposure Assessment, the proposed standard also allows a performance
option for exposure assessment that is expected to reduce the
amount of monitoring needed. OSHA solicits comment on this topic
in Section I. Issues (See Provisions of the Standards—Exposure Assessment).
As described in the Summary and Explanation for paragraph (e) Regulated Areas and Access Control, OSHA has proposed a limited requirement for use of protective clothing or other means to remove
silica dust from contaminated clothing. This requirement would apply
only in regulated areas where there is the potential for work clothing
to become grossly contaminated with silica dust. No requirement for
hygiene facilities is included in the proposed standard. OSHA solicits
comment regarding appropriate requirements for use of protective
clothing and hygiene facilities in Section I. Issues (See Provisions of
the Standards—Regulated areas and access control).
The provisions requiring B-readers and pulmonary specialists are discussed in the Summary and Explanation of paragraph (n) Medical
Surveillance, and the numbers of available specialists are reported.
OSHA solicits comment on this issue in Section I. Issues (See Provisions of the Standards—Medical surveillance).
As described in the Summary and Explanation for paragraph (n) Medical Surveillance, an initial examination is required within 30 days
after initial assignment to a job with exposure above the action level
for more than 30 days per year. OSHA solicits comment on this proposed requirement in Section I. Issues (See Provisions of the Standards—Medical surveillance).
The proposed standard does not specify wording for labels. OSHA solicits comment on this issue in Section I. Issues (See Provisions of
the Standards—Hazard communication).
(Construction) The Panel recommended that OSHA carefully address
the issues of reliability of exposure measurement for silica and laboratory requirements. The Panel also recommended that OSHA seek
approaches to a construction standard that can mitigate the need for
extensive exposure monitoring to the extent possible.
(Construction) As in general industry, many SERs were concerned
about all of these provisions because, they contended, silica is not
recognized as either a take-home or dermal hazard. Further, many
said that these provisions would be unusually expensive in the context of construction work. Other SERs pointed out that protective
clothing could lead to heat stress problems in some circumstances.
The Panel recommended that OSHA carefully re-examine the need for
these provisions in the construction industry and solicit comment on
this issue.
(Construction) The Panel recommended that OSHA explicitly examine
the issue of availability of specialists called for by these provisions,
and re-examine the costs and feasibility of such requirements based
on their findings with respect to availability, as needed.
(Construction) The Panel recommended that OSHA carefully consider
the need for pre-placement physicals in construction, the possibility
of delayed initial screening (so only employees who had been on the
job a certain number of days would be required to have initial
screening), and solicit comment on this issue.
(Construction) Like the general industry SERs, construction SERs
raised the issue that they would prefer a warning label with wording
similar to that used in asbestos and lead.
The Panel recommended that OSHA consider this suggestion and solicit comment on it.
(Construction) Some SERs questioned whether hazard communication
requirements made sense on a construction site where there are
tons of silica-containing dirt, bricks, and concrete.
The Panel recommended OSHA consider how to address this issue in
the context of hazard communication.
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(Construction) The Panel recommended that OSHA carefully review the
recordkeeping requirements with respect to both their utility and burden.
The Panel recommended that OSHA, to the extent permitted by the
availability of economic data, update economic data to better reflect
recent changes in the economic status of the affected industries consistent with its statutory mandate.
SERs in construction, and some in general industry, felt the estimate of
affected small entities and employees did not give adequate consideration to workers who would be subject to exposure at a site but
were not directly employed by firms engaged in silica-associated
work, such as employees of other subcontractors at a construction
site, visitors to a plant, etc.
The Panel recommended that OSHA carefully examine this issue, considering both the possible costs associated with such workers, and
ways of clarifying what workers are covered by the standard
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The proposed standard requires hazard communication for employees
who are potentially exposed to respirable crystalline silica. Many of
the proposed requirements are already required by OSHA’s Hazard
Communication Standard. The Agency requests comment on the
proposed requirements in Section I. Issues (See Provisions of the
Standards—Hazard communication).
OSHA has reviewed the recordkeeping requirements as required by
the Paperwork Reduction Act. Detailed analysis of the recordkeeping
requirements can be found in OSHA’s information collection request
submitted to OMB.
The recordkeeping requirements are discussed in the Summary and
Explanation for paragraph (j) Recordkeeping. OSHA solicits comment on these requirements in Section I. Issues (See Provisions of
the Standards—Recordkeeping).
OSHA has prepared the PEA using the most current economic data
available.
The scope of the proposed standard is discussed in the Summary and
Explanation for paragraph (a) Scope and Application.
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TABLE VIII–33—SBREFA PANEL RECOMMENDATIONS AND OSHA RESPONSES—Continued
SBREFA Panel recommendation
OSHA response
The Panel recommended that OSHA clarify in any rulemaking action
how its action is or is not related to designating silica-containing materials as hazardous wastes.
Some SERs also noted the issue that the use of wet methods in some
areas may violate EPA rules with respect to suspended solids in runoff unless provision is made for recycling or settling the suspended
solids out of the water.
The Panel recommended that OSHA investigate this issue, add appropriate costs if necessary, and solicit comment on this issue.
The relationship between the proposed rule and EPA requirements is
discussed in Section XVI, Environmental Impacts.
The Panel recommended that OSHA (1) carefully consider and solicit
comment on the alternative of improved outreach and support for the
existing standard; (2) examine what has and has not been accomplished by existing outreach and enforcement efforts; and (3) examine and fully discuss the need for a new standard and if such a
standard can accomplish more than improved outreach and enforcement.
The Panel recommended, if there is to be a standard for construction,
that OSHA: (1) seek ways to greatly simplify the standard and restrict the number of persons in respirators; (2) consider the alternative of a standard oriented to engineering controls and work practices in construction; and (3) analyze and solicit comment on ways to
simplify the standard.
The Panel recommended that, if there is to be a standard, OSHA consider and solicit comment on maintaining the existing PEL. The
Panel also recommends that OSHA examine each of the ancillary
provisions on a provision-by-provision basis in light of the comments
of the SERs on the costs and lack of need for some of these provisions.
(General Industry) The Panel recommended that OSHA carefully examine the technological and economic feasibility of the draft proposed
standard in light of these SER comments.
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(General Industry) Some SERs were concerned that the prohibition on
dry sweeping was not feasible or cost effective in their industries.
The Panel recommended that OSHA consider this issue and solicit
comment on the costs and necessity of such a prohibition.
(General Industry) The Panel recommended that OSHA carefully consider whether regulated area provisions should be included in the
draft proposed standard, and, if so, where and how regulated areas
are to be established. OSHA should also clarify in the preamble and
in its compliance assistance materials how compliance is expected to
be achieved in the various circumstances raised by the SERs.
(General Industry) The Panel recommended that OSHA carefully examine the issues associated with reliability of monitoring and laboratory
standards in light of the SER comments, and solicit comment on
these issues.
(General Industry) Some SERs preferred the more performance-oriented Option 2 provision included in the draft exposure assessment
requirements, stating that fixed-frequency exposure monitoring can
be unnecessary and wasteful. However, other SERs expressed concern over whether such a performance-oriented approach would be
consistently interpreted by enforcement officers.
The Panel recommended that OSHA continue to consider Option 2 but,
should OSHA decide to include it in a proposed rule, clarify what
would constitute compliance with the provision. Some SERs were
also concerned about the wording of the exposure assessment provision.
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Silica wastes are not classified as hazardous. Therefore OSHA believes that the incremental disposal costs resulting from dust collected in vacuums and other sources are likely to be quite small. An
analysis of wet methods for dust controls suggests that in most
cases the amount of slurry discharged are not sufficient to cause a
run off to storm drains. OSHA solicits comments on this topic in Section I. Issues (See Environmental Impacts).
A review of OSHA’s outreach efforts is provided in Section III, Events
Leading to the Proposed Standards. OSHA solicits comment on this
topic in Section I. Issues (See Alternatives/Ways to Simplify a New
Standard).
OSHA has made a preliminary determination that compliance with the
proposed PEL can be achieved in most operations most of the time
through the use of engineering and work practice controls. However,
as described in the Summary and Explanation of paragraphs (f)
Methods of Compliance and (g) Respiratory Protection and in the
Technological Feasibility chapter of the PEA, use of respiratory protection will be required for some operations. OSHA solicits comment
on this topic in Section I. Issues (See Technological and Economic
Feasibility of the Proposed PEL). OSHA also solicits comment on
ways to simplify the standard in Section I. Issues (See Alternatives/
Ways to Simplify a New Standard).
As discussed in the Summary and Explanation for paragraph (c) Permissible Exposure Limit (PEL), OSHA has made a preliminary determination that the proposed PEL is necessary to meet the legal requirements to reduce significant risk to the extent feasible. Because
the proposed PEL is a fixed value, OSHA also believes it is easier to
understand when compared to the current PEL. OSHA solicits comment on the proposed PEL in Section I. Issues (See Provisions of
the Standards—PEL and action level).
The PEA reflects OSHA’s judgment on the technological and economic
feasibility of the proposed standard and includes responses to specific issues raised by the Panel. OSHA solicits comment on the accuracy and reasonableness of these judgments in Section I. Issues
(See Technological and Economic Feasibility of the Proposed PEL).
OSHA has proposed to limit the prohibition on dry sweeping to situations where this activity could contribute to exposure that exceeds
the PEL. The Agency solicits comment on this topic in Section I.
Issues (See Provisions of the Standards—Methods of compliance).
Proposed regulated area provisions are explained in the Summary and
Explanation for paragraph (e) Regulated Areas and Access Control.
The proposed standard also includes a provision for implementation
of ‘‘access control plans’’ in lieu of establishing regulated areas.
Clarification for establishing an access control plan is provided in the
Summary and Explanation.
OSHA has made a preliminary determination in the proposed rule that
only certain sampling and analytical methods can be used to measure airborne crystalline silica at the proposed PEL. Issues related to
sampling and analytical methods are discussed in the Technological
Feasibility section of the PEA. OSHA solicits comment on the Agency’s preliminary determination in Section I. Issues (See Provisions of
the Standards—Exposure Assessment).
The proposed standard provides two options for periodic exposure assessment; (1) a fixed schedule option, and (2) a performance option.
The performance option provides employers flexibility in the methods
used to determine employee exposures, but requires employers to
accurately characterize employee exposures. The proposed approach is explained in the Summary and Explanation for paragraph
(d) Exposure Assessment. OSHA solicits comments on the proposed
exposure assessment provision in Section I. Issues (See Provisions
of the Standards—Exposure Assessment).
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TABLE VIII–33—SBREFA PANEL RECOMMENDATIONS AND OSHA RESPONSES—Continued
SBREFA Panel recommendation
OSHA response
(General Industry) Some SERs were also concerned about the wording
of the exposure assessment provision of the draft proposed standard. These SERs felt that the wording could be taken to mean that
an employer needed to perform initial assessments annually.
The Panel recommended that OSHA clarify this issue.
(General Industry) While some SERs currently provide both protective
clothing and hygiene facilities, others provide neither. Those SERs
that do not currently provide either felt that these provisions were
both highly expensive and unnecessary. Some SERs stated that
these provisions were pointless because silica is not a take-home
hazard or a dermal hazard. Others suggested that such provisions
only be required when the PEL is exceeded.
The Panel recommended that OSHA carefully consider the need for
these provisions, and solicit comment on the need for these provisions, and how they might be limited.
(General Industry) The SER comments included several suggestions
regarding the nature and wording of the health screening requirements. (See, e.g., OSHA, 2003, pp. 25–28.).
The Panel recommended that OSHA consider revising the standard in
light of these comments, as appropriate.
(General Industry) The Panel recommended that OSHA explicitly examine and report on the availability of specialists called for by these
provisions, and re-examine the costs and feasibility of such requirements based on their findings with respect to availability, as needed.
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(General Industry) Though the provision for hazard communication simply repeats such provisions already in existence, some SERs urged
OSHA to use this opportunity to change the requirement so that
warning labels would only be required of substances that were more
than 1% (rather than the current 0.1%) by weight of silica.
The Panel recommended that OSHA consider this suggestion and solicit comment on it.
(General Industry) The Panel recommended that OSHA carefully review the recordkeeping requirements with respect to both their utility
and burden.
(Construction) The Panel recommended that OSHA continue to evaluate the appropriateness of and consider modifications to scope Option 2 that can more readily serve to limit the scope of the standard.
(Construction) Many SERs found the requirements for a competent
person hard to understand. Many SERs took the competent person
requirement as requiring a person with a high level of skills, such as
the ability to conduct monitoring. Other SERs said this requirement
would require training a high percentage of their employees as competent persons because they typically had many very small crews at
many sites. In general, the SERs thought this requirement as written
would be difficult to comply with and costly.
The Panel recommended that OSHA seek ways to clarify OSHA’s intent with respect to this requirement and more clearly delineate the
responsibilities of competent persons.
(Construction) Many SERs did not understand that Table 1 was offered
as an alternative to exposure assessment and demonstration that the
PEL is being met. Some SERs, however, understood the approach
and felt that it had merit. These SERs raised several issues concerning the use of Table 1, including:.
• The Table should be expanded to include all construction activities
covered by the standard, or the scope of the standard should be reduced to only those activities covered by Table 1;
• The control measures endorsed in Table 1 need to be better established, as necessary; and
• Table 1 should require less use of, and possibly no use of, respirators.
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The requirement for initial exposure assessment is clarified in the Summary and Explanation of paragraph (d) Exposure Assessment. The
term ‘‘initial’’ indicates that this is the first action required to assess
exposure and is required only once.
As described in the Summary and Explanation for paragraph (e) Regulated Areas and Access Control, OSHA has proposed a limited requirement for use of protective clothing or other means to remove
silica dust from contaminated clothing. This requirement would apply
only in regulated areas where there is the potential for work clothing
to become grossly contaminated with silica dust. No requirement for
hygiene facilities is included in the proposed standard. OSHA solicits
comment regarding appropriate requirements for use of protective
clothing and hygiene facilities in Section I. Issues (See Provisions of
the Standards—Regulated areas and access control).
OSHA has considered these comments and revised the proposed
standard where appropriate. The revisions are discussed in the Summary and Explanation of paragraph (n) Medical Surveillance.
The provisions requiring B-readers and pulmonary specialists are discussed in the Summary and Explanation of paragraph (n) Medical
Surveillance, and the numbers of available specialists are reported.
OSHA solicits comment on this topic in Section I. Issues (See Provisions of the Standards—Medical surveillance).
OSHA has preliminarily determined to rely on the provisions of the
Hazard Communication Standard (HCS) in the proposed rule. The
HCS requires labels for mixtures that contain more than 0.1% of a
carcinogen. OSHA solicits comment on this topic in Section I. Issues
(See Provisions of the Standards—Medical surveillance).
The recordkeeping requirements are discussed in the Summary and
Explanation for paragraph (j) Recordkeeping. OSHA solicits comment on these requirements in Section I. Issues (See Provisions of
the Standards—Recordkeeping).
OSHA has made the preliminary determination that scope Option 1 is
most appropriate. OSHA solicits comment on this subject in Section
I. Issues (See Provisions of the Standards—Scope).
The standard requires a competent person only in limited circumstances when an employer selects the option to implement an
‘‘access control plan’’ in lieu of establishing a regulated area. Further
clarification is provided in the Summary and Explanation of paragraph (e) Regulated Areas and Access Control.
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TABLE VIII–33—SBREFA PANEL RECOMMENDATIONS AND OSHA RESPONSES—Continued
SBREFA Panel recommendation
OSHA response
The Panel recommended that OSHA carefully consider these suggestions, expand Table 1, and make other modifications, as appropriate
The rationale for the operations and control measures to be included in
Table 1 is provided in the Summary and Explanation for paragraph
(f) Methods of Compliance. Table 1 includes some operations for
which it is anticipated that even with the implementation of control
measures, exposure levels will routinely exceed the proposed PEL,
and thus reliance on the use of respiratory protection is appropriate.
Table 1 has been modified to limit requirements for respirator use
where operations are performed for less than 4 hours per day.
OSHA solicits comment on the proposed requirements in Section I.
Issues (See Provisions of the Standards—Methods of compliance).
OSHA significantly expanded its economic impact and economic feasibility analyses in Chapter VI of the PEA. As part of the impact analysis, OSHA added data on normal year-to-year variations in prices
and profit rates in affected industries to provide a context for evaluating potential price and profit impacts of the proposed rule. A section was also added to estimate the potential international trade impacts of the proposed rule. OSHA solicits comments in Chapter VI of
the PEA on the issues of the economic impacts and the economic
feasibility of the proposed rule.
OSHA re-examined and updated its cost estimates for each type of
respirator. Unit respirator costs included the cost of the respirator
itself and the annualized cost of respirator use, to include accessories (e.g., filters), training, fit testing, and cleaning. All costs were
updated to 2009 dollars. In addition, OSHA added a cost for employers to establish a respirator program. OSHA solicits comments on
this issue in Chapter V of the PEA.
To reflect the fact that an industrial hygienist could not typically take as
many samples a day in a small establishment as in a large one,
OSHA developed cost estimates for exposure monitoring as a function of the size of the establishment. OSHA’s cost estimates therefore now reflect the fact that smaller entities will tend to experience
larger unit costs for exposure monitoring.
To reflect possible problems of unpredictability of exposure in construction, Table 1 in the proposed standard has been designed to allow
establishments in construction the option, for certain operations, to
implement engineering controls, work practices, and respiratory protection without the need for exposure assessment.
OSHA has carefully reviewed the basis for its exposure monitoring cost
estimates and considered the concerns raised by the SERs. OSHA
solicits comments on this issue in Chapter V of the PEA.
OSHA has conducted a comprehensive review of the scientific evidence from toxicological and epidemiological studies on adverse
health effects associated with occupational exposure to respirable
crystalline silica. This review is summarized in Section V of this preamble, Health Effects Summary, and estimates of the risks of developing silica-related diseases are summarized in Section VI, Summary of the Preliminary Quantitative Risk Assessment. The significance of these risks is examined in Section VII, Significance of Risk.
The benefits associated with the proposed rule are summarized in
Section VIII.G, Benefits and Net Benefits. Although OSHA’s preliminary analysis indicates that a variety of factors may affect the
toxicologic potency of crystalline silica found in different work environments, OSHA has not identified information that would allow the
Agency to calculate how these influences may affect disease risk to
workers in any particular workplace setting.
OSHA has carefully considered the Panel recommendations, and the
Agency’s responses are listed in this table. In addition, specific
issues raised in comments by individual SERs are addressed
throughout the preamble.
The Panel recommends that OSHA thoroughly review the economic
impacts of compliance with a proposed silica standard and develop
more detailed feasibility analyses where appropriate..
(Construction) The panel recommends that OSHA re-examine its cost
estimates for respirators to make sure that the full cost of putting employees in respirators is considered.
(Construction) Some SERs indicated that the unit costs were underestimated for monitoring, similar to the general industry issues raised
previously. In addition, special issues for construction were raised
(i.e., unpredictability of exposures), suggesting the rule would be
costly, if not impossible to comply with.
The Panel recommends that OSHA carefully review the basis for its estimated compliance costs, consider the concerns raised by the
SERs, and ensure that its estimates are revised, as appropriate, to
fully reflect the costs likely to be incurred by potentially affected establishments.
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(General Industry) The Panel recommends that OSHA use the best scientific evidence and methods available to determine the significance
of risks and magnitude of benefits for occupational exposure to silica.
The Panel further recommends that OSHA evaluate existing state silicosis surveillance data to determine whether there are industry-specific differences in silicosis risks, and whether or how the draft standard should be revised to reflect such differences.
The SERs, however, also had many specific issues concerning what
OSHA should do if it chooses to go forward with a proposed rule. In
order to reflect these specific issues, the Panel has made many recommendations concerning issues to be considered if the Agency
goes forward with a rule. The Panel also recommends that OSHA
take great care in reviewing and considering all comments made by
the SERs.
IX. OMB Review Under the Paperwork
Reduction Act of 1995
A. Overview
The proposed general industry/
maritime and construction standards
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(‘‘the standards’’) for respirable
crystalline silica contain collection of
information (paperwork) requirements
that are subject to review by the Office
of Management and Budget (OMB)
under the Paperwork Reduction Act of
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1995 (PRA–95), 44 U.S.C. 3501 et seq,
and OMB’s regulations at 5 CFR part
1320. PRA–95 defines ‘‘collection of
information’’ to mean, ‘‘the obtaining,
causing to be obtained, soliciting, or
requiring the disclosure to third parties
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or the public, of facts or opinions by or
for an agency, regardless of form or
format’’ (44 U.S.C. 3502(3)(A)). Under
PRA–95, a Federal agency cannot
conduct or sponsor a collection of
information unless OMB approves it,
and the agency displays a currently
valid OMB control number.
B. Solicitation of Comments
OSHA prepared and submitted an
Information Collection Request (ICR) for
the collection of information
requirements identified in this NPRM to
OMB for review in accordance with 44
U.S.C. 3507(d). The Agency solicits
comments on the proposed new
collection of information requirements
and the estimated burden hours
associated with these requirements,
including comments on the following
items:
• Whether the proposed collection of
information requirements are necessary
for the proper performance of the
Agency’s functions, including whether
the information is useful;
• The accuracy of OSHA’s estimate of
the burden (time and cost) of the
information collection requirements,
including the validity of the
methodology and assumptions used;
• The quality, utility and clarity of
the information collected; and
• Ways to minimize the compliance
burden on employers, for example, by
using automated or other technological
techniques for collecting and
transmitting information.
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C. Proposed Revisions to Information
Collection Requirements
As required by 5 CFR 1320.5(a)(1)(iv)
and 1320.8(d)(2), the following
paragraphs provide information about
this ICR.
1. Title: Respirable Crystalline Silica
Standards for General Industry/
Maritime (§ 1910.1053) and
Construction (§ 1926.1053)
2. Description of the ICR: The
proposed respirable crystalline silica
standards contain collection of
information requirements which are
essential components of the
occupational safety and health
standards that will assist both
employers and their employees in
identifying exposures to crystalline
silica, the medical effects of such
exposures, and means to reduce or
eliminate respirable crystalline silica
overexposures.
3. Summary of the Collections of
Information:
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1910.1053(d) and 1926.1053(d)—
Exposure Assessment
Under paragraph (d)(6) of the
proposed rule, employers covered by
the general industry/maritime standard
must notify each affected employee
within 15 working days of completing
an exposure assessment. In
construction, employers must notify
each affected employee not more than 5
working days after completing the
exposure assessment. In these
standards, the following provisions
require exposure assessment
monitoring: § 1910.1053(d)(1) and
§ 1926.1053(d)(1), General;
§ 1910.1053(d)(2) and § 1926.1053(d)(2),
Initial Exposure Assessment;
§ 1910.1053(d)(3) and § 1926.1053(d)(3),
Periodic Exposure Assessments;
§ 1910.1053 (d)(4) and
§ 1926.1053(d)(4), Additional Exposure
Assessments; and § 1926.1053(d)(8)(ii),
Specific Operations.
Under § 1910.1053(d)(6)(i) and
§ 1926.1053(d)(6)(i), employers must
either notify each affected employee in
writing or post the monitoring results in
an appropriate location accessible to all
affected employees. In addition,
paragraph (d)(6)(ii) of § 1910.1053 and
§ 1926.1053 require that whenever the
employer exceeds the permissible
exposure limit (PEL), the written
notification must contain a description
of the corrective action(s) the employer
is taking to reduce employee exposures
to or below the PEL.
1910.1053(e)(3) and 1926.1053(e)(3)—
Written Access Control Plan
The standard provides employers
with the option to develop and
implement a written access control plan
in lieu of establishing regulated areas
under paragraph (e)(3). Paragraph
(e)(3)(ii) sets out the requirements for a
written access control plan. The plan
must contain provisions for a competent
person to identify the presence and
location of any areas where respirable
crystalline silica exposures are, or can
reasonably be expected to be, in excess
of the PEL. It must describe how the
employer will notify employees of the
presence and location of areas where
exposures are, or can reasonably be
expected to be, in excess of the PEL, and
how the employer will demarcate these
areas from the rest of the workplace. For
multi-employer workplaces, the plan
must identify the methods the
employers will use to inform other
employers of the presence, and the
location, of areas where respirable
crystalline silica exposures may exceed
the PEL, and any precautionary
measures the employers need to take to
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protect employees. The written plan
must contain provisions for restricting
access to these areas to minimize the
number of employees exposed, and the
level of employee exposure. The plan
also must describe procedures for
providing each employee entering areas
where respirable crystalline silica
exposures may exceed the PEL, with an
appropriate respirator in accordance
with paragraph (g) of the proposed rule;
the employer also must provide this
information to the employee’s
designated representative. Additionally,
where there is the potential for
employees’ work clothing to become
grossly contaminated with finely
divided material containing crystalline
silica, the plan must include provisions
for the employer to provide either
appropriate protective clothing or other
means to remove excessive silica dust
from contaminated clothing, as well as
provisions for the removal or cleaning of
such clothing.
The employer must review and
evaluate the effectiveness of the written
access control plan at least annually,
and update it as necessary. The written
access control plan must be available for
examination and copying, upon request,
to employees, their designated
representatives, the Assistant Secretary,
and the Director.
1910.1053(f)—Methods of Compliance
Where the employer conducts
abrasive blasting operations, paragraph
(f)(2) in the general industry/maritime
standard requires the employer to
comply with the requirements of 29 CFR
part 1915, subpart I (Personal Protective
Equipment), as applicable. Subpart I
contains several information collection
requirements. Under subpart I, when
conducting hazard assessments, the
employer must: (1) Select the type of
personal protective equipment (PPE)
that will protect the affected employee
from the hazards identified in the
occupational hazard assessment; (2)
communicate selection decisions to
affected employees; (3) select PPE that
properly fits each affected employee;
and (4) verify that the required
occupational hazard assessment has
been performed. Additionally, subpart I
requires employers to provide training
and verification of training for each
employee required to wear PPE.
1910.1053(g) and 1926.1053(g)—
Respiratory Protection
Paragraph (g) in the standards
requires the employer to institute a
respiratory protection program in
accordance with 29 CFR 1910.134. The
Respiratory Protection Standard’s
information collection requirements
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provide that employers must: develop a
written respirator program; obtain and
maintain employee medical evaluation
records; provide the physician or other
licensed health care professional
(PLHCP) with information about the
employee’s respirator and the
conditions under which the employee
will use the respirator; administer fit
tests for employees who will use
negative- or positive-pressure, tightfitting facepieces; and establish and
retain written information regarding
medical evaluations, fit testing, and the
respirator program.
1910.1053(h) and 1926.1053(h)—
Medical Surveillance
Paragraph (h)(2) in the standards
requires employers to make available to
covered employees an initial medical
examination within 30 days after initial
assignment unless the employee
received a medical examination
provided in accordance with the
standard within the past three years.
Proposed paragraphs (h)(2)(i)–(vi)
specify that the baseline medical
examination provided by the PLHCP
must consist of the following
information:
1. A medical and work history, with
emphasis on: past, present, and
anticipated exposure to respirable
crystalline silica, dust, and other agents
affecting the respiratory system; any
history of respiratory system
dysfunction, including signs and
symptoms of respiratory disease; history
of tuberculosis; and smoking status and
history;
2. A physical examination with
special emphasis on the respiratory
system;
3. A chest X-ray interpreted and
classified according to the International
Labour Organization International
Classification of Radiographs of
Pneumoconioses by a National Institute
for Occupational Safety and Health
(NIOSH)-certified ‘‘B’’ reader, or an
equivalent diagnostic study;
4. A pulmonary function test
administered by a spirometry technician
with current certification from a NIOSHapproved spirometry course;
5. Testing for latent tuberculosis
infection; and
6. Any other tests deemed appropriate
by the PLHCP.
Paragraph (h)(3) in the standards
requires periodic medical examinations
administered by a PLHCP, every three
years or more frequently if
recommended by the PLHCP, for
covered employees, including medical
and work history, physical examination
emphasizing the respiratory system,
chest X-rays or equivalent diagnostic
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study, pulmonary function tests, and
other tests deemed to be appropriate by
the PLHCP.
Paragraph (h)(4) in the standards
requires the employer to provide the
examining PLHCP with a copy of the
standard. In addition, for each employee
receiving a medical examination, the
employer must provide the PLHCP with
the following information: a description
of the affected employee’s former,
current, and anticipated duties as they
relate to the employee’s occupational
exposure to respirable crystalline silica;
the employee’s former, current, and
anticipated levels of occupational
exposure to respirable crystalline silica;
a description of any PPE used or to be
used by the employee, including when
and for how long the employee has used
that equipment; and information from
records of employment-related medical
examinations previously provided to the
affected employee and currently within
the control of the employer.
Paragraph (h)(5) in the standards
requires the employer to obtain a
written medical opinion from the
PLHCP within 30 days of each medical
examination performed on each
employee. The employer must provide
the employee with a copy the PLHCPs’
written medical opinion within two
weeks of receipt. This written opinion
must contain the following information:
1. A description of the employee’s
health condition as it relates to exposure
to respirable crystalline silica, including
the PLHCP’s opinion as to whether the
employee has any detected medical
condition(s) that would place the
employee at increased risk of material
impairment to health from exposure to
respirable crystalline silica;
2. Any recommended limitations
upon the employee’s exposure to
respirable crystalline silica or on the use
of PPE such as respirators;
3. A statement that the employee
should be examined by an American
Board Certified Specialist in Pulmonary
Disease (‘‘pulmonary specialist’’)
pursuant to paragraph (h)(6) if the ‘‘B’’
reader classifies the chest X-ray as 1/0
or higher, or if referral to a pulmonary
specialist is otherwise deemed
appropriate by the PLHCP; and
4. A statement that the PLHCP
explained to the employee the results of
the medical examination, including
findings of any medical conditions
related to respirable crystalline silica
exposure that require further evaluation
or treatment, and any recommendations
related to use of protective clothing or
equipment.
If the PLHCP’s written medical
opinion indicates that a pulmonary
specialist should examine an employee,
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paragraph (h)(6) in the standards
requires the employer to make available
for the employee a medical examination
by a pulmonary specialist within 30
days after receiving the PLHCP’s written
medical opinion. The employer must
provide the examining pulmonary
specialist with information specified by
paragraph (h)(4). The employer must
obtain a written opinion from the
pulmonary specialist within 30 days of
the examination. The written opinion
must be comparable to the written
opinion obtained from the original
PLHCP. The pulmonary specialist also
must state in the written opinion that
the specialist explained these findings
to the employee. The employer also
must provide a copy of the PLHCP’s
written medical opinion to the
examined employee within two weeks
after receiving it.
1910.1053(i) and 1926.1053(i)—
Communication of Respirable
Crystalline Silica Hazards to Employees
Paragraph (i)(1) of the standards
requires compliance with the Hazard
Communication Standard (29 CFR
1910.1200), and lists cancer, lung
effects, immune system effects, and
kidney effects as hazards that the
employer must address in its hazard
communication program. Additionally,
employers must ensure that each
employee has access to labels on
containers of crystalline silica and
safety data sheets. Under paragraph
(i)(2)(ii), the employer must make a
copy of this section readily available
without cost to each affected employee.
1910.1053(j) and 1926.1053(j)—
Recordkeeping
Paragraph (j)(1)(i) of the standards
requires that employers maintain an
accurate record of all employee
exposure measurement results as
prescribed in paragraph (d) of these
standards. The record must include the
following information: the date of
measurement for each sample taken; the
operation monitored; sampling and
analytical methods used; number,
duration, and results of samples taken;
identity of the laboratory that performed
the analysis; type of PPE, such as
respirators, worn by the employees
monitored; and the name, social
security number, and job classification
of all employees represented by the
monitoring, indicating which employees
were monitored. The employer must
maintain, and make available, employee
exposure records in accordance with 29
CFR 1910.1020.
Paragraph (j)(2)(i) requires the
employer to maintain an accurate record
of all objective data relied on to comply
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with the proposed requirements of this
section. The record must include the
following information: the crystalline
silica-containing material in question;
the source of the objective data; the
testing protocol and results of testing;
and a description of the process,
operation, or activity, and how the data
support the assessment; and other data
relevant to the process, operation,
activity, material, or employee
exposures. The employer must
maintain, and make available, the
objective data records in accordance
with 29 CFR 1910.1020.
Paragraph (j)(3)(i) requires the
employer to establish and maintain an
accurate record for each employee
covered by medical surveillance under
paragraph (h). The record must include
the following information: the
employee’s name and social security
number; a copy of the PLHCP’s and
pulmonary specialist’s written opinions;
and a copy of the information provided
to the PLHCP and pulmonary specialist
as required by paragraph (h)(4) of the
proposed rule. The employer must
maintain, and make available, the
medical surveillance records in
accordance with 29 CFR 1910.1020.
4. Number of respondents: Employers
in general industry, maritime, or
construction that have employees
working in jobs affected by respirable
crystalline silica exposure (543,041
businesses).
5. Frequency of responses: Frequency
of response varies depending on the
specific collection of information.
6. Number of responses: 4,242,296.
7. Average time per response: Varies
from 5 minutes (.08 hour) for the
employer to provide a copy of the
written physician’s opinion to the
employee, to 8 hours to establish a new
respiratory protection program in large
establishments.
8. Estimated total burden hours:
2,585,164.
9. Estimated costs (capital-operation
and maintenance): $273,504,281.
D. Submitting Comments
Members of the public who wish to
comment on the paperwork
requirements in this proposal must send
their written comments to the Office of
Information and Regulatory Affairs,
Attn: OMB Desk Officer for the
Department of Labor, OSHA (RIN–1218
–AB70), Office of Management and
Budget, Room 10235, Washington, DC
20503, Telephone: 202–395–6929/Fax:
202–395–6881 (these are not toll-free
numbers), email: OIRA_submission@
omb.eop.gov. The Agency encourages
commenters also to submit their
comments on these paperwork
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requirements to the rulemaking docket
(Docket Number OSHA–2010–0034),
along with their comments on other
parts of the proposed rule. For
instructions on submitting these
comments to the rulemaking docket, see
the sections of this Federal Register
notice titled DATES and ADDRESSES.
Comments submitted in response to this
notice are public records; therefore,
OSHA cautions commenters about
submitting personal information such as
Social Security numbers and date of
birth.
E. Docket and Inquiries
To access the docket to read or
download comments and other
materials related to this paperwork
determination, including the complete
Information Collection Request (ICR)
(containing the Supporting Statement
with attachments describing the
paperwork determinations in detail) use
the procedures described under the
section of this notice titled ADDRESSES.
You also may obtain an electronic copy
of the complete ICR by visiting the Web
page at http://www.reginfo.gov/public/
do/PRAMain, scroll under ‘‘Currently
Under Review’’ to ‘‘Department of Labor
(DOL)’’ to view all of the DOL’s ICRs,
including those ICRs submitted for
proposed rulemakings. To make
inquiries, or to request other
information, contact Mr. Todd Owen,
Directorate of Standards and Guidance,
OSHA, Room N–3609, U.S. Department
of Labor, 200 Constitution Avenue NW.,
Washington, DC 20210; telephone (202)
693–2222.
OSHA notes that a federal agency
cannot conduct or sponsor a collection
of information unless it is approved by
OMB under the PRA and displays a
currently valid OMB control number,
and the public is not required to
respond to a collection of information
unless the collection of information
displays a currently valid OMB control
number. Also, notwithstanding any
other provision of law, no person shall
be subject to penalty for failing to
comply with a collection of information
if the collection of information does not
display a currently valid OMB control
number.
X. Federalism
The Agency reviewed the proposed
crystalline silica rule according to the
Executive Order on Federalism
(Executive Order 13132, 64 FR 43255,
Aug. 10, 1999), which requires that
Federal agencies, to the extent possible,
refrain from limiting State policy
options, consult with States before
taking actions that would restrict States’
policy options and take such actions
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only when clear constitutional authority
exists and the problem is of national
scope. The Executive Order allows
Federal agencies to preempt State law
only with the expressed consent of
Congress; in such cases, Federal
agencies must limit preemption of State
law to the extent possible.
Under Section 18 of the Occupational
Safety and Health Act (the ‘‘Act’’’ or
‘‘OSH Act,’’ 29 U.S.C. 667), Congress
expressly provides that States may
adopt, with Federal approval, a plan for
the development and enforcement of
occupational safety and health
standards; States that obtain Federal
approval for such a plan are referred to
as ‘‘State-Plan States.’’ (29 U.S.C. 667).
Occupational safety and health
standards developed by State-Plan
States must be at least as effective in
providing safe and healthful
employment and places of employment
as the Federal standards. Subject to
these requirements, State-Plan States are
free to develop and enforce their own
requirements for occupational safety
and health standards.
While OSHA drafted the proposed
rule to protect employees in every State,
Section 18(c)(2) of the OSHA Act
permits State-Plan States to develop and
enforce their own standards, provided
the requirements in these standards are
at least as safe and healthful as the
requirements specified in the proposed
rule if it is promulgated.
In summary, the proposed rule
complies with Executive Order 13132.
In States without OSHA-approved State
plans, Congress expressly provides for
OSHA standards to preempt State
occupational safety and health
standards in areas addressed by the
Federal standards; in these States, this
rule limits State policy options in the
same manner as every standard
promulgated by the Agency. In States
with OSHA-approved State plans, this
rulemaking does not significantly limit
State policy options.
XI. State-Plan States
When Federal OSHA promulgates a
new standard or a more stringent
amendment to an existing standard, the
27 State and U.S. territories with their
own OSHA-approved occupational
safety and health plans (‘‘State-Plan
States’’) must revise their standards to
reflect the new standard or amendment.
The State standard must be at least as
effective as the Federal standard or
amendment, and must be promulgated
within six months of the publication
date of the final Federal rule. 29 CFR
1953.5(a).
The State may demonstrate that a
standard change is not necessary
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because, for example, the State standard
is already the same as or at least as
effective as the Federal standard change.
In order to avoid delays in worker
protection, the effective date of the State
standard and any of its delayed
provisions must be the date of State
promulgation or the Federal effective
date, whichever is later. The Assistant
Secretary may permit a longer time
period if the State makes a timely
demonstration that good cause exists for
extending the time limitation. 29 CFR
1953.5(a).
Of the 27 States and territories with
OSHA-approved State plans, 22 cover
public and private-sector employees:
Alaska, Arizona, California, Hawaii,
Indiana, Iowa, Kentucky, Maryland,
Michigan, Minnesota, Nevada, New
Mexico, North Carolina, Oregon, Puerto
Rico, South Carolina, Tennessee, Utah,
Vermont, Virginia, Washington, and
Wyoming. The five states and territories
whose OSHA-approved State plans
cover only public-sector employees are:
Connecticut, Illinois, New Jersey, New
York, and the Virgin Islands.
This proposed crystalline silica rule
applies to general industry, construction
and maritime, and would impose
additional or more stringent
requirements. If adopted as proposed,
all State Plan States would be required
to revise their general industry and
construction standards appropriately
within six months of Federal
promulgation. In addition, State plans
that cover private sector maritime
employment issues and/or have public
employees working in the maritime
industry covered by this standard would
be required to adopt comparable
provisions to their maritime
employment standards within six
months of publication of the final rule.
XII. Unfunded Mandates
Under Section 202 of the Unfunded
Mandates Reform Act of 1995 (UMRA),
2 U.S.C. 1532, an agency must prepare
a written ‘‘qualitative and quantitative
assessment’’ of any regulation creating a
mandate that ‘‘may result in the
expenditure by the State, local, and
tribal governments, in the aggregate, or
by the private sector, of $100,000,000 or
more’’ in any one year before issuing a
notice of proposed rulemaking. OSHA’s
proposal does not place a mandate on
State or local governments, for purposes
of the UMRA, because OSHA cannot
enforce its regulations or standards on
State or local governments. (See 29
U.S.C. 652(5).) Under voluntary
agreement with OSHA, some States
enforce compliance with their State
standards on public sector entities, and
these agreements specify that these State
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standards must be equivalent to OSHA
standards. The OSH Act also does not
cover tribal governments in the
performance of traditional governmental
functions, though it does when tribal
governments engage in commercial
activity. However, the proposal would
not require tribal governments to
expend, in the aggregate, $100,000,000
or more in any one year for their
commercial activities. Thus, although
OSHA may include compliance costs for
affected governmental entities in its
analysis of the expected impacts
associated with a proposal, the proposal
does not trigger the requirements of
UMRA based on its impact on State,
local, or tribal governments.
Based on the analysis presented in the
Preliminary Economic Analysis (see
Section VIII above), OSHA concludes
that the proposal would impose a
Federal mandate on the private sector in
excess of $100 million in expenditures
in any one year. The Preliminary
Economic Analysis constitutes the
written statement containing a
qualitative and quantitative assessment
of the anticipated costs and benefits
required under Section 202(a) of the
UMRA (2 U.S.C. 1532).
XIII. Protecting Children From
Environmental Health and Safety Risks
Executive Order 13045 requires that
Federal agencies submitting covered
regulatory actions to OMB’s Office of
Information and Regulatory Affairs
(OIRA) for review pursuant to Executive
Order 12866 must provide OIRA with
(1) an evaluation of the environmental
health or safety effects that the planned
regulation may have on children, and
(2) an explanation of why the planned
regulation is preferable to other
potentially effective and reasonably
feasible alternatives considered by the
agency. Executive Order 13045 defines
‘‘covered regulatory actions’’ as rules
that may (1) be economically significant
under Executive Order 12866 (i.e., a
rulemaking that has an annual effect on
the economy of $100 million or more, or
would adversely effect in a material way
the economy, a sector of the economy,
productivity, competition, jobs, the
environment, public health or safety, or
State, local, or tribal governments or
communities), and (2) concern an
environmental health risk or safety risk
that an agency has reason to believe may
disproportionately affect children. In
this context, the term ‘‘environmental
health risks and safety risks’’ means
risks to health or safety that are
attributable to products or substances
that children are likely to come in
contact with or ingest (e.g., through air,
food, water, soil, product use).
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The proposed respirable crystalline
silica rule is economically significant
under Executive Order 12866 (see
Section VIII of this preamble). However,
after reviewing the proposed respirable
crystalline silica rule, OSHA has
determined that the rule would not
impose environmental health or safety
risks to children as set forth in
Executive Order 13045. The proposed
rule would require employers to limit
employee exposure to respirable
crystalline silica and take other
precautions to protect employees from
adverse health effects associated with
exposure to respirable crystalline silica.
OSHA is not aware of any studies
showing that exposure to respirable
crystalline silica disproportionately
affects children or that employees under
18 years of age who may be exposed to
respirable crystalline silica are
disproportionately affected by such
exposure. Based on this preliminary
determination, OSHA believes that the
proposed respirable crystalline silica
rule does not constitute a covered
regulatory action as defined by
Executive Order 13045. However, if
such conditions exist, children who are
exposed to respirable crystalline silica
in the workplace would be better
protected from exposure to respirable
crystalline silica under the proposed
rule than they are currently.
XIV. Environmental Impacts
OSHA has reviewed the silica
proposal according to the National
Environmental Policy Act (NEPA) of
1969 (42 U.S.C. 4321 et seq.), the
regulations of the Council on
Environmental Quality (40 CFR part
1500), and the Department of Labor’s
NEPA procedures (29 CFR part 11).
Based on that review, OSHA does not
expect that the proposed rule, in and of
itself, would create additional
environmental issues. However, as
noted in the SBREFA report (OSHA,
2003, p. 77), some Small Entity
Representatives (SERs) raised the
possibility that the use of wet methods
to limit occupational (and
environmental) exposures in some areas
may violate EPA rules with respect to
suspended solids in runoff unless
provision is made for recycling or
settling the suspended solids out of the
water. The SBREFA Panel
recommended that OSHA investigate
this issue, add appropriate costs if
necessary, and solicit comment on this
issue.
Some large construction projects may
already require a permit to address
storm water runoff, independent of any
OSHA requirements to limit worker
exposure to silica. These environmental
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requirements come from or reference the
Clean Water Act of 1987. As applied to
construction activities, EPA
requirements generally pertain to
projects of one acre or more and impose
the use of Best Management Practices
(BMPs) to minimize the pollution, via
water runoff, of storm water collect
