[Federal Register Volume 82, Number 5 (Monday, January 9, 2017)]
[Rules and Regulations]
[Pages 2470-2757]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-30409]



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Vol. 82

Monday,

No. 5

January 9, 2017

Part II





Department of Labor





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Occupational Safety and Health Administration





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29 CFR Parts 1910, 1915, and 1926





Occupational Exposure to Beryllium; Final Rule

Federal Register / Vol. 82 , No. 5 / Monday, January 9, 2017 / Rules 
and Regulations

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

29 CFR Parts 1910, 1915, and 1926

[Docket No. OSHA-H005C-2006-0870]
RIN 1218-AB76


Occupational Exposure to Beryllium

AGENCY: Occupational Safety and Health Administration (OSHA), 
Department of Labor.

ACTION: Final rule.

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SUMMARY: The Occupational Safety and Health Administration (OSHA) is 
amending its existing standards for occupational exposure to beryllium 
and beryllium compounds. OSHA has determined that employees exposed to 
beryllium at the previous permissible exposure limits face a 
significant risk of material impairment to their health. The evidence 
in the record for this rulemaking indicates that workers exposed to 
beryllium are at increased risk of developing chronic beryllium disease 
and lung cancer. This final rule establishes new permissible exposure 
limits of 0.2 micrograms of beryllium per cubic meter of air (0.2 
[mu]g/m\3\) as an 8-hour time-weighted average and 2.0 [mu]g/m\3\ as a 
short-term exposure limit determined over a sampling period of 15 
minutes. It also includes other provisions to protect employees, such 
as requirements for exposure assessment, methods for controlling 
exposure, respiratory protection, personal protective clothing and 
equipment, housekeeping, medical surveillance, hazard communication, 
and recordkeeping.
    OSHA is issuing three separate standards--for general industry, for 
shipyards, and for construction--in order to tailor requirements to the 
circumstances found in these sectors.

DATES: Effective date: The final rule becomes effective on March 10, 
2017.
    Compliance dates: Compliance dates for specific provisions are set 
in Sec.  1910.1024(o) for general industry, Sec.  1915.1024(o) for 
shipyards, and Sec.  1926.1124(o) for construction. There are a number 
of collections of information contained in this final rule (see Section 
IX, OMB Review under the Paperwork Reduction Act of 1995). 
Notwithstanding the general date of applicability that applies to all 
other requirements contained in the final rule, affected parties do not 
have to comply with the collections of information until the Department 
of Labor publishes a separate document in the Federal Register 
announcing the Office of Management and Budget has approved them under 
the Paperwork Reduction Act.

ADDRESSES: In accordance with 28 U.S.C. 2112(a), the Agency designates 
Ann Rosenthal, Associate Solicitor of Labor for Occupational Safety and 
Health, Office of the Solicitor of Labor, Room S-4004, U.S. Department 
of Labor, 200 Constitution Avenue NW., Washington, DC 20210, to receive 
petitions for review of the final rule.

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; email 
[email protected].
    For technical inquiries, contact William Perry or Maureen Ruskin, 
Directorate of Standards and Guidance, Room N-3718, OSHA, U.S. 
Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210; 
telephone (202) 693-1950.

SUPPLEMENTARY INFORMATION: The preamble to the rule on occupational 
exposure to beryllium follows this outline:

I. Executive Summary
II. Pertinent Legal Authority
III. Events Leading to the Final Standards
IV. Chemical Properties and Industrial Uses
V. Health Effects
VI. Risk Assessment
VII. Significance of Risk
VIII. Summary of the Final Economic Analysis and Final Regulatory 
Flexibility Analysis
IX. OMB Review Under the Paperwork Reduction Act of 1995
X. Federalism
XI. State-Plan States
XII. Unfunded Mandates Reform Act
XIII. Protecting Children From Environmental Health and Safety Risks
XIV. Environmental Impacts
XV. Consultation and Coordination With Indian Tribal Governments
XVI. Summary and Explanation of the Standards
    Introduction
    (a) Scope and Application
    (b) Definitions
    (c) Permissible Exposure Limits (PELs)
    (d) Exposure Assessment
    (e) Beryllium Work Areas and Regulated Areas (General Industry); 
Regulated Areas (Maritime); and Competent Person (Construction)
    (f) Methods of Compliance
    (g) Respiratory Protection
    (h) Personal Protective Clothing and Equipment
    (i) Hygiene Areas and Practices
    (j) Housekeeping
    (k) Medical Surveillance
    (l) Medical Removal
    (m) Communication of Hazards
    (n) Recordkeeping
    (o) Dates
    (p) Appendix A (General Industry)
Authority and Signature
Amendments to Standards

Citation Method

    In the docket for the beryllium rulemaking, found at http://www.regulations.gov, every submission was assigned a document 
identification (ID) number that consists of the docket number (OSHA-
H005C-2006-0870) followed by an additional four-digit number. For 
example, the document ID number for OSHA's Preliminary Economic 
Analysis and Initial Regulatory Flexibility Analysis is OSHA-H005C-
2006-0870-0426. Some document ID numbers include one or more 
attachments, such as the National Institute for Occupational Safety and 
Health (NIOSH) prehearing submission (see Document ID OSHA-H005C-2006-
0870-1671).
    When citing exhibits in the docket, OSHA includes the term 
``Document ID'' followed by the last four digits of the document ID 
number, the attachment number or other attachment identifier, if 
applicable, page numbers (designated ``p.'' or ``Tr.'' for pages from a 
hearing transcript). In a citation that contains two or more document 
ID numbers, the document ID numbers are separated by semi-colons. In 
some sections, such as Section V, Health Effects, author names and year 
of study publication are included before the document ID number in a 
citation, for example: (Deubner et al., 2011, Document ID 0527). Where 
multiple exhibits are listed with author names and year of study 
publication, document ID numbers after the first are in parentheses, 
for example: (Elder et al., 2005, Document ID 1537; Carter et al., 2006 
(1556); Refsnes et al., 2006 (1428)).

I. Executive Summary

    This final rule establishes new permissible exposure limits (PELs) 
for beryllium of 0.2 micrograms of beryllium per cubic meter of air 
(0.2 [mu]g/m\3\) as an 8-hour time-weighted average (TWA) and 2.0 
[mu]g/m\3\ as a short-term exposure limit (STEL) determined over a 
sampling period of 15 minutes. In addition to the PELs, the rule 
includes provisions to protect employees such as requirements for 
exposure assessment, methods for controlling exposure, respiratory 
protection, personal protective clothing and equipment, housekeeping, 
medical surveillance, hazard communication, and recordkeeping. OSHA is 
issuing three separate standards--for general

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industry, for shipyards, and for construction--in order to tailor 
requirements to the circumstances found in these sectors. There are, 
however, numerous common elements in the three standards.
    The final rule 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, Pertinent Legal Authority, for a full discussion of 
OSH Act legal requirements.
    OSHA has conducted an extensive review of the literature on adverse 
health effects associated with exposure to beryllium. OSHA has also 
developed estimates of the risk of beryllium-related diseases, assuming 
exposure over a working lifetime, at the preceding PELs as well as at 
the revised PELs and action level. Comments received on OSHA's 
preliminary analysis, and the Agency's final findings, are discussed in 
Section V, Health Effects, Section VI, Risk Assessment, and Section 
VII, Significance of Risk. OSHA finds that employees exposed to 
beryllium at the preceding PELs are at an increased risk of developing 
chronic beryllium disease (CBD) and lung cancer. As discussed in 
Section VII, OSHA concludes that exposure to beryllium constitutes a 
significant risk of material impairment to health and that the final 
rule will substantially lower that risk. The Agency considers the level 
of risk remaining at the new TWA PEL to still be significant. However, 
OSHA did not adopt a lower TWA PEL because the Agency could not 
demonstrate technological feasibility of a lower TWA PEL. The Agency 
has adopted the STEL and ancillary provisions of the rule to further 
reduce the remaining significant risk.
    OSHA's examination of the technological and economic feasibility of 
the rule is presented in the Final Economic Analysis and Regulatory 
Flexibility Analysis (FEA), and is summarized in Section VIII of this 
preamble. OSHA concludes that the final PELs are technologically 
feasible for all affected industries and application groups. Thus, OSHA 
concludes that engineering and work practice controls will be 
sufficient to reduce and maintain beryllium exposures to the new PELs 
or below in most operations most of the time in the affected 
industries. For those few operations within an industry or application 
group where compliance with the PELs cannot be achieved even when 
employers implement all feasible engineering and work practice 
controls, use of respirators will be required.
    OSHA developed quantitative estimates of the compliance costs of 
the 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 rule and an evaluation of the 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 finds that compliance with the 
requirements of the rule is economically feasible in every affected 
industry sector.
    The final rule includes several major changes from the proposed 
rule as a result of OSHA's analysis of comments and evidence received 
during the comment periods and public hearings. The major changes are 
summarized below and are fully discussed in Section XVI, Summary and 
Explanation of the Standards. OSHA also presented a number of 
regulatory alternatives in the Notice of Proposed Rulemaking (80 FR 
47566, 47729-47748 (8/7/2015). Where the Agency received substantive 
comments on a regulatory alternative, those comments are also discussed 
in Section XVI. A full discussion of all regulatory alternatives can be 
found in Chapter VIII of the Final Economic Analysis (FEA).
    Scope. OSHA proposed to cover occupational exposures to beryllium 
in general industry, with an exemption for articles and an exemption 
for materials containing less than 0.1% beryllium by weight. OSHA has 
made a final determination to cover exposures to beryllium in general 
industry, shipyards, and construction under the final rule, and to 
issue separate standards for each sector. The final rule also provides 
an exemption for materials containing less than 0.1% beryllium by 
weight only where the employer has objective data demonstrating that 
employee exposure to beryllium will remain below the action level of 
0.1 [mu]g/m\3\ as an 8-hour TWA under any foreseeable conditions.
    Exposure Assessment. The proposed rule would have required periodic 
exposure monitoring annually where employee exposures are at or above 
the action level but at or below the TWA PEL; no periodic monitoring 
would have been required where employee exposures exceeded the TWA PEL. 
The final rule specifies that exposure monitoring must be repeated 
within six months where employee exposures are at or above the action 
level but at or below the TWA PEL, and within three months where 
employee exposures are above the TWA PEL or STEL. The final rule also 
includes provisions allowing the employer to discontinue exposure 
monitoring where employee exposures fall below the action level and 
STEL. In addition, the final rule includes a new provision that allows 
employers to assess employee exposures using any combination of air 
monitoring data and objective data sufficient to accurately 
characterize airborne exposure to beryllium (i.e., the ``performance 
option'').
    Beryllium Work Areas. The proposed rule would have required the 
employer to establish and maintain a beryllium work area wherever 
employees are, or can reasonably be expected to be, exposed to airborne 
beryllium, regardless of the level of exposure. As discussed in the 
Summary and Explanation section of this preamble, OSHA has narrowed the 
definition of beryllium work area in the final rule from the proposal. 
The final rule now limits the requirement to work areas containing a 
process or operation that can release beryllium where employees are, or 
can reasonably be expected to be, exposed to airborne beryllium at any 
level. The final rule expands the exposure requirement to include work 
areas containing a process or operation where there is potential dermal 
contact with beryllium based on comments from public health experts 
that relying solely on airborne exposure omits the potential 
contribution of dermal exposure to total exposure. See the Summary and 
Explanation section of this preamble for a full discussion of the 
relevant comments and reasons for changes from the proposed standard. 
Beryllium work areas are not required under the standards for shipyards 
and construction.
    Respiratory Protection. OSHA has added a provision in the final 
rule requiring the employer to provide a powered air-purifying 
respirator (PAPR) instead of a negative pressure respirator where 
respiratory protection is required by the rule and the employee 
requests a PAPR, provided that the PAPR provides adequate protection.
    Personal Protective Clothing and Equipment. The proposed rule would 
have required use of protective clothing and equipment where employee 
exposure exceeds, or can reasonably be expected to exceed the TWA PEL 
or STEL; where employees' clothing or skin may become visibly 
contaminated with beryllium; and where employees'

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skin can reasonably be expected to be exposed to soluble beryllium 
compounds. The final rule requires use of protective clothing and 
equipment where employee exposure exceeds, or can reasonably be 
expected to exceed the TWA PEL or STEL; or where there is a reasonable 
expectation of dermal contact with beryllium.
    Medical Surveillance. The exposure trigger for medical examinations 
has been revised from the proposal. The proposed rule would have 
required that medical examinations be offered to each employee who has 
worked in a regulated area (i.e., an area where an employee's exposure 
exceeds, or can reasonably be expected to exceed, the TWA PEL or STEL) 
for more than 30 days in the last 12 months. The final rule requires 
that medical examinations be offered to each employee who is or is 
reasonably expected to be exposed at or above the action level for more 
than 30 days per year. A trigger to offer periodic medical surveillance 
when recommended by the most recent written medical opinion was also 
added the final rule. Under the final rule, the licensed physician 
recommends continued periodic medical surveillance for employees who 
are confirmed positive for sensitization or diagnosed with CBD. The 
proposed rule also would have required that medical examinations be 
offered annually; the final rule requires that medical examinations be 
offered at least every two years.
    The final medical surveillance provisions have been revised to 
provide enhanced privacy for employees. The rule requires the employer 
to obtain a written medical opinion from a licensed physician for 
medical examinations provided under the rule but limits the information 
provided to the employer to the date of the examination, a statement 
that the examination has met the requirements of the standard, any 
recommended limitations on the employee's use of respirators, 
protective clothing, and equipment, and a statement that the results of 
the exam have been explained to the employee. The proposed rule would 
have required that such opinions contain additional information, 
without requiring employee authorization, such as the physician's 
opinion as to whether the employee has any detected medical condition 
that would place the employee at increased risk of CBD from further 
exposure, and any recommended limitations upon the employee's exposure 
to beryllium. In the final rule, the written opinion provided to the 
employer will only include recommended limitations on the employee's 
exposure to beryllium, referral to a CBD diagnostic center, a 
recommendation for continued periodic medical surveillance, or a 
recommendation for medical removal if the employee provides written 
authorization. The final rule requires a separate written medical 
report provided to the employee to include this additional information, 
as well as detailed information related to the employee's health.
    The proposed rule would have required that the licensed physician 
provide the employer with a written medical opinion within 30 days of 
the examination. The final rule requires that the licensed physician 
provide the employee with a written medical report and the employer 
with a written medical opinion within 45 days of the examination, 
including any follow-up beryllium lymphocyte proliferation test 
(BeLPTs).
    The final rule also adds requirements for the employer to provide 
the CBD diagnostic center with the same information provided to the 
physician or other licensed health care professional who administers 
the medical examination, and for the CBD diagnostic center to provide 
the employee with a written medical report and the employer with a 
written medical opinion. Under the final standard, employees referred 
to a CBD diagnostic center can choose to have future evaluations 
performed there. A requirement that laboratories performing BeLPTs be 
certified was also added to the final rule.
    The proposed rule would have required that employers provide low 
dose computed tomography (LDCT) scans to employees who met certain 
exposure criteria. The final rule requires LDCT scans when recommended 
by the physician or other licensed healthcare professional 
administering the medical exam, after considering the employee's 
history of exposure to beryllium along with other risk factors.
    Dates. OSHA proposed an effective date 60 days after publication of 
the rule; a date for compliance with all provisions except change rooms 
and engineering controls of 90 days after the effective date; a date 
for compliance with change room requirements, which was one year after 
the effective date; and a date for compliance with engineering control 
requirements of two years after the effective date.
    OSHA has revised the proposed compliance dates. The final rule is 
effective 60 days after publication. All obligations for compliance 
commence one year after the effective date, with two exceptions: The 
obligation for change rooms and showers commences two years after the 
effective date; and the obligation for engineering controls commences 
three years after the effective date.\1\
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    \1\ Note that the main analysis of costs and benefits presented 
in this FEA does not take into account the lag in effective dates 
but, instead, assumes that the rule takes effect in Year 1. To 
account for the lag in effective dates, OSHA has provided in the 
sensitivity analysis in Chapter VII of the FEA an estimate of its 
separate effects on costs and benefits relative to the main 
analysis. This analysis, which appears in Table VII-16 of the FEA, 
indicates that if employers delayed implementation of all provisions 
until legally required, and no benefits occurred until all 
provisions went into effect, this would decrease the estimated costs 
by 3.9 percent; the estimated benefits by 8.5 percent, and the 
estimated net benefits of the standard by 9.2 percent (to $442 
million).
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    Under the OSH Act's legal standard directing OSHA to set health 
standards based on findings of significant risk of material impairment 
and technological and economic feasibility, OSHA does not use cost-
benefit analysis to determine the PEL or other aspects of the rule. It 
does, however, determine and analyze costs and benefits for its own 
informational purposes and to meet certain Executive Order 
requirements, as discussed in Section VIII, Summary of the Final 
Economic Analysis and Final Regulatory Flexibility Analysis and in the 
FEA. Table I-1--which 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 rule using a discount rate of 3 percent. 
As shown, the rule is estimated to prevent 90 fatalities and 46 new 
cases of CBD annually once the full effects are realized, and the 
estimated cost of the rule is $73.9 million annually. Also as shown in 
Table I-1, the discounted monetized benefits of the rule are estimated 
to be $560.9 annually, and the rule is estimated to generate net 
benefits of approximately $487 annually; however, there is a great deal 
of uncertainty in those benefits due to assumptions made about dental 
workers' exposures and reductions; see Section VIII of this preamble. 
As that section shows, benefits significantly exceed costs regardless 
of how dental workers' exposures are treated.

 Table I-1--Annualized Benefits, Costs and Net Benefits of OSHA's Final
                           Beryllium Standard
                 [3 Percent discount rate, 2015 dollars]
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Annualized Costs:
  Control Costs.........................................     $12,269,190
  Rule Familiarization..................................         180,158
  Exposure Assessment...................................      13,748,676
  Regulated Areas.......................................         884,106

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  Beryllium Work Areas..................................         129,648
  Medical Surveillance..................................       7,390,958
  Medical Removal.......................................       1,151,058
  Written Exposure Control Plan.........................       2,339,058
  Protective Work Clothing & Equipment..................       1,985,782
  Hygiene Areas and Practices...........................       2,420,584
  Housekeeping..........................................      22,763,595
  Training..............................................       8,284,531
  Respirators...........................................         320,885
                                                         ---------------
      Total Annualized Costs (Point Estimate)...........     $73,868,230
Annual Benefits: Number of Cases Prevented:
  Fatal Lung Cancers (Midpoint Estimate)................               4
  Fatal Chronic Beryllium Disease.......................              86
  Beryllium-Related Mortality...........................              90
  Beryllium Morbidity...................................              46
  Monetized Annual Benefits (Midpoint Estimate).........    $560,873,424
Net Benefits:
  Net Benefits..........................................    $487,005,194
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Sources: US DOL, OSHA, Directorate of Standards and Guidance, Office of
  Regulatory Analysis.

II. Pertinent Legal Authority

    The purpose of the Occupational Safety and Health Act (29 U.S.C. 
651 et seq.) (``the Act'' or ``the OSH Act''), is ``to assure so far as 
possible every working man and woman in the Nation safe and healthful 
working conditions and to preserve our human resources'' (29 U.S.C. 
651(b)). To achieve this goal Congress authorized the Secretary of 
Labor (``the Secretary'') ``to set mandatory occupational safety and 
health standards applicable to businesses affecting interstate 
commerce'' (29 U.S.C. 651(b)(3); see 29 U.S.C. 654(a) (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 primary statutory provision relied upon by the Agency in 
promulgating health standards is section 6(b)(5) of the Act; other 
sections of the OSH Act, however, authorize the Occupational Safety and 
Health Administration (``OSHA'') to require labeling and other 
appropriate forms of warning, exposure assessment, medical 
examinations, and recordkeeping in its standards (29 U.S.C. 655(b)(5), 
655(b)(7), 657(c)).
    The Act provides that in promulgating standards dealing with toxic 
materials or harmful physical agents, such as beryllium, the Secretary 
``shall set the standard which most adequately assures, to the extent 
feasible, on the basis of the best available evidence, that no employee 
will suffer material impairment of health or functional capacity even 
if such employee has regular exposure to the hazard dealt with by such 
standard for the period of his working life'' (29 U.S.C. 655(b)(5)). 
Thus, ``[w]hen Congress passed the Occupational Safety and Health Act 
in 1970, it chose to place pre-eminent value on assuring employees a 
safe and healthful working environment, limited only by the feasibility 
of achieving such an environment'' (American Textile Mfrs. Institute, 
Inc. v. Donovan, 452 US 490, 541 (1981) (``Cotton Dust'')).
    OSHA proposed this new standard for beryllium and beryllium 
compounds and conducted its rulemaking pursuant to section 6(b)(5) of 
the Act ((29 U.S.C. 655(b)(5)). The preceding beryllium standard, 
however, was adopted under the Secretary's authority in section 6(a) of 
the OSH Act (29 U.S.C. 655(a)), to adopt national consensus and 
established Federal standards within two years of the Act's enactment 
(see 29 CFR 1910.1000 Table Z-1). Any rule that ``differs substantially 
from an existing national consensus standard'' must ``better effectuate 
the purposes of this Act than the national consensus standard'' (29 
U.S.C. 655(b)(8)). Several additional legal requirements arise from the 
statutory language in sections 3(8) and 6(b)(5) of the Act (29 U.S.C. 
652(8), 655(b)(5)). The remainder of this section discusses these 
requirements, which OSHA must consider and meet before it may 
promulgate this occupational health standard regulating exposure to 
beryllium and beryllium compounds.

Material Impairment of Health

    Subject to the limitations discussed below, when setting standards 
regulating exposure to toxic materials or harmful physical agents, the 
Secretary is required to set health standards that ensure that ``no 
employee will suffer material impairment of health or functional 
capacity. . .'' (29 U.S.C. 655(b)(5)). ``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 (AFL-CIO, 965 F.2d at 975). Thus the 
Agency has taken the position that ``subclinical'' health effects, 
which may be precursors to more serious disease, can be material 
impairments of health that OSHA should address when feasible (43 FR 
52952, 52954 (11/14/78) (Lead Preamble)).

Significant Risk

    Section 3(8) of the Act requires that workplace safety and health 
standards be ``reasonably necessary or appropriate to provide safe or 
healthful employment'' (29 U.S.C. 652(8)). The Supreme Court, in its 
decision on OSHA's benzene standard, interpreted section 3(8) to mean 
that before promulgating any standard, the Secretary must evaluate 
whether ``significant risk[ ]'' exists under current conditions and to 
then determine whether that risk can be ``eliminated or lessened'' 
through regulation (Indus. Union Dep't, AFL-CIO v. Am. Petroleum Inst., 
448 U.S. 607, 642 (1980) (plurality opinion) (``Benzene'')). The 
Court's holding is consistent with 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 that, in determining regulatory priorities, ``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)).
    The Supreme Court in Benzene clarified that ``[i]t is the Agency's 
responsibility to determine, in the first instance, what it considers 
to be a `significant' risk'' (Benzene, 448 U.S. at 655), and that it 
was not the Court's responsibility to ``express any opinion on the . . 
. difficult question of what factual determinations would warrant a 
conclusion that significant risks are present which make promulgation 
of a new standard reasonably necessary or appropriate'' (Benzene, 448 
U.S. at 659). The Court stated, however, that the section 6(f) (29 
U.S.C. 655(b)(f)) substantial evidence standard applicable to OSHA's 
significant risk determination does not require the Agency ``to support 
its finding that a significant risk exists with anything approaching 
scientific certainty'' (Benzene, 448 U.S. at 656). Rather, OSHA may 
rely on ``a body of reputable scientific thought'' to which 
``conservative assumptions in interpreting the data . . . '' may be 
applied, ``risking error on the side of

[[Page 2474]]

overprotection'' (Benzene, 448 U.S. at 656; see also United 
Steelworkers of Am., AFL-CIO-CLC v. Marshall, 647 F.2d 1189, 1248 (D.C. 
Cir. 1980) (``Lead I'') (noting the Benzene court's application of this 
principle to carcinogens and applying it to the lead standard, which 
was not based on carcinogenic effects)). OSHA may thus act with a 
``pronounced bias towards worker safety'' in making its risk 
determinations (Bldg & Constr. Trades Dep't v. Brock, 838 F.2d 1258, 
1266 (D.C. Cir. 1988) (``Asbestos II'').
    The Supreme Court further recognized that what constitutes 
``significant risk'' is ``not a mathematical straitjacket'' (Benzene, 
448 U.S. at 655) and will be ``based largely on policy considerations'' 
(Benzene, 448 U.S. at 655 n. 62). The Court gave the following example:

    If . . . 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 . . . (Benzene, 448 U.S. at 655).

Following Benzene, OSHA has, in many of its health standards, 
considered the one-in-a-thousand metric when determining whether a 
significant risk exists. Moreover, as ``a prerequisite to more 
stringent regulation'' in all subsequent health standards, OSHA has, 
consistent with the Benzene plurality decision, based each standard on 
a finding of significant risk at the ``then prevailing standard'' of 
exposure to the relevant hazardous substance (Asbestos II, 838 F.2d at 
1263). The Agency's final risk assessment is derived from existing 
scientific and enforcement data and its final conclusions are made only 
after considering all evidence in the rulemaking record. Courts 
reviewing the validity of these standards have uniformly held the 
Secretary to the significant risk standard first articulated by the 
Benzene plurality and have generally upheld the Secretary's significant 
risk determinations as supported by substantial evidence and ``a 
reasoned explanation for his policy assumptions and conclusions'' 
(Asbestos II, 838 F.2d at 1266).
    Once OSHA makes its significant risk finding, the ``more stringent 
regulation'' (Asbestos II, 838 F.2d at 1263) it promulgates must be 
``reasonably necessary or appropriate'' to reduce or eliminate that 
risk, within the meaning of section 3(8) of the Act (29 U.S.C. 652(8)) 
and Benzene (448 U.S. at 642) (see Asbestos II, 838 F.2d at 1269). The 
courts have interpreted section 6(b)(5) of the OSH Act as requiring 
OSHA to set the standard that eliminates or reduces risk to the lowest 
feasible level; as discussed below, the limits of technological and 
economic feasibility usually determine where the new standard is set 
(see UAW v. Pendergrass, 878 F.2d 389, 390 (D.C. Cir. 1989)). In 
choosing among regulatory alternatives, however, ``[t]he determination 
that [one standard] is appropriate, as opposed to a marginally [more or 
less protective] standard, is a technical decision entrusted to the 
expertise of the agency . . . '' (Nat'l Mining Ass'n v. Mine Safety and 
Health Admin., 116 F.3d 520, 528 (D.C. Cir. 1997)) (analyzing a Mine 
Safety and Health Administration standard under the Benzene significant 
risk standard). In making its choice, OSHA may incorporate a margin of 
safety even if it theoretically regulates below the lower limit of 
significant risk (Nat'l Mining Ass'n, 116 F.3d at 528 (citing American 
Petroleum Inst. v. Costle, 665 F.2d 1176, 1186 (D.C. Cir. 1982))).

Working Life Assumption

    The OSH Act requires OSHA to set the standard that most adequately 
protects employees against harmful workplace exposures for the period 
of their ``working life'' (29 U.S.C. 655(b)(5)). OSHA's longstanding 
policy is to define ``working life'' as constituting 45 years; thus, it 
assumes 45 years of exposure when evaluating the risk of material 
impairment to health caused by a toxic or hazardous substance. This 
policy is not based on empirical data that most employees are exposed 
to a particular hazard for 45 years. Instead, OSHA has adopted the 
practice to be consistent with the statutory directive that ``no 
employee'' suffer material impairment of health ``even if'' such 
employee is exposed to the hazard for the period of his or her working 
life (see 74 FR 44796 (8/31/09)). OSHA's policy was given judicial 
approval in a challenge to an OSHA standard that lowered the 
permissible exposure limit (PEL) for asbestos (Asbestos II, 838 F.2d at 
1264-1265). In that case, the petitioners claimed that the median 
duration of employment in the affected industry sectors was only five 
years. Therefore, according to petitioners, OSHA erred in assuming a 
45-year working life in calculating the risk of health effects caused 
by asbestos exposure. The D.C. Circuit disagreed, stating ``[e]ven if 
it is only the rare worker who stays with asbestos-related tasks for 45 
years, that worker would face a 64/1000 excess risk of contracting 
cancer; Congress clearly authorized OSHA to protect such a worker'' 
(Asbestos II, 838 F.2d at 1264-1265). OSHA might calculate the health 
risks of exposure, and the related benefits of lowering the exposure 
limit, based on an assumption of a shorter working life, such as 25 
years, but such estimates are for informational purposes only.

Best Available Evidence

    Section 6(b)(5) of the Act requires OSHA to set standards ``on the 
basis of the best available evidence'' and to consider the ``latest 
available scientific data in the field'' (29 U.S.C. 655(b)(5)). As 
noted above, the Supreme Court, in its Benzene decision, explained that 
OSHA must look to ``a body of reputable scientific thought'' in making 
its material harm and significant risk determinations, while noting 
that 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).
    The courts of appeals have afforded OSHA similar latitude to issue 
health standards in the face of scientific uncertainty. The Second 
Circuit, in upholding the vinyl chloride standard, stated: ``[T]he 
ultimate facts here in dispute are `on the frontiers of scientific 
knowledge', and, though the factual finger points, it does not 
conclude. Under the command of OSHA, it remains the duty of the 
Secretary to act to protect the workingman, and to act even in 
circumstances where existing methodology or research is deficient'' 
(Society of the Plastics Industry, Inc. v. OSHA, 509 F.2d 1301, 1308 
(2d Cir. 1975) (quoting Indus. Union Dep't, AFL-CIO v. Hodgson, 499 
F.2d 467, 474 (D.C. Cir. 1974) (``Asbestos I''))). The D.C. Circuit, in 
upholding the cotton dust standard, stated: ``OSHA's mandate 
necessarily requires it to act even if information is incomplete when 
the best available evidence indicates a serious threat to the health of 
workers'' (Am. Fed'n of Labor & Cong. of Indus. Orgs. v. Marshall, 617 
F.2d 636, 651 (D.C. Cir. 1979), aff'd in part and vacated in part on 
other grounds, American Textile Mfrs. Inst., Inc. v. Donovan, 452 U.S. 
490 (1981)). When there is disputed scientific evidence in the record, 
OSHA must review the evidence on both sides and ``reasonably resolve'' 
the dispute (Pub. Citizen Health Research Grp. v. Tyson, 796 F.2d 1479, 
1500 (D.C. Cir. 1986)). The Court in Public Citizen further noted that, 
where ``OSHA has the expertise we lack and it has exercised that 
expertise by carefully reviewing the scientific data,'' a dispute 
within the scientific community is not occasion for the reviewing court 
to take sides about which view is correct (Pub. Citizen Health Research 
Grp., 796 F.2d

[[Page 2475]]

at 1500) or for OSHA or the courts to `` `be paralyzed by debate 
surrounding diverse medical opinions' '' (Pub. Citizen Health Research 
Grp., 796 F.2d at 1497 (quoting H.R. Rep. No. 91-1291, 91st Cong., 2d 
Sess. 18 (1970), reprinted in Legislative History of the Occupational 
Safety and Health Act of 1970 at 848 (1971))). Provided the Agency gave 
adequate notice in the proposal's preamble discussion of potential 
regulatory alternatives that the Secretary would be considering one or 
more stated options for regulation, OSHA is not required to prefer the 
option in the text of the proposal over a given regulatory alternative 
that was addressed in the rulemaking if substantial evidence in the 
record supports inclusion of the alternative in the final standard. See 
Owner-Operator Independent Drivers Ass'n, Inc. v. Federal Motor Carrier 
Safety Admin., 494 F.3d 188, 209 (D.C. Cir. 2007) (notice by agency 
concerning modification of sleeper-berth requirements for truck drivers 
was sufficient because proposal listed several options and asked a 
question regarding the details of the one option that ultimately 
appeared in final rule); Kooritzky v. Reich, 17 F.3d 1509, 1513 (D.C. 
Cir. 1994) (noting that a final rule need not match a proposed rule, as 
long as ``the agency has alerted interested parties to the possibility 
of the agency's adopting a rule different than the one proposed'' and 
holding that agency failed to comply with notice and comment 
requirements when ``preamble in July offered no clues of what was to 
come in October'').

Feasibility

    The OSH Act requires that, in setting a standard, OSHA must 
eliminate the risk of material health impairment ``to the extent 
feasible'' (29 U.S.C. 655(b)(5)). The statutory mandate to consider the 
feasibility of the standard encompasses both technological and economic 
feasibility; these analyses have been done primarily on an industry-by-
industry basis (Lead I, 647 F.2d at 1264, 1301). The Agency has also 
used application groups, defined by common tasks, as the structure for 
its feasibility analyses (Pub. Citizen Health Research Grp. v. OSHA, 
557 F.3d 165, 177-179 (3d Cir. 2009)). The Supreme Court has broadly 
defined feasible as ``capable of being done'' (Cotton Dust, 452 U.S. at 
509-510).
    Although OSHA must set the most protective PEL that the Agency 
finds to be technologically and economically feasible, it retains 
discretion to set a uniform PEL even when the evidence demonstrates 
that certain industries or operations could reasonably be expected to 
meet a lower PEL. OSHA health standards generally set a single PEL for 
all affected employers; OSHA exercised this discretion most recently in 
its final rules on occupational exposure to Chromium (VI) (71 FR 10100, 
10337-10338 (2/28/2006) and Respirable Crystalline Silica (81 FR 16285, 
16576-16575 (3/25/2016); see also 62 FR 1494, 1575 (1/10/97) (methylene 
chloride)). In its decision upholding the chromium (VI) standard, 
including the uniform PEL, the Court of Appeals for the Third Circuit 
addressed this issue as one of deference, stating ``OSHA's decision to 
select a uniform exposure limit is a legislative policy decision that 
we will uphold as long as it was reasonably drawn from the record'' 
(Chromium (VI), 557 F.3d at 183 (3d Cir. 2009)); see also Am. Iron & 
Steel Inst. v. OSHA, 577 F.2d 825, 833 (3d Cir. 1978)). OSHA's reasons 
for choosing one chromium (VI) PEL, rather than imposing different PELs 
on different application groups or industries, included: Multiple PELs 
would create enforcement and compliance problems because many 
workplaces, and even workers, were affected by multiple categories of 
chromium (VI) exposure; discerning individual PELs for different groups 
of establishments would impose a huge evidentiary burden on the Agency 
and unnecessarily delay implementation of the standard; and a uniform 
PEL would, by eliminating confusion and simplifying compliance, enhance 
worker protection (Chromium (VI), 557 F.3d at 173, 183-184). The Court 
held that OSHA's rationale for choosing a uniform PEL, despite evidence 
that some application groups or industries could meet a lower PEL, was 
reasonably drawn from the record and that the Agency's decision was 
within its discretion and supported by past practice (Chromium (VI), 
557 F.3d at 183-184).

Technological Feasibility

    A standard is technologically feasible if the protective measures 
it requires already exist, can be brought into existence with available 
technology, or can be created with technology that can reasonably be 
expected to be developed (Lead I, 647 F.2d at 1272; Amer. Iron & Steel 
Inst. v. OSHA, 939 F.2d 975, 980 (D.C. Cir. 1991) (``Lead II'')). 
OSHA's standards may be ``technology forcing,'' i.e., where the Agency 
gives an industry a reasonable amount of time to develop new 
technologies, OSHA is not bound by the ``technological status quo'' 
(Lead I, 647 F.2d at 1264). While the test for technological 
feasibility is normally articulated in terms of the ability of 
employers to decrease exposures to the PEL, provisions such as exposure 
measurement requirements must also be technologically feasible (see 
Forging Indus. Ass'n v. Sec'y of Labor, 773 F.2d 1436, 1453 (4th Cir. 
1985)).
    In its Lead decisions, the D.C. Circuit described OSHA's obligation 
to demonstrate the technological feasibility of reducing occupational 
exposure to a hazardous substance.

    [W]ithin the limits of the best available evidence . . . 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 engineering and work 
practice controls to the extent feasible, and for using them to 
reduce . . . exposure as far as these controls can do so (Lead I, 
647 F.2d at 1272).

Additionally, the D.C. Circuit 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 . . .'' (Lead II, 939 F.2d 
at 990).
    Courts have given OSHA significant deference in reviewing its 
technological feasibility findings. ``So long as we require OSHA to 
show that any required means of compliance, even if it carries no 
guarantee of meeting the PEL, will substantially lower . . . exposure, 
we can uphold OSHA's determination that every firm must exploit all 
possible means to meet the standard'' (Lead I, 647 F.2d at 1273). Even 
in the face of significant uncertainty about technological feasibility 
in a given industry, OSHA has been granted broad discretion in making 
its findings (Lead I, 647 F.2d at 1285). ``OSHA cannot let workers 
suffer while it awaits . . . scientific certainty. It can and must make 
reasonable [technological feasibility] predictions on the basis of 
`credible sources of information,' whether data from existing plants or 
expert testimony'' (Lead I, 647 F.2d at 1266 (quoting Am. Fed'n of 
Labor & Cong. of Indus. Orgs., 617 F.2d at 658)). For example, in Lead 
I, the D.C. Circuit allowed OSHA to use, as best available evidence, 
information about new and expensive industrial smelting processes that 
had not yet been adopted in the U.S. and would require the rebuilding 
of plants (Lead I, 647 F.2d at 1283-1284). Even under circumstances 
where

[[Page 2476]]

OSHA's feasibility findings were less certain and the Agency was 
relying on its ``legitimate policy of technology forcing,'' the D.C. 
Circuit approved of OSHA's feasibility findings when the Agency granted 
lengthy phase-in periods to allow particular industries time to comply 
(Lead I, 647 F.2d at 1279-1281, 1285).
    OSHA is permitted to adopt a standard that some employers will not 
be able to meet some of the time, with employers limited to challenging 
feasibility at the enforcement stage (Lead I, 647 F.2d at 1273 & n. 
125; Asbestos II, 838 F.2d at 1268). Even when the Agency recognized 
that it might have to balance its general feasibility findings with 
flexible enforcement of the standard in individual cases, the courts of 
appeals have generally upheld OSHA's technological feasibility findings 
(Lead II, 939 F.2d at 980; see Lead I, 647 F.2d at 1266-1273; Asbestos 
II, 838 F.2d at 1268). Flexible enforcement policies have been approved 
where there is variability in measurement of the regulated hazardous 
substance or where exposures can fluctuate uncontrollably (Asbestos II, 
838 F.2d at 1267-1268; Lead II, 939 F.2d at 991). A common means of 
dealing with the measurement variability inherent in sampling and 
analysis is for the Agency to add the standard sampling error to its 
exposure measurements before determining whether to issue a citation 
(e.g., 51 FR 22612, 22654 (06/20/86) (Asbestos Preamble)).

Economic Feasibility

    In addition to technological feasibility, OSHA is required to 
demonstrate that its standards are economically feasible. A reviewing 
court will 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 . . .'' (Lead 
I, 647 F.2d at 1265 (omitting citation)). As articulated by the D.C. 
Circuit in Lead I, ``OSHA must construct a reasonable estimate of 
compliance costs and demonstrate a reasonable likelihood that these 
costs will not threaten the existence or competitive structure of an 
industry, even if it does portend disaster for some marginal firms'' 
(Lead I, 647 F.2d at 1272). A reasonable estimate entails assessing 
``the likely range of costs and the likely effects of those costs on 
the industry'' (Lead I, 647 F.2d at 1266). As with OSHA's consideration 
of scientific data and control technology, however, the estimates need 
not be precise (Cotton Dust, 452 U.S. at 528-29 & n. 54) as long as 
they are adequately explained. Thus, as the D.C. Circuit further 
explained:

    Standards may be economically feasible even though, from the 
standpoint of employers, they are financially burdensome and affect 
profit margins adversely. Nor does the concept of economic 
feasibility necessarily guarantee the continued existence of 
individual employers. It would appear to be consistent with the 
purposes of the Act to envisage the economic demise of an employer 
who has lagged behind the rest of the industry in protecting the 
health and safety of employees and is consequently financially 
unable to comply with new standards as quickly as other employers. 
As the effect becomes more widespread within an industry, the 
problem of economic feasibility becomes more pressing (Asbestos I, 
499 F.2d. at 478).

OSHA standards therefore satisfy the economic feasibility criterion 
even if they impose significant costs on regulated industries so long 
as they do not cause massive economic dislocations within a particular 
industry or imperil the very existence of the industry (Lead II, 939 
F.2d at 980; Lead I, 647 F.2d at 1272; Asbestos I, 499 F.2d. at 478). 
As with its other legal findings, OSHA ``is not required to prove 
economic feasibility with certainty, but is required to use the best 
available evidence and to support its conclusions with substantial 
evidence'' ((Lead II, 939 F.2d at 980-981) (citing Lead I, 647 F.2d at 
1267)).
    Because section 6(b)(5) of the Act explicitly imposes the ``to the 
extent feasible'' limitation on the setting of health standards, OSHA 
is not permitted to use cost-benefit analysis to make its standards-
setting decisions (29 U.S.C. 655(b)(5)).

    Congress itself defined the basic relationship between costs and 
benefits, by placing the ``benefit'' of worker health above all 
other considerations save those making attainment of this 
``benefit'' unachievable. Any standard based on a balancing of costs 
and benefits by the Secretary that strikes a different balance than 
that struck by Congress would be inconsistent with the command set 
forth in Sec.  6(b)(5) (Cotton Dust, 452 U.S. at 509).

Thus, while OSHA estimates the costs and benefits of its proposed and 
final rules, these calculations do not form the basis for the Agency's 
regulatory decisions; rather, they are performed to ensure compliance 
with requirements such as those in Executive Orders 12866 and 13563.

Structure of OSHA Health Standards

    OSHA's health standards traditionally incorporate a comprehensive 
approach to reducing occupational disease. OSHA substance-specific 
health standards generally include the ``hierarchy of controls,'' 
which, as a matter of OSHA's preferred policy, mandates that employers 
install and implement all feasible engineering and work practice 
controls before respirators may be used. The Agency's adherence to the 
hierarchy of controls has been upheld by the courts (ASARCO, Inc. v. 
OSHA, 746 F.2d 483, 496-498 (9th Cir. 1984); Am. Iron & Steel Inst. v. 
OSHA, 182 F.3d 1261, 1271 (11th Cir. 1999)). In fact, courts view the 
legal standard for proving technological feasibility as incorporating 
the hierarchy: ``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'' (Lead I, 647 F.2d at 
1272).
    The reasons supporting OSHA's continued reliance on the hierarchy 
of controls, as well as its reasons for limiting the use of 
respirators, are numerous and grounded in good industrial hygiene 
principles (see discussion in Section XVI. Summary and Explanation of 
the Standards, Methods of Compliance). The hierarchy of controls 
focuses on removing harmful airborne materials at their source ``to 
prevent atmospheric contamination'' to which the employee would be 
exposed, rather than relying on the proper functioning of a respirator 
as the primary means of protecting the employee (see 29 CFR 1910.134, 
1910.1000(e), 1926.55(b)).
    In health standards such as this one, the hierarchy of controls is 
augmented by ancillary provisions. These provisions work with the 
hierarchy of controls and personal protective equipment requirements to 
provide comprehensive protection to employees in affected workplaces. 
Such provisions typically include exposure assessment, medical 
surveillance, hazard communication, and recordkeeping.
    The OSH Act compels OSHA to require all feasible measures for 
reducing significant health risks (29 U.S.C. 655(b)(5); Pub. Citizen 
Health Research Grp., 796 F.2d at 1505 (``if in fact a STEL [short-term 
exposure limit] would further reduce a significant health risk and is 
feasible to implement, then the OSH Act compels the agency to adopt it 
(barring alternative avenues to the same result)''). When there is 
significant risk below the PEL, the D.C. Circuit indicated that OSHA 
should use its regulatory authority to impose additional requirements 
on employers when those requirements will result in

[[Page 2477]]

a greater than de minimis incremental benefit to workers' health 
(Asbestos II, 838 F.2d at 1274). The Supreme Court alluded to a similar 
issue in Benzene, pointing out that ``in setting a permissible exposure 
level in reliance on less-than-perfect methods, OSHA would have the 
benefit of a backstop in the form of monitoring and medical testing'' 
(Benzene, 448 U.S. at 657). OSHA concludes that the ancillary 
provisions in this final standard provide significant benefits to 
worker health by providing additional layers and types of protection to 
employees exposed to beryllium and beryllium compounds.

III. Events Leading to the Final Standards

    The first occupational exposure limit for beryllium was set in 1949 
by the Atomic Energy Commission (AEC), which required that beryllium 
exposure in the workplaces under its jurisdiction be limited to 2 
[micro]g/m\3\ as an 8-hour time-weighted average (TWA), and 25 
[micro]g/m\3\ as a peak exposure never to be exceeded (Document ID 
1323). These exposure limits were adopted by all AEC installations 
handling beryllium, and were binding on all AEC contractors involved in 
the handling of beryllium.
    In 1956, the American Industrial Hygiene Association (AIHA) 
published a Hygienic Guide which supported the AEC exposure limits. In 
1959, the American Conference of Governmental Industrial Hygienists 
(ACGIH[supreg]) also adopted a Threshold Limit Value (TLV[supreg]) of 2 
[micro]g/m\3\ as an 8-hour TWA (Borak, 2006). In 1970, ANSI issued a 
national consensus standard for beryllium and beryllium compounds (ANSI 
Z37.29-1970). The standard set a permissible exposure limit (PEL) for 
beryllium and beryllium compounds at 2 [micro]g/m\3\ as an 8-hour TWA; 
5 [micro]g/m\3\ as an acceptable ceiling concentration; and 25 
[micro]g/m\3\ as an acceptable maximum peak above the acceptable 
ceiling concentration for a maximum duration of 30 minutes in an 8-hour 
shift (Document ID 1303).
    In 1971, OSHA adopted, under Section 6(a) of the Occupational 
Safety and Health Act of 1970, and made applicable to general industry, 
the ANSI standard (Document ID 1303). Section 6(a) provided that in the 
first two years after the effective date of the Act, OSHA was to 
promulgate ``start-up'' standards, on an expedited basis and without 
public hearing or comment, based on national consensus or established 
Federal standards that improved employee safety or health. Pursuant to 
that authority, in 1971, OSHA promulgated approximately 425 PELs for 
air contaminants, including beryllium, derived principally from Federal 
standards applicable to government contractors under the Walsh-Healey 
Public Contracts Act, 41 U.S.C. 35, and the Contract Work Hours and 
Safety Standards Act (commonly known as the Construction Safety Act), 
40 U.S.C. 333. The Walsh-Healey Act and Construction Safety Act 
standards, in turn, had been adopted primarily from ACGIH[supreg]'s 
TLV[supreg]s as well as several from United States of America Standards 
Institute (USASI) [later the American National Standards Institute 
(ANSI)].
    The National Institute for Occupational Safety and Health (NIOSH) 
issued a document entitled Criteria for a Recommended Standard: 
Occupational Exposure to Beryllium (Criteria Document) in June 1972 
with Recommended Exposure Limits (RELs) of 2 [micro]g/m\3\ as an 8-hour 
TWA and 25 [micro]g/m\3\ as an acceptable maximum peak above the 
acceptable ceiling concentration for a maximum duration of 30 minutes 
in an 8-hour shift. OSHA reviewed the findings and recommendations 
contained in the Criteria Document along with the AEC control 
requirements for beryllium exposure. OSHA also considered existing data 
from animal and epidemiological studies, and studies of industrial 
processes of beryllium extraction, refinement, fabrication, and 
machining. In 1975, OSHA asked NIOSH to update the evaluation of the 
existing data pertaining to the carcinogenic potential of beryllium. In 
response to OSHA's request, the Director of NIOSH stated that, based on 
animal data and through all possible routes of exposure including 
inhalation, ``beryllium in all likelihood represents a carcinogenic 
risk to man.''
    In October 1975, OSHA proposed a new beryllium standard for all 
industries based on information from studies finding that beryllium 
caused cancer in animals (40 FR 48814 (10/17/75)). Adoption of this 
proposal would have lowered the 8-hour TWA exposure limit from 2 
[micro]g/m\3\ to 1 [micro]g/m\3\. In addition, the proposal included 
ancillary provisions for such topics as exposure monitoring, hygiene 
facilities, medical surveillance, and training related to the health 
hazards from beryllium exposure. The rulemaking was never completed.
    In 1977, NIOSH recommended an exposure limit of 0.5 [micro]g/m\3\ 
and identified beryllium as a potential occupational carcinogen. In 
December 1998, ACGIH published a Notice of Intended Change for its 
beryllium exposure limit. The notice proposed a lower TLV of 0.2 
[micro]g/m\3\ over an 8-hour TWA based on evidence of CBD and 
sensitization in exposed workers. Then in 2009, ACGIH adopted a revised 
TLV for beryllium that lowered the TWA to 0.05 [mu]g/m\3\ (inhalable) 
(see Document ID 1755, Tr. 136).
    In 1999, the Department of Energy (DOE) issued a Chronic Beryllium 
Disease Prevention Program (CBDPP) Final Rule for employees exposed to 
beryllium in its facilities (Document ID 1323). The DOE rule set an 
action level of 0.2 [mu]g/m\3\, and adopted OSHA's PEL of 2 [mu]g/m\3\ 
or any more stringent PEL OSHA might adopt in the future (10 CFR 
850.22; 64 FR 68873 and 68906, Dec. 8, 1999).
    Also in 1999, OSHA was petitioned by the Paper, Allied-Industrial, 
Chemical and Energy Workers International Union (PACE) (Document ID 
0069) and by Dr. Lee Newman and Ms. Margaret Mroz, from the National 
Jewish Health (NJH) (Document ID 0069), to promulgate an Emergency 
Temporary Standard (ETS) for beryllium in the workplace. In 2001, OSHA 
was petitioned for an ETS by Public Citizen Health Research Group and 
again by PACE (Document ID 0069). In order to promulgate an ETS, the 
Secretary of Labor must prove (1) that employees are exposed to grave 
danger from exposure to a hazard, and (2) that such an emergency 
standard is necessary to protect employees from such danger (29 U.S.C. 
655(c) [6(c)]). The burden of proof is on the Department and because of 
the difficulty of meeting this burden, the Department usually proceeds 
when appropriate with ordinary notice and comment [section 6(b)] 
rulemaking rather than a 6(c) ETS. Thus, instead of granting the ETS 
requests, OSHA instructed staff to further collect and analyze research 
regarding the harmful effects of beryllium in preparation for possible 
section 6(b) rulemaking.
    On November 26, 2002, OSHA published a Request for Information 
(RFI) for ``Occupational Exposure to Beryllium'' (Document ID 1242). 
The RFI contained questions on employee exposure, health effects, risk 
assessment, exposure assessment and monitoring methods, control 
measures and technological feasibility, training, medical surveillance, 
and impact on small business entities. In the RFI, OSHA expressed 
concerns about health effects such as chronic beryllium disease (CBD), 
lung cancer, and beryllium sensitization. OSHA pointed to studies 
indicating that even short-term exposures below OSHA's PEL of 2 
[micro]g/m\3\ could lead to CBD. The RFI also cited studies describing 
the relationship between beryllium sensitization and CBD (67 FR at 
70708). In addition,

[[Page 2478]]

OSHA stated that beryllium had been identified as a carcinogen by 
organizations such as NIOSH, the International Agency for Research on 
Cancer (IARC), and the Environmental Protection Agency (EPA); and 
cancer had been evidenced in animal studies (67 FR at 70709).
    On November 15, 2007, OSHA convened a Small Business Advocacy 
Review Panel for a draft proposed standard for occupational exposure to 
beryllium. OSHA convened this panel under Section 609(b) of the 
Regulatory Flexibility Act (RFA), as amended by the Small Business 
Regulatory Enforcement Fairness Act of 1996 (SBREFA) (5 U.S.C. 601 et 
seq.).
    The Panel included representatives from OSHA, the Solicitor's 
Office of the Department of Labor, the Office of Advocacy within the 
Small Business Administration, and the Office of Information and 
Regulatory Affairs of the Office of Management and Budget. Small Entity 
Representatives (SERs) made oral and written comments on the draft rule 
and submitted them to the panel.
    The SBREFA Panel issued a report on January 15, 2008 which included 
the SERs' comments. SERs expressed concerns about the impact of the 
ancillary requirements such as exposure monitoring and medical 
surveillance. Their comments addressed potential costs associated with 
compliance with the draft standard, and possible impacts of the 
standard on market conditions, among other issues. In addition, many 
SERs sought clarification of some of the ancillary requirements such as 
the meaning of ``routine'' contact or ``contaminated surfaces.''
    OSHA then developed a draft preliminary beryllium health effects 
evaluation (Document ID 1271) and a draft preliminary beryllium risk 
assessment (Document ID 1272), and in 2010, OSHA hired a contractor to 
oversee an independent scientific peer review of these documents. The 
contractor identified experts familiar with beryllium health effects 
research and ensured that these experts had no conflict of interest or 
apparent bias in performing the review. The contractor selected five 
experts with expertise in such areas as pulmonary and occupational 
medicine, CBD, beryllium sensitization, the Beryllium Lymphocyte 
Proliferation Test (BeLPT), beryllium toxicity and carcinogenicity, and 
medical surveillance. Other areas of expertise included animal 
modeling, occupational epidemiology, biostatistics, risk and exposure 
assessment, exposure-response modeling, beryllium exposure assessment, 
industrial hygiene, and occupational/environmental health engineering.
    Regarding the preliminary health effects evaluation, the peer 
reviewers concluded that the health effect studies were described 
accurately and in sufficient detail, and OSHA's conclusions based on 
the studies were reasonable (Document ID 1210). The reviewers agreed 
that the OSHA document covered the significant health endpoints related 
to occupational beryllium exposure. Peer reviewers considered the 
preliminary conclusions regarding beryllium sensitization and CBD to be 
reasonable and well presented in the draft health evaluation section. 
All reviewers agreed that the scientific evidence supports 
sensitization as a necessary condition in the development of CBD. In 
response to reviewers' comments, OSHA made revisions to more clearly 
describe certain sections of the health effects evaluation. In 
addition, OSHA expanded its discussion regarding the BeLPT.
    Regarding the preliminary risk assessment, the peer reviewers were 
highly supportive of the Agency's approach and major conclusions 
(Document ID 1210). The peer reviewers stated that the key studies were 
appropriate and their selection clearly explained in the document. They 
regarded the preliminary analysis of these studies to be reasonable and 
scientifically sound. The reviewers supported OSHA's conclusion that 
substantial risk of sensitization and CBD were observed in facilities 
where the highest exposure generating processes had median full-shift 
exposures around 0.2 [micro]g/m\3\ or higher, and that the greatest 
reduction in risk was achieved when exposures for all processes were 
lowered to 0.1 [micro]g/m\3\ or below.
    In February 2012, the Agency received for consideration a draft 
recommended standard for beryllium (Materion and USW, 2012, Document ID 
0754). This draft standard was the product of a joint effort between 
two stakeholders: Materion Corporation, a leading producer of beryllium 
and beryllium products in the United States, and the United 
Steelworkers, an international labor union representing workers who 
manufacture beryllium alloys and beryllium-containing products in a 
number of industries. They sought to craft an OSHA-like model beryllium 
standard that would have support from both labor and industry. OSHA has 
considered this proposal along with other information submitted during 
the development of the Notice of Proposed Rulemaking (NPRM) for 
beryllium. As described in greater detail in the Introduction to the 
Summary and Explanation of the final rule, there was substantial 
agreement between the submitted joint standard and the OSHA proposed 
standard.
    On August 7, 2015, OSHA published its NPRM in the Federal Register 
(80 FR 47565 (8/7/15)). In the NPRM, the Agency made a preliminary 
determination that employees exposed to beryllium and beryllium 
compounds at the preceding PEL face a significant risk to their health 
and that promulgating the proposed standard would substantially reduce 
that risk. The NPRM (Section XVIII) also responded to the SBREFA Panel 
recommendations, which OSHA carefully considered, and clarified the 
requirements about which SERs expressed confusion. OSHA also discussed 
the regulatory alternatives recommended by the SBREFA Panel in NPRM, 
Section XVIII, and in the PEA (Document ID 0426).
    The NPRM invited interested stakeholders to submit comments on a 
variety of issues and indicated that OSHA would schedule a public 
hearing upon request. Commenters submitted information and suggestions 
on a variety of topics. In addition, in response to a request from the 
Non-Ferrous Founders' Society, OSHA scheduled an informal public 
hearing on the proposed rule. The Agency invited interested persons to 
participate by providing oral testimony and documentary evidence at the 
hearing. OSHA also welcomed presentation of data and documentary 
evidence that would provide the Agency with the best available evidence 
to use in determining whether to develop a final rule.
    The public hearing was held in Washington, DC on March 21 and 22, 
2016. Administrative Law Judge William Colwell presided over the 
hearing. The Agency heard testimony from several organizations, such as 
public health groups, the Non-Ferrous Founders' Society, other industry 
representatives, and labor unions. Following the hearing, participants 
who had filed notices of intent to appear were allowed 30 days--until 
April 21, 2016--to submit additional evidence and data, and an 
additional 15 days--until May 6, 2016--to submit final briefs, 
arguments, and summations (Document ID 1756, Tr. 326).
    In 2016, in an action parallel to OSHA's rulemaking, DOE proposed 
to update its action level to 0.05 [mu]g/m\3\ (81 FR 36704-36759, June 
7, 2016). The DOE action level triggers workplace precautions and 
control measures such as periodic monitoring, exposure

[[Page 2479]]

reduction or minimization, regulated areas, hygiene facilities and 
practices, respiratory protection, protective clothing and equipment, 
and warning signs (Document ID 1323; 10 CFR 850.23(b)). Unlike OSHA's 
PEL, however, DOE's selection of an action level is not required to 
meet statutory requirements of technological and economic feasibility.
    In all, the OSHA rulemaking record contains over 1,900 documents, 
including all the studies OSHA relied on in its preliminary health 
effects and risk assessment analyses, the hearing transcript and 
submitted testimonies, the joint Materion-USW draft proposed standard, 
and the pre- and post-hearing comments and briefs. The final rule on 
occupational exposure to beryllium and beryllium compounds is thus 
based on consideration of the entire record of this rulemaking 
proceeding, including materials discussed or relied upon in the 
proposal, the record of the hearing, and all written comments and 
exhibits timely received. Based on this comprehensive record, OSHA 
concludes that employees exposed to beryllium and beryllium compounds 
are at significant risk of material impairment of health, including 
chronic beryllium disease and lung cancer. The Agency concludes that 
the PEL of 0.2 [mu]g/m\3\ reduces the significant risks of material 
impairments of health posed to workers by occupational exposure to 
beryllium and beryllium compounds to the maximum extent that is 
technologically and economically feasible. OSHA's substantive 
determinations with regard to the comments, testimony, and other 
information in the record, the legal standards governing the decision-
making process, and the Agency's analysis of the data resulting in its 
assessments of risks, benefits, technological and economic feasibility, 
and compliance costs are discussed elsewhere in this preamble. More 
technical or complex issues are discussed in greater detail in the 
background documents referenced in this preamble.

IV. Chemical Properties and Industrial Uses

Chemical and Physical Properties

    Beryllium (Be; CAS Number 7440-41-7) is a silver-grey to greyish-
white, strong, lightweight, and brittle metal. It is a Group IIA 
element with an atomic weight of 9.01, atomic number of 4, melting 
point of 1,287 [deg]C, boiling point of 2,970 [deg]C, and a density of 
1.85 at 20 [deg]C (Document ID 0389, p. 1). It occurs naturally in 
rocks, soil, coal, and volcanic dust (Document ID 1567, p. 1). 
Beryllium is insoluble in water and soluble in acids and alkalis. It 
has two common oxidation states, Be(0) and Be(+2). There are several 
beryllium compounds with unique CAS numbers and chemical and physical 
properties. Table IV-1 describes the most common beryllium compounds.

                                               Table IV-1--Properties of Beryllium and Beryllium Compounds
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                  Synonyms  and     Molecular    Melting point
         Chemical name              CAS No.        trade  names      weight         ([deg]C)         Description      Density  (g/cm3)     Solubility
--------------------------------------------------------------------------------------------------------------------------------------------------------
Beryllium metal...............       7440-41-7  Beryllium;             9.0122  1287.............  Grey, close-       1.85 (20 [deg]C).  Soluble in most
                                                 beryllium-9,                                      packed,                               dilute acids
                                                 beryllium                                         hexagonal,                            and alkali;
                                                 element;                                          brittle metal.                        decomposes in
                                                 beryllium                                                                               hot water;
                                                 metallic.                                                                               insoluble in
                                                                                                                                         mercury and
                                                                                                                                         cold water.
Beryllium chloride............       7787-47-5  Beryllium               79.92  399.2............  Colorless to       1.899 (25 [deg]C)  Soluble in
                                                 dichloride.                                       slightly yellow;                      water, ethanol,
                                                                                                   orthorhombic,                         diethyl ether
                                                                                                   deliques-cent                         and pyridine;
                                                                                                   crystal.                              slightly
                                                                                                                                         soluble in
                                                                                                                                         benzene, carbon
                                                                                                                                         disulfide and
                                                                                                                                         chloroform;
                                                                                                                                         insoluble in
                                                                                                                                         acetone,
                                                                                                                                         ammonia, and
                                                                                                                                         toluene.
Beryllium fluoride............       7787-49-7  Beryllium               47.01  555..............  Colorless or       1.986............  Soluble in
                                  (12323-05-6)   difluoride.                                       white,                                water, sulfuric
                                                                                                   amorphous,                            acid, mixture
                                                                                                   hygroscopic                           of ethanol and
                                                                                                   solid.                                diethyl ether;
                                                                                                                                         slightly
                                                                                                                                         soluble in
                                                                                                                                         ethanol;
                                                                                                                                         insoluble in
                                                                                                                                         hydrofluoric
                                                                                                                                         acid.
Beryllium hydroxide...........      13327-32-7  Beryllium                43.3  138 (decomposes    White, amorphous,  1.92.............  Soluble in hot
                                   (1304-49-0)   dihydroxide.                   to beryllium       amphoteric                            concentrated
                                                                                oxide).            powder.                               acids and
                                                                                                                                         alkali;
                                                                                                                                         slightly
                                                                                                                                         soluble in
                                                                                                                                         dilute alkali;
                                                                                                                                         insoluble in
                                                                                                                                         water.
Beryllium sulfate.............      13510-49-1  Sulfuric acid,         105.07  550-600 [deg]C     Colorless crystal  2.443............  Forms soluble
                                                 beryllium salt                 (decomposes to                                           tetrahydrate in
                                                 (1:1).                         beryllium oxide).                                        hot water;
                                                                                                                                         insoluble in
                                                                                                                                         cold water.
Beryllium sulfate tetrhydrate.       7787-56-6  Sulfuric acid;         177.14  100 [deg]C.......  Colorless,         1.713............  Soluble in
                                                 beryllium salt                                    tetragonal                            water; slightly
                                                 (1:1),                                            crystal.                              soluble in
                                                 tetrahydrate.                                                                           concentrated
                                                                                                                                         sulfuric acid;
                                                                                                                                         insoluble in
                                                                                                                                         ethanol.
Beryllium Oxide...............       1304-56-9  Beryllia;               25.01  2508-2547 [deg]C.  Colorless to       3.01 (20 [deg]C).  Soluble in
                                                 beryllium                                         white, hexagonal                      concentrated
                                                 monoxide                                          crystal or                            acids and
                                                 thermalox TM.                                     amorphous,                            alkali;
                                                                                                   amphoteric                            insoluble in
                                                                                                   powder.                               water.
Beryllium carbonate...........       1319-43-3  Carbonic acid,         112.05  No data..........  White powder.....  No data..........  Soluble in acids
                                                 beryllium salt,                                                                         and alkali;
                                                 mixture with                                                                            insoluble in
                                                 beryllium                                                                               cold water;
                                                 hydroxide.                                                                              decomposes in
                                                                                                                                         hot water.
Beryllium nitrate trihydrate..       7787-55-5  Nitric acid,           187.97  60...............  White to faintly   1.56.............  Very soluble in
                                                 beryllium salt,                                   yellowish,                            water and
                                                 trihydrate.                                       deliquescent                          ethanol.
                                                                                                   mass.
Beryllium phosphate...........      13598-15-7  Phosphoric acid,       104.99  No data..........  Not reported.....  Not reported.....  Slightly soluble
                                                 beryllium salt                                                                          in water.
                                                 (1:1).
--------------------------------------------------------------------------------------------------------------------------------------------------------
ATSDR, 2002.


[[Page 2480]]

    The physical and chemical properties of beryllium were realized 
early in the 20th century, and it has since gained commercial 
importance in a wide range of industries. Beryllium is lightweight, 
hard, spark resistant, non-magnetic, and has a high melting point. It 
lends strength, electrical and thermal conductivity, and fatigue 
resistance to alloys (Document ID 0389, p. 1). Beryllium also has a 
high affinity for oxygen in air and water, which can cause a thin 
surface film of beryllium oxide to form on the bare metal, making it 
extremely resistant to corrosion. These properties make beryllium 
alloys highly suitable for defense, nuclear, and aerospace applications 
(Document ID 1342, pp. 45, 48).
    There are approximately 45 mineralized forms of beryllium. In the 
United States, the predominant mineral form mined commercially and 
refined into pure beryllium and beryllium alloys is bertrandite. 
Bertrandite, while containing less than 1% beryllium compared to 4% in 
beryl, is easily and efficiently processed into beryllium hydroxide 
(Document ID 1342, p. 48). Imported beryl is also converted into 
beryllium hydroxide as the United States has very little beryl that can 
be economically mined (Document ID 0616, p. 28).

Industrial Uses

    Materion Corporation (Materion), formerly called Brush Wellman, is 
the only producer of primary beryllium in the United States. Beryllium 
is used in a variety of industries, including aerospace, defense, 
telecommunications, automotive, electronic, and medical specialty 
industries. Pure beryllium metal is used in a range of products such as 
X-ray transmission windows, nuclear reactor neutron reflectors, nuclear 
weapons, precision instruments, rocket propellants, mirrors, and 
computers (Document ID 0389, p. 1). Beryllium oxide is used in 
components such as ceramics, electrical insulators, microwave oven 
components, military vehicle armor, laser structural components, and 
automotive ignition systems (Document ID 1567, p. 147). Beryllium oxide 
ceramics are used to produce sensitive electronic items such as lasers 
and satellite heat sinks.
    Beryllium alloys, typically beryllium/copper or beryllium/aluminum, 
are manufactured as high beryllium content or low beryllium content 
alloys. High content alloys contain greater than 30% beryllium. Low 
content alloys are typically less than 3% beryllium. Beryllium alloys 
are used in automotive electronics (e.g., electrical connectors and 
relays and audio components), computer components, home appliance 
parts, dental appliances (e.g., crowns), bicycle frames, golf clubs, 
and other articles (Document ID 0389, p. 2; 1278, p. 182; 1280, pp. 1-
2; 1281, pp. 816, 818). Electrical components and conductors are 
stamped and formed from beryllium alloys. Beryllium-copper alloys are 
used to make switches in automobiles (Document ID 1280, p. 2; 1281, p. 
818) and connectors, relays, and switches in computers, radar, 
satellite, and telecommunications equipment (Document ID 1278, p. 183). 
Beryllium-aluminum alloys are used in the construction of aircraft, 
high resolution medical and industrial X-ray equipment, and mirrors to 
measure weather patterns (Document ID 1278, p. 183). High content and 
low content beryllium alloys are precision machined for military and 
aerospace applications. Some welding consumables are also manufactured 
using beryllium.
    Beryllium is also found as a trace metal in materials such as 
aluminum ore, abrasive blasting grit, and coal fly ash. Abrasive 
blasting grits such as coal slag and copper slag contain varying 
concentrations of beryllium, usually less than 0.1% by weight. The 
burning of bituminous and sub-bituminous coal for power generation 
causes the naturally occurring beryllium in coal to accumulate in the 
coal fly ash byproduct. Scrap and waste metal for smelting and refining 
may also contain beryllium. A detailed discussion of the industries and 
job tasks using beryllium is included in the Preliminary Economic 
Analysis (Document ID 0385, 0426).
    Occupational exposure to beryllium can occur from inhalation of 
dusts, fume, and mist. Beryllium dusts are created during operations 
where beryllium is cut, machined, crushed, ground, or otherwise 
mechanically sheared. Mists can also form during operations that use 
machining fluids. Beryllium fume can form while welding with or on 
beryllium components, and from hot processes such as those found in 
metal foundries.
    Occupational exposure to beryllium can also occur from skin, eye, 
and mucous membrane contact with beryllium particulate or solutions.

V. Health Effects

Overview of Findings and Supportive Comments

    As discussed in detail throughout this section (section V, Final 
Health Effects) and in Section VI, Final Quantitative Risk Assessment 
and Significance of Risk, OSHA finds, based upon the best available 
evidence in the record, that exposure to soluble and poorly soluble 
forms of beryllium are associated with several adverse health outcomes 
including sensitization, chronic beryllium disease, acute beryllium 
disease and lung cancer.
    The findings and conclusions in this section are consistent with 
those of the National Academies of Sciences (NAS), the World Health 
Organization's International Agency for Research on Cancer (IARC), the 
U.S. Department of Health and Human Services' (HHS) National Toxicology 
Program (NTP), the National Institute for Occupational Safety and 
Health (NIOSH), the Agency for Toxic Substance and Disease Registry 
(ATSDR), the European Commission on Health, Safety and Hygiene at Work, 
and many other organizations and individuals, as evidenced in the 
rulemaking record and further discussed below. Other scientific 
organizations and governments have recognized the strong body of 
scientific evidence pointing to the health risks of exposure to 
beryllium and have deemed it necessary to take action to reduce those 
risks. In 1999, the Department of Energy (DOE) updated its airborne 
beryllium concentration action level to 0.2 [mu]g/m\3\ (Document ID 
1323). In 2009, the American Conference of Governmental Industrial 
Hygienists (ACGIH), a professional society that has been recommending 
workplace exposure limits for six decades, revised its Threshold Limit 
Value (TLV) for beryllium and beryllium-containing compounds to 0.05 
[mu]g/m\3\ (Document ID 1304).
    In finalizing this Health Effects preamble section for the final 
rule, OSHA updated the preliminary Health Effects section published in 
the NPRM based on the stakeholder response received by the Agency 
during the public comment period and public hearing. OSHA also 
corrected several non-substantive errors that were published in the 
NPRM as well as those identified by NIOSH and Materion including 
several minor organizational changes made to sections V.D.3 and V.E.2.b 
(Document ID 1671, pp. 10-11; 1662, pp. 3-5). A section titled ``Dermal 
Effects'' was added to V.F.5 based on comments received by the American 
Thoracic Society (ATS), National Jewish Health, and the National 
Supplemental Screening Program (Document ID 1688, p. 2; 1664, p. 5; 
1677, p. 3). Additionally, the Agency responded to relevant stakeholder 
comments contained in specific sections.
    In developing its review of the preliminary health effects from 
beryllium exposure and assessment of risk for the NPRM, OSHA prepared a

[[Page 2481]]

pair of draft documents, entitled ``Occupation Exposure to Beryllium: 
Preliminary Health Effects Evaluation'' (OSHA, 2010, Document ID 1271) 
and ``Preliminary Beryllium Risk Assessment'' (OSHA, 2010, Document ID 
1272), that underwent independent scientific peer review in accordance 
with the Office of Management and Budget's (OMB) Information Quality 
Bulletin for Peer Review. Eastern Research Group, Inc. (ERG), under 
contract with OSHA, selected five highly qualified experts with 
collective expertise in occupational epidemiology, occupational 
medicine, toxicology, immunology, industrial hygiene, and risk 
assessment methodology.\2\ The peer reviewers responded to 27 questions 
that covered the accuracy, completeness, and understandability of key 
studies and adverse health endpoints as well as questions regarding the 
adequacy, clarity and reasonableness of the risk analysis (ERG, 2010; 
Document ID 1270).
---------------------------------------------------------------------------

    \2\ The five selected peer reviewers were John Balmes, MD, 
University of California-San Francisco; Patrick Breysse, Ph.D., 
Johns Hopkins University, Bloomberg School of Public Health; Terry 
Gordon, Ph.D., New York University School of Medicine; Milton 
Rossman, MD, University of Pennsylvania School of Medicine; Kyle 
Steenland, Ph.D., Emory University, Rollins School of Public Health.
---------------------------------------------------------------------------

    Overall, the peer reviewers found that the OSHA draft health 
effects evaluation described the studies in sufficient detail, 
appropriately addressed their strengths and limitations, and drew 
scientifically sound conclusions. The peer reviewers were also 
supportive of the Agency's preliminary risk assessment approach and the 
major conclusions. OSHA provided detailed responses to reviewer 
comments in its publication of the NPRM (80 FR 47646-47652, 8/7/2015). 
Revisions to the draft health effects evaluation and preliminary risk 
assessment in response to the peer review comments were reflected in 
sections V and VI of the same publication (80 FR 47581-47646, 8/7/
2015). OSHA received public comment and testimony on the Health Effects 
and Preliminary Risk Assessment sections published in the NPRM, which 
are discussed in this preamble.
    The Agency received a wide variety of stakeholder comments and 
testimony for this rulemaking on issues related to the health effects 
and risk of beryllium exposure. Statements supportive of OSHA's Health 
Effects section include comments from NIOSH, the National Safety 
Council, the American Thoracic Society (ATS), Representative Robert C. 
``Bobby'' Scott, Ranking Member of Committee on Education and the 
Workforce, the U.S. House of Representatives, national labor 
organizations (American Federation of Labor--Congress of Industrial 
Organizations (AFL-CIO), North American Building Trades Unions (NABTU), 
United Steelworkers (USW), Public Citizen, ORCHSE, experts from 
National Jewish Health (Lisa Maier, MD and Margaret Mroz, MSPH), the 
American Association for Justice, and the National Council for 
Occupational Safety and Health.
    For example, NIOSH commented in its prepared written hearing 
testimony:

    OSHA has appropriately identified and documented all critical 
health effects associated with occupational exposure to beryllium 
and has appropriately focused its greatest attention on beryllium 
sensitization (BeS), chronic beryllium disease (CBD) and lung cancer 
. . .

NIOSH went on to say that sensitization was more than a test result 
with little meaning. It relates to a condition in which the immune 
system is able to recognize and adversely react to beryllium in a way 
that increases the risk of developing CBD. NIOSH agrees with OSHA that 
sensitization is a functional change that is necessary in order to 
proceed along the pathogenesis to serious lung disease.
    The National Safety Council, a congressionally chartered nonprofit 
safety organization, also stated that ``beryllium represents a serious 
health threat resulting from acute or chronic exposures.'' (Document ID 
1612, p. 5). Representative Robert C. ``Bobby'' Scott, Ranking Member 
of Committee on Education and the Workforce, the U.S. House of 
Representatives, submitted a statement recognizing that the evidence 
strongly supports the conclusion that sensitization can occur from 
exposure to soluble and poorly soluble forms of beryllium (Document ID 
1672, p. 3).
    OSHA also received supporting statements from ATS and ORCHSE on the 
inclusion of beryllium sensitization, CBD, skin disease, and lung 
cancer as major adverse health effects associated with beryllium 
exposure (Document ID 1688, p. 7; 1691, p. 14). ATS specifically 
stated:

. . . the ATS supports the inclusion of beryllium sensitization, 
CBD, and skin disease as the major adverse health effects associated 
with exposure to beryllium at or below 0.1 [mu]g/m\3\ and acute 
beryllium disease at higher exposures based on the currently 
available epidemiologic and experimental studies. (Document ID 1688, 
p. 2)

In addition, OSHA received supporting comments from labor organizations 
representing workers exposed to beryllium. The AFL-CIO, NABTU, and USW 
submitted comments supporting the inclusion of beryllium sensitization, 
CBD and lung cancer as health effects from beryllium exposure (Document 
ID 1689, pp. 1, 3; 1679, p. 6; 1681, p. 19). AFL-CIO commented that 
``[t]he proposal is based on extensive scientific and medical evidence 
. . .'' and ``[b]eryllium exposure causes immunological sensitivity, 
CBD and lung cancer. These health effects are debilitating, progressive 
and irreversible. Workers are exposed to beryllium through respiratory, 
dermal and gastrointestinal routes.'' (Document ID 1689, pp. 1, 3). 
Comments submitted by USW state that ``OSHA has correctly identified, 
and comprehensively documented the material impairments of health 
resulting from beryllium exposure.'' (Document ID 1681, p. 19).
    Dr. Lisa Maier and Ms. Margaret Mroz of National Jewish Health 
testified about the health effects of beryllium in support of the 
beryllium standard:

    We know that chronic beryllium disease often will not manifest 
clinically until irreversible lung scarring has occurred, often 
years after exposure, with a latency of 20 to 30 years as discussed 
yesterday. Much too late to make changes in the work place. We need 
to look for early markers of health effects, cast the net widely to 
identify cases of sensitization and disease, and use screening 
results in concert with exposure sampling to identify areas of 
increased risk that can be modified in the work place. (Document ID 
1756, Tr. 102; 1806).

American Association for Justice noted that:

    Unlike many toxins, there is no threshold below which no worker 
will become sensitized to beryllium. Worker sensitization to 
beryllium is a precursor to CBD, but not cancer. The symptoms of 
chronic beryllium disease (CBD) are part of a continuum of disease 
that is progressive in nature. Early recognition of and treatment 
for CBD may lead to a lessening of symptoms and may prevent the 
disease from progressing further. Symptoms of CBD may occur at 
exposure levels well below the proposed permissible exposure limit 
of .2 [micro]g/m\3\ and even below the action level of .1 [micro]g/
m\3\. OSHA has clear authority to regulate health effects across the 
entire continuum of disease to protect workers. We applaud OSHA for 
proposing to do so. (Document ID 1683, pp. 1-2).

National Committee for Occupational Safety and Health support OSHA 
findings of health effects due to beryllium exposure (1690, p. 1). 
Comments from Public Citizen also support OSHA findings: ``Beryllium is 
toxic at extremely low levels and exposure can result in BeS, an immune 
response that eventually can lead to an autoimmune granulomatous lung 
disease known as CBD. BeS is a necessary prerequisite to the 
development of CBD, with OSHA's

[[Page 2482]]

NPRM citing studies showing that 31-49 percent of all sensitized 
workers were diagnosed with CBD after clinical evaluations. Beryllium 
also is a recognized carcinogen that can cause lung cancer.'' (Document 
ID 1670, p.2).
    In addition to the comments above and those noted throughout this 
Health Effects section, Materion submitted their correspondence to the 
National Academies (NAS) regarding the company's assessment of the NAS 
beryllium studies and their correspondence to NIOSH regarding the 
Cummings 2009 study (Document 1662, Attachments) to OSHA. For the NAS 
study, Materion included a series of comments regarding studies 
included in the NAS report. OSHA has reviewed these comments and found 
that the comments submitted to the NAS critiquing their review of the 
health effects of beryllium were considered and incorporated where 
appropriate. For the NIOSH study Materion included comments regarding 2 
cases of acute beryllium disease evaluated in a study published by 
Cummings et al., 2009. NIOSH also dealt with the comments from Materion 
as they found appropriate. However, none of the changes recommended by 
Materion to the NAS or NIOSH altered the overall findings or 
conclusions from either study. OSHA has taken the Materion comments 
into account in the review of these documents. OSHA found them not to 
be sufficient to discount either the findings of the NAS or NIOSH.

Introduction

    Beryllium-associated health effects, including acute beryllium 
disease (ABD), beryllium sensitization (also referred to in this 
preamble as ``sensitization''), chronic beryllium disease (CBD), and 
lung cancer, can lead to a number of highly debilitating and life-
altering conditions including pneumonitis, loss of lung capacity 
(reduction in pulmonary function leading to pulmonary dysfunction), 
loss of physical capacity associated with reduced lung capacity, 
systemic effects related to pulmonary dysfunction, and decreased life 
expectancy (NIOSH, 1972, Document ID 1324, 1325, 1326, 1327, 1328; 
NIOSH, 2011 (0544)).
    This Health Effects section presents information on beryllium and 
its compounds, the fate of beryllium in the body, research that relates 
to its toxic mechanisms of action, and the scientific literature on the 
adverse health effects associated with beryllium exposure, including 
ABD, sensitization, CBD, and lung cancer. OSHA considers CBD to be a 
progressive illness with a continuous spectrum of symptoms ranging from 
no symptomatology at its earliest stage following sensitization to mild 
symptoms such as a slight almost imperceptible shortness of breath, to 
loss of pulmonary function, debilitating lung disease, and, in many 
cases, death. This section also discusses the nature of these 
illnesses, the scientific evidence that they are causally associated 
with occupational exposure to beryllium, and the probable mechanisms of 
action with a more thorough review of the supporting studies.
A. Beryllium and Beryllium Compounds--Particle Characterization
1. Particle Physical/Chemical Properties
    Beryllium has two oxidative states: Be(0) and Be(2\+\) (Agency for 
Toxic Substance and Disease Registry (ATSDR) 2002, Document ID 1371). 
It is likely that the Be(2\+\) state is the most biologically reactive 
and able to form a bond with peptides leading to it becoming antigenic 
(Snyder et al., 2003) as discussed in more detail in the Beryllium 
Sensitization section below. Beryllium has a high charge-to-radius 
ratio, forming various types of ionic bonds. In addition, beryllium has 
a strong tendency for covalent bond formation (e.g., it can form 
organometallic compounds such as Be(CH3)2 and 
many other complexes) (ATSDR, 2002, Document ID 1371; Greene et al., 
1998 (1519)). However, it appears that few, if any, toxicity studies 
exist for the organometallic compounds. Additional physical/chemical 
properties, such as solubility, for beryllium compounds that may be 
important in their biological response are summarized in Table 1 below. 
Solubility (as discussed in biological fluids in Section V.A.2.A below) 
is an important factor in evaluating the biological response to 
beryllium. For comparative purposes, water solubility is used in Table 
1. The International Chemical Safety Cards lists water solubility as a 
way to standardize solubility values among particles and fibers. The 
information contained within Table 1 was obtained from the 
International Chemical Safety Cards (ICSC) for beryllium metal (ICSC 
0226, Document ID 0438), beryllium oxide (ICSC 1325, Document ID 0444), 
beryllium sulfate (ICSC 1351, Document ID 0443), beryllium nitrate 
(ICSC 1352, Document ID 0442), beryllium carbonate (ICSC 1353, Document 
ID 0441), beryllium chloride (ICSC 1354, Document ID 0440), beryllium 
fluoride (ICSC 1355, Document ID 0439) and from the hazardous substance 
data bank (HSDB) for beryllium hydroxide (CASRN: 13327-32-7), and 
beryllium phosphate (CASRN: 13598-15-7, Document ID 0533). Additional 
information on chemical and physical properties as well as industrial 
uses for beryllium can be found in this preamble at Section IV, 
Chemical Properties and Industrial Uses.

                                Table 1--Beryllium Characteristics and Properties
----------------------------------------------------------------------------------------------------------------
                                                                                                  Solubility in
        Compound name                 Chemical formula          Molecular      Acute physical      water at 20
                                                                   mass           hazards             [deg]C
----------------------------------------------------------------------------------------------------------------
Beryllium Metal..............  Be............................          9.0  Combustible; Finely  None.
                                                                             dispersed
                                                                             particles--Explosi
                                                                             ve.
Beryllium Oxide..............  BeO...........................         25.0  Not combustible or   Very sparingly
                                                                             explosive.           soluble.
Beryllium Carbonate..........  Be2CO3(OH)/Be2CO5 H2..........       181.07  Not combustible or   None.
                                                                             explosive.
Beryllium Sulfate............  BeSO4.........................        105.1  Not combustible or   Slightly
                                                                             explosive.           soluble.
Beryllium Nitrate............  BeN2O6/Be(NO3)2...............        133.0  Enhances combustion  Very soluble
                                                                             of other             (1.66 x 10\6\
                                                                             substances.          mg/L).
Beryllium Hydroxide..........  Be(OH)2.......................         43.0  Not reported.......  Slightly
                                                                                                  soluble 0.8 x
                                                                                                  10\-4\ mol/L
                                                                                                  (3.44 mg/L).
Beryllium Chloride...........  BeCl2.........................         79.9  Not combustible or   Soluble.
                                                                             explosive.
Beryllium Fluoride...........  BeF2..........................         47.0  Not combustible or   Very soluble.
                                                                             explosive.
Beryllium Phosphate..........  Be3(PO4)2.....................        271.0  Not reported.......  Soluble.
----------------------------------------------------------------------------------------------------------------


[[Page 2483]]

    Beryllium shows a high affinity for oxygen in air and water, 
resulting in a thin surface film of beryllium oxide on the bare metal. 
If the surface film is disturbed, it may become airborne and cause 
respiratory tract exposure or dermal exposure (also referred to as 
dermal contact). The physical properties of solubility, particle 
surface area, and particle size of some beryllium compounds are 
examined in more detail below. These properties have been evaluated in 
many toxicological studies. In particular, the properties related to 
the calcination (firing temperatures) and differences in crystal size 
and solubility are important aspects in their toxicological profile.
2. Factors Affecting Potency and Effect of Beryllium Exposure
    The effect and potency of beryllium and its compounds, as for any 
toxicant, immunogen, or immunotoxicant, may be dependent upon the 
physical state in which they are presented to a host. For occupational 
airborne materials and surface contaminants, it is especially critical 
to understand those physical parameters in order to determine the 
extent of exposure to the respiratory tract and skin since these are 
generally the initial target organs for either route of exposure.
    For example, solubility has an important part in determining the 
toxicity and bioavailability of airborne materials as well. Respiratory 
tract retention and skin penetration are directly influenced by the 
solubility and reactivity of airborne material. Large particles may 
have less of an effect in the lung than smaller particles due to 
reduced potential to stay airborne, to be inhaled, or be deposited 
along the respiratory tract. In addition, once inhalation occurs 
particle size is critical in determining where the particle will 
deposit along the respiratory tract.
    These factors may be responsible, at least in part, for the process 
by which beryllium sensitization progresses to CBD in exposed workers. 
Other factors influencing beryllium-induced toxicity include the 
surface area of beryllium particles and their persistence in the lung. 
With respect to dermal contact or exposure, the physical 
characteristics of the particle are also important since they can 
influence skin absorption and bioavailability. This section addresses 
certain physical characteristics (i.e., solubility, particle size, 
particle surface area) that influence the toxicity of beryllium 
materials in occupational settings.
a. Solubility
    Solubility has been shown to be an important determinant of the 
toxicity of airborne materials, influencing the deposition and 
persistence of inhaled particles in the respiratory tract, their 
bioavailability, and the likelihood of presentation to the immune 
system. A number of chemical agents, including metals that contact and 
penetrate the skin, are able to induce an immune response, such as 
sensitization (Boeniger, 2003, Document ID 1560; Mandervelt et al., 
1997 (1451)). Similar to inhaled agents, the ability of materials to 
penetrate the skin is also influenced by solubility because dermal 
absorption may occur at a greater rate for soluble materials than 
poorly soluble materials (Kimber et al., 2011, Document ID 0534). In 
post-hearing comments, NIOSH explained:

    In biological systems, solubility is used to describe the rate 
at which a material will undergo chemical clearance and dissolve in 
a fluid (airway lining, inside phagolysomes) relative to the rate of 
mechanical clearance. For example, in the lung a ``poorly soluble'' 
material is one that dissolves at a rate slower than the rate of 
mechanical removal via the mucociliary escalator. Examples of poorly 
soluble forms of beryllium are beryllium silicates, beryllium oxide, 
and beryllium metal and alloys (Deubner et al. 2011; Huang et al. 
2011; Duling et al. 2012; Stefaniak et al. 2006, 201la, 2012). A 
highly soluble material is one that dissolves at a rate faster than 
mechanical clearance. Examples of highly soluble forms of beryllium 
are beryllium fluoride, beryllium sulfate, and beryllium chloride. 
(Document ID 1660-A2, p. 9).

This section reviews the relevant information regarding solubility, its 
importance in a biological matrix and its relevance to sensitization 
and beryllium lung disease. The weight of evidence presented below 
suggests that both soluble and poorly soluble forms of beryllium can 
induce a sensitization response and result in progression of lung 
disease.
    Beryllium salts, including the chloride (BeCl2), 
fluoride (BeF2), nitrate (Be(NO3)2), 
phosphate (Be3 (PO4)2), and sulfate 
(tetrahydrate) (BeSO4 [middot] 4H2O) salts, are 
all water soluble. However, soluble beryllium salts can be converted to 
less soluble forms in the lung (Reeves and Vorwald, 1967, Document ID 
1309). According to an EPA report, aqueous solutions of the soluble 
beryllium salts are acidic as a result of the formation of 
Be(OH2)4 2\+\, the tetrahydrate, which will react 
to form poorly soluble hydroxides or hydrated complexes within the 
general physiological range of pH values (between 5 and 8) (EPA, 1998, 
Document ID 1322). This may be an important factor in the development 
of CBD since lower-soluble forms of beryllium have been shown to 
persist in the lung for longer periods of time and persistence in the 
lung may be needed in order for this disease to occur (NAS, 2008, 
Document ID 1355).
    Beryllium oxide (BeO), hydroxide (Be(OH)2), carbonate 
(Be2 CO3 (OH)2), and sulfate 
(anhydrous) (BeSO4) are either insoluble, slightly soluble, 
or considered to be sparingly or poorly soluble (almost insoluble or 
having an extremely slow rate of dissolution and most often referred to 
as poorly soluble in more recent literature). The solubility of 
beryllium oxide, which is prepared from beryllium hydroxide by 
calcining (heating to a high temperature without fusing in order to 
drive off volatile chemicals) at temperatures between 500 and 1,750 
[deg]C, has an inverse relationship with calcination temperature. 
Although the solubility of the low-fired crystals can be as much as 10 
times that of the high-fired crystals, low-fired beryllium oxide is 
still only sparingly soluble (Delic, 1992, Document 1547). In a study 
that measured the dissolution kinetics (rate to dissolve) of beryllium 
compounds calcined at different temperatures, Hoover et al., compared 
beryllium metal to beryllium oxide particles and found them to have 
similar solubilities. This was attributed to a fine layer of beryllium 
oxide that coats the metal particles (Hoover et al., 1989, Document ID 
1510). A study conducted by Deubner et al. (2011) determined ore 
materials to be more soluble than beryllium oxide at pH 7.2 but similar 
in solubility at pH 4.5. Beryllium hydroxide was more soluble than 
beryllium oxide at both pHs (Deubner et al., 2011, Document ID 0527).
    Investigators have also attempted to determine how biological 
fluids can dissolve beryllium materials. In two studies, poorly soluble 
beryllium, taken up by activated phagocytes, was shown to be ionized by 
myeloperoxidases (Leonard and Lauwerys, 1987, Document ID 1293; 
Lansdown, 1995 (1469)). The positive charge resulting from ionization 
enabled the beryllium to bind to receptors on the surface of cells such 
as lymphocytes or antigen-presenting cells which could make it more 
biologically active (NAS, 2008, Document ID 1355). In a study utilizing 
phagolysosomal-simulating fluid (PSF) with a pH of 4.5, both beryllium 
metal and beryllium oxide dissolved at a greater rate than that 
previously reported in water or SUF (simulant fluid) (Stefaniak et al., 
2006, Document ID 1398), and the rate of dissolution of the multi-
constituent (mixed) particles

[[Page 2484]]

was greater than that of the single-constituent beryllium oxide powder. 
The authors speculated that copper in the particles rapidly dissolves, 
exposing the small inclusions of beryllium oxide, which have higher 
specific surface areas (SSA) and therefore dissolve at a higher rate. A 
follow-up study by the same investigational team (Duling et al., 2012, 
Document ID 0539) confirmed dissolution of beryllium oxide by PSF and 
determined the release rate was biphasic (initial rapid diffusion 
followed by a latter slower surface reaction-driven release). During 
the latter phase, dissolution half-times were 1,400 to 2,000 days. The 
authors speculated this indicated bertrandite was persistent in the 
lung (Duling et al., 2012, Document ID 0539).
    In a recent study investigating the dissolution and release of 
beryllium ions for 17 beryllium-containing materials (ore, hydroxide, 
metal, oxide, alloys, and processing intermediates) using artificial 
human airway epithelial lining fluid, Stefaniak et al. (2011) found 
release of beryllium ions within 7 days (beryl ore smelter dust). The 
authors calculated dissolution half-times ranging from 30 days 
(reduction furnace material) to 74,000 days (hydroxide). Stefaniak et 
al. (2011) speculated that despite the rapid mechanical clearance, 
billions of beryllium ions could be released in the respiratory tract 
via dissolution in airway lining fluid (ALF). Under this scenario, 
beryllium-containing particles depositing in the respiratory tract 
dissolving in ALF could provide beryllium ions for absorption in the 
lung and interact with immune cells in the respiratory tract (Stefaniak 
et al., 2011, Document ID 0537).
    Huang et al. (2011) investigated the effect of simulated lung fluid 
(SLF) on dissolution and nanoparticle generation and beryllium-
containing materials. Bertrandite-containing ore, beryl-containing ore, 
frit (a processing intermediate), beryllium hydroxide (a processing 
intermediate) and silica (used as a control), were equilibrated in SLF 
at two pH values (4.5 and 7.2) to reflect inter- and intra-cellular 
environments in the lung tissue. Concentrations of beryllium, aluminum, 
and silica ions increased linearly during the first 20 days in SLF, and 
rose more slowly thereafter, reaching equilibrium over time. The study 
also found nanoparticle formation (in the size range of 10-100 nm) for 
all materials (Huang et al., 2011, Document ID 0531).
    In an in vitro skin model, Sutton et al. (2003) demonstrated the 
dissolution of beryllium compounds (poorly soluble beryllium hydroxide, 
soluble beryllium phosphate) in a simulated sweat fluid (Document ID 
1393). This model showed beryllium can be dissolved in biological 
fluids and be available for cellular uptake in the skin. Duling et al. 
(2012) confirmed dissolution and release of ions from bertrandite ore 
in an artificial sweat model (pH 5.3 and pH 6.5) (Document ID 0539).
    In summary, studies have shown that soluble forms of beryllium 
readily dissolve into ionic components making them biologically 
available for dermal penetration and activation of immune cells 
(Stefaniak et al., 2011; Document ID 0537). Soluble forms can also be 
converted to less soluble forms in the lung (Reeves and Vorwald, 1967, 
Document ID 1309) making persistence in the lung a possibility and 
increasing the potential for development of CBD (see section V.D.2). 
Studies by Stefaniak et al. (2003, 2006, 2011, 2012) (Document ID 1347; 
1398; 0537; 0469), Huang et al. (2011), Duling et al. (2012), and 
Deubner et al. (2011) have demonstrated poorly soluble forms can be 
readily dissolved in biological fluids such as sweat, lung fluid, and 
cellular fluids. The dissolution of beryllium ions into biological 
fluids increases the likelihood of beryllium presentation to immune 
cells, thus increasing the potential for sensitization through dermal 
contact or lung exposure (Document ID 0531; 0539; 0527) (see section 
V.D.1).
    OSHA received comments from the Non-Ferrous Founders' Society 
(NFFS) contending that the scientific evidence does not support 
insoluble beryllium as a causative agent for sensitization and CBD 
(Document ID 1678, p. 6). The NFFS contends that insoluble beryllium is 
not carcinogenic or a sensitizer to humans, and argues that based on 
this information, OSHA should consider a bifurcated standard with 
separate PELs for soluble and poorly soluble beryllium and beryllium 
compounds and insoluble beryllium metallics (Document ID 1678, p. 7). 
As evidence supporting its conclusion, the NFFS cited a 2010 statement 
written by Dr. Christian Strupp commissioned by the beryllium industry 
(Document ID 1785, 1814), which reviewed selected studies to evaluate 
the toxic potential of beryllium metal and alloys (Document ID 1678, 
pp. 7). The Strupp and Furnes statement (2010) cited by the NFFS is the 
background material and basis of the Strupp (2011a and 2011b) studies 
in the docket (Document ID 1794; 1795). In response to Strupp 2011 (a 
and b), Aleks Stefaniak of NIOSH published a letter to the editor 
refuting some of the evidence presented by Strupp (2011a and b, 
Document ID 1794; 1795). The first study by Strupp (2011a) evaluated 
selected animal studies and concluded that beryllium metal was not a 
sensitizer. Stefaniak (2011) evaluated the validity of the Strupp 
(2011a) study of beryllium toxicity and noted numerous deficiencies, 
including deficiencies in the study design, improper administration of 
beryllium test compounds, and lack of proper controls (Document ID 
1793). In addition, Strupp (2011a) omitted numerous key animal and 
epidemiological studies demonstrating the potential of poorly soluble 
beryllium and beryllium metal as a sensitizing agent. One such study, 
Tinkle et al. (2003), demonstrated that topical application of poorly 
soluble beryllium induced skin sensitization in mice (Document ID 
1483). Comments from NIOSH and National Jewish Medical Center state 
that poorly soluble beryllium materials are capable of dissolving in 
sweat (Document ID 1755; 1756). After evaluating the scientific 
evidence from epidemiological and animal studies, OSHA finds, based on 
the best available evidence, that soluble and poorly soluble forms of 
beryllium and beryllium compounds are causative agents of sensitization 
and CBD.
b. Particle Size
    The toxicity of beryllium as exemplified by beryllium oxide is 
dependent, in part, on the particle size, with smaller particles (less 
than 10 [mu]m in diameter) able to penetrate beyond the larynx 
(Stefaniak et al., 2008, Document ID 1397). Most inhalation studies and 
occupational exposures involve quite small (less than 1-2 [mu]m in 
diameter) beryllium oxide particles that can penetrate to the pulmonary 
regions of the lung (Stefaniak et al., 2008, Document ID 1397). In 
inhalation studies with beryllium ores, particle sizes are generally 
much larger, with deposition occurring in several areas throughout the 
respiratory tract for particles less than 10 [mu]m in diameter.
    The temperature at which beryllium oxide is calcined influences its 
particle size, surface area, solubility, and ultimately its toxicity 
(Delic, 1992, Document ID 1547). Low-fired (500 [deg]C) beryllium oxide 
is predominantly made up of poorly crystallized small particles, while 
higher firing temperatures (1000-1750 [deg]C) result in larger particle 
sizes (Delic, 1992, Document ID 1547).
    In order to determine the extent to which particle size plays a 
role in the toxicity of beryllium in occupational settings, several key 
studies are reviewed and detailed below. The findings on particle size 
have been related, where possible, to work process

[[Page 2485]]

and biologically relevant toxicity endpoints of either sensitization or 
CBD.
    Numerous studies have been conducted evaluating the particle size 
generated during basic industrial and machining operations. In a study 
by Cohen et al. (1983), a multi-cyclone sampler was utilized to measure 
the size mass distribution of the beryllium aerosol at a beryllium-
copper alloy casting operation (Document ID 0540). Briefly, Cohen et 
al. (1983) found variable particle size generation based on the 
operations being sampled with particle size ranging from 3 to 16 [mu]m. 
Hoover et al. (1990) also found variable particle sizes being generated 
across different operations (Document ID 1314). In general, Hoover et 
al. (1990) found that milling operations generated smaller particle 
sizes than sawing operations. Hoover et al. (1990) also found that 
beryllium metal generated higher concentrations than metal alloys. 
Martyny et al. (2000) characterized generation of particle size during 
precision beryllium machining processes (Document ID 1053). The study 
found that more than 50 percent of the beryllium machining particles 
collected in the breathing zone of machinists were less than 10 [mu]m 
in aerodynamic diameter with 30 percent of those smaller particles 
being less than 0.6 [mu]m. A study by Thorat et al. (2003) found 
similar results with ore mixing, crushing, powder production and 
machining ranging from 5.0 to 9.5 [mu]m (Document ID 1389). Kent et al. 
(2001) measured airborne beryllium using size-selective samplers in 
five furnace areas at a beryllium processing facility (Document ID 
1361). A statistically significant linear trend was reported between 
the alveolar-deposited particle mass concentration and prevalence of 
CBD and sensitization in the furnace production areas. The study 
authors suggested that the concentration of alveolar-deposited 
particles (e.g., <3.5 [mu]m) may be a better predictor of sensitization 
and CBD than the total mass concentration of airborne beryllium.
    A recent study by Virji et al. (2011) evaluated particle size 
distribution, chemistry, and solubility in areas with historically 
elevated risk of sensitization and CBD at a beryllium metal powder, 
beryllium oxide, and alloy production facility (Document ID 0465). The 
investigators observed that historically, exposure-response 
relationships have been inconsistent when using mass concentration to 
identify process-related risk, possibly due to incomplete particle 
characterization. Two separate exposure surveys were conducted in March 
1999 and June-August 1999 using multi-stage personal impactor samplers 
(to determine particle size distribution) and personal 37 mm closed 
face cassette (CFC) samplers, both located in workers' breathing zones. 
One hundred and ninety eight time-weighted-average (TWA) personal 
impactor samples were analyzed for representative jobs and processes. A 
total of 4,026 CFC samples were collected over the collection period 
and analyzed for mass concentration, particle size, chemical content 
and solubility and compared to process areas with high risk of 
sensitization and CBD. The investigators found that total beryllium 
concentration varied greatly between workers and among process areas. 
Analysis of chemical form and solubility also revealed wide variability 
among process areas, but high risk process areas had exposures to both 
soluble and poorly soluble forms of beryllium. Analysis of particle 
size revealed most process areas had particles ranging from 5 to 14 
[micro]m mass median aerodynamic diameter (MMAD). Rank order 
correlating jobs to particle size showed high overall consistency 
(Spearman r = 0.84) but moderate correlation (Pearson r = 0.43). The 
investigators concluded that by considering more relevant aspects of 
exposure such as particle size distribution, chemical form, and 
solubility could potentially improve exposure assessments (Virji et 
al., 2011, Document ID 0465).
    To summarize, particle size influences deposition of beryllium 
particles in the lung, thereby influencing toxicity. Studies by 
Stefaniak et al. (2008) demonstrated that the majority of particles 
generated by beryllium processing operations were in the respirable 
range (less than 1-2 [mu]m) (Document ID 1397). However, studies by 
Virji et al. (2011) (Document ID 0465), Cohen et al. (1983) (Document 
ID 0540) and Hoover et al. (1990) (Document ID 1314) showed that some 
operations could generate particle sizes ranging from 3 to 16 [mu]m.
c. Particle Surface Area
    Particle surface area has been postulated as an important metric 
for beryllium exposure. Several studies have demonstrated a 
relationship between the inflammatory and tumorigenic potential of 
ultrafine particles and their increased surface area (Driscoll, 1996, 
Document ID 1539; Miller, 1995 (0523); Oberdorster et al., 1996 
(1434)). While the exact mechanism explaining how particle surface area 
influences its biological activity is not known, a greater particle 
surface area has been shown to increase inflammation, cytokine 
production, pro- and anti-oxidant defenses and apoptosis, which has 
been shown to increase the tumorigenic potential of poorly-soluble 
particles (Elder et al., 2005, Document ID 1537; Carter et al., 2006 
(1556); Refsnes et al., 2006 (1428)).
    Finch et al. (1988) found that beryllium oxide calcined at 
500[deg]C had 3.3 times greater specific surface area (SSA) than 
beryllium oxide calcined at 1000 [deg]C, although there was no 
difference in size or structure of the particles as a function of 
calcining temperature (Document ID 1317). The beryllium-metal aerosol 
(airborne beryllium particles), although similar to the beryllium oxide 
aerosols in aerodynamic size, had an SSA about 30 percent that of the 
beryllium oxide calcined at 1000 [deg]C. As discussed above, a later 
study by Delic (1992) found calcining temperatures had an effect on SSA 
as well as particle size (Document ID 1547).
    Several studies have investigated the lung toxicity of beryllium 
oxide calcined at different temperatures and generally have found that 
those calcined at lower temperatures have greater toxicity and effect 
than materials calcined at higher temperatures. This may be because 
beryllium oxide fired at the lower temperature has a loosely formed 
crystalline structure with greater specific surface area than the fused 
crystal structure of beryllium oxide fired at the higher temperature. 
For example, beryllium oxide calcined at 500 [deg]C has been found to 
have stronger pathogenic effects than material calcined at 1,000 
[deg]C, as shown in several of the beagle dog, rat, mouse and guinea 
pig studies discussed in the section on CBD pathogenesis that follows 
(Finch et al., 1988, Document ID 1495; Pol[aacute]k et al., 1968 
(1431); Haley et al., 1989 (1366); Haley et al., 1992 (1365); Hall et 
al., 1950 (1494)). Finch et al. have also observed higher toxicity of 
beryllium oxide calcined at 500 [deg]C, an observation they attribute 
to the greater surface area of beryllium particles calcined at the 
lower temperature (Finch et al., 1988, Document ID 1495). These authors 
found that the in vitro cytotoxicity to Chinese hamster ovary (CHO) 
cells and cultured lung epithelial cells of 500 [deg]C beryllium oxide 
was greater than that of 1,000 [deg]C beryllium oxide, which in turn 
was greater than that of beryllium metal. However, when toxicity was 
expressed in terms of particle surface area, the cytotoxicity of all 
three forms was similar. Similar results were observed in a study 
comparing the cytotoxicity of beryllium metal particles of various 
sizes to cultured rat alveolar macrophages, although specific surface

[[Page 2486]]

area did not entirely predict cytotoxicity (Finch et al., 1991, 
Document ID 1535).
    Stefaniak et al. (2003) investigated the particle structure and 
surface area of beryllium metal, beryllium oxide, and copper-beryllium 
alloy particles (Document ID 1347). Each of these samples was separated 
by aerodynamic size, and their chemical compositions and structures 
were determined with x-ray diffraction and transmission electron 
microscopy, respectively. In summary, beryllium-metal powder varied 
remarkably from beryllium oxide powder and alloy particles. The metal 
powder consisted of compact particles, in which SSA decreases with 
increasing surface diameter. In contrast, the alloys and oxides 
consisted of small primary particles in clusters, in which the SSA 
remains fairly constant with particle size. SSA for the metal powders 
varied based on production and manufacturing process with variations 
among samples as high as a factor of 37. Stefaniak et al. (2003) found 
lesser variation in SSA for the alloys or oxides (Document ID 1347). 
This is consistent with data from other studies summarized above 
showing that process may affect particle size and surface area. 
Particle size and/or surface area may explain differences in the rate 
of beryllium sensitization and CBD observed in some epidemiological 
studies. However, these properties have not been consistently 
characterized in most studies.
B. Kinetics and Metabolism of Beryllium
    Beryllium enters the body by inhalation, absorption through the 
skin, or ingestion. For occupational exposure, the airways and the skin 
are the primary routes of uptake.
1. Exposure Via the Respiratory System
    The respiratory tract, especially the lung, is the primary target 
of inhalation exposure in workers. Disposition (deposition and 
clearance) of the particle or droplet along the respiratory tract 
influences the biological response to the toxicant (Schlesinger et al., 
1997, Document ID 1290). Inhaled beryllium particles are deposited 
along the respiratory tract in a size dependent manner as described by 
the International Commission for radiological Protection (ICRP) model 
(Figure 1). In general, particles larger than 10 [mu]m tend to deposit 
in the upper respiratory tract or nasal region and do not appreciably 
penetrate lower in the tracheobronchial or pulmonary regions (Figure 
1). Particles less than 10 [mu]m increasingly penetrate and deposit in 
the tracheobronchial and pulmonary regions with peak deposition in the 
pulmonary region occurring below 5 [mu]m in particle diameter. The CBD 
pathology of concern is found in the pulmonary region. For particles 
below 1 [mu]m in particle diameter, regional deposition changes 
dramatically. Ultrafine particles (generally considered to be 100 nm or 
lower) have a higher rate of deposition along the entire respiratory 
system (ICRP model, 1994). However, due to the hygroscopic nature of 
soluble particles, deposition patterns may be slightly different with 
an enhanced preference for the tracheobronchial or bronchial region of 
the lung. Nonetheless, soluble particles are still capable of 
depositing in the pulmonary region (Schlesinger et al., 1997, Document 
ID 1290).
    Particles depositing in the lung and along the entire respiratory 
tract may encounter immunologic cells or may move into the vascular 
system where they are free to leave the lung and can contribute to 
systemic beryllium concentrations.
[GRAPHIC] [TIFF OMITTED] TR09JA17.000

    Beryllium is removed from the respiratory tract by various 
clearance mechanisms. Soluble beryllium is removed from the respiratory 
tract via absorption or chemical clearance (Schlesinger, 1997, Document 
ID 1290). Sparingly soluble or poorly soluble beryllium is removed via 
mechanical mechanisms and may remain in the

[[Page 2487]]

lungs for many years after exposure, as has been observed in workers 
(Schepers, 1962, Document ID 1414). Clearance mechanisms for sparingly 
soluble or poorly soluble beryllium particles include: In the nasal 
passage, sneezing, mucociliary transport to the throat, or dissolution; 
in the tracheobronchial region, mucociliary transport, coughing, 
phagocytosis, or dissolution; in the pulmonary or alveolar region, 
phagocytosis, movement through the interstitium (translocation), or 
dissolution (Schlesinger, 1997, Document ID 1290). Mechanical clearance 
mechanisms may occur slowly in humans, which is consistent with some 
animal and human studies. For example, subjects in the Beryllium Case 
Registry (BCR), which identifies and tracks cases of acute and chronic 
beryllium diseases, had elevated concentrations of beryllium in lung 
tissue (e.g., 3.1 [mu]g/g of dried lung tissue and 8.5 [mu]g/g in a 
mediastinal node) more than 20 years after termination of short-term 
(generally between 2 and 5 years) occupational exposure to beryllium 
(Sprince et al., 1976, Document ID 1405).
    Due to physiological differences, clearance rates can vary between 
humans and animal species (Schlesinger, 1997, Document ID 1290; Miller, 
2000 (1831)). However, clearance rates are also dependent upon the 
solubility, dose, and size of the inhaled beryllium compound. As 
reviewed in a WHO Report (2001) (Document ID 1282), more soluble 
beryllium compounds generally tend to be cleared from the respiratory 
system and absorbed into the bloodstream more rapidly than less soluble 
compounds (Van Cleave and Kaylor, 1955, Document ID 1287; Hart et al., 
1980 (1493); Finch et al., 1990 (1318)). Animal inhalation or 
intratracheal instillation studies administering soluble beryllium 
salts demonstrated significant absorption of approximately 20 percent 
of the initial lung burden with rapid dissolution of soluble compounds 
from the lung (Delic, 1992, Document ID 1547). Absorption of poorly 
soluble compounds such as beryllium oxide administered via inhalation 
or intratracheal instillation was slower and less significant (Delic, 
1992, Document ID 1547). Additional animal studies have demonstrated 
that clearance of poorly soluble beryllium compounds was biphasic: A 
more rapid initial mucociliary transport phase of particles from the 
tracheobronchial tree to the gastrointestinal tract, followed by a 
slower phase via translocation to tracheobronchial lymph nodes, 
alveolar macrophages uptake, and beryllium particles dissolution 
(Camner et al., 1977, Document ID 1558; Sanders et al., 1978 (1485); 
Delic, 1992 (1547); WHO, 2001 (1282)). Confirmatory studies in rats 
have shown the half-time for the rapid phase to be between 1 and 60 
days, while the slow phase ranged from 0.6 to 2.3 years. Studies have 
also shown that this process was influenced by the solubility of the 
beryllium compounds: Weeks/months for soluble compounds, months/years 
for poorly soluble compounds (Reeves and Vorwald, 1967; Reeves et al., 
1967; Rhoads and Sanders, 1985). Studies in guinea pigs and rats 
indicate that 40-50 percent of the inhaled soluble beryllium salts are 
retained in the respiratory tract. Similar data could not be found for 
the poorly soluble beryllium compounds or metal administered by this 
exposure route. (WHO, 2001, Document ID 1282; ATSDR, 2002 (1371).)
    Evidence from animal studies suggests that greater amounts of 
beryllium deposited in the lung may result in slower clearance times. 
Acute inhalation studies performed in rats and mice using a single dose 
of inhaled aerosolized beryllium metal showed that exposure to 
beryllium metal can slow particle clearance and induce lung damage in 
rats and mice (Finch et al., 1998, Document ID 1317; Haley et al., 1990 
(1314)). In another study, Finch et al. (1994) exposed male F344/N rats 
to beryllium metal at concentrations resulting in beryllium lung 
burdens of 1.8, 10, and 100 [mu]g. These exposure levels resulted in an 
estimated clearance half-life ranging from 250 to 380 days for the 
three concentrations. For mice (Finch et al., 1998, Document ID 1317), 
lung clearance half-lives were 91-150 days (for 1.7- and 2.6-[mu]g lung 
burden groups) or 360-400 days (for 12- and 34-[mu]g lung burden 
groups). While the lower exposure groups were quite different for rats 
and mice, the highest groups were similar in clearance half-lives for 
both species.
    Beryllium absorbed from the respiratory system was shown to 
distribute primarily to the tracheobronchial lymph nodes via the lymph 
system, bloodstream, and skeleton (Stokinger et al., 1953, Document ID 
1277; Clary et al., 1975 (1320); Sanders et al., 1975 (1486); Finch et 
al., 1990 (1318)). Studies in rats demonstrated accumulation of 
beryllium chloride in the skeletal system following intraperitoneal 
injection (Crowley et al., 1949, Document ID 1551; Scott et al., 1950 
(1413)) and accumulation of beryllium phosphate and beryllium sulfate 
in both non-parenchymal and parenchymal cells of the liver after 
intravenous administration in rats (Skilleter and Price, 1978, Document 
ID 1408). Studies have also demonstrated intracellular accumulation of 
beryllium oxide in bone marrow throughout the skeletal system after 
intravenous administration to rabbits (Fodor, 1977, Document ID 1532; 
WHO, 2001 (1282)). Trace amounts of beryllium have also been shown to 
be distributed throughout the body (WHO, 2001, Document ID 1282).
    Systemic distribution of the more soluble compounds was shown to be 
greater than that of the poorly soluble compounds (Stokinger et al., 
1953, Document ID 1277). Distribution has also been shown to be dose 
dependent in research using intravenous administration of beryllium in 
rats; small doses were preferentially taken up in the skeleton, while 
higher doses were initially distributed preferentially to the liver.
    Beryllium was later mobilized from the liver and transferred to the 
skeleton (IARC, 1993, Document ID 1342). A half-life of 450 days has 
been estimated for beryllium in the human skeleton (ICRP, 1960, 
Document ID 0248). This indicates the skeleton may serve as a 
repository for beryllium that may later be reabsorbed by the 
circulatory system, making beryllium available to the immunological 
system (WHO, 2001, Document ID 1282). In a recent review of the 
information, the American Conference of Governmental Industrial 
Hygienists (ACGIH, 2010) was not able to confirm the association 
between occupational inhalation and urinary excretion (Document ID 
1662, p. 4). However, IARC (2012) noted that an accidental exposure of 
25 people to beryllium dust reported in a study by Zorn et al. (1986) 
resulted in a mean serum concentration of 3.5 [mu]g/L one day after the 
exposure, which decreased to 2.4 [mu]g/L by day six. The IARC report 
concluded that beryllium from beryllium metal was biologically 
available for systemic distribution from the lung (IARC, 2012, Document 
ID 0650).
    Based on these studies, OSHA finds that the respiratory tract is a 
primary pathway for beryllium exposure. While particle size and surface 
area may contribute to the toxicity of beryllium, there is not 
sufficient evidence for OSHA to regulate based on size and surface 
area. However, the Agency finds that both soluble and poorly soluble 
forms of beryllium and beryllium compounds can contribute to exposure 
via the respiratory system and therefore can be causative agents of 
sensitization and CBD.

[[Page 2488]]

2. Dermal Exposure
    Beryllium compounds have been shown to cause skin irritation and 
sensitization in humans and certain animal models (Van Ordstrand et 
al., 1945, Document ID 1383; de Nardi et al., 1953 (1545); Nishimura, 
1966 (1435); Epstein, 1991 (0526); Belman, 1969 (1562); Tinkle et al., 
2003 (1483); Delic, 1992 (1547)). The Agency for Toxic Substances and 
Disease Registry (ATSDR) estimated that less than 0.1 percent of 
beryllium compounds are absorbed through the skin (ATSDR, 2002, 
Document ID 1371). However, even minute contact and absorption across 
the skin may directly elicit an immunological response resulting in 
sensitization (Deubner et al., 2001, Document ID 1543; Toledo et al., 
2011 (0522)). Studies by Tinkle et al. (2003) showed that penetration 
of beryllium oxide particles was possible ex vivo for human intact skin 
at particle sizes of less than or equal to 1[mu]m in diameter, as 
confirmed by scanning electron microscopy (Document ID 1483). Using 
confocal microscopy, Tinkle et al. demonstrated that surrogate 
fluorescent particles up to 1 [mu]m in size could penetrate the mouse 
epidermis and dermis layers in a model designed to mimic the flexing 
and stretching of human skin in motion. Other poorly soluble particles, 
such as titanium dioxide, have been shown to penetrate normal human 
skin (Tan et al., 1996, Document ID 1391) suggesting the flexing and 
stretching motion as a plausible mechanism for dermal penetration of 
beryllium as well. As earlier summarized, poorly soluble forms of 
beryllium can be solubilized in biological fluids (e.g., sweat) making 
them available for absorption through intact skin (Sutton et al., 2003, 
Document ID 1393; Stefaniak et al., 2011 (0537) and 2014 (0517); Duling 
et al., 2012 (0539)).
    Although its precise role remains to be elucidated, there is 
evidence that dermal exposure can contribute to beryllium 
sensitization. As early as the 1940s it was recognized that dermatitis 
experienced by workers in primary beryllium production facilities was 
linked to exposures to the soluble beryllium salts. Except in cases of 
wound contamination, dermatitis was rare in workers whose exposures 
were restricted to exposure to poorly soluble beryllium-containing 
particles (Van Ordstrand et al., 1945, Document ID 1383). Further 
investigation by McCord in 1951 (Document ID 1448) indicated that 
direct skin contact with soluble beryllium compounds, but not beryllium 
hydroxide or beryllium metal, caused dermal lesions (reddened, 
elevated, or fluid-filled lesions on exposed body surfaces) in 
susceptible persons. Curtis, in 1951, demonstrated skin sensitization 
to beryllium with patch testing using soluble and poorly soluble forms 
of beryllium in beryllium-na[iuml]ve subjects. These subjects later 
developed granulomatous skin lesions with the classical delayed-type 
contact dermatitis following repeat challenge (Curtis, 1951, Document 
ID 1273). These lesions appeared after a latent period of 1-2 weeks, 
suggesting a delayed allergic reaction. The dermal reaction occurred 
more rapidly and in response to smaller amounts of beryllium in those 
individuals previously sensitized (Van Ordstrand et al., 1945, Document 
ID 1383). Contamination of cuts and scrapes with beryllium can result 
in the beryllium becoming embedded within the skin causing an 
ulcerating granuloma to develop in the skin (Epstein, 1991, Document ID 
0526). Soluble and poorly soluble beryllium-compounds that penetrate 
the skin as a result of abrasions or cuts have been shown to result in 
chronic ulcerations and skin granulomas (Van Ordstrand et al., 1945, 
Document ID 1383; Lederer and Savage, 1954 (1467)). Beryllium 
absorption through bruises and cuts has been demonstrated as well 
(Rossman et al., 1991, Document ID 1332).
    In a study by Ivannikov et al. (1982) (as cited in Deubner et al., 
2001, Document ID 0023), beryllium chloride was applied directly to 
three different types of wounded skin: abrasions (superficial skin 
trauma), cuts (skin and superficial muscle trauma), and penetration 
wounds (deep muscle trauma). According to Deubner et al. (2001) the 
percentage of the applied dose systemically absorbed during a 24-hour 
exposure was significant, ranging from 7.8 percent to 11.4 percent for 
abrasions, from 18.3 percent to 22.9 percent for cuts, and from 34 
percent to 38.8 percent for penetration wounds (Deubner et al., 2001, 
Document ID 0023).
    A study by Deubner et al. (2001) concluded that exposure across 
damaged skin can contribute as much systemic loading of beryllium as 
inhalation (Deubner et al., 2001, Document ID 1543). Deubner et al. 
(2001) estimated dermal loading (amount of particles penetrating into 
the skin) in workers as compared to inhalation exposure. Deubner's 
calculations assumed a dermal loading rate for beryllium on skin of 
0.43 [mu]g/cm\2\, based on the studies of loading on skin after workers 
cleaned up (Sanderson et al.., 1999, Document ID 0474), multiplied by a 
factor of 10 to approximate the workplace concentrations and the very 
low absorption rate of beryllium into skin of 0.001 percent (taken from 
EPA estimates). As cited by Deubner et al. (2001), the EPA noted that 
these calculations did not take into account absorption of soluble 
beryllium salts that might occur across nasal mucus membranes, which 
may result from contact between contaminated skin and the nose (Deubner 
et al., 2001, Document ID 1543).
    A study conducted by Day et al. (2007) evaluated the effectiveness 
of a dermal protection program implemented in a beryllium alloy 
facility in 2002 (Document ID 1548). The investigators evaluated levels 
of beryllium in air, on workplace surfaces, on cotton gloves worn over 
nitrile gloves, and on the necks and faces of workers over a six day 
period. The investigators found a strong correlation between air 
concentrations determined from sampling data and work surface 
contamination at this facility. The investigators also found measurable 
levels of beryllium on the skin of workers as a result of work 
processes even from workplace areas promoted as ``visually clean'' by 
the company housekeeping policy. Importantly, the investigators found 
that the beryllium contamination could be transferred from body region 
to body region (e.g., hand to face, neck to face) demonstrating the 
importance of dermal protection measures since sensitization can occur 
via dermal exposure as well as respiratory exposure. The investigators 
demonstrated multiple pathways of exposure which could lead to 
sensitization, increasing risk for developing CBD (Day et al., 2007, 
Document ID 1548).
    The same group of investigators extended their work on 
investigating multiple exposure pathways contributing to sensitization 
and CBD (Armstrong et al., 2014, Document ID 0502). The investigators 
evaluated four different beryllium manufacturing and processing 
facilities to assess the contribution of various exposure pathways on 
worker exposure. Airborne, work surface and cotton glove beryllium 
concentrations were evaluated. The investigators found strong 
correlations between air and surface concentrations; glove and surface 
concentrations; and air and glove concentrations at this facility. This 
work supports findings from Day et al. (2007) (Document ID 1548) 
demonstrating the importance of airborne beryllium concentrations to 
surface contamination and dermal exposure even at exposures below the

[[Page 2489]]

preceding OSHA PEL (Armstrong et al., 2014, Document ID 0502).
    OSHA received comments regarding the potential for dermal 
penetration of poorly soluble particles. Materion contended there is no 
supporting evidence to suggest that insoluble or poorly soluble 
particles penetrate skin and stated:

. . . we were aware that, a hypothesis has been put forth which 
suggests that being sensitized to beryllium either through a skin 
wound or via penetration of small beryllium particles through intact 
skin could result in sensitization to beryllium which upon receiving 
a subsequent inhalation dose of airborne beryllium could result in 
CBD. However, there are no studies that skin absorption of insoluble 
beryllium results in a systemic effect. The study by Curtis, the 
only human study looking for evidence of a beryllium sensitization 
reaction occurring through intact human skin, found no sensitization 
reaction using insoluble forms of beryllium. (Document ID 1661, p. 
12).

OSHA disagrees with the assertion that no studies are available 
indicating skin absorption of poorly soluble (insoluble) beryllium. In 
addition to the study cited by Materion (Curtis, 1951, Document ID 
1273), OSHA reviewed numerous studies on the effects of beryllium 
solubility and dermal penetration (see section V. B. 2) including the 
Tinkle et al. (2003) (Document ID 1483) study which demonstrated the 
potential for poorly soluble beryllium particles to penetration skin 
using an ex vivo human skin model. While OSHA believes that these 
studies demonstrate poorly soluble beryllium can in fact penetrate 
intact skin, penetration through intact skin is not the only means for 
a person to become sensitized through skin contact with poorly soluble 
beryllium. During the informal hearing proceedings, NIOSH was asked 
about the role of poorly soluble beryllium in sensitizing workers to 
beryllium. Aleks Stefaniak, Ph.D., NIOSH, stated that ``intact skin 
naturally has a barrier that prevents moisture from seeping out of the 
body and things from getting into the body. Very few people actually 
have fully intact skin, especially in an industrial environment. So the 
skin barrier is often compromised, which would make penetration of 
particles much easier.'' (Document ID 1755, Tr. 36).
    As summarized above, poorly soluble beryllium particles have been 
shown to solubilize in biological fluids (e.g., sweat) releasing 
beryllium ions and making them available for absorption through intact 
skin (Sutton et al., 2003, Document ID 1393; Stefaniak et al. 2014 
(0517); Duling et al., 2012 (0539)). Epidemiological studies evaluating 
the effectiveness of PPE in facilities working with beryllium (with 
special emphasis on skin protection) have demonstrated a reduced rate 
of beryllium sensitization after implementation of this type of control 
(Day et al., 2007, Document ID 1548; Armstrong et al., 2014 (0502)). 
Dr. Stefaniak confirmed these findings:


    [T]he particles can actually dissolve when they're in contact 
with liquids on the skin, like sweat. So we've actually done a 
series of studies, using a simulant of sweat, but it had 
characteristics that very closely matched human sweat. We see in 
those studies that, in fact, beryllium particles, beryllium oxide, 
beryllium metal, beryllium alloys, all these sort of what we call 
insoluble forms actually do in fact dissolve very readily in analog 
of human sweat. And once beryllium is in an ionic form on the skin, 
it's actually very easy for it to cross the skin barrier. And that's 
been shown many, many times in studies that beryllium ions can cross 
the skin and induce sensitization. (Document ID 1755, Tr. 36-37).

    Based on information from various studies demonstrating that poorly 
soluble particles have the potential to penetrate skin, that skin as a 
barrier is rarely intact (especially in industrial settings), and that 
beryllium particles can readily dissolve in sweat and other biological 
fluids, OSHA finds that dermal exposure to poorly soluble beryllium can 
cause sensitization (Rossman, et al., 1991, Document ID 1332; Deubner 
et al., 2001 (1542); Tinkle et al., 2003 (1483); Sutton et al., 2003 
(1393); Stefaniak et al., 2011 (0537) and 2014 (0517); Duling et al., 
2012 (0539); Document ID 1755, Tr. 36-37).
3. Oral and Gastrointestinal Exposure
    According to the WHO Report (2001), gastrointestinal absorption of 
beryllium can occur by both the inhalation and oral routes of exposure 
(Document ID 1282). In the case of inhalation, a portion of the inhaled 
material is transported to the gastrointestinal tract by the 
mucociliary escalator or by the swallowing of the poorly soluble 
material deposited in the upper respiratory tract (Schlesinger, 1997, 
Document ID 1290). Animal studies have shown oral administration of 
beryllium compounds to result in very limited absorption and storage 
(as reviewed by U.S. EPA, 1998, Document ID 0661). Oral studies 
utilizing radio-labeled beryllium chloride in rats, mice, dogs, and 
monkeys, found the majority of the beryllium was unabsorbed by the 
gastrointestinal tract and was eliminated in the feces. In most 
studies, less than 1 percent of the administered radioactivity was 
absorbed into the bloodstream and subsequently excreted in the urine 
(Crowley et al., 1949, Document ID 1551; Furchner et al., 1973 (1523); 
LeFevre and Joel, 1986 (1464)). Research using soluble beryllium 
sulfate has shown that as the compound passes into the intestine, which 
has a higher pH than the stomach (approximate pH of 6 to 8 for the 
intestine, pH of 1 or 2 for the stomach), the beryllium is precipitated 
as the poorly soluble phosphate and is not absorbed (Reeves, 1965, 
Document ID 1430; WHO, 2001 (1282)).
    Further studies suggested that beryllium absorbed into the 
bloodstream is primarily excreted via urine (Crowley et al., 1949, 
Document ID 1551; Furchner et al., 1973 (1523); Scott et al., 1950 
(1413); Stiefel et al., 1980 (1288)). Unabsorbed beryllium is primarily 
excreted via the fecal route (Finch et al., 1990, Document ID 1318; 
Hart et al., 1980 (1493)). Parenteral administration in a variety of 
animal species demonstrated that beryllium was eliminated at much 
higher percentages in the urine than in the feces (Crowley et al., 
1949, Document ID 1551; Furchner et al., 1973 (1523); Scott et al., 
1950 (1413)). A study using percutaneous administration of soluble 
beryllium nitrate in rats demonstrated that more than 90 percent of the 
beryllium in the bloodstream was eliminated via urine (WHO, 2001, 
Document ID 1282). Greater than 99 percent of ingested beryllium 
chloride was excreted in the feces (Mullen et al., 1972, Document ID 
1442). A study of mice, rats, monkeys, and dogs given intravenously 
dosed with beryllium chloride determined elimination half-times to be 
between 890 to 1,770 days (2.4 to 4.8 years) (Furchner et al., 1973, 
Document ID 1523). In a comparison study, baboons and rats were 
instilled intratracheally with beryllium metal. Mean daily excretion 
rates were calculated as 4.6 x 10-5 percent of the dose 
administered in baboons and 3.1 x 10-5 percent in rats 
(Andre et al., 1987, Document ID 0351).
    In summary, animal studies evaluating the absorption, distribution 
and excretion of beryllium compounds found that, in general, poorly 
soluble beryllium compounds were not readily absorbed in the 
gastrointestinal tract and was mostly excreted via feces (Hart et al., 
1980, Document ID 1493; Finch et al., 1990 (1318); Mullen et al., 1972 
(1442)). Soluble beryllium compounds orally administered were partially 
cleared via urine; however, some soluble forms are precipitated in the 
gastrointestinal tract due to different pH values between the intestine 
and the stomach (Reeves, 1965, Document ID 1430). Intravenous 
administration of

[[Page 2490]]

poorly soluble beryllium compounds were distributed systemically 
through the lymphatics and stored in the skeleton for potential later 
release (Furchner et al., 1973, Document ID 1523). Therefore, while 
intravenous administration can lead to uptake, OSHA does not consider 
oral and gastrointestinal exposure to be a major route for the uptake 
of beryllium because poorly soluble beryllium is not readily absorbed 
in the gastrointestinal tract.
4. Metabolism
    Beryllium and its compounds may not be metabolized or 
biotransformed, but soluble beryllium salts may be converted to less 
soluble forms in the lung (Reeves and Vorwald, 1967, Document ID 1309). 
As stated earlier, solubility is an important factor for persistence of 
beryllium in the lung. Poorly soluble phagocytized beryllium particles 
can be dissolved into an ionic form by an acidic cellular environment 
and by myeloperoxidases or macrophage phagolysomal fluids (Leonard and 
Lauwerys, 1987, Document ID 1293; Lansdown, 1995 (1469); WHO, 2001 
(1282); Stefaniak et al., 2006 (1398)). The positive charge of the 
beryllium ion could potentially make it more biologically reactive 
because it may allow the beryllium to bind to a peptide or protein and 
be presented to the T cell receptor or antigen-presenting cell 
(Fontenot, 2000, Document ID 1531).
5. Conclusion For Particle Characterization and Kinetics and Metabolism 
of Beryllium
    The forms and concentrations of beryllium across the workplace vary 
substantially based upon location, process, production and work task. 
Many factors may influence the potency of beryllium including 
concentration, composition, structure, size, solubility and surface 
area of the particle.
    Studies have demonstrated that beryllium sensitization can occur 
via the skin or inhalation from soluble or poorly soluble beryllium 
particles. Beryllium must be presented to a cell in a soluble form for 
activation of the immune system (NAS, 2008, Document ID 1355), and this 
will be discussed in more detail in the section to follow. Poorly 
soluble beryllium can be solubilized via intracellular fluid, lung 
fluid and sweat to release beryllium ions (Sutton et al., 2003, 
Document ID 1393; Stefaniak et al., 2011(0537) and 2014(0517)). For 
beryllium to persist in the lung it needs to be poorly soluble. 
However, soluble beryllium has been shown to precipitate in the lung to 
form poorly soluble beryllium (Reeves and Vorwald, 1967, Document ID 
1309).
    Some animal and epidemiological studies suggest that the form of 
beryllium may affect the rate of development of BeS and CBD. Beryllium 
in an inhalable form (either as soluble or poorly soluble particles or 
mist) can deposit in the respiratory tract and interact with immune 
cells located along the entire respiratory tract (Scheslinger, 1997, 
Document ID 1290). Interaction and presentation of beryllium (either in 
ionic or particulate form) is discussed further in Section V.D.1.
C. Acute Beryllium Diseases
    Acute beryllium disease (ABD) is a relatively rapid onset 
inflammatory reaction resulting from breathing high airborne 
concentrations of beryllium. It was first reported in workers 
extracting beryllium oxide (Van Ordstrand et al., 1943, Document ID 
1383) and later reported by Eisenbud (1948) and Aub (1949) (as cited in 
Document ID 1662, p. 2). Since the Atomic Energy Commission's adoption 
of a maximum permissible peak occupational exposure limit of 25 [mu]g/
m\3\ for beryllium beginning in 1949, cases of ABD have been much 
rarer. According to the World Health Organization (2001), ABD is 
generally associated with exposure to beryllium levels at or above 100 
[mu]g/m\3\ and may be fatal in 10 percent of cases (Document ID 1282). 
However, cases of ABD have been reported with beryllium exposures below 
100 [micro]g/m\3\ (Cummings et al., 2009, Document ID 1550). The 
Cummings et al. (2009) study examined two cases of workers exposed to 
soluble and poorly soluble beryllium below 100 [micro]g/m\3\ using data 
obtained from company records. Cummings et al. (2009) also examined the 
possibility that an immune-mediated mechanism may exist for ABD as well 
as CBD and that ABD and CBD are on a pathological continuum since some 
patients would later develop CBD after recovering from ABD (ACCP, 1965, 
Document ID 1286; Hall, 1950 (1494); Cummings et al., 2009 (1550)).
    ABD involves an inflammatory or immune-mediated reaction that may 
include the entire respiratory tract, involving the nasal passages, 
pharynx, bronchial airways and alveoli. Other tissues including skin 
and conjunctivae may be affected as well. The clinical features of ABD 
include a nonproductive cough, chest pain, cyanosis, shortness of 
breath, low-grade fever and a sharp drop in functional parameters of 
the lungs. Pathological features of ABD include edematous distension, 
round cell infiltration of the septa, proteinaceous materials, and 
desquamated alveolar cells in the lung. Monocytes, lymphocytes and 
plasma cells within the alveoli are also characteristic of the acute 
disease process (Freiman and Hardy, 1970, Document ID 1527).
    Two types of acute beryllium disease have been characterized in the 
literature: A rapid and severe course of acute fulminating pneumonitis 
generally developing within 48 to 72 hours of a massive exposure, and a 
second form that takes several days to develop from exposure to lower 
concentrations of beryllium (still above the levels set by regulatory 
and guidance agencies) (Hall, 1950, Document ID 1494; DeNardi et al., 
1953 (1545); Newman and Kreiss, 1992 (1440)). Evidence of a dose-
response relationship to the concentration of beryllium is limited 
(Eisenbud et al., 1948, Document ID 0490; Stokinger, 1950 (1484); 
Sterner and Eisenbud, 1951 (1396)). Recovery from either type of ABD is 
generally complete after a period of several weeks or months (DeNardi 
et al., 1953, Document ID 1545). However, deaths have been reported in 
more severe cases (Freiman and Hardy, 1970, Document ID 1527). 
According to the BCR, in the United States, approximately 17 percent of 
ABD patients developed CBD (BCR, 2010). The majority of ABD cases 
occurred between 1932 and 1970 (Eisenbud, 1982, Document ID 1254; 
Middleton, 1998 (1445)). ABD is extremely rare in the workplace today 
due to more stringent exposure controls implemented following 
occupational and environmental standards set in 1970-1971 (ACGIH, 1971, 
Document ID 0543; ANSI, 1970 (1303); OSHA, 1971, see 39 FR 23513; EPA, 
1973 (38 FR 8820)).
    Materion submitted post-hearing comments regarding ABD (Document ID 
1662, p. 2; Attachment A, p. 1). Materion contended that only soluble 
forms of beryllium have been demonstrated to produce ABD at exposures 
above 100 [micro]g/m\3\ because cases of ABD were only found in workers 
exposed to beryllium during beryllium extraction processes which always 
contain soluble beryllium (Document ID 1662, pp. 2, 3). Citing 
communications between Marc Kolanz (Materion) and Dr. Eisenbud, 
Materion noted that when Mr. Kolanz asked Dr. Eisenbud if he ever 
``observed an acute reaction to beryllium that did not involve the 
beryllium extraction process and exposure to soluble salts of 
beryllium,'' Dr. Eisenbud responded that ``he did not know of a case 
that was not either directly associated with

[[Page 2491]]

exposure to soluble compounds or where the work task or operation would 
have been free from exposure to soluble beryllium compounds from 
adjacent operations.'' (Document ID 1662, p. 3). OSHA acknowledges that 
workers with ABD may have been exposed to a combination of soluble and 
poorly soluble beryllium. This alone, however, cannot completely 
exclude poorly soluble beryllium as a causative or contributing agent 
of ABD. The WHO (2001) has concluded that both ABD and CBD results from 
exposure to both soluble and insoluble forms of beryllium. In addition, 
the European Commission has classified poorly soluble beryllium and 
beryllium oxide as acute toxicity categories 2 and 3 (Document ID 1669, 
p. 2).
    Additional comments from Materion regarding ABD criticized the 
study by Cummings et al. (2009), stating that it ``incompletely 
explained the source of the workers exposures, which resulted in the 
use of a misleading statement that, `None of the measured air samples 
exceeded 100 [mu]g/m\3\ and most were less than 10 [mu]g/m\3\.' '' 
(Document ID 1662, p. 3). Materion argues that the Cummings et al. 
study is not valid because workers in that study ``had been involved 
with high exposures to soluble beryllium salts caused by upsets during 
the chemical extraction of beryllium.'' (Document ID 1662, pp. 3-4). In 
response, NIOSH written testimony explained that the measurements in 
the study ``were collected in areas most likely to be sources of high 
beryllium exposures in processes, but were not personal breathing zone 
measurements in the usual sense.'' (Document ID 1725, p. 3). ``Cummings 
et al. (2009) made every effort to overestimate (rather than 
underestimate) exposure,'' including ``select[ing] the highest time 
weighted average (TWA) value from the work areas or activities 
associated with a worker's job and tenure'' and not adjusting for 
``potential protective effects of respirators, which were reportedly 
used for some tasks and during workplace events potentially associated 
with uncontrolled higher exposures.'' Even so, ``the available TWA data 
did not exceed 100 [mu]g/m\3\ even on days with evacuations.'' 
(Document ID 1725, p. 3). Furthermore, OSHA notes that, the discussion 
in Cummings et al. (2009) stated, ``we cannot rule out the possibility 
of unusually elevated airborne concentrations of beryllium that went 
unmeasured.'' (Document ID 1550, p. 5).
    In response to Materion's contention that OSHA should eliminate the 
section on ABD because this disease is no longer a concern today 
(Document ID 1661, p. 2), OSHA notes that the discussion on ABD is 
included for thoroughness in review of the health effects caused by 
exposure to beryllium. As indicated above, the Agency acknowledges that 
ABD is extremely rare, but not non-existent, in workplaces today due to 
the more stringent exposure controls implemented since OSHA's inception 
(OSHA, 1971, see 39 FR 23513).
D. Beryllium Sensitization and Chronic Beryllium Disease
    This section provides an overview of the immunology and 
pathogenesis of BeS and CBD, with particular attention to the role of 
skin sensitization, particle size, beryllium compound solubility, and 
genetic variability in individuals' susceptibility to beryllium 
sensitization and CBD.
    Chronic beryllium disease (CBD), formerly known as ``berylliosis'' 
or ``chronic berylliosis,'' is a granulomatous disorder primarily 
affecting the lungs. CBD was first described in the literature by Hardy 
and Tabershaw (1946) as a chronic granulomatous pneumonitis (Document 
ID 1516). It was proposed as early as 1951 that CBD could be a chronic 
disease resulting from sensitization to beryllium (Sterner and 
Eisenbud, 1951, Document ID 1396; Curtis, 1959 (1273); Nishimura, 1966 
(1435)). However, for a time, there remained some controversy as to 
whether CBD was a delayed-onset hypersensitivity disease or a toxicant-
induced disease (NAS, 2008, Document ID 1355). Wide acceptance of CBD 
as a hypersensitivity lung disease did not occur until bronchoscopy 
studies and bronchoalveolar lavage (BAL) studies were performed 
demonstrating that BAL cells from CBD patients responded to beryllium 
challenge (Epstein et al., 1982, Document ID 0436; Rossman et al., 1988 
(0476); Saltini et al., 1989 (1351)).
    CBD shares many clinical and histopathological features with 
pulmonary sarcoidosis, a granulomatous lung disease of unknown 
etiology. These similarities include such debilitating effects as 
airway obstruction, diminishment of physical capacity associated with 
reduced lung function, possible depression associated with decreased 
physical capacity, and decreased life expectancy. Without appropriate 
information, CBD may be difficult to distinguish from sarcoidosis. It 
is estimated that up to 6 percent of all patients diagnosed with 
sarcoidosis may actually have CBD (Fireman et al., 2003, Document ID 
1533; Rossman and Kreider, 2003 (1423)). Among patients diagnosed with 
sarcoidosis in which beryllium exposure can be confirmed, as many as 40 
percent may actually have CBD (Muller-Quernheim et al., 2005, Document 
ID 1262; Cherry et al., 2015 (0463)).
    Clinical signs and symptoms of CBD may include, but are not limited 
to, a simple cough, shortness of breath or dypsnea, fever, weight loss 
or anorexia, skin lesions, clubbing of fingers, cyanosis, night sweats, 
cor pulmonale, tachycardia, edema, chest pain and arthralgia. Changes 
or loss of pulmonary function also occur with CBD such as decrease in 
vital capacity, reduced diffusing capacity, and restrictive breathing 
patterns. The signs and symptoms of CBD constitute a continuum of 
symptoms that are progressive in nature with no clear demarcation 
between any stages in the disease (Pappas and Newman, 1993, Document ID 
1433; Rossman, 1996 (1283); NAS, 2008 (1355)). These symptoms are 
consistent with the CBD symptoms described during the public hearing by 
Dr. Kristin Cummings of NIOSH and Dr. Lisa Maier of National Jewish 
Health (Document ID 1755, Tr. 70-71; 1756, Tr. 105-107).
    Besides these listed symptoms from CBD patients, there have been 
reported cases of CBD that remained asymptomatic (Pappas and Newman, 
1993, Document ID 1433; Muller-Querheim, 2005 (1262); NAS, 2008 (1355); 
NIOSH, 2011 (0544)). Asymptomatic CBD refers to those patients that 
have physiological changes upon clinical evaluation yet exhibit no 
outward signs or symptoms (also referred to as subclinical CBD).
    Unlike ABD, CBD can result from inhalation exposure to beryllium at 
levels below the preceding OSHA PEL, can take months to years after 
initial beryllium exposure before signs and symptoms of CBD occur 
(Newman 1996, Document ID 1283, 2005 (1437) and 2007 (1335); 
Henneberger, 2001 (1313); Seidler et al., 2012 (0457); Schuler et al., 
2012 (0473)), and may continue to progress following removal from 
beryllium exposure (Newman, 2005, Document ID 1437; Sawyer et al., 2005 
(1415); Seidler et al., 2012 (0457)). Patients with CBD can progress to 
a chronic obstructive lung disorder resulting in loss of quality of 
life and the potential for decreased life expectancy (Rossman, et al., 
1996, Document ID 1425; Newman et al., 2005 (1437)). The National 
Academy of Sciences (NAS) report (2008) noted the general lack of 
published studies on progression of CBD from an early asymptomatic 
stage to functionally significant lung disease (NAS, 2008, Document ID 
1355). The report emphasized that risk factors and

[[Page 2492]]

time course for clinical disease have not been fully delineated. 
However, for people now under surveillance, clinical progression from 
sensitization and early pathological lesions (i.e., granulomatous 
inflammation) prior to onset of symptoms to symptomatic disease appears 
to be slow, although more follow-up is needed (NAS, 2008, Document ID 
1355). A study by Newman (1996) emphasized the need for prospective 
studies to determine the natural history and time course from beryllium 
sensitization and asymptomatic CBD to full-blown disease (Newman, 1996, 
Document ID 1283). Drawing from his own clinical experience, Dr. Newman 
was able to identify the sequence of events for those with symptomatic 
disease as follows: Initial determination of beryllium sensitization; 
gradual emergence of chronic inflammation of the lung; pathologic 
alterations with measurable physiologic changes (e.g., pulmonary 
function and gas exchange); progression to a more severe lung disease 
(with extrapulmonary effects such as clubbing and cor pulmonale in some 
cases); and finally death in some cases (reported between 5.8 to 38 
percent) (NAS, 2008, Document ID 1355; Newman, 1996 (1283)).
    In contrast to some occupationally related lung diseases, the early 
detection of chronic beryllium disease may be useful since treatment of 
this condition can lead not only to regression of the signs and 
symptoms, but also may prevent further progression of the disease in 
certain individuals (Marchand-Adam et al., 2008, Document ID 0370; NAS, 
2008 (1355)). The management of CBD is based on the hypothesis that 
suppression of the hypersensitivity reaction (i.e., granulomatous 
process) will prevent the development of fibrosis. However, once 
fibrosis has developed, therapy cannot reverse the damage.
    A study by Pappas and Newman (1993) observed that patients with 
known prior beryllium exposure and identified as confirmed positive for 
beryllium sensitization through the beryllium lymphocyte proliferation 
test (BeLPT) screening were evaluated for physiological changes in the 
lung. Pappas and Newman categorized the patients as being either 
``clinically identified,'' meaning they had known physiological 
abnormalities (e.g., abnormal chest radiogram, respiratory symptoms) or 
``surveillance-identified,'' meaning they had BeLPT positive results 
with no reported symptoms, to differentiate state of disease 
progression. Physiological changes were identified by three factors: 
(1) Reduced tolerance to exercise; (2) abnormal pulmonary function test 
during exercise; (3) abnormal arterial blood gases during exercise. Of 
the patients identified as ``surveillance identified,'' 52 percent had 
abnormal exercise physiologies while 87 percent of the ``clinically 
identified'' patients had abnormal physiologies (Pappas and Newman, 
1993, Document ID 1433). During the public hearing, Dr. Newman noted 
that:

. . . one of the sometimes overlooked points is that in that study . 
. . the majority of people who were found to have early stage 
disease already had physiologic impairment. So before the x-ray or 
the CAT scan could find it the BeLPT had picked it up, we had made a 
diagnosis of pathology in those people, and their lung function 
tests--their measures of gas exchange, were already abnormal. Which 
put them on our watch list for early and more frequent monitoring so 
that we could observe their worsening and then jump in with 
treatment at the earliest appropriate time. So there is advantage of 
having that early diagnosis in terms of the appropriate tracking and 
appropriate timing of treatment. (Document ID 1756, p. 112).

    OSHA was unable to find any controlled studies to determine the 
optimal treatment for CBD (see Rossman, 1996, Document ID 1425; NAS 
2008 (1355); Sood, 2009 (0456)), and none were added to the record 
during the public comment period. Management of CBD is generally 
modeled after sarcoidosis treatment. Oral corticosteroid treatment can 
be initiated in patients with evidence of disease (either by 
bronchoscopy or other diagnostic measures before progression of disease 
or after clinical signs of pulmonary deterioration occur). This 
includes treatment with other anti-inflammatory agents (NAS, 2008. 
Document ID 1355; Maier et al., 2012 (0461); Salvator et al., 2013 
(0459)) as well. It should be noted, however, that treatment with 
corticosteroids has side-effects of their own that need to be measured 
against the possibility of progression of disease (Gibson et al., 1996, 
Document ID 1521; Zaki et al., 1987 (1374)). Alternative treatments 
such as azathioprine and infliximab, while successful at treating 
symptoms of CBD, have been demonstrated to have side effects as well 
(Pallavicino et al., 2013, Document ID 0630; Freeman, 2012 (0655)).
1. Development of Beryllium Sensitization
    Sensitization to beryllium is an essential step for worker 
development of CBD. Sensitization to beryllium can result from 
inhalation exposure to beryllium (Newman et al., 2005, Document ID 
1437; NAS, 2008 (1355)), as well as from skin exposure to beryllium 
(Curtis, 1951, Document ID 1273; Newman et al., 1996 (1439); Tinkle et 
al., 2003 (1483); Rossman, et al., 1991, (1332); Deubner et al., 2001 
(1542); Tinkle et al., 2003 (1483); Sutton et al., 2003 (1393); 
Stefaniak et al., 2011 (0537) and 2014 (0517); Duling et al., 2012 
(0539); Document ID 1755, Tr. 36-37). Representative Robert C. 
``Bobby'' Scott, Ranking Member of Committee on Education and the 
Workforce, the U.S. House of Representatives, provided comments to the 
record stating that ``studies have demonstrated that beryllium 
sensitization, an indicator of immune response to beryllium, can occur 
from both soluble and poorly soluble beryllium particles.'' (Document 
ID 1672, p. 3).
    Sensitization is currently detected using the BeLPT (a laboratory 
blood test) described in section V.D.5. Although there may be no 
clinical symptoms associated with beryllium sensitization, a sensitized 
worker's immune system has been activated to react to beryllium 
exposures such that subsequent exposure to beryllium can progress to 
serious lung disease (Kreiss et al., 1996, Document ID 1477; Newman et 
al., 1996 (1439); Kreiss et al., 1997 (1360); Kelleher et al., 2001 
(1363); Rossman, 2001 (1424); Newman et al., 2005 (1437)). Since the 
pathogenesis of CBD involves a beryllium-specific, cell-mediated immune 
response, CBD cannot occur in the absence of sensitization (NAS, 2008, 
Document ID 1355). The expert peer reviewers agreed that the scientific 
evidence supported sensitization as a necessary condition and an early 
endpoint in the development of CBD (ERG, 2010, Document ID 1270, pp. 
19-21). Dr. John Balmes remarked that the ``scientific evidence 
reviewed in the [Health Effects] document supports consideration of 
beryllium sensitization as an early endpoint and as a necessary 
condition in the development of CBD.'' Dr. Patrick Breysee stated that 
``there is strong scientific consensus that sensitization is a key 
first step in the progression of CBD.'' Dr. Terry Gordon stated that 
``[a]s discussed in the draft [Health Effects] document, beryllium 
sensitization should be considered as an early endpoint in the 
development of CBD.'' Finally, Dr. Milton Rossman agreed ``that 
sensitization is necessary for someone to develop CBD and should be 
considered a condition/risk factor for the development of CBD.'' 
Various factors, including genetic susceptibility, have been shown to 
influence risk of developing sensitization and CBD (NAS 2008, Document 
ID 1355) and will be discussed later in this section.

[[Page 2493]]

    While various mechanisms or pathways may exist for beryllium 
sensitization, the most plausible mechanisms supported by the best 
available and most current science are discussed below. Sensitization 
occurs via the formation of a beryllium-protein complex (an antigen) 
that causes an immunological response. In some instances, onset of 
sensitization has been observed in individuals exposed to beryllium for 
only a few months (Kelleher et al., 2001, Document ID 1363; Henneberger 
et al., 2001 (1313)). This suggests the possibility that relatively 
brief, short-term beryllium exposures may be sufficient to trigger the 
immune hypersensitivity reaction. Several studies (Newman et al., 2001, 
Document ID 1354; Henneberger et al., 2001 (1313); Rossman, 2001 
(1424); Schuler et al., 2005 (0919); Donovan et al., 2007 (0491), 
Schuler et al., 2012 (0473)) have detected a higher prevalence of 
sensitization among workers with less than one year of employment 
compared to some cross-sectional studies which, due to lack of 
information regarding initial exposure, cannot determine time of 
sensitization (Kreiss et al., 1996, Document ID 1477; Kreiss et al., 
1997 (1360)). While only very limited evidence has described humoral 
changes in certain patients with CBD (Cianciara et al., 1980, Document 
ID 1553), clear evidence exists for an immune cell-mediated response, 
specifically the T-cell (NAS, 2008, Document ID 1355). Figure 2 
delineates the major steps required for progression from beryllium 
contact to sensitization to CBD.
[GRAPHIC] [TIFF OMITTED] TR09JA17.001

    Beryllium presentation to the immune system is believed to occur 
either by direct presentation or by antigen processing. It has been 
postulated that beryllium must be presented to the immune system in an 
ionic form for cell-mediated immune activation to occur (Kreiss et al., 
2007, Document ID 1475). Some soluble forms of beryllium are readily 
presented, since the soluble beryllium form disassociates into its 
ionic components. However, for poorly soluble forms, dissolution may 
need to occur. A study by Harmsen et al. (1986) suggested that a 
sufficient rate of dissolution of small amounts of poorly soluble 
beryllium compounds might occur in the lungs to allow persistent

[[Page 2494]]

low-level beryllium presentation to the immune system (Document ID 
1257). Stefaniak et al. (2006 and 2012) reported that poorly soluble 
beryllium particles phagocytized by macrophages were dissolved in 
phagolysomal fluid (Stefaniak et al., 2006, Document ID 1398; Stefaniak 
et al., 2012 (0469)) and that the dissolution rate stimulated by 
phagolysomal fluid was different for various forms of beryllium 
(Stefaniak et al., 2006, Document ID 1398; Duling et al., 2012 (0539)). 
Several studies have demonstrated that macrophage uptake of beryllium 
can induce aberrant apoptotic processes leading to the continued 
release of beryllium ions which will continually stimulate T-cell 
activation (Sawyer et al., 2000, Document ID 1417; Sawyer et al., 2004 
(1416); Kittle et al., 2002 (0485)). Antigen processing can be mediated 
by antigen-presenting cells (APC). These may include macrophages, 
dendritic cells, or other antigen-presenting cells, although this has 
not been well defined in most studies (NAS, 2008, Document ID 1355).
    Because of their strong positive charge, beryllium ions have the 
ability to haptenate and alter the structure of peptides occupying the 
antigen-binding cleft of major histocompatibility complex (MHC) class 
II on antigen-presenting cells (APC). The MHC class II antigen-binding 
molecule for beryllium is the human leukocyte antigen (HLA) with 
specific alleles (e.g., HLA-DP, HLA-DR, HLA-DQ) associated with the 
progression to CBD (NAS, 2008, Document ID 1355; Yucesoy and Johnson, 
2011 (0464); Petukh et al., 2014 (0397)). Several studies have also 
demonstrated that the electrostatic charge of HLA may be a factor in 
binding beryllium (Snyder et al., 2003, Document ID 0524; Bill et al., 
2005 (0499); Dai et al., 2010 (0494)). The strong positive ionic charge 
of the beryllium ion would have a strong attraction for the negatively 
charged patches of certain HLA alleles (Snyder et al., 2008, Document 
ID 0471; Dai et al., 2010 (0494); Petukh et al., 2014 (0397)). 
Alternatively, beryllium oxide has been demonstrated to bind to the MHC 
class II receptor in a neutral pH. The six carboxylates in the amino 
acid sequence of the binding pocket provide a stable bond with the Be-
O-Be molecule when the pH of the substrate is neutral (Keizer et al., 
2005, Document ID 0455). The direct binding of BeO may eliminate the 
biological requirement for antigen processing or dissolution of 
beryllium oxide to activate an immune response.
    Once the beryllium-MHC-APC complex is established, the complex 
binds to a T-cell receptor (TCR) on a na[iuml]ve T-cell which 
stimulates the proliferation and accumulation of beryllium-specific 
CD4\+\ (cluster of differentiation 4\+\) T-cells (Saltini et al., 1989, 
Document ID 1351 and 1990 (1420); Martin et al., 2011 (0483)) as 
depicted in Figure 3. Fontenot et al. (1999) demonstrated that 
diversely different variants of TCR were expressed by CD4\+\ T-cells in 
peripheral blood cells of CBD patients. However, the CD4\+\ T-cells 
from the lung were more homologous in expression of TCR variants in CBD 
patients, suggesting clonal expansion of a subset of T-cells in the 
lung (Fontenot et al., 1999, Document ID 0489). This may also indicate 
a pathogenic potential for subsets of T-cell clones expressing this 
homologous TCR (NAS, 2008, Document ID 1355). Fontenot et al. (2006) 
(Document ID 0487) reported beryllium self-presentation by HLA-DP 
expressing BAL CD4\+\ T-cells. According the NAS report, BAL T-cell 
self-presentation in the lung granuloma may result in cell death, 
leading to oligoclonality (only a few clones) of the T-cell population 
characteristic of CBD (NAS, 2008, Document ID 1355).

[[Page 2495]]

[GRAPHIC] [TIFF OMITTED] TR09JA17.002

    As CD4\+\ T-cells proliferate, clonal expansion of various subsets 
of the CD4\+\ beryllium specific T-cells occurs (Figure 3). In the 
peripheral blood, the beryllium-specific CD4\+\ T cells require co-
stimulation with a co-stimulant CD28 (cluster of differentiation 28). 
During the proliferation and differentiation process CD4\+\ T-cells 
secrete pro-inflammatory cytokines that may influence this process 
(Sawyer et al., 2004, Document ID 1416; Kimber et al., 2011 (0534)).
    In summary, OSHA concludes that sensitization is a necessary and 
early functional change in the immune system that leads to the 
development of CBD.
2. Development of CBD
    The continued presence of residual beryllium in the lung leads to a 
T-cell maturation process. A large portion of beryllium-specific CD4\+\ 
T cells were shown to cease expression of CD28 mRNA and protein, 
indicating these cells no longer required co-stimulation with the CD28 
ligand (Fontenot et al., 2003, Document ID 1529). This change in 
phenotype correlated with lung inflammation (Fontenot et al., 2003, 
Document ID 1529). While these CD4\+\ independent cells continued to 
secrete cytokines necessary for additional recruitment of inflammatory 
and immunological cells, they were less proliferative and less 
susceptible to cell death compared to the CD28 dependent cells 
(Fontenot et al., 2005, Document ID 1528; Mack et al., 2008 (1460)). 
These beryllium-specific CD4\+\ independent cells are considered to be 
mature memory effector cells (Ndejembi et al., 2006, Document ID 0479; 
Bian et al., 2005 (0500)). Repeat exposure to beryllium in the lung 
resulting in a mature population of T cell development independent of 
co-stimulation by CD28 and development of a population of T effector 
memory cells (Tem cells) may be one of the mechanisms that 
lead to the more severe reactions observed specifically in the lung 
(Fontenot et al., 2005, Document ID 1528).
    CD4\+\ T cells created in the sensitization process recognize the 
beryllium antigen, and respond by proliferating and secreting cytokines 
and inflammatory mediators, including IL-2, IFN-[gamma], and TNF-
[alpha] (Tinkle et al., 1997, Document ID 1387; Tinkle et al., 1997 
(1388); Fontenot et al., 2002 (1530)) and MIP-1[alpha] and GRO-1 (Hong-
Geller, 2006, Document ID 1511). This also results in the accumulation 
of various types of inflammatory cells including mononuclear cells 
(mostly CD4\+\ T cells) in the BAL fluid (Saltini et al., 1989, 
Document ID 1351, 1990 (1420)).
    The development of granulomatous inflammation in the lung of CBD 
patients has been associated with the accumulation of beryllium 
responsive CD4\+\ Tem cells in BAL fluid (NAS, 2008, 
Document ID 1355). The subsequent release of pro-inflammatory 
cytokines, chemokines and reactive oxygen species by these cells may 
lead to migration of additional inflammatory/immune cells and the 
development of a microenvironment that contributes to the development 
of CBD (Sawyer et al., 2005, Document ID 1415; Tinkle et al., 1996 
(0468); Hong-Geller et al., 2006 (1511); NAS, 2008 (1355)).
    The cascade of events described above results in the formation of a 
noncaseating granulomatous lesion. Release of cytokines by the 
accumulating T cells leads to the formation of granulomatous lesions 
that are characterized by an outer ring of histiocytes surrounding non-
necrotic tissue with embedded multi-nucleated giant cells (Saltini et 
al., 1989, Document ID 1351, 1990 (1420)).
    Over time, the granulomas spread and can lead to lung fibrosis and 
abnormal

[[Page 2496]]

pulmonary function, with symptoms including a persistent dry cough and 
shortness of breath (Saber and Dweik, 2000, Document ID 1421). Fatigue, 
night sweats, chest and joint pain, clubbing of fingers (due to 
impaired oxygen exchange), loss of appetite or unexplained weight loss, 
and cor pulmonale have been experienced in certain patients as the 
disease progresses (Conradi et al., 1971, Document ID 1319; ACCP, 1965 
(1286); Kriebel et al., 1988, Document ID 1292; Kriebel et al., 1988 
(1473)). While CBD primarily affects the lungs, it can also involve 
other organs such as the liver, skin, spleen, and kidneys (ATSDR, 2002, 
Document ID 1371).
    As previously mentioned, the uptake of beryllium may lead to an 
aberrant apoptotic process with rerelease of beryllium ions and 
continual stimulation of beryllium-responsive CD4\+\ cells in the lung 
(Sawyer et al., 2000, Document ID 1417; Kittle et al., 2002 (0485); 
Sawyer et al., 2004 (1416)). Several research studies suggest apoptosis 
may be one mechanism that enhances inflammatory cell recruitment, 
cytokine production and inflammation, thus creating a scenario for 
progressive granulomatous inflammation (Palmer et al., 2008, Document 
ID 0478; Rana, 2008 (0477)). Macrophages and neutrophils can 
phagocytize beryllium particles in an attempt to remove the beryllium 
from the lung (Ding, et al., 2009, Document ID 0492)). Multiple studies 
(Sawyer et al., 2004, Document ID 1416; Kittle et al., 2002 (0485)) 
using BAL cells (mostly macrophages and neutrophils) from patients with 
CBD found that in vitro stimulation with beryllium sulfate induced the 
production of TNF-[alpha] (one of many cytokines produced in response 
to beryllium), and that production of TNF-[alpha] might induce 
apoptosis in CBD and sarcoidosis patients (Bost et al., 1994, Document 
ID 1299; Dai et al., 1999 (0495)). The stimulation of CBD-derived 
macrophages by beryllium sulfate resulted in cells becoming apoptotic, 
as measured by propidium iodide. These results were confirmed in a 
mouse macrophage cell-line (p388D1) (Sawyer et al., 2000, Document ID 
1417). However, other factors, such as genetic factors and duration or 
level of exposure leading to a continued presence of beryllium in the 
lung, may influence the development of CBD and are outlined in the 
following sections V.D.3 and V.D.4.
    In summary, the persistent presence of beryllium in the lung of a 
sensitized individual creates a progressive inflammatory response that 
can culminate in the granulomatous lung disease, CBD.
3. Genetic and Other Susceptibility Factors
    Evidence from a variety of sources indicates genetic susceptibility 
may play an important role in the development of CBD in certain 
individuals, especially at levels low enough not to invoke a response 
in other individuals. Early occupational studies proposed that CBD was 
an immune reaction based on the high susceptibility of some individuals 
to become sensitized and progress to CBD and the lack of CBD in others 
who were exposed to levels several orders of magnitude higher (Sterner 
and Eisenbud, 1951, Document ID 1396). Recent studies have confirmed 
genetic susceptibility to CBD involves either, HLA variants, T-cell 
receptor clonality, tumor necrosis factor (TNF-[alpha]) polymorphisms 
and/or transforming growth factor-beta (TGF-[beta]) polymorphisms 
(Fontenot et al., 2000, Document ID 1531; Amicosante et al., 2005 
(1564); Tinkle et al., 1996 (0468); Gaede et al., 2005 (0486); Van Dyke 
et al., 2011 (1696); Silveira et al., 2012 (0472)).
    Potential sources of variation associated with genetic 
susceptibility have been investigated. Single Nucleotide Polymorphisms 
(SNPs) have been studied with regard to genetic variations associated 
with increased risk of developing CBD. SNPs are the most abundant type 
of human genetic variation. Polymorphisms in MHC class II and pro-
inflammatory genes have been shown to contribute to variations in 
immune responses contributing to the susceptibility and resistance in 
many diseases including auto-immunity, beryllium sensitization, and CBD 
(McClesky et al., 2009, as cited in Document ID 1808, p. 3). Specific 
SNPs have been evaluated as a factor in the Glu69 variant from the HLA-
DPB1 locus (Richeldi et al., 1993, Document ID 1353; Cai et al., 2000 
(0445); Saltini et al., 2001 (0448); Silviera et al., 2012 (0472); Dai 
et al., 2013 (0493)). Other SNPs lacking the Glu69 variant, such as 
HLA-DRPhe[beta]47, have also been evaluated for an association with CBD 
(Amicosante et al., 2005, Document ID 1564).
    HLA-DPB1 (one of 2 subtypes of HLA-DP) with a glutamic acid at 
amino position 69 (Glu69) has been shown to confer increased risk of 
beryllium sensitization and CBD (Richeldi et al., 1993, Document ID 
1353; Saltini et al., 2001 (0448); Amicosante et al., 2005 (1564); Van 
Dyke et al., 2011 (1696); Silveira et al., 2012 (0472)). In vitro human 
research has identified genes coding for specific protein molecules on 
the surface of the immune cells of sensitized individuals from a cohort 
of beryllium workers (McCanlies et al., 2004, Document ID 1449). The 
research identified the HLA-DPB1 (Glu69) allele that place carriers at 
greater risk of becoming sensitized to beryllium and developing CBD 
than those not carrying this allele (McCanlies et al., 2004, Document 
ID 1449). Fontenot et al. (2000) demonstrated that beryllium 
presentation by certain alleles of the class II human leukocyte 
antigen-DP (HLA-DP \3\) to CD4\+\ T cells is the mechanism underlying 
the development of CBD (Document ID 1531). Richeldi et al. (1993) 
reported a strong association between the MHC class II allele HLA-DPB 1 
and the development of CBD in beryllium-exposed workers from a Tucson, 
AZ facility (Document ID 1353). This marker was found in 32 of the 33 
workers who developed CBD, but in only 14 of 44 similarly exposed 
workers without CBD. The more common alleles of the HLA-DPB 1 
containing a variant of Glu69 are negatively charged at this site and 
could directly interact with the positively charged beryllium ion. 
Additional studies by Amicosante et al. (2005) (Document ID 1564) using 
blood lymphocytes derived from beryllium-exposed workers found a high 
frequency of this gene in those sensitized to beryllium. In a study of 
82 CBD patients (beryllium-exposed workers), Stubbs et al. (1996) 
(Document ID 1394) also found a relationship between the HLA-DP 1 
allele and beryllium sensitization. The glutamate-69 allele was present 
in 86 percent of sensitized subjects, but in only 48 percent of 
beryllium-exposed, non-sensitized subjects. Some variants of the HLA-
DPB1 allele convey higher risk of sensitization and CBD than others. 
For example, HLA-DPB1*0201 yielded an approximately 3-fold increase in 
disease outcome relative to controls; HLA-DPB1*1901 yielded an 
approximately 5-fold increase, and HLA-DPB1*1701 yielded an 
approximately 10-fold increase (Weston et al., 2005, Document ID 1345; 
Snyder et al., 2008 (0471)). Specifically, Snyder et al. (2008) found 
that variants of the Glu69 allele with the greatest negative charge may 
confer greater risk for developing CBD (Document ID 0471). The study by 
Weston et al. (2005) assigned odds ratios for specific alleles on the 
basis of previous studies discussed above (Document ID 1345). The 
researchers found a strong

[[Page 2497]]

correlation (88 percent) between the reported risk of CBD and the 
predicted surface electrostatic potential and charge of the isotypes of 
the genes. They were able to conclude that the alleles associated with 
the most negatively charged proteins carry the greatest risk of 
developing beryllium sensitization and CBD (Weston et al., 2005, 
Document ID 1345). This confirms the importance of beryllium charge as 
a key factor in its ability to induce an immune response.
---------------------------------------------------------------------------

    \3\ HLA-DP and HLA DPB1 alleles have been associated with 
genetic susceptibility for developing CBD. HLA-DP has 2 subtypes, 
HLA-DPA and HLA-DPB. HLA-DBP1 is involved with the Glu69 allele most 
associated with genetic susceptibility.
---------------------------------------------------------------------------

    In contrast, the HLA-DRB1 allele, which lacks Glu69, has also been 
shown to increase the risk of developing sensitization and CBD 
(Amicosante et al., 2005, Document ID 1564; Maier et al., 2003 (0484)). 
Bill et al. (2005) found that HLA-DR has a glutamic acid at position 71 
of the [beta] chain, functionally equivalent to the Glu69 of HLA-DP 
(Bill et al., 2005, Document ID 0499). Associations with BeS and CBD 
have also been reported with the HLA-DQ markers (Amicosante et al., 
2005, Document ID 1564; Maier et al., 2003 (0484)). Stubbs et al. also 
found a biased distribution of the MHC class II HLA-DR gene between 
sensitized and non-sensitized subjects. Neither of these markers was 
completely specific for CBD, as each study found beryllium 
sensitization or CBD among individuals without the genetic risk factor. 
While there remains uncertainty as to which of the MHC class II genes 
interact directly with the beryllium ion, antibody inhibition data 
suggest that the HLA-DR gene product may be involved in the 
presentation of beryllium to T lymphocytes (Amicosante et al., 2002, 
Document ID 1370). In addition, antibody blocking experiments revealed 
that anti-HLA-DP strongly reduced proliferation responses and cytokine 
secretion by BAL CD4 T cells (Chou et al., 2005, Document ID 0497). In 
the study by Chou (2005), anti-HLA-DR ligand antibodies mainly affected 
beryllium-induced proliferation responses with little impact on 
cytokines other than IL-2, thus implying that non-proliferating BAL CD4 
T cells may still contribute to inflammation leading to the progression 
of CBD (Chou et al., 2005, Document ID 0497).
    TNF alpha (TNF-[alpha]) polymorphisms and TGF beta (TGF-[beta]) 
polymorphisms have also been shown to confer a genetic susceptibility 
for developing CBD in certain individuals. TNF-[alpha] is a pro-
inflammatory cytokine that may be associated with a more progressive 
form of CBD (NAS, 2008). Beryllium exposure has been shown to 
upregulate transcription factors AP-1 and NF-[kappa]B (Sawyer et al., 
2007, as cited in Document ID 1355) inducing an inflammatory response 
by stimulating production of pro-inflammatory cytokines such as TNF-
[alpha] by inflammatory cells. Polymorphisms in the 308 position of the 
TNF-[alpha] gene have been demonstrated to increase production of the 
cytokine and increase severity of disease (Maier et al., 2001, Document 
ID 1456; Saltini et al., 2001 (0448); Dotti et al., 2004 (1540)). While 
a study by McCanlies et al. (2007) (Document ID 0482) of 886 beryllium 
workers (including 64 sensitized for beryllium and 92 with CBD) found 
no relationship between TNF-[alpha] polymorphism and sensitization or 
CBD, the National Academies of Sciences noted that ``discrepancies 
between past studies showing associations and the more recent studies 
may be due to misclassification, exposure differences, linkage 
disequilibrium between HLA-DRB1 and TNF-[alpha] genes, or statistical 
power.'' (NAS, 2008, Document ID 1355).
    Other genetic variations have been shown to be associated with 
increased risk of beryllium sensitization and CBD (NAS, 2008, Document 
ID 1355). These include TGF-[beta] (Gaede et al., 2005, Document ID 
0486), angiotensin-1 converting enzyme (ACE) (Newman et al., 1992, 
Document ID 1440; Maier et al., 1999 (1458)) and an enzyme involved in 
glutathione synthesis (glutamate cysteine ligase) (Bekris et al., 2006, 
as cited in Document ID 1355). McCanlies et al. (2010) evaluated the 
association between polymorphisms in a select group of interleukin 
genes (IL-1A; IL-1B, IL-1RN, IL-2, IL-9, IL-9R) due to their role in 
immune and inflammatory processes (Document ID 0481). The study 
evaluated SNPs in three groups of workers from large beryllium 
manufacturing facilities in OH and AZ. The investigators found a 
significant association between variants IL-1A-1142, IL-1A-3769 and IL-
1A-4697 and CBD but not between those variants and beryllium 
sensitization.
    In addition to the genetic factors which may contribute to the 
susceptibility and severity of disease, other factors such as smoking 
and sex may play a role in the development of CBD (NAS, 2008, Document 
ID 1355). A recent longitudinal cohort study by Mroz et al. (2009) of 
229 individuals identified with beryllium sensitization or CBD through 
workplace medical surveillance found that the prevalence of CBD among 
ever smokers was significantly lower than among never smokers (38.1 
percent versus 49.4 percent, p = 0.025). BeS subjects that never smoked 
were found to be more likely to develop CBD over the course of the 
study compared to current smokers (12.6 percent versus 6.4 percent, p = 
0.10). The authors suggested smoking may confer a protective effect 
against development of lung granulomas as has been demonstrated with 
hypersensitivity pneumonitis (Mroz et al., 2009, Document ID 1356).
4. Beryllium Sensitization and CBD in the Workforce
    Sensitization to beryllium is currently detected in the workforce 
with the beryllium lymphocyte proliferation test (BeLPT), a laboratory 
blood test developed in the 1980s, also referred to as the LTT 
(Lymphocyte Transformation Test) or BeLTT (Beryllium Lymphocyte 
Transformation Test). In this test, lymphocytes obtained from either 
bronchoalveolar lavage fluid (the BAL BeLPT) or from peripheral blood 
(the blood BeLPT) are cultured in vitro and exposed to beryllium 
sulfate to stimulate lymphocyte proliferation. The observation of 
beryllium-specific proliferation indicates beryllium sensitization. 
Hereafter, ``BeLPT'' generally refers to the blood BeLPT, which is 
typically used in screening for beryllium sensitization. This test is 
described in more detail in subsection D.5.b.
    CBD can be detected at an asymptomatic stage by a number of 
techniques including bronchoalveolar lavage and biopsy (Cordeiro et 
al., 2007, Document ID 1552; Maier, 2001 (1456)). Bronchoalveolar 
lavage is a method of ``washing'' the lungs with fluid inserted via a 
flexible fiberoptic instrument known as a bronchoscope, removing the 
fluid and analyzing the content for the inclusion of immune cells 
reactive to beryllium exposure, as described earlier in this section. 
Fiberoptic bronchoscopy can be used to detect granulomatous lung 
inflammation prior to the onset of CBD symptoms as well, and has been 
used in combination with the BeLPT to diagnose pre-symptomatic CBD in a 
number of recent screening studies of beryllium-exposed workers, which 
are discussed in the following section detailing diagnostic procedures. 
Of workers who were found to be sensitized and underwent clinical 
evaluation, 31 to 49 percent of them were diagnosed with CBD (Kreiss et 
al., 1993, Document ID 1479; Newman et al., 1996 (1283), 2005 (1437), 
2007 (1335); Mroz, 2009 (1356)), although some estimate that with 
increased surveillance that percentage could be much higher (Newman, 
2005, Document ID 1437; Mroz, 2009 (1356)). It has been estimated from 
ongoing surveillance studies of sensitized individuals with an average 
follow-up time of 4.5 years that

[[Page 2498]]

31 percent of beryllium-sensitized employees were estimated to progress 
to CBD (Newman et al., 2005, Document ID 1437). The study by Newman et 
al. (2005) was the first longitudinal study to assess the progression 
from beryllium sensitization to CBD in individuals undergoing clinical 
evaluation at National Jewish Medical and Research Center from 1988 
through 1998. Approximately 50 percent of sensitized individuals (as 
identified by BeLPT) had CBD at their initial clinical evaluation. The 
remaining 50 percent, or 76 individuals, without evidence of CBD were 
monitored at approximately two year intervals for indication of disease 
progression by pulmonary function testing, chest radiography (with 
International Labour Organization B reading), fiberoptic bronchoscopy 
with bronchoalveolar lavage, and transbronchial lung biopsy. Fifty-five 
of the 76 individuals were monitored with a range of two to five 
clinical evaluations each. The Newman et al. (2005) study found that 
CBD developed in 31 percent of individuals (17 of the 55) in a period 
ranging from 1.0 to 9.5 years (average 3.8 years). After an average of 
4.8 years (range 1.7 to 11.6 years) the remaining individuals showed no 
signs of progression to CBD. A study of nuclear weapons facility 
employees enrolled in an ongoing medical surveillance program found 
that the sensitization rate in exposed workers increased rapidly over 
the first 10 years of beryllium exposure and then more gradually in 
succeeding years. On the other hand, the rate of CBD pathology 
increased slowly over the first 15 years of exposure and then climbed 
more steeply following 15 to 30 years of beryllium exposure (Stange et 
al., 2001, Document ID 1403). The findings from these longitudinal 
studies of sensitized workers provide evidence of CBD progression over 
time from asymptomatic to symptomatic disease. One limitation for all 
these studies is lack of long-term follow-up. Newman suggested that it 
may be necessary to continue to monitor these workers in order to 
determine whether all sensitized workers will develop CBD (Newman et 
al., 2005, Document ID 1437).
    CBD has a clinical spectrum ranging from evidence of beryllium 
sensitization and granulomas in the lung with little symptomatology to 
loss of lung function and end stage disease, which may result in the 
need for lung transplantation and decreased life expectancy. 
Unfortunately, there are very few published clinical studies describing 
the full range and progression of CBD from the beginning to the end 
stages and very few of the risk factors for progression of disease have 
been delineated (NAS, 2008, Document ID 1355). OSHA requested 
additional information in the NPRM, but no additional studies were 
added during the public comment period. Clinical management of CBD is 
modeled after sarcoidosis where oral corticosteroid treatment is 
initiated in patients who have evidence of progressive lung disease, 
although progressive lung disease has not been well defined (NAS, 2008, 
Document ID 1355). In advanced cases of CBD, corticosteroids are the 
standard treatment (NAS, 2008, Document ID 1355). No comprehensive 
studies have been published measuring the overall effect of removal of 
workers from beryllium exposure on sensitization and CBD (NAS, 2008, 
Document ID 1355) although this has been suggested as part of an 
overall treatment regime for CBD (Mapel et al., 2002, as cited in 
Document ID 1850; Sood et al., 2004 (1331); Sood, 2009 (0456); Maier et 
al., 2012 (0461)). Expert testimony from Dr. Lee Newman and Dr. Lisa 
Maier agreed that while no studies exist on the efficacy of removal 
from beryllium exposure, it is medically prudent to reduce beryllium 
exposure once someone is sensitized (Document ID 1756, Tr. 142). Sood 
et al. reported that cessation of exposure can sometimes have 
beneficial effects on lung function (Sood et al., 2004, Document ID 
1331). However, this was based on anecdotal evidence from six patients 
with CBD, while this indicates a benefit of removal of patients from 
exposure, more research is needed to better determine the relationship 
between exposure duration and disease progression.
    Materion commented that sensitization should be defined as a test 
result indicating an immunological sensitivity to beryllium without 
identifiable adverse health effects or other signs of illness or 
disability. It went on to say that, for these reasons, sensitization is 
not on a pathological continuum with CBD (Document ID 1661, pp. 4-7). 
Other commenters disagreed. NIOSH addressed whether sensitization 
should be considered an adverse health effect and said the following in 
their written hearing testimony:

    Some have questioned whether BeS should be considered an adverse 
health effect. NIOSH views it as such, since it is a biological 
change in people exposed to beryllium that is associated with 
increased risk for developing CBD. BeS refers to the immune system's 
ability to recognize and react to beryllium. BeS is an antigen-
specific cell mediated immunity to beryllium, in which CD4+ T cells 
recognize a complex composed of beryllium ion, self-peptide, and 
major histocompatibility complex (MHC) Class II molecule on an 
antigen-presenting cell [Falta et al. (2013); Fontenot et al. 
(2016)]. BeS necessarily precedes CBD. Pathogenesis depends on the 
immune system's recognition of and reaction to beryllium in the 
lung, resulting in granulomatous lung disease. BeS can be detected 
with tests that assess the immune response, such as the beryllium 
lymphocyte proliferation test (BeLPT), which measures T cell 
activity in the presence of beryllium salts [Balmes et al. (2014)]. 
Furthermore, after the presence of BeS has been confirmed, periodic 
medical evaluation at 1-3 year intervals thereafter is required to 
assess whether BeS has progressed to CBD [Balmes et al. (2014)]. 
Thus, BeS is not just a test result, but an adverse health effect 
that poses risk of the irreversible lung disease CBD. (Document ID 
1725, p. 2)

    The American College of Occupational and Environmental Medicine 
(ACOEM) also commented that the term pathological ``continuum'' should 
only refer to signs and symptoms associated with CBD because some 
sensitized workers never develop CBD (Document ID 1685, p. 6). However, 
Dr. Newman, testifying on behalf of ACOEM, clarified that not all 
members of the ACOEM task force agreed:

    So I hope I'm reflecting to you the range and variety of 
outcomes relating to this. My own view is that it's on a continuum. 
I do want to reflect back that the divided opinion among people on 
the ACOEM task force was that we should call it a spectrum because 
not everybody is necessarily lock step into a continuum that goes 
from sensitization to fatality. (Document ID 1756, Tr. 133).

Lisa Maier, MD of National Jewish Health agreed with Dr. Newman 
(Document ID 1756, Tr. 133-134). Additionally, Dr. Weissman of NIOSH 
testified that sensitization is ``a biological change in people exposed 
to beryllium that is associated with increased risk for developing 
CBD'' and should be considered an adverse health effect (Document ID 
1755, Tr. 13).
    OSHA agrees that not every sensitized worker develops CBD, and that 
other factors such as extent of exposure, particulate characteristics, 
and genetic susceptibility influence the development and progression of 
disease. The mechanisms by which beryllium sensitization leads to CBD 
are described in earlier sections and are supported by numerous studies 
(Newman et al., 1996a, Document ID 1439; Newman et al., 2005 (1437); 
Saltini et al., 1989 (1351); Amicosante et al., 2005a (1564); 
Amicosante et al., 2006 (1465); Fontenot et al., 1999 (0489); Fontenot 
et al., 2005 (1528)). OSHA concludes that sensitization is an 
immunological condition that increases one's likelihood

[[Page 2499]]

of developing CBD. As such, sensitization is a necessary step along a 
continuum to clinical lung disease.
5. Human Epidemiological Studies
    This section describes the human epidemiological data supporting 
the mechanistic overview of beryllium-induced disease in workers. It 
has been divided into reviews of epidemiological studies performed 
prior to development and implementation of the BeLPT in the late 1980s 
and after wide use of the BeLPT for screening purposes. Use of the 
BeLPT has allowed investigators to screen for beryllium sensitization 
and CBD prior to the onset of clinical symptoms, providing a more 
sensitive and thorough analysis of the worker population. The 
discussion of the studies has been further divided by manufacturing 
processes that may have similar exposure profiles. Table A.1 in the 
Supplemental Information for the Beryllium Health Effects Section 
summarizes the prevalence of beryllium sensitization and CBD, range of 
exposure measurements, and other salient information from the key 
epidemiological studies (Document ID 1965).
    It has been well-established that beryllium exposure, either via 
inhalation or skin, may lead to beryllium sensitization, or, with 
inhalation exposure, may lead to the onset and progression of CBD. The 
available published epidemiological literature discussed below provides 
strong evidence of beryllium sensitization and CBD in workers exposed 
to airborne beryllium well below the preceding OSHA PEL of 2 [mu]g/
m\3\. Several studies demonstrate the prevalence of sensitization and 
CBD is related to the level of airborne exposure, including a cross-
sectional survey of employees at a beryllium ceramics plant in Tucson, 
AZ (Henneberger et al., 2001, Document ID 1313), case-control studies 
of workers at the Rocky Flats nuclear weapons facility (Viet et al., 
2000, Document ID 1344), and workers from a beryllium machining plant 
in Cullman, AL (Kelleher et al., 2001, Document ID 1363). The 
prevalence of beryllium sensitization also may be related to dermal 
exposure. An increased risk of CBD has been reported in workers with 
skin lesions, potentially increasing the uptake of beryllium (Curtis, 
1951, Document ID 1368; Johnson et al., 2001 (1505); Schuler et al., 
2005 (0919)). Three studies describe comprehensive preventive programs, 
which included expanded respiratory protection, dermal protection, and 
improved control of beryllium dust migration, that substantially 
reduced the rate of beryllium sensitization among new hires (Cummings 
et al., 2007; Thomas et al., 2009 (0590); Bailey et al., 2010 (0676); 
Schuler et al., 2012(0473)).
    Some of the epidemiological studies presented in this section 
suffer from challenges common to many published epidemiological 
studies: Limitations in study design (particularly cross-sectional); 
small sample size; lack of personal and/or short-term exposure data, 
particularly those published before the late 1990s; and incomplete 
information regarding specific chemical form and/or particle 
characterization. Challenges that are specific to beryllium 
epidemiological studies include: uncertainty regarding the contribution 
of dermal exposure; use of various BeLPT protocols; a variety of case 
definitions for determining CBD; and use of various exposure sampling/
assessment methods (e.g., daily weighted average (DWA), lapel 
sampling). Even with these limitations, the epidemiological evidence 
presented in this section clearly demonstrates that beryllium 
sensitization and CBD are continuing to occur from present-day 
exposures below OSHA's preceding PEL of 2 [mu]g/m\3\. The available 
literature also indicates that the rate of beryllium sensitization can 
be substantially lowered by reducing inhalation exposure and minimizing 
dermal contact.
a. Studies Conducted Prior to the BeLPT
    First reports of CBD came from studies performed by Hardy and 
Tabershaw (1946) (Document ID 1516). Cases were observed in industrial 
plants that were refining and manufacturing beryllium metal and 
beryllium alloys and in plants manufacturing fluorescent light bulbs 
(NAS, 2008, Document ID 1355). From the late 1940s through the 1960s, 
clusters of non-occupational CBD cases were identified around beryllium 
refineries in Ohio and Pennsylvania, and outbreaks in family members of 
beryllium factory workers were assumed to be from exposure to 
contaminated clothes (Hardy, 1980, Document ID 1514). It had been 
established that the risk of disease among beryllium workers was 
variable and generally rose with the levels of airborne concentrations 
(Machle et al., 1948, Document ID 1461). And while there was a 
relationship between air concentrations of beryllium and risk of 
developing disease both in and surrounding these plants, the disease 
rates outside the plants were higher than expected and not very 
different from the rate of CBD within the plants (Eisenbud et al., 
1949, Document ID 1284; Lieben and Metzner, 1959 (1343)). There 
remained considerable uncertainty regarding diagnosis due to lack of 
well-defined cohorts, modern diagnostic methods, or inadequate follow-
up. In fact, many patients with CBD may have been misdiagnosed with 
sarcoidosis (NAS, 2008, Document ID 1355).
    The difficulties in distinguishing lung disease caused by beryllium 
from other lung diseases led to the establishment of the BCR in 1952 to 
identify and track cases of ABD and CBD. A uniform diagnostic criterion 
was introduced in 1959 as a way to delineate CBD from sarcoidosis. 
Patient entry into the BCR required either: Documented past exposure to 
beryllium or the presence of beryllium in lung tissue as well as 
clinical evidence of beryllium disease (Hardy et al., 1967, Document ID 
1515); or any three of the six criteria listed below (Hasan and Kazemi, 
1974, Document ID 0451). Patients identified using the above criteria 
were registered and added to the BCR from 1952 through 1983 (Eisenbud 
and Lisson, 1983, Document ID 1296).
    The BCR listed the following criteria for diagnosing CBD (Eisenbud 
and Lisson, 1983, Document ID 1296):
    (1) Establishment of significant beryllium exposure based on sound 
epidemiologic history;
    (2) Objective evidence of lower respiratory tract disease and 
clinical course consistent with beryllium disease;
    (3) Chest X-ray films with radiologic evidence of interstitial 
fibronodular disease;
    (4) Evidence of restrictive or obstructive defect with diminished 
carbon monoxide diffusing capacity (DL CO) by physiologic 
studies of lung function;
    (5) Pathologic changes consistent with beryllium disease on 
examination of lung tissue; and
    (6) Presence of beryllium in lung tissue or thoracic lymph nodes.
    Prevalence of CBD in workers during the time period between the 
1940s and 1950s was estimated to be between 1-10% (Eisenbud and Lisson, 
1983, Document ID 1296). In a 1969 study, Stoeckle et al. presented 60 
case histories with a selective literature review utilizing the above 
criteria except that urinary beryllium was substituted for lung 
beryllium to demonstrate beryllium exposure. Stoeckle et al. (1969) 
were able to demonstrate corticosteroids as a successful treatment 
option in one case of confirmed CBD (Document ID 0447). This study also 
presented a 28 percent mortality rate from complications of CBD at the 
time of publication. However, even with the improved

[[Page 2500]]

methodology for determining CBD based on the BCR criteria, these 
studies suffered from lack of well-defined cohorts, modern diagnostic 
techniques or adequate follow-up.
b. Criteria for Beryllium Sensitization and CBD Case Definition 
Following the Development of the BeLPT
    The criteria for diagnosis of CBD have evolved over time as more 
advanced diagnostic technology, such as the blood BeLPT and BAL BeLPT, 
has become available. More recent diagnostic criteria have both higher 
specificity than earlier methods and higher sensitivity, identifying 
subclinical effects. Recent studies typically use the following 
criteria (Newman et al., 1989, Document ID 0196; Pappas and Newman, 
1993 (1433); Maier et al., 1999 (1458)):
    (1) History of beryllium exposure;
    (2) Histopathological evidence of non-caseating granulomas or 
mononuclear cell infiltrates in the absence of infection; and
    (3) Positive blood or BAL BeLPT (Newman et al., 1989, Document ID 
0196).
    The availability of transbronchial lung biopsy facilitates the 
evaluation of the second criterion, by making histopathological 
confirmation possible in almost all cases.
    A significant component for the identification of CBD is the 
demonstration of a confirmed abnormal BeLPT result in a blood or BAL 
sample (Newman, 1996, Document ID 1283). Since the development of the 
BeLPT in the 1980s, it has been used to screen beryllium-exposed 
workers for sensitization in a number of studies to be discussed below. 
The BeLPT is a non-invasive in vitro blood test that measures the 
beryllium antigen-specific T-cell mediated immune response and is the 
most commonly available diagnostic tool for identifying beryllium 
sensitization. The BeLPT measures the degree to which beryllium 
stimulates lymphocyte proliferation under a specific set of conditions, 
and is interpreted based upon the number of stimulation indices that 
exceed the normal value. The ``cut-off'' is based on the mean value of 
the peak stimulation index among controls plus 2 or 3 standard 
deviations. This methodology was modeled into a statistical method 
known as the ``least absolute values'' or ``statistical-biological 
positive'' method and relies on natural log modeling of the median 
stimulation index values (DOE, 2001, Document ID 0068; Frome, 2003 
(0462)). In most applications, two or more stimulation indices that 
exceed the cut-off constitute an abnormal test.
    Early versions of the BeLPT test had high variability, but the use 
of tritiated thymidine to identify proliferating cells has led to a 
more reliable test (Mroz et al., 1991, 0435; Rossman et al., 2001 
(1424)). In recent years, the peripheral blood test has been found to 
be as sensitive as the BAL assay, although larger abnormal responses 
have been observed with the BAL assay (Kreiss et al., 1993, Document ID 
1478; Pappas and Newman, 1993 (1433)). False negative results have also 
been observed with the BAL BeLPT in cigarette smokers who have marked 
excess of alveolar macrophages in lavage fluid (Kreiss et al., 1993, 
Document ID 1478). The BeLPT has also been a useful tool in animal 
studies to identify those species with a beryllium-specific immune 
response (Haley et al., 1994, Document ID 1364).
    Screenings for beryllium sensitization have been conducted using 
the BeLPT in several occupational surveys and surveillance programs, 
including nuclear weapons facilities operated by the Department of 
Energy (Viet et al., 2000, Document ID 1344; Stange et al., 2001 
(1403); DOE/HSS Report, 2006 (0664)), a beryllium ceramics plant in 
Arizona (Kreiss et al., 1996, Document ID 1477; Henneberger et al., 
2001 (1313); Cummings et al., 2007 (1369)), a beryllium production 
plant in Ohio (Kreiss et al., 1997, Document ID 1476; Kent et al., 2001 
(1112)), a beryllium machining facility in Alabama (Kelleher et al., 
2001, Document ID 1363; Madl et al., 2007 (1056)), a beryllium alloy 
plant (Schuler et al., 2005, Document ID 0473; Thomas et al., 2009 
(0590)), and another beryllium processing plant (Rosenman et al., 2005, 
Document ID 1352) in Pennsylvania. In most of these studies, 
individuals with an abnormal BeLPT result were retested and were 
identified as sensitized (i.e., confirmed positive) if the abnormal 
result was repeated.
    In order to investigate the reliability and laboratory variability 
of the BeLPT, Stange et al. (2004, Document ID 1402) studied the BeLPT 
by splitting blood samples and sending samples to two laboratories 
simultaneously for BeLPT analysis. Stange et al. found the range of 
agreement on abnormal (positive BeLPT) results was 26.2--61.8 percent 
depending upon the labs tested (Stange et al., 2004, Document ID 1402). 
Borak et al. (2006) contended that the positive predictive value (PPV) 
\4\ is not high enough to meet the criteria of a good screening tool 
(Document ID 0498). Middleton et al. (2008) used the data from the 
Stange et al. (2004) study to estimate the PPV and determined that the 
PPV of the BeLPT could be improved from 0.383 to 0.968 when an abnormal 
BeLPT result is confirmed with a second abnormal result (Middleton et 
al., 2008, Document ID 0480). In April 2006, the Agency for Toxic 
Substances and Disease Registry (ATSDR) convened an expert panel of 
seven physicians and scientists to discuss the BeLPT and to consider 
what algorithm should be used to interpret BeLPT results to establish 
beryllium sensitization (Middleton et al., 2008, Document ID 0480). The 
three criteria proposed by panel members were Criterion A (one abnormal 
BeLPT result establishes sensitization); Criterion B (one abnormal and 
one borderline result establish sensitization); and Criterion C (two 
abnormal results establish sensitization). Using the single-test 
outcome probabilities developed by Stange et al., the panel convened by 
ATSDR calculated and compared the sensitivity, specificity, and 
positive predictive values (PPVs) for each algorithm. The 
characteristics for each algorithm were as follows:
---------------------------------------------------------------------------

    \4\ PPV is the portion of patients with positive test result 
correctly diagnosed.

               Table 2--Characteristics of BeLPT Algorithms (Adapted from Middleton et al., (2008)
                             [Adapted from Middleton et al., 2008, Document ID 0480]
----------------------------------------------------------------------------------------------------------------
                                                                                    Criterion B
                                                                    Criterion A    (1 abnormal +    Criterion C
                                                                   (1 abnormal)    1 borderline)   (2 abnormal)
----------------------------------------------------------------------------------------------------------------
Sensitivity.....................................................           68.2%           65.7%           61.2%
Specificity.....................................................          98.89%          99.92%          99.98%
PPV at 1% prevalence............................................           38.3%           89.3%           96.8%
PPV at 10% prevalence...........................................           87.2%           98.9%           99.7%

[[Page 2501]]

 
False positives per 10,000......................................             111               8               2
----------------------------------------------------------------------------------------------------------------

    The Middleton et al. (2008) study demonstrated that confirmation of 
BeLPT results, whether as one abnormal and one borderline abnormal or 
as two abnormals, enhances the test's PPV and protects the persons 
tested from unnecessary and invasive medical procedures. In populations 
with a high prevalence of beryllium sensitization (i.e., 10 percent or 
more), however, a single test may be adequate to predict sensitization 
(Middleton et al., 2008, Document ID 0480).
    Still, there has been criticism regarding the reliability and 
specificity of the BeLPT as a screening tool and that the BeLPT has not 
been validated appropriately (Cher et al., 2006, as cited in Document 
ID 1678; Borak et al., 2006 (0498); Donovan et al., 2007 (0491); 
Document ID 1678, Attachment 1, p. 6). Even when a confirmational 
second test is performed, an apparent false positive can occur in 
people not occupationally exposed to beryllium (NAS, 2008, Document ID 
1355). An analysis of survey data from the general workforce and new 
employees at a beryllium manufacturer was performed to assess the 
reliability of the BeLPT (Donovan et al. 2007, Document ID 0491). 
Donovan et al. analyzed more than 10,000 test results from nearly 2400 
participants over a 12-year period. Donovan et al. found that 
approximately 2 percent of new employees had at least one positive 
BeLPT at the time of hire and 1 percent of new hires with no known 
occupational exposure were confirmed positive at the time of hire with 
two BeLPTs. However, this should not be considered unusual because 
there have been reported incidences of non-occupational and community-
based beryllium sensitization (Eisenbud et al., 1949, Document ID 1284; 
Leiben and Metzner, 1959 (1343); Newman and Kreiss, 1992 (1440); Maier 
and Rossman, 2008 (0598); NAS, 2008 (1355); Harber et al., 2014 (0415), 
Harber et al., 2014 (0421)).
    Materion objected to OSHA treating ``two or three uninterpretable 
or borderline abnormal BeLPT test results as confirmation of BeS for 
the purposes of the standard'' (Document ID 1808, p. 4). In order to 
address some criticism regarding the PPV of the BeLPT, Middleton et al. 
(2011) conducted another study to evaluate borderline results from 
BeLPT testing (Document ID 0399). Utilizing the common clinical 
algorithm with a criterion that accepted one abnormal result and one 
borderline result as establishing beryllium sensitization resulted in a 
PPV of 94.4 percent. This study also found that three borderline 
results resulted in a PPV of 91 percent. Both of these PPVs were based 
on a population prevalence of 2 percent. This study further 
demonstrates the value of borderline results in predicting beryllium 
sensitization using the BeLPT. OSHA finds that multiple, consistent 
borderline BeLPT results (as found with three borderline results) 
recognize a change in a person's immune system to beryllium exposure. 
In addition, a study by Harber et al. (2014) reexamined the algorithms 
to determine sensitization and CBD data using the BioBank data.\5\ The 
study suggested that changing the algorithm could potentially help 
distinguish sensitization from progression to CBD (Harber et al., 2014, 
Document ID 0363).
---------------------------------------------------------------------------

    \5\ BioBank is a repository of biological specimens and clinical 
data collected from beryllium-exposed Department of Energy workers 
and contractors.
---------------------------------------------------------------------------

    Materion further contended that ``[w]hile some refer to BeLPT 
testing as a `gold' standard for BeS, it is hardly `golden,' as 
numerous commentators have noted.'' (Document ID 1808, p. 4). NIOSH 
submitted testimony to OSHA comparing the use of the BeLPT for 
determining beryllium sensitization to other common medical screening 
tools such as mammography for breast cancer, tuberculin skin test for 
latent tuberculosis infection, prostate-specific antigen (PSA) for 
prostate cancer, and fecal occult blood testing for colon cancer. NIOSH 
stated that ``[a]lthough there is no gold standard test to identify 
beryllium sensitization, BeLPT has been estimated to have a sensitivity 
of 66-86% and a specificity of >99% for sensitization [Middleton et al. 
(2006)]. These values are comparable or superior to those of other 
common medical screening tests.'' (Document ID 1725, pp. 32-33). In 
addition, Dr. Maier of National Jewish Health stated during the public 
hearing that ``medical surveillance should rely on the BeLPT or a 
similar test if validated in the future, as it detects early and late 
beryllium health effects. It has been validated in many population-
based studies.'' (Document ID 1756, Tr. 103).
    Since there are currently no alternatives to the BeLPT in a 
beryllium sensitization screening program, many programs rely on a 
second test to confirm a positive result (NAS, 2008). Various expert 
organizations support the use of the BeLPT (with a second 
confirmational test) as a screening tool for beryllium sensitization 
and CBD. The American Thoracic Society (ATS), based on a systematic 
review of the literature, noted that ``the BeLPT is the cornerstone of 
medical surveillance'' (Balmes et al., 2014; Document ID 0364, pp. 1-
2). The use of the BeLPT in medical surveillance has been endorsed by 
the National Academies in their review of beryllium-related diseases 
and disease prevention programs for the U. S. Air Force (NAS, 2008, 
Document ID 1355). In 2011, NIOSH issued an alert ``Preventing 
Sensitization and Disease from Beryllium Exposure'' where the BeLPT is 
recommended as part of a medical screening and surveillance program 
(NIOSH, 2011, Document ID 0544). OSHA finds that the BeLPT is a useful 
and reliable test method that has been utilized in numerous studies and 
validated and improved through multiple studies.
    The epidemiological studies presented in this section utilized the 
BeLPT as either a surveillance tool or a screening tool for determining 
sensitization status and/or sensitization/CBD prevalence in workers for 
inclusion in the published studies. Most epidemiological studies have 
reported rates of sensitization and disease based on a single screening 
of a working population (``cross-sectional'' or ``population 
prevalence'' rates). Studies of workers in a beryllium machining plant 
and a nuclear weapons facility have included follow-up of the 
population originally screened, resulting in the detection of 
additional cases of sensitization over several years (Newman et al., 
2001, Document ID 1354; Stange et al., 2001 (1403)). Based on the 
studies above, as well as comments from NIOSH, ATS, and National Jewish 
Health, OSHA regards

[[Page 2502]]

the BeLPT as a reliable medical surveillance tool.
c. Beryllium Mining and Extraction
    Mining and extraction of beryllium usually involves the two major 
beryllium minerals, beryl (an aluminosilicate containing up to 4 
percent beryllium) and bertrandite (a beryllium silicate hydrate 
containing generally less than 1 percent beryllium) (WHO, 2001, 
Document ID 1282). The United States is the world leader in beryllium 
extraction and also leads the world in production and use of beryllium 
and its alloys (WHO, 2001, Document ID 1282). Most exposures from 
mining and extraction come in the form of beryllium ore, beryllium 
salts, beryllium hydroxide (NAS, 2008, Document ID 1355) or beryllium 
oxide (Stefaniak et al., 2008, Document ID 1397).
    Deubner et al. published a study of 75 workers employed at a 
beryllium mining and extraction facility in Delta, UT (Deubner et al., 
2001b, Document ID 1543). Of the 75 workers surveyed for sensitization 
with the BeLPT, three were identified as sensitized by an abnormal 
BeLPT result. One of those found to be sensitized was diagnosed with 
CBD. Exposures at the facility included primarily beryllium ore and 
salts. General area (GA), breathing zone (BZ), and personal lapel (LP) 
exposure samples were collected from 1970 to 1999. Jobs involving 
beryllium hydrolysis and wet-grinding activities had the highest air 
concentrations, with an annual median GA concentration ranging from 0.1 
to 0.4 [mu]g/m\3\. Median BZ concentrations were higher than either LP 
or GA concentrations. The average duration of exposure for beryllium 
sensitized workers was 21.3 years (27.7 years for the worker with CBD), 
compared to an average duration for all workers of 14.9 years. However, 
these exposures were less than either the Elmore, OH, or Tucson, AZ, 
facilities described below, which also had higher reported rates of BeS 
and CBD. A study by Stefaniak et al. (2008) demonstrated that beryllium 
was present at the mill in three forms: Mineral, poorly crystalline 
oxide, and hydroxide (Document ID 1397).
    There was no sensitization or CBD among those who worked only at 
the mine where exposure to beryllium resulted solely from working with 
bertrandite ore. The authors concluded that the results of this study 
indicated that beryllium ore and salts may pose less of a hazard than 
beryllium metal and beryllium hydroxide. These results are consistent 
with the previously discussed animal studies examining solubility and 
particle size.
d. Beryllium Metal Processing and Alloy Production
    Kreiss et al. (1997) conducted a study of workers at a beryllium 
production facility in Elmore, OH (Document ID 1360). The plant, which 
opened in 1953 and initially specialized in production of beryllium-
copper alloy, later expanded its operations to include beryllium metal, 
beryllium oxide, and beryllium-aluminum alloy production; beryllium and 
beryllium alloy machining; and beryllium ceramics production, which was 
moved to a different factory in the early 1980s. Production operations 
included a wide variety of jobs and processes, such as work in arc 
furnaces and furnace rebuilding, alloy melting and casting, beryllium 
powder processing, and work in the pebble plant. Non-production work 
included jobs in the analytical laboratory, engineering research and 
development, maintenance, laundry, production-area management, and 
office-area administration. While the publication refers to the use of 
respiratory protection in some areas, such as the pebble plant, the 
extent of its use across all jobs or time periods was not reported. Use 
of dermal PPE was not reported.
    The authors characterized exposures at the plant using industrial 
hygiene (IH) samples collected between 1980 and 1993. The exposure 
samples and the plant's formulas for estimating workers' DWA exposures 
were used, together with study participants' work histories, to 
estimate their cumulative and average beryllium exposure levels. 
Exposure concentrations reflected the high exposures found historically 
in beryllium production and processing. Short-term BZ measurements had 
a median of 1.4 [mu]g/m\3\, with 18.5 percent of samples exceeding 
OSHA's preceding permissible ceiling concentration of 5.0 [mu]g/m\3\. 
Particularly high beryllium concentrations were reported in the areas 
of beryllium powder production, laundry, alloy arc furnace 
(approximately 40 percent of DWA estimates over 2.0 [mu]g/m\3\) and 
furnace rebuild (28.6 percent of short-term BZ samples over the 
preceding OSHA permissible ceiling concentration of 5 [mu]g/m\3\). LP 
samples (n = 179), which were available from 1990 to 1992, had a median 
value of 1 [mu]g/m\3\.
    Of 655 workers employed at the time of the study, 627 underwent 
BeLPT screening. Blood samples were divided and split between two labs 
for analysis, with repeat testing for results that were abnormal or 
indeterminate. Thirty-one workers had an abnormal blood test result 
upon initial testing and at least one of two subsequent test results 
for each of those workers confirmed the worker as sensitized. These 
workers, together with 19 workers who had an initial abnormal result 
and one subsequent indeterminate result, were offered clinical 
evaluation for CBD including the BAL-BeLPT and transbronchial lung 
biopsy. Nine workers with an initial abnormal test followed by two 
subsequent normal tests were not clinically evaluated, although four 
were found to be sensitized upon retesting in 1995. Of 47 workers who 
proceeded with evaluation for CBD (3 of the 50 initial workers with 
abnormal results declined to participate), 24 workers were diagnosed 
with CBD based on evidence of granulomas on lung biopsy (20 workers) or 
on other findings consistent with CBD (4 workers) (Kreiss et al., 1997, 
Document ID 1360). After including five workers who had been diagnosed 
prior to the study, a total of 29 (4.6 percent of the 627 workers who 
underwent BeLPT screening) workers still employed at the time of the 
study were found to have CBD. In addition, the plant medical department 
identified 24 former workers diagnosed with CBD before the study.
    Kreiss et al. reported that the highest prevalence of sensitization 
and CBD occurred among workers employed in beryllium metal production, 
even though the highest airborne total mass concentrations of beryllium 
were generally among employees operating the beryllium alloy furnaces 
in a different area of the plant (Kreiss et al., 1997, Document ID 
1360). Preliminary follow-up investigations of particle size-specific 
sampling at five furnace sites within the plant determined that the 
highest respirable (i.e., particles <10 [mu]m in diameter as defined by 
the authors) and alveolar-deposited (i.e., particles <1 [mu]m in 
diameter as defined by the authors) beryllium mass and particle number 
concentrations, as collected by a general area impactor device, were 
measured at the beryllium metal production furnaces rather than the 
beryllium alloy furnaces (Kent et al., 2001, Document ID 1361; McCawley 
et al., 2001 (1357)). A statistically significant linear trend was 
reported between the above alveolar-deposited particle mass 
concentration and prevalence of CBD and sensitization in the furnace 
production areas. The authors concluded that alveolar-deposited 
particles may be a more relevant exposure metric for predicting the 
incidence of CBD or sensitization

[[Page 2503]]

than the total mass concentration of airborne beryllium.
    Bailey et al. (2010) (Document ID 0610) evaluated the effectiveness 
of a workplace preventive program in lowering incidences of 
sensitization at the beryllium metal, oxide, and alloy production plant 
studied by Kreiss et al. (1997) (Document ID 1360). The preventive 
program included use of administrative and PPE controls (e.g., improved 
training, skin protection and other PPE, half-mask or air-purified 
respirators, medical surveillance, improved housekeeping standards, 
clean uniforms) as well as engineering and administrative controls 
(e.g., migration controls, physical separation of administrative 
offices from production facilities) implemented over the course of five 
years.
    In a cross-sectional/longitudinal hybrid study, Bailey et al. 
compared rates of sensitization in pre-program workers to those hired 
after the preventive program began. Pre-program workers were surveyed 
cross-sectionally in 1993-1994, and again in 1999 using the BeLPT to 
determine sensitization and CBD prevalence rates. The 1999 cross-
sectional survey was conducted to determine if improvements in 
engineering and administrative controls were successful. However, 
results indicated no improvement in reducing rates of sensitization or 
CBD.
    An enhanced preventive program including particle migration 
control, respiratory and dermal protection, and process enclosure was 
implemented in 2000, with continuing improvements made to the program 
in 2001, 2002-2004, and 2005. Workers hired during this period were 
longitudinally surveyed for sensitization using the BeLPT. Both the 
pre-program and program survey of worker sensitization status utilized 
split-sample testing to verify positive test results using the BeLPT. 
Of the total 660 workers employed at the production plant, 258 workers 
participated from the pre-program group while 290 participated from the 
program group (206 partial program, 84 full program). Prevalence 
comparisons of the pre-program and program groups (partial and full) 
were performed by calculating prevalence ratios. A 95 percent 
confidence interval (95 percent CI) was derived using a cohort study 
method that accounted for the variance in survey techniques (cross-
sectional versus longitudinal) (Bailey et al., 2010). The sensitization 
prevalence of the pre-program group was 3.8 times higher (95 percent 
CI, 1.5-9.3) than the program group, 4.0 times higher (95 percent CI, 
1.4-11.6) than the partial program subgroup, and 3.3 times higher (95 
percent CI, 0.8-13.7) than the full program subgroup indicating that a 
comprehensive preventive program can reduce, but not eliminate, 
occurrence of sensitization among non-sensitized workers (Bailey et 
al., 2010, Document ID 0610).
    Rosenman et al. (2005) studied a group of several hundred workers 
who had been employed at a beryllium production and processing facility 
that operated in eastern Pennsylvania between 1957 and 1978 (Document 
ID 1352). Of 715 former workers located, 577 were screened for 
beryllium sensitization with the BLPT and 544 underwent chest 
radiography to identify cases of beryllium sensitization and CBD. 
Workers were reported to have exposure to beryllium dust and fume in a 
variety of chemical forms including beryl ore, beryllium metal, 
beryllium fluoride, beryllium hydroxide, and beryllium oxide.
    Rosenman et al. used the plant's DWA formulas to assess workers' 
full-shift exposure levels, based on IH data collected between 1957-
1962 and 1971-1976, to calculate exposure metrics including cumulative, 
average, and peak for each worker in the study (Document ID 1352). The 
DWA was calculated based on air monitoring that consisted of GA and 
short-term task-based BZ samples. Workers' exposures to specific 
chemical and physical forms of beryllium were assessed, including 
poorly soluble beryllium (metal and oxide), soluble beryllium (fluoride 
and hydroxide), mixed soluble and poorly soluble beryllium, beryllium 
dust (metal, hydroxide, or oxide), fume (fluoride), and mixed dust and 
fume. Use of respiratory or dermal protection by workers was not 
reported. Exposures in the plant were high overall. Representative 
task-based IH samples ranged from 0.9 [mu]g/m\3\ to 84 [mu]g/m\3\ in 
the 1960s, falling to a range of 0.5-16.7 [mu]g/m\3\ in the 1970s. A 
large number of workers' mean DWA estimates (25 percent) were above the 
preceding OSHA PEL of 2.0 [mu]g/m\3\, while most workers had mean DWA 
exposures between 0.2 and 2.0 [mu]g/m\3\ (74 percent) or below 0.02 
[mu]g/m\3\ (1 percent) (Rosenman et al., Table 11; revised erratum 
April, 2006, Document ID 1352).
    Blood samples for the BeLPT were collected from the former workers 
between 1996 and 2001 and were evaluated at a single laboratory. 
Individuals with an abnormal test result were offered repeat testing, 
and were classified as sensitized if the second test was also abnormal. 
Sixty workers with two positive BeLPTs and 50 additional workers with 
chest radiography suggestive of disease were offered clinical 
evaluation, including bronchoscopy with bronchial biopsy and BAL-BeLPT. 
Seven workers met both criteria. Only 56 (51 percent) of these workers 
proceeded with clinical evaluation, including 57 percent of those 
referred on the basis of confirmed abnormal BeLPT and 47 percent of 
those with abnormal radiographs (Document ID 1352).
    Of the 577 workers who were evaluated for CBD, 32 (5.5 percent) 
with evidence of granulomas were classified as ``definite'' CBD cases 
(as identified by bronchoscopy). Twelve (2.1 percent) additional 
workers with positive BAL-BeLPT or confirmed positive BeLPT and 
radiographic evidence of upper lobe fibrosis were classified as 
``probable'' CBD cases. Forty workers (6.9 percent) without upper lobe 
fibrosis who had confirmed abnormal BeLPT, but who were not biopsied or 
who underwent biopsy with no evidence of granuloma, were classified as 
sensitized without disease. It is not clear how many of those 40 
workers underwent biopsy. Another 12 (2.1 percent) workers with upper 
lobe fibrosis and negative or unconfirmed positive BeLPT were 
classified as ``possible'' CBD cases. Nine additional workers who were 
diagnosed with CBD before the screening were included in some parts of 
the authors' analysis (Document ID 1352).
    The authors reported a total prevalence of 14.5 percent for CBD 
(definite and probable) and sensitization. This rate, considerably 
higher than the overall prevalence of sensitization and disease in 
several other worker cohorts as described earlier in this section, 
reflects in part the very high exposures experienced by many workers 
during the plant's operation in the 1950s, 1960s and 1970s. A total of 
115 workers had mean DWAs above the preceding OSHA PEL of 2 [mu]g/m\3\. 
Of those, seven (6.0 percent) had definite or probable CBD and another 
13 (11 percent) were classified as sensitized without disease. The true 
prevalence of CBD in the group may be higher than reported, due to the 
low rate of clinical evaluation among sensitized workers (Document ID 
1352).
    Although most of the workers in this study had high exposures, 
sensitization and CBD also were observed within the small subgroup of 
participants believed to have relatively low beryllium exposures. 
Thirty-three cases of CBD and 24 additional cases of sensitization 
occurred among 339 workers with mean DWA exposures below OSHA's PEL of 
2.0 [mu]g/m\3\ (Rosenman et al., Table 11, erratum 2006, Document ID 
1352). Ten cases of sensitization and five cases of

[[Page 2504]]

CBD were found among office and clerical workers, who were believed to 
have low exposures (levels not reported).
    Follow-up time for sensitization screening of workers in this study 
who became sensitized during their employment had a minimum of 20 years 
to develop CBD prior to screening. In this sense the cohort is 
especially well suited to compare the exposure patterns of workers with 
CBD and those sensitized without disease, in contrast to several other 
studies of workers with only recent beryllium exposures. Rosenman et 
al. characterized and compared the exposures of workers with definite 
and probable CBD, sensitization only, and no disease or sensitization 
using chi-squared tests for discrete outcomes and analysis of variance 
(ANOVA) for continuous variables (cumulative, mean, and peak exposure 
levels). Exposure-response relationships were further examined with 
logistic regression analysis, adjusting for potential confounders 
including smoking, age, and beryllium exposure from outside of the 
plant. The authors found that cumulative, peak, and duration of 
exposure were significantly higher for workers with CBD than for 
sensitized workers without disease (p <0.05), suggesting that the risk 
of progressing from sensitization to CBD is related to the level or 
extent of exposure a worker experiences. The risk of developing CBD 
following sensitization appeared strongly related to exposure to poorly 
soluble forms of beryllium, which are cleared slowly from the lung and 
increase beryllium lung burden more rapidly than quickly mobilized 
soluble forms. Individuals with CBD had higher exposures to poorly 
soluble beryllium than those classified as sensitized without disease, 
while exposure to soluble beryllium was higher among sensitized 
individuals than those with CBD (Document ID 1352).
    Cumulative, mean, peak, and duration of exposure were found to be 
comparable for workers with CBD and workers without sensitization or 
CBD (``normal'' workers). Cumulative, peak, and duration of exposure 
were significantly lower for sensitized workers without disease than 
for normal workers. Rosenman et al. suggested that genetic 
predisposition to sensitization and CBD may have obscured an exposure-
response relationship in this study, and plan to control for genetic 
risk factors in future studies. Exposure misclassification from the 
1950s and 1960s may have been another limitation in this study, 
introducing bias that could have influenced the lack of exposure 
response. It is also unknown if the 25 percent who died from CBD-
related conditions may have had higher exposures (Document ID 1352).
    A follow-up was conducted of the cross-sectional study of a 
population of workers first evaluated by Kreiss et al. (1997) (Document 
ID 1360) and Rosenman et al. (2005) (Document ID 1352) by Schuler et 
al. (2012) (Document ID 0473), and in a companion study by Virji et al. 
(2012) (Document ID 0466). Schuler et al. evaluated the worker 
population employed in 1999 with six years or less work tenure in a 
cross-sectional study. The investigators evaluated the worker 
population by administering a work history questionnaire with a follow-
up examination for sensitization and CBD. A job-exposure matrix (JEM) 
was combined with work histories to create individual estimates of 
average, cumulative, and highest-job-related exposure for total, 
respirable, and sub-micron beryllium mass concentration. Of the 291 
eligible workers, 90.7 percent (264) participated in the study. 
Sensitization prevalence was 9.8 percent (26/264) with CBD prevalence 
of 2.3 percent (6/264). The investigators found a general pattern of 
increasing sensitization prevalence as the exposure quartile increased 
indicating an exposure-response relationship. The investigators found 
positive associations with both total and respirable mass concentration 
with sensitization (average and highest job) and CBD (cumulative). 
Increased sensitization prevalence was observed with metal oxide 
production alloy melting and casting, and maintenance. CBD was 
associated with melting and casting. The investigators summarized that 
both total and respirable mass concentration were relevant predictors 
of risk (Schuler et al., 2012, Document ID 0473).
    In the companion study by Virji et al. (2012), the investigators 
reconstructed historical exposure from 1994 to 1999 utilizing the 
personal sampling data collected in 1999 as baseline exposure estimates 
(BEE) (Document ID 0466). The study evaluated techniques for 
reconstructing historical data to evaluate exposure-response 
relationships for epidemiological studies. The investigators 
constructed JEMs using the BEE and estimates of annual changes in 
exposure for 25 different process areas. The investigators concluded 
these reconstructed JEMs could be used to evaluate a range of exposure 
parameters from total, respirable and submicron mass concentration 
including cumulative, average, and highest exposure.
e. Beryllium Machining Operations
    Newman et al. (2001) (Document ID 1354) and Kelleher et al. (2001) 
(Document ID 1363) studied a group of 235 workers at a beryllium metal 
machining plant. Since the plant opened in 1969, its primary operations 
have been machining and polishing beryllium metal and high-beryllium 
content composite materials, with occasional machining of beryllium 
oxide/metal matrix (`E-metal'), and beryllium alloys. Other functions 
include machining of metals other than beryllium; receipt and 
inspection of materials; acid etching; final inspection, quality 
control, and shipping of finished materials; tool making; and 
engineering, maintenance, administrative, and supervisory functions 
(Newman et al., 2001, Document ID 1354; Madl et al., 2007 (1056)). 
Machining operations, including milling, grinding, lapping, deburring, 
lathing, and electrical discharge machining (EDM) were performed in an 
open-floor plan production area. Most non-machining jobs were located 
in a separate, adjacent area; however, non-production employees had 
access to the machining area.
    Engineering and administrative controls, rather than PPE, were 
primarily used to control beryllium exposures at the plant (Madl et 
al., 2007, Document ID 1056). Based on interviews with long-standing 
employees of the plant, Kelleher et al. reported that work practices 
were relatively stable until 1994, when a worker was diagnosed with CBD 
and a new exposure control program was initiated. Between 1995 and 
1999, new engineering and work practice controls were implemented, 
including removal of pressurized air hoses and discouragement of dry 
sweeping (1995), enclosure of deburring processes (1996), mandatory 
uniforms (1997), and installation or updating of local exhaust 
ventilation (LEV) in EDM, lapping, deburring, and grinding processes 
(1998) (Madl et al., 2007, Document ID 1056). Throughout the plant's 
history, respiratory protection was used mainly for ``unusually large, 
anticipated exposures'' to beryllium (Kelleher et al., 2001, Document 
ID 1363), and was not routinely used otherwise (Newman et al., 2001, 
Document ID 1354).
    All workers at the plant participated in a beryllium disease 
surveillance program initiated in 1994, and were screened for beryllium 
sensitization with the BeLPT beginning in 1995. A BeLPT result was 
considered abnormal if two or more of six stimulation indices exceeded 
the normal range (see section

[[Page 2505]]

on BeLPT testing above), and was considered borderline if one of the 
indices exceeded the normal range. A repeat BeLPT was conducted for 
workers with abnormal or borderline initial results. Workers were 
identified as beryllium sensitized and referred for a clinical 
evaluation, including BAL and transbronchial lung biopsy, if the repeat 
test was abnormal. CBD was diagnosed upon evidence of sensitization 
with granulomas or mononuclear cell infiltrates in the lung tissue 
(Newman et al., 2001, Document ID 1354). Following the initial plant-
wide screening, plant employees were offered BeLPT testing at two-year 
intervals. Workers hired after the initial screening were offered a 
BeLPT within 3 months of their hire date, and at 2-year intervals 
thereafter (Madl et al., 2007, Document ID 1056).
    Kelleher et al. performed a nested case-control study of the 235 
workers evaluated in Newman et al. (2001) to evaluate the relationship 
between beryllium exposure levels and risk of sensitization and CBD 
(Kelleher et al., 2001, Document ID 1363). The authors evaluated 
exposures at the plant using IH samples they had collected between 1996 
and 1999, using personal cascade impactors designed to measure the mass 
of beryllium particles less than 6 [mu]m in diameter, particles less 
than 1 [mu]m in diameter, and total mass. The great majority of 
workers' exposures were below the preceding OSHA PEL of 2 [mu]g/m\3\. 
However, a few higher exposure levels were observed in machining jobs 
including deburring, lathing, lapping, and grinding. Based on a 
statistical comparison between their samples and historical data 
provided by the plant, the authors concluded that worker beryllium 
exposures across all time periods included in the study parameters 
(1981 to 1984, 1995 to 1997, and 1998 to 1999) could be approximated 
using the 1996-1999 data. They estimated workers' cumulative and 
``lifetime weighted'' (LTW) beryllium exposure based on the exposure 
samples they collected for each job in 1996-1999 and company records of 
each worker's job history.
    Twenty workers with beryllium sensitization or CBD (cases) were 
compared to 206 workers (controls) for the case-control analysis from 
the study evaluating workers originally conducted by Newman et al. Of 
the 20 workers composing the case group, thirteen workers were 
diagnosed with CBD based on lung biopsy evidence of granulomas and/or 
mononuclear cell infiltrates (11) or positive BAL results with evidence 
of lymphocytosis (2). The other seven were evaluated for CBD and found 
to be sensitized only. Nine of the remaining 215 workers first 
identified in original study (Newman et al., 2001, Document ID 1354) 
were excluded due to incomplete job history information, leaving 206 
workers in the control group.
    Kelleher et al.'s analysis included comparisons of the case and 
control groups' median exposure levels; calculation of odds ratios for 
workers in high, medium, and low exposure groups; and logistic 
regression testing of the association of sensitization or CBD with 
exposure level and other variables. Median cumulative exposures for 
total mass, particles less than 6 [mu]m in diameter, and particles less 
than 1 [mu]m in diameter were approximately three times higher among 
the cases than controls, although the relationships observed were not 
statistically significant (p values ~ 0.2). No clear difference between 
cases and controls was observed for the median LTW exposures. Odds 
ratios with sensitization and CBD as outcomes were elevated in high 
(upper third) and intermediate exposure groups relative to low (lowest 
third) exposure groups for both cumulative and LTW exposure, though the 
results were not statistically significant (p >0.1). In the logistic 
regression analysis, only machinist work history was a significant 
predictor of case status in the final model. Quantitative exposure 
measures were not significant predictors of sensitization or disease 
risk.
    Citing an 11.5 percent prevalence of beryllium sensitization or CBD 
among machinists as compared with 2.9 percent prevalence among workers 
with no machinist work history, the authors concluded that the risk of 
sensitization and CBD is increased among workers who machine beryllium. 
Although differences between cases and controls in median cumulative 
exposure did not achieve conventional thresholds for statistical 
significance, the authors noted that cumulative exposures were 
consistently higher among cases than controls for all categories of 
exposure estimates and for all particle sizes, suggesting an effect of 
cumulative exposure on risk. The levels at which workers developed CBD 
and sensitization were predominantly below OSHA's preceding PEL of 2 
[mu]g/m\3\, and no cases of sensitization or CBD were observed among 
workers with LTW exposure less than 0.02 [mu]g/m\3\. Twelve (60 
percent) of the 20 sensitized workers had LTW exposures >0.20 [mu]g/
m\3\.
    In 2007, Madl et al. published an additional study of 27 workers at 
the machining plant who were found to be sensitized or diagnosed with 
CBD between the start of medical surveillance in 1995 and 2005 (Madl et 
al., 2007, Document ID 1056). As previously described, workers were 
offered a BeLPT in the initial 1995 screening (or within 3 months of 
their hire date if hired after 1995) and at 2-year intervals after 
their first screening. Workers with two positive BeLPTs were identified 
as sensitized and offered clinical evaluation for CBD, including 
bronchoscopy with BAL and transbronchial lung biopsy. The criteria for 
CBD in this study were somewhat stricter than those used in the Newman 
et al. study, requiring evidence of granulomas on lung biopsy or 
detection of X-ray or pulmonary function changes associated with CBD, 
in combination with two positive BeLPTs or one positive BAL-BeLPT.
    Based on the history of the plant's control efforts and their 
analysis of historical IH data, Madl et al. identified three ``exposure 
control eras'': A relatively uncontrolled period from 1980-1995; a 
transitional period from 1996 to 1999; and a relatively well-controlled 
``modern'' period from 2000-2005. They found that the engineering and 
work practice controls instituted in the mid-1990s reduced workers' 
exposures substantially, with nearly a 15-fold difference in reported 
exposure levels between the pre-control and the modern period (Madl et 
al., 2007, Document ID 1056). Madl et al. estimated workers' exposures 
using LP samples collected between 1980 and 2005, including those 
collected by Kelleher et al., and work histories provided by the plant. 
As described more fully in the study, they used a variety of approaches 
to describe individual workers' exposures, including approaches 
designed to characterize the highest exposures workers were likely to 
have experienced. Their exposure-response analysis was based primarily 
on an exposure metric they derived by identifying the year and job of 
each worker's pre-diagnosis work history with the highest reported 
exposures. They used the upper 95th percentile of the LP samples 
collected in that job and year (in some cases supplemented with data 
from other years) to characterize the worker's upper-level exposures.
    Based on their estimates of workers' upper level exposures, Madl et 
al. concluded that sensitized workers or workers with CBD were likely 
to have been exposed to airborne beryllium levels greater than 0.2 
[mu]g/m\3\ as an 8-hour TWA at some point in their history of 
employment in the plant. Madl et al. also concluded that most 
sensitization and CBD cases were likely to have been exposed to levels 
greater than 0.4 [mu]g/m\3\

[[Page 2506]]

at some point in their work at the plant. Madl et al. did not 
reconstruct exposures for workers at the plant who were not sensitized 
and did not develop CBD and therefore could not determine whether non-
cases had upper-bound exposures lower than these levels. They found 
that upper-bound exposure estimates were generally higher for workers 
with CBD than for those who were sensitized but not diagnosed with CBD 
at the conclusion of the study (Madl et al., 2007, Document ID 1056). 
Because CBD is an immunological disease and beryllium sensitization has 
been shown to occur within a year of exposure for some workers, Madl et 
al. argued that their estimates of workers' short-term upper-bound 
exposures may better capture the exposure levels that led to 
sensitization and disease than estimates of long-term cumulative or 
average exposures such as the LTW exposure measure constructed by 
Kelleher et al. (Madl et al., 2007, Document ID 1056).
f. Beryllium Oxide Ceramics
    Kreiss et al. (1993) conducted a screening of current and former 
workers at a plant that manufactured beryllium ceramics from beryllium 
oxide between 1958 and 1975, and then transitioned to metalizing 
circuitry onto beryllium ceramics produced elsewhere (Document ID 
1478). Of the plant's 1,316 current and 350 retired workers, 505 
participated who had not previously been diagnosed with CBD or 
sarcoidosis, including 377 current and 128 former workers. Although 
beryllium exposure was not estimated quantitatively in this survey, the 
authors conducted a questionnaire to assess study participants' 
exposures qualitatively. Results showed that 55 percent of participants 
reported working in jobs with exposure to beryllium dust. Close to 25 
percent of participants did not know if they had exposure to beryllium, 
and just over 20 percent believed they had not been exposed.
    BeLPT tests were administered to all 505 participants in the 1989-
1990 screening period and evaluated at a single lab. Seven workers had 
confirmed abnormal BeLPT results and were identified as sensitized; 
these workers were also diagnosed with CBD based on findings of 
granulomas upon clinical evaluation. Radiograph screening led to 
clinical evaluation and diagnosis of two additional CBD cases, who were 
among three participants with initially abnormal BeLPT results that 
could not be confirmed on repeat testing. In addition, nine workers had 
been previously diagnosed with CBD, and another five were diagnosed 
shortly after the screening period, in 1991-1992.
    Eight of the 9 CBD cases identified in the screening population 
were hired before the plant stopped producing beryllium ceramics in 
1975, and were among the 216 participants who had reported having been 
near or exposed to beryllium dust. Particularly high CBD rates of 11.1 
to 15.8 percent were found among screening participants who had worked 
in process development/engineering, dry pressing, and ventilation 
maintenance jobs believed to have high or uncontrolled dust exposure. 
One case (0.6 percent) of CBD was diagnosed among the 171 study 
participants who had been hired after the plant stopped producing 
beryllium ceramics. Although this worker was hired eight years after 
the end of ceramics production, he had worked in an area later found to 
be contaminated with beryllium dust. The authors concluded that the 
study results suggested an exposure-response relationship between 
beryllium exposure and CBD, and recommended beryllium exposure control 
to reduce workers' risk of CBD.
    Kreiss et al. later published a study of workers at a second 
ceramics plant located in Tucson, AZ (Kreiss et al., 1996, Document ID 
1477), which since 1980 had produced beryllium ceramics from beryllium 
oxide powder manufactured elsewhere. IH measurements collected between 
1981 and 1992, primarily GA or short-term BZ samples and a few (<100) 
LP samples, were available from the plant. Airborne beryllium exposures 
were generally low. The majority of area samples were below the 
analytical detection limit of 0.1 [mu]g/m\3\, while LP and short-term 
BZ samples had medians of 0.3 [mu]g/m\3\. However, 3.6 percent of 
short-term BZ samples and 0.7 percent of GA samples exceeded 5.0 [mu]g/
m\3\, while LP samples ranged from 0.1 to 1.8 [mu]g/m\3\. Machining 
jobs had the highest beryllium exposure levels among job tasks, with 
short-term BZ samples significantly higher for machining jobs than for 
non-machining jobs (median 0.6 [mu]g/m\3\ vs. 0.3 [mu]g/m\3\, p = 
0.0001). The authors used DWA formulas provided by the plant to 
estimate workers' full-shift exposure levels, and to calculate 
cumulative and average beryllium exposures for each worker in the 
study. The median cumulative exposure was 591.7 mg-days/m\3\ and the 
median average exposure was 0.35 [mu]g/m\3\ as a DWA.
    One hundred thirty-six of the 139 workers employed at the plant at 
the time of the Kreiss et al. (1996) study underwent BeLPT screening 
and chest radiographs in 1992 (Document ID 1477). Blood samples were 
split between two laboratories. If one or both test results were 
abnormal, an additional sample was collected and split between the 
labs. Seven workers with an abnormal result on two draws were initially 
identified as sensitized. Those with confirmed abnormal BeLPTs or 
abnormal chest X-rays were offered clinical evaluation for CBD, 
including transbronchial lung biopsy and BAL BeLPT. CBD was diagnosed 
based on observation of granulomas on lung biopsy, in five of the six 
sensitized workers who accepted evaluation. An eighth case of 
sensitization and sixth case of CBD were diagnosed in one worker hired 
in October 1991 whose initial BeLPT was normal, but who was confirmed 
as sensitized and found to have lung granulomas less than two years 
later, after sustaining a beryllium-contaminated skin wound. The plant 
medical department reported 11 additional cases of CBD among former 
workers (Kreiss et al., 1996, Document ID 1477). The overall prevalence 
of sensitization in the plant was 5.9 percent, with a 4.4 percent 
prevalence of CBD.
    Kreiss et al. (1996) (Document ID 1477) reported that six (75 
percent) of the eight sensitized workers were exposed as machinists 
during or before the period October 1985-March 1988, when measurements 
were first available for machining jobs. The authors reported that 14.3 
percent of machinists were sensitized, compared to 1.2 percent of 
workers who had never been machinists (p <0.01). Workers' estimated 
cumulative and average beryllium exposures did not differ significantly 
for machinists and non-machinists, or for cases and non-cases. As in 
the previous study of the same ceramics plant published by Kreiss et 
al. in 1993 (Document ID 1478), one case of CBD was diagnosed in a 
worker who had never been employed in a production job. This worker was 
employed in office administration, a job with a median DWA of 0.1 
[mu]g/m\3\ (range 0.1-0.3 [mu]g/m\3\).
    In 1998, Henneberger et al. conducted a follow-up cross-sectional 
survey of 151 employees employed at the beryllium ceramics plant 
studied by Kreiss et al. (1996) (Henneberger et al., 2001, Document ID 
1313). All current plant employees were eligible for the study unless 
they had previously been diagnosed with CBD. The study tracked two sets 
of workers in presenting prevalence outcomes and exposure 
characterization. ``Short-term workers'' were those hired since the 
last plant survey in 1992. ``Long-term workers''

[[Page 2507]]

were those hired before 1992 and had a longer history of beryllium 
exposures. There were 74 short-term and 77 long-term workers in the 
survey (Henneberger et al., 2001, Document ID 1313).
    The authors estimated workers' cumulative, average, and peak 
beryllium exposures based on the plant's formulas for estimating job-
specific DWA exposures, participants' work histories, and area and 
short-term task-specific BZ samples collected from the start of full 
production at the plant in 1981 to 1998. The long-term workers, who 
were hired before the 1992 study was conducted, had generally higher 
estimated exposures (median--0.39 [mu]g/m\3\; mean--14.9 [mu]g/m\3\) 
than the short-term workers, who were hired after 1992 (median--0.28 
[mu]g/m\3\, mean--6.1 [mu]g/m\3\).
    Fifteen cases of sensitization were found in the 151 study 
participants (15/151; 9.9%), including seven among short-term (7/74; 
9.5%) and eight among long-term workers (8/77; 10.4%). There were eight 
cases of CBD (8/151; 5.3%) identified in the study. One sensitized 
short-term worker developed CBD (1/74; 1.4%). Seven of the eight 
sensitized long-term workers developed CBD (7/77; 9.1%). The other 
sensitized long-term worker declined to participate in the clinical 
evaluation.
    Henneberger et al. (2001) reported a higher prevalence of 
sensitization among long-term workers with ``high'' (greater than 
median) peak exposures compared to long-term workers with ``low'' 
exposures; however, this relationship was not statistically significant 
(Document ID 1313). No association was observed for average or 
cumulative exposures. The authors reported higher (but not 
statistically significant) prevalence of sensitization among short-term 
workers with ``high'' (greater than median) average, cumulative, and 
peak exposures compared to short-term workers with ``low'' exposures of 
each type.
    The cumulative incidence of sensitization and CBD was investigated 
in a cohort of 136 workers at the beryllium ceramics plant previously 
studied by the Kreiss and Henneberger groups (Schuler et al., 2008. 
Document ID 1291). The study cohort consisted of those who participated 
in the plant-wide BeLPT screening in 1992. Both current and former 
workers from this group were invited to participate in follow-up BeLPT 
screenings in 1998, 2000, and 2002-2003. A total of 106 of the 128 non-
sensitized individuals in 1992 participated in the 11-year follow-up. 
Sensitization was defined as a confirmed abnormal BeLPT based on the 
split blood sample-dual laboratory protocol described earlier. CBD was 
diagnosed in sensitized individuals based on pathological findings from 
transbronchial biopsy and BAL fluid analysis. The 11-year crude 
cumulative incidence of sensitization and CBD was 13 percent (14 of 
106) and 8 percent (9 of 106) respectively. The cumulative prevalence 
was about triple the point prevalences determined in the initial 1992 
cross-sectional survey. The corrected cumulative prevalences for those 
that ever worked in machining were nearly twice that for non-
machinists. The data illustrate the value of longitudinal medical 
screening over time to obtain a more accurate estimate of the 
occurrence of sensitization and CBD among an exposed working 
population.
    Following the 1998 survey, the company continued efforts to reduce 
exposures and risk of sensitization and CBD by implementing additional 
engineering, administrative, and PPE measures (Cummings et al., 2007, 
Document ID 1369). Respirator use was required in production areas 
beginning in 1999, and latex gloves were required beginning in 2000. 
The lapping area was enclosed in 2000, and enclosures were installed 
for all mechanical presses in 2001. Between 2000 and 2003, water-
resistant or water-proof garments, shoe covers, and taped gloves were 
incorporated to keep beryllium-containing fluids from wet machining 
processes off the skin. The new engineering measures did not appear to 
substantially reduce airborne beryllium levels in the plant. LP samples 
collected between 2000 and 2003 had a median of 0.18 [mu]g/m\3\ in 
production, similar to the 1994-1999 samples. However, respiratory 
protection requirements to control workers' airborne beryllium 
exposures were instituted prior to the 2000 sample collections, so 
actual exposure to the production workers may have been lower than the 
airborne beryllium levels indicate.
    To test the efficacy of the new measures instituted after 1998, in 
January 2000 the company began screening new workers for sensitization 
at the time of hire and at 3, 6, 12, 24, and 48 months of employment. 
These more stringent measures appear to have substantially reduced the 
risk of sensitization among new employees. Of 126 workers hired between 
2000 and 2004, 93 completed BeLPT testing at hire and at least one 
additional test at 3 months of employment. One case of sensitization 
was identified at 24 months of employment (1 percent of 126 workers). 
This worker had experienced a rash after an incident of dermal exposure 
to lapping fluid through a gap between his glove and uniform sleeve, 
indicating that he may have become sensitized via the skin. He was 
tested again at 48 months of employment, with an abnormal result.
    A second worker in the 2000-2004 group had two abnormal BeLPT tests 
at the time of hire, and a third had one abnormal test at hire and a 
second abnormal test at 3 months. Both had normal BeLPTs at 6 months, 
and were not tested thereafter. A fourth worker had one abnormal BeLPT 
result at the time of hire, a normal result at 3 months, an abnormal 
result at 6 months, and a normal result at 12 months. Four additional 
workers had one abnormal result during surveillance, which could not be 
confirmed upon repeat testing.
    Cummings et al. (2007) calculated two sensitization rates based on 
these screening results: (1) A rate using only the sensitized worker 
identified at 24 months, and (2) a rate including all four workers who 
had repeated abnormal results (Document ID 1369). They reported a 
sensitization incidence rate (IR) of 0.7 per 1,000 person-months to 2.7 
per 1,000 person-months for the workers hired between 2000 and 2004, 
using the sum of sensitization-free months of employment among all 93 
workers as the denominator.
    The authors also estimated an incidence rate (IR) of 5.6 per 1,000 
person-months for workers hired between 1993 and the 1998 survey. This 
estimated IR was based on one BeLPT screening, rather than BeLPTs 
conducted throughout the workers' employment. The denominator in this 
case was the total months of employment until the 1998 screening. 
Because sensitized workers may have been sensitized prior to the 
screening, the denominator may overestimate sensitization-free time in 
the legacy group, and the actual sensitization IR for legacy workers 
may be somewhat higher than 5.6 per 1,000 person-months. Based on 
comparison of the IRs, the authors concluded that the addition of 
respirator use, dermal protection, and particle migration control 
(housekeeping) improvements appeared to have reduced the risk of 
sensitization among workers at the plant, even though airborne 
beryllium levels in some areas of the plant had not changed 
significantly since the 1998 survey.
g. Copper-Beryllium Alloy Processing and Distribution
    Schuler et al. (2005) studied a group of 152 workers at a facility 
who processed copper-beryllium alloys and small quantities of nickel-
beryllium alloys and converted semi-finished alloy

[[Page 2508]]

strip and wire into finished strip, wire, and rod. Production 
activities included annealing, drawing, straightening, point and 
chamfer, rod and wire packing, die grinding, pickling, slitting, and 
degreasing. Periodically in the plant's history, it also performed salt 
baths, cadmium plating, welding and deburring. Since the late 1980s, 
rod and wire production processes have been physically segregated from 
strip metal production. Production support jobs included mechanical 
maintenance, quality assurance, shipping and receiving, inspection, and 
wastewater treatment. Administration was divided into staff primarily 
working within the plant and personnel who mostly worked in office 
areas (Schuler, et al., 2005, Document ID 0919). Workers' respirator 
use was limited, mostly to occasional tasks where high exposures were 
anticipated.
    Following the 1999 diagnosis of a worker with CBD, the company 
surveyed the workforce, offering all current employees BeLPT testing in 
2000 and offering sensitized workers clinical evaluation for CBD, 
including BAL and transbronchial biopsy. Of the facility's 185 
employees, 152 participated in the BeLPT screening. Samples were split 
between two laboratories, with additional draws and testing for 
confirmation if conflicting tests resulted in the initial draw. Ten 
participants (7 percent) had at least two abnormal BeLPT results. The 
results of nine workers who had abnormal BeLPT results from only one 
laboratory were not included because the authors believed the 
laboratory was experiencing technical problems with the test (Schuler 
et al., 2005, Document ID 0919). CBD was diagnosed in six workers (4 
percent) on evidence of pathogenic abnormalities (e.g., granulomas) or 
evidence of clinical abnormalities consistent with CBD based on 
pulmonary function testing, pulmonary exercise testing, and/or chest 
radiography. One worker diagnosed with CBD had been exposed to 
beryllium during previous work at another copper-beryllium processing 
facility.
    Schuler et al. (2005) evaluated airborne beryllium levels at the 
plant using IH samples collected between 1969 and 2000, including 4,524 
GA samples, 650 LP samples and 815 short-duration (3-5 min) high volume 
(SD-HV) BZ task-specific samples (Document ID 0919). Occupational 
exposures to airborne beryllium were generally low. Ninety-nine percent 
of all LP measurements were below the preceding OSHA PEL of 2.0 [mu]g/
m\3\ (8-hr TWA); 93 percent were below the new final OSHA PEL of 0.2 
[mu]g/m\3\ and the median value was 0.02 [mu]g/m\3\. The SD-HV BZ 
samples had a median value of 0.44 [mu]g/m\3\, with 90 percent below 
the preceding OSHA ceiling limit of 5.0 [mu]g/m\3\. The highest levels 
of beryllium exposure were found in rod and wire production, 
particularly in wire annealing and pickling, the only production job 
with a median personal sample measurement greater than 0.1 [mu]g/m\3\ 
(median 0.12 [mu]g/m\3\; range 0.01-7.8 [mu]g/m\3\) (Schuler et al., 
Table 4). These concentrations were significantly higher than the 
exposure levels in the strip metal area (median 0.02 [mu]g/m\3\, range 
0.01-0.72 [mu]g/m\3\), in production support jobs (median 0.02 [mu]g/
m\3\, range <0.01-0.33 [mu]g/m\3\), plant administration (median 0.02 
[mu]g/m\3\, range <0.01-0.11 [mu]g/m\3\), and office administration 
jobs (median 0.01 [mu]g/m\3\, range <0.01-0.06 [mu]g/m\3\).
    The authors reported that eight of the ten sensitized employees, 
including all six CBD cases, had worked in both major production areas 
during their tenure with the plant. The 7 percent prevalence (6 of 81 
workers) of CBD among employees who had ever worked in rod and wire was 
statistically significantly elevated compared with employees who had 
never worked in rod and wire (p <0.05), while the 6 percent prevalence 
(6 of 94 workers) among those who had worked in strip metal was not 
significantly elevated compared to workers who had never worked in 
strip metal (p > 0.1). Based on these results, together with the higher 
exposure levels reported for the rod and wire production area, Schuler 
et al. (2005) concluded that work in rod and wire was a key risk factor 
for CBD in this population. Schuler et al. also found a high prevalence 
(13 percent) of sensitization among workers who had been exposed to 
beryllium for less than a year at the time of the screening, a rate 
similar to that found by Henneberger et al. (2001) among beryllium 
ceramics workers exposed for one year or less (16 percent) (Henneberger 
et al., 2001, Document ID 1313). All four workers who were sensitized 
without disease had been exposed for 5 years or less; conversely, all 
six of the workers with CBD had first been exposed to beryllium at 
least five years prior to the screening (Schuler et al., 2005, Table 2, 
Document ID 0919).
    As has been seen in other studies, beryllium sensitization and CBD 
were found among workers who were typically exposed to low time-
weighted average airborne concentrations of beryllium. While jobs in 
the rod and wire area had the highest exposure levels in the plant, the 
median personal sample value was only 0.12 [mu]g/m\3\ as a DWA. 
However, workers may have occasionally been exposed to higher beryllium 
levels for short periods during specific tasks. A small fraction of 
personal samples recorded in rod and wire were above the preceding OSHA 
PEL of 2.0 [mu]g/m\3\, and half of workers with sensitization or CBD 
reported that they had experienced a ``high-exposure incident'' at some 
point in their work history (Schuler et al., 2005, Document ID 0919). 
The only group of workers with no cases of sensitization or CBD, a 
group of 26 office administration workers, was the group with the 
lowest recorded exposures (median personal sample 0.01 [mu]g/m\3\, 
range <0.01-0.06 [mu]g/m\3\).
    After the BeLPT screening was conducted in 2000, the company began 
implementing new measures to further reduce workers' exposure to 
beryllium (Thomas et al., 2009, Document ID 1061). Measures designed to 
minimize dermal contact with beryllium, including long-sleeve facility 
uniforms and polymer gloves, were instituted in production areas in 
2000. In 2001, the company installed LEV in die grinding and polishing. 
LP samples collected between June 2000 and December 2001 show reduced 
exposures plant-wide. Of 2,211 exposure samples collected, 98 percent 
were below 0.2 [mu]g/m\3\, and 59 percent below the limit of detection 
(LOD), which was either 0.02 [micro]g/m\3\ or 0.2 [micro]g/m\3\ 
depending on the method of sample analysis (Thomas et al., 2009). 
Median values below 0.03 [mu]g/m\3\ were reported for all processes 
except the wire annealing and pickling process. Samples for this 
process remained somewhat elevated, with a median of 0.1 [mu]g/m\3\. In 
January 2002, the plant enclosed the wire annealing and pickling 
process in a restricted access zone (RAZ), requiring respiratory 
protection in the RAZ and implementing stringent measures to minimize 
the potential for skin contact and beryllium transfer out of the zone. 
While exposure samples collected by the facility were sparse following 
the enclosure, they suggest exposure levels comparable to the 2000-2001 
samples in areas other than the RAZ. Within the RAZ, required use of 
powered air-purifying respirators indicates that actual respiratory 
exposure was negligible (Thomas et al., 2009, Document ID 1061).
    To test the efficacy of the new measures in preventing 
sensitization and CBD, in June 2000 the facility began an intensive 
BeLPT screening program for all new workers. The company screened 
workers at the time of hire; at intervals of 3, 6, 12, 24, and 48 
months;

[[Page 2509]]

and at 3-year intervals thereafter. Among 82 workers hired after 1999, 
three (3.7 percent) cases of sensitization were found. Two (5.4 
percent) of 37 workers hired prior to enclosure of the wire annealing 
and pickling process were found to be sensitized within 6 months of 
beginning work at the plant. One (2.2 percent) of 45 workers hired 
after the enclosure was confirmed as sensitized (Thomas et al., 2009, 
Document ID 1061).
    Thomas et al. (2009) calculated a sensitization IR of 1.9 per 1,000 
person-months for the workers hired after the exposure control program 
was initiated in 2000 (``program workers''), using the sum of 
sensitization-free months of employment among all 82 workers as the 
denominator (Thomas et al., 2009, Document ID 1061). They calculated an 
estimated IR of 3.8 per 1,000 person-months for 43 workers hired 
between 1993 and 2000 who had participated in the 2000 BeLPT screening 
(``legacy workers''). This estimated IR was based on one BeLPT 
screening, rather than BeLPTs conducted throughout the legacy workers' 
employment. The denominator in this case is the total months of 
employment until the 2000 screening. Because sensitized workers may 
have been sensitized prior to the screening, the denominator may 
overestimate sensitization-free time in the legacy group, and the 
actual sensitization IR for legacy workers may be somewhat higher than 
3.8 per 1,000 person-months. Based on comparison of the IRs and the 
prevalence rates discussed previously, the authors concluded that the 
combination of dermal protection, respiratory protection, housekeeping 
improvements and engineering controls implemented beginning in 2000 
appeared to have reduced the risk of sensitization among workers at the 
plant. However, they noted that the small size of the study population 
and the short follow-up time for the program workers suggested that 
further research is needed to confirm the program's efficacy (Thomas et 
al., 2009, Document ID 1061).
    Stanton et al. (2006) (Document ID 1070) conducted a study of 
workers in three different copper-beryllium alloy distribution centers 
in the United States. The distribution centers, consisting of one bulk 
products center established in 1963 and strip metal centers established 
in 1968 and 1972, sell products received from beryllium production and 
finishing facilities and small quantities of copper-beryllium, 
aluminum-beryllium, and nickel-beryllium alloy materials. Work at 
distribution centers does not require large-scale heat treatment or 
manipulation of material typical of beryllium processing and machining 
plants, but involves final processing steps that can generate airborne 
beryllium. Slitting, the main production activity at the two strip 
product distribution centers, generates low levels of airborne 
beryllium particles, while operations such as tensioning and welding 
used more frequently at the bulk products center can generate somewhat 
higher levels. Non-production jobs at all three centers included 
shipping and receiving, palletizing and wrapping, production-area 
administrative work, and office-area administrative work.
    Stanton et al. (2006) estimated workers' beryllium exposures using 
IH data from company records and job history information collected 
through interviews conducted by a company occupational health nurse 
(Document ID 1090). Stanton et al. evaluated airborne beryllium levels 
in various jobs based on 393 full-shift LP samples collected from 1996 
to 2004. Airborne beryllium levels at the plant were generally very 
low, with 54 percent of all samples at or below the LOD, which ranged 
from 0.02 to 0.1 [mu]g/m\3\. The authors reported a median of 0.03 
[mu]g/m\3\ and an arithmetic mean of 0.05 [mu]g/m\3\ for the 393 full-
shift LP samples, where samples below the LOD were assigned a value of 
half the applicable LOD. Median values for specific jobs ranged from 
0.01-0.07 [micro]g/m\3\ while geometric mean values for specific jobs 
ranged from 0.02-0.07 [micro]g/m\3\. All measurements were below the 
preceding OSHA PEL of 2.0 [mu]g/m\3\ and 97 percent were below the new 
final OSHA PEL of 0.2 [mu]g/m\3\. The study does not report use of 
respiratory or skin protection.
    Eighty-eight of the 100 workers (88 percent) employed at the three 
centers at the time of the study participated in screening for 
beryllium sensitization. Blood samples were collected between November 
2000 and March 2001 by the company's medical staff. Samples collected 
from employees of the strip metal centers were split and evaluated at 
two laboratories, while samples from the bulk product center workers 
were evaluated at a single laboratory. Participants were considered to 
be ``sensitized'' to beryllium if two or more BeLPT results, from two 
laboratories or from repeat testing at the same laboratory, were found 
to be abnormal. One individual was found to be sensitized and was 
offered clinical evaluation, including BAL and fiberoptic bronchoscopy. 
He was found to have lung granulomas and was diagnosed with CBD.
    The worker diagnosed with CBD had been employed at a strip metal 
distribution center from 1978 to 2000 as a shipper and receiver, 
loading and unloading trucks delivering materials from a beryllium 
production facility and to the distribution center's customers. 
Although the LP samples collected for his job between 1996 and 2000 
were generally low (n = 35, median 0.01 [micro]g/m\3\, range <0.02-0.13 
[micro]g/m\3\), it is not clear whether these samples adequately 
characterize his exposure conditions over the course of his work 
history. He reported that early in his work history, containers of 
beryllium oxide powder were transported on the trucks he entered. While 
he did not recall seeing any breaks or leaks in the beryllium oxide 
containers, some containers were known to have been punctured by 
forklifts on trailers used by the company during the period of his 
employment, and could have contaminated trucks he entered. With 22 
years of employment at the facility, this worker had begun beryllium-
related work earlier and performed it longer than about 90 percent of 
the study population (Stanton et al., 2006, Document ID 1090).
h. Nuclear Weapons Production Facilities and Cleanup of Former 
Facilities
    Primary exposure from nuclear weapons production facilities comes 
from beryllium metal and beryllium alloys. A study conducted by Kreiss 
et al. (1989) (Document ID 1480) documented sensitization and CBD among 
beryllium-exposed workers in the nuclear industry. A company medical 
department identified 58 workers with beryllium exposure among a work 
force of 500, of whom 51 (88 percent) participated in the study. 
Twenty-four workers were involved in research and development (R&D), 
while the remaining 27 were production workers. The R&D workers had a 
longer tenure with a mean time from first exposure of 21.2 years, 
compared to a mean time since first exposure of 5 years among the 
production workers. Six workers had abnormal BeLPT readings, and four 
were diagnosed with CBD. This study classified workers as sensitized 
after one abnormal BeLPT reading, so this resulted in an estimated 11.8 
percent prevalence of sensitization.
    Kreiss et al. (1993) expanded the work of Kreiss et al. (1989) 
(Document ID 1480) by performing a cross-sectional study of 895 current 
and former beryllium workers in the same nuclear weapons plant 
(Document ID 1479). Participants were placed in qualitative exposure 
groups (``no exposure,'' ``minimal exposure,'' ``intermittent

[[Page 2510]]

exposure,'' and ``consistent exposure'') based on questionnaire 
responses. Eighteen workers had abnormal BeLPT test results, with 12 
being diagnosed with CBD. Three additional sensitized workers (those 
with abnormal BeLPT results) developed CBD over the next 2 years. 
Sensitization occurred in all of the qualitatively defined exposure 
groups. Individuals who had worked as machinists were statistically 
overrepresented among beryllium-sensitized cases, compared with non-
cases. Cases were more likely than non-cases to report having had a 
measured overexposure to beryllium (p = 0.009), a factor which proved 
to be a significant predictor of sensitization in logistic regression 
analyses, as was exposure to beryllium prior to 1970. Beryllium 
sensitized cases were also significantly more likely to report having 
had cuts that were delayed in healing (p = 0.02). The authors concluded 
that both individual susceptibility to sensitization and exposure 
circumstance affect the development of beryllium sensitization and CBD.
    In 1991, the Beryllium Health Surveillance Program (BHSP) was 
established at the Rocky Flats Nuclear Weapons Facility to offer BeLPT 
screening to current and former employees who may have been exposed to 
beryllium (Stange et al., 1996, Document ID 0206). Participants 
received an initial BeLPT and follow-ups at one and three years. Based 
on histologic evidence of pulmonary granulomas and a positive BAL-
BeLPT, Stange et al. published a study of 4,397 BHSP participants 
tested from June 1991 to March 1995, including current employees (42.8 
percent) and former employees (57.2 percent). Twenty-nine cases of CBD 
and 76 cases of sensitization were identified. The sensitization rate 
for the population was 2.43 percent. Available exposure data included 
fixed airhead exposure samples collected between 1970 and 1988 (mean 
concentration 0.016 [micro]g/m\3\) and personal samples collected 
between 1984 and 1987 (mean concentration 1.04 [micro]g/m\3\). Cases of 
CBD and sensitization were noted in individuals in all jobs 
classifications, including those believed to involve minimal exposure 
to beryllium. The authors recommended ongoing surveillance for workers 
in all jobs with potential for beryllium exposure.
    Stange et al. (2001) extended the previous study, evaluating 5,173 
participants in the Rocky Flats BHSP who were tested between June 1991 
and December 1997 (Document ID 1403). Three-year serial testing was 
offered to employees who had not been tested for three years or more 
and did not show beryllium sensitization during the previous study. 
This resulted in 2,891 employees being tested. Of the 5,173 workers 
participating in the study, 172 were found to have abnormal BeLPT test 
results. Ninety-eight (3.33 percent) of the workers were found to be 
sensitized (confirmed abnormal BeLPT results) in the initial screening, 
conducted in 1991. Of these workers 74 were diagnosed with CBD, based 
on a history of beryllium exposure, evidence of non-caseating 
granulomas or mononuclear cell infiltrates on lung biopsy, and a 
positive BeLPT or BAL-BeLPT. A follow-up survey of 2,891 workers three 
years later identified an additional 56 sensitized workers and an 
additional seven cases of CBD. Sensitization and CBD rates were 
analyzed with respect to gender, building work locations, and length of 
employment. Historical employee data included hire date, termination 
date, leave of absences, and job title changes. Exposure to beryllium 
was determined by job categories and building or work area codes. In 
order to determine beryllium exposure for all participants in the 
study, personal beryllium air monitoring results were used, when 
available, from employees with the same job title or similar job. 
However, no quantitative exposure information was presented in the 
study. The authors conclude that for some individuals, exposure to 
beryllium at levels below the preceding OSHA PEL appears to cause 
sensitization and CBD.
    Viet et al. (2000) conducted a case-control study of the Rocky 
Flats worker population studied by Stange et al. (1996 and 2001, 
Document ID 0206 and 1403) to examine the relationship between 
estimated beryllium exposure level and risk of sensitization or CBD. 
The worker population included 74 beryllium-sensitized workers and 50 
workers diagnosed with CBD. Beryllium exposure levels were estimated 
based on fixed airhead samples from Building 444, the beryllium machine 
shop, where machine operators were considered to have the highest 
exposures at the Rocky Flats facility. These fixed air samples were 
collected away from the breathing zone of the machine operator and 
likely underestimated exposure. To estimate levels in other locations, 
these air sample concentrations were used to construct a job exposure 
matrix that included the determination of the Building 444 exposure 
estimates for a 30-year period; each subject's work history by job 
location, task, and time period; and assignment of exposure estimates 
to each combination of job location, task, and time period as compared 
to Building 444 machinists. The authors adjusted the levels observed in 
the machine shop by factors based on interviews with former workers. 
Workers' estimated mean exposure concentrations ranged from 0.083 
[micro]g/m\3\ to 0.622 [micro]g/m\3\. Estimated maximum air 
concentrations ranged from 0.54 [micro]g/m\3\ to 36.8 [micro]g/m\3\. 
Cases were matched to controls of the same age, race, gender, and 
smoking status (Viet et al., 2000, Document ID 1344).
    Estimated mean and cumulative exposure levels and duration of 
employment were found to be significantly higher for CBD cases than for 
controls. Estimated mean exposure levels were significantly higher for 
sensitization cases than for controls but no significant difference was 
observed for estimated cumulative exposure or duration of exposure. 
Similar results were found using logistic regression analysis, which 
identified statistically significant relationships between CBD and both 
cumulative and mean estimated exposure, but did not find significant 
relationships between estimated exposure levels and sensitization 
without CBD. Comparing CBD with sensitization cases, Viet et al. found 
that workers with CBD had significantly higher estimated cumulative and 
mean beryllium exposure levels than workers who were sensitized but did 
not have CBD.
    Johnson et al. (2001) conducted a review of personal sampling 
records and medical surveillance reports at an atomic weapons 
establishment in Cardiff, United Kingdom (Document ID 1505). The study 
evaluated airborne samples collected over the 36-year period of 
operation for the plant. Data included 367,757 area samples and 217,681 
personal lapel samples from 194 workers from 1981-1997. The authors 
estimated that over the 17 years of measurement data analyzed, airborne 
beryllium concentrations did exceed 2.0 [micro]g/m\3\, but due to the 
limitations with regard to collection times, it is difficult to assess 
the full reliability of this estimate. The authors noted that in the 
entire plant's history, only one case of CBD had been diagnosed. It was 
also noted that BeLPT had not been routinely conducted among any of the 
workers at this facility.
    Arjomandi et al. (2010) (Document ID 1275) conducted a cross-
sectional study of workers at a nuclear weapons research and 
development (R&D) facility to determine the risk of developing CBD in 
sensitized workers at facilities with exposures much lower than 
production plants (Document ID 1275). Of the 1,875 current or former 
workers at the R&D facility, 59 were determined to be

[[Page 2511]]

sensitized based on at least two positive BeLPTs (i.e., samples drawn 
on two separate occasions or on split samples tested in two separate 
DOE-approved laboratories) for a sensitization rate of 3.1 percent. 
Workers found to have positive BeLPTs were further evaluated in an 
Occupational Medicine Clinic between 1999 and 2005. Arjomandi et al. 
(2010) evaluated 50 of the sensitized workers who also had medical and 
occupational histories, physical examination, chest imaging with high-
resolution computed tomography (HRCT) (N = 49), and pulmonary function 
testing (nine of the 59 workers refused physical examinations so were 
not included in this study). Forty of the 50 workers chosen for this 
study underwent bronchoscopy for bronchoalveolar lavage and 
transbronchial biopsies in additional to the other testing. Five of the 
49 workers had CBD at the time of evaluation (based on histology or 
high-resolution computed tomography); three others had evidence of 
probable CBD; however, none of these cases were classified as severe at 
the time of evaluation. The rate of CBD at the time of study among 
sensitized individuals was 12.5 percent (5/40) for those using 
pathologic review of lung tissue, and 10.2 percent (5/49) for those 
using HRCT as a criteria for diagnosis. The rate of CBD among the 
entire population (5/1875) was 0.3 percent.
    The mean duration of employment at the facility was 18 years, and 
the mean latency period (from first possible exposure) to time of 
evaluation and diagnosis was 32 years. There was no available exposure 
monitoring in the breathing zone of workers at the facility, but the 
authors believed beryllium levels were relatively low (possibly less 
than 0.1 [mu]g/m\3\ for most jobs). There was not an apparent exposure-
response relationship for sensitization or CBD. The sensitization 
prevalence was similar across exposure categories and the CBD 
prevalence higher among workers with the lower-exposure jobs. The 
authors concluded that these sensitized workers, who were subjected to 
an extended duration of low potential beryllium exposures over a long 
latency period, had a low prevalence of CBD (Arjomandi et al., 2010, 
Document ID 1275).
i. Aluminum Smelting
    Bauxite ore, the primary source of aluminum, contains naturally 
occurring beryllium. Worker exposure to beryllium can occur at aluminum 
smelting facilities where aluminum extraction occurs via electrolytic 
reduction of aluminum oxide into aluminum metal. Characterization of 
beryllium exposures and sensitization prevalence rates were examined by 
Taiwo et al. (2010) in a study of nine aluminum smelting facilities 
from four different companies in the U.S., Canada, Italy, and Norway 
(Document ID 0621).
    Of the 3,185 workers determined to be potentially exposed to 
beryllium, 1,932 (60 percent) agreed to participate in a medical 
surveillance program between 2000 and 2006. The medical surveillance 
program included BeLPT analysis, confirmation of an abnormal BeLPT with 
a second BeLPT, and follow-up of all confirmed positive BeLPT results 
by a pulmonary physician to evaluate for progression to CBD.
    Eight-hour TWA exposures were assessed utilizing 1,345 personal 
samples collected from the 9 smelters. The personal beryllium samples 
obtained showed a range of 0.01-13.00 [mu]g/m\3\ TWA with an arithmetic 
mean of 0.25 [mu]g/m\3\ and geometric mean of 0.06 [mu]g/m\3\. Based on 
a survey of published studies, the investigators concluded that 
exposure levels to beryllium observed in aluminum smelters were similar 
to those seen in other industries that utilize beryllium. Of the 1,932 
workers surveyed by BeLPT, nine workers were diagnosed with 
sensitization (prevalence rate of 0.47 percent, 95% confidence interval 
= 0.21-0.88 percent) with 2 of these workers diagnosed with probable 
CBD after additional medical evaluations.
    The authors concluded that compared with beryllium-exposed workers 
in other industries, the rate of sensitization among aluminum smelter 
workers appears lower. The authors speculated that this lower observed 
rate could be related to a more soluble form of beryllium found in the 
aluminum smelting work environment as well as the consistent use of 
respiratory protection. However, the authors also speculated that the 
low participation rate of 60 percent may have underestimated the 
sensitization rate in this worker population.
    A study by Nilsen et al. (2010) also found a low rate of 
sensitization among aluminum workers in Norway. Three-hundred sixty-two 
workers and thirty-one control individuals were tested for beryllium 
sensitization based on the BeLPT. The results found that one (0.28%) of 
the smelter workers had been sensitized. No borderline results were 
reported. The exposures estimated in this plant were 0.1 [micro]g/m\3\ 
to 0.31 [micro]g/m\3\ (Nilsen et al., 2010, Document ID 0460).
6. Animal Models of CBD
    This section reviews the relevant animal studies supporting the 
biological mechanisms outlined above. In order for an animal model to 
be useful for investigating the mechanisms underlying the development 
of CBD, the model should include: The demonstration of a beryllium-
specific immune response; the formation of immune granulomas following 
inhalation exposure to beryllium; and progression of disease as 
observed in human disease. While exposure to beryllium has been shown 
to cause chronic granulomatous inflammation of the lung in animal 
studies using a variety of species, most of the granulomatous lesions 
were not immune-induced reactions (which would predominantly consist of 
T-cells or lymphocytes), but were foreign-body-induced reactions, which 
predominantly consist of macrophages and monocytes, with only a small 
numbers of lymphocytes. Although no single model has completely 
mimicked the disease process as it progresses in humans, animal studies 
have been useful in providing biological plausibility for the role of 
immunological alterations and lung inflammation and in clarifying 
certain specific mechanistic aspects of beryllium disease, such as 
sensitization and CBD. However, there is no dependable animal model 
that mimics all facets of the human response, and studies thus far have 
been limited by single dose experiments, too few animals, or 
abbreviated observation periods. Therefore, the utility of this data is 
limited. The following is a discussion of the most relevant animal 
studies regarding the mechanisms of sensitization and CBD development 
in humans. Table A.2 in the Supplemental Information for the Beryllium 
Health Effects Section summarizes species, route, chemical form of 
beryllium, dose levels, and pathological findings of the key studies 
(Document ID 1965).
    Harmsen et al. performed a study to assess whether the beagle dog 
could provide an adequate model for the study of beryllium-induced lung 
diseases (Harmsen et al., 1986, Document ID 1257). One group of dogs 
served as an air inhalation control group and four other groups 
received high (approximately 50 [mu]g/kg) and low (approximately 20 
[mu]g/kg) doses of beryllium oxide calcined at 500 [deg]C or 1,000 
[deg]C, administered as aerosols in a single exposure.\6\
---------------------------------------------------------------------------

    \6\ As discussed above, calcining temperature affects the 
solubility and SSA of beryllium particles. Those particles calcined 
at higher temperatures (e.g., 1,000 [deg]C) are less soluble and 
have lower SSA than particles calcined at lower temperatures (e.g., 
500 [deg]C). Solubility and SSA are factors in determining the toxic 
potential of beryllium compounds or materials.

---------------------------------------------------------------------------

[[Page 2512]]

    BAL content was collected at 30, 60, 90, 180, and 210 days after 
exposure, and lavage fluid and cellular content was evaluated for 
neutrophilic and lymphocytic infiltration. In addition, BAL cells were 
evaluated at the 210 day period to determine activation potential by 
phytohemagglutinin (PHA) or beryllium sulfate as mitogen. BAL 
neutrophils were significantly elevated only at 30 days with exposure 
to either dose of 500 [deg]C beryllium oxide. BAL lymphocytes were 
significantly elevated at all time points of the high dose of beryllium 
oxide. No significant effect of 1,000 [deg]C beryllium oxide exposure 
on mitogenic response of any lymphocytes was seen. In contrast, 
peripheral blood lymphocytes from the 500 [deg]C beryllium oxide 
exposed groups were significantly stimulated by beryllium sulfate 
compared with the phytohemagglutinin exposed cells. Only the BAL 
lymphocytes from animals exposed to the 500 [deg]C beryllium oxide 
responded to stimulation by either PHA or beryllium sulfate.
    In a series of studies, Haley et al. also found that the beagle dog 
models certain aspects of human CBD (Haley et al., 1989, 1991 and 1992; 
Document ID 1366, 1315, 1365. Briefly, dogs were exposed by inhalation 
to a single exposure to beryllium aerosol generated from beryllium 
oxide calcined at 500 [deg]C or 1,000 [deg]C for initial lung burdens 
of 17 or 50 [mu]g beryllium/kg body weight (Haley et al., 1989, 
Document ID 1366; 1991 (1315)). The dogs were monitored for lung 
pathologic effects, particle clearance, and immune sensitization of 
peripheral blood leukocytes. Lung retention was higher in the 1,000 
[deg]C treated beryllium oxide group (Haley et al., 1989, Document ID 
1366).
    Haley et al. (1989) described the bronchoalveolar lavage (BAL) and 
histopathological changes in dogs exposed as described above. One group 
of dogs underwent BAL for lung lymphocyte analysis at 3, 6, 7, 11, 15, 
18, and 22 months post exposure. The investigators found an increase in 
the percentage and numbers of lymphocytes in BAL fluid at 3 months 
post-exposure in dogs exposed to either dose of beryllium oxide 
calcined at 500 [deg]C and 1,000 [deg]C. Positive BeLPT results were 
observed with BAL lymphocytes only in the group with a high initial 
lung burden of the material calcined at 500 [deg]C at 3 and 6 month 
post exposure. Another group underwent histopathological examination at 
days 8, 32, 64, 180, and 365 (Haley et al., 1989, Document ID 1366; 
1991 (1315)). Histopathologic examination revealed peribronchiolar and 
perivascular lymphocytic histiocytic inflammation, peaking at 64 days 
after beryllium oxide exposure. Lymphocytes were initially well 
differentiated, but progressed to lymphoblastic cells and aggregated in 
lymphofollicular nodules or microgranulomas over time. Although there 
was considerable inter-animal variation, lesions were generally more 
severe in the dogs exposed to material calcined at 500 [deg]C. The 
investigators observed granulomatous lesions and lung lymphocyte 
responses consistent with those observed in humans with CBD, including 
perivascular and peribronchiolar infiltrates of lymphocytes and 
macrophages, progressing to microgranulomas with areas of granulomatous 
pneumonia and interstitial fibrosis. However, lesions declined in 
severity after 64 days post-exposure. The lesions found in dog lungs 
closely resembled those found in humans with CBD: Severe granulomas, 
lymphoblast transformation, increased pulmonary lymphocyte 
concentrations and variation in beryllium sensitivity. It was concluded 
that the canine model for CBD may provide insight into this disease.
    In a follow-up experiment, control dogs and those exposed to 
beryllium oxide calcined at 500 [deg]C were allowed to rest for 2.5 
years, and then re-exposed to filtered air (controls) or beryllium 
oxide calcined at 500 [deg]C (cases) for an initial lung burden target 
of 50 [mu]g beryllium oxide/kg body weight (Haley et al., 1992, 
Document ID 1365). Immune responses of blood and BAL lymphocytes, as 
well as lung lesions in dogs sacrificed 210 days post-exposure, were 
compared with results following the initial exposure. The severity of 
lung lesions was comparable under both conditions, suggesting that a 
2.5-year interval was sufficient to prevent cumulative pathologic 
effects in beagle dogs.
    In a comparison study of dogs and monkeys, Conradi et al. (1971) 
exposed animals via inhalation to an average aerosol to either 0, 3,300 
or 4,380 [mu]g/m\3\ of beryllium as beryllium oxide calcined at 1,400 
[deg]C for 30 minutes, once per month for 3 months (Document ID 1319). 
Conradi et al. found no changes in the histological or ultrastructure 
of the lung of animals exposed to beryllium versus control animals. 
This was in contrast to previous findings reported in other studies 
cited by Conradi et al. The investigators speculated that the 
differences may be due in part to calcination temperature or follow-up 
time after initial exposure. The findings from Haley et al. (1989, 
Document ID 1366; 1991 (1915); and 1992 (1365)) as well as Harmsen et 
al. (1986, Document ID 1257) suggest that the beagle model for 
sensitization of CBD is more closely related to the human response that 
other species such as the monkey (and those reviewed in Table A2 of the 
Supplemental Information for the Beryllium Health Effects Section).
    A 1994 study by Haley et al. comparing the potential toxicity of 
beryllium oxide versus beryllium metal showed that instillation of both 
beryllium oxide and beryllium metal induced an immune response in 
monkeys. Briefly, male cynomolgus monkeys were exposed to either 
beryllium metal or beryllium oxide calcined at 500 [deg]C via 
intrabronchiolar instillation as a saline suspension. Lymphocyte counts 
in BAL fluid were observed through bronchoalveolar lavage at 14, 30, 
60, 90, and 120 days post exposure, and were found to be significantly 
increased in monkeys exposed to beryllium metal on post-exposure days 
14, 30, 60, and 90, and in monkeys exposed to beryllium oxide on post-
exposure day 30 and 60. Histological examination of lung tissue 
revealed that monkeys exposed to beryllium metal developed interstitial 
fibrosis, Type II cell hyperplasia with increased lymphocytes 
infiltration, and lymphocytic mantles accumulating around alveolar 
macrophages. Similar but much less severe lesions were observed in 
beryllium-oxide-exposed monkeys. Only monkeys exposed to beryllium 
metal had positive BAL BeLPT results (Haley et al., 1994, Document ID 
1364).
    As discussed earlier in this Health Effects section, at the 
cellular level, beryllium dissolution may be necessary in order for 
either a dendritic cell or a macrophage to present beryllium as an 
antigen to induce the cell-mediated CBD immune reactions (NAS, 2008, 
Document ID 1355). Several studies have shown that low-fired beryllium 
oxide, which is predominantly made up of poorly crystallized small 
particles, is more immunologically reactive than beryllium oxide 
calcined at higher firing temperatures that result in less reactivity 
due to increasing crystal size (Stefaniak et al., 2006, Document ID 
1398). As discussed previously, Haley et al. (1989, Document ID 1366) 
found more severe lung lesions and a stronger immune response in beagle 
dogs receiving a single inhalation exposure to beryllium oxide calcined 
at 500 [deg]C than in dogs receiving an equivalent initial lung burden 
of beryllium oxide calcined at 1,000 [deg]C. Haley et al. found that 
beryllium oxide calcined at 1,000 [deg]C

[[Page 2513]]

elicited little local pulmonary immune response, whereas the much more 
soluble beryllium oxide calcined at 500 [deg]C produced a beryllium-
specific, cell-mediated immune response in dogs (Haley et al., 1989, 
Document ID 1366 and 1991 (1315)).
    In a later study, beryllium metal appeared to induce a greater 
toxic response than beryllium oxide following intrabronchiolar 
instillation in cynomolgus monkeys, as evidenced by more severe lung 
lesions, a larger effect on BAL lymphocyte counts, and a positive 
response in the BeLPT with BAL lymphocytes only after exposure to 
beryllium metal (Haley et al., 1994, Document ID 1364). A study by 
Mueller and Adolphson (1979) observed that an oxide layer can develop 
on beryllium-metal surfaces after exposure to air (Mueller and 
Adolphson, 1979, Document ID 1260). According to the NAS report, 
Harmesen et al (1994) suggested that the presence of beryllium metal 
could lead to persistent exposures of small amounts beryllium oxide 
sufficient for presentation to the immune system (NAS, 2008, Document 
ID 1355).
    Genetic studies in humans led to the creation of an animal model 
containing different human HLA-DP alleles inserted into FVB/N mice for 
mechanistic studies of CBD. Three strains of genetically engineered 
mice (transgenic mice) were created that conferred different risks for 
developing CBD based on human studies (Weston et al., 2005, Document ID 
1345; Snyder et al., 2008 (0471)): (1) The HLA-DPB1*0401 transgenic 
strain, where the transgene codes for lysine residue at the 69th 
position of the B-chain conferred low risk of CBD; (2) the HLA-
DPB1*0201 mice, where the transgene codes for glutamic acid residue at 
the 69th position of the B-chain conferred medium risk of CBD; and (3) 
the HLA-DPB1*1701 mice, where the transgene codes for glutamic acid at 
the 69th position of the B-chain but coded for a more negatively 
charged protein to confer higher risk of CBD (Tarantino-Hutchinson et 
al., 2009, Document ID 0536).
    In order to validate the transgenic model, Tarantino-Hutchison et 
al. challenged the transgenic mice along with seven different inbred 
mouse strains to determine the susceptibility and sensitivity to 
beryllium exposure. Mice were dermally exposed with either saline or 
beryllium, then challenged with either saline or beryllium (as 
beryllium sulfate) using the MEST protocol (mouse ear-swelling test). 
The authors determined that the high risk HLA-DPB1*1701 transgenic 
strain responded 4 times greater (as measured via ear swelling) than 
control mice and at least 2 times greater than other strains of mice. 
The findings correspond to epidemiological study results reporting an 
enhanced CBD odds ratio for the HLA-DPB1*1701 in humans (Weston et al., 
2005, Document ID 1345; Snyder et al., 2008 (0471)). Transgenic mice 
with the genes corresponding to the low and medium odds ratio study did 
not respond significantly over the control group. The authors concluded 
that while HLA-DPB1*1701 is important to beryllium sensitization and 
progression to CBD, other genetic and environmental factors contribute 
to the disease process as well.
7. Beryllium Sensitization and CBD Conclusions
    There is substantial evidence that skin and inhalation exposure to 
beryllium may lead to sensitization (section V.D.1) and that inhalation 
exposure, or skin exposure coupled with inhalation exposure, may lead 
to the onset and progression of CBD (section V.D.2). These conclusions 
are supported by extensive human studies (section V.D.5). While all 
facets of the biological mechanism for this complex disease have yet to 
be fully elucidated, many of the key events in the disease sequence 
have been identified and described in the earlier sections (sections 
V.D.1-5). Sensitization is considered to be a necessary first step to 
the onset of CBD (NAS, 2008, Document ID 1355; ERG, 2010 (1270)). 
Sensitization is the process by which the immune system recognizes 
beryllium as a foreign substance and responds in a manner that may lead 
to development of CBD. It has been documented that a substantial 
proportion of sensitized workers exposed to airborne beryllium can 
progress to CBD (Rosenman et al., 2005, Document ID 1352; NAS, 2008 
(1355); Mroz et al., 2009 (1356)). Animal studies, particularly in dogs 
and monkeys, have provided supporting evidence for T cell lymphocyte 
proliferation in the development of granulomatous lung lesions after 
exposure to beryllium (Harmsen et al., 1986, Document ID 1257; Haley et 
al., 1989 (1366), 1992 (1365), 1994 (1364)). The animal studies have 
also provided important insights into the roles of chemical form, 
genetic susceptibility, and residual lung burden in the development of 
beryllium lung disease (Harmsen et al., 1986, Document ID 1257; Haley 
et al., 1992 (1365); Tarantino-Hutchison et al., 2009 (0536)). The 
evidence supports sensitization as an early functional change that 
allows the immune system to recognize and adversely react to beryllium. 
As such, OSHA regards beryllium sensitization as a necessary first step 
along a continuum that can culminate in clinical lung disease.
    The epidemiological evidence presented in section V.D.5 
demonstrates that sensitization and CBD are continuing to occur from 
exposures below OSHA's preceding PEL. The prevalence of sensitization 
among beryllium-exposed workers, as measured by the BeLPT and reported 
in 16 surveys of occupationally exposed cohorts reviewed by the Agency, 
ranged from 0.3 to 14.5 percent (Deubner et al., 2001, Document ID 
1543; Kreiss et al., 1997 (1360); Rosenman et al., 2005 (1352); Schuler 
et al., 2012 (0473); Bailey et al., 2010 (0676); Newman et al., 2001 
(1354); OSHA, 2014 (1589); Kreiss et al., 1996 (1477); Henneberger et 
al., 2001 (0589); Cummings et al., 2007 (1369); Schuler et al., 2005 
(0919); Thomas et al., 2009 (1061); Kreiss et al., 1989 (1480); 
Arjomandi et al., 2010 (1275); Taiwo et al., 2011 (0621); Nilson et 
al., 2010 (0460)). The lower prevalence estimates (0.3 to 3.7 percent) 
were from facilities known to have implemented respiratory protection 
programs and have lower personal exposures (Cummings et al., 2007, 
Document ID 1369; Thomas et al., 2009 (1061); Bailey et al., 2010 
(0676); Taiwo et al, 2011 (0621), Nilson et al., 2010 (0460); Arjomandi 
et al., 2010 (1275)). Thirteen of the surveys also evaluated workers 
for CBD and reported prevalences of CBD ranging from 0.1 to 7.8 
percent. The cohort studies cover workers across many different 
industries and processes as discussed in section V.D.5. Several studies 
show that incidence of sensitization among workers can be reduced by 
reducing inhalation exposure and that minimizing skin exposure may 
serve to further reduce sensitization (Cummings et al., 2007, Document 
ID 1369; Thomas et al., 2009 (1061); Bailey et al., 2010 (0676)). The 
risk assessment further discusses the effectiveness of interventions to 
reduce beryllium exposures and the risk of sensitization and CBD (see 
section VI of this preamble, Risk Assessment).
    Longitudinal studies of sensitized workers found early signs of 
asymptomatic CBD that can progress to clinical disease in some 
individuals. One study found that 31 percent of beryllium-exposed 
sensitized employees progressed to CBD with an average follow-up time 
of 3.8 years (Newman, 2005, Document ID 1437). However, Newman (2005) 
went on to suggest that if follow-up times were much longer, the rate 
of progression from

[[Page 2514]]

sensitization to CBD could be much higher. Mroz et al. (2009) (Document 
ID 1356) conducted a longitudinal study between 1982 and 2002 in which 
they followed 171 cases of CBD and 229 cases of sensitization initially 
evaluated through workforce medical surveillance by National Jewish 
Health. All study subjects had abnormal BeLPTs upon study entry and 
were then clinically evaluated and treated for CBD. Over the 20-year 
study period, 22 sensitized individuals went on to develop CBD which 
was an incidence of 8.8 percent (i.e., 22 cases out of 251 sensitized, 
calculated by adding those 22 cases to the 229 initially classified as 
sensitized). The findings from this study indicated that the average 
span of time from initial beryllium exposure to CBD diagnosis for those 
22 workers was 24 years (Mroz et al., 2009, Document ID 1356).
    A study of sensitized workers believed to have been exposed to low 
levels of airborne beryllium metal (e.g., 0.01 [micro]g/m\3\ or less) 
at a nuclear weapons research and development facility were clinically 
evaluated between 1999 and 2005 (Arjomandi et al., 2010, Document ID 
1275). Five of 49 sensitized workers (10.2 percent incidence) were 
found to have pathology consistent with CBD. The CBD was asymptomatic 
and had not progressed to clinical disease. The mean duration of 
employment among workers in the study was 18 years with mean latency of 
32 years to time of CBD diagnosis (Arjomandi et al., 2010, Document ID 
1275). This suggests that some sensitized individuals can develop CBD 
even from low levels of beryllium exposure. Another study of nuclear 
weapons facility employees enrolled in an ongoing medical surveillance 
program found that sensitization rate among exposed workers was highest 
over the first 10 years of beryllium exposure while onset of CBD 
pathology was greatest following 15 to 30 years of exposure (Stange et 
al., 2001, Document ID 1403). This indicates length of exposure may 
play a role in further development of the disease. OSHA concludes from 
the study evidence that the persistent presence of beryllium in the 
lungs of sensitized workers can lead to a progression of CBD over time 
from an asymptomatic stage to serious clinical disease.
E. Beryllium Lung Cancer Section
    Beryllium exposure is associated with a variety of adverse health 
effects, including lung cancer. The potential for beryllium and its 
compounds to cause cancer has been previously assessed by various other 
agencies (EPA, ATSDR, NAS, NIEHS, and NIOSH), with each agency 
identifying beryllium as a potential carcinogen. In addition, IARC did 
an extensive evaluation in 1993 (Document ID 1342) and reevaluation in 
April 2009 (IARC, 2012, Document ID 0650). In brief, IARC determined 
beryllium and its compounds to be carcinogenic to humans (Group 1 
category), while EPA considers beryllium to be a probable human 
carcinogen (EPA, 1998, Document ID 0661), and the National Toxicology 
Program (NTP) classifies beryllium and its compounds as known 
carcinogens (NTP, 2014, Document ID 0389). OSHA has conducted an 
independent evaluation of the carcinogenic potential of beryllium and 
these compounds. The following is a summary of the studies used to 
support the Agency's finding that beryllium and its compounds are human 
carcinogens.
1. Genotoxicity Studies
    Genotoxicity can be an important indicator for screening the 
potential of a material to induce cancer and an important mechanism 
leading to tumor formation and carcinogenesis. In a review conducted by 
the National Academy of Science, beryllium and its compounds have 
tested positively in nearly 50 percent of the genotoxicity studies 
conducted without exogenous metabolic activity. However, they were 
found to be non-genotoxic in most bacterial assays (NAS, 2008, Document 
ID 1355).
    Non-mammalian test systems (generally bacterial assays) are often 
used to identify genotoxicity of a compound. In bacteria studies 
evaluating beryllium sulfate for mutagenicity, all studies performed 
utilizing the Ames assay (Simmon, 1979, Document ID 0434; Dunkel et 
al., 1981 (0432); Arlauskas et al., 1985 (0454); Ashby et al., 1990 
(0437)) and other bacterial assays (E. coli pol A (Rosenkranz and 
Poirer, 1979, Document ID 1426); E. coli WP2 uvrA (Dunkel et al., 1981, 
Document ID 0432), as well as those utilizing Saccharomyces cerevisiae 
(Simmon, 1979, Document ID 0434)) were reported as negative, with the 
exception of results reported for Bacillus subtilis rec assay (Kada et 
al., 1980, Document ID 0433; Kanematsu et al., 1980 (1503)). Beryllium 
nitrate was also reported as negative in the Ames assay (Tso and Fung, 
1981, Document ID 0446; Kuroda et al., 1991 (1471)) but positive in a 
Bacillus subtilis rec assay (Kuroda et al., 1991, Document ID 1471). In 
addition, beryllium chloride was reported as negative using the Ames 
assay (Ogawa et al., 1987, as cited in Document ID 1341, p. 112; Kuroda 
et al., 1991 (1471)) and other bacterial assays (E. coli WP2 uvrA 
(Rossman et al., 1984, Document ID 0431), as well as the Bacillus 
subtilis rec assay (Nishioka, 1975, Document ID 0449)) and failed to 
induce SOS DNA repair in E. coli (Rossman et al., 1984, Document ID 
0431). Positive results for beryllium chloride were reported for 
Bacillus subtilis rec assay using spores (Kuroda et al., 1991, Document 
ID 1471) as well as increased mutations in the lacI gene of E. coli 
KMBL 3835 (Zakour and Glickman, 1984, Document ID 1373). Beryllium 
oxide was reported to be negative in the Ames assay and Bacillus 
subtilis rec assays (Kuroda et al., 1991, Document ID 1471; EPA, 1998 
(0661)).
    Mutations using in vitro mammalian systems were also evaluated. 
Beryllium chloride induced mutations in V79 and CHO cultured cells 
(Miyaki et al., 1979, Document ID 0450; Hsie et al., 1978 (0427); 
Vegni-Talluri and Guiggiani, 1967 (1382)), and beryllium sulfate 
induced clastogenic alterations, producing breakage or disrupting 
chromosomes in mammalian cells (Brooks et al., 1989, Document ID 0233; 
Larramendy et al., 1981 (1468); Gordon and Bowser, 2003 (1520)). 
However, beryllium sulfate did not induce unscheduled DNA synthesis in 
primary rat hepatocytes and was not mutagenic when injected 
intraperitoneally in adult mice in a host-mediated assay using 
Salmonella typhimurium (Williams et al., 1982). Positive results were 
found for beryllium chloride when evaluating the hprt gene in Chinese 
hamster lung V79 cells (Miyaki et al., 1979, Document ID 0450).
    Data from in vivo genotoxicity testing of beryllium are limited. 
Beryllium metal was found to induce methylation of the p16 gene in the 
lung tumors of rats exposed to beryllium metal (Swafford et al., 1997, 
Document ID 1392) (described in more detail in section V.E.3). A study 
by Nickell-Brady et al., (1994) found that beryllium sulfate (1.4 and 
2.3 g/kg, 50 percent and 80 percent of median lethal dose) administered 
by gavage did not induce micronuclei in the bone marrow of CBA mice. 
However, a marked depression of red blood cell production was 
suggestive of bone marrow toxicity, which was evident 24 hours after 
dosing. No mutations were seen in p53 or c-raf-1 and only weak 
mutations were detected in K-ras in lung carcinomas from F344/N rats 
given a single nose-only exposure to beryllium metal (described in more 
detail in section V. E. 3) (Nickell-Brady et al., 1994, Document ID 
1312). On the other hand, beryllium chloride evaluated in a mouse model 
indicated increased DNA strand breaks and the formation of micronuclei

[[Page 2515]]

in bone marrow (Attia et al., 2013, Document ID 0501).
    In summary, genetic mutations have been observed in mammalian 
systems (in vitro and in vivo) with beryllium chloride, beryllium 
sulfate, and beryllium metal in a number of studies (Miyaki et al., 
1979, Document ID 0450; Hsie et al., 1978 (0427); Vegni-Talluri and 
Guiggiani, 1967 (1382); Brooks et al., 1989 (0233); Larramendy et al., 
1981 (1468); Miyaki et al., 1979 (0450); Swafford et al., 1997 (1392); 
Attia et al., 2013 (0501); EPA, 1998 (0661); Gordon and Bowser, 2003 
(1520)). However, most studies utilizing non-mammalian test systems 
(either with or without metabolic activity) have found that beryllium 
chloride, beryllium nitrate, beryllium sulfate, and beryllium oxide did 
not induce gene mutations, with the exception of Kada et al. (1980, 
Document ID 0433) (Kanematsu et al.,1980, Document ID 1503; Kuroda et 
al., 1991 (1471)).
2. Human Epidemiological Studies
    This section describes the human epidemiological data supporting 
the mechanistic overview of beryllium-induced lung cancer in workers. 
It has been divided into reviews of epidemiological studies by industry 
and beryllium form. The epidemiological studies utilizing data from the 
BCR, in general, focus on workers mainly exposed to soluble forms of 
beryllium. Those studies evaluating the epidemiological evidence by 
industry or process are, in general, focused on exposures to poorly 
soluble or mixed (soluble and poorly soluble) compounds. Table A.3 in 
the Supplemental Information for the Beryllium Health Effects Section 
summarizes the important features and characteristics of each study 
discussed herein (Document ID 1965).
a. Beryllium Case Registry (BCR)
    Two studies evaluated participants in the BCR (Infante et al., 
1980, Document ID 1507; Steenland and Ward, 1991 (1400)). Infante et 
al. (1980) evaluated the mortality patterns of white male participants 
in the BCR diagnosed with non-neoplastic respiratory symptoms of 
beryllium disease. Of the 421 cases evaluated, 7 of the participants 
had died of lung cancer. Six of the deaths occurred more than 15 years 
after initial beryllium exposure. The duration of exposure for 5 of the 
7 participants with lung cancer was less than 1 year, with the time 
since initial exposure ranging from 12 to 29 years. One of the 
participants was exposed for 4 years with a 26-year interval since the 
initial exposure. Exposure duration for one participant diagnosed with 
pulmonary fibrosis could not be determined; however, it had been 32 
years since the initial exposure. Based on BCR records, the 
participants were classified as being in the acute respiratory group 
(i.e., those diagnosed with acute respiratory illness at the time of 
entry in the registry) or the chronic respiratory group (i.e., those 
diagnosed with pulmonary fibrosis or some other chronic lung condition 
at the time of entry into the BCR). The 7 participants with lung cancer 
were in the BCR because of diagnoses of acute respiratory illness. For 
only one of those individuals was initial beryllium exposure less than 
15 years prior. Only 1 of the 6 (with greater than 15 years since 
initial exposure to beryllium) had been diagnosed with chronic 
respiratory disease. The study did not report exposure concentrations 
or smoking habits. The authors concluded that the results from this 
cohort agreed with previous animal studies and with epidemiological 
studies demonstrating an increased risk of lung cancer in workers 
exposed to beryllium.
    Steenland and Ward (1991) (Document ID 1400) extended the work of 
Infante et al. (1980) (Document ID 1507) to include females and to 
include 13 additional years of follow-up. At the time of entry in the 
BCR, 93 percent of the women in the study, but only 50 percent of the 
men, had been diagnosed with CBD. In addition, 61 percent of the women 
had worked in the fluorescent tube industry and 50 percent of the men 
had worked in the basic manufacturing industry with confirmed beryllium 
exposure. A total of 22 males and 6 females died of lung cancer. Of the 
28 total deaths from lung cancer, 17 had been exposed to beryllium for 
less than 4 years and 11 had been exposed for greater than 4 years. The 
study did not report exposure concentrations. Survey data collected in 
1965 provided information on smoking habits for 223 cohort members (32 
percent), on the basis of which the authors suggested that the rate of 
smoking among workers in the cohort may have been lower than U.S. 
rates. The authors concluded that there was evidence of increased risk 
of lung cancer in workers exposed to beryllium and then diagnosed with 
beryllium disease (ABD and CBD).
b. Beryllium Manufacturing and/or Processing Plants (Extraction, 
Fabrication, and Processing)
    Several epidemiological cohort studies have reported excess lung 
cancer mortality among workers employed in U.S. beryllium production 
and processing plants during the 1930s to 1960s.
    Bayliss et al. (1971) (Document ID 1285) performed a nested cohort 
study of 7,948 former workers from the beryllium processing industry 
who were employed from 1942-1967. Information for the workers was 
collected from the personnel files of participating companies. Of the 
7,948 employees, a cause of death was known for 753 male workers. The 
number of observed lung cancer deaths was 36 compared to 34.06 expected 
for a standardized mortality ratio (SMR) of 1.06. When evaluated by the 
number of years of employment, 24 of the 36 men were employed for less 
than 1 year in the industry (SMR = 1.24), 8 were employed for 1 to 5 
years (SMR 1.40), and 4 were employed for more than 5 years (SMR = 
0.54). Half of the workers who died from lung cancer began employment 
in the beryllium production industry prior to 1947. When grouped by job 
classification, over two thirds of the workers with lung cancer were in 
production-related jobs while the rest were classified as office 
workers. The authors concluded that while the lung cancer mortality 
rates were the highest of all other mortality rates, the SMR for lung 
cancer was still within range of the expected based on death rates in 
the United States. The limitations of this study included the lack of 
information regarding exposure concentrations, smoking habits, and the 
age and race of the participants.
    Mancuso (1970, Document ID 1453; 1979, (0529); 1980 (1452)) and 
Mancuso and El-Attar (1969) (Document ID 1455) performed a series of 
occupational cohort studies on a group of workers (primarily white 
males) employed in the beryllium manufacturing industry during 1937-
1948. The cohort identified in Mancuso and El-Attar (1969) was a study 
of 3,685 workers (primarily white males) while Mancuso (1970, 1976, 
1980) continued the study follow-up with 3266 workers due to several 
limitations in identifying specific causes for mortality as identified 
in Mancuso and El-Attar (1969). The beryllium production facilities 
were located in Ohio and Pennsylvania and the records for the 
employees, including periods of employment, were obtained from the 
Social Security Administration. These studies did not include analyses 
of mortality by job title or exposure category (exposure data was taken 
from a study by Zielinsky et al., 1961 (as cited in Mancuso, 1970)). In 
addition, there were no exposure concentrations estimated or 
adjustments for smoking. The estimated duration of employment ranged 
from less than 1 year to greater than 5 years. In the most recent study 
(Mancuso, 1980), employees from the

[[Page 2516]]

viscose rayon industry served as a comparison population. There was a 
significant excess of lung cancer deaths based on the total number of 
80 observed lung cancer mortalities at the end of 1976 compared to an 
expected number of 57.06 based on the comparison population resulting 
in an SMR of 1.40 (p <0.01) (Mancuso, 1980). There was a statistically 
significant excess in lung cancer deaths for the shortest duration of 
employment (<12 months, p <0.05) and the longest duration of employment 
(>49 months, p <0.01). Based on the results of this study, the author 
concluded that the ability of beryllium to induce cancer in workers 
does not require continuous exposure and that it is reasonable to 
assume that the amount of exposure required to produce lung cancer can 
occur within a few months of initial exposure regardless of the length 
of employment.
    Wagoner et al. (1980) (Document ID 1379) expanded the work of 
Mancuso (1970, Document ID 1453; 1979 (0529); 1980 (1452)) using a 
cohort of 3,055 white males from the beryllium extraction, processing, 
and fabrication facility located in Reading, Pennsylvania. The men 
included in the study worked at the facility sometime between 1942 and 
1968, and were followed through 1976. The study accounted for length of 
employment. Other factors accounted for included age, smoking history, 
and regional lung cancer mortality. Forty-seven members of the cohort 
died of lung cancer compared to an expected 34.29 based on U.S. white 
male lung cancer mortality rates (p <.05). The results of this cohort 
showed an excess risk of lung cancer in beryllium-exposed workers at 
each duration of employment (<5 years and >=5 years), with a 
statistically significant excess noted at <5 years of employment and a 
>=25-year interval since the beginning of employment (p <0.05). The 
study was criticized by two epidemiologists (MacMahon, 1978, Document 
ID 0107; Roth, 1983 (0538)), by a CDC Review Committee appointed to 
evaluate the study (as cited in Document ID 0067), and by one of the 
study's coauthors (Bayliss, 1980, Document ID 0105) for inadequate 
discussion of possible alternative explanations of excess lung cancer 
in the cohort. The specific issues identified include the use of 1965-
1967 U.S. white male lung cancer mortality rates to generate expected 
numbers of lung cancers in the period 1968-1975 (which may 
underestimate the expected number of lung cancer deaths for the cohort) 
and inadequate adjustment for smoking.
    One occupational nested case-control study evaluated lung cancer 
mortality in a cohort of 3,569 male workers employed at a beryllium 
alloy production plant in Reading, PA, from 1940 to 1969 and followed 
through 1992 (Sanderson et al., 2001, Document ID 1250). There were a 
total of 142 known lung cancer cases and 710 controls. For each lung 
cancer death, 5 age- and race-matched controls were selected by 
incidence density sampling. Confounding effects of smoking were 
evaluated. Job history and historical air measurements at the plant 
were used to estimate job-specific beryllium exposures from the 1930s 
to 1990s. Calendar-time-specific beryllium exposure estimates were made 
for every job and used to estimate workers' cumulative, average, and 
maximum exposures. Because of the long period of time required for the 
onset of lung cancer, an ``exposure lag'' was employed to discount 
recent exposures less likely to contribute to the disease.
    The largest and most comprehensive study investigated the mortality 
experience of 9,225 workers employed in 7 different beryllium 
processing plants over a 30-year period (Ward et al., 1992, Document ID 
1378). The workers at the two oldest facilities (i.e., Lorain, OH, and 
Reading, PA) were found to have significant excess lung cancer 
mortality relative to the U.S. population. The workers at these two 
plants were believed to have the highest exposure levels to beryllium. 
Ward et al. (1992) performed a retrospective mortality cohort study of 
9,225 male workers employed at seven beryllium processing facilities, 
including the Ohio and Pennsylvania facilities studied by Mancuso and 
El-Attar (1969) (Document ID 1455), Mancuso (1970, Document ID 1453; 
1979 (0529); 1980 (1452)), and Wagoner et al. (1980) (Document ID 
1379). The men were employed for no less than 2 days between January 
1940 and December 1969. Medical records were followed through 1988. At 
the end of the study 61.1 percent of the cohort was known to be living 
and 35.1 percent was known to be deceased. The duration of employment 
ranged from 1 year or less to greater than 10 years with the largest 
percentage of the cohort (49.7 percent) employed for less than one 
year, followed by 1 to 5 years of employment (23.4 percent), greater 
than 10 years (19.1 percent), and 5 to 10 years (7.9 percent). Of the 
3,240 deaths, 280 observed deaths were caused by lung cancer compared 
to 221.5 expected deaths, yielding a statistically significant SMR of 
1.26 (p <0.01). Information on the smoking habits of 15.9 percent of 
the cohort members, obtained from a 1968 Public Health Service survey 
conducted at four of the plants, was used to calculate a smoking-
adjusted SMR of 1.12, which was not statistically significant. The 
number of deaths from lung cancer was also examined by decade of hire. 
The authors reported a relationship between earlier decades of hire and 
increased lung cancer risk.
    A different analysis of the lung cancer mortality in this cohort 
using various local reference populations and alternate adjustments for 
smoking generally found smaller, non-significant rates of excess 
mortality among the beryllium-exposed employees (Levy et al., 2002, 
Document ID 1463). Both cohort studies (Levy et al., 2002, Document ID 
1463; Ward et al., 1992 (1378)) are limited by a lack of job history 
and air monitoring data that would allow investigation of mortality 
trends with different levels and durations of beryllium exposure. The 
majority of employees at the Lorain, OH, and Reading, PA, facilities 
were employed for a relatively short period of less than one year.
    Levy et al. (2002) (Document ID 1463) questioned the results of 
Ward et al. (1992) (Document ID 1378) and performed a reanalysis of the 
Ward et al. data. The Levy et al. reanalysis differed from the Ward et 
al. analysis in the following significant ways. First, Levy et al. 
(2002) (Document ID 1463) examined two alternative adjustments for 
smoking, which were based on (1) a different analysis of the American 
Cancer Society (ACS) data used by Ward et al. (1992) (Document ID 1378) 
for their smoking adjustment, or (2) results from a smoking/lung cancer 
study of veterans. Second, Levy et al. (2002) also examined the impact 
of computing different reference rates derived from information about 
the lung cancer rates in the cities in which most of the workers at two 
of the plants lived (Document ID 1463). Finally, Levy et al. (2002) 
considered a meta-analytical approach to combining the results across 
beryllium facilities (Document ID 1463). For all of the alternatives 
Levy et al. (2002) (Document ID 1463) considered, except the meta-
analysis, the facility-specific and combined SMRs derived were lower 
than those reported by Ward et al. (1992) (Document ID 1378). Only the 
SMR for the Lorain, OH, facility remained statistically significantly 
elevated in some reanalyses. The SMR obtained when combining over the 
plants was not statistically significant in eight of the nine 
approaches they examined, leading

[[Page 2517]]

Levy et al. (2002) (Document ID 1463) to conclude that there was little 
evidence of statistically significant elevated SMRs in those plants. 
This study was not included in the synthesis of epidemiological studies 
assessed by IARC due to several methodological limitations (IARC, 2012, 
Document ID 0650).
    The EPA Integrated Risk Information System (IRIS), IARC, and 
California EPA Office of Environmental Health Hazard Assessment (OEHHA) 
all based their cancer assessments on the Ward et al. 1992 study, with 
supporting data concerning exposure concentrations from Eisenbud and 
Lisson (1983) (Document ID 1296) and NIOSH (1972) (Document ID 0560), 
who estimated that the lower-bound estimate of the median exposure 
concentration exceeded 100 [micro]g/m\3\ and found that concentrations 
in excess of 1,000 [micro]g/m\3\ were common. The IRIS cancer risk 
assessment recalculated expected lung cancers based on U.S. white male 
lung cancer rates (including the period 1968-1975) and used an 
alternative adjustment for smoking. In addition, one individual with 
lung cancer, who had not worked at the plant, was removed from the 
cohort. After these adjustments were made, an elevated rate of lung 
cancer was still observed in the overall cohort (46 cases vs. 41.9 
expected cases). However, based on duration of employment or interval 
since beginning of employment, neither the total cohort nor any of the 
subgroups had a statistically significant increase in lung cancer 
deaths (EPA, 1987, Document ID 1295). Based on its evaluation of this 
and other epidemiological studies, the EPA characterized the human 
carcinogenicity data then available as ``limited'' but ``suggestive of 
a causal relationship between beryllium exposure and an increased risk 
of lung cancer'' (EPA, 1998, Document ID 0237). The EPA report includes 
quantitative estimates of risk that were derived using the information 
presented in Wagoner et al. (1980), the expected lung cancers 
recalculated by the EPA, and bounds on presumed exposure levels.
    Sanderson et al. (2001) (Document ID 1419) estimated the 
cumulative, average, and maximum beryllium exposure concentration for 
the 142 known lung cancer cases to be 46.06  9.3[micro]g/
m\3\-days, 22.8  3.4 [micro]g/m\3\, and 32.4  
13.8 [micro]g/m\3\, respectively. The lung cancer mortality rate was 
1.22 (95 percent CI = 1.03 - 1.43). Exposure estimates were lagged by 
10 and 20 years in order to account for exposures that did not 
contribute to lung cancer because they occurred after the induction of 
cancer. In the 10- and 20-year lagged exposures the geometric mean 
tenures and cumulative exposures of the lung cancer mortality cases 
were higher than the controls. In addition, the geometric mean and 
maximum exposures of the workers were significantly higher than 
controls when the exposure estimates were lagged 10 and 20 years (p 
<0.01).
    Results of a conditional logistic regression analysis indicated 
that there was an increased risk of lung cancer in workers with higher 
exposures when dose estimates were lagged by 10 and 20 years (Sanderson 
et al., 2001, Document ID 1419). There was also a lack of evidence that 
confounding factors such as smoking affected the results of the 
regression analysis. The authors noted that there was considerable 
uncertainty in the estimation of exposure in the 1940s and 1950s and 
the shape of the dose-response curve for lung cancer (Sanderson et al., 
2001, Document ID 1419). Another analysis of the study data using a 
different statistical method did not find a significantly greater 
relative risk of lung cancer with increasing beryllium exposures (Levy 
et al., 2007). The average beryllium air levels for the lung cancer 
cases were estimated to be an order of magnitude above the preceding 8-
hour OSHA TWA PEL (2 [mu]g/m\3\) and roughly two orders of magnitude 
higher than the typical air levels in workplaces where beryllium 
sensitization and pathological evidence of CBD have been observed. IARC 
evaluated this reanalysis in 2012 and found the study introduced a 
downward bias into risk estimates (IARC, 2012, Document ID 0650). NIOSH 
comments in the rulemaking docket support IARC's finding (citing 
Schubauer-Berigan et al., 2007; Hein et al., 2009, 2011; Langholz and 
Richardson 2009; Wacholder 2009) (Document ID 1671, Attachment 1, p. 
10).
    Schubauer-Berigan et al. (2008) (Document ID 1350) reanalyzed data 
from the Sanderson et al. (2001) nested case-control study of 142 lung 
cancer cases in the Reading, PA, beryllium processing plant. This 
dataset was reanalyzed using conditional (stratified by case age) 
logistic regression. Independent adjustments were made for potential 
confounders of birth year and hire age. Average and cumulative 
exposures were analyzed using the values reported in the original 
study. The objective of the reanalysis was to correct for the known 
differences in smoking rates by birth year. In addition, the authors 
evaluated the effects of age at hire to determine differences observed 
by Sanderson et al. in 2001 (Document ID 1419). The effect of birth 
cohort adjustment on lung cancer rates in beryllium-exposed workers was 
evaluated by adjusting in a multivariable model for indicator variables 
for the birth cohort quartiles.
    Unadjusted analyses showed little evidence of lung cancer risk 
associated with beryllium occupational exposure using cumulative 
exposure until a 20-year lag was used. Adjusting for either birth 
cohort or hire age attenuated the risk for lung cancer associated with 
cumulative exposure. Using a 10- or 20-year lag in workers born after 
1900 also showed little evidence of lung cancer risk, while those born 
prior to 1900 did show a slight elevation in risk. Unlagged and lagged 
analysis for average exposure showed an increase in lung cancer risk 
associated with occupational exposure to beryllium. The finding was 
consistent for either workers adjusted or unadjusted for birth cohort 
or hire age. Using a 10-year lag for average exposure showed a 
significant effect by birth cohort.
    Schubauer-Berigan et al. stated that the reanalysis indicated that 
differences in the hire ages among cases and controls, first noted by 
Deubner et al. (2001) (Document ID 0109) and Levy et al. (2007) 
(Document ID 1462), were primarily due to the fact that birth years 
were earlier among controls than among cases, resulting from much lower 
baseline risk of lung cancer for men born prior to 1900 (Schubauer-
Berigan et al., 2008, Document ID 1350). The authors went on to state 
that the reanalysis of the previous NIOSH case-control study suggested 
the relationship observed previously between cumulative beryllium 
exposure and lung cancer was greatly attenuated by birth cohort 
adjustment.
    Hollins et al. (2009) (Document ID 1512) re-examined the weight of 
evidence of beryllium as a lung carcinogen in a recent publication. 
Citing more than 50 relevant papers, the authors noted the 
methodological shortcomings examined above, including lack of well-
characterized historical occupational exposures and inadequacy of the 
availability of smoking history for workers. They concluded that the 
increase in potential risk of lung cancer was observed among those 
exposed to very high levels of beryllium and that beryllium's 
carcinogenic potential in humans at these very high exposure levels was 
not relevant to today's industrial settings. IARC performed a similar 
re-evaluation in 2009 (IARC, 2012, Document ID 0650) and found that the 
weight of evidence for beryllium lung carcinogenicity, including the 
animal studies described below, still warranted a Group I 
classification, and that

[[Page 2518]]

beryllium should be considered carcinogenic to humans.
    Schubauer-Berigan et al. (2011) (Document ID 1266) extended their 
analysis from a previous study estimating associations between 
mortality risk and beryllium exposure to include workers at 7 beryllium 
processing plants. The study followed the mortality incidences of 9,199 
workers from 1940 through 2005 at the 7 beryllium plants. JEMs were 
developed for three plants in the cohort: The Reading plant, the 
Hazleton plant, and the Elmore plant. The last is described in Couch et 
al. 2010. Including these JEMs substantially improved the evidence base 
for evaluating the carcinogenicity of beryllium, and this change 
represents more than an update of the beryllium cohort. Standardized 
mortality ratios (SMRs) were estimated based on U.S. population 
comparisons for lung, nervous system and urinary tract cancers, chronic 
obstructive pulmonary disease (COPD), chronic kidney disease, and 
categories containing chronic beryllium disease (CBD) and cor 
pulmonale. Associations with maximum and cumulative exposure were 
calculated for a subset of the workers.
    Overall mortality in the cohort compared with the U.S. population 
was elevated for lung cancer (SMR 1.17; 95% CI 1.08 to 1.28), COPD (SMR 
1.23; 95% CI 1.13 to 1.32), and the categories containing CBD (SMR 
7.80; 95% CI 6.26 to 9.60) and cor pulmonale (SMR 1.17; 95% CI 1.08 to 
1.26) (Schubauer-Berigan et al., 2011, Document ID 1266). Mortality 
rates for most diseases of interest increased with time since hire. For 
the category including CBD, rates were substantially elevated compared 
to the U.S. population across all exposure groups. Workers whose 
maximum beryllium exposure was >=10 [mu]g/m\3\ had higher rates of lung 
cancer, urinary tract cancer, COPD and the category containing cor 
pulmonale than workers with lower exposure. These studies showed strong 
associations for cumulative exposure (when short-term workers were 
excluded), maximum exposure, or both. Significant positive trends with 
cumulative exposure were observed for nervous system cancers (p = 
0.0006) and, when short-term workers were excluded, lung cancer (p = 
0.01), urinary tract cancer (p = 0.003), and COPD (p <0.0001).
    The authors concluded that the findings from this reanalysis 
reaffirmed that lung cancer and CBD are related to beryllium exposure. 
The authors went on to suggest that beryllium exposures may be 
associated with nervous system and urinary tract cancers and that 
cigarette smoking and other lung carcinogens were unlikely to explain 
the increased incidences in these cancers. The study corrected an error 
that was discovered in the indirect smoking adjustment initially 
conducted by Ward et al., concluding that cigarette smoking rates did 
not differ between the cohort and the general U.S. population. No 
association was found between cigarette smoking and either cumulative 
or maximum beryllium exposure, making it very unlikely that smoking was 
a substantial confounder in this study (Schubauer-Berigan et al., 2011, 
Document ID 1266).
    A study by Boffetta et al. (2014, Document ID 0403) and an abstract 
by Boffetta et al., (2015, Document ID 1661, Attachment 1) were 
submitted by Materion for Agency consideration (Document ID 1661, p. 
3). Briefly, Boffetta et al. investigated lung cancer and other 
diseases in a cohort of 4,950 workers in four beryllium manufacturing 
facilities. Based on available process information from the facilities, 
the cohort of workers included only those working with poorly soluble 
beryllium. Workers having potential for soluble beryllium exposure were 
excluded from the study. Boffetta et al. reported a slight increase in 
lung cancer rates among workers hired prior to 1960, but the increase 
was reported as not statistically significant. Bofetta et al. (2014) 
indicated that ``[t]his study confirmed the lack of an increase in 
mortality from lung cancer and nonmalignant respiratory diseases 
related to [poorly] soluble beryllium compounds'' (Document ID 0403, p. 
587). OSHA disagrees, and a more detailed analysis of the Boffetta et 
al. (2014, Document ID 0403) study is provided in the Risk Assessment 
section (VI) of this preamble. The Boffetta et al. (2015, Document ID 
1661, Attachment 1) study cited by Materion was an abstract to the 48th 
annual Society of Epidemiological Research conference and does not 
provide sufficient information for OSHA to consider.
    To summarize, most of the epidemiological studies reviewed in this 
section show an elevated lung cancer rate in beryllium-exposed workers 
compared to control groups. While exposure data was incomplete in many 
studies inferences can be made based on industry profiles. 
Specifically, studies reviewing excess lung cancer in workers 
registered in the BCR found an elevated lung cancer rate in those 
patients identified as having acute beryllium disease (ABD). ABD 
patients are most closely associated with exposure to soluble forms of 
beryllium (Infante et al., 1980, Document ID 1507; Steenland and Ward, 
1991 (1348)). Industry profiles in processing and extraction indicate 
that most exposures would be due to poorly soluble forms of beryllium. 
Excess lung cancer rates were observed in workers in industries 
associated with extraction and processing (Schubauer-Berigan et al., 
2008, Document ID 1350; Schubauer-Berigan et al. 2011 (1266, 1815 
Attachment 105); Ward et al., 1992 (1378); Hollins et al., 2009 (1512); 
Sanderson et al., 2001 (1419); Mancuso et al., 1980 (1452); Wagoner et 
al., 1980 (1379)). During the public comment period NIOSH noted that:

. . . in Table 1 of Ward et al. (1992), all three of these beryllium 
plants were engaged in operations associated with both soluble and 
[poorly soluble] forms of beryllium. Industrial hygienists from 
NIOSH [Sanderson et al. (2001); Couch et al. (2011)] and elsewhere 
[Chen (2001); Rosenman et al. (2005)] created job-exposure matrices 
(JEMs), which estimated the form of beryllium exposure (soluble, 
consisting of beryllium salts; [poorly soluble], consisting of 
beryllium metal, alloys, or beryllium oxide; and mixed forms) 
associated with each job, department and year combination at each 
plant. Unpublished evaluations of these JEM estimates linked to the 
employee work histories in the NIOSH risk assessment study 
[Schubauer-Berigan et al., 2011b, Document ID 0521] show that the 
vast majority of beryllium work-time at all three of these 
facilities was due to either [poorly] soluble or mixed chemical 
forms. In fact, [poorly] soluble beryllium was the largest single 
contributor to work-time (for beryllium exposure of known solubility 
class) at the three facilities across most time periods . . . . 
Therefore, the strong and consistent exposure-response pattern that 
was observed in the published NIOSH studies was very likely 
associated with exposure to [poorly] soluble as well as soluble 
forms of beryllium. (Document ID 1725, p. 9)

    Taken collectively, the Agency finds that the epidemiological data 
presented in the reviewed studies provides sufficient evidence to 
demonstrate carcinogenicity in humans of both soluble and poorly 
soluble forms of beryllium.
3. Animal Cancer Studies
    This section reviews the animal literature used to support the 
findings for beryllium-induced lung cancer. Early animal studies 
revealed that some beryllium compounds are carcinogenic when inhaled 
(ATSDR, 2002, Document ID 1371). Lung tumors have been induced via 
inhalation and intratracheal administration of beryllium to rats and 
monkeys, and osteosarcomas have been induced via intravenous and 
intramedullary (inside the bone) injection of beryllium in rabbits and 
mice. In addition to lung cancer,

[[Page 2519]]

osteosarcomas have been produced in mice and rabbits exposed to various 
beryllium salts by intravenous injection or implantation into the bone 
(NTP, 1999, Document ID 1341: IARC, 2012 (0650)). While not completely 
understood, experimental studies in animals (in vitro and in vivo) have 
found that a number of mechanisms are likely involved in beryllium-
induced carcinogenicity, including chronic inflammation, genotoxicity, 
mitogenicity, oxidative stress, and epigenetic changes.
    In an inhalation study assessing the potential tumorigenicity of 
beryllium, Schepers et al. (1957) (Document ID 0458) exposed 115 albino 
Sherman and Wistar rats (male and female) via inhalation to 0.0357 mg 
beryllium/m\3\ (1 [gamma] beryllium/ft\3\) \7\ as an aqueous aerosol of 
beryllium sulfate for 44 hours/week for 6 months, and observed the rats 
for 18 months after exposure. Three to four control rats were killed 
every two months for comparison purposes. Seventy-six lung 
neoplasms,\8\ including adenomas, squamous-cell carcinomas, acinous 
adenocarcinomas, papillary adenocarcinomas, and alveolar-cell 
adenocarcinomas, were observed in 52 of the rats exposed to the 
beryllium sulfate aerosol. Adenocarcinomas were the most numerous. 
Pulmonary metastases tended to localize in areas with foam cell 
clustering and granulomatosis. No neoplasia was observed in any of the 
control rats. The incidence of lung tumors in exposed rats is presented 
in the following Table 3:
---------------------------------------------------------------------------

    \7\ Schepers et al. (1957) reported concentrations in [gamma] 
Be/ft\3\; however, [gamma]/ft\3\ is no longer a common unit. 
Therefore, the concentration was converted to mg/m\3\.
    \8\ While a total of 89 tumors were observed or palpated at the 
time of autopsy in the BeSO4-exposed animals, only 76 
tumors are listed as histologically neoplastic. Only the new growths 
identified in single midcoronal sections of both lungs were 
recorded.

       Table 3--Neoplasm Analysis, Based on Schepers et al. (1957)
------------------------------------------------------------------------
                    Neoplasm                       Number    Metastases
------------------------------------------------------------------------
Adenoma........................................         18             0
Squamous carcinoma.............................          5             1
Acinous adenocarcinoma.........................         24             2
Papillary adenocarcinoma.......................         11             1
Alveolar-cell adenocarcinoma...................          7             0
Mucigenous tumor...............................          7             1
Endothelioma...................................          1             0
Retesarcoma....................................          3             3
                                                ------------------------
    Total......................................         76             8
------------------------------------------------------------------------

    Schepers (1962) (Document ID 1414) reviewed 38 existing beryllium 
studies that evaluated seven beryllium compounds and seven mammalian 
species. Beryllium sulfate, beryllium fluoride, beryllium phosphate, 
beryllium alloy (BeZnMnSiO4), and beryllium oxide were 
proven to be carcinogenic. Ten varieties of tumors were observed, with 
adenocarcinoma being the most common variety.
    In another study, Vorwald and Reeves (1959) (Document ID 1482) 
exposed Sherman albino rats via the inhalation route to aerosols of 
0.006 mg beryllium/m\3\ as beryllium oxide and 0.0547 mg beryllium/m\3\ 
as beryllium sulfate for 6 hours/day, 5 days/week for an unspecified 
duration. Lung tumors (single or multifocal) were observed in the 
animals sacrificed following 9 months of daily inhalation exposure. The 
histologic pattern of the cancer was primarily adenomatous; however, 
epidermoid and squamous cell cancers were also observed. Infiltrative, 
vascular, and lymphogenous extensions often developed with secondary 
metastatic growth in the tracheobronchial lymph nodes, the mediastinal 
connective tissue, the parietal pleura, and the diaphragm.
    In the first of two articles, Reeves et al. (1967) investigated the 
carcinogenic process in lungs resulting from chronic (up to 72 weeks) 
beryllium sulfate inhalation (Document ID 1310). One hundred fifty male 
and female Sprague Dawley C.D. strain rats were exposed to beryllium 
sulfate aerosol at a mean atmospheric concentration of 34.25 [mu]g 
beryllium/m\3\ (with an average particle diameter of 0.12 [micro]m). 
Prior to initial exposure and again during the 67-68 and 75-76 weeks of 
life, the animals received prophylactic treatments of tetracycline-HCl 
to combat recurrent pulmonary infections.
    The animals entered the exposure chamber at 6 weeks of age and were 
exposed 7 hours per day/5 days per week for up to 2,400 hours of total 
exposure time. An equal number of unexposed controls were held in a 
separate chamber. Three male and three female rats were sacrificed 
monthly during the 72-week exposure period. Mortality due to 
respiratory or other infections did not appear until 55 weeks of age, 
and 87 percent of all animals survived until their scheduled 
sacrifices.
    Average lung weight towards the end of exposure was 4.25 times 
normal with progressively increasing differences between control and 
exposed animals. The increase in lung weight was accompanied by notable 
changes in tissue texture with two distinct pathological processes--
inflammatory and proliferative. The inflammatory response was 
characterized by marked accumulation of histiocytic elements forming 
clusters of macrophages in the alveolar spaces. The proliferative 
response progressed from early epithelial hyperplasia of the alveolar 
surfaces, through metaplasia (after 20-22 weeks of exposure), anaplasia 
(cellular dedifferentiation) (after 32-40 weeks of exposure), and 
finally to lung tumors.
    Although the initial proliferative response occurred early in the 
exposure period, tumor development required considerable time. Tumors 
were first identified after nine months of beryllium sulfate exposure, 
with rapidly increasing rates of incidence until tumors were observed 
in 100 percent of exposed animals by 13 months. The 9-to-13-month 
interval is consistent with earlier studies. The tumors showed a high 
degree of local invasiveness. No tumors were observed in control rats. 
All 56 tumors studied appeared to be alveolar adenocarcinomas and 3 
were ``fast-growing'' tumors that reached a very large size 
comparatively early. About one-third of the tumors showed small foci 
where the histologic pattern differed. Most of the early tumor foci 
appeared to be alveolar rather than bronchiolar, which is consistent 
with the expected pathogenesis, since permanent deposition of beryllium 
was more likely on the alveolar epithelium rather than on the 
bronchiolar epithelium. Female rats appeared to have an increased 
susceptibility to beryllium exposure. Not only did they have a higher 
mortality (control males [n = 8], exposed males [n = 9] versus control 
females [n = 4], exposed females [n = 17]) and body weight loss than 
male rats, but the three ``fast-growing'' tumors occurred in females.
    In the second article, Reeves et al. (1967) (Document ID 1309) 
described the rate of accumulation and clearance of beryllium sulfate 
aerosol from the same experiment (Reeves et al., 1967) (Document ID 
1310). At the time of the monthly sacrifice, beryllium assays were 
performed on the lungs, tracheobronchial lymph nodes, and blood of the 
exposed rats. The pulmonary beryllium levels of rats showed a rate of 
accumulation which

[[Page 2520]]

decreased during continuing exposure and reached a plateau (defined as 
equilibrium between deposition and clearance) of about 13.5 [mu]g 
beryllium for males and 9 [mu]g beryllium for females in whole lungs 
after approximately 36 weeks. Females were notably less efficient than 
males in utilizing the lymphatic route as a method of clearance, 
resulting in slower removal of pulmonary beryllium deposits, lower 
accumulation of the inhaled material in the tracheobronchial lymph 
nodes, and higher morbidity and mortality.
    There was no apparent correlation between the extent and severity 
of pulmonary pathology and total lung load. However, when the beryllium 
content of the excised tumors was compared with that of surrounding 
nonmalignant pulmonary tissues, the former showed a notable decrease 
(0.50  0.35 [mu]g beryllium/gram versus 1.50  
0.55 [mu]g beryllium/gram). This was believed to be largely a result of 
the dilution factor operating in the rapidly growing tumor tissue. 
However, other factors, such as lack of continued local deposition due 
to impaired respiratory function and enhanced clearance due to high 
vascularity of the tumor, may also have played a role. The portion of 
inhaled beryllium retained in the lungs for a longer duration, which is 
in the range of one-half of the original pulmonary load, may have 
significance for pulmonary carcinogenesis. This pulmonary beryllium 
burden becomes localized in the cell nuclei and may be an important 
factor in eliciting the carcinogenic response associated with beryllium 
inhalation.
    Groth et al. (1980) (Document ID 1316) conducted a series of 
experiments to assess the carcinogenic effects of beryllium, beryllium 
hydroxide, and various beryllium alloys. For the beryllium metal/alloys 
experiment, 12 groups of 3-month-old female Wistar rats (35 rats/group) 
were used. All rats in each group received a single intratracheal 
injection of either 2.5 or 0.5 mg of one of the beryllium metals or 
beryllium alloys as described in Table 3 below. These materials were 
suspended in 0.4 cc of isotonic saline followed by 0.2 cc of saline. 
Forty control rats were injected with 0.6 cc of saline. The geometric 
mean particle sizes varied from 1 to 2 [micro]m. Rats were sacrificed 
and autopsied at various intervals ranging from 1 to 18 months post-
injection.

                        Table 4--Summary of Beryllium Dose, Based on Groth et al. (1980)
                                               [Document ID 1316]
----------------------------------------------------------------------------------------------------------------
                                                  Percent other    Total Number      Compound
          Form of Be              Percent Be        compounds     rats autopsied     dose(mg)       Be dose(mg)
----------------------------------------------------------------------------------------------------------------
Be metal.....................  100.............  None...........              16             2.5             2.5
                                                                              21             0.5             0.5
Passivated Be metal..........  99..............  0.26% Chromium.              26             2.5             2.5
                                                                              20             0.5             0.5
BeAl alloy...................  62..............  38% Aluminum...              24             2.5            1.55
                                                                              21             0.5             0.3
BeCu alloy...................  4...............  96% Copper.....              28             2.5             0.1
                                                                              24             0.5            0.02
BeCuCo alloy.................  2.4.............  0.4% Cobalt....              33             2.5            0.06
                                                 96% Copper.....              30             0.5           0.012
BeNi alloy...................  2.2.............  97.8% Nickel...              28             2.5           0.056
                                                                              27             0.5           0.011
----------------------------------------------------------------------------------------------------------------

Lung tumors were observed only in rats exposed to beryllium metal, 
passivated beryllium metal, and beryllium-aluminum alloy. Passivation 
refers to the process of removing iron contamination from the surface 
of beryllium metal. As discussed, metal alloys may have a different 
toxicity than beryllium alone. Rats exposed to 100 percent beryllium 
exhibited relatively high mortality rates, especially in the groups 
where lung tumors were observed. Nodules varying from 1 to 10 mm in 
diameter were also observed in the lungs of rats exposed to beryllium 
metal, passivated beryllium metal, and beryllium-aluminum alloy. These 
nodules were suspected of being malignant.
    To test this hypothesis, transplantation experiments involving the 
suspicious nodules were conducted in nine rats. Seven of the nine 
suspected tumors grew upon transplantation. All transplanted tumor 
types metastasized to the lungs of their hosts. Lung tumors were 
observed in rats injected with both the high and low doses of beryllium 
metal, passivated beryllium metal, and beryllium-aluminum alloy. No 
lung tumors were observed in rats injected with the other compounds. Of 
a total of 32 lung tumors detected, most were adenocarcinomas and 
adenomas; however, two epidermoid carcinomas and at least one poorly 
differentiated carcinoma were observed. Bronchiolar alveolar cell 
tumors were frequently observed in rats injected with beryllium metal, 
passivated beryllium metal, and beryllium-aluminum alloy. All stages of 
cuboidal, columnar, and squamous cell metaplasia were observed on the 
alveolar walls in the lungs of rats injected with beryllium metal, 
passivated beryllium metal, and beryllium-aluminum alloy. These lesions 
were generally reduced in size and number or absent from the lungs of 
animals injected with the other alloys (BeCu, BeCuCo, BeNi).
    The extent of alveolar metaplasia could be correlated with the 
incidence of lung cancer. The incidences of lung tumors in the rats 
that received 2.5 mg of beryllium metal, and 2.5 and 0.5 mg of 
passivated beryllium metal, were significantly different (p <=0.008) 
from controls. When autopsies were performed at the 16-to-19-month 
interval, the incidence (2/6) of lung tumors in rats exposed to 2.5 mg 
of beryllium-aluminum alloy was statistically significant (p = 0.004) 
when compared to the lung tumor incidence (0/84) in rats exposed to 
BeCu, BeNi, and BeCuCo alloys, which contained much lower 
concentrations of Be (Groth et al., 1980, Document ID 1316).
    Finch et al. (1998b) (Document ID 1367) investigated the 
carcinogenic effects of inhaled beryllium on heterozygous TSG-p53 
knockout (p53 +/-) mice and wild-type (p53+/+) mice. 
Knockout mice can be valuable tools in determining the role played by 
specific genes in the toxicity of a material of interest, in this case 
beryllium. Equal numbers of approximately 10-week-old male and female 
mice were used for this study. Two exposure groups were used to provide 
dose-response information on lung carcinogenicity. The maximum initial 
lung burden (ILB) target of 60 [mu]g

[[Page 2521]]

beryllium was based on previous acute inhalation exposure studies in 
mice. The lower exposure target level of 15 [mu]g was selected to 
provide a lung burden significantly less than the high-level group, but 
high enough to yield carcinogenic responses. Mice were exposed in 
groups to beryllium metal or to filtered air (controls) via nose-only 
inhalation. The specific exposure parameters are presented in Table 4 
below. Mice were sacrificed 7 days post exposure for ILB analysis, and 
either at 6 months post exposure (n = 4-5 mice per group per gender) or 
when 10 percent or less of the original population remained (19 months 
post exposure for p53 +/- knockout and 22.5 months post 
exposure for p53+/+ wild-type mice). The sacrifice time was extended in 
the study because a significant number of lung tumors were not observed 
at 6 months post exposure.

                          Table 5--Summary of Animal Data, Based on Finch et al. (1998)
                                               [Document ID 1367]
----------------------------------------------------------------------------------------------------------------
                                                                                                     Number of
                                         Target                       Mean daily                    mice  with 1
                   Mean exposure     beryllium lung    Number of       exposure        Mean ILB     or more lung
 Mouse strain      concentration         burden           mice         duration        ([mu]g)      tumors/total
                    ([mu]g Be/L)         ([mu]g)                       (minutes)                       number
                                                                                                      examined
----------------------------------------------------------------------------------------------------------------
Knockout (p53   34                   15              30             112 (single)    NA             0/29
 +/-)           36                   60              30             139             NA             4/28
Wild-type (p53  34                   15              6              112 (single)    12  4      0/28
                                                                                    54  6
Knockout (p53   NA (air)             Control         30             60-180          NA             0/30
 +/-)                                                                (single)
----------------------------------------------------------------------------------------------------------------

    Lung burdens of beryllium measured in wild-type mice at 7 days post 
exposure were approximately 70-90 percent of target levels. No 
exposure-related effects on body weight were observed in mice; however, 
lung weights and lung-to-body-weight ratios were somewhat elevated in 
60 [mu]g target ILB p53 +/- knockout mice compared to 
controls (0.05 +/- knockout mice and beryllium exposure 
tended to decrease survival time in both groups. The incidence of 
beryllium-induced lung tumors was marginally higher in the 60 [mu]g 
target ILB p53 +/- knockout mice compared to 60 [mu]g target 
ILB p53+/+ wild-type mice (p= 0.056). The incidence of lung tumors in 
the 60 [mu]g target ILB p53 +/- knockout mice was also 
significantly higher than controls (p = 0.048). No tumors developed in 
the control mice, 15 [mu]g target ILB p53 +/- knockout mice, 
or 60 [mu]g target ILB p53+/+ wild-type mice throughout the length of 
the study. Most lung tumors in beryllium-exposed mice were squamous 
cell carcinomas, three of four of which were poorly circumscribed and 
all of which were associated with at least some degree of granulomatous 
pneumonia. The study results suggest that having an inactivated p53 
allele is associated with lung tumor progression in p53 +/- 
knockout mice. This is based on the significant difference seen in the 
incidence of beryllium-induced lung neoplasms for the p53 
+/- knockout mice compared with the p53 \+/+\ wild-type 
mice. The authors conclude that since there was a relatively late onset 
of tumors in the beryllium-exposed p53 +/- knockout mice, a 
6-month bioassay in this mouse strain might not be an appropriate model 
for lung carcinogenesis (Finch et al., 1998, Document ID 1367).
    During the public comment period Materion submitted correspondence 
from Dr. Finch speculating on the reason for the less-robust lung 
cancer response observed in mice (versus that observed in rats) 
(Document ID 1807, Attachment 11, p. 1). Materion contended that this 
was support for their assertion of evidence that ``directly contradicts 
the claims that beryllium metal causes cancer in animals'' (Document ID 
1807, p. 6). OSHA reviewed this correspondence and disagrees with 
Materion's assertion. While Dr. Finch did suggest that the mouse lung 
cancer response was less robust, it was still present. Dr. Finch went 
on to suggest that while the rat has a more profound neutrophilic 
response (typical of a ``foreign body response), the mouse has a lung 
response more typical of humans (neutrophilic and lymphocytic) 
(Document ID 1807, Attachment 11, p. 1).
    Nickell-Brady et al. (1994) investigated the development of lung 
tumors in 12-week-old F344/N rats after a single nose-only inhalation 
exposure to beryllium aerosol, and evaluated whether beryllium lung 
tumor induction involves alterations in the K-ras, p53, and c-raf-1 
genes (Document ID 1312). Four groups of rats (30 males and 30 females 
per group) were exposed to different mass concentrations of beryllium 
(Group 1: 500 mg/m\3\ for 8 min; Group 2: 410 mg/m\3\ for 30 min; Group 
3: 830 mg/m\3\ for 48 min; Group 4: 980 mg/m\3\ for 39 min). The 
beryllium mass median aerodynamic diameter was 1.4 [mu]m 
([sigma]g= 1.9). The mean beryllium lung burdens for each 
exposure group were 40, 110, 360, and 430 [mu]g, respectively.
    To examine genetic alterations, DNA isolation and sequencing 
techniques (PCR amplification and direct DNA sequence analysis) were 
performed on wild-type rat lung tissue (i.e., control samples) along 
with two mouse lung tumor cell lines containing known K-ras mutations, 
12 carcinomas induced by beryllium (i.e., experimental samples), and 12 
other formalin-fixed specimens. Tumors appeared in beryllium-exposed 
rats by 14 months, and 64 percent of exposed rats developed lung tumors 
during their lifetime. Lungs frequently contained multiple tumor sites, 
with some of the tumors greater than 1 cm. A total of 24 tumors were 
observed. Most of the tumors (n = 22) were adenocarcinomas exhibiting a 
papillary pattern characterized by cuboidal or columnar cells, although 
a few had a tubular or solid pattern. Fewer than 10 percent of the 
tumors were adenosquamous (n = 1) or squamous cell (n = 1) carcinomas.
    No transforming mutations of the K-ras gene (codons 12, 13, or 61) 
were detected by direct sequence analysis in any of the lung tumors 
induced by beryllium. However, using a more sensitive sequencing 
technique (PCR enrichment restriction fragment length polymorphism 
(RFLP) analysis) resulted in the detection of K-ras codon 12 GGT to GTT 
transversions in 2 of 12 beryllium-induced adenocarcinomas. No p53 or 
c-raf-1 alterations were observed in any of the tumors induced by 
beryllium exposure (i.e., no differences observed between beryllium-
exposed and control rat tissues). The authors note that the results 
suggest that

[[Page 2522]]

activation of the K-ras proto-oncogene is both a rare and late event, 
possibly caused by genomic instability during the progression of 
beryllium-induced rat pulmonary adenocarcinomas. It is unlikely that 
the K-ras gene plays a role in the carcinogenicity of beryllium. The 
results also indicate that p53 mutation is unlikely to play a role in 
tumor development in rats exposed to beryllium.
    Belinsky et al. (1997) reviewed the findings by Nickell-Brady et 
al. (1994) (Document ID 1312) to further examine the role of the K-ras 
and p53 genes in lung tumors induced in the F344 rat by non-mutagenic 
(non-genotoxic) exposures to beryllium. Their findings are discussed 
along with the results of other genomic studies that look at 
carcinogenic agents that are either similarly non-mutagenic or, in 
other cases, mutagenic. The authors concluded that the identification 
of non-ras transforming genes in rat lung tumors induced by non-
mutagenic exposures, such as beryllium, as well as mutagenic exposures 
will help define some of the mechanisms underlying cancer induction by 
different types of DNA damage.
    The inactivation of the p16 INK4a(p16) gene is a contributing 
factor in disrupting control of the normal cell cycle and may be an 
important mechanism of action in beryllium-induced lung tumors. 
Swafford et al. (1997) investigated the aberrant methylation and 
subsequent inactivation of the p16 gene in primary lung tumors induced 
in F344/N rats exposed to known carcinogens via inhalation (Document ID 
1392). The research involved a total of 18 primary lung tumors that 
developed after exposing rats to five agents, one of which was 
beryllium. In this study, only one of the 18 lung tumors was induced by 
beryllium exposure; the majority of the other tumors were induced by 
radiation (x-rays or plutonium-239 oxide). The authors hypothesized 
that if p16 inactivation plays a central role in development of non-
small-cell lung cancer, then the frequency of gene inactivation in 
primary tumors should parallel that observed in the corresponding cell 
lines. To test the hypothesis, a rat model for lung cancer was used to 
determine the frequency and mechanism for inactivation of p16 in 
matched primary lung tumors and derived cell lines. The methylation-
specific PCR (MSP) method was used to detect methylation of p16 
alleles. The results showed that the presence of aberrant p16 
methylation in cell lines was strongly correlated with absent or low 
expression of the gene. The findings also demonstrated that aberrant 
p16 CpG island methylation, an important mechanism in gene silencing 
leading to the loss of p16 expression, originates in primary tumors.
    Building on the rat model for lung cancer and associated findings 
from Swafford et al. (1997) (Document ID 1392), Belinsky et al. (2002) 
(Document ID 1300) conducted experiments in 12-week-old F344/N rats 
(male and female) to determine whether beryllium-induced lung tumors 
involve inactivation of the p16 gene and estrogen receptor [alpha] (ER) 
gene. Rats received a single nose-only inhalation exposure to beryllium 
aerosol at four different exposure levels. The mean lung burdens 
measured in each exposure group were 40, 110, 360, and 430 [mu]g. The 
methylation status of the p16 and ER genes was determined by MSP. A 
total of 20 tumors detected in beryllium-exposed rats were available 
for analysis of gene-specific promoter methylation. Three tumors were 
classified as squamous cell carcinomas and the others were determined 
to be adenocarcinomas. Methylated p16 was present in 80 percent (16/
20), and methylated ER was present in one-half (10/20), of the lung 
tumors induced by exposure to beryllium. Additionally, both genes were 
methylated in 40 percent of the tumors. The authors noted that four 
tumors from beryllium-exposed rats appeared to be partially methylated 
at the p16 locus. Bisulfite sequencing of exon 1 of the ER gene was 
conducted on normal lung DNA and DNA from three methylated, beryllium-
induced tumors to determine the density of methylation within amplified 
regions of exon 1 (referred to as CpG sites). Two of the three 
methylated, beryllium-induced lung tumors showed extensive methylation, 
with more than 80 percent of all CpG sites methylated.
    The overall findings of this study suggest that inactivation of the 
p16 and ER genes by promoter hypermethylation are likely to contribute 
to the development of lung tumors in beryllium-exposed rats. The 
results showed a correlation between changes in p16 methylation and 
loss of gene transcription. The authors hypothesize that the mechanism 
of action for beryllium-induced p16 gene inactivation in lung tumors 
may be inflammatory mediators that result in oxidative stress. The 
oxidative stress damages DNA directly through free radicals or 
indirectly through the formation of 8-hydroxyguanosine DNA adducts, 
resulting primarily in a single-strand DNA break.
    Wagner et al. (1969) (Document ID 1481) studied the development of 
pulmonary tumors after intermittent daily chronic inhalation exposure 
to beryllium ores in three groups of male squirrel monkeys. One group 
was exposed to bertrandite ore, a second to beryl ore, and the third 
served as unexposed controls. Each of these three exposure groups 
contained 12 monkeys. Monkeys from each group were sacrificed after 6, 
12, or 23 months of exposure. The 12-month sacrificed monkeys (n = 4 
for bertrandite and control groups; n = 2 for beryl group) were 
replaced by a separate replacement group to maintain a total animal 
population approximating the original numbers and to provide a source 
of confirming data for biologic responses that might arise following 
the ore exposures. Animals were exposed to bertrandite and beryl ore 
concentrations of 15 mg/m\3\, corresponding to 210 [mu]g beryllium/m\3\ 
and 620 [mu]g beryllium/m\3\ in each exposure chamber, respectively. 
The parent ores were reduced to particles with geometric mean diameters 
of 0.27 [mu]m ( 2.4) for bertrandite and 0.64 [mu]m ( 2.5) for beryl. Animals were exposed for approximately 6 hours/
day, 5 days/week. The histological changes in the lungs of monkeys 
exposed to bertrandite and beryl ore exhibited a similar pattern. The 
changes generally consisted of aggregates of dust-laden macrophages, 
lymphocytes, and plasma cells near respiratory bronchioles and small 
blood vessels. There were, however, no consistent or significant 
pulmonary lesions or tumors observed in monkeys exposed to either of 
the beryllium ores. This is in contrast to the findings in rats exposed 
to beryl ore and to a lesser extent bertrandite, where atypical cell 
proliferation and tumors were frequently observed in the lungs. The 
authors hypothesized that the rats' greater susceptibility may be 
attributed to the spontaneous lung disease characteristic of rats, 
which might have interfered with lung clearance.
    As previously described, Conradi et al. (1971) investigated changes 
in the lungs of monkeys and dogs two years after intermittent 
inhalation exposure to beryllium oxide calcined at 1,400 [deg]C 
(Document ID 1319). Five adult male and female monkeys (Macaca irus) 
weighing between 3 and 5.75 kg were used in the study. The study 
included two control monkeys. Beryllium concentrations in the 
atmosphere of whole-body exposed monkeys varied between 3.30 and 4.38 
mg/m\3\. Thirty-minute exposures occurred once a month for three 
months, with beryllium oxide concentrations increasing at each exposure 
interval. Lung tissue was investigated using electron microscopy

[[Page 2523]]

and morphometric methods. Beryllium content in portions of the lungs of 
five monkeys was measured two years following exposure by emission 
spectrography. The reported concentrations in monkeys (82.5, 143.0, and 
112.7 [mu]g beryllium per 100 gm of wet tissue in the upper lobe, lower 
lobe, and combined lobes, respectively) were higher than those in dogs. 
No neoplastic or granulomatous lesions were observed in the lungs of 
any exposed animals and there was no evidence of chronic proliferative 
lung changes after two years.
    To summarize, animal studies show that multiple forms of beryllium, 
when inhaled or instilled in the respiratory tract of rats, mice, and 
monkeys, lead to increased incidence of lung tumors. Animal studies 
have demonstrated a consistent scenario of beryllium exposure resulting 
in chronic pulmonary inflammation and tumor formation at levels below 
overload conditions (Groth et al., 1980, Document ID 1316; Finch et 
al., 1998 (1367); Nickel-Brady et al., 1994 (1312)). The animal studies 
support the human epidemiological evidence and contributed to the 
findings of the NTP, IARC, and others that beryllium and beryllium-
containing material should be regarded as known human carcinogens. The 
beryllium compounds found to be carcinogenic in animals include both 
soluble beryllium compounds, such as beryllium sulfate and beryllium 
hydroxide, as well as poorly soluble beryllium compounds, such as 
beryllium oxide and beryllium metal. The doses that produce tumors in 
experimental animal are fairly large and also lead to chronic pulmonary 
inflammation. The exact tumorigenic mechanism for beryllium is unclear 
and a number of mechanisms are likely involved, including chronic 
inflammation, genotoxicity, mitogenicity, oxidative stress, and 
epigenetic changes.
4. In Vitro Studies
    The exact mechanism by which beryllium induces pulmonary neoplasms 
in animals remains unknown (NAS 2008, Document ID 1355). Keshava et al. 
(2001) performed studies to determine the carcinogenic potential of 
beryllium sulfate in cultured mammalian cells (Document ID 1362). 
Joseph et al. (2001) investigated differential gene expression to 
understand the possible mechanisms of beryllium-induced cell 
transformation and tumorigenesis (Document ID 1490). Both 
investigations used cell transformation assays to study the cellular/
molecular mechanisms of beryllium carcinogenesis and assess 
carcinogenicity. Cell lines were derived from tumors developed in nude 
mice injected subcutaneously with non-transformed BALB/c-3T3 cells that 
were morphologically transformed in vitro with 50-200 [mu]g beryllium 
sulfate/ml for 72 hours. The non-transformed cells were used as 
controls.
    Keshava et al. (2001) found that beryllium sulfate is capable of 
inducing morphological cell transformation in mammalian cells and that 
transformed cells are potentially tumorigenic (Document ID 1362). A 
dose-dependent increase (9-41 fold) in transformation frequency was 
noted. Using differential polymerase chain reaction (PCR), gene 
amplification was investigated in six proto-oncogenes (K-ras, c-myc, c-
fos, c-jun, c-sis, erb-B2) and one tumor suppressor gene (p53). Gene 
amplification was found in c-jun and K-ras. None of the other genes 
tested showed amplification. Additionally, Western blot analysis showed 
no change in gene expression or protein level in any of the genes 
examined. Genomic instability in both the non-transformed and 
transformed cell lines was evaluated using random amplified polymorphic 
DNA fingerprinting (RAPD analysis). Using different primers, 5 of the 
10 transformed cell lines showed genomic instability when compared to 
the non-transformed BALB/c-3T3 cells. The results indicate that 
beryllium sulfate-induced cell transformation might, in part, involve 
gene amplification of K-ras and c-jun and that some transformed cells 
possess neoplastic potential resulting from genomic instability.
    Using the Atlas mouse 1.2 cDNA expression microarrays, Joseph et 
al. (2001) studied the expression profiles of 1,176 genes belonging to 
several different functional categories after beryllium sulfate 
exposure in a mouse cell line (Document ID 1490). Compared to the 
control cells, expression of 18 genes belonging to two functional 
groups (nine cancer-related genes and nine DNA synthesis, repair, and 
recombination genes) was found to be consistently and reproducibly 
different (at least 2-fold) in the tumor cells. Differential gene 
expression profile was confirmed using reverse transcription-PCR with 
primers specific to the differentially expressed genes. Two of the 
differentially expressed genes (c-fos and c-jun) were used as model 
genes to demonstrate that the beryllium-induced transcriptional 
activation of these genes was dependent on pathways of protein kinase C 
and mitogen-activated protein kinase and independent of reactive oxygen 
species in the control cells. These results indicate that beryllium-
induced cell transformation and tumorigenesis are associated with up-
regulated expression of the cancer-related genes (such as c-fos, c-jun, 
c-myc, and R-ras) and down-regulated expression of genes involved in 
DNA synthesis, repair, and recombination (such as MCM4, MCM5, PMS2, 
Rad23, and DNA ligase I).
    In summary, in vitro studies have been used to evaluate the 
neoplastic potential of beryllium compounds and the possible underlying 
mechanisms. Both Keshava et al. (2001) (Document ID 1362) and Joseph et 
al. (2001) (Document ID 1490) have found that beryllium sulfate induced 
a number of onco-genes (c-fos, c-jun, c-myc, and R-ras) and down-
regulated genes responses for normal cellular function and repair 
(including those involved in DNA synthesis, repair, and recombination).
5. Lung Cancer Conclusions
    OSHA has determined that substantial evidence in the record 
indicates that beryllium compounds should be regarded as occupational 
lung carcinogens. Many well-respected scientific organizations, 
including IARC, NTP, EPA, NIOSH, and ACGIH, have reached similar 
conclusions with respect to the carcinogenicity of beryllium.
    While some evidence exists for direct-acting genotoxicity as a 
possible mechanism for beryllium carcinogenesis, the weight of evidence 
suggests that an indirect mechanism, such as inflammation or other 
epigenetic changes, may be responsible for most tumorigenic activity of 
beryllium in animals and humans (IARC, 2012, Document ID 0650). 
Inflammation has been postulated to be a key contributor to many 
different forms of cancer (Jackson et al., 2006; Pikarsky et al., 2004; 
Greten et al., 2004; Leek, 2002). In fact, chronic inflammation may be 
a primary factor in the development of up to one-third of all cancers 
(Ames et al., 1990; NCI, 2010).
    In addition to a T-cell-mediated immunological response, beryllium 
has been demonstrated to produce an inflammatory response in animal 
models similar to the response produced by other particles (Reeves et 
al., 1967, Document ID 1309; Swafford et al., 1997 (1392); Wagner et 
al., 1969 (1481)), possibly contributing to its carcinogenic potential. 
Studies conducted in rats have demonstrated that chronic inhalation of 
materials similar in solubility to beryllium results in increased 
pulmonary inflammation,

[[Page 2524]]

fibrosis, epithelial hyperplasia, and, in some cases, pulmonary 
adenomas and carcinomas (Heinrich et al., 1995, Document ID 1513; NTP, 
1993 (1333); Lee et al., 1985 (1466); Warheit et al., 1996 (1377)). 
This response is generally referred to as an ``overload'' response and 
is specific to particles of low solubility with a low order of 
toxicity, which are non-mutagenic and non-genotoxic (i.e., poorly 
soluble particles like titanium dioxide and non-asbestiform talc); this 
response is observed only in rats (Carter et al., 2006, Document ID 
1556). ``Overload'' is described in ECETOC (2013) as inhalation of high 
concentrations of low solubility particles resulting in lung burdens 
that impair particle clearance mechanisms (ECETOC, 2013 as cited in 
Document ID 1807, Attachment 10, p. 3 (pdf p. 87)). Substantial data 
indicate that tumor formation in rats after exposure to some poorly 
soluble particles at doses causing marked, chronic inflammation is due 
to a secondary mechanism unrelated to the genotoxicity (or lack 
thereof) of the particle itself. Because these specific particles 
(i.e., titanium dioxide and non-asbestiform talc) exhibit no 
cytotoxicity or genotoxicity, they are considered to be biologically 
inert (ECETOC, 2013; see Document ID 1807, Attachment 10, p. 3 (pdf p. 
87)). Animal studies, as summarized above, have demonstrated a 
consistent scenario of beryllium exposure resulting in chronic 
pulmonary inflammation below an overload scenario. NIOSH submitted 
comments describing the findings from a low-dose study of beryllium 
metal among male and female F344 rats (Document ID 1960, p. 11). The 
study by Finch et al. (2000) indicated lung tumor rates of 4, 4, 12, 
50, 61, and 91 percent in animals with beryllium metal lung burdens of 
0, 0.3, 1, 3, 10, and 50 [mu]g respectively (Finch et al., 2000 as 
cited in Document ID 1960, p. 11). NIOSH noted the lung burden levels 
were much lower than those from previous studies, such as a 1998 Finch 
et al. study with initial lung burdens of 15 and 60 [mu]g (Document ID 
1960, p. 11). Based on evidence from mammalian studies of the 
mutagenicity and genotoxicity of beryllium (as described in above in 
section V.E.1) and the evidence of tumorigenicity at lung burden levels 
well below overload, OSHA concludes that beryllium particles are not 
poorly soluble particles like titanium dioxide and non-asbestiform 
talc.
    It has been hypothesized that the recruitment of neutrophils during 
the inflammatory response and subsequent release of oxidants from these 
cells play an important role in the pathogenesis of rat lung tumors 
(Borm et al., 2004, Document ID 1559; Carter and Driscoll, 2001 (1557); 
Carter et al., 2006 (1556); Johnston et al., 2000 (1504); Knaapen et 
al., 2004 (1499); Mossman, 2000 (1444)). This is one potential 
carcinogenic pathway for beryllium particles. Inflammatory mediators, 
acting at levels below overload doses as characterized in many of the 
studies summarized above, have been shown to play a significant role in 
the recruitment of cells responsible for the release of reactive oxygen 
and hydrogen species. These species have been determined to be highly 
mutagenic as well as mitogenic, inducing a proliferative response 
(Ferriola and Nettesheim, 1994, Document ID 0452; Coussens and Werb, 
2002 (0496)). The resultant effect is an environment rich for 
neoplastic transformations and the progression of fibrosis and tumor 
formation. This is consistent with findings from the National Cancer 
Institute, which has estimated that one-third of all cancers may be due 
to chronic inflammation (NCI, 2010, Document ID 0532). However, an 
inflammation-driven contribution to the neoplastic transformation does 
not imply no risk at levels below inflammatory response; rather, the 
overall weight of evidence suggests a mechanism of an indirect 
carcinogen at levels where inflammation is seen. While tumorigenesis 
secondary to inflammation is one reasonable mode of action, other 
plausible modes of action independent of inflammation (e.g., 
epigenetic, mitogenic, reactive oxygen mediated, indirect genotoxicity, 
etc.) may also contribute to the lung cancer associated with beryllium 
exposure. As summarized above, animal studies have consistently 
demonstrated beryllium exposure resulting in chronic pulmonary 
inflammation below overload conditions in multiple species (Groth et 
al., 1980, Document ID 1316; Finch et al., 1998 (1367); Nickel-Brady et 
al., 1994 (1312)). While OSHA recognizes chronic inflammation as one 
potential pathway to carcinogencity the Agency finds that other 
carcinogenic pathways such as genotoxicity and epigenetic changes may 
also contribute to beryllium-induced carcinogenesis.
    During the public comment period OSHA received several comments on 
the carcinogenicity of beryllium. The NFFS agreed with OSHA that ``the 
science is quite clear in linking these soluble Beryllium compounds'' 
to lung cancer (Document ID 1678, p. 6). It also, however, contended 
that there is considerable scientific dispute regarding the 
carcinogenicity of beryllium metal (i.e., poorly soluble beryllium), 
citing findings by the EU's REACH Beryllium Commission (later clarified 
as the EU Beryllium Science and Technology Association) (Document ID 
1785, p. 1; Document ID 1814) and a study by Strupp and Furnes (2010) 
(Document ID 1678, pp. 6-7, and Attachment 1). Materion, similarly, 
commented that ``[a] report conclusion during the recent review of the 
European Cancer Directive for the European Commission stated regarding 
beryllium: `There was little evidence for any important health impact 
from current or recent past exposures in the EU' '' (Document ID 1958, 
p. 4).
    The contentions of both Materion and NFFS regarding scientific 
findings from the EU is directly contradicted by the document submitted 
to the docket by the European Commission on Health, Safety and Hygiene 
at Work, discussed above. This document states that the European 
Chemicals Agency (ECHA) has determined that all forms of beryllium 
(soluble and poorly soluble) are carcinogenic (Category 1B) with the 
exception of aluminum beryllium silicates (which have not been 
allocated a classification) (Document ID 1692, pp. 2-3).
    OSHA also disagrees with NFFS's other contention that there is a 
scientific dispute regarding the carcinogenicity of poorly soluble 
forms of beryllium. In coming to the conclusion that all forms of 
beryllium and beryllium compounds are carcinogenic, OSHA independently 
evaluated the scientific literature, including the findings of 
authoritative entities such as NIOSH, NTP, EPA, and IARC (see section 
V.E). The evidence from human, animal, and mechanistic studies together 
demonstrates that both soluble and poorly soluble beryllium compounds 
are carcinogenic (see sections V.E.2, V.E.3, V.E.4). The well-respected 
scientific bodies mentioned above came to the same conclusion: That 
both soluble and poorly soluble beryllium compounds are carcinogenic to 
humans.
    As supporting documentation the NFFS submitted an ``expert 
statement'' by Strupp and Furnes (2010), which reviews the 
toxicological and epidemiological information regarding beryllium 
carcinogenicity. Based on select information in the scientific 
literature on lung cancer, the Strupp and Furnes (2010) study concluded 
that there was insufficient evidence in humans and animals to conclude 
that insoluble (poorly soluble) beryllium was carcinogenic (Document ID 
1678, Attachment 1, pp. 21-23). Strupp and Furnes (2010) asserted that 
this was based on criteria established under

[[Page 2525]]

Annex VI of Directive 67/548/EEC which establishes criteria for 
classification and labelling of hazardous substances under the UN 
Globally Harmonized System of Classification and Labelling of Chemicals 
(GHS). OSHA reviewed the Strupp and Furnes (2010) ``expert statement'' 
submitted by NFFS and found it to be unpersuasive. Its review of the 
epidemiological evidence mischaracterized the findings from the NIOSH 
cohort and the nested case-control studies (Ward et al., 1992; 
Sanderson et al., 2001; Schubauer-Berigan et al., 2008) and 
misunderstood the methods commonly used to analyze occupational cohort 
studies (Document ID 1725, pp. 27-28).
    The Strupp and Furnes statement also did not include the more 
recent studies by Schubauer-Berigan et al. (2011, Document ID 1815, 
Attachment 105, 2011 (0626)), which demonstrated elevated rates for 
lung cancer (SMR 1.17; 95% CI 1.08 to 1.28) in a study of 7 beryllium 
processing plants. In addition, Strupp and Furnes did not consider 
expert criticism from IARC on the studies by Levy et al. (2007) and 
Deubner et al., (2007), which formed the basis of their findings. NIOSH 
submitted comments that stated:

    The Strupp (2011b) review of the epidemiological evidence for 
lung carcinogenicity of beryllium contained fundamental 
mischaracterizations of the findings of the NIOSH cohort and nested 
case-control studies (Ward et al. 1992; Sanderson et al. 2001; 
Schubauer-Berigan et al. 2008), as well as an apparent 
misunderstanding of the methods commonly used to analyze 
occupational cohort studies (Document ID 1960, Attachment 2, p. 10).

As further noted by NIOSH:

    Strupp's epidemiology summary mentions two papers that were 
critical of the Sanderson et al. (2001) nested case-control study. 
The first of these, Levy et al. (2007a), was a re-analysis that 
incorporated a nonstandard method of selecting control subjects and 
the second, Deubner et al. (2007), was a simulation study designed 
to evaluate Sanderson's study design. Both of these papers have 
themselves been criticized for using faulty methods (Schubauer-
Berigan et al. 2007; Kriebel, 2008; Langholz and Richardson, 2008); 
however, Strupp's coverage of this is incomplete. (Document ID 1960, 
Attachment 2, Appendix, p. 19).

    NIOSH went on to state that while the Sanderson et al. (2001) used 
standard accepted methods for selecting the control group, the Deubner 
et al. (2007) study limited control group eligibility and failed to 
adequately match control and case groups (Document ID 1960, Attachment 
2, Appendix, pp. 19-20). NIOSH noted that an independent analysis 
published by Langholz and Richardson (2009) and Hein et al., (2009) (as 
cited in Document ID 1960, Attachment 2, Appendix, p. 20) found that 
Levy et al.'s method of eliminating controls from the study had the 
effect of ``always produc[ing] downwardly biased effect estimates and 
for many scenarios the bias was substantial.'' (Document ID 1960, 
Attachment 2, Appendix, p. 20). NIOSH went on to cite numerous errors 
in the studies cited by Strupp (2011) (Document ID 1794, 1795).\9\ OSHA 
finds NIOSH's criticisms of the Strupp (2011) studies as well as their 
criticism of studies by Levy et al., 2007 and Deubner et al., 2007 to 
be reliable and credible.
---------------------------------------------------------------------------

    \9\ Strupp and Furnes was the background information for the 
Strupp (2011) publications (Document ID, Attachment 2, Appendix, p. 
20).
---------------------------------------------------------------------------

    The Strupp and Furnes (2010) statement provided insufficient 
information on the extraction of beryllium metal for OSHA to fully 
evaluate the merit of the studies regarding potential genotoxicity of 
poorly soluble beryllium (Document ID 1678, Attachment 1, pp. 18-20). 
In addition, Strupp and Furnes did not consider the peer-reviewed 
published studies evaluating the genotoxicity of beryllium metal (see 
section V.E.1 and V.E.2).
    In coming to the conclusion that the evidence is insufficient for 
classification under GHS, Strupp and Furnes failed to consider the full 
weight of evidence in their evaluation using the criteria set forth 
under Annex VI of Directive 67/548/EEC which establishes criteria for 
classification and labelling of hazardous substances under the UN 
Globally Harmonized System of Classification and Labelling of Chemicals 
(GHS) (Document ID 1678, attachment 1, pp. 21-23). Thus, the Agency 
concludes that the Strupp and Furnes statement does not constitute the 
best available scientific evidence for the evaluation of whether poorly 
soluble forms of beryllium cause cancer.
    Materion also submitted comments indicating there is an ongoing 
scientific debate regarding the relevance of the rat lung tumor 
response to humans with respect to poorly soluble beryllium compounds 
(Document ID 1807, Attachment 10, pp. 1-3 (pdf pp. 85-87)), Materion 
contended that the increased lung cancer risk in beryllium-exposed 
animals is due to a particle overload phenomenon, in which lung 
clearance of beryllium particles initiates a non-specific neutrophilic 
response that results in intrapulmonary lung tumors. The materials 
cited by Materion as supportive of its argument--Obedorster (1995), a 
2009 working paper to the UN Subcommittee on the Globally Harmonized 
System of Classification and Labelling of Chemicals (citing ILSI (2000) 
as supporting evidence for poorly soluble particles), Snipes (1996), 
the Health Risk Assessment Guidance for Metals, ICMM (2007), and ECETOC 
(2013)--discuss the inhalation of high exposure levels of poorly 
soluble particles in rats and the relevance of these studies to the 
human carcinogenic response (Document ID 1807, Attachment 10, pp. 1-3 
(pdf pp. 85-87)). Using particles such as titanium dioxide, carbon 
black, non-asbestiform talc, coal dust, and diesel soot as models, ILSI 
(2000) and ECETOC (2013) describe studies that have demonstrated that 
chronic inhalation of poorly soluble particles can result in pulmonary 
inflammation, fibrosis, epithelial cell hyperplasia, and adenomas and 
carcinomas in rats at exposure levels that exceed lung clearance 
mechanisms (the ``overload'' phenomenon) (ILSI (2000) \10\, p. 2, as 
cited in Document ID 1807, Attachment 10, pp. 1-3 (pdf pp. 85-87)).
---------------------------------------------------------------------------

    \10\ It is important to note that the ILSI report states that in 
interpreting data from rat studies alone, ``in the absence of 
mechanistic data to the contrary it must be assumed that the rat 
model can identify potential hazards to humans'' (ILSI, 2000, p. 2, 
as cited in Document ID 1807, Attachment 10, p. 1 (pdf p. 85)). The 
report by Oberdorster has similar language to the ILSI report (see 
Document ID 1807, Attachment 10, pp. 1, 3 (pdf pp. 85, 87). It 
should also be noted that the working paper to the UN Subcommittee 
on the Globally Harmonized System of Classification and Labelling of 
Chemicals, which cited ILSI (2000), was not adopted and has not been 
included in any revision to the GHS (http://www.unece.org/fileadmin/DAM/trans/doc/2009/ac10c4/ST-SG-AC10-C4-34e.pdf).
---------------------------------------------------------------------------

    However, these expert reports indicate that the ``overload'' 
phenomenon caused by biologically inert particles (poorly soluble 
particles of low cytotoxicity for which there is no evidence of 
genotoxicity) is relevant only to the rat species. (Document ID 1807, 
Attachment 10, pp. 1-3 (pdf pp. 85-87)). OSHA finds that this model is 
not in keeping with the data presented for beryllium for several 
reasons. First, beryllium has been shown to be a ``biologically 
active'' particle due to its ability to induce an immune response in 
multiple species including humans, has been shown to be genotoxic in 
certain mammalian test systems, and induces epigenetic changes (e.g. 
DNA methylation) (as described in detail in sections V. D. 6, V.E.1, 
V.E.3 and V.E.4). Second, beryllium has been shown to produce lung 
tumors after inhalation or instillation in several animal species, 
including rats, mice, and monkeys (Finch et al., 1998, Document ID 
1367; Schepers et al., 1957 (0458) and 1962 (1414); Wagner et al., 1969 
(1481); Belinsky et al., 2002 (1300); Groth et al.,

[[Page 2526]]

1980 (1316); Vorwald and Reeves, 1957 (1482); Nickell-Brady et al., 
1994 (1312); Swafford et al., 1997 (1392); IARC, 2012 (1355)). In 
addition, poorly soluble beryllium has been demonstrated to produce 
chronic inflammation at levels below overload (Groth et al., 1980, 
Document ID 1316; Nickell-Brady et al., 1994 (1312); Finch et al., 1998 
(1367); Finch et al., 2000 (as cited in Document ID 1960, p. 11)).
    In addition, IARC and NAS performed an extensive review of the 
available animal studies and their findings were supportive of the OSHA 
findings of carcinogenicity (IARC, 2012, Document ID 0650; NAS, 2008 
(1355)). OSHA performed an independent evaluation as outlined in 
section V.E.3 and found sufficient evidence of tumor formation in 
multiple species (rats, mice, and monkeys) after inhalation at levels 
below overload conditions. The Agency has found evidence supporting the 
hypothesis that multiple mechanisms may be at work in the development 
of cancer in experimental animals and humans and cannot dismiss the 
roles of inflammation (neutrophilic and T-cell mediated), genotoxicity, 
and epigenetic factors (see section V.E.1, V.E. 3, V.E.4). After 
evaluating the best scientific evidence available from epidemiological 
and animal studies (see section V.E) OSHA concludes the weight of 
evidence supports a mechanistic finding that both soluble and poorly 
soluble forms of beryllium and beryllium-containing compounds are 
carcinogenic.

F. Other Health Effects

    Past studies on other health effects have been thoroughly reviewed 
by several scientific organizations (NTP, 1999, Document ID 1341; EPA, 
1998 (0661); ATSDR, 2002 (1371); WHO, 2001 (1282); HSDB, 2010 (0533)). 
These studies include summaries of animal studies, in vitro studies, 
and human epidemiological studies associated with cardiovascular, 
hematological, hepatic, renal, endocrine, reproductive, ocular and 
mucosal, and developmental effects. High-dose exposures to beryllium 
have been shown to have an adverse effect upon a variety of organs and 
tissues in the body, particularly the liver. The adverse systemic 
effects on humans mostly occurred prior to the introduction of 
occupational and environmental standards set in 1970-1972 OSHA, 1971, 
see 39 FR 23513; EPA, 1973 (38 FR 8820)). (OSHA, 1971, see 39 FR 23513; 
ACGIH, 1971 (0543); ANSI, 1970 (1303)) and EPA, 1973 (38 FR 8820) and 
therefore are less relevant today than in the past. The available data 
is fairly limited. The hepatic, cardiovascular, renal, and ocular and 
mucosal effects are briefly summarized below. Health effects in other 
organ systems listed above were only observed in animal studies at very 
high exposure levels and are, therefore, not discussed here. During the 
public comment period OSHA received comments suggesting that OSHA add 
dermal effects to this section. Therefore, dermal effects have been 
added, below, and are also discussed in the section on kinetics and 
metabolism (section V.B.2).
1. Hepatic Effects
    Beryllium has been shown to accumulate in the liver and a 
correlation has been demonstrated between beryllium content and hepatic 
damage. Different compounds have been shown to distribute differently 
within the hepatic tissues. For example, in one study, beryllium 
phosphate accumulated almost exclusively within sinusoidal (Kupffer) 
cells of the liver, while beryllium sulfate was found mainly in 
parenchymal cells. Conversely, beryllium sulphosalicylic acid complexes 
were rapidly excreted (Skilleter and Paine, 1979, Document ID 1410).
    According to a few autopsies, beryllium-laden livers had central 
necrosis, mild focal necrosis and inflammation, as well as, 
occasionally, beryllium granuloma (Sprince et al., 1975, Document ID 
1405).
2. Cardiovascular Effects
    Severe cases of CBD can result in cor pulmonale, which is 
hypertrophy of the right heart ventricle. In a case history study of 17 
individuals exposed to beryllium in a plant that manufactured 
fluorescent lamps, autopsies revealed right atrial and ventricular 
hypertrophy (Hardy and Tabershaw, 1946, Document ID 1516). It is not 
likely that these cardiac effects were due to direct toxicity to the 
heart, but rather were a response to impaired lung function. However, 
an increase in deaths due to heart disease or ischemic heart disease 
was found in workers at a beryllium manufacturing facility (Ward et 
al., 1992, Document ID 1378). Additionally, a study by Schubauer-
Berigan et al. (2011) found an increase in mortality due to cor 
pulmonale in a follow-up study of workers at seven beryllium processing 
plants who were exposed to beryllium levels near the preceding OSHA PEL 
of 2.0 [mu]g/m\3\ (Schubauer-Berigan et al., 2011, Document ID 1266).
    Animal studies performed in monkeys indicate heart enlargement 
after acute inhalation exposure to 13 mg beryllium/m\3\ as beryllium 
hydrogen phosphate, 0.184 mg beryllium/m\3\ as beryllium fluoride, or 
0.198 mg beryllium/m\3\ as beryllium sulfate (Schepers, 1957, Document 
ID 0458). Decreased arterial oxygen tension was observed in dogs 
exposed to 30 mg beryllium/m\3\ as beryllium oxide for 15 days (HSDB, 
2010, Document ID 0533), 3.6 mg beryllium/m\3\ as beryllium oxide for 
40 days (Hall et al., 1950, Document ID 1494), and 0.04 mg beryllium/
m\3\ as beryllium sulfate for 100 days (Stokinger et al., 1950, 
Document ID 1484). These are thought to be indirect effects on the 
heart due to pulmonary fibrosis and toxicity, which can increase 
arterial pressure and restrict blood flow.
3. Renal Effects
    Renal or kidney stones have been found in severe cases of CBD that 
resulted from high levels of beryllium exposure. Renal stones 
containing beryllium occurred in about 10 percent of patients affected 
by high exposures (Barnett et al., 1961, Document ID 0453). The ATSDR 
reported that 10 percent of the CBD cases found in the BCR reported 
kidney stones. In addition, an excess of calcium in the blood and urine 
was frequently found in patients with CBD (ATSDR, 2002, Document ID 
1371).
4. Ocular and Mucosal Effects
    Soluble and poorly soluble beryllium compounds have been shown to 
cause ocular irritation in humans (VanOrdstrand et al., 1945, Document 
ID 1383; De Nardi et al., 1953 (1545); Nishimura, 1966 (1435); Epstein, 
1991 (0526); NIOSH, 1994 (1261). In addition, soluble and poorly 
soluble beryllium has been shown to induce acute conjunctivitis with 
corneal maculae and diffuse erythema (HSDB, 2010, Document ID 0533).
    The mucosa (mucosal membrane) is the moist lining of certain 
tissues/organs including the eyes, nose, mouth, lungs, and the urinary 
and digestive tracts. Soluble beryllium salts have been shown to be 
directly irritating to mucous membranes (HSDB, 2010, Document ID 0533).
5. Dermal Effects
    Several commenters suggested OSHA add dermal effects to this Health 
Effects section. National Jewish Health noted that rash and 
granulomatous reactions of the skin still occur in occupational 
settings (Document ID 1664, p. 5). The National Supplemental Screening 
Program also recommended including skin conditions such as dermatitis 
and nodules (Document ID 1677, p. 3). The American Thoracic Society 
also recommended including ``beryllium sensitization, CBD, and skin 
disease as the major adverse health effects

[[Page 2527]]

associated with exposure to beryllium at or below 0.1 [mu]g/m\3\ and 
acute beryllium disease at higher exposures based on the currently 
available epidemiologic and experimental studies'' (Document ID 1688, 
p. 2). OSHA agrees and has included dermal effects in this section of 
the final preamble.
    As summarized in Epstein (1991), skin exposure to soluble beryllium 
compounds (mainly beryllium fluoride but also beryllium metal which may 
contain beryllium fluoride) resulted in irritant dermatitis with 
inflammation, and local edema. Beryllium oxide, beryllium alloys and 
nearly pure beryllium metal did not produce such responses in the skin 
of workers (Epstein, 1991, Document ID 0526). Skin lacerations or 
abrasions contaminated with soluble beryllium can lead to skin 
ulcerations (Epstein, 1991, Document ID 0526). Soluble and poorly 
soluble beryllium-compounds that penetrate the skin as a result of 
abrasions or cuts have been shown to result in chronic ulcerations and 
skin granulomas (VanOrdstrand et al., 1945, Document ID 1383; Lederer 
and Savage, 1954 (1467)). However, ulcerating granulomatous formation 
of the skin is generally associated with poorly soluble forms of 
beryllium (Epstein, 1991, Document ID 0526). Beryllium, beryllium oxide 
and other soluble and poorly soluble forms of beryllium have been 
classified as a skin irritant (category 2) in accordance with the EU 
Classification, Labelling and Packaging Regulation (Document ID 1669, 
p. 2). Contact dermatitis (skin hypersensitivity) was observed in some 
individuals exposed via skin to soluble forms of beryllium, especially 
individuals with a dermal irritant response (Epstein, 1991, Document ID 
0526). Contact allergy has been observed in workers exposed to 
beryllium chloride (Document ID 0522).
G. Summary of Conclusions Regarding Health Effects
    Through careful analysis of the best available scientific 
information outlined in this section, OSHA has determined that 
beryllium and beryllium-containing compounds can cause sensitization, 
CBD, and lung cancer. The Agency has determined through its review and 
evaluation of the studies outlined in section V.A.2 of this health 
effects section that skin and inhalation exposure to beryllium can lead 
to sensitization; and inhalation exposure, or skin exposure coupled 
with inhalation, can cause onset and progression of CBD. In addition, 
the Agency's review and evaluation of the studies outlined in section 
V.E. of this health effects section led to a finding that inhalation 
exposure to beryllium and beryllium-containing materials can cause lung 
cancer.
1. OSHA's Evaluation of the Evidence Finds That Beryllium Causes 
Sensitization Below the Preceding PEL and Sensitization is a Precursor 
to CBD
    Through the biological and immunological processes outlined in 
section V.B. of the Health Effects, the Agency has concluded that the 
scientific evidence supports the following mechanisms for the 
development of sensitization and CBD.
     Inhaled beryllium and beryllium-containing materials able 
to be retained and solubilized in the lungs have the ability to 
initiate sensitization and facilitate CBD development (section V.B.5). 
Genetic susceptibility may play a role in the development of 
sensitization and progression to CBD in certain individuals.
     Beryllium compounds that dissolve in biological fluids, 
such as sweat, can penetrate intact skin and initiate sensitization 
(section V.A.2; V.B). Phagosomal fluid and lung fluid have the capacity 
to dissolve beryllium compounds in the lung (section V.A.2a).
     Sensitization occurs through a T-cell mediated process 
with both soluble and poorly soluble beryllium and beryllium-containing 
compounds through direct antigen presentation or through further 
antigen processing in the skin or lung. T-cell mediated responses, such 
as sensitization, are generally regarded as long-lasting (e.g., not 
transient or readily reversible) immune conditions (section V.D.1).
     Beryllium sensitization and CBD are adverse events along a 
pathological continuum in the disease process with sensitization being 
the necessary first step in the progression to CBD (section V.D).
     Particle characteristics such as size, solubility, surface 
area, and other properties may play a role in the rate of development 
of beryllium sensitization and CBD. However, there is currently not 
sufficient information to delineate the biological role these 
characteristics may play.
     Animal studies have provided supporting evidence for T-
cell proliferation in the development of granulomatous lung lesions 
after beryllium exposure (sections V.D.2; V.D.6).
     Since the pathogenesis of CBD involves a beryllium-
specific, cell-mediated immune response, CBD cannot occur in the 
absence of beryllium sensitization (section V.D.1). While no clinical 
symptoms are associated with sensitization, a sensitized worker is at 
risk of developing CBD when inhalation exposure to beryllium has 
occurred. Epidemiological evidence that covers a wide variety of 
beryllium compounds and industrial processes demonstrates that 
sensitization and CBD are continuing to occur at present-day exposures 
below OSHA's preceding PEL (sections V.D.4; V.D.5 and section VI of 
this preamble).
     OSHA considers CBD to be a progressive illness with a 
continuous spectrum of symptoms ranging from its earliest asymptomatic 
stage following sensitization through to full-blown CBD and death 
(section V.D.7).
     Genetic variabilities appear to enhance risk for 
developing sensitization and CBD in some groups (section V.D.3).
    In addition, epidemiological studies outlined in section V.D.5 have 
demonstrated that efforts to reduce exposures have succeeded in 
reducing the frequency of sensitization and CBD.
2. OSHA's Evaluation of the Evidence Has Determined Beryllium To Be a 
Human Carcinogen
    OSHA conducted an evaluation of the available scientific 
information regarding the carcinogenic potential of beryllium and 
beryllium-containing compounds (section V.E). Based on the weight of 
evidence and plausible mechanistic information obtained from in vitro 
and in vivo animal studies as well as clinical and epidemiological 
investigations, the Agency has determined that beryllium and beryllium-
containing materials are properly regarded as human carcinogens. This 
information is in accordance with findings from IARC, NTP, EPA, NIOSH, 
and ACGIH (section V.E). Key points from this analysis are summarized 
briefly here.
     Epidemiological cohort studies have reported statistically 
significant excess lung cancer mortality among workers employed in U.S. 
beryllium production and processing plants during the 1930s to 1970s 
(section V.E.2).
     Significant positive associations were found between lung 
cancer mortality and both average and cumulative beryllium exposures 
when appropriately adjusted for birth cohort and short-term work status 
(section V.E.2).
     Studies in which large amounts of different beryllium 
compounds were inhaled or instilled in the respiratory tracts in 
multiple species of laboratory animals resulted in an increased

[[Page 2528]]

incidence of lung tumors (section V.E.3).
     Authoritative scientific organizations, such as the IARC, 
NTP, and EPA, have classified beryllium as a known or probable human 
carcinogen (section V.E).
    While OSHA has determined there is sufficient evidence of beryllium 
carcinogenicity, the Agency acknowledges that the exact tumorigenic 
mechanism for beryllium has yet to be determined. A number of 
mechanisms are likely involved, including chronic inflammation, 
genotoxicity, mitogenicity, oxidative stress, and epigenetic changes 
(section V.E.3).
     Studies of beryllium-exposed animals have consistently 
demonstrated chronic pulmonary inflammation after exposure (section 
V.E.3). Substantial data indicate that tumor formation in certain 
animals after inhalation exposure to poorly soluble particles at doses 
causing marked, chronic inflammation is due to a secondary mechanism 
unrelated to the genotoxicity of the particles (section V.E.5).
     A review conducted by the NAS (2008) (Document ID 1355) 
found that beryllium and beryllium-containing compounds tested positive 
for genotoxicity in nearly 50 percent of studies without exogenous 
metabolic activity, suggesting a possible direct-acting mechanism may 
exist (section V.E.1) as well as the potential for epigenetic changes 
(section V.E.4).
    Other health effects are discussed in sections F of the Health 
Effects Section and include hepatic, cardiovascular, renal, ocular, and 
mucosal effects. The adverse systemic effects from human exposures 
mostly occurred prior to the introduction of occupational and 
environmental standards set in 1970-1973 (ACGIH, 1971, Document ID 
0543; ANSI, 1970 (1303); OSHA, 1971, see 39 FR 23513; EPA, 1973 (38 FR 
8820)) and therefore are less relevant.

VI. Risk Assessment

    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.'' 
Section 6(b)(5) of the OSH Act, 29 U.S.C. 655(b). 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. Section II, Pertinent Legal 
Authority, of this preamble addresses the statutory bases for these 
requirements and how they have been construed by the Supreme Court and 
federal courts of appeals.
    It is OSHA's practice to evaluate risk to workers and determine the 
significance of that risk based on the best available evidence. Using 
that evidence, OSHA identifies material health impairments associated 
with potentially hazardous occupational exposures, assesses whether 
exposed workers' risks are significant, and determines whether a new or 
revised rule will substantially reduce these risks. As discussed in 
Section II, Pertinent Legal Authority, when determining whether a 
significant risk exists OSHA considers whether there is a risk of at 
least one-in-a-thousand of developing amaterial health impairment from 
a working lifetime of exposure at the prevailing OSHA standard 
(referred to as the ``preceding standard'' or ``preceding TWA PEL'' in 
this preamble). For this purpose, OSHA generally assumes that a term of 
45 years constitutes a working life. The Supreme Court has found that 
OSHA is not required to support its finding of significant risk with 
scientific certainty, but may instead rely on a body of reputable 
scientific thought and may make conservative assumptions (i.e., err on 
the side of protecting the worker) in its interpretation of the 
evidence (see Section II, Pertinent Legal Authority).
    For single-substance standards governed by section 6(b)(5) of the 
OSH Act, 29 U.S.C. 655(b)(5), OSHA sets a permissible exposure limit 
(PEL) based on its risk assessment as well as feasibility 
considerations. These health and risk determinations are made in the 
context of a rulemaking record in which the body of evidence used to 
establish material impairment, assess risks, and identify affected 
worker population, as well as the Agency's preliminary risk assessment, 
are placed in a public rulemaking record and subject to public comment. 
Final determinations regarding the standard, including final 
determinations of material impairment and risk, are thus based on 
consideration of the entire rulemaking record.
    OSHA's approach for the risk assessment for beryllium incorporates 
both: (1) A review of the literature on populations of workers exposed 
to beryllium at and below the preceding time-weighted average 
permissible exposure limit (TWA PEL) of 2 [mu]g/m\3\; and (2) OSHA's 
own analysis of a data set of beryllium-exposed machinists. The 
Preliminary Risk Assessment included in the NPRM evaluated risk at 
several alternate TWA PELs that the Agency was considering (1 [mu]g/
m\3\, 0.5 [mu]g/m\3\, 0.2 [mu]g/m\3\, and 0.1 [mu]g/m\3\), as well as 
OSHA's preceding TWA PEL of 2 [mu]g/m\3\. OSHA's risk assessment relied 
on available epidemiological studies to evaluate the risk of 
sensitization and CBD for workers exposed to beryllium at and below the 
preceding TWA PEL and the effectiveness of exposure control programs in 
reducing risk. OSHA also conducted a statistical analysis of the 
exposure-response relationship for sensitization and CBD at the 
preceding PEL and alternate PELs the Agency was considering. For this 
analysis, OSHA used data provided by National Jewish Health (NJH), a 
leading medical center specializing in the research and treatment of 
CBD, on a population of workers employed at a beryllium machining plant 
in Cullman, AL. The review of the epidemiological studies and OSHA's 
own analysis both show significant risk of sensitization and CBD among 
workers exposed at and below the preceding TWA PEL of 2 [mu]g/m\3\. 
They also show substantial reduction in risk where employers 
implemented a combination of controls, including stringent control of 
airborne beryllium levels and additional measures, such as respirators 
and dermal personal protective equipment (PPE) to further protect 
workers against dermal contact and airborne beryllium exposure.
    To evaluate lung cancer risk, OSHA relied on a quantitative risk 
assessment published in 2011 by Schubauer-Berigan et al. (Document ID 
1265). Schubauer-Berigan et al. found that lung cancer risk was 
strongly and significantly related to mean, cumulative, and maximum 
measures of workers' exposure; the authors predicted significant risk 
of lung cancer at the preceding TWA PEL, and substantial reductions in 
risk at the alternate PELs OSHA considered in the proposed rule, 
including the final TWA PEL of 0.2 [mu]g/m\3\ (Schubauer-Berigan et 
al., 2011).
    OSHA requested input on the preliminary risk assessment presented 
in the NPRM, and received comments from a variety of public health 
experts and organizations, unions, industrial organizations, individual 
employers, and private citizens. While many comments supported OSHA's 
general approach to the risk assessment and the conclusions of the risk 
assessment, some commenters raised specific concerns with OSHA's 
analytical methods or recommended additional studies for OSHA's 
consideration. Comments about the risk assessment as a whole are 
reviewed here, while comments on specific aspects of the risk 
assessment are addressed in the relevant sections throughout the 
remainder of

[[Page 2529]]

this chapter and in the background document, Risk Analysis of the NJH 
Data Set from the Beryllium Machining Facility in Cullman, Alabama--CBD 
and Sensitization (OSHA, 2016), which can be found in the rulemaking 
docket (docket number OSHA-H005C-2006-0870) at www.regulations.gov. 
Following OSHA's review of all the comments submitted on the 
preliminary risk assessment, and its incorporation of suggested changes 
to the risk assessment, where appropriate, the Agency reaffirms its 
conclusion that workers' risk of material impairment of health from 
beryllium exposure at the preceding PEL of 2 [mu]g/m\3\ is significant, 
and is substantially reduced but still significant at the new PEL of 
0.2 [mu]g/m\3\ (see this preamble at Section VII, Significance of 
Risk).
    The comments OSHA received on its preliminary risk analysis 
generally supported OSHA's overall approach and conclusions. NIOSH 
indicated that OSHA relied on the best available evidence in its risk 
assessment and concurred with ``OSHA's careful review of the available 
literature on [beryllium sensitization] and CBD, OSHA's recognition of 
dermal exposure as a potential pathway for sensitization, and OSHA's 
careful approach to assessing risk for [beryllium sensitization] and 
CBD'' (Document ID 1725, p. 3). NIOSH agreed with OSHA's approach to 
the preliminary lung cancer risk assessment (Document ID 1725, p. 7) 
and the selection of a 2011 analysis (Schubauer-Berigan et al., 2011, 
Document ID 1265) as the basis of that risk assessment (Document ID 
1725, p. 7). NIOSH further supported OSHA's preliminary conclusions 
regarding the significance of risk of material health impairment at the 
preceding TWA PEL of 2 [mu]g/m\3\, and the substantial reduction of 
such risk at the new TWA PEL of 0.2 [mu]g/m\3\ (Document ID 1725, p. 
3). Finally, NIOSH agreed with OSHA's preliminary conclusion that 
compliance with the new PEL would lessen but not eliminate risk to 
exposed workers, noting that OSHA likely underestimated the risks of 
beryllium sensitization and CBD (Document ID 1725, pp. 3-4).
    Other commenters also agreed with the general approach and 
conclusions of OSHA's preliminary risk assessment. NJH, for example, 
determined that ``OSHA performed a thorough assessment of risk for 
[beryllium sensitization], CBD and lung cancer using all available 
studies and literature'' (Document ID 1664, p. 5). Dr. Kenny Crump and 
Ms. Deborah Proctor commented, on behalf of beryllium producer 
Materion, that they ``agree with OSHA's conclusion that there is a 
significant risk (>1/1000 risk of CBD) at the [then] current PEL, and 
that risk is reduced at the proposed PEL (0.2 [mu]g/m\3\) in 
combination with stringent measures (ancillary provisions) to reduce 
worker's exposures'' (Document ID 1660, p. 2). They further stated that 
OSHA's ``finding is evident based on the available literature . . . and 
the prevalence data [OSHA] presented for the Cullman facility'' 
(Document ID 1660, p. 2).
    OSHA also received comments objecting to OSHA's conclusions 
regarding risk of lung cancer from beryllium exposure and suggesting 
additional published analyses for OSHA's consideration (e.g., Document 
ID 1659; 1661, pp. 1-3). One comment critiqued the statistical 
exposure-response model OSHA presented as one part of its preliminary 
risk analysis for sensitization and CBD (Document ID 1660). These 
comments are discussed and addressed in the remainder of this chapter.

A. Review of Epidemiological Literature on Sensitization and Chronic 
Beryllium Disease

    As discussed in the Health Effects section, studies of beryllium-
exposed workers conducted using the beryllium lymphocyte proliferation 
test (BeLPT) have found high rates of beryllium sensitization and CBD 
among workers in many industries, including at some facilities where 
exposures were primarily below OSHA's preceding PEL of 2 [mu]g/m\3\ 
(e.g., Kreiss et al., 1993, Document ID 1478; Henneberger et al., 2001 
(1313); Schuler et al., 2005 (0919); Schuler et al., 2012 (0473)). In 
the mid-1990s, some facilities using beryllium began to aggressively 
monitor and reduce workplace exposures. In the NPRM, OSHA reviewed 
studies of workers at four plants where several rounds of BeLPT 
screening were conducted before and after implementation of new 
exposure control methods. These studies provide the best available 
evidence on the effectiveness of various exposure control measures in 
reducing the risk of sensitization and CBD. The experiences of these 
plants--a copper-beryllium processing facility in Reading, PA, a 
ceramics facility in Tucson, AZ, a beryllium processing facility in 
Elmore, OH, and a machining facility in Cullman, AL--show that 
comprehensive exposure control programs that used engineering controls 
to reduce airborne exposure to beryllium, required the use of 
respiratory protection, controlled dermal contact with beryllium using 
PPE, and employed stringent housekeeping methods to keep work areas 
clean and prevent transfer of beryllium between work areas, sharply 
curtailed new cases of sensitization among newly-hired workers. In 
contrast, efforts to prevent sensitization and CBD by using engineering 
controls to reduce workers' beryllium exposures to median levels around 
0.2 [mu]g/m\3\, with no corresponding emphasis on PPE, were less 
effective than comprehensive exposure control programs implemented more 
recently. OSHA also reviewed additional, but more limited, information 
on the occurrence of sensitization and CBD among workers with low-level 
beryllium exposures at nuclear facilities and aluminum smelting plants. 
A summary discussion of the experiences at all of these facilities is 
provided in this section. Additional discussion of studies on these 
facilities and several other studies of sensitization and CBD among 
beryllium-exposed workers is provided in Section V, Health Effects.
    The Health Effects section also discusses OSHA's findings and the 
supporting evidence concerning the role of particle characteristics and 
beryllium compound solubility in the development of sensitization and 
CBD among beryllium-exposed workers. First, it finds that respirable 
particles small enough to reach the deep lung are responsible for CBD. 
However, larger inhalable particles that deposit in the upper 
respiratory tract may lead to sensitization. Second, it finds that both 
soluble and poorly soluble forms of beryllium are able to induce 
sensitization and CBD. Poorly soluble forms of beryllium that persist 
in the lung for longer periods may pose greater risk of CBD while 
soluble forms may more easily trigger immune sensitization. Although 
particle size and solubility may influence the toxicity of beryllium, 
the available data are too limited to reliably account for these 
factors in the Agency's estimates of risk.
1. Reading, PA, Plant
    Schuler et al. (2005, Document ID 0919) and Thomas et al. (2009, 
Document ID 0590) conducted studies of workers at a copper-beryllium 
processing facility in Reading, PA. Exposures at this plant were 
believed to be low throughout its history due to both the low 
percentage of beryllium in the metal alloys used and the relatively low 
exposures found in general area samples collected starting in 1969 
(sample median <=0.1 [mu]g/m\3\, 97% < 0.5 [mu]g/m\3\) (Schuler et al., 
2005). Ninety-nine percent of personal lapel sample measurements were 
below the preceding OSHA TWA PEL of 2 [mu]g/m\3\; 93 percent were below 
the new TWA

[[Page 2530]]

PEL of 0.2 [mu]g/m\3\ (Schuler et al., 2005). Schuler et al. (2005) 
screened 152 workers at the facility with the BeLPT in 2000. The 
reported prevalences of sensitization (6.5 percent) and CBD (3.9 
percent) showed substantial risk at this facility, even though airborne 
exposures were primarily below both the preceding and final TWA 
PELs.\11\ The only group of workers with no cases of sensitization or 
CBD, a group of 26 office administration workers, was the group with 
the lowest recorded exposures (median personal sample 0.01 [mu]g/m\3\, 
range <0.01-0.06 [mu]g/m\3\ (Schuler et al., 2005).
---------------------------------------------------------------------------

    \11\ Although OSHA reports percentages to indicate the risks of 
sensitization and CBD in this section, the benchmark OSHA typically 
uses to demonstrate significant risk, as discussed in Pertinent 
Legal Authority, is greater than or equal to 1 in 1,000 workers. One 
in 1,000 workers is equivalent to 0.1 percent. Therefore, any value 
of 0.1 percent or higher when reporting occurrence of a health 
effect is considered by OSHA to indicate a significant risk.
---------------------------------------------------------------------------

    After the initial BeLPT screening was conducted in 2000, the 
company began implementing new measures to further reduce workers' 
exposure to beryllium (Thomas et al. 2009, Document ID 0590). 
Requirements designed to minimize dermal contact with beryllium, 
including long-sleeve facility uniforms and polymer gloves, were 
instituted in production areas in 2000-2002. In 2001, the company 
installed local exhaust ventilation (LEV) in die grinding and polishing 
operations (Thomas et al., 2009, Figure 1). Personal lapel samples 
collected between June 2000 and December 2001, showed reduced exposures 
plant-wide (98 percent were below 0.2 [mu]g/m\3\). Median, arithmetic 
mean, and geometric mean values less than or equal to 0.03 [mu]g/m\3\ 
were reported in this period for all processes except one, a wire 
annealing and pickling process. Samples for this process remained 
elevated, with a median of 0.1 [mu]g/m\3\ (arithmetic mean of 0.127 
[mu]g/m\3\, geometric mean of 0.083 [mu]g/m\3\) (Thomas et al., 2009, 
Table 3). In January 2002, the company enclosed the wire annealing and 
pickling process in a restricted access zone (RAZ). Beginning in 2002, 
the company required use of powered air-purifying respirators (PAPRs) 
in the RAZ, and implemented stringent measures to minimize the 
potential for skin contact and beryllium transfer out of the zone, such 
as requiring RAZ workers to shower before leaving the zone (Thomas et 
al., 2009, Figure 1). While exposure samples collected by the facility 
were sparse following the enclosure, they suggest exposure levels 
comparable to the 2000-2001 samples in areas other than the RAZ (Thomas 
et al., 2009, Table 3). The authors reported that outside the RAZ, 
``the vast majority of employees do not wear any form of respiratory 
protection due to very low airborne beryllium concentrations'' (Thomas 
et al., 2009, p. 122).
    To test the efficacy of the new measures in preventing 
sensitization and CBD, in June 2000 the facility began an intensive 
BeLPT screening program for all new workers (Thomas et al., 2009, 
Document ID 0590). Among 82 workers hired after 1999, three cases of 
sensitization were found (3.7 percent). Two (5.4 percent) of 37 workers 
hired prior to enclosure of the wire annealing and pickling process, 
which had been releasing beryllium into the surrounding area, were 
found to be sensitized within 3 and 6 months of beginning work at the 
plant. One (2.2 percent) of 45 workers hired after the enclosure was 
built was confirmed as sensitized. From these early results comparing 
the screening conducted on workers hired before 2000 and those hired in 
2000 and later, especially following the enclosure of the RAZ, it 
appears that the greatest reduction in sensitization risk (to one 
sensitized worker, or 2.2 percent) was achieved after workers' 
exposures were reduced to below 0.1 [mu]g/m\3\ and PPE to prevent 
dermal contact was instituted (Thomas et al., 2009).
2. Tucson, AZ, Plant
    Kreiss et al. (1996, Document ID 1477), Cummings et al. (2007, 
Document ID 1369), and Henneberger et al. (2001, Document ID 1313) 
conducted studies of workers at a beryllia ceramics plant in Tucson, 
Arizona. Kreiss et al. (1996) screened 136 workers at this plant with 
the BeLPT in 1992. Full-shift area samples collected between 1983 and 
1992 showed primarily low airborne beryllium levels at this facility 
(76 percent of area samples were at or below 0.1 [mu]g/m\3\ and less 
than 1 percent exceeded 2 [mu]g/m\3\). 4,133 short-term breathing zone 
measurements collected between 1981 and 1992 had a median of 0.3 [mu]g/
m\3\. A small set (75) of personal lapel samples collected at the plant 
beginning in 1991 had a median of 0.2 [mu]g/m\3\ and ranged from 0.1 to 
1.8 [mu]g/m\3\ (arithmetic and geometric mean values not reported) 
(Kreiss et al., 1996).
    Kreiss et al. reported that eight (5.9 percent) of the 136 workers 
tested in 1992 were sensitized, six (4.4 percent) of whom were 
diagnosed with CBD. One sensitized worker was one of 13 administrative 
workers screened, and was among those diagnosed with CBD. Exposures of 
administrative workers were not well characterized, but were believed 
to be among the lowest in the plant. Personal lapel samples taken on 
administrative workers during the 1990s were below the detection limit 
at the time, 0.2 [mu]g/m\3\ (Cummings et al., 2007, Document ID 1369).
    Following the 1992 screening, the facility reduced exposures in 
machining areas (for example, by enclosing additional machines and 
installing additional exhaust ventilation), resulting in median 
exposures of 0.2 [mu]g/m\3\ in production jobs and 0.1 [mu]g/m\3\ in 
production support jobs (Cummings et al., 2007). In 1998, a second 
screening found that 7 out of 74 tested workers hired after the 1992 
screening (9.5 percent) were sensitized, one of whom was diagnosed with 
CBD. All seven of these sensitized workers had been employed at the 
plant for less than two years (Henneberger et al., 2001, Document ID 
1313, Table 3). Of 77 Tucson workers hired prior to 1992 who were 
tested in 1998, 8 (10.4 percent) were sensitized and 7 of these (9.7 
percent) were diagnosed with CBD (Henneberger et al., 2001).
    Following the 1998 screening, the company continued efforts to 
reduce exposures, along with risk of sensitization and CBD, by 
implementing additional engineering and administrative controls and a 
comprehensive PPE program which included the use of respiratory 
protection (1999) and latex gloves (2000) (Cummings et al., 2007, 
Document ID 1369). Enclosures were installed for various beryllium-
releasing processes by 2001. Between 2000 and 2003, water-resistant or 
water-proof garments, shoe covers, and taped gloves were incorporated 
to keep beryllium-containing fluids from wet machining processes off 
the skin. To test the efficacy of the new measures instituted after 
1998, in January 2000 the company began screening new workers for 
sensitization at the time of hire and at 3, 6, 12, 24, and 48 months of 
employment. These more stringent measures appear to have substantially 
reduced the risk of sensitization among new employees. Of 97 workers 
hired between 2000 and 2004, one case of sensitization was identified 
(1 percent) (Cummings et al., 2007).
3. Elmore, OH, Plant
    Kreiss et al. (1997, Document ID 1360), Bailey et al. (2010, 
Document ID 0676), and Schuler et al. (2012, Document ID 0473) 
conducted studies of workers at a beryllium metal, alloy, and oxide 
production plant in Elmore, Ohio. Workers participated in several 
plant-wide BeLPT surveys beginning in 1993-1994 (Kreiss et al., 1997; 
Schuler et al., 2012) and in a series of screenings

[[Page 2531]]

for workers hired in 2000 and later, conducted beginning in 2000 
(Bailey et al., 2010).
    Exposure levels at the plant between 1984 and 1993 were 
characterized using a mixture of general area, short-term breathing 
zone, and personal lapel samples (Kreiss et al., 1997, Document ID 
1360). Kreiss et al. reported that the median area samples for various 
work areas ranged from 0.1 to 0.7 [micro]g/m\3\, with the highest 
values in the alloy arc furnace and alloy melting-casting areas. 
Personal lapel samples were available from 1990-1992, and showed high 
exposures overall (median value of 1.0 [micro]g/m\3\), with very high 
exposures for some processes. Kreiss et al. reported median sample 
values from the personal lapel samples of 3.8 [micro]g/m\3\ for 
beryllium oxide production, 1.75 [micro]g/m\3\ for alloy melting and 
casting, and 1.75 [micro]g/m\3\ for the arc furnace. The authors 
reported that 43 (6.9 percent) of 627 workers tested in 1993-1994 were 
sensitized. 29 workers (including 5 previously identified) were 
diagnosed with CBD (29/632, or 4.6 percent) (Kreiss et al., 1997).
    In 1996-1999, the company took further steps to reduce workers' 
beryllium exposures, including enclosure of some beryllium-releasing 
processes, establishment of restricted-access zones, and installation 
or updating of certain engineering controls (Bailey et al., 2010, 
Document ID 0676, Tables 1-2). Beginning in 1999, all new employees 
were required to wear loose-fitting PAPRs in manufacturing buildings. 
Skin protection became part of the protection program for new employees 
in 2000, and glove use was required in production areas and for 
handling work boots beginning in 2001. By 2001, either half-mask 
respirators or PAPRs were required throughout the production facility 
(type determined by airborne beryllium levels) and respiratory 
protection was required for roof work and during removal of work boots 
(Bailey et al., 2010).
    Beginning in 2000, newly hired workers were offered periodic BeLPT 
testing to evaluate the effectiveness of the new exposure control 
program implemented by the company (Bailey et al., 2010). Bailey et al. 
compared the occurrence of beryllium sensitization and disease among 
258 employees who began work at the Elmore plant between January 15, 
1993 and August 9, 1999 (the ``pre-program group'') with that of 290 
employees who were hired between February 21, 2000 and December 18, 
2006, and were tested at least once after hire (the ``program group''). 
They found that, as of 1999, 23 (8.9 percent) of the pre-program group 
were sensitized to beryllium. Six (2.1 percent) of the program group 
had confirmed abnormal results on their final round of BeLPTs, which 
occurred in different years for different employees. This four-fold 
reduction in sensitization suggests that beryllium-exposed workers' 
risk of sensitization (and therefore of CBD, which develops only 
following sensitization) can be much reduced by the combination of 
process controls, respiratory protection requirements, and PPE 
requirements applied in this facility. Because most of the workers in 
the study had been employed at the facility for less than two years, 
and CBD typically develops over a longer period of time (see section V, 
Health Effects), Bailey et al. did not report the incidence of CBD 
among the sensitized workers (Bailey et al., 2010). Schuler et al. 
(2012, Document ID 0473) published a study examining beryllium 
sensitization and CBD among short-term workers at the Elmore, OH plant, 
using exposure estimates created by Virji et al. (2012, Document ID 
0466). The study population included 264 workers employed in 1999 with 
up to 6 years tenure at the plant (91 percent of the 291 eligible 
workers). By including only short-term workers, Virji et al. were able 
to construct participants' exposures with more precision than was 
possible in studies involving workers exposed for longer durations and 
in time periods with less exposure sampling. A set of 1999 exposure 
surveys and employee work histories was used to estimate employees' 
long-term lifetime weighted (LTW) average, cumulative, and highest-job-
worked exposures for total, respirable, and submicron beryllium mass 
concentrations (Schuler et al., 2012; Virji et al., 2012).
    As reported by Schuler et al. (2012), the overall prevalence of 
sensitization was 9.8 percent (26/264). Sensitized workers were offered 
further evaluation for CBD. Twenty-two sensitized workers consented to 
clinical testing for CBD via transbronchial biopsy. Although follow-up 
time was too short (at most 6 years) to fully evaluate CBD in this 
group, 6 of those sensitized were diagnosed with CBD (2.3 percent, 6/
264). Schuler et al. (2012) found 17 cases of sensitization (8.6%) 
within the first 3 quartiles of LTW average exposure (198 workers with 
LTW average total mass exposures lower than 1.1 [micro]g/m\3\) and 4 
cases of CBD (2.2%) within those first 3 quartiles (183 workers with 
LTW average total mass exposures lower than 1.07 [micro]g/m\3\)\12\ The 
authors found 3 cases (4.6%) of sensitization among 66 workers with 
total mass LTW average exposures below 0.1 [micro]g/m\3\, and no cases 
of sensitization among workers with total mass LTW average exposures 
below 0.09 [micro]g/m\3\, suggesting that beryllium-exposed workers' 
risk can be much reduced or eliminated by reducing airborne exposures 
to average levels below 0.1 [micro]g/m\3\.
---------------------------------------------------------------------------

    \12\ The total number of workers Schuler et al. reported in 
their table of LTW average quartiles for sensitization differs from 
the total number of workers reported in their table of LTW average 
quartiles for CBD. The table for CBD appeared to exclude 20 workers 
with sensitization and no CBD.
---------------------------------------------------------------------------

    Schuler et al. (2012, Document ID 0473) then used logistic 
regression to explore the relationship between estimated beryllium 
exposure and sensitization and CBD. For beryllium sensitization, the 
logistic models by Schuler et al. showed elevated odds ratios (OR) for 
LTW average (OR 1.48) and highest job (OR 1.37) exposure for total mass 
exposure; the OR for cumulative exposure was smaller (OR 1.23) and 
borderline statistically significant (95 percent CI barely included 
unity).\13\ Relationships between sensitization and respirable exposure 
estimates were similarly elevated for LTW average (OR 1.37) and highest 
job (OR 1.32) exposures. Among the submicron exposure estimates, only 
highest job (OR 1.24) had a 95 percent CI that just included unity for 
sensitization. For CBD, elevated odds ratios were observed only for the 
cumulative exposure estimates and were similar for total mass and 
respirable exposure (total mass OR 1.66, respirable OR 1.68). 
Cumulative submicron exposure showed an elevated, borderline 
significant odds ratio (OR 1.58). The odds ratios for average exposure 
and highest-exposed job were not statistically significantly elevated. 
Schuler et al. concluded that both total and respirable mass 
concentrations of beryllium exposure were relevant predictors of risk 
for beryllium sensitization and CBD. Average and highest job exposures 
were predictive of risk for sensitization, while cumulative exposure 
was predictive of risk for CBD (Schuler et al., 2012).
---------------------------------------------------------------------------

    \13\ An odds ratio (OR) is a measure of association between an 
exposure and an outcome. The OR represents the odds that an outcome 
will occur given a particular exposure, compared to the odds of the 
outcome occurring in the absence of that exposure.
---------------------------------------------------------------------------

    Materion submitted comments supporting OSHA's use of the Schuler et 
al. (2012) study as a basis for the final TWA PEL of 0.2 [micro]g/m\3\. 
Materion stated that ``the best available evidence to establish a risk-
based OEL [occupational exposure limit] is the study conducted by NIOSH 
and presented in Schuler 2012. The exposure assessment in

[[Page 2532]]

Schuler et al. was based on a highly robust workplace monitoring 
dataset and the study provides improved data for determining OELs'' 
(Document ID 1661, pp. 9-10). Materion also submitted an unpublished 
manuscript documenting an analysis it commissioned, entitled ``Derived 
No-Effect Levels for Occupational Beryllium Exposure Using Cluster 
Analysis and Benchmark Dose Modeling'' (Proctor et al., Document ID 
1661, Attachment 5). In this document, Proctor et al. used data from 
Schuler et al. 2012 to develop a Derived No-Effect Level (DNEL) for 
beryllium measured as respirable beryllium, total mass of beryllium, 
and inhalable beryllium.\14\ OSHA's beryllium standard measures 
beryllium as total mass; thus, the results for total mass are most 
relevant to OSHA's risk analysis for the beryllium standard. The 
assessment reported a DNEL of 0.14 [micro]g/m\3\ for total mass 
beryllium (Document ID 1661, Attachment 5, p. 16). Materion commented 
that this finding ``add[s] to the body of evidence that supports the 
fact that OSHA is justified in lowering the existing PEL to 0.2 
[micro]g/m\3\'' (Document ID 1661, p. 11).
---------------------------------------------------------------------------

    \14\ Derived No-Effect Level (DNEL) is used in REACH 
quantitative risk characterizations to mean the level of exposure 
above which humans should not be exposed. It is intended to 
represent a safe level of exposure for humans., REACH is the 
European Union's regulation on Registration, Evaluation, 
Authorization and Restriction of Chemicals.
---------------------------------------------------------------------------

    Proctor et al. characterized the DNEL of 0.14 [micro]g/m\3\ as 
``inherently conservative because average exposure metrics were used to 
determine DNELs, which are limits not [to] be exceeded on a daily 
basis'' (Document ID 1661, Attachment 5, p. 22). Materion referred to 
the DNELs derived by Proctor et al. as providing an ``additional margin 
of safety'' for similar reasons (Document ID 1661, p. 11).
    Consistent with NIOSH comments discussed in the next paragraph, 
OSHA disagrees with this characterization of the DNEL as representing a 
``no effect level'' for CBD or as providing a margin of safety for 
several reasons. The DNEL from Proctor et al. is based on CBD findings 
among a short-term worker population and thus cannot represent the risk 
presented to workers who are exposed over a working lifetime. Proctor 
et al. noted that it is ``important to consider that these data are 
from relatively short-term exposures [median tenure 20.9 months] and 
are being used to support DNELs for lifetime occupational exposures,'' 
but considered the duration of exposure to be sufficient because ``CBD 
can develop with latency as short as 3 months of exposure, and . . . 
the risk of CBD declines over time'' (Document ID 1661, Attachment 5, 
p. 19). In stating this, Procter et al. cite studies by Newman et al. 
(2001, Document ID 1354) and Harber et al. (2009, as cited in Document 
ID 1661). Newman et al. (2001) studied a group of workers in a 
machining plant with job tenures averaging 11.7 years, considerably 
longer than the worker cohort from the study used by Procter et al., 
and identified new cases of CBD from health screenings conducted up to 
4 years after an initial screening. Harber et al., (2009) developed an 
analytic model of disease progression from beryllium exposure and found 
that, although the rate at which new cases of CBD declined over time, 
the overall proportion of individuals with CBD increased over time from 
initial exposure (see Figure 2 of Haber et al., 2009). Furthermore, the 
study used by Proctor et al. to derive the DNEL, Schuler et al. (2012), 
did report finding that the risk of CBD increased with cumulative 
exposure to beryllium, as summarized above. Therefore, OSHA is not 
convinced that a ``no effect level'' for beryllium that is based on the 
health experience of workers with a median job tenure of 20.9 months 
can represent a ``no-effect level'' for workers exposed to beryllium 
for as long as 45 years.
    NIOSH commented on the results of Proctor et al.'s analysis and the 
underlying data set, noting several features of the dataset that are 
common to the beryllium literature, such as uncertain date of 
sensitization or onset of CBD and no ``background'' rate of beryllium 
sensitization or CBD, that make statistical analyses of the data 
difficult and add uncertainty to the derivation of a DNEL (Document ID 
1725, p. 5). NIOSH also noted that risk of CBD may be underestimated in 
the underlying data set if workers with CBD were leaving employment 
due, in part, to adverse health effects (``unmeasured survivor bias'') 
and estimated that as much as 30 percent of the cohort could have been 
lost over the 6-year testing period (Document ID 1725, p. 5). NIOSH 
concluded that Proctor et al.'s analysis ``does not contribute to the 
risk assessment for beryllium workers'' (Document ID 1725, p. 5). OSHA 
agrees with NIOSH that the DNEL identified by Proctor et al. cannot be 
considered a reliable estimate of a no-effect level for beryllium.
4. Cullman, AL, Plant
    Newman et al. (2001, Document ID 1354), Kelleher et al. (2001, 
Document ID 1363), and Madl et al. (2007, Document ID 1056) studied 
beryllium workers at a precision machining facility in Cullman, 
Alabama. After a case of CBD was diagnosed at the plant in 1995, the 
company began BeLPT screenings to identify workers at risk of CBD and 
implemented engineering and administrative controls designed to reduce 
workers' beryllium exposures in machining operations. Newman et al. 
(2001) conducted a series of BeLPT screenings of workers at the 
facility between 1995 and 1999. The authors reported 22 (9.4 percent) 
sensitized workers among 235 tested, 13 of whom were diagnosed with CBD 
within the study period. Personal lapel samples collected between 1980 
and 1999 indicate that median exposures were generally well below the 
preceding PEL (<=0.35 [micro]g/m\3\ in all job titles except 
maintenance (median 3.1 [micro]g/m\3\ during 1980-1995) and gas 
bearings (1.05 [micro]g/m\3\ during 1980-1995)).
    Between 1995 and 1999, the company built enclosures around several 
beryllium-releasing operations; installed or updated LEV for several 
machining departments; replaced pressurized air hoses and dry sweeping 
with wet methods and vacuum systems for cleaning; changed the layout of 
the plant to keep beryllium-releasing processes close together; limited 
access to the production area of the plant; and required the use of 
company uniforms. Madl et al. (2007, Document ID 1056) reported that 
engineering and work process controls, rather than personal protective 
equipment, were used to limit workers' exposure to beryllium. In 
contrast to the Reading and Tucson plants, gloves were not required at 
this plant. Personal lapel samples collected extensively between 1996 
and 1999 in machining and non-machining jobs had medians of 0.16 
[micro]g/m\3\ and 0.08 [micro]g/m\3\, respectively (Madl et al., 2007, 
Table IV). At the time that Newman et al. reviewed the results of BeLPT 
screenings conducted in 1995-1999, a subset of 60 workers had been 
employed at the plant for less than a year and had therefore benefitted 
to some extent from the controls described above. Four (6.7 percent) of 
these workers were found to be sensitized, of whom two were diagnosed 
with CBD and one with probable CBD (Newman et al., 2001, Document ID 
1354). The later study by Madl. et al. reported seven sensitized 
workers who had been hired between 1995 and 1999, of whom four had 
developed CBD as of 2005 (2007, Table II) (total number of workers 
hired between 1995 and 1999 not reported).
    Beginning in 2000 (after the implementation of controls between 
1997 and 1999), exposures in all jobs at the machining facility were 
reduced to

[[Page 2533]]

extremely low levels (Madl et al., 2007, Document ID 1056). Personal 
lapel samples collected between 2000 and 2005 had a median of 0.12 
[micro]g/m\3\ or less in all machining and non-machining processes 
(Madl. et al., 2007, Table IV). Only one worker hired after 1999 became 
sensitized (Madl et al. 2007, Table II). The worker had been employed 
for 2.7 years in chemical finishing, which had the highest median 
exposure of 0.12 [micro]g/m\3\ (medians for other processes ranged from 
0.02 to 0.11 [micro]g/m\3\); Madl et al. 2007, Table II). This result 
from Madl et al. (2007) suggests that beryllium-exposed workers' risk 
of sensitization can be much reduced by steps taken to reduce workers' 
airborne exposures in this facility, including enclosure of beryllium-
releasing processes, LEV, wet methods and vacuum systems for cleaning, 
and limiting worker access to production areas.
    The Cullman, AL facility was also the subject of a case-control 
study published by Kelleher et al. in 2001 (Document ID 1363). After 
the diagnosis of a case of CBD at the plant in 1995, NJH researchers, 
including Kelleher, worked with the plant to conduct the medical 
surveillance program mentioned above, using the BeLPT to screen workers 
biennially for beryllium sensitization and offering sensitized workers 
further evaluation for CBD (Kelleher et al., 2001). Concurrently, 
research was underway by Martyny et al. to characterize the particle 
size distribution of beryllium exposures generated by processes at this 
plant (Martyny et al., 2000, Document ID 1358). Kelleher et al. used 
the dataset of 100 personal lapel samples collected by Martyny et al. 
and other NJH researchers to characterize exposures for each job in the 
plant. Detailed work history information gathered from plant data and 
worker interviews was used in combination with job exposure estimates 
to characterize cumulative and LTW average beryllium exposures for 
workers in the surveillance program. In addition to cumulative and LTW 
average exposure estimates based on the total mass of beryllium 
reported in their exposure samples, Kelleher et al. calculated 
cumulative and LTW average estimates based specifically on exposure to 
particles <6 [mu]m and particles <1 [mu]m in diameter. To analyze the 
relationship between exposure level and risk of sensitization and CBD, 
Kelleher et al. performed a case-control analysis using measures of 
both total beryllium exposure and particle size-fractionated exposure. 
The results, however, were inconclusive, probably due to the relatively 
small size of the dataset (Kelleher et al., 2001).
5. Aluminum Smelting Plants
    Taiwo et al. (2008, Document ID 0621; 2010 (0583) and Nilsen et al. 
(2010, Document ID 0460) studied the relationship between beryllium 
exposure and adverse health effects among workers at aluminum smelting 
plants. Taiwo et al. (2008) studied a population of 734 employees at 4 
aluminum smelters located in Canada (2), Italy (1), and the United 
States (1). In 2000, a company-wide beryllium exposure limit of 0.2 
[mu]g/m\3\ and an action level of 0.1 [mu]g/m\3\, expressed as 8-hour 
TWAs, and a short-term exposure limit (STEL) of 1.0 [mu]g/m\3\ (15-
minute sample) were instituted at these plants. Sampling to determine 
compliance with the exposure limit began at all four smelters in 2000. 
Table VI-1 below, adapted from Taiwo et al. (2008), shows summary 
information on samples collected from the start of sampling through 
2005.

                             Table VI-1--Exposure Sampling Data By Plant--2000-2005
----------------------------------------------------------------------------------------------------------------
                                                                                    Arithmetic
                     Smelter                      Number samples  Median ([mu]g/   mean ([mu]g/   Geometric mean
                                                                       m\3\)           m\3\)       ([mu]g/m\3\)
----------------------------------------------------------------------------------------------------------------
Canadian smelter 1..............................             246            0.03            0.09            0.03
Canadian smelter 2..............................             329            0.11            0.29            0.08
Italian smelter.................................              44            0.12            0.14            0.10
US smelter......................................             346            0.03            0.26            0.04
----------------------------------------------------------------------------------------------------------------
Adapted from Taiwo et al., 2008, Document ID 0621, Table 1.

    All employees potentially exposed to beryllium levels at or above 
the action level for at least 12 days per year, or exposed at or above 
the STEL 12 or more times per year, were offered medical surveillance, 
including the BeLPT (Taiwo et al., 2008). Table VI-2 below, adapted 
from Taiwo et al. (2008), shows test results for each facility between 
2001 and 2005.

                                  Table VI-2--BeLPT Results By Plant--2001-2005
----------------------------------------------------------------------------------------------------------------
                                                                                     Abnormal
                     Smelter                         Employees        Normal           BeLPT         Confirmed
                                                      tested                       (unconfirmed)    sensitized
----------------------------------------------------------------------------------------------------------------
Canadian smelter 1..............................             109             107               1               1
Canadian smelter 2..............................             291             290               1               0
Italian smelter.................................              64              63               0               1
US smelter......................................             270             268               2               0
----------------------------------------------------------------------------------------------------------------
Adapted from Taiwo et al., 2008, Document ID 0621, Table 2

    The two workers with confirmed beryllium sensitization were offered 
further evaluation for CBD. Both were diagnosed with CBD, based on 
broncho-alveolar lavage (BAL) results in one case and pulmonary 
function tests, respiratory symptoms, and radiographic evidence in the 
other.
    In 2010, Taiwo et al. (Document ID 0583) published a study of 
beryllium-exposed workers from four companies, with a total of nine 
smelting operations. These workers included some of the workers from 
the 2008 study. 3,185 workers were determined to be ``significantly 
exposed'' to beryllium and invited to participate in BeLPT screening. 
Each company used different

[[Page 2534]]

criteria to determine ``significant'' exposure, and the criteria 
appeared to vary considerably (Taiwo et al., 2010); thus, it is 
difficult to compare rates of sensitization across companies in this 
study. 1932 workers, about 60 percent of invited workers, participated 
in the program between 2000 and 2006, of whom 9 were determined to be 
sensitized (.4 percent). The authors stated that all nine workers were 
referred to a respiratory physician for further evaluation for CBD. Two 
were diagnosed with CBD (.1 percent), as described above (see Taiwo et 
al., 2008).
    In general, there appeared to be a low level of sensitization and 
CBD among employees at the aluminum smelters studied by Taiwo et al. 
(2008; 2010). This is striking in light of the fact that many of the 
employees tested had worked at the smelters long before the institution 
of exposure limits for beryllium at some smelters in 2000. However, the 
authors noted that respiratory and dermal protection had been used at 
these plants to protect workers from other hazards (Taiwo et al., 
2008).
    A study by Nilsen et al. (2010, Document ID 0460) of aluminum 
workers in Norway also found a low rate of sensitization. In the study, 
362 workers and 31 control individuals received BeLPT testing for 
beryllium sensitization. The authors found one sensitized worker (0.28 
percent). No borderline results were reported. The authors reported 
that exposure measurements in this plant ranged from 0.1 [mu]g/m\3\ to 
0.31 [mu]g/m\3\ (Nilsen et al., 2010) and that respiratory protection 
was in use, as was the case in the smelters studied by Taiwo et al. 
(2008; 2010).
6. Nuclear Weapons Facilities
    Viet et al. (2000, Document ID 1344) and Arjomandi et al. (2010, 
Document ID 1275) evaluated beryllium-exposed nuclear weapons workers. 
In 2000, Viet et al. published a case-control study of participants in 
the Rocky Flats Beryllium Health Surveillance Program (BHSP), which was 
established in 1991 to screen workers at the Department of Energy's 
Rocky Flats, CO, nuclear weapons facility for beryllium sensitization 
and evaluate sensitized workers for CBD. The program, which the authors 
reported had tested over 5,000 current and former Rocky Flats employees 
for sensitization, had identified a total of 127 sensitized individuals 
as of 1994 when Viet et al. initiated their study; 51 of these 
sensitized individuals had been diagnosed with CBD.
    Using subjects from the BHSP, Viet et al. (2000) matched a total of 
50 CBD cases to 50 controls who tested negative for beryllium 
sensitization and had the same age ( 3 years), gender, race 
and smoking status, and were otherwise randomly selected from the 
database. Using the same matching criteria, 74 sensitized workers who 
were not diagnosed with CBD were matched to 74 control individuals from 
the BHSP database who tested negative for beryllium sensitization.
    Viet et al. (2000) developed exposure estimates for the cases and 
controls based on daily fixed airhead (FAH) beryllium air samples 
collected in one of 36 buildings at Rocky Flats where beryllium was 
used, the Building 444 Beryllium Machine Shop. Annual mean FAH samples 
in Building 444 collected between 1960 and 1988 ranged from a low of 
0.096 [mu]g/m\3\ (1988) to a high of 0.622 [mu]g/m\3\ (1964) (Viet et 
al., 2000, Table II). Because exposures in this shop were better 
characterized than in other buildings, the authors developed estimates 
of exposures for all workers based on samples from Building 444. The 
authors' statistical analysis of the resulting data set included 
conditional logistic regression analysis, modeling the relationship 
between risk of each health outcome and individuals' log-transformed 
cumulative exposure estimate (CEE) and mean exposure estimate (MEE). 
These coefficients corresponded to odds ratios of 6.9 and 7.2 per 10-
fold increase in exposure, respectively. Risk of sensitization without 
CBD did not show a statistically significant relationship with log-CEE 
(coef = 0.111, p = 0.32), but showed a nearly-significant relationship 
with log-MEE (coef = 0.230, p = 0.097). Viet et al. found highly 
statistically significant relationships between log-CEE and risk of CBD 
(coef = 0.837, p = 0.0006) and between log-MEE (coef = 0.855, p = 
0.0012) and risk of CBD, indicating that risk of CBD increases with 
exposure level.
    Arjomandi et al. (2010) published a study of 50 sensitized workers 
from a nuclear weapons research and development facility who were 
evaluated for CBD. Quantitative exposure estimates for the workers were 
not presented; however, the authors characterized their likely 
exposures as low (possibly below 0.1 [mu]g/m\3\ for most jobs). In 
contrast to the studies of low-exposure populations discussed 
previously, this group had much longer follow-up time (mean time since 
first exposure = 32 years) and length of employment at the facility 
(mean of 18 years).
    Five of the 50 evaluated workers (10 percent) were diagnosed with 
CBD based on histology or high-resolution computed tomography. An 
additional three (who had not undergone full clinical evaluation for 
CBD) were identified as probable CBD cases, bringing the total 
prevalence of CBD and probable CBD in this group to 16 percent. OSHA 
notes that this prevalence of CBD among sensitized workers is lower 
than the prevalence of CBD that has been observed in some other worker 
groups known to have exposures exceeding the action level of 0.1 [mu]g/
m\3\. For example, as discussed above, Newman et al. (2001, Document ID 
1354) reported 22 sensitized workers, 13 of whom (59 percent) were 
diagnosed with CBD within the study period. Comparison of these results 
suggests that controlling respiratory exposure to beryllium may reduce 
risk of CBD among already-sensitized workers as well as reducing risk 
of CBD via prevention of sensitization. However, it also demonstrates 
that some workers in low-exposure environments can become sensitized 
and then develop CBD.
7. Conclusions
    The published literature on beryllium sensitization and CBD 
discussed above shows that risk of both health effects can be 
significant in workplaces in compliance with OSHA's preceding PEL 
(e.g., Kreiss et al., 1996, Document ID 1477; Henneberger et al., 2001 
(1313); Newman et al., 2001 (1354); Schuler et al., 2005 (0919), 2012 
(0473); Madl et al., 2007 (1056)). For example, in the Tucson beryllia 
ceramics plant discussed above, Kreiss et al. (1996) reported that 8 
(5.9 percent) of the 136 workers tested in 1992 were sensitized, 6 (4.4 
percent) of whom were diagnosed with CBD. In addition, of 77 Tucson 
workers hired prior to 1992 who were tested in 1998, 8 (10.4 percent) 
were sensitized and 7 of these (9.7 percent) were diagnosed with CBD 
(Henneberger et al., 2001, Document ID 1313). Full-shift area samples 
showed airborne beryllium levels below the preceding PEL (76 percent of 
area samples collected between 1983 and 1992 were at or below 0.1 
[mu]g/m\3\ and less than 1 percent exceeded 2 [mu]g/m\3\; short-term 
breathing zone measurements collected between 1981 and 1992 had a 
median of 0.3 [mu]g/m\3\; personal lapel samples collected at the plant 
beginning in 1991 had a median of 0.2 [mu]g/m\3\) (Kreiss et al., 
1996).
    Results from the Elmore, OH beryllium metal, alloy, and oxide 
production plant and Cullman, AL machining facility also showed 
significant risk of sensitization and CBD

[[Page 2535]]

among workers with exposures below the preceding TWA PEL. Schuler et 
al. (2012, Document ID 0473) found 17 cases of sensitization (8.6%) 
among Elmore, OH workers within the first three quartiles of LTW 
average exposure (198 workers with LTW average total mass exposures 
lower than 1.1 [mu]g/m\3\) and 4 cases of CBD (2.2%) within the first 
three quartiles of LTW average exposure (183 workers with LTW average 
total mass exposures lower than 1.07 [mu]g/m\3\; note that follow-up 
time of up to 6 years for all study participants was very short for 
development of CBD). At the Cullman, AL machining facility, Newman et 
al. (2001, Document ID 1354) reported 22 (9.4 percent) sensitized 
workers among 235 tested in 1995-1999, 13 of whom were diagnosed with 
CBD. Personal lapel samples collected between 1980 and 1999 indicate 
that median exposures were generally well below the preceding PEL 
(<=0.35 [mu]g/m\3\ in all job titles except maintenance (median 3.1 
[mu]g/m\3\ during 1980-1995) and gas bearings (1.05 [mu]g/m\3\ during 
1980-1995)).
    There is evidence in the literature that although risk will be 
reduced by compliance with the new TWA PEL, significant risk of 
sensitization and CBD will remain in workplaces in compliance with 
OSHA's new TWA PEL of 0.2 [mu]g/m\3\ and could extend down to the new 
action level of 0.1 [mu]g/m\3\, although there is less information and 
therefore greater uncertainty with respect to significant risk from 
airborne beryllium exposures at and below the action level. For 
example, Schuler et al. (2005, Document ID 0919) reported substantial 
prevalences of sensitization (6.5 percent) and CBD (3.9 percent) among 
152 workers at the Reading, PA facility who had BeLPT screening in 
2000. These results showed significant risk at this facility, even 
though airborne exposures were primarily below both the preceding and 
final TWA PELs due to the low percentage of beryllium in the metal 
alloys used (median general area samples <=0.1 [mu]g/m\3\, 97% <=0.5 
[mu]g/m\3\); 93% of personal lapel samples were below the new TWA PEL 
of 0.2 [mu]g/m\3\). The only group of workers with no cases of 
sensitization or CBD, a group of 26 office administration workers, was 
the group with exposures below the new action level of 0.1 [mu]g/m\3\ 
(median personal sample 0.01 [mu]g/m\3\, range <0.01-0.06 [mu]g/m\3\ 
(Schuler et al., 2005). The Schuler et al. (2012, Document ID 0473) 
study of short-term workers in the Elmore, OH facility found 3 cases 
(4.6%) of sensitization among 66 workers with total mass LTW average 
exposures below 0.1 [mu]g/m\3\; 3 of these workers had LTW average 
exposures of approximately 0.09 [mu]g/m\3\.
    Furthermore, cases of sensitization and CBD continued to arise in 
the Cullman, AL machining plant after control measures implemented 
beginning in 1995 brought median airborne exposures below 0.2 [mu]g/
m\3\ (personal lapel samples between 1996 and 1999 in machining jobs 
had a median of 0.16 [mu]g/m\3\ and 0.08 [mu]g/m\3\ in non-machining 
jobs) (Madl et al., 2007, Document ID 1056, Table IV). At the time that 
Newman et al. (2001, Document ID 1354) reviewed the results of BeLPT 
screenings conducted in 1995-1999, a subset of 60 workers had been 
employed at the plant for less than a year and had therefore benefitted 
to some extent from the exposure reductions. Four (6.7 percent) of 
these workers were found to be sensitized, two of whom were diagnosed 
with CBD and one with probable CBD (Newman et al., 2001). A later study 
by Madl. et al. (2007, Document ID 1056) reported seven sensitized 
workers who had been hired between 1995 and 1999, of whom four had 
developed CBD as of 2005 (Table II; total number of workers hired 
between 1995 and 1999 not reported).
    The experiences of several facilities in developing effective 
industrial hygiene programs have shown the importance of minimizing 
both airborne exposure and dermal contact to effectively reduce risk of 
sensitization and CBD. Exposure control programs that have used a 
combination of engineering controls and PPE to reduce workers' airborne 
exposure and dermal contact have substantially lowered risk of 
sensitization among newly hired workers.\15\ Of 97 workers hired 
between 2000 and 2004 in the Tucson, AZ plant after the introduction of 
mandatory respirator use in production areas beginning in 1999 and 
mandatory use of latex gloves beginning in 2000, one case of 
sensitization was identified (1 percent) (Cummings et al., 2007, 
Document ID 1369). In Elmore, OH, where all workers were required to 
wear respirators and skin PPE in production areas beginning in 2000-
2001, the estimated prevalence of sensitization among workers hired 
after these measures were put in place was around 2 percent (Bailey et 
al., 2010, Document ID 0676). In the Reading, PA facility, only one 
(2.2 percent) of 45 workers hired after workers' exposures were reduced 
to below 0.1 [mu]g/m\3\ and PPE to prevent dermal contact was 
instituted was sensitized (Thomas et al., 2009, Document ID 0590). And, 
in the aluminum smelters discussed by Taiwo et al. (2008, Document ID 
0621), where available exposure samples from four plants indicated 
median beryllium levels of about 0.1 [mu]g/m\3\ or below (measured as 
an 8-hour TWA) and workers used respiratory and dermal protection, 
confirmed cases of sensitization were rare (zero or one case per 
location).
---------------------------------------------------------------------------

    \15\ As discussed in Section V, Health Effects, beryllium 
sensitization can occur from dermal contact with beryllium. Studies 
conducted in the 1950s by Curtis et al. showed that soluble 
beryllium particles could cause beryllium hypersensitivity (Curtis, 
1951, Document ID 1273; NAS, 2008, Document ID 1355). Tinkle et al. 
established that 0.5- and 1.0-[mu]m particles can penetrate intact 
human skin surface and reach the epidermis, where beryllium 
particles would encounter antigen-presenting cells and initiate 
sensitization (Tinkle et al., 2003, Document ID 1483). Tinkle et al. 
further demonstrated that beryllium oxide and beryllium sulfate, 
applied to the skin of mice, generate a beryllium-specific, cell-
mediated immune response similar to human beryllium sensitization.
---------------------------------------------------------------------------

    OSHA recognizes that the studies on recent programs to reduce 
workers' risk of sensitization and CBD were conducted on populations 
with very short exposure and follow-up time. Therefore, they could not 
adequately address the question of how frequently workers who become 
sensitized in environments with extremely low airborne exposures 
(median <0.1 [mu]g/m\3\) develop CBD. Clinical evaluation for CBD was 
not reported for sensitized workers identified in the studies examining 
the post-2000, very low-exposed worker cohorts in Tucson, Reading, and 
Elmore (Cummings et al. 2007, Document ID 1369; Thomas et al. 2009 
(0590); Bailey et al. 2010 (0676)). In Cullman, however, two of the 
workers with CBD had been employed for less than a year and worked in 
jobs with very low exposures (median 8-hour personal sample values of 
0.03-0.09 [mu]g/m\3\) (Madl et al., 2007, Document ID 1056, Table III). 
The body of scientific literature on occupational beryllium disease 
also includes case reports of workers with CBD who are known or 
believed to have experienced minimal beryllium exposure, such as a 
worker employed only in shipping at a copper-beryllium distribution 
center (Stanton et al., 2006, Document ID 1070), and workers employed 
only in administration at a beryllium ceramics facility (Kreiss et al., 
1996, Document ID 1477). Therefore, there is some evidence that cases 
of CBD can occur in work environments where beryllium exposures are 
quite low.
8. Community-Acquired CBD
    In the NPRM, OSHA discussed an additional source of information on 
low-level beryllium exposure and CBD: Studies of community-acquired 
chronic beryllium disease (CA-CBD) in residential areas surrounding 
beryllium

[[Page 2536]]

production facilities. The literature on CA-CBD, including the Eisenbud 
(1949, Document ID 1284), Leiben and Metzner (1959, Document ID 1343), 
and Maier et al. (2008, Document ID 0598) studies, documents cases of 
CBD among individuals exposed to airborne beryllium at concentrations 
below the new PEL. OSHA included a review of these studies in the NPRM 
as a secondary source of information on risk of CBD from low-level 
beryllium exposure. However, the available studies of CA-CBD have 
important limitations. These case studies do not provide information on 
how frequently individuals exposed to very low airborne levels develop 
CBD. In addition, the reconstructed exposure estimates for CA-CBD cases 
are less reliable than the exposure estimates for working populations 
reviewed in the previous sections. The literature on CA-CBD therefore 
was not used by OSHA as a basis for its quantitative risk assessment 
for CBD, and the Agency did not receive any comments or testimony on 
this literature. Nevertheless, these case reports and the broader CA-
CBD literature indicate that individuals exposed to airborne beryllium 
below the final TWA PEL can develop CBD (e.g., Leiben and Metzner, 
1959; Maier et al., 2008).

B. OSHA's Prevalence Analysis for Sensitization and CBD

    OSHA evaluated exposure and health outcome data on a population of 
workers employed at the Cullman machining facility as one part of the 
Agency's Preliminary Risk Analysis presented in the NPRM. A summary of 
OSHA's preliminary analyses of these data, a discussion of comments 
received on the analyses and OSHA's responses to these comments, as 
well as a summary OSHA's final quantitative analyses, are presented in 
the remainder of this section. A more detailed discussion of the data, 
background information on the facility, and OSHA's analyses appears in 
the background document OSHA has placed in the record (Risk Analysis of 
the NJH Data Set from the Beryllium Machining Facility in Cullman, 
Alabama--CBD and Sensitization, OSHA, 2016).
    NJH researchers, with consent and information provided by the 
Cullman facility, compiled a dataset containing employee work 
histories, medical diagnoses, and air sampling results and provided it 
to OSHA for analysis. OSHA's contractors from Eastern Research Group 
(ERG) gathered additional information about work operations and 
conditions at the plant, developed exposure estimates for individual 
workers in the dataset, and helped to conduct quantitative analyses of 
the data to inform OSHA's risk assessment (Document ID tbd).
1. Worker Exposure Reconstruction
    The work history database contains job history records for 348 
workers. ERG calculated cumulative and average exposure estimates for 
each worker in the database. Cumulative exposure was calculated as,
[GRAPHIC] [TIFF OMITTED] TR09JA17.003

where e(i) is the exposure level for job (i), and t(i) is the time 
spent in job (i). Cumulative exposure was divided by total exposure 
time to estimate each worker's long-term average exposure. These 
exposures were computed in a time-dependent manner for the statistical 
modeling.\16\ For workers with beryllium sensitization or CBD, exposure 
estimates excluded exposures following diagnosis.
---------------------------------------------------------------------------

    \16\ Each worker's exposure was calculated at each time that 
BeLPT testing was conducted.
---------------------------------------------------------------------------

    Workers who were employed for long time periods in jobs with low-
level exposures tend to have low average and cumulative exposures due 
to the way these measures are constructed, incorporating the worker's 
entire work history. As discussed in the Health Effects chapter, 
higher-level exposures or short-term peak exposures such as those 
encountered in machining jobs may be highly relevant to risk of 
sensitization. However, individuals' beryllium exposure levels and 
sensitization status are not continuously monitored, so it is not known 
exactly when workers became sensitized or what their ``true'' peak 
exposures leading up to sensitization were. Only a rough approximation 
of the upper levels of exposure a worker experienced is possible. ERG 
attempted to represent workers' highest exposures by constructing a 
third type of exposure estimate reflecting the exposure level 
associated with the highest-exposure job (HEJ) and time period 
experienced by each worker. This exposure estimate (HEJ), the 
cumulative exposure estimate, and the average exposure were used in the 
quartile analysis and statistical analyses presented below.
2. Prevalence of Sensitization and CBD
    In the database provided to OSHA, 7 workers were reported as 
sensitized only (that is, sensitized with no known development of CBD). 
Sixteen workers were listed as sensitized and diagnosed with CBD upon 
initial clinical evaluation. Three workers, first shown to be 
sensitized only, were later diagnosed with CBD. Tables VI-3, VI-4, and 
VI-5 below present the prevalence of sensitization and CBD cases across 
several categories of LTW average, cumulative, and HEJ exposure. 
Exposure values were grouped by quartile. For this analysis, OSHA 
excluded 8 workers with no job title listed in the data set (because 
their exposures could not be estimated); 7 workers whose date of hire 
was before 1969 (because this indicates they worked in the company's 
previous plant, for which no exposure measurements were available); and 
14 workers who had zero exposure time in the data set, perhaps 
indicating that they had been hired but had not come to work at 
Cullman. After these exclusions, a total of 319 workers remained. None 
of the excluded workers were identified as having beryllium 
sensitization or CBD.
    Note that all workers with CBD are also sensitized. Thus, the 
columns ``Total Sensitized'' and ``Total %'' refer to all sensitized 
workers in the dataset, including workers with and without a diagnosis 
of CBD.

                            Table VI-3--Prevalence of Sensitization and CBD by LTW Average Exposure Quartile in NJH Data Set
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                            Sensitized                         Total
           LTW average exposure  ([mu]g/m\3\)               Group size         only             CBD         sensitized      Total  (%)       CBD  (%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
0.0-0.080...............................................              91               1               1               2             2.2             1.0
0.081-0.18..............................................              73               2               4               6             8.2             5.5
0.19-0.51...............................................              77               0               6               6             7.8             7.8
0.51-2.15...............................................              78               4               8              12            15.4            10.3
                                                         =================

[[Page 2537]]

                                                         =================
--------------------------------------------------------------------------------------------------------------------------------------------------------


                             Table VI-4--Prevalence of Sensitization and CBD by Cumulative Exposure Quartile in NJH Data Set
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                            Sensitized                         Total
         Cumulative  exposure  ([mu]g/m\3\-yrs)             Group size         only             CBD         sensitized      Total  (%)       CBD  (%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
0.0-0.147...............................................              81               2               2               4             4.9             2.5
0.148-1.467.............................................              79               0               2               2             2.5             2.5
1.468-7.008.............................................              79               3               8              11            13.9             8.0
7.009-61.86.............................................              80               2               7               9            11.3             8.8
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................             319               7              19              26            8.2%            6.0%
--------------------------------------------------------------------------------------------------------------------------------------------------------


                        Table VI-5--Prevalence of Sensitization and CBD by Highest-Exposed Job Exposure Quartile in NJH Data Set
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                            Sensitized                         Total
               HEJ exposure  ([mu]g/m\3\)                   Group size         only             CBD         sensitized      Total  (%)       CBD  (%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
0.0-0.086...............................................              86               1               0               1             1.2             0.0
0.091-0.214.............................................              81               1               6               7             8.6             7.4
0.387-0.691.............................................              76               2               9              11            14.5            11.8
0.954-2.213.............................................              76               3               4               7             9.2             5.3
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................             319               7              19              26             8.2             6.0
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Table VI-3 shows increasing prevalence of total sensitization and 
CBD with increasing LTW average exposure. The lowest prevalence of 
sensitization and CBD was observed among workers with average exposure 
levels less than or equal to 0.08 [mu]g/m\3\, where two sensitized 
workers (2.2 percent), including one case of CBD (1.0 percent), were 
found. The sensitized worker in this category without CBD had worked at 
the facility as an inspector since 1972, one of the lowest-exposed jobs 
at the plant. Because the job was believed to have very low exposures, 
it was not sampled prior to 1998. Thus, estimates of exposures in this 
job are based on data from 1998-2003 only. It is possible that 
exposures earlier in this worker's employment history were somewhat 
higher than reflected in his estimated average exposure. The worker 
diagnosed with CBD in this group had been hired in 1996 in production 
control, and had an estimated average exposure of 0.08 [mu]g/m\3\. This 
worker was diagnosed with CBD in 1997.
    The second quartile of LTW average exposure (0.081-0.18 [mu]g/m\3\) 
shows a marked rise in overall prevalence of beryllium-related health 
effects, with 6 workers sensitized (8.2 percent), of whom 4 (5.5 
percent) were diagnosed with CBD. Among 6 sensitized workers in the 
third quartile (0.19-0.51 [mu]g/m\3\), all were diagnosed with CBD (7.8 
percent). Another increase in prevalence is seen from the third to the 
fourth quartile, with 12 cases of sensitization (15.4 percent), 
including eight (10.3 percent) diagnosed with CBD.
    The quartile analysis of cumulative exposure also shows generally 
increasing prevalence of sensitization and CBD with increasing 
exposure. As shown in Table VI-4, the lowest prevalences of CBD and 
sensitization are in the first two quartiles of cumulative exposure 
(0.0-0.147 [mu]g/m\3\-yrs, 0.148-1.467 [mu]g/m\3\-yrs). The upper bound 
on this cumulative exposure range, 1.467 [mu]g/m\3\-yrs, is the 
cumulative exposure that a worker would have if exposed to beryllium at 
a level of 0.03 [mu]g/m\3\ for a working lifetime of 45 years; 0.15 
[mu]g/m\3\ for ten years; or 0.3 [mu]g/m\3\ for five years. These 
exposure levels are in the range of those OSHA was interested in 
evaluating for purposes of this rulemaking.
    A sharp increase in prevalence of sensitization and CBD occurs in 
the third quartile (1.468-7.008 [mu]g/m\3\-yrs), with roughly similar 
levels of both in the highest group (7.009-61.86 [mu]g/m\3\-yrs). 
Cumulative exposures in the third quartile would be experienced by a 
worker exposed for 45 years to levels between 0.03 and 0.16 [mu]g/m\3\, 
for 10 years to levels between 0.15 and 0.7 [mu]g/m\3\, or for 5 years 
to levels between 0.3 and 1.4 [mu]g/m\3\.
    When workers' exposures from their highest-exposed job are 
considered, the exposure-response pattern is similar to that for LTW 
average exposure in the lower quartiles. In Table VI-5, the lowest 
prevalence is observed in the first quartile (0.0-0.086 [mu]g/m\3\), 
with sharply rising prevalence from first to second and second to third 
exposure quartiles. The prevalence of sensitization and CBD in the top 
quartile (0.954-2.213 [mu]g/m\3\) decreases relative to the third, with 
levels similar to the overall prevalence in the dataset. Many workers 
in the highest exposure quartiles are long-time employees, who were 
hired during the early years of the shop when exposures were highest. 
One possible explanation for the drop in prevalence in the highest 
exposure quartiles is that other highly-exposed workers from early 
periods may have developed CBD and left the plant before sensitization 
testing began in 1995 (i.e., the healthy worker survivor effect).
    The results of this prevalence analysis support OSHA's conclusion 
that maintaining exposure levels below the new TWA PEL will help to 
reduce risk

[[Page 2538]]

of beryllium sensitization and CBD, and that maintaining exposure 
levels below the action level can further reduce risk of beryllium 
sensitization and CBD. However, risk of both sensitization and CBD 
remains even among the workers with the lowest airborne exposures in 
this data set.

C. OSHA's Statistical Modeling for Sensitization and CBD

1. OSHA's Preliminary Analysis of the NJH Data Set
    In the course of OSHA's development of the proposed rule, OSHA's 
contractor (ERG) also developed a statistical analysis using the NJH 
data set and a discrete time proportional hazards analysis (DTPHA). 
This preliminary analysis predicted significant risks of both 
sensitization (96-394 cases per 1,000, or 9.6-39.4 percent) and CBD 
(44-313 cases per 1,000, or 4.4-31.3 percent) at the preceding TWA PEL 
of 2 [mu]g/m\3\ for an exposure duration of 45 years (90 [mu]g/m\3\-
yr). The predicted risks of 8.2-39.9 cases of sensitization per 1,000 
(0.8-3.9 percent) and 3.6 to 30.0 cases of CBD per 1,000 (0.4-3 
percent) were approximately 10-fold less, but still significant, for a 
45-year exposure at the new TWA PEL of 0.2 [mu]g/m\3\ (9 [mu]g/m\3\-
yr).
    In interpreting the risk estimates, OSHA took into consideration 
limitations in the preliminary statistical analysis, primarily study 
size-related constraints. Consequently, as discussed in the NPRM, OSHA 
did not rely on the preliminary statistical analysis for its 
significance of risk determination or to develop its benefits analysis. 
The Agency relied primarily on the previously-presented analysis of the 
epidemiological literature and the prevalence analysis of the Cullman 
data for its preliminary significance of risk determination, and on the 
prevalence analysis for its preliminary estimate of benefits. Although 
OSHA did not rely on the results of the preliminary statistical 
analysis for its findings, the Agency presented the DTPHA in order to 
inform the public of its results, explain its limitations, and solicit 
public comment on the Agency's approach.
    Dr. Kenny Crump and Ms. Deborah Proctor submitted comments on 
OSHA's preliminary risk assessment (Document ID 1660). Crump and 
Proctor agreed with OSHA's review of the epidemiological literature and 
the prevalence analysis presented previously in this section. They 
stated, ``we agree with OSHA's conclusion that there is a significant 
risk (>1/1000 risk of CBD) at the [then] current PEL, and that risk is 
reduced at the [then] proposed PEL (0.2 [mu]g/m\3\) in combination with 
stringent measures (ancillary provisions) to reduce worker's exposures. 
This finding is evident based on the available literature, as described 
by OSHA, and the prevalence data presented for the Cullman facility'' 
(Document ID 1660, p. 2). They also presented a detailed evaluation of 
the statistical analysis of the Cullman data presented in the NPRM, 
including a critique of OSHA's modeling approach and interpretation and 
suggestions for alternate analyses. However, they emphasized that the 
new beryllium rule should not be altered or delayed due to their 
comments regarding the statistical model (Document ID 1660, p. 2).
    After considering comments on this preliminary model, OSHA 
instructed its contractor to change the statistical analysis to address 
technical concerns and to incorporate suggestions from Crump and 
Proctor, as well as NIOSH (Document ID 1660; 1725). OSHA reviews and 
addresses these comments on the preliminary statistical analysis and 
provides a presentation of the final statistical analysis in the 
background document (Risk Analysis of the NJH Data Set from the 
Beryllium Machining Facility in Cullman, Alabama--CBD and 
Sensitization, OSHA, 2016). The results of the final statistical 
analysis are summarized here.
2. OSHA's Final Statistical Analysis of the NJH Data Set
    As noted above, Dr. Roslyn Stone of University of Pittsburgh School 
of Public Health reanalyzed for OSHA the Cullman data set in order to 
address concerns raised by Crump and Proctor (Document ID 1660). The 
reanalysis uses a Cox proportional hazards model instead of the DTPHA. 
The Cox model, a regression method for survival data, provides an 
estimate of the hazard ratio (HR) and its confidence interval.\17\ Like 
the DTPHA, the Cox model can accommodate time-dependent data; however, 
the Cox model has an advantage over the DTPHA for OSHA's purpose of 
estimating risk to beryllium-exposed workers in that it does not 
estimate different ``baseline'' rates of sensitization and CBD for 
different years. Time-specific risk sets were constructed to 
accommodate the time-dependent exposures. P-values were based on 
likelihood ratio tests (LRTs), with p-values <0.05 considered to be 
statistically significant.
---------------------------------------------------------------------------

    \17\ The hazard ratio is an estimate of the ratio of the hazard 
rate in the exposed group to that of the control group.
---------------------------------------------------------------------------

    As in the preliminary statistical analysis, Dr. Stone used 
fractional polynomials \18\ to check for possible nonlinearities in the 
exposure-response models, and checked the effects of age and smoking 
habits using data on birth year and smoking (current, former, never) 
provided in the Cullman data set. Data on workers' estimated exposures 
and health outcomes through 2005 were included in the reanalysis.\19\ 
The 1995 risk set (e.g., analysis of cases of sensitization and CBD 
identified in 1995) was excluded from all models in the reanalysis so 
as not to analyze long-standing (prevalent) cases of sensitization and 
CBD together with newly arising (incident) cases of sensitization and 
CBD. Finally, Dr. Stone used the testing protocols provided in the 
literature on the Cullman study population to determine the years in 
which each employee was scheduled to be tested, and excluded employees 
from the analysis for years in which they were not scheduled to be 
tested (Newman et al., 2001, Document ID 1354).
---------------------------------------------------------------------------

    \18\ Fractional polynomials are linear combinations of 
polynomials that provide flexible shapes of exposure response.
    \19\ Data from 2003 to 2005 were excluded in some previous 
analyses due to uncertainty in some employees' work histories. OSHA 
accepted the.Crump and Proctor recommendation that these data should 
be included, so as to treat uncertain exposure estimates 
consistently in the reanalysis (data prior to the start of sampling 
in 1980 were included in the previous analysis and most models in 
the reanalysis).
---------------------------------------------------------------------------

    In the reanalysis of the NJH data set, the HR for sensitization 
increased significantly with increasing LTW average exposure (HR = 
2.92, 95% CI = 1.51-5.66, p = 0.001; note that HRs are rounded to the 
second decimal place). Cumulative exposure was also a statistically 
significant predictor for beryllium sensitization, although it was not 
as strongly related to sensitization as LTW average exposure (HR = 
1.04, 95% CI 1.00-1.07, p = 0.03). The HR for CBD increased 
significantly with increasing cumulative exposure (HR = 1.04, 95% CI = 
1.01-1.08, p = 0.02). The HR for CBD increased somewhat with increasing 
LTW average exposure, but this increase was not significant at the 0.05 
level (HR = 2.25, 95% CI = 0.94-5.35, p = 0.07).
    None of the analyses Dr. Stone performed to check for 
nonlinearities in exposure-response or the effects of smoking or age 
substantially impacted the results of the analyses for beryllium 
sensitization or CBD. The sensitivity analysis recommended by Crump and 
Proctor, excluding workers hired prior to 1980 (see Document ID 1660, 
p. 11), did not substantially impact the results

[[Page 2539]]

of the analyses for beryllium sensitization, but did affect the results 
for CBD. The HR for CBD using cumulative exposure dropped to slightly 
below 1 and was not statistically significant following exclusion of 
workers hired before 1980 (HR 0.96, 95% CI 0.81-1.13, p = 0.6). OSHA 
discusses this result further in the background document, concluding 
that the reduced follow-up time for CBD in the subcohort hired in 1980 
or later, in combination with genetic risk factors that may attenuate 
both exposure-response and disease latency in some people, may explain 
the lack of significant exposure-response observed in this sensitivity 
analysis.
    Because LTW average exposure was most strongly associated with 
beryllium sensitization, OSHA used the final model for LTW average 
exposure to estimate risk of sensitization at the preceding TWA PEL, 
the final TWA PEL, and several alternate TWA PELs it considered. 
Similarly, because cumulative exposure was most strongly associated 
with CBD, OSHA used the final model for cumulative exposure to estimate 
risk of CBD at the preceding, final, and alternate TWA PELs. In 
calculating these risks, OSHA used a small, fixed estimate of 
``baseline'' risk (i.e., risk of sensitization or CBD among persons 
with no known exposure to beryllium), as suggested by Crump and Proctor 
(Document ID 1660) and NIOSH (Document ID 1725). Table VI-6 presents 
the risk estimates for sensitization and the corresponding 95 percent 
confidence intervals using two different fixed ``background'' rates of 
sensitization, 1 percent and 0.5 percent. Table VI-7 presents the risk 
estimates for sensitization and the corresponding 95 percent confidence 
intervals using a fixed ``background'' rate of CBD of 0.5 percent. The 
corresponding interval is based on the uncertainty in the exposure 
coefficient (i.e., the predicted values based on the 95 percent 
confidence limits for the exposure coefficient). Since the Cox 
proportional hazards model does not estimate a baseline risk, this 95 
percent interval fully represents statistical uncertainty in the risk 
estimates.

Table VI-6--Predicted Cases of Sensitization per 1,000 Workers Exposed at the Preceding and Alternate PELs Based
    on Cox Proportional Hazards Model, LTW Average Exposure Metric, With Corresponding Interval Based on the
                                    Uncertainty in the Exposure Coefficient.
                                      [1 Percent and 0.5 percent baselines]
----------------------------------------------------------------------------------------------------------------
                                                     Estimated                       Estimated
          Exposure level  ([mu]g/m\3\)              cases/1000,       95% CI        cases/1000,       95% CI
                                                   .5% baseline                     1% baseline
----------------------------------------------------------------------------------------------------------------
2.0.............................................           42.75     11.4-160.34           85.49    22.79-320.69
1.0.............................................           14.62      7.55-28.31           29.24     15.10-56.63
0.5.............................................            8.55      6.14-11.90           17.10     12.29-23.80
0.2.............................................            6.20       5.43-7.07           12.39     10.86-14.15
0.1.............................................            5.57       5.21-5.95           11.13     10.42-11.89
----------------------------------------------------------------------------------------------------------------


 Table VI-7--Predicted Cases of CBD per 1,000 Workers Exposed at the Preceding and Alternative PELs Based on Cox Proportional Hazards Model, Cumulative
                            Exposure Metric, with Corresponding Interval Based on the Uncertainty in the Exposure Coefficient
                                                                 [0.5 percent baseline]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                           Exposure Duration
                                              ----------------------------------------------------------------------------------------------------------
                                                        5 years                    10 years                   20 years                  45 years
         Exposure level ([mu]g/m\3\)          ----------------------------------------------------------------------------------------------------------
                                                Cumulative    Estimated                  Estimated                  Estimated                 Estimated
                                               ([mu]g/m\3\-  cases/1000   [mu]g/m\3\-   cases/1000   [mu]g/m\3\-   cases/1000   [mu]g/m\3\-   cases/1000
                                                   yrs)        95% CI         yrs         95% CI         yrs         95% CI         yrs         95% CI
--------------------------------------------------------------------------------------------------------------------------------------------------------
2.0..........................................         10.0         7.55          20.0        11.39          40.0        25.97          90.0       203.60
                                                             5.34-10.67                 5.70-22.78                 6.5-103.76                9.02-4595.6
                                                                                                                                                       7
1.0..........................................          5.0         6.14          10.0         7.55          20.0        11.39          45.0        31.91
                                                              5.17-7.30                 5.34-10.67                 5.70-22.78                6.72-151.59
0.5..........................................          2.5         5.54           5.0         6.14          10.0         7.55          22.5        12.63
                                                              5.08-6.04                  5.17-7.30                 5.34-10.67                 5.79-27.53
0.2..........................................          1.0         5.21           2.0         5.43           4.0          5.9           9.0         7.24
                                                              5.03-5.39                  5.07-5.82                  5.13-6.77                  5.30-9.89
0.1..........................................          0.5          5.1           1.0         5.21           2.0         5.43           4.5         6.02
                                                              5.02-5.19                  5.03-5.39                  5.07-5.82                  5.15-7.03
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The Cox proportional hazards model, used with the fixed 
``baseline'' rates of 0.5 percent and 1 percent, predicted risks of 
sensitization totaling 43 and 86 cases per 1,000 workers, respectively, 
or 4.3 and 8.6 percent, at the preceding PEL of 2 [mu]g/m\3\. The 
predicted risk of CBD is 203 cases per 1,000 workers, or 20.3 percent, 
at the preceding PEL of 2 [mu]g/m\3\, assuming 45 years of exposure 
(cumulative exposure of 90 [mu]g/m\3\-yr).\20\ The predicted risks of 
sensitization at the new PEL of 0.2 [mu]g/m\3\ are substantially lower, 
at 6 and 12 cases per 1,000 for the baselines of 0.5% and 1.0%, 
respectively. The predicted risk of CBD is also much lower at the new 
TWA PEL of 0.2 [mu]g/m\3\ (9 [mu]g/m\3\-year), at 7 cases per 1,000 
assuming 45 years of exposure.
---------------------------------------------------------------------------

    \20\ The predictions for each model represent the estimated 
probability of being sensitized or having CBD at one point in time, 
rather than the cumulative risk over a lifetime of exposure, which 
would be higher. Lifetime risks are presented in the FEA, Benefits 
Analysis.
---------------------------------------------------------------------------

    Due to limitations in the Cox analysis, including the small size of 
the dataset, relatively limited exposure data from the plant's early 
years, study size-related constraints on the statistical analysis of 
the dataset, limited follow-

[[Page 2540]]

up time on many workers, and sensitivity of the results to the 
``baseline'' values assumed for sensitization and CBD, OSHA must 
interpret the model-based risk estimates presented in Tables VI-6 and 
VI-7 with caution. Uncertainties in these risk estimates are discussed 
in the background document (Risk Analysis of the NJH Data Set from the 
Beryllium Machining Facility in Cullman, Alabama--CBD and 
Sensitization, OSHA, 2016). However, these uncertainties do not alter 
OSHA's conclusions with regard to the significance of risk at the 
preceding PEL and alternate PELs that OSHA considered, which are based 
primarily on the Agency's review of the literature and the prevalence 
analysis presented earlier in this section (also see Section VII, 
Significance of Risk).

D. Lung Cancer

    As discussed more fully in the Health Effects section of the 
preamble, OSHA has determined beryllium to be a carcinogen based on an 
extensive review of the scientific literature regarding beryllium and 
cancer (see Section V.E). This review included an evaluation of the 
human epidemiological, animal cancer, and mechanistic studies described 
in the Health Effects section of this preamble. OSHA's conclusion is 
supported by the findings of public health organizations such as the 
International Agency for Research on Cancer (IARC), which has 
determined beryllium and its compounds to be carcinogenic to humans 
(Group 1 category) (IARC 2012, Document ID 0650); the National 
Toxicology Program (NTP), which classifies beryllium and its compounds 
as known carcinogens (NTP 2014, Document ID 0389); and the 
Environmental Protection Agency (EPA), which considers beryllium to be 
a probable human carcinogen (EPA 1998, Document ID 0661).
    The Sanderson et al. study previously discussed in Health Effects 
evaluated the association between beryllium exposure and lung cancer 
mortality based on data from a beryllium processing plant in Reading, 
PA (Sanderson et al., 2001, Document ID 1419). Specifically, this case-
control study evaluated lung cancer mortality in a cohort of 3,569 male 
workers employed at the plant from 1940 to 1969 and followed through 
1992. For each lung cancer victim, 5 age- and race-matched controls 
were selected by incidence density sampling, for a total of 142 
identified lung cancer cases and 710 controls.
    A conditional logistic regression analysis showed an increased risk 
of death from lung cancer in workers with higher exposures when dose 
estimates were lagged by 10 and 20 years (Sanderson et al., 2001, 
Document ID 1419). This lag was incorporated in order to account for 
exposures that did not contribute to lung cancer because they occurred 
after the induction of cancer. The authors noted that there was 
considerable uncertainty in the estimation of exposure levels for the 
1940s and 1950s and in the shape of the dose-response curve for lung 
cancer. In a 2008 study, Schubauer-Berigan et al. reanalyzed the data, 
adjusting for potential confounders of hire age and birth year 
(Schubauer-Berigan et al., 2008, Document ID 1350). The study reported 
a significant increasing trend (p < 0.05) in lung cancer mortality when 
average (log transformed) exposure was lagged by 10 years. However, it 
did not find a significant trend when cumulative (log transformed) 
exposure was lagged by 0, 10, or 20 years (Schubauer-Berigan et al., 
2008, Table 3).
    In formulating the final rule, OSHA was particularly interested in 
lung cancer risk estimates from a 45-year (i.e., working lifetime) 
exposure to beryllium levels between 0.1 [mu]g/m\3\ and 2 [mu]g/m\3\. 
The majority of case and control workers in the Sanderson et al. (2001, 
Document ID 1419) case-control analysis were first hired during the 
1940s and 50s when exposures were extremely high (estimated daily 
weighted averages (DWAs) >20 [mu]g/m\3\ for most jobs) in comparison to 
the exposure range of interest to OSHA (Sanderson et al. 2001, Document 
ID 1419, Table II). About two-thirds of cases and half of controls 
worked at the plant for less than a year. Thus, a risk assessment based 
on this exposure-response analysis would have needed to extrapolate 
from very high to low exposures, based on a working population with 
extremely short tenure. While OSHA risk assessments must often make 
extrapolations to estimate risk within the range of exposures of 
interest, the Agency acknowledges that these issues of short tenure and 
high exposures would have created substantial uncertainty in a risk 
assessment based on this particular study population.
    In addition, the relatively high exposures of the least-exposed 
workers in the study population might have created methodological 
issues for the lung cancer case-control study design. Mortality risk is 
expressed as an odds ratio that compares higher exposure quartiles to 
the lowest quartile. It is preferable that excess risks attributable to 
occupational beryllium be determined relative to an unexposed or 
minimally exposed reference population. However, in this study 
population, workers in the lowest quartile were exposed well above the 
preceding OSHA TWA PEL (average exposure <11.2 [mu]g/m\3\) and may have 
had a significant lung cancer risk. This issue would have introduced 
further uncertainty into the lung cancer risks.
    In 2011, Schubauer-Berigan et al. published a quantitative risk 
assessment that addressed several of OSHA's concerns regarding the 
Sanderson et al. analysis. This new risk assessment was based on an 
update of the Reading cohort analyzed by Sanderson et al., as well as 
workers from two smaller plants (Schubauer-Berigan et al. 2011, 
Document ID 1265). This study population was exposed, on average, to 
lower levels of beryllium and had fewer short-term workers than the 
previous cohort analyzed by Sanderson et al. (2001, Document ID 1250) 
and Schubauer-Berigan et al. (2008, Document ID 1350). Schubauer-
Berigan et al. (2011) followed the study population through 2005 where 
possible, increasing the length of follow-up time overall by an 
additional 17 years of observation compared to the previous analyses. 
For these reasons, OSHA considered the Schubauer-Berigan (2011) 
analysis more appropriate than Sanderson et al. (2001) and Schubauer-
Berigan (2008) for its risk assessment. OSHA therefore based its 
preliminary QRA for lung cancer on the results from Schubauer-Berigan 
et al. (2011).
    OSHA received several comments about its choice of Schubauer-
Berigan et al. (2011) as the basis for its preliminary QRA for lung 
cancer. NIOSH commented that OSHA's choice of Schubauer-Berigan et al. 
for its preliminary analysis was appropriate because ``[n]o other study 
is available that presents quantitative dose-response information for 
lung cancer, across a range of beryllium processing facilities'' 
(Document ID 1725, p. 7). In supporting OSHA's use of this study, NIOSH 
emphasized in particular the study's inclusion of relatively low-
exposed workers from two facilities that began operations in the 1950s 
(after employer awareness of acute beryllium disease (ABD) and CBD led 
to efforts to minimize worker exposures to beryllium), as well as the 
presence of both soluble and poorly soluble forms of beryllium in the 
facilities studied (Document ID 1725, p. 7).
    According to Dr. Paolo Boffetta, who submitted comments on this 
study,

[[Page 2541]]

Schubauer-Berigan et al. (2011) is not the most relevant study 
available to OSHA for its lung cancer risk analysis. Dr. Boffetta 
argued that the most informative study of lung cancer risk in the 
beryllium industry after 1965 is one that he developed in 2015 
(Boffetta et al., 2015), which he described as a pooled analysis of 11 
plants and 4 distribution centers (Document ID 1659, p. 1). However, 
Dr. Boffetta did not provide OSHA with the manuscript of his study, 
which he stated was under review for publication. Instead, he reported 
some results of the study and directed OSHA to an abstract of the study 
in the 2015 Annual Conference of the Society for Epidemiologic Research 
(Document ID 1659; Document ID 1661, Attachment 1).
    Because only an abstract of Boffetta et al.'s 2015 study was 
available to OSHA (see Document ID 1661, Attachment 1), OSHA could not 
properly evaluate it or use it as the basis of a quantitative risk 
assessment for lung cancer. Nevertheless, OSHA has addressed comments 
Dr. Boffetta submitted based on his analyses in the relevant sections 
of the final QRA for lung cancer below. Because it was not possible to 
use this study for its lung cancer QRA and OSHA is not aware of other 
studies appropriate for use in its lung cancer QRA (nor did commenters 
besides Dr. Boffetta suggest that OSHA use any additional studies for 
this purpose), OSHA finds that the body of available evidence has not 
changed since the Agency conducted its preliminary QRA based on 
Schubauer-Berigan et al. (2011, Document ID 1265). Therefore, OSHA 
concludes that Schubauer-Berigan et al. (2011) is the most appropriate 
study for its final lung cancer QRA, presented below.
1. QRA for Lung Cancer Based on Schubauer-Berigan et al. (2011)
    The cohort studied by Schubauer-Berigan et al. (2011, Document ID 
1265) included 5,436 male workers who had worked for at least 2 days at 
the Reading facility or at the beryllium processing plants in Hazleton, 
PA and Elmore, OH prior to 1970. The authors developed job-exposure 
matrices (JEMs) for the three plants based on extensive historical 
exposure data, primarily short-term general area and personal breathing 
zone samples, collected on a quarterly basis from a wide variety of 
operations. These samples were used to create DWA estimates of workers' 
full-shift exposures, using records of the nature and duration of tasks 
performed by workers during a shift. Details on the JEM and DWA 
construction can be found in Sanderson et al. (2001, Document ID 1250), 
Chen et al. (2001, Document ID 1593), and Couch et al. (2010, Document 
ID 0880).
    Workers' cumulative exposures ([mu]g/m\3\-days) were estimated by 
summing daily average exposures (assuming five workdays per week) 
(Schubauer-Berigan et al., 2011). To estimate mean exposure ([mu]g/
m\3\), cumulative exposure was divided by exposure time (in days), 
accounting where appropriate for lag time. Maximum exposure ([mu]g/
m\3\) was calculated as the highest annual DWA on record for a worker 
from the first exposure until the study cutoff date of December 31, 
2005, again accounting where appropriate for lag time. Exposure 
estimates were lagged by 5, 10, 15, and 20 years in order to account 
for exposures that may not have contributed to lung cancer because of 
the long latency required for manifestation of the disease. The authors 
also fit models with no lag time.
    As shown in Table VI-8 below, estimated exposure levels for workers 
from the Hazleton and Elmore plants were on average far lower than 
those for workers from the Reading plant (Schubauer-Berigan et al., 
2011). Whereas the median worker from Hazleton had a mean exposure 
across his tenure of less than 1.5 [mu]g/m\3\ and the median worker 
from Elmore had a mean exposure of less than 1 [mu]g/m\3\, the median 
worker from Reading had a mean exposure of 25 [mu]g/m\3\. The Elmore 
and Hazleton worker populations also had fewer short-term workers than 
the Reading population. This was particularly evident at Hazleton, 
where the median value for cumulative exposure among cases was higher 
than at Reading despite the much lower mean and maximum exposure 
levels.

                                       Table VI-8--Cohort Description and Distribution of Cases by Exposure Level
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                            All plants     Reading plant  Hazleton plant   Elmore plant
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of cases................................  .......................................             293             218              30              45
Number of non-cases............................  .......................................            5143            3337             583            1223
Median value for mean exposure.................  No lag.................................           15.42              25           1.443           0.885
([mu]g/m\3\) among cases.......................  10-year lag............................           15.15              25           1.443           0.972
Median value for cumulative exposure...........  No lag.................................            2843            2895            3968            1654
([mu]g/m\3\-days) among cases..................  10-year lag............................            2583            2832            3648            1449
Median value for maximum exposure..............  No lag.................................              25            25.1            3.15            2.17
([mu]g/m\3\) among cases.......................  10-year lag............................              25              25            3.15            2.17
Number of cases with potential asbestos          .......................................       100 (34%)        68 (31%)        16 (53%)        16 (36%)
 exposure.
Number of cases who were professional workers..  .......................................         26 (9%)        21 (10%)         3 (10%)          2 (4%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
 Table adapted from Schubauer-Berigan et al., 2011, Document ID 1265, Table 1.

    Schubauer-Berigan et al. analyzed the data set using a variety of 
exposure-response modeling approaches, including categorical analyses, 
continuous-variable piecewise log-linear models, and power models 
(2011, Document ID 1265). All models adjusted for birth cohort and 
plant. Because exposure values were log-transformed for the power model 
analyses, the authors added small values to exposures of 0 in lagged 
analyses (0.05 [mu]g/m\3\ for mean and maximum exposure, 0.05 [mu]g/
m\3\-days for cumulative exposure). The authors used restricted cubic 
spline models to assess the shape of the exposure-response curves and 
suggest appropriate parametric model forms. The Akaike Information 
Criterion (AIC) value was used to evaluate the fit of different model 
forms and lag times.
    Because smoking information was available for only about 25 percent 
of the cohort (those employed in 1968), smoking could not be controlled 
for directly in the models. Schubauer-Berigan et al. reported that 
within the subset with smoking information, there was little difference 
in smoking by cumulative or maximum exposure category, suggesting that 
smoking was unlikely to act as a confounder in the cohort. In addition 
to models based on the full cohort, Schubauer-Berigan et al. also 
prepared risk estimates based on models excluding professional workers 
(ten percent of cases) and workers believed to have asbestos exposure 
(one-third of cases). These models were

[[Page 2542]]

intended to mitigate the potential impact of smoking and asbestos as 
confounders.\21\
---------------------------------------------------------------------------

    \21\ The authors appeared to reason that if professional workers 
had both lower beryllium exposures and lower smoking rates than 
production workers, smoking could be a confounder in the cohort 
comprising both production and professional workers. However, 
smoking was unlikely to be correlated with beryllium exposure among 
production workers, and would therefore probably not act as a 
confounder in a cohort excluding professional workers.
---------------------------------------------------------------------------

    The authors found that lung cancer risk was strongly and 
significantly related to mean, cumulative, and maximum measures of 
workers' exposure (all models reported in Schubauer-Berigan et al., 
2011, Document ID 1265). They selected the best-fitting categorical, 
power, and monotonic piecewise log-linear (PWL) models with a 10-year 
lag to generate HRs for male workers with a mean exposure of 0.5 [mu]g/
m\3\ (the current NIOSH Recommended Exposure Limit for beryllium).\22\ 
In addition, they estimated the daily weighted average exposure that 
would be associated with an excess lung cancer mortality risk of one in 
one thousand (.005 [mu]g/m\3\ to .07 [mu]g/m\3\ depending on model 
choice). To estimate excess risk of cancer, they multiplied these 
hazard ratios by the 2004 to 2006 background lifetime lung cancer rate 
among U.S. males who had survived, cancer-free, to age 30. At OSHA's 
request, Dr. Schubauer-Berigan also estimated excess lung cancer risks 
for workers with mean exposures at the preceding PEL of 2 [mu]g/m\3\ 
and at each of the other alternate PELs that were under consideration: 
1 [mu]g/m\3\, 0.2 [mu]g/m\3\, and 0.1 [mu]g/m\3\ (Document ID 0521). 
The resulting risk estimates are presented in Table VI-9 below.
---------------------------------------------------------------------------

    \22\ Here, ``monotonic PWL model'' means a model producing a 
monotonic exposure-response curve in the 0 to 2 [mu]g/m\3\ range.

   Table VI-9--Excess Lung Cancer Risk per 1,000 [95% Confidence Interval] For Male Workers at Alternate PELs
                                    [Based on Schubauer-Berigan et al., 2011]
----------------------------------------------------------------------------------------------------------------
                                                                   Mean exposure
     Exposure-response model     -------------------------------------------------------------------------------
                                  0.1 [mu]g/m\3\  0.2 [mu]g/m\3\  0.5 [mu]g/m\3\   1 [mu]g/m\3\    2 [mu]g/m\3\
----------------------------------------------------------------------------------------------------------------
Best monotonic PWL--all workers.    7.3 [2.0-13]     15 [3.3-29]       45 [9-98]    120 [20-340]    140 [29-370]
Best monotonic PWL--excluding        3.1 [<0-11]     6.4 [<0-23]      17 [<0-74]     39 [39-230]     61 [<0-280]
 professional and asbestos
 workers........................
Best categorical--all workers...     4.4 [1.3-8]      9 [2.7-17]       25 [6-48]     59 [13-130]    170 [29-530]
Best categorical--excluding         1.4 [<0-6.0]     2.7 [<0-12]     7.1 [<0-35]      15 [<0-87]     33 [<0-290]
 professional and asbestos
 workers........................
Power model--all workers........       12 [6-19]     19 [9.3-29]      30 [15-48]      40 [19-66]      52 [23-88]
Power model--excluding               19 [8.6-31]      30 [13-50]      49 [21-87]     68 [27-130]     90 [34-180]
 professional and asbestos
 workers........................
----------------------------------------------------------------------------------------------------------------
Source: Schubauer-Berigan, Document ID 0521, pp. 6-10.

    Schubauer-Berigan et al. (2011, Document ID 1265) discuss several 
strengths, weaknesses, and uncertainties of their analysis. Strengths 
include a long (>30 years) follow-up time and the extensive exposure 
and work history data available for the development of exposure 
estimates for workers in the cohort. Weaknesses and uncertainties of 
the study include the limited information available on workers' smoking 
habits: As mentioned above, smoking information was available only for 
workers employed in 1968, about 25 percent of the cohort. Another 
potential weakness was that the JEMs used did not account for possible 
respirator use among workers in the cohort. The authors note that 
workers' exposures may therefore have been overestimated, and that 
overestimation may have been especially severe for workers with high 
estimated exposures. They suggest that overestimation of exposures for 
workers in highly exposed positions may have caused attenuation of the 
exposure-response curve in some models at higher exposures. This could 
cause the relationship between exposure level and lung cancer risk to 
appear weaker than it would in the absence of this source of error in 
the estimation of workers' beryllium exposures.
    Schubauer-Berigan et al. (2011) did not discuss the reasons for 
basing risk estimates on mean exposure rather than cumulative exposure, 
which is more commonly used for lung cancer risk analysis. OSHA 
believes the decision may involve the non-monotonic relationship the 
authors observed between cancer risk and cumulative exposure level. As 
discussed previously, workers from the Reading plant frequently had 
very short tenures and high exposures, yielding lower cumulative 
exposures compared to cohort workers from other plants with longer 
employment. Despite the low estimated cumulative exposures among the 
short-term Reading workers, they may have been at high risk of lung 
cancer due to the tendency of beryllium to persist in the lung for long 
periods. This could lead to the appearance of a non-monotonic 
relationship between cumulative exposure and lung cancer risk. It is 
possible that a dose-rate effect may exist for beryllium, such that the 
risk from a cumulative exposure gained by long-term, low-level exposure 
is not equivalent to the risk from a cumulative exposure gained by very 
short-term, high-level exposure. In this case, mean exposure level may 
better correlate with the risk of lung cancer than cumulative exposure 
level. For these reasons, OSHA considers the authors' use of the mean 
exposure metric to be appropriate and scientifically defensible for 
this particular dataset.
    Dr. Boffetta's comment, mentioned above, addressed the relevance of 
the Schubauer-Berigan et al. (2011) cohort to determining whether 
workers currently employed in the beryllium industry experience an 
increased lung cancer hazard (Document ID 1659, pp. 1-2). His comment 
also analyzed the methods and findings in Schubauer-Berigan et al. 
(2011) (Document ID 1659, pp. 2-3). Notably, he stated that his own 
study, Boffetta et al. (2015) provides better information for risk 
assessment than does Schubauer-Berigan et al. (2011) (Document ID 1659, 
pp. 1-2). As discussed above, OSHA cannot rely on a study for its QRA 
(Boffetta et al., 2015) that has not been submitted to the record and 
is not otherwise available to OSHA. However, in the discussion below, 
OSHA addresses Dr. Boffetta's study to the extent it can given the

[[Page 2543]]

limited information available to the Agency. OSHA also responds to Dr. 
Boffetta's comments on Schubauer-Berigan et al. (2011, Document ID 
1265) and Boffetta et al. (2014, Document ID 0403), which Dr. Boffetta 
asserts provides evidence that poorly soluble beryllium compounds are 
not associated with lung cancer (Document ID 1659, p. 1).
    Boffetta argued that the most informative study in the modern 
(post-1965) beryllium industry is Boffetta et al. (2015, Document ID 
1661, Attachment 1). According to Boffetta's comment, the study found 
an SMR of 1.02 (95% CI 0.94-1.10, based on 672 deaths) for the overall 
cohort and an SMR for lung cancer among workers exposed only to 
insoluble beryllium of 0.93 (95% CI 0.79-1.08, based on 157 deaths). 
Boffetta noted that his study was based on 23 percent more overall 
deaths than the Schubauer-Berigan et al. cohort (Document ID 1659, pp. 
1-2). As stated earlier, this study is unpublished and was not provided 
to OSHA. The abstract provided by Materion (Document ID 1661, 
Attachment 1) included very little information beyond the SMRs 
reported; for example, it provided no information about the 
manufacturing plants and distribution centers included, workers' 
beryllium exposure levels, how the cohorts were defined, or how the 
authors determined the solubility of the beryllium to which workers 
were exposed. OSHA is therefore unable to evaluate the quality or 
conclusions of this study.
    Dr. Boffetta also commented that there is a lack of evidence of 
increased lung cancer risk among workers exposed only to poorly soluble 
beryllium compounds (Document ID 1659, p. 1). To support this 
statement, he cited a study he published in 2014 of workers at four 
``insoluble facilities'' (Boffetta et al., 2014) and Schubauer-Berigan 
et al.'s 2011 study, arguing that increased cancer risk in beryllium-
exposed workers in those two studies was only observed in workers 
employed in Reading and Lorain prior to 1955. Workers employed at the 
other plants and workers who were first employed in Reading and Lorain 
after 1955, according to Dr. Boffetta, were exposed primarily to poorly 
soluble forms of beryllium and did not experience an increased risk of 
lung cancer. Dr. Boffetta further stated that his unpublished paper 
(Boffetta et al., 2015) shows a similar result (Document ID 1659, p. 
1).
    OSHA carefully considered Dr. Boffetta's argument regarding the 
status of poorly soluble beryllium compounds, and did not find 
persuasive evidence showing that the solubility of the beryllium to 
which the workers in the studies he cited were exposed accounts for the 
lack of statistically significantly elevated risk in the Boffetta et 
al. (2014) cohort or the Schubauer-Berigan et al. (2011) subcohort. 
While it is true that the SMR for lung cancer was not statistically 
significantly elevated in the Schubauer-Berigan et al. (2011) study 
when workers hired before 1955 in the Reading and Lorain plants were 
excluded from the study population, or in the study of four facilities 
published by Boffetta et al. in 2014, there are various possible 
reasons for these results that Dr. Boffetta did not consider in his 
comment. As discussed below, OSHA finds that the type of beryllium 
compounds to which these workers were exposed is not likely to explain 
Dr. Boffetta's observations.
    As discussed in Section V, Health Effects and in comments submitted 
by NIOSH, animal toxicology evidence shows that poorly soluble 
beryllium compounds can cause cancer. IARC determined that poorly 
soluble forms of beryllium are carcinogenic to humans in its 2012 
review of Group I carcinogens (see section V.E.5 of this preamble; 
Document ID 1725, p. 9; IARC, 2012, Document ID 0650). NIOSH noted that 
poorly soluble forms of beryllium remain in the lung for longer time 
periods than soluble forms, and can therefore create prolonged exposure 
of lung tissue to beryllium (Document ID 1725, p. 9). This prolonged 
exposure may lead to the sustained tissue inflammation that causes many 
forms of cancer and is believed to be one pathway for carcinogenesis 
due to beryllium exposure (see Section V, Health Effects).
    The comments from NIOSH also demonstrate that the available 
information cannot distinguish between the effects of soluble and 
poorly soluble beryllium. NIOSH submitted information on the solubility 
of beryllium in the Schubauer-Berigan et al. (2011) cohort, stating 
that operations typically involving both soluble and poorly soluble 
beryllium were performed at all three of the beryllium plants included 
in the study (Document ID 1725, p. 9; Ward et al., 1992, Document ID 
1378). Based on evaluations of the JEMs and work histories of employees 
in the cohort (which were not published in the 2011 Schubauer-Berigan 
et al. paper), NIOSH stated that ``the vast majority of beryllium work-
time at all three of these facilities was due to either insoluble or 
mixed chemical forms. In fact, insoluble beryllium was the largest 
single contributor to work-time (for beryllium exposure of known 
solubility class) at the three facilities across most time periods'' 
(Document ID 1725, p. 9). NIOSH also provided figures showing the 
contribution of insoluble beryllium to exposure over time in the 
Schubauer-Berigan et al. (2011) study, as well as the relatively small 
proportion of work years during which workers in the study were exposed 
exclusively to either soluble or poorly soluble forms (Document ID 
1725, pp. 10-11).
    Boffetta et al. (2014, Document ID 0403) examined a population of 
workers allegedly exposed exclusively to poorly soluble beryllium 
compounds, in which overall SMR for lung cancer was not statistically 
significantly elevated (SMR 96.0, 95% CI 80.0-114.3). Boffetta et al. 
concluded, ``[a]lthough a small risk for lung cancer is compatible with 
our results, we can confidently exclude an excess greater than 20%'' in 
the study population (Boffetta et al., 2014, p. 592). Limitations of 
the study include a lack of information on many workers' job titles, a 
lack of any beryllium exposure measurements, and the very short-term 
employment of most cohort members at the study facilities (less than 5 
years for 72 percent of the workers) (Boffetta et al., 2014).
    OSHA reviewed this study, and finds that it does not contradict the 
findings of the Schubauer-Berigan et al. (2011) lung cancer risk 
analysis for several reasons. First, as shown in Table VI-9 above, none 
of the predictions of excess risk in the risk analysis exceed 20 
percent (200 per 1,000 workers); most are well below this level, and 
thus are well within the range that Boffetta et al. (2014) state they 
cannot confidently exclude. Thus, the statement by Boffetta et al. that 
the risk of excess lung cancer is no higher than 20 percent is actually 
consistent with the risk findings from Schubauer-Berigan et al. (2011) 
presented above. Second, the fact that most workers in the cohort were 
employed for less than five years suggests that most workers' 
cumulative exposures to beryllium were likely to be quite low, which 
would explain the non-elevated SMR for lung cancer in the study 
population regardless of the type of beryllium to which workers were 
exposed. The SMR for workers employed in the study facilities for at 
least 20 years was elevated (112.7, CI 66.8-178.1) (Boffetta et al., 
2014, Document ID 0403, Table 3),\23\ supporting OSHA's observation 
that the lack of elevated SMR in the cohort overall may be due to 
short-term

[[Page 2544]]

employment and low cumulative exposures.
---------------------------------------------------------------------------

    \23\ This SMR was not statistically significantly elevated, 
probably due to the small size of this subcohort (153 total deaths, 
18 lung cancer deaths).
---------------------------------------------------------------------------

    Finally, the approach of Boffetta et al. (2014), which relies on 
SMR analyses, does not account for the healthy worker effect. SMRs are 
calculated by comparing disease levels in the study population to 
disease levels in the general population, using regional or national 
reported disease rates. However, because working populations tend to 
have lower disease rates than the overall population, SMRs can 
underestimate excess risk of disease in those populations. The SMR in 
Boffetta et al. (2014) for overall mortality in the study population 
was statistically significantly reduced (94.7, 95 percent CI 89.9-
99.7), suggesting a possible healthy worker effect. The SMR for overall 
mortality was even further reduced in the category of workers with at 
least 20 years of employment (87.7, 95 percent CI 74.3-102.7), in which 
an elevated SMR for lung cancer was observed. NIOSH commented that 
``[i]n a modern industrial population, the expected SMR for lung cancer 
would be approximately 0.93 [Park et al. (1991)]'' (Document ID 1725, 
p. 8). This is lower than the SMR for lung cancer (96) observed in 
Boffetta et al. (2014) and much lower than the SMR for lung cancer in 
the category of workers employed for at least 20 years (112.7), which 
is the group most likely to have had sufficient exposure and latency to 
show excess lung cancer (Boffetta et al., 2014, Document ID 0403, 
Tables 2 and 3). Thus, it appears that the healthy worker effect is 
another factor (in addition to low cumulative exposures) that may 
account for the findings of Boffetta et al.'s 2014 study.
    Taken together, OSHA finds that the animal toxicology evidence on 
the carcinogenicity of poorly soluble beryllium forms, the long 
residence of poorly soluble beryllium in the lung, the likelihood that 
most workers in Schubauer-Berigan et al. (2011) were exposed to a 
mixture of soluble and poorly soluble beryllium forms, and the points 
raised above regarding Boffetta et al. (2014) rebut Boffetta's claim 
that low solubility of beryllium compounds is the most likely 
explanation for the lack of statistically significantly elevated SMR 
results.
    Dr. Boffetta's comment also raised technical questions regarding 
the Schubauer-Berigan et al. (2011, Document ID 1265) risk analysis. He 
noted that risk estimates at low exposures are dependent on choice of 
model in their analysis; the authors' choice of a single ``best'' model 
was based on purely statistical criteria, and the results of the 
statistics used (AIC) were similar between the models'' (Document ID 
1659, p. 2). Therefore, according to Dr. Boffetta, ``there is ample 
uncertainty about the shape of the dose-response function in the low-
dose range'' (Document ID 1659, p. 3).
    OSHA agrees that it is difficult to distinguish a single ``best'' 
model from the set of models presented by Schubauer-Berigan et al. 
(2011), and that risk estimates at low exposure levels vary depending 
on choice of model. That is one reason OSHA presented results from all 
of the models (see Table VI-9). OSHA further agrees that there is 
uncertainty in the lung cancer risk estimates, the estimation of which 
(unlike for CBD) required extrapolation below beryllium exposure levels 
experienced by workers in the Schubauer-Berigan et al. (2011) study. 
However, the Schubauer-Berigan risk assessment's six best-fitting 
models all support OSHA's significant risk determination, as they all 
predict a significant risk of lung cancer at the preceding TWA PEL of 2 
[mu]g/m\3\ (estimates ranging from 33 to 170 excess lung cancers per 
1,000 workers) and a substantially reduced, though still significant, 
risk of lung cancer at the new TWA PEL of 0.2 [mu]g/m\3\ (estimates 
ranging from 3 to 30 excess lung cancers per 1,000 workers) (see Table 
VI-9).
    Dr. Boffetta also noted that the risk estimates provided by 
Schubauer-Berigan et al. (2011, Document ID 1265) for OSHA's lung 
cancer risk assessment depend on the background lung cancer rate used 
in excess risk calculations, and that industrial workers may have a 
different background lung cancer risk than the U.S. population as a 
whole (Document ID 1659, p. 2). OSHA agrees that choice of background 
risk could influence the number of excess lung cancers predicted by the 
models the Agency relied on for its lung cancer risk estimates. 
However, choice of background risk did not influence OSHA's finding 
that excess lung cancer risks would be substantially reduced by a 
decrease in exposure from the preceding TWA PEL to the final TWA PEL, 
because the same background risk was factored into estimates of risk at 
both levels. Furthermore, the Schubauer-Berigan et al. (2011) estimates 
of excess lung cancer from exposure at the preceding PEL of 2 [mu]g/
m\3\ (ranging from 33 to 170 excess lung cancers per 1,000 workers, 
depending on the model) are much higher than the level of 1 per 1,000 
that OSHA finds to be clearly significant. Even at the final TWA PEL of 
0.2 [mu]g/m\3\, the models demonstrate a range of risks of excess lung 
cancers of 3 to 30 per 1,000 workers, estimates well above the 
threshold for significant risk (see Section II, Pertinent Legal 
Authority). Small variations in background risk across different 
populations are highly unlikely to influence excess lung cancer risk 
estimates sufficiently to influence OSHA's finding of significant risk 
at the preceding TWA PEL, which is the finding OSHA relies on to 
support the need for a new standard.
    Finally, Dr. Boffetta noted that the models that exclude 
professional and asbestos workers (the groups that Schubauer-Berigan et 
al. believed could be affected by confounding from tobacco and asbestos 
exposure) showed non-significant increases in lung cancer with 
increasing beryllium exposure. According to Dr. Boffetta, this suggests 
that confounding may contribute to the results of the models based on 
the full population. He speculates that if more precise information on 
confounding exposures were available, excess risk estimates might be 
further reduced (Document ID 1659, p. 2).
    OSHA agrees with Dr. Boffetta that there is uncertainty in the 
Schubauer-Berigan et al. (2011) lung cancer risk estimates, including 
uncertainty due to limited information on possible confounding from 
associations between beryllium exposure level and workers' smoking 
habits or occupational co-exposures. However, in the absence of 
detailed smoking and co-exposure information, the models excluding 
professional and asbestos workers are a reasonable approach to 
addressing the possible effects of unmeasured confounding. OSHA's 
decision to include these models in its preliminary and final QRAs 
therefore represents the Agency's best available means of dealing with 
this uncertainty.

E. Risk Assessment Conclusions

    As described above, OSHA's risk assessment for beryllium 
sensitization and CBD relied on two approaches: (1) Review of the 
literature, and (2) analysis of a data set provided by NJH. OSHA has a 
high level of confidence in its finding that the risks of sensitization 
and CBD are above the benchmark of 1 in 1,000 at the preceding PEL, and 
the Agency believes that a comprehensive standard requiring a 
combination of more stringent controls on beryllium exposure will 
reduce workers' risk of both sensitization and CBD. Programs that have 
reduced median levels to below 0.1 [mu]g/m\3\ and tightly controlled 
both respiratory exposure and dermal contact have substantially reduced 
risk of sensitization within the first years of exposure. These 
conclusions are supported by the results of several studies conducted 
in facilities dealing

[[Page 2545]]

with a variety of production activities and physical forms of beryllium 
that have reduced workers' exposures substantially by implementing 
stringent exposure controls and PPE requirements since approximately 
2000. In addition, these conclusions are supported by OSHA's analyses 
of the NJH data set, which contains highly-detailed exposure and work 
history information on several hundred beryllium workers.
    Furthermore, OSHA believes that more stringent control of airborne 
beryllium exposures will reduce beryllium-exposed workers' significant 
risk of lung cancer. The risk estimates from the lung cancer study by 
Schubauer-Berigan et al. (2011, Document ID 1265; 0521), described 
above, range from 33 to 170 excess lung cancers per 1,000 workers 
exposed at the preceding PEL of 2 [mu]g/m\3\, based on the study's six 
best-fitting models. These models each predict substantial reductions 
in risk with reduced exposure, ranging from 3 to 30 excess lung cancers 
per 1,000 workers exposed at the final PEL of 0.2 [mu]g/m\3\. The 
evidence of lung cancer risk from the Schubauer-Berigan et al. (2011) 
risk assessment provides additional support for OSHA's conclusions 
regarding the significance of risk of adverse health effects for 
workers exposed to beryllium levels at and below the preceding PEL. 
However, the lung cancer risks required a sizable low dose 
extrapolation below beryllium exposure levels experienced by workers in 
the Schubauer-Berigan et al. (2011) study. As a result, there is 
greater uncertainty regarding the lung cancer risk estimates than there 
is for the risk estimates for beryllium sensitization and CBD. The 
conclusions with regard to significance of risk are presented and 
further discussed in section VII of the preamble.

VII. Significance of Risk

    In this section, OSHA discusses its findings that workers exposed 
to beryllium at and below the preceding TWA PEL face a significant risk 
of material impairment of health or functional capacity within the 
meaning of the OSH Act, and that the new standards will substantially 
reduce this risk. To make the significance of risk determination for a 
new final or proposed standard, OSHA uses the best available scientific 
evidence to identify material health impairments associated with 
potentially hazardous occupational exposures and to evaluate exposed 
workers' risk of these impairments assuming exposure over a working 
lifetime. As discussed in section II, Pertinent Legal Authority, courts 
have stated that OSHA should consider all forms and degrees of material 
impairment--not just death or serious physical harm. To evaluate the 
significance of the health risks that result from exposure to hazardous 
chemical agents, OSHA relies on epidemiological, toxicological, and 
experimental evidence. The Agency uses both qualitative and 
quantitative methods to characterize the risk of disease resulting from 
workers' exposure to a given hazard over a working lifetime (generally 
45 years) at levels of exposure reflecting compliance with the 
preceding standard and compliance with the new standards (see Section 
II, Pertinent Legal Authority). When determining whether a significant 
risk exists OSHA considers whether there is a risk of at least one-in-
a-thousand of developing a material health impairment from a working 
lifetime of exposure. The Supreme Court has found that OSHA is not 
required to support its finding of significant risk with scientific 
certainty, but may instead rely on a body of reputable scientific 
thought and may make conservative assumptions (i.e., err on the side of 
protecting the worker) in its interpretation of the evidence (Section 
II, Pertinent Legal Authority).
    OSHA's findings in this section follow in part from the conclusions 
of the preceding sections V, Health Effects, and VI, Risk Assessment. 
In this preamble at section V, Health Effects, OSHA reviewed the 
scientific evidence linking occupational beryllium exposure to a 
variety of adverse health effects and determined that beryllium 
exposure causes sensitization, CBD, and lung cancer, and is associated 
with various other adverse health effects (see section V.D, V.E, and 
V.F). In this preamble at section VI, Risk Assessment, OSHA found that 
the available epidemiological data are sufficient to evaluate risk for 
beryllium sensitization, CBD, and lung cancer among beryllium-exposed 
workers. OSHA evaluated the risk of sensitization, CBD, and lung cancer 
from levels of airborne beryllium exposure that were allowed under the 
previous standard, as well as the expected impact of the new standards 
on risk of these conditions. In this section of the preamble, OSHA 
explains its determination that the risk of material impairments of 
health, particularly CBD and lung cancer, from occupational exposures 
allowable under the preceding TWA PEL of 2 [mu]g/m\3\ is significant, 
and is substantially reduced but still significant at the new TWA PEL 
of 0.2 [mu]g/m\3\. Furthermore, evidence reviewed in section VI, Risk 
Assessment, shows that significant risk of CBD and lung cancer could 
remain in workplaces with exposures as low as the new action level of 
0.1 [mu]g/m\3\. OSHA also explains here that the new standards will 
reduce the occurrence of sensitization.
    In the NPRM, OSHA preliminarily determined that both CBD and lung 
cancer are material impairments of health. OSHA also preliminarily 
determined that a working lifetime (45 years) of exposure to airborne 
beryllium at the preceding time-weighted average permissible exposure 
limit (TWA PEL) of 2 [mu]g/m\3\ would pose a significant risk of both 
CBD and lung cancer, and that this risk is substantially reduced but 
still significant at the new TWA PEL of 0.2 [mu]g/m\3\. OSHA did not 
make a preliminary determination as to whether beryllium sensitization 
is a material impairment of health because, as the Agency explained in 
the NPRM, it was not necessary to make such a determination. The 
Agency's preliminary findings on CBD and lung cancer were sufficient to 
support the promulgation of new beryllium standards.
    Upon consideration of the entire rulemaking record, including the 
comments and information submitted to the record in response to the 
preliminary Health Effects, Risk Assessment, and Significance of Risk 
analyses (NPRM Sections V, VI, and VIII), OSHA reaffirms its 
preliminary findings that long-term exposure at the preceding TWA PEL 
of 2 [mu]g/m\3\ poses a significant risk of material impairment of 
workers' health, and that adoption of the new TWA PEL of 0.2 [mu]g/m\3\ 
and other provisions of the final standards will substantially reduce 
this risk.

Material Impairment of Health

    As discussed in Section V, Health Effects, CBD is a respiratory 
disease caused by exposure to beryllium. CBD develops when the body's 
immune system reacts to the presence of beryllium in the lung, causing 
a progression of pathological changes including chronic inflammation 
and tissue scarring. CBD can also impair other organs such as the 
liver, skin, spleen, and kidneys and cause adverse health effects such 
as granulomas of the skin and lymph nodes and cor pulmonale (i.e., 
enlargement of the heart) (Conradi et al., 1971 (Document ID 1319); 
ACCP, 1965 (1286); Kriebel et al., 1988a (1292) and b (1473)).
    In early, asymptomatic stages of CBD, small granulomatous lesions 
and mild inflammation occur in the lungs. Over time, the granulomas can 
spread and lead to lung fibrosis (scarring) and

[[Page 2546]]

moderate to severe loss of pulmonary function, with symptoms including 
a persistent dry cough and shortness of breath (Saber and Dweik, 2000, 
Document ID 1421). Fatigue, night sweats, chest and joint pain, 
clubbing of fingers (due to impaired oxygen exchange), loss of 
appetite, and unexplained weight loss may occur as the disease 
progresses (Conradi et al., 1971, Document ID 1319; ACCP, 1965 (1286); 
Kriebel et al., 1988 (1292); Kriebel et al., 1988 (1473)).
    Dr. Lee Newman, speaking at the public hearing on behalf of the 
American College of Occupational and Environmental Medicine (ACOEM), 
testified on his experiences treating patients with CBD: ``as a 
physician who has spent most of my [practicing] career seeing patients 
with exposure to beryllium, with beryllium sensitization, and with 
chronic beryllium disease including those who have gone on to require 
treatment and to die prematurely of this disease . . . [I've seen] 
hundreds and hundreds, probably over a thousand individuals during my 
career who have suffered from this condition'' (Document ID 1756, Tr. 
79). Dr. Newman further testified about his 30 years of experience 
treating CBD in patients at various stages of the disease:

    . . . some of them will go from being sensitized to developing 
subclinical disease, meaning that they have no symptoms. As I 
mentioned earlier, most of those will, if we actually do the tests 
of their lung function and their oxygen levels in their blood, those 
people are already demonstrating physiologic abnormality. They 
already have disease affecting their health. They go on to develop 
symptomatic disease and progress to the point where they require 
treatment. And sometimes to the extent of even requiring a [lung] 
transplant (Document ID 1756, Tr. 131).

    Dr. Newman described one example of a patient who developed CBD 
from his occupational beryllium exposure and ``who went on to die 
prematurely with a great deal of suffering along the way due to the 
condition chronic beryllium disease'' (Document ID 1756, Tr. 80).
    During her testimony at the public hearing, Dr. Lisa Maier of 
National Jewish Health (NJH) provided an example from her experience 
with treating CBD patients. ``This gentleman started to have a cough, a 
dry cough in 2011 . . . His symptoms progressed and he developed 
shortness of breath, wheezing, chills, night sweats, and fatigue. These 
were so severe that he was eventually hospitalized'' (Document ID 1756, 
Tr. 105). Dr. Maier noted that this patient had no beryllium exposure 
prior to 2006, and that his CBD had developed from beryllium exposure 
in his job melting an aluminum alloy in a foundry casting airplane 
parts (Document ID 1756, Tr. 105-106). She described how her patient 
could no longer work because of his condition. ``He requires oxygen and 
systemic therapy . . . despite aggressive treatment [his] test findings 
continue to demonstrate worsening of his disease and increased needs 
for oxygen and medications as well as severe side effects from 
medications. This patient may well need a lung transplant if this 
disease continues to progress . . . '' (Document ID 1756, Tr. 106-107).
    The likelihood, speed, and severity of individuals' transition from 
asymptomatic to symptomatic CBD is understood to vary widely, with some 
individuals responding differently to exposure cessation and treatment 
than others (Sood, 2009, Document ID 0456; Mroz et al., 2009 (1443)). 
In the public hearing, Dr. Newman testified that the great majority of 
individuals with very early stage CBD in a cross-sectional study he 
published (Pappas and Newman, 1993) had physiologic impairment. Thus, 
even before x-rays or CAT scans found evidence of CBD, the lung 
functions of those individuals were abnormal (Document ID 1756, Tr. 
112). Materion commented that the best available evidence on the 
transition from asymptomatic to more severe CBD is a recent 
longitudinal study by Mroz et al. (2009, Document ID 1443), which found 
that 19.3 percent of individuals with CBD developed clinical 
abnormalities requiring oral immunosuppressive therapy (Document ID 
1661, pp. 5-6). The authors' overall conclusions in that study include 
a finding that adverse physiological changes among initially 
asymptomatic CBD patients progress over time, requiring many 
individuals to be treated with corticosteroids, and that the patients' 
levels of beryllium exposure may affect progression (Mroz et al., 
2009). Dr. Maier, a co-author of the study, testified that studies 
``indicate that higher levels of exposure not only are risk factors for 
[developing CBD in general] but also for more severe [CBD] (Document ID 
1756, Tr. 111).\24\
---------------------------------------------------------------------------

    \24\ The study by Mroz et al. (2009, Document ID 1443) included 
all individuals who were clinically evaluated at NJH between 1982 
and 2002 and were found to have CBD on baseline clinical evaluation. 
All cohort members were identified by abnormal BeLPTs before 
identification of symptoms, physiologic abnormalities, or 
radiographic changes. All members were offered evaluation for 
clinical abnormalities every 2 years through 2002, including 
pulmonary function testing, exercise testing, chest radiograph with 
International Labor Organization (ILO) B-reading, fiberoptic 
bronchoscopy with bronchoalveolar lavage (BAL), and transbronchial 
lung biopsies. Of 171 CBD cases, 33 (19.3%) developed clinical 
abnormalities requiring oral immunosuppressive therapy, at an 
average of 1.4 years after the initial diagnosis of CBD. To examine 
the effect of beryllium exposure level on the progression of CBD, 
Mroz et al. compared clinical manifestations of CBD among machinists 
(the group of patients likely to have had the highest beryllium 
exposures) to non- machinists, including only CBD patients who had 
never smoked. Longitudinal analyses showed significant declines in 
some clinical indicators over time since first exposure for 
machinists (p <0.01) as well as faster development of illness (p < 
0.05), compared to a control group of non-machinists.
---------------------------------------------------------------------------

    Treatment of CBD using inhaled and systemic steroid therapy has 
been shown to ease symptoms and slow or prevent some aspects of disease 
progression. As explained below, these treatments can be most 
effectively applied when CBD is diagnosed prior to development of 
symptoms. In addition, the forms of treatment that can be used to 
manage early-stage CBD have relatively minor side effects on patients, 
while systemic steroid treatments required to treat later-stage CBD 
often cause severe side effects.
    In the public hearing, Dr. Newman and Dr. Maier testified about 
their experiences treating patients with CBD at various stages of the 
disease. Dr. Newman stated that patients' outcomes depend greatly on 
how early they are diagnosed. ``So there are those people who are 
diagnosed very late in the course of disease where there's little that 
we can do to intervene and they are going to die prematurely. There are 
those people who may be detected with milder disease where there are 
opportunities to intervene'' (Document ID 1756, Tr. 132). Both Dr. 
Maier and Dr. Newman emphasized the importance of early detection and 
diagnosis, stating that removing the patient from exposure and 
providing treatment early in the course of the disease can slow or even 
halt progression of the disease (Document ID 1756, Tr. 111, 132).
    Dr. Maier testified that inhaled steroids can be used to treat 
relatively mild symptoms that may occur in early stages of the disease, 
such as a cough during exercise (Document ID 1756, Tr. 139). Inhaled 
steroids, she stated, are commonly used to treat other health 
conditions and have fewer and milder side effects than forms of steroid 
treatment that are used to treat more severe forms of CBD (Document ID 
1756, Tr. 140). Early detection of CBD helps physicians to properly 
treat early-onset symptoms, since appropriate forms of treatment for 
early stage CBD can differ from treatments for conditions it is 
commonly mistaken for, such as chronic obstructive pulmonary disease

[[Page 2547]]

(COPD) and asthma (Document ID 1756, Tr. 140-141).
    CBD in later stages is often managed using systemic steroid 
treatments such as corticosteroids. In workers with CBD whose beryllium 
exposure has ceased, corticosteroid therapy has been shown to control 
inflammation, ease symptoms (e.g., difficulty breathing, fever, cough, 
and weight loss), and in some cases prevent the development of fibrosis 
(Marchand-Adam et al., 2008, Document ID 0370). Thus, although there is 
no cure for CBD, properly-timed treatment can lead to CBD regression in 
some patients (Sood, 2004, Document ID 1331). Other patients have shown 
short-term improvements from corticosteroid treatment, but then 
developed serious fibrotic lesions (Marchand-Adam et al., 2008). Ms. 
Peggy Mroz, of NJH, discussed the results of the Marchand-Adam et al. 
study in the hearing, stating that treatment of CBD using steroids has 
been most successful when treatment begins prior to the development of 
lung fibrosis (Document ID 1756, Tr. 113). Once fibrosis has developed 
in the lungs, corticosteroid treatment cannot reverse the damage (Sood, 
2009, Document ID 0456). Persons with late-stage CBD experience severe 
respiratory insufficiency and may require supplemental oxygen (Rossman, 
1991, Document 1332). Historically, late-stage CBD often ended in death 
(NAS, 2008, Document ID 1355). While the use of steroid treatments can 
help to reduce the effects of CBD, OSHA is not aware of any studies 
showing the effect of these treatments on the frequency of premature 
death among patients with CBD.
    Treatment with corticosteroids has severe side effects 
(Trikudanathan and McMahon, 2008, Document ID 0366; Lipworth, 1999 
(0371); Gibson et al., 1996 (1521); Zaki et al., 1987 (1374)). Adverse 
effects associated with long-term corticosteroid use include, but are 
not limited to: increased risk of opportunistic infections (Lionakis 
and Kontoyiannis, 2003, Document ID 0372; Trikudanathan and McMahon, 
2008 (0366)); accelerated bone loss or osteoporosis leading to 
increased risk of fractures or breaks (Hamida et al., 2011, Document ID 
0374; Lehouck et al., 2011 (0355); Silva et al., 2011 (0388); Sweiss et 
al., 2011 (0367); Langhammer et al., 2009 (0373)); psychiatric effects 
including depression, sleep disturbances, and psychosis (Warrington and 
Bostwick, 2006, Document ID 0365; Brown, 2009 (0377)); adrenal 
suppression (Lipworth, 1999, Document ID 0371; Frauman, 1996 (0356)); 
ocular effects including cataracts, ocular hypertension, and glaucoma 
(Ballonzoli and Bourcier, 2010, Document ID 0391; Trikudanathan and 
McMahon, 2008 (0366); Lipworth, 1999 (0371)); an increase in glucose 
intolerance (Trikudanathan and McMahon, 2008, Document ID 0366); 
excessive weight gain (McDonough et al., 2008, Document ID 0369; Torres 
and Nowson, 2007 (0387); Dallman et al., 2007 (0357); Wolf, 2002 
(0354); Cheskin et al., 1999 (0358)); increased risk of atherosclerosis 
and other cardiovascular syndromes (Franchimont et al., 2002, Document 
ID 0376); skin fragility (Lipworth, 1999, Document ID 0371); and poor 
wound healing (de Silva and Fellows, 2010, Document ID 0390).
    Based on the above, OSHA considers late-stage CBD to be a material 
impairment of health, as it involves permanent damage to the pulmonary 
system, causes additional serious adverse health effects, can have 
adverse occupational and social consequences, requires treatment that 
can cause severe and lasting side effects, and may in some cases cause 
premature death.
    Furthermore, OSHA has determined that early-stage CBD, an 
asymptomatic period during which small lesions and inflammation appear 
in the lungs, is also a material impairment of health. OSHA bases this 
conclusion on evidence and expert testimony that early-stage CBD is a 
measurable change in an individual's state of health that, with and 
sometimes without continued exposure, can progress to symptomatic 
disease (e.g., Mroz et al., 2009 (1443); 1756, Tr. 131). Thus, 
prevention of the earliest stages of CBD will prevent development of 
more serious disease. In OSHA's Lead standard, promulgated in 1978, the 
Agency stated its position that a ``subclinical'' health effect may be 
regarded as a material impairment of health. In the preamble to that 
standard, the Agency said:


    OSHA believes that while incapacitating illness and death 
represent one extreme of a spectrum of responses, other biological 
effects such as metabolic or physiological changes are precursors or 
sentinels of disease which should be prevented. . . . Rather than 
revealing the beginnings of illness the standard must be selected to 
prevent an earlier point of measurable change in the state of health 
which is the first significant indicator of possibly more severe ill 
health in the future. The basis for this decision is twofold--first, 
pathophysiologic changes are early stages in the disease process 
which would grow worse with continued exposure and which may include 
early effects which even at early stages are irreversible, and 
therefore represent material impairment themselves. Secondly, 
prevention of pathophysiologic changes will prevent the onset of the 
more serious, irreversible and debilitating manifestations of 
disease (43 FR 52952, 52954).

    Since the Lead rulemaking, OSHA has also found other non-
symptomatic (or sub-clinical) health conditions to be material 
impairments of health. In the Bloodborne Pathogens rulemaking, OSHA 
maintained that material impairment includes not only workers with 
clinically ``active'' hepatitis from the hepatitis B virus (HBV) but 
also includes asymptomatic HBV ``carriers'' who remain infectious and 
are able to put others at risk of serious disease through contact with 
body fluids (e.g., blood, sexual contact) (56 FR 64004). OSHA stated: 
``Becoming a carrier [of HBV] is a material impairment of health even 
though the carrier may have no symptoms. This is because the carrier 
will remain infectious, probably for the rest of his or her life, and 
any person who is not immune to HBV who comes in contact with the 
carrier's blood or certain other body fluids will be at risk of 
becoming infected'' (56 FR 64004, 64036).
    OSHA finds that early-stage CBD is the type of asymptomatic health 
effect the Agency determined to be a material impairment of health in 
the Lead and Bloodborne Pathogens standards. Early stage CBD involves 
lung tissue inflammation without symptoms that can worsen with--or 
without--continued exposure. The lung pathology progresses over time 
from a chronic inflammatory response to tissue scarring and fibrosis 
accompanied by moderate to severe loss in pulmonary function. Early 
stage CBD is clearly a precursor of advanced clinical disease, 
prevention of which will prevent symptomatic disease. OSHA determined 
in the Lead standard that such precursor effects should be considered 
material health impairments in their own right, and that the Agency 
should act to prevent them when it is feasible to do so. Therefore, 
OSHA finds all stages of CBD to be material impairments of health 
within the meaning of section 6(b)(5) of the OSH Act (29 U.S.C. 
655(b)(5)).
    In reviewing OSHA's Lead standard in United Steelworkers of 
America, AFL-CIO v. Marshall, 647 F.2d 1189, 1252 (D.C. Cir. 1980) 
(Lead I), the D.C. Circuit affirmed that the OSH Act ``empowers OSHA to 
set a PEL that prevents the subclinical effects of lead that lie on a 
continuum shared with overt lead disease.'' See also AFL-CIO v. 
Marshall, 617 F.2d 636, 654 n.83 (D.C. Cir. 1979) (upholding OSHA's 
authority to prevent early symptoms of a disease, even if the effects 
of the disease are, at that point, reversible). According to the Court, 
OSHA only had to demonstrate,

[[Page 2548]]

on the basis of substantial evidence, that preventing the subclinical 
effects would help prevent the clinical phase of disease (United 
Steelworkers of America, AFL-CIO, 647 F.2d at 1252). Thus, OSHA has the 
authority to regulate to prevent asymptomatic CBD whether or not it is 
properly labeled as a material impairment of health.
    OSHA has also determined that exposure to beryllium can cause 
beryllium sensitization. Sensitization is a precursor to development of 
CBD and an essential step for development of the disease. As discussed 
in Section V, Health Effects, only sensitized individuals can develop 
CBD (NAS, 2008, Document ID 1355).\25\ As explained above, OSHA has the 
authority to promulgate regulations designed to prevent precursors to 
material impairments of health. Therefore, OSHA's new beryllium 
standards aim to prevent sensitization as well as the development of 
CBD and lung cancer. OSHA's risk assessment for sensitization, 
presented in section VI, informs the Agency's understanding of what 
exposure control measures have been successful in preventing 
sensitization, which in turn prevents development of CBD. Therefore, 
OSHA addresses sensitization in this section on significance of risk.
---------------------------------------------------------------------------

    \25\ In the NPRM, OSHA took no position on whether beryllium 
sensitization by itself is a material impairment of health, stating 
it was unnecessary to do so as part of this rulemaking. The only 
comment on this issue came from Materion, which argued that ``BeS 
does not constitute a material impairment of health or functional 
capacity'' (document ID 1958). Because BeS is also a precursor to 
CBD, OSHA finds it unnecessary to resolve this issue here.
---------------------------------------------------------------------------

Risk Assessment

    As discussed in Section VI, Risk Assessment, the risk assessment 
for beryllium sensitization and CBD relied on two approaches: (1) 
OSHA's review of epidemiological studies of sensitization and CBD that 
contain information on exposures in the range of interest to OSHA (2 
[mu]g/m\3\ and below), and (2) OSHA's analysis of a NJH data set on 
sensitization and CBD in a group of beryllium-exposed machinists in 
Cullman, AL.
    OSHA's review of the literature includes studies of beryllium-
exposed workers at a Tucson, AZ ceramics plant (Kreiss et al., 1996, 
Document ID 1477; Henneberger et al., 2001 (1313); Cummings et al., 
2007 (1369)); a Reading, PA copper-beryllium processing plant (Schuler 
et al., 2005, Document ID 0919; Thomas et al., 2009 (0590)); a Cullman, 
AL beryllium machining plant (Newman et al., 2001, Document ID 1354; 
Kelleher et al., 2001 (1363); Madl et al., 2007 (1056)); an Elmore, OH 
metal, alloy, and oxide production plant (Kreiss et al., 1993 Document 
ID 1478; Bailey et al., 2010 (0676); Schuler et al., 2012 (0473)); 
aluminum smelting facilities (Taiwo et al. 2008, Document ID 0621; 2010 
(0583); Nilsen et al., 2010 (0460)); and nuclear facilities (Viet et 
al., 2000, Document ID 1344; Arjomandi et al., 2010 (1275)).
    The published literature on beryllium sensitization and CBD 
discussed in section VI shows that the risk of both can be significant 
in workplaces where exposures are at or below OSHA's preceding PEL of 2 
[mu]g/m\3\ (e.g., Kreiss et al., 1996, Document ID 1477; Henneberger et 
al., 2001 (1313); Newman et al., 2001 (1354); Schuler et al., 2005 
(0919), 2012 (0473); Madl et al., 2007 (1056)). For example, in the 
Tucson ceramics plant mentioned above, Kreiss et al. (1996) reported 
that eight (5.9 percent) \26\ of the 136 workers tested in 1992 were 
sensitized, six (4.4 percent) of whom were diagnosed with CBD. In 
addition, of 77 Tucson workers hired prior to 1992 who were tested in 
1998, eight (10.4 percent) were sensitized and seven of these (9.7 
percent) were diagnosed with CBD (Henneberger et al., 2001, Document ID 
1313). Full-shift area samples showed most airborne beryllium levels 
below the preceding PEL: 76 percent of area samples collected between 
1983 and 1992 were at or below 0.1 [mu]g/m\3\ and less than 1 percent 
exceeded 2 [mu]g/m\3\; short-term breathing zone measurements collected 
between 1981 and 1992 had a median of 0.3 [mu]g/m\3\; and personal 
lapel samples collected at the plant beginning in 1991 had a median of 
0.2 [mu]g/m\3\ (Kreiss et al., 1996).
---------------------------------------------------------------------------

    \26\ Although OSHA reports percentages to indicate the risks of 
sensitization and CBD in this section, the benchmark OSHA typically 
uses to demonstrate significant risk, as discussed earlier, is 
greater than or equal to 1 in 1,000 workers. One in 1,000 workers is 
equivalent to 0.1 percent. Therefore, any value of 0.1 percent or 
higher when reporting occurrence of a health effect is considered by 
OSHA to indicate a significant risk.
---------------------------------------------------------------------------

    Results from the Elmore, OH beryllium metal, alloy, and oxide 
production plant and the Cullman, AL machining facility also showed 
significant risk of sensitization and CBD among workers with exposures 
below the preceding TWA PEL. Schuler et al. (2012, Document ID 0473) 
found 17 cases of sensitization (8.6 percent) among Elmore, OH workers 
within the first three quartiles of LTW average exposure (198 workers 
with LTW average total mass exposures lower than 1.1 [mu]g/m\3\) and 4 
cases of CBD (2.2 percent) within those quartiles of LTW average 
exposure (183 workers with LTW average total mass exposures lower than 
1.07 [mu]g/m\3\; note that follow-up time of up to 6 years for all 
study participants was very short for development of CBD). At the 
Cullman, AL machining facility, Newman et al. (2001, Document ID 1354) 
reported 22 (9.4 percent) sensitized workers among 235 tested in 1995-
1999, 13 of whom were diagnosed with CBD within the study period. 
Personal lapel samples collected between 1980 and 1999 indicate that 
median exposures were generally well below the preceding PEL (<=0.35 
[mu]g/m\3\ in all job titles except maintenance (median 3.1 [mu]g/m\3\ 
during 1980-1995) and gas bearings (1.05 [mu]g/m\3\ during 1980-1995)).
    Although risk will be reduced by compliance with the new TWA PEL, 
evidence in the epidemiological studies reviewed in section VI, Risk 
Assessment, shows that significant risk of sensitization and CBD could 
remain in workplaces with exposures as low as the new action level of 
0.1 [mu]g/m\3\. For example, Schuler et al. (2005, Document ID 0919) 
reported substantial prevalences of sensitization (6.5 percent) and CBD 
(3.9 percent) among 152 workers at the Reading, PA facility screened 
with the BeLPT in 2000. These results showed significant risk at this 
facility, even though airborne exposures were primarily below both the 
preceding and final TWA PELs due to the low percentage of beryllium in 
the metal alloys used (median general area samples <=0.1 [mu]g/m\3\, 
97% < 0.5 [mu]g/m\3\; 93% of personal lapel samples below the new TWA 
PEL of 0.2 [mu]g/m\3\). The only group of workers with no cases of 
sensitization or CBD, a group of 26 office administration workers, was 
the group with exposures below the new action level of 0.1 [mu]g/m\3\ 
(median personal sample 0.01 [mu]g/m\3\, range <0.01-0.06 [mu]g/m\3\) 
(Schuler et al., 2005). The Schuler et al. (2012, Document ID 0473) 
study of short-term workers in the Elmore, OH facility found three 
cases (4.6%) of sensitization among 66 workers with total mass LTW 
average exposures below 0.1 [mu]g/m\3\. All three of these sensitized 
workers had LTW average exposures of approximately 0.09 [mu]g/m\3\.
    Furthermore, cases of sensitization and CBD continued to arise in 
the Cullman, AL machining plant after control measures implemented 
beginning in 1995 brought median airborne exposures below 0.2 [mu]g/
m\3\ (personal lapel samples between 1996 and 1999 in machining jobs 
had a median of 0.16 [mu]g/m\3\ and the median was 0.08 [mu]g/m\3\ in 
non-machining jobs)

[[Page 2549]]

(Madl et al., 2007, Document ID 1056, Table IV). At the time that 
Newman et al. (2001, Document ID 1354) reviewed the results of BeLPT 
screenings conducted in 1995-1999, a subset of 60 workers had been 
employed at the plant for less than a year and had therefore benefitted 
to some extent from the exposure reductions. Four (6.7 percent) of 
these workers were found to be sensitized, of whom two were diagnosed 
with CBD and one with probable CBD (Newman et al., 2001). A later study 
by Madl. et al. (2007, Document ID 1056) reported seven sensitized 
workers who had been hired between 1995 and 1999, of whom four had 
developed CBD as of 2005 (Table II; total number of workers hired 
between 1995 and 1999 not reported).
    The enhanced industrial hygiene programs that have proven effective 
in several facilities demonstrate the importance of minimizing both 
airborne exposure and dermal contact to effectively reduce risk of 
sensitization and CBD. Exposure control programs that have used a 
combination of engineering controls, PPE, and stringent housekeeping 
measures to reduce workers' airborne exposure and dermal contact have 
substantially lowered risk of sensitization among newly-hired 
workers.\27\ Of 97 workers hired between 2000 and 2004 in the Tucson, 
AZ plant after the introduction of a comprehensive program which 
included the use of respiratory protection (1999) and latex gloves 
(2000), one case of sensitization was identified (1 percent) (Cummings 
et al., 2007, Document ID 1369). In Elmore, OH, where all workers were 
required to wear respirators and skin PPE in production areas beginning 
in 2000-2001, the estimated prevalence of sensitization among workers 
hired after these measures were put in place was around 2 percent 
(Bailey et al., 2010, Document ID 0676). In the Reading, PA facility, 
after workers' exposures were reduced to below 0.1 [mu]g/m\3\ and PPE 
to prevent dermal contact was instituted, only one (2.2 percent) of 45 
workers hired was sensitized (Thomas et al. 2009, Document ID 0590). 
And, in the aluminum smelters discussed by Taiwo et al. (2008, Document 
ID 0621), where available exposure samples from four plants indicated 
median beryllium levels of about 0.1 [mu]g/m\3\ or below (measured as 
an 8-hour TWA) and workers used respiratory and dermal protection, 
confirmed cases of sensitization were rare (zero or one case per 
location).
---------------------------------------------------------------------------

    \27\ As discussed in Section V, Health Effects, beryllium 
sensitization can occur from dermal contact with beryllium.
---------------------------------------------------------------------------

    OSHA notes that the studies on recent programs to reduce workers' 
risk of sensitization and CBD were conducted on populations with very 
short exposure and follow-up time. Therefore, they could not adequately 
address the question of how frequently workers who become sensitized in 
environments with extremely low airborne exposures (median <0.1 [mu]g/
m\3\) develop CBD. Clinical evaluation for CBD was not reported for 
sensitized workers identified in the studies examining the post-2000 
worker cohorts with very low exposures in Tucson, Reading, and Elmore 
(Cummings et al. 2007, Document ID 1369; Thomas et al. 2009, (0590); 
Bailey et al. 2010, (0676)). In Cullman, however, two of the workers 
with CBD had been employed for less than a year and worked in jobs with 
very low exposures (median 8-hour personal sample values of 0.03-0.09 
[mu]g/m\3\) (Madl et al., 2007, Document ID 1056, Table III). The body 
of scientific literature on occupational beryllium disease also 
includes case reports of workers with CBD who are known or believed to 
have experienced minimal beryllium exposure, such as a worker employed 
only in shipping at a copper-beryllium distribution center (Stanton et 
al., 2006, Document ID 1070), and workers employed only in 
administration at a beryllium ceramics facility (Kreiss et al., 1996, 
Document ID 1477). Therefore, there is some evidence that cases of CBD 
can occur in work environments where beryllium exposures are quite low.
    In summary, the epidemiological literature on beryllium 
sensitization and CBD that OSHA's risk assessment relied on show 
sufficient occurrence of sensitization and CBD to be considered 
significant within the meaning of the OSH Act. These demonstrated risks 
are far in excess of 1 in 1,000 among workers who had full-shift 
exposures well below the preceding TWA PEL of 2 [mu]g/m\3\ and workers 
who had median full-shift exposures down to the new action level of 0.1 
[mu]g/m\3\. These health effects occurred among populations of workers 
whose follow-up time was much less than 45 years. As stated earlier, 
OSHA is interested in the risk associated with a 45-year (i.e., working 
lifetime) exposure. Because CBD often develops over the course of years 
following sensitization, the risk of CBD that would result from 45 
years of occupational exposure to airborne beryllium is likely to be 
higher than the prevalence of CBD observed among these workers.\28\ In 
either case, based on these studies, the risks to workers from long-
term exposure at the preceding TWA PEL and below are clearly 
significant. OSHA's review of epidemiological studies further showed 
that worker protection programs that effectively reduced the risk of 
beryllium sensitization and CBD incorporated engineering controls, work 
practice controls, and personal protective equipment (PPE) that reduce 
workers' airborne beryllium exposure and dermal contact with beryllium. 
OSHA has therefore determined that an effective worker protection 
program should incorporate both airborne exposure reduction and dermal 
protection provisions.
---------------------------------------------------------------------------

    \28\ This point was emphasized by members of the scientific peer 
review panel for OSHA's Preliminary Risk Assessment (see the NPRM 
preamble at section VII).
---------------------------------------------------------------------------

    OSHA's conclusions on significance of risk at the final PEL and 
action level are further supported by its analysis of the data set 
provided to OSHA by NJH from which OSHA derived additional information 
on sensitization and CBD at exposure levels of interest. The data set 
describes a population of 319 beryllium-exposed workers at a Cullman, 
AL machining facility. It includes exposure samples collected between 
1980 and 2005, and has updated work history and screening information 
through 2003. Seven (2.2 percent) workers in the data set were reported 
as sensitized only. Sixteen (5.0 percent) workers were listed as 
sensitized and diagnosed with CBD upon initial clinical evaluation. 
Three (0.9 percent) workers, first shown to be sensitized only, were 
later diagnosed with CBD. The data set includes workers exposed at 
airborne beryllium levels near the new TWA PEL of 0.2 [mu]g/m\3\, and 
extensive exposure data collected in workers' breathing zones, as is 
preferred by OSHA. Unlike the Tucson, Reading, and Elmore facilities 
after 2000, respirator use was not generally required for workers at 
the Cullman facility. Thus, analysis of this data set shows the risk 
associated with varying levels of airborne exposure rather than 
estimating exposure accounting for respirators. Also unlike the Tucson, 
Elmore, and Reading facilities, glove use was not reported to be 
mandatory in the Cullman facility. Therefore, OSHA believes reductions 
in risk at the Cullman facility to be the result of airborne exposure 
control, rather than the combination of airborne and dermal exposure 
controls used at other facilities.
    OSHA analyzed the prevalence of beryllium sensitization and CBD 
among

[[Page 2550]]

workers at the Cullman facility who were exposed to airborne beryllium 
levels at and below the preceding TWA PEL of 2 [mu]g/m\3\. In addition, 
a statistical modeling analysis of the NJH Cullman data set was 
conducted under contract with Dr. Roslyn Stone of the University of 
Pittsburgh Graduate School of Public Heath, Department of 
Biostatistics. OSHA summarizes these analyses briefly below, and in 
more detail in section VI, Risk Assessment and in the background 
document (Risk Analysis of the NJH Data Set from the Beryllium 
Machining Facility in Cullman, Alabama--CBD and Sensitization, OSHA, 
2016).
    Tables VII-1 and VII-2 below present the prevalence of 
sensitization and CBD cases across several categories of lifetime-
weighted (LTW) average and highest-exposed job (HEJ) exposure at the 
Cullman facility. The HEJ exposure is the exposure level associated 
with the highest-exposure job and time period experienced by each 
worker. The columns ``Total'' and ``Total percent'' refer to all 
sensitized workers in the data set, including workers with and without 
a diagnosis of CBD.

                            Table VII-1--Prevalence of Sensitization and CBD by LTW Average Exposure Quartile in NJH Data Set
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                            Sensitized
            LTW average exposure ([mu]g/m\3\)               Group size         only             CBD            Total        Total  (%)       CBD  (%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
0.0-0.080...............................................              91               1               1               2             2.2             1.0
0.081-0.18..............................................              73               2               4               6             8.2             5.5
0.19-0.51...............................................              77               0               6               6             7.8             7.8
0.51-2.15...............................................              78               4               8              12            15.4            10.3
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................             319               7              19              26             8.2             6.0
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: Section VI, Risk Assessment.


                        Table VII-2--Prevalence of Sensitization and CBD by Highest-Exposed Job Exposure Quartile in NJH Data Set
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                            Sensitized
                HEJ exposure ([mu]g/m\3\)                   Group size         only             CBD            Total         Total (%)        CBD (%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
0.0-0.086...............................................              86               1               0               1             1.2             0.0
0.091-0.214.............................................              81               1               6               7             8.6             7.4
0.387-0.691.............................................              76               2               9              11            14.5            11.8
0.954-2.213.............................................              76               3               4               7             9.2             5.3
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................             319               7              19              26             8.2             6.0
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: Section VI, Risk Assessment.

    The preceding PEL of 2 [mu]g/m\3\ is close to the upper bound of 
the highest quartile of LTW average (0.51-2.15 [mu]g/m\3\) and HEJ 
(0.954-2.213 [mu]g/m\3\) exposure levels. In the highest quartile of 
LTW average exposure, there were 12 cases of sensitization (15.4 
percent), including eight (10.3 percent) diagnosed with CBD. Notably, 
the Cullman workers had been exposed to beryllium dust for considerably 
less than 45 years at the time of testing. A high prevalence of 
sensitization (9.2 percent) and CBD (5.3 percent) is seen in the top 
quartile of HEJ exposure as well, with even higher prevalences in the 
third quartile (0.387-0.691 [mu]g/m\3\).\29\
---------------------------------------------------------------------------

    \29\ This exposure-response pattern, wherein higher rates of 
response are seen in workers with lower exposures, is sometimes 
attributed to a ``healthy worker effect'' or to exposure 
misclassification, as discussed in this preamble at section VI, Risk 
Assessment.
---------------------------------------------------------------------------

    The new TWA PEL of 0.2 [mu]g/m\3\ is close to the upper bound of 
the second quartile of LTW average (0.81-0.18 [mu]g/m\3\) and HEJ 
(0.091-0.214 [mu]g/m\3\) exposure levels and to the lower bound of the 
third quartile of LTW average (0.19-0.50 [mu]g/m\3\) exposures. The 
second quartile of LTW average exposure shows a high prevalence of 
beryllium-related health effects, with six workers sensitized (8.2 
percent), of whom four (5.5 percent) were diagnosed with CBD. The 
second quartile of HEJ exposure also shows a high prevalence of 
beryllium-related health effects, with seven workers sensitized (8.6 
percent), of whom six (7.4 percent) were diagnosed with CBD. Among six 
sensitized workers in the third quartile of LTW average exposures, all 
were diagnosed with CBD (7.8 percent). The prevalence of CBD among 
workers in these quartiles was approximately 5-8 percent, and overall 
sensitization (including workers with and without CBD) was about 8-9 
percent. OSHA considers these rates to be evidence that the risks of 
developing sensitization and CBD are significant among workers exposed 
at and below the preceding TWA PEL, and even below the new TWA PEL. 
These risks are much higher than the benchmark for significant risk of 
1 in 1,000. Much lower prevalences of sensitization and CBD were found 
among workers with exposure levels less than or equal to about 0.08 
[mu]g/m\3\, although these risks are still significant. Two sensitized 
workers (2.2 percent), including one case of CBD (1.0 percent), were 
found among workers with LTW average exposure levels less than or equal 
to 0.08 [mu]g/m\3\. One case of sensitization (1.2 percent) and no 
cases of CBD were found among workers with HEJ exposures of at most 
0.086 [mu]g/m\3\. Strict control of airborne exposure to levels below 
0.1 [mu]g/m\3\ using engineering and work practice controls can, 
therefore, substantially reduce risk of sensitization and CBD. Although 
OSHA recognizes that maintaining exposure levels below 0.1 [mu]g/m\3\ 
may not be feasible in some operations (see this preamble at section 
VIII, Summary of the Economic Analysis and Regulatory Flexibility 
Analysis), the Agency finds that workers in facilities that meet the 
action level of 0.1 [mu]g/m\3\ will face lower risks of sensitization 
and CBD than workers in facilities that cannot meet the action level.
    Table VII-3 below presents the prevalence of sensitization and CBD 
cases across cumulative exposure quartiles, based on the same Cullman 
data used to derive Tables 1 and 2. Cumulative exposure is the sum of a 
worker's exposure across the duration of his or her employment.

[[Page 2551]]



                            Table VII-3--Prevalence of Sensitization and CBD by Cumulative Exposure Quartile in NJH Data Set
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                            Sensitized
          Cumulative exposure ([mu]g/m\3\-yrs)              Group size         only             CBD            Total          Total %          CBD %
--------------------------------------------------------------------------------------------------------------------------------------------------------
0.0-0.147...............................................              81               2               2               4             4.9             2.5
0.148-1.467.............................................              79               0               2               2             2.5             2.5
1.468-7.008.............................................              79               3               8              11            13.9             8.0
7.009-61.86.............................................              80               2               7               9            11.3             8.8
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................             319               7              19              26             8.2             6.0
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: Section VI, Risk Assessment.

    A 45-year working lifetime of occupational exposure at the 
preceding PEL would result in 90 [mu]g/m\3\-years of exposure, a value 
far higher than the cumulative exposures of workers in this data set, 
who worked for periods of time less than 45 years and whose exposure 
levels were mostly well below the previous PEL. Workers with 45 years 
of exposure to the new TWA PEL of 0.2 [mu]g/m\3\ would have a 
cumulative exposure (9 [mu]g/m\3\-years) in the highest quartile for 
this worker population. As with the average and HEJ exposures, the 
greatest risk of sensitization and CBD appears at the higher exposure 
levels (<1.467 [mu]g/m\3\-years). The third cumulative quartile, at 
which a sharp increase in sensitization and CBD appears, is bounded by 
1.468 and 7.008 [mu]g/m\3\-years. This is equivalent to 0.73-3.50 years 
of exposure at the preceding PEL of 2 [mu]g/m\3\, or 7.34-35.04 years 
of exposure at the new TWA PEL of 0.2 [mu]g/m\3\. Prevalence of both 
sensitization and CBD is substantially lower in the second cumulative 
quartile (0.148-1.467 [mu]g/m\3\-years). This is equivalent to 
approximately 0.7 to 7 years at the new TWA PEL of 0.2 [mu]g/m\3\, or 
1.5 to 15 years at the action level of 0.1 [mu]g/m\3\. Risks at all 
levels of cumulative exposure presented in Table 3 are significant. 
These findings support OSHA's determination that maintaining exposure 
levels below the new TWA PEL will help to protect workers against risk 
of beryllium sensitization and CBD. Moreover, while OSHA finds that 
significant risk remains at the PEL, OSHA's analysis shows that further 
reductions of risk will ensue if employers are able to reduce exposure 
to the action level or even below.

Lung Cancer

    Lung cancer, a frequently fatal disease, is a well-recognized 
material impairment of health. OSHA has determined that beryllium 
causes lung cancer based on an extensive review of the scientific 
literature regarding beryllium and cancer. This review included an 
evaluation of the human epidemiological, animal cancer, and mechanistic 
studies described in section V, Health Effects. OSHA's conclusion that 
beryllium is carcinogenic is supported by the findings of expert public 
health and governmental organizations such as the International Agency 
for Research on Cancer (IARC), which has determined beryllium and its 
compounds to be carcinogenic to humans (Group 1 category) (IARC, 2012, 
Document ID 0650); the National Toxicology Program (NTP), which 
classifies beryllium and its compounds as known carcinogens (NTP, 2014, 
Document ID 0389); and the Environmental Protection Agency (EPA), which 
considers beryllium to be a probable human carcinogen (EPA, 1998, 
Document ID 0661).
    OSHA's review of epidemiological studies of lung cancer mortality 
among beryllium workers found that most of them did not characterize 
exposure levels sufficiently to evaluate the risk of lung cancer at the 
preceding and new TWA PELs. However, as discussed in this preamble at 
section V, Health Effects and section VI, Risk Assessment, Schubauer-
Berigan et al. published a quantitative risk assessment based on 
beryllium exposure and lung cancer mortality among 5,436 male workers 
first employed at beryllium processing plants in Reading, PA, Elmore, 
OH, and Hazleton, PA, prior to 1970 (Schubauer-Berigan et al., 2011, 
Document ID 1265). This risk assessment addresses important sources of 
uncertainty for previous lung cancer analyses, including the sole prior 
exposure-response analysis for beryllium and lung cancer, conducted by 
Sanderson et al. (2001) on workers from the Reading plant alone. 
Workers from the Elmore and Hazleton plants who were added to the 
analysis by Schubauer-Berigan et al. were, in general, exposed to lower 
levels of beryllium than those at the Reading plant. The median worker 
from Hazleton had a LTW average exposure of less than 1.5 [mu]g/m\3\, 
while the median worker from Elmore had a LTW average exposure of less 
than 1 [mu]g/m\3\. The Elmore and Hazleton worker populations also had 
fewer short-term workers than the Reading population. Finally, the 
updated cohorts followed the worker populations through 2005, 
increasing the length of follow-up time compared to the previous 
exposure-response analysis. For these reasons, OSHA based the 
preliminary risk assessment for lung cancer on the Schubauer-Berigan 
risk analysis.
    Schubauer-Berigan et al. (2011, Document ID 1265) analyzed the data 
set using a variety of exposure-response modeling approaches, described 
in this preamble at section VI, Risk Assessment. The authors found that 
lung cancer mortality risk was strongly and significantly correlated 
with mean, cumulative, and maximum measures of workers' exposure to 
beryllium (all of the models reported in the study). They selected the 
best-fitting models to generate risk estimates for male workers with a 
mean exposure of 0.5 [mu]g/m\3\ (the current NIOSH Recommended Exposure 
Limit for beryllium). In addition, they estimated the daily weighted 
average exposure that would be associated with an excess lung cancer 
mortality risk of one in one thousand (.005 [mu]g/m\3\ to .07 [mu]g/
m\3\ depending on model choice). At OSHA's request, the authors also 
estimated excess lifetime risks for workers with mean exposures at the 
preceding TWA PEL of 2 [mu]g/m\3\ as well as at each of the alternate 
TWA PELs that were under consideration: 1 [mu]g/m\3\, 0.2 [mu]g/m\3\, 
and 0.1 [mu]g/m\3\. Table VII-4 presents the estimated excess risk of 
lung cancer mortality associated with various levels of beryllium 
exposure, based on the final models presented in Schubauer-Berigan et 
al's risk assessment.\30\
---------------------------------------------------------------------------

    \30\ The estimates for lung cancer represent ``excess'' risks in 
the sense that they reflect the risk of dying from lung cancer over 
and above the risk of dying from lung cancer faced by those who are 
not occupationally exposed to beryllium.

[[Page 2552]]



 Table VII-4--Excess Risk of Lung Cancer Mortality per 1,000 Male Workers at Alternate PELs (based on Schubauer-
                                              Berigan et al., 2011)
----------------------------------------------------------------------------------------------------------------
                                                                   Mean exposure
     Exposure-response model     -------------------------------------------------------------------------------
                                  0.1 [mu]g/m\3\  0.2 [mu]g/m\3\  0.5 [mu]g/m\3\   1 [mu]g/m\3\    2 [mu]g/m\3\
----------------------------------------------------------------------------------------------------------------
Best monotonic PWL-all workers..             7.3              15              45             120             140
Best monotonic PWL--excluding                3.1             6.4              17              39              61
 professional and asbestos
 workers........................
Best categorical--all workers...             4.4               9              25              59             170
Best categorical--excluding                  1.4             2.7             7.1              15              33
 professional and asbestos
 workers........................
Power model--all workers........              12              19              30              40              52
Power model--excluding                        19              30              49              68              90
 professional and asbestos
 workers........................
----------------------------------------------------------------------------------------------------------------
Source: Schubauer-Berigan, Document ID 0521, pp. 6-10.

    The lowest estimate of excess lung cancer deaths from the six final 
models presented by Schubauer-Berigan et al. is 33 per 1,000 workers 
exposed at a mean level of 2 [mu]g/m\3\, the preceding TWA PEL. Risk 
estimates as high as 170 lung cancer deaths per 1,000 result from the 
other five models presented. Regardless of the model chosen, the excess 
risk of about 33 to 170 per 1,000 workers is clearly significant, 
falling well above the level of risk the Supreme Court indicated a 
reasonable person might consider acceptable (see Benzene, 448 U.S. at 
655). The new PEL of 0.2 [mu]g/m\3\ is expected to reduce these risks 
significantly, to somewhere between 2.7 and 30 excess lung cancer 
deaths per 1,000 workers. At the new action level of 0.1 [mu]g/m\3\, 
risk falls within the range of 1.4 to 19 excess lung cancer deaths. 
These risk estimates still fall above the threshold of 1 in 1,000 that 
OSHA considers clearly significant. However, the Agency believes the 
lung cancer risks should be regarded as less certain than the risk 
estimates for CBD and sensitization discussed previously. While the 
risk estimates for CBD and sensitization at the preceding and new TWA 
PELs were determined from exposure levels observed in occupational 
studies, the lung cancer risks were extrapolated from much higher 
exposure levels.

Conclusions

    As discussed throughout this section, OSHA used the best available 
scientific evidence to identify adverse health effects of occupational 
beryllium exposure, and to evaluate exposed workers' risk of these 
impairments. The Agency reviewed extensive epidemiological and 
experimental research pertaining to adverse health effects of 
occupational beryllium exposure, including lung cancer, CBD, and 
beryllium sensitization, and has evaluated the risk of these effects 
from exposures allowed under the preceding and new TWA PELs. The Agency 
has, additionally, reviewed the medical literature, as well as previous 
policy determinations and case law regarding material impairment of 
health, and has determined that CBD, at all stages, and lung cancer 
constitute material health impairments.
    OSHA has determined that long-term exposure to beryllium at the 
preceding TWA PEL would pose a risk of CBD and lung cancer greater than 
the risk of 1 per 1,000 exposed workers the Agency considers clearly 
significant, and that adoption of the new TWA PEL, action level, and 
dermal protection requirements of the final standards will 
substantially reduce this risk. OSHA believes substantial evidence 
supports its determinations, including its choices of the best 
available published studies on which to base its risk assessment, its 
examination of the prevalence of sensitization and CBD among workers 
with exposure levels comparable to the preceding TWA PEL and new TWA 
PEL in the NJH data set, and its selection of the Schubauer-Berigan QRA 
to form the basis for its lung cancer risk estimates. The previously-
described analyses demonstrate that workers with occupational exposure 
to airborne beryllium at the preceding PEL face risks of developing CBD 
and dying from lung cancer that far exceed the value of 1 in 1,000 used 
by OSHA as a benchmark of clearly significant risk. Furthermore, OSHA's 
risk assessment indicates that risk of CBD and lung cancer can be 
significantly reduced by reduction of airborne exposure levels, and 
that dermal protection measures will additionally help reduce risk of 
sensitization and, therefore, of CBD.
    OSHA's risk assessment also indicates that, despite the reduction 
in risk expected with the new PEL, the risks of CBD and lung cancer to 
workers with average exposure levels of 0.2 [mu]g/m\3\ are still 
significant and could extend down to 0.1 [mu]g/m\3\, although there is 
greater uncertainty in this finding for 0.1 [mu]g/m\3\ since there is 
less information available on populations exposed at and below this 
level. Although significant risk remains at the new TWA PEL, OSHA is 
also required to consider the technological and economic feasibility of 
the standard in determining exposure limits. As explained in Section 
VIII, Summary of the Final Economic Analysis and Final Regulatory 
Flexibility Analysis, OSHA determined that the new TWA PEL of 0.2 
[mu]g/m\3\ is both technologically and economically feasible in the 
general industry, construction, and shipyard sectors. OSHA was unable 
to demonstrate, however, that a lower TWA PEL of 0.1 [mu]g/m\3\ would 
be technologically feasible. Therefore, OSHA concludes that, in setting 
a TWA PEL of 0.2 [mu]g/m\3\, the Agency is reducing the risk to the 
extent feasible, as required by the OSH Act (see section II, Pertinent 
Legal Authority). In this context, the Agency finds that the action 
level of 0.1 [mu]g/m\3\, dermal protection requirements, and other 
ancillary provisions of the final rule are critically important in 
reducing the risk of sensitization, CBD, and lung cancer among workers 
exposed to beryllium. Together, these provisions, along with the new 
TWA PEL of 0.2 [mu]g/m\3\, will substantially reduce workers' risk of 
material impairment of health from occupational beryllium exposure.

VIII. Summary of the Final Economic Analysis and Final Regulatory 
Flexibility Analysis

A. Introduction

    OSHA's Final Economic Analysis and Final Regulatory Flexibility 
Analysis (FEA) addresses issues related to the costs, benefits, 
technological and economic feasibility, and the economic impacts 
(including impacts on small entities) of this final beryllium rule and 
evaluates regulatory alternatives to the final rule. Executive Orders 
13563 and

[[Page 2553]]

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 FEA has 
been placed in OSHA rulemaking docket OSHA-H005C-2006-0870. This rule 
is an economically significant regulatory action under Sec. 3(f)(1) of 
Executive Order 12866 and has been reviewed by the Office of 
Information and Regulatory Affairs in the Office of Management and 
Budget, as required by executive order.
    The purpose of the FEA is to:
     Identify the establishments and industries potentially 
affected by the final rule;
     Estimate current exposures and the technologically 
feasible methods of controlling these exposures;
     Estimate the benefits resulting from employers coming into 
compliance with the final rule in terms of reductions in cases of lung 
cancer, chronic beryllium disease;
     Evaluate the costs and economic impacts that 
establishments in the regulated community will incur to achieve 
compliance with the final rule;
     Assess the economic feasibility of the final rule for 
affected industries; and
     Assess the impact of the final rule on small entities 
through a Final Regulatory Flexibility Analysis (FRFA), to include an 
evaluation of significant regulatory alternatives to the final rule 
that OSHA has considered.
Significant Changes to the FEA Between the Proposed Standards and the 
Final Standards
    OSHA made changes to the Preliminary Economic Analysis (PEA) for 
several reasons:
     Changes to the rule, summarized in Section I of the 
preamble and discussed in detail in the Summary and Explanation;
     Comments on the PEA;
     Updates of economic data; and
     Recognition of errors in the PEA.
    OSHA revised its technological and economic analysis in response to 
these changes and to comments received on the NPRM. The FEA contains 
some costs that were not included in the PEA and updates data to use 
more recent data sources and, in some cases, revised methodologies. 
Detailed discussions of these changes are included in the relevant 
sections throughout the FEA.
    The Final Economic Analysis contains the following chapters:

Chapter I. Introduction
Chapter II. Market Failure and the Need for Regulation
Chapter III. Profile of Affected Industries
Chapter IV. Technological Feasibility
Chapter V. Costs of Compliance
Chapter VI. Economic Feasibility Analysis and Regulatory Flexibility 
Determination
Chapter VII. Benefits and Net Benefits
Chapter VIII. Regulatory Alternatives
Chapter IX. Final Regulatory Flexibility Analysis

    Table VIII-1 provides a summary of OSHA's best estimate of the 
costs and benefits of the final rule using a discount rate of 3 
percent. As shown, the final rule is estimated to prevent 90 fatalities 
and 46 beryllium-related illnesses annually once it is fully effective, 
and the estimated cost of the rule is $74 million annually. Also as 
shown in Table VIII-1, the discounted monetized benefits of the final 
rule are estimated to be $561 million annually, and the final rule is 
estimated to generate net benefits of $487 million annually. Table 
VIII-1 also presents the estimated costs and benefits of the final rule 
using a discount rate of 7 percent.

   Table VIII-1--Annualized Benefits, Costs and Net Benefits of OSHA's
                        Final Beryllium Standard
                 [3 Percent Discount Rate, 2015 dollars]
------------------------------------------------------------------------
 
------------------------------------------------------------------------
Annualized Costs:
  Control Costs.........................................     $12,269,190
  Rule Familiarization..................................         180,158
  Exposure Assessment...................................      13,748,676
  Regulated Areas.......................................         884,106
  Beryllium Work Areas..................................         129,648
  Medical Surveillance..................................       7,390,958
  Medical Removal.......................................       1,151,058
  Written Exposure Control Plan.........................       2,339,058
  Protective Work Clothing & Equipment..................       1,985,782
  Hygiene Areas and Practices...........................       2,420,584
  Housekeeping..........................................      22,763,595
  Training..............................................       8,284,531
  Respirators...........................................         320,885
                                                         ---------------
      Total Annualized Costs (Point Estimate)...........      73,868,230
Annual Benefits: Number of Cases Prevented:
  Fatal Lung Cancers (Midpoint Estimate)................               4
  Fatal Chronic Beryllium Disease.......................              86
  Beryllium-Related Mortality...........................              90
  Beryllium Morbidity...................................              46
  Monetized Annual Benefits (Midpoint Estimate).........    $560,873,424
Net Benefits:
  Net Benefits..........................................    $487,005,194
------------------------------------------------------------------------
Sources: US DOL, OSHA, Directorate of Standards and Guidance, Office of
  Regulatory Analysis

    The remainder of this section (Section VIII) of the preamble is 
organized as follows:

B. Market Failure and the Need for Regulation
C. Profile of Affected Industries
D. Technological Feasibility
E. Costs of Compliance
F. Economic Feasibility Analysis and Regulatory Flexibility 
Determination
G. Benefits and Net Benefits
H. Regulatory Alternatives
I. Final Regulatory Flexibility Analysis.

B. Market Failure and the Need for Regulation

    Employees in work environments addressed by the final beryllium 
rule are exposed to a variety of significant hazards that can and do 
cause serious injury and death. As described in Chapter II of the FEA 
in support of the final rule, OSHA concludes there is a demonstrable 
failure of private markets to protect workers from exposure to 
unnecessarily high levels beryllium and that private markets, as well 
as information dissemination programs, workers' compensation systems, 
and tort liability options, each may fail to protect workers from 
beryllium exposure, resulting in the need for a more protective OSHA 
beryllium rule.
    After carefully weighing the various potential advantages and 
disadvantages of using a regulatory approach to improve upon the 
current situation, OSHA concludes that, in the case of beryllium 
exposure, the final mandatory standards represent the best choice for 
reducing the risks to employees.

C. Profile of Affected Industries

    Chapter III of the FEA presents profile data for industries 
potentially affected by the final beryllium rule. This Chapter provides 
the background data used throughout the remainder of the FEA including 
estimates of what industries are affected, and their economic and 
beryllium exposure characteristics. OSHA identified the following 
application groups as affected by the standard:

 Beryllium Production
 Beryllium Oxide Ceramics and Composites
 Nonferrous Foundries
 Secondary Smelting, Refining, and Alloying
 Precision Turned Products
 Copper Rolling, Drawing, and Extruding
 Fabrication of Beryllium Alloy Products
 Welding
 Dental Laboratories
 Aluminum Production
 Coal-Fired Electric Power Generation

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 Abrasive Blasting

    Table VIII-3 shows the affected industries by application group and 
selected economic characteristics of these affected industries. Table 
VIII-4 provides industry-by-industry estimates of current exposure.

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D. Technological Feasibility of the Final Standard on Occupational 
Exposure to Beryllium

    The OSH Act requires OSHA to demonstrate that a proposed health 
standard is technologically feasible (29 U.S.C. 655(b)(5)). As 
described in the preamble to the final rule (see Section II, Pertinent 
Legal Authority), technological feasibility has been interpreted 
broadly to mean ``capable of being done'' (Am. Textile Mfrs. Inst. v. 
Donovan, 452 U.S. 490, 509-510 (1981) (``Cotton Dust'')). A standard is 
technologically feasible if the protective measures it requires already 
exist, can be brought into existence with available technology, or can 
be created with technology that can reasonably be expected to be 
developed, i.e., technology that ``looms on today's horizon'' (United 
Steelworkers of Am., AFL-CIO-CLC v. Marshall, 647 F.2d 1189, 1272 (D.C. 
Cir. 1980) (``Lead I''); Amer. Iron & Steel Inst. v. OSHA, 939 F.2d 
975, 980 (D.C. Cir. 1991) (``Lead II''); AFL-CIO v. Brennan, 530 F.2 
109, 121 (3rd Cir. 1975)). Courts have also interpreted technological 
feasibility to mean that, for health standards, a typical firm in each 
affected industry will reasonably be able to implement engineering and 
work practice controls that can reduce workers' exposures to meet the 
permissible exposure limit in most operations most of the time, without 
reliance on respiratory protection (see Lead I, 647 F.2d at 1272; Lead 
II, 939 F.2d at 990).
    OSHA's technological feasibility analysis is presented in Chapter 
IV of the FEA. The technological feasibility analysis identifies the 
affected industries and application groups in which employees can 
reasonably be expected to be exposed to beryllium, summarizes the 
available air sampling data used to develop employee exposure profiles, 
and provides descriptions of engineering controls and other measures 
employers can take to reduce their employees' exposures to beryllium. 
For each affected industry sector or application group, OSHA provides 
an assessment of the technological feasibility of compliance with the 
final permissible exposure limit (PEL) of 0.2 [mu]g/m\3\ as an 8-hour 
TWA and a 15-minute short-term exposure limit (STEL) of 2.0 [mu]g/m\3\.
    The technological feasibility analysis covers twelve application 
groups that correspond to specific industries or production processes 
that involve the potential for occupational exposures to materials 
containing beryllium and that OSHA has determined fall within the scope 
of this final beryllium standard. Within each of these application 
groups, exposure profiles have been developed to characterize the 
distribution of the available exposure measurements by job title or 
group of jobs. Each section includes descriptions of existing, or 
baseline, engineering controls for operations that generate beryllium 
exposure. For those job groups in which current exposures were found to 
exceed the final PEL, OSHA identifies and describes additional 
engineering and work practice controls that can be implemented to 
reduce exposure and achieve compliance with the final PEL. For each 
application group or industry, a final determination is made regarding 
the technological feasibility of achieving the proposed permissible 
exposure limits based on the use of engineering and work practice 
controls and without reliance on the use of respiratory protection. The 
determination is made based on the legal standard of whether the PEL 
can be achieved for most operations most of the time using such 
controls. In a separate chapter on short-term exposures, OSHA also 
analyzes the feasibility of achieving compliance with the Short-Term 
Exposure Limit (STEL).
    The analysis is based on the best evidence currently available to 
OSHA, including a comprehensive review of the industrial hygiene 
literature, National Institute for Occupational Safety and Health 
(NIOSH) Health Hazard Evaluations and case studies of beryllium 
exposure, site visits conducted by an OSHA contractor (Eastern Research 
Group (ERG)), and inspection data from OSHA's Integrated Management 
Information System (IMIS) and OSHA's Information System (OIS). OSHA 
also obtained information on beryllium production processes, worker 
exposures, and the effectiveness of existing control measures from 
Materion Corporation, the primary beryllium producer in the United 
States, interviews with industry experts, and comments submitted to the 
rulemaking docket in response to the Notice of Proposed Rulemaking and 
informal public hearings. All of this evidence is in the rulemaking 
record.
    The twelve application groups are:
     Primary Beryllium Production,
     Beryllium Oxide Ceramics and Composites,
     Nonferrous Foundries,
     Secondary Smelting, Refining, and Alloying, Including 
Handling of Scrap and Recycled Materials,
     Precision Turned Products,
     Copper Rolling, Drawing, and Extruding,
     Fabrication of Beryllium Alloy Products,
     Welding,
     Dental Laboratories,
     Abrasive Blasting,
     Coal-Fired Electric Power Generation,
     Aluminum Production
    For discussion purposes, the twelve application groups are divided 
into four general categories based on the distribution of exposures in 
the exposure profiles: (1) Application groups in which baseline 
exposures for most jobs are already at or below the final PEL of 0.2 
[mu]g/m\3\; (2) application groups in which baseline exposures for one 
or more jobs exceed the final PEL of 0.2 [mu]g/m\3\, but additional 
controls have been identified that could achieve exposures at or below 
the final PEL for most of the operations most of the time; (3) 
application groups in which exposures in one or more jobs routinely 
exceed the preceding PEL of 2.0 [mu]g/m\3\, and therefore substantial 
reductions in exposure would be required to achieve the final PEL; and 
(4) application groups in which exposure to beryllium occurs due to 
trace levels of beryllium found in dust or fumes that nonetheless can 
result in exposures that exceed 0.1 [mu]g/m\3\ as an 8-hour TWA under 
foreseeable conditions.
    The application groups in category 1, where exposures for most jobs 
are already at or below the final PEL of 0.2 [mu]g/m\3\, typically 
handle beryllium alloys containing a low percentage of beryllium (<2 
percent) using processes that do not result in significant airborne 
exposures. These four application groups are (1) copper rolling, 
drawing, and extruding; (2) fabrication of beryllium alloy products; 
(3) welding; and (4) aluminum production. The handling of beryllium 
alloys in solid form is not expected to result in exposures of concern. 
For example, beryllium alloys used in copper rolling, drawing, and 
extruding typically contain 2 percent beryllium by weight or less 
(Document ID 0081, Attachment 1). One facility noted that the copper-
beryllium alloys it used contained as little as 0.1 percent beryllium 
(Document ID 0081, Attachment 1). These processes, such as rolling 
operations that consist of passing beryllium alloys through a rolling 
press to conform to a desired thickness, tend to produce less 
particulate and fume than high energy processes. Exposures can be 
controlled using containment, exhaust ventilation, and work practices 
that include rigorous housekeeping. In addition, the heating of metal 
during welding operations results in the release of fume, but the 
beryllium in the welding fume accounts for a relatively small 
percentage of the beryllium exposure. Worker exposure to beryllium

[[Page 2583]]

during welding activities is largely attributable to flaking oxide 
scale on the base metal, which can be reduced through chemically 
stripping or pickling the beryllium alloy piece prior to welding on it, 
and/or enhancing exhaust ventilation (Corbett, 2006; Kent, 2005; 
Materion Information Meeting, 2012).
    For application groups in category 2, where baseline exposures for 
one or more jobs exceed the final PEL of 0.2 [mu]g/m \3\, but 
additional controls have been identified that could achieve exposures 
at or below the final PEL for most of the operations most of the time, 
workers may encounter higher content beryllium (20 percent or more by 
weight), or higher temperature processes (Document ID 1662, p. 4.) The 
application groups in the second category are: (1) Precision turned 
products and (2) secondary smelting, refining, and alloying. While the 
median exposures for most jobs in these groups are below the preceding 
PEL of 2.0 [mu]g/m\3\, the median exposures for some jobs in these 
application groups exceed the final PEL of 0.2 [mu]g/m\3\ when not 
adequately controlled. For these application groups, additional 
exposure controls and work practices will be required to reduce 
exposures to or below the final PEL for most operations most of the 
time. For example, personal samples collected at a precision turned 
products facility that machined pure beryllium metal and high beryllium 
content materials (40-60 percent) measured exposures on two machinists 
of 2.9 and 6.6 [mu]g/m3 (ERG Beryllium Site 4, 2003). A second survey 
at this same facility conducted after an upgrade to the ventilation 
systems in the mill and lathe departments measured PBZ exposures for 
these machinists of 1.1 and 2.3 [mu]g/m\3\ (ERG Beryllium Site 9, 
2004), and it was noted that not all ventilation was optimally 
positioned, indicating that further reduction in exposure could be 
achieved. In 2007, the company reported that after the installation of 
enclosures on milling machines and additional exhaust, average 
exposures to mill and lathe operators were reduced to below 0.2 
[micro]g/m\3\ (ICBD, 2007). For secondary smelting operations, several 
surveys conducted at electronic recycling and precious metal recovery 
operations indicate that exposures for mechanical processing operators 
can be controlled to or below 0.2 [micro]g/m\3\. However, for furnace 
operations in secondary smelting, the median value in the exposure 
profile exceeds the preceding PEL. Furnace operations involve high 
temperatures that produce significant amounts of fumes and particulate 
that can be difficult to contain. Therefore, the reduction of 8-hour 
average exposures to or below the final PEL may not be achievable for 
most furnace operations involved with secondary smelting of beryllium 
alloys. In these cases, the supplemental use of respiratory protection 
for specific job tasks will be needed to adequately protect furnace 
workers for operations where exposures are found to exceed 0.2 [mu]g/
m\3\ despite the implementation of all feasible engineering and work 
practice controls.
    The application groups in category 3 include application groups for 
which the exposure profiles indicate that exposures in one or more jobs 
routinely exceed the preceding PEL of 2.0 [mu]g/m\3\. The three 
application groups in this category are: (1) Beryllium production, (2) 
beryllium oxide ceramics production, and (3) nonferrous foundries. For 
the job groups in which exposures have been found to routinely exceed 
the preceding PEL, OSHA identifies additional exposure controls and 
work practices that the Agency has determined can reduce exposures to 
or below the final PEL, most of the time. For example, OSHA concluded 
that exposures to beryllium resulting from material transfer, loading, 
and spray drying of beryllium oxide powders can be reduced to or below 
0.2 [micro]g/m3 with process enclosures, ventilation hoods, and 
diligent housekeeping for material preparation operators working in 
beryllium oxide ceramics and composites facilities (FEA, Chapter IV-
04). However, for furnace operations in primary beryllium production 
and nonferrous foundries, and shakeout operations at nonferrous 
foundries, OSHA recognizes that even after installation of feasible 
controls, supplemental use of respiratory protection may be needed to 
protect workers adequately (FEA, Chapter IV-03 and IV-05). The evidence 
in the rulemaking record is insufficient to conclude that these 
operations would be able to reduce the majority of the exposure to 
levels below 0.2 [mu]g/m\3\ most of the time, and therefore some 
increased supplemental use of respiratory protection may be required 
for certain tasks in these jobs.
    Category 4 includes application groups that encounter exposure to 
beryllium due to trace levels found in dust or fumes that nonetheless 
can exceed 0.1 [mu]g/m\3\ as an 8-hour TWA under foreseeable 
conditions. The application groups in this category are (1) coal-fired 
power plants in which exposure to beryllium can occur due to trace 
levels of beryllium in the fly ash during very dusty maintenance 
operations, such as cleaning the air pollution control devices; (2) 
aluminum production in which exposure to beryllium can occur due to 
naturally occurring trace levels of beryllium found in bauxite ores 
used to make aluminum; and (3) abrasive blasting using coal and copper 
slag that can contain trace levels of beryllium. Workers who perform 
abrasive blasting using either coal or copper slag abrasives are 
potentially exposed to beryllium due to the high total exposure to the 
blasting media. Due to the very small amounts of beryllium in these 
materials, the final PEL for beryllium will be exceeded only during 
operations that generate excessive amount of visible airborne dust, for 
which engineering controls and respiratory protection are already 
required. However, the other workers in the general vicinity do not 
experience these high exposures if proper engineering controls and work 
practices, such as temporary enclosures and maintaining appropriate 
distance during the blasting or maintenance activities, are 
implemented.
    During the rulemaking process, OSHA requested and received comments 
regarding the feasibility of the PEL of 0.2 [mu]g/m\3\, as well as the 
proposed alternative PEL of 0.1 [micro]g/m\3\ (80 FR 47565, 47780 (Aug. 
7, 2015)). OSHA did this because it recognizes that significant risk of 
beryllium disease is not eliminated at an exposure level of 0.2 [mu]g/
m\3\. As discussed below, OSHA finds that the proposed PEL of 0.2 
[mu]g/m\3\ can be achieved through engineering and work practice 
controls in most operations most of the time in all the affected 
industry sectors and application groups, and therefore is feasible for 
these industries and application groups under the OSH Act. OSHA could 
not find, however, that the proposed alternative PEL of 0.1 [mu]g/m\3\ 
is also feasible for all of the affected industry sectors and 
application groups.
    The majority of commenters, including stakeholders in labor and 
industry, public health experts, and the general public, explicitly 
supported the proposed PEL of 0.2 [micro]g/m\3\ (NIOSH, Document ID 
1671, Attachment 1, p. 2; National Safety Council, 1612, p. 3; 
Beryllium Health and Safety Committee Task Group, 1655, p. 2; Newport 
News Shipbuilding, 1657, p. 1; National Jewish Health (NJH), 1664, p. 
2; the Aluminum Association, 1666, p. 1; the Boeing Company, 1667, p. 
1; American Industrial Hygiene Association, 1686, p. 2; United 
Steelworkers (USW), 1681, p. 7; Andrew Brown, 1636, p. 6; Department of 
Defense, 1684, p. 1). In addition, Materion Corporation, the sole

[[Page 2584]]

primary beryllium production company in the U.S., and USW, jointly 
submitted a draft proposed rule that included an exposure limit of 0.2 
[mu]g/m\3\ (Document ID 0754, p. 4). In its written comments, Materion 
explained that it is feasible to control exposure to levels below 0.2 
[mu]g/m\3\ through the use of engineering controls and work practices 
in most, but not all, operations:

    Based on many years' experience in controlling beryllium 
exposures, its vigorous product stewardship program in affected 
operations, and the judgment of its professional industrial hygiene 
staff, Materion Brush believes that the 0.2 [mu]g/m\3\ PEL for 
beryllium, based on median exposures, can be achieved in most 
operations, most of the time. Materion Brush does recognize that it 
is not feasible to reduce exposures to below the PEL in some 
operations, and in particular, certain beryllium production 
operations, solely through the use of engineering and work practice 
controls (Document ID 1052).

    On the other hand, the Nonferrous Founders' Society (NFFS) asserted 
that OSHA had not demonstrated that the final PEL of 0.2 [micro]g/m\3\ 
was feasible for the nonferrous foundry industry (Document ID 1678, pp. 
2-3). NFFS asserted that ``OSHA has failed to meet its burden of proof 
that a ten-fold reduction to the current two micrograms per cubic meter 
limit is technologically or economically feasible in the non-ferrous 
foundry industry'' (Document ID 1678, pp. 2-3; 1756, Tr. 18). In 
written testimony submitted as a hearing exhibit, NFFS claimed that 
OSHA's supporting documentation in the PEA had no ``concrete assurance 
on technologic feasibility either by demonstration or technical 
documentation'' (Document ID 1732, Appendix A, p. 4).
    However, contrary to the NFFS comments, which are addressed at 
greater length in Section IV-5 of the FEA, OSHA's exposure profile is 
based on the best available evidence for nonferrous foundries; the 
exposure data are taken from NIOSH surveys, an ERG site visit, and the 
California Cast Metals Association (Document ID 1217; 1185; 0341, 
Attachment 6; 0899). Materion also submitted substantial amounts of 
monitoring data, process descriptions and information of engineering 
controls that have been implemented in its facilities to control 
beryllium exposure effectively, including operations that involve the 
production of beryllium alloys using the same types of furnace and 
casting operations as those conducted at nonferrous foundries producing 
beryllium alloys (Document ID 0719; 0720; 0723). Furthermore, Materion 
submitted the above-referenced letter to the docket stating that, based 
on its many years of experience controlling beryllium exposures, a PEL 
of 0.2 [mu]g/m\3\ can be achieved in most operations, most of the time 
(Document ID 1052). Materion's letter is consistent with the monitoring 
data Materion submitted, and OSHA considers its statement regarding 
feasibility at the final PEL relevant to nonferrous foundries because 
Materion has similar operations in its facilities, such as beryllium 
alloy production. As stated in Section IV-5 of the FEA, the size and 
configuration of nonferrous foundries may vary, but they all use 
similar processes; they melt and pour molten metal into the prepared 
molds to produce a casting, and remove excess metal and blemishes from 
the castings (NIOSH 85-116, 1985). While the design may vary, the basic 
operations and worker job tasks are similar regardless of whether the 
casting metal contains beryllium.
    In the NPRM, OSHA requested that affected industries submit to the 
record any available exposure monitoring data and comments regarding 
the effectiveness of currently implemented control measures to inform 
the Agency's final feasibility determinations. During the informal 
public hearings, OSHA asked the NFFS panel to provide information on 
current engineering controls or the personal protective equipment used 
in foundries claiming to have difficulty complying with the preceding 
PEL, but no additional information was provided (Document ID 1756; Tr. 
24-25; 1785, p. 1). Thus, the NFFS did not provide any sampling data or 
other evidence regarding current exposure levels or existing control 
measures to support its assertion that a PEL of 0.2 [mu]g/m\3\ is not 
feasible, and did not show that the data in the record are insufficient 
to demonstrate technological feasibility for nonferrous foundry 
industry.
    In sum, while OSHA agrees that two of the operations in the 
nonferrous foundry industry, furnace and shakeout operations, employing 
a relatively small percentage of workers in the industry, may not be 
able to achieve the final PEL of 0.2 [mu]g/m\3\ most of the time, 
evidence in the record indicates that the final PEL is achievable in 
the other six job categories in this industry. Therefore, in the FEA, 
OSHA finds the PEL of 0.2 [mu]g/m\3\ is technologically feasible for 
the nonferrous foundry industry.
    OSHA also recognizes that engineering and work practice controls 
may not be able to consistently reduce and maintain exposures to the 
final PEL of 0.2 [mu]g/m\3\ in some job categories in other application 
groups, due to the processing of materials containing high 
concentrations of beryllium, which can result in the generation of 
substantial amounts of fumes and particulate. For example, the final 
PEL of 0.2 [mu]g/m\3\ cannot be achieved most of the time for furnace 
operations in primary beryllium production and for some furnace 
operation activities in secondary smelting, refining, and alloying 
facilities engaged in beryllium recovery and alloying. Workers may need 
supplementary respiratory protection during these high exposure 
activities where exposures exceed the final PEL of 0.2 [mu]g/m\3\ or 
STEL of 2.0 [mu]g/m\3\ with engineering and work practice controls. In 
addition, OSHA has determined that workers who perform open-air 
abrasive blasting using mineral grit (i.e., coal slag) will routinely 
be exposed to levels above the final PEL (even after the installation 
of feasible engineering and work practice controls), and therefore, 
these workers will also be required to wear respiratory protection.
    Overall, however, based on the information discussed above and the 
other evidence in the record and described in Chapter IV of the FEA, 
OSHA has determined that for the majority of the job groups evaluated 
exposures are either already at or below the final PEL, or can be 
adequately controlled to levels below the final PEL through the 
implementation of additional engineering and work practice controls for 
most operations most of the time. Therefore, OSHA concludes that the 
final PEL of 0.2 [mu]g/m\3\ is technologically feasible.
    In contrast, the record evidence does not show that it is feasible 
for most operations in all affected industries and application groups 
to achieve the alternative PEL of 0.1 [mu]g/m\3\ most of the time. As 
discussed below, although a number of operations can achieve this 
level, they may be interspersed with operations that cannot, and OSHA 
sees value in having a uniform PEL that can be enforced consistently 
for all operations, rather than enforcing different PELs for the same 
contaminant in different operations.
    Several commenters supported a PEL of 0.1 [mu]g/m\3\. Specifically, 
Public Citizen; the American Federation of Labor and Congress of 
Industrial Organizations (AFL-CIO); the International Union, United 
Automobile, Aerospace, and Agriculture Implement Workers of America 
(UAW); North America's Building Trades Unions (NABTU); and the American 
College of Occupational and Environmental Medicine contended that OSHA 
should adopt this lower level because of the residual risk at 0.2 
[mu]g/m\3\

[[Page 2585]]

(Document ID 1689, p. 7; 1693, p. 3; 1670, p. 1; 1679, pp. 6-7; 1685, 
p. 1; 1756, Tr. 167). Two of these commenters, Public Citizen and the 
AFL-CIO, also contended that a TWA PEL of 0.1 [mu]g/m3 is feasible 
(Document ID 1756, Tr. 168-169, 197-198). Neither of those commenters, 
however, submitted any additional evidence to the record that OSHA 
could rely on to conclude that a PEL of 0.1 [mu]g/m\3\ is achievable.
    On the other hand, the Beryllium Health and Safety Committee and 
NJH specifically rejected a PEL of 0.1 [mu]g/m\3\ in their comments. 
They explained that they believed the proposed PEL of 0.2 [mu]g/m\3\ 
and the ancillary provisions would reduce the prevalence of beryllium 
sensitization and chronic beryllium disease (CBD) and be the best 
overall combination for protecting workers when taking into 
consideration the analytical chemistry capabilities and economic 
considerations (Document ID 1655, p. 16; 1664, p. 2).
    Based on the record evidence, OSHA cannot conclude that the 
alternative PEL of 0.1 [mu]g/m\3\ is achievable most of the time for at 
least one job category in 8 of the 12 application groups or industries 
included in this analysis: Primary beryllium production; beryllium 
oxide ceramics and composites; nonferrous foundries; secondary 
smelting, refining, and alloying, including handling of scrap and 
recycled materials; precision turned products; dental laboratories; 
abrasive blasting; and coal-fired electric power generation. In 
general, OSHA's review of the available sampling data indicates that 
the alternative PEL of 0.1 [mu]g/m\3\ cannot be consistently achieved 
with engineering and work practice controls in application groups that 
use materials containing high percentages of beryllium or that involve 
processes that result in the generation of substantial amounts of fumes 
and particulate. Variability in processes and materials for operations 
involving the heating or machining of beryllium alloys or beryllium 
oxide ceramics also makes it difficult to conclude that exposures can 
be routinely reduced to below 0.1 [mu]g/m\3\. For example, in the 
precision turned products industry, OSHA has concluded that exposures 
for machinists machining pure beryllium or high beryllium alloys can be 
reduced to or below 0.2 [mu]g/m\3\, but not 0.1 [mu]g/m\3\. 
Additionally, OSHA has determined that job categories that involve 
high-energy operations will not be able to consistently achieve 0.1 
[mu]g/m\3\ (e.g., abrasive blasting with coal slag in open-air). These 
operations can cause workers to have elevated exposures even when 
available engineering and work practice controls are used.
    In other cases, paucity of data or other data issues prevent OSHA 
from determining whether engineering and work practice controls can 
reduce exposures to or below 0.1 [mu]g/m\3\ most of the time (see 
Chapter IV of the FEA). A large portion of the sample results obtained 
by OSHA for the dental laboratories industry and for two of the job 
categories in the coal-fired electric power generation industry 
(operations workers and routine maintenance workers) were below the 
reported limit of detection (LOD). Because the LODs for many of these 
samples were higher than 0.1 [mu]g/m\3\, OSHA could not assess whether 
exposures were below 0.1 [mu]g/m\3\. For example, studies of dental 
laboratories showed that use of well-controlled ventilation can 
consistently reduce exposures to below the LOD of 0.2 [mu]g/m\3\. 
However, without additional information, OSHA cannot conclude that 
exposures can be reduced to or below 0.1 [mu]g/m\3\ most of the time. 
Therefore, OSHA cannot determine if a PEL of 0.1 [mu]g/m\3\ would be 
feasible for the dental laboratory industry.
    The lack of available data has also prevented OSHA from determining 
whether exposures at or below of 0.1 [mu]g/m\3\ can be consistently 
achieved for machining operators in the beryllium oxide ceramics and 
composites industry. As discussed in Section IV-4 of the FEA, the 
exposure profile for dry (green) machining and lapping and plate 
polishing (two tasks within the machining operator job category) is 
based on 240 full-shift PBZ samples obtained over a 10-year period 
(1994 to 2003). The median exposure levels in the exposure profile for 
green machining and lapping and polishing are 0.16 [mu]g/m\3\ and 0.29 
[mu]g/m\3\, respectively. While the record indicates that improvements 
in exposure controls were implemented over time (Frigon, 2005, Document 
ID 0825; Frigon, 2004 (Document ID 0826)), data showing to what extent 
exposures have been reduced are not available. Nonetheless, because the 
median exposures for green machining are already below 0.2 [mu]g/m\3\, 
and the median exposures for lapping and polishing are only slightly 
above the PEL of 0.2 [mu]g/m\3\, OSHA concluded that the controls that 
have been implemented are sufficient to reduce exposures to at or below 
0.2 [mu]g/m\3\ most of the time. However, without additional 
information, OSHA cannot conclude that exposures could be reduced to or 
below 0.1 [mu]g/m\3\ most of the time for these tasks.
    Most importantly for this analysis, the available evidence 
demonstrates that the alternative PEL of 0.1 [mu]g/m\3\ is not 
achievable in five out of the eight job categories in the nonferrous 
foundries industry: Furnace operator, shakeout operator, pouring 
operator, material handler, and molder. As noted above, the first two 
of these job categories, furnace operator and shakeout operator, which 
together employ only a small fraction of the workers in this industry, 
cannot achieve the final PEL of 0.2 [mu]g/m\3\ either, but evidence in 
the record demonstrates that nonferrous foundries can reduce the 
exposures of most of the rest of the workers in the other six job 
categories to or below the final PEL of 0.2 [mu]g/m\3\, most of the 
time. However, OSHA's feasibility determination for the pouring 
operator, material handler, and molder job categories, which together 
employ more than half the workers at these foundries, does not allow 
the Agency to conclude that exposures for those jobs can be 
consistently lowered to the alternative PEL of 0.1 [mu]g/m\3\. See 
Section IV-5 of the FEA. Thus, OSHA cannot conclude that most 
operations in the nonferrous foundries industry can achieve a PEL of 
0.1 [mu]g/m\3\, most of the time. Accordingly, OSHA finds that the 
alternative PEL of 0.1 [mu]g/m\3\ is not feasible for the nonferrous 
foundries industry.
    OSHA has also determined either that information in the rulemaking 
record demonstrates that 0.1 [mu]g/m\3\ is not consistently achievable 
in a number of operations in other affected industries or that the 
information is insufficient to establish that engineering and work 
practice controls can consistently reduce exposures to or below 0.1 
[mu]g/m\3\. Therefore, OSHA finds that the proposed alternative PEL of 
0.1 [mu]g/m\3\ is not appropriate, and the rule's final PEL of 0.2 
[mu]g/m\3\ is the lowest exposure limit that can be found to be 
technologically feasible through engineering and work practice controls 
in all of the affected industries and application groups included in 
this analysis.
    Because of this inability to achieve 0.1 [mu]g/m\3\ in many 
operations, if OSHA were to adopt a PEL of 0.1 [mu]g/m\3\, a 
substantial number of employees would be required to wear respirators. 
As discussed in the Summary and Explanation for paragraph (f), Methods 
of Compliance, use of respirators in the workplace presents a number of 
independent safety and health concerns. Workers wearing respirators may 
experience diminished vision, and respirators can impair the ability of 
employees to communicate with one another. Respirators can impose 
physiological burdens on employees due to the weight of the respirator 
and increased breathing resistance

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experienced during operation. The level of physical work effort 
required, the use of protective clothing, and environmental factors 
such as temperature extremes and high humidity can interact with 
respirator use to increase the physiological strain on employees. 
Inability to cope with this strain as a result of medical conditions 
such as cardiovascular and respiratory diseases, reduced pulmonary 
function, neurological or musculoskeletal disorders, impaired sensory 
function, or psychological conditions can place employees at increased 
risk of illness, injury, and even death. The widespread, routine use of 
respirators for extended periods of time that may be required by a PEL 
of 0.1 [mu]g/m\3\ creates more significant concerns than the less 
frequent respirator usage that is required by a PEL of 0.2 [mu]g/m\3\.
    Furthermore, OSHA concludes that it would complicate both 
compliance and enforcement of the rule if it were to set a PEL of 0.1 
[mu]g/m\3\ for some industries or operations and a PEL of 0.2 [mu]g/
m\3\ for the remaining industries and operations where technological 
feasibility at the lower PEL is either unattainable or unknown. OSHA 
may exercise discretion to issue a uniform PEL if it determines that 
the PEL is technologically feasible for all affected industries (if not 
for all affected operations) and that a uniform PEL would constitute 
better public policy. See Pertinent Legal Authority (discussing the 
Chromium decision). In declining to lower the PEL to 0.1 [mu]g/m\3\ for 
any segment of the affected industries, OSHA has made that 
determination here. Therefore, OSHA has determined that the proposed 
alternative PEL of 0.1 [mu]g/m\3\ is not appropriate.
    OSHA also evaluated the technological feasibility of the final STEL 
of 2.0 [mu]g/m\3\ and the alternative STEL of 1.0 [mu]g/m\3\. An 
analysis of the available short-term exposure measurements presented in 
Chapter IV, Section 15 of the FEA indicates that elevated exposures can 
occur during short-term tasks such as those associated with the 
operation and maintenance of furnaces at primary beryllium production 
facilities, at nonferrous foundries, and at secondary smelting 
operations. Peak exposures can also occur during the transfer and 
handling of beryllium oxide powders. OSHA finds that in many cases, the 
control of peak short-term exposures associated with these intermittent 
tasks will be necessary to reduce workers' TWA exposures to or below 
the final PEL. The short-term exposure data presented in the FEA show 
that the majority (79%) of these exposures are already below 2.0 [mu]g/
m\3\.
    A number of stakeholders submitted comments related to the proposed 
and alternative STELs. Some of these stakeholders supported a STEL of 
2.0 [mu]g/m\3\. Materion stated that a STEL of 2.0 [mu]g/m\3\ for 
controlling the upper range of worker short term exposures is 
sufficient to prevent CBD (Document ID 1661, p. 3). Other commenters 
recommended a STEL of 1.0 [mu]g/m\3\ (Document ID 1661, p. 19; 1681, p. 
7). However, no additional engineering controls capable of reducing 
short term exposures to at or below 1.0 [mu]g/m\3\ were identified by 
these commenters. OSHA provides a full discussion of the public 
comments in the Summary and Explanation section of this preamble. OSHA 
has determined that the implementation of engineering and work practice 
controls required to maintain full shift exposures at or below a PEL of 
0.2 [mu]g/m\3\ will reduce short term exposures to 2.0 [mu]g/m\3\ or 
below, and that a STEL of 1.0 [mu]g/m\3\ would require additional 
respirator use. Furthermore, OSHA notes that the combination of a PEL 
of 0.2 [mu]g/m\3\ and a STEL of 2.0 [mu]g/m\3\ would, in most cases, 
keep workers from being exposed to 15 minute intervals of 1.0 [mu]g/
m\3\. See Table IV.78 of Chapter IV of the FEA.
    Therefore, OSHA concludes that the STEL of 2.0 [mu]g/m\3\ can be 
achieved for most operations most of the time, given that most short-
term exposures are already below 2.0 [mu]g/m\3\. OSHA recognizes that 
for a small number of tasks, short-term exposures may exceed the final 
STEL, even after feasible control measures to reduce TWA exposure to or 
below the final PEL have been implemented, and therefore, some limited 
use of respiratory protection will continue to be required for short-
term tasks in which peak exposures cannot be reduced to less than 2.0 
[mu]g/m\3\ through use of engineering controls.
    After careful consideration of the record, including all available 
data and stakeholder comments in the record, OSHA has determined that a 
STEL of 2.0 [mu]g/m\3\ is technologically feasible. Thus, as explained 
in the Summary and Explanation for paragraph (c), OSHA has retained the 
proposed value of 2.0 [mu]g/m\3\ as the final STEL.

E. Costs of Compliance

    In Chapter V, Costs of Compliance, OSHA assesses the costs to 
general industry, maritime, and construction establishments in all 
affected application groups of reducing worker exposures to beryllium 
to an eight-hour time-weighted average (TWA) permissible exposure limit 
(PEL) of 0.2 [mu]g/m\3\ and to the final short-term exposure limit 
(STEL) of 2.0 [mu]g/m\3\, as well as of complying with the final 
standard's ancillary provisions. These ancillary provisions encompass 
the following requirements: Exposure monitoring, regulated areas (and 
competent person in construction), a written exposure control plan, 
protective work clothing, hygiene areas and practices, housekeeping, 
medical surveillance, medical removal, familiarization, and worker 
training. This final cost assessment is based in part on OSHA's 
technological feasibility analysis presented in Chapter IV of the FEA; 
analyses of the costs of the final standard conducted by OSHA's 
contractor, Eastern Research Group (ERG); and the comments submitted to 
the docket in response to the request for information (RFI) as part of 
the Small Business Regulatory Enforcement Fairness Act (SBREFA) 
process, comments submitted to the docket in response to the PEA, 
comments during the hearings conducted in March 2016, and comments 
submitted to the docket after the hearings concluded.
    Table VIII-4 presents summary of the annualized costs. All costs in 
this chapter are expressed in 2015 dollars and were annualized using a 
discount rate of 3 percent. (Costs at other discount rates are 
presented in the chapter itself). Annualization periods for 
expenditures on equipment are based on equipment life, and one-time 
costs are annualized over a 10-year period. Chapter V provides detailed 
explanation of the basis for these cost estimates.

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F. Economic Feasibility and Regulatory Flexibility Determination

    In Chapter VI, OSHA investigates the economic impacts of its final 
beryllium rule on affected employers. This impact investigation has two 
overriding objectives: (1) To establish whether the final rule is 
economically feasible for all affected application groups/
industries,\31\ and (2) to determine if the Agency can certify that the 
final rule will not have a significant economic impact on a substantial 
number of small entities.
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    \31\ As noted in the FEA, OSHA uses the umbrella term 
``application group'' to refer either to an industrial sector or to 
a cross-industry group with a common process. In the industrial 
profile chapter, because some of the discussion being presented has 
historically been framed in the context of the economic feasibility 
for an ``industry,'' the Agency uses the term ``application group'' 
and ``industry'' interchangeably.
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    Table VIII-5 presents OSHA's screening analysis, which shows costs 
as percentage of revenues and as a percentage of profits. The chapter 
explains why these screening analysis

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results can reasonably be viewed as economically feasible. Section 
VIII.j shows similar results for small and very small entities.
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    In Chapter VII, OSHA estimates the benefits and net benefits of the 
final beryllium rule. The methodology for these estimates largely 
remains the same as in the PEA. OSHA did not receive many comments 
challenging any aspect

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of the benefits analysis presented in the PEA. There are, however, a 
few significant alterations, such as: Using an empirical turnover rate 
as part of the estimation of exposure response functions, full analysis 
of the population model with varying turnover (a model only briefly 
presented in the PEA), and presentation of a statistical proportional 
hazard model in response to comment. The other large change to the 
benefits analysis is the result of the increase in the scope of the 
rule to protect workers in the construction and ship-building 
industries. In the proposed rule, coverage of these latter industries 
was only presented as an alternative and therefore were not included in 
the benefits in the PEA, but they are covered by the final rule.
    This chapter proceeds in five steps. The first step estimates the 
numbers of diseases and deaths prevented by comparing the current 
(baseline) situation to a world in which the final PEL is adopted in a 
final standard, and in which employees are exposed throughout their 
working lives to either the baseline or the final PEL. The second step 
also assumes that the final PEL is adopted, but uses the results from 
the first step to estimate what would happen under a realistic scenario 
in which new employees will not be exposed above the final PEL, while 
employees already at work will experience a combination of exposures 
below the final PEL and baseline exposures that exceed the final PEL 
over their working lifetime. The comparison of these steps is given in 
Table VIII-6. OSHA also presents in Chapter VII similar kinds of 
results for a variety of other risk assessment and population models.
[GRAPHIC] [TIFF OMITTED] TR09JA17.041

    The third step covers the monetization of benefits. Table VIII-7 
presents the monetization of benefits at various interest rates and 
monetization values.

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    In the fourth step, OSHA estimates the net benefits of the final 
rule by comparing the monetized benefits to the costs presented in 
Chapter V of the FEA. These values are presented in Table VIII-8. The 
table shows that benefits exceed costs for all situations except for 
the low estimate of benefits using a 7 percent discount rate. The low 
estimate of benefits reflects the assumption that the ancillary 
provisions have no independent effect in reducing cases of CBD. OSHA 
considers this assumption to be very unlikely, based on the available 
evidence.

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    In the fifth step, OSHA provides a sensitivity analysis to explore 
the robustness of the estimates of net benefits with respect to many of 
the assumptions made in developing and applying the underlying models. 
This is done because the models underlying each step inevitably need to 
make a variety of assumptions based on limited data. OSHA invited 
comments on each aspect of the data and methods used in this chapter, 
and received none specifically on the sensitivity analysis. Because 
dental laboratories constituted a significant source of both costs and 
benefits to the proposal, the PEA indicated that OSHA was particularly 
interested in comments regarding the appropriateness of the model, 
assumptions, and data for estimating the benefits to workers in that 
industry. Although the Agency did not receive any comments on this 
question directly, the American Dental Association's comments relevant 
to the underlying use of beryllium alloys in dental labs are addressed 
in Chapter III of the FEA. The Agency has not altered its main 
estimates of the exposure profile for dental laboratory workers, but 
provides sensitivity analyses in the FEA to examine the outcome if a 
lower percentage of dental laboratories were to substitute materials 
that do not contain beryllium for beryllium-containing materials. OSHA 
also estimates net benefits with a variety of scenarios in which dental 
laboratories are not included. All of these results are presented in 
Chapter VII of the FEA.

H. Regulatory Alternatives

    Chapter VIII presents the costs, benefits and net benefits of a 
variety of regulatory alternatives.

I. Final Regulatory Flexibility Analysis

    The Regulatory Flexibility Act, (RFA), Public Law 96-354, 94 Stat. 
1164 (codified at 5 U.S.C. 601), requires Federal agencies to consider 
the economic impact that a final rulemaking will have on small 
entities. The RFA states that whenever an agency promulgates a final 
rule that is required to conform to the notice-and-comment rulemaking 
requirements of section 553 of the Administrative Procedure Act (APA), 
the agency shall prepare a final regulatory flexibility analysis 
(FRFA). 5 U.S.C. 604(a).
    However, 5 U.S.C. 605(b) of the RFA states that Section 604 shall 
not apply to any final rule if the head of the agency certifies that 
the rule will not, if promulgated, have a significant economic impact 
on a substantial number of small entities. As discussed in Chapter VI 
of the FEA, OSHA was unable to so certify for the final beryllium rule.
    For OSHA rulemakings, as required by 5 U.S.C. 604(a), the FRFA must 
contain:
    1. A statement of the need for, and objectives of, the rule;
    2. a statement of the significant issues raised by the public 
comments in response to the initial regulatory flexibility analysis, a 
statement of the assessment of the agency of such issues, and a 
statement of any changes made in the proposed rule as a result of such 
comments;
    3. the response of the agency to any comments filed by the Chief 
Counsel for Advocacy of the Small Business Administration (SBA) in 
response to the proposed rule, and a detailed statement of any change 
made to the proposed rule in the final rule as a result of the 
comments;
    4. a description of and an estimate of the number of small entities 
to which the rule will apply or an explanation of why no such estimate 
is available;
    5. a description of the projected reporting, recordkeeping and 
other

[[Page 2600]]

compliance requirements of the rule, including an estimate of the 
classes of small entities which will be subject to the requirement and 
the type of professional skills necessary for preparation of the report 
or record;
    6. a description of the steps the agency has taken to minimize the 
significant economic impact on small entities consistent with the 
stated objectives of applicable statutes, including a statement of the 
factual, policy, and legal reasons for selecting the alternative 
adopted in the final rule and why each one of the other significant 
alternatives to the rule considered by the agency which affect the 
impact on small entities was rejected; and for a covered agency, as 
defined in section 609(d)(2), a description of the steps the agency has 
taken to minimize any additional cost of credit for small entities.
    The Regulatory Flexibility Act further states that the required 
elements of the FRFA 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 FRFA. 5 U.S.C. 605(a).
    In addition to these elements, OSHA also includes in this section 
the recommendations from the Small Business Advocacy Review (SBAR) 
Panel and OSHA's responses to those recommendations.
    While a full understanding of OSHA's analysis and conclusions with 
respect to costs and economic impacts on small entities requires a 
reading of the complete FEA and its supporting materials, this FRFA 
will summarize the key aspects of OSHA's analysis as they affect small 
entities.
 The Need for, and Objective of, the Rule
    The objective of the final beryllium standard is to reduce the 
number of fatalities and illnesses occurring among employees exposed to 
beryllium. This objective will be achieved by requiring employers to 
install engineering controls where appropriate and to provide employees 
with the equipment, respirators, training, medical surveillance, and 
other protective measures necessary 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. 
655(b)(5). See Section II of the preamble for a more detailed 
discussion.
    Chronic beryllium disease (CBD) is a hypersensitivity, or allergic 
reaction, to beryllium that leads to a chronic inflammatory disease of 
the lungs. It takes months to years after final beryllium exposure 
before signs and symptoms of CBD occur. Removing an employee with CBD 
from the beryllium source does not always lead to recovery. In some 
cases CBD continues to progress following removal from beryllium 
exposure. CBD is not a chemical pneumonitis but an immune-mediated 
granulomatous lung disease. OSHA's final risk assessment, presented in 
Section VI of the preamble, indicates that there is significant risk of 
beryllium sensitization and chronic beryllium disease from a 45-year 
(working life) exposure to beryllium at the current TWA PEL of 2 [mu]g/
m\3\. The risk assessment further indicates that there is significant 
risk of lung cancer to workers exposed to beryllium at the current TWA 
PEL of 2 [mu]g/m\3\. The final standard, with a lower PEL of 0.2 [mu]g/
m\3\, will help to address these health concerns. See the Health 
Effects and Risk Assessment sections of the preamble for further 
discussion.
 Summary of Significant Issues Raised by Comments on the 
Initial Regulatory Flexibility Analysis (IRFA) and OSHA's Assessment 
of, and Response to, Those Issues
    This section of the FRFA focuses only on public comments concerning 
significant issues raised on the Initial Regulatory Flexibility 
Analysis (IRFA). OSHA received only one such comment.
    The Non-Ferrous Founders' Society claimed that the costs of the 
rule will disproportionately affect small employers and result in job 
losses to foreign competition (Document ID 1678, p. 3). This comment is 
addressed in the FEA in the section on International Trade Effects in 
Chapter VI: Economic Feasibility Analysis and Regulatory Flexibility 
Determination. The summary of OSHA's response is that, in general, 
metalcasters in the U.S. have shortened lead times, improved 
productivity through computer design and logistics management, expanded 
design and development services to customers, and provided a higher 
quality product than foundries in China and other nations where labor 
costs are low (Document ID 1780, p. 3-12). All of these measures, 
particularly the higher quality of many U.S. metalcasting products and 
the ability of domestic foundries to fulfill orders quickly, are 
substantial advantages for U.S. metalcasters that may outweigh the very 
modest price increases that might occur due to the final rule. For a 
more detailed response please see the section on International Trade 
Effects in Chapter VI of the FEA.
Response to Comments by the Chief Counsel for Advocacy of the Small 
Business Administration and OSHA'S Response to Those Comments
    The Chief Counsel for Advocacy of the Small Business Administration 
(``Advocacy'') did not provide OSHA with comments on this rule.
 A Description of, and an Estimate of, the Number of Small 
Entities To Which the Rule Will Apply
    OSHA has analyzed the impacts associated with this final rule, 
including the type and number of small entities to which the standard 
will apply. In order to determine the number of small entities 
potentially affected by this rulemaking, OSHA used the definitions of 
small entities developed by the Small Business Administration (SBA) for 
each industry.
    OSHA estimates that approximately 6.600 small business entities 
would be affected by the beryllium standard. Within these small 
entities, 33,800 workers are exposed to beryllium and would be 
protected by this final standard. A breakdown, by industry, of the 
number of affected small entities is provided in Table III-14 in 
Chapter III of the FEA.
    OSHA estimates that approximately 5,280 very small entities--those 
with fewer than 20 employees--would be affected by the beryllium 
standard. Within these very small entities, 11,800 workers are exposed 
to beryllium and would be protected by the standard. A breakdown, by 
industry, of the number of affected very small entities is provided in 
Table III-15 in Chapter III of the FEA.
A Description of the Projected Reporting, Recordkeeping, and Other 
Compliance Requirements of the Rule
    Tables VIII-9 and VIII-10 show the average costs of the beryllium 
standard and the costs of compliance as a percentage of profits and 
revenues by NAICS code for, respectively, small entities (classified as 
small by SBA) and very small entities (those with fewer than 20 
employees). The full derivation of these costs is presented in Chapter 
V. The cost for SBA-defined small entities ranges from a low of $832 
per entity for

[[Page 2601]]

entities in NAICS 339116a: Dental Laboratories, to a high of about 
$599,836 for NAICS 331313: Alumina Refining and Primary Aluminum 
Production.
    The annualized cost for very small entities ranges from a low of 
$542 for entities in NAICS 339116a: Dental Laboratories, to a high of 
about $34,222 for entities in NAICS 331529b: Other Nonferrous Metal 
Foundries (except Die-Casting).\32\
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    \32\ The cost of $542 for NAICS 339116a is the sum of a $524 
cost to substitute for a non-hazard material and $19 for cost of 
ancillary provisions. The total cost of $34,222 for NAICS 331529b is 
the sum of $22,601 for engineering controls, $186 for respirator 
costs, and $11,435 for ancillary provisions.

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Description of the Steps OSHA Has Taken To Minimize the Significant 
Economic Impact on Small Entities Consistent With the Stated Objectives 
of Applicable Statutes and Statement of the Reasons For Selecting the 
Alternative Adopted in the Final Rule
    OSHA has made a number of changes in the final beryllium rule that 
will serve to minimize significant impacts on small entities consistent 
with the objectives of the OSH Act. These changes are explained in more 
detail in Section XVI: Summary and Explanation in this preamble.
    During the SBAR Panel, SERs requested a clearer definition of the 
triggers for medical surveillance. This concern was rooted in the cost 
of BeLPTs and the trigger of potential skin contact. For the final 
rule, the Agency has removed skin contact as a trigger for medical 
surveillance. OSHA has also reduced the frequency of medical 
surveillance from annually (in the proposed rule) to biennially in the 
final rule.
    In the final rule, OSHA has added a performance option, as an 
alternative to scheduled monitoring, to allow employers to comply with 
exposure assessment requirements. This performance option should allow 
employers more flexibility, and often lower cost, in complying with the 
exposure assessment requirements.
    Some SERs were already applying many of the protective controls and 
practices that would be required by the ancillary provisions of the 
standard. However, many SERs objected to the requirements regarding 
hygiene facilities. For this final rule, OSHA has concluded that all 
affected employers currently have hand washing facilities. OSHA has 
also concluded that no affected employers will be required to install 
showers. OSHA noted in the PEA that some facilities already have 
showers. There were no comments challenging the Agency's preliminary 
determinations regarding the existing availability of shower facilities 
or the means of preventing contamination, so the Agency concludes that 
all employers have showers where needed. Therefore, employers will not 
need to provide any new shower facilities to comply with the 
standard.\33\
---------------------------------------------------------------------------

    \33\ OSHA reached the same conclusion in the PEA (p. V-118). For 
information purposes, OSHA estimated the initial cost of installing 
portable showers at $39,687, with an annualized cost of $4,653 per 
facility (Id.) and did not receive any comments suggesting that 
shower costs should be included or regarding the cost of installing 
them. The annual cost per employee for shower supplies, towels, and 
time required for showering was estimated to be $1,519. However, as 
indicated above in the text, the Agency believed that employers 
would be able to comply with the standard by less costly means than 
the installation of shower facilities.
---------------------------------------------------------------------------

    Similarly, in the PEA the Agency included no additional costs for 
readily accessible washing facilities, under the expectation that 
employers already have such facilities in place (PEA p. IX-19). 
Although the abrasive blasters exposed to beryllium in maritime and 
construction work may not have been expressly addressed in the PEA, 
OSHA notes that their employers are typically already required to 
provide readily accessible washing facilities to comply with other OSHA 
standards such as its sanitation standard at 29 CFR 1926.51(f)(1).\34\ 
In the absence of additional comment, OSHA is not including any costs 
for washing facilities in the FEA.
---------------------------------------------------------------------------

    \34\ OSHA's shipyard standard at 29 CFR 1915.58(e) requires 
handwashing facilities ``at or adjacent to each toilet facility'' 
and ``equipped with . . . running water and soap, or with waterless 
skin-cleansing agents that are capable of . . . neutralizing the 
contaminants to which the employee may be exposed.'' OSHA's 
construction standard at 29 CFR 1926.51(f)(1) requires ``adequate 
washing facilities for employees engaged in . . . operations where 
contaminants may be harmful to the employees. Such facilities shall 
be in near proximity to the worksite and shall be so equipped as to 
enable employees to remove such substances.''
---------------------------------------------------------------------------

    OSHA's shipyard standard at 29 CFR 1915.58(e) requires handwashing 
facilities ``at or adjacent to each toilet facility'' and ``equipped 
with . . . running water and soap, or with waterless skin-cleansing 
agents that are capable of . . . neutralizing the contaminants to which 
the employee may be exposed.'' OSHA's construction standard at 29 CFR 
1926.51(f)(1) requires ``adequate washing facilities for employees 
engaged in . . . operations where contaminants may be harmful to the 
employees. Such facilities shall be in near proximity to the worksite 
and shall be so equipped as to enable employees to remove such 
substances.''

[[Page 2610]]

    The Agency has determined that the long-term rental of modular 
units was representative of costs for a range of reasonable approaches 
to comply with the change room part of the provision. Alternatively, 
employers could renovate and rearrange their work areas in order to 
meet the requirements of this provision.
    Finally, in the final rule, OSHA has extended the compliance 
deadlines for change rooms from one year to two years and for 
engineering controls from two years to three years.
 Regulatory Alternatives
    For the convenience of those persons interested only in OSHA's 
regulatory flexibility analysis, this section repeats the discussion 
presented in Chapter VIII of the FEA, but only for the regulatory 
alternatives to the final OSHA beryllium standard that would have 
lowered costs.
    Each regulatory alternative presented here is described and 
analyzed relative to the final rule. Where appropriate, the Agency 
notes whether the regulatory alternative, to have been a legitimate 
candidate for OSHA consideration, required evidence contrary to the 
Agency's final findings of significant risk and feasibility. For this 
chapter on the Final Regulatory Flexibility Analysis, the Agency is 
only presenting regulatory alternatives that would have reduced costs 
for small entities. (See Chapter VIII for the full list of all 
alternatives analyzed.) There are 14 alternatives that would have 
reduced costs for small entities (and for all businesses in total). 
Using the numbering scheme from Chapter VIII of the FEA, these are 
Regulatory Alternatives #1a, #2a, #2b, #5, #6, #7, #8, #9, #10, #11, 
#12, #13, #15, #16, #18, and #22. OSHA has organized these 16 cost-
reducing alternatives (and a general discussion of considered phase-ins 
of the rule) into four categories: (1) Scope; (2) exposure limits; (3) 
methods of compliance; and (4) ancillary provisions.
(1) Scope Alternatives
    The scope of the beryllium final rule applies to general industry 
work, construction and maritime activities. In addition, the final rule 
provides an exemption for those working with materials containing only 
trace amounts of beryllium (less than 0.1% by weight) when the employer 
has objective data that employee exposure to beryllium will remain 
below the action level as an 8-hour TWA under any foreseeable 
conditions.
    The first set of regulatory alternatives would alter the scope of 
the final standard by differing in coverage of groups of employees and 
employers. Regulatory Alternatives #1a, #2a, and #2b would decrease the 
scope of the final standard.
    Regulatory Alternative #1a would exclude all operations where 
beryllium exists only as a trace contaminant; that is, where the 
materials used contain less than 0.1% beryllium by weight, with no 
other conditions. OSHA has identified two industries with workers 
engaged in general industry work that would be excluded under 
Regulatory Alternative #1a: Primary aluminum production and coal-fired 
power generation.
    Table VIII-11 presents, for informational purposes, the estimated 
costs, benefits, and net benefits of Regulatory Alternative #1a using 
alternative discount rates of 3 percent and 7 percent. In addition, 
this table presents the incremental costs, incremental benefits, and 
incremental net benefits of this alternative relative to the final 
rule. Table VIII-11 also breaks out costs by provision, and benefits by 
type of disease and by morbidity/mortality prevented. (Note: 
``morbidity'' cases are cases where health effects are limited to non-
fatal illness; in these cases there is no further disease progression 
to fatality).
    As shown in Table VIII-11, Regulatory Alternative #1a would 
decrease the annualized cost of the rule from $73.9 million to $64.6 
million using a 3 percent discount rate and from $76.6 million to $67.0 
million using a 7 percent discount rate. Annualized benefits in 
monetized terms would decrease from $560.9 million to $515.7 million, 
using a 3 percent discount rate, and from $249.1 million to $229.0 
million using a 7 percent discount rate. Net benefits would decrease 
from $487.0 million to $451.1 million using a 3 percent discount rate 
and from $172.4 million to $162.0 million using a 7 percent discount 
rate.

[[Page 2611]]

[GRAPHIC] [TIFF OMITTED] TR09JA17.052

    Regulatory Alternative #2a would exclude construction and maritime 
work from the scope of the final standard. For example, this 
alternative would exclude abrasive blasters, pot tenders, and cleanup 
staff working in

[[Page 2612]]

construction and shipyards who have the potential for airborne 
beryllium exposure during blasting operations and during cleanup of 
spent media.
    Table VIII-12 presents the estimated costs, benefits, and net 
benefits of Regulatory Alternative #2a using alternative discount rates 
of 3 percent and 7 percent. In addition, this table presents the 
incremental costs, incremental benefits, and incremental net benefits 
of these alternatives relative to the final rule. Table VIII-12 also 
breaks out costs by provision and benefits by type of disease and by 
morbidity/mortality.
    As shown in Table VIII-12, Regulatory Alternative #2a would 
decrease costs from $73.9 million to $62.0 million, using a 3 percent 
discount rate, and from $76.6 million to $64.4 million using a 7 
percent discount rate. Annualized benefits would decrease from $560.9 
million to $533.3 million, using a 3 percent discount rate, and from 
$249.1 million to $236.8 million using a 7 percent discount rate. Net 
benefits would change from $487.0 million to $471.3 million, using a 3 
percent discount rate, and is essentially unchanged at a discount rate 
of 7 percent, with the final rule having net benefits of $172.4 million 
while the alternative has $172.5 million. Thus, at a 7 percent discount 
rate, the costs exceed the benefits for this alternative by $0.1 
million per year. However, OSHA believes that for these industries, the 
cost estimate is severely overestimated because 45 percent of the costs 
are for exposure monitoring assuming that employers use the periodic 
monitoring option. Employers in this sector are far more likely to use 
the performance based monitoring options at considerably reduced costs. 
If this is the case, benefits would exceed costs even at a 7 percent 
discount rate.
    Regulatory Alternative #2b would eliminate the ancillary provisions 
in the final rule for the shipyard and construction sectors and for any 
operations where beryllium exists only as a trace contaminant. 
Accordingly, only the final TWA PEL and STEL would apply to employers 
in these sectors and operations (through 29 CFR 1910.1000 Tables Z-1 
and Z-2, 1915.1000 Table Z, and 1926.55 Appendix A). Operations in 
general industry where the ancillary provisions would be eliminated 
under Regulatory Alternative #2b include aluminum smelting and 
production and coal-powered utility facilities and any other operations 
where beryllium is present only as a trace contaminant (in addition to 
all operations in construction and shipyards).
    As shown in Table VIII-13, Regulatory Alternative #2b would 
decrease the annualized cost of the rule from $73.9 million to $53.5 
million using a 3 percent discount rate, and from $76.6 to $55.6 
million using a 7 percent discount rate. Annualized benefits would 
decrease from $560.9 million to $493.3 million, using a 3 percent 
discount rate, and from $249.1 million to $219.1 million, using a 7 
percent discount rate. Net benefits would decrease from $487.0 million 
to $439.8 million, using a 3 percent discount rate, and from $172.4 
million to $163.5 million, using a 7 percent discount rate.

[[Page 2613]]

[GRAPHIC] [TIFF OMITTED] TR09JA17.053


[[Page 2614]]


[GRAPHIC] [TIFF OMITTED] TR09JA17.054


[[Page 2615]]


(2) Exposure Limit (TWA PEL, STEL, and Action Level) Alternatives
    Paragraph (c) of the three final standards establishes two PELs for 
beryllium in all forms, compounds, and mixtures: An 8-hour TWA PEL of 
0.2 [mu]g/m\3\ (paragraph (c)(1)), and a 15-minute short-term exposure 
limit (STEL) of 2.0 [mu]g/m\3\ (paragraph (c)(2)). OSHA has defined the 
action level for the final standard as an airborne concentration of 
beryllium of 0.1 [mu]g/m\3\ calculated as an eight-hour TWA (paragraph 
(b)). In this final rule, as in other standards, the action level has 
been set at one half of the TWA PEL.
    Regulatory Alternative #5 would set a higher TWA PEL at 0.5 
[micro]g/m\3\ and an action level at 0.25 [micro]g/m\3\. This 
alternative responds to an issue raised during the Small Business 
Advocacy Review (SBAR) process conducted in 2007 to consider a draft 
OSHA beryllium proposed rule that culminated in an SBAR Panel report 
(SBAR, 2008). That report included a recommendation that OSHA consider 
both the economic impact of a low TWA PEL and regulatory alternatives 
that would ease cost burden for small entities. OSHA has provided a 
full analysis of the economic impact of its final PELs (see Chapter VI 
of the FEA), and Regulatory Alternative #5 was considered in response 
to the second half of that recommendation. However, the higher 0.5 
[micro]g/m\3\ TWA PEL is not consistent with the Agency's mandate under 
the OSH Act to promulgate a lower PEL if it is feasible and could 
prevent additional fatalities and non-fatal illnesses. The data 
presented in Table VIII-14 below indicate that the final TWA PEL would 
prevent additional fatalities and non-fatal illnesses relative to 
Regulatory Alternative #5.
    Table VIII-14 below presents, for informational purposes, the 
estimated costs, benefits, and net benefits of the final rule under the 
final TWA PEL of 0.2 [mu]g/m\3\ and for the regulatory alternative TWA 
PEL of 0.5 [mu]g/m\3\ (Regulatory Alternative #5), using alternative 
discount rates of 3 percent and 7 percent. In addition, the table 
presents the incremental costs, the incremental benefits, and the 
incremental net benefits of going from a TWA PEL of 0.5 [mu]g/m\3\ to 
the final TWA PEL of 0.2 [mu]g/m\3\. Table VIII-14 also breaks out 
costs by provision and benefits by type of disease and by morbidity/
mortality.
    As Table VIII-14 shows, going from a TWA PEL of 0.5 [mu]g/m\3\ to a 
TWA PEL of 0.2 [mu]g/m\3\ would prevent, annually, an additional 30 
beryllium-related fatalities and an additional 16 non-fatal illnesses. 
This is consistent with OSHA's final risk assessment, which indicates 
significant risk to workers exposed at a TWA PEL of 0.5 [mu]g/m\3\; 
furthermore, OSHA's final feasibility analysis indicates that a lower 
TWA PEL than 0.5 [mu]g/m\3\ is feasible. Net benefits of this 
regulatory alternative versus the final TWA PEL of 0.2 [mu]g/m\3\ would 
decrease from $487.0 million to $376.5 million using a 3 percent 
discount rate and from $172.4 million to $167.2 million using 7 percent 
discount rate.

[[Page 2616]]

[GRAPHIC] [TIFF OMITTED] TR09JA17.055


[[Page 2617]]


Regulatory Alternative With Unchanged PEL But Full Ancillary Provisions
    An Informational Analysis: This final regulation has the somewhat 
unusual feature for an OSHA substance-specific health standard that 
most of the quantified benefits that OSHA estimated would come from the 
ancillary provisions rather than from meeting the PEL solely with 
engineering controls (see Chapter VII of the FEA for a more detailed 
discussion). OSHA decided to analyze for informational purposes the 
effect of retaining the preceding PEL but applying all of the ancillary 
provisions, including respiratory protection. Under this approach, the 
TWA PEL would remain at 2.0 micrograms per cubic meter, but all of the 
other final provisions (including respiratory protection) would be 
required with their triggers remaining the same as in the final rule--
either the presence of airborne beryllium at any level (e.g., initial 
monitoring, written exposure control plan), at certain kinds of dermal 
exposure (PPE), at the action level of 0.1 [micro]g/m\3\ (e.g., 
periodic monitoring, medical removal), or at 0.2 [micro]g/m\3\ (e.g., 
regulated areas, respiratory protection, medical surveillance).
    Given the record regarding beryllium exposures, this approach is 
not one OSHA could legally adopt. The absence of engineering controls 
would not be consistent with OSHA's application of the hierarchy of 
controls, in which engineering controls are applied to eliminate or 
control hazards, before administrative controls and personal protective 
equipment are applied to address remaining exposures. Section 6(b)(5) 
of the OSH Act requires OSHA to ``set the standard which most 
adequately assures, to the extent feasible, on the basis of the best 
available evidence, that no employee will suffer material impairment of 
health or functional capacity even if such employee has regular 
exposure to the hazard dealt with by such standard for the period of 
his working life.'' For that reason, this additional analysis is 
provided strictly for informational purposes. E.O. 12866 and E.O. 13563 
direct agencies to identify approaches that maximize net benefits, and 
this analysis is purely for the purpose of exploring whether this 
approach would hold any real promise to maximize net benefits if it was 
permissible under the OSH Act. It does not appear to hold such promise 
because an ancillary-provisions-only approach would not be as 
protective and thus offers fewer benefits than one that includes a 
lower PEL and engineering controls. Also, OSHA estimates the costs 
would be about the same (or slightly lower, depending on certain 
assumptions) under that approach as under the traditional final 
approach.
    When examined on an industry-by-industry basis, OSHA found that 
some industries would have lower costs if they could adopt the 
ancillary-provision-only approach. Some employers would use engineering 
controls where they are cheaper, even if they are not mandatory. OSHA 
does not have sufficient information to do an analysis employer-by-
employer of when the ancillary-provisions-only approach might be 
cheaper. In the majority of affected industries, the Agency estimates 
there are no cost savings to the ancillary-provisions-only approach. 
However, OSHA estimates an annualized total cost saving of $2.7 million 
per year for entire industries where the ancillary-provisions-only 
approach would be less expensive.
    The above discussion does not account for the possibility that the 
lack of engineering controls would result in higher beryllium exposures 
for workers in adjacent (non-production) work areas due to the 
increased level of beryllium in the air. Because of a lack of data, and 
because the issue did not arise in the other regulatory alternatives 
OSHA considered (all of which have a PEL of less than 2.0 [micro]g/
m\3\), OSHA did not examine exposure levels in non-production areas for 
either cost or benefit purposes. To the extent such exposure levels 
would be above the action level, there would be additional costs for 
respiratory protection and medical surveillance.
    If respirators were as effective as engineering controls, the 
ancillary-provisions-only approach would have benefits comparable to 
the benefits of the final rule. However, in this alternative most 
exposed individuals would be required to use respirators, which OSHA 
considers less effective than engineering controls in preventing 
employee exposure to beryllium. OSHA also examined what the benefits 
would be if respirators were not required, were not worn, or were 
ineffective. OSHA found that, if all of the other aspects of the 
benefits analysis remained the same, the annualized benefits would be 
reduced by from $33.2 million using a discount rate of 3 percent, and 
$22.4 using a discount rate of 7 percent, largely as a result of 
failing to reduce deaths from lung cancer, which are unaffected by the 
ancillary provisions. However, there are also other reasons to believe 
that benefits may be even lower:
    (1) As noted above, in the final rule OSHA did not consider 
benefits caused by reductions in exposure in non-production areas. 
Unless employers act to reduce exposures in the production areas, the 
absence of a requirement for such controls would largely negate such 
benefits from reductions in exposure in the non-productions areas.
    (2) OSHA judges that the benefits of the ancillary provisions (a 
midpoint estimate of eliminating 45 percent of all remaining cases of 
CBD for all sectors except for abrasive blasting and coal-fired power 
plants, and an estimate of 11.25 percent, or one fourth of the 
percentage for other sectors, for abrasive blasting and coal-fired 
power plants) would be partially or wholly negated in the absence of 
engineering controls that would reduce both airborne and surface dust 
levels. The Agency's high estimate (90 percent for all sectors except 
abrasive blasting and coal fired power plants, 22.5 percent for 
abrasive blasting and coal-fired power plants) of the proportion of 
remaining CBD cases eliminable by ancillary provisions is based on data 
from a facility with average exposure levels of less than 0.2 [micro]g/
m\3\.
    Based on these considerations, OSHA finds that the ancillary-
provisions-only approach is not one that is likely to maximize net 
benefits. The cost savings, if any, are estimated to be small, and the 
difficult-to-measure declines in benefits could be substantial.
(2) A Method-of-Compliance Alternative
    Paragraph (f)(2)(i) of the final standards contains requirements 
for the implementation of engineering and work practice controls to 
minimize beryllium exposures in general industry, maritime, and 
construction. For each operation in a beryllium work area in general 
industry or where exposures are or can reasonably be expected to be 
above the action level in shipyards or construction, employers must 
ensure that one or more of the following are in place to minimize 
employee exposure: Material and/or process substitution; isolation, 
such as ventilated partial or full enclosures; local exhaust 
ventilation; or process controls, such as wet methods and automation. 
Employers are exempt from using these methods only when they can show 
that such methods are not feasible or where exposures are below the 
action level based on two exposure samples taken at least seven days 
apart.
    OSHA believes that the methods outlined in paragraph (f)(2)(i) 
provide the most reliable means to control variability in exposure 
levels. However, OSHA also recognizes that the requirements of 
paragraph (f)(2)(i) are not typical of OSHA standards, which usually 
require engineering controls

[[Page 2618]]

only where exposures exceed the TWA PEL or STEL. The Agency therefore 
also considered Regulatory Alternative #6, which would drop the 
provisions of (f)(2)(i) from the final standard and make conforming 
edits to paragraphs (f)(2)(ii) and (iii). This regulatory alternative 
does not eliminate the need for engineering controls to comply with the 
final TWA PEL and STEL, but does eliminate the requirement to use one 
or more of the specified engineering or work practice controls where 
exposures equal or exceed the action level. As shown in Table VIII-15, 
Regulatory Alternative #6 would decrease the annualized cost of the 
final rule by $606,706 using a discount rate of 3 percent and by 
$638,100 using a discount rate of 7 percent.
    In the PEA, OSHA had been unable to estimate the benefits of this 
alternative and invited public comment. The Agency did not receive 
public comment and therefore has not estimated the change in benefits 
resulting from Regulatory Alternative #6.
[GRAPHIC] [TIFF OMITTED] TR09JA17.056

(4) Regulatory Alternatives That Affect Ancillary Provisions
    The final standard contains several ancillary provisions 
(provisions other than the exposure limits), including requirements for 
exposure assessment, medical surveillance, medical removal, training, 
competent person, and regulated areas or access control. As reported in 
Chapter V of the FEA, these ancillary provisions account for $61.3 
million (about 83 percent) of the total annualized costs of the rule 
($73.4 million) using a 3 percent discount rate. The most expensive of 
the ancillary provisions are the requirements for housekeeping and 
exposure monitoring, with annualized costs of $22.8 million and $13.7 
million, respectively, at a 3 percent discount rate.
    OSHA's reasons for including each of the final ancillary provisions 
are explained in Section XVI of the preamble, Summary and Explanation 
of the Standards.
    OSHA has examined a variety of regulatory alternatives involving 
changes to one or more of the final ancillary provisions. The 
incremental cost of each of these regulatory alternatives and its 
impact on the total costs of the final rule are summarized in Table 
VIII-16 at the end of this section. OSHA has determined that several of 
these ancillary provisions will increase the benefits of the final 
rule, for example, by helping to ensure the TWA PEL is not exceeded or 
by lowering the risks to workers given the significant risk remaining 
at the final TWA PEL. However, except for Regulatory Alternative #7 
(involving the elimination of all ancillary provisions), OSHA did not 
estimate changes in monetized benefits for the regulatory alternatives 
that affect ancillary provisions. Two regulatory alternatives that 
involve all ancillary provisions are presented below (#7 and #8), 
followed by regulatory alternatives for exposure monitoring (#9, #10, 
and #11), for regulated areas (#12), for personal protective clothing 
and equipment (#13), for medical surveillance (#14 through #20), and 
for medical removal protection (#22).
All Ancillary Provisions
    The SBAR Panel recommended that OSHA analyze a PEL-only standard as 
a regulatory alternative. The Panel also recommended that OSHA consider 
not applying ancillary provisions of the standard where exposure levels 
are low so as to minimize costs for small businesses (SBAR, 2008). In 
response to these recommendations, OSHA analyzed Regulatory Alternative 
#7, a PEL-only standard, and Regulatory Alternative #8, which would 
apply ancillary provisions of the beryllium standard only where 
exposures exceed the final TWA PEL of 0.2 [mu]g/m\3\ or the final STEL 
of 2.0 [mu]g/m\3\.
    Regulatory Alternative #7 would only update 1910.1000 Tables Z-1 
and Z-2, so that the final TWA PEL and STEL would apply to all workers 
in general industry, construction, and maritime. This alternative would 
eliminate all of the ancillary provisions of the final rule, including 
exposure assessment, medical surveillance, medical removal protection, 
PPE, housekeeping, training, competent person, and regulated areas or 
access control. Under this regulatory alternative, OSHA estimates that 
the costs for the final ancillary provisions of the rule (estimated at 
$61.4 million annually at a 3 percent discount rate) would be 
eliminated. In order to meet the PELs, employers would still commonly 
need to do monitoring, train workers on the use of controls, and set up 
some kind of regulated areas to indicate where respirator use would be 
required. It is also likely that, under this alternative, many 
employers would follow the recommendations of Materion and the United 
Steelworkers to provide medical surveillance, PPE, and other protective 
measures for their workers (Materion and United Steelworkers, 2012). 
OSHA has not attempted to estimate the extent to which these ancillary 
provision costs would be incurred if they were not formally required or 
whether any of

[[Page 2619]]

these costs under Regulatory Alternative #7 would reasonably be 
attributable to the final rule. The total costs for this alternative 
are $12.5 million at a 3% discount rate and $13.5 million at a 7% 
discount rate.
    OSHA has also estimated the effect of this regulatory alternative 
on the benefits of the rule, presented in Table VIII-16. As a result of 
eliminating all of the ancillary provisions, annualized benefits are 
estimated to decrease 71 percent, relative to the final rule, from 
$560.9 million to $211.9 million, using a 3 percent discount rate, and 
from $249.1 million to $94.0 million using a 7 percent discount rate. 
This estimate follows from OSHA's analysis of benefits in Chapter VII 
of the FEA, which found that about 68 percent of the benefits of the 
final rule, evaluated at their mid-point value, were attributable to 
the combination of the ancillary provisions. As these estimates show, 
OSHA expects that the benefits estimated under the final rule will not 
be fully achieved if employers do not implement the ancillary 
provisions of the final rule.
    Both industry and worker groups have recognized that a 
comprehensive standard is needed to protect workers exposed to 
beryllium. The stakeholders' recommended standard--that representatives 
of Materion, the primary beryllium producer, and the United 
Steelworkers union provided to OSHA--confirms the importance of 
ancillary provisions in protecting workers from the harmful effects of 
beryllium exposure (Materion and United Steelworkers, 2012). Ancillary 
provisions such as personal protective clothing and equipment, 
regulated areas, medical surveillance, hygiene areas, housekeeping 
requirements, and hazard communication all serve to reduce the risks to 
beryllium-exposed workers beyond that which the final TWA PEL alone 
could achieve.
    Under Regulatory Alternative #8, several ancillary provisions that 
the current final rule would require under a variety of exposure 
conditions (e.g., dermal contact, any airborne exposure, exposure at or 
above the action level) would instead only apply where exposure levels 
exceed the TWA PEL or STEL.
    Regulatory Alternative #8 affects the following provisions of the 
final standard:

--Exposure monitoring: Whereas the scheduled monitoring option of the 
final standards requires monitoring every six months when exposure 
levels are at or above the action level and at or below the TWA PEL and 
every three months when exposure levels exceed the TWA PEL, Regulatory 
Alternative #8 would require annual exposure monitoring where exposure 
levels exceed the TWA PEL or STEL;

    [cir] Written exposure control plan: Whereas the final standards 
require written exposure control plans to be maintained in any facility 
covered by the standard, Regulatory Alternative #8 would require only 
facilities with exposures above the TWA PEL or STEL to maintain a plan;

    [cir] PPE: Whereas the final standards require PPE when airborne 
exposure to beryllium exceeds, or can reasonably be expected to exceed, 
the PEL or STEL, and where there is a reasonable expectation of dermal 
contact with beryllium, Alternative #8 would require PPE only for 
employees exposed above the TWA PEL or STEL;

    [cir] Medical Surveillance: Whereas the final standard's medical 
surveillance provisions require employers to offer medical surveillance 
to employees exposed above the action level for 30 days per year, 
showing signs or symptoms of CBD, exposed to beryllium in an emergency, 
or when recommended by a medical opinion, Alternative #8 would require 
surveillance only for those employees exposed above the TWA PEL or 
STEL.
    To estimate the cost savings for this alternative, OSHA re-
estimated the group of workers that would fall under the above 
provisions, with results presented in Table VIII-16. Combining these 
various adjustments along with associated unit costs, OSHA estimates 
that, under this regulatory alternative, the costs for the final rule 
would decline from $73.9 million to $35.8 million, using a 3 percent 
discount rate, and from $76.6 million to $37.9 million, using a 7 
percent discount rate.
    The Agency has not quantified the impact of this alternative on the 
benefits of the rule. However, ancillary provisions that offer 
protective measures to workers exposed below the final TWA PEL, such as 
personal protective clothing and equipment, beryllium work areas, 
hygiene areas, housekeeping requirements, and hazard communication, all 
serve to reduce the risks to beryllium-exposed workers beyond that 
which the final TWA PEL and STEL could achieve.
    The remainder of this chapter discusses additional regulatory 
alternatives that apply to individual ancillary provisions.
Exposure Monitoring
    Paragraph (d) of the final standard, Exposure Assessment, allows 
employers to choose either the performance option or scheduled 
monitoring. The scheduled monitoring option requires semi-annual 
monitoring for those workers exposed at or above the action level but 
at or below the PEL and quarterly exposure monitoring for those workers 
exposed above the PEL. The rationale for this provision is provided in 
the preamble discussion of paragraph (a) in Section XVI, Summary and 
Explanation of the Standards.
    OSHA has examined three regulatory alternatives that would modify 
the requirements of periodic monitoring in the final rule. Under 
Regulatory Alternative #9, employers would be required to perform 
periodic exposure monitoring annually when exposures are at or above 
the action level or above the STEL, but at or below the TWA PEL. As 
shown in Table VIII-16, Regulatory Alternative #9 would decrease the 
annualized cost of the final rule by about $4.3 million using either a 
3 percent or 7 percent discount rate.
    Under Regulatory Alternative #10, employers would be required to 
perform periodic exposure monitoring annually when exposures are at or 
above the action level. As shown in Table VIII-16, Regulatory 
Alternative #10 would decrease the annualized cost of the final rule by 
about $4.9 million using either a 3 percent or 7 percent discount rate.
    Under Regulatory Alternative #11, employers would be required to 
perform annual exposure monitoring where exposures are at or above the 
action level but at or below the TWA PEL and STEL. When exposures are 
above the TWA PEL, no periodic monitoring would be required. As shown 
in Table VIII-16, Regulatory Alternative #11 would decrease the 
annualized cost of the final rule by about $5.0 million using either a 
3 percent or 7 percent discount rate. OSHA is unable to quantify the 
effect of this change on benefits but has judged the alternative 
adopted necessary and protective.
Regulated Areas
    Final paragraph (e) for General Industry requires employers to 
establish and maintain beryllium work areas in any work area containing 
a process or operation that can release beryllium where employees are, 
or can reasonably be expected to be, exposed to airborne beryllium at 
any level or where there is the potential for dermal contact with 
beryllium, and regulated areas wherever airborne concentrations of 
beryllium exceed, or can reasonably be expected to

[[Page 2620]]

exceed, the TWA PEL or STEL. The Shipyards standard also requires 
regulated areas. The Construction standard has a comparable competent 
person requirement. Employers in General Industry and Shipyards are 
required to demarcate regulated areas and limit access to regulated 
areas to authorized persons.
    The SBAR Panel report recommended that OSHA consider dropping or 
limiting the provision for regulated areas (SBAR, 2008). In response to 
this recommendation, OSHA examined Regulatory Alternative #12, which 
would eliminate the requirement that employers establish regulated 
areas in the General Industry and Maritime standards, and eliminate the 
competent person requirement in the Construction standard. This 
alternative would not eliminate the final requirement to establish 
beryllium work areas, where required. As shown in Table VIII-16, 
Regulatory Alternative #12 would decrease the annualized cost of the 
final rule by about $1.0 million using either a 3 or 7 percent discount 
rate.
Personal Protective Clothing and Equipment
    Regulatory Alternative #13 would modify the requirements for 
personal protective equipment (PPE) by eliminating the requirement for 
appropriate PPE whenever there is potential for skin contact with 
beryllium or beryllium-contaminated surfaces. This alternative would be 
narrower, and thus less protective, than the PPE requirement in the 
final standards, which require PPE to be used where airborne exposure 
exceeds, or can reasonably be expected to exceed, the TWA PEL or STEL, 
or where there is a reasonable expectation of dermal contact with 
beryllium.
    The economic analysis for the final standard already contains costs 
for protective clothing, namely gloves, for all employees who can 
reasonably be expected to be have dermal contact with beryllium; thus 
OSHA estimated the cost of this alternative as the cost reduction from 
not providing gloves under these circumstances. As shown in Table VIII-
16, Regulatory Alternative #13 would decrease the annualized cost of 
the final rule by about $481,000 using either a 3 percent or 7 percent 
discount rate.
 Medical Surveillance
    The final requirements for medical surveillance include: (1) 
Medical examinations, including a test for beryllium sensitization, for 
employees who are or are reasonably expected to be exposed to beryllium 
at or above the action level for more than 30 days per year, who show 
signs or symptoms of CBD or other beryllium-related health effects, are 
exposed to beryllium in an emergency, or whose more recent written 
medical opinion required by paragraph (k)(6) or (k)(7) recommends such 
surveillance, and (2) low dose CT scans for employees when recommended 
by the PLCHP. The final standards require biennial medical exams to be 
provided for eligible employees. The standards also require tests for 
beryllium sensitization to be provided to eligible employees 
biennially.
    OSHA estimated in Chapter V of the FEA that the medical 
surveillance requirements would apply to 4,528 workers in general 
industry, of whom 387 already receive medical surveillance.\35\ In 
Chapter V of the FEA, OSHA estimated the costs of medical surveillance 
for the remaining 4,141 workers who would now have such protection due 
to the final standard. The Agency's final analysis indicates that 4 
workers with beryllium sensitization and 6 workers with CBD will be 
referred to a CBD diagnostic center annually as a result of this 
medical surveillance. Medical surveillance is particularly important 
for this rule because beryllium-exposed workers, including many workers 
exposed below the final PELs, are at significant risk of illness.\36\
---------------------------------------------------------------------------

    \35\ See baseline compliance rates for medical surveillance in 
Chapter III of the FEA, Table III-20.
    \36\ OSHA did not estimate, and the benefits analysis does not 
include, monetized benefits resulting from early discovery of 
illness.
---------------------------------------------------------------------------

    OSHA has examined four regulatory alternatives (#15, #16, #18, and 
#22) that would modify the final rule's requirements for employee 
eligibility, the tests that must be offered, and the frequency of 
periodic exams. Medical surveillance was a subject of special concern 
to SERs during the SBAR Panel process, and the SBAR Panel offered many 
comments and recommendations related to medical surveillance for OSHA's 
consideration. Some of the Panel's concerns have been partially 
addressed in this final rule, which was modified since the SBAR Panel 
was convened (see the preamble at Section XVI, Summary and Explanation 
of the Standards, for more detailed discussion). Regulatory Alternative 
#16 also responds to recommendations by the SBAR Panel to reduce 
burdens on small businesses by dropping or reducing the frequency of 
medical surveillance requirements.
    OSHA has determined that a significant risk of beryllium 
sensitization, CBD, and lung cancer exists at exposure levels below the 
final TWA PEL and that there is evidence that beryllium sensitization 
can occur even from short-term exposures (see the preamble at Section 
V, Health Effects, and Section VII, Significance of Risk). The Agency 
therefore anticipates that more employees would develop adverse health 
effects without receiving the benefits of early intervention in the 
disease process because they are not eligible for medical surveillance 
(see section XVI of this preamble, the Summary and Explanation for 
paragraph (k)).
    Regulatory Alternative #15 would decrease eligibility for medical 
surveillance to employees who are exposed to beryllium above the final 
PEL
    To estimate the cost of Regulatory Alternative #15, OSHA assumed 
that all workers exposed above the PEL before the final rule would 
continue to be exposed after the standard is promulgated. Thus, this 
alternative eliminates costs for medical exams for the number of 
workers exposed between the action level and the TWA PEL. As shown in 
Table VIII-16, Regulatory Alternative #15 would decrease the annualized 
cost of the final rule by about $4.5 million using a discount rate of 3 
percent, and by about $4.8 million using a discount rate of 7 percent.
    In response to concerns raised during the SBAR Panel process about 
testing requirements, OSHA considered two regulatory alternatives that 
would provide greater flexibility in the program of tests provided as 
part of an employer's medical surveillance program. Under Regulatory 
Alternative #16, employers would not be required to offer employees 
testing for beryllium sensitization. As shown in Table VIII-16, this 
alternative would decrease the annualized cost of the final rule by 
about $2.4 million using either a 3 percent or 7 percent discount rate.
    Regulatory Alternative #18 would eliminate the CT scan requirement 
from the final rule. This alternative would decrease the annualized 
cost of the final rule by about $613,000 using a discount rate of 3 
percent, and by about $643,000 using a discount rate of 7 percent.
 Medical Removal
    Under paragraph (l) of the final standard, Medical Removal, 
employees in jobs with exposure at or above the action level become 
eligible for medical removal when they provide their employers with a 
written medical report indicating they are diagnosed with CBD or 
confirmed positive for beryllium sensitization, or if a written medical 
opinion recommends medical removal

[[Page 2621]]

in accordance with the medical surveillance paragraph of the standards. 
When an employee chooses removal, the employer is required to remove 
the employee to comparable work in an environment where beryllium 
exposure is below the action level if such work is available and the 
employee is either already qualified or can be trained within one 
month. If comparable work is not available, the employer must place the 
employee on paid leave for six months or until comparable work becomes 
available (whichever comes first). Or, rather than choosing removal, an 
eligible employee could choose to remain in a job with exposure at or 
above the action level, in which case the employer would have to 
provide, and the employee would have to use, a respirator.
    The SBAR Panel report included a recommendation that OSHA give 
careful consideration to the impacts that an MRP requirement could have 
on small businesses (SBAR, 2008). In response to this recommendation, 
OSHA analyzed Regulatory Alternative #22, which would remove the final 
requirement that employers offer MRP. As shown in Table VIII-16, this 
alternative would decrease the annualized cost of the final rule by 
about $1.2 million using a discount rate of 3 percent, and by about 
$1.3 million using a discount rate of 7 percent.

[[Page 2622]]

[GRAPHIC] [TIFF OMITTED] TR09JA17.057


[[Page 2623]]


SBAR Panel
    Table VIII-17 lists all of the SBAR Panel recommendations and 
OSHA's response to those recommendations.
 Table VIII-17: SBAR Panel Recommendations and OSHA Responses

------------------------------------------------------------------------
          Panel recommendation                    OSHA response
------------------------------------------------------------------------
The Panel recommends that OSHA evaluate  OSHA has reviewed its cost
 carefully the costs and technological    estimates and the
 feasibility of engineering controls at   technological feasibility of
 all PEL options, especially those at     engineering controls at
 the lowest levels.                       various PEL levels. These
                                          issues are discussed in the
                                          Regulatory Alternatives
                                          Chapter.
The Panel recommends that OSHA consider  OSHA has removed the initial
 alternatives that would alleviate the    exposure monitoring
 need for monitoring in operations with   requirement for workers likely
 exposures far below the PEL. The Panel   to be exposed to beryllium by
 also recommends that OSHA consider       skin or eye contact through
 explaining more clearly how employers    routine handling of beryllium
 may use ``objective data'' to estimate   powders or dusts or contact
 exposures. Although the draft proposal   with contaminated surfaces.
 contains a provision allowing           The periodic monitoring
 employers to initially estimate          requirement presented in the
 exposures using ``objective data''       SBAR Panel report required
 (e.g., data showing that the action      monitoring every 6 months for
 level is unlikely to be exceeded for     airborne levels at or above
 the kinds of process or operations an    the action level but below the
 employer has), the SERs did not appear   PEL, and every 3 months for
 to have fully understood how this        exposures at or above the PEL.
 alternative may be used.                 The final standard, in line
                                          with OSHA's normal practice,
                                          requires exposure monitoring
                                          every three months for levels
                                          above the PEL or STEL and
                                          every six months for exposures
                                          between the action level and
                                          the PEL. In the preamble to
                                          the final standard, OSHA
                                          provides further explanation
                                          on the use of objective data,
                                          which would exempt employers
                                          from the requirements of the
                                          final rule.
                                         These issues are discussed in
                                          the preamble at Section XVI,
                                          Summary and Explanation of the
                                          Standards, (d): Exposure
                                          Monitoring.
The Panel recommends that OSHA consider  In the preamble to the final
 providing some type of guidance to       standards, OSHA discusses the
 describe how to use objective data to    issue of objective data. While
 estimate exposures in lieu of            OSHA recognizes that some
 conducting personal sampling.            establishments will have
Using objective data could provide        objective data, for purposes
 significant regulatory relief to         of estimating the cost of this
 several industries where airborne        rule, the Agency is assuming
 exposures are currently reported by      that no establishments will
 SERs to be well below even the lowest    use objective data. The Agency
 PEL option. In particular, since         recognizes that this will
 several ancillary provisions, which      overestimate costs.
 may have significant costs for small    The use of objective data is
 entities may be triggered by the PEL     discussed in the preamble at
 or an action level, OSHA should          Section XVI, Summary and
 consider encouraging and simplifying     Explanation of the Standards,
 the development of objective data from   (d): Exposure Monitoring.
 a variety of sources.
The Panel recommends that OSHA revisit   SERs with very low exposure
 its analysis of the costs of regulated   levels or only occasional work
 areas if a very low PEL is proposed.     with beryllium will not be
 Drop or limit the provision for          required to have regulated
 regulated areas: SERs with very low      areas unless exposures are
 exposure levels or only occasional       above the final PEL of 0.2
 work with beryllium questioned the       [mu]g/m\3\.
 need for separating areas of work by    The final standards for general
 exposure level. Segregating machines     industry and maritime require
 or operations, SERs said, would affect   the employer to establish and
 productivity and flexibility. Until      maintain a regulated area
 the health risks of beryllium are        wherever employees are, or can
 known in their industries, SERs          be expected to be, exposed to
 challenged the need for regulated        airborne beryllium at levels
 areas.                                   above the PEL of 0.2 [mu]g/
                                          m\3\. There is no regulated
                                          area requirement in
                                          Construction.
The Panel recommends that OSHA revisit   In General industry employers
 its cost model for hygiene areas to      must ensure that employees who
 reflect SERs' comments that estimated    have dermal contact with
 costs are too low and more carefully     beryllium wash any exposed
 consider the opportunity costs of        skin at the end of the
 using space for hygiene areas where      activity, process, or work
 SERs report they have no unused space    shift and prior to eating,
 in their physical plant for them. The    drinking, smoking, chewing
 Panel also recommends that OSHA          tobacco or gum, applying
 consider more clearly defining the       cosmetics, or using the
 triggers (skin exposure and              toilet. In General Industry,
 contaminated surfaces) for the hygiene   although there is a shower
 areas provisions. In addition, the       requirement, OSHA has
 Panel recommends that OSHA consider      determined that establishments
 alternative requirements for hygiene     required to have showers will
 areas dependent on airborne exposure     already have them, and
 levels or types of processes. Such       employers will not have to
 alternatives might include, for          install showers to comply with
 example, hand washing facilities in      the beryllium standard (Please
 lieu of showers in particular cases or   see the Hygiene Areas and
 different hygiene area triggers where    Practices section in Chapter V
 exposure levels are very low.            of the FEA). In Construction
                                          and Maritime, for each
                                          employee required to use
                                          personal protective clothing
                                          or equipment, the employer
                                          must ensure that employees who
                                          have dermal contact with
                                          beryllium wash any exposed
                                          skin at the end of the
                                          activity, process, or work
                                          shift and prior to eating,
                                          drinking, smoking, chewing
                                          tobacco or gum, applying
                                          cosmetics, or using the
                                          toilet. For Construction and
                                          Maritime, language involving
                                          showers has been removed but
                                          employers are still required
                                          to provide change rooms. Where
                                          personal protective clothing
                                          or equipment must be used, the
                                          employer must provide washing
                                          facilities. The standards do
                                          not require that eating and
                                          drinking areas be provided,
                                          but impose requirements when
                                          the employer chooses to have
                                          eating and drinking areas.
                                         Change rooms have been costed
                                          in general industry for
                                          employees who work in a
                                          beryllium work area and in
                                          construction and maritime for
                                          employees who required to use
                                          personal protective clothing
                                          or equipment. The Agency has
                                          determined that the long-term
                                          rental of modular units is
                                          representative of costs for a
                                          range of reasonable approaches
                                          to comply with the change room
                                          part of the provision.
                                          Alternatively, employers could
                                          renovate and rearrange their
                                          work areas in order to meet
                                          the requirements of this
                                          provision.

[[Page 2624]]

 
The Panel recommends that OSHA consider  In the preamble to the final
 clearly explaining the purpose of the    rule, OSHA has clarified the
 housekeeping provision and describing    purpose of the housekeeping
 what affected employers must do to       provision. However, due to the
 achieve it.                              variety of work settings in
For example, OSHA should consider         which beryllium is used, OSHA
 explaining more specifically what        has concluded that a highly
 surfaces need to be cleaned and how      specific directive in the
 frequently they need to be cleaned.      preamble on what surfaces need
 The Panel recommends that the Agency     to be cleaned, and how
 consider providing guidance in some      frequently, would not provide
 form so that employers understand what   effective guidance to
 they must do. The Panel also             businesses. Instead, at the
 recommends that once the requirements    suggestion of industry and
 are clarified that the Agency re-        union stakeholders (Materion
 analyze its cost estimates.              and USW, 2012), OSHA's final
The Panel also recommends that OSHA       standards include a more
 reconsider whether the risk and cost     flexible requirement for
 of all parts of the medical              employers to develop a written
 surveillance provisions are              exposure control plan specific
 appropriate where exposure levels are    to their facilities. In
 very low. In that context, the Panel     general industry, the employer
 recommends that OSHA should also         must establish procedures to
 consider the special problems and        maintain all surfaces in
 costs to small businesses that up        beryllium work areas as free
 until now may not have had to provide    as practicable of beryllium as
 or manage the various parts of an        required by the written
 occupational health standard or          exposure control plan. Other
 program.                                 than requirements pertaining
                                          to eating and drinking areas,
                                          there are no requirements to
                                          maintain surface cleanliness
                                          in construction or maritime.
                                          These issues are discussed in
                                          the preamble at Section XVI,
                                          Summary and Explanation of the
                                          Standards, (f) Methods of
                                          Compliance and (j)
                                          Housekeeping. The adoption of
                                          Regulatory Alternative #20 in
                                          the PEA reduced the frequency
                                          of physical examinations from
                                          annual to biennial, matching
                                          the frequency of BeLPT testing
                                          in the final rule.
                                         These alternatives for medical
                                          surveillance are discussed in
                                          the Regulatory Alternatives
                                          Chapter, Chapter VIII and in
                                          the preamble at section XVI,
                                          Summary and Explanation of the
                                          Standards, (k) Medical
                                          Surveillance.
The Panel recommends that OSHA consider  Under the final standards, skin
 that small entities may lack the         exposure is not a trigger for
 flexibility and resources to provide     medical removal (unlike the
 alternative jobs to employees who test   draft version used for the
 positive for the BeLPT, and whether      SBAR Panel). Employees are
 medical removal protection (MRP)         only eligible for medical
 achieves its intended purpose given      removal if they are in a job
 the course of beryllium disease. The     with airborne exposure at or
 Panel also recommends that if MRP is     above the action level and
 implemented, that its effects on the     provide the employer with a
 viability of very small firms with a     written medical report
 sensitized employee be considered        confirming that they are
 carefully.                               sensitized or have been
                                          diagnosed with CBD, or that
                                          the physician recommends
                                          removal, or if the employer
                                          receives a written medical
                                          opinion recommending removal
                                          of the employee. After
                                          becoming eligible for medical
                                          removal an employee may choose
                                          to remain in a job with
                                          exposure at or above the
                                          action level, provided that
                                          the employer provides and the
                                          employee wears a respirator in
                                          accordance with the
                                          Respiratory Protection
                                          standard (29 CFR 1910.134). If
                                          the employee chooses removal,
                                          the employer is only required
                                          to place the employee in
                                          comparable work with exposure
                                          below the action level if such
                                          work is available; if such
                                          work is not available, the
                                          employer may place the
                                          employee on paid leave for six
                                          months or until such work
                                          becomes available, whichever
                                          comes first.
                                         OSHA discusses the basis of the
                                          provision in the preamble at
                                          Section XVI, Summary and
                                          Explanation of the Standards,
                                          (l) Medical Removal
                                          Protection. OSHA provides an
                                          analysis of costs and economic
                                          impacts of the provision in
                                          the FEA in Chapter V and
                                          Chapter VI, respectively.
The Panel recommends that OSHA consider  As stated above, the triggers
 more clearly defining the trigger        for medical surveillance in
 mechanisms for medical surveillance      the final standard have
 and also consider additional or          changed from those presented
 alternative triggers--such as limiting   to the SBAR Panel. Whereas the
 the BeLPT to a narrower range of         draft standard presented at
 exposure scenarios and reducing the      the SBAR Panel required
 frequency of BeLPT tests and physical    medical surveillance for
 exams. The Panel also recommends that    employees with skin contact--
 OSHA reconsider whether the risk and     potentially applying to
 cost of all parts of the medical         employees with any level of
 surveillance provisions are              airborne exposure--the final
 appropriate where exposure levels are    standard ties medical
 very low. In that context, the Panel     surveillance to exposures at
 recommends that OSHA should also         or above the action level for
 consider the special problems and        more than 30 days per year (or
 costs to small businesses that up        signs or symptoms of beryllium-
 until now may not have had to provide    related health effects,
 or manage the various parts of an        emergency exposure, or a
 occupational health standard or          medical opinion recommending
 program.                                 medical surveillance on the
                                          basis of a CBD or
                                          sensitization diagnosis).
                                          Thus, small businesses with
                                          exposures below the final
                                          action level would not need to
                                          provide or manage medical
                                          surveillance for their
                                          employees unless employees
                                          develop signs or symptoms of
                                          beryllium-related health
                                          effects or are exposed in
                                          emergencies.
                                         These issues are discussed in
                                          the preamble at section XVI,
                                          Summary and Explanation of the
                                          Standards, (k) Medical
                                          Surveillance.
The Panel recommends that the Agency,    OSHA has reviewed the possible
 in evaluating the economic feasibility   effects of the final
 of a potential regulation, consider      regulation on market demand
 not only the impacts of estimated        and/or foreign production, in
 costs on affected establishments, but    addition to the Agency's usual
 also the effects of the possible         measures of economic impact
 outcomes cited by SERs: Loss of market   (costs as a fraction of
 demand, the loss of market to foreign    revenues and profits). This
 competitors, and of U.S. production      discussion can be found in
 being moved abroad by U.S. firms. The    Chapter VI of the FEA
 Panel also recommends that OSHA          (entitled Economic Feasibility
 consider the potential burdens on        Analysis and Regulatory
 small businesses of dealing with         Flexibility Determination).
 employees who have a positive test
 from the BeLPT. OSHA may wish to
 address this issue by examining the
 experience of small businesses that
 currently provide the BeLPT test.

[[Page 2625]]

 
The Panel recommends that OSHA consider  The provisions in the standard
 seeking ways of minimizing costs for     presented in the SBAR panel
 small businesses where the exposure      report applied to all
 levels may be very low. Clarifying the   employees, whereas the final
 use of objective data, in particular,    standard's ancillary
 may allow industries and                 provisions are only applied to
 establishments with very low exposures   employees in work areas who
 to reduce their costs and involvement    are, or can reasonably be
 with many provisions of a standard.      expected to be, exposed to
 The Panel also recommends that the       airborne beryllium. In
 Agency consider tiering the              addition, the scope of the
 application of ancillary provisions of   final standard includes
 the standard according to exposure       several limitations. Whereas
 levels and consider a more limited or    the standard presented in the
 narrowed scope of industries.            SBAR panel report covered
                                          beryllium in all forms and
                                          compounds in general industry,
                                          construction, and maritime,
                                          the scope of the final
                                          standard (1) does not apply to
                                          beryllium-containing articles
                                          that the employer does not
                                          process; and (2) does not
                                          apply to materials that
                                          contain less than 0.1%
                                          beryllium by weight if the
                                          employer has objective data
                                          demonstrating that employee
                                          exposure to beryllium will
                                          remain below the action level
                                          as an 8-hour TWA under any
                                          foreseeable conditions.
                                         In the preamble to the final
                                          standard, OSHA has clarified
                                          the circumstances under which
                                          an employer may use historical
                                          and objective data in lieu of
                                          initial monitoring (Section
                                          XVI, Summary and Explanation
                                          of the Standards, (d) Exposure
                                          Monitoring).
                                         OSHA also considered two
                                          Regulatory Alternatives that
                                          would reduce the impact of
                                          ancillary alternatives on
                                          employers, including small
                                          businesses. Regulatory
                                          Alternative #7, a PEL-only
                                          standard, would drop all
                                          ancillary provisions from the
                                          standard. Regulatory
                                          Alternative #8 would limit the
                                          application of several
                                          ancillary provisions,
                                          including Exposure Monitoring,
                                          the written exposure control
                                          plan section of Method of
                                          Compliance, PPE, Housekeeping,
                                          and Medical Surveillance, to
                                          operations or employees with
                                          exposure levels exceeding the
                                          TWA PEL or STEL.
                                         These alternatives are
                                          discussed in the Regulatory
                                          Alternatives, Chapter VIII of
                                          the FEA.
The Panel recommends that OSHA provide   The explanation and analysis
 an explanation and analysis for all      for all health outcomes (and
 health outcomes (and their scientific    their scientific basis) are
 basis) upon which it is regulating       discussed in the preamble to
 employee exposure to beryllium. The      the final standard at Section
 Panel also recommends that OSHA          V, Health Effects, and Section
 consider to what extent a very low PEL   VI, Risk Assessment. They are
 (and lower action level) may result in   also reviewed in the preamble
 increased costs of ancillary             to the final standard at
 provisions to small entities (without    Section VII, Significance of
 affecting airborne employee              Risk, and the Benefits Chapter
 exposures). Since in the draft           of the FEA.
 proposal the PEL and action level are   As discussed above, OSHA
 critical triggers, the Panel             considered Regulatory
 recommends that OSHA consider            Alternatives #7 and #8, which
 alternate action levels, including an    would eliminate or reduce the
 action level set at the PEL, if a very   impact of ancillary provisions
 low PEL is proposed.                     on employers, respectively.
                                          These alternatives are
                                          discussed in Chapter VIII of
                                          the FEA.
The Panel recommends that OSHA consider  OSHA has removed skin exposure
 more clearly and thoroughly defining     as a trigger for several
 the triggers for ancillary provisions,   ancillary provisions in the
 particularly the skin exposure           final standard, including
 trigger. In addition, the Panel          Exposure Assessment and
 recommends that OSHA clearly explain     Medical Surveillance. For each
 the basis and need for small entities    employee working in a
 to comply with ancillary provisions.     beryllium work area in general
 The Panel also recommends that OSHA      industry, and for each
 consider narrowing the trigger related   employee required to use
 to skin and contamination to capture     personal protective clothing
 only those situations where surfaces     or equipment in construction
 and surface dust may contain beryllium   and maritime, the employer
 in a concentration that is significant   must ensure that employees who
 enough to pose any risk--or limiting     have dermal contact with
 the application of the trigger for       beryllium wash any exposed
 some ancillary provisions.               skin at the end of the
                                          activity, process, or work
                                          shift and prior to eating,
                                          drinking, smoking, chewing
                                          tobacco or gum, applying
                                          cosmetics, or using the
                                          toilet. In addition, the
                                          potential for dermal contact
                                          with beryllium triggers
                                          requirements related to
                                          beryllium work areas, the
                                          written exposure control plan,
                                          washing facilities,
                                          housekeeping and training: For
                                          some ancillary provisions,
                                          including PPE and
                                          Housekeeping, the requirements
                                          are triggered by visible
                                          contamination with beryllium
                                          or dermal contact with
                                          beryllium.
                                         In Construction and Maritime,
                                          for each employee required to
                                          use personal protective
                                          clothing or equipment, the
                                          employer must ensure that
                                          employees who have dermal
                                          contact with beryllium wash
                                          any exposed skin at the end of
                                          the activity, process, or work
                                          shift and prior to eating,
                                          drinking, smoking, chewing
                                          tobacco or gum, applying
                                          cosmetics, or using the
                                          toilet. For Construction and
                                          Maritime, language involving
                                          showers has been removed and
                                          employers are required to
                                          provide change rooms for
                                          employees required to use
                                          personal protective clothing
                                          or equipment and required to
                                          remove their personal
                                          clothing. Where dermal contact
                                          occurs, employers must provide
                                          washing facilities.
                                         These requirements are
                                          discussed in the preamble at
                                          Section XVI, Summary and
                                          Explanation of the Standards.
                                          The Agency has also explained
                                          the basis and need for
                                          compliance with ancillary
                                          provisions in the preamble at
                                          Section XVI, Summary and
                                          Explanation of the Standards.

[[Page 2626]]

 
Several SERs said that OSHA should       In the Technological
 first assume the burden of describing    Feasibility Analysis presented
 the exposure level in each industry      in the FEA, OSHA has described
 rather than employers doing so. Others   the baseline exposure levels
 said that the Agency should accept       in each industry or
 exposure determinations made on an       application group.
 industry-wide basis, especially where   In the preamble to the final
 exposures were far below the PEL         standards, OSHA discusses the
 options under consideration.             issue of objective data. While
As noted above, the Panel recommends      OSHA recognizes that some
 that OSHA consider alternatives that     establishments will have
 would alleviate the need for             objective data, for purposes
 monitoring in operations or processes    of the economic analysis, the
 with exposures far below the PEL. The    Agency is choosing to assume
 use of objective data is a principal     that no establishments will
 method for industries with low           use objective data. The Agency
 exposures to satisfy compliance with a   recognizes that this will
 proposed standard. The Panel             overestimate costs.
 recommends that OSHA consider
 providing some guidance to small
 entities in the use of objective data.
The Panel recommends that OSHA consider  OSHA has provided discussion of
 more fully evaluating whether the        the BeLPT in the preamble to
 BeLPT is suitable as a test for          the final rule at section V,
 beryllium sensitization in an OSHA       Health Effects; and in the
 standard and respond to the points       preamble at section XVI,
 raised by the SERs about its efficacy.   Summary and Explanation of the
 In addition, the Agency should           Standards, (b) Definitions and
 consider the availability of other       (k) Medical Surveillance. In
 tests under development for detecting    the regulatory text, OSHA has
 beryllium sensitization and not limit    clarified that a test for
 either employers' choices or new         beryllium sensitization other
 science and technology in this area.     than the BeLPT may be used in
 Finally, the Panel recommends that       lieu of the BeLPT if a more
 OSHA re-consider the trigger for         reliable and accurate
 medical surveillance where exposures     diagnostic test is developed.
 are low and consider if there are       As stated above, the triggers
 appropriate alternatives.                for medical surveillance in
                                          the final standard have
                                          changed from those presented
                                          to the SBAR Panel. Whereas the
                                          draft standard presented
                                          during the SBREFA process
                                          required medical surveillance
                                          for employees with skin
                                          contact--potentially applying
                                          to employees with any level of
                                          airborne exposure--the final
                                          standard ties medical
                                          surveillance to exposures
                                          above the final action level
                                          of 0.1 [mu]g/m\3\ (or signs or
                                          symptoms of beryllium-related
                                          health effects, emergency
                                          exposure, or a medical opinion
                                          recommending medical
                                          surveillance on the basis of a
                                          CBD or sensitization
                                          diagnosis). The triggers for
                                          medical surveillance are
                                          discussed in the preamble at
                                          section XVI, Summary and
                                          Explanation of the Standards,
                                          (k) Medical Surveillance.
                                         OSHA has considered Regulatory
                                          Alternative #16, where
                                          employers would not be
                                          required to offer employees a
                                          BeLPT that tests for beryllium
                                          sensitization. from the final
                                          standard. This alternative is
                                          discussed in the Regulatory
                                          Alternatives Chapter and in in
                                          the preamble at Section XVI,
                                          Summary and Explanation of the
                                          Final Standard, (k) Medical
                                          Surveillance.
Seeking ways of minimizing costs to low- The standard presented in the
 risk processes and operations: OSHA      SBAR panel report had skin
 should consider alternatives for         exposure as a trigger. The
 minimizing costs to industries,          final standards require PPE
 operations, or processes that have low   when there is a reasonable
 exposures. Such alternatives may         expectation of dermal contact
 include, but not be limited to:          with beryllium. The employer
 Encouraging the use of objective data    must ensure that employees who
 by such mechanisms as providing          have dermal contact with
 guidance for objective data; assuring    beryllium wash any exposed
 that triggers for skin exposure and      skin at the end of the
 surface contamination are clear and do   activity, process, or work
 not pull in low-risk operations;         shift and prior to eating,
 providing guidance on least-cost ways    drinking, smoking, chewing
 for low risk facilities to determine     tobacco or gum, applying
 what provisions of the standard they     cosmetics, or using the
 need to comply with; and considering     toilet. OSHA uses an exposure
 ways to limit the scope of the           profile to determine which
 standard if it can be ascertained that   workers will be affected by
 certain processes do not represent a     the standards. As a result, in
 significant risk.                        General Industry and Maritime,
                                          the final standards require
                                          regulated areas where
                                          exposures can exceed the PEL
                                          or STEL. In General Industry,
                                          beryllium work areas must be
                                          established in areas that
                                          contain a process or operation
                                          that can release beryllium
                                          where employees are, or can
                                          reasonably be expected to be,
                                          exposed to airborne beryllium
                                          at any level or where there is
                                          the potential for dermal
                                          contact with beryllium.
                                         In Construction, the written
                                          exposure control plan must
                                          contain procedures used to
                                          restrict access to work areas
                                          when airborne exposures are,
                                          or can reasonably be expected
                                          to be, above the TWA PEL or
                                          STEL, and the competent person
                                          must implement the plan.
                                         In addition, the scope of the
                                          final standards includes
                                          several limitations. Whereas
                                          the standard presented in the
                                          SBAR panel report covered
                                          beryllium in all forms and
                                          compounds in general industry,
                                          construction, and maritime,
                                          the scope of the final
                                          standard (1) does not apply to
                                          beryllium-containing articles
                                          that the employer does not
                                          process; and (2) does not
                                          apply to materials that
                                          contain less than 0.1%
                                          beryllium by weight where the
                                          employer has objective data
                                          demonstrating that employee
                                          exposure to beryllium will
                                          remain below the action level
                                          as an 8-hour TWA under any
                                          foreseeable conditions. In the
                                          preamble to the final
                                          standards, OSHA discusses the
                                          issue of objective data. While
                                          OSHA recognizes that some
                                          establishments will have
                                          objective data, for purposes
                                          of this rule, the Agency is
                                          choosing to assume that no
                                          establishments will use
                                          objective data. The Agency
                                          recognizes that this will
                                          overestimate costs.

[[Page 2627]]

 
PEL-only standard: One SER recommended   OSHA considered Regulatory
 a PEL-only standard. This would          Alternative #7, a PEL-only
 protect employees from airborne          standard. This alternative is
 exposure risks while relieving the       discussed in Chapter VIII of
 beryllium industry of the cost of the    the FEA.
 ancillary provisions. The Panel
 recommends that OSHA, consistent with
 its statutory obligations, analyze
 this alternative.
Alternative triggers for ancillary       OSHA has removed skin exposure
 provisions: The Panel recommends that    as a trigger for several
 OSHA clarify and consider eliminating    ancillary provisions in the
 or narrowing the triggers for            final standard, including
 ancillary provisions associated with     Exposure Monitoring and
 skin exposure or contamination. In       Medical Surveillance. In
 addition, the Panel recommends that      General Industry, the employer
 OSHA should consider trying ancillary    must ensure that employees who
 provisions dependent on exposure         have dermal contact with
 rather than have these provisions all    beryllium wash any exposed
 take effect with the same trigger. If    skin at the end of the
 OSHA does rely on a trigger related to   activity, process, or work
 skin exposure, OSHA should thoroughly    shift and prior to eating,
 explain and justify this approach        drinking, smoking, chewing
 based on an analysis of the scientific   tobacco or gum, applying
 or research literature that shows a      cosmetics, or using the
 risk of sensitization via exposure to    toilet.
 skin. If OSHA adopts a relatively low   In Construction and Maritime,
 PEL, OSHA should consider the effects    for each employee required to
 of alternative airborne action levels    use personal protective
 in pulling in many low risk facilities   clothing or equipment, the
 that may be unlikely to exceed the       employer must ensure that
 PEL--and consider using only the PEL     employees who have dermal
 as a trigger at very low levels.         contact with beryllium wash
                                          any exposed skin at the end of
                                          the activity, process, or work
                                          shift and prior to eating,
                                          drinking, smoking, chewing
                                          tobacco or gum, applying
                                          cosmetics, or using the
                                          toilet.
                                         In addition, the language of
                                          the final standard regarding
                                          skin exposure has changed: For
                                          some ancillary provisions,
                                          including PPE and
                                          Housekeeping, the requirements
                                          are triggered by visible
                                          contamination with beryllium
                                          or skin contact with beryllium
                                          compounds.
                                         These requirements are
                                          discussed in the preamble at
                                          Section XVI, Summary and
                                          Explanation of the Standards.
                                         OSHA has explained the
                                          scientific basis for
                                          minimizing skin exposure to
                                          beryllium in the preamble to
                                          the final rule at Section V,
                                          Health Effects, and explains
                                          the basis for specific
                                          ancillary provisions related
                                          to skin exposure in the
                                          preamble at Section XVI,
                                          Summary and Explanation of the
                                          Standards. In the final
                                          standards, the application of
                                          ancillary provisions is
                                          dependent on exposure, and not
                                          all provisions take effect
                                          with the same trigger. A
                                          number of requirements are
                                          triggered by exposures (or a
                                          reasonable expectation of
                                          exposures) above the PEL or
                                          action level (AL). As
                                          discussed above, OSHA
                                          considered Regulatory
                                          Alternatives #7 and #8, which
                                          would eliminate or reduce the
                                          impact of ancillary provisions
                                          on employers, respectively.
                                          These alternatives are
                                          discussed in Chapter VIII of
                                          the FEA.
Revise the medical surveillance          After considering comments from
 provisions, including eliminating the    SERs, OSHA has revised the
 BeLPT: The BeLPT was the most common     medical surveillance provision
 complaint from SERs. The Panel           and removed the skin exposure
 recommends that OSHA carefully examine   trigger for medical
 the value of the BeLPT and consider      surveillance. As a result,
 whether it should be a requirement of    OSHA estimates that the number
 a medical surveillance program. The      of small-business employees
 Panel recommends that OSHA present the   requiring a BELPT will be
 scientific evidence that supports the    substantially reduced.
 use of the BeLPT as several SERs were   OSHA has provided discussion of
 doubtful of its reliability. The Panel   the BeLPT in the preamble to
 recommends that OSHA also consider       the final rule at section V,
 reducing the frequency of physicals      Health Effects; and in the
 and the BeLPT, if these provisions are   preamble at section XVI,
 included in a proposal. The Panel        Summary and Explanation of the
 recommends that OSHA also consider a     Standards, (b) Definitions and
 performance-based medical surveillance   (k) Medical Surveillance. In
 program, permitting employers in         the regulatory text, OSHA has
 consultation with physicians and         clarified that a test for
 health experts to develop appropriate    beryllium sensitization other
 tests and their frequency.               than the BeLPT may be used in
                                          lieu of the BeLPT if a more
                                          reliable and accurate
                                          diagnostic test is developed.
                                         The frequency of periodic BeLPT
                                          testing in the final standard
                                          is biennial, whereas annual
                                          testing was included in the
                                          draft standard presented to
                                          the SBAR Panel.
                                         Regulatory Alternative #20
                                          would reduce the frequency of
                                          physical examinations from
                                          biennial to annual, matching
                                          the frequency of BeLPT testing
                                          in the final rule.
                                         In response to the suggestion
                                          to allow performance-based
                                          medical surveillance, OSHA
                                          considered two regulatory
                                          alternatives that would
                                          provide greater flexibility in
                                          the program of tests provided
                                          as part of an employer's
                                          medical surveillance program.
                                          Regulatory Alternative #16
                                          would eliminate BeLPT testing
                                          requirements from the final
                                          standard. Regulatory
                                          Alternative #18 would
                                          eliminate the CT scan
                                          requirement from the final
                                          standard. These alternatives
                                          are discussed in the
                                          Regulatory Alternatives
                                          Chapter and in the preamble at
                                          Section XVI, Summary and
                                          Explanation of the Standards,
                                          (k) Medical Surveillance.

[[Page 2628]]

 
No medical removal protection (MRP):     The final standard includes an
 OSHA's draft proposed standard did not   MRP provision. OSHA discusses
 include any provision for medical        the basis of the provision in
 removal protection, but OSHA did ask     the preamble at Section XVI,
 the SERs to comment on MRP as a          Summary and Explanation of the
 possibility. Based on the SER            Standards, (l) Medical Removal
 comments, the Panel recommends that if   Protection. OSHA provides an
 OSHA includes an MRP provision, the      analysis of costs and economic
 agency provide a thorough analysis of    impacts of the provision in
 why such a provision is needed, what     the FEA in Chapter V and
 it might accomplish, and what its full   Chapter VI, respectively.
 costs and economic impacts on those     The Agency considered
 small businesses that need to use it     Alternative #22, which would
 might be.                                eliminate the MRP requirement
                                          from the standard. This
                                          alternative is discussed in
                                          the Regulatory Alternatives
                                          Chapter and in the preamble at
                                          section XVI, Summary and
                                          Explanation of the Standards,
                                          (l) Medical Removal
                                          Protection.
------------------------------------------------------------------------

IX. OMB Review Under the Paperwork Reduction Act of 1995

Introduction

    The three final beryllium standards (collectively ``the 
standards'') for occupational exposure to beryllium--general industry 
(29 CFR 1910.1024), construction (29 CFR 1926.1124), and shipyard (29 
CFR 1915.1024)--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 1995 (PRA), 44 U.S.C. 
3501 et seq, and OMB's regulations at 5 CFR part 1320. The PRA requires 
that agencies obtain approval from OMB before conducting any collection 
of information (44 U.S.C. 3507). The PRA defines ``collection of 
information'' to mean ``the obtaining, causing to be obtained, 
soliciting, or requiring the disclosure to third parties or the public, 
of facts or opinions by or for an agency, regardless of form or 
format'' (44 U.S.C. 3502(3)(A)).
    In accordance with the PRA (44 U.S.C. 3506(c)(2)), OSHA solicited 
public comments on the Beryllium Standard for General Industry (29 CFR 
1910.1024), Information Collection Request (ICR) (paperwork burden hour 
and cost analysis) for the proposed rule (80 FR 47555). The Department 
submitted this ICR to OMB for review in accordance with 44 U.S.C. 
3507(d) on August 7, 2015. A copy of this ICR is available to the 
public at http://www.reginfo.gov/public/do/PRAOMBHistory?ombControlNumber=1218-0267).
    On October 21, 2015, OMB issued a Notice of Action (NOA) assigning 
Beryllium Standard for General Industry new OMB Control Number 1218-
0267 to use in future paperwork submissions involving this rulemaking. 
OMB requested that, ``Prior to publication of the final rule, the 
agency should provide a summary of any comments related to the 
information collection and their response, including any changes made 
to the ICR as a result of comments. In addition, the agency must enter 
the correct burden estimates.''
    The proposed rule invited the public to submit comments to OMB, in 
addition to OSHA, on the proposed collections of information with 
regard to the following:
     Whether the proposed collections of information 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 collections of information, 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 (78 FR 56438).
    No public comments were received specifically in response to the 
proposed ICR submitted to OMB for review. However, several public 
comments submitted in response to the Notice of Proposed Rulemaking 
(NPRM), described earlier in this preamble, substantively addressed 
provisions containing collections of information and contained 
information relevant to the burden hour and costs analysis. These 
comments are addressed in the preamble, and OSHA considered them when 
it developed the revised ICR associated with these final standards.
    The Department of Labor submitted the final ICR January 9, 2017 
containing a full analysis and description of the burden hours and 
costs associated with the collections of information of the standards 
to OMB for approval. A copy of the ICR is available to the public at 
http://www.reginfo.gov. OSHA will publish a separate notice in the 
Federal Register that will announce the results of OMB's review. That 
notice will also include a list of OMB approved collections of 
information and total burden hours and costs imposed by the new 
standards.
    Under the PRA, Federal agency cannot conduct or sponsor a 
collection of information unless it is approved by OMB under the PRA, 
and the collection of information notice displays a currently valid OMB 
control number (44 U.S.C. 3507(a)(3)). Also, notwithstanding any other 
provision of law, no employer 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 (44 
U.S.C. 3512). The major collections of information found in the 
standards are listed below.

Summary of Information Collection Requirements

    The Beryllium 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 the exposures to beryllium and beryllium 
compounds, the medical effects of such exposures, and the means to 
reduce the risk of overexposures to beryllium and beryllium compounds. 
In the final ICR, OSHA has expanded its coverage to include the 
construction and shipyard industries--in order to tailor the collection 
of information requirements to the circumstances found in these 
sectors. The decision to include standards for construction and 
shipyards is based on information and comment submitted in response to 
the NPRM request for comment, and during the informal public hearing.
    1. Title: Beryllium (29 CFR 1910.1024; 29 CFR 1915.1024; 29 CFR 
1926. 1124).
    2. Type of Review: New.
    3. OMB Control Number: 1218-0267.
    4. Affected Public: Business or other for-profit. This standard 
applies to employers in general industry, shipyard, and construction 
who have employees that may have occupational exposures to any form of 
beryllium, including compounds and mixtures, except those articles and 
materials exempted by paragraphs (a)(2) and (a)(3) of the Final 
standard.

[[Page 2629]]

    5. Number of Respondents: 5,872 affected employers.
    6. Frequency of Responses: On occasion; quarterly, semi-annually, 
annual; biannual.
    7. Number of Responses: 246,433.
    8. Average Time per Response: Varies from 5 minutes (.08 hours) for 
a clerical worker to generate and maintain an employee medical record, 
to more than 8 hours for a human resource manager to develop and 
implement a written exposure control plan.
    9. Estimated Total Burden Hours: 196,894.
    10. Estimated Cost (capital-operation and maintenance): 
$46,158,266.

Discussion of Significant Changes in the Collections of Information 
Requirements

    Below is a summary of the collection of information requirements 
contained in the final rule, and a brief description of the most 
significant changes between the proposal and the final rule portions of 
the regulatory text containing collection of information requirements. 
One of the most significant changes between the NPRM and this final 
rule is that OSHA extended the scope of the rule so that the most of 
the provisions now also apply to construction and shipyard work. As a 
result, while most of the provisions are identical across all three 
standards (general industry, construction, and shipyards), there are 
technically more collections of information. However, for purposes of 
the review and explanation that follows, OSHA has focused on the 
changes to the general industry provisions and has not separately 
identified the additions to the construction and shipyard standard 
unless they deviate from the requirements in the general industry 
standard. A more detailed discussion of all the changes made to the 
proposed rule, including the requirements that include identified 
collection of information, is in Section XVIII: Summary and 
Explanation. The impact on information collections is also discussed in 
more detail in Item 8 of the ICR.

Exposure Assessment

    Paragraph (d) sets forth requirements for assessing employee 
exposures to beryllium. Consistent with the definition of ``airborne 
exposure'' in paragraph (b) of these standards, exposure monitoring 
results must reflect the exposure to airborne beryllium that would 
occur if the employee were not using a respirator.
    Proposed paragraph (d) used the term ``Exposure monitoring.'' In 
the final rule, this term was changed to ``Exposure assessment'' 
throughout the paragraph. This change in the final standards was made 
to align the provision's purpose with the broader concept of exposure 
assessment beyond conducting air monitoring, including the use of 
objective data.
    OSHA added a paragraph (d)(2) as an alternative exposure assessment 
method to the scheduled monitoring requirements in the proposed rule. 
Under this option employers must assess 8-hour TWA exposure and the 15-
minute short term exposure for each employee using any combination of 
air monitoring data and objective data sufficient to accurately 
characterize airborne exposure to beryllium.
    Proposed paragraph (d)(3), Periodic Exposure Monitoring, would have 
required employers whose initial monitoring results indicated that 
employee's exposures results are at or above the action level and at or 
below the TWA PEL to conduct periodic exposure monitoring at least 
annually. Final paragraph (d)(3), Scheduled Monitoring Option, 
increased the frequency schedule for periodic monitoring and added a 
requirement to perform periodic exposure monitoring when exposures are 
above the PEL, paragraph (d)(3)(vi) and when exposures are above the 
STEL in paragraph (d)(3)(viii).
    Proposed paragraph (d)(4) would have required employers to conduct 
exposure monitoring within 30 days after a change in production 
processes, equipment, materials, personnel, work practices, or control 
methods that could reasonably be expected to result in new or 
additional exposures. OSHA changed the proposed requirement to require 
that employers perform reassessment of exposures when there is a change 
in ``production, process, control equipment, personnel, or work 
practices'' that may reasonably be expected to result in new or 
additional exposures at or above the action level or STEL. In addition, 
OSHA added ``at or above the action level or STEL'' to final paragraph 
(d)(4). In summary, the final rule requires that employers must perform 
reassessment of exposures when there is a change in production, 
process, control equipment, personnel, or work practices that may 
reasonably be expected to result in new or additional exposures at or 
above the action level or STEL.
    Proposed paragraph (d)(5)(i), Employee Notification of Monitoring 
Results, would have required employers in general industry to inform 
their employees of results within 15 working days after receiving the 
results of any exposure monitoring completed under this standard. Final 
paragraph (d)(6), Employee Notification of Assessment Results, requires 
that employers in general industry, construction and shipyards inform 
their employees of results within 15 working days after completing an 
exposure assessment.
    Proposed paragraph (d)(5)(ii) (paragraph (d)(6)(ii) of the final 
standards) would have required that whenever an exposure assessment 
indicates that airborne exposure is above the TWA PEL or STEL, the 
employer must include in the written notification the suspected or 
known sources of exposure and the corrective action(s) the employer has 
taken or will take to reduce exposure to or below the PELs, where 
feasible corrective action exists but had not been implemented when the 
monitoring was conducted. Final paragraph (d)(6)(ii) removes the 
requirement that employers include suspected or known sources of 
exposure in the written notification.

Methods of Compliance

    Proposed paragraph (f)(1)(i) would have required employers to 
establish, implement and maintain a written control plan for beryllium 
work areas. OSHA has retained the requirement for a written exposure 
control plan and incorporated most provisions of the proposed paragraph 
(f)(1)(i) into the final standards for construction and shipyards, with 
certain modifications due to the work processes and worksites 
particular to these sectors.
    Paragraph (f)(1)(i) differs from the proposal in that it requires a 
written exposure control plan for each facility, whereas the proposal 
would have required a written exposure control plan for beryllium work 
areas within each facility. OSHA has modified the requirement of a list 
of operations and job titles reasonably expected to have exposure to 
include those operations and job titles that are reasonably expected to 
have dermal contact with beryllium. Finally, OSHA modified the proposed 
requirement to inventory engineering and work practice controls 
required by paragraph (f)(2) of this standard to include respiratory 
protection.
    Paragraph (f)(1)(ii) of the final standards requires the employer 
to review and evaluate the effectiveness of each written exposure 
control plan at least annually and update it when: (A) Any change in 
production processes, materials, equipment, personnel, work practices, 
or control methods results or can reasonably be expected to result in 
additional or new airborne exposure to beryllium; (B) the employer is 
notified that an employee is eligible for medical removal in accordance 
with paragraph

[[Page 2630]]

(l)(1) of this standard, referred for evaluation at a CBD Diagnostic 
Center, or shows signs or symptoms associated with airborne exposure to 
or dermal contact with beryllium; or (C) the employer has any reason to 
believe that new or additional airborne exposure is occurring or will 
occur.
    OSHA made several changes to that paragraph. First, OSHA added a 
requirement to review and evaluate the effectiveness of each written 
exposure control plan at least annually. Second, OSHA changed the 
proposed language of (f)(1)(ii)(B) to reflect other changes in the 
standard, including a change to ensure that employers are not 
automatically notified of cases of sensitization or CBD among their 
employees. Third, OSHA modified (f)(1)(ii)(B) to clarify the Agency's 
understanding that signs and symptoms of beryllium exposure may be 
related to inhalation or dermal exposure. Finally, OSHA modified the 
wording of (f)(1)(ii) to require the employer to update ``each'' 
written exposure control plan rather than ``the'' written exposure 
control plan, since an employer who operates multiple facilities is 
required to establish, implement and maintain a written exposure 
control plan for each facility.
    Paragraph (f)(1)(iii) of the proposed rule would have required the 
employer to make a copy of the exposure control plan accessible to each 
employee who is or can reasonably be expected to be exposed to airborne 
beryllium in accordance with OSHA's Access to Employee Exposure and 
Medical Records (Records Access) standard (29 CFR 1910.1020(e)). OSHA 
did not receive comments specific to this provision, and has retained 
it in the final standard for general industry and included the 
paragraph in the final standards for construction and shipyards.

Respiratory Protection

    Proposed Paragraph (g) of the standard would have established the 
requirements for the use of respiratory protection. OSHA added language 
to paragraph (g) to clarify that both the selection and use of 
respiratory protection must be in accordance with the Respiratory 
Protection standard 29 CFR 1910.134, which is cross-referenced, and to 
provide a powered air-purifying respirator (PAPR) when requested by an 
employee. The Respiratory protection standard contains collection of 
information requirements, include a written respiratory protection 
program and fit-testing records (29 CFR 1910.134(c)). The collection of 
information requirements contained in the Respiratory Protection 
Program standard are approved under OMB Control Number 1218-0099.

Personal Protective Equipment

    Final paragraph (h)(3)(iii), like proposed paragraph (h)(3), 
requires employers to inform in writing the persons or the business 
entities who launder, clean or repair the protective clothing or 
equipment required by this standard of the potentially harmful effects 
of exposure to airborne beryllium and contact with soluble beryllium 
compounds and how the protective clothing and equipment must be handled 
in accordance with the standard.

Housekeeping

    Paragraph (j)(3) requires warning labels in accordance with the 
requirements in paragraph (m) when employer transfer materials 
containing beryllium. Medical Surveillance Final paragraph (k) sets 
forth requirements for the medical surveillance provisions. The 
paragraph specifies which employees must be offered medical 
surveillance, as well as the frequency and content of medical 
examinations. It also sets forth the information that the licensed 
physician and CBD diagnostic center is to provide to the employee and 
employer.
    In paragraphs (k)(1)(i)(A)-(D) of the proposal, OSHA specified that 
employers must make medical surveillance required by this paragraph 
available for each employee: (1) Who has worked in a regulated area for 
more than 30 days in the last 12 months; (2) showing symptoms or signs 
of CBD, such as shortness of breath after a short walk or climbing 
stairs, persistent dry cough, chest pain, or fatigue; or (3) exposed to 
beryllium during an emergency; and (4) who was exposed to airborne 
beryllium above .2 [mu]g/m\3\ for more than 30 days in a 12-month 
period for 5 years or more, limited to the procedures described in 
paragraph (k)(3)(ii)(F) of this section unless the employee also 
qualifies for an examination under paragraph (k)(1)(i)(A), (B), or (C) 
of this section. OSHA revised the first proposed medical surveillance 
trigger to require the offering of medical surveillance based on 
exposures at or above the action level, rather than the PEL. In 
addition, OSHA revised the proposed trigger to require employers to 
make medical surveillance available to each employee who is or is 
reasonably expected to be exposed at or above the action level for more 
than 30 days a year, rather than waiting for the 30th day of exposure 
to occur.
    Paragraph (k)(1)(i)(B) has been revised to include signs or 
symptoms of other beryllium-related health effects.
    Proposed paragraph (k)(1)(i)(C) required employers to offer medical 
surveillance to employees exposed during an emergency. No revisions 
were made to this paragraph.
    OSHA added final paragraph (k)(1)(i)(D), which requires that 
medical surveillance be made available when the most recent written 
medical opinion to the employer recommends continued medical 
surveillance. Under final paragraphs (k)(6) and (k)(7), the written 
opinion must contain a recommendation for continued periodic medical 
surveillance if the employee is confirmed positive or diagnosed with 
CBD, and the employee provides written authorization.
    Frequency: Proposed paragraph (k)(2) specified when and how 
frequently medical examinations were to be offered to those employees 
covered by the medical surveillance program. Under proposed paragraph 
(k)(2)(i)(A), employers would have been required to provide each 
employee with a medical examination within 30 days after making a 
determination that the employee had worked in a regulated area for more 
than 30 days in the past 12 months, unless the employee had received a 
medical examination provided in accordance with this standard within 
the previous 12 months. OSHA made several changes to this requirement. 
First, OSHA revised the medical surveillance trigger of employees 
working in a regulated area to a determination that employee is or is 
reasonably expected to be exposed at or above the action level for more 
than 30 days of year; or who shows signs or symptoms of CBD or other 
beryllium-related health effects. Second, the Agency changed the 
extended the length of time from within the last 12 months to within 
the last two years.
    Proposed paragraph (k)(2)(ii) required employers to provide an 
examination annually (after the first examination is made available) to 
employees who continue to meet the criteria of proposed paragraph 
(k)(1)(i)(A) or (B). OSHA revised the paragraph to specify that medical 
examinations were to be made available ``at least'' every two years and 
to include employees who continue to meet the criteria of final 
paragraph (k)(1)(i)(D), i.e., each employee whose most recent written 
medical opinion required by paragraph (k)(6) or (k)(7) recommends 
periodic medical surveillance. Under the final standards, employees 
exposed in an

[[Page 2631]]

emergency, who are covered by paragraph (k)(1)(i)(C), are not included 
in the biennial examination requirement unless they also meet the 
criteria of paragraphs (k)(1)(i)(A) or (B) or (D). Final paragraph 
(k)(2)(i)(A) also differs from the proposal in that in the proposed 
paragraph the employer did not have to offer an examination if the 
employee had received an equivalent examination within the last 12 
months. In the final rule, this was increased to within two years to 
align that provision with the frequency of periodic examinations, which 
is every two years in the final rule.
    Proposed paragraph (k)(2)(iii) required the employer to offer a 
medical examination at the termination of employment, if the departing 
employee met any of the criteria of proposed paragraphs (k)(1) at the 
termination of employment for each employee who met the criteria of 
paragraphs (k)(1)(i)(A), (B), or (C), unless an examination has been 
provided in accordance with the standard during the 6 months prior to 
the date of termination.
    Final paragraph (k)(2)(iii) requires the employer to make a medical 
examination available to each employee who meets the criteria of final 
paragraph (k)(1)(i) at the termination of employment, unless the 
employee received an exam meeting the requirements of the standards 
within the last 6 months. OSHA extended the requirement to employees 
who meet the criteria of final paragraph (k)(1)(i)(D).
    Contents of Examination. Paragraph (k)(3) details the contents of 
the examination. Paragraph (k)(3)(i) requires the employer to ensure 
that the PLHCP advised the employee of the risks and benefits of 
participating in the medical surveillance program and the employee's 
right to opt out of any or all parts of the medical examination.
    Paragraphs (k)(3)(ii)(A)-(D) detail the content of the medical 
examination. The final rule made several changes to the content of the 
employee medical examination including, but not limited to, revising 
paragraphs: (k)(3)(ii)(A), to include emphasis on past and present 
airborne exposure to or dermal contact with beryllium; (k)(3)(ii)(C) to 
require a physical examination for skin rashes, rather than an 
examination for breaks and wounds; (k)(3)(ii)(E) to require the BeLPT 
test to be offered ``at least'' every two years, rather than every two 
years; (k)(3)(ii)(F) to include an LDCT scan when recommended by the 
PLHCP. With these changes, final paragraphs (k)(3)(ii)(A)-(D) require 
the medical examination to include: (1) Medical and work history, with 
emphasis on past and present airborne exposure to or dermal contact 
with beryllium, any history of respiratory dysfunction and smoking 
history, and; (2) a physical examination with emphasis on the 
respiratory system; (3) a physical examination for skin rashes; and (4) 
a pulmonary function test, performed in accordance with guidelines 
established by the ATS including forced vital capacity (FVC) and a 
forced expiratory volume in one second (FEV1). A more detailed 
discussion regarding all of the changes to the content of the Medical 
examinations may be found in section XVI, Summary and Explanation of 
the Standards, under (k) Medical Surveillance.

Information Provided to the PLHCP

    Proposed paragraph (k)(4) detailed which information must be 
provided to the PHLCP. Specifically, the proposed standard required the 
employer to provide to the examining PLHCP the following information, 
if known to the employer: A description of the employee's former and 
current duties that relate to the employee's occupational exposure 
((k)(4)(i)); the employee's former and current levels of occupational 
exposure ((k)(4)(ii)); a description of any personal protective 
clothing and equipment, including respirators, used by the employee, 
including when and for how long the employee has used that clothing and 
equipment ((k)(4)(iii)); and information the employer has obtained from 
previous medical examinations provided to the employee, that is 
currently within the employer's control, if the employee provides a 
medical release of the information ((k)(4)(iv)). OSHA made several 
changes to this paragraph. First, OSHA updated paragraph (k)(4)(i) to 
require the employer to provide a description of the employee's former 
and current duties that relate to both the employee's airborne exposure 
to and dermal contact with beryllium, instead of merely requiring the 
provision of information related to occupational exposure. Second, OSHA 
changed the requirement that the employer obtain a ``medical release'' 
from the employee to ``written consent'' before providing the PLHCP 
with information from records of employment-related medical 
examinations. Third, OSHA revised the provision to require that the 
employer ensure that the same information provided to the PLHCP is also 
provided to the agreed-upon CBD diagnostic center, if an evaluation is 
required under paragraph (k)(7) of the standard.

Licensed Physician's Written Medical Opinion

    Paragraph (k)(5) of the proposed standard provided for the licensed 
physician to give a written medical opinion to the employer, but relied 
on the employer to give the employee a copy of that opinion; thus, 
there was no difference between information the employer and employee 
received. The final standards differentiate the types of information 
the employer and employee receive by including two separate paragraphs 
within the medical surveillance section that require a written medical 
report to go to the employee, and a more limited written medical 
opinion to go to the employer. The requirement to provide the medical 
opinion to the employee is in paragraph (k)(5) of the final standards; 
the requirement for providing documentation to the employer is in 
paragraph (k)(6) of the final standards. Most significantly, OSHA 
removed the requirement that the medical opinion pass through the 
employer to the employee.

Licensed Physician's Written Medical Report for the Employee

    Final paragraphs (k)(5)(i)-(v) provide the contents of the licensed 
physician's written medical report for the employee. They include: The 
results of the medical examination, including any medical condition(s), 
such as CBD or beryllium sensitization (i.e., the employee is confirmed 
positive, as is defined in paragraph (b) of the standard), that may 
place the employee at increased risk from further airborne exposure; 
any medical conditions related to airborne exposure that require 
further evaluation or treatment (this requirement was not expressly 
included in the proposal); any recommendations on the employee's use of 
respirators, protective clothing, or equipment; and any recommended 
limitations on airborne beryllium exposure.
    Paragraph (k)(5) also provides that if the employee is confirmed 
positive or diagnosed with CBD, or if the physician otherwise deems it 
appropriate, the written medical report must also contain a referral to 
a CBD diagnostic center, a recommendation for continued medical 
surveillance, and a recommendation for medical removal from airborne 
beryllium exposures above the action level, as described in paragraph 
(l) of the standard. Proposed paragraph (k)(6) also addressed 
information provided to employees who were confirmed positive or 
diagnosed with CBD, but simply required a consultation with the 
physician.

[[Page 2632]]

Licensed Physician's Written Medical Opinion for the Employer

    Paragraph (k)(6)(i) requires employers to obtain a written medical 
opinion from the licensed physician within 45 days of the medical 
examination (including any follow-up BeLPT required under 
(k)(3)(ii)(E)). In proposed (k)(5), the physician would have been 
required to share most of the information identified now provided 
directly to the employee per final (k)(5) with the employer, but in the 
final rule OSHA limited the information that could be shared with the 
employer. In final (k)(6) the written medical opinion for the employer 
must contain only the date of the examination, a statement that the 
examination has met the requirements of this standard, and any 
recommended limitations on the employee's use of respirators, 
protective clothing, and equipment; and a statement that the PLHCP 
explained the results of the examination to the employee, including any 
tests conducted, any medical conditions related to airborne exposure 
that require further evaluation or treatment, and any special 
provisions for use of personal protective clothing or equipment.
    Paragraph (k)(6)(ii) states that if the employee provides written 
authorization, the written medical opinion for the employer must also 
contain any recommended limitations on the employee's airborne exposure 
to beryllium. The requirement for written authorization was not in the 
proposal. Paragraphs (k)(6)(iii)-(v) state that if an employee is 
confirmed positive or diagnosed with CBD and the employee provides 
written authorization, the written opinion must also contain a referral 
for evaluation at a CBD diagnostic center and recommendations for 
continued medical surveillance and medical removal from airborne 
exposure to beryllium as described in paragraph (l).
    Paragraph (k)(6)(vi) requires the employer to ensure that employees 
receive a copy of the written medical opinion for the employer within 
45 days of any medical examination (including any follow-up BeLPT 
required under paragraph (k)(3)(ii)(E) of this standard) performed for 
that employee. A similar requirement was included in proposed 
(k)(5)(iii), but the time period was two weeks.

Beryllium Sensitization Test Results Research (Removed)

    Proposed paragraph (k)(7) would have required employers to convey 
the results of beryllium sensitization tests to OSHA for evaluation and 
analysis at the request of OSHA. Based on comments received during the 
comment period, OSHA decided not to include the proposed paragraph 
(k)(7) in the final standard.

Referral to a Diagnostic Center

    Final paragraph (k)(7) requires that if the employee wants a 
clinical evaluation at a CBD diagnostic center, the employer must 
provide the examination at no cost to the employee. OSHA made several 
changes to final paragraph (k)(7) as compared to similar provisions in 
paragraph (k)(6) of the proposal. First, OSHA changed the trigger for 
referral to a CBD diagnostic center to include both confirmed positive 
and a CBD diagnosis for consistency with final paragraphs (k)(5)(iii) 
and (k)(6)(iii). Second, OSHA removed the requirement for a 
consultation between the physician and employee. However, final 
paragraph (k)(7)(i) requires that employers provide a no-cost 
evaluation at a CBD-diagnostic center that is mutually agreed upon by 
the employee and employer.
    Final paragraph (k)(7) requires the employer to ensure that the 
employee receives a written medical report form the CBD diagnostic 
center that contains all the information required in paragraph 
(k)(5)(i), (ii), (iv) and (v) and that the PLHCP explains the results 
of the examination of the employee within 30 days of the examination.

Communication of Hazards

    Proposed paragraph (m)(1)(i) required chemical manufacturers, 
importers, distributors, and employers to comply with all applicable 
requirements of the HCS (29 CFR 1910.1200) for beryllium. No 
substantive changes were made to this paragraph.
    Proposed paragraph (m)(1)(ii) would have required employers to 
address at least the following, in classifying the hazards of 
beryllium: Cancer; lung effects (chronic beryllium disease and acute 
beryllium disease); beryllium sensitization; skin sensitization; and 
skin, eye, and respiratory tract irritation. According to the HCS, 
employers must classify hazards if they do not rely on the 
classifications of chemical manufacturers, importers, and distributors 
(see 29 CFR 1910.1200(d)(1)). OSHA revised the language to bring it 
into conformity with other substance specific standards so it is clear 
that chemical manufacturers, importers, and distributors are among the 
entities required to classify the hazards of beryllium. OSHA has chosen 
not to include an equivalent requirement in the final standards for 
construction and shipyards since employers in construction and 
shipyards are generally downstream users of beryllium products 
(blasting media) and would not therefore be classifying chemicals.
    Proposed paragraph (m)(1)(iii) would have required employers to 
include beryllium in the hazard communication program established to 
comply with the HCS, and ensure that each employee has access to labels 
on containers and safety data sheets for beryllium and is trained in 
accordance with the HCS and the training paragraph of the standard. The 
final paragraph (m)(1)(iii) applies to the general industry, shipyards, 
and construction. The final provisions are substantively unchanged from 
the proposal.

Recordkeeping

    Paragraph (n) of the final standards sets forth the employer's 
obligation to comply with requirements to maintain records of air 
monitoring data, objective data, medical surveillance, and training.
    Proposed paragraph (n)(1)(i) required employers to maintain records 
of all measurements taken to monitor employee exposure to beryllium as 
required by paragraph (d) of the standard. OSHA made one minor 
modification in the final standard: OSHA added the words ``make and'' 
prior to ``maintain'' in order to clarify that the employer's 
obligation is to create and preserve such records.
    Proposed paragraph (n)(1)(ii) required that records of all 
measurements taken to monitor employee exposure include at least the 
following information: The date of measurement for each sample taken; 
the operation being monitored; the sampling and analytical methods used 
and evidence of their accuracy; the number, duration, and results of 
samples taken; the type of personal protective clothing and equipment, 
including respirators, worn by monitored employees at the time of 
monitoring; and the name, social security number, and job 
classification of each employee represented by the monitoring, 
indicating which employees were actually monitored. OSHA has made one 
editorial modification to paragraph (n)(1)(ii)(B), which is to change 
``operation'' to ``task.'' Proposed paragraph (n)(1)(iii) required 
employers to maintain employee exposure monitoring records in 
accordance with 29 CFR 1910.1020(d)(1)(ii). OSHA has changed the 
requirement that the employer ``maintain this record as required by'' 
OSHA's Records Access standard to ``ensure that exposure records are 
maintained and made available in accordance with'' that standard.

[[Page 2633]]

Proposed Paragraph (n)(2) Historical Monitoring Data (Removed)
    Proposed paragraph (n)(2) contained the requirement to retain 
records of any historical monitoring data used to satisfy the proposed 
standard's the initial monitoring requirements. OSHA deleted the 
separate recordkeeping requirement for historical data.
Final (n)(2)(i), (ii), and (iii) Objective Data
    As a result of deleting paragraph (n)(2) Historical Data, OSHA has 
included proposed paragraph (n)(3) as paragraph (n)(2) in the final 
standards, with minor alterations. Paragraph (n)(2) contains the 
requirements to keep accurate records of objective data. Paragraph 
(n)(2)(i) requires employers to establish and maintain accurate records 
of the objective data relied upon to satisfy the requirement for 
initial monitoring in paragraph (d)(2). Under paragraph (n)(2)(ii), the 
record is required to contain at least the following information: (A) 
The data relied upon; (B) the beryllium-containing material in 
question; (C) source of the data; (D) description of the process, task, 
or activity on which the objective data were based; (E) other data 
relevant to the process, task, activity, material, or airborne exposure 
on which the objective data were based. These requirements included 
minor changes in the description of the last two changes, but were not 
substantively different.
    Paragraph (n)(2)(iii) of the final standard (paragraph (n)(3)(iii) 
in the proposal) requires the employer to maintain a record of 
objective data relied upon as required by the Records Access standard, 
which specifies that exposure records must be maintained for 30 years 
(29 CFR 1910.1020(d)(1)(ii)).
Paragraph (n)(3)(i), (ii), & (iii) Medical Surveillance Records
    Paragraph (n)(3) of the final standards (paragraph (n)(4) in the 
proposal), addresses medical surveillance records. Employers must 
establish and maintain medical surveillance records for each employee 
covered by the medical surveillance requirements in paragraph (k). 
Paragraph (n)(3)(ii) lists the categories of information that an 
employer was required to record: The employee's name, social security 
number, and job classification; a copy of all licensed physicians' 
written medical opinions; and a copy of the information provided to the 
PLHCP. OSHA has moved the requirement that the record include copies of 
all licensed physicians' written opinions from proposed paragraph 
(n)(4)(ii)(B) to paragraph (n)(3)(ii)(B) of the final standards.
    Proposed paragraph (n)(4)(iii) required the employer to maintain 
employee medical records in accordance with OSHA's Records Access 
Standard at 29 CFR 1910.1020. OSHA has added ``and made available'' 
after ``maintained'' in final paragraph (n)(3)(iii) of the standards, 
but the requirement is otherwise unchanged.
Paragraph (n)(4)(i) and (ii) Training Records
    Paragraph (n)(4) of the final standards (paragraph (n)(5) of the 
proposal) requires employers to preserve training records, including 
records of annual retraining or additional training, for a period of 
three years after the completion of the training. At the completion of 
training, the employer is required to prepare a record that includes 
the name, social security number, and job classification of each 
employee trained; the date the training was completed; and the topic of 
the training. This record maintenance requirement also applied to 
records of annual retraining or additional training as described in 
paragraph (m)(4). This paragraph is substantively unchanged from the 
proposal.
Paragraph (n)(5) Access to Records
    Paragraph (n)(5) of the final standards (paragraph (n)(6) of the 
proposal), requires employers to make all records mandated by these 
standards available for examination and copying to the Assistant 
Secretary, the Director of NIOSH, each employee, and each employee's 
designated representative as stipulated by OSHA's Records Access 
standard (29 CFR 1910.1020). This paragraph is substantively unchanged 
from the proposal.
Paragraph (n)(6) Training Records
    Paragraph (n)(6) of the final standards (paragraph (n)(6) in the 
proposal), requires that employers comply with the Records Access 
standard regarding the transfer of records, 29 CFR 1910.1020(h), which 
instructs employers either to transfer records to successor employers 
or, if there is no successor employer, to inform employees of their 
access rights at least three months before the cessation of the 
employer's business. This paragraph is substantively unchanged from the 
proposal.

X. Federalism

    OSHA reviewed the final beryllium rule according to the most recent 
Executive Order (``E.O.'') on Federalism, E.O. 13132, 64 FR 43255 (Aug. 
10, 1999). The E.O. 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 only when clear constitutional authority 
exists and the problem is of national scope. The E.O. allows Federal 
agencies to preempt State law only with the expressed consent of 
Congress. In such cases, Federal agencies must limit preemption of 
State law to the extent possible.
    Under Section 18 of the Occupational Safety and Health Act (the 
``Act'' or ``OSH Act''), 29 U.S.C. 667, Congress expressly provides 
that States may adopt, with Federal approval, a plan for the 
development and enforcement of occupational safety and health 
standards. OSHA refers to States that obtain Federal approval for such 
plans 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 
occupational safety and health standards.
    While OSHA wrote this final rule to protect employees in every 
State, Section 18(c)(2) of the OSH Act permits State-Plan States to 
develop and enforce their own standards, provided those standards 
require workplaces to be at least as safe and healthful as this final 
rule requires. Additionally, standards promulgated under the OSH Act do 
not apply to any worker whose employer is a state or local government. 
29 U.S.C. 652(5).
    This final rule complies with E.O. 13132. In States without OSHA-
approved State plans, Congress expressly provides for OSHA standards to 
preempt State occupational safety and health standards in areas 
addressed by the Federal standards. In these States, this rule limits 
State policy options in the same manner as every standard promulgated 
by the Agency. In States with OSHA-approved State plans, this 
rulemaking does not significantly limit State policy options to adopt 
stricter standards.

XI. State-Plan States

    When Federal OSHA promulgates a new standard or a more stringent 
amendment to an existing standard, the States and U.S. territories with 
their own OSHA-approved occupational safety and health plans (``State-
Plan

[[Page 2634]]

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). Currently, there are 28 State-Plan States.
    A State-Plan State may demonstrate that a standard change is not 
necessary because the State standard is already the same as or at least 
as effective as the new or amended Federal standard. 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 28 States and territories with OSHA-approved State plans, 22 
cover public and private-sector employees: Alaska, Arizona, California, 
Hawaii, Indiana, Iowa, Kentucky, Maryland, Michigan, Minnesota, Nevada, 
New Mexico, North Carolina, Oregon, Puerto Rico, South Carolina, 
Tennessee, Utah, Vermont, Virginia, Washington, and Wyoming. The 
remaining six states and territories cover only public-sector 
employees: Connecticut, Illinois, New Jersey, Maine, New York, and the 
Virgin Islands.
    This beryllium rule applies to general industry, construction, and 
shipyards. This rule requires that all State-Plan States revise their 
standards appropriately within six months of the date of this notice.

XII. Unfunded Mandates Reform Act

    Under Section 202 of the Unfunded Mandates Reform Act of 1995 
(``UMRA''), 2 U.S.C. 1532, an agency must prepare a written 
``qualitative and quantitative assessment'' of any regulation creating 
a mandate that ``may result in the expenditure by the State, local, and 
tribal governments, in the aggregate, or by the private sector, of 
$100,000,000 or more (adjusted annually for inflation)'' in any one 
year before promulgating a final rule. OSHA's rule 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. 29 U.S.C. 652(5). Under voluntary agreement with 
OSHA, some States require public sector entities to comply with State 
standards, and these agreements specify that these State standards must 
be at least as protective as OSHA standards. The OSH Act does not cover 
tribal governments in the performance of traditional governmental 
functions, though it does cover tribal governments when they engage in 
commercial activity. However, the final rule will not require tribal 
governments to expend, in the aggregate, $100,000,000 or more in any 
one year for their commercial activities. Thus, the final rule does not 
trigger the requirements of UMRA based on its impact on State, local, 
or tribal governments.
    Based on the analysis presented in the Final Economic Analysis (see 
Section VIII above), OSHA concludes that the rule would not impose a 
Federal mandate on the private sector in excess of $100 million 
(adjusted annually for inflation) in expenditures in any one year. As 
noted below, OSHA also reviewed this final rule in accordance with E.O. 
13175 on Consultation and Coordination with Indian Tribal Governments, 
65 FR 67249 (Nov. 9, 2000), and determined that it does not have 
``tribal implications'' as defined in that Order.

XIII. Protecting Children From Environmental Health and Safety Risks

    E.O. 13045, 66 FR 19931 (Apr. 23, 2003), requires that Federal 
agencies submitting covered regulatory actions to OMB's Office of 
Information and Regulatory Affairs (``OIRA'') for review pursuant to 
E.O. 12866, 58 FR 51735 (Oct. 4, 1993), must provide OIRA with (1) an 
evaluation of the environmental health or safety effects that the 
planned regulation may have on children, and (2) an explanation of why 
the planned regulation is preferable to other potentially effective and 
reasonably feasible alternatives considered by the agency. E.O. 13045 
defines ``covered regulatory actions'' as rules that may (1) be 
economically significant under E.O. 12866 (i.e., a rulemaking that has 
an annual effect on the economy of $100 million or more, or would 
adversely affect in a material way the economy, a sector of the 
economy, productivity, competition, jobs, the environment, public 
health or safety, or State, local, or tribal governments or 
communities), and (2) concern an environmental health risk or safety 
risk that an agency has reason to believe may disproportionately affect 
children. In this context, the term ``environmental health risks and 
safety risks'' means risks to health or safety that are attributable to 
products or substances that children are likely to come in contact with 
or ingest (e.g., through air, food, water, soil, or product use).
    The final beryllium rule is economically significant under E.O. 
12866 (see Section IX of this preamble). However, after reviewing the 
rule, OSHA has determined that it will not impose environmental health 
or safety risks to children as set forth in E.O. 13045. The final rule 
will require employers to limit employee exposure to beryllium and take 
other precautions to protect employees from adverse health effects 
associated with exposure to beryllium. OSHA is not aware of any studies 
showing that exposure to beryllium in workplaces disproportionately 
affects children, who typically are not allowed in workplaces where 
such exposure exists. OSHA is also not aware that there are a 
significant number of employees under 18 years of age who may be 
exposed to beryllium, or that employees of that age are 
disproportionately affected by such exposure. One commenter, Kimberly-
Clark Professional, noted that children may be subject to secondary 
beryllium exposure due to beryllium particles being carried home on 
their parents' work clothing, shoes, and hair (Document ID 1962, p. 2). 
Commenter Evan Shoemaker also noted that ``beryllium can collect on 
surfaces such as shoes, clothing, and hair as well as vehicles leading 
to contamination of the family and friends of workers exposed to 
beryllium'' (Document ID 1658, p. 3). However, OSHA does not believe 
beryllium exposure disproportionately affects children or that 
beryllium particles brought home on work clothing, shoes, and hair 
result in exposures at or near the action level. Furthermore, Kimberly-
Clark Professional also noted that potential secondary exposures can be 
controlled through the use of personal protective equipment in the 
workplace (Document ID 1676, p. 2). The final standards contain 
ancillary provisions, such as personal protective clothing and hygiene 
areas, which are specifically designed to minimize the amount of 
beryllium leaving the workplace. Therefore, OSHA believes that the 
final beryllium rule does not constitute a covered regulatory action as 
defined by E.O. 13045.

XIV. Environmental Impacts

    OSHA has reviewed the final beryllium rule according to the 
National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321 et 
seq.), the regulations of the Council on Environmental Quality (40 CFR 
part 1500), and the Department of Labor's NEPA procedures (29 CFR part 
11). OSHA made a preliminary determination that the proposed

[[Page 2635]]

standard would have no significant impact on air, water, or soil 
quality; plant or animal life; the use of land or aspects of the 
external environment. No comments to the record questioned this 
determination, nor has the Agency found other evidence to invalidate 
it. Therefore, OSHA concludes that the final beryllium standard will 
have no significant environmental impacts.

XV. Consultation and Coordination With Indian Tribal Governments

    OSHA reviewed this final rule in accordance with E.O. 13175 on 
Consultation and Coordination with Indian Tribal Governments, 65 FR 
67249 (Nov. 9, 2000), and determined that it does not have ``tribal 
implications'' as defined in that order. The OSH Act does not cover 
tribal governments in the performance of traditional governmental 
functions, so the rule will not have substantial direct effects on one 
or more Indian tribes in their sovereign capacity, on the relationship 
between the Federal government and Indian tribes, or on the 
distribution of power and responsibilities between the Federal 
government and Indian tribes. On the other hand, employees in 
commercial businesses owned by tribes or tribal members will receive 
the same protections and benefits of the standard as all other covered 
employees.

XVI. Summary and Explanation of the Standards

    OSHA proposed a standard for occupational exposure to beryllium and 
beryllium compounds in general industry and proposed regulatory 
alternatives to address beryllium exposures in the construction and 
maritime industries. The proposed standard for general industry was 
structured according to OSHA's traditional approach, with permissible 
exposure limits, and ancillary provisions such as exposure assessment, 
methods of compliance, and medical surveillance. As discussed below, 
OSHA based the proposal substantively on a joint industry and labor 
stakeholders' draft occupational health standard developed and 
submitted to OSHA by Materion Corporation (Materion) and the United 
Steelworkers (USW). The final rule, however, is based on the entirety 
of the rulemaking record.
    In the final rule, OSHA is expanding coverage to include the 
construction and shipyard industries and establishing separate final 
standards for occupational exposure to beryllium in general industry, 
construction, and shipyards. In the NPRM, OSHA discussed Regulatory 
Alternative 2a to include both the construction and shipyard industries 
in the final rule (80 FR 47732-47734), presented estimated costs and 
benefits associated with extending the scope of the final rule, and 
requested comment on the alternative. The decision to include standards 
for construction and shipyards is based on information and comment 
submitted in response to this request for comment and evaluated by OSHA 
during the public comment periods and the informal public hearing. OSHA 
decided to issue three separate standards because there are some 
variations in the standards for each industry, although the structure 
of the final standards for general industry, construction, and 
shipyards remains generally consistent with other OSHA health 
standards. The most significant change is in the standard for 
construction where paragraph (e) Competent person, replaces paragraph 
(e) Beryllium work areas and regulated areas in general industry and 
paragraph (e) Regulated areas in shipyards.
    All three final standards have a provision for methods of 
compliance, although in the standard for construction this provision 
has an additional requirement to describe procedures used by the 
designated competent person to restrict access to work areas, when 
necessary, to minimize the number of employees exposed to airborne 
beryllium above the PEL or STEL. This requirement allows the competent 
person to perform essentially the same role as the requirement 
governing regulated areas in general industry and shipyards, which is 
to regulate and minimize the number of workers exposed to hazardous 
levels of beryllium. OSHA decided to include a competent person 
provision in the final standard for construction because of the 
industry's familiarity with this concept and its past successful use in 
many OSHA construction standards and documents. ``Competent person'' is 
defined in OSHA's Safety and Health Regulations for Construction (29 
CFR 1926.32(f)) as being a person who is capable of identifying 
existing and predictable hazards in the surroundings or working 
conditions which are unsanitary, hazardous, or dangerous to employees, 
and who has authorization to take prompt corrective measures to 
eliminate them. This generally applicable definition corresponds well 
with the definition for ``competent person'' in the standard for 
construction: In this context, ``competent person'' means an individual 
who is capable of identifying existing and foreseeable beryllium 
hazards in the workplace and who has authorization to take prompt 
corrective measures to eliminate or minimize them. The competent person 
must have the knowledge, ability, and authority necessary to fulfill 
the responsibilities set forth in paragraph (e) of this standard.
    OSHA has retained, in modified form, the scope exemption from the 
proposed standard for materials containing less than 0.1 percent 
beryllium by weight in the standard for general industry and included 
it in the standards for construction and shipyards. The scope exemption 
has been modified in the final standards with the additional 
requirement that the employer must have objective data demonstrating 
that employee exposure to beryllium will remain below the action level 
as an 8-hour TWA under any foreseeable conditions. The 0.1 percent 
exemption was generally supported by commenters from general industry 
and shipyards; construction employers did not comment. Other 
commenters, especially those representing workers or public health 
organizations, expressed concern that these materials, in some cases, 
could expose workers to hazardous levels of beryllium. As discussed in 
more detail in the summary and explanation for Scope and application, 
the objective data requirement addresses these concerns and ensures the 
protection of workers who experience significant exposures from 
materials containing trace amounts of beryllium. Employers who have 
objective data showing that employees will not be exposed at or above 
the action level under any foreseeable conditions when processing 
materials containing less than 0.1 percent beryllium by weight are 
exempt from the standard.
    OSHA decided to add a performance option in paragraph (d), Exposure 
assessment, as an alternative exposure assessment method to the 
scheduled monitoring requirements in the proposed rule, based on public 
comment received from industry and labor. OSHA believes the performance 
option, which encompasses either exposure monitoring or assessments 
based on objective data, gives employers flexibility in determining 
employee exposure to beryllium based on to their unique workplace 
circumstances. OSHA has provided this performance option in recent 
health standards such as respirable crystalline silica (29 CFR 
1910.1053(d)(2)) and chromium VI (29 CFR 1910.1026(d)(3)).
    OSHA also received comments about other provisions in the proposed 
standard, and in some cases, OSHA responded with changes from the

[[Page 2636]]

proposed rule that were based on the evidence provided in the record. 
Any changes made to the provisions in the final standards are described 
in detail in their specific summary and explanation sections.
    Although details of the final standards for general industry, 
construction, and shipyards differ slightly, most of the requirements 
are the same or similar in all three standards. Therefore, the summary 
and explanation is organized according to the main requirements of the 
standards, but includes paragraph references to the standards for 
general industry, construction, and shipyards. The summary and 
explanation uses the term ``standards'' or ``final standards'' when 
referring to all three standards. Generally, when the summary and 
explanation refers to the term ``standards,'' it is referring to the 
final standards. To avoid confusion, the term ``final rule'' is 
sometimes used when making a comparison to or clarifying a change from 
the proposed rule.
    The proposed rule applied to occupational exposure to beryllium in 
all forms, compounds, and mixtures in general industry, except those 
articles and materials exempted by proposed paragraphs (a)(2) and 
(a)(3) of the proposed standard. The final standards are identical in 
their application to occupational exposures to beryllium. In the 
summary and explanation sections, OSHA has changed ``beryllium and 
beryllium compounds'' or anything specifying soluble beryllium to just 
``beryllium.'' OSHA intends the term ``beryllium'' to cover all forms 
of beryllium, including compounds and mixtures, both soluble and poorly 
soluble, throughout the summary and explanation sections. Other global 
changes in the regulatory text include changing ``shall'' to ``must'' 
to make it clear when a provision is a requirement and adding 
``personal'' to ``protective clothing or equipment'' and ``protective 
clothing and equipment'' consistently. OSHA has changed ``exposure'' to 
``airborne exposure'' to make it clear when referring to just airborne 
exposure, and specifically noting when OSHA intends to cover dermal 
contact.
    As noted above, OSHA's proposed rule was based, in part, upon a 
draft occupational health standard submitted to the Agency by Materion, 
the leading producer of beryllium and beryllium products in the United 
States, and USW, an international labor union representing workers who 
manufacture beryllium alloys and beryllium-containing products in a 
number of industries (Document ID 0754). Materion and USW worked 
together to craft a model beryllium standard that OSHA could adopt and 
that would have support from both labor and industry. They submitted 
their joint draft standard to OSHA in February 2012.
    Like the proposal, many of the provisions in the final rules are 
identical or substantively similar to those contained in Materion and 
USW's draft standard. For example, the final rule for general industry 
and the Materion/USW draft standard both include an exclusion for 
materials containing less than 0.1 percent beryllium; both contain many 
similar definitions; both contain a time weighted average (TWA) PEL of 
0.2 [mu]g/m\3\; both include exposure monitoring provisions, including 
provisions for scheduled monitoring, employee notification of results, 
methods of sample analysis, and observation of monitoring; both contain 
similar requirements for beryllium work areas and regulated areas; both 
mandate a written exposure control plan and engineering and work 
practice controls that follow OSHA's traditional hierarchy of controls; 
and both include similar provisions related to respiratory protection, 
protective clothing and equipment, hygiene areas and practices, 
housekeeping, medical surveillance, medical removal protection, 
training and communication of hazards, recordkeeping, and compliance 
dates.

(a) Scope and Application

    Separate standards for general industry, construction, and 
shipyards. OSHA proposed a standard addressing occupational exposure to 
beryllium in general industry and regulatory alternatives to address 
exposures in the construction and maritime industries.\37\ The proposal 
was modeled on a suggested rule that was crafted by two major 
stakeholders in general industry, Materion Corporation (Materion) and 
the United Steelworkers (USW) (Document ID 0754). Materion and USW 
provided OSHA with data on exposure and control measures and 
information on their experiences with handling beryllium in general 
industry settings (80 FR 47774). At the time, the information available 
to OSHA on beryllium exposures outside of general industry was limited. 
Therefore, the Agency preliminarily decided to limit the scope of its 
beryllium rule proposal to general industry but propose regulatory 
alternatives that would expand the scope of the proposed standard to 
also include employers in construction and maritime if it turned out 
the record evidence warranted it. Specifically, OSHA requested comment 
on Regulatory Alternative #2a, which would expand the scope of the 
proposed standard to also include employers in construction and 
maritime, and Regulatory Alternative #2b, which would update 29 CFR 
1910.1000 Tables Z-1 and Z-2, 1915.1000 Table Z, and 1926.55 Appendix A 
so that the proposed TWA PEL and STEL would apply to all employers and 
employees in general industry, shipyards, and construction, including 
occupations where beryllium exists only as a trace contaminant. OSHA 
also requested stakeholder comment and data on employees in 
construction or maritime, or in general industry, not covered in the 
scope of the proposed standard, who deal with beryllium only as a trace 
contaminant, who may be at significant risk from occupational beryllium 
exposures.
---------------------------------------------------------------------------

    \37\ The proposed rule did not cover agricultural employers 
because OSHA had not found any evidence indicating that beryllium is 
used or handled in agriculture in a way that might result in 
beryllium exposure. OSHA's authority is also restricted in this 
area; since 1976, an annual rider in the Agency's Congressional 
appropriations bill has limited OSHA's use of funds with respect to 
farming operations that employ fewer than ten employees 
(Consolidated Appropriations Act, 1976, 94, 90 Stat. 1420, 1421 
(1976) (and subsequent appropriations acts)). In the Notice of 
Proposed Rulemaking (NPRM), the Agency requested information on 
whether employees in the agricultural sector are exposed to 
beryllium in any form and, if so, their levels of exposure and what 
types of exposure controls are currently in place (80 FR 47565, 
47775). OSHA did not receive comment on beryllium and the 
agriculture industry or information that would support coverage of 
agricultural operations. Therefore, agriculture employers and 
operations are not covered by the rule.
---------------------------------------------------------------------------

    OSHA did not receive any additional exposure data for construction 
or shipyards in response to OSHA's request in the NPRM. However, since 
the proposal, OSHA reviewed its OIS compliance exposure database and 
identified personal exposure sample results on beryllium for abrasive 
blasting workers in construction, general industry and maritime, which 
can be found broken out by sector in FEA Table IV.68.
    The vast majority of stakeholders who submitted comments on this 
issue supported extending the scope of the proposed rule to cover 
workers in the construction and maritime industries who are exposed to 
beryllium (e.g., Document ID 1592; 1625, p. 3; 1655, p. 15; 1658, p. 5; 
1664, pp. 1-2; 1670, p. 7; 1671, Attachment 1, p. 5; 1672, p. 1; 1675, 
p. 2; 1676, p. 1; 1677, p. 1; 1679, p. 2; 1681, pp. 5, 16; 1683, p. 2; 
1684, Attachment 2, p. 3; 1685, p. 2; 1686, p. 2; 1689, p. 6; 1690, p. 
2; 1693, p. 3; 1703, p. 2; 1705, p. 1). For example, the National 
Council for Occupational Safety and Health (National COSH) urged that 
OSHA should ensure greater

[[Page 2637]]

protections to beryllium exposed workers by extending the scope of the 
proposed standard to workers in the construction and maritime 
industries. National COSH explained: ``In the proposed preamble, OSHA 
recognizes that these workers are exposed to beryllium during abrasive 
blasting and clean-up of spent material. The risks that construction 
and maritime workers face when exposed to beryllium particulate is the 
same as the risk faced at similar exposures by general industry 
workers'' (Document ID 1690, p. 2). The American Federation of Labor 
and Congress of Industrial Organizations (AFL-CIO) agreed, adding that 
``[a]vailable data in the construction and maritime sector shows that 
there is a significant risk of sensitization and CBD among these 
workers'' (Document ID 1689, p. 6). Similarly, the American Industrial 
Hygiene Association (AIHA) warned that the ``[p]otential for exposure, 
especially in the construction industry, is very high'' (Document ID 
1686, p. 2).
    OSHA also heard testimony during the public hearing from Dr. Lee 
Newman of the American College of Occupational and Environmental 
Medicine (ACOEM), Peggy Mroz of National Jewish Health (NJH), Emily 
Gardner of Public Citizen, Mary Kathryn Fletcher of AFL-CIO, and Mike 
Wright of the USW that supported covering workers in the construction 
and maritime industries (Document ID 1756, Tr. 81; 1756, Tr. 97-98; 
1756, Tr. 172-175; 1756, Tr. 198-199; 1755, Tr. 181). Peggy Mroz of NJH 
testified that ``[b]ased on the data presented, [NJH] support[s] 
expanding the scope of the proposed standard to include . . . employers 
in construction and maritime'' (Document ID 1756, Tr. 98). Emily 
Gardner of Public Citizen argued that ``the updated standard cannot 
leave construction and shipyard workers vulnerable to the devastating 
effects of beryllium'' (Document ID 1756, Tr. 175). She added that 
``Public Citizen urges OSHA to revise the proposed rule to cover these 
workers'' (Document ID 1756, Tr. 175).
    Several commenters specifically supported Regulatory Alternative 
#2a. For example, the International Union, United Automobile, 
Aerospace, and Agriculture Implement Workers of America (UAW) indicated 
its support for this alternative (Document ID 1693, p. 3 (pdf)). UAW 
added that Alternative #2a would cover abrasive blasters, pot tenders, 
and cleanup staff working in construction and shipyards who have the 
potential for airborne beryllium exposure during blasting operations 
and during cleanup of spent media (Document ID 1693, p. 3 (pdf)). 
Kimberly-Clark Professional (KCP) similarly indicated that it favored 
the adoption of this alternative (Document ID 1676, p. 1). KCP 
explained that ``[h]azardous exposures are equally dangerous to workers 
regardless of whether the worker is in a factory or on a construction 
site, and the worker protection provided by OSHA regulations should 
also be equal'' (Document ID 1676, p. 1). In addition, 3M Company also 
observed that Regulatory Alternative #2a is a more protective 
alternative (Document ID 1625, p. 3 (pdf)).
    However, other commenters argued in favor of keeping the proposed 
scope unchanged (e.g., Document ID 1583; 1661, Attachment 2, pp. 6-7; 
1673, pp. 12-23). Some of these stakeholders contended that adding 
construction and maritime was not necessary (e.g., Document ID 1673, 
pp. 20-22). For example, Materion opined that ``the requirements of [29 
CFR] 1910.94 provide sufficient protections for the construction and 
maritime industries and accordingly, [Materion and USW] did not include 
construction and maritime within [their] assessment of technological 
feasibility or the scope of the standard'' (Document ID 1661, 
Attachment 2, p. 7). Materion added that ``it is [its] understanding 
that in the absence of a specific maritime standard, OSHA applies 
general industry standards to the maritime industries'' (Document ID 
1661, Attachment 2, p. 7). While this may be the general practice of 
the industry, OSHA does not enforce general industry standards where 
the shipyard standards apply unless they are specifically cross 
referenced in the shipyard standards.
    Some of these commenters offered specific concerns with covering 
the construction and maritime industries, or with covering abrasive 
blasting in general. For instance, Jack Allen, Inc. argued against 
extending the proposed rule to cover the use of coal slag in the 
sandblasting industry because the industry already has processes and 
controls in place to prevent exposures to all dusts during operations 
(Document ID 1582). The Abrasive Blasting Manufacturers Alliance (ABMA) 
presented a number of arguments against the coverage of abrasive 
blasting. ABMA argued that regulating the trace amounts of beryllium in 
abrasive blasting will increase the use of silica-based blasting agents 
``despite OSHA's longstanding recommendation of substitution for 
silica-based materials'' (Document ID 1673, p. 14). ABMA added that 
scoping in abrasive blasting would increase the amount of coal slag 
materials ``going to landfills rather than being used for beneficial 
purpose'' (Document ID 1673, p. 14). ABMA also cited to technological 
feasibility issues in sampling and analysis, noted that the proposed 
standard was not appropriately tailored to construction and maritime 
worksites, and argued that it is not appropriate to regulate abrasive 
blasting on a chemical-by-chemical basis (Document ID 1673, pp. 8, 21-
23).
    After careful consideration of these comments and those relating to 
Regulatory #2b discussed below, OSHA has decided to adopt Regulatory 
Alternative #2a to expand the proposal's scope to cover construction 
and shipyards. As noted by commenters like the AFL-CIO, record evidence 
shows that exposures above the new action level and PEL, primarily from 
abrasive blasting operations, occur in both the construction and 
shipyard industries (see Chapter IV of the Final Economic Analysis and 
Regulatory Flexibility Analysis (FEA)). As discussed in Section V, 
Health Effects, and Section VII, Significance of Risk, employees 
exposed to airborne beryllium at these levels are at significant risk 
of developing adverse health effects, primarily chronic beryllium 
disease (CBD) and lung cancer. And under the OSH Act, and specifically 
section 6(b)(5), the Agency is required to set health standards which 
most adequately assure, to the extent feasible, 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 
standards for the period of his working life. Therefore, OSHA finds it 
would be inappropriate to exclude construction and shipyard employers 
from coverage under this rule.
    OSHA disagrees with Materion's assertion that existing standards 
render it unnecessary to have this standard cover construction and 
shipyard employers whose employees are exposed to beryllium during 
abrasive blasting operations. The OSHA Ventilation standard referenced 
by Materion (29 CFR 1910.94) applies only to general industry and does 
not cover construction and shipyard workers. The OSHA Ventilation 
standard in construction (1926.57) and Mechanical paint removers 
standard in shipyards (1915.34) provide some general protections for 
abrasive blasting workers but do not provide the level of protection 
provided by the ancillary provisions contained in the final standards 
such as medical surveillance, personal protective clothing and 
equipment, and beryllium-specific training.

[[Page 2638]]

    OSHA also disagreed with Jack Allen, Inc.'s assertion that the 
employers conducting abrasive blasting already have sufficient 
processes and controls in place to prevent exposures to all dusts 
during operations. OSHA's examination of the record identifies data on 
beryllium exposure in the abrasive blasting industry showing beryllium 
exposure above the action level and TWA PEL when beryllium-containing 
slags are used (e,g., Document ID 1166; 1815, Attachment 35; 1880). And 
even in abrasive blasting operations where all available controls and 
work processes to reduce beryllium exposure are used, additional 
ancillary provisions are still as necessary to protect workers from the 
harmful effects of exposure to beryllium as in general industry. OSHA 
also finds unsubstantiated ABMA's assertion that regulating the trace 
amounts of beryllium in abrasive blasting will increase the use of 
silica-based blasting agents and result in an increase in the amount of 
coal slag materials going to landfills. OSHA has identified several 
controls for abrasive blasting in its technological feasibility 
analysis (see Chapter IV of the FEA). OSHA also noted that substitution 
is not always feasible and employers should be cautious to not 
introduce additional hazards when switching to an alternate media. The 
Agency is certainly not encouraging employers to increase the use of 
silica sand as a blasting media. However, workers using silica-based 
blasting materials are protected under a new comprehensive silica 
standard (29 CFR 1910.1053, 29 CFR 1926.1153). Employers are in the 
best position to determine which blasting material to use and how to 
weigh the costs of compliance with the two rules. A 1998 NIOSH-funded 
study on substitute materials for silica sand in abrasive blasting 
provides comprehensive information on alternative media and can be used 
by employers seeking to identify appropriate abrasive blasting media 
alternatives (Document ID 1815, Attachment 85-87). In fact, exploring 
the use of alternative media for safer abrasive blasting media is 
already underway (Document ID 1741, p. 2). OSHA anticipates that the 
amount of slag material being deposited in landfills will remain 
constant regardless of its use prior to disposal, as the spent slag 
material used in abrasive blasting will still need to be disposed of. 
OSHA is also not persuaded by ABMA's technological feasibility argument 
that regulating trace amounts of beryllium would require testing below 
the limit of detection and that it is not technologically feasible to 
measure beryllium exposures in abrasive blasting. As explained in 
sections 2 and 12 of Chapter IV of the Final Economic Analysis, there 
are a number of available sampling and analytical methods that are 
capable of detecting beryllium at air concentrations below the action 
level of 0.1 [mu]g/m\3\, as well as existing exposure data for 
beryllium in abrasive blasting operations. And finally, OSHA disagrees 
with ABMA's assertion that regulating abrasive blasting on a chemical-
by-chemical basis is inappropriate. The beryllium rule is typical of 
OSHA substance-specific health standards that have been promulgated for 
the construction and shipyard industries and include abrasive blasting 
operations, such as the Lead standard for construction (1926.62) and 
the Lead standard for general industry (1910.1025), which applies to 
the shipyard industry.
    However, OSHA does agree with ABMA's observation that many of the 
conditions in the construction and shipyard industries are distinct 
from those in general industry, and agrees that the standard as 
proposed was not tailored to construction and shipyard worksites. The 
Agency has long recognized a distinction between the construction and 
general industry sectors and has issued standards specifically 
applicable to construction and shipyard work under 29 CFR part 1926 and 
29 CFR part 1915, respectively. OSHA's understanding of the differences 
between these industries is why OSHA specifically asked stakeholders 
with experience and knowledge of the construction or shipyard 
industries to opine on whether coverage of those industries is 
appropriate and, if so, how the proposal should be revised to best 
protect workers in those industries. As discussed throughout the rest 
of this Summary and Explanation section, many stakeholders responded to 
OSHA's request.
    After careful consideration of the record, OSHA finds that the 
unique needs of, conditions in, and challenges posed by the 
construction and maritime sectors, particularly concerning abrasive 
blasting operations at construction sites and shipyards, warrant 
different requirements from general industry. Therefore, OSHA is 
issuing three separate standards--one for each of these sectors. OSHA 
judges that the primary source of beryllium exposure at construction 
worksites and in shipyards is from abrasive blasting operations when 
using abrasives that contain trace amounts beryllium.
    Abrasive blasters and their helpers are exposed to beryllium from 
coal slag and other abrasive blasting material like copper slag that 
may contain beryllium as a trace contaminant. The most commonly used 
abrasives in the construction industry include coal slag and steel 
grit, which are used to remove old coatings and etch the surfaces of 
outdoor structures, such as bridges, prior to painting (Document ID 
1815, Attachment 93, p. 80). Shipyards are large users of mineral slag 
abrasives. In a recent survey conducted for the Navy, the use of coal 
slag abrasives accounted for 68 percent and copper slag accounted for 
20 percent of abrasive media usage as reported by 26 U.S. shipyards and 
boatyards (Document ID 0767). The use of coal and copper slag abrasives 
has increased in recent years as industries have sought substitutes for 
silica sand blasting abrasives to avoid health risks associated with 
respirable crystalline silica (Document ID 1671, Attachment 3; 1681, 
Attachment 1, pp. 1-2).
    OSHA's exposure profile for abrasive blasters, pot tenders/helpers, 
and abrasive material cleanup workers is found in Section 12 of Chapter 
IV in the FEA. The exposure profile for abrasive blasters shows a 
median of 0.2 [mu]g/m\3\, a mean of 2.18 [mu]g/m\3\, and a range from 
0.004 [mu]g/m\3\ to 66.5 [mu]g/m\3\. The mean level of 2.18 [micro]g/
m\3\ is above the preceding PEL for beryllium. For pot tenders/helpers, 
the exposure profile shows a median of 0.09 [mu]g/m\3\, a mean of 0.10 
[mu]g/m\3\, and a range from 0.04 to 0.20 [mu]g/m\3\. Beryllium 
exposure for workers engaged in abrasive material cleanup shows a 
median of 0.18 [mu]g/m\3\, a mean of 1.76 [mu]g/m\3\, and a range from 
0.04 [mu]g/m\3\ to 7.4 [mu]g/m\3\ (see Section 12 of Chapter IV in the 
FEA). OSHA concludes that abrasive blasters, pot tenders/helpers, and 
cleanup workers have the potential for significant airborne beryllium 
exposure during abrasive blasting operations and during cleanup of 
spent abrasive material. Accordingly, these workers require protection 
under the beryllium standards. To address high concentrations of 
various hazardous chemicals in abrasive blasting, employers are already 
required to use engineering and work practice controls to limit 
workers' exposures and supplement these controls with respiratory 
protection when necessary. For example, abrasive blasters in the 
construction industry fall under the protection of the Ventilation 
standard (29 CFR 1926.57). The Ventilation standard includes an 
abrasive blasting subsection (29 CFR 1926.57(f)), which requires that 
abrasive blasting respirators be worn by all abrasive

[[Page 2639]]

blasting operators when working inside blast-cleaning rooms (29 CFR 
1926.57(f)(5)(ii)(A)), when using silica sand in manual blasting 
operations where the nozzle and blast are not physically separated from 
the operator in an exhaust-ventilated enclosure (29 CFR 
1926.57(f)(5)(ii)(B)), or when needed to protect workers from exposures 
to hazardous substances in excess of the limits set in Sec.  1926.55 
(29 CFR 1926.57(f)(5)(ii)(C)). For the shipyard industry, paragraph (c) 
of the Mechanical paint removers standard (29 CFR 1915.34) also has 
respiratory protection requirements for abrasive blasting operations. 
Because of these requirements, OSHA believes that employers already 
have those controls in place and provide respiratory protection during 
abrasive blasting operations. Nonetheless, the construction and 
shipyard standards' new ancillary provisions such as medical 
surveillance, personal protective clothing and equipment, housekeeping, 
and beryllium-specific training will provide increased protections to 
workers in these industries.
    OSHA also received comment and heard testimony on potential 
beryllium exposure from other sources. NIOSH commented that 
construction workers may be exposed to beryllium when demolishing 
buildings or building equipment, based on a study of workers 
demolishing oil-fired boilers (Document ID 1671, Attachment 1, pp. 5, 
15; 1671, Attachment 21). Peggy Mroz of NJH testified that ``[n]umerous 
studies have documented beryllium exposure sensitization and chronic 
beryllium disease in construction industries, demolition and 
decommissioning, and among workers who use non-sparking tools'' 
(Document ID 1756, Tr. 98). Many such cases were discovered among trade 
workers at Department of Energy sites from the National Supplemental 
Screening Program (Document ID 1756, Tr. 81-82). Ashlee Fitch from the 
USW testified that in addition to abrasive blasting using beryllium-
contaminated slags, workers in the maritime industry use non-sparking 
tools that are composed of beryllium alloys. Ms. Fitch stated that 
these tools can create beryllium particulate when they are dressed 
(e.g., sharpening, grinding, straightening). She also noted that 
shipyards may use beryllium for other tasks in the future. Ms. Fitch 
alluded to a 2000 Navy survey of potential exposure to beryllium in 
shipyards which identified potential beryllium sources in welding, 
abrasive blasting, and metal machining (Document ID 1756, Tr. 242-243). 
Mr. Wright of the USW testified that shipyard management told a USW 
representative ``that most of the beryllium that they're aware of comes 
in in the form of articles . . . . That is to say, it might be part of 
some assembly . . . [a]nd it comes in and it's sealed and closed'' 
(Document ID 1756, Tr. 270). However, Mr. Wright stated that beryllium 
is a high-tech material and that ``there is nothing more high-tech than 
an aircraft carrier or a nuclear submarine'' so exposure from 
beryllium-containing alloys cannot be ruled out in these operations 
(Document ID 1756, Tr. 270).
    Despite requesting information both in the NPRM and during the 
public hearing, OSHA does not have sufficient data on beryllium 
exposures in the construction and shipyard industries to characterize 
exposures of workers in application groups other than abrasive blasting 
with beryllium-containing slags. OSHA could not develop exposure 
profiles for construction and shipyard workers engaged in activities 
involving non-sparking tools, demolition of beryllium-contaminated 
buildings or equipment, and working with beryllium-containing alloys. 
However, OSHA acknowledges the USW's concerns about future beryllium 
use and recognizes that there is potential for exposure to beryllium in 
construction and shipyard operations other than abrasive blasting. As 
such, workers engaged in such operations are exposed to the same hazard 
of developing CBD and other beryllium-related disease, and therefore 
deserve the same level of protection as do workers who are engaged in 
abrasive blasting or covered in the general industry final rule. 
Therefore, although at this time OSHA cannot specifically quantify 
exposures in construction or shipyard operations outside of abrasive 
blasting, OSHA has determined that it is necessary for the final 
standards for construction and maritime to cover all occupational 
exposures to beryllium in those industries in order to ensure that the 
standard is broadly effective and addresses all potential harmful 
exposures.
    Three commenters representing the maritime industry supported 
Regulatory Alternative #2b--adopting the new PELs for construction and 
maritime by updating the existing Z tables to incorporate them, but not 
applying the other ancillary provisions of this standard to 
construction and maritime (Document ID 1595, p. 2; 1618, p. 2; 1657. p. 
1). The Shipbuilders Council of America (SCA) supported lowering the 
PEL for beryllium from 2.0 [mu]/m\3\ to 0.2 [mu]/m\3\ in 29 CFR 
1915.1000 Table Z, but argued that a new beryllium standard would prove 
to be redundant. SCA contended that many shipyards maintain a 
comprehensive industrial hygiene program focused on exposure 
assessments and protective measures for a variety of metals in shipyard 
tasks, and that shipyards encounter beryllium only at trace contaminant 
levels in materials involved in the welding and abrasive blasting 
processes. SCA stated that the potential hazards inherent in and unique 
to abrasive blasting in shipyards are already effectively controlled 
through existing regulations (Document ID 1618, pp. 2-4). General 
Dynamics' Bath Iron Works expressed similar views in their comments on 
this issue, as did Newport News Shipbuilding (Document 1595, p. 2; 
1657, p. 1).
    In addition to the commenters representing the maritime industry, 
Ameren, an electric and natural gas public utility, also supported 
applying the proposed TWA PEL and STEL to all employers in general 
industry, construction, and maritime even where beryllium exists only 
as a trace contaminant (Document ID 1675, p. 3). However, not all 
commenters endorsed Alternative #2b. The Department of Energy's 
National Supplemental Screening Program (NSSP) did not support this 
alternative because the other provisions of the standard would only 
cover employers and employees within the scope of the proposed general 
industry rule (Document ID 1677, p. 2). Furthermore, many commenters 
supported extending the full protections of the standard to the 
construction and maritime industries as set forth in Regulatory 
Alternative #2a, discussed earlier, which implicitly rejects Regulatory 
Alternative #2b (see, e.g., Document ID 1756, Tr. 81; 1756, Tr. 97-98; 
1756, Tr. 172-175; 1756, Tr. 198-199; 1755, Tr. 181).
    OSHA is not persuaded by the maritime industry commenters' 
assertions that the ancillary provisions of the beryllium standard 
would be redundant. While OSHA acknowledges that shipyards encounter 
beryllium only at trace levels in materials involved in the welding and 
abrasive blasting processes, OSHA disagrees with their contention that 
updating the PEL and STEL will provide adequate protection to shipyard 
workers. OSHA agrees with NSSP and all the commenters supporting 
Regulatory Alternative #2a that a comprehensive standard specific to 
beryllium will provide the important protection of ancillary 
provisions, such as medical surveillance and medical removal 
protection. OSHA intends to

[[Page 2640]]

ensure that workers exposed to beryllium in the construction and 
shipyard industries are provided with protection that is comparable to 
the protection afforded workers in general industry. Therefore, OSHA 
has set an identical PEL and STEL and, where no meaningful distinctions 
are identified in the record, included substantially the same or 
approximately equivalent ancillary provisions in all three standards. 
For further discussion of the differences among the standards, see the 
provision-specific sections included in this Summary and Explanation.
    Therefore, OSHA declines to adopt Regulatory Alternative #2b, 
which, as noted above, would have updated 29 CFR 1910.1000 Tables Z-1 
and Z-2, 29 CFR 1915.1000 Table Z, and 29 CFR 1926.55 Appendix A so 
that the new TWA PEL and STEL, but not the standard's ancillary 
provisions, would apply to all employers and employees in general 
industry, shipyards, and construction, including occupations where 
beryllium exists only as a trace contaminant. The Agency intends for 
employers that are exempt from the scope of these comprehensive 
standards in accordance with paragraph (a) to comply with the preceding 
TWA PEL and STEL in 29 CFR 1910.1000 Table Z-2, 29 CFR 1915.1000 Table 
Z, and 29 CFR 1926.55 Appendix A, as applicable. Given that the Agency 
is issuing separate beryllium standards for the construction and 
shipyard industries, OSHA is also adding to these tables a cross-
reference to the new standards and clarifying that if the new standards 
are stayed or otherwise not in effect, the preceding PEL and short-term 
ceiling limit apply.
    Paragraph (a)(1). Proposed paragraph (a)(1) applied the standard to 
occupational exposures to beryllium in all forms, compounds, and 
mixtures in general industry, except those articles and materials 
exempted by paragraphs (a)(2) and (a)(3) of the standards. As OSHA 
explained in the proposal, the Agency preliminarily chose to treat 
beryllium generally, instead of individually addressing specific 
compounds, forms, and mixtures. This decision was based on the Agency's 
preliminary determination that the toxicological effects of beryllium 
exposure on the human body are similar regardless of the form of 
beryllium (80 FR 47774).
    Several commenters offered opinions on this approach. The Non-
Ferrous Founders' Society (NFFS) expressed concern that beryllium metal 
was being treated the same as soluble beryllium compounds, such as 
salts, even though NFFS believes these soluble compounds are more 
hazardous and suggested that OSHA establish a bifurcated standard for 
insoluble beryllium versus soluble beryllium compounds (Document ID 
1732, p. 3; 1678, p. 2; 1756, Tr. 18). In related testimony, NIOSH's 
Dr. Aleks Stefaniak discussed the dermal exposure mechanisms of poorly 
soluble beryllium through particle penetration and particle dissolving 
(Document ID 1755, pp. 35-39). Dr. Stefaniak testified that while 
``intact skin naturally has a barrier . . . [v]ery few people actually 
have fully intact skin, especially in an industrial environment'' 
(Document ID 1755, p. 36). He added:

in fact, beryllium particles, beryllium oxide, beryllium metal, 
beryllium alloys, all these sort of what we call insoluble forms 
actually do in fact dissolve very readily in analog of human sweat. 
And once beryllium is in an ionic form on the skin, it's actually 
very easy for it to cross the skin barrier (Document ID 1755, pp. 
36-37).

NIOSH also provided additional information on beryllium solubility and 
the development of CBD in its post-hearing brief, labeling as untrue 
NFFS's assertion that insoluble beryllium does not cause CBD (Document 
ID 1960, Attachment 2, pp. 8-10), citing studies showing that workers 
exposed to insoluble forms of beryllium have developed sensitization 
and CBD (Kreiss, et al., 1997, Document ID 1360; Schuler et al., 2005 
(1349); Schuler et al., 2008 (1291); Wegner et al., 2000, (1960, 
Attachment 7)).
    After careful consideration of the various comments on this issue, 
OSHA is not persuaded that there are differences in workers' health 
risks that justify treating poorly soluble beryllium differently than 
soluble compounds. The Agency is persuaded by NIOSH that poorly soluble 
beryllium presents a significant risk of beryllium-related disease to 
workers and discusses this topic further in Section V of this preamble, 
Health Effects. OSHA has determined that the toxicological effects of 
beryllium exposure on the human body are similar regardless of the form 
of beryllium. Therefore, the Agency concludes that the record supports 
issuing standards that apply to beryllium in all forms, compounds, and 
mixtures. Final paragraph (a)(1) is therefore substantively unchanged 
from the proposal in all three standards.
    Paragraph (a)(2). Proposed paragraph (a)(2) excluded from the 
standard's scope articles, as defined in the Hazard Communication 
standard (HCS) (29 CFR 1910.1200(c)), that contain beryllium and that 
the employer does not process. As OSHA explained in the proposal (80 FR 
47775), the HCS defines an ``article'' as

a manufactured item other than a fluid or particle: (i) Which is 
formed to a specific shape or design during manufacture; (ii) which 
has end use function(s) dependent in whole or in part upon its shape 
or design during end use; and (iii) which under normal conditions of 
use does not release more than very small quantities, e.g., minute 
or trace amounts of a hazardous chemical . . ., and does not pose a 
physical hazard or health risk to employees.

OSHA preliminarily found that items or parts containing beryllium that 
employers assemble where the physical integrity of the item is not 
compromised are unlikely to release beryllium that would pose a 
physical or health hazard for workers. Therefore, OSHA proposed to 
exempt such articles from the scope of the standard. This proposed 
provision was intended to ease the burden on employers by exempting 
items from coverage where they are unlikely to pose a risk to 
employees.
    Commenters generally supported this proposed exemption. For 
example, NFFS stated that the exemption was ``important and practical'' 
(Document ID 1678, p. 2; Document ID 1756, Tr. 35-36)). However, two 
commenters requested minor amendments to the exemption. First, ORCHSE 
Strategies (ORCHSE) asked OSHA to ``clarify'' that proposed paragraph 
(a)(2) ``exempts `articles' even if they are processed, unless the 
processing releases beryllium to an extent that negates the definition 
of an `article' '' (Document ID 1691, Attachment 1, p. 16). ORCHSE 
asserted that the standard should not apply in a workplace when ``the 
item actually meets OSHA's definition of an article'' and that OSHA 
should change the regulation's language accordingly (Document ID 1691, 
Attachment 1, pp. 16-17). Second, the American Dental Association (ADA) 
asked that OSHA clarify the article exemption, specifically that 
employers who use but do not process articles are fully exempt from all 
requirements of the proposed rule, including those established for 
recordkeeping (Document ID 1597, p. 1).
    In contrast, Public Citizen objected to the inclusion of this 
exemption because exempting articles that are not processed does not 
take into consideration dermal exposure from handling articles 
containing beryllium (Document ID 1670, p. 7). Public Citizen pointed 
to OSHA's proposed rule in which OSHA acknowledged that beryllium 
absorbed through the skin can induce a sensitization response that is a 
necessary first step toward CBD and that there is evidence that the 
risk is not limited to soluble forms. However, during follow-up 
questioning at the beryllium public hearings, Dr. Almashat

[[Page 2641]]

of Public Citizen was unable to provide any examples of dermal exposure 
from articles through their handling, as opposed to when processing 
beryllium materials (Document ID 1756, Tr. 178-180). And, in its post-
hearing comments, Public Citizen did not provide evidence of dermal 
exposure to workers handling beryllium materials that would fall under 
the definition of article (Document ID 1964). In the final standard, 
OSHA has decided not to alter the proposed exemption of articles. OSHA 
is not persuaded by ORCHSE's argument that OSHA should change the 
regulation's language to exempt articles even if they are processed, 
unless the processing releases beryllium to an extent that negates the 
definition of an article. The HCS defines an article as

a manufactured item other than a fluid or particle: (i) Which is 
formed to a specific shape or design during manufacture; (ii) which 
has end use function(s) dependent in whole or in part upon its shape 
or design during end use; and (iii) which under normal conditions of 
use does not release more than very small quantities, e.g., minute 
or trace amounts of a hazardous chemical (as determined under 
paragraph (d) of this section), and does not pose a physical hazard 
or health risk to employees. (29 CFR 1910.1200(c)).

Whether a particular item is an ``article'' under the HCS depends on 
the physical properties and intended use of that item. However, 
employers may use and process beryllium-containing items in ways not 
necessarily intended by the manufacturer. Therefore, OSHA has decided 
not to link the processing limitation to the definition of an 
``article'' and is retaining the language of proposed (a)(2) to comport 
with the intention of the exemption.
    In response to the ADA's request for clarification that employers 
who use but do not process articles are fully exempt from all 
requirements of the rule, OSHA notes that paragraph (a)(2) of the final 
standards states that the ``standard does not apply'' to those 
articles. Furthermore, the recordkeeping requirement for objective data 
in paragraph (n)(2) of the standards states that it applies to 
objective data used to satisfy exposure assessment requirements, but 
does not mention any data used to determine coverage under paragraph 
(a). Therefore, OSHA has determined that no further clarification in 
the regulatory text is necessary.
    In response to the comment from Public Citizen, OSHA did not 
receive any evidence on the issue of beryllium exposure through dermal 
contact with unprocessed articles. Therefore, OSHA cannot find that 
such contact poses a risk.
    Paragraph (a)(2) of the final standards therefore remains unchanged 
from the proposed standard. The final standards do not apply to 
articles, as defined in the Hazard Communication standard (HCS) (29 CFR 
1910.1200(c)), that contain beryllium and that the employer does not 
process.
    Paragraph (a)(3). Proposed paragraph (a)(3) exempted from coverage 
materials containing less than 0.1 percent beryllium by weight. 
Requesting comment on this exemption (80 FR 47776), OSHA presented 
Regulatory Alternative #1a, which would have eliminated the proposal's 
exemption for materials containing less than 0.1 percent beryllium by 
weight, and #1b, which would have exempted operations where the 
employer can show that employees' exposures will not meet or exceed the 
action level or exceed the STEL. The Agency asked whether it is 
appropriate to include an exemption for operations where beryllium 
exists only as a trace contaminant, but some workers can nevertheless 
be significantly exposed. And the Agency asked whether it should 
consider dropping the exemption, or limiting it to operations where 
exposures are below the proposed action level and STEL. In addition, 
OSHA requested additional data describing the levels of airborne 
beryllium in workplaces that fall under this exemption. Some 
stakeholders supported keeping the 0.1 percent exemption as proposed 
(Document ID 1661, p. 6; 1666, p. 2; 1668, p. 2; 1673, p. 8; 1674, p. 
3; 1687, Attachment 2, p. 8; 1691, Attachment 1, p. 3; 1756, Tr. 35-36, 
63). For example, the Edison Electric Institute (EEI) strongly 
supported the exemption and asserted ``that abandoning the exemption 
would result in no additional benefits from a reduction in the 
beryllium permissible exposure limit (PEL) or from ancillary provisions 
similar to those already in place for the arsenic and other standards'' 
(Document ID 1674, p. 3). Mr. Weaver of NFFS also opposed eliminating 
the exemption, testifying that without the 0.1 percent exemption, 900 
to 1,100 foundries would come under the scope of the rule (Document ID 
1756, Tr. 55-56).
    ABMA also supported the proposed 0.1 percent exemption, suggesting 
that there is a lack of evidence of significant risk from working with 
material containing beryllium in trace amounts and that OSHA needs 
substantial evidence that it is ``at least more likely than not'' that 
exposure to beryllium in trace amounts presents significant risk of 
harm, under court decisions concerning the Benzene rule (Document ID 
1673, pp. 8-9). ABMA further argued that significant risk does not 
exist even below the previous PEL of 2.0 [mu]g/m\3\ (Document ID 1673, 
pp. 8-9, 11). ABMA added that its members collectively have over 200 
years of experience producing coal and/or copper slag abrasive material 
and have employed thousands of employees in this production process. 
ABMA explained:

    Through the years, Alliance members have worked with and put to 
beneficial use over 100 million tons of slag material that would 
otherwise have been landfilled. Despite this extensive history, the 
Alliance members have no history of employees with beryllium 
sensitization or beryllium-related illnesses. Indeed, the Alliance 
members are not aware of a single documented case of beryllium 
sensitization or beryllium-related illness associated with coal or 
copper slag abrasive production among their employees, or their 
customers' employees working with the products of Alliance members 
(Document ID 1673, p. 9).

    OSHA is not persuaded by these arguments. The lack of anecdotal 
evidence of sensitization or beryllium-related illness does not mean 
these workers are not at risk. As noted by Representative Robert C. 
``Bobby'' Scott, Ranking Member of the U.S. House of Representatives 
Committee on Education and the Workforce the U.S. House of 
Representatives, ``medical surveillance has not been required for 
beryllium-exposed workers outside of the U.S. Department of Energy. The 
absence of evidence is not evidence of absence'' (Document ID 1672). As 
discussed in Section II of this preamble, Pertinent Legal Authority, 
courts have not required OSHA ``to support its finding that a 
significant risk exists with anything approaching scientific 
certainty'' (Benzene, 448 U.S. 607, 656 (1980)). Rather, OSHA may rely 
on ``a body of reputable scientific thought'' to which ``conservative 
assumptions in interpreting the data . . .'' may be applied, ``risking 
error on the side of overprotection'' (Benzene, 448 U.S. at 656). OSHA 
may thus act with a ``pronounced bias towards worker safety'' in making 
its risk determinations (Bldg & Constr. Trades Dep't v. Brock, 838 F.2d 
1258, 1266 (D.C. Cir. 1988). Where, as here, the Agency has evidence 
indicating that a certain operation can result in exposure levels that 
the Agency knows can pose a significant risk--such as evidence that 
workers that have been exposed to beryllium at the final PEL of 0.2 
[mu]g/m\3\ in primary beryllium production and beryllium machining 
operations have developed CBD (see this preamble at section V, Risk 
assessment)--OSHA need not wait until it has specific evidence that 
employees in that

[[Page 2642]]

particular industry are suffering. A number of commenters supported 
Regulatory Alternative #1a, proposing to eliminate the proposal's 
exemption for materials containing less than 0.1 percent beryllium by 
weight (Document ID 1655, p. 15; 1664, p. 2; 1670, p. 7; 1671, 
Attachment 1, p. 5; 1672, pp. 4-5; 1683, p. 2; 1686, p. 2; 1689, pp. 6-
7; 1690, p. 3; 1693, p. 3; 1720, pp. 1, 4). Public Citizen expressed 
concern with the proposed exemption and pointed out that OSHA 
identified studies in its proposal unequivocally demonstrating that 
beryllium sensitization and CBD occur in multiple industries utilizing 
products containing trace amounts of beryllium and that such an 
exemption would expose workers in such industries to the risks of 
beryllium toxicity (Document ID 1670, p. 7). The American Association 
for Justice, the AFL-CIO, and the UAW were all concerned that the 
proposed standard's 0.1 percent exemption would result in workers being 
exposed to significant amounts of beryllium from abrasive blasting 
(Document ID 1683, p. 2; 1689, pp. 6-7, 10-11; 1693, p. 3). Both Dr. 
Sammy Almashat and Emily Gardner of Public Citizen testified that they 
support inclusion of work processes that involve materials containing 
less than 0.1 percent of beryllium because the beryllium can become 
concentrated in air, even when using materials with only trace amounts 
(Document ID 1756, Tr. 174, 177-178, 185-186). Similarly, the AFL-CIO 
stated that ``there are known over-exposures among industries that use 
materials with less than 0.1% beryllium by weight, including an 
estimated 1,665 workers in primary aluminum production and 14,859 coal-
fired electric power generation workers'' (Document ID 1689, p. 7). 
Mary Kathryn Fletcher of the AFL-CIO further explained that the AFL-CIO 
supported eliminating the exemption because these employees are at 
significant risk for developing sensitization, chronic beryllium 
disease (CBD), and lung cancer (Document ID 1756, Tr. 198-199). The 
Sampling and Analysis Subcommittee Task Group of the Beryllium Health 
and Safety Committee (BHSC Task Group) recommended that OSHA remove the 
exemption (Document ID 1655, p. 15). AIHA also recommended eliminating 
or reducing the percentage content exemption until data is available to 
demonstrate that materials with very low beryllium content will not 
result in potential exposure above the proposed PEL (Document ID 1686, 
p. 2).
    Both NIOSH and North America's Building Trades Unions (NABTU) 
expressed concern that the 0.1 percent exemption would expose 
construction and shipyard workers conducting abrasive blasting with 
coal slags to beryllium in concentrations above the final PEL. NIOSH 
and NABTU cited a study by the Center for Construction Research and 
Training, and NIOSH also cited one of its exposure assessment studies 
of a coal slag blaster showing beryllium air concentrations exceeding 
the preceding OSHA PEL (Document ID 1671, Attachment 1, p. 5; 1679, pp. 
3-4). In addition, NIOSH points out that although the abrasive blasting 
workers may use personal protective equipment that limits exposure, 
supervisors and other bystanders may be exposed. NIOSH gave other 
examples where the 0.1 percent exemption could result in workers being 
exposed to beryllium, such as building or building equipment demolition 
and work in dental offices that fabricate or modify beryllium-
containing dental alloys, but did not provide reference material or 
exposure data for these examples (Document ID 1671, pp. 5-6). In its 
post-hearing brief, NIOSH also specifically disagreed with EEI's 
contention that compliance with the arsenic and asbestos standards 
satisfies the proposed regulatory requirements of the beryllium rule. 
NIOSH argued that, unlike arsenic and lead, beryllium is a sensitizer, 
and as such, necessary and sufficient controls are required to protect 
workers from life-long risk of beryllium sensitization and disease 
(Document ID 1960, Attachment 2, p. 6).
    OSHA also received comment and heard testimony from Dr. Weissman of 
NIOSH recommending that the scope of the standard be based on employee 
exposures and not the concentration of beryllium in the material 
(Document ID 1671, pp. 5-6; Document ID 1755, Tr. 17-18). NIOSH 
identified coal-fired electric power generation and primary aluminum 
production as industries that could fall under the 0.1 percent 
exemption (Document ID 1671, Attachment 1, p. 6). Stating it was not 
aware of any medical screening of utility workers exposed to fly ash, 
NIOSH recommended that OSHA include coal-fired electric power 
generation in the scope of the standard unless and until available data 
can demonstrate that there is no risk of sensitization to those workers 
(Document ID 1671, p. 6). NIOSH did not offer specifics on the 
magnitude of beryllium exposure in the aluminum production industry. In 
its post-hearing brief, NIOSH recommended that OSHA remove the 0.1 
percent exemption from the rule, allowing the rule to cover a broad 
range of construction, shipyard, and electric utility power generation 
activities that are associated with beryllium exposure, such as 
abrasive blasting with coal or copper slag, repairing and maintaining 
structures contaminated with fly ash, and remediation or demolition 
(Document ID 1960, Attachment 2, p. 2). And Peggy Mroz of NJH testified 
that beryllium sensitization and CBD have been reported in the aluminum 
industry and that NJH has continued to see cases of severe CBD in 
workers exposed to beryllium through medical recycling and metal 
reclamation (Document ID 1756, Tr. 98-99).
    Other commenters suggested limiting the exemption, as OSHA proposed 
in Regulatory Alternative #1b, to require employers to demonstrate, 
using objective data, that the materials, when processed or handled, 
cannot release beryllium in concentrations at or above the action level 
as an 8-hour TWA under any foreseeable conditions (Document ID 1597, p. 
1; 1681, pp. 5-6). For example, the Materion-USW proposed standard 
included the 0.1 percent exemption unless objective data or initial 
monitoring showed exposures could exceed the action level or STEL. USW 
asserted that not including this requirement in the rule would be a 
mistake (Document ID 1681, pp. 5-6). The AFL-CIO also supported the 
joint USW-Materion scope provision (Document ID 1756, Tr. 212). Mike 
Wright of the USW asserted that maintaining the 0.1 percent exemption 
would leave thousands of workers unprotected, including those 
performing abrasive blasting operations in general industry, ship 
building, and construction (Document ID 1755, Tr. 111-114). Mr. Wright 
argued that in the 1,3 Butadiene standard OSHA recognized that the 0.1 
percent exemption would not protect some workers and therefore included 
additional language limiting the exemption where objective data showed 
``that airborne concentrations generated by such mixtures can exceed 
the action level or STEL under reasonably predictable conditions of 
processing, use or handling that will cause the greatest possible 
release'' (Document ID 1755, Tr. 113; 29 CFR 1910.1051(a)(2)(ii)). Mr. 
Wright urged OSHA to include similar language in the beryllium standard 
(Document ID 1755, Tr. 113-114).
    Some commenters endorsed a modified version of Alternative #1b. For 
example, the Department of Defense (DOD) supported Alternative #1b, but 
also suggested limiting the exemption if exposures ``could present a 
health risk

[[Page 2643]]

to employees'' (Document ID 1684, Attachment 2, pp. 1, 3). Boeing 
suggested adding a different exemption to the scope of the standard:

where the employer has objective data demonstrating that a material 
containing beryllium or a specific process, operation, or activity 
involving beryllium cannot release dusts, fumes, or mists of 
beryllium in concentrations at or above 0.02 [mu]g/m\3\ as an 8-hour 
time-weighted average (TWA) or at or above 0.2 [mu]g/m\3\ as 
determined over a sampling period of 15 minutes under any expected 
conditions of use (Document ID 1667, p. 12).

Other commenters, like ABMA, criticized Regulatory Alternative #1b, 
insisting that the rulemaking record contained no evidence to support 
expanding the scope, but that if the scope was expanded to cover trace 
beryllium, a significant exemption would be needed. ABMA argued that 
such an exemption would need to go considerably beyond that of using 
the action level or STEL because of the substantial costs, particularly 
on small businesses, that would be incurred where there is no evidence 
of benefit. However, ABMA did not specify what such an exemption would 
look like (Document ID 1673, p. 11). Similarly, the National Rural 
Electric Cooperative Association (NRECA) objected to Regulatory 
Alternative #1b as being unnecessary to protect employees from CBD in 
coal fired power plants (Document ID 1687, p. 2).
    Ameren did not agree with the objective data requirement in 
Regulatory Alternative #1b because it would be difficult to perform 
sampling in a timely manner for the many different maintenance 
operations that occur infrequently. This would include in the scope of 
the rule activities for which exposures are difficult to measure, but 
are less likely to cause exposure than other operations (Document ID 
1675, p. 2). The NSSP also does not support Regulatory Alternative #1b 
because without first expanding the scope of the rule to cover the 
construction and maritime sectors, employers in construction and 
maritime would still be excluded (Document ID 1677, p. 1).
    OSHA agrees with the many commenters and testimony expressing 
concern that materials containing trace amounts of beryllium (less than 
0.1 percent by weight) can result in hazardous exposures to beryllium. 
We disagree, however, with those who supported completely eliminating 
the exemption because this could have unintended consequences of 
expanding the scope to cover minute amounts of naturally occurring 
beryllium (Ex 1756 Tr. 55). Instead, we believe that alternative #1b--
essentially as proposed by Materion and USW and acknowledging that 
workers can have significant beryllium exposures even with materials 
containing less than 0.1%--is the most appropriate approach. Therefore, 
in the final standard, it is exempting from the standard's application 
materials containing less than 0.1% beryllium by weight only where the 
employer has objective data demonstrating that employee exposure to 
beryllium will remain below the action level as an 8-hour TWA under any 
foreseeable conditions.
    As noted by NIOSH, NABTU, and the AFL-CIO, and discussed in Chapter 
IV of the FEA, workers in abrasive blasting operations using materials 
that contain less than 0.1 percent beryllium still have the potential 
for significant airborne beryllium exposure during abrasive blasting 
operations and during cleanup of spent abrasive material. NIOSH and the 
AFL-CIO also identified coal-fired electric power generation and 
primary aluminum production as industries that could fall under the 0.1 
percent exemption but still have significant worker exposure to 
beryllium. Furthermore, OSHA agrees with NIOSH that the Agency should 
regulate based on the potential for employee exposures and not the 
concentration of beryllium in the material being handled. However, OSHA 
acknowledges the concerns expressed by ABMA and EEI that processing 
materials with trace amounts of beryllium may not necessarily cause 
significant exposures to beryllium. OSHA does not have evidence that 
all materials containing less than 0.1 percent beryllium by weight can 
result in significant exposure to beryllium, but the record contains 
ample evidence that there are significant exposures in operations using 
materials with trace amounts of beryllium, such as abrasive blasting, 
coal-fired power generation, and primary aluminum production. As 
discussed in Section VII of this preamble, Significance of Risk, 
preventing airborne exposures at or above the action level reduces the 
risk of beryllium-related health effects to workers. OSHA is also not 
persuaded by comments that claim obtaining this exposure data is too 
difficult for infrequent or short-term tasks because employers must be 
able to establish their eligibility for the exemption before being able 
to take advantage of it. If an employer cannot establish by objective 
data, including actual monitoring data, that exposures will not exceed 
the action level, then the beryllium standards apply to protect that 
employer's workers.
    As pointed out by commenters such as the USW, similar exemptions 
are included in other OSHA standards, including Benzene (29 CFR 
1910.1028), Methylenedianiline (MDA) (29 CFR 1910.1050), and 1,3-
Butadiene (BD) (29 CFR 1910.1051). These exemptions were established 
because workers in the exempted industries or workplaces were not 
exposed to the subject chemical substances at levels of significant 
risk. In the preamble to the MDA standard, OSHA states that the Agency 
relied on data showing that worker exposure to mixtures or materials of 
MDA containing less than 0.1 percent MDA did not create any hazards 
other than those expected from worker exposure beneath the action level 
(57 FR 35630, 35645-46). The exemption in the BD standard does not 
apply where airborne concentrations generated by mixtures containing 
less than 0.1 percent BD by volume can exceed the action level or STEL 
(29 CFR 1910.1051(a)(2)(ii)). The exemption in the Benzene standard was 
based on indications that exposures resulting from substances 
containing trace amounts of benzene would generally be below the 
exposure limit and on OSHA's determination that the exemption would 
encourage employers to reduce the concentration of benzene in certain 
substances (43 FR 27962, 27968).
    OSHA's decision to maintain the 0.1 percent exemption and require 
employers to demonstrate, using objective data, that the materials, 
when processed or handled, cannot release beryllium in concentrations 
at or above the action level as an 8-hour TWA under any foreseeable 
conditions, is a change from proposed paragraph (a)(3) that specified 
only that the standard did not apply to materials containing less than 
0.1 percent beryllium by weight. This is also a change from Regulatory 
Alternative #1b in another respect, insofar as it proposed requiring 
objective data demonstrating that employee exposure to beryllium will 
remain below both the proposed action level and STEL. OSHA removed the 
STEL requirement as largely redundant because if exposures exceed the 
STEL of 2.0 [micro]g/m\3\ for more than one 15-minute period per 8-hour 
shift, even if exposures are non-detectable for the remainder of the 
shift, the 8-hour TWA would exceed the action level of 0.1 [mu]g/m\3\.
    Further, OSHA added the phrase ``under any foreseeable conditions'' 
to paragraph (a)(3) of the final standards to make clear that limited 
sampling results indicating exposures are below the

[[Page 2644]]

action level would be insufficient to take advantage of this exemption. 
When using the phrase ``any foreseeable conditions,'' OSHA is referring 
to situations that can reasonably be anticipated. For example, annual 
maintenance of equipment during which exposures could exceed the action 
level would be a situation that is generally foreseeable.
    In sum, the proposed standard covered occupational exposures to 
beryllium in all forms, compounds, and mixtures in general industry. It 
did not apply to articles, as defined by the HCS, or to materials 
containing less than 0.1 percent beryllium by weight. After a thorough 
review of the record, OSHA has decided to adopt Regulatory Alternative 
#2a and include the construction and shipyard sectors within the scope 
of the final rule. This decision was in response to the majority of 
comments recommending that OSHA protect workers in these sectors under 
the final rule and the exposure data in these sectors contained in the 
record. OSHA has also decided to adopt a modified version of Regulatory 
Alternative #1b and limit the 0.1 percent exemption to those employers 
who have objective data demonstrating that employee exposure to 
beryllium will remain below the action level as an 8-hour TWA under any 
foreseeable conditions.
    Therefore, the final rule contains three standards--one each for 
general industry, construction, and shipyard. The article exemption has 
remained unchanged, and the 0.1 percent exemption has been limited to 
protect workers with significant exposures despite working with 
materials with trace amounts of beryllium.

(b) Definitions

    Paragraph (b) includes definitions of key terms used in the 
standard. To the extent possible, OSHA uses the same terms and 
definitions in the standard as the Agency has used in other OSHA health 
standards. Using similar terms across health standards, when possible, 
makes them more understandable and easier for employers to follow. In 
addition, using similar terms and definitions helps to facilitate 
uniformity of interpretation and enforcement.
    Action level means a concentration of airborne beryllium of 0.1 
micrograms per cubic meter of air ([mu]g/m\3\) calculated as an 8-hour 
time-weighted average (TWA). Exposures at or above the action level 
trigger requirements for periodic exposure monitoring when the employer 
is following the scheduled monitoring option (see paragraph (d)(3)). In 
addition, paragraph (f)(1)(i)(B) requires employers to list as part of 
their written exposure control plan the operations and job titles 
reasonably expected to have exposure at or above the action level. 
Paragraph (f)(2) requires employers to ensure that at least one of the 
controls listed in paragraph (f)(2)(i) is in place unless employers can 
demonstrate for each operation or process either that such controls are 
not feasible, or that employee exposures are below the action level 
based on at least two representative personal breathing zone samples 
taken at least seven days apart. In addition, under paragraph 
(k)(1)(i)(A), employee exposure at or above the action level for more 
than 30 days per year triggers requirements for medical surveillance. 
The medical surveillance provision triggered by the action level allows 
employees to receive exams at least every two years at no cost to the 
employee. The action level is also relevant to the medical removal 
requirements. Employees eligible for removal can choose to remain in 
environments with exposures at or above the action level, provided they 
wear respirators (paragraph (l)(2)(ii)). These employees may also 
choose to be transferred to comparable work in environments with 
exposures below the action level (if comparable work is not available, 
the employer must maintain the employee's earnings and benefits for six 
months or until comparable work becomes available (paragraph (l)(3)).
    OSHA's risk assessment indicates that significant risk remains at 
and below the TWA PEL (see this preamble at section VII, Significance 
of Risk). When there is significant risk remaining at the PEL, the 
courts have ruled that OSHA has the legal authority to impose 
additional requirements, such as action levels, on employers to further 
reduce risk when those requirements will result in a greater than 
minimal incremental benefit to workers' health (Asbestos II, 838 F.2d 
at 1274). OSHA concludes that an action level for beryllium exposure 
will result in a further reduction in risk beyond that provided by the 
PEL alone.
    Another important reason to set an action level involves the 
variable nature of employee exposures to beryllium. Because of this 
fact, OSHA concludes that maintaining exposures below the action level 
provides reasonable assurance that employees will not be exposed to 
beryllium above the TWA PEL on days when no exposure measurements are 
made. This consideration is discussed later in this section of the 
preamble regarding paragraph (d)(3).
    The United Steelworkers (USW) commented in support of the action 
level, noting that it is typical in OSHA standards to have an action 
level at one half of the PEL (Document ID 1681, p. 11). The USW also 
commented that the ``action level will further reduce exposure to 
beryllium by workers and will incentivize employers to implement best 
practice controls keeping exposures at a minimum as well as reducing 
costs of monitoring and assessments'' (Document ID 1681, p. 11). 
National Jewish Health (NJH) also supported OSHA's proposal for a more 
comprehensive standard and noted that the action level in the 
Department of Energy's beryllium standard has been ``very effective at 
reducing exposures and rates of beryllium sensitization and chronic 
beryllium disease in those facilities'' (Document ID 1756, p. 90).
    As noted by the commenters, OSHA's decision to set an action level 
of one-half of the TWA PEL is consistent with previous standards, 
including those for inorganic arsenic (29 CFR 1910.1018), chromium (VI) 
(29 CFR 1910.1026), benzene (29 CFR 1910.1028), ethylene oxide (29 CFR 
1910.1047), methylene chloride (29 CFR 1910.1052), and respirable 
crystalline silica (29 CFR 1910.1053).
    The definition of ``action level'' is therefore unchanged from the 
proposal. Some of the ancillary provisions triggered by the action 
level have changed since the proposal. Those changes are discussed in 
more detail in the Summary and Explanation sections for those 
provisions.
    Airborne exposure and airborne exposure to beryllium mean the 
exposure to airborne beryllium that would occur if the employee were 
not using a respirator.
    OSHA included a definition for the terms ``exposure'' and 
``exposure to beryllium'' in the proposed rule, and defined the terms 
to mean ``the exposure to airborne beryllium that would occur if the 
employee were not using a respirator.'' In the final rule, the word 
``airborne'' is added to the terms to make clear that they refer only 
to airborne beryllium, and not to dermal contact with beryllium. The 
modified terms replace ``exposure'' and ``exposure to beryllium'' in 
the rule, and the terms ``exposure'' and ``exposure to beryllium'' are 
no longer defined.
    Assistant Secretary means the Assistant Secretary of Labor for 
Occupational Safety and Health, United States Department of Labor, or 
designee. OSHA received no comments on this definition, and it is 
unchanged from the proposal.
    Beryllium lymphocyte proliferation test (BeLPT) means the 
measurement of blood lymphocyte proliferation in a

[[Page 2645]]

laboratory test when lymphocytes are challenged with a soluble 
beryllium salt. For additional explanation of the BeLPT, see the Health 
Effects section of this preamble (section V). Under paragraph 
(f)(1)(ii)(B), an employer must review and evaluate its written 
exposure control plan when an employee is confirmed positive. The BeLPT 
could be used to determine whether an employee is confirmed positive 
(see definition of ``confirmed positive'' in paragraph (b) of this 
standard). Paragraph (k)(3)(ii)(E) requires the BeLPT unless a more 
reliable and accurate test becomes available.
    NJH supported OSHA's definition of the BeLPT in the NPRM (Document 
ID 1664, p. 5). However, OSHA has made one change from the proposed 
definition of the BeLPT in the NPRM to the final definition to provide 
greater clarity. The Agency has moved the characterization of a 
confirmed positive result from the BeLPT definition to the ``confirmed 
positive'' definition because it was more appropriate there.
    Beryllium work area means any work area containing a process or 
operation that can release beryllium where employees are, or can 
reasonably be expected to be, exposed to airborne beryllium at any 
level or where there is potential for dermal contact with beryllium. 
The definition of ``beryllium work area'' has been changed from the 
proposed definition to reflect stakeholder concerns regarding the 
overlap between a beryllium work area and regulated area, and to 
include the potential for dermal exposure. The definition only appears 
in the general industry standard because the requirement for a 
beryllium work area only applies to the general industry standard. 
Beryllium work areas are areas where employees are or can reasonably be 
expected to be exposed to airborne beryllium at any level, whereas an 
area is a regulated area only if employees are or can reasonably be 
expected to be exposed above the TWA PEL or STEL; the regulated area, 
therefore, is either a subset of the beryllium work area or, less 
likely, identical to it, depending on the configuration and 
circumstances of the worksite. Dermal exposure has also been included 
in the final definition to address the potential for sensitization from 
dermal contact. Therefore, while not all beryllium work areas are 
regulated areas, all regulated areas are beryllium work areas because 
they are areas with employee exposure to beryllium. Accordingly, all 
requirements for beryllium work areas also apply in all regulated 
areas, but requirements specific to regulated areas apply only to 
regulated areas and not to beryllium work areas where exposures do not 
exceed the TWA PEL or STEL. For further discussion, see this section of 
the preamble regarding paragraph (e), Beryllium work areas and 
regulated areas.
    The presence of a beryllium work area triggers a number of the 
requirements in the general industry standard. Under paragraph 
(d)(3)(i), employers must determine exposures for each beryllium work 
area. Paragraphs (e)(1)(i) and (e)(2)(i) require employers to 
establish, maintain, identify, and demarcate the boundaries of each 
beryllium work area. Under paragraph (f)(1)(i)(D), employers must 
minimize cross-contamination by preventing the transfer of beryllium 
between surfaces, equipment, clothing, materials, and articles within a 
beryllium work area. Paragraph (f)(1)(i)(F) states that employers must 
minimize migration of beryllium from the beryllium work area to other 
locations within and outside the workplace. Paragraph (f)(2) requires 
employers to implement at least one of the controls listed in 
(f)(2)(i)(A) through (D) for each operation in a beryllium work area 
unless one of the exemptions in (f)(2)(ii) applies. Paragraph (i)(1) 
requires employers to provide readily accessible washing facilities to 
employees working in a beryllium work area, and to ensure that 
employees who have dermal contact with beryllium wash any exposed skin 
at the end of the activity, process, or work shift and prior to eating, 
drinking, smoking, chewing tobacco or gum, applying cosmetics, or using 
the toilet. In addition employers must ensure that these areas comply 
with the Sanitation standard (29 CFR 1910.141) (paragraph (i)(4)). 
Employers must maintain surfaces in all beryllium work areas as free as 
practicable of beryllium (paragraph (j)(1)(i)). Paragraph (j)(2) 
requires certain practices and prohibits other practices for cleaning 
surfaces in beryllium work areas. Under paragraph (m)(4)(ii)(B), 
employers must ensure workers demonstrate knowledge of the written 
exposure control plan with emphasis on the location(s) of beryllium 
work areas.
    CBD diagnostic center means a medical diagnostic center that has an 
on-site pulmonary specialist and on-site facilities to perform a 
clinical evaluation for the presence of chronic beryllium disease 
(CBD). This evaluation must include pulmonary function testing (as 
outlined by the American Thoracic Society criteria), bronchoalveolar 
lavage (BAL), and transbronchial biopsy. The CBD diagnostic center must 
also have the capacity to transfer BAL samples to a laboratory for 
appropriate diagnostic testing within 24 hours. The on-site pulmonary 
specialist must be able to interpret the biopsy pathology and the BAL 
diagnostic test results. For purposes of these standards, the term 
``CBD diagnostic center'' refers to any medical facility that meets 
these criteria, whether or not the medical facility formally refers to 
itself as a CBD diagnostic center. For example, if a hospital has all 
of the capabilities required by this standard for CBD diagnostic 
centers, the hospital would be considered a CBD diagnostic center for 
purposes of these standards.
    OSHA received comments from NJH and ORCHSE Strategies (ORCHSE) 
regarding the definition of the ``CBD diagnostic center.'' NJH 
commented that CBD diagnostic centers do not need to be able to perform 
the BeLPT but should be able to process the BAL appropriately and ship 
samples within 24 hours to a facility that can perform the BeLPT. NJH 
also indicated that CBD diagnostic centers should be able to perform CT 
scans, pulmonary function tests with DLCO (diffusing capacity of the 
lungs for carbon monoxide), and measure gas exchange abnormalities. NJH 
further indicated that CBD diagnostic centers should have a medical 
doctor who has experience and expertise, or is willing to obtain such 
expertise, in the diagnosis and treatment of chronic beryllium disease 
(Document ID 1664, pp. 5-6). ORCHSE argued that CBD diagnostic centers 
should be allowed to rely on off-site interpretation of transbronchial 
biopsy pathology, reasoning that this change would broaden the 
accessibility of CBD diagnostic centers to more affected employees 
(Document ID 1691, p. 3).
    OSHA evaluated these recommendations and included the language 
regarding sample processing and removed the proposal's requirement that 
BeLPTs be performed on-site. The Agency also changed the requirement 
that pulmonary specialist perform testing as outlined in the proposal 
to the final definition which requires that a pulmonary specialist be 
on-site. This requirement addresses the concerns ORCHSE raised about 
accessibility of CBD diagnostic centers by increasing the number of 
facilities that would qualify as centers. This also preserves the 
expertise required to diagnose and treat CBD as stated by NJH (Document 
1664, p. 6).
    Paragraph (k)(7) includes provisions providing for an employee who 
has been confirmed positive to receive an initial clinical evaluation 
and subsequent medical examinations at a CBD diagnostic center.
    Chronic beryllium disease (CBD) means a chronic lung disease 
associated

[[Page 2646]]

with exposure to airborne beryllium. The Health Effects section of this 
preamble, section V, contains more information on CBD. CBD is relevant 
to several provisions of this standard. Under paragraph (k)(1)(i)(B), 
employers must make medical surveillance available at no cost to 
employees who show signs and symptoms of CBD. Paragraph (k)(3)(ii)(B) 
requires medical examinations conducted under this standard to include 
a physical examination with emphasis on the respiratory system, in 
order to identify respiratory conditions such as CBD. Under paragraph 
(k)(5)(i)(A), the licensed physician's report must advise the employee 
on whether or not the employee has any detected medical condition that 
would place the employee at an increased risk of CBD from further 
exposure to beryllium. Furthermore, CBD is a criterion for medical 
removal under paragraph (l)(1). Under paragraph (m)(1)(ii), employers 
must address CBD in classifying beryllium hazards under the hazard 
communication standard (HCS) (29 CFR 1910.1200). Employers must also 
train employees on the signs and symptoms of CBD (see paragraph 
(m)(4)(ii)(A) of the general industry and shipyard standards and 
paragraph (m)(3)(ii)(A) of the construction standard).
    Competent person means an individual on a construction site who is 
capable of identifying existing and foreseeable beryllium hazards in 
the workplace and who has authorization to take prompt corrective 
measures to eliminate or minimize them. The competent person must have 
the knowledge, ability, and authority necessary to fulfill the 
responsibilities set forth in paragraph (e) of the standard for 
construction. This definition appears only in the standard for 
construction.
    The competent person concept has been broadly used in OSHA 
construction standards (e.g., 29 CFR 1926.32(f) and 1926.20(b)(2)), 
including in the recent health standard for respirable crystalline 
silica (29 CFR 1926.1153). Under 29 CFR 1926.32(f), competent person is 
defined as ``one capable of identifying existing and predictable 
hazards in the surroundings or working conditions that are unsanitary, 
hazardous, or dangerous to employees and who is authorized to take 
prompt corrective measures to eliminate them.'' OSHA has adapted this 
definition for the beryllium construction standard by specifying 
``foreseeable beryllium hazards in the workplace'' instead of 
``predictable hazards in the surroundings or working conditions that 
are unsanitary, hazardous, or dangerous to employees.'' The Agency also 
replaced the word ``one'' with ``an individual.'' The Agency revised 
the phrase ``to eliminate them'' to read ``to eliminate or minimize 
them'' to denote there may be cases where complete elimination would 
not be feasible. The definition of competent person also indicates that 
the competent person must have the knowledge, ability, and authority 
necessary to fulfill the responsibilities set forth in paragraph (e) of 
the construction standard, in order to ensure that the competent has 
appropriate training, education, or experience. See the discussion of 
``competent person'' in the summary and explanation of paragraphs (e), 
Beryllium work areas and regulated areas, and (f), Methods of 
compliance, in this section.
    Confirmed positive means the person tested has beryllium 
sensitization, as indicated by two (either consecutive or non-
consecutive) abnormal BeLPT test results, an abnormal and borderline 
test result, or three borderline test results. The definition of 
``confirmed positive'' also includes a single result of a more reliable 
and accurate test indicating that a person has been identified as 
sensitized to beryllium if the test has been validated by repeat 
testing to have more accurate and precise diagnostic capabilities 
within a single test result than the BeLPT. OSHA recognizes that 
diagnostic tests for beryllium sensitization could eventually be 
developed that would not require a second test to confirm 
sensitization. Alternative test results would need to have comparable 
or increased sensitivity, specificity and positive predictive value 
(PPV) in order to replace the BeLPT as an acceptable test to evaluate 
beryllium sensitization (see section V.D.5.b of this preamble).
    OSHA received comments from NJH, the American Thoracic Society 
(ATS) and ORCHSE regarding the requirement for consecutive test results 
within a two year time frame, and the inclusion of borderline test 
results (Document ID 1664, p.5; 1668, p. 2; 1691, p. 20). NJH and ATS 
submitted similar comments regarding the requirement of two abnormal 
BeLPT test results to be consecutive and within two years. According to 
NJH, ``the definition of `confirmed positive' [should] include two 
abnormals, an abnormal and a borderline test result, and/or three 
borderline tests. This recommendation is based on studies of Middleton 
et al. (2008, and 2011), which showed that these other two combinations 
result in a PPV similar to two abnormal test results and are an equal 
predictor of CBD.'' (Document ID 1664, p. 5). In addition, the ATS 
stated:

    These test results need not be from consecutive BeLPTs or from a 
second abnormal BeLPT result within a two-year period of the first 
abnormal result. These recommendations are based on the many studies 
cited in the docket, as well as those of Middleton, et al. (2006, 
2008, and 2011), which showed that an abnormal and a borderline 
result provide a positive predictive value (PPV) similar to that of 
two abnormal test results for the identification of both beryllium 
sensitization and for CBD (Document ID 1668, p. 2).

    Materion Corporation (Materion) opposed changing the requirement 
for two abnormal BeLPT results and opposed allowing two or three 
borderline results to determine sensitization (Document ID 1808, p. 4). 
Without providing scientific studies or other bases for its position, 
Materion argued that ``[m]aking a positive BeS determination for an 
individual without any confirmed abnormal test result is not warranted 
and clearly is not justifiable from a scientific, policy or legal 
perspective'' (Document ID 1808, p. 4).
    OSHA evaluated these comments and modified the definition of 
``confirmed positive'' accordingly for reasons described more fully 
within the Health Effects section of this preamble, V.D.5.b, including 
reliance on the Middleton studies (2008, 2011). The original definition 
for ``confirmed positive'' in the proposed standard was adapted from 
the model standard submitted to OSHA by Materion and the USW in 2012. 
Having carefully considered all these comments and their supporting 
evidence, where provided, the Agency finds the arguments from NJH, ATS, 
and ORCHSE persuasive. In particular ATS points out the Middleton et 
al. studies ``. . . showed that an abnormal and a borderline result 
provide a positive predictive value (PPV) similar to that of two 
abnormal test results for the identification of both beryllium 
sensitization and for CBD.'' (Document ID. 1688 p. 3). Therefore, the 
Agency recognizes that a borderline BeLPT test result when accompanied 
by an abnormal test result, or three separate borderline test results, 
should also be considered ``confirmed positive.''
    In addition, ORCHSE commented on the use of a single test result 
from a more reliable and accurate test (Document ID 1691, p. 20). 
Specifically, ORCHSE recommended revising the language to include ``the 
result of a more reliable and accurate test such that beryllium 
sensitization can be confirmed after one test, indicating a person has 
been identified as having beryllium sensitization'' (Document ID 1691, 
p. 20). In response to the comment from ORCHSE, the Agency has included

[[Page 2647]]

additional language regarding the results from an alternative test 
(Document ID 1691, p. 20). OSHA inserted additional language clarifying 
that the alternative test has to be validated by repeat testing 
indicating that it has comparable or increased sensitivity, specificity 
and PPV than the BeLPT. The Agency finds that this language provides 
more precise direction for acceptance of an alternative test.
    Director means the Director of the National Institute for 
Occupational Safety and Health (NIOSH), U.S. Department of Health and 
Human Services, or designee. The recordkeeping requirements mandate 
that, upon request, employers make all records required by this 
standard available to the Director (as well as the Assistant Secretary) 
for examination and copying (see paragraph (n)(6)). Typically, the 
Assistant Secretary sends representatives to review workplace safety 
and health records. However, the Director may also review these records 
while conducting studies such as Health Hazard Evaluations of 
workplaces, or for other purposes. OSHA received no comments on this 
definition, and it is unchanged from the proposal.
    Emergency means any uncontrolled release of airborne beryllium. An 
emergency could result from equipment failure, rupture of containers, 
or failure of control equipment, among other causes.
    An emergency triggers several requirements of this standard. Under 
paragraph (g)(1)(iv), respiratory protection is required during 
emergencies to protect employees from potential overexposures. 
Emergencies also trigger clean-up requirements under paragraph 
(j)(1)(ii), and medical surveillance under paragraph (k)(1)(i)(C). In 
addition, under paragraph (m)(4)(ii)(D) of the standards for general 
industry and shipyards and paragraph (m)(3)(ii)(D) of the standard for 
construction, employers must train employees in applicable emergency 
procedures.
    High-efficiency particulate air (HEPA) filter means a filter that 
is at least 99.97 percent effective in removing particles 0.3 
micrometers in diameter (see Department of Energy Technical Standard 
DOE-STD-3020-2005). HEPA filtration is an effective means of removing 
hazardous beryllium particles from the air. The standard requires 
beryllium-contaminated surfaces to be cleaned by HEPA vacuuming or 
other methods that minimize the likelihood of exposure (see paragraphs 
(j)(2)(i) and (ii)). OSHA received no comments on this definition, and 
it is unchanged from the proposal.
    Objective data means information, such as air monitoring data from 
industry-wide surveys or calculations based on the composition of a 
substance, demonstrating airborne exposure to beryllium associated with 
a particular product or material or a specific process, task, or 
activity. The data must reflect workplace conditions closely resembling 
or with a higher airborne exposure potential than the processes, types 
of material, control methods, work practices, and environmental 
conditions in the employer's current operations.
    OSHA did not include a definition of ``objective data'' in the 
proposed rule. Use of objective data was limited in the proposed rule, 
and applied only to an exception from initial monitoring requirements 
in proposed paragraph (d)(2). Proposed paragraph (d)(2)(ii) included 
criteria for objective data.
    The final rule allows for expanded use of objective data. Paragraph 
(a)(3) allows for use of objective data to support an exception from 
the scope of the standards. Paragraph (d)(2) allows for use of 
objective data as part of the performance option for exposure 
assessment. OSHA is therefore including a definition of ``objective 
data'' in paragraph (b) of the standards. The definition is generally 
consistent with the criteria included in proposed paragraph (d)(2)(ii), 
and with the use of this term in other OSHA substance-specific health 
standards such as the standards addressing exposure to cadmium (29 CFR 
1910.1027), chromium (VI) (29 CFR 1010.1026), and respirable 
crystalline silica (29 CFR 1910.1053).
    Physician or other licensed health care professional (PLHCP) means 
an individual whose legally permitted scope of practice, such as 
license, registration, or certification, allows the person to 
independently provide or be delegated the responsibility to provide 
some or all of the health care services required in paragraph (k). The 
Agency recognizes that personnel qualified to provide medical 
surveillance may vary from State to State, depending on State licensing 
requirements. Whereas all licensed physicians would meet this 
definition of PLHCP, not all PLHCPs must be physicians.
    Under paragraph (k)(5) of the standards, the written medical report 
for the employee must be completed by a licensed physician. Under 
paragraph (k)(6) of the standard, the written medical opinion for the 
employer must also be completed by a licensed physician. However, other 
requirements of paragraph (k) may be performed by a PLHCP under the 
supervision of a licensed physician (see paragraphs (k)(1)(ii), 
(k)(3)(i), (k)(3)(ii)(F), (k)(3)(ii)(G), and (k)(5)(iii)). The standard 
also identifies what information the employer must give to the PLHCP 
providing the services listed in this standard, and requires that 
employers maintain a record of this information for each employee (see 
paragraphs (k)(4) and (n)(3)(ii)(C), and the summary and explanation of 
paragraphs (k), Medical surveillance, in this section).
    Allowing a PLHCP to provide some of the services required under 
this rule is consistent with other recent OSHA health standards, such 
as bloodborne pathogens (29 CFR 1910.1030), respiratory protection (29 
CFR 1910.134), methylene chloride (29 CFR 1910.1052), and respirable 
crystalline silica (29 CFR 1910.1053). OSHA received no comments on 
this definition, and it is unchanged from the proposal.
    Regulated area means an area, including temporary work areas where 
maintenance or non-routine tasks are performed, where an employee's 
airborne exposure exceeds, or can reasonably be expected to exceed, 
either the TWA PEL or STEL. For an explanation of the distinction and 
overlap between beryllium work areas and regulated areas, see the 
definition of ``beryllium work area'' earlier in this section of the 
preamble and the summary and explanation for paragraph (e), Beryllium 
work areas and regulated areas. Regulated areas appear only in the 
general industry and shipyard standards, and they trigger several other 
requirements.
    Paragraphs (e)(1)(ii) and (e)(2)(ii) require employers to establish 
and demarcate regulated areas. Note that the demarcation requirements 
for regulated areas are more specific than those for other beryllium 
work areas (see also paragraph (m)(2) of the standards for general 
industry and shipyards). Paragraph (e)(3) requires employers to 
restrict access to regulated areas to authorized persons, and paragraph 
(e)(4) requires employers to provide all employees in regulated areas 
appropriate respiratory protection and personal protective clothing and 
equipment, and to ensure that these employees use the required 
respiratory protection and protective clothing and equipment. Paragraph 
(i)(5)(i) prohibits employers from allowing employees to eat, drink, 
smoke, chew tobacco or gum, or apply cosmetics in regulated areas. 
Paragraph (m)(2) requires warning signs associated with regulated areas 
to meet

[[Page 2648]]

certain specifications. Paragraph (m)(4)(ii)(B) requires employers to 
train employees on the written exposure control plan required by 
paragraph (f)(1), including the location of regulated areas and the 
specific nature of operations that could result in airborne exposure.
    In the proposed rule, OSHA included in the definition of the term 
``regulated area'' that it was ``an area that the employer must 
demarcate.'' Because the requirement to demarcate regulated areas is 
presented elsewhere in the standards, the reference in the definition 
to ``an area that the employer must demarcate'' is redundant, and has 
been removed from the final definition of the term.
    This definition of regulated areas is consistent with other 
substance-specific health standards that apply to general industry and 
shipyards, such as the standards addressing occupational exposure to 
cadmium (29 CFR 1910.1027 and 29 CFR 1915.1027), benzene (29 CFR 
1910.1028 and 29 CFR 1915.1028), and methylene chloride (29 CFR 
1910.1052 and 29 CFR 1915.1052).
    This standard means the beryllium standard in which it appears. In 
the general industry standard, it refers to 29 CFR 1910.1024. In the 
shipyard standard, it refers to 29 CFR 1915.1024. In the construction 
standard, it refers to 29 CFR 1926.1124. This definition elicited no 
comments and differs from the proposal only in that it appears in the 
three separate standards.

(c) Permissible Exposure Limits (PELs)

    Paragraph (c) of the standards establishes two permissible exposure 
limits (PELs) for beryllium in all forms, compounds, and mixtures: An 
8-hour time-weighted average (TWA) PEL of 0.2 [mu]g/m\3\ (paragraph 
(c)(1)), and a 15-minute short-term exposure limit (STEL) of 2.0 [mu]g/
m\3\ (paragraph (c)(2)). The TWA PEL section of the standards requires 
employers to ensure that no employee's exposure to beryllium, averaged 
over the course of an 8-hour work shift, exceeds 0.2 [mu]g/m\3\. The 
STEL section of the standards requires employers to ensure that no 
employee's exposure, sampled over any 15-minute period during the work 
shift, exceeds 2.0 [mu]g/m\3\. While the proposed rule contained 
slightly different language in paragraph (c), i.e. requiring that 
``each employee's airborne exposure does not exceed'' the TWA PEL and 
STEL, the final language was chosen by OSHA to remain consistent with 
prior OSHA health standards and to clarify that OSHA did not intend a 
different interpretation of the PELs in this standard. The same PELs 
apply to general industry, construction, and shipyards.
    TWA PEL. OSHA proposed a new TWA PEL of 0.2 [mu]g/m\3\ of 
beryllium--one-tenth the preceding TWA PEL of 2 [mu]g/m\3\--because 
OSHA preliminarily found that occupational exposure to beryllium at and 
below the preceding TWA PEL of 2 [mu]g/m\3\ poses a significant risk of 
material impairment of health to exposed workers. As with several other 
provisions of these standards, OSHA's proposed TWA PEL followed the 
draft recommended standard submitted to the Agency by Materion 
Corporation (Materion) and the United Steelworkers (USW) (see this 
preamble at section III, Events Leading to the Standards).
    After evaluating the record, including published studies and more 
recent exposure data from industrial facilities involved in beryllium 
work, OSHA is adopting the proposed TWA PEL of 0.2 [mu]g/m\3\. OSHA has 
made a final determination that occupational exposure to a variety of 
beryllium compounds at levels below the preceding PELs poses a 
significant risk to workers (see this preamble at section VII, 
Significance of Risk). OSHA's risk assessment, presented in section VI 
of this preamble, indicates that there is significant risk of beryllium 
sensitization,\38\ CBD, and lung cancer from a 45-year (working life) 
exposure to beryllium at the preceding TWA PEL of 2 [mu]g/m\3\. The 
risk assessment further indicates that, although the risk is much 
reduced, significant risk remains at the new TWA PEL of 0.2 [mu]g/m\3\.
---------------------------------------------------------------------------

    \38\ As discussed in section VII of this preamble, Significance 
of Risk, beryllium sensitization is a necessary precursor to 
developing CBD.
---------------------------------------------------------------------------

    OSHA has determined that the new TWA PEL is feasible across all 
affected industry sectors (see section VIII.D of this preamble, 
Technological Feasibility) and that compliance with the new PEL will 
substantially reduce employees' risks of beryllium sensitization, 
Chronic Beryllium Disease (CBD), and lung cancer (see section VI of 
this preamble, Risk Assessment). OSHA's conclusion about feasibility is 
supported both by the results of the Agency's feasibility analysis and 
by the recommendation of the PEL of 0.2 [mu]g/m\3\ by Materion and the 
USW.
     Materion is the sole beryllium producer in the U.S., and its 
facilities include some of the processes where OSHA expects it will be 
most challenging to control beryllium exposures. Although OSHA also 
found that there is significant risk at the proposed alternative TWA 
PEL of 0.1 [mu]g/m\3\, OSHA did not adopt that alternative because the 
Agency could not demonstrate technological feasibility at that level 
(see section VIII.D of this preamble, Technological Feasibility).
    The TWA PEL was the subject of numerous comments in the rulemaking 
record. Comments from stakeholders in labor and industry, public health 
experts, and the general public supported OSHA's selection of 0.2 
[mu]g/m\3\ as the final PEL (NIOSH, Document ID 1671, Attachment 1, p. 
2; National Safety Council, 1612, p. 3; The Sampling and Analysis 
Subcommittee Task Group of the Beryllium Health and Safety Committee of 
the Department of Energy's National Nuclear Security Administration 
Lawrence Livermore National Lab (BHSC Task Group), 1655, p. 2; Newport 
News Shipbuilding, 1657, p. 1; National Jewish Health (NJH),1664, p. 2; 
The Aluminum Association, 1666, p. 1; The Boeing Company (Boeing), 
1667, p. 1; American Industrial Hygiene Association (AIHA), 1686, p. 2; 
United Steelworkers (USW), 1681, p. 7; Andrew Brown, 1636, p. 6; 
Department of Defense, 1684, p. 1). Materion stated that the record 
does not support the feasibility of any limit lower than 0.2 [mu]g/m\3\ 
(Document ID 1808, p. 2). OSHA also received comments supporting 
selection of a lower TWA PEL of 0.1 [mu]g/m\3\ from Public Citizen, the 
AFL-CIO, the United Automobile, Aerospace & Agricultural Implement 
Workers of America (UAW), North America's Building Trades Unions 
(NABTU), and the American College of Occupational and Environmental 
Medicine (ACOEM) (Document ID 1689, p. 7; 1693, p. 3; 1670, p. 1; 1679, 
pp. 6-7; 1685, p. 1; 1756, Tr. 167). These commenters based their 
recommendations on the significant risk of material health impairment 
from exposure at the TWA PEL of 0.2 [mu]g/m\3\ and below, which OSHA 
acknowledges.
    In addition to their concerns about risk, Public Citizen and the 
American Federation of Labor and Congress of Industrial Organizations 
(AFL-CIO) argued that a TWA PEL of 0.1 [mu]g/m\3\ is feasible (Document 
ID 1756, Tr. 168-169, 197-198). As discussed further below, however, 
OSHA's selection of the TWA PEL in this case was limited by the 
findings of its technological feasibility analysis. No commenter 
provided information that would permit OSHA to show the feasibility of 
a TWA PEL of 0.1 [mu]g/m\3\ in industries where OSHA did not have 
sufficient information to make this determination at the proposal 
stage. Public Citizen instead argued that insufficient evidence that 
engineering and work practice controls can maintain exposures at or 
below a TWA PEL of 0.1

[[Page 2649]]

[mu]g/m\3\ should not preclude OSHA from establishing such a PEL; and 
that workplaces unable to achieve a TWA PEL of 0.1 [mu]g/m\3\ should be 
required to reduce airborne exposures as much as possible using 
engineering and work practice controls, supplemented with a respiratory 
protection program (Document ID 1670, p. 5).
    OSHA has determined that Public Citizen's claim that the Agency 
should find a PEL of 0.1 [mu]g/m\3\ technologically feasible is 
inconsistent with the test for feasibility as described by the courts 
as well as the evidence in the rulemaking record. OSHA bears the 
evidentiary burden of establishing feasibility in a rulemaking 
challenge. The D.C. Circuit, in its decision on OSHA's Lead standard 
(United Steelworkers of America v. Marshall, 647 F.2d 1189 (D.C. Cir. 
1981) (``Lead'')), explained that in order to establish that a standard 
is technologically feasible, ``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'' (Lead, 647 F.2d at 1272). ``The effect of such proof,'' 
the court continued, ``is to establish a presumption that industry can 
meet the PEL without relying on respirators'' (Lead, 647 F.2d at 1272). 
The court's definition of technological feasibility thus recognizes 
that, for a standard based on a hierarchy of controls prioritizing 
engineering and work practice controls over respirators, a particular 
PEL is not technologically feasible simply because it can be achieved 
through the widespread use of respirators (see Lead, 647 F.2d at 1272). 
OSHA's long-held policy of avoiding requirements that will result in 
extensive respirator use is consistent with this legal standard.
    In considering an alternative TWA PEL of 0.1 [mu]g/m\3\ that would 
reduce risks to workers further than would the TWA PEL of 0.2 [mu]g/
m\3\, OSHA was unable to determine that this level was technologically 
feasible. For some work operations, the evidence is insufficient for 
OSHA to demonstrate that a TWA PEL of 0.1 [mu]g/m\3\ could be achieved 
most of the time. In other operations, a TWA PEL of 0.1 [mu]g/m\3\ 
appears to be impossible to achieve without resort to respirators (see 
section VIII.D of this preamble, Technological Feasibility, for a 
detailed discussion of OSHA's feasibility findings). Thus, OSHA was 
unable to meet its legal burden to demonstrate the technological 
feasibility of the alternative TWA PEL of 0.1 [mu]g/m\3\ (see Lead, 647 
F.2d at 1272; Amer. Iron & Steel Inst. v. OSHA, 939 F.2d 975, 990 (D.C. 
Cir. 1991)) and has adopted the proposed PEL of 0.2 [mu]g/m\3\, for 
which there is substantial evidence demonstrating technological 
feasibility.
    OSHA also invited comment on and considered an alternative TWA PEL 
of 0.5 [mu]g/m\3\--two-and-a-half times greater than the proposed PEL 
that it is adopting. As noted above, OSHA determined that significant 
risk to worker health exists at the preceding PEL of 2.0 [mu]g/m\3\ as 
well as at the new TWA PEL of 0.2 [mu]g/m\3\. Because OSHA found that a 
TWA PEL of 0.2 [mu]g/m\3\ is technologically and economically feasible, 
the Agency concludes that setting the TWA PEL at 0.5 [mu]g/m\3\--a 
level that would leave workers exposed to even greater health risks 
than they will face at the new PEL of 0.2 [mu]g/m\3\--would be contrary 
to the OSH Act, which requires OSHA to eliminate the risk of material 
health impairment ``to the extent feasible'' (29 U.S.C. 655(b)(5)). 
Thus, the Agency is not adopting the proposed alternative TWA PEL of 
0.5 [mu]g/m\3\.
    Because significant risks of sensitization, CBD, and lung cancer 
remain at the new TWA PEL of 0.2 [mu]g/m\3\, the final standards 
include a variety of ancillary provisions to further reduce risk to 
workers. These ancillary provisions include implementation of feasible 
engineering controls in beryllium work areas, respiratory protection, 
personal protective clothing and equipment, exposure monitoring, 
regulated areas, medical surveillance, medical removal, hygiene areas, 
housekeeping requirements, and hazard communication. The Agency has 
determined that these provisions will reduce the risk beyond that which 
the TWA PEL alone could achieve. These provisions are discussed later 
in this Summary and Explanation section of the preamble.
    STEL. OSHA is also promulgating a STEL of 2.0 [mu]g/m\3\, as 
determined over a sampling period of 15 minutes. The new STEL of 2 
[mu]g/m\3\ was suggested by the joint Materion-USW proposed rule and 
proposed in the NPRM. As discussed in section VII of this preamble, 
significant risks of sensitization, CBD, and lung cancer remain at the 
TWA PEL of 0.2 [mu]g/m\3\. Where a significant risk of material 
impairment of health remains at the TWA PEL, OSHA must impose a STEL if 
doing so would further reduce risk and is feasible to implement (Pub. 
Citizen Health Research Grp. v. Tyson, 796 F.2d 1479, 1505 (D.C. Cir. 
1986) (``Ethylene Oxide''); see also Building and Construction Trades 
Department, AFL-CIO v. Brock, 838 F.2d 1258, 1271 (D.C. Cir. 1988)). In 
this case, the evidence in the record demonstrates that the STEL is 
feasible and that it will further reduce the risk remaining at the TWA 
PEL. The goal of a STEL is to protect employees from the risk of harm 
that can occur as a result of brief exposures that exceed the TWA PEL. 
Without a STEL, the only protection workers would have from high short-
duration exposures is that, when those exposures are factored in, they 
cannot exceed the cumulative 8-hour exposure at the proposed 0.2 [mu]g/
m\3\ TWA PEL (i.e., 1.6 [mu]g/m\3\). Since there are 32 15-minute 
periods in an 8-hour work shift, a worker's 15-minute exposure in the 
absence of a STEL could be as high as 6.4 [mu]g/m\3\ (32 x 0.2 [mu]g/
m\3\) if that worker's exposures during the remainder of the 8-hour 
work shift are non-detectable. A STEL serves to minimize high, task-
based exposures by requiring feasible controls in these situations, and 
has the added effect of further reducing the 8-hour TWA exposure.
    OSHA believes a STEL for beryllium will help reduce the risk of 
sensitization and CBD in beryllium-exposed employees. As discussed in 
this preamble at section V, Health Effects, beryllium sensitization is 
the initial step in the development of CBD. Sensitization has been 
observed in some workers who were only exposed to beryllium for a few 
months (see section V.D.1 of this preamble), and tends to be more 
strongly associated with 'peak' and highest-job-worked exposure metrics 
than cumulative exposure (see section V.D.5 of this preamble). Short-
term exposures to beryllium have also been shown to contribute to the 
development of lung disease in laboratory animals (see this preamble at 
section V, Health Effects). These study findings indicate that adverse 
effects to the lung may occur from beryllium exposures of relatively 
short duration. Thus OSHA expects a STEL to add further protection from 
the demonstrated significant risk of harm than that afforded by the new 
0.2 [mu]g/m\3\ TWA PEL alone.
    STEL exposures are typically associated with, and need to be 
measured by the employer during, the highest-exposure operations that 
an employee performs (see paragraph (d)(3)(ii)). OSHA has determined 
that the STEL of 2.0 [mu]g/m\3\ can be measured for this brief period 
of time using OSHA's available sampling and analytical methodology, and 
that feasible means exist to maintain 15-minute short-term exposures at 
or below the proposed STEL (see section VIII.D of this preamble, 
Technological Feasibility). Comments on the STEL were generally 
supportive of OSHA's

[[Page 2650]]

decision to include a beryllium STEL, but differed on the appropriate 
level. NIOSH recommended a STEL of at most 1 [mu]g/m\3\, noting that 
available exposure assessment methods are sensitive enough to support a 
STEL of 1 [mu]g/m\3\ and that it is likely to be more protective than 
the proposed STEL of 2 [mu]g/m\3\ (Document ID 1960, Attachment 2, p. 
4; 1725, p. 35; 1755, Tr. 22). NJH's comments also supported a STEL of 
1 [mu]g/m\3\ as the best option (Document ID 1664, p. 3). Public 
Citizen and the AFL-CIO advocated for a STEL of 1 [mu]g/m\3\, stating 
that it would be more protective than the proposed STEL of 2 [mu]g/m\3\ 
(Document ID 1670, p. 6; 1689, p. 7-8). The AFL-CIO and Public Citizen 
both stated that a STEL of 1 [mu]g/m\3\ is supported in the record, 
including by exposure data from OSHA workplace inspections (Document ID 
1670, p. 6; 1756, Tr. 171). However, no additional engineering controls 
capable of reducing short term exposures to or below 1.0 [mu]g/m\3\ 
were identified by commenters. Public commenters did not provide any 
empirical data to suggest that those exposed to working conditions 
associated with a STEL of 2.0 [mu]g/m\3\ would be more likely to be 
sensitized than those exposed to working conditions associated with a 
STEL of 1.0 [mu]g/m\3\. However, OSHA notes that the available 
epidemiological literature on beryllium-related disease does not 
address the question of whether those exposed to working conditions 
associated with a STEL of 2.0 [mu]g/m\3\ would be more likely to be 
sensitized than those exposed to working conditions associated with a 
STEL of 1.0 [mu]g/m\3\. Detailed documentation of workers' short-term 
exposures is typically not available to researchers. Therefore, OSHA 
cannot exclusively rely on evidence relating health effects to specific 
short-term exposure levels to set a STEL. In setting a STEL, OSHA also 
examines the likelihood that a given STEL will help to reduce 
excursions above the TWA PEL and the feasibility of meeting a given 
STEL using engineering controls. The UAW emphasized that ``OSHA must 
include the STEL in the standard to ensure that peak exposures are 
characterized and controlled'' (Document ID 1693, p. 3). The UAW 
argued, specifically, for a STEL of five times the PEL (recommending a 
STEL of 0.5 [mu]g/m\3\ based on a TWA PEL of 0.1 [mu]g/m\3\), noting 
that single short-term, high-level beryllium exposures can lead to 
sensitization, and that UAW members in industries such as nonferrous 
foundries and scrap metal reclamation may experience such exposures 
even when not exposed above the 8 hour TWA PEL (Document ID 1693, p. 
3). Ameren Services Company, a public utility that includes electric 
power generation companies, expressed support for the proposed PEL and 
STEL, but also expressed support for selecting a STEL of five times the 
PEL in order to maintain consistency with OSHA's typical approach to 
setting STELs (Document ID 1675, p. 3).
    In contrast, NGK Metals Corporation (NGK) supported the proposed 
STEL of 2 [mu]g/m\3\, and specifically argued against a STEL of 0.5 
[mu]g/m\3\ on the basis that a reduced STEL would not be feasible or 
offer significantly more protection than the proposed STEL (Document ID 
1663, p. 4). Materion emphasized the need for ``proactive operational 
control'' of tasks that could generate high, short-term beryllium 
exposures, and supported the STEL of 2 [mu]g/m\3\ contained in OSHA's 
proposed rule (Document ID 1661, pp. 3, 5). Materion indicated in its 
comments that the proposed STEL of 2.0 [mu]g/m\3\ was based on 
controlling the upper range of worker short term exposures (Document ID 
1661). Materion used data provided in the Johnson study of the United 
Kingdom Atomic Weapons Establishment (AWE) in Cardiff, Wales, as 
supporting evidence for the proposed STEL (Document ID 1505). However, 
Dr. Christine Schuler from NIOSH commented that the AWE study was not 
an appropriate basis for an OSHA STEL because the AWE study was based 
on workers showing physical signs of CBD (``If somebody became really 
apparently ill, then they would have identified them.'') (Document ID 
1755, Tr. 35). Dr. Schuler additionally commented that the studies 
performed in the United States are more appropriate since they are 
based on identified cases of CBD at an earlier stage where there are 
generally very few symptoms (called asymptomatic or subclinical) 
(Document ID 1755, Tr. 34-35). OSHA agrees with Dr. Schuler's 
assessment and that the AWE study should not be used as scientific 
evidence to support a STEL of 2.0 [mu]g/m\3\.
    After careful consideration of the record, including all available 
data and stakeholder comments, OSHA has reaffirmed its preliminary 
determinations that a STEL of 2.0 [mu]g/m\3\ (ten times the final PEL 
of 0.2 [mu]g/m\3\) is technologically feasible and will help reduce the 
risk of beryllium-related health effects in exposed employees. As 
discussed in section VIII.D of this preamble, Technological 
Feasibility, OSHA has determined that the implementation of engineering 
and work practice controls required to maintain full shift exposures at 
or below a PEL of 0.2 [mu]g/m\3\ will reduce short term exposures to 
2.0 [mu]g/m\3\ or below. However, adopting a STEL of 1.0 [mu]g/m\3\ or 
lower would likely require additional respirator use in some 
situations. Thus, OSHA has retained the proposed value of 2.0 [mu]g/
m\3\ as the final STEL.
    OSHA also received a comment from Paul Wambach, (an independent 
commenter) stating that a STEL should not be included in the final 
rule, arguing that the diseases associated with beryllium exposure are 
chronic in nature and therefore are not affected by brief excursions 
above the TWA PEL (Document ID 1591, p. 1). However, as discussed 
above, OSHA has determined that there is sufficient evidence that 
brief, high-level exposures to beryllium contribute to the development 
of beryllium sensitization and CBD to support inclusion of a STEL in 
the final rule (see this preamble at section V, Health Effects). This 
comment also discussed the statistical relationship between a 15-minute 
STEL and 8-hour TWA PEL and issues of sampling strategy, discussed in 
section VIII.D of this preamble, Technological Feasibility.
    CFR Entries. OSHA's preceding PELs for ``beryllium and beryllium 
compounds,'' were contained in 29 CFR 1910.1000 Table Z-2 for general 
industry. Table Z-2 contained two PELs: (1) A 2 [mu]g/m\3\ TWA PEL, and 
(2) a ceiling concentration of 5 [mu]g/m\3\ that employers must ensure 
is not exceeded during the 8-hour work shift, except for a maximum peak 
of 25 [mu]g/m\3\ over a 30-minute period in an 8-hour work shift. The 
preceding PELs for beryllium and beryllium compounds in shipyards (29 
CFR 1915.1000 Table Z) and construction (29 CFR 1926.55 Appendix A) 
were also 2 [mu]g/m\3\, but did not include ceiling or peak exposure 
limits. OSHA adopted the preceding PELs in 1972 pursuant to section 
6(a) of the OSH Act (29 U.S.C. 655(a)). The 1972 PELs were based on the 
1970 American National Standards Institute (ANSI) Beryllium and 
Beryllium Compounds standard (Document ID 1303), which in turn was 
based on a 1949 U.S. Atomic Energy Commission adoption of a threshold 
limit for beryllium of 2.0 [mu]/m\3\ and was included in the 1971 
American Conference of Governmental Industrial Hygienists Documentation 
of the Threshold Limit Values for Substances in Workroom Air (Document 
ID 0543).
    OSHA is revising the entry for beryllium and beryllium compounds in 
29 CFR 1910.1000 Table Z-1 to cross-reference the new general industry 
standard, 1910.1024. A comparable revision to 29 CFR 1915.1000 Table Z

[[Page 2651]]

cross-references the shipyard standard, 1915.1024, and 29 CFR 1926.55 
Appendix A is revised to cross-reference the construction standard, 
1926.1124. A footnote is added to 29 CFR 1910.1000 Table Z-1, which 
refers to 29 CFR 1910.1000 Table Z-2 for situations when the new 
exposure limits in 1910.1024 are stayed or otherwise not in effect. The 
preceding PELs for beryllium are retained in 29 CFR 1910.1000 Table Z-
2, 29 CFR 1915.1000 Table Z, and 29 CFR 1926.55 Appendix A. Footnotes 
are added to these tables to make clear that the preceding PELs apply 
to any sectors or operations where the new TWA PEL of 0.2 [mu]g/m\3\ 
and STEL of 2.0 [mu]g/m\3\ are not in effect. The preceding PELs are 
also applicable during the time between publication of the beryllium 
rule and the dates established for compliance with the rule, as well as 
in the event of regulatory delay, a stay, or partial or full 
invalidation by the Court.

(d) Exposure Assessment

    Paragraph (d) of the final standards for general industry, 
construction, and shipyards sets forth requirements for assessing 
employee exposures to beryllium. The requirements are issued pursuant 
to section 6(b)(7) of the OSH Act, which mandates that any standard 
promulgated under section 6(b) shall, where appropriate, ``provide for 
monitoring or measuring employee exposure at such locations and 
intervals, and in such manner as may be necessary for the protection of 
employees.'' 29 U.S.C. 655(b)(7). Consistent with the definition of 
``airborne exposure'' in paragraph (b) of these standards, exposure 
monitoring results must reflect the exposure to airborne beryllium that 
would occur if the employee were not using a respirator. Exposures must 
be assessed using the new performance option (i.e., use of any 
combination of air monitoring data or objective data sufficient to 
accurately characterize employee exposures) or by following the 
scheduled monitoring option (with the frequency of monitoring 
determined by the results of the initial and subsequent monitoring). 
The performance option provides flexibility for employers who are able 
to accurately characterize employee exposures through alternative 
methods like objective data and has been successfully applied in the 
Chromium (VI) standard and recently included in the respirable 
crystalline silica standard. The scheduled monitoring option provides a 
framework that is familiar to many employers, having been a customary 
practice in past substance-specific OSHA health standards. Under either 
option, employers must assess the exposure of each employee who is or 
may reasonably be expected to be exposed to airborne beryllium.
    In the proposed exposure monitoring provision, OSHA required 
employers to assess the exposure of employees who are, or may 
reasonably be expected to be, exposed to airborne beryllium. This 
obligation consisted of an initial exposure assessment, unless the 
employer relied on objective data to demonstrate that exposures would 
be below the action level or the short term exposure level (STEL) under 
any expected conditions; periodic exposure monitoring (at least 
annually if initial exposure monitoring indicates that exposures are at 
or above the action level and at or below the time-weighted average 
(TWA) PEL); and additional monitoring if changes in the workplace could 
reasonably be expected to result in new or additional exposures to 
beryllium. In the proposed rule, monitoring to determine employee TWA 
exposures had to represent the employee's average exposure to airborne 
beryllium over an eight-hour workday. STEL exposures had to be 
characterized by sampling periods of 15 minutes for each operation 
likely to produce exposures above the STEL. Samples taken had to 
reflect the exposure of employees on each work shift, for each job 
classification, in each beryllium work area. Samples had to be taken 
within an employee's breathing zone. The proposed rule also included 
provisions for employee notification of monitoring results and 
observation of monitoring.
    OSHA received comments on a variety of issues pertaining to the 
proposal's exposure monitoring provision. In hearing testimony, Dr. 
Lisa Maier from National Jewish Health (NJH) expressed general support 
for exposure monitoring in the workplace ``to target areas that are at 
or above the action level and to regulate these areas to trigger 
administrative controls'' (Document ID 1756, Tr. 108). All other 
comments regarding the exposure monitoring requirements focused on 
specific areas of those requirements and are discussed in the 
appropriate subject section below.
    OSHA has retained the provisions related to exposure assessment in 
the final standards. These provisions are important because assessing 
employee exposure to toxic substances is a well-recognized and accepted 
risk management tool. As the Agency noted in the proposal, the purposes 
of requiring assessment of employee exposures to beryllium include 
determination of the extent and degree of exposure at the worksite; 
identification and prevention of employee overexposure; identification 
of the sources of exposure to beryllium; collection of exposure data so 
that the employer can select the proper control methods to be used; and 
evaluation of the effectiveness of those selected methods. Assessment 
enables employers to meet their legal obligation to ensure that their 
employees are not exposed in excess of the permissible exposure limit 
(PEL) or short-term exposure limit (STEL) and to ensure employees have 
access to accurate information about their exposure levels, as required 
by section 8(c)(3) of the Act, 29 U.S.C. 657(c)(3). In addition, 
exposure data enable physicians or other licensed health care 
professionals (PLHCPs) performing medical examinations to be informed 
of the extent of the worker's exposure to beryllium.
    In the final standards, paragraph (d) is now titled ``Exposure 
assessment.'' This change from ``exposure monitoring'' in the proposal 
to ``exposure assessment'' in the final standards was made to align the 
provision's purpose with the broader concept of exposure assessment 
beyond conducting air monitoring, including the use of objective data.
    General Requirements. Proposed paragraph (d)(1)(i) contained the 
general requirement that the exposure assessment provisions would apply 
when employees ``are, or may reasonably be expected to be, exposed to 
airborne beryllium.'' OSHA did not receive comment on this specific 
provision. However, in paragraph (d)(1) of the final standards for 
general industry, construction, and shipyards, the Agency has changed 
the proposed requirement that ``These exposure monitoring requirements 
apply when employees are, or may reasonably be expected to be, exposed 
to airborne beryllium'' to ``The employer must assess the airborne 
exposure of each employee who is or may reasonably be expected to be 
exposed to airborne beryllium.'' This change aligns the language to 
other OSHA standards such as respirable crystalline silica (29 CFR 
1910.1053) and hexavalent chromium ([delta]1910.1026) as well as 
clarifies the employer's obligation to assess each employee's beryllium 
exposure. Additionally, for reasons discussed below, paragraph (d)(1) 
of the final standards now requires the employer to assess employee 
exposure in accordance with either the new performance option, added at 
paragraph (d)(2), or the scheduled monitoring option, moved to 
paragraph (d)(3) of this section. Changes from the proposed exposure 
monitoring provision also include an increased

[[Page 2652]]

frequency schedule for periodic monitoring and a requirement to perform 
periodic exposure monitoring when exposures are above the PEL in the 
scheduled monitoring option in paragraph (d)(3)(vi) and when exposures 
are above the STEL in the scheduled monitoring option in paragraph 
(d)(3)(viii).
    Proposed paragraphs (d)(1)(ii)-(v) have been moved to different 
paragraphs in the final standards and will be discussed in the 
appropriate sections below.
    The performance option. Proposed paragraph (d)(2) set forth initial 
exposure monitoring requirements and the circumstances under which 
employers do not need to conduct initial exposure monitoring. In the 
proposal, employers did not have to conduct initial exposure monitoring 
if they relied on historical data or objective data. The proposal also 
set forth requirements for the sufficiency of any historical data or 
objective data used to satisfy proposed paragraph (d)(2). OSHA has 
decided to remove this provision from the final standards as part of 
the change to allow employers to choose between the scheduled 
monitoring option and the performance option for all exposure 
assessment. Paragraph (d)(2) of the final standards for general 
industry, construction, and shipyards describes the exposure assessment 
performance option. OSHA has included this option because it provides 
employers flexibility to assess the 8-hour TWA and STEL exposure for 
each employee on the basis of any combination of air monitoring data or 
objective data sufficient to accurately characterize employee exposures 
to beryllium. OSHA recognizes that exposure monitoring may present 
challenges in certain instances, particularly when tasks are of short 
duration or performed under varying environmental conditions. The 
performance option is intended to allow employers flexibility in 
assessing the beryllium exposures of their employees. The performance 
option for exposure assessment is consistent with other OSHA standards, 
such as those for exposure to respirable crystalline silica (29 CFR 
1910.1053) and chromium (VI) (29 CFR 1910.1026).
    When the employer elects the performance option, the employer must 
initially conduct the exposure assessment and must demonstrate that 
employee exposures have been accurately characterized. As evident in 
final paragraph (d)(3), OSHA considers exposures to be accurately 
characterized when they reflect the exposures of employees on each 
shift, for each job classification, in each work area. However, under 
this option, the employer has flexibility to determine how to achieve 
this. For example, under this option an employer could determine that 
there are no differences between the exposure of an employee in a 
certain job classification who performs a task in a particular work 
area on one shift and the exposure of another employee in the same job 
classification who performs the same task in the same work area on 
another shift. In that case, the employer could characterize the 
exposure of the second employee based on the first employee's exposure.
    Accurately characterizing employee exposures under the performance 
option is also an ongoing duty. In order for exposures to continue to 
be accurately characterized, the employer is required to reassess 
exposures whenever a change in production, process, control equipment, 
personnel, or work practices may reasonably be expected to result in 
new or additional exposures at or above the action level or STEL, or 
when the employer has any reason to believe that new or additional 
exposures at or above the action level have occurred (see discussion 
below of paragraph (d)(4) of the final standards for general industry, 
construction, and shipyards).
    When using the performance option, the burden is on the employer to 
demonstrate that the data accurately characterize employee exposure. 
However, the employer can characterize employee exposure within a 
range, in order to account for variability in exposures. For example, 
an employer could use the performance option and determine that an 
employee's exposure is above the action level but below the PEL. Based 
on this exposure assessment, the employer would be required under 
paragraph (k)(1)(i)(A) to provide medical surveillance if the employee 
is exposed for more than 30 days per year.
    OSHA has not included specific criteria for implementing the 
performance option in the final standards. Because the goal of the 
performance option is to give employers flexibility to accurately 
characterize employee exposures using whatever combination of air 
monitoring data and objective data is most appropriate for their 
circumstances, OSHA concludes it would be inconsistent to specify in 
the standards exactly how and when data should be collected. When an 
employer wants a more structured approach for meeting their exposure 
assessment obligations, it may opt for the scheduled monitoring option.
    OSHA does, however, offer two clarifying points. First, the Agency 
clarifies that when using the term ``air monitoring data'' in this 
paragraph, OSHA refers to any monitoring conducted by the employer to 
comply with the requirements of these standards, including the 
prescribed accuracy and confidence requirements in paragraph (d)(5). 
Second, objective data can include historic air monitoring data, but 
that data must reflect workplace conditions closely resembling or with 
a higher airborne exposure potential than the processes, types of 
material, control methods, work practices, and environmental conditions 
in the employer's current operations. Additional discussion of the 
types of data and exposure assessment strategies that may be used by 
employers as ``objective data'' to accurately characterize employee 
exposures to beryllium can be found in the summary and explanation of 
``objective data'' in paragraph (b) (``Definitions'').
    Where employers rely on objective data generated by others as an 
alternative to developing their own air monitoring data, they will be 
responsible for ensuring that the data relied upon from other sources 
are accurate measures of their employees' exposures. Thus, the burden 
is on the employer to show that the exposure assessment is sufficient 
to accurately characterize employee exposures to beryllium.
    As with the Chromium (VI) standard, 29 CFR 1910.1026, OSHA does not 
limit when objective data can be used to characterize exposure. OSHA 
permits employers to rely on objective data for meeting their exposure 
assessment obligations, even where exposures may exceed the action 
level or PEL. OSHA's intent is to allow employers flexibility to assess 
employee exposures to beryllium, but to ensure that the data used are 
accurate in characterizing employee exposures. For example, where an 
employer has a substantial body of data (from previous monitoring, 
industry-wide surveys, or other sources) indicating that employee 
exposures in a given task are between the action level and PEL, the 
employer may choose to rely on those data to determine his or her 
compliance obligations (e.g., medical surveillance).
    OSHA has also not established time limitations for air monitoring 
results used to characterize employee exposures under the performance 
option. The burden is on the employer to show that the data accurately 
characterize employee exposure to beryllium. This burden applies to the 
age of the data as well as to the source of the data. For example, 
monitoring results obtained 18 months prior to the effective date of 
the standards could be

[[Page 2653]]

used to determine employee exposures, but only if the employer could 
show that the data were obtained during work operations conducted under 
conditions closely resembling the processes, types of material, control 
methods, work practices, and environmental conditions in the employer's 
current operations. Regardless of when they were collected, the data 
must accurately reflect current conditions.
    Any air monitoring data relied upon by employers must be maintained 
and made available in accordance with the recordkeeping requirements in 
paragraph (n)(1) of the final standards for general industry, 
construction, and shipyards. Any objective data relied upon must be 
maintained and made available in accordance with the recordkeeping 
requirements in paragraph (n)(2) of the standards.
    The scheduled monitoring option. Paragraph (d)(3) of the final 
standards for general industry, construction, and shipyards describes 
the scheduled monitoring option. Parts of the scheduled monitoring 
option in the final standards come from proposed paragraphs (d)(1)(ii)-
(iv), which set out the general exposure monitoring requirements. 
Proposed paragraph (d)(1)(ii) required the employer to determine the 8-
hour TWA exposure for each employee, and proposed paragraph (d)(1)(iii) 
required the employer to determine the 15-minute short-term exposure 
for each employee. Both proposed paragraph (d)(1)(ii) and (d)(1)(iii) 
required breathing zone samples to represent the employee's exposure on 
each work shift, for each job classification, in each beryllium work 
area.
    Some commenters disagreed with the requirement to perform exposure 
monitoring on each work shift. NGK stated that sampling on each shift 
is overly burdensome and unnecessary since samples are collected from 
those employees who are expected to have the highest exposure (Document 
ID 1663, p. 1). Materion and the United Steelworkers (USW) recommended 
representative sampling instead of sampling all employees, and sampling 
from the shift expected to have the highest exposures (Document ID 
1680, p. 3). Materion separately commented that monitoring on all three 
shifts is not warranted, would be burdensome to small businesses, and 
does not align well with other standards (Document ID 1661, p. 14 
(pdf)). In post-hearing comments, Materion submitted an analysis of 
exposure variation by shift at one of their facilities and argued that 
the data are the best available evidence that monitoring on all three 
shifts is not justifiable or necessary to fulfill the requirements of 
the OSH Act (Document ID 1807, Attachment 1, p. 5, Attachment 7, p. 82; 
1958, pp. 5-6). In an individual submission, the USW also stated that 
three-shift monitoring would add unnecessary compliance costs. 
Additionally, it commented that if the operations are identical, the 
shift chosen will not matter, while if they are not identical, then 
monitoring on the highest exposed shift will overestimate exposures on 
the other shifts (Document ID 1681, Attachment 1, p. 8). Conversely, 
the American Federation of Labor and Congress of Industrial 
Organizations (AFL-CIO) noted in post-hearing comments that widely 
accepted industrial hygiene practice includes exposure monitoring 
during different shifts, tasks, and times of the year and that 
monitoring is specifically designed this way to characterize exposure 
under different conditions (Document ID 1809, p. 1). During the 
hearings, Dr. Virji from NIOSH testified that because exposure is 
variable and ``different things happen at different shifts,'' including 
maintenance activities, ``it is hard to . . . gauge . . . which shift 
[has] the highest exposure,'' so ``it is important that multiple shifts 
get representative sampling'' (Document ID 1755, Tr. 50-51).
    OSHA agrees with the AFL-CIO and Dr. Virji and has retained the 
requirement in proposed paragraphs (d)(1)(ii) and (iii) that samples 
reflect exposures on each shift, for each job classification, and in 
each work area. This requirement is included in final paragraphs 
(d)(3)(i) and (ii). However, in response to the comments from Materion 
and the USW, OSHA restructured the exposure assessment requirements in 
order to provide employers with greater flexibility to meet their 
exposure assessment obligations by using either the performance option 
or the scheduled monitoring option depending on the operation and 
information available. OSHA believes that conducting exposure 
assessment on a specific schedule provides employers with a workable 
structure to properly assess their employees' exposure to beryllium and 
provides sufficient information for employers to make informed 
decisions regarding exposure prevention measures. Alternatively, the 
performance option provides employers with flexibility in accurately 
characterizing employee exposures to beryllium on the bases of any 
combination of air monitoring and objective data.
    Comments submitted from Mr. Paul Wambach, a private citizen, stated 
that the proposed short-term exposure limit (STEL) of 2 [mu]g/m\3\ has 
the potential for being misinterpreted as requiring the use of 
impractical exposure monitoring methods that would require collecting 
32 consecutive 15-minute samples while providing no real health 
protection benefit and should be dropped from the final rule (Document 
ID 1591, p. 3). OSHA's intent, however, is that compliance with the 
STEL can be assessed using a task specific monitoring strategy, during 
which representative 15-minute samples can be taken to evaluate peak 
exposures. OSHA maintains that consistent with the comments from 
Materion, the identification and control of short-term exposures is 
critical to the protection of worker health from exposure to beryllium.
    OSHA has decided to include the scheduled monitoring option in the 
final standards because it provides employers with a clearly defined, 
structured approach to assessing employee exposures. Under paragraph 
(d)(3)(i) of the final standards, employers who select the scheduled 
monitoring option must conduct initial monitoring to determine employee 
exposure to beryllium. Air monitoring to determine employee exposures 
must represent the employee's 8-hour TWA exposure to beryllium. Final 
paragraph (d)(3)(ii) requires the employer to perform initial 
monitoring to assess the employee's 15-minute short-term exposure. 
Under both paragraphs (d)(3)(i) and (d)(3)(ii), samples must be taken 
within the employee's personal breathing zone, and must represent the 
employee's airborne exposure on each shift, for each job 
classification, in each work area. In the final standards, OSHA has 
changed ``in each beryllium work area'' to ``in each work area'' to 
avoid confusion with the beryllium work areas defined in paragraphs (b) 
and (e) of the final standard for general industry. In other OSHA 
standards, the term ``work area'' is used to describe the general 
worksite where employees are present and performing tasks or where work 
processes and operations are being carried out. Employers following the 
scheduled monitoring option should conduct initial monitoring as soon 
as work on a task or project involving beryllium exposure begins so 
they can identify situations where control measures are needed.
    Representative sampling. Paragraph (d)(3)(iii) of the final 
standards, like proposed paragraph (d)(1)(iv), describes the 
circumstances under which employers may use representative sampling. 
Proposed paragraphs (d)(1)(iv)(A)-(C) permitted the use of

[[Page 2654]]

representative sampling to characterize exposures of non-sampled 
employees, provided that the employer performed such sampling where 
several employees performed the same job tasks, in the same job 
classification, on the same work shift, and in the same work area, and 
had similar duration and frequency of exposure; took breathing zone 
samples sufficient to accurately characterize exposure on each work 
shift, for each job classification, in each work area; and sampled the 
employees expected to have the highest exposure.
    The USW and AFL-CIO supported the representative sampling provision 
in OSHA's proposed exposure monitoring requirements (Document ID 1681, 
p. 8; 1689, p. 11). OSHA has decided to retain the representative 
sampling provision in the final standards to provide employers with 
greater flexibility in meeting their exposure assessment obligations. 
Under the scheduled monitoring option, just as under the performance 
option, employers must accurately characterize the exposure of each 
employee to beryllium. In some cases, this will entail monitoring all 
exposed employees. In other cases, monitoring of ``representative'' 
employees is sufficient. As in the proposal, representative exposure 
sampling is permitted under the final standards when several employees 
perform the same tasks on the same shift and in the same work area. 
However, OSHA has not included the requirement in proposed paragraph 
(d)(1)(iv)(A) that employees ``have similar duration and frequency of 
exposure'' in final paragraph (d)(3)(iii). This provision is 
unnecessary because final paragraph (d)(3)(iii), like proposed 
paragraph (d)(1)(iv)(C), requires the employer to sample the 
employee(s) expected to have the highest exposures to beryllium. 
Additionally, the requirement in proposed paragraph (d)(1)(iv)(B) that 
employers take ``sufficient breathing zone samples to accurately 
characterize exposure on each work shift, for each job classification, 
in each work area'' has been removed because when performing exposure 
monitoring under final paragraphs (d)(3)(i) or (d)(3)(ii), employers 
already must assess exposures based on personal breathing zone air 
samples that reflect the airborne exposure of employees on each shift, 
for each job classification, and in each work area. Under these 
conditions, OSHA expects that exposures will be accurately 
characterized.
    Finally, the proposed requirement in paragraph (d)(1)(iv)(C) that 
employers must monitor the employee(s) expected to have the highest 
exposures has been retained in the final standards. For example, this 
could involve monitoring the beryllium exposure of the employee closest 
to an exposure source. The exposure result may then be attributed to 
other employees who perform the same tasks on the same shift and in the 
same work area. Exposure assessment should include, at a minimum, one 
full-shift sample and one 15 minute sample taken for each job 
classification, in each work area, for each shift.
    Where employees are not performing the same tasks on the same shift 
and in the same work area, representative sampling will not adequately 
characterize actual exposures of those employees, and individual 
monitoring is necessary.
    Frequency of monitoring under scheduled monitoring option. 
Paragraph (d)(3) of the proposed standard required periodic monitoring 
at least annually if initial exposure monitoring indicated that 
exposures were at or above the action level and at or below the TWA 
PEL. The proposal did not require periodic exposure monitoring if 
initial monitoring indicated that exposures were below the action 
level.
    In the NPRM, OSHA solicited comment on the reasonableness of 
discontinuing monitoring based on one sample below the action level. In 
response, many commenters discussed the importance of taking multiple 
samples to evaluate a worker's exposure even if initial results are 
below the action level. NJH emphasized that ``[i]t is NOT reasonable to 
discontinue monitoring after one sample result below the action level'' 
because ``a single sample result does not reflect the random variation 
in sampling and analytical methods'' (Document ID 1664, p. 6). NIOSH 
commented that, because occupational exposure distributions are right-
skewed (i.e., the mean is higher than the median so most sample results 
will be below the average exposure level), collecting fewer samples 
leads to a higher likelihood of showing compliance when it may not be 
warranted (Document ID 1671, Attachment 1, p. 6). Also during the 
hearings, Marc Kolanz of Materion stated that one sample does not 
provide ``a good understanding of what's out there,'' and there is 
``value in trying to collect at least a few samples'' (Document ID 
1755, Tr. 140). The Department of Defense (DOD) commented that it is 
not appropriate to discontinue monitoring based on one sample below the 
action level (Document ID 1684, Attachment 2, p. 3). The American 
College of Occupational and Environmental Medicine (ACOEM) commented 
that ``[t]here is significant uncertainty associated with limited 
sample numbers'' (Document 1685, p. 3). Ameren Corporation (Ameren), an 
electric utility company, stated that the number of samples needed 
``depend[s] on how well the sample characterizes the work performed'' 
(Document ID 1675, p. 10). The Sampling and Analysis Subcommittee Task 
Group of the Beryllium Health and Safety Committee (BHSC Task Group), a 
non-profit organization promoting the understanding and prevention of 
beryllium-induced conditions and illnesses, commented that it would not 
consider a single sample to be a reasonable determination of exposures 
(Document ID 1665, p. 6). North America's Building Trades Unions 
(NABTU) commented that it was unreasonable to allow discontinuation of 
monitoring based on one sample below the action level, because that 
sample could be a statistical aberration, and ``the assumption that if 
a workplace is in compliance at one time it will stay in compliance in 
the future is a fallacy, particularly on an active, dynamic 
construction site'' (Document ID 1679, p. 8). The USW and Materion 
stated that exposure characterization often requires more than one 
sample (Document ID 1680, p. 3). Southern Company suggested that 
``language regarding initial and periodic monitoring, and the 
discontinuation of both, [should] be consistent with existing substance 
specific standards'' (Document ID 1668, p. 3).
    OSHA has considered these comments and has determined that if 
initial monitoring indicates that employee exposures are below the 
action level and at or below the STEL, no further monitoring is 
required. Paragraph (d)(3)(iv) of the final standards permits employers 
to discontinue monitoring of employees whose exposure is represented by 
such monitoring where initial monitoring indicates that exposure is 
below the action level and at or below the STEL. However, a single 
sample below the action level and at or below the STEL does not 
necessarily warrant discontinuation of exposure monitoring. OSHA has 
clarified in final paragraphs (d)(3)(i) and (d)(3)(ii) that any initial 
monitoring conducted under the scheduled monitoring option must reflect 
exposures on each shift, for each job classification, and in each work 
area. Therefore, where there is more than one shift or work area for a 
particular task, there will be more than one sample; accordingly, it is 
unlikely that an employer would be able to sufficiently characterize 
and assess employee

[[Page 2655]]

exposure for a given job classification under the scheduled monitoring 
option using a single sample.
    In paragraph (d)(3) of the proposed rule, periodic exposure 
monitoring was required at least annually if initial exposure 
monitoring found exposures at or above the action level and at or below 
the TWA PEL. In the NPRM, OSHA asked a question about the frequency of 
monitoring and the reasoning behind that frequency. During the 
hearings, Peggy Mroz with NJH testified that periodic monitoring 
conducted at least every 180 days when exposures are at or above the 
action level is ``the most protective for workers'' (Document ID 1756, 
Tr. 99-100). Ms. Mroz further stated that exposure monitoring should 
also be conducted at least annually for all other processes and jobs 
where initial monitoring shows levels below the action level since 
changes in working conditions can affect monitoring results, and ``[i]t 
has already been shown that beryllium sensitization and CBD occur at 
measured exposures below the proposed action level'' (Document ID 1756, 
Tr. 100). Both NIOSH and NJH recommended more frequent monitoring for 
employers to fully understand levels of exposure that may vary over 
time and to assess whether proper controls are in place after a high 
exposure level is documented (Document ID 1725, p. 29; 1720, p. 5). The 
BHSC Task Group stated that annual monitoring is inadequate, and 
recommended sampling more frequently than every 180 days (Document ID 
1665, pp. 15, 17). And, the AFL-CIO commented that annual exposure 
monitoring is inadequate and does not provide the employer with enough 
information to make appropriate changes to prevent and minimize 
exposure. The AFL-CIO cited various OSHA health standards that required 
more frequent periodic exposure monitoring, including cadmium, 
asbestos, vinyl chloride, arsenic, lead, and respirable crystalline 
silica (Document ID 1809, pp. 1-2). In contrast, Ameren agreed with the 
proposal's requirement to conduct monitoring annually if exposures are 
at or above the action level, because the proposal already requires 
additional monitoring when work conditions change (Document ID 1675, p. 
4). And, the Edison Electric Institute (EEI) commented that beryllium 
exposure in the electric utility industry occurs during maintenance 
outages, ``which more closely align with the annual re-sampling 
requirements than the 180 [day] provisions in these alternatives'' 
(Document ID 1674, p. 14).
    OSHA is persuaded by the commenters recommending more frequent 
periodic monitoring and has changed the frequency required for 
exposures between the action level and the TWA PEL in the scheduled 
monitoring option in the final standards. Paragraph (d)(3)(v) of the 
final standards requires monitoring every six months if initial 
exposure monitoring indicates that exposures are at or above the action 
level but at or below the TWA PEL, which is the typical frequency in 
other health standards for carcinogens such as respirable crystalline 
silica, cadmium, vinyl chloride, and asbestos for this level of 
exposure. Alternatively, employers in general industry, construction, 
and shipyards can use the performance option in paragraph (d)(2), which 
provides employers greater flexibility to meet their exposure 
assessment obligations.
    In the proposal, OSHA did not require periodic exposure monitoring 
if initial exposure monitoring indicated that exposures were above the 
TWA PEL or STEL. In response to a question in the NPRM about monitoring 
above the PEL, Materion commented that there is no benefit to expending 
time and money monitoring exposures that exceed the PEL, because it is 
more important that activities be directed toward the exposure control 
plan. Based on their experience, Materion believes that employers will 
conduct monitoring as often as necessary to demonstrate that exposures 
have been reduce to below the PEL (Document ID 1661, p. 24 (pdf)). 
Other commenters disagreed with OSHA's proposal not to require periodic 
exposure monitoring above the PEL. The DOD commented that periodic 
monitoring should also be performed when levels are above the PEL to 
ensure respiratory protection is adequate and to test the effectiveness 
of engineering controls (Document ID 1684, Attachment 2, p. 9). In 
response to a question during the hearings on the benefits of 
monitoring above the PEL, NIOSH's Dr. Virji testified that exposure can 
vary within a job and that even though an employer may know exposures 
are high in a particular area, the information is ``useful because then 
it allows an understanding of what level of engineering controls that 
would be required to bring down the exposures to acceptable levels'' 
(Document ID 1755, Tr. 49-50). In her testimony, Mary Kathryn Fletcher 
with the AFL-CIO expressed support for monitoring above the PEL, 
stating that ``exposure monitoring is important to reevaluate control 
measures in cases of over-exposure,'' and ``[it is] important to 
characterize the job to know the exposures if you're going to try to 
reduce those exposures'' (Document ID 1756, Tr. 236). Also during the 
hearings, Ashlee Fitch with the Health, Safety, and Environment 
Department of the USW responded to a similar question on the benefits 
of air monitoring in cases where exposures are believed to exceed the 
PEL. She stated, ``You see oftentimes that employers used exposure 
rates to measure how well ventilation systems are working or what the 
exposure is, and after they implement engineering controls, what that 
exposure goes to'' (Document ID 1756, Tr. 282). In her testimony, Peggy 
Mroz with NJH expressed support for periodic exposure monitoring every 
90 days where exposures exceed the TWA PEL or STEL as ``routine and 
regular sampling and repeated sampling should be done to assess whether 
proper controls are in place after a high sample is documented as we 
know that beryllium sensitization and chronic beryllium disease can 
occur within a few weeks of exposure'' (Document ID 1756, Tr. 100).
    Based on these comments received in the record and testimony 
obtained from the public hearing, OSHA's final standards require 
periodic exposure monitoring every three months when exposures are 
above the TWA PEL or STEL under the scheduled monitoring option in 
paragraphs (d)(3)(vi) and (d)(3)(viii). Alternatively, employers in 
general industry, construction, and shipyards can use the performance 
option in paragraph (d)(2) which provides employers with greater 
flexibility to meet their exposure assessment obligations.
    Proposed paragraph (d) did not include a separate provision to 
allow employers to discontinue monitoring if exposures were 
subsequently reduced to below the action level, as demonstrated by 
periodic monitoring. In the NPRM, OSHA solicited comment on the 
reasonableness of discontinuing monitoring based on one sample below 
the action level. As discussed more fully in the explanation of final 
paragraph (d)(3)(iv), many commenters discussed the importance of 
taking multiple samples to confirm exposures are below the action level 
before allowing the discontinuation of monitoring. For example, ORCHSE 
Strategies (ORCHSE) commented that allowing discontinuation of 
monitoring based on one sample is not appropriate and that two 
consecutive samples taken at least seven days apart, that show exposure 
below the action level, should be required to allow monitoring to be

[[Page 2656]]

discontinued (Document ID 1691, Attachment 1, p. 3).
    As stated in the explanation of final paragraph (d)(3)(iv), OSHA 
has carefully considered these comments and agrees that a single sample 
is not sufficient to allow employers to discontinue monitoring. OSHA 
has therefore decided to add paragraph (d)(3)(vii) to the final 
standards. This provision requires that, where the most recent exposure 
monitoring indicates that employee exposure is below the action level, 
the employer must repeat exposure monitoring within six months of the 
most recent monitoring. The employer may discontinue TWA monitoring, 
for those employees whose exposure is represented by such monitoring, 
only when two consecutive measurements, taken seven or more days apart, 
are below the action level, except as otherwise provided in the 
reassessment of exposures requirements in paragraph (d)(4) of the final 
standards. Additionally, OSHA has added paragraph (d)(3)(viii) to the 
final standards. This provision requires that, where the most recent 
exposure monitoring indicates that employee exposure is above the STEL, 
the employer must repeat exposure monitoring within three months of the 
most recent short-term exposure monitoring until two consecutive 
measurements, taken seven or more days apart, are below the STEL. At 
this point, the employer may discontinue monitoring for those employees 
whose exposure is represented by such monitoring. As discussed below, 
reassessment is always required whenever a change in the workplace may 
be reasonably expected to result in new or additional exposures at or 
above the action level or above the STEL or the employer has any reason 
to believe that new or additional exposures at or above the action 
level or above the STEL have occurred, regardless of whether the 
employer has ceased monitoring because exposures are below the action 
level or at or below the STEL under paragraphs (d)(3)(iv), (d)(3)(vii), 
or (d)(3)(viii) of the final standards. Exposure assessment in 
construction and shipyard industries. Beryllium exposure occurs in the 
construction and shipyard industries primarily during abrasive blasting 
operations that use coal and copper slags containing trace amounts of 
beryllium (Document ID 1815, Attachment 85, pp. 70-72; 0767, p. 6).
    During the public hearing, testimony was heard about abrasive 
blasting operations using slags at a shipyard facility. Mike Wright, 
with the USW, testified that the use of enclosure (containment) is 
important to prevent the escape of beryllium dust during abrasive 
blasting operations and that exposure monitoring could help determine 
the integrity of the enclosure along with establishing a perimeter 
where beryllium contamination is controlled (Document ID 1756, Tr. 274-
275). Ashlee Fitch, also representing the USW, testified about 
monitoring worker exposure to beryllium in the maritime industry. Ms. 
Fitch stated that abrasive blasting using beryllium-containing abrasive 
materials should be done in full containment and that exposures outside 
the containment should not exceed the PEL or STEL (Document ID 1756, 
Tr. 244-245). Ms. Fitch recommended that in cases where full 
containment is used, ``the employer shall do an initial monitoring for 
each configuration of the containment'' and ``if the initial monitoring 
shows exposures above the action level, monitoring shall be performed 
for every blasting operation.'' She also recommended air monitoring of 
exposed workers outside of the containment or through monitoring of the 
positions where exposure is likely to be the highest, or if full 
containment is not used, ``around any abrasive blasting operation'' 
(Document ID 1756, Tr. 245). Representative Robert Scott, the ranking 
minority member on the Committee on Education and the Workforce of the 
U.S. House of Representatives (Representative Scott), commented that 
when workers are engaged in abrasive blasting and the abrasive blasting 
area is contained, exposure monitoring should be routinely performed 
when levels exceed the action level (Document ID 1672, p.4).
    Substantially agreeing with these comments, in paragraph (d)(3) of 
the final standards, OSHA is requiring monitoring on each work shift, 
for each job classification, and in each work area when employers are 
following the scheduled monitoring option. OSHA also agrees that 
monitoring should be of the positions where exposure is likely to be 
the highest, so when employers engage in representative sampling under 
the scheduled monitoring option, final paragraph (d)(3)(iii) requires 
that they must sample the employee(s) expected to have the highest 
airborne exposure to beryllium. OSHA also agrees with Representative 
Scott that exposure monitoring should be routinely performed for 
abrasive blasting and all other operations exposing workers to 
beryllium when exposures exceed the action level. If exposures exceed 
the action level or STEL, the employer is required to monitor exposures 
at frequencies indicated in the scheduled monitoring option or using 
the performance option to accurately assess the beryllium exposure of 
their employees. However, OSHA does not consider monitoring to be 
necessary each time there is an abrasive blasting or other operation 
that fits within the profile of a previously taken representative 
sample.
    Reassessment of exposures. Paragraph (d)(4) of the final standards, 
like paragraph (d)(4) of the proposal, describes the employer's 
obligation to reassess employee exposures under certain circumstances. 
Proposed paragraphs (d)(4)(i) and (d)(4)(ii) required the employer to 
conduct exposure monitoring within 30 days after a change in production 
processes, equipment, materials, personnel, work practices, or control 
methods that could reasonably be expected to result in new or 
additional exposure, or if the employer had any other reason to believe 
that new or additional exposure was occurring.
    Commenters generally advocated for monitoring to assess any new 
exposures. For example, in her testimony, Mary Kathryn Fletcher with 
the AFL-CIO expressed support for exposure monitoring even if exposure 
is reduced as far as feasible, because exposures can change, so ``it's 
important to monitor as tasks change and over time, there are different 
procedures, different workers in the area, doing different things'' 
(Document ID 1756, Tr. 236). Also, NJH commented that ``periodic 
sampling, even of low exposure potential tasks, ensures that despite 
changes in processes, personnel, exhaust systems, and other control 
measures, the exposure remains low and workers remain safe'' (Document 
ID 1664, p. 6). Therefore, the Agency has decided to retain the 
requirement of proposed paragraph (d)(4) that employers reassess 
exposures, but has made minor changes to the regulatory text. OSHA has 
changed the title ``Additional Monitoring'' in proposed paragraph 
(d)(4) to ``Reassessment of exposures'' in paragraph (d)(4) of the 
final standards to be consistent with the change in paragraph (d) 
terminology from ``exposure monitoring'' to ``exposure assessment.'' 
OSHA has also changed the proposed requirement that employers conduct 
exposure monitoring within 30 days after a change in ``production 
processes, equipment, materials, personnel, work practices, or control 
methods'' that could reasonably be expected to result in new or 
additional exposures to the requirement in the final standards that 
employers must perform reassessment of exposures

[[Page 2657]]

when there is a change in ``production, process, control equipment, 
personnel, or work practices'' that may reasonably be expected to 
result in new or additional exposures at or above the action level or 
STEL. OSHA made these changes to provide clarity and consistency with 
other OSHA health standards.
    In addition, there may be other situations that can result in new 
or additional exposures that are unique to an employer's work 
situation. In order to cover those special situations, OSHA has 
retained the requirement in proposed paragraph (d)(4)(ii) that the 
employer must reassess exposures whenever the employer has any reason 
to believe that a change has occurred that may result in new or 
additional exposures, and has added ``at or above the action level or 
STEL'' to final paragraph (d)(4). Under this provision, for example, an 
employer is required to reassess exposures when an employee has a 
confirmed positive result for beryllium sensitization, exhibits signs 
or symptoms of CBD, or is diagnosed with CBD. These conditions 
necessitate a reassessment of exposures to ascertain if airborne 
exposures contributed to the beryllium-related health effects. 
Additionally, reassessment of exposures would be required following a 
process modification that increases the amount of beryllium-containing 
material used, thereby possibly increasing employee exposure. 
Reassessment of exposures will also be required when a shipyard or 
construction employer introduces a new beryllium-containing slag for 
use in an abrasive blasting operation. Once reassessment of exposures 
is performed and if exposures are above the action level, TWA PEL, or 
STEL, the employer can take appropriate action to protect exposed 
employees and must perform periodic monitoring as discussed above.
    Methods of sample analysis. Paragraph (d)(5) of the final 
standards, like proposed paragraph (d)(1)(v), addresses methods for 
evaluating air monitoring samples. Proposed paragraph (d)(1)(v) 
required employers to use a method of exposure monitoring and analysis 
that could measure beryllium to an accuracy of plus or minus 25 percent 
within a statistical confidence level of 95 percent for airborne 
concentrations at or above the action level. This provision is largely 
unchanged in the final standards. OSHA has changed the title ``Accuracy 
of measurement'' in the proposal's paragraph (d)(1)(v) to ``Methods of 
sample analysis'' in paragraph (d)(5) of the final standards. OSHA made 
this change to more accurately describe the purpose of this 
requirement. Additionally, OSHA changed the requirement that employers 
``use a method of exposure monitoring and analysis'' in the proposed 
rule to require that employers ``ensure that all samples taken to 
satisfy the monitoring requirements of paragraph (d) are evaluated by a 
laboratory'' to clarify that employers may send samples to a laboratory 
for analysis, and OSHA does not intend to require employers to have a 
laboratory to analyze samples at the worksite.
    Under final paragraph (d)(5), the employer is required to make sure 
that all samples taken to satisfy the monitoring requirements of 
paragraph (d) are evaluated by a laboratory that can measure airborne 
levels of beryllium to an accuracy of plus or minus 25 percent within a 
statistical confidence level of 95 percent for airborne concentrations 
at or above the action level. The following methods meet these 
criteria: NIOSH 7704 (also ASTM D7202), ASTM D7439, OSHA 206, OSHA 
125G, and OSHA 125G using ICP-MS. All of these methods are available to 
commercial laboratories analyzing beryllium samples. However, not all 
of these methods are appropriate for measuring beryllium oxide, so 
employers must verify that the analytical method used is appropriate 
for measuring the form(s) of beryllium present in the workplace.
    In the NPRM, OSHA requested comment on whether these methods would 
satisfy the requirements of this paragraph, and if there were other 
methods that would also meet these criteria. The BHSC Task Group 
commented that OSHA's accuracy criteria could be met for full shift 
samples using available analytical methods. The BHSC Task Group agreed 
with the guidance in OSHA's NPRM to use ICP-MS or fluorescence to 
assure adequate sensitivity and analytical precision (Document ID 1655, 
p. 2). In response to a question on whether the current methods were 
sufficiently sensitive, Kevin Ashley with NIOSH testified that both the 
fluorescence method (NIOSH method 7704) and the inductively coupled 
plasma mass spectrometry (ASTM method D7439) were adequately sensitive 
to measure at the proposed PEL and STEL (Document ID 1755, Tr. 58). The 
DOD commented that the current limit of quantification (LOQ) of 0.05 
[micro]g for beryllium using the NIOSH 7300 and OSHA 125G methods would 
be adequate to detect exposures below the proposed action level of 0.1 
[micro]g/m\3\ and the proposed STEL of 2 [micro]g/m\3\ (Document ID 
1684, Attachment 2, p. 9). OSHA has identified several sampling and 
analysis methods for beryllium that are capable of detecting beryllium 
at air concentrations below the final action level of 0.1 [micro]g/m\3\ 
and the final STEL of 2.0 [micro]g/m\3\ for a 15-minute sampling period 
(see Chapter IV of the Final Economic Analysis, Technological 
Feasibility). Therefore, OSHA has determined that the sampling and 
analytical methods currently available to employers are sufficient to 
measure beryllium as required in paragraph (d) of the final standards.
    Rather than specifying a particular method that must be used, the 
final standards allow for a performance-oriented approach that allows 
the employer to use the method and analytical laboratory of its 
choosing as long as that method meets the accuracy specifications in 
paragraph (d)(5) and the reported results represent the total airborne 
concentration of beryllium for the worker being characterized. Other 
methods, such as a respirable fraction sample or size selective sample, 
would not provide results directly comparable to either PEL, and 
therefore would not be considered valid.
    Employee Notification of Assessment Results. Paragraph (d)(6) of 
the final standards, like proposed paragraph (d)(5), addresses employee 
notification requirements. OSHA did not receive comment specifically on 
this provision, but several commenters supported the exposure 
monitoring provisions as a whole, and after reviewing the record, OSHA 
has decided to retain the employee notification requirements in the 
final standards. OSHA has changed the title ``Employee Notification of 
Monitoring Results'' in proposed paragraph (d)(5) to ``Employee 
Notification of Assessment Results'' in final paragraph (d)(6) to 
reflect the change in the title of paragraph (d). This requirement is 
consistent with other OSHA standards, such as those for respirable 
crystalline silica (29 CFR 1910.1053), methylenedianiline (29 CFR 
1910.1050), 1,3-butadiene (29 CFR 1910.1051), and methylene chloride 
(29 CFR 1910.1052).
    Proposed paragraph (d)(5)(i) required employers to notify each 
employee of his or her monitoring results within 15 working days after 
receiving the results of any exposure monitoring. Both the employees 
whose exposures were measured directly and those whose exposures were 
represented by the monitoring had to be notified. The employer had to 
notify each employee individually in writing or post the monitoring 
results in an appropriate location accessible to all employees required 
to be notified. Proposed paragraph (d)(5)(i) is now paragraph (d)(6)(i) 
in the final standards, and has

[[Page 2658]]

been edited to reflect the change in language from ``exposure 
monitoring'' to ``exposure assessment,'' discussed earlier. This can be 
in print or electronically as long as the affected employees have 
access to the information and have been informed of the posting 
location. Final paragraph (d)(6)(i) for general industry, construction, 
and shipyards is substantively unchanged from the proposal. However, 
due to the transient nature of construction work and the need to 
receive exposure assessment results while the work is still occurring, 
OSHA recommends that employers in the construction industry make every 
effort to notify employees of their monitoring results as soon as 
possible.
    Proposed paragraph (d)(5)(ii) required that, whenever exposures 
exceeded the TWA PEL or STEL, the written notification required by 
proposed paragraph (d)(5)(i) include (1) suspected or known sources of 
exposure and (2) a description of the corrective action(s) that have 
been taken or will be taken by the employer to reduce the employee's 
exposure to or below the TWA PEL or STEL where feasible corrective 
action exists but was not implemented at the time of the monitoring. 
OSHA did not receive comment on this specific provision, and after 
reviewing the record, including comments supporting paragraph (d) 
generally, OSHA has decided to retain a notification requirement 
focused on individual exposure assessments and the corrective actions 
being taken for exposures above the PEL or STEL. It is necessary to 
assure employees that the employer is making efforts to furnish them 
with a safe and healthful work environment, and to provide employees 
with information about their exposures. Furthermore, notification to 
employees of exposures above a prescribed PEL and the corrective 
actions being taken is required under section 8(c)(3) of the Act (29 
U.S.C. 657(c)(3)). In order to provide consistency with other OSHA 
health standards, OSHA has removed the requirement in proposed 
paragraph (d)(5)(ii) that employers include suspected or known sources 
of exposure in the written notification. Proposed paragraph (d)(5)(ii), 
as revised, is now paragraph (d)(6)(ii) in the final standards.
    Observation of monitoring. Paragraph (d)(7) of the final standards, 
like proposed paragraph (d)(6), requires employers to provide for 
observation of exposure monitoring. OSHA did not receive comment on 
this specific provision, and after reviewing the record, including 
comments supporting paragraph (d) generally, OSHA has decided to retain 
it in the final standards because it promotes occupational safety and 
health and is required by the OSH Act. Section 8(c)(3) of the Act (29 
U.S.C. 657(c)(3)) mandates that regulations requiring employers to keep 
records of employee exposures to toxic materials or harmful physical 
agents provide employees or their representatives with the opportunity 
to observe monitoring or measurements.
    Proposed paragraph (d)(6)(i) required the employer to provide an 
opportunity to observe any exposure monitoring required by the 
standards to each employee whose airborne exposure was measured or 
represented by the monitoring and to each employee's representative(s). 
Proposed paragraph (d)(6)(i) is now paragraph (d)(7)(i) in the final 
standards, and is substantively unchanged from the proposal. When 
observation of monitoring required entry into an area where the use of 
protective clothing or equipment was required, proposed paragraph 
(d)(6)(ii) required the employer to provide the observer with that 
personal protective clothing or equipment, at no cost. The employer was 
also required to ensure that the observer used such clothing or 
equipment appropriately. Proposed paragraph (d)(6)(ii) is now paragraph 
(d)(7)(ii) in the final standards, and is substantively unchanged from 
the proposal. Paragraph (d)(6)(iii) of the proposal required employers 
to ensure that each observer complied with all applicable OSHA 
requirements and the employer's workplace safety and health procedures. 
Proposed paragraph (d)(6)(iii) is now paragraph (d)(7)(iii) in the 
final standards. OSHA has changed the proposed language to require that 
employers ensure that each observer follows all other applicable safety 
and health procedures to clarify that the burden to comply with OSHA 
requirements remains on the employer, not the observer.

(e) Beryllium Work Areas and Regulated Areas (General Industry); 
Regulated Areas (Shipyards); and Competent Person (Construction)

    Paragraph (e) of the standards for general industry and shipyards 
sets forth the requirements for establishing, maintaining, demarcating, 
and limiting access to certain areas of the workplace to aid in 
minimizing employee exposure to beryllium. As discussed below, the 
general industry standard includes requirements for both ``work areas'' 
and ``regulated areas,'' which are subsets of work areas. The shipyard 
standard includes requirements for regulated areas, but not work areas. 
Paragraph (e) of the construction standard does not require either work 
areas or regulated areas, but instead includes requirements for a 
``competent person,'' who has responsibility for demarcating certain 
areas of beryllium exposure for similar purposes.
    Specifically, paragraph (e)(1)(i) and (e)(2)(i) of the standard for 
general industry requires employers to establish, maintain, and 
demarcate one or more ``beryllium work area,'' which is defined as a 
work area containing a process or operation that can release beryllium 
where employees are, or can reasonably be expected to be, exposed to 
airborne beryllium at any level or where there is the potential for 
dermal contact with beryllium. OSHA intends these beryllium work area 
provisions to apply to the area surrounding the process, operation, or 
task where airborne beryllium is released or the potential for dermal 
contact is created. Beryllium work areas are also referenced in the 
general industry standard in paragraphs (f)(1) (the written exposure 
control plan), (f)(2) (engineering and work practice controls), and (j) 
(housekeeping). Under paragraphs (e)(1)(ii) and (e)(1) of the standards 
for general industry and shipyards, respectively, employers are also 
required to establish and maintain regulated areas wherever employees 
are, or can reasonably be expected to be, exposed to airborne beryllium 
at levels above the TWA PEL or STEL. As indicated and discussed in more 
detail below, the final standards for shipyards and construction do not 
contain provisions for beryllium work areas and the standard for 
construction does not require employers to establish regulated areas. 
In lieu of regulated areas, paragraph (e) of the final standard for 
construction, Competent Person, consists of a set of requirements 
designed to provide most of the same protections as regulated areas in 
general industry and shipyards, using a competent person instead of 
demarcated areas to achieve these ends.
    The requirements to establish beryllium work areas and regulated 
areas or designate competent persons serve several important purposes. 
First, requiring employers to establish and demarcate beryllium work 
areas in general industry ensures that workers and other persons are 
aware of the potential for work processes to release airborne beryllium 
or cause dermal contact with beryllium. Second, the required 
demarcation of regulated areas in general industry and shipyards in 
accordance with the paragraph (m) requirements for warning signs 
ensures that all persons entering regulated areas

[[Page 2659]]

will be aware of the serious health effects associated with exposure to 
beryllium. Similarly, assignment of a competent person to carry out the 
provisions of paragraph (e) in the construction standard where 
exposures may exceed the TWA PEL or STEL provides employees in 
construction with a knowledgeable on-site authority to convey 
information about the hazards of beryllium exposure. Third, limiting 
access to regulated areas (general industry and shipyards) or areas 
where exposures may exceed the TWA PEL or STEL (construction) restricts 
the number of workers potentially exposed to beryllium at levels above 
the TWA PEL or STEL. Finally, provisions for respiratory protection and 
PPE ensure that those who must enter regulated areas (general industry 
and shipyards) or areas where exposures may exceed the TWA PEL or STEL 
(construction) are properly protected, thereby reducing the risk of 
serious health effects associated with airborne beryllium exposure and 
dermal contact with beryllium.
    The remainder of this section provides detailed discussion of each 
provision in paragraph (e) of the final standards for general industry, 
shipyards, and construction, as well as comments OSHA received on 
paragraph (e) of the proposed standard, OSHA's response to these 
comments, and the reasons for OSHA's decisions regarding the provisions 
of paragraph (e) in each final standard.
    Beryllium Work Areas (General Industry). Provisions for the 
establishment of beryllium work areas were included in the proposed 
standard for general industry in paragraph (e)(1)(i). This proposed 
provision required employers to establish and maintain beryllium work 
areas where employees are, or can reasonably be expected to be, exposed 
to airborne beryllium. OSHA explained that it intended the provision to 
apply to all areas and situations where employees are actually exposed 
to airborne beryllium and to areas and situations where the employer 
has reason to anticipate or believe that airborne exposures may occur. 
The Agency further explained that--unlike the requirements for 
regulated areas--the proposed requirements were not tied to a 
particular level of exposure, but rather were triggered by the presence 
of airborne beryllium at any exposure level. The provision was based on 
a provision recommended by Materion Corporation (Materion) and the 
United Steelworkers (USW) in their joint submission, (see previous 
discussion in the Introduction to this Summary and Explanation 
section).
    A number of stakeholders commented on the proposed definition of a 
beryllium work area. Some commenters, such as NGK Metals Corporation 
(NGK) and ORCHSE Strategies (ORCHSE), argued that the definition of a 
beryllium work area is vague and requested that OSHA trigger the 
requirement to establish and maintain beryllium work areas at a 
measureable threshold, such as the action level (e.g., Document ID 
1663, p. 1; 1691, Attachment 1, p. 15). Edison Electric Institute 
(EEI), an industry association representing electric utility companies, 
also did not agree with the beryllium work area definition (Document ID 
1674, p. 13). Like NGK and ORCHSE, EEI recommended that OSHA tie the 
beryllium work area requirements to a quantifiable exposure level, like 
the action level or the PEL (Document ID 1674, p. 13). The Boeing 
Company (Boeing) also recommended the use of a quantifiable trigger, 
but suggested a much lower trigger of 0.02 [micro]g/m\3\ (Document ID 
1667, p. 3). Boeing explained that not including a specific threshold 
can lead to inconsistent results because it depends on the sensitivity 
of the measurement method (Document ID 1667, p. 3).
    Other commenters supported the proposed standard's establishment of 
beryllium work areas at any level of airborne beryllium exposure. For 
example, AWE commented that its ``supervised beryllium workspaces'' 
align with the proposal's beryllium work areas (Document ID 1615, p. 
1). NIOSH observed that the proposed approach is feasible and 
appropriate for beryllium work settings where work such as production, 
processing, handling, and manufacturing of beryllium products is 
performed and areas where needed preventive controls can be relatively 
easily demarcated (Document ID 1725, pp. 29-30). Materion and USW 
reiterated their support for provisions related to beryllium work areas 
``where operations generate airborne beryllium particulate'', which 
were included in the recommended model standard they submitted to OSHA 
(Document ID 1680, p. 3).
    The purpose of a beryllium work area is to establish a demarcated 
area in which workers and other persons authorized to be in the area 
are made aware of the potential for beryllium exposure and must take 
certain precautions accordingly. OSHA finds that establishing beryllium 
work areas where exposures are at the action level or above the PEL 
would not adequately protect exposed workers operating outside 
demarcated regulated areas, for which the applicable trigger is the TWA 
PEL or STEL. Because, as discussed in Section V, Health Effects, there 
is still a potential health risk to workers exposed to beryllium below 
the action level, the establishment and demarcation of beryllium work 
areas at any level of airborne exposure will provide additional 
protection for these workers by ensuring that they are aware of the 
presence of processes that release beryllium. OSHA similarly finds that 
Boeing's suggested trigger of 0.02 [micro]g/m\3\ is not suitable 
because OSHA has not established a level of exposure at which beryllium 
does not pose a risk to workers (see this preamble at Section VI, Risk 
Assessment). Therefore, OSHA finds that establishing and demarcating 
beryllium work areas wherever processes or operations release beryllium 
is more protective. OSHA also does not agree with those commenters who 
find the trigger for establishing beryllium work areas vague. As 
explained previously, OSHA has modified the beryllium work areas 
provision in the final standard for general industry to specify that 
the source of the airborne beryllium exposure and potential for dermal 
contact triggering the requirement for a beryllium work area must be 
generated from a process or operation within that area, not just the 
fact that an employee may be handling an article containing beryllium. 
An employer can (but is not required to) use air monitoring to 
determine the presence of airborne beryllium in the area surrounding 
the process, operation, or task that may be releasing beryllium or wipe 
sampling to determine the presence of beryllium on surfaces that 
workers may come into contact with. Affording the employer such 
flexibility to comply with this performance-based provision does not 
make it impermissibly vague. Accordingly, OSHA has decided to retain, 
as modified, the requirement that beryllium work areas must be 
established and maintained where there is a process or operation that 
can release beryllium and employees are, or can reasonably be expected 
to be, exposed to airborne beryllium at any level. However, as 
discussed below, OSHA has somewhat modified the definition of beryllium 
work areas in response to comments from other stakeholders and NIOSH.
    Two electric utility companies, Southern Company and Ameren 
Corporation (Ameren), argued that a work area requirement defined by 
any level of airborne beryllium exposure was subjective and would 
result in their entire facility falling under this

[[Page 2660]]

requirement (Document ID 1668, pp. 3-4; 1675 p. 5). The Aluminum 
Association stated that there may be areas where airborne beryllium 
exposures are present but have been found through exposure assessments 
and monitoring to be insignificant; therefore, beryllium work areas are 
overly broad as defined in the proposal and should be dropped from the 
final standard (Document ID 1666, p. 2). The American College of 
Occupational and Environmental Medicine (ACOEM) also did not agree with 
the proposed definition of beryllium work areas because it is not 
specific to workplaces where beryllium is used or processed (Document 
ID 1685, p. 2). ACOEM argued that airborne beryllium is essentially 
ubiquitous at very low levels, and that the proposed definition of 
beryllium work areas could be interpreted to apply to most worksites 
regardless of work activity. Therefore, ACOEM suggested clarifying the 
requirement using language that specifies ``worksites in which any 
beryllium or beryllium-containing materials are or have been processed 
using methods capable of generating dust or fume'' (Document ID 1685, 
p. 2).
    OSHA did not intend a scenario where an entire facility becomes a 
beryllium work area from environmental or other non-occupational 
sources of beryllium. Nor did the Agency intend to cause the entirety 
of any worksite covered by the rule to become a beryllium work area, 
even where the amount of airborne beryllium is insignificant in the 
sense that it is residually present at very low levels in areas of a 
facility where work processes that release airborne beryllium do not 
occur. (Note that the best available scientific evidence has not 
identified a medically insignificant level of beryllium exposure; as 
discussed in Section VI, Risk Assessment, beryllium sensitization has 
been found among individuals whose exposures are below the action 
level.) Such a situation might occur in a coal-fired electric 
generating plant or a foundry where a very small amount of beryllium 
may be detectable far away from the processes that released it. To 
avoid these unintended consequences, OSHA has modified the beryllium 
work areas provision in the final standard for general industry to 
specify that the source of the airborne beryllium exposure and 
potential for dermal contact triggering the requirement for a beryllium 
work area must be generated from a process or operation within that 
area. This modification is similar to ACOEM's suggestion to define 
beryllium work areas as areas where beryllium or beryllium-containing 
materials are or have been processed (Document ID 1685, p. 2). While 
the trigger for beryllium work area is based on whether the beryllium 
is processed by controlling the release of airborne beryllium from the 
particular process, operation, or task, the employer can limit the size 
of the beryllium work area and eliminate the likelihood of an entire 
facility becoming a beryllium work area. OSHA believes this modified 
definition of beryllium work areas addresses the concerns raised by 
employers and ACOEM, while also maintaining the protective benefits 
associated with beryllium work areas for beryllium-exposed employees.
    In addition to commenting on the level of exposure that should 
trigger the establishment and maintenance of a beryllium work area, 
NIOSH offered an opinion on the type of exposure that should trigger 
beryllium work areas. Specifically, NIOSH argued that limiting the 
definition of beryllium work area to employee exposure to airborne 
beryllium omits the potential contribution of dermal exposure to total 
exposure (Document ID 1725, p. 30). To support its point, NIOSH cited 
to Armstrong et al. (2014), which reported that work processes 
associated with elevated risk for beryllium sensitization had high air/
high dermal exposure, high air/low dermal exposure, or low air/high 
dermal exposure indicating that dermal exposures should be considered 
as relevant pathways (Document ID 1725, p. 30). OSHA agrees with NIOSH 
and has modified the beryllium work areas section of the final standard 
for general industry to include potential dermal exposure.
    OSHA also made two other minor, nonsubstantive changes to the 
proposed provision to help streamline the final general industry 
standard. First, instead of restating the definition of beryllium work 
area in paragraph (e)(1)(i) (as in the proposal), OSHA has modified 
final paragraph (e)(1)(i) in the proposal to merely refer to the term 
as defined in paragraph (b) of the standard for general industry. 
Second, the definition of beryllium work area in the final general 
industry standard includes the qualifier ``where employees are, or can 
reasonably be expected to be, exposed to airborne beryllium at any 
level.'' This is a modification from the proposed beryllium work area 
definition wording ``where employees are, or can reasonably be expected 
to be, exposed to airborne beryllium, regardless of the level of 
exposure.'' Both of these changes were intended only to simplify the 
language of the regulatory text and should not be read to suggest a 
change in substantive requirements or the Agency's intent.
    The construction and shipyard sectors were not included in the 
proposed standard. However, OSHA requested comments on Regulatory 
Alternative #2a in the NPRM, which would apply all provisions of the 
proposed standard to facilities in construction and shipyards, 
including provisions pertaining to the establishment of beryllium work 
areas. Following careful consideration of the comments OSHA received 
from a variety of stakeholders and from NIOSH on this topic, OSHA has 
concluded that the requirement to establish and maintain beryllium work 
areas are not appropriate for construction or shipyards. The work 
processes (primarily abrasive blasting), worksites, and conditions in 
construction and shipyards differ substantially from those typically 
found in general industry; as discussed further below, establishment of 
beryllium work areas in these sectors is likely to be impractical. 
However, OSHA has modified the standards so that most of the protective 
measures related to beryllium work areas in the general industry 
standard apply to operations in construction and shipyards, using 
triggers more suitable for these sectors. Thus, OSHA believes the final 
standards for construction and shipyards provide employees protection 
similar to employees in general industry, but avoid the difficulties 
associated with establishment of beryllium work areas in the context of 
abrasive blasting operations in these sectors.
    NIOSH commented that while it supported triggering the requirement 
to establish beryllium work areas at any level of airborne exposures, 
it is not clear how such a requirement would work in an outdoor 
environment (Document ID 1725, p. 30). It explained that it is possible 
that even ambient conditions could cause an outdoor work environment to 
qualify as a ``beryllium work area'' (Document ID 1725, p. 30). NIOSH 
also noted that it was unclear how to delineate beryllium work areas in 
an outdoor setting when abrasive blasting the outer hull of a large 
ship and questioned how the beryllium work area trigger of any level of 
airborne exposure to beryllium could be applied only to that specified 
area (Document 1755, Tr. 21). NIOSH further explained that establishing 
a beryllium work area for abrasive blasting in an outdoor environment 
is difficult because outdoor blasting operations often involve large 
structures and constant moving of the operation (Document ID 1755, Tr. 
55).

[[Page 2661]]

    Newport News Shipbuilding (NNS) similarly commented that since 
beryllium is primarily encountered in shipyards as a trace element in 
coal slag blasting media, the requirement to establish and maintain 
beryllium work areas is not appropriate for shipyards. NNS stated, 
``[i]t is relatively easy to control a work area to a stated number 
such as a permissible exposure limit or an action level, but 
controlling `regardless of level of exposure' for a trace contaminant 
in dust is impractical'' (Document ID 1657, pp. 1-2).
    Recognizing the difficulties described by NIOSH and NNS, the Agency 
decided not to require employers in construction and shipyards to 
establish and maintain beryllium work areas. However, OSHA has modified 
provisions associated with beryllium work areas in paragraph (f)(1) and 
paragraph (h) of the proposed standard so as to provide employees in 
all sectors with largely equivalent protective measures. For example, 
employers in all sectors are required to create, implement, and 
maintain a written exposure control plan that lists jobs and operations 
where beryllium exposure may occur, and that documents procedures for 
limiting cross-contamination and migration of beryllium (see Summary 
and Explanation of paragraph (f)(1)). Similarly, whereas employers in 
general industry are required under paragraph (f)(2) to take certain 
steps to reduce airborne beryllium in beryllium work areas where 
exposures meet or exceed the action level, employers in construction 
and shipyards have a nearly identical requirement to take steps to 
reduce exposures where exposures meet or exceed the action level. Thus, 
the only provisions related to beryllium work areas that apply in 
general industry but not in construction and shipyards are those OSHA 
is persuaded add protective value in general industry but would be 
unworkable or ineffective in the construction and shipyard contexts of 
abrasive blasting and outdoor operations, e.g., certain housekeeping 
provisions related to surface contamination (see Summary and 
Explanation, paragraph (j), Housekeeping, for further discussion).
    Regulated Areas. Paragraph (e)(1)(ii) of the proposed standard 
required employers to establish and maintain regulated areas wherever 
employees are, or can reasonably be expected to be, exposed to airborne 
concentrations of beryllium in excess of the TWA PEL or STEL. OSHA 
explained that the requirement to establish and maintain regulated 
areas would apply if any exposure monitoring or objective data indicate 
that airborne exposures are in excess of either the TWA PEL or STEL, or 
if the employer has reason to anticipate or believe that airborne 
exposures may be above the TWA PEL or STEL, even if the employer has 
not yet characterized or monitored those exposures. For example, if 
newly introduced processes involving beryllium appear to be creating 
dust and have not yet been monitored, the employer should reasonably 
anticipate that airborne exposures could exceed the TWA PEL or STEL. In 
this situation, the employer would be required to designate the area as 
a regulated area to protect workers and other persons until monitoring 
results establish that exposures are at or below the TWA PEL and STEL. 
In the proposed standard, work in regulated areas triggered additional 
requirements for medical surveillance (see Summary and Explanation for 
paragraph (k)), PPE (see Summary and Explanation for paragraph (h)), 
and hazard communication (see Summary and Explanation for paragraph 
(m)). The construction and shipyard sectors were not included in the 
proposed standard, but were included in Regulatory Alternative #2a in 
the NPRM, which would extend all provisions of the proposed standard 
for general industry to construction and shipyards, including 
provisions pertaining to regulated areas. OSHA requested comments on 
this proposed regulatory alternative.
    OSHA received relatively few comments