[Federal Register Volume 80, Number 152 (Friday, August 7, 2015)]
[Proposed Rules]
[Pages 47565-47828]
[FR Doc No: 2015-17596]

Vol. 80

Friday,

No. 152

August 7, 2015

Part II

Department of Labor

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 Occupational Safety and Health Administration

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29 CFR Part 1910

 Occupational Exposure to Beryllium and Beryllium Compounds; Proposed
Rule

Federal Register / Vol. 80 , No. 152 / Friday, August 7, 2015 /
Proposed Rules

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

29 CFR Part 1910

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

Occupational Exposure to Beryllium and Beryllium Compounds

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

ACTION: Proposed rule; request for comments.

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SUMMARY: The Occupational Safety and Health Administration (OSHA)
proposes to amend its existing exposure limits for occupational
exposure in general industry to beryllium and beryllium compounds and
promulgate a substance-specific standard for general industry
regulating occupational exposure to beryllium and beryllium compounds.
This document proposes a new permissible exposure limit (PEL), as well
as ancillary provisions for employee protection such as methods for
controlling exposure, respiratory protection, medical surveillance,
hazard communication, and recordkeeping. In addition, OSHA seeks
comment on a number of alternatives, including a lower PEL, that could
affect construction and maritime, as well as general industry.

DATES: Written comments. Written comments, including comments on the
information collection determination described in Section IX of the
preamble (OMB Review under the Paperwork Reduction Act of 1995), must
be submitted (postmarked, sent, or received) by November 5, 2015.
    Informal public hearings. The Agency will schedule an informal
public hearing on the proposed rule if requested during the comment
period. The location and date of the hearing, procedures for interested
parties to notify the Agency of their intention to participate, and
procedures for participants to submit their testimony and documentary
evidence will be announced in the Federal Register if a hearing is
requested.

ADDRESSES: Written comments. You may submit comments, identified by
Docket No. OSHA-H005C-2006-0870, by any of the following methods:
    Electronically: You may submit comments and attachments
electronically at http://www.regulations.gov, which is the Federal e-
Rulemaking Portal. Follow the instructions on-line for making
electronic submissions. When uploading multiple attachments into
Regulations.gov, please number all of your attachments because
www.Regulations.gov will not automatically number the attachments. This
will be very useful in identifying all attachments in the beryllium
rule. For example, Attachment 1_title of your document, Attachment 2_
title of your document, Attachment 3_title of your document, etc.
Specific instructions on uploading all documents are found in the
Facts, Answer, Questions portion and the commenter check list on
Regulations.gov Web page.
    Fax: If your submissions, including attachments, are not longer
than 10 pages, you may fax them to the OSHA Docket Office at (202) 693-
1648.
    Mail, hand delivery, express mail, messenger, or courier service:
You may submit your comments to the OSHA Docket Office, Docket No.
OSHA-H005C-2006-0870, U.S. Department of Labor, Room N-2625, 200
Constitution Avenue NW., Washington, DC 20210, telephone<PHONE_NUMBER>
(OSHA's TTY number is<PHONE_NUMBER>). Deliveries (hand, express mail,
messenger, or courier service) are accepted during the Docket Office's
normal business hours, 8:15 a.m.-4:45 p.m., E.S.T.
    Instructions: All submissions must include the Agency name and the
docket number for this rulemaking (Docket No. OSHA-H005C-2006-0870).
All comments, including any personal information you provide, are
placed in the public docket without change and may be made available
online at http://www.regulations.gov. Therefore, OSHA cautions you
about submitting personal information such as Social Security numbers
and birthdates.
    If you submit scientific or technical studies or other results of
scientific research, OSHA requests (but is not requiring) that you also
provide the following information where it is available: (1)
Identification of the funding source(s) and sponsoring organization(s)
of the research; (2) the extent to which the research findings were
reviewed by a potentially affected party prior to publication or
submission to the docket, and identification of any such parties; and
(3) the nature of any financial relationships (e.g., consulting
agreements, expert witness support, or research funding) between
investigators who conducted the research and any organization(s) or
entities having an interest in the rulemaking. If you are submitting
comments or testimony on the Agency's scientific or technical analyses,
OSHA requests that you disclose: (1) The nature of any financial
relationships you may have with any organization(s) or entities having
an interest in the rulemaking; and (2) the extent to which your
comments or testimony were reviewed by an interested party before you
submitted them. Disclosure of such information is intended to promote
transparency and scientific integrity of data and technical information
submitted to the record. This request is consistent with Executive
Order 13563, issued on January 18, 2011, which instructs agencies to
ensure the objectivity of any scientific and technological information
used to support their regulatory actions. OSHA emphasizes that all
material submitted to the rulemaking record will be considered by the
Agency to develop the final rule and supporting analyses.
    Docket: To read or download comments and materials submitted in
response to this Federal Register notice, go to Docket No. OSHA-H005C-
2006-0870 at http://www.regulations.gov, or to the OSHA Docket Office
at the address above. All comments and submissions are listed in the
http://www.regulations.gov index; however, some information (e.g.,
copyrighted material) is not publicly available to read or download
through that Web site. All comments and submissions are available for
inspection at the OSHA Docket Office.
    Electronic copies of this Federal Register document are available
at http://www.regulations.gov. Copies also are available from the OSHA
Office of Publications, Room N-3101, U.S. Department of Labor, 200
Constitution Avenue NW., Washington, DC 20210; telephone (202) 693-
1888. This document, as well as news releases and other relevant
information, is also available at OSHA's Web site at http://www.osha.gov.
    OSHA has not provided the document ID numbers for all submissions
in the record for this beryllium proposal. The proposal only contains a
reference list for all submissions relied upon. The public can find all
document ID numbers in an Excel spreadsheet that is posted on OSHA's
rulemaking Web page (see www.osha.gov/berylliumrulemaking). The public
will be able to locate submissions in the record in the public docked
Web page: http://www.regulations.gov. To locate a particular submission
contained in http://www.regulations.gov, the public should enter the
full document ID number in the search bar.

FOR FURTHER INFORMATION CONTACT: For general information and press
inquiries, contact Frank Meilinger, Director, Office of Communications,
Room N-3647,

OSHA, U.S. Department of Labor, 200 Constitution Avenue NW.,
Washington, DC 20210; telephone:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>. 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<PHONE_NUMBER> or fax<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    The preamble to the proposed standard on occupational exposure to
beryllium and beryllium compounds follows this outline:

Executive Summary

I. Issues and Alternatives
II. Pertinent Legal Authority
III. Events Leading to the Proposed Standards
IV. Chemical Properties and Industrial Uses
V. Health Effects
VI. Preliminary Risk Assessment
VII. Response to Peer Review
VIII. Significance of Risk
IX. Summary of the Preliminary Economic Analysis and Initial
Regulatory Flexibility Analysis
X. OMB Review under the Paperwork Reduction Act of 1995
XI. Federalism
XII. State-Plan States
XIII. Unfunded Mandates Reform Act
XIV. Protecting Children from Environmental Health and Safety Risks
XV. Environmental Impacts
XVI. Consultation and Coordination with Indian Tribal Governments
XVII. Public Participation
XVIII. Summary and Explanation of the Proposed Standard
    (a) Scope and Application
    (b) Definitions
    (c) Permissible Exposure Limits (PELs)
    (d) Exposure Assessment
    (e) Beryllium Work Areas and Regulated Areas
    (f) Methods of Compliance
    (g) Respiratory Protection
    (h) Personal Protective Clothing and Equipment
    (i) Hygiene Areas and Practices
    (j) Housekeeping
    (k) Medical Surveillance
    (l) Medical Removal
    (m) Communication of Hazards to Employees
    (n) Recordkeeping
    (o) Dates
XIX. References

Executive Summary

    OSHA currently enforces permissible exposure limits (PELs) for
beryllium in general industry, construction, and shipyards. These PELs
were adopted in 1971, shortly after the Agency was created, and have
not been updated since then. The time-weighted average (TWA) PEL for
beryllium is 2 micrograms per cubic meter of air ([mu]g/m\3\) as an 8-
hour time-weighted average. OSHA is proposing a new TWA PEL of 0.2
[mu]g/m\3\ in general industry. OSHA is also proposing other elements
of a comprehensive health standard, including requirements for exposure
assessment, preferred methods for controlling exposure, respiratory
protection, personal protective clothing and equipment (PPE), medical
surveillance, medical removal, hazard communication, and recordkeeping.
    OSHA's proposal is based on the requirements of the Occupational
Safety and Health Act (OSH Act) and court interpretations of the Act.
For health standards issued under section 6(b)(5) of the OSH Act, OSHA
is required to promulgate a standard that reduces significant risk to
the extent that it is technologically and economically feasible to do
so. See Section II of this preamble, Pertinent Legal Authority, for a
full discussion of OSHA legal requirements.
    OSHA has conducted an extensive review of the literature on adverse
health effects associated with exposure to beryllium. The Agency has
also assessed the risk of beryllium-related diseases at the current TWA
PEL, the proposed TWA PEL and the alternative TWA PELs. These analyses
are presented in this preamble at Section V, Health Effects, Section
VI, Preliminary Risk Assessment, and Section VIII, Significance of
Risk. As discussed in Section VIII of this preamble, Significance of
Risk, the available evidence indicates that worker exposure to
beryllium at the current PEL poses a significant risk of chronic
beryllium disease (CBD) and lung cancer, and that the proposed standard
will substantially reduce this risk.
    Section 6(b) of the OSH Act requires OSHA to determine that its
standards are technologically and economically feasible. OSHA's
examination of the technological and economic feasibility of the
proposed rule is presented in the Preliminary Economic Analysis and
Initial Regulatory Flexibility Analysis (PEA) (OSHA, 2014), and is
summarized in Section IX of this preamble, Summary of the Preliminary
Economic Analysis and Initial Regulatory Flexibility Analysis. OSHA has
preliminarily concluded that the proposed PEL of 0.2 [mu]g/m\3\ is
technologically feasible for all affected industries and application
groups. Thus, OSHA preliminarily concludes that engineering and work
practices will be sufficient to reduce and maintain beryllium exposures
to the proposed PEL of 0.2 [mu]g/m\3\ or below in most operations most
of the time in the affected industries. For those few operations within
an industry or application group where compliance with the proposed PEL
cannot be achieved even when employers implement all feasible
engineering and work practice controls, the proposed standard would
require employers to supplement controls with respirators.
    OSHA developed quantitative estimates of the compliance costs of
the proposed rule for each of the affected industry sectors. The
estimated compliance costs were compared with industry revenues and
profits to provide a screening analysis of the economic feasibility of
complying with the revised standard and an evaluation of the potential
economic impacts. Industries with unusually high costs as a percentage
of revenues or profits were further analyzed for possible economic
feasibility issues. After performing these analyses, OSHA has
preliminarily concluded that compliance with the requirements of the
proposed rule would be economically feasible in every affected industry
sector.
    The Regulatory Flexibility Act, as amended by the Small Business
Regulatory Enforcement Fairness Act (SBREFA), requires that OSHA either
certify that a rule would not have a significant economic impact on a
substantial number of small entities or prepare a regulatory
flexibility analysis and hold a Small Business Advocacy Review (SBAR)
Panel prior to proposing the rule. OSHA has determined that a
regulatory flexibility analysis is needed and has provided this
analysis in Chapter IX of the PEA (OSHA, 2014). A summary is provided
in Section IX of this preamble, Summary of the Preliminary Economic
Analysis and Initial Regulatory Flexibility Analysis. OSHA also
previously held a SBAR Panel for this rule. The recommendations of the
Panel and OSHA's response to them are summarized in Section IX of this
preamble.
    Executive Orders 13563 and 12866 direct agencies to assess all
costs and benefits of available regulatory alternatives. Executive
Order 13563 emphasizes the importance of quantifying both costs and
benefits, of reducing costs, of harmonizing rules, and of promoting
flexibility. This rule has been designated an economically significant
regulatory action under section 3(f)(1) of Executive Order 12866.
Accordingly, this proposed rule has been reviewed by the Office of
Management and Budget. The remainder of this section summarizes the key
findings of the analysis with respect to costs and benefits of the
proposed standard, presents alternatives

to the proposed standard, and requests comments on a number of issues.
    Table I-1, which is derived from material presented in the PEA,
provides a summary of OSHA's best estimate of the costs and benefits of
this proposed rule. As shown, this proposed rule is estimated to
prevent 96 fatalities and 50 non-fatal beryllium-related illnesses
annually once it is fully effective, and the monetized annualized
benefits of the proposed rule are estimated to be $576 million using a
3-percent discount rate and $255 million using a 7-percent discount
rate. Also as shown in Table I-1, the estimated annualized cost of the
rule is $37.6 million using a 3-percent discount rate and $39.1 million
using a 7-percent discount rate. This proposed rule is estimated to
generate net benefits of $538 million annually using a 3-percent
discount rate and $216 million annually using a 7-percent discount
rate. These estimates are for informational purposes only and have not
been used by OSHA as the basis for its decision concerning the choice
of a PEL or of other ancillary requirements for this proposed beryllium
rule. The courts have ruled that OSHA may not use benefit-cost analysis
or a criterion of maximizing net benefits as a basis for setting OSHA
health standards.\1\
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    \1\ Am. Textile Mfrs. Inst., Inc. v. Nat'l Cotton Council of
Am., 452 U.S. 490, 513 (1981); Pub. Citizen Health Research Group v.
U.S. Dep't of Labor, 557 F.3d 165, 177 (3d Cir. 2009).

 Table I-1--Annualized Costs, Benefits and Net Benefits of OSHA's Proposed Beryllium Standard of 0.2 [mu]g/m\3\
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                  Discount rate                                            3%                       7%
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Annualized Costs
    Engineering Controls.........................                            $9,540,189              $10,334,036
    Respirators..................................                               249,684                  252,281
    Exposure Assessment..........................                             2,208,950                2,411,851
    Regulated Areas and Beryllium Work Areas.....                               629,031                  652,823
    Medical Surveillance.........................                             2,882,076                2,959,448
    Medical Removal..............................                               148,826                  166,054
    Exposure Control Plan........................                             1,769,506                1,828,766
    Protective Clothing and Equipment............                             1,407,365                1,407,365
    Hygiene Areas and Practices..................                               389,241                  389,891
    Housekeeping.................................                            12,574,921               12,917,944
    Training.....................................                             5,797,535                5,826,975
Total Annualized Costs (Point Estimate)..........                            37,597,325               39,147,434
Annual Benefits: Number of Cases Prevented
    Fatal Lung Cancer............................          4.0
    CBD-Related Mortality........................         92.0
    Total Beryllium Related Mortality............         96.0              572,981,864              253,743,368
Morbidity........................................         49.5                2,844,770                1,590,927
Monetized Annual Benefits (midpoint estimate)....                           575,826,633              255,334,295
        Net Benefits.............................                           538,229,308              216,186,861
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Source: OSHA, Directorate of Standards and Guidance, Office of Regulatory Analysis.

    Both the costs and benefits of Table I-1 reflect the incremental
costs and benefits associated with achieving full compliance with the
proposed standard. They do not include costs and benefits associated
with employers' current exposure control measures or other aspects of
the proposed standard they have already implemented. For example, for
employers whose exposures are already below the proposed PEL, OSHA's
estimated costs and benefits for the proposed standard do not include
the costs of their exposure control measures or the benefits of these
employers' compliance with the proposed PEL. The costs and benefits of
Table I-1 also do not include costs and benefits associated with
achieving compliance with existing requirements, to the extent that
some employers may currently not be fully complying with applicable
regulatory requirements.

I. Issues and Alternatives

    In addition to the proposed standard itself, this preamble
discusses more than two dozen regulatory alternatives, including
various sub-alternatives, to the proposed standard and requests
comments and information on a variety of topics pertinent to the
proposed standard. The regulatory alternatives OSHA is considering
include alternatives to the proposed scope of the standard, regulatory
alternatives to the proposed TWA PEL of 0.2 [mu]g/m\3\ and proposed
STEL of 2 [mu]g/m\3\, a regulatory alternative that would modify the
proposed methods of compliance, and regulatory alternatives that affect
proposed ancillary provisions. The Agency solicits comment on the
proposed phase-in schedule for the various provisions of the standard.
Additional requests for comments and information follow the summaries
of regulatory alternatives, under the ``Issues'' heading.

Regulatory Alternatives

    OSHA believes that inclusion of regulatory alternatives serves two
important functions. The first is to explore the possibility of less
costly ways (than the proposed standard) to provide an adequate level
of worker protection from exposure to beryllium. The second is tied to
the Agency's statutory requirement, which underlies the proposed
standard, to reduce significant risk to the extent feasible. Each
regulatory alternative presented here is described and analyzed more
fully elsewhere in this preamble or in the PEA. Where appropriate, the
alternative is included in this preamble at the end of the relevant
section of Section XVIII, Summary and Explanation of the Proposed
Standard, to facilitate comparison of the alternative to the proposed
standard. For example, alternative PELs under consideration by the
Agency are presented in the discussion of paragraph (c) in Section
XVIII. In addition, all

alternatives are discussed in the PEA, Chapter VIII: Regulatory
Alternatives (OSHA, 2014). The costs and benefits of each regulatory
alternative are presented both in Section IX of this preamble and in
Chapter VIII of the PEA.
    The more than two dozen regulatory alternatives, including various
sub-alternatives regulatory alternatives under consideration are
summarized below, and are organized into the following categories:
alternatives to the proposed scope of the standard; alternatives to the
proposed PELs; alternatives to the proposed methods of compliance;
alternatives to the proposed ancillary provisions; and the timing of
the standard.
Scope
    OSHA has examined three alternatives that would alter the groups of
employers and employees covered by this rulemaking. Regulatory
Alternative #1a would expand the scope of the proposed standard to
include all operations in general industry where beryllium exists only
as a trace contaminant; that is, where the materials used contain no
more than 0.1% beryllium by weight. Regulatory Alternative #1b is
similar to Regulatory Alternative #1a, but exempts operations where the
employer can show that employees' exposures will not meet or exceed the
action level or exceed the STEL. Where the employer has objective data
demonstrating that a material containing beryllium or a specific
process, operation, or activity involving beryllium cannot release
beryllium in concentrations at or above the proposed action level or
above the proposed STEL under any expected conditions of use, that
employer would be exempt from the proposed standard except for
recordkeeping requirements pertaining to the objective data.
Alternative #1a and Alternative #1b, like the proposed rule, would not
cover employers or employees in construction or shipyards.
    Regulatory Alternative #2a would expand the scope of the proposed
standard to also include employers in construction and maritime. For
example, this alternative would cover abrasive blasters, pot tenders,
and cleanup staff working in construction and shipyards who have the
potential for airborne beryllium exposure during blasting operations
and during cleanup of spent media. Regulatory Alternative #2b would
update Sec. Sec.  1910.1000 Tables Z-1 and Z-2, 1915.1000 Table Z, and
1926.55 Appendix A so that the proposed TWA PEL and STEL would apply to
all employers and employees in general industry, shipyards, and
construction, including occupations where beryllium exists only as a
trace contaminant. However, all other provisions of the standard would
be in effect only for employers and employees that fall within the
scope of the proposed rule. More detailed discussion of Regulatory
Alternatives #1a, #1b, #2a, and #2b appears in Section IX of this
preamble and in Chapter VIII of the PEA (OSHA, 2014). In addition,
Section XVIII of this preamble, Summary and Explanation, includes a
discussion of paragraph (a) that describes the scope of the proposed
rule, issues with the proposed scope, and Regulatory Alternatives #1a,
#1b, #2a, and #2b.
    Another regulatory alternative that would impact the scope of
affected industries, extending eligibility for medical surveillance to
employees in shipyards, construction, and parts of general industry
excluded from the scope of the proposed standard, is discussed along
with other medical surveillance alternatives later in this section
(Regulatory Alternative #21) and in the discussion of paragraph (k) in
this preamble at Section XVIII, Summary and Explanation of the Proposed
Standard.
Permissible Exposure Limits
    OSHA has examined several regulatory alternatives that would modify
the TWA PEL or STEL for the proposed rule. Under Regulatory Alternative
#3, OSHA would adopt a STEL of 5 times the proposed PEL. Thus, this
alternative STEL would be 1.0 [mu]g/m\3\ if OSHA adopts a PEL of 0.2
[mu]g/m\3\; it would be 0.5 [mu]g/m\3\ if OSHA adopts a PEL of 0.1
[mu]g/m\3\; and it would be 2.5 [micro]g/m\3\ if OSHA adopts a PEL of
0.5 [micro]g/m\3\ (see Regulatory Alternatives #4 and #5). Under
Regulatory Alternative #4, the proposed PEL would be lowered from 0.2
[mu]g/m\3\ to 0.1 [mu]g/m\3\. Under Regulatory Alternative #5, the
proposed PEL would be raised from 0.2 [mu]g/m\3\ to 0.5 [mu]g/m\3\. In
addition, for informational purposes, OSHA examined a regulatory
alternative that would maintain the TWA PEL at 2.0 [mu]g/m\3\, but all
of the other proposed provisions would be required with their triggers
remaining the same as in the proposed rule. This alternative is not one
OSHA could legally adopt because the absence of a more protective
requirement for engineering controls would not be consistent with
section 6(b)(5) of the OSH Act. More detailed discussion of these
alternatives to the proposed PEL appears in Section IX of this preamble
and in Chapter VIII of the PEA (OSHA, 2014). In addition, in Section
XVIII of this preamble, Summary and Explanation of the Proposed
Standard, the discussion of proposed paragraph (c) describes the
proposed TWA PEL and STEL, issues with the proposed exposure limits,
and Regulatory Alternatives #3, #4, and #5.
Methods of Compliance
    The proposed standard would require employers to implement
engineering and work practice controls to reduce employees' exposures
to or below the TWA PEL and STEL. Where engineering and work practice
controls are insufficient to reduce exposures to or below the TWA PEL
and STEL, employers would still be required to implement them to reduce
exposure as much as possible, and to supplement them with a respiratory
protection program. In addition, for each operation where there is
airborne beryllium exposure, the employer must ensure that one or more
of the engineering and work practice controls listed in paragraph
(f)(2) are in place, unless all of the listed controls are infeasible,
or the employer can demonstrate that exposures are below the action
level based on two samples taken seven days apart. Regulatory
Alternative #6 would eliminate the engineering and work practice
controls provision currently specified in paragraph (f)(2). This
regulatory alternative does not eliminate the need for engineering
controls to lower exposure levels to or below the TWA PEL and STEL;
rather, it dispenses with the mandatory use of certain engineering
controls that must be installed above the action level but at or below
the TWA PEL.
    More detailed discussion of Regulatory Alternative #6 appears in
Section IX of this preamble and in Chapter VIII of the PEA (OSHA,
2014). In addition, the discussion of paragraph (f) in Section XVIII of
this preamble, Summary and Explanation, provides a more detailed
explanation of the proposed methods of compliance, issues with the
proposed methods of com pli ance, and Regulatory Alternative #6.
Ancillary Provisions
    The proposed rule contains several ancillary provisions, including
requirements for exposure assessment, personal protective clothing and
equipment (PPE), medical surveillance, medical removal, training, and
regulated areas or access control. OSHA has examined a variety of
regulatory alternatives involving changes to one or more of these
ancillary provisions. OSHA has preliminarily determined that several of
these ancillary provisions will increase the benefits of the proposed
rule, for example, by helping to ensure the TWA PEL is not exceeded

or by lowering the risks to workers given the significant risk
remaining at the proposed TWA PEL. However, except for Regulatory
Alternative #7 (involving the elimination of all ancillary provisions),
OSHA did not estimate changes in monetized benefits for the regulatory
alternatives that affect ancillary provisions. Two regulatory
alternatives that involve all ancillary provisions are presented below
(#7 and #8), followed by regulatory alternatives for exposure
monitoring (#9, #10, and #11), for regulated areas (#12), for personal
protective clothing and equipment (#13), for medical surveillance (#14
through #21), and for medical removal (#22).
All Ancillary Provisions
    During the Small Business Regulatory Fairness Act (SBREFA) process
conducted in 2007, the SBAR Panel recommended that OSHA analyze a PEL-
only standard as a regulatory alternative. The Panel also recommended
that OSHA consider applying ancillary provisions of the standard so as
to minimize costs for small businesses where exposure levels are low
(OSHA, 2008b). In response to these recommendations, OSHA analyzed
Regulatory Alternative #7, a PEL-only standard, and Regulatory
Alternative #8, which would only apply ancillary provisions of the
beryllium standard at exposures above the proposed PEL of 0.2 [micro]g/
m\3\ or the proposed STEL of 2 [micro]g/m\3\. Regulatory Alternative #7
would update the Z tables for Sec.  1910.1000, so that the proposed TWA
PEL and STEL would apply to all workers in general industry. All other
provisions of the proposed standard would be dropped.
    As indicated previously, OSHA has preliminarily determined that
there is significant risk remaining at the proposed PEL of 0.2 [mu]g/
m\3\. However, the available evidence on feasibility suggests that 0.2
[mu]g/m\3\ may be the lowest feasible PEL (see Chapter IV of the PEA,
OSHA 2014). Therefore, the Agency believes that it is necessary to
include ancillary provisions in the proposed rule to further reduce the
remaining risk. In addition, the recommended standard provided to OSHA
by representatives of the primary beryllium manufacturing industry and
the Steelworkers Union further supports the importance of ancillary
provisions in protecting workers from the harmful effects of beryllium
exposure (Materion and USW, 2012).
    Under Regulatory Alternative #8, several ancillary provisions that
the current proposal would require under a variety of exposure
conditions (e.g., dermal contact; any airborne exposure; exposure at or
above the action level) would instead only apply where exposure levels
exceed the TWA PEL or STEL. Regulatory Alternative #8 affects the
following provisions of the proposed standard:

--Exposure monitoring. Whereas the proposed standard requires annual
monitoring where exposure levels are at or above the action level and
at or below the TWA PEL, Alternative #8 would require annual exposure
monitoring only where exposure levels exceed the TWA PEL or STEL;
-- Written exposure control plan. Whereas the proposed standard
requires written exposure control plans to be maintained in any
facility covered by the standard, Alternative #8 would require only
facilities with exposures above the TWA PEL or STEL to maintain a plan;
--PPE. Whereas the proposed standard requires PPE for employees under a
variety of conditions, such as exposure to soluble beryllium or visible
contamination with beryllium, Alternative #8 would require PPE only for
employees exposed above the TWA PEL or STEL;
--Housekeeping. Whereas the proposed standard's housekeeping
requirements apply across a wide variety of beryllium exposure
conditions, Alternative #8 would limit housekeeping requirements to
areas with exposures above the TWA PEL or STEL.
--Medical Surveillance. Whereas the proposed standard's medical
surveillance provisions require employers to offer medical surveillance
to employees with signs or symptoms of beryllium-related health effects
regardless of their exposure level, Alternative #8 would make
surveillance available to such employees only if they were exposed
above the TWA PEL or STEL.

More detailed discussions of Regulatory Alternatives #7 and #8,
including a description of the considerations pertinent to these
alternatives, appear in Section IX of this preamble and in Chapter VIII
of the PEA (OSHA, 2014).
Exposure Monitoring
    OSHA has examined three regulatory alternatives that would modify
the proposed standard's provisions on exposure monitoring, which
require periodic monitoring annually where exposures are at or above
the action level and at or below the TWA PEL. Under Regulatory
Alternative #9, employers would be required to perform periodic
exposure monitoring every 180 days where exposures are at or above the
action level or above the STEL, and at or below the TWA PEL. Under
Regulatory Alternative #10, employers would be required to perform
periodic exposure monitoring every 180 days where exposures are at or
above the action level or above the STEL, including where exposures
exceed the TWA PEL. Under Regulatory Alternative #11, employers would
be required to perform periodic exposure monitoring every 180 days
where exposures are at or above the action level or above the STEL, and
every 90 days where exposures exceed the TWA PEL. More detailed
discussions of Regulatory Alternatives #9, #10, and #11 appear in
Section IX of this preamble and in Chapter VIII of the PEA (OSHA,
2014). In addition, the discussion of proposed paragraph (d) in Section
XVIII of this preamble, Summary and Explanation of the Proposed
Standard, provides a more detailed explanation of the proposed
requirements for exposure monitoring, issues with exposure monitoring,
and the considerations pertinent to Regulatory Alternatives #9, #10,
and #11.
Regulated Areas
    The proposed standard would require employers to establish and
maintain two types of areas: beryllium work areas, wherever employees
are, or can reasonably be expected to be, exposed to any level of
airborne beryllium; and regulated areas, wherever employees are, or can
reasonably be expected to be, exposed to airborne beryllium at levels
above the TWA PEL or STEL. Employers are required to demarcate
beryllium work areas, but are not required to restrict access to
beryllium work areas or provide respiratory protection or other forms
of PPE within work areas that are not also regulated areas. Employers
must demarcate regulated areas, restrict access to them, post warning
signs and provide respiratory protection and other PPE within regulated
areas, as well as medical surveillance for employees who work in
regulated areas for more than 30 days in a 12-month period. During the
SBREFA process conducted in 2007, the SBAR Panel recommended that OSHA
consider dropping or limiting the provision for regulated areas (OSHA,
2008b). In response to this recommendation, OSHA analyzed Regulatory
Alternative #12, which would not require employers to establish
regulated areas. More detailed discussion of Regulatory Alternative #12
appears in Section IX of this preamble and in Chapter VIII of the PEA
(OSHA, 2014). In addition, the discussion of

paragraph (e) in Section XVIII of this preamble, Summary and
Explanation, provides a more detailed explanation of the proposed
requirements for regulated areas, issues with regulated areas, and
considerations pertinent to Regulatory Alternative #12.
Personal Protective Clothing and Equipment (PPE)
    Regulatory Alternative #13 would modify the proposed requirements
for PPE, which require PPE where exposure exceeds the TWA PEL or STEL;
where employees' clothing or skin may become visibly contaminated with
beryllium; and where employees may have skin contact with soluble
beryllium compounds. The requirement to use PPE where work clothing or
skin may become ``visibly contaminated'' with beryllium differs from
prior standards that do not require contamination to be visible in
order for PPE to be required. In the case of beryllium, which OSHA has
preliminarily concluded can sensitize through dermal exposure, the
exposure levels capable of causing adverse health effects and the PELs
in effect are so low that beryllium surface contamination is unlikely
to be visible (see this preamble at section V, Health Effects). OSHA is
therefore considering Regulatory Alternative #13, which would require
appropriate PPE wherever there is potential for skin contact with
beryllium or beryllium-contaminated surfaces. More detailed discussion
of Regulatory Alternative #13 is provided in Section IX of this
preamble and in Chapter VIII of the PEA (OSHA, 2014). In addition, the
discussion of paragraph (h) in Section XVIII of this preamble, Summary
and Explanation, provides a more detailed explanation of the proposed
requirements for PPE, issues with PPE, and the considerations pertinent
to Regulatory Alternative #13.
Medical Surveillance
    The proposed requirements for medical surveillance include: (1)
Medical examinations, including a test for beryllium sensitization, for
employees who are exposed to beryllium above the proposed PEL for 30
days or more per year, who are exposed to beryllium in an emergency, or
who show signs or symptoms of CBD; and (2) low-dose helical tomography
(low-dose computed tomography, hereafter referred to as ``CT scans''),
for employees who were exposed above the proposed PEL for more than 30
days in a 12-month period for 5 years or more. This type of CT scan is
a method of detecting tumors, and is commonly used to diagnose lung
cancer. The proposed standard would require periodic medical exams to
be provided for employees in the medical surveillance program annually,
while tests for beryllium sensitization and CT scans would be provided
to eligible employees biennially.
    OSHA has examined eight regulatory alternatives (#14 through #21)
that would modify the proposed rule's requirements for employee
eligibility, the types of exam that must be offered, and the frequency
of periodic exams. Medical surveillance was a subject of special
concern to SERs during the SBREFA process, and the SBREFA Panel offered
many comments and recommendations related to medical surveillance for
OSHA's consideration. Some of the Panel's concerns have been addressed
in this proposal, which was modified since the SBREFA Panel was
convened (see this preamble at Section XVIII, Summary and Explanation
of the Proposed Standard, for more detailed discussion). Several of the
alternatives presented here (#16, #18, and #20) also respond to
recommendations by the SBREFA Panel to reduce burdens on small
businesses by dropping or reducing the frequency of medical
surveillance requirements. OSHA also seeks to ensure that the
requirements of the final standard offer workers adequate medical
surveillance while limiting the costs to employers. Thus, OSHA requests
feedback on several additional alternatives and on a variety of issues
raised later in this section of the preamble.
    Regulatory Alternatives #14, #15, and #21 would expand eligibility
for medical surveillance to a broader group of employees than would be
eligible in the proposed standard. Under Regulatory Alternative #14,
medical surveillance would be available to employees who are exposed to
beryllium above the proposed PEL, including employees exposed for fewer
than 30 days per year. Regulatory Alternative #15 would expand
eligibility for medical surveillance to employees who are exposed to
beryllium above the proposed action level, including employees exposed
for fewer than 30 days per year. Regulatory Alternative #21 would
extend eligibility for medical surveillance as set forth in proposed
paragraph (k) to all employees in shipyards, construction, and general
industry who meet the criteria of proposed paragraph (k)(1) (or any of
the alternative criteria under consideration). However, all other
provisions of the standard would be in effect only for employers and
employees that fall within the scope of the proposed rule.
    Regulatory Alternatives #16 and #17 would modify the proposed
standard's requirements to offer beryllium sensitization testing to
eligible employees. Under Regulatory Alternative #16, employers would
not be required to offer employees testing for beryllium sensitization.
Regulatory Alternative #17 would increase the frequency of periodic
sensitization testing, from the proposed standard's biennial
requirement to annual testing. Regulatory Alternatives #18 and #19
would similarly modify the proposed standard's requirements to offer CT
scans to eligible employees. Regulatory Alternative #18 would drop the
CT scan requirement from the proposed rule, whereas Regulatory
Alternative #19 would increase the frequency of periodic CT scans from
biennial to annual scans. Finally, under Regulatory Alternative #20,
all periodic components of the medical surveillance exams would be
available biennially to eligible employees. Instead of requiring
employers to offer eligible employees a medical examination every year,
employers would be required to offer eligible employees a medical
examination every other year. The frequency of testing for beryllium
sensitization and CT scans would also be biennial for eligible
employees, as in the proposed standard.
    More detailed discussions of Regulatory Alternatives #14, #15, #16,
#17, #18, #19, #20, and #21 appear in Section IX of this preamble and
in Chapter VIII of the PEA (OSHA, 2014). In addition, Section XVIII of
this preamble, Summary and Explanation, paragraph (k) provides a more
detailed explanation of the proposed requirements for medical
surveillance, issues with medical surveillance, and the considerations
pertinent to Regulatory Alternatives #14 through #21.
Medical Removal Protection (MRP)
    The proposed requirements for medical removal protection provide an
option for medical removal to an employee who is working in a job with
exposure at or above the action level and is diagnosed with CBD or
confirmed positive for beryllium sensitization. If the employee chooses
removal, the employer must either remove the employee to comparable
work in a work environment where exposure is below the action level, or
if comparable work is not available, must place the employee on paid
leave for 6 months or until such time as comparable work becomes
available. In either case, the employer must maintain for 6 months the
employee's base earnings, seniority,

and other rights and benefits that existed at the time of removal.
During the SBREFA process, the Panel recommended that OSHA give careful
consideration to the impacts that an MRP requirement could have on
small businesses (OSHA, 2008b). In response to this recommendation,
OSHA analyzed Regulatory Alternative #22, which would not require
employers to offer MRP. More detailed discussion of Regulatory
Alternative #22 appears in Section IX of this preamble and in Chapter
VIII of the PEA (OSHA, 2014). In addition, the discussion of paragraph
(l) in section XVIII of this preamble, Summary and Explanation,
provides a more detailed explanation of the proposed requirements for
MRP, issues with MRP, and considerations pertinent to Regulatory
Alternative #22.
Timing of the Standard
    The proposed standard would become effective 60 days following
publication of the final standard in the Federal Register. The
effective date is the date on which the standard imposes compliance
obligations on employers. However, the standard would not become
enforceable by OSHA until 90 days following the effective date for
exposure monitoring, work areas and regulated areas, written exposure
control plan, respiratory protection, other personal protective
clothing and equipment, hygiene areas and practices (except change
rooms), housekeeping, medical surveillance, and medical removal. The
proposed requirement for change rooms would not be enforceable until
one year after the effective date, and the requirements for engineering
controls would not be enforceable until two years after the effective
date. In summary, employers will have some period of time after the
standard becomes effective to come into compliance before OSHA will
begin enforcing it: 90 days for most provisions, one year for change
rooms, and two years for engineering controls. Beginning 90 days
following the effective date, during periods necessary to install or
implement feasible engineering controls where exposure exceed the TWA
PEL or STEL, employers must provide employees with respiratory
protection as described in the proposed standard under section (g),
Respiratory Protection.
    OSHA invites comment and suggestions for phasing in requirements
for engineering controls, medical surveillance, and other provisions of
the standard. A longer phase-in time would have several advantages,
such as reducing initial costs of the standard or allowing employers to
coordinate their environmental and occupational safety and health
control strategies to minimize potential costs. However, a longer
phase-in would also postpone and reduce the benefits of the standard.
Suggestions for alternatives may apply to specific industries (e.g.,
industries where first-year or annualized cost impacts are highest),
specific size-classes of employers (e.g., employers with fewer than 20
employees), combinations of these factors, or all firms covered by the
rule.
    OSHA requests comments on these regulatory alternatives, including
the Agency's choice of regulatory alternatives (and whether there are
other regulatory alternatives the Agency should consider) and the
Agency's analysis of them. In addition, OSHA requests comments and
information on a number of specific topics and issues pertinent to the
proposed standard. These are summarized below.

Regulatory Issues

    In this section, we solicit public feedback on issues associated
with the proposed standard and request information that would help the
Agency craft the final standard. In addition to the issues specified
here, OSHA also raises issues for comment on technical questions and
discussions of economic issues in the PEA (OSHA, 2014). OSHA requests
comment on all relevant issues, including health effects, risk
assessment, significance of risk, technological and economic
feasibility, and the provisions of the proposed regulatory text. In
addition, OSHA requests comments on all of the issues raised by the
Small Business Advocacy Review (SBAR) Panel, as summarized in the SBAR
report (OSHA, 2008b)
    We present these issues and requests for information in the first
chapter of the preamble to assist readers as they review the preamble
and consider any comments they may want to submit. The issues are
presented here in summary form. However, to fully understand the
questions in this section and provide substantive input in response to
them, the sections of the preamble relevant to these issues should be
reviewed. These include: Section V, Health Effects; Section VI, the
Preliminary Risk Assessment; Section VIII, Significance of Risk;
Section IX, Summary of the Preliminary Economic Analysis and Initial
Regulatory Flexibility Analysis; and Section XVIII, Summary and
Explanation of the Proposed Standard.
    OSHA requests that comments be organized, to the extent possible,
around the following issues and numbered questions. Comment on
particular provisions should contain a heading setting forth the
section and the paragraph in the proposed standard that the comment
addresses. Comments addressing more than one section or paragraph will
have correspondingly more headings.
    Submitting comments in an organized manner and with clear reference
to the issue raised will enable all participants to easily see what
issues the commenter addressed and how they were addressed. Many
commenters, especially small businesses, are likely to confine their
comments to the issues that affect them, and they will benefit from
being able to quickly identify comments on these issues in others'
submissions. The Agency welcomes comments concerning all aspects of
this proposal. However, OSHA is especially interested in responses,
supported by evidence and reasons, to the following questions:

Health Effects

    1. OSHA has described a variety of studies addressing the major
adverse health effects that have been associated with exposure to
beryllium. Using currently available epidemiologic and experimental
studies, OSHA has made a preliminary determination that beryllium
presents risks of lung cancer; sensitization; CBD at 0.1 [micro]g/m\3\;
and at higher exposures acute beryllium disease, and hepatic, renal,
cardiovascular and ocular diseases. Is this determination correct? Are
there additional studies or other data OSHA should consider in
evaluating any of these health outcomes?
    2. Has OSHA adequately identified and documented all critical
health impairments associated with occupational exposure to beryllium?
If not, what other adverse health effects should be added? Are there
additional studies or other data OSHA should consider in evaluating any
of these health outcomes?
    3. Are there any additional studies, other data, or information
that would affect the information discussed or significantly change the
determination of material health impairment?
    Please submit any relevant information, data, or additional studies
(or citations to studies), and explain your reasons for recommending
any studies you suggest.

Risk Assessment and Significance of Risk

    4. OSHA has developed an analysis of health risks associated with
occupational beryllium exposure, including an analysis of sensitization
and CBD based on a selection of recent

studies in the epidemiological literature, a data set on a population
of beryllium machinists provided by the National Jewish Medical
Research Center (NJMRC), and an assessment of lung cancer risk using an
analysis provided by NIOSH. Did OSHA rely on the best available
evidence in its risk assessment? Are there additional studies or other
data OSHA should consider in evaluating risk for these health outcomes?
Please provide the studies, citations to studies, or data you suggest.
    5. OSHA preliminarily concluded that there is significant risk of
material health impairment (lung cancer or CBD) from a working lifetime
of occupational exposure to beryllium at the current TWA PEL of 2
[micro]g/m\3\, which would be substantially reduced by the proposed TWA
PEL of 0.2 [micro]g/m\3\ and the alternative TWA PEL of 0.1 [micro]g/
m\3\. OSHA's preliminary risk assessment also concludes that there is
still significant risk of CBD and lung cancer at the proposed PEL and
the alternative PELs, although substantially less than at the current
PEL. Are these preliminary conclusions reasonable, based on the best
available evidence? If not, please provide a detailed explanation of
your position, including data to support your position and a detailed
analysis of OSHA's risk assessment if appropriate.
    6. Please provide comment on OSHA's analysis of risk for beryllium
sensitization, CBD and lung cancer. Are there important gaps or
uncertainties in the analysis, such that the Agency's preliminary
conclusions regarding significance of risk at the current, proposed,
and alternative PELs may be in error? If so, please provide a detailed
explanation and suggestions for how OSHA's analysis should be corrected
or improved.
    7. OSHA has made a preliminary determination that the available
data are not sufficient or suitable for risk analysis of effects other
than beryllium sensitization, CBD and lung cancer. Do you have, or are
you aware of, studies or data that would be suitable for a risk
assessment for these adverse health effects? Please provide the
studies, citations to studies, or data you suggest.

(a) Scope

    8. Has OSHA defined the scope of the proposed standard
appropriately? Does it currently include employers who should not be
covered, or exclude employers who should be covered by a comprehensive
beryllium standard? Are you aware of employees in construction or
maritime, or in general industry who deal with beryllium only as a
trace contaminant, who may be at significant risk from occupational
beryllium exposure? Please provide the basis for your response and any
applicable supporting information.

(b) Definitions

    9. Has OSHA defined the Beryllium lymphocyte proliferation test
appropriately? If not, please provide the definition that you believe
is appropriate. Please provide rationale and citations supporting your
comments.
    10. Has OSHA defined CBD Diagnostic Center appropriately? In
particular, should a CBD diagnostic center be required to analyze
biological samples on-site, or should diagnostic centers be allowed to
send samples off-site for analysis? Is the list of tests and procedures
a CBD Diagnostic Center is required to be able to perform appropriate?
Should any of the tests or procedures be removed from the definition?
Should other tests or procedures be added to the definition? Please
provide rationale and information supporting your comments.

(d) Exposure Monitoring

    11. Do you currently monitor for beryllium exposures in your
workplace? If so, how often? Please provide the reasoning for the
frequency of your monitoring. If periodic monitoring is performed at
your workplace for exposures other than beryllium, with what frequency
is it repeated?
    12. Is it reasonable to allow discontinuation of monitoring based
on one sample below the action level? Should more than one result below
the action level be required to discontinue monitoring?

(e) Work Areas and Regulated Areas

    The proposed standard would require employers to establish and
maintain two types of areas: beryllium work areas, wherever employees
are, or can reasonably be expected to be, exposed to any level of
airborne beryllium; and regulated areas, wherever employees are, or can
reasonably be expected to be, exposed to airborne beryllium at levels
above the TWA PEL or STEL. Employers are required to demarcate
beryllium work areas, but are not required to restrict access to
beryllium work areas or provide respiratory protection or other forms
of PPE within work areas with exposures at or below the TWA PEL or
STEL. Employers must also demarcate regulated areas, including posting
warning signs; restrict access to regulated areas; and provide
respiratory protection and other PPE within regulated areas.
    13. Does your workplace currently have regulated areas? If so, how
are regulated areas demarcated?
    14. Please describe work settings where establishing regulated
areas could be problematic or infeasible. If establishing regulated
areas is problematic, what approaches might be used to warn employees
in such work settings of high risk areas?

(f) Methods of Compliance

    Paragraph (f)(2) of the proposed standard would require employers
to implement engineering and work practice controls to reduce
employees' exposures to or below the TWA PEL and STEL. Where
engineering and work practice controls are insufficient to reduce
exposures to or below the TWA PEL and STEL, employers would still be
required to implement them to reduce exposure as much as possible, and
to supplement them with a respiratory protection program. In addition,
for each operation where there is airborne beryllium exposure, the
employer must ensure that at least one of the engineering and work
practice controls listed in paragraph (f)(2) is in place, unless all of
the listed controls are infeasible, or the employer can demonstrate
that exposures are below the action level based on no fewer than two
samples taken seven days apart.
    15. Do you usually use engineering or work practices controls
(local exhaust ventilation, isolation, substitution) to reduce
beryllium exposures? If so, which controls do you use?
    16. Are the controls and processes listed in paragraph (f)(2)(i)(A)
appropriate for controlling beryllium exposures? Are there additional
controls or processes that should be added to paragraph (f)(2)(i)(A)?

(g) Respiratory Protection

    17. OSHA's asbestos standard (CFR 1910.1001) requires employers to
provide each employee with a tight-fitting, powered air-purifying
respirator (PAPR) instead of a negative pressure respirator when the
employee chooses to use a PAPR and it provides adequate protection to
the employee. Should the beryllium standard similarly require employers
to provide PAPRs (instead of allowing a negative pressure respirator)
when requested by the employee? Are there other circumstances where a
PAPR should be specified as the appropriate respiratory protection?
Please provide the basis for your response and any applicable
supporting information.

(h) Personal Protective Clothing and Equipment

    18. Do you currently require specific PPE or respirators when
employees are working with beryllium? If so, what type?
    19. The proposal requires PPE wherever work clothing or skin may
become visibly contaminated with beryllium; where employees' skin can
reasonably be expected to be exposed to soluble beryllium compounds; or
where employee exposure exceeds or can reasonably be expected to exceed
the TWA PEL or STEL. The requirement to use PPE where work clothing or
skin may become ``visibly contaminated'' with beryllium differs from
prior standards which do not require contamination to be visible in
order for PPE to be required. Is ``visibly contaminated'' an
appropriate trigger for PPE? Is there reason to require PPE where
employees' skin can be exposed to insoluble beryllium compounds? Please
provide the basis for your response and any applicable supporting
information.

(i) Hygiene Areas and Practices

    20. The proposal requires employers to provide showers in their
facilities if (A) Exposure exceeds or can reasonably be expected to
exceed the TWA PEL or STEL; and (B) Beryllium can reasonably be
expected to contaminate employees' hair or body parts other than hands,
face, and neck. Is this requirement reasonable and adequately
protective of beryllium-exposed workers? Should OSHA amend the
provision to require showers in facilities where exposures exceed the
PEL or STEL, without regard to areas of bodily contamination?

(j) Housekeeping

    21. The proposed rule prohibits dry sweeping or brushing for
cleaning surfaces in beryllium work areas unless HEPA-filtered
vacuuming or other methods that minimize the likelihood and level of
exposure have been tried and were not effective. Please comment on this
provision. What methods do you use to clean work surfaces at your
facility? Are HEPA-filtered vacuuming or other methods to minimize
beryllium exposure used to clean surfaces at your facility? Have they
been effective? Are there any circumstances under which dry sweeping or
brushing are necessary? Please explain your response.
    22. The proposed rule requires that materials designated for
recycling that are visibly contaminated with beryllium particulate
shall be cleaned to remove visible particulate, or placed in sealed,
impermeable enclosures. However, small particles (<10 [mu]g) may not be
visible to the naked eye, and there are studies suggesting that small
particles may penetrate the skin, beyond which beryllium sensitization
can occur (Tinkle et al., 2003). OSHA requests feedback on this
provision. Should OSHA require that all material to be recycled be
decontaminated regardless of perceived surface cleanliness? Should OSHA
require that all material disposed or discarded be in enclosures
regardless of perceived surface cleanliness? Please provide explanation
or data to support your comments.

 (k) Medical Surveillance

    The proposed requirements for medical surveillance include: (1)
Medical examinations, including a test for beryllium sensitization, for
employees who are exposed to beryllium above the proposed PEL for 30
days or more per year, who are exposed to beryllium in an emergency, or
who show signs or symptoms of CBD; and (2) CT scans for employees who
were exposed above the proposed PEL for more than 30 days in a 12-month
period for 5 years or more. The proposed standard would require
periodic medical exams to be provided for employees in the medical
surveillance program annually, while tests for beryllium sensitization
and CT scans would be provided to eligible employees biennially.
    23. Is medical surveillance being provided for beryllium-exposed
employees at your worksite? If so:
    a. Do you provide medical surveillance to employees under another
OSHA standard or as a matter of company policy? What OSHA standard(s)
does the program address?
    b. How many employees are included, and how do you determine which
employees receive medical surveillance (e.g., by exposure level, other
factors)?
    c. Who administers and implements the medical surveillance (e.g.,
company doctor, nurse practitioner, physician assistant, or nurse; or
outside doctor, nurse practitioner, physician assistant, or nurse)?
    d. What examinations, tests, or evaluations are included in the
medical surveillance program, and with what frequency are they
administered? Does your program include a surveillance program
specifically for beryllium-related health effects (e.g., the BeLPT or
other tests for beryllium sensitization)?
    e. If your facility offers the BeLPT, please provide feedback and
data on your experience with the BeLPT, including the analytical or
interpretive procedure you use and its role in your facility's exposure
control program. Has identification of sensitized workers led to
interventions to reduce exposures to sensitized individuals, or in the
facility generally? If a worker is found to be sensitized, do you track
worker health and possible progression of disease beyond sensitization?
If so, how is this done?
    f. What difficulties and benefits (e.g., health, reduction in
absenteeism, or financial) have you experienced with your medical
surveillance program? If applicable, please discuss benefits and
difficulties you have experienced with the use of the BeLPT, providing
detailed information or examples if possible.
    g. What are the costs of your medical surveillance program? How do
your costs compare with OSHA's estimated unit costs for the physical
examination and employee time involved in the medical surveillance
program? Are OSHA's baseline assumptions and cost estimates for medical
surveillance consistent with your experiences providing medical
surveillance to your employees?
    24. Please review paragraph (k) of the proposed rule, Medical
Surveillance, and comment on the frequency and contents of medical
surveillance in the proposed rule. Is 30 days from initial assignment a
reasonable time at which to provide a medical exam? Should there be a
requirement for beryllium sensitization testing at time of employment?
Should there be a requirement for beryllium sensitization testing at an
employee's exit exam, regardless of when the employee's most recent
sensitization test was administered? Are the tests required and the
testing frequencies specified appropriate? Should sensitized employees
have the opportunity to be examined at a CBD Diagnostic Center more
than once following a confirmed positive BeLPT? Are there additional
tests or alternate testing schedules you would suggest? Should the skin
be examined for signs and symptoms of beryllium exposure or other
medical issues, as well as for breaks and wounds? Please explain the
basis for your position and provide data or studies if applicable.
    25. Please provide comments on the proposed requirements regarding
referral of a sensitized employee to a CBD diagnostic center, which
specify referral to a diagnostic center ``mutually agreed upon'' by the
employer and employee. Is this requirement for mutual agreement
necessary and appropriate? How should a diagnostic center be chosen if
the employee and employer cannot come to agreement? Should OSHA
consider alternate language, such as referral for CBD

evaluation at a diagnostic center in a reasonable location?
    26. In the proposed rule, OSHA specifies that all medical
examinations and procedures required by the standard must be performed
by or under the direction of a licensed physician. Are physicians
available in your geographic area to provide medical surveillance to
workers who are covered by the proposed rule? Are other licensed health
care professionals available to provide medical surveillance? Do you
have access to other qualified personnel such as qualified X-ray
technicians, and pulmonary specialists? Should the proposal be amended
to allow examination by, or under the direction of, a physician or
other licensed health care professional (PLHCP)? Please explain your
position. Please note what you consider your geographic area in
responding to this question.
    27. The proposed standard requires the employer to obtain the
Licensed Physician's Written Medical Opinion from the PLHCP within 30
days of the examination. Should OSHA revise the medical surveillance
provisions of the proposed standard to allow employees to choose what,
if any, medical information goes to the employer from the PLHCP? For
example, the employer could instead be required to obtain a
certification from the PLCHP within 30 days of the examination stating
(1) when the examination took place, (2) that the examination complied
with the standard, and (3) that the PLHCP provided the employee a copy
of the Licensed Physician's Written Medical Opinion required by the
standard. The PLHCP would need the employee's written consent to send
the employer the Licensed Physician's Written Medical Opinion or any
other medical information about the employee. This approach might lead
to corresponding changes in proposed paragraphs (f)(1) (written
exposure control program), (l) (medical removal) and (n)
(recordkeeping) to reflect that employers will not automatically be
receiving any medical information about employees as a result of the
medical surveillance required by the proposed standard, but would
instead only receive medical information the employee chooses to share
with the employer. Please comment on the relative merits of the
proposed standard's requirement that employers obtain the PLHCP's
written opinion or an alternative that would provide employees with
greater discretion over the information that goes to employers, and
explain the basis for your position and the potential impact on the
benefits of medical surveillance.
    28. Appendix A to the proposed standard reviews procedures for
conducting and interpreting the results of BeLPT testing for beryllium
sensitization. Is there now, or should there be, a standard method for
BeLPT laboratory procedure? If yes, please describe the existing or
proposed method. Is there now, or should there be, a standard algorithm
for interpreting BeLPT results to determine sensitization? Please
describe the existing or proposed laboratory method or interpretation
algorithm. Should OSHA require that BeLPTs performed to comply with the
medical surveillance provisions of this rule adhere to the Department
of Energy (DOE) analytical and interpretive specifications issued in
2001? Should interpretation of laboratory results be delegated to the
employee's occupational physician or PLHCP?
    29. Should OSHA require the clinical laboratories performing the
BeLPT to be accredited by the College of American Pathologists or
another accreditation organization approved under the Clinical
Laboratory Improvement Amendments (CLIA)? What other standards, if any,
should be required for clinical laboratories providing the BeLPT?
    30. Are there now, or are there being developed, alternative tests
to the BeLPT you would suggest? Please explain the reasons for your
suggestion. How should alternative tests for beryllium sensitization be
evaluated and validated? How should OSHA determine whether a test for
beryllium sensitization is more reliable and accurate than the BeLPT?
Please see Appendix A to the proposed standard for a discussion of the
accuracy of the BeLPT.
    31. The proposed rule requires employers to provide OSHA with the
results of BeLPTs performed to comply with the medical surveillance
provisions upon request, provided that the employer obtains a release
from the tested employee. Will this requirement be unduly burdensome
for employers? Are there alternative organizations that would be
appropriate to send test results to?

 (l) Medical Removal Protection

    The proposed requirements for medical removal protection provide an
option for medical removal to an employee who is working in a job with
exposure at or above the action level and is diagnosed with CBD or
confirmed positive for beryllium sensitization. If the employee chooses
removal, the employer must remove the employee to comparable work in a
work environment where exposure is below the action level, or if
comparable work is not available, must place the employee on paid leave
for 6 months or until such time as comparable work becomes available.
In either case, the employer must maintain for 6 months the employee's
base earnings, seniority, and other rights and benefits that existed at
the time of removal.
    32. Do you provide MRP at your facility? If so, please comment on
the program's benefits, difficulties, and costs, and the extent to
which eligible employees make use of MRP.
    33. OSHA has included requirements for medical removal protection
(MRP) in the proposed rule, which includes provisions for medical
removal for employees with beryllium sensitization or CBD, and an
extension of removed employees' rights and benefits for six months. Are
beryllium sensitization and CBD appropriate triggers for medical
removal? Are there other medical conditions or findings that should
trigger medical removal? For what amount of time should a removed
employee's benefits be extended?

(p) Appendices

    34. Some OSHA health standards include appendices that address
topics such as the hazards associated with the regulated substance,
health screening considerations, occupational disease questionnaires,
and PLHCP obligations. In this proposed rule, OSHA has included a non-
mandatory appendix to describe and discuss the BeLPT (Appendix A), and
a non-mandatory appendix presenting a non-exhaustive list of
engineering controls employers may use to comply with paragraph (f)
(Appendix B). What would be the advantages and disadvantages of
including each appendix in the final rule? What would be the advantages
and disadvantages of providing this information in guidance materials?
    35. What additional information, if any, should be included in the
appendices? What additional information, if any, should be provided in
guidance materials?

General

    36. The current beryllium proposal includes triggers that require
employers to initiate certain provisions, programs, and activities to
protect workers from beryllium exposure. All employers covered under an
OSHA health standard are required to initiate certain activities such
as initial monitoring to evaluate the potential hazard to employees.
OSHA health standards typically include ancillary provisions with
various triggers indicating when an

employer covered under the standard would need to comply with a
provision. The most common triggers are ones based an exposure level
such as the PEL or action level. These exposure level triggers are
sometimes combined with a minimum duration of exposure (e.g., >= 30
days per year). Other triggers may include reasonably anticipated
exposure, medical surveillance findings, certain work activities, or
simply the presence of the regulated substance in the workplace.
    For the current Proposal, exposures to beryllium above the TWA PEL
or STEL trigger the provisions for regulated areas, additional or
enhanced engineering or work practice controls to reduce airborne
exposures to or below the TWA PEL and STEL, personal protective
clothing and equipment, medical surveillance, showers, and respiratory
protection if feasible engineering and work practice controls cannot
reduce airborne exposures to or below the TWA PEL and STEL. Exposures
at or above the action level in turn trigger the provisions for
periodic exposure monitoring, and medical removal eligibility (along
with a diagnosis of CBD or confirmed positive for beryllium
sensitization). Finally, an employer covered under the scope of the
proposed standard must establish a beryllium work area where employees
are, or can reasonably be expected to be, exposed to airborne beryllium
regardless of the level of exposure. In beryllium work areas, employers
must implement a written exposure control plan, provide washing
facilities and change rooms (change rooms are only necessary if
employees are required to remove their personal clothing), and follow
housekeeping provisions. The employers must also implement at least one
of the engineering and work practice controls listed in paragraph
(f)(2) of the proposed standard. An employer is exempt from this
requirement if he or she can demonstrate that such controls are not
feasible or that exposures are below the action level.
    Certain provisions are triggered by one condition and other
provisions are triggered only if multiple conditions are present. For
example, medical removal is only triggered if an employee has CBD or is
confirmed positive AND the employee is exposed at or above the action
level.
    OSHA is requesting comment on the triggers in the proposed
beryllium standard. Are the triggers OSHA has proposed appropriate?
OSHA is also requesting comment on these triggers relative to the
regulatory alternatives affecting the scope and PELs as described in
this preamble in section I, Issues and Alternatives. For example, are
the triggers in the proposed standard appropriate for Alternative #1a,
which would expand the scope of the proposed standard to include all
operations in general industry where beryllium exists only as a trace
contaminant (less than 0.1% beryllium by weight)? Are the triggers
appropriate for the alternatives that change the TWA PEL, STEL, and
action level? Please specify the trigger and the alternative, if
applicable, and why you agree or disagree with the trigger.

Relevant Federal Rules Which May Duplicate, Overlap, or Conflict With
the Proposed Rule

    37. In Section IX--Preliminary Economic Analysis under the Initial
Regulatory Flexibility Analysis, OSHA identifies, to the extent
practicable, all relevant Federal rules which may duplicate, overlap,
or conflict with the proposed rule. One potential area of overlap is
with the U.S. Department of Energy (DOE) beryllium program. In 1999,
DOE established a chronic beryllium disease prevention program (CBDPP)
to reduce the number of workers (DOE employees and DOE contractors)
exposed to beryllium at DOE facilities (10 CFR part 850, published at
64 FR 68854-68914 (Dec. 8, 1999)). In establishing this program, DOE
has exercised its statutory authority to prescribe and enforce
occupational safety and health standards. Therefore pursuant to section
4(b)(1) of the OSH Act, 29 U.S.C. 653(b)(1), the DOE facilities are
exempt from OSHA jurisdiction.
    Nevertheless, under 10 CFR 850.22, DOE has included in its CBDPP
regulation a requirement for compliance with the current OSHA
permissible exposure limit (PEL), and any lower PEL that OSHA
establishes in the future. Thus, although DOE has preempted OSHA's
standard from applying at DOE facilities and OSHA cannot exercise any
authority at those facilities, DOE relies on OSHA's PEL in implementing
its own program. However, DOE's decision to tie its own standard to
OSHA's PEL has little consequence to this rulemaking because the
requirements in DOE's beryllium program (controls, medical
surveillance, etc.) are triggered by DOE's action level of 0.2
[micro]g/m\3\, which is much lower than DOE's existing PEL and the same
as OSHA's proposed PEL. DOE's action level is not tied to OSHA's
standard, so 10 CFR 850.22 would not require the CBDPP's action level
or any non-PEL requirements to be automatically adjusted as a result of
OSHA's rulemaking. For this reason, DOE has indicated to OSHA that
OSHA's proposed rule would not have any impact on DOE's CBDPP,
particularly since 10 CFR 850.25(b), Exposure reduction and
minimization, requires DOE contractors to reduce exposures to below the
DOE's action level of 0.2 [micro]g/m\3\, if practicable.
    DOE has expressed to OSHA that DOE facilities are already in
compliance with 10 CFR 850 and its action level of 0.2 [micro]g/
m\3\,\2\ so the only potential impact on DOE's CBDPP that could flow
from OSHA's rulemaking would be if OSHA ultimately adopted a PEL of 0.1
[micro]g/m\3\, as discussed in alternative #4, instead of the proposed
PEL of 0.2 [micro]g/m\3\, and DOE did not make any additional
adjustments to its standards. Even in that hypothetical scenario, the
impact would still be limited because of the odd result that DOE's PEL
would drop below its own action level, while the action level would
continue to serve as the trigger for most of DOE's program
requirements.
---------------------------------------------------------------------------

    \2\ This would mean the prevailing beryllium exposures at DOE
facilities are at or below 0.2 [micro]g/m\3\.
---------------------------------------------------------------------------

    DOE also has noted some potential overlap with a separate DOE
provision in 10 CFR part 851, which requires its contractors to comply
with DOE's CBDPP (10 CFR 851.23(a)(1)) and also with all OSHA standards
under 29 CFR part 1910 except ``Ionizing Radiation'' (Sec.  1910.1096)
(10 CFR 851.23(a)(3)). These requirements, which DOE established in
2006 (71 FR 6858 (February 9, 2006)), make sense in light of OSHA's
current regulation because OSHA's only beryllium protection is a PEL,
so compliance with 10 CFR 851.23(a)(1) and (3) merely make OSHA's
current PEL the relevant level for purposes of the CBDPP. However, its
function would be less clear if OSHA adopts a beryllium standard as
proposed. OSHA's proposed beryllium standard would establish additional
substantive protections beyond the PEL. Consequently, notwithstanding
the CBDPP's preemptive effect on the OSHA beryllium standard as a
result of 29 U.S.C. 653(b)(1), 10 CFR 851.23(a)(3) could be read to
require DOE contractors to comply with all provisions in OSHA's
proposal (if finalized), including the ancillary provisions, creating a
dual regulatory scheme for beryllium protection at DOE facilities.
    DOE officials have indicated that this is not their intent.
Instead, their intent is that DOE contractors comply solely with the
CBDPP provisions in 10 CFR part 850 for protection from beryllium.

Based on its discussions with DOE officials, OSHA anticipates that DOE
will clarify that its contractors do not need to comply with any
ancillary provisions in a beryllium standard that OSHA may promulgate.
    OSHA can envision several potential scenarios developing from its
rulemaking, ranging from OSHA retaining the proposed PEL of 0.2
[micro]g/m\3\ and action level of 0.1 [micro]g/m\3\ in the final rule
to adopting the PEL of 0.1 [micro]g/m\3\, as discussed in alternative
#4. Because OSHA's beryllium standard does not apply directly to DOE
facilities, and the only impact of its rules on those facilities is the
result of DOE's regulatory choices, there is also a range of actions
that DOE could take to minimize any potential impact of any change to
OSHA's rules, including (1) taking no action at all, (2) simply
clarifying the CBDPP, as described above, to mean that OSHA's beryllium
standard (other than its PEL) does not apply to contractors, or (3)
revising both parts 850 and 851 to completely disassociate DOE's
regulation of beryllium at DOE facilities from OSHA's regulation of
beryllium.
    OSHA is aware that, in the preamble to its 1999 CBDPP rule, DOE
analyzed the costs for implementing the CBDPP for action levels of 0.1
[micro]g/m\3\, 0.2 [micro]g/m\3\, and 0.5 [micro]g/m\3\ (64 FR 68875,
December 8, 1999). DOE estimated costs for periodic exposure
monitoring, notifying workers of the results of such monitoring,
exposure reduction and minimization, regulated areas, change rooms and
showers, respiratory protection, protective clothing, and disposal of
protective clothing. All of these provisions are triggered by DOE's
action level (64 FR 68874, December 8, 1999). Although DOE's rule is
not identical to OSHA's proposed standard, OSHA believes that DOE's
costs are sufficiently representative to form the basis of a
preliminary estimate of the costs that could flow from OSHA's standard,
if finalized.
    Based on the range of potential scenarios and the prior DOE cost
estimates, OSHA estimates that the annual cost impact on DOE facilities
could range from $0 to $4,065,768 (2010 dollars). The upper end of the
cost range would reflect the unlikely scenario in which OSHA
promulgates a final PEL of 0.1 [micro]g/m\3\, 10 CFR 851.23(a)(3) is
found to compel DOE contractors to comply with OSHA's comprehensive
beryllium standard in addition to DOE's CBDPP, and DOE takes no action
to clarify that OSHA's beryllium standard does not apply to DOE
contractors. The lower end of the cost range assumes OSHA promulgates
its rule as proposed with a PEL of 0.2 [micro]g/m\3\ and action level
of 0.1 [micro]g/m\3\, and DOE clarifies that it intends its contractors
to follow DOE's CBDPP and not OSHA's beryllium standard, so that the
ancillary provisions of OSHA's beryllium standard do not apply to DOE
facilities. Additionally, OSHA assumes that DOE contractors are in
compliance with DOE's current rule and therefore took the difference in
cost between implementation of an action level of 0.2 [micro]g/m\3\ and
an action level of 0.1 [micro]g/m\3\ for the above estimates. Finally,
OSHA used the GDP price deflator to present the cost estimate in 2010
dollars.
    OSHA requests comment on the potential overlap of DOE's rule with
OSHA's proposed rule.

II. Pertinent Legal Authority

    The purpose of the Occupational Safety and Health Act, 29 U.S.C.
651 et seq. (``the Act''), is to ``. . . assure so far as possible
every working man and woman in the nation safe and healthful working
conditions and to preserve our human resources.'' 29 U.S.C. 651(b).
    To achieve this goal Congress authorized the Secretary of Labor
(the Secretary) to promulgate and enforce occupational safety and
health standards. 29 U.S.C. 654(b) (requiring employers to comply with
OSHA standards), 655(a) (authorizing summary adoption of existing
consensus and federal standards within two years of the Act's
enactment), and 655(b) (authorizing promulgation, modification or
revocation of standards pursuant to notice and comment).
    The Act provides that in promulgating health standards dealing with
toxic materials or harmful physical agents, such as this proposed
standard regulating occupational exposure to beryllium, the Secretary,
shall set the standard which most adequately assures, to the extent
feasible, on the basis of the best available evidence that no employee
will suffer material impairment of health or functional capacity even
if such employee has regular exposure to the hazard dealt with by such
standard for the period of his working life. See 29 U.S.C. 655(b)(5).
    The Supreme Court has held that before the Secretary can promulgate
any permanent health or safety standard, he must make a threshold
finding that significant risk is present and that such risk can be
eliminated or lessened by a change in practices. Industrial Union
Dept., AFL-CIO v. American Petroleum Institute, 448 U.S. 607, 641-42
(1980) (plurality opinion) (``The Benzene case''). Thus, section
6(b)(5) of the Act requires health standards to reduce significant risk
to the extent feasible. Id.
    The Court further observed that what constitutes ``significant
risk'' is ``not a mathematical straitjacket'' and must be ``based
largely on policy considerations.'' The Benzene case, 448 U.S. at 655.
The Court gave the example that if,

    . . . the odds are one in a billion that a person will die from
cancer . . . the risk clearly could not be considered significant.
On the other hand, if the odds are one in one thousand that regular
inhalation of gasoline vapors that are 2% benzene will be fatal, a
reasonable person might well consider the risk significant. [Id.]

    OSHA standards must be both technologically and economically
feasible. United Steelworkers v. Marshall, 647 F.2d 1189, 1264 (D.C.
Cir. 1980) (``The Lead I case''). The Supreme Court has defined
feasibility as ``capable of being done.'' Am. Textile Mfrs. Inst. v.
Donovan, 452 U.S. 490, 509-510 (1981) (``The Cotton Dust case''). The
courts have further clarified that a standard is technologically
feasible if OSHA proves a reasonable possibility,

    . . . within the limits of the best available evidence . . .
that the typical firm will be able to develop and install
engineering and work practice controls that can meet the PEL in most
of its operations. [See The Lead I case, 647 F.2d at 1272]

    With respect to economic feasibility, the courts have held that a
standard is feasible if it does not threaten massive dislocation to or
imperil the existence of the industry. Id. at 1265. A court must
examine the cost of compliance with an OSHA standard,

    . . . in relation to the financial health and profitability of
the industry and the likely effect of such costs on unit consumer
prices . . . [T]he practical question is whether the standard
threatens the competitive stability of an industry, . . . or whether
any intra-industry or inter-industry discrimination in the standard
might wreck such stability or lead to undue concentration. [Id.
(citing Indus. Union Dep't, AFL-CIO v. Hodgson, 499 F.2d 467 (D.C.
Cir. 1974))]

The courts have further observed that granting companies reasonable
time to comply with new PELs may enhance economic feasibility. The Lead
I case at 1265. While a standard must be economically feasible, the
Supreme Court has held that a cost-benefit analysis of health standards
is not required by the Act because a feasibility analysis is required.
The Cotton Dust case, 453 U.S. at 509.

    Finally, sections 6(b)(7) and 8(c) of the Act authorize OSHA to
include among a standard's requirements labeling, monitoring, medical
testing, and other information-gathering and -transmittal provisions.
29 U.S.C. 655(b)(7), 657(c).

III. Events Leading to the Proposed Standards

    The first occupational exposure limit for beryllium was set in 1949
by the Atomic Energy Commission (AEC), which required that beryllium
exposure in the workplaces under its jurisdiction be limited to 2
[micro]g/m\3\ as an 8-hour time-weighted average (TWA), and 25
[micro]g/m\3\ as a peak exposure never to be exceeded (Department of
Energy, 1999). These exposure limits were adopted by all AEC
installations handling beryllium, and were binding on all AEC
contractors involved in the handling of beryllium.
    In 1956, the American Industrial Hygiene Association (AIHA)
published a Hygienic Guide which supported the AEC exposure limits. In
1959, the American Conference of Governmental Industrial Hygienists
(ACGIH[supreg]) also adopted a Threshold Limit Value (TLV[supreg]) of 2
[micro]g/m\3\ as an 8-hour TWA (Borak, 2006).
    In 1971, OSHA adopted, under Section 6(a) of the Occupational
Safety and Health Act of 1970, and made applicable to general industry,
a national consensus standard (ANSI Z37.29-1970) for beryllium and
beryllium compounds. The standard set a permissible exposure limit
(PEL) for beryllium and beryllium compounds at 2 [micro]g/m\3\ as an 8-
hour TWA; 5 [micro]g/m\3\ as an acceptable ceiling concentration; and
25 [micro]g/m\3\ as an acceptable maximum peak above the acceptable
ceiling concentration for a maximum duration of 30 minutes in an 8-hour
shift (OSHA, 1971).
    Section 6(a) stipulated that in the first two years after the
effective date of the Act, OSHA was to promulgate ``start-up''
standards, on an expedited basis and without public hearing or comment,
based on national consensus or established Federal standards that
improved employee safety or health. Pursuant to that authority, in
1971, OSHA promulgated approximately 425 PELs for air contaminants,
including beryllium, derived principally from Federal standards
applicable to government contractors under the Walsh-Healey Public
Contracts Act, 41 U.S.C. 35, and the Contract Work Hours and Safety
Standards Act (commonly known as the Construction Safety Act), 40
U.S.C. 333. The Walsh-Healey Act and Construction Safety Act standards,
in turn, had been adopted primarily from ACGIH[supreg]'s TLV[supreg]s.
    The National Institute for Occupational Safety and Health (NIOSH)
issued a document entitled Criteria for a Recommended Standard:
Occupational Exposure to Beryllium (Criteria Document) in June 1972.
OSHA reviewed the findings and recommendations contained in the
Criteria Document along with the AEC control requirements for beryllium
exposure. OSHA also considered existing data from animal and
epidemiological studies, and studies of industrial processes of
beryllium extraction, refinement, fabrication, and machining. In 1975,
OSHA asked NIOSH to update the evaluation of the existing data
pertaining to the carcinogenic potential of beryllium. In response to
OSHA's request, the Director of NIOSH stated that, based on animal data
and through all possible routes of exposure including inhalation,
``beryllium in all likelihood represents a carcinogenic risk to man.''
    In October 1975, OSHA proposed a new beryllium standard for all
industries based on information that beryllium caused cancer in animal
experiments (40 FR 48814 (October 17, 1975)). Adoption of this proposal
would have lowered the 8-hour TWA exposure limit from 2 [micro]g/m\3\
to 1 [micro]g/m\3\. In addition, the proposal included ancillary
provisions for such topics as exposure monitoring, hygiene facilities,
medical surveillance, and training related to the health hazards from
beryllium exposure. The rulemaking was never completed.
    In 1977, NIOSH recommended an exposure limit of 0.5 [micro]g/m\3\
and identified beryllium as a potential occupational carcinogen. In
December 1998, ACGIH published a Notice of Intended Change for its
beryllium exposure limit. The notice proposed a lower TLV of 0.2
[micro]g/m\3\ over an 8-hour TWA based on evidence of CBD and
sensitization in exposed workers.
    In 1999, the Department of Energy (DOE) issued a Chronic Beryllium
Disease Prevention Program (CBDPP) Final Rule for employees exposed to
beryllium in its facilities (DOE, 1999). The DOE rule set an action
level of 0.2 [mu]g/m\3\, and adopted OSHA's PEL of 2 [mu]g/m\3\ or any
more stringent PEL OSHA might adopt in the future. The DOE action level
triggers workplace precautions and control measures such as periodic
monitoring, exposure reduction or minimization, regulated areas,
hygiene facilities and practices, respiratory protection, protective
clothing and equipment, and warning signs (DOE, 1999).
    Also in 1999, OSHA was petitioned by the Paper, Allied-Industrial,
Chemical and Energy Workers International Union (PACE) (OSHA, 2002) and
by Dr. Lee Newman and Ms. Margaret Mroz, from the National Jewish
Medical Research Center (NJMRC) (OSHA, 2002), to promulgate an
Emergency Temporary Standard (ETS) for beryllium in the workplace. In
2001, OSHA was petitioned for an ETS by Public Citizen Health Research
Group and again by PACE (OSHA, 2002). In order to promulgate an ETS,
the Secretary of Labor must prove (1) that employees are exposed to
grave danger from exposure to a hazard, and (2) that such an emergency
standard is necessary to protect employees from such danger (29 U.S.C.
655(c)). The burden of proof is on the Department and because of the
difficulty of meeting this burden, the Department usually proceeds when
appropriate with 6(b) rulemaking rather than a 6(c) ETS. Thus, instead
of granting the ETS requests, OSHA instructed staff to further collect
and analyze research regarding the harmful effects of beryllium.
    On November 26, 2002, OSHA published a Request for Information
(RFI) for ``Occupational Exposure to Beryllium'' (OSHA, 2002). The RFI
contained questions on employee exposure, health effects, risk
assessment, exposure assessment and monitoring methods, control
measures and technological feasibility, training, medical surveillance,
and impact on small business entities. In the RFI, OSHA expressed
concerns about health effects such as CBD, lung cancer, and beryllium
sensitization. OSHA pointed to studies indicating that even short-term
exposures below OSHA's PEL of 2 [micro]g/m\3\ could lead to CBD. The
RFI also cited studies describing the relationship between beryllium
sensitization and CBD (67 FR at 70708). In addition, OSHA stated that
beryllium had been identified as a carcinogen by organizations such as
NIOSH, the International Agency for Research on Cancer (IARC), and the
Environmental Protection Agency (EPA); and cancer had been evidenced in
animal studies (67 FR at 70709).
    On November 15, 2007, OSHA convened a Small Business Advocacy
Review Panel for a draft proposed standard for occupational exposure to
beryllium. OSHA convened this panel under Section 609(b) of the
Regulatory Flexibility Act (RFA), as amended by the Small Business
Regulatory Enforcement Fairness Act of 1996 (SBREFA) (5 U.S.C. 601 et
seq.).
    The Panel included representatives from OSHA, the Solicitor's
Office of the Department of Labor, the Office of Advocacy within the
Small Business Administration, and the Office of Information and
Regulatory Affairs of the Office of Management and Budget. Small Entity
Representatives (SERs) made oral and written comments on the

draft rule and submitted them to the panel.
    The SBREFA Panel issued a report which included the SERs' comments
on January 15, 2008. SERs expressed concerns about the impact of the
ancillary requirements such as exposure monitoring and medical
surveillance. Their comments addressed potential costs associated with
compliance with the draft standard, and possible impacts of the
standard on market conditions, among other issues. In addition, many
SERs sought clarification of some of the ancillary requirements such as
the meaning of ``routine'' contact or ``contaminated surfaces.''
    The SBREFA Panel issued a number of recommendations, which OSHA
carefully considered. In section XVIII of this preamble, Summary and
Explanation, OSHA has responded to the Panel's recommendations and
clarified the requirements about which SERs expressed confusion. OSHA
also examined the regulatory alternatives recommended by the SBREFA
Panel. The regulatory alternatives examined by OSHA are listed in
section I of this preamble, Issues and Alternatives. The alternatives
are discussed in greater detail in section XVIII of this preamble,
Summary and Explanation, and in the PEA (OSHA, 2014). In addition, the
Agency intends to develop interpretive guidance documents following the
publication of a final rule.
    In 2010, OSHA hired a contractor to oversee an independent
scientific peer review of a draft preliminary beryllium health effects
evaluation (OSHA, 2010a) and a draft preliminary beryllium risk
assessment (OSHA, 2010b). The contractor identified experts familiar
with beryllium health effects research and ensured that these experts
had no conflict of interest or apparent bias in performing the review.
The contractor selected five experts with expertise in such areas as
pulmonary and occupational medicine, CBD, beryllium sensitization, the
BeLPT, beryllium toxicity and carcinogenicity, and medical
surveillance. Other areas of expertise included animal modeling,
occupational epidemiology, biostatistics, risk and exposure assessment,
exposure-response modeling, beryllium exposure assessment, industrial
hygiene, and occupational/environmental health engineering.
    Regarding the health effects evaluation, the peer reviewers
concluded that the health effect studies were described accurately and
in sufficient detail, and OSHA's conclusions based on the studies were
reasonable. The reviewers agreed that the OSHA document covered the
significant health endpoints related to occupational beryllium
exposure. Peer reviewers considered the preliminary conclusions
regarding beryllium sensitization and CBD to be reasonable and well
presented in the draft health evaluation section. All reviewers agreed
that the scientific evidence supports sensitization as a necessary
condition in the development of CBD. In response to reviewers'
comments, OSHA made revisions to more clearly describe certain sections
of the health effects evaluation. In addition, OSHA expanded its
discussion regarding the BeLPT.
    Regarding the preliminary risk assessment, the peer reviewers were
highly supportive of the Agency's approach and major conclusions. The
peer reviewers stated that the key studies were appropriate and their
selection clearly explained in the document. They regarded the
preliminary analysis of these studies to be reasonable and
scientifically sound. The reviewers supported OSHA's conclusion that
substantial risk of sensitization and CBD were observed in facilities
where the highest exposure generating processes had median full-shift
exposures around 0.2 [micro]g/m\3\ or higher, and that the greatest
reduction in risk was achieved when exposures for all processes were
lowered to 0.1 [micro]g/m\3\ or below.
    In February 2012 the Agency received for consideration a draft
recommended standard for beryllium (Materion and USW, 2012). This draft
proposal was the product of a joint effort between two stakeholders:
Materion Corporation, a leading producer of beryllium and beryllium
products in the United States, and the United Steelworkers, an
international labor union representing workers who manufacture
beryllium alloys and beryllium-containing products in a number of
industries. The United Steelworkers and Materion sought to craft an
OSHA-like model beryllium standard that would have support from both
labor and industry. OSHA has considered this proposal along with other
information submitted during the development of the Notice of Proposed
Rulemaking for beryllium.

IV. Chemical Properties and Industrial Uses

Chemical and Physical Properties

    Beryllium (Be; CAS Number 7440-41-7) is a silver-grey to greyish-
white, strong, lightweight, and brittle metal. It is a Group IIA
element with an atomic weight of 9.01, atomic number of 4, melting
point of 1,287 [deg]C, boiling point of 2,970[deg]C, and a density of
1.85 at 20 [deg]C (NTP 2014). It occurs naturally in rocks, soil, coal,
and volcanic dust (ATSDR, 2002). Beryllium is insoluble in water and
soluble in acids and alkalis. It has two common oxidation states, Be(0)
and Be(+2). There are several beryllium compounds with unique CAS
numbers and chemical and physical properties. Table IV-1 describes the
most common beryllium compounds.

                                              Table IV--1, Properties of Beryllium and Beryllium Compounds
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                Synonyms and     Molecular     Melting point
         Chemical name            CAS No.       trade names        weight        ([deg]C)         Description    Density  (g/cm3)        Solubility
--------------------------------------------------------------------------------------------------------------------------------------------------------
Beryllium metal...............    7440-41-7  Beryllium;              9.0122  1287............  Grey, close-      1.85 (20 [deg]C)  Soluble in most
                                              beryllium-9,                                      packed,                             dilute acids and
                                              beryllium                                         hexagonal,                          alkali; decomposes
                                              element;                                          brittle metal.                      in hot water;
                                              beryllium                                                                             insoluble in mercury
                                              metallic.                                                                             and cold water.
Beryllium chloride............    7787-47-5  Beryllium              79.92    399.2...........  Colorless to      1.899 (25         Soluble in water,
                                              dichloride.                                       slightly          [deg]C).          ethanol, diethyl
                                                                                yellow;                             ether and pyridine;
                                                                                orthorhombic,                       slightly soluble in
                                                                                deliquescent                        benzene, carbon
                                                                                crystal.                            disulfide and
                                                                                chloroform;
                                                                                insoluble in
                                                                                acetone, ammonia,
                                                                                and toluene.

Beryllium fluoride............    7787-49-7  Beryllium              47.01    555.............  Colorless or      1.986...........  Soluble in water,
                                (12323-05-6   difluoride.                                       white,                              sulfuric acid,
                                          )                                                     amorphous,                          mixture of ethanol
                                                                                hygroscopic                         and diethyl ether;
                                                                                solid.                              slightly soluble in
                                                                                ethanol; insoluble
                                                                                in hydrofluoric
                                                                                acid.
Beryllium hydroxide...........   13327-32-7  Beryllium              43.3     138 (decomposes   White,            1.92............  Soluble in hot
                                (1304-49-0)   dihydroxide.                    to beryllium      amorphous,                          concentrated acids
                                                                              oxide).           amphoteric                          and alkali; slightly
                                                                                powder.                             soluble in dilute
                                                                                alkali; insoluble in
                                                                                water.
Beryllium sulfate.............   13510-49-1  Sulfuric acid,        105.07    550-600 [deg]C    Colorless         2.443...........  Forms soluble
                                              beryllium salt                  (decomposes to    crystal.                            tetrahydrate in hot
                                              (1:1).                          beryllium                                             water; insoluble in
                                                                              oxide).                                               cold water.
Beryllium sulfate tetrhydrate.    7787-56-6  Sulfuric acid;        177.14    100 [deg]C......  Colorless,        1.713...........  Soluble in water;
                                              beryllium salt                                    tetragonal                          slightly soluble in
                                              (1:1),                                            crystal.                            concentrated
                                              tetrahydrate.                                                                         sulfuric acid;
                                                                                insoluble in
                                                                                ethanol.
Beryllium Oxide...............    1304-56-9  Beryllia;              25.01    2508-2547 [deg]C  Colorless to      3.01 (20 [deg]C)  Soluble in
                                              beryllium                                         white,                              concentrated acids
                                              monoxide                                          hexagonal                           and alkali;
                                              thermalox TM.                                     crystal or                          insoluble in water.
                                                                                amorphous,
                                                                                amphoteric
                                                                                powder.
Beryllium carbonate...........    1319-43-3  Carbonic acid,        112.05    No data.........  White powder....  No data.........  Soluble in acids and
                                              beryllium salt,                                                                       alkali; insoluble in
                                              mixture with                                                                          cold water;
                                              beryllium                                                                             decomposes in hot
                                              hydroxide.                                                                            water.
Beryllium nitrate trihydrate..    7787-55-5  Nitric acid,          187.97    60..............  White to faintly  1.56............  Very soluble in water
                                              beryllium salt,                                   yellowish,                          and ethanol.
                                              trihydrate.                                       deliquescent
                                                                                mass.
Beryllium phosphate...........   13598-15-7  Phosphoric acid,      104.99    No data.........  Not reported....  Not reported....  Slightly soluble in
                                              beryllium salt                                                                        water.
                                              (1:1).
--------------------------------------------------------------------------------------------------------------------------------------------------------
ATSDR, 2002.

    The physical and chemical properties of beryllium were realized
early in the 20th century, and it has since gained commercial
importance in a wide range of industries. Beryllium is lightweight,
hard, spark resistant, non-magnetic, and has a high melting point. It
lends strength, electrical and thermal conductivity, and fatigue
resistance to alloys (NTP, 2014). Beryllium also has a high affinity
for oxygen in air and water, which can cause a thin surface film of
beryllium oxide to form on the bare metal, making it extremely
resistant to corrosion. These properties make beryllium alloys highly
suitable for defense, nuclear, and aerospace applications (IARC, 1993).
    There are approximately 45 mineralized forms of beryllium. In the
United States, the predominant mineral form mined commercially and
refined into pure beryllium and beryllium alloys is bertrandite.
Bertrandite, while containing less than 1% beryllium compared to 4% in
beryl, is easily and efficiently processed into beryllium hydroxide
(IARC, 1993). Imported beryl is also converted into beryllium hydroxide
as the United States has very little beryl that can be economically
mined (USGS, 2013a).

Industrial Uses

    Materion Corporation, formerly called Brush Wellman, is the only
producer of primary beryllium in the United States. Beryllium is used
in a variety of industries, including aerospace, defense,
telecommunications, automotive, electronic, and medical specialty
industries. Pure beryllium metal is used in a range of products such as
X-ray transmission windows, nuclear reactor neutron reflectors, nuclear
weapons, precision instruments, rocket propellants, mirrors, and
computers (NTP, 2014). Beryllium oxide is used in components such as
ceramics, electrical insulators, microwave oven components, military
vehicle armor, laser structural components, and automotive ignition
systems (ATSDR, 2002). Beryllium oxide ceramics are used to produce
sensitive electronic items such as lasers and satellite heat sinks.
    Beryllium alloys, typically beryllium/copper or beryllium/aluminum,
are manufactured as high beryllium content or low beryllium content
alloys. High content alloys contain greater than 30% beryllium. Low
content alloys are typically less than 3% beryllium. Beryllium alloys
are used in automotive electronics (e.g., electrical connectors and
relays and audio components), computer components, home appliance
parts, dental appliances (e.g., crowns), bicycle frames, golf clubs,
and other articles (NTP, 2014; Ballance et al., 1978; Cunningham et
al., 1998; Mroz, et al., 2001). Electrical components and conductors
are stamped and formed from beryllium alloys. Beryllium-copper

alloys are used to make switches in automobiles (Ballance et al., 1978,
2002; Cunningham et al., 1998) and connectors, relays, and switches in
computers, radar, satellite, and telecommunications equipment (Mroz et
al., 2001). Beryllium-aluminum alloys are used in the construction of
aircraft, high resolution medical and industrial X-ray equipment, and
mirrors to measure weather patterns (Mroz et al., 2001). High content
and low content beryllium alloys are precision machined for military
and aerospace applications. Some welding consumables are also
manufactured using beryllium.
    Beryllium is also found as a trace metal in materials such as
aluminum ore, abrasive blasting grit, and coal fly ash. Abrasive
blasting grits such as coal slag and copper slag contain varying
concentrations of beryllium, usually less than 0.1% by weight. The
burning of bituminous and sub-bituminous coal for power generation
causes the naturally occurring beryllium in coal to accumulate in the
coal fly ash byproduct. Scrap and waste metal for smelting and refining
may also contain beryllium. A detailed discussion of the industries and
job tasks using beryllium is included in the Preliminary Economic
Analysis (OSHA, 2014).
    Occupational exposure to beryllium can occur from inhalation of
dusts, fume, and mist. Beryllium dusts are created during operations
where beryllium is cut, machined, crushed, ground, or otherwise
mechanically sheared. Mists can also form during operations that use
machining fluids. Beryllium fume can form while welding with or on
beryllium components, and from hot processes such as those found in
metal foundries.
    Occupational exposure to beryllium can also occur from skin, eye,
and mucous membrane contact with beryllium particulate or solutions.

V. Health Effects

    Beryllium-associated health effects, including acute beryllium
disease (ABD), beryllium sensitization (also referred to in this
preamble as ``sensitization''), chronic beryllium disease (CBD), and
lung cancer, can lead to a number of highly debilitating and life-
altering conditions including pneumonitis, loss of lung capacity
(reduction in pulmonary function leading to pulmonary dysfunction),
loss of physical capacity associated with reduced lung capacity,
systemic effects related to pulmonary dysfunction, and decreased life
expectancy (NIOSH, 1972).
    This Health Effects section presents information on beryllium and
its compounds, the fate of beryllium in the body, research that relates
to its toxic mechanisms of action, and the scientific literature on the
adverse health effects associated with beryllium exposure, including
ABD, sensitization, CBD, and lung cancer. OSHA considers CBD to be a
progressive illness with a continuous spectrum of symptoms ranging from
no symptomatology at its earliest stage following sensitization to mild
symptoms such as a slight almost imperceptible shortness of breath, to
loss of pulmonary function, debilitating lung disease, and, in many
cases, death. This section also discusses the nature of these
illnesses, the scientific evidence that they are causally associated
with occupational exposure to beryllium, and the probable mechanisms of
action with a more thorough review of the supporting studies.

A. Beryllium and Beryllium Compounds

1. Particle Physical/Chemical Properties
    Beryllium (Be; CAS No. 7440-41-7) is a steel-grey, brittle metal
with an atomic number of 4 and an atomic weight of 9.01 (Group IIA of
the periodic table). Because of its high reactivity, beryllium is not
found as a free metal in nature; however, there are approximately 45
mineralized forms of beryllium. Beryllium compounds and alloys include
commercially valuable metals and gemstones.
    Beryllium has two oxidative states: Be(0) and Be(2\+\) Agency for
Toxic Substance and Disease Registry (ATSDR) 2002). It is likely that
the Be(2\+\) state is the most biologically reactive and able to form a
bond with peptides leading to it becoming antigenic (Snyder et al.,
2003). This will be discussed in more detail in the Beryllium
Sensitization section below. Beryllium has a high charge-to-radius
ratio and in addition to forming various types of ionic bonds,
beryllium has a strong tendency for covalent bond formation (e.g., it
can form organometallic compounds such as
Be(CH3)2 and many other complexes) (ATSDR, 2002;
Greene et al., 1998). However, it appears that few, if any, toxicity
studies exist for the organometallic compounds. Additional physical/
chemical properties for beryllium compounds that may be important in
their biological response are summarized in Table 1 below. This
information was obtained from their International Chemical Safety Cards
(ICSC) (beryllium metal (ICSC 0226), beryllium oxide (ICSC 1325),
beryllium sulfate (ICSC 1351), beryllium nitrate (ICSC 1352), beryllium
carbonate (ICSC 1353), beryllium chloride (ICSC 1354), beryllium
fluoride (ICSC 1355)) and from the hazardous substance data bank (HSDB)
for beryllium hydroxide (CASRN: 13327-32-7), and beryllium phosphate
(CASRN: 13598-15-7). Additional information on chemical and physical
properties as well as industrial uses for beryllium can be found in
this preamble at Section IV, Chemical Properties and Industrial Uses.

                                            Table 1--Physical/Chemical Properties of Beryllium and Compounds
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Solubility in water at
           Compound name              Physical  appearance      Chemical formula     Molecular mass     Acute physical hazards           20 [deg]C
--------------------------------------------------------------------------------------------------------------------------------------------------------
Beryllium Metal....................  Grey to White Powder..  Be....................             9.0  Combustible; Finely          None.
                                                                                dispersed particles--
                                                                                Explosive.
Beryllium Oxide....................  White Crystals or       BeO...................            25.0  Not combustible or           Very sparingly
                                      Powder.                                                         explosive.                   soluble.
Beryllium Carbonate................  White Powder..........  Be2CO3(OH)/Be2CO5H2...          181.07  Not combustible or           None.
                                                                                explosive.
Beryllium Sulfate..................  Colorless Crystals....  BeSO4.................           105.1  Not combustible or           Slightly soluble.
                                                                                explosive.
Beryllium Nitrate..................  White to Yellow Solid.  BeN2O6/Be(NO3)2.......           133.0  Enhances combustion of       Very soluble (1.66 x
                                                                                other substances.            10\6\ mg/L).
Beryllium Hydroxide................  White amorphous powder  Be(OH)2...............            43.0  Not reported...............  Slightly soluble 0.8 x
                                      or crystalline solid.                                                                        10-4 mol/L
                                                                                (3.44 mg/L).
Beryllium Chloride.................  Colorless to Yellow     BeCl2.................            79.9  Not combustible or           Soluble.
                                      Crystals.                                                       explosive.
Beryllium Fluoride.................  Colorless Lumps.......  BeF2..................            47.0  Not combustible or           Very soluble.
                                                                                explosive.

Beryllium Phosphate................  White solid...........  Be3(PO4)2.............           271.0  Not reported...............  Soluble.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: International Chemical Safety Cards (except beryllium phosphate and hydroxide--HSDB).

    Beryllium shows a high affinity for oxygen in air and water,
resulting in a thin surface film of beryllium oxide on the bare metal.
If the surface film is disturbed, it may become airborne or dermal
exposure may occur. The solubility, particle surface area, and particle
size of some beryllium compounds are examined in more detail below.
These properties have been evaluated in many toxicological studies. In
particular, the properties related to the calcination (firing
temperatures) and differences in crystal size and solubility are
important aspects in their toxicological profile.
2. Factors Affecting Potency and Effect of Beryllium Exposure
    The effect and potency of beryllium and its compounds, as for any
toxicant, immunogen, or immunotoxicant, may be dependent upon the
physical state in which they are presented to a host. For occupational
airborne materials and surface contaminants, it is especially critical
to understand those physical parameters in order to determine the
extent of exposure to the respiratory tract and skin since these are
generally the initial target organs for either route of exposure.
    For example, large particles may have less of an effect in the lung
than smaller particles due to reduced potential to stay airborne to be
inhaled or be deposited along the respiratory tract. In addition, once
inhalation occurs particle size is critical in determining where the
particle will deposit along the respiratory tract. Solubility also has
an important part in determining the toxicity and bioavailability of
airborne materials as well. Respiratory tract retention and skin
penetration are directly influenced by the solubility and reactivity of
airborne material.
    These factors may be responsible, at least in part, for the process
by which beryllium sensitization progresses to CBD in exposed workers.
Other factors influencing beryllium-induced toxicity include the
surface area of beryllium particles and their persistence in the lung.
With respect to dermal exposure, the physical characteristics of the
particle are important as well since they can influence skin absorption
and bioavailability. This section addresses certain physical
characteristics (i.e., solubility, particle size, particle surface
area) that are important in influencing the toxicity of beryllium
materials in occupational settings.
a. Solubility
    Solubility may be an important determinant of the toxicity of
airborne materials, influencing the deposition and persistence of
inhaled particles in the respiratory tract, their bioavailability, and
the likelihood of presentation to the immune system. A number of
chemical agents, including metals that contact and penetrate the skin,
are able to induce an immune response, such as sensitization (Boeniger,
2003; Mandervelt et al., 1997). Similar to inhaled agents, the ability
of materials to penetrate the skin is also influenced by solubility
since dermal absorption may occur at a greater rate for soluble
materials than insoluble materials (Kimber et al., 2011).
    This section reviews the relevant information regarding solubility,
its importance in a biological matrix and its relevance to
sensitization and beryllium lung disease. The weight of evidence
presented below suggests that both soluble and non-soluble forms of
beryllium can induce a sensitization response and result in progression
of lung disease.
    Beryllium salts, including the chloride (BeCl2),
fluoride (BeF2), nitrate (Be(NO3)2),
phosphate (Be3(PO4)2), and sulfate
(tetrahydrate) (BeSO4 [middot] 4H2O) salts, are
all water soluble. However, soluble beryllium salts can be converted to
less soluble forms in the lung (Reeves and Vorwald, 1967). Aqueous
solutions of the soluble beryllium salts are acidic as a result of the
formation of Be(OH2)4 2\+\, the tetrahydrate,
which will react to form insoluble hydroxides or hydrated complexes
within the general physiological range of pH values (between 5 and 8)
(EPA, 1998). This may be an important factor in the development of CBD
since lower-solubility forms of beryllium have been shown to persist in
the lung for longer periods of time and persistence in the lung may be
needed in order for this disease to occur (NAS, 2008).
    Beryllium oxide (BeO), hydroxide (Be(OH)2), carbonate
(Be2CO3(OH)2), and sulfate (anhydrous)
(BeSO4) are either insoluble, slightly soluble, or
considered to be sparingly soluble (almost insoluble or having an
extremely slow rate of dissolution). The solubility of beryllium oxide,
which is prepared from beryllium hydroxide by calcining (heating to a
high temperature without fusing in order to drive off volatile
chemicals) at temperatures between 500 and 1,750 [deg]C, has an inverse
relationship with calcination temperature. Although the solubility of
the low-fired crystals can be as much as 10 times that of the high-
fired crystals, low-fired beryllium oxide is still only sparingly
soluble (Delic, 1992). In a study that measured the dissolution
kinetics (rate to dissolve) of beryllium compounds calcined at
different temperatures, Hoover et al., compared beryllium metal to
beryllium oxide particles and found them to have similar solubilities.
This was attributed to a fine layer of beryllium oxide that coats the
metal particles (Hoover et al., 1989). A study conducted by Deubner et
al., (2011) determined ore materials to be more soluble than beryllium
oxide at pH 7.2 but similar in solubility at pH 4.5. Beryllium
hydroxide was more soluble than beryllium oxide at both pHs (Deubner et
al., 2011).